Thursday, September 29, 2016

Panacur Paste





Dosage Form: FOR ANIMAL USE ONLY
panacur®

(fenbendazole)

Paste 10% (100 mg/g) Equine Dewormer



Panacur Paste Description


Panacur® (fenbendazole) Paste 10% contains the active anthelmintic, fenbendazole. The chemical name of fenbendazole is methyl 5-(phenylthio)-2-benzimidazole carbamate.


The chemical structure is:



Each gram of Panacur® (fenbendazole) Paste 10% contains 100 mg of fenbendazole and is flavored with artificial apple-cinnamon liquid.



ACTIONS


The antiparasitic action of Panacur® (fenbendazole) Paste 10% is believed to be due to the inhibition of energy metabolism in the parasite.



INDICATIONS


Panacur® (fenbendazole) Paste 10% is indicated for the control of large strongyles (Strongylus edentatus, S. equinus, S. vulgaris), encysted early third stage (hypobiotic), late third stage and fourth stage cyathostome larvae, small strongyles, pinworms (Oxyuris equi), ascarids (Parascaris equorum), and arteritis caused by fourth stage larvae of Strongylus vulgaris in horses.


Panacur® (fenbendazole) Paste 10% is approved for use concomitantly with an approved form of trichlorfon. Trichlorfon is approved for the treatment of stomach bots (Gasterophilus spp.) in horses. Refer to the manufacturer's label for directions for use and cautions for trichlorfon.



Precautions


Side effects associated with Panacur® (fenbendazole) Paste 10% could not be established in well-controlled safety studies in horses with single doses as high as 454 mg/lb (1,000 mg/kg) and 15 consecutive daily doses of 22.7 mg/lb (50 mg/kg). Particularly with higher doses, the lethal action of fenbendazole may cause the release of antigens by the dying parasites. This phenomenon may result in either a local or systemic hypersensitive reaction. As with any drug, these reactions should be treated symptomatically.


Panacur® (fenbendazole) Paste 10% has been evaluated for safety in pregnant mares during all stages of gestation with doses as high as 11.4 mg/lb (25 mg/kg) and in stallions with doses as high as 11.4 mg/lb (25 mg/kg). No adverse effects on reproductivity were detected. The recommended dose for control of 4th stage larvae of Strongylus vulgaris, 4.6 mg/lb (10 mg/kg) daily for 5 consecutive days, has not been evaluated for safety in stallions or pregnant mares.



Internal Parasites


Regular deworming at intervals of six to eight weeks may be required due to the possibility of reinfection.



Migrating Tissue Parasites


In the case of 4th stage larvae of Strongylus vulgaris, treatment and retreatment should be based on the life cycle and the epidemiology. Treatment should be initiated in the spring and repeated in the fall after a six month interval.



Optimum Deworming Program for control of S. vulgaris


Optimum reduction of S. vulgaris infections is achieved by reducing the infectivity of the pastures. When horses are running on pasture, in temperate North America, maximum pasture infectivity occurs in October-December. If horses are removed from those pastures in January, pasture infectivity will decline to zero by July 1. Egg production of S. vulgaris is minimal from January through April, peaking in August and declining to minimal values in December.



Recommended Deworming Program


**December 1, February 1, April 1, June 1, August 1, October 1.


The two treatments that are in bold type are the recommended periods when the 5 day treatment regimen for the control of the migrating larvae of S. vulgaris should be performed.


**For other areas in the world, retreatment periods for the migrating larvae of S. vulgaris may be different; consult with your veterinarian.



CAUTIONS


Keep this and all medication out of the reach of children.


When using Panacur® (fenbendazole) Paste 10% concomitantly with trichlorfon, refer to the manufacturer's labels for use and cautions for trichlorfon.



Warning


Do not use in horses intended for human consumption



DOSAGE


Panacur® (fenbendazole) Paste 10% is administered orally at a rate of 2.3 mg/lb (5 mg/kg) for the control of large strongyles, small strongyles, and pinworms. One syringe will deworm a 1,100 lb horse. For foals and weanlings (less than 18 months of age) where ascarids are a common problem, the recommended dose is 4.6 mg/lb (10 mg/kg); one syringe will deworm a 550 lb horse.


For control of encysted early third stage (hypobiotic), late third stage and fourth stage cyathostome larvae, and fourth stage larvae of Strongylus vulgaris, the recommended dose is 4.6 mg/lb (10 mg/kg) daily for 5 consecutive days; administer one syringe for each 550 Ibs body weight per day.


SEE PRECAUTIONS FOR RETREATMENT RECOMMENDATIONS.



DIRECTIONS FOR USE


  1. Determine the weight of the horse.

  2. Remove syringe tip.

  3. Turn the dial ring until the edge of the ring nearest the tip lines up with zero.

  4. Depress plunger to advance paste to tip.

  5. Now set the dial ring at the graduation nearest the weight of the horse (do not underdose).

  6. Horse's mouth must be free of food.

  7. Insert nozzle of syringe through the interdental space and deposit the paste on the back of the tongue by depressing the plunger.


How is Panacur Paste Supplied


Panacur® (fenbendazole) Paste 10% Equine Dewormer is supplied in 25 g syringes.



Store at or below 25°C (77°F).



CONSULT YOUR VETERINARIAN FOR ASSISTANCE IN THE DIAGNOSIS, TREATMENT AND CONTROL OF PARASITISM.



Made in France


Distributed by:

Intervet Inc.

Millsboro, DE 19966


NADA # 120-648, Approved by FDA

For use in animals only.



PRINCIPAL DISPLAY PANEL - 100 mg/g Syringe Carton


intervet


panacur®

(fenbendazole)


Equine Dewormer


Equine

Dewormer

25 gram Paste 10%

(100 mg/g)










PANACUR 
fenbendazole  paste










Product Information
Product TypePRESCRIPTION ANIMAL DRUGNDC Product Code (Source)57926-081
Route of AdministrationORALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Fenbendazole (Fenbendazole)Fenbendazole100 mg  in 1 g




















Inactive Ingredients
Ingredient NameStrength
Carbomer Homopolymer Type B 
Propylene Glycol 
Glycerin 
Sorbitol 
Water 
Sodium Hydroxide 
Methylparaben 
Propylparaben 


















Product Characteristics
Color    Score    
ShapeSize
FlavorAPPLE, CINNAMONImprint Code
Contains      














Packaging
#NDCPackage DescriptionMultilevel Packaging
157926-081-441 SYRINGE In 1 CARTONcontains a SYRINGE, PLASTIC
125 g In 1 SYRINGE, PLASTICThis package is contained within the CARTON (57926-081-44)










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NADANADA12064805/10/2010


Labeler - Schering Corporation (001317601)









Establishment
NameAddressID/FEIOperations
Intervet Production S.A.771867553ANALYSIS, MANUFACTURE
Revised: 05/2010Schering Corporation



Wednesday, September 28, 2016

Protonix



Generic Name: pantoprazole (Oral route)

pan-TOE-pra-zole

Commonly used brand name(s)

In the U.S.


  • Protonix

Available Dosage Forms:


  • Tablet

  • Tablet, Enteric Coated

  • Packet

Pharmacologic Class: Proton Pump Inhibitor


Uses For Protonix


Pantoprazole is used to treat certain conditions in which there is too much acid in the stomach. It is used to treat erosive esophagitis or "heartburn" caused by gastroesophageal reflux disease (GERD), a condition where the acid in the stomach washes back up into the esophagus. This medicine may also be used to treat Zollinger-Ellison syndrome, a condition where the stomach produces too much acid.


Pantoprazole is a proton pump inhibitor (PPI). It works by decreasing the amount of acid produced by the stomach.


This medicine is available only with your doctor's prescription.


Before Using Protonix


In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.


Pediatric


Appropriate studies have not been performed on the relationship of age to the effects of pantoprazole in the pediatric population. Safety and efficacy have not been established.


Geriatric


Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of pantoprazole in the elderly.


Pregnancy








Pregnancy CategoryExplanation
All TrimestersBAnimal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding


There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.


Interactions with Medicines


Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.


Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.


  • Rilpivirine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.


  • Atazanavir

  • Citalopram

  • Dasatinib

  • Erlotinib

  • Methotrexate

  • Mycophenolate Mofetil

  • Nelfinavir

  • Nilotinib

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.


  • Cranberry

  • Itraconazole

  • Warfarin

Interactions with Food/Tobacco/Alcohol


Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.


Other Medical Problems


The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:


  • Hypomagnesemia (low magnesium in the blood), history of or

  • Osteoporosis (bone problem) or

  • Seizures, history of—Use with caution. May make these conditions worse.

  • Vitamin B-12 deficiency—If used for a long time, this medicine may make this condition worse.

Proper Use of Protonix


Swallow the delayed-release tablet whole. Do not split, crush, or chew it. You may take the tablet with or without food.


The delayed-release oral suspension granules should only be mixed with applesauce or apple juice. Do not mix the granules with water, other liquids, or food. Do not chew or crush the granules. Take the mixture at least 30 minutes before a meal. If you have a nasogastric feeding tube, make sure the tube is not clogged before you put this medicine in the tube with apple juice.


Dosing


The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.


The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.


  • For oral dosage forms (delayed-release tablets or suspension):
    • For erosive esophagitis:
      • Adults—40 milligrams (mg) once a day for up to 8 weeks. Your doctor may want you to take pantoprazole for more than 8 weeks for certain conditions.

      • Children—Use and dose must be determined by your doctor.


    • For Zollinger-Ellison syndrome:
      • Adults—At first, 40 milligrams (mg) two times a day. Your doctor may increase your dose if needed.

      • Children—Use and dose must be determined by your doctor.



Missed Dose


If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.


Storage


Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.


Keep out of the reach of children.


Do not keep outdated medicine or medicine no longer needed.


Ask your healthcare professional how you should dispose of any medicine you do not use.


Precautions While Using Protonix


It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.


Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine. .


Taking this medicine for a long time may make it harder for your body to absorb vitamin B-12. Tell your doctor if you have concerns about vitamin B-12 deficiency. .


Pantoprazole may increase your risk of having fractures of the hip, wrist, and spine. This is more likely if you are 50 years of age and older, if you receive high doses of this medicine, or use it for one year or more.


This medicine may cause hypomagnesemia (low magnesium in the blood). This is more likely to occur if you are taking this medicine for more than one year, or if you are taking this medicine together with digoxin (Lanoxin®) or certain diuretics or "water pills". Stop using this medicine and check with your doctor right away if you have convulsions (seizures); fast, racing, or uneven heartbeat; muscle spasms (tetany); tremors; or unusual tiredness or weakness.


Do not stop taking this medicine without first checking with your doctor, or unless told to do so by your doctor.


Do not take other medicines unless they have been discussed with your doctor. This includes prescription (e.g., atazanavir, Reyataz®) or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.


Protonix Side Effects


Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.


Check with your doctor immediately if any of the following side effects occur:


Less common
  • Abdominal or stomach pain

  • blurred vision

  • dry mouth

  • flushed, dry skin

  • fruit-like breath odor

  • increased hunger

  • increased thirst

  • increased urination

  • nausea

  • sweating

  • troubled breathing

  • unexplained weight loss

  • vomiting

Incidence not known
  • Absence of or decrease in body movements

  • blindness

  • blistering, peeling, or loosening of the skin

  • bloating

  • bloody or cloudy urine

  • bloody, black, or tarry stools

  • blurred vision

  • chills

  • clay-colored stools

  • constipation

  • continuous ringing or buzzing or other unexplained noise in the ears

  • cough

  • dark-colored urine

  • decreased vision

  • diarrhea

  • difficulty with speaking

  • difficulty with swallowing

  • dizziness or lightheadedness

  • drowsiness

  • fast heartbeat

  • feeling of constant movement of self or surroundings

  • fever

  • general feeling of tiredness or weakness

  • greatly decreased frequency of urination or amount of urine

  • headache

  • hearing loss

  • high fever

  • hives

  • indigestion

  • itching

  • joint pain

  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

  • light-colored stools

  • loss of appetite

  • mood or mental changes

  • muscle cramps

  • muscle pain or stiffness

  • muscle spasms (tetany) or twitching seizures

  • pains in the stomach, side, or abdomen, possibly radiating to the back

  • pale skin

  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

  • red skin lesions, often with a purple center

  • red, irritated eyes

  • sensation of spinning

  • shortness of breath

  • skin rash

  • sore throat

  • sores, ulcers, or white spots on the lips or in the mouth

  • stomach pain, continuing

  • swelling of the feet or lower legs

  • swollen glands

  • tightness in the chest

  • trembling

  • unexplained bleeding or bruising

  • unpleasant breath odor

  • unusual tiredness or weakness

  • vomiting of blood

  • wheezing

  • yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:


Less common
  • Belching

  • bloated, full feeling

  • excess air or gas in the stomach or intestines

  • passing gas

  • sleeplessness

  • trouble sleeping

  • unable to sleep

Incidence not known
  • Increased watering of the mouth

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.


Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Protonix side effects (in more detail)



The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.


The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.


More Protonix resources


  • Protonix Side Effects (in more detail)
  • Protonix Use in Pregnancy & Breastfeeding
  • Drug Images
  • Protonix Drug Interactions
  • Protonix Support Group
  • 27 Reviews for Protonix - Add your own review/rating


  • Protonix Prescribing Information (FDA)

  • Protonix Monograph (AHFS DI)

  • Protonix Delayed-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

  • Protonix Consumer Overview

  • Pantoprazole MedFacts Consumer Leaflet (Wolters Kluwer)

  • Pantoprazole Prescribing Information (FDA)



Compare Protonix with other medications


  • Barrett's Esophagus
  • Duodenal Ulcer
  • Erosive Esophagitis
  • GERD
  • Helicobacter Pylori Infection
  • Peptic Ulcer
  • Stomach Ulcer
  • Stress Ulcer Prophylaxis
  • Zollinger-Ellison Syndrome

Pramox Gel


Pronunciation: pra-MOX-een
Generic Name: Pramoxine
Brand Name: Examples include PrameGel and Pramox


Pramox Gel is used for:

Temporarily relieving pain and itching caused by minor skin irritations, minor cuts and burns, sunburn, insect bites, scrapes, and rashes caused by poison ivy, oak, or sumac.


Pramox Gel is a topical anesthetic. It works by blocking pain signals from the nerve endings in the skin, which helps relieve discomfort.


Do NOT use Pramox Gel if:


  • you are allergic to any ingredient in Pramox Gel

Contact your doctor or health care provider right away if any of these apply to you.



Before using Pramox Gel:


Some medical conditions may interact with Pramox Gel. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:


  • if you are pregnant, planning to become pregnant, or are breast-feeding

  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

  • if you have allergies to medicines, foods, or other substances

Some MEDICINES MAY INTERACT with Pramox Gel. Because little, if any, of Pramox Gel is absorbed into the blood, the risk of it interacting with another medicine is low.


Ask your health care provider if Pramox Gel may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.


How to use Pramox Gel:


Use Pramox Gel as directed by your doctor. Check the label on the medicine for exact dosing instructions.


  • Wash the affected area with soap and water, and gently pat dry.

  • Apply Pramox Gel to the affected area as directed by your doctor or on the package labeling.

  • Wash your hands immediately after using Pramox Gel, unless your hands are a part of the treated area.

  • If you miss a dose of Pramox Gel, apply it as soon as possible. If you do not remember until the next day, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Pramox Gel.



Important safety information:


  • Pramox Gel is for external use only. Do not get it in your eyes, nose, or mouth. If you get it in any of these areas, rinse right away with cool water.

  • Do NOT use more than the recommended dose or use for longer than prescribed without checking with your doctor.

  • If your symptoms do not get better within 7 days, if they become worse, or if they clear up and then come back, check with your doctor.

  • Do not apply Pramox Gel over large areas of your body without first checking with your doctor.

  • Do not use Pramox Gel in CHILDREN younger than 2 years old without first checking with the child's doctor; safety and effectiveness in these children have not been confirmed.

  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Pramox Gel while you are pregnant. It is not know if Pramox Gel is found in breast milk. If you are or will be breast-feeding while you use Pramox Gel, check with your doctor. Discuss any possible risks to your baby.


Possible side effects of Pramox Gel:


All medicines may cause side effects, but many people have no, or minor side effects. When used in small doses, no COMMON side effects have been reported with this product. Seek medical attention right away if any of these SEVERE side effects occur:



Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); new or worsening skin irritation.



This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.


See also: Pramox side effects (in more detail)


If OVERDOSE is suspected:


Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Pramox Gel may be harmful if swallowed.


Proper storage of Pramox Gel:

Store in an upright position at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat and light. Keep Pramox Gel out of the reach of children and away from pets.


General information:


  • If you have any questions about Pramox Gel, please talk with your doctor, pharmacist, or other health care provider.

  • Pramox Gel is to be used only by the patient for whom it is prescribed. Do not share it with other people.

  • If your symptoms do not improve or if they become worse, check with your doctor.

  • Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Pramox Gel. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.



Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Pramox resources


  • Pramox Side Effects (in more detail)
  • Pramox Use in Pregnancy & Breastfeeding
  • Pramox Support Group
  • 0 Reviews for Pramox - Add your own review/rating


Compare Pramox with other medications


  • Anal Itching
  • Pain
  • Pruritus

Tuesday, September 27, 2016

Proquin XR


Generic Name: ciprofloxacin (oral) (SIP roe FLOX a sin)

Brand Names: Cipro, Cipro XR, Proquin XR


What is ciprofloxacin?

Ciprofloxacin is an antibiotic in a group of drugs called fluoroquinolones (flor-o-KWIN-o-lones). Ciprofloxacin fights bacteria in the body.


Ciprofloxacin is used to treat different types of bacterial infections.


Ciprofloxacin may also be used for purposes not listed in this medication guide.


What is the most important information I should know about ciprofloxacin?


You should not use this medication if you are taking tizanidine (Zanaflex), if you have a history of myasthenia gravis, or if you are allergic to ciprofloxacin (Cipro) or similar antibiotics such as gemifloxacin (Factive), levofloxacin (Levaquin), moxifloxacin (Avelox), norfloxacin (Noroxin), and others.

Before taking ciprofloxacin, tell your doctor if you have a heart rhythm disorder, kidney or liver disease, joint problems, diabetes, muscle weakness or trouble breathing, a condition called pseudotumor cerebri, a history of seizures, a history of head injury or brain tumor, low levels of potassium in your blood, a personal or family history of Long QT syndrome, or if you have ever had an allergic reaction to an antibiotic.


Do not take ciprofloxacin with dairy products such as milk or yogurt, or with calcium-fortified juice. Avoid taking antacids, vitamin or mineral supplements, sucralfate (Carafate), or didanosine (Videx) powder or chewable tablets within 6 hours before or 2 hours after you take ciprofloxacin. Ciprofloxacin may cause swelling or tearing of a tendon (the fiber that connects bones to muscles in the body), especially in the Achilles' tendon of the heel. Stop taking ciprofloxacin and call your doctor at once if you have sudden pain, swelling, tenderness, stiffness, or movement problems in any of your joints. Rest the joint until you receive medical care or instructions.

What should I discuss with my healthcare provider before taking ciprofloxacin?


You should not use ciprofloxacin if:

  • you are also taking tizanidine (Zanaflex);




  • you have a history of myasthenia gravis; or




  • you are allergic to ciprofloxacin or similar medications such as gemifloxacin (Factive), levofloxacin (Levaquin), moxifloxacin (Avelox), ofloxacin (Floxin), norfloxacin (Noroxin), and others.



To make sure you can safely take ciprofloxacin, tell your doctor if you have any of these other conditions:



  • heart rhythm disorder, especially if you take quinidine (Quin-G), disopyramide (Norpace), bretylium (Bretylol), procainamide (Pronestyl, Procan SR), amiodarone (Cordarone, Pacerone), or sotalol (Betapace);




  • a history of head injury or brain tumor;




  • a condition called pseudotumor cerebri (high pressure inside the skull that may cause headaches, vision loss, or other symptoms);




  • a history of allergic reaction to an antibiotic;




  • joint problems;




  • kidney or liver disease;




  • epilepsy or seizures;




  • diabetes;




  • muscle weakness or trouble breathing;




  • low levels of potassium in your blood (hypokalemia); or




  • a personal or family history of Long QT syndrome.




FDA pregnancy category C. It is not known whether ciprofloxacin will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Ciprofloxacin passes into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Ciprofloxacin may cause swelling or tearing of a tendon (the fiber that connects bones to muscles in the body), especially in the Achilles' tendon of the heel. These effects may be more likely to occur if you are over 60, if you take steroid medication, or if you have had a kidney, heart, or lung transplant. Stop taking ciprofloxacin and call your doctor at once if you have sudden pain, swelling, tenderness, stiffness, or movement problems in any of your joints. Rest the joint until you receive medical care or instructions. Do not share this medication with another person (especially a child), even if they have the same symptoms you have.

How should I take ciprofloxacin?


Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.


Take ciprofloxacin with a full glass of water (8 ounces). Drink several extra glasses of fluid each day while you are taking ciprofloxacin. Ciprofloxacin may be taken with or without food, but take it at the same time each day. Shake the oral suspension (liquid) for at least 15 seconds just before you measure a dose. To be sure you get the correct dose, measure the liquid with a marked measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

When taking the oral liquid, swallow it without chewing the medicine beads you may notice in the liquid.


Do not crush, chew, or break an extended-release tablet. Swallow it whole. Breaking the pill may cause too much of the drug to be released at one time. Do not take ciprofloxacin with dairy products such as milk or yogurt, or with calcium-fortified juice. You may eat or drink these products as part of a regular meal, but do not use them alone when taking ciprofloxacin. They could make the medication less effective. Take this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics. Ciprofloxacin will not treat a viral infection such as the common cold or flu. Store at room temperature away from moisture and heat. Do not allow the liquid medicine to freeze.

What happens if I miss a dose?


Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.


What happens if I overdose?


Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include seizures, urination problems, weakness, or blue lips with pale skin.

What should I avoid while taking ciprofloxacin?


You may be taking certain other medicines that should not be taken at the same time as ciprofloxacin. Avoid taking the following medicines within 6 hours before or 2 hours after you take ciprofloxacin. These other medicines can make ciprofloxacin much less effective when taken at the same time:

  • antacids that contain calcium, magnesium or aluminum (such as Tums, Mylanta, or Rolaids);




  • the ulcer medicine sucralfate (Carafate);




  • didanosine (Videx) powder or chewable tablets; or




  • vitamin or mineral supplements that contain calcium, iron, or zinc.




Avoid caffeine while you are taking ciprofloxacin, because the medication can make the effects of caffeine stronger. Avoid exposure to sunlight or tanning beds. Ciprofloxacin can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors. Call your doctor if you have severe burning, redness, itching, rash, or swelling after being in the sun.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, stop taking ciprofloxacin and call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.


Ciprofloxacin may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Ciprofloxacin side effects


Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Stop using ciprofloxacin and call your doctor at once if you have a serious side effect such as:

  • severe dizziness, fainting, fast or pounding heartbeats;




  • sudden pain, snapping or popping sound, bruising, swelling, tenderness, stiffness, or loss of movement in any of your joints;




  • diarrhea that is watery or bloody;




  • confusion, hallucinations, depression, unusual thoughts or behavior;




  • seizure (convulsions);




  • severe headache, ringing in your ears, dizziness, nausea, vision problems, pain behind your eyes;




  • pale or yellowed skin, dark colored urine, fever, weakness;




  • urinating less than usual or not at all;




  • easy bruising or bleeding;




  • numbness, tingling, or unusual pain anywhere in your body;




  • the first sign of any skin rash, no matter how mild; or




  • severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.



Less serious side effects may include:



  • nausea, vomiting;




  • dizziness or drowsiness;




  • blurred vision;




  • feeling nervous, anxious, or agitated; or




  • sleep problems (insomnia or nightmares).



This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.


What other drugs will affect ciprofloxacin?


Do not take ciprofloxacin together with tizanidine (Zanaflex).

Tell your doctor about all other medicines you use, especially:



  • a blood thinner such as warfarin (Coumadin, Jantoven);




  • clozapine (Clozaril, FazaClo);




  • cyclosporine (Gengraf, Neoral, Sandimmune);




  • glyburide (Micronase, Diabeta, Glynase);




  • methotrexate (Rheumatrex, Trexall);




  • metoclopramide (Reglan);




  • phenytoin (Dilantin);




  • probenecid (Benemid);




  • ropinirole (Requip);




  • theophylline (Elixophyllin, Theo-24, Theochron, Uniphyl);




  • an NSAID (non-steroidal anti-inflammatory drug) such as ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Arthrotec, Cambia, Cataflam, Voltaren, Flector Patch, Pennsaid, Solareze), indomethacin (Indocin), meloxicam (Mobic), and others; or




  • steroid medication (prednisone and others).



This list is not complete and other drugs may interact with ciprofloxacin. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.



More Proquin XR resources


  • Proquin XR Side Effects (in more detail)
  • Proquin XR Use in Pregnancy & Breastfeeding
  • Proquin XR Drug Interactions
  • Proquin XR Support Group
  • 0 Reviews for Proquin XR - Add your own review/rating


  • Proquin XR Extended-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

  • Proquin XR Prescribing Information (FDA)

  • Proquin XR Consumer Overview

  • Ciprofloxacin Prescribing Information (FDA)

  • Ciprofloxacin Professional Patient Advice (Wolters Kluwer)

  • Cipro Prescribing Information (FDA)

  • Cipro Advanced Consumer (Micromedex) - Includes Dosage Information

  • Cipro Consumer Overview

  • Cipro MedFacts Consumer Leaflet (Wolters Kluwer)

  • Cipro I.V.

  • Cipro I.V. MedFacts Consumer Leaflet (Wolters Kluwer)

  • Cipro XR Extended-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

  • Cipro XR Prescribing Information (FDA)

  • Ciprofloxacin Hydrochloride Monograph (AHFS DI)



Compare Proquin XR with other medications


  • Bacterial Infection
  • Bladder Infection
  • Epididymitis, Sexually Transmitted
  • Urinary Tract Infection


Where can I get more information?


  • Your pharmacist can provide more information about ciprofloxacin.

See also: Proquin XR side effects (in more detail)


Pizotifène




Pizotifène may be available in the countries listed below.


Ingredient matches for Pizotifène



Pizotifen

Pizotifène (DCF) is also known as Pizotifen (Rec.INN)

International Drug Name Search

Glossary

DCFDénomination Commune Française
Rec.INNRecommended International Nonproprietary Name (World Health Organization)

Click for further information on drug naming conventions and International Nonproprietary Names.

Prohistine-D


Generic Name: pheniramine/ pyrilamine/ phenyltoloxamine/ phenylpropanolamine (fen IR a meen/pie RILL a meen/fen ill toe LOX a meen/fen ill proe pa NOLE a meen)

Brand Names: Delhist D, Delhistine D, Histine-D, Iohist D, KG-Hist D, Liqui-Histine-D, Metahistine D, Multihist D, Multihistamine-D, Poly-D, Poly-Histine-D, Prohistine-D, Trihist-D


What is Prohistine-D (pheniramine/ pyrilamine/ phenyltoloxamine/ phenylpropanolamine)?

Pheniramine, pyrilamine, and phenyltoloxamine are antihistamines. They block the effects of the naturally occurring chemical histamine in the body. Pheniramine, pyrilamine, and phenyltoloxamine prevent sneezing; itchy, watery eyes and nose; and other symptoms of allergies and hay fever.


Phenylpropanolamine is a decongestant. It constricts (shrinks) blood vessels (veins and arteries). This reduces the blood flow to certain areas and allows nasal and respiratory (breathing) passages to open up.


Pheniramine/pyrilamine/phenyltoloxamine/phenylpropanolamine is used to treat nasal congestion and sinusitis (inflammation of the sinuses) associated with allergies, hay fever, and the common cold.


Phenylpropanolamine, an ingredient in this product, has been associated with an increased risk of hemorrhagic stroke (bleeding into the brain or into tissue surrounding the brain) in women. Men may also be at risk. Although the risk of hemorrhagic stroke is low, the U.S. Food and Drug Administration (FDA) recommends that consumers not use any products that contain phenylpropanolamine.


Pheniramine/pyrilamine/phenyltoloxamine/phenylpropanolamine may also be used for purposes other than those listed in this medication guide.


What is the most important information I should know about Prohistine-D (pheniramine/ pyrilamine/ phenyltoloxamine/ phenylpropanolamine)?


Phenylpropanolamine, an ingredient in this product, has been associated with an increased risk of hemorrhagic stroke (bleeding into the brain or into tissue surrounding the brain) in women. Men may also be at risk. Although the risk of hemorrhagic stroke is low, the U.S. Food and Drug Administration (FDA) recommends that consumers not use any products that contain phenylpropanolamine.


Use caution when driving, operating machinery, or performing other hazardous activities. Pheniramine/pyrilamine/phenyltoloxamine/phenylpropanolamine may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities. Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while taking this medication.

Do not take more of this medication than is recommended. If your symptoms do not improve, or if they worsen, talk to your doctor.


Who should not take Prohistine-D (pheniramine/ pyrilamine/ phenyltoloxamine/ phenylpropanolamine)?


Do not take pheniramine/pyrilamine/phenyltoloxamine/phenylpropanolamine if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Before taking this medication, tell your doctor if you have


  • kidney disease,

  • liver disease,


  • diabetes,




  • glaucoma,




  • any type of heart disease or high blood pressure,




  • thyroid disease,




  • emphysema or chronic bronchitis, or




  • difficulty urinating or an enlarged prostate.



You may not be able to take pheniramine/pyrilamine/phenyltoloxamine/phenylpropanolamine, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.


Pheniramine/pyrilamine/phenyltoloxamine/phenylpropanolamine is in the FDA pregnancy category B. This means that it is unlikely to harm an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant. Pheniramine/pyrilamine/phenyltoloxamine/phenylpropanolamine passes into breast milk and may harm a nursing infant. Do not take this medication without first talking to your doctor if you are breast-feeding a baby. If you are over 65 years of age, you may be more likely to experience side effects from pheniramine/pyrilamine/phenyltoloxamine/phenylpropanolamine. You may require a lower dose of this medication. Read the package label for directions or consult your doctor or pharmacist before treating a child with this medication. Children are more susceptible than adults to the effects of medicines and may have unusual reactions.

How should I take Prohistine-D (pheniramine/ pyrilamine/ phenyltoloxamine/ phenylpropanolamine)?


Take pheniramine/pyrilamine/phenyltoloxamine/phenylpropanolamine exactly as directed. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.


Take each dose with a full glass of water. Do not crush, chew, or break the long-acting or sustained-release forms of this medication. Swallow them whole. If you are unsure about the formulation of the medicine, ask your pharmacist for help.

If you cannot swallow the tablets or capsules, look for a liquid form of this medication.


To ensure that you get a correct dose, measure the liquid form of pheniramine/pyrilamine/phenyltoloxamine/phenylpropanolamine with a special dose-measuring spoon or cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one.


Do not take more of this medication than is recommended. An overdose can cause serious harm.

Do not take pheniramine/pyrilamine/phenyltoloxamine/phenylpropanolamine for longer than 7 days in a row. If your symptoms do not improve, if they get worse, or if you have a fever, talk to your doctor.


Store pheniramine/pyrilamine/phenyltoloxamine/phenylpropanolamine at room temperature away from moisture and heat.

What happens if I miss a dose?


Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose of this medication.


What happens if I overdose?


Seek emergency medical attention.

Symptoms of a pheniramine/pyrilamine/phenyltoloxamine/phenylpropanolamine overdose include a dry mouth, large pupils, flushing, nausea, and vomiting.


What should I avoid while taking Prohistine-D (pheniramine/ pyrilamine/ phenyltoloxamine/ phenylpropanolamine)?


Use caution when driving, operating machinery, or performing other hazardous activities. Pheniramine/pyrilamine/phenyltoloxamine/phenylpropanolamine may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities. Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while taking pheniramine/pyrilamine/phenyltoloxamine/phenylpropanolamine.

Prohistine-D (pheniramine/ pyrilamine/ phenyltoloxamine/ phenylpropanolamine) side effects


Serious side effects are unlikely to occur. Stop taking pheniramine/pyrilamine/phenyltoloxamine/phenylpropanolamine and seek emergency medical attention if you experience an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives).

Other, less serious side effects may be more likely to occur. Continue to take pheniramine/pyrilamine/phenyltoloxamine/phenylpropanolamine and talk to your doctor or try another similar medication if you experience



  • dryness of the eyes, nose, and mouth;




  • drowsiness or dizziness;




  • blurred vision;




  • difficulty urinating; or




  • excitation in children.



Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.


What other drugs will affect Prohistine-D (pheniramine/ pyrilamine/ phenyltoloxamine/ phenylpropanolamine)?


Do not take pheniramine/pyrilamine/phenyltoloxamine/phenylpropanolamine if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Do not take other over-the-counter cough, cold, allergy, diet, or sleep aids while taking pheniramine/pyrilamine/phenyltoloxamine/phenylpropanolamine without first talking to your doctor or pharmacist. Other medications may also contain pheniramine, pyrilamine, phenyltoloxamine, phenylpropanolamine, or other similar drugs. You may accidentally take too much of these medicines.


Pheniramine/pyrilamine/phenyltoloxamine/phenylpropanolamine may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, other antihistamines, pain relievers, anxiety medicines, seizure medicines, and muscle relaxants. Dangerous sedation, dizziness, or drowsiness may occur if pheniramine/pyrilamine/phenyltoloxamine/phenylpropanolamine is taken with any of these medications.


Drugs other than those listed here may also interact with pheniramine/pyrilamine/phenyltoloxamine/phenylpropanolamine. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including herbal products.



More Prohistine-D resources


  • Prohistine-D Drug Interactions
  • Prohistine-D Support Group
  • 0 Reviews for Prohistine-D - Add your own review/rating


Compare Prohistine-D with other medications


  • Allergies
  • Eye Dryness/Redness
  • Eye Redness/Itching
  • Hay Fever
  • Nasal Congestion
  • Rhinorrhea
  • Sinusitis
  • Upper Respiratory Tract Infection


Where can I get more information?


  • Your pharmacist has additional information about pheniramine/pyrilamine/phenyltoloxamine/phenylpropanolamine written for health professionals that you may read.

What does my medication look like?


Pheniramine/pyrilamine/phenyltoloxamine/phenylpropanolamine is available with a prescription under the brand names Poly-Histine-D (capsules and elixir) and Liqui-Histine Elixir. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.



pralidoxime Injection


pral-i-DOX-eem


Commonly used brand name(s)

In the U.S.


  • Protopam Chloride

Available Dosage Forms:


  • Powder for Solution

  • Injectable

Therapeutic Class: Nerve Gas Antidote


Uses For pralidoxime


Pralidoxime injection is used together with another medicine called atropine to treat poisoning caused by organic phosphorus pesticides (e.g., diazinon, malathion, mevinphos, parathion, and sarin) and by organophosphate chemicals (“nerve gases”) used in chemical warfare.


Pralidoxime injection is also used to treat overdose of medicines (e.g., ambenonium, neostigmine, pyridostigmine), that are used to treat myasthenia gravis. Poisoning with these chemicals or medicines causes your muscles, including the muscles that help you breathe, to become weak. Pralidoxime is used to help you get back strength in your muscles.


pralidoxime is to be given only by or under the direct supervision of a doctor or trained military personnel.


Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in product labeling, pralidoxime has been used in some patients to treat poisoning caused by certain carbamate pesticides.


Before Using pralidoxime


In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For pralidoxime, the following should be considered:


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to pralidoxime or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.


Pediatric


Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of pralidoxime injection in children.


Geriatric


Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of pralidoxime injection in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving pralidoxime injection.


Pregnancy








Pregnancy CategoryExplanation
All TrimestersCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding


There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.


Interactions with Medicines


Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.


Interactions with Food/Tobacco/Alcohol


Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.


Other Medical Problems


The presence of other medical problems may affect the use of pralidoxime. Make sure you tell your doctor if you have any other medical problems, especially:


  • Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

  • Myasthenia gravis (severe muscle weakness)—Use with caution. May make this condition worse.

Proper Use of pralidoxime


A nurse or other trained health professional will give you pralidoxime in a hospital or clinic. You may also be taught how to give your medicine at home. pralidoxime is preferably given through a needle placed in one of your veins. It may also be given as a shot under your skin or into a muscle.


pralidoxime is available in two forms: a vial and an autoinjector.


For patients using the pralidoxime autoinjector (automatic injection device):


  • You will be trained to use the pralidoxime autoinjector by a medic or other trained military personnel. You will also be told the conditions under which it should be used.

  • The autoinjector also comes with patient directions. Read them carefully before you actually need to use pralidoxime. Then, when an emergency arises, you will know how to inject the pralidoxime.

  • It is important that you do not remove the safety cap on the autoinjector until you are ready to use it. This prevents spillage of the medicine from the device during storage and handling.

  • To use the pralidoxime autoinjector:
    • Remove the gray safety cap.

    • Place the black tip of the device on the thigh, with the injector pointed straight at the thigh.

    • Press hard into the thigh until the autoinjector functions. Hold in place for several seconds. Remove the autoinjector and dispose of it as directed.

    • Massage the injected area for 10 seconds.


Dosing


The dose of pralidoxime will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of pralidoxime. If your dose is different, do not change it unless your doctor tells you to do so.


The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.


  • For injection dosage form:
    • For treatment of organic phosphorus pesticide poisoning:
      • Adults and teenagers—At first, 1000 to 2000 milligrams (mg) injected into a vein usually as an infusion in 100 milliliters (mL) of normal saline, over a 15- to 30-minute period. The dose may be repeated after one hour, and then every eight to twelve hours if muscle weakness persists.

      • Children and teenagers 16 years of age and younger—Dose is based on body weight and must be determined by your doctor. The dose is usually 20 to 50 milligrams (mg) per kilogram (kg) (9.07 to 22.7 mg per pound) of body weight injected into a vein. The dose may be repeated after one hour, and then every ten to twelve hours if muscle weakness persists.


    • For treatment of organic phosphorus chemical (“nerve gas”) poisoning:
      • Adults, teenagers, and children weighing 40 kilograms (kg) or more—600 milligrams (mg) or 2 milliliters (mL) injected into a muscle. The dose may be repeated fifteen minutes after the first dose and fifteen minutes after the second dose, if needed.

      • Children and teenagers 16 years of age and younger weighing less than 40 kilograms (kg)—Dose is based on body weight and must be determined by your doctor. The dose is 15 milligrams (mg) per kilogram (kg) of body weight injected into the muscles of the thighs. The dose may be repeated fifteen minutes after the first dose and fifteen minutes after the second dose, if needed.


    • For treatment of overdose of medicines used to treat myasthenia gravis:
      • Adults and teenagers—At first, 1000 to 2000 milligrams (mg) injected into a vein. Then, 250 mg is injected into a vein every five minutes.

      • Children—Use and dose must be determined by your doctor.



Storage


Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.


Keep out of the reach of children.


Do not keep outdated medicine or medicine no longer needed.


Ask your healthcare professional how you should dispose of any medicine you do not use.


Precautions While Using pralidoxime


Your doctor will check your progress closely while you or your child are receiving pralidoxime. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it. Blood tests may be needed to check for unwanted effects.


Call your doctor right away if you or your child have fast heartbeat, difficulty or trouble with breathing, increased muscle weakness, or severe tiredness after receiving pralidoxime.


pralidoxime will add to the effects of CNS depressants (medicines that may make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using pralidoxime.


Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.


pralidoxime Side Effects


Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.


Check with your doctor or nurse immediately if any of the following side effects occur:


More common
  • Blurred or double vision

  • change in near or distance vision

  • difficult or rapid breathing

  • difficulty in focusing the eyes

  • difficulty with speaking

  • dizziness

  • fast, pounding, or irregular heartbeat or pulse

  • muscle stiffness or weakness

  • pain at the injection site (after injection into a muscle)

Incidence not known
  • Deep or fast breathing with dizziness

  • numbness of the feet, hands, and around the mouth

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:


More common
  • Drowsiness

  • headache

  • nausea

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.


Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: pralidoxime Injection side effects (in more detail)



The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.


The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.


More pralidoxime Injection resources


  • Pralidoxime Injection Side Effects (in more detail)
  • Pralidoxime Injection Use in Pregnancy & Breastfeeding
  • Pralidoxime Injection Drug Interactions
  • Pralidoxime Injection Support Group
  • 0 Reviews for Pralidoxime Injection - Add your own review/rating


Compare pralidoxime Injection with other medications


  • Anticholinesterase Overdose
  • Nerve Agent Poisoning
  • Organophosphate Poisoning

Paxil



Generic Name: Paroxetine Hydrochloride
Class: Selective Serotonin-reuptake Inhibitors
VA Class: CN609
Chemical Name: trans-(-)-3-[(1,3-Benzodioxol-5-yloxy)methyl]-4-(4-fluorophenyl)piperidine hydrochloride hemihydrate
Molecular Formula: C19H20FNO3•HCl•½H2O
CAS Number: 110429-35-1


Special Alerts:


[Posted 05/02/2007] FDA notified healthcare professionals that the Agency proposed that makers of all antidepressant medications update the existing black box warning on the prescribing information for their products to include warnings about the increased risks of suicidal thinking and behavior in young adults ages 18 to 24 years old during the first one to two months of treatment. The proposed labeling changes also state that scientific data did not show this increased risk in adults older than 24 years of age and that adults 65 years of age and older taking antidepressants have a decreased risk of suicidality. The proposed updates apply to the entire category of antidepressants. Individuals currently taking prescribed antidepressant medications should not stop taking them and should notify their healthcare professional if they have concerns. Manufacturers of antidepressant medications will have 30 days to submit their revised product labeling and revised Medication Guides to FDA for review. See the FDA press release for the list of products affected by the proposed antidepressant product labeling changes. For more information visit the FDA website at: , and .


[Posted 07/19/2006] FDA notified healthcare professionals and consumers of important information from two recent studies that should be considered when making treatment decisions in pregnant women who take antidepressants. The studies included pregnant women who were treated with selective serotonin reuptake inhibitors (SSRIs), or in a few cases, other antidepressant medications.


One study illustrated the potential risk of relapsed depression after stopping antidepressant medication during pregnancy. In this study, women who stopped their medicine were five times more likely to have a relapse of depression during their pregnancy than were women who continued to take their antidepressant medicine while pregnant.


The second study suggests there may be additional, though rare, risks of taking SSRI medications during pregnancy. This study focused on newborn babies with persistent pulmonary hypertension (PPHN), which is a serious and life-threatening lung condition that occurs soon after birth. Babies born with PPHN have high pressure in their lung blood vessels and are not able to get enough oxygen into their bloodstream. In this study, PPHN was six times more common in babies whose mothers took an SSRI antidepressant after the 20th week of pregnancy compared to babies whose mothers did not take an antidepressant. The study was too small to compare the risk of one drug compared to another. The finding of PPHN in babies of mothers who used a SSRI antidepressant in the second half of pregnancy adds to concerns from previous reports that infants of mothers taking SSRIs late in pregnancy may experience difficulties such as irritability, difficulty feeding and in very rare cases, difficulty breathing.


Additionally, the labeling for paroxetine (Paxil) was recently changed to add information about findings in an epidemiologic study that suggests that exposure to the drug in the first trimester of pregnancy may be associated with an increased risk of cardiac birth defects.


Women who are pregnant or thinking about becoming pregnant should not stop any antidepressant medication without first consulting their physician. The FDA is seeking additional information about the possible risk of PPHN in newborn babies of mothers who took SSRI antidepressants in pregnancy. FDA has asked the sponsors of all SSRIs to change prescribing information to describe the potential risk for PPHN. For more information visit the FDA website at: and .


[Posted 07/19/2006] FDA notified healthcare professionals and consumers of new safety information regarding taking medications used to treat migraine headaches (triptans) together with certain types of antidepressant and mood disorder medications (selective serotonin reuptake inhibitors (SSRIs) and selective serotonin/norepinephrine reuptake inhibitors (SNRIs). A life-threatening condition called serotonin syndrome may occur when triptans are used together with a SSRI or a SNRI.


Serotonin syndrome occurs when the body has too much of a chemical found in the nervous system (serotonin). Each of the above medications (triptans, SSRIs, and SNRIs), cause an increase in serotonin levels. Symptoms of serotonin syndrome may include restlessness, hallucinations, loss of coordination, fast heart beat, rapid changes in blood pressure, increased body temperature, overactive reflexes, nausea, vomiting, and diarrhea.


Healthcare professionals prescribing a triptan, SSRI or SNRI should keep in mind that triptans are often used intermittently and either the triptan, SSRI or SNRI may be prescribed by a different physician; weigh the potential risk of serotonin syndrome with the expected benefit of using the above combination; discuss the possibility of serotonin syndrome with patients if a triptan and an SSRI or SNRI will be used together; and follow patients closely during treatment if a triptan and an SSRI or SNRI are used together.


Patients taking a triptan along with an SSRI or SNRI should talk to their doctor before stopping their medication and should immediately seek medical attention if they experience any of the above symptoms. FDA requested that all manufacturers of triptans, SSRIs and SNRIs update their prescribing information to warn of the possibility of serotonin syndrome when these medications are taken together. For more information visit the FDA website at: and .




  • Suicidality in Children and Adolescents


  • Antidepressants may increase risk of suicidal thinking and behavior (suicidality) in children and adolescents with major depressive disorder and other psychiatric disorders (see Pediatric Use under Cautions); balance this risk with clinical need.1 311 312 314 315 Paroxetine is not approved for use in pediatric patients.1 312




  • Closely monitor pediatric patients who are started on paroxetine therapy for clinical worsening, suicidality, or unusual changes in behavior; involve family members and/or caregivers in this process.1 312 314 (See Worsening of Depression and Suicidality Risk under Cautions.)




Introduction

Antidepressant; selective serotonin-reuptake inhibitor (SSRI).1 2 5 6


Uses for Paxil


Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.


Major Depressive Disorder


Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.


Management of major depressive disorder.1 5 8 9 10 11 12 13 14 15 16 17 18 19 20 21 26 30 39 42 74 76 131 132 134 135 155


Efficacy in hospital settings not established.1


Obsessive-Compulsive Disorder (OCD)


Management of OCD;1 49 50 SSRIs reduce but do not completely eliminate obsessions and compulsions.1


Panic Disorder


Management of panic disorder with or without agoraphobia.1 48 53 54 180 186 187 190 192 272


Social Phobia


Management of social phobia (social anxiety disorder).1 155 158 159 160 161


Anxiety Disorders


Management of generalized anxiety disorder.1


Posttraumatic Stress Disorder (PTSD)


Management of PTSD (alone or in combination with psychotherapy).1 168 296 297 298


Premenstrual Dysphoric Disorder (PMDD)


Management of PMDD.79 80 155 162


Premature Ejaculation


Has been used for the management of premature ejaculation.169 170 171 172 173 174


Diabetic Neuropathy


Has been used for the management of diabetic neuropathy.24 136


Chronic Headache


Has been used for the management of chronic headache.155 163 164


Paxil Dosage and Administration


General



  • Allow at least 2 weeks to elapse between discontinuance of an MAO inhibitor and initiation of paroxetine, and vice versa.1




  • Monitor for possible worsening of depression or suicidality, especially at the beginning of therapy or during periods of dosage adjustments.1 312 314 (See Worsening of Depression and Suicidality Risk under Cautions.)




  • Sustained therapy may be required;1 42 51 52 101 102 103 104 129 130 133 monitor periodically for need for continued therapy.1




  • Avoid abrupt discontinuance of therapy;24 184 197 198 200 204 to avoid withdrawal reactions, taper dosage gradually over a period of several weeks.184 194 197 198 200 (See Withdrawal of Therapy under Cautions.)




  • Consider cautiously tapering dosage during third trimester of pregnancy prior to delivery.1 312 329 330 331 332 (See Pregnancy under Cautions.)



Administration


Oral Administration


Administer orally once daily (in the morning) without regard to meals;1 7 8 19 92 312 however, administration with food may minimize adverse GI effects.8 19


Shake oral suspension well just prior to administration.1


Swallow extended-release tablets whole; do not chew or crush.304


Dosage


Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.


Available as paroxetine hydrochloride; dosage expressed in terms of paroxetine.1


Adults


Major Depressive Disorder

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.


Oral

Conventional tablets or suspension: Initially, 20 mg once daily.1 304 If no improvement, dosage may be increased in 10-mg increments at weekly intervals.1 304


Extended-release tablets: Initially, 25 mg once daily.1 304 If no improvement, dosage may be increased in 12.5-mg increments at weekly intervals.1 304


Optimum duration not established; may require several months of therapy or longer.1 22 42 101 102 103 104 129 130 133 304 Antidepressant efficacy demonstrated for up to 1 year at mean dosage of 30 mg daily as conventional tablets or suspension, which corresponds to a 37.5 mg daily dosage as extended-release tablets.1 133


Obsessive-Compulsive Disorder

Oral

Conventional tablets or suspension: Initially, 20 mg once daily.1 If no improvement, dosage may be increased in 10-mg increments at weekly intervals, to 40 mg daily.1


Optimum duration not established; efficacy has been demonstrated in a 6-month relapse prevention trial.1 Obsessive-compulsive disorder is chronic and requires several months or longer of sustained therapy.1 51 52 May continue therapy in responding patients, 1 51 52 but use lowest effective dosage and periodically reassess need for continued therapy.1


Panic Disorder

Oral

Conventional tablets or suspension: Initially, 10 mg once daily.1 48 If no improvement, dosage may be increased in 10-mg increments at weekly intervals, to 40 mg daily.1 48


Extended-release tablets: Initially, 12.5 mg once daily.312 If no improvement, dosage may be increased in 12.5-mg increments at weekly intervals.312


Optimum duration not established; efficacy demonstrated in a 3-month relapse prevention trial.1 48 54 184 May continue therapy in responding patients,1 48 54 184 but use lowest effective dosage and periodically reassess need for continued therapy.1


Social Phobia

Oral

Conventional tablets or suspension: 20 mg once daily; no additional clinical benefit was observed with higher dosages.1


Extended-release tablets: Initially, 12.5 mg once daily.312 If dosage is increased, use increments of 12.5-mg increments at weekly intervals.312


Long-term efficacy (>12 weeks) not demonstrated; may consider continuation in patient who responds, but use lowest effective dosage and periodically reassess need for continued therapy.1


Anxiety Disorders

Oral

Conventional tablets or suspension: Initially, 20 mg daily; no additional clinical benefit was observed with higher dosages.1 If needed, dosage may be increased in 10-mg increments at weekly intervals.1


Optimum duration not established; efficacy has been demonstrated in a 24-week relapse prevention trial.1 321 Generalized anxiety disorder is chronic.1 321 May continue therapy in responding patients.1 321 If used for extended periods, adjust dosage so that patients are maintained on lowest effective dosage and periodically reassess need for continued therapy.1


Posttraumatic Stress Disorder

Oral

Conventional tablets or suspension: 20 mg daily; insufficient evidence to suggest greater clinical benefit with higher dosages.1 If needed, dosage may be increased in 10-mg increments at weekly intervals.1


Consider alternative therapy if patient fails to achieve ≥25% reduction in PTSD symptoms at week 8.300 If >75% reduction in PTSD symptoms and response maintained for ≥3 months, may consider up to 24 months of drug therapy.300 If used for extended periods, adjust dosage so that patients are maintained on lowest effective dosage and periodically reassess need for continued therapy.1


Premenstrual Dysphoric Disorder

Oral

Conventional tablets or suspension: 5–30 mg daily.79


Extended-release tablets: Initially, 12.5 mg once daily; may be administered daily throughout menstrual cycle or only during luteal phase.312 Dosage may be increased in intervals of ≥1 week.312 Dosages of 12.5–25 mg were effective in clinical studies.312


Premature Ejaculation

Oral

Conventional tablets or suspension: 10–40 mg once daily.172 173 279 280 281 Alternatively, 20 mg taken 3–4 hours before planned intercourse on an “as needed” basis.280 281


Diabetic Neuropathy

Oral

Conventional tablets or suspension: 40 mg daily.24 136


Chronic Headache

Oral

Conventional tablets or suspension: 10–50 mg daily for 3–9 months.164


Prescribing Limits


Adults


Major Depressive Disorder

Oral

Conventional tablets or suspension: Maximum 50 mg daily.


Extended-release tablets: 62.5 mg daily.1 304


Obsessive-Compulsive Disorder

Oral

Conventional tablets or suspension: Maximum 60 mg daily.1


Panic Disorder

Oral

Conventional tablets or suspension: Maximum 60 mg daily.1


Extended-release tablets: 75 mg daily.312


Social Phobia

Oral

Extended-release tablets: 37.5 mg daily.312


Special Populations


Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.


Hepatic Impairment


Oral

In patients with severe hepatic impairment, an initial dosage of 10 mg daily (as conventional tablets or suspension) or 12.5 mg daily (as extended-release tablets).1 304 If no clinical improvement is apparent, dosage may be titrated with caution up to a maximum of 40 mg daily (for conventional tablets or suspension) or 50 mg (for extended-release tablets).1 98 99 304


Renal Impairment


Oral

In patients with severe renal impairment, an initial dosage of 10 mg daily (as conventional tablets or suspension) or 12.5 mg daily (as extended-release tablets).1 304 If no clinical improvement is apparent, dosage may be titrated with caution up to a maximum of 40 mg daily (for conventional tablets or suspension) or 50 mg (for extended-release tablets).1 98 99 304


Geriatric or Debilitated Patients


Initially, 10 mg daily (as conventional tablets or suspension) or 12.5 mg daily (as extended-release tablets); if no clinical improvement is apparent, dosage may be titrated up to a maximum of 40 mg daily (as conventional tablets or suspension) or 50 mg daily (as extended-release tablets).1 95 304


Cautions for Paxil


Contraindications



  • Concurrent or recent (i.e., within 2 weeks) therapy with an MAO inhibitor.1 5




  • Concurrent therapy with thioridazine.1 (See Drug Interactions under Warnings.)




  • Concurrent pimozide therapy.1 312 (See Interactions.)




  • Known hypersensitivity to paroxetine or any ingredient in the formulation.1



Warnings/Precautions


Warnings


Drug Interactions

Concomitant use of some SSRIs with MAO inhibitor associated with serious, sometimes fatal reactions, including manifestations resembling serotonin syndrome (e.g., hyperthermia, rigidity, myoclonus, autonomic instability, mental status changes) or neuroleptic malignant syndrome (NMS).1 (See Contraindications.)


May inhibit CYP2D6, resulting in increased risk of QT prolongation and/or ventricular tachycardia of the torsades de pointes type associated with elevated plasma concentrations of thioridazine.1 (See Contraindications.)


Worsening of Depression and Suicidality Risk

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.


Possible worsening of depression and/or the emergence of suicidal ideation and behavior (suicidality) in both adult and pediatric patients with major depressive disorder; may persist until clinically important remission occurs with therapy.1 312 314


Possible increased risk of suicidal behavior in young adult patients (18–30 years of age), particularly those with major depressive disorder.a b c Increased risk of suicidal behavior and thoughts in patients with a history of suicidal behavior or thoughts and in patients exhibiting a substantial degree of suicidal ideation prior to initiating therapy.a b c Increased risk of suicidal behavior was observed despite evidence of paroxetine efficacy in patients being treated for major depressive disorder.b


Closely supervise pediatric patients receiving paroxetine for any reason and adult patients with major depressive disorder or other psychiatric illness with comorbid depression during initiation of therapy and during periods of dosage adjustments.1 312 314 (See Boxed Warning.) Carefully monitor all patients, particularly young adults and those that are improving, during paroxetine therapy regardless of the condition being treated.b


If anxiety, agitation, panic attacks, insomnia, irritability, hostility, impulsivity, akathisia, hypomania, and/or mania occur, consider changing or discontinuing therapy, particularly if severe, abrupt in onset, or not part of patient’s presenting symptoms.1 312 314 If decision is made to discontinue therapy, taper paroxetine dosage as rapidly as is feasible but consider risks of abrupt discontinuance.1 312 314 (See General under Dosage and Administration.)


Prescribe in smallest quantity consistent with good patient management to reduce risk of overdosage.1 312 314


Observe these precautions for patients with psychiatric (e.g., major depressive disorder, obsessive-compulsive disorder) or nonpsychiatric disorders.1 312 314


Bipolar Disorder

May unmask bipolar disorder.1 312 314 (See Activation of Mania or Hypomania under Cautions.) Paroxetine is not approved for use in treating bipolar depression.1 312


Screen for risk of bipolar disorder by obtaining detailed psychiatric history (e.g., family history of suicide, bipolar disorder, depression) prior to initiating therapy.1 312 314


Fetal/Neonatal Morbidity and Mortality

May increase risk of fetal defects (e.g., cardiovascular malformations, principally ventricular and atrial septal defects; other major congenital malformations) when administered to pregnant women.326 333 337 338 a c


If a patient becomes pregnant during treatment, advise patient of the potential hazard to the fetus.337 338 a c Unless the potential benefits to the mother justify continuing treatment, consider discontinuing paroxetine therapy or switching to another antidepressant.337 338 a c For women who intend to become pregnant or are in their first trimester of pregnancy, initiate paroxetine only after consideration of other available treatment options.337 338 a c


Possible complications, sometimes severe and requiring prolonged hospitalization, respiratory support, enteral nutrition, and other forms of supportive care in neonates exposed to paroxetine, other SSRIs, or selective serotonin- and norepinephrine-reuptake inhibitors (SNRIs) late in the third trimester; may arise immediately upon delivery.1 312 327 328 329 330 331 332


Increased risk of persistent pulmonary hypertension of the newborn (PPHN) in infants exposed to SSRIs during late pregnancy; associated with substantial neonatal morbidity and mortality.a c


Carefully consider both the potential risks and benefits of treatment when used during the third trimester of pregnancy.1 312 326 328 329 330 Be aware that in a longitudinal study involving women with a history of major depressive disorder who were euthymic while receiving antidepressant therapy at the beginning of pregnancy, women who discontinued antidepressant therapy during pregnancy were more likely to experience a relapse of depression than those who remained on antidepressant therapy.1 312 Consider cautiously tapering dose during third trimester prior to delivery.1 312 329 330 331 332


General Precautions


Activation of Mania or Hypomania

Possible activation of mania or hypomania.1 2 Use with caution in patients with a history of mania.1 312 (See Bipolar Disorder under Cautions.)


Seizures

Seizures have been reported.1 2 Limited experience with use of paroxetine in patients with a history of seizures; use with caution in such patients.1 Discontinue if seizures occur.1


Akathisia

Akathisia has been reported.1 226 227 312 Most likely to occur within the first few weeks of therapy.1 312


Hyponatremia

May occur secondary to SIADH;24 25 28 apparently reversible following discontinuance of the drug and/or fluid restriction.1 22 24 28 210 215 217 Occurs mainly in older patients1 22 24 25 28 and those receiving diuretics or otherwise volume depleted.1 (See Geriatric Use under Cautions.)


Abnormal Bleeding

Possible increased risk of bleeding, including upper GI bleeding;1 312 323 324 325 use with caution.a


Concomitant use of an NSAIA (e.g., aspirin) or warfarin may potentiate such risk.1 6 147 312 323 324 325


Concomitant Disease

May be less cardiotoxic than most older antidepressant agents but experience is limited in patients with recent MI or unstable heart disease.1 2 18 24 145 Use with caution.1 98 99 145 225


May cause mydriasis.1 299 Use with caution in patients with angle-closure glaucoma.1


Cognitive and Motor Performance

Does not appear to produce substantial cognitive or motor impairment,1 2 3 18 19 24 62 72 73 but patients should be cautioned to avoid activities requiring alertness or physical coordination until effects on individual are known.1 62


Withdrawal of Therapy

Possible withdrawal reactions following abrupt discontinuance or intermittent noncompliance with therapy.1 23 24 32 33 46 47 196 197 198 199 200 201 202 203 204 205 206 Avoid abrupt discontinuance of therapy;24 184 197 198 200 204 taper dosage gradually over a period of several weeks.184 194 197 198 200


If intolerable symptoms occur, reinstitute at the previously prescribed dosage until such symptoms abate.1 304 Clinicians may resume dosage reductions at that time but at a more gradual rate.1 304


Electroconvulsive Therapy (ECT)

Effects of concomitant use with ECT have not been systematically evaluated.1


Specific Populations


Pregnancy

Category D.337 338 a c See Fetal/Neonatal Morbidity and Mortality under Cautions.


Lactation

Distributed into human milk;1 100 use with caution.1


Pediatric Use

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.


Safety and efficacy not established in children <18 years of age.1 271 312


Greater risk of suicidal thinking or behavior (suicidality) occurred during first few months of antidepressant treatment (4%) compared with placebo (2%) in children and adolescents with major depressive disorder, obsessive-compulsive disorder, or other psychiatric disorders based on pooled analyses of short-term placebo-controlled trials of 9 antidepressant drugs (SSRIs and others).1 312 314 315 No suicides occurred in these trials.1 312 314 315 If considering use of paroxetine in a child or adolescent, balance potential risks with clinical need.1 311 312 314 315 (See Worsening of Depression and Suicidality Risk under Cautions.)


Geriatric Use

Possible decreased clearance; however, efficacy and adverse effects similar to those in younger adults.1 2 4 7 18 24 83 95 96 97 Initiate therapy at a lower dosage.1 8 95 (See Geriatric or Debilitated Patients under Dosage and Administration.)


May be more likely than younger patients to develop hyponatremia and transient SIADH.1 22 24 25 28 214 215 Periodically monitor serum sodium concentrations, especially during the first several months of therapy.181 217


Hepatic Impairment

Increased plasma concentrations1 4 98 99 and decreased clearance reported.1 137 Use with caution; use at a reduced initial dosage if impairment is severe.1 98 99 145 225 (See Hepatic Impairment under Dosage and Administration.)


Renal Impairment

Increased plasma concentrations1 4 98 99 and decreased clearance reported.1 137 Use with caution; use at a reduced initial dosage if impairment is severe.1 98 99 145 225 (See Renal Impairment under Dosage and Administration.)


Common Adverse Effects


Nervous system effects (e.g., asthenia, somnolence, dizziness, insomnia, tremor, nervousness), GI effects (e.g., nausea, decreased appetite, constipation, dry mouth), impotence, ejaculatory dysfunction, female genital disorders (e.g., anorgasmia or difficulty reaching climax/orgasm), sweating.1 2 3 24 76


Interactions for Paxil


Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.


Metabolized partially by CYP2D6.1 Inhibits the activity of CYP2D6 and to a lesser extent CYP3A4.1 91


Drugs Metabolized by Hepatic Microsomal Enzymes


Substrates of CYP2D6 or CYP3A4: possible increased plasma concentrations of the substrates.1 91 277


Use with caution and consider reducing dosage of concomitantly administered CYP2D6 substrate, particularly those with a narrow therapeutic index, such as TCAs, class IC antiarrhythmics and some phenothiazines.1 91 277


Drugs Affecting Hepatic Microsomal Enzymes


Inhibitors or inducers of CYP isoenzymes (e.g., CYP2D6): potential pharmacokinetic interaction (altered paroxetine metabolism and plasma concentrations).a


Drugs Associated with Serotonin Syndrome


Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.


Potential pharmacodynamic interaction (serotonin syndrome).1 229 230 231 232 233 234 235 Although usually mild, serious complications and death occasionally have been reported.1 230 231 233 236 237 238 239 Serotonin syndrome most commonly occurs when serotonergic agents with different mechanisms of action are given concurrently or in close succession.230 231 233 236 237 Avoid such use, or use with caution.237 239


Drugs Affecting Hemostasis


Potential pharmacologic interaction (increased risk of bleeding) with concomitant use of drugs that affect hemostasis.1 6 147 323 312 324 325 Use with caution.1


Specific Drugs


















Drug



Interaction



Comments



Alcohol



Does not potentiate cognitive and motor effects of alcohol;1 2 3 6 19 24 146 possible serotonergically mediated pharmacodynamic interaction in CNS146



Avoid concomitant use1



Antacids



Pharmacokinetic interactions unlikely6 19 92



Antiarrhythmic agents, class IC (e.g., encainide, flecainide, propafenone)



Possible inhibition of metabolism by paroxetinea



Use cautiona



Antidepressants, tricyclic (TCA)



Increased peak plasma concentrations, AUC, and elimination half-life of TCA1



Use with caution1


May need to monitor plasma tricyclic concentrations; consider reducing tricyclic dosage1



Atomoxetine