Moclobemide (Oral)

Moclobemide is a type of monoamine oxidase (MAO) inhibitor used to treat certain types of mental depression. It works by reversibly blocking the action of a chemical called monoamine oxidase A (MAO-A) in the nervous system.

Although this medicine is very effective for certain patients, it may also cause some unwanted reactions if not taken correctly. It is very important to avoid certain beverages and medicines while you are using moclobemide. Your doctor may give you a list to remind you of which products to avoid.

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

When taken with certain drinks or other medicines, moclobemide and other monoamine oxidase inhibitors can cause very dangerous reactions, like sudden high blood pressure (hypertensive crisis). To avoid these reactions, follow these caution rules:

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

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

Do not stop taking this medicine without checking with your doctor first. Your doctor may want you to gradually lower your dose before stopping completely.

Dizziness, lightheadedness, or fainting may occur, especially when you suddenly get up from lying or sitting. Getting up slowly may help. When getting up from lying down, sit on the edge of the bed with your feet hanging for 1 or 2 minutes, then stand up slowly. If the problem continues or worsens, talk to your doctor.

This medicine may cause blurred vision or make some people drowsy or less alert than usual. Make sure you know how this medicine affects you before driving, using machines, or doing anything else that could be dangerous if you are unable to see well or are not alert.

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

After you stop using this medicine, continue to be cautious for at least 2 weeks with your foods, drinks, and other medicines, as these may still interact with moclobemide.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the benefits it will provide. This is a decision you and your doctor will make together. For this medicine, consider the following:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also inform your healthcare professional about any other allergies you have, such as to foods, dyes, preservatives, or animals. For over-the-counter products, read the label or package ingredients carefully.

Pediatric

Studies on moclobemide have only been conducted in adult patients, and there is no specific information comparing the use of moclobemide in children to its use in other age groups.

Geriatric

Older adults are particularly 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 usually react more strongly than younger adults to these effects.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction could happen. In these situations, your doctor may want to adjust the dose, or other precautions may be necessary. When you are taking this medicine, it is particularly important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions have been selected based on their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may choose not to prescribe this medication to you or may adjust some of the other medicines you take.

• Amitriptyline
• Amoxapine
• Amphetamine
• Apraclonidine
• Benzphetamine
• Brimonidine
• Bupropion
• Carbamazepine
• Carbidopa
• Carbinoxamine
• Clomipramine
• Codeine
• Cyclobenzaprine
• Cyproheptadine
• Desipramine
• Deutetrabenazine
• Dexfenfluramine
• Dextroamphetamine
• Dextromethorphan
• Diethylpropion
• Dothiepin
• Doxepin
• Doxylamine
• Eliglustat
• Fenfluramine
• Guanadrel
• Guanethidine
• Hydroxytryptophan
• Imipramine
• Isometheptene
• Levodopa
• Levomethadyl
• Lisdexamfetamine
• 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
• Venlafaxine
• Viloxazine

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some situations. If both medicines are prescribed together, your doctor may adjust 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
• Remifentanil
• St John's Wort
• Sufentanil
• Tamoxifen
• Tyrosine
• Ziprasidone

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both medicines 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

Interactions with food and alcohol

Unlike monoamine oxidase inhibitors, you do not generally need to follow special dietary restrictions while taking moclobemide. Some people taking moclobemide may be sensitive to tyramine and should avoid foods that are high in tyramine, such as aged cheeses, cured meats, broad bean pods, yeast-extract spreads, and soy products. Tyramine sensitivity reactions may be reduced by taking moclobemide right after meals.

Do not drink excessive amounts of alcohol while taking moclobemide.

Other Medical Problems

Having other medical problems may affect how you can use this medicine. Make sure to inform your doctor if you have any other medical issues, especially:

• Hypertension—This may worsen this condition.
• Liver disease—Effects may be increased due to slower removal of the medicine from your body.

Along with its necessary effects, this medicine may cause some unwanted effects. Not all of these side effects may occur, but if they do, they may need medical attention.

Stop taking this medicine and get emergency help right away if any of the following effects happen:

• Fast or racing heartbeat
• Pounding or irregular heartbeat
• Neck stiffness
• Severe throbbing headache that starts at the back of the head and moves forward
• Slow heartbeat

Check with your doctor right away if any of the following side effects happen:

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 standing up suddenly 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 with speaking
• Fast, slow, or irregular heartbeat
• Feeling of something in the eye
• General feeling of illness
• Severe headache
• Increased 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 the body
• Uncontrolled movements, especially of the face, neck, and back

Get emergency help right away 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. Your health care professional may also 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 in 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.

Pharmacologic Class: Monoamine Oxidase Inhibitor, Type A

• 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.