Pronunciation:

moe-KLOE-be-mide

Classifications:

Pharmacologic—

Monoamine Oxidase Inhibitor, Type A

Uses of This Medicine:

Moclobemide is a monoamine oxidase (MAO) inhibitor used to treat 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 taken the wrong way. It is very important to avoid certain beverages and medicines while you are using moclobemide. 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.

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 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.

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 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.

• Amitriptyline
• Amoxapine
• Apraclonidine
• Benzphetamine
• Brimonidine
• Bupropion
• Carbidopa
• Carbinoxamine
• Clomipramine
• Codeine
• Cyclobenzaprine
• Cyproheptadine
• Desipramine
• Deutetrabenazine
• Dexfenfluramine
• Dextromethorphan
• Diethylpropion
• Dothiepin
• Doxepin
• Doxylamine
• Eliglustat
• Fenfluramine
• Guanadrel
• Guanethidine
• Hydroxytryptophan
• Imipramine
• Isometheptene
• Levodopa
• Levomethadyl
• Lofepramine
• Maprotiline
• Mavacamten
• Mazindol
• Meperidine
• Methamphetamine
• Methotrimeprazine
• Methyldopa
• Mirtazapine
• Nefopam
• Nortriptyline
• Opipramol
• Ozanimod
• Phendimetrazine
• Phenmetrazine
• Phentermine
• Phenylalanine
• Protriptyline
• Pseudoephedrine
• Reserpine
• Safinamide
• Selegiline
• Sibutramine
• Solriamfetol
• Sumatriptan
• Tetrabenazine
• Tramadol
• Tranylcypromine
• Trazodone
• Trimipramine
• Tryptophan
• Viloxazine

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

• Alfentanil
• Atropine
• Belzutifan
• Benzhydrocodone
• Buspirone
• Butorphanol
• Cilostazol
• Clovoxamine
• Clozapine
• Difenoxin
• Dihydrocodeine
• Diphenoxylate
• Dolasetron
• Droperidol
• Ethchlorvynol
• Femoxetine
• Fentanyl
• Frovatriptan
• Granisetron
• Guarana
• Hydrocodone
• Hydromorphone
• Iobenguane I 123
• Iobenguane I 131
• Kava
• Lasmiditan
• Levorphanol
• Licorice
• Lithium
• Ma Huang
• Mate
• Metaxalone
• Methadone
• Methylene Blue
• Metoclopramide
• Midodrine
• Morphine
• Morphine Sulfate Liposome
• Nalbuphine
• Naratriptan
• Nebivolol
• Nefazodone
• Norepinephrine
• Ondansetron
• Oxycodone
• Oxymetazoline
• Oxymorphone
• Palonosetron
• Pentazocine
• Phenobarbital
• Primidone
• Reboxetine
• St John's Wort
• Tamoxifen
• Tyrosine
• Ziprasidone

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

• Ginseng

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Avocado
• Bitter Orange

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:

• Hypertension—May make this condition worse.
• Liver disease—Effects may be increased because of slower removal of the medicine from the body.

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

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

• For oral dosage form (tablets):
  • For treatment of depression:
    • Adults—At first, 150 milligrams (mg) two times a day. Your doctor may adjust your dose as needed. However, 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—

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.

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, follow these 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 medicine for colds (including nose drops or sprays), cough, hay fever, and appetite control; "stay 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 that starts at the back of the head and radiates forward; stiff neck; fast or racing heartbeat; pounding, irregular, 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 gradually reduce the amount you are using before stopping it completely.

Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position suddenly. 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, 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 2 weeks with your foods, drinks, and other medicines, since these items 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 get emergency help immediately if any of the following 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 immediately if any of the following side effects occur:

More common

Mild to moderate headache, or pressure in the 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 suddenly

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 with 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 the mouth

itching, redness, and swelling of the 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 the ears

seeing, hearing, or feeling 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 the face, neck, and back

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

Symptoms of overdose

Agitation

confusion

convulsions (seizures)

decreased reflexes

extreme drowsiness

high blood pressure

loss of memory

nausea

slurred speech

vomiting

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

More common

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 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.