Marplan

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

• Marplan^®

Frequency Not Defined

Common

• Orthostatic hypotension
• Dizziness
• Crowsiness
• Fatigue
• Headache
• Hyperreflexia
• Sleep disturbance
• Weakness
• Tremor
• Constipation
• Dry mouth

Less Common

• Confusion
• Decreased memory
• Paresthesia
• Anorexia
• Nausea
• Vomiting
• Impotence
• Urinary frequency or retention
• Nystagmus

Uncommon

• Edema
• Anxiety
• Hypomania
• Irritation
• Hypermetabolic syndrome (hyperpyrexia, tachycardia, tachypnea, incr CPK, acidosis)
• SIADH
• Arthralgia

Rare

• Risk of hypertensive crisis (usually due to drug interaction)
• Ataxia
• Seizure
• Jaundice
• Visual disturbance

Marplan is indicated for the treatment of depression. Because of its potentially serious side effects, Marplan is not an antidepressant of first choice in the treatment of newly diagnosed depressed patients.

The efficacy of Marplan in the treatment of depression was established in 6-wreek controlled trials of depressed outpatients. These patients had symptoms that corresponded to the DSM-IV category of major depressive disorder; however, they often also had signs and symptoms of anxiety (anxious mood, panic, and/or phobic symptoms) (See CLINICAL PHARMACOLOGY).

A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation.

The antidepressant effectiveness of Marplan in hospitalized depressed patients, or in endogenomorphically retarded and delusionally depressed patients, has not been adequately studied.

The effectiveness of Marplan in long-term use, that is, for more than 6 weeks, has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use Marplan for extended periods should periodically evaluate the long-term usefulness of the drug for the individual patient.

The lethal dose of Marplan in humans is not known. There has been one report of a fatality in a patient who ingested 400 mg of Marplan together with an unspecified amount of another drug. Symptoms: Major overdosage may be evidenced by tachycardia, hypotension, coma, convulsions, respiratory depression, sluggish reflexes, pyrexia, and diaphoresis; these signs may persist for 8 to 14 days. Treatment: General supportive measures should be used, along with immediate gastric lavage or emetics. If the latter are given, the danger of aspiration must be borne in mind. An adequate airway should be maintained, with supplemental oxygen if necessary. The mechanism by which amine-oxidase inhibitors produce hypotension is not fully understood, but there is evidence that these agents block the vascular bed response. Thus it is suggested that plasma may be of value in the management of this hypotension. Administration of pressor amines such as Levophed8 (levarterenol bitartrate) may be of limited value (note that their effects may be potentiated by Marplan). Continue treatment for several days until homeostasis is restored. Liver function studies are recommended during the 4 to 6 weeks after recovery, as well as the time of overdosage.

In managing overdosage, consider the possibility of multiple drug involvement. The physician should consider contacting a poison control center on the treatment of any overdose.

• Store at room temperature between 15°C and 30°C (59°F - 86°F).
• Keep this and all medications out of the reach of children.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• chills
• cold sweats
• confusion
• difficult urination
• dizziness, faintness, or lightheadedness when getting up from lying or sitting position
• fainting
• fast, irregular, pounding, or racing heartbeat or pulse
• fear or nervousness
• heavy feeling
• increased need to urinate
• passing urine more often
• restlessness
• shakiness in the legs, arms, hands, or feet
• sudden jerky movements of the body
• sweating
• trembling or shaking of the hands or feet
• trouble sitting still

• Agitation
• burning while urinating
• change in consciousness
• decrease in frequency of urination
• decrease in urine volume
• decreased urine output
• depression
• difficulty in passing urine (dribbling)
• dizziness
• false or unusual sense of well-being
• headache
• hostility
• irritability
• loss of bladder control
• loss of consciousness
• muscle twitching
• nausea
• need to keep moving
• numbness or tingling of the hands, feet, or face
• rapid weight gain
• seeing, hearing, or feeling things that are not there
• seizures
• shakiness and unsteady walk
• stupor
• swelling of the face, ankles, or hands
• unsteadiness, trembling, or other problems with muscle control or coordination
• unusual tiredness or weakness

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:

• Constipation
• dry mouth

• Decreased interest in sexual intercourse
• drowsiness
• inability to have or keep an erection
• loss in sexual ability, desire, drive, or performance
• relaxed and calm
• sleepiness
• sleeplessness
• trouble sleeping
• unable to sleep
• unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

• Black tongue
• blurred vision
• change in vision
• impaired vision
• increased sensitivity of the skin to sunlight
• itching
• raised, dark red, wart-like spots on the skin, especially when used on the face
• redness or other discoloration of the skin
• severe sunburn
• skin rash

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.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time Marplan is refilled. If you have any questions about this medicine, please talk with the doctor, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take Marplan or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Marplan. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017