Drug monograph for the active ingredient in Manerix

The following information is an educational aid only. It is not intended as medical advice for individual conditions or treatments. Talk to your doctor, nurse or pharmacist before following any medical regimen to see if it is safe and effective for you.

MOCLOBEMIDE (Systemic)*

Some commonly used brand names are:

In Canada—

• Manerix

Another commonly used name is RO 11-1163.

* Not commercially available in the U.S.

Category

• Antidepressant

Description

Moclobemide (moe-KLOE-be-mide)

is a monoamine oxidase (MAO) inhibitor used to relieve certain types of mental depression. It works by blocking the action of a chemical substance known as monoamine oxidase (MAO) in the nervous system.

Although this medicine is very effective for certain patients, it may also cause some unwanted reactions if not taken in the right way. It is very important to avoid certain beverages and medicines while you are being treated with an MAO inhibitor. Your doctor may provide a list as a reminder of which products you should avoid.

This medicine is available only with your doctor's prescription, in the following dosage forms:

Oral
• Moclobemide
  • Tablets (Canada)

Before Using This Medicine

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 moclobemide, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to moclobemide or monoamine oxidase inhibitors. Also tell your doctor and pharmacist if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Studies of moclobemide use in pregnant women have not been done. In some animal studies, weight gain was decreased in pregnant females or their offspring after high doses of moclobemide. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding—Small quantities of moclobemide pass into the breast milk. Moclobemide is not recommended during breast-feeding, because it may cause unwanted effects in nursing babies.

Children—Studies on moclobemide have been done only in adult patients, and there is no specific information comparing use of moclobemide in children with use in other age groups.

Older adults—Older adults are especially sensitive to the effects of moclobemide. This may increase the chance of side effects during treatment. Dizziness or lightheadedness may be especially likely to occur in elderly patients, who are usually more sensitive than younger adults to these effects.

Other 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 moclobemide, it is especially important that your doctor and pharmacist know if you are taking any of the following:

• Amphetamines or
• Appetite suppressants (diet pills) or
• Dextromethorphan or
• Medicine for asthma or other breathing problems
• Medicines for colds, sinus problems, or hay fever or other allergies (including nose drops or sprays) or
• Meperidine (e.g., Demerol) or
• Selective serotonin reuptake inhibitor antidepressants (fluvoxamine [e.g., Luvox], fluoxetine [e.g., Prozac], paroxetine [e.g., Paxil], sertraline [e.g., Zoloft]) or
• Tricyclic antidepressants (amitriptyline [e.g., Elavil], amoxapine [e.g., Asendin], clomipramine [e.g., Anafranil], desipramine [e.g., Norpramin], doxepin [e.g., Sinequan], imipramine [e.g., Tofranil], nortriptyline [e.g., Aventyl], protriptyline [e.g., Vivactil], trimipramine [e.g., Surmontil]—Using these medicines together may increase the chance of serious side effects

• Cimetidine (e.g., Tagamet)—May increase the effect of moclobemide; moclobemide doses may need to be lowered by approximately 50% in patients using cimetidine

• Monoamine oxidase (MAO) inhibitor activity (isocarboxazid [e.g., Marplan], phenelzine [e.g., Nardil], procarbazine [e.g., Matulane], selegiline [e.g., Eldepryl], tranylcypromine [e.g., Parnate])—Taking moclobemide while you are taking or within 2 weeks of taking monoamine oxidase (MAO) inhibitors may cause very serious side effects, such as sudden high body temperature, extremely high blood pressure, and severe convulsions; at least 14 days should be allowed between stopping treatment with one medicine and starting treatment with the other

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

• Hypertension—Moclobemide may make the problem worse
• Liver disease—Effects of moclobemide may be increased because of slower removal of the medicine from the body; your doctor may need to change your dose

Proper Use of This Medicine

• Ask your doctor about any changes you should make to your diet.
• Do not drink excessive amounts of alcohol while you are taking this medicine.

Sometimes this medicine must be taken for several weeks before you begin to feel better. Your doctor should check your progress at regular visits, especially during the first few months of treatment, to make sure that this medicine is working properly and to check for unwanted effects .

Take this medicine only 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.

Moclobemide should be taken after a meal. However, if your doctor tells you to take the medicine a certain way, take it exactly as directed.

Dosing—The dose of moclobemide 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 moclobemide. If your dose is different, do not change it unless your doctor tells you to do so.

The number of tablets 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 taking moclobemide .

• For oral dosage form (tablets):
  • For treatment of depression:
    • Adults—At first, 150 milligrams (mg), two times a day. Your doctor may increase your dose as needed, but the total daily dose is usually not more than 600 mg.
    • 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—To store this medicine:

• Keep out of the reach of children. Overdose of moclobemide is very dangerous in young children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

When taken with certain drinks or other medicines, moclobemide and other monoamine oxidase inhibitors can cause very dangerous reactions such as sudden high blood pressure (also called hypertensive crisis). To avoid such reactions, obey the following rules of caution :

• Do not drink excessive amounts of alcohol.
• Do not take any other medicine unless approved or prescribed by your doctor. This especially includes nonprescription (over-the-counter [OTC]) medicine, such as that for colds (including nose drops or sprays), cough, hay fever, and appetite control; "keep awake" products; or products that make you sleepy.

Check with your doctor immediately if you experience any combination of the following symptoms: severe throbbing headache which starts at the back of the head and radiates forward, stiff neck, fast or racing heartbeat, pounding or irregular heartbeat, or slow heartbeat. These may be symptoms of a serious side effect that should have a doctor's attention.

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

Dizziness, lightheadedness, or fainting may occur , especially when you get up from a lying or sitting position. Getting up slowly may help . When you get up from lying down, sit on the edge of the bed with your feet dangling for 1 or 2 minutes. Then stand up slowly. If the problem continues or gets worse, check with your doctor.

This medicine may cause blurred vision or make some people drowsy or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are unable to see well or are not alert .

Before having any kind of surgery, dental treatment, or emergency treatment, tell the medical doctor or dentist in charge that you are using this medicine or have used it within the past 2 weeks . Taking moclobemide together with medicines that are used during surgery or dental or emergency treatments may increase the risk of serious side effects.

After you stop using this medicine, you must continue to exercise caution for at least 1 to 2 weeks concerning drink and other medicine, since these things may continue to react with moclobemide.

Side Effects of This Medicine

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.

Stop taking this medicine and check with your doctor immediately if any combination of the following side effects occur:

Fast or racing heartbeat; pounding or irregular heartbeat; neck stiffness; severe throbbing headache which starts at the back of the head and radiates forward; slow heartbeat

Check with your doctor as soon as possible if any of the following side effects occur:

More common

Mild to moderate headache, or pressure in head

Less common

Anxiety; blurred vision or other changes in vision; dizziness, faintness, or lightheadedness, especially when getting up from a sitting or lying position; fast or racing heartbeat; high blood pressure; irritability; nervousness; pounding or irregular heartbeat; restlessness; unusual tiredness or weakness

Rare

Aggressive behavior; bleeding gums; burning, prickling, or tingling sensations; chest pain ; confusion; increased depression, or other mood and mental changes; difficulty in speaking; fast, slow, or irregular heart beat; feeling of something in the eye; general feeling of illness; headache (severe); increase in urination; increased sensitivity of eyes to light; irregular or prolonged menstrual periods; irritation or soreness of mouth; itching, redness, and swelling of eye; loss of balance control; loss of interest in self or surroundings; memory problems; pain or straining to pass urine or stool; painful urination; restlessness or desire to keep moving; ringing or noise in ears; seeing, hearing, or feeling something things that are not there; skin rash, hives, or itching; stomach pain or burning; slow heartbeat; troubled breathing; twisting movements of body; uncontrolled movements, especially of face, neck, and back

Symptoms of overdose

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

Agitation; confusion; convulsions (seizures); decreased reflexes; extreme drowsiness; high blood pressure; loss of memory; nausea; slurred speech; vomiting

Other 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. However, check with your doctor if any of the following side effects continue or are bothersome.

More common

Dryness of mouth; trembling or shaking of arms or legs

Less common or rare

Abdominal or stomach pain or discomfort; change in your sense of taste; constipation; diarrhea; dizziness; drowsiness; feeling of warmth of the face, neck, arms, and occasionally upper chest; heartburn or indigestion; increased or decreased appetite; increased sweating; joint or muscle pain; nightmares; trouble sleeping.

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

Developed: 05/17/2000

The information contained in the Thomson Healthcare products 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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