Monoket

Generic Name: isosorbide mononitrate (Oral route)

eye-soe-SOR-bide mon-oh-NYE-trate

Commonly used brand name(s)

In the U.S.

• Imdur


• Imdur ER


• Ismo


• Monoket

Available Dosage Forms:

• Tablet, Extended Release


• Tablet

Therapeutic Class: Antianginal

Chemical Class: Nitrate

Uses For Monoket

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

Isosorbide mononitrate 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 Monoket

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 isosorbide mononitrate 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 isosorbide mononitrate 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 isosorbide mononitrate.

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

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:

• 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 isosorbide mononitrate

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

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

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 extended-release form releases medicine gradually to provide its effect for 8 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 take 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 take 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.

Swallow the extended-release tablet whole with a half glass of water. Do not split, crush, or chew it.

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 oral dosage form (extended-release tablets):
    
    • Adults—At first, 30 or 60 milligrams (mg) once a day. Take the dose in the morning right after you wake up. Your doctor may increase your dose as needed.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For oral dosage form (tablets):
    
    • Adults—20 milligrams (mg) two times a day. Take the first dose in the morning right after you wake up, and the second dose 7 hours later.
    
    
    • 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 Monoket

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 first with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely.

Monoket 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

• Abnormal heart sound


• absence of or decrease in body movement


• arm, back, or jaw pain


• black, tarry stools


• bladder pain


• bleeding after defecation


• bleeding gums


• blood in the urine or stools


• blurred vision


• body aches or pain


• burning while urinating


• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings


• chest pain or discomfort


• chest tightness or heaviness


• chills


• cold sweats


• colds


• confusion


• convulsions


• cough or hoarseness


• decreased urine


• diarrhea


• difficult or labored breathing


• difficult, burning, or painful urination


• dilated neck veins


• dizziness


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


• dry mouth


• ear congestion


• extra heartbeats


• fainting


• fast, slow, irregular, pounding, or racing heartbeat or pulse


• fever or chills


• flu-like symptoms


• frequent urge to urinate


• frequent urination


• general feeling of discomfort or illness


• headache


• headache, severe and throbbing


• heart murmur


• increased need to urinate


• increased sweating


• increased thirst


• increased volume of pale, dilute urine


• irregular breathing


• itching, pain, redness, or swelling on the leg


• joint pain, stiffness, or swelling


• lightheadedness


• loss of appetite


• loss of voice


• lower back, side, or stomach pain


• mood changes


• muscle aches and pains


• muscle cramps


• nasal congestion


• nausea or vomiting


• nervousness


• numbness or tingling in the hands, feet, or lips


• pain or discomfort in the arms, jaw, back, or neck


• pain, tension, and weakness upon walking that subsides during periods of rest


• partial or slight paralysis


• passing urine more often


• pinpoint red or purple spots on the skin


• pounding in the ears


• runny nose


• shakiness in the legs, arms, hands, or feet


• shivering


• shortness of breath


• sneezing


• sore on the leg


• sore throat


• sudden decrease in the amount of urine


• sweating


• swelling


• swelling of the face, fingers, feet, or lower legs


• tightness in the chest


• trembling or shaking of the hands or feet


• trouble with sleeping


• troubled breathing


• uncomfortable swelling around the anus


• unusual bleeding or bruising


• unusual tiredness or weakness


• vomiting of blood or material that looks like coffee grounds


• weakness


• weight gain


• wheezing

Rare

• Bluish-colored lips, fingernails, or palms


• dark urine


• pale skin


• rapid heart rate

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:

Less common

• Acid or sour stomach


• anxiety


• back pain


• belching


• blemishes on the skin


• bloated


• breast pain


• burning feeling in the chest or stomach


• burning, dry, or itching eyes


• change in color vision


• changes in vision


• cold sweats


• congestion


• constipation


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


• cough producing mucus


• decreased interest in sexual intercourse


• difficulty seeing at night


• difficulty with moving


• discharge, excessive tearing


• double vision


• drooping upper eyelids


• dull ache or feeling of pressure or heaviness in the legs


• earache


• excess air or gas in the stomach or intestines


• feeling of constant movement of self or surroundings


• feeling of warmth


• feeling unusually cold


• frequent urge to defecate


• frozen shoulder


• full feeling


• hearing loss


• heartburn


• hyperventilation


• inability to have or keep an erection


• increased appetite


• increased sensitivity of the eyes to sunlight


• increased sputum


• indigestion


• irritability


• itching skin near damaged veins


• lack or loss of strength


• loss in sexual ability, desire, drive, or performance


• muscle or bone pain


• muscle stiffness or weakness


• nightmares


• noisy breathing


• pain or tenderness around the eyes and cheekbones


• passing gas


• pimples


• poor concentration


• rash


• redness of the face, neck, arms, and occasionally, upper chest


• redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid


• redness, swelling, or soreness of the tongue


• restlessness


• seeing double


• sensation of spinning


• sleepiness or unusual drowsiness


• sleeplessness


• small clicking, bubbling, or rattling sounds in the lung when listening with a stethoscope


• small lumps under the skin


• sore mouth or tongue


• stiff neck


• stomach bloating, burning, cramping, or pain


• stomach discomfort or upset


• straining while passing stool


• stuffy nose


• sudden sweating


• swollen feet and ankles


• tender, swollen glands in the neck


• tenderness in the stomach area


• terrifying dreams causing sleep disturbances


• tooth disorder


• trouble with swallowing


• unable to sleep


• uncontrolled twisting movements of the neck


• voice changes


• weight loss


• white patches in the mouth, tongue, or throat

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: Monoket side effects (in more detail)

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More Monoket resources

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

• Monoket MedFacts Consumer Leaflet (Wolters Kluwer)


• Monoket Prescribing Information (FDA)


• Isosorbide Mononitrate Prescribing Information (FDA)


• Isosorbide Mononitrate Professional Patient Advice (Wolters Kluwer)


• Imdur Consumer Overview


• Imdur Prescribing Information (FDA)


• Imdur Sustained-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Ismo Prescribing Information (FDA)

Compare Monoket with other medications

• Angina Pectoris Prophylaxis
• Heart Failure

Emtriva

Generic Name: Emtricitabine
Class: Nucleoside and Nucleotide Reverse Transcriptase Inhibitors
VA Class: AM800
Chemical Name: 5-Fluoro-1-(2R, 5S)-[2-(hydroxymethyl)-1,3-oxathiolan-5-yl] cytosine
Molecular Formula: C₈H₁₀FN₃O₃S
CAS Number: 143491-57-0

• 
  

  Lactic acidosis and severe hepatomegaly with steatosis (including some fatalities) reported rarely in patients receiving nucleoside reverse transcriptase inhibitors (NRTIs) alone or in conjunction with other antiretrovirals.¹ (See Hepatic Effects and Lactic Acidosis under Cautions.)

  
  


• 
  

  Single entity or fixed-combination preparations containing emtricitabine not indicated for treatment of chronic hepatitis B virus (HBV) infection; safety and efficacy not established for treatment of HIV infection in patients coinfected with HBV.¹

  
  


• 
  

  Severe, acute exacerbations of HBV reported following discontinuance of emtricitabine.¹ Monitor hepatic function closely with both clinical and laboratory follow-up for at least several months after emtricitabine is discontinued in patients coinfected with HBV and HIV.¹ If appropriate, initiation of treatment for HBV infection may be warranted.¹

  
  

Introduction

Antiretroviral; nucleoside reverse transcriptase inhibitor (NRTI).¹

Uses for Emtriva

Treatment of HIV Infection

Treatment of HIV-1 infection in conjunction with other antiretrovirals.^{1 2 3}

A preferred or alternative NRTI for use in multiple-drug antiretroviral regimens for initial therapy in adults.⁴

Fixed-combination preparation containing emtricitabine and tenofovir (Truvada) used in conjunction with other antiretrovirals.¹⁰ Can be used to decrease pill burden,⁴ but should not be used as a component of a triple NRTI regimen.¹⁰

Fixed-combination preparation containing efavirenz, emtricitabine, and tenofovir (Atripla) used alone or in conjunction with other antiretrovirals.¹⁴ Used to decrease pill burden and improve compliance.¹⁴

Base decision to use emtricitabine in previously treated adults on laboratory testing (e.g., genotype testing, phenotype testing) and treatment history.¹

For treatment of HIV in patients coinfected with hepatitis B virus (HBV), some experts recommend an NRTI combination of tenofovir and (emtricitabine or lamivudine); avoid use of only 1 of these antiretrovirals (may increase risk of HBV resistance).^{4 17}

Postexposure Prophylaxis following Occupational Exposure to HIV

Postexposure prophylaxis of HIV infection† in health-care workers and others exposed occupationally via percutaneous injury or mucous membrane or nonintact skin contact with blood, tissues, or other body fluids associated with risk for transmission of the virus.¹³ Used in conjunction with other antiretrovirals.¹³

Postexposure Prophylaxis following Nonoccupational Exposure to HIV

Postexposure prophylaxis of HIV infection† in individuals who have had nonoccupational exposure to blood, genital secretions, or other potentially infectious body fluids of a person known to be infected with HIV when that exposure represents a substantial risk for HIV transmission.¹² Used in conjunction with other antiretrovirals.¹²

Emtriva Dosage and Administration

Administration

Oral Administration

Administer single-entity preparation (Emtriva) or fixed-combination preparation (Truvada) orally without regard to meals.^{1 10} Administer fixed-combination preparation (Atripla) orally once daily on an empty stomach, preferably at bedtime.¹⁴

Because the dosage of emtricitabine and tenofovir cannot be adjusted individually, the fixed combination containing emtricitabine and tenofovir (Truvada) should not be used in pediatric patients; patients with severe renal impairment (Cl_cr <30 mL/minute); or patients who experience dose-limiting adverse effects.¹⁰

Because the dosage of efavirenz, emtricitabine, and tenofovir cannot be adjusted individually, the fixed combination containing efavirenz, emtricitabine, and tenofovir (Atripla) should not be used in patients with moderate to severe renal impairment (Cl_cr <50 mL/minute).¹⁴

Dosage

Emtricitabine capsules and oral solution are not bioequivalent.¹ (See Bioavailability under Pharmacokinetics.)

Emtriva and Truvada must be given in conjunction with other antiretrovirals.^{1 10} Atripla may be used alone or in conjunction with other antiretrovirals.¹⁴

Dosage of Truvada and Atripla expressed as number of tablets.^{10 14}

Pediatric Patients

Treatment of HIV Infection

Oral

Infants 0–3 months of age: 3 mg/kg (as the oral solution) once daily.¹

Children 3 months to 17 years of age: 6 mg/kg (up to a maximum of 240 mg as the oral solution) once daily.^{1 11}

Children weighing >33 kg who can swallow an intact capsule: 200 mg (as the capsule) once daily.^{1 11}

Adults

Treatment of HIV Infection

Oral

200 mg (as the capsule) once daily.¹ Alternatively, 240 mg (as the oral solution) once daily.^{1 4}

Truvada: 1 tablet once daily.^{4 10}

Atripla: 1 tablet once daily.^{4 14}

Postexposure Prophylaxis following Occupational Exposure to HIV†

Oral

200 mg (as the capsule) once daily.¹³

Initiate postexposure prophylaxis as soon as possible following exposure (within hours rather than days) and continue for 4 weeks, if tolerated.¹³

Postexposure Prophylaxis following Nonoccupational Exposure to HIV†

Oral

200 mg (as the capsule) once daily.¹²

Initiate postexposure prophylaxis as soon as possible following exposure (preferably ≤72 hours after exposure) and continue for 28 days.¹²

Prescribing Limits

Pediatric Patients

Treatment of HIV Infection

Oral

Children 3 months to 17 years of age: Maximum 240 mg (as the oral solution) once daily.¹

Special Populations

Renal Impairment

Treatment of HIV Infection

Oral

Reduce dosage in adults with Cl_cr <50 mL/minute (see tables).¹

Data insufficient to make specific dosage recommendations for pediatric patients with renal impairment; consider reducing dose and/or increasing dosing interval.¹

Table 1. Emtriva Dosage in Adults with Renal Impairment14

Clcr (mL/minute)	Dosage of Capsules	Dosage of Oral Solution
≥50	200 mg every 24 hours	240 mg every 24 hours
30–49	200 mg every 48 hours	120 mg every 24 hours
15–29	200 mg every 72 hours	80 mg every 24 hours
<15	200 mg every 96 hours	60 mg every 24 hours
Hemodialysis patients	200 mg every 96 hours; on day of dialysis, give dose after the procedure	60 mg every 24 hours; give dose after hemodialysis

Table 2. Truvada Dosage in Adults with Renal Impairment10

Clcr (mL/minute)	Dose and Dosing Interval
≥50	One tablet every 24 hours
30–49	One tablet every 48 hours (monitor clinical response and renal function since dosage has not been evaluated clinically)
<30 (including hemodialysis patients)	Not recommended

Atripla: Dosage adjustment not necessary in patients with Cl_cr ≥50 mL/minute.¹⁴ Not recommended in patients with Cl_cr < 50 mL/minute.¹⁴

Geriatric Patients

Select dosage with caution because of age-related decreases in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy.¹

Cautions for Emtriva

Contraindications

• 
  

  Known hypersensitivity to emtricitabine or any ingredient in the formulation.¹

  
  

Warnings/Precautions

Warnings

Hepatic Effects and Lactic Acidosis

Lactic acidosis and severe hepatomegaly with steatosis (sometimes fatal) reported in patients receiving emtricitabine.¹ Reported most frequently in women; obesity and long-term NRTI therapy also may be risk factors.¹ Has been reported in patients with no known risk factors.¹

Use with caution in patients with known risk factors for liver disease.¹

Interrupt therapy if there are clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity (e.g., hepatomegaly and steatosis even in the absence of marked increases in serum aminotransferase concentrations).¹

HIV-infected Individuals Coinfected with Hepatitis B Virus (HBV)

Test all HIV patients for presence of HBV before initiating antiretroviral therapy.¹

Not indicated for treatment of chronic HBV infection.¹

Safety and efficacy not established for treatment of HIV infection in patients coinfected with HBV.¹ (See Treatment of HIV Infection under Uses.)

Severe acute exacerbations of HBV reported following discontinuance of emtricitabine.¹ Exacerbations of HBV have been associated with hepatic decompensation and hepatic failure.¹ If used in those coinfected with HIV and HBV, closely monitor hepatic function (using both clinical and laboratory follow-up) for at least several months after emtricitabine is discontinued.¹ If appropriate, initiation of treatment for HBV infection may be warranted.¹

General Precautions

Do not use multiple emtricitabine-containing preparations concomitantly.¹

Emtricitabine should not be administered with lamivudine or fixed-combination preparations containing lamivudine (Combivir, Epivir, Epivir-HBV, Epzicom, Trizivir).¹

Use of Fixed Combinations

When used in fixed combination with tenofovir (Truvada), consider the cautions, precautions, and contraindications associated with tenofovir.¹⁰

When used in fixed combination with tenofovir and efavirenz (Atripla), consider the cautions, precautions, and contraindications associated with the concomitant agents.¹⁴

Adipogenic Effects

Possible redistribution or accumulation of body fat, including central obesity, dorsocervical fat enlargement (“buffalo hump”), peripheral wasting, breast enlargement, and general cushingoid appearance.¹

Immune Reconstitution Syndrome

During initial treatment, patients who respond to antiretroviral therapy may develop an inflammatory response to indolent or residual opportunistic infections (e.g., Mycobacterium avium complex [MAC], M. tuberculosis, cytomegalovirus [CMV], Pneumocystis jiroveci [formerly P. carinii]);¹ this may necessitate further evaluation and treatment.¹

Specific Populations

Pregnancy

Category B.¹

Antiretroviral Pregnancy Registry at 800-258-4263.¹

Some experts state that emtricitabine is an alternative (not a preferred) NRTI for use in multiple-drug antiretroviral regimens in pregnant women.¹⁶

Lactation

Not known whether distributed into human milk.¹

Instruct HIV-infected women not to breast-feed because of risk of HIV transmission and risk of adverse effects in the infant.¹

Pediatric Use

Emtriva: Safety and efficacy in pediatric patients 3 months through 21 years of age supported by evidence from studies in pediatric patients.¹

Pharmacokinetics evaluated in a limited number of neonates born to HIV-infected mothers; efficacy in preventing or treating HIV infection in these neonates not determined.^{1 20}

Adverse effects reported in children similar to adults.¹

Truvada: Safety and efficacy not established in children <18 years of age.^{8 10}

Atripla: Safety and efficacy not established in children <18 years of age.¹⁴

Geriatric Use

Insufficient experience in those ≥65 years of age to determine whether they respond differently than younger adults.¹

Select dosage with caution because of age-related decreases in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy.¹

Renal Impairment

Dosage adjustment necessary based on degree of renal impairment.¹ Monitor clinical response and renal function in patients with renal impairment.¹ (See Renal Impairment under Dosage and Administration.)

Hepatic Impairment

Emtricitabine not metabolized by liver enzymes; any impact of hepatic impairment expected to be limited.¹

Use with caution in patients with known risk factors for liver disease.¹

Common Adverse Effects

Mild to moderate headache; GI effects (diarrhea, nausea); rash.¹

Interactions for Emtriva

Emtricitabine does not inhibit CYP1A2, CYP2A6, CYP2B6, CYP2C9, CYP2C19, CYP2D6, or CYP3A4.¹ Interactions with drugs metabolized by these CYP isoenzymes unlikely.¹

Emtricitabine does not inhibit glucuronosyltransferase (uridine diphosphoglucuronosyltransferase, UDP-glucuronate β-d-glucuronosyltransferase [acceptor-unspecific]), an enzyme responsible for glucuronidation.¹ Pharmacokinetic interactions unlikely.¹

Specific Drugs

Drug	Interaction	Comments
Abacavir	In vitro evidence of additive or synergistic antiretroviral effects1
Darunavir	Pharmacokinetic interaction unlikely18
Delavirdine	In vitro evidence of additive or synergistic antiretroviral effects1
Efavirenz	In vitro evidence of additive or synergistic antiretroviral effects1
Famciclovir	Pharmacokinetic interaction unlikely1
Indinavir	Pharmacokinetic interaction unlikely1
Lamivudine		Do not use concomitantly;1 4 no potential benefit since emtricitabine is an analog of lamivudine and has the same resistance profile4
Nelfinavir	In vitro evidence of additive or synergistic antiretroviral effects1
Nevirapine	In vitro evidence of additive or synergistic antiretroviral effects1
Ritonavir	In vitro evidence of additive or synergistic antiretroviral effects1
Saquinavir	In vitro evidence of additive or synergistic antiretroviral effects1
Stavudine	Pharmacokinetic interaction unlikely1 In vitro evidence of additive or synergistic antiretroviral effects1
Tenofovir	Pharmacokinetic interaction unlikely1 In vitro evidence of additive or synergistic antiretroviral effects1
Tipranavir	In vitro evidence of additive antiretroviral effects19
Zidovudine	In vitro evidence of additive or synergistic antiretroviral effects1

Emtriva Pharmacokinetics

Absorption

Bioavailability

Rapidly and extensively absorbed; peak plasma concentrations attained within 1–2 hours.¹

Capsules: Bioavailability is 93%.¹

Oral solution: Bioavailability is 75%.¹

Fixed-combination tablet containing emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg (Truvada) is bioequivalent to a 200-mg capsule of emtricitabine and a 300-mg tablet of tenofovir disoproxil fumarate given simultaneously.¹⁰

Fixed-combination tablet containing efavirenz 600 mg, tenofovir disoproxil fumarate 300 mg, and emtricitabine 200 mg (Atripla) is bioequivalent to a 600-mg tablet of efavirenz, a 300-mg tablet of tenofovir disoproxil fumarate, and a 200-mg capsule of emtricitabine given simultaneously.¹⁴

Food

Food does not appear to affect absorption.¹

Special Populations

Peak plasma concentrations and AUC increased in patients with renal impairment due to a reduction in renal clearance of the drug.¹ Dosage adjustment needed.¹

AUC reported in pediatric patients 3 months to 17 years of age receiving the recommended dosage (6 mg/kg daily [up to 240 mg daily] as the oral solution or 200-mg capsule once daily) similar to that reported in adults receiving 200 mg daily.¹ AUC reported in neonates receiving 3 mg/kg daily for 4 days similar to that reported in children 3 months to 17 years of age receiving the recommended dosage.¹

Distribution

Extent

Not well characterized.¹

Not known whether crosses the placenta or is distributed into milk.¹

Plasma Protein Binding

<4 %.¹

Elimination

Metabolism

Undergoes oxidation and conjugation with glucuronic acid.¹

Intracellularly, emtricitabine is phosphorylated and converted by cellular enzymes to the active metabolite, emtricitabine 5′-triphosphate.¹

Elimination Route

Excreted in urine (86%) and feces (14%).¹ Eliminated by glomerular filtration and active tubular secretion.¹

Removed by hemodialysis; not known whether removed by peritoneal dialysis.¹

Half-life

10 hours.¹

Special Populations

Renal impairment reduces renal clearance.¹

Stability

Storage

Oral

Capsules

Emtriva: 25°C (may be exposed to 15–30°C).¹

Solution

Emtriva: 2–8°C until dispensed.¹ For patient use, store at 25°C (may be exposed to 15–30°C); use within 3 months.¹

Tablets

Truvada: 25°C (may be exposed to 15–30°C).¹⁰

Atripla: 25°C (may be exposed to 15–30°C).¹⁴

Actions and SpectrumActions

• 
  

  Thio analog of cytidine.¹

  
  


• 
  

  Pharmacologically related to other NRTIs (e.g., abacavir, didanosine, lamivudine, stavudine, zidovudine); differs structurally from these drugs; also differs pharmacologically and structurally from other currently available antiretroviral agents.¹

  
  


• 
  

  Active in vitro against HIV-1 and HIV-2.¹ Also has some activity against HBV.^{5 7}

  
  


• 
  

  Inhibits replication of HIV by interfering with viral RNA-directed DNA polymerase (reverse transcriptase).¹

  
  


• 
  

  Strains of HIV-1 with reduced susceptibility to emtricitabine have been produced in vitro and have emerged during therapy with the drug.¹

  
  


• 
  

  Strains of HIV resistant to emtricitabine may be cross-resistant to some other NRTIs (e.g., lamivudine).¹

  
  


• 
  

  Cross-resistance between emtricitabine and PIs is highly unlikely since the drugs have different target enzymes.⁴ Cross-resistance between emtricitabine and NNRTIs is considered to be low since the drugs bind at different sites on reverse transcriptase and have different mechanisms of action.⁴

  
  

Advice to Patients

• 
  

  Critical nature of compliance with HIV therapy.¹ Importance of using emtricitabine in conjunction with other antiretrovirals—not for monotherapy.¹

  
  


• 
  

  Antiretroviral therapy is not a cure for HIV infection, and opportunistic infections still may occur.¹ HIV transmission via sexual contact or sharing needles is not prevented by antiretrovirals.¹

  
  


• 
  

  Redistribution/accumulation of body fat may occur, with as yet unknown long-term health effects.¹

  
  


• 
  

  Importance of informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal products.¹

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.¹

  
  


• 
  

  Importance of advising patients of other important precautionary information.¹ (See Cautions.)

  
  

Preparations

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

Emtricitabine

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Capsules	200 mg	Emtriva	Gilead
	Solution	10 mg/mL	Emtriva	Gilead

Emtricitabine Combinations

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Tablets, film-coated	200 mg with Tenofovir Disoproxil Fumarate 300 mg	Truvada	Gilead
		200 mg with Tenofovir Disoproxil Fumarate 300 mg and Efavirenz 600 mg	Atripla	Bristol-Myers Squibb and Gilead

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 04/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Atripla 600-200-300MG Tablets (BRISTOL-MYERS SQUIBB/GILEAD): 30/$1795.72 or 90/$5154.14

Emtriva 200MG Capsules (GILEAD SCIENCES): 30/$466 or 60/$883.01

Truvada 200-300MG Tablets (GILEAD SCIENCES): 30/$1071.69 or 90/$3180.65

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 01, 2009. 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

1. Gilead Sciences, Inc. Emtriva (emtricitabine) capsules prescribing information. Foster City, CA; 2008 May.

2. Saag M, Cahn P, Raffi F et al. A randomized, double-blind, multicenter comparison of emtricitabine QD to stavudine BID. Proceedings of ICAAC San Diego 2002. Abstract No. LB-1.

3. Sanne I, van der Horst C, Shaw A et al. Two randomized, controlled, equivalence trials of emtricitabine (FTC) to lamivudine (3TC). Poster presented at the XIV International AIDS Conference. Barcelona, Spain: 2002 Jul 7-12.

4. Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents (November 3, 2008). From the US Department of Health and Human Services HIV/AIDS Information Services (AIDSinfo) website.

5. Seigneres B, Martin P, Werle B et al. Effects of pyrimidine and purine analog combinations in the duck hepatitis B virus infection model. Antimicrob Agents Chemother. 2003; 47:1842-52. [PubMed 12760857]

6. AIDSinfo Drugs Database. Emtricitabine. From the US Department of Health and Human Services HIV/AIDS Information Services (AIDSinfo) web site. Accessed 7 Oct 2003.

7. Gish RG, Leung NWY, Wright TL et al. Dose range study of pharmacokinetics, safety, and preliminary antiviral activity of emtricitabine in adults with hepatitis B virus infection. Antimicrob Agents Chemother. 2002; 46:1734-40. [IDIS 481640] [PubMed 12019083]

8. Gilead, Foster City, CA: Personal communication.

9. Saez-Llorens X, Violari A, Ndiweni D et al. Once daily emtricitabine (FTC) in HIV-infected pediatric patients with other antiretroviral agents. Poster presented at the 10th Conference on Retroviruses and Opportunistic Infections. Boston, MA: 2003 Feb 10-4.

10. Gilead Sciences, Inc. Truvada (emtricitabine and tenofovir disoproxil fumarate) tablet prescribing information. Foster City, CA; 2005 Jan.

11. Working Group on Antiretroviral Therapy and Medical Management of HIV-infected Children of the National Resource Center at the François-Xavier Bagnoud Center, Health Resources and Services Administration (HRSA), and National Institutes of Health (NIH). Guidelines for the use of antiretroviral agents in pediatric HIV infection (February 23, 2009). From the US Department of Health and Human Services HIV/AIDS Information Services (AIDSinfo) website.

12. Center for Disease Control and Prevention. Antiretroviral postexposure prophylaxis after sexual, injection-drug use, or other nonoccupational exposure to HIV in the United States: Recommendations from the U.S. Department of Health and Human Services. MMWR Recomm Rep. 2005; 54(No. RR-2):1-19.

13. Center for Disease Control and Prevention. Updated U.S. public health service guidelines for the management of occupational exposures to HIV and recommendations for postexposure prophylaxis. MMWR Recomm Rep. 2005; 54(No. RR-9):1-17.

14. Bristol-Myers Squibb and Gilead. Atripla (efavirenz 600 mg/emtricitabine 200mg /tenofovir disoproxil fumarate 300mg) tablets prescribing information. Foster City, CA; 2006 Jul.

15. Gallant JE, DeJesus E, Arribas JR et al. Tenofovir DF, emtricitabine, and efavirenz vs. zidovudine, lamivudine, and efavirenz for HIV. N Engl J Med. 2006; 354:251-60. [PubMed 16421366]

16. Perinatal HIV Guidelines Working Group. US Public Health Service Task Force recommendations for use of antiretroviral drugs in pregnant HIV-infected women for maternal health and interventions to reduce perinatal HIV-1 transmission in the United States (April 29, 2009). From the US Department of Health and Human Services HIV/AIDS Information Services (AIDSinfo) website.

17. Hammer SM, Saag MS, Schechter M et al. Treatment of adult HIV infection: 2006 recommendations of the International AIDS Society–USA panel. JAMA. 2006; 296:827-43. [PubMed 16905788]

18. Tibotec. Prezista (darunavir) prescribing information. Raritan, NJ; 2006 Jun.

19. Boehringer Ingelheim. Aptivus (tipranavir) capsules prescribing information. Ridgefield, CT; 2006 Jun 27.

20. Blum MR, Ndiweni D, Chittick G et al. Steady-state pharmacokinetic evaluation of emtricitabine in neonates exposed to HIV in utero. Poster presented at the 13th Conference on Retroviruses and Opportunistic Infections. Denver, CO: 2006 Feb 5-9.

More Emtriva resources

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

• Emtriva Prescribing Information (FDA)


• Emtriva Consumer Overview


• Emtriva Advanced Consumer (Micromedex) - Includes Dosage Information


• Emtriva MedFacts Consumer Leaflet (Wolters Kluwer)


• Emtricitabine Professional Patient Advice (Wolters Kluwer)

Compare Emtriva with other medications

• HIV Infection
• Nonoccupational Exposure

Mapap Sinus Congestion and Pain

Generic Name: acetaminophen and phenylephrine (a SEET a MIN oh fen and FEN il EFF rin)

Brand Names: Alka-Seltzer Plus Cold and Sinus, Excedrin Sinus Headache Caplet, Mapap Sinus Congestion and Pain, Robitussin Nasal Relief, Sinus Congestion and Pain Daytime Cool Ice, Sinus Pain & Pressure, Sudafed PE Sinus Headache, Theraflu Daytime Severe Cold, Tylenol Sinus Congestion Daytime

What is Mapap Sinus Congestion and Pain (acetaminophen and phenylephrine)?

Acetaminophen is a pain reliever and a fever reducer.

Phenylephrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

The combination of acetaminophen and phenylephrine is used to treat headache, fever, body aches, stuffy nose, and sinus congestion caused by allergies, the common cold, or the flu.

Acetaminophen and phenylephrine may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Mapap Sinus Congestion and Pain (acetaminophen and phenylephrine)?

Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death. Do not take this medication without a doctor's advice if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. Do not use this medicine if you have untreated or uncontrolled diseases such as glaucoma, asthma or COPD, high blood pressure, heart disease, coronary artery disease, or overactive thyroid. Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen. Do not use acetaminophen and phenylephrine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects. Ask a doctor or pharmacist before using any other pain, cold, allergy, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP.

What should I discuss with my healthcare provider before taking Mapap Sinus Congestion and Pain (acetaminophen and phenylephrine)?

Do not take this medication without a doctor's advice if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You may not be able to take acetaminophen. Do not use this medicine if you have untreated or uncontrolled diseases such as glaucoma, asthma or COPD, high blood pressure, heart disease, coronary artery disease, or overactive thyroid. Do not use this medicine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Ask a doctor or pharmacist if it is safe for you to take this medicine if you have:

• 
  

  liver disease, cirrhosis, or a history of alcoholism;

  
  


• 
  

  diabetes;

  
  


• 
  

  glaucoma;

  
  


• 
  

  epilepsy or other seizure disorder;

  
  


• 
  

  enlarged prostate or urination problems; or

  
  


• 
  

  pheochromocytoma (an adrenal gland tumor).

  
  

It is not known whether acetaminophen and phenylephrine will harm an unborn baby. Do not use this medicine without a doctor's advice if you are pregnant. Acetaminophen and phenylephrine may pass into breast milk and may harm a nursing baby. Decongestants may also slow breast milk production. Do not use this medicine without a doctor's advice if you are breast-feeding a baby.

How should I take Mapap Sinus Congestion and Pain (acetaminophen and phenylephrine)?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. This medicine is usually taken only for a short time until your symptoms clear up.

Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death. Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

Dissolve one packet of the powder in at least 4 ounces of water. Stir this mixture and drink all of it right away.

Drop the effervescent tablets into a glass of water (at least 4 ounces, or one-half cup). Stir this mixture and drink all of it right away.

Do not take for longer than 7 days in a row. Stop taking the medicine and call your doctor if you still have a fever after 3 days of use, you still have pain after 7 days (or 5 days if treating a child), if your symptoms get worse, or if you have a skin rash, ongoing headache, or any redness or swelling. If you need surgery or medical tests, tell the surgeon or doctor ahead of time if you have taken this medicine within the past few days. Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Since this medicine is taken when needed, you may not be on a dosing schedule. If you are taking the medication regularly, 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. An overdose of acetaminophen can be fatal.

The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.

Overdose symptoms may also include severe forms of some of the side effects listed in this medication guide.

What should I avoid while taking Mapap Sinus Congestion and Pain (acetaminophen and phenylephrine)?

Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP. Avoid drinking alcohol. It may increase your risk of liver damage while you are taking acetaminophen. This medicine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Mapap Sinus Congestion and Pain (acetaminophen and phenylephrine) 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 this medication and call your doctor at once if you have a serious side effect such as:

• 
  

  chest pain, fast, slow, or uneven heart rate;

  
  


• 
  

  confusion, hallucinations;

  
  


• 
  

  tremor, seizure (convulsions);

  
  


• 
  

  urinating less than usual or not at all;

  
  


• 
  

  nausea, pain in your upper stomach, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of your skin or eyes); or

  
  


• 
  

  dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, chest pain, uneven heartbeats, seizure).

  
  

Less serious side effects may include:

• 
  

  dizziness, weakness;

  
  


• 
  

  mild headache;

  
  


• 
  

  mild nausea, diarrhea, upset stomach;

  
  


• 
  

  runny nose;

  
  


• 
  

  feeling nervous, restless, or anxious; or

  
  


• 
  

  sleep problems (insomnia).

  
  

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 Mapap Sinus Congestion and Pain (acetaminophen and phenylephrine)?

Ask a doctor or pharmacist if it is safe for you to take acetaminophen and phenylephrine if you are also using any of the following drugs:

• 
  

  leflunomide (Arava);

  
  


• 
  

  an antibiotic, antifungal medicine, sulfa drug, or tuberculosis medicine;

  
  


• 
  

  birth control pills or hormone replacement therapy;

  
  


• 
  

  blood pressure medication;

  
  


• 
  

  cancer medicine;

  
  


• 
  

  cholesterol-lowering medications such as Lipitor, Niaspan, Zocor, Vytorin, and others;

  
  


• 
  

  gout or arthritis medications (including gold injections);

  
  


• 
  

  HIV/AIDS medication;

  
  


• 
  

  medicines to treat psychiatric disorders;

  
  


• 
  

  an NSAID such as Advil, Aleve, Arthrotec, Cataflam, Celebrex, Indocin, Motrin, Naprosyn, Treximet, Voltaren, others; or

  
  


• 
  

  seizure medication.

  
  

This list is not complete and other drugs may interact with acetaminophen and phenylephrine. 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 Mapap Sinus Congestion and Pain resources

• Mapap Sinus Congestion and Pain Use in Pregnancy & Breastfeeding
• Mapap Sinus Congestion and Pain Drug Interactions
• 0 Reviews for Mapap Sinus Congestion and Pain - Add your own review/rating

Compare Mapap Sinus Congestion and Pain with other medications

• Headache
• Nasal Congestion
• Sinus Symptoms

Where can I get more information?

• Your pharmacist can provide more information about acetaminophen and phenylephrine.

Endo Pharmaceuticals

Address Endo Pharmaceuticals, 220 Lake Drive Newark, DE 19702 Contact Details Phone: (800) 462-3636 Website: http://www.endo.com/ Careers: http://www.endo.com/careers.aspx

Monistat 5

Generic Name: miconazole vaginal (my CAW nah zole)

Brand Names: M-Zole Dual Pack, Micon 7, Monistat 3, Monistat 5, Monistat 7

What is Monistat 5 (miconazole vaginal)?

Miconazole is an antifungal medication. It prevents fungus from growing.

Miconazole vaginal is used to treat vaginal candida (yeast) infections.

Miconazole vaginal may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Monistat 5 (miconazole vaginal)?

Use this medication for the full amount of time prescribed by your doctor or recommended in the package even if you begin to feel better. The symptoms may improve before the infection is completely healed.

Avoid wearing tight-fitting, synthetic clothing (e.g., panty hose) that does not allow air circulation. Wear loose-fitting clothing made of cotton and other natural fibers until the infection is healed.

Avoid getting this medication in the eyes, nose, or mouth.

What should I discuss with my healthcare provider before using Monistat 5 (miconazole vaginal)?

If this is the first time that you have ever had symptoms of a vaginal yeast infection, consult your doctor before using this medication.

Do not use miconazole vaginal if you have ever had an allergic reaction to it.

Before using miconazole vaginal, talk to your doctor if you have

• 
  

  a fever,

  
  


• 
  

  abdominal pain,

  
  


• 
  

  foul-smelling discharge,

  
  


• 
  

  diabetes, or

  
  


• 
  

  HIV or AIDS.

  
  

You may not be able to use miconazole vaginal, or you may require special monitoring during treatment if you have any of the conditions listed above.

Do not use miconazole vaginal without first talking to your doctor if you are pregnant. Do not use miconazole vaginal without first talking to your doctor if you are breast-feeding a baby.

How should I use Monistat 5 (miconazole vaginal)?

Use miconazole vaginal exactly as directed by your doctor or follow the directions that accompany the package. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.

Wash your hands before and after using the medication.

Insert the tablet, suppository, or cream into the vagina using the applicator as directed.

Use this medication for the full amount of time prescribed by your doctor or recommended in the package even if you begin to feel better. The symptoms may improve before the infection is completely healed.

Use this medication continuously, even during your menstrual period.

You can use a sanitary napkin to prevent the medication from staining your clothing but do not use a tampon.

If the infection does not clear up after you have finished one course of therapy, or if it appears to get worse, see your doctor. You may have another type of infection.

Avoid getting this medication in the eyes, nose, or mouth. Store miconazole vaginal at room temperature away from moisture and heat.

What happens if I miss a dose?

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

What happens if I overdose?

An overdose of miconazole vaginal is unlikely. If you do suspect that a much larger than normal dose has been used or that miconazole vaginal has been ingested, contact an emergency room or a poison control center.

What should I avoid while using Monistat 5 (miconazole vaginal)?

Avoid wearing tight-fitting, synthetic clothing (e.g., panty hose) that does not allow air circulation. Wear loose-fitting clothing made of cotton and other natural fibers until the infection is healed.

Miconazole may damage a condom or diaphragm. Use another form of birth control while using miconazole vaginal.

Monistat 5 (miconazole vaginal) side effects

Stop using miconazole vaginal and seek emergency medical attention if you experience an allergic reaction (shortness of breath; closing of your throat; swelling of your lips, face, or tongue; or hives).

Other, less serious side effects may be more likely to occur. These include burning, itching, irritation of the skin, and an increased need to urinate.

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. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Monistat 5 (miconazole vaginal)?

Do not use miconazole vaginal without first talking to your doctor if you are taking warfarin (Coumadin). Special monitoring or a dosage adjustment may be necessary.

Avoid using other vaginal creams or douches at the same time as miconazole vaginal unless otherwise directed by your doctor.

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

More Monistat 5 resources

• Monistat 5 Side Effects (in more detail)
• Monistat 5 Use in Pregnancy & Breastfeeding
• Monistat 5 Drug Interactions
• Monistat 5 Support Group
• 4 Reviews for Monistat 5 - Add your own review/rating

• Baza Antifungal Topical Advanced Consumer (Micromedex) - Includes Dosage Information


• Cruex Prescription Strength Topical Advanced Consumer (Micromedex) - Includes Dosage Information


• Lotrimin AF Lotion MedFacts Consumer Leaflet (Wolters Kluwer)


• Micatin Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• Monistat 3 Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• Monistat 3 Prescribing Information (FDA)


• Monistat 7 Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• Zeasorb-AF Gel MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Monistat 5 with other medications

• Vaginal Yeast Infection

Where can I get more information?

• Your pharmacist has additional information about miconazole vaginal written for health professionals that you may read.

See also: Monistat 5 side effects (in more detail)

measles, mumps, rubella and varicella virus vaccine

Generic Name: measles, mumps, rubella and varicella virus vaccine (MEE zels, MUMPS, roo BEL a, var i SEL a)

Brand Names: ProQuad

What is measles, mumps, rubella, and varicella virus vaccine?

Measles, mumps, rubella, and varicella are serious diseases caused by viruses. They are spread from person to person through the air.

Measles virus can cause minor symptoms such as skin rash, cough, runny nose, eye irritation, or mild fever. It can also cause more serious symptoms such as ear infection, pneumonia, seizures, permanent brain damage, or death.

Mumps virus causes fever, headache, and swollen glands, but more serious symptoms include hearing loss, and painful swelling of the testicles or ovaries. Mumps can cause breathing problems or meningitis, and these infections can be fatal.

Rubella virus (also called German Measles) causes skin rash, mild fever, and joint pain. Becoming infected with rubella during pregnancy can result in a miscarriage or serious birth defects.

Varicella (commonly known as chickenpox) is a common childhood disease that causes fever, skin rash, and a breakout of fluid-filled blisters on the skin. Most people who receive this vaccine will not get chickenpox, or will get only a mild case and will recover faster. Chickenpox is usually mild, but it can be serious or even fatal in young infants and in adults. It can lead to severe skin infection, breathing problems, brain damage, or death. A person who has had chickenpox can develop herpes zoster (also called shingles) later in life, which causes severe nerve pain, and hearing or vision problems, which may last for months or years.

Measles, mumps, rubella, and varicella are spread from person to person.

The measles, mumps, rubella, and varicella vaccine is used to help prevent these diseases in children. This vaccine works by exposing your child to a small dose of the virus or a protein from the virus, which causes the body to develop immunity to the disease. This vaccine will not treat an active infection that has already developed in the body.

Measles, mumps, rubella, and varicella vaccine is for use in children between the ages of 12 months and 12 years old.

Like any vaccine, the measles, mumps, rubella, and varicella vaccine may not provide protection from disease in every person.

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

The measles, mumps, rubella, and varicella vaccine is usually given only once when the child is between 12 months and 12 years old. If a booster dose is needed, At least 3 months should pass between the first and second doses of this vaccine.

Your child should not receive a booster vaccine if he or she had a life threatening allergic reaction after the first shot. Your child can still receive a vaccine if he or she has a minor cold. In the case of a more severe illness with a fever or any type of infection, wait until the child gets better before receiving this vaccine. Keep track of any and all side effects your child has after receiving this vaccine. If the child ever needs to receive a booster dose, you will need to tell the doctor if the previous shots caused any side effects.

Becoming infected with measles, mumps, rubella, or varicella is much more dangerous to your child's health than receiving this vaccine. However, like any medicine, this vaccine can cause side effects but the risk of serious side effects is extremely low.

Do not give your child salicylates such as aspirin, Disalcid, Doan's Pills, Dolobid, Salflex, Tricosal, and others for at least 6 weeks after receiving this vaccine. A serious condition called Reye's Syndrome has been reported in patients with chickenpox who take aspirin or salicylates.

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

Your child should not receive this vaccine if he or she is allergic to eggs, gelatin, or neomycin (Mycifradin, Neo-Fradin, Neo-Tab), or if the child has ever had a life-threatening allergic reaction to any vaccine containing measles, mumps, rubella, or varicella.

Your child should also not receive this vaccine if he or she has:

• 
  

  active tuberculosis infection;

  
  


• 
  

  a cancer such as leukemia or lymphoma;

  
  


• 
  

  a history of Guillain-Barré syndrome;

  
  


• 
  

  a chronic disease such as asthma or other breathing disorder, diabetes, kidney disease, or a blood cell disorder such as anemia;

  
  


• 
  

  severe immune suppression caused by disease (such as cancer, HIV, or AIDS), or by receiving certain medicines such as steroids, chemotherapy or radiation;

  
  


• 
  

  if the child has recently taken aspirin or other similar medicines such as Disalcid, Doan's Pills, Dolobid, Salflex, Tricosal, and others;

  
  


• 
  

  if the child has recently received a stem cell transplant;

  
  


• 
  

  if someone in the child's household has a weak immune system; or

  
  


• 
  

  if the child is pregnant.

  
  

If your child has any of these other conditions, this vaccine may need to be postponed or not given at all:

• 
  

  thrombocytopenia purpura (easy bruising or bleeding);

  
  


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  a history of seizures;

  
  


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

  
  


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

  
  


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  if the child has received an immune globulin or other blood product within the past year; or

  
  


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  if the child has received a measles, mumps, and rubella (MMR) vaccine within the past 28 days (4 weeks).

  
  

Your child can still receive a vaccine if he or she has a minor cold. In the case of a more severe illness with a fever or any type of infection, wait until the child gets better before receiving this vaccine.

Pregnant women should wait to get this vaccine until after they have given birth. Women should not get pregnant for 3 months after getting the vaccine. A woman should not receive this vaccine without telling the doctor if she is breast-feeding a baby.

How is this vaccine given?

This vaccine is given as an injection under the skin. You will receive this injection in a doctor's office or clinic setting.

The measles, mumps, rubella, and varicella vaccine is usually given only once when the child is between 12 months and 12 years old. If a booster dose is needed, At least 3 months should pass between the first and second doses of this vaccine.

Your child's booster schedule may be different from these guidelines. Follow your doctor's instructions or the schedule recommended by your local health department.

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 give your child.

It is especially important to prevent fever from occurring in a child who has a seizure disorder such as epilepsy.

This vaccine can cause false results on a skin test for tuberculosis for up to 6 weeks. Tell any doctor who treats you if you have received this vaccine within the past 4 to 6 weeks.

What happens if I miss a dose?

Since this vaccine is usually given only once, you are not likely to miss a dose. Contact your doctor if you do not receive all recommended doses.

What happens if I overdose?

An overdose of this vaccine is unlikely to occur.

What should I avoid before or after receiving this vaccine?

Your child should not receive another "live" vaccine for at least 4 weeks after receiving the measles, mumps, rubella, and varicella vaccine. The other live vaccine may not work as well during this time, and may not fully protect your child from disease. Live vaccines include measles, mumps, rubella (MMR), Bacillus Calmette-Guérin (BCG), oral polio, rotavirus, smallpox, typhoid, yellow fever, varicella (chickenpox), H1N1 influenza, and nasal flu vaccine.

Do not give your child salicylates such as aspirin, Disalcid, Doan's Pills, Dolobid, Salflex, Tricosal, and others for at least 6 weeks after receiving this vaccine. A serious condition called Reye's Syndrome has been reported in patients with chickenpox who take aspirin or salicylates.

This vaccine side effects

Your child should not receive a booster vaccine if he or she had a life-threatening allergic reaction after the first shot. Keep track of any and all side effects your child has after receiving this vaccine. If the child ever needs to receive a booster dose, you will need to tell the doctor if the previous shots caused any side effects.

Becoming infected with measles, mumps, rubella, or varicella is much more dangerous to your child's health than receiving this vaccine. However, like any medicine, this vaccine can cause side effects but the risk of serious side effects is extremely low.

Get emergency medical help if your child has 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 your child has any of these serious side effects:

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  problems with hearing or vision;

  
  


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  extreme drowsiness, fainting;

  
  


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  fussiness, irritability, crying for an hour or longer;

  
  


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  easy bruising or bleeding, unusual weakness;

  
  


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  seizure (black-out or convulsions); or

  
  


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  high fever (within a few hours or a few days after the vaccine).

  
  

Less serious side effects include:

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  redness, pain, swelling, or a lump where the shot was given;

  
  


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  headache, dizziness;

  
  


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  low fever, joint or muscle pain; or

  
  


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  nausea, vomiting, diarrhea.

  
  

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 vaccine side effects to the US Department of Health and Human Services at 1-800-822-7967.

Measles, mumps, rubella and varicella virus vaccine Dosing Information

Usual Pediatric Dose for Varicella-Zoster -- Prophylaxis:

12 month to 12 years: 0.5 mL subcutaneously preferably into the outer aspect of the deltoid region of the upper arm or in the higher anterolateral area of the thigh. The first dose is usually administered at 12-15 months of age. If a second dose is needed, measles/mumps/rubella/varicella virus vaccine can be used and is usually administered at 4 to 6 years of age. The second dose may be administered before age 4 if needed, as long as 3 or more months have elapsed since the first dose.

ACIP recommendations: For children receiving their first dose at 12 to 47 months of age, either the measles/mumps/rubella/varicella virus vaccine combination vaccine or separate measles/mumps/rubella virus vaccine and varicella vaccines can be used. However, the ACIP prefers administration of separate MMR and varicella vaccines as the first dose in this age group unless the parent or caregiver expresses preference for the MMRV combination. For children receiving the first dose at more than 48 months of age or their second dose at any age, use of measles/mumps/rubella/varicella virus vaccine is preferred. The ACIP recommends that children with a personal or family history of seizures be vaccinated with separate measles/mumps/rubella virus vaccine and varicella vaccines, as opposed to the measles/mumps/rubella/varicella virus vaccine combination vaccine.

Allow at least 1 month between administering a dose of a measles-containing vaccine (eg, M-M-R II) and ProQuad.

Allow at least 3 months between administering a varicella-containing vaccine (eg, Varivax) and ProQuad.

Usual Pediatric Dose for Mumps Prophylaxis:

12 month to 12 years: 0.5 mL subcutaneously preferably into the outer aspect of the deltoid region of the upper arm or in the higher anterolateral area of the thigh. The first dose is usually administered at 12-15 months of age. If a second dose is needed, measles/mumps/rubella/varicella virus vaccine can be used and is usually administered at 4 to 6 years of age. The second dose may be administered before age 4 if needed, as long as 3 or more months have elapsed since the first dose.

ACIP recommendations: For children receiving their first dose at 12 to 47 months of age, either the measles/mumps/rubella/varicella virus vaccine combination vaccine or separate measles/mumps/rubella virus vaccine and varicella vaccines can be used. However, the ACIP prefers administration of separate MMR and varicella vaccines as the first dose in this age group unless the parent or caregiver expresses preference for the MMRV combination. For children receiving the first dose at more than 48 months of age or their second dose at any age, use of measles/mumps/rubella/varicella virus vaccine is preferred. The ACIP recommends that children with a personal or family history of seizures be vaccinated with separate measles/mumps/rubella virus vaccine and varicella vaccines, as opposed to the measles/mumps/rubella/varicella virus vaccine combination vaccine.

Allow at least 1 month between administering a dose of a measles-containing vaccine (eg, M-M-R II) and ProQuad.

Allow at least 3 months between administering a varicella-containing vaccine (eg, Varivax) and ProQuad.

Usual Pediatric Dose for Rubella Prophylaxis:

12 month to 12 years: 0.5 mL subcutaneously preferably into the outer aspect of the deltoid region of the upper arm or in the higher anterolateral area of the thigh. The first dose is usually administered at 12-15 months of age. If a second dose is needed, measles/mumps/rubella/varicella virus vaccine can be used and is usually administered at 4 to 6 years of age. The second dose may be administered before age 4 if needed, as long as 3 or more months have elapsed since the first dose.

ACIP recommendations: For children receiving their first dose at 12 to 47 months of age, either the measles/mumps/rubella/varicella virus vaccine combination vaccine or separate measles/mumps/rubella virus vaccine and varicella vaccines can be used. However, the ACIP prefers administration of separate MMR and varicella vaccines as the first dose in this age group unless the parent or caregiver expresses preference for the MMRV combination. For children receiving the first dose at more than 48 months of age or their second dose at any age, use of measles/mumps/rubella/varicella virus vaccine is preferred. The ACIP recommends that children with a personal or family history of seizures be vaccinated with separate measles/mumps/rubella virus vaccine and varicella vaccines, as opposed to the measles/mumps/rubella/varicella virus vaccine combination vaccine.

Allow at least 1 month between administering a dose of a measles-containing vaccine (eg, M-M-R II) and ProQuad.

Allow at least 3 months between administering a varicella-containing vaccine (eg, Varivax) and ProQuad.

Usual Pediatric Dose for Measles Prophylaxis:

12 month to 12 years: 0.5 mL subcutaneously preferably into the outer aspect of the deltoid region of the upper arm or in the higher anterolateral area of the thigh. The first dose is usually administered at 12-15 months of age. If a second dose is needed, measles/mumps/rubella/varicella virus vaccine can be used and is usually administered at 4 to 6 years of age. The second dose may be administered before age 4 if needed, as long as 3 or more months have elapsed since the first dose.

ACIP recommendations: For children receiving their first dose at 12 to 47 months of age, either the measles/mumps/rubella/varicella virus vaccine combination vaccine or separate measles/mumps/rubella virus vaccine and varicella vaccines can be used. However, the ACIP prefers administration of separate MMR and varicella vaccines as the first dose in this age group unless the parent or caregiver expresses preference for the MMRV combination. For children receiving the first dose at more than 48 months of age or their second dose at any age, use of measles/mumps/rubella/varicella virus vaccine is preferred. The ACIP recommends that children with a personal or family history of seizures be vaccinated with separate measles/mumps/rubella virus vaccine and varicella vaccines, as opposed to the measles/mumps/rubella/varicella virus vaccine combination vaccine.

Allow at least 1 month between administering a dose of a measles-containing vaccine (eg, M-M-R II) and ProQuad.

Allow at least 3 months between administering a varicella-containing vaccine (eg, Varivax) and ProQuad.

What other drugs will affect measles, mumps, rubella, and varicella virus vaccine?

Before receiving this vaccine, tell the doctor about all other vaccines your child has recently received.

Also tell the doctor if your child has recently received drugs or treatments that can weaken the immune system, including:

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

  
  


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

  
  


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  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).

  
  

If your child is receiving any of these medications, he or she may not be able to receive the vaccine, or may need to wait until the other treatments are finished.

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

More measles, mumps, rubella and varicella virus vaccine resources

• Measles, mumps, rubella and varicella virus vaccine Use in Pregnancy & Breastfeeding
• Measles, mumps, rubella and varicella virus vaccine Drug Interactions
• Measles, mumps, rubella and varicella virus vaccine Support Group
• 0 Reviews for Measles, mumps, rubella and varicella virus vaccine - Add your own review/rating

Compare measles, mumps, rubella and varicella virus vaccine with other medications

• Measles Prophylaxis
• Mumps Prophylaxis
• Rubella Prophylaxis
• Varicella-Zoster, Prophylaxis

Where can I get more information?

• Your doctor or pharmacist can provide more information about this vaccine. Additional information is available from your local health department or the Centers for Disease Control and Prevention.