Meclizine Hydrochloride

Class: Antihistamines
VA Class: CN550
CAS Number: 31884-77-2
Brands: Antivert, Bonine, Dramamine Less Drowsy, Meni-D

Introduction

Antiemetic; piperazine-derivative antihistamine.^{a b c}

Uses for Meclizine Hydrochloride

Motion Sickness

Self-medication for prevention and treatment of nausea, vomiting, and/or dizziness associated with motion sickness.^{b c e}

Vertigo

Symptomatic management of vertigo^e associated with diseases affecting the vestibular system (e.g., labyrinthitis, Ménière’s disease).^{a b}

Other Uses

Use in allergic states not evaluated.^a

Meclizine Hydrochloride Dosage and Administration

Administration

Oral Administration

For prevention of motion sickness, administer orally 1 hour before exposure to motion; may repeat every 24 hours for duration of journey.^{101 102 d}

Dosage

Available as meclizine hydrochloride; dosage expressed in terms of meclizine.^{b c d}

Pediatric Patients

Motion Sickness

Oral

For self-medication in children ≥12 years of age, 25–50 mg once daily or as directed by clinician.^{a b c d e}

Adults

Motion Sickness

Oral

For self-medication, 25–50 mg once daily or as directed by clinician.^{a b c d}

Vertigo

Oral

25–100 mg daily, administered in divided doses, depending on clinical response.^{a b}

Cautions for Meclizine Hydrochloride

Contraindications

• 
  

  Known hypersensitivity to meclizine.^b

  
  

Warnings/Precautions

Warnings

CNS Effects

Possible drowsiness.^{b e}

Possible additive CNS depression with other CNS depressants.^{b e} (See Specific Drugs under Interactions.)

Anticholinergic Effects

Due to potential anticholinergic activity, use with caution in patients with breathing problems (e.g., asthma, emphysema, chronic bronchitis), angle-closure glaucoma, or prostatic hypertrophy.^{b c d e}

Sensitivity Reactions

Tartrazine Sensitivity

Some formulations contain tartrazine dye (FD&C; yellow No. 5), which may cause allergic reactions (i.e., bronchial asthma) in susceptible individuals.^d Incidence of tartrazine sensitivity is low, but it frequently occurs in patients who have aspirin hypersensitivity.^d

Specific Populations

Pregnancy

Category B.^b

Lactation

Antihistamines may inhibit lactation and small amounts appear to be distributed into milk.^f Due to potential for serious adverse effects (e.g., CNS effects) in nursing infants, discontinue nursing or the drug.^f

Pediatric Use

Safety and efficacy not established in children <12 years of age.^{a b c e}

Common Adverse Effects

Drowsiness, fatigue, dry mouth.^{a b c}

Interactions for Meclizine Hydrochloride

Specific Drugs

Drug	Interaction	Comments
CNS depressants (e.g., alcohol, barbiturates, tranquilizers)	Additive CNS depressionb e	Avoid alcoholic beverages;b e use other CNS depressants with cautiona

Meclizine Hydrochloride Pharmacokinetics

Absorption

Onset

About 1 hour.^a

Duration

Effects persist for 8–24 hours following a single oral dose.^a

Distribution

Extent

Distributed throughout most body tissues; crosses placenta.^a

Elimination

Metabolism

Metabolic fate in humans is unknown.^a In rats, metabolized (probably in the liver) to norchlorcyclizine.^a

Elimination Route

Excreted in feces as unchanged drug and in urine as norchlorcyclizine.^a

Half-life

6 hours.^a

Stability

Storage

Oral

Capsules and Tablets

Tight, light-resistant container at 15–30°C.^{a c d}

ActionsActions

• 
  

  Exhibits CNS depressant, anticholinergic, antiemetic, antispasmodic, and local anesthetic effects in addition to antihistaminic activity.^a

  
  


• 
  

  Depresses labyrinth excitability and conduction in vestibular-cerebellar pathways.^a

  
  


• 
  

  Antiemetic and antimotion-sickness actions result, at least in part, from central anticholinergic and CNS depressant properties.^a

  
  

Advice to Patients

• 
  

  Risk of drowsiness; use caution when driving or operating machinery.^{b c d}

  
  


• 
  

  Importance of avoiding alcohol during therapy.^{b c d}

  
  


• 
  

  Importance of patients informing clinicians of existing or contemplated therapy, including prescription and OTC drugs, as well as any concomitant illnesses.^{b c d}

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.^{b c d}

  
  


• 
  

  Importance of informing patients of other important precautionary information.^{b c d} (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

Meclizine Hydrochloride

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Capsules	25 mg	Meni-D	Seatrace
	Tablets	12.5 mg*	Antivert	Pfizer
		25 mg*	Antivert	Pfizer
			Dramamine Less Drowsy	Pfizer
		50 mg*	Antivert (scored)	Pfizer
	Tablets, chewable	25 mg*	Bonine (scored)	Insight

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.

Antivert 12.5MG Tablets (PFIZER U.S.): 30/$30.99 or 90/$69.97

Antivert 25MG Tablets (PFIZER U.S.): 30/$46.99 or 90/$112.97

Antivert 50MG Tablets (PFIZER U.S.): 30/$67.99 or 90/$194.98

Meclizine HCl 12.5MG Tablets (RUGBY): 30/$12.99 or 60/$14.98

Meclizine HCl 25MG Tablets (PAR): 30/$19.99 or 60/$30.97

Travel Sickness 25MG Chewable Tablets (RUGBY): 100/$14.99 or 200/$18.97

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 July 2006. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

100. Food and Drug Administration. Antiemetic drug products for over-the-counter human use; final monograph. Fed Regist. 1987; 52:15886-93.

101. Leeming Division. Bonine (meclizine hydrochloride) chewable tablets prescribing information. In: Huff BB, ed. Physicians’ desk reference for nonprescription drugs. 9th ed. Oradell, NJ: Medical Economics Company Inc; 1988:569.

102. Roerig. Antivert tablets, Antivert25 tablets, Antivert25 chewable tablets, and Antivert50 tablets prescribing information. In: Huff BB, ed. Physicians’ desk reference. 43rd ed. Oradell, NJ: Medical Economics Company Inc; 1989:1774.

103. Food and Drug Administration. Over-the-counter drug products; final monographs for antiemetic, antitussive, bronchodilator, and antihelmintic drug products; updating and technical changes. Fed Regist. 1988; 53:35808-10.

a. AHFS drug information 2004. McEvoy GK, ed. Meclizine hydrochloride. Bethesda, MD: American Society of Health-System Pharmacists; 2004:2787-8.

b. Antivert (meclizine hydrochloride) tablets prescribing information. In: PDR.net [database online]. Montvale, NJ: Thomson Healthcare; 2003. Updated 1996 Jun.

c. Bonine (meclizine hydrochloride) tablets prescribing information. In: PDR.net [database online]. Montvale, NJ: Thomson Healthcare; 2003.

d. Par Pharmaceutical, Inc. Meclizine hydrochloride tablets prescribing information. Spring Valley, NY; 2000 Apr.

e. Department of Health and Human Services, Food and Drug Administration. Antiemetic drug products for over-the-counter human use. (21CFR336). 2001 Apr; 5:231-3.

f. AHFS drug information 2004. McEvoy GK, ed. Antihistamines. Bethesda, MD: American Society of Health-System Pharmacists; 2004:2-9.

More Meclizine Hydrochloride resources

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

• Meclizine Prescribing Information (FDA)


• Meclizine Professional Patient Advice (Wolters Kluwer)


• Antivert MedFacts Consumer Leaflet (Wolters Kluwer)


• Antivert Prescribing Information (FDA)


• Antivert Consumer Overview

Compare Meclizine Hydrochloride with other medications

• Motion Sickness
• Nausea/Vomiting
• Vertigo

Mandelamine

Generic Name: methenamine (meh THEH na meen)

Brand Names: Hiprex, Mandelamine, Urex

What is Mandelamine (methenamine)?

Methenamine is a urinary antiinfective medicine. Methenamine fights bacteria in the urine and bladder.

Methenamine may be used to treat and prevent urinary tract infections.

Methenamine may also be used for purposes other than those listed here.

What is the most important information I should know about Mandelamine (methenamine)?

Take all of the methenamine that has been prescribed for you even if you begin to feel better. Symptoms may start to improve before the infection is completely treated. Take each dose with a full glass of water. Plenty of fluid should be consumed while taking methenamine.

Your healthcare provider may recommend drinking additional water and/or certain fruit juices (e.g., cranberry, plum, prune) and increased protein in the diet while taking methenamine to ensure adequate hydration and acidity of the urine. It may also be recommended to avoid citrus fruits and juices (e.g., orange, grapefruit, lemon), milk and dairy products, and antacids during treatment with methenamine. These products may decrease the effectiveness of methenamine. Follow your healthcare provider's instructions.

What should I discuss with my healthcare provider before taking Mandelamine (methenamine)?

Before taking methenamine, talk to your doctor if you

• have liver problems;


• have kidney problems;


• 
  

  have other medical conditions; or

  
  


• 
  

  take other medications.

  
  

You may not be able to take methenamine, or you may require a dosage adjustment or special monitoring during treatment.

Methenamine is in the FDA pregnancy category C. This means that it is not known whether it will be harmful to an unborn baby. Do not take methenamine without first talking to your doctor if you are pregnant or could become pregnant during treatment. Methenamine passes into breast milk and may affect a nursing baby. Do not take methenamine without first talking to your doctor if you are breast-feeding a baby.

How should I take Mandelamine (methenamine)?

Take methenamine exactly as directed by your doctor. If you do not understand these instructions, ask your doctor, nurse, or pharmacist to explain them to you.

Take each dose with a full glass of water. Plenty of fluid should be consumed while taking methenamine. Methenamine should be taken with food to reduce stomach upset. Do not crush or chew the enteric-coated tablets. Swallow them whole. They are specially formulated to be less irritating to the stomach. Talk to your doctor if swallowing the tablets is difficult. Shake the liquid form of methenamine well before measuring a dose. To ensure that you get the correct dose, measure the suspension with a dose-measuring spoon, dropper, or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one.

It is important to take methenamine at regularly scheduled intervals to get the most benefit.

Take all of the methenamine that has been prescribed for you even if you begin to feel better. Symptoms may start to improve before the infection is completely treated.

Your healthcare provider may recommend drinking additional water and/or certain fruit juices (e.g., cranberry, plum, prune) and increased protein in the diet while taking methenamine to ensure adequate hydration and acidity of the urine. It may also be recommended to avoid citrus fruits and juices (e.g., orange, grapefruit, lemon), milk and dairy products, and antacids during treatment with methenamine. These products may decrease the effectiveness of methenamine. Follow your healthcare provider's instructions.

Store methenamine at room temperature away from moisture and heat.

What happens if I miss a dose?

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

What happens if I overdose?

Seek emergency medical attention if an overdose is suspected.

Symptoms of a methenamine overdose are not known.

What should I avoid while taking Mandelamine (methenamine)?

Your healthcare provider may recommend drinking additional water and/or certain fruit juices (e.g., cranberry, plum, prune) and increased protein in the diet while taking methenamine to ensure adequate hydration and acidity of the urine. It may also be recommended to avoid citrus fruits and juices (e.g., orange, grapefruit, lemon), milk and dairy products, and antacids during treatment with methenamine. These products may decrease the effectiveness of methenamine. Follow your healthcare provider's instructions.

Mandelamine (methenamine) side effects

If you experience any of the following serious side effects, stop taking methenamine and seek emergency medical attention or contact your doctor immediately:

• 
  

  an allergic reaction (shortness of breath; closing of the throat; swelling of the lips, face, or tongue; or hives;

  
  


• 
  

  lower back or side pain;

  
  


• 
  

  blood in urine; or

  
  


• 
  

  increasingly painful or difficult urination.

  
  

Other, less serious side effects may be more likely to occur. Continue to take methenamine and talk to your doctor if you experience

• 
  

  nausea or upset stomach;

  
  


• 
  

  decreased appetite; or

  
  


• 
  

  skin rash.

  
  

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 Mandelamine (methenamine)?

Do not take methenamine without first talking to your doctor if you are taking:

• 
  

  a carbonic anhydrase inhibitor such as acetazolamide (Diamox), dichlorphenamide (Daranide), or methazolamide (Glauctabs, MZM, Neptazane);

  
  


• 
  

  a sulfa product such as sulfadiazine, sulfamethoxazole (Bactrim, Septra, others), sulfasalazine (Azulfidine), and others;

  
  


• 
  

  a diuretic (water pill); or

  
  


• 
  

  a product that contains aluminum, calcium, magnesium, sodium bicarbonate, potassium or sodium citrate, or citric acid (such as antacids, vitamin or mineral pills, urinary alkalinizers, and other medications).

  
  

You may not be able to take methenamine, or you may require a dosage adjustment or special monitoring during treatment if you are taking any of the medicines listed above.

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

More Mandelamine resources

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

• Mandelamine MedFacts Consumer Leaflet (Wolters Kluwer)


• Mandelamine Advanced Consumer (Micromedex) - Includes Dosage Information


• Methenamine Prescribing Information (FDA)


• Methenamine Monograph (AHFS DI)


• Hiprex Prescribing Information (FDA)

Compare Mandelamine with other medications

• Bladder Infection
• Prevention of Bladder infection

Where can I get more information?

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

See also: Mandelamine side effects (in more detail)

Mangimin

Generic Name: manganese supplement (Oral route, Parenteral route)

Commonly used brand name(s)

In the U.S.

• Mangimin

Available Dosage Forms:

• Tablet


• Capsule

Uses For Mangimin

Manganese supplements are used to prevent or treat manganese deficiency.

The body needs manganese for normal growth and health. For patients who are unable to get enough manganese in their regular diet or who have a need for more manganese, manganese supplements may be necessary. Manganese helps your body break down fats, carbohydrates, and proteins. It does so as part of several enzymes.

Manganese deficiency has not been reported in humans. Lack of manganese in animals has been found to cause improper formation of bone and cartilage, may decrease the body's ability to use sugar properly, and may cause growth problems.

Injectable manganese supplements are given by or under the supervision of a health care professional.

Importance of Diet

For good health, it is important that you eat a balanced and varied diet. Follow carefully any diet program your health care professional may recommend. For your specific dietary vitamin and/or mineral needs, ask your health care professional for a list of appropriate foods. If you think that you are not getting enough vitamins and/or minerals in your diet, you may choose to take a dietary supplement.

Manganese is found in whole grains, cereal products, lettuce, dry beans, and peas.

The daily amount of manganese needed is defined in several different ways.

• For U.S.—


• Recommended Dietary Allowances (RDAs) are the amount of vitamins and minerals needed to provide for adequate nutrition in most healthy persons. RDAs for a given nutrient may vary depending on a person's age, sex, and physical condition (e.g., pregnancy).


• Daily Values (DVs) are used on food and dietary supplement labels to indicate the percent of the recommended daily amount of each nutrient that a serving provides. DV replaces the previous designation of United States Recommended Daily Allowances (USRDAs).

• For Canada—


• Recommended Nutrient Intakes (RNIs) are used to determine the amounts of vitamins, minerals, and protein needed to provide adequate nutrition and lessen the risk of chronic disease.

Because a lack of manganese is rare, there is no RDA or RNI for it. The following daily intakes are thought to be plenty for most individuals:

• Infants and children—
  
  • Birth to 3 years of age: 0.3 to 1.5 milligrams (mg).
  
  
  • 4 to 6 years of age: 1.5 to 2 mg.
  
  
  • 7 to 10 years of age: 2 to 3 mg.
  
  


• Adolescents and adults—2 to 5 mg.

Before Using Mangimin

If you are taking a dietary supplement without a prescription, carefully read and follow any precautions on the label. For these supplements, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group 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

Problems in children have not been reported with intake of normal daily recommended amounts.

Geriatric

Problems in older adults have not been reported with intake of normal daily recommended amounts.

Pregnancy

It is especially important that you are receiving enough vitamins and minerals when you become pregnant and that you continue to receive the right amount of vitamins and minerals throughout your pregnancy. The healthy growth and development of the fetus depend on a steady supply of nutrients from the mother. However, taking large amounts of a dietary supplement in pregnancy may be harmful to the mother and/or fetus and should be avoided.

Breast Feeding

It is important that you receive the right amounts of vitamins and minerals so that your baby will also get the vitamins and minerals needed to grow properly. However, taking large amounts of a dietary supplement while breast-feeding may be harmful to the mother and/or baby and should be avoided.

Interactions with Medicines

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

Interactions with Food/Tobacco/Alcohol

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

Other Medical Problems

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

• Biliary disease or


• Liver disease—Taking manganese supplements may cause high blood levels of manganese, and dosage of manganese may have to be changed.

Proper Use of Mangimin

Dosing

The dose medicines in this class 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 these medicines. If your dose is different, do not change it unless your doctor tells you to do so.

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

• For oral dosage form (as part of a multivitamin/mineral supplement):
  
  • To prevent deficiency, the amount taken by mouth is based on normal daily recommended intakes:
    
    • Adults and teenagers—2 to 5 milligrams (mg) per day.
    
    
    • Children 7 to 10 years of age—2 to 3 mg per day.
    
    
    • Children 4 to 6 years of age—1.5 to 2 mg per day.
    
    
    • Children birth to 3 years of age—0.3 to 1.5 mg per day.
    
    
  
  
  • To treat deficiency:
    
    • Adults, teenagers, and children—Treatment dose is determined by prescriber for each individual based on severity of deficiency.
    
    
  
  

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.

If you miss taking manganese supplements for one or more days there is no cause for concern, since it takes some time for your body to become seriously low in manganese. However, if your health care professional has recommended that you take manganese, try to remember to take it as directed every day.

Storage

Keep out of the reach of children.

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

Do not keep outdated medicine or medicine no longer needed.

Mangimin Side Effects

No side effects or toxic effects have been reported for manganese. However, check with your health care professional if you notice any unusual effects while you are taking it.

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.

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Meloxicam Suspension

Pronunciation: mel-OX-i-kam
Generic Name: Meloxicam
Brand Name: Mobic

Meloxicam Suspension is a nonsteroidal anti-inflammatory drug (NSAID). It may cause an increased risk of serious and sometimes fatal heart and blood vessel problems (eg, heart attack, stroke). The risk may be greater if you already have heart problems or if you take Meloxicam Suspension for a long time. Do not use Meloxicam Suspension right before or after bypass heart surgery.

Meloxicam Suspension may cause an increased risk of serious and sometimes fatal stomach ulcers and bleeding. Elderly patients may be at greater risk. This may occur without warning signs.

Meloxicam Suspension is used for:

Treating rheumatoid arthritis, osteoarthritis, and juvenile arthritis. It may also be used for other conditions as determined by your doctor.

Meloxicam Suspension is an NSAID. Exactly how it works is not known. It may block certain substances in the body that are linked to inflammation. NSAIDs treat the symptoms of pain and inflammation. They do not treat the disease that causes those symptoms.

Do NOT use Meloxicam Suspension if:

• you are allergic to any ingredient in Meloxicam Suspension


• you have had a severe allergic reaction (eg, severe rash, hives, trouble breathing, growths in the nose, dizziness) to aspirin or a nonsteroidal anti-inflammatory drug (NSAID) (eg, ibuprofen, celecoxib)


• you have recently had or will be having bypass heart surgery


• you have a peptic ulcer


• you are in the last 3 months of pregnancy


• you take sodium polystyrene sulfonate

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

Before using Meloxicam Suspension:

Some medical conditions may interact with Meloxicam Suspension. 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 a history of kidney or liver disease, diabetes, stomach or bowel problems (eg, bleeding, perforation, ulcers), or H. pylori infection


• if you have a history of swelling or fluid buildup, asthma, growths in the nose (nasal polyps), or mouth inflammation


• if you have high blood pressure, blood disorders, bleeding or clotting problems, heart problems (eg, heart failure), or blood vessel disease, or if you are at risk for any of these diseases


• if you have poor health, dehydration or low fluid volume, or low blood sodium levels, you drink alcohol or smoke, or you have a history of alcohol abuse

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

• Anticoagulants (eg, warfarin), antiplatelet medicines (eg, clopidogrel), aspirin, bisphosphonates (eg, alendronate), corticosteroids (eg, prednisone), dabigatran, desirudin, heparin, rivaroxaban, or serotonin reuptake inhibitors (eg, fluoxetine) because the risk of stomach bleeding may be increased


• Sodium polystyrene sulfonate because a serious and possibly fatal bowel problem (intestinal necrosis) may occur


• Probenecid because it may increase the risk of Meloxicam Suspension's side effects


• Cholestyramine because it may decrease Meloxicam Suspension's effectiveness


• Cyclosporine, lithium, methotrexate, quinolones (eg, ciprofloxacin), or sulfonylureas (eg, glipizide) because the risk of their side effects may be increased by Meloxicam Suspension


• Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril), angiotensin receptor blockers (eg, losartan), or diuretics (eg, furosemide, hydrochlorothiazide) because their effectiveness may be decreased by Meloxicam Suspension and the risk of kidney problems may be increased

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

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

• Meloxicam Suspension comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Meloxicam Suspension refilled.


• Take Meloxicam Suspension by mouth. It may be taken with food if it upsets your stomach. Taking it with food may not lower the risk of stomach or bowel problems (eg, bleeding, ulcers).


• Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.


• Shake gently before each use.


• Take Meloxicam Suspension with a full glass of water (8 oz/240 mL) as directed by your doctor.


• If you miss a dose of Meloxicam Suspension, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

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

Important safety information:

• Meloxicam Suspension may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Meloxicam Suspension with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Serious stomach ulcers or bleeding can occur with the use of Meloxicam Suspension. Taking it in high doses or for a long time, smoking, or drinking alcohol increases the risk of these side effects. Taking Meloxicam Suspension with food will NOT reduce the risk of these effects. Contact your doctor or emergency room at once if you develop severe stomach or back pain; black, tarry stools; vomit that looks like blood or coffee grounds; or unusual weight gain or swelling.


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


• Meloxicam Suspension has an NSAID in it. Before you start any new medicine, check the label to see if it has an NSAID (eg, ibuprofen) in it too. If it does or if you are not sure, check with your doctor or pharmacist.


• Do not take aspirin while you are using Meloxicam Suspension unless your doctor tells you to.


• Lab tests, including kidney function, complete blood cell counts, and blood pressure, may be performed while you use Meloxicam Suspension. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Meloxicam Suspension with caution in the ELDERLY; they may be more sensitive to its effects, especially stomach bleeding and kidney problems.


• Caution is advised when using Meloxicam Suspension in CHILDREN; they may be more sensitive to its effects, especially diarrhea, fever, headache, stomach pain, and vomiting.


• Meloxicam Suspension should be used with extreme caution in CHILDREN younger than 2 years old; safety and effectiveness in these children have not been determined.


• PREGNANCY and BREAST-FEEDING: Meloxicam Suspension may cause harm to the fetus. Do not use it during the last 3 months of pregnancy. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Meloxicam Suspension while you are pregnant. It is not known if Meloxicam Suspension is found in breast milk. Do not breast-feed while taking Meloxicam Suspension.

Possible side effects of Meloxicam Suspension:

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:

Constipation; diarrhea; dizziness; gas; headache; heartburn; mild stomach pain; nausea; stomach upset; trouble sleeping; vomiting.

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

Severe allergic reactions (rash; hives; itching; trouble breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); bloody or black, tarry stools; change in the amount of urine produced; chest pain; confusion; dark urine; difficult or painful urination; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; loss of appetite; mental or mood changes (eg, depression); numbness of an arm or leg; one-sided weakness; pale stools; red, swollen, blistered, or peeling skin; ringing in the ears; seizures; severe or persistent headache or dizziness; severe or persistent stomach pain or nausea; severe vomiting; shortness of breath; sudden or unexplained weight gain; swelling of hands, legs, or feet; unusual bruising or bleeding; unusual joint or muscle pain; unusual tiredness or weakness; vision or speech changes; vomit that looks like coffee grounds; yellowing of the skin or eyes.

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: Meloxicam 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. Symptoms may include chest pain; decreased urination; loss of consciousness; seizures; severe dizziness, headache, or drowsiness; severe nausea, vomiting, or stomach pain; slow or troubled breathing; sluggishness; symptoms of liver problems (eg, dark urine, loss of appetite, pale stools, severe stomach pain, yellowing of the skin or eyes); symptoms of stomach or bowel bleeding (eg, bloody or black, tarry stools; vomit that looks like coffee grounds).

Proper storage of Meloxicam Suspension:

Store Meloxicam Suspension at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Meloxicam Suspension out of the reach of children and away from pets.

General information:

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


• Meloxicam Suspension 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 summary only. It does not contain all information about Meloxicam Suspension. 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 Meloxicam resources

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

Compare Meloxicam with other medications

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• Osteoarthritis
• Rheumatoid Arthritis
• Tendonitis

Marplan

Generic Name: isocarboxazid (eye so kar BOX a zid)

Brand Names: Marplan

What is Marplan (isocarboxazid)?

Isocarboxazid is a monoamine oxidase inhibitor (MAOI) that works by increasing the levels of certain chemicals in the brain.

Isocarboxazid is used to treat symptoms of depression that may include anxiety, panic, or phobias. This medication is usually given after other antidepressants have been tried without successful treatment of symptoms.

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

What is the most important information I should know about Marplan (isocarboxazid)?

There are many other medicines that can cause serious or life-threatening medical problems if you take them together with isocarboxazid. Do not take isocarboxazid before telling your doctor about all other prescription and over-the-counter medications you use, including vitamins, minerals, and herbal products. Keep a list with you of all the medicines you use and show this list to any doctor, dentist, or other healthcare provider who treats you.

You may have thoughts about suicide when you first start taking an antidepressant, especially if you are younger than 24 years old. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

Video: Treatment for Depression

Treatments for depression are getting better everyday and there are things you can start doing right away.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself. While you are taking isocarboxazid, you must not drink alcohol or eat foods that are high in tyramine, listed in the "What should I avoid while taking isocarboxazid?" section of this leaflet. Eating tyramine while you are taking isocarboxazid can raise your blood pressure to dangerous levels, causing symptoms that include sudden and severe headache, rapid heartbeat, stiffness in your neck, nausea, vomiting, cold sweat, vision problems, and sensitivity to light. Stop taking isocarboxazid and call your doctor at once if you have any of these symptoms. Isocarboxazid can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

What should I discuss with my doctor before taking Marplan (isocarboxazid)?

Do not use this medication if you have used another MAOI such as phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take isocarboxazid before another MAOI has cleared from your body. Do not take this medication if you are allergic to isocarboxazid, or if you have:

• 
  

  pheochromocytoma (tumor of the adrenal gland);

  
  


• 
  

  a history of stroke or blood clots;

  
  


• 
  

  liver disease;

  
  


• 
  

  kidney disease;

  
  


• 
  

  heart disease;

  
  


• 
  

  high blood pressure; or

  
  


• 
  

  a history of severe or frequent headaches.

  
  

There are many other medicines that can cause serious or life-threatening medical problems if you take them together with isocarboxazid. The following drugs should not be used while you are taking isocarboxazid:

• 
  

  diet pills, caffeine, stimulants, ADHD medication, asthma medication, over-the-counter cough and cold or allergy medicines;

  
  


• 
  

  blood pressure medication;

  
  


• 
  

  diuretics (water pills);

  
  


• 
  

  bupropion (Wellbutrin, Zyban);

  
  


• 
  

  buspirone (BuSpar);

  
  


• 
  

  carbamazepine (Carbatrol, Tegretol);

  
  


• 
  

  furazolidone (Furoxone);

  
  


• 
  

  meperidine (Demerol, Mepergan);

  
  


• 
  

  pargyline (Eutonyl);

  
  


• 
  

  procarbazine (Matulane);

  
  


• 
  

  alcohol or medicines that make you sleepy (such as cold medicine, pain medication, muscle relaxers, and medicine for seizures, depression or anxiety).

  
  


• 
  

  antidepressants such as amitriptyline (Elavil, Etrafon), amoxapine (Ascendin), clomipramine (Anafranil), desipramine (Norpramin), doxepin (Adepin, Sinequan), imipramine (Janimine, Tofranil), nortriptyline (Pamelor), protriptyline (Vivactil), or trimipramine (Surmontil); or

  
  


• 
  

  antidepressants such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), paroxetine (Paxil), or sertraline (Zoloft).

  
  

If you have any of these other conditions, you may need an isocarboxazid dose adjustment or special tests:

• 
  

  high blood pressure;

  
  


• 
  

  diabetes;

  
  


• 
  

  a thyroid disorder;

  
  


• 
  

  schizophrenia;

  
  


• 
  

  epilepsy or other seizure disorder;

  
  


• 
  

  if you have taken another antidepressant within the past 5 weeks; or

  
  


• 
  

  if you are also taking tryptophan (L-tryptophan), guanethidine (Ismelin), levodopa (Larodopa, Parcopa, Sinemet), or methyldopa (Aldomet).

  
  

You may have thoughts about suicide when you first start taking an antidepressant, especially if you are younger than 24 years old. Tell your doctor if you have worsening symptoms of depression or suicidal thoughts during the first several weeks of treatment, or whenever your dose is changed.

Your family or other caregivers should also be alert to changes in your mood or symptoms. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

FDA pregnancy category C. It is not known whether isocarboxazid will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether isocarboxazid 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. Do not give isocarboxazid to anyone younger than 16 years old without the advice of a doctor.

How should I take Marplan (isocarboxazid)?

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

Your doctor may occasionally change your dose to make sure you get the best results.

Your blood pressure will need to be tested often. Visit your doctor regularly.

Take this medication for the entire length of time prescribed by your doctor. It may take up to 6 weeks or longer before you notice improvement in your symptoms. Store at room temperature away from moisture and heat.

See also: Marplan dosage (in more detail)

What happens if I miss a dose?

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

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include shallow breathing, fast heart rate, sweating, fever, slow reflexes, feeling light-headed, fainting, or seizure (convulsions).

What should I avoid while taking Marplan (isocarboxazid)?

While you are taking isocarboxazid you must not eat foods that are high in tyramine, including:

• 
  

  cheese (especially strong or aged cheeses);

  
  


• 
  

  sour cream and yogurt;

  
  


• 
  

  beer (including non-alcoholic beer), sherry, Chianti wine, liquers;

  
  


• 
  

  dry sausage (such as hard salami, pepperoni), anchovies, caviar, liver, pickled herring;

  
  


• 
  

  canned figs, raisins, bananas;

  
  


• 
  

  avocados;

  
  


• 
  

  chocolate or caffeine;

  
  


• 
  

  soy sauce;

  
  


• 
  

  sauerkraut;

  
  


• 
  

  fava beans;

  
  


• 
  

  yeast extracts;

  
  


• 
  

  meat extracts;

  
  


• 
  

  meat prepared with tenderizer; or

  
  


• 
  

  over-the-counter supplements or cough and cold medicines that contain dextromethorphan or tyramine.

  
  

You should become very familiar with the list of foods and medicines you must avoid while you are taking isocarboxazid. Eating tyramine while you are taking isocarboxazid can raise your blood pressure to dangerous levels which could cause life-threatening side effects.

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

Marplan (isocarboxazid) 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 new or worsening symptoms such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Stop using isocarboxazid and call your doctor at once if you have any of these serious side effects:

• 
  

  sudden and severe headache, rapid heartbeat, stiffness in your neck, nausea, vomiting, cold sweat, sweating, vision problems, sensitivity to light;

  
  


• 
  

  chest pain, fast or slow heart rate;

  
  


• 
  

  swelling, rapid weight gain;

  
  


• 
  

  jaundice (yellowing of the skin or eyes); or

  
  


• 
  

  feeling light-headed, fainting.

  
  

Less serious side effects may include:

• 
  

  dizziness, headache;

  
  


• 
  

  tremors or shaking;

  
  


• 
  

  constipation, nausea; or

  
  


• 
  

  dry mouth.

  
  

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 Marplan (isocarboxazid)?

There are many other medicines that can cause serious or life-threatening medical problems if you take them together with isocarboxazid. Do not take isocarboxazid before telling your doctor about all other prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor, dentist, or other healthcare provider who treats you.

More Marplan resources

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

• Marplan Prescribing Information (FDA)


• Marplan Advanced Consumer (Micromedex) - Includes Dosage Information


• Marplan MedFacts Consumer Leaflet (Wolters Kluwer)


• Isocarboxazid Professional Patient Advice (Wolters Kluwer)

Compare Marplan with other medications

• Depression

Where can I get more information?

• Your pharmacist can provide more information about isocarboxzazid.

See also: Marplan side effects (in more detail)

Metaproterenol Syrup

Pronunciation: met-a-proe-TER-e-nol
Generic Name: Metaproterenol
Brand Name: Alupent

Metaproterenol Syrup is used for:

Treating or preventing symptoms of asthma, emphysema, bronchitis, and other reversible breathing problems. It may also be used for other conditions as determined by your doctor.

Metaproterenol Syrup is a beta-adrenergic agonist bronchodilator. It works by relaxing the smooth muscle in the airways, allowing air to flow in and out of the lungs more easily.

Do NOT use Metaproterenol Syrup if:

• you are allergic to any ingredient in Metaproterenol Syrup


• you have had an unexpected reaction to another sympathomimetic (eg, albuterol, pseudoephedrine)


• you have a fast heartbeat


• you are taking another beta-adrenergic bronchodilator (eg, albuterol) or droxidopa

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

Before using Metaproterenol Syrup:

Some medical conditions may interact with Metaproterenol Syrup. 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, food, or other substances


• if you have heart problems (eg, irregular heartbeat, congestive heart failure) or high blood pressure


• if you have a history of seizures (eg, epilepsy), diabetes, an overactive thyroid, or have an adrenal gland tumor (eg, pheochromocytoma)

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

• Beta-blockers (eg, propranolol) because the effectiveness of Metaproterenol Syrup may be decreased


• Beta-adrenergic bronchodilators (eg, albuterol), catechol-O-methyltransferase (COMT) inhibitors (eg, entacapone), monoamine oxidase (MAO) inhibitors (eg, phenelzine), sympathomimetics (eg, pseudoephedrine), or tricyclic antidepressants (eg, amitriptyline) because side effects may be increased by Metaproterenol Syrup


• Droxidopa because the risk of side effects, such as irregular heartbeat or heart attack, may be increased

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

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

• Metaproterenol Syrup may be taken with or without food. If stomach upset occurs, take with food to reduce stomach irritation.


• Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.


• If you miss a dose of Metaproterenol Syrup, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

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

Important safety information:

• Metaproterenol Syrup may cause dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Metaproterenol Syrup. Using Metaproterenol Syrup alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.


• Do not exceed the recommended dose or use Metaproterenol Syrup for longer than prescribed without checking with your doctor.


• If the asthma attack continues or worsens, contact your doctor.


• If the usual dose fails to provide relief or if you need to take it more often than normal, contact your doctor at once. This may be a sign of seriously worsening asthma, which may require changing your medication.


• Contact your health care provider about taking other asthma or inhaled medications while taking Metaproterenol Syrup.


• LAB TESTS, including lung function, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.


• Use Metaproterenol Syrup with caution in the ELDERLY because they may be more sensitive to its effects.


• Caution is advised when using Metaproterenol Syrup in CHILDREN because they may be more sensitive to its effects.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Metaproterenol Syrup during pregnancy. It is unknown if Metaproterenol Syrup is excreted in breast milk. If you are or will be breast-feeding while using Metaproterenol Syrup, contact your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Metaproterenol Syrup:

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:

Difficulty sleeping; dizziness; headache; hyperactivity; nausea; nervousness; stomach upset.

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); chest pain; fainting; fast or irregular heartbeat; fever, chills, or sore throat; increased difficulty breathing; itching; pounding in the chest; severe or persistent dizziness; swelling; tremors; wheezing; worsened asthma symptoms.

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: Metaproterenol 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. Symptoms may include chest pain; fast or irregular heartbeat; severe or persistent nervousness, headache, nausea, dizziness, or trouble sleeping.

Proper storage of Metaproterenol Syrup:

Store Metaproterenol Syrup at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Metaproterenol Syrup out of the reach of children and away from pets.

General information:

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


• Metaproterenol Syrup 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 Metaproterenol Syrup. 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 Metaproterenol resources

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

Compare Metaproterenol with other medications

• Asthma, acute
• Asthma, Maintenance
• COPD, Acute
• COPD, Maintenance

Macugen

pegaptanib sodium

Dosage Form: injection, solution
FULL PRESCRIBING INFORMATION

Indications and Usage for Macugen

Macugen is indicated for the treatment of neovascular (wet) age-related macular degeneration.

Macugen Dosage and Administration

General Dosing Information

FOR OPHTHALMIC INTRAVITREAL INJECTION ONLY.

Dosing

Macugen 0.3 mg should be administered once every six weeks by intravitreous injection into the eye to be treated.

Preparation for Administration

Macugen should be inspected visually for particulate matter and discoloration prior to administration. If visible particulates are observed and/or the liquid in the syringe is discolored, the syringe must not be used.

Administration of the syringe contents involves assembly of the syringe with the administration needle. The injection procedure should be carried out under controlled aseptic conditions, which includes the use of sterile gloves, a sterile drape, and a sterile eyelid speculum (or equivalent). When ready to assemble syringe and administer injection, carefully peel open pouches, remove contents, and place on sterile field. If upon opening the pouch, the plastic clip is missing or not attached to the syringe, the syringe should not be used.

To avoid compromising the sterility of the product, do not pull back on the plunger.

1. Remove the syringe from the plastic clip.


2. Twist off cap.


3. Attach the sterile BD® 30G 1/2" Precision Glide® administration needle (included) to the syringe by screwing it into the syringe tip.
   
   --Another sterile BD® 30G 1/2" Precision Glide® administration needle may be used in lieu of the one included. Remove the plastic needle shield from the needle.


4. Holding the syringe with the needle pointing up, check the syringe for bubbles. If there are bubbles, gently tap the syringe with your finger until the bubbles rise to the top of the syringe. SLOWLY depress the plunger to eliminate all the bubbles and to expel the excess drug so that the top edge of the 3rd rib on the plunger stopper aligns with the pre-printed black dosing line (See Figure 2, below).


5. Inject the entire contents of the syringe.

PRIOR to Injection

Figure1. Before expelling air bubble and excess drug

READY for Injection

Figure 2. After expelling air bubble and excess drug

Administration

The injection procedure should be carried out under controlled aseptic conditions, which includes the use of sterile gloves, a sterile drape, and a sterile eyelid speculum (or equivalent). Adequate anesthesia and a broad-spectrum microbicide should be given prior to the injection.

The patient's medical history for hypersensitivity reactions should be evaluated prior to performing the intravitreal procedure [see Warnings and Precautions (5) and Adverse Events (6)].

Following the injection, patients should be monitored for elevation in intraocular pressure and for endophthalmitis. Monitoring may consist of a check for perfusion of the optic nerve head immediately after the injection, tonometry within 30 minutes following the injection, and monitoring during the week following the injection. Patients should be instructed to report any symptoms suggestive of endophthalmitis without delay.

No special dosage modification is required for any of the populations that have been studied (i.e. gender, elderly).

The safety and efficacy of Macugen therapy administered to both eyes concurrently have not been studied.

Dosage Forms and Strengths

Single-use glass syringe pre-filled with 0.3 mg of Macugen® in a nominal 90 μL solution for intravitreal injection.

Contraindications

Ocular or Periocular Infections

Macugen is contraindicated in patients with ocular or periocular infections.

Hypersensitivity

Macugen is contraindicated in patients with known hypersensitivity to pegaptanib sodium or any other excipient in this product.

Warnings and Precautions

Endophthalmitis

Intravitreous injections, including those with Macugen, have been associated with endophthalmitis. Proper aseptic injection technique should always be utilized when administering Macugen. In addition, patients should be monitored during the week following the injection to permit early treatment, should an infection occur [see Dosage and Administration (2.4)].

Increases in Intraocular Pressure

Increases in intraocular pressure have been seen within 30 minutes of injection with Macugen. Therefore, intraocular pressure as well as the perfusion of the optic nerve head should be monitored and managed appropriately [see Dosage and Administration (2.4)].

Anaphylaxis

Rare cases of anaphylaxis/anaphylactoid reactions, including angioedema, have been reported in the post-marketing experience following the Macugen intravitreal administration procedure [see Adverse Events (6.3) and Dosage and Administration (2.4)].

Adverse Reactions

Injection Procedure

Serious adverse events related to the injection procedure occurring in < 1% of intravitreous injections included endophthalmitis [see Warnings and Precautions (5.1)], retinal detachment, and iatrogenic traumatic cataract.

Clinical Studies Experience

The most frequently reported adverse events in patients treated with Macugen 0.3 mg for up to two years were anterior chamber inflammation, blurred vision, cataract, conjunctival hemorrhage, corneal edema, eye discharge, eye irritation, eye pain, hypertension, increased intraocular pressure (IOP), ocular discomfort, punctate keratitis, reduced visual acuity, visual disturbance, vitreous floaters, and vitreous opacities. These events occurred in approximately 10-40% of patients.

The following events were reported in 6-10% of patients receiving Macugen 0.3 mg therapy:

Ocular: blepharitis, conjunctivitis, photopsia, vitreous disorder.

Non-Ocular: bronchitis, diarrhea, dizziness, headache, nausea, urinary tract infection.

The following events were reported in 1-5% of patients receiving Macugen 0.3 mg therapy:

Ocular: allergic conjunctivitis, conjunctival edema, corneal abrasion, corneal deposits, corneal epithelium disorder, endophthalmitis, eye inflammation, eye swelling, eyelid irritation, meibomianitis, mydriasis, periorbital hematoma, retinal edema, vitreous hemorrhage.

Non-Ocular: arthritis, bone spur, carotid artery occlusion, cerebrovascular accident, chest pain, contact dermatitis, contusion, diabetes mellitus, dyspepsia, hearing loss, pleural effusion, transient ischemic attack, urinary retention, vertigo, vomiting.

Postmarketing Experience

Anaphylaxis/anaphylactoid reactions, including angioedema, have been identified during postapproval use of Macugen. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure [see Warnings and Precautions (5.3) and Dosage and Administration (2.4)].

USE IN SPECIFIC POPULATIONS

Pregnancy

Teratogenic Effects: Pregnancy Category B. Pegaptanib produced no maternal toxicity and no evidence of teratogenicity or fetal mortality in mice at intravenous doses of up to 40 mg/kg/day (about 7,000 times the recommended human monocular ophthalmic dose of 0.3 mg/eye). Pegaptanib crosses the placenta in mice.

There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers

It is not known whether pegaptanib is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Macugen is administered to a nursing woman.

Pediatric Use

Safety and effectiveness of Macugen in pediatric patients have not been established.

Geriatric Use

Approximately 94% (834/892) of the patients treated with Macugen were ≥ 65 years of age and approximately 62% (553/892) were ≥ 75 years of age. No difference in treatment effect or systemic exposure was seen with increasing age.

Overdosage

Doses of Macugen up to 10 times the recommended dosage of 0.3 mg have been studied. No additional adverse events have been noted but there is decreased efficacy with doses above 1 mg.

Macugen Description

Macugen (pegaptanib sodium injection) is a sterile, aqueous solution containing pegaptanib sodium for intravitreous injection. Macugen is supplied in a single-dose, pre-filled syringe and is formulated as a 3.47 mg/mL solution, measured as the free acid form of the oligonucleotide. The active ingredient is 0.3 mg of the free acid form of the oligonucleotide without polyethylene glycol, in a nominal volume of 90 μL. This dose is equivalent to 1.6 mg of pegaptanib sodium (pegylated oligonucleotide) or 0.32 mg when expressed as the sodium salt form of the oligonucleotide moiety. The product is a sterile, clear, preservative-free solution containing sodium chloride, monobasic sodium phosphate monohydrate, dibasic sodium phosphate heptahydrate, hydrochloric acid, and/or sodium hydroxide to adjust the pH and water for injection.

Pegaptanib sodium is a covalent conjugate of an oligonucleotide of twenty-eight nucleotides in length that terminates in a pentylamino linker, to which two 20-kilodalton monomethoxy polyethylene glycol (PEG) units are covalently attached via the two amino groups on a lysine residue.

Pegaptanib sodium is represented by the following structural formula:

Where R is

and n is approximately 450.

The chemical name for pegaptanib sodium is as follows: RNA, ((2' - deoxy - 2' - fluoro)C - Gm - Gm - A - A - (2' - deoxy - 2' - fluoro)U - (2' - deoxy - 2' - fluoro)C - Am - Gm - (2' - deoxy - 2' - fluoro)U - Gm - Am - Am - (2' - deoxy - 2' - fluoro)U - Gm - (2' - deoxy - 2' - fluoro)C - (2' - deoxy - 2' - fluoro)U - (2' - deoxy - 2' - fluoro)U - Am - (2' - deoxy - 2' - fluoro)U - Am - (2' - deoxy - 2' - fluoro)C - Am - (2' - deoxy - 2' - fluoro)U - (2' - deoxy - 2' - fluoro)C - (2' - deoxy - 2' - fluoro)C - Gm - (3'→3') - dT), 5'-ester with α,α'-[4,12-dioxo-6-[[[5-(phosphoonoxy)pentyl]amino] carbonyl]-3,13-dioxa-5,11-diaza-1,15-pentadecanediyl]bis[ω-methoxypoly(oxy-1,2-ethanediyl)], sodium salt.

The molecular formula for pegaptanib sodium is C294H342F13N107Na28O188P28[C2H4O]n (where n is approximately 900) and the molecular weight is approximately 50 kilodaltons.

Macugen is formulated to have an osmolality of 280-360 mOsm/Kg, and a pH of 6-7.

Macugen - Clinical Pharmacology

Mechanism of Action

Pegaptanib is a selective vascular endothelial growth factor (VEGF) antagonist. VEGF is a secreted protein that selectively binds and activates its receptors located primarily on the surface of vascular endothelial cells. VEGF induces angiogenesis, and increases vascular permeability and inflammation, all of which are thought to contribute to the progression of the neovascular (wet) form of age-related macular degeneration (AMD), a leading cause of blindness. VEGF has been implicated in blood retinal barrier breakdown and pathological ocular neovascularization.

Pegaptanib is an aptamer, a pegylated modified oligonucleotide, which adopts a three-dimensional conformation that enables it to bind to extracellular VEGF. Under in vitro testing conditions, pegaptanib binds to the major pathological VEGF isoform, extracellular VEGF165, thereby inhibiting VEGF165 binding to its VEGF receptors. The inhibition of VEGF164, the rodent counterpart of human VEGF165, was effective at suppressing pathological neovascularization.

Pharmacokinetics

Absorption

In animals, pegaptanib is slowly absorbed into the systemic circulation from the eye after intravitreous administration. The rate of absorption from the eye is the rate limiting step in the disposition of pegaptanib in animals and is likely to be the rate limiting step in humans.

In humans, a mean maximum plasma concentration of about 80 ng/mL occurs within 1 to 4 days after a 3 mg monocular dose (10 times the recommended dose). The mean area under the plasma concentration-time curve (AUC) is about 25 μg•hr/mL at this dose.

Pegaptanib is metabolized by nucleases and is generally not affected by the cytochrome P450 system.

Two early clinical studies conducted in patients who received Macugen alone and in combination with photodynamic therapy (PDT) revealed no apparent difference in the plasma pharmacokinetics of pegaptanib.

Distribution/Metabolism/Excretion

Twenty-four hours after intravitreous administration of a radiolabeled dose of pegaptanib to both eyes of rabbits, radioactivity was mainly distributed in vitreous fluid, retina, and aqueous fluid. After intravitreous and intravenous administrations of radiolabeled pegaptanib to rabbits, the highest concentrations of radioactivity (excluding the eye for the intravitreous dose) were obtained in the kidney. In rabbits, the component nucleotide, 2'-fluorouridine is found in plasma and urine after single radiolabeled pegaptanib intravenous and intravitreous doses. In rabbits, pegaptanib is eliminated as parent drug and metabolites primarily in the urine.

Based on preclinical data, pegaptanib is metabolized by endo- and exonucleases.

In humans, after a 3 mg monocular dose (10 times the recommended dose), the average (± standard deviation) apparent plasma half-life of pegaptanib is 10 (±4) days.

Special Populations

Plasma concentrations do not appear to be affected by age or gender, but have not been studied in patients under the age of 50.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity studies with pegaptanib have not been conducted. No data are available to evaluate male or female mating or fertility indices.

Animal Toxicology and/or Pharmacology

Pegaptanib and its monomer component nucleotides (2'-MA, 2'-MG, 2'-FU, 2'-FC) were evaluated for genotoxicity in a battery of in vitro and in vivo assay systems. Pegaptanib, 2'-O-methyladenosine (2'-MA), and 2'-O-methylguanosine (2'-MG) were negative in all assay systems evaluated. 2'-fluorouridine (2'-FU) and 2'-fluorocytidine (2'-FC) were nonclastogenic and were negative in all S. typhimurium tester strains, but produced a non-dose related increase in revertant frequency in a single E. coli tester strain. Pegaptanib, 2'-FU, and 2'-FC tested negative in cell transformation assays.

Clinical Studies

Macugen was studied in two controlled, double-masked, and identically designed randomized studies in patients with neovascular AMD. Patients were randomized to receive control (sham treatment) or 0.3 mg, 1 mg or 3 mg Macugen administered as intravitreous injections every 6 weeks for 48 weeks. A total of approximately 1200 patients were enrolled with 892 patients receiving Macugen and 298 receiving a sham injection. The median age of the patients was 77 years. Patients received a mean 8.5 treatments out of a possible 9 total treatments across all treatment arms. Patients were re-randomized between treatment and no treatment during the second year. Patients who continued treatment in year 2 received a mean of 16 treatments out of a possible total 17 overall.

The two trials enrolled patients with neovascular AMD characteristics including classic, occult, and mixed lesions of up to 12 disc areas and baseline visual acuity in the study eye between 20/40 and 20/320. The primary efficacy endpoint was the proportion of patients losing less than 15 letters of visual acuity, from baseline up to 54 week assessment. Verteporfin PDT usage was permitted at the discretion of the investigators in patients with predominantly classic lesions.

The groups treated with Macugen 0.3 mg exhibited a statistically significant result in both trials for the primary efficacy endpoint at 1 year: Study EOP1003, Macugen 73% vs. Sham 60%; Study EOP1004, Macugen 67% vs. Sham 53%. Concomitant use of PDT overall was low. More sham treated patients (75/296) received PDT than Macugen 0.3 mg treated patients (58/294).

On average, Macugen 0.3 mg treated patients and sham treated patients continued to experience vision loss. However, the rate of vision decline in the Macugen treated group was slower than the rate in the patients who received sham treatment. See Figure 1.

At the end of the first year (week 54), approximately 1050 of the original 1200 patients were re-randomized to either continue the same treatment or to discontinue treatment through week 102. See Figure 2.

Macugen was less effective during the second year than during the first year. The percentage of patients losing less than 15 letters from baseline to week 102 was: Study EOP1003, Macugen 38/67 (57%); Sham 30/54 (56%); Study EOP1004, Macugen 40/66 (61%); Sham 18/53 (34%).

Dose levels above 0.3 mg did not demonstrate any additional benefit.

The safety or efficacy of Macugen beyond 2 years has not been demonstrated.

How Supplied/Storage and Handling

Macugen (pegaptanib sodium injection) is supplied in a sterile foil pouch as a single-use glass syringe pre-filled with 0.3 mg of Macugen® in a nominal 90 μL deliverable volume pack. A sterile packaged BD® single use 30G x 1/2" Precision Glide® Luer Lok® needle is supplied in a separate pouch. The foil pouch and needle are packaged together in a carton (NDC 68782-001-02).

Store in the refrigerator at 2° to 8°C (36° to 46°F). Do not freeze or shake vigorously.

Rx only.

Patient Counseling Information

In the days following Macugen administration, patients are at risk for the development of endophthalmitis. If the eye becomes red, sensitive to light, painful or develops a change in vision, the patient should seek the immediate care with their ophthalmologist [see Warnings and Precautions (5.1)].

Macugen®(pegaptanib sodium injection)

Manufactured by:

Gilead Sciences, Inc

650 Cliffside Drive

San Dimas, CA 91773

For:

Eyetech Inc.

11360 Jog Road, Suite 200

Palm Beach Gardens, Florida 33418

BD and Precision Glide Luer Lok® are registered trademarks of Becton Dickinson & CO, Franklin Lakes, New Jersey 07417

70-6127-00-4

PRINCIPAL DISPLAY PANEL

NDC 68782-001-02

Rx only

Macugen®

(pegaptanib sodium injection)

For Intravitreous Injection

0.3 mg / 90 μL*

 

Macugen  pegaptanib sodium  injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 68782-001 Route of Administration INTRAVITREAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PEGAPTANIB SODIUM (PEGAPTANIB) PEGAPTANIB 3.47 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE   SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE   SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE   HYDROCHLORIC ACID   SODIUM HYDROXIDE   WATER

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 68782-001-02 1 SYRINGE In 1 CARTON contains a SYRINGE 1 0.09 mL In 1 SYRINGE This package is contained within the CARTON (68782-001-02)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA021756	12/17/2004

Labeler - Eyetech Inc. (828561485)

Establishment
Name	Address	ID/FEI	Operations
Gilead Sciences, Inc.		941715849	manufacture

Revised: 10/2011Eyetech Inc.

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