Nitrofurazone Soluble Dressing

Dosage Form: FOR ANIMAL USE ONLY
EQUI-PHAR NITROZONE SOLUBLE DRESSINNG

INDICATIONS:

For the prevention or treatment of surface bacterial infections of wounds, burns, and cutaneous ulcers.

ADMINISTRATION:

Apply directly on the lesion with a spatula, or first place on a piece of gauze. Application of a bandage is optional.

This preparation should be in contact with the lesion for at least 24 hours. The dressing may be changed several times daily or left on the lesion for a longer period.

PRECAUTION:

In case of deep or puncture wounds or serious burns, use only as recommended by a veterinarian. If redness, irritation, or swelling persists or increases, discontinue use, reconsult veterinarian. Avoid exposure to alkaline material and fluorescent lighting.

KEEP AWAY FROM EXCESSIVE HEAT OR DIRECT SUNLIGHT.

CONTENTS:

0.2% Nitrofurazone in a Water-soluble base of Polyethylene Glycols.

HUMAN WARNINGS:

CARCINOGENESIS: NITROFURAZONE, THE ACTIVE INGREDIENT OF Nitrofurazone Soluble Dressing, HAS BEEN SHOWN TO PROOUCE MAMMARY TUMORS IN RATS AND OVARIAN TUMORS IN MICE.

SOME PEOPLE MAY BE HYPERSENSITIVE TO THIS PRODUCT. EITHER WEAR GLOVES WHEN APPLYING, OR WASH HANDS AFTERWARDS.

STORAGE:

Store at controlled room temperature between 15°-30°C (59°-86°F).  Keep container tightly closed when not In use.

DISPLAY PANEL

For Use In Horses Only

An Antibacterial Preparation for Topical Application


CAUTION: FEDERAL LAW PROHIBITS THE USE OF THIS PRODUCT IN FOOD-PRODUCING ANIMALS.

FOR ANIMAL USE ONLY

KEEP OUT OF REACH OF CHILDREN

Distributed By:  VEDCO, INC., St. Joseph, MO 64507

Iss. 09 - 09                             

NET CONTENTS:

1 lb (453.6 g)

IMAGE OF LABEL

NITROFURAZONE  SOLUBLE DRESSING nitrofurazone  ointment

Product Information Product Type OTC ANIMAL DRUG NDC Product Code (Source) 50989-165 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NITROFURAZONE (NITROFURAZONE) NITROFURAZONE 0.2 g  in 1 g

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color yellow (YELLOW) Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 50989-165-26 12 JAR In 1 CASE contains a JAR 1 453.6 g In 1 JAR This package is contained within the CASE (50989-165-26)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANADA	ANADA200425	09/01/2009

Labeler - VEDCO INCORPORATED (021634266)

Revised: 09/2009VEDCO INCORPORATED

Feminil

Feminil may be available in the countries listed below.

Ingredient matches for Feminil

Cyproterone

Cyproterone 17α-acetate (a derivative of Cyproterone) is reported as an ingredient of Feminil in the following countries:

• Finland

Ethinylestradiol

Ethinylestradiol is reported as an ingredient of Feminil in the following countries:

• Finland

International Drug Name Search

Nitrek

Generic Name: nitroglycerin (Transdermal route)

nye-troe-GLIS-er-in

Commonly used brand name(s)

In the U.S.

• Minitran


• Nitrek


• Nitro-Bid


• Nitro-Dur

In Canada

• Nitrodur 0.2


• Nitro-Dur 0.2


• Nitro-Dur 0.3


• Nitrodur 0.4


• Nitro-Dur 0.4


• Nitrodur 0.6


• Nitro-Dur 0.6


• Nitro-Dur 0.8


• Transderm-Nitro


• Trinipatch 0.2


• Trinipatch 0.4


• Trinipatch 0.6

Available Dosage Forms:

• Ointment


• Patch, Extended Release

Therapeutic Class: Antianginal

Chemical Class: Nitrate

Uses For Nitrek

Nitroglycerin transdermal is used to prevent angina (chest pain) caused by coronary artery disease. It does not work fast enough to relieve the pain of an angina attack that has already started.

Nitroglycerin transdermal belongs to the group of medicines called nitrates. It works by relaxing the blood vessels and increasing the supply of blood and oxygen to the heart while reducing its work load. When used regularly on a long-term basis, this helps prevent angina attacks from occurring.

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

Before Using Nitrek

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 nitroglycerin transdermal 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 nitroglycerin transdermal in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving nitroglycerin transdermal.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal 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. 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.

• Sildenafil


• Tadalafil


• Vardenafil

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.

• Alteplase, Recombinant

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.

• Acetylcysteine


• Aspirin


• Dihydroergotamine


• Pancuronium

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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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:

• Cardioversion (medical heart procedure) or


• Defibrillation (medical heart procedure)—Use with caution. The patch should be removed before having these procedures.

• Congestive heart failure or


• Heart attack, recent or


• Hypertrophic cardiomyopathy (a heart disease) or


• Hypotension (low blood pressure) or


• Hypovolemia (low amount of blood)—Use with caution. May make these conditions worse.

Proper Use of nitroglycerin

This section provides information on the proper use of a number of products that contain nitroglycerin. It may not be specific to Nitrek. Please read with care.

Use this medicine exactly as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. It will only work if applied correctly.

This form of nitrate is used to reduce the number of angina attacks over a long time. It will not relieve an attack that has already started because it works too slowly. The ointment and patch forms release medicine gradually to provide an effect for 7 to 10 hours. Check with your doctor if you also need a fast-acting medicine to relieve the pain of an angina attack.

You should use this medicine first thing in the morning and follow the same schedule each day. This medicine works best if you have a "drug-free" period of time every day when you do not use it. Your doctor will schedule your doses during the day to allow for a drug-free time. Follow the schedule of dosing carefully so the medicine will work properly.

This medicine comes with a patient information leaflet. Read and follow the instructions in the leaflet carefully. Ask your doctor if you have any questions.

For patients using the ointment:

• Before applying a new dose of ointment, remove any ointment remaining on the skin from a previous dose. This will allow the fresh ointment to release the nitroglycerin properly.


• This medicine comes with papers to help measure the dose. Use them to measure the length of ointment squeezed from the tube and to apply the ointment to the skin. Do not rub or massage the ointment into the skin. Spread it in a thin, even layer, and cover an area of skin that is the same size each time it is applied.


• Apply the ointment to skin with little or no hair that is free of scars, cuts, or irritation.


• Apply each dose of ointment to a different area of skin to prevent irritation.


• If your doctor has ordered an airtight covering or dressing (such as plastic kitchen wrap) be placed over this medicine, make sure you know how to apply it. Airtight dressings will increase the amount of medicine absorbed through the skin and may cause more side effects. Use them only as directed and check with your doctor if you have any questions about this.

For patients using the patch system:

• Wash your hands with soap and water before and after applying a patch. Do not touch your eyes until after you have washed your hands.


• Do not try to trim or cut the adhesive patch to adjust the dosage. Check with your doctor if you think the medicine is not working as it should.


• Apply the patch to a clean, dry skin area with little or no hair that is free of scars, cuts, or irritation.


• Always remove a previous patch before applying a new one.


• Apply a new patch if the first one becomes loose or falls off.


• Apply each patch to a different area to prevent skin irritation.

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 angina prevention:
  
  • For transdermal dosage form (ointment):
    
    • Adults—At first, 7.5 milligrams (mg), one-half inch of ointment, two times a day. Apply the first dose in the morning right after you wake up, and the second dose 6 hours later. Your doctor may increase your dose as needed.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For transdermal dosage form (skin patch):
    
    • Adults—Apply one patch once a day in the morning. Leave the patch in place for a total of 12 to 14 hours.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, apply 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.

If you forget to wear or change a patch, put one on as soon as you can. If it is almost time to put on your next patch, wait until then to apply a new patch and skip the one you missed. Do not apply extra patches to make up for a missed dose.

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.

After removing a used patch, fold it in half with the sticky sides together. Make sure to dispose of it out of the reach of children and pets.

Precautions While Using Nitrek

If you will be taking this medicine for a long time, it is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Do not take sildenafil (Viagra®), tadalafil (Cialis®), or vardenafil (Levitra®) while you are using this medicine. Using these medicines together may cause blurred vision, dizziness, lightheadedness, or fainting. If you are taking these medicines and you experience an angina attack, you must go to the hospital right away.

This medicine may cause headaches. These headaches are a sign that the medicine is working. Do not stop using the medicine or change the time you use it in order to avoid the headaches. If you have severe pain, talk with your doctor.

Dizziness, lightheadedness, or faintness may occur, especially when you get up quickly from a lying or sitting position. Getting up slowly may help.

Dizziness, lightheadedness, or fainting is also more likely to occur if you drink alcohol, stand for long periods of time, exercise, or if the weather is hot. While you are taking this medicine, be careful to limit the amount of alcohol you drink. Also, use extra care during exercise or hot weather or if you must stand for long periods of time.

Do not stop using this medicine without checking with your doctor first. Your doctor may want you to gradually reduce the amount you are using before stopping it completely.

Tell the doctor in charge that you are using this medicine before having a magnetic resonance imaging (MRI) scan. Skin burns may occur at the site where the patch is worn during this procedure. Ask your doctor if the patch should be removed before having an MRI scan. You might need to put on a new patch after the procedure.

Nitrek 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:

More common

• Lightheadedness

Less common

• Arm, back, or jaw pain


• blurred vision


• chest pain or discomfort


• chest tightness or heaviness


• confusion


• dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly


• fainting


• fast or irregular heartbeat


• nausea


• shortness of breath


• sweating


• unusual tiredness or weakness

Rare

• Bluish-colored lips, fingernails, or palms


• dark urine


• difficulty with breathing


• fever


• headache


• pale skin


• rapid heart rate


• sore throat


• unusual bleeding or bruising

Incidence not known

• Blistering, burning, crusting, dryness, or flaking of the skin


• cough


• difficulty with swallowing


• hives


• itching, scaling, severe redness, soreness, or swelling of the skin


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


• skin rash


• wheezing

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Blurred or loss of vision


• bulging soft spot on the head of an infant


• change in consciousness


• change in the ability to see colors, especially blue or yellow


• cold, clammy skin


• disturbed color perception


• double vision


• feeling of constant movement of self or surroundings


• halos around lights


• headache, severe and throbbing


• loss of consciousness


• night blindness


• overbright appearance of lights


• paralysis


• sensation of spinning


• tunnel vision

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:

Rare

• Burning, itching, redness, skin rash, swelling, or soreness at the application site

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: Nitrek 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 Nitrek resources

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

• Nitroglycerin Professional Patient Advice (Wolters Kluwer)


• Nitroglycerin Monograph (AHFS DI)


• Nitroglycerin MedFacts Consumer Leaflet (Wolters Kluwer)


• Minitran Prescribing Information (FDA)


• Minitran Patch MedFacts Consumer Leaflet (Wolters Kluwer)


• Nitro-Bid Ointment MedFacts Consumer Leaflet (Wolters Kluwer)


• Nitro-Bid Prescribing Information (FDA)


• Nitro-Dur Prescribing Information (FDA)


• Nitro-Time Controlled-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)


• Nitro-Time Prescribing Information (FDA)


• NitroMist Aerosol MedFacts Consumer Leaflet (Wolters Kluwer)


• NitroMist Consumer Overview


• NitroMist Prescribing Information (FDA)


• NitroQuick MedFacts Consumer Leaflet (Wolters Kluwer)


• Nitrogard MedFacts Consumer Leaflet (Wolters Kluwer)


• Nitrolingual Prescribing Information (FDA)


• Nitrostat Prescribing Information (FDA)


• Rectiv Consumer Overview

Compare Nitrek with other medications

• Angina
• Angina Pectoris Prophylaxis
• Heart Attack
• Heart Failure
• High Blood Pressure

Mefenamic Acid

Class: Other Nonsteroidal Anti-inflammatory Agents
VA Class: MS120
Chemical Name: N-(2,3-xylyl)anthranilic acid
Molecular Formula: C₁₅H₁₅NO₂
CAS Number: 61-68-7
Brands: Ponstel

• Cardiovascular Risk


• 
  

  Possible increased risk of serious (sometimes fatal) cardiovascular thrombotic events (e.g., MI, stroke).^{125 b} Risk may increase with duration of use.^{125 b} Individuals with cardiovascular disease or risk factors for cardiovascular disease may be at increased risk.^{125 b} (See Cardiovascular Effects under Cautions.)

  
  


• 
  

  Contraindicated for the treatment of pain in the setting of CABG surgery.^{125 b}

  
  

• GI Risk


• 
  

  Increased risk of serious (sometimes fatal) GI events (e.g., bleeding, ulceration, perforation of the stomach or intestine).^{100 104 125 b} Serious GI events can occur at any time and may not be preceded by warning signs and symptoms.^{100 101 104 125 b} Geriatric individuals are at greater risk for serious GI events.^{125 b} (See GI Effects under Cautions.)

  
  

Introduction

Prototypical NSAIA; anthranilic acid derivative (fenamate); structurally and pharmacologically related to meclofenamate sodium.^{125 a}

Uses for Mefenamic Acid

Consider potential benefits and risks of mefenamic acid therapy as well as alternative therapies before initiating therapy with the drug.^{125 b} Use lowest possible effective dosage and shortest duration of therapy consistent with patient’s treatment goals.^{125 b}

Pain

Relief of mild to moderate pain in patients ≥14 years of age when the duration of therapy ≤1 week.^{125 b}

Dysmenorrhea

Treatment of primary dysmenorrhea.^{125 b}

Fever

Has been used for reduction of fever† associated with infection in children; routine use as an antipyretic not recommended because of potential adverse effects.^a

Mefenamic Acid Dosage and Administration

General

• 
  

  Consider potential benefits and risks of mefenamic acid therapy as well as alternative therapies before initiating therapy with the drug.^{125 b}

  
  

Administration

Oral Administration

Administer orally.¹²⁵ May be administered in divided doses up to 4 times daily.¹²⁵

Dosage

To minimize the potential risk of adverse cardiovascular and/or GI events, use lowest effective dosage and shortest duration of therapy consistent with the patient’s treatment goals.^{125 b} Adjust dosage based on individual requirements and response; attempt to titrate to the lowest effective dosage.^{125 b}

Pediatric Patients

Pain

Oral

Adolescents ≥14 years of age should receive dosage recommended for adults.¹²⁵ (See Adult Dosage.)

Adults

Pain

Oral

For mild to moderate pain in adults, 500 mg initially followed by 250 mg every 6 hours as necessary.¹²⁵

Dysmenorrhea

Oral

For relief of primary dysmenorrhea in adults, 500 mg initially followed by 250 mg every 6 hours as necessary.¹²⁵ Initiate at onset of bleeding and associated symptoms; treatment should not be necessary for >2–3 days.¹²⁵

Prescribing Limits

Pediatric Patients

Pain

Oral

Duration of therapy usually should not exceed 1 week.¹²⁵

Adults

Pain

Oral

Duration of therapy usually should not exceed 1 week.¹²⁵

Dysmenorrhea

Oral

Therapy should not be necessary for more than 2–3 days.¹²⁵

Special Populations

Hepatic Impairment

Dosage reduction may be required.¹²⁵

Renal Impairment

Dosage reduction may be required if used in patients with renal impairment.¹²⁵

Use not recommended in patients with preexisting renal disease or substantial renal impairment.¹²⁵

Geriatric Patients

Select dosage carefully since may be more likely to have decreased renal function.^{125 b}

Cautions for Mefenamic Acid

Contraindications

• 
  

  Known hypersensitivity to mefenamic acid or any ingredient in the formulation.^{125 b}

  
  


• 
  

  History of asthma, urticaria, or other sensitivity reaction precipitated by aspirin or other NSAIAs.^{125 b}

  
  


• 
  

  Treatment of perioperative pain in the setting of CABG surgery.^{125 b}

  
  


• 
  

  Active ulceration or chronic inflammation of upper or lower GI tract.¹²⁵

  
  


• 
  

  Preexisting renal disease.¹²⁵

  
  

Warnings/Precautions

Warnings

Cardiovascular Effects

Selective COX-2 inhibitors have been associated with increased risk of cardiovascular events (e.g., MI, stroke) in certain situations.^{125 129} Several prototypical NSAIAs also have been associated with increased risk of cardiovascular events.^{125 133 134 135} Information not available on risk associated with mefenamic acid at this time.^{133 134 135 136}

Use NSAIAs with caution and careful monitoring (e.g., monitor for development of cardiovascular events) and at the lowest effective dosage for the shortest duration necessary.^{125 b}

Short-term use to relieve acute pain, especially at low dosages, does not appear to be associated with increased risk of serious cardiovascular events (except immediately following CABG surgery).^{125 b}

No consistent evidence that concomitant use of low-dose aspirin mitigates the increased risk of serious adverse cardiovascular events associated with NSAIAs.^{125 b} (See Specific Drugs under Interactions.)

Hypertension and worsening of preexisting hypertension reported; either event may contribute to the increased incidence of cardiovascular events.^{125 b} Use with caution in patients with hypertension; monitor BP.^{125 b} Impaired response to certain diuretics may occur.^{125 b} (See Specific Drugs under Interactions.)

Fluid retention and edema reported.^{125 b} Caution in patients with fluid retention or heart failure.^{125 b}

GI Effects

Serious GI toxicity (e.g., bleeding, ulceration, perforation) can occur with or without warning symptoms; increased risk in those with a history of GI bleeding or ulceration, geriatric patients, smokers, those with alcohol dependence, and those in poor general health.^{100 104 124 125 126 b}

For patients at high risk for complications from NSAIA-induced GI ulceration (e.g., bleeding, perforation), consider concomitant use of misoprostol;^{124 127 h i} alternatively, consider concomitant use of a proton-pump inhibitor (e.g., omeprazole)^{124 h i} or use of an NSAIA that is a selective inhibitor of COX-2 (e.g., celecoxib).^{125 h}

Renal Effects

Direct renal injury, including renal papillary necrosis, reported in patients receiving long-term NSAIA therapy.^{125 b}

Potential for overt renal decompensation.^{125 b} Increased risk of renal toxicity in patients with renal or hepatic impairment or heart failure, in geriatric patients, in patients with volume depletion, and in those receiving a diuretic, ACE inhibitor, or angiotensin II receptor antagonist.^{125 128 b} (See Renal Impairment under Cautions.)

Sensitivity Reactions

Hypersensitivity Reactions

Anaphylactoid reactions reported.^{125 b}

Immediate medical intervention and discontinuance for anaphylaxis.^{125 b}

Avoid in patients with aspirin triad (aspirin sensitivity, asthma, nasal polyps); caution in patients with asthma.^{125 b}

Dermatologic Reactions

Serious skin reactions (e.g., exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis) reported; can occur without warning.^{125 b} Discontinue at first appearance of rash or any other signs of hypersensitivity (e.g., blisters, fever, pruritus).^{125 b}

General Precautions

Hepatic Effects

Severe reactions including jaundice, fatal fulminant hepatitis, liver necrosis, and hepatic failure (sometimes fatal) reported rarely with NSAIAs.^{125 b}

Elevations of serum ALT or AST reported.^{125 b}

Monitor for symptoms and/or signs suggesting liver dysfunction; monitor abnormal liver function test results.^{125 b} Discontinue if signs or symptoms of liver disease or systemic manifestations (e.g., eosinophilia, rash) occur.^{125 b}

Hematologic Effects

Anemia reported rarely.^{125 b} Determine hemoglobin concentration or hematocrit in patients receiving long-term therapy if signs or symptoms of anemia occur.^{125 b}

May inhibit platelet aggregation and prolong bleeding time.^{125 b}

Ocular Effects

Visual disturbances reported; ophthalmic evaluation recommended if visual changes occur.^{125 a}

Other Precautions

Not a substitute for corticosteroid therapy; not effective in the management of adrenal insufficiency.^{125 b}

May mask certain signs of infection.^{125 b}

Obtain CBC and chemistry profile periodically during long-term use.^{125 b}

Specific Populations

Pregnancy

Category C.^{125 b} Avoid use in third trimester because of possible premature closure of the ductus arteriosus.^{125 b}

Lactation

Distributed into milk.^{125 c} Discontinue nursing or the drug.¹²⁵

Pediatric Use

Safety and efficacy not established in children <14 years of age.¹²⁵

Geriatric Use

Use with caution in patients ≥65 years of age.^{125 b} Geriatric adults appear to tolerate therapy less well (e.g., possible higher incidence of adverse GI effects, greater risk of developing renal decompensation) than younger individuals.^{125 b} Fatal adverse GI effects reported more frequently in geriatric patients than younger adults.^{125 b}

Substantially eliminated by kidneys; periodic monitoring of renal function may be useful since geriatric patients are more likely to have decreased renal function.¹²⁵ (See Geriatric Patients under Dosage and Administration and Renal Impairment under Cautions.)

Renal Impairment

Use not recommended in patients with preexisting renal disease or substantial renal impairment.¹²⁵

Common Adverse Effects

Abdominal pain,¹²⁵ constipation,¹²⁵ diarrhea,¹²⁵ dyspepsia,¹²⁵ flatulence,¹²⁵ gross bleeding/perforation,¹²⁵ heartburn,¹²⁵ nausea,¹²⁵ GI ulcers (gastric/duodenal),¹²⁵ vomiting,¹²⁵ abnormal renal function,¹²⁵ anemia,¹²⁵ dizziness,¹²⁵ edema,¹²⁵ elevated liver enzymes,¹²⁵ headaches,¹²⁵ increased bleeding time,¹²⁵ pruritus,¹²⁵ rashes,¹²⁵ tinnitus.¹²⁵

Interactions for Mefenamic Acid

Protein-bound Drugs

Possible pharmacokinetic interaction; potential for mefenamic acid to be displaced from binding sites by, or to displace from binding sites, other protein-bound drugs (e.g., oral anticoagulants, hydantoins, salicylates, sulfonamides, and sulfonylureas).^{125 a f} Observe for adverse effects if used with other protein-bound drugs.^a

Drugs Affecting Hepatic Microsomal Enzymes

Inhibitors of CYP2C9: possible altered safety and efficacy of mefenamic acid.¹²⁵

Specific Drugs

Drug	Interaction	Comments
ACE inhibitors	Reduced BP response to ACE inhibitor possible 125 128 b Possible deterioration of renal function in individuals with renal impairment128	Monitor BP128
Angiotensin II receptor antagonists	Reduced BP response to angiotensin II receptor antagonist possible128 Possible deterioration of renal function in individuals with renal impairment128	Monitor BP128
Antacids (magnesium-containing)	Increased peak plasma concentrations and AUC of mefenamic acid125 d
Anticoagulants (e.g., warfarin)	Possible bleeding complications125 128 a b e	Use with caution; frequent monitoring of PT advised125 128 a e
Aspirin	Increased risk of GI ulceration or other complications 125 128 b No consistent evidence that low-dose aspirin mitigates the increased risk of serious cardiovascular events associated with NSAIAs125 b	Concomitant use generally not recommended125 b
Diuretics (furosemide, thiazides)	Reduced natriuretic effects possible125 b	Monitor for diuretic efficacy and renal failure125 b
Lithium	Increased plasma lithium concentrations105 125 b	Monitor for lithium toxicity105 125 b
Methotrexate	Possible toxicity associated with increased plasma methotrexate concentrations during concomitant NSAIA use125 b	Caution advised125 b

Mefenamic Acid Pharmacokinetics

Absorption

Bioavailability

Rapidly absorbed following oral administration.^{125 a} Peak plasma concentrations usually attained within 2–4 hours.^{125 a}

Food

Effect of food on rate and extent of absorption not known.¹²⁵

Distribution

Extent

Appears to cross the placenta.^g

Distributed into milk in small amounts.^{125 c}

Plasma Protein Binding

>90%.¹²⁵

Elimination

Metabolism

Metabolized by CYP2C9 to 3′-hydroxymethyl mefenamic acid; further oxidation to 3′-carboxymefenamic acid may occur. ¹²⁵ Mefenamic acid and its metabolites also are glucuronidated.¹²⁵

Elimination Route

Excreted in urine (52%) primarily as glucuronic acid conjugates of the drug and its metabolites and in feces (<20%).¹²⁵

Half-life

Mefenamic acid: approximately 2 hours.¹²⁵ Half-lives of 3′-hydroxymethyl mefenamic acid and 3′-carboxymefenamic acid may be longer than parent compound.¹²⁵

Special Populations

Half-life 5 times longer in preterm infants compared with adults.¹²⁵

In patients with renal or hepatic impairment, clearance of metabolites may be decreased.¹²⁵

Not substantially removed by hemodialysis.^{125 a}

Stability

Storage

Oral

Capsules

20–25°C (may be exposed to 15–30°C).^{125 a}

ActionsActions

• 
  

  Inhibits cyclooxygenase-1 (COX-1) and COX-2.^{117 118 119 120 121 122}

  
  


• 
  

  Pharmacologic actions similar to those of other prototypical NSAIAs; exhibits anti-inflammatory, analgesic, and antipyretic activity.^{125 a}

  
  

Advice to Patients

• 
  

  Importance of reading the medication guide for NSAIAs that is provided to the patient each time the drug is dispensed.^{125 b}

  
  


• 
  

  Risk of serious cardiovascular events with long-term use.^{125 133 134 135 136 b} Importance of notifying clinician if signs and symptoms of a cardiovascular event (chest pain, dyspnea, weakness, slurred speech) occur.^{125 b}

  
  


• 
  

  Risk of GI bleeding and ulceration.^{100 104 125 b} Importance of notifying a clinician if signs and symptoms of serious adverse GI effects occur.^{125 b}

  
  


• 
  

  Importance of discontinuing mefenamic acid and contacting clinician if rash or other signs of hypersensitivity (blisters, fever, pruritus) develop.^{125 b} Importance of seeking immediate medical attention if an anaphylactic reaction occurs.^{125 b}

  
  


• 
  

  Risk of hepatotoxicity.^{125 b} Importance of discontinuing therapy and contacting a clinician immediately if signs and symptoms of hepatotoxicity (nausea, fatigue, lethargy, pruritus, jaundice, upper right quadrant tenderness, flu-like symptoms) occur.^{125 b}

  
  


• 
  

  Importance of notifying clinician if signs and symptoms of unexplained weight gain or edema develop.^{125 b}

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.¹²⁵ Importance of avoiding mefenamic acid in late pregnancy (third trimester).¹²⁵

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.¹²⁵

  
  


• 
  

  Importance of informing patients of other important precautionary information.¹²⁵ (See Cautions.)

  
  

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Mefenamic Acid

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Capsules	250 mg*	Ponstel	First Horizon

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Ponstel 250MG Capsules (SHIONOGI PHARMA): 100/$1345.97 or 300/$3989.97

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions November 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

100. Palmer JF. Letter sent to Lents CE, of Parke Davis, Division of Warner-Lambert Company regarding labeling revisions about gastrointestinal adverse reactions to Ponstel (mefenamic acid). Rockville, MD: Food and Drug Administration, Division of Oncology and Radiopharmaceutical Drug Products. 1988 Sep.

101. Food and Drug Administration. Labeling revisions for NSAIDs. FDA Drug Bull. 1989; 19:3-4.

102. Searle. Cytotec (misoprostol) prescribing information. Skokie, IL; 1989 Jan.

104. Soll AH, Weinstein WM, Kurata J et al. Nonsteroidal anti-inflammatory drugs and peptic ulcer disease. Ann Intern Med. 1991; 114:307-19. [IDIS 277370] [PubMed 1987878]

105. Nonsteroidal anti-inflammatory drug interactions: Lithium. In: Hansten PD, Horn JR. Drug interactions and updates. Vancouver, WA: Applied Therapeutics, Inc; 1993:608-9.

106. Miller LG, Bowman RC, Bakht F. Sparing effect of sulindac on lithium levels. J Fam Prac. 1989; 28:592-3.

107. Corticosteroid interactions: nonsteroidal anti-inflammatory drugs (NSAIDs). In: Hansten PD, Horn JR. Drug interactions and updates. Vancouver, WA: Applied Therapeutics, Inc; 1993:562.

108. Garcia Rodriguez LA, Jick H. Risk of upper gastrointestinal bleeding and perforation associated with individual non-steroidal anti-inflammatory drugs. Lancet. 1994; 343:769-72. [IDIS 328176] [PubMed 7907735]

109. Hollander D. Gastrointestinal complications of nonsteroidal anti-inflammatory drugs: prophylactic and therapeutic strategies. Am J Med. 1994; 96:274-81. [IDIS 328041] [PubMed 8154516]

110. Schubert TT, Bologna SD, Yawer N et al. Ulcer risk factors: interaction between Helicobacter pylori infection, nonsteroidal use, and age. Am J Med. 1993; 94:413-7. [IDIS 314155] [PubMed 8475935]

111. Bateman DN, Kennedy JG. Non-steroidal anti-inflammatory drugs and elderly patients: the medicine may be worse than the disease. BMJ. 1995; 310:817-8. [IDIS 345154] [PubMed 7711609]

112. Piper JM, Ray WA, Daugherty JR et al. Corticosteroid use and peptic ulcer disease: role of nonsteroidal anti-inflammatory drugs. Ann Intern Med. 1991; 114:735-40. [IDIS 280191] [PubMed 2012355]

113. Lithium interactions: diclofenac. In: Hansten PD, Horn JR. Drug interactions and updates. Vancouver, WA: Applied Therapeutics, Inc; 1993:607.

114. Ciba Geigy, Ardsley, NY: Personal communication on diclofenac 28:08.04.

115. Reviewers’ comments (personal observations) on diclofenac 28:08.04.

116. Searle. Cytotec (misoprostol) prescribing information. 1989 Jan.

117. Hawkey CJ. COX-2 inhibitors. Lancet. 1999; 353:307-14. [IDIS 418284] [PubMed 9929039]

118. Kurumbail RG, Stevens AM, Gierse JK et al. Structural basis for selective inhibition of cyclooxygenase-2 by anti-inflammatory agents. Nature. 1996; 384:644-8. [PubMed 8967954]

119. Riendeau D, Charleson S, Cromlish W et al. Comparison of the cyclooxygenase-1 inhibitory properties of nonsteroidal anti-inflammatory drugs (NSAIDs) and selective COX-2 inhibitors, using sensitive microsomal and platelet assays. Can J Physiol Pharmaco. 1997; 75:1088-95.

120. DeWitt DL, Bhattacharyya D, Lecomte M et al. The differential susceptibility of prostaglandin endoperoxide H synthases-1 and -2 to nonsteroidal anti-inflammatory drugs: aspirin derivatives as selective inhibitors. Med Chem Res. 1995; 5:325-43.

121. Cryer B, Dubois A. The advent of highly selective inhibitors of cyclooxygenase—a review. Prostaglandins Other Lipid Mediators. 1998; 56:341-61. [PubMed 9990677]

122. Simon LS, Role and regulation of cyclooxygenase-2 during inflammation. Am J Med. 1999; 106(Suppl 5B):37-42S.

123. Morrison BW, Daniels SE, Kotey P et al. Rofecoxib, a specific cyclooxygenase-2 inhibitor, in primary dysmenorrhea: a randomized controlled study. Obstet Gynecol. 1999; 94:504-8. [IDIS 437014] [PubMed 10511349]

124. Wolfe MM, Lichtenstein DR, Singh G. Gastrointestinal toxicity of nonsteroidal antiinflammatory drugs. N Engl J Med. 1999; 340:1888-99. [IDIS 426864] [PubMed 10369853]

125. First Horizon Pharmaceutical Corporation. Ponstel (mefenamic acid) capsules prescribing information. Alpharetta, GA; 2006 Jan.

126. Singh G, Triadafilopoulos G. Epidemiology of NSAID induced gastrointestinal complications. J Rheumatol. 1999; 26(suppl 56):18-24.

127. Lanza FL, and the Ad Hoc Committee on Practice Parameters of the American College of Gastroenterology. A guideline for the treatment and prevention of NSAID-induced ulcers. Am J Gastroenterol. 1998; 93:2037-46. [IDIS 417402] [PubMed 9820370]

128. Merck & Co., Inc. Clinoril (sulindac) tablets prescribing information. Whitehouse Station, NJ; 2007 Feb.

129. Food and Drug Administration. Analysis and recommendations for agency action regarding non-steroidal anti-inflammatory drugs and cardiovascular risk. 2005 Apr 6.

130. Cush JJ. The safety of COX-2 inhibitors: deliberations from the February 16-18, 2005, FDA meeting. From the American College of Rheumatology website (). Accessed 2005 Oct 12.

131. Novartis Pharmaceuticals. Diovan (valsartan) capsules prescribing information (dated 1997 Apr). In: Physicians’ desk reference. 53rd ed. Montvale, NJ: Medical Economics Company Inc; 1999:2013-5.

132. Pharmacia. Daypro (oxaprozin) caplets prescribing information. Chicago, IL; 2002 May.

133. McGettigan P, Henry D. Cardiovascular risk and inhibition of cyclooxygenase: a systematic review of observational studies of selective and nonselective inhibitors of cyclooxygenase 2. JAMA. 2006; 296: 1633-44. [PubMed 16968831]

134. Kearney PM, Baigent C, Godwin J et al. Do selective cyclo-oxygenase-2 inhibitors and traditional non-steroidal anti-inflammatory drugs increase the risk of atherothrombosis? Meta-analysis of randomised trials. BMJ. 2006; 332: 1302-5. [PubMed 16740558]

135. Graham DJ. COX-2 inhibitors, other NSAIDs, and cardiovascular risk; the seduction of common sense. JAMA. 2006; 296:1653-6. [PubMed 16968830]

136. Chou R, Helfand M, Peterson K et al. Comparative effectiveness and safety of analgesics for osteoarthritis. Comparative effectiveness review no. 4. (Prepared by the Oregon evidence-based practice center under contract no. 290-02-0024.) . Rockville, MD: Agency for Healthcare Research and Quality. 2006 Sep. Available at: .

a. AHFS drug information 2007. McEvoy GK, ed. Mefenamic acid. Bethesda, MD: American Society of Health-System Pharmacists; 2007:2096-9.

b. US Food and Drug Administration. Proposed NSAID Package Insert Labeling Template 1. From the FDA website (). Accessed 10 Oct 2005.

c. Buchanan RA, Eaton CJ, Koeff ST et al. The breast milk excretion of mefenamic acid. Curr Ther Res Clin Exp. 1968; 10: 592-7. [PubMed 4973976]

d. Neuvonen PJ, Kivistö KT. Enhancement of drug absorption by antacids: an unrecognized drug interaction. Clin Pharmacokinet. 1994; 27:120-8. [PubMed 7955775]

e. Chan TY. Adverse interactions between warfarin and nonsteroidal antinflammatory drugs: mechanisms, clinical significance, and avoidance. Ann Pharmacother. 1995; 29:1274-83. [PubMed 8672833]

f. Diana FJ, Veronich K, Kapoor AL. Binding of nonsteroidal anti-inflammatory agents and their effect on binding of racemic warfarin and its enantiomers to human serum albumin. J Pharm Sci. 1989; 78: 195-9. [PubMed 2724076]

g. MacKenzie IZ, Graf AK, Mitchell MD. Prostaglandins in the fetal circulation following maternal ingestion of a prostaglandin synthetase inhibitor during mid-pregnancy. Int J Gynaecol Obstet. 1985; 23: 455-8. [PubMed 2868938]

h. American College of Rheumatology Subcommittee on Rheumatoid Arthritis Guidelines. Guidelines for the management of rheumatoid arthritis; 2002 update. Arthritis Rheum. 2002; 46:328-46. [IDIS 476480] [PubMed 11840435]

i. Anon. Drugs for rheumatoid arthritis. Med Lett Drugs Ther. 2000; 42:57-64. [PubMed 10887424]

More Mefenamic Acid resources

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

• Mefenamic Acid MedFacts Consumer Leaflet (Wolters Kluwer)


• Mefenamic Acid Prescribing Information (FDA)


• Mefenamic Acid Professional Patient Advice (Wolters Kluwer)


• mefenamic acid Concise Consumer Information (Cerner Multum)


• mefenamic acid Advanced Consumer (Micromedex) - Includes Dosage Information


• Ponstel Prescribing Information (FDA)

Compare Mefenamic Acid with other medications

• Pain
• Period Pain

Fluvirin Preservative-Free injectable

Generic Name: influenza virus vaccine (injectable) (in floo ENZ a VYE rus VAK seen)

Brand Names: Afluria, Fluarix, FluLaval, Fluvirin, Fluvirin Preservative-Free, Fluzone, Fluzone Preservative-Free, Fluzone Preservative-Free Pediatric

What is influenza virus injectable vaccine?

Influenza virus (commonly known as "the flu") is a serious disease caused by a virus. Influenza virus can spread from one person to another through small droplets of saliva that are expelled into the air when an infected person coughs or sneezes. The virus can also be passed through contact with objects the infected person has touched, such as a door handle or other surfaces.

Influenza virus vaccine is used to prevent infection caused by influenza virus. The vaccine is redeveloped each year to contain specific strains of inactivated (killed) flu virus that are recommended by public health officials for that year.

The injectable influenza virus vaccine (flu shot) is a "killed virus" vaccine. Influenza virus vaccine is also available in a nasal spray form, which is a "live virus" vaccine.

Influenza virus vaccine works by exposing you to a small dose of the virus, which helps your body to develop immunity to the disease. Influenza virus vaccine will not treat an active infection that has already developed in the body.

Influenza virus vaccine is for use in adults and children who are at least 6 months old.

Becoming infected with influenza (commonly known as "the flu") is much more dangerous to your health than receiving the vaccine to protect against it. Influenza causes thousands of deaths each year, and hundreds of thousands of hospitalizations. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.

Like any vaccine, influenza virus vaccine may not provide protection from disease in every person. This vaccine will not prevent illness caused by avian flu ("bird flu").

What is the most important information I should know about this vaccine?

The injectable influenza virus vaccine (flu shot) is a "killed virus" vaccine. Influenza virus vaccine is also available in a nasal spray form, which is a "live virus" vaccine. This medication guide addresses only the injectable form of this vaccine.

You can still receive a vaccine if you have a cold or fever. In the case of a more severe illness with a fever or any type of infection, wait until you get better before receiving this vaccine.

Keep track of any and all side effects you have after receiving this vaccine. If you ever have to receive another influenza virus vaccine in the future, you will need to tell the doctor if the first shot caused any side effects.

Like any vaccine, influenza virus vaccine may not provide protection from disease in every person. This vaccine will not prevent illness caused by avian flu ("bird flu").

Becoming infected with influenza (commonly known as "the flu") is much more dangerous to your health than receiving the vaccine to protect against it. Influenza causes thousands of deaths each year, and hundreds of thousands of hospitalizations. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.

What should I discuss with my healthcare provider before receiving this vaccine?

Do not receive this vaccine if you have ever had an allergic reaction to a flu vaccine, or if you have:

• 
  

  an active or uncontrolled neurologic disorder (such as Parkinson's disease, Alzheimer's disease, or epilepsy);

  
  


• 
  

  a history of Guillain-Barré syndrome (especially if you had it within 6 weeks after having a flu vaccine); or

  
  


• 
  

  if you are allergic to chicken or egg products.

  
  

Before receiving influenza virus vaccine, tell your doctor if you are allergic to any drugs, or if you have:

• 
  

  a bleeding or blood clotting disorder such as hemophilia or easy bruising;

  
  


• 
  

  a neurologic disorder or disease affecting the brain (or if this was a reaction to a previous vaccine);

  
  


• 
  

  an allergy to latex rubber;

  
  


• 
  

  a weak immune system caused by disease, bone marrow transplant, or by using certain medicines or receiving cancer treatments; or

  
  


• 
  

  if you are taking a blood thinner such as warfarin (Coumadin).

  
  

You can still receive a vaccine if you have a cold or fever. In the case of a more severe illness with a fever or any type of infection, wait until you get better before receiving this vaccine.

Vaccines may be harmful to an unborn baby and generally should not be given to a pregnant woman. However, not vaccinating the mother could be more harmful to the baby if the mother becomes infected with a disease that this vaccine could prevent. Your doctor will decide whether you should receive this vaccine, especially if you have a high risk of infection with influenza. It is not known whether influenza virus vaccine passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. This vaccine should not be given to a child younger than 6 months old.

How is this given?

Some brands of this vaccine are made for use in adults and not in children. Your child's doctor can recommend the best influenza virus vaccine for your child.

This vaccine is given as an injection (shot) into a muscle. You will receive this injection in a doctor's office or other clinic setting.

You should receive a flu vaccine every year. Your immunity will gradually decrease over the 12 months after you receive the influenza virus vaccine. Children receiving this vaccine may need a booster shot one month after receiving the first vaccine.

The influenza virus vaccine is usually given in October or November. Some people may need to have their vaccines earlier or later. Follow your doctor's instructions.

Your doctor may recommend treating fever and pain with an aspirin-free pain reliever such as acetaminophen (Tylenol) or ibuprofen (Motrin, Advil, and others) when the shot is given and for the next 24 hours. Follow the label directions or your doctor's instructions about how much of this medicine to take.

It is especially important to prevent fever from occurring if you have a seizure disorder such as epilepsy.

What happens if I miss a dose?

Since flu shots are usually given only one time per year, you will most likely not be on a dosing schedule. Call your doctor if you forget to receive your yearly flu shot in October or November.

If your child misses a booster dose of this vaccine, call your doctor for instructions.

What happens if I overdose?

An overdose of this vaccine is unlikely to occur.

What should I avoid before or after receiving this vaccine?

Follow your doctor's instructions about any restrictions on food, beverages, or activity after you receive this vaccine.

Influenza virus injectable vaccine side effects

Influenza virus injectable (killed virus) vaccine will not cause you to become ill with the flu virus that it contains. However, you may have flu-like symptoms at any time during flu season that may be caused by other strains of influenza virus.

You should not receive a booster vaccine if you had a life-threatening allergic reaction after the first shot. Keep track of any and all side effects you have after receiving this vaccine. If you ever have to receive another influenza virus vaccine in the future, you will need to tell the doctor if the first shot caused any side effects. Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:

• 
  

  severe weakness or unusual feeling in your arms and legs (may occur 2 to 4 weeks after you receive the vaccine);

  
  


• 
  

  high fever; or

  
  


• 
  

  unusual bleeding.

  
  

Less serious side effects may include:

• 
  

  low fever, chills;

  
  


• 
  

  redness, bruising, pain, swelling, or a lump where the vaccine was injected;

  
  


• 
  

  headache, tired feeling; or

  
  


• 
  

  joint or muscle pain.

  
  

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect influenza virus injectable vaccine?

Before receiving this vaccine, tell your doctor if you are using phenytoin (Dilantin), theophylline (Respbid, Slo-Bid, Theodur, Uniphyl), or a blood thinner (warfarin, Coumadin).

Also tell the doctor if you have recently received drugs or treatments that can weaken the immune system, including:

• 
  

  an oral, nasal, inhaled, or injectable steroid medicine;

  
  


• 
  

  medications to treat psoriasis, rheumatoid arthritis, or other autoimmune disorders, such as azathioprine (Imuran), efalizumab (Raptiva), etanercept (Enbrel), leflunomide (Arava), and others; or

  
  


• 
  

  medicines to treat or prevent organ transplant rejection, such as basiliximab (Simulect), cyclosporine (Sandimmune, Neoral, Gengraf), muromonab-CD3 (Orthoclone), mycophenolate mofetil (CellCept), sirolimus (Rapamune), or tacrolimus (Prograf).

  
  

This list is not complete and there may be other drugs that can interact with this vaccine. Tell your doctor about all the prescription and over-the-counter medications you have received. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More Fluvirin Preservative-Free resources

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

Compare Fluvirin Preservative-Free with other medications

• Influenza Prophylaxis

Where can I get more information?

• Your doctor or pharmacist may have information about influenza virus vaccine written for health professionals that you may read. You may also find additional information from your local health department or the Centers for Disease Control and Prevention.

See also: Fluvirin Preservative-Free side effects (in more detail)

Folnak

Folnak may be available in the countries listed below.

Ingredient matches for Folnak

Folic Acid

Folic Acid is reported as an ingredient of Folnak in the following countries:

• Serbia

International Drug Name Search

Nipent

Pronunciation: PEN-toe-sta-tin
Generic Name: Pentostatin
Brand Name: Nipent

The use of doses higher than specified by the manufacturer of Nipent is not recommended. Severe kidney, liver, lung, and central nervous system problems (toxicities) have occurred in some studies when using higher than recommended doses. Nipent is not recommended for use with fludarabine. The use of pentostatin in combination with fludarabine has caused severe lung problems; in some cases, this has led to death. Ask your doctor or pharmacist for more information.

Nipent is used for:

Treating certain types of cancer.

Nipent is an antineoplastic. How it prevents growth of cancer cells is unknown.

Do NOT use Nipent if:

• you are allergic to any ingredient in Nipent


• you are taking fludarabine

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

Before using Nipent:

Some medical conditions may interact with Nipent. 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


• if you have an infection, chickenpox, kidney problems, or blood problems

Some MEDICINES MAY INTERACT with Nipent. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Carmustine, cyclophosphamide, etoposide, fludarabine, or vidarabine because the risk of side effects, including life-threatening lung toxicity, may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Nipent 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 Nipent:

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

• Nipent is administered as an injection at your doctor's office, hospital, or clinic.


• If Nipent accidentally spills on your skin, wash it off immediately with soap and water.


• Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor or pharmacist to explain local regulations for proper disposal.


• If you miss a dose of Nipent, contact your doctor right away.

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

Important safety information:

• Nipent may reduce the number of clot-forming cells (platelets) in your blood. To prevent bleeding, avoid situations in which bruising or injury may occur. Report any unusual bleeding, bruising, blood in stools, or dark, tarry stools to your doctor.


• Nipent may lower your body's ability to fight infection. Prevent infection by avoiding contact with people with colds or other infections. Notify your doctor of any signs of infection, including fever, sore throat, rash, or chills.


• If nausea, vomiting, or loss of appetite occurs, ask your doctor or pharmacist for ways to lessen these effects.


• Check with your doctor before having vaccinations while you are using Nipent.


• Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Nipent.


• The use of birth control is recommended while you are using Nipent.


• LAB TESTS, including liver function, kidney function, and complete blood cell count, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.


• Use Nipent with extreme caution in CHILDREN. Safety and effectiveness have not been confirmed.


• PREGNANCY and BREAST-FEEDING: Nipent has been shown to cause harm to the fetus. Avoid becoming pregnant while taking Nipent. If you think you may be pregnant, discuss with your doctor the benefits and risks of using Nipent during pregnancy. It is unknown if Nipent is excreted in breast milk. Do not breast-feed while taking Nipent.

Possible side effects of Nipent:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; fatigue; headache; loss of appetite; muscle pain; nausea; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chills; cough; eye pain or changes in vision; fever; hoarseness; itching; pain, redness, or swelling at the injection site; sore throat; sores on the mouth or lips; unusual bruising or bleeding; unusual tiredness or weakness

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: Nipent 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.

Proper storage of Nipent:

Nipent is usually handled and stored by a health care provider. If you are using Nipent at home, store Nipent as directed by your pharmacist or health care provider.

General information:

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


• Nipent 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 Nipent. 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 Nipent resources

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

• Nipent Prescribing Information (FDA)


• Nipent Advanced Consumer (Micromedex) - Includes Dosage Information


• Nipent Concise Consumer Information (Cerner Multum)


• Nipent Monograph (AHFS DI)


• Pentostatin Prescribing Information (FDA)


• Pentostatin Professional Patient Advice (Wolters Kluwer)

Compare Nipent with other medications

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