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SYMMETREL (AMANTADINE HCL) TABLETS AND SYRUP: PRECAUTIONS

Symmetrel should not be discontinued abruptly in patients with Parkinson's disease since a few patients have experienced a parkinsonian crisis, i.e., a sudden marked clinical deterioration, when this medication was suddenly stopped. The dose of anticholinergic drugs or of Symmetrel (Amantadine Hydrochloride) should be reduced if atropine-like effects appear when these drugs are used concurrently. Abrupt discontinuation may also precipitate delirium, delusions, agitation, hallucinations, stupor, paranoid reaction, anxiety, depression and slurred speech.

Neuroleptic Malignant Syndrome (NMS)

Sporadic cases of possible Neuroleptic Malignant Syndrome (NMS) have been reported in association with dose reduction or withdrawal of Symmetrel therapy. Therefore, patients should be observed carefully when the dosage of Symmetrel (Amantadine Hydrochloride) tablets and syrup is reduced abruptly or discontinued, especially if the patient is receiving neuroleptics.

NMS is an uncommon but life-threatening syndrome characterized by fever or hyperthermia; neurologic findings including muscle rigidity, involuntary movements, altered consciousness; mental status changes; other disturbances such as tachycardia, autonomic dysfunction, tachypnea, hyper- or hypotension; laboratory findings such as creatine phosphokinase elevation, myoglobinuria, leukocytosis, and increased serum myoglobin.

The early diagnosis of this condition is important for the appropriate management of these patients. Considering NMS as a possible diagnosis and ruling out other acute illnesses (e.g., systemic infection, pneumonia, etc.) is essential. This may be especially complex if the clinical presentation includes both serious medical illness and untreated or inadequately treated extrapyramidal signs and symptoms (EPS). Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, drug fever and primary central nervous system (CNS) pathology.

The management of NMS should include: intensive symptomatic treatment and medical monitoring, and treatment of any concomitant serious medical problems for which specific treatments are available. Dopamine agonists, such as bromocriptine, and muscle relaxants, such as dantrolene are often used in the treatment of NMS, however, their effectiveness has not been demonstrated in controlled studies.

Renal disease

Because Symmetrel is mainly excreted in the urine, it accumulates in the plasma and in the body when renal function declines. Thus, the dose of Amantadine (Symmetrel) should be reduced in patients with renal impairment and in individuals who are 65 years of age or older.

Liver disease

Care should be exercised when administering Symmetrel to patients with liver disease. Rare instances of reversible elevation of liver enzymes have been reported in patients receiving Amantadine (Symmetrel) tablets and syrup, though a specific relationship between the drug and such changes has not been established.

Melanoma

Epidemiological studies have shown that patients with Parkinson's disease have a higher risk (2- to approximately 6-fold higher) of developing melanoma than the general population. Whether the increased risk observed was due to Parkinson's disease or other factors, such as drugs used to treat Parkinson's disease, is unclear.

For the reasons stated above, patients and providers are advised to monitor for melanomas frequently and on a regular basis when using Symmetrel for any indication. Ideally, periodic skin examinations should be performed by appropriately qualified individuals (e.g., dermatologists).

Other

The dose of Amantadine HCl (Symmetrel) may need careful adjustment in patients with congestive heart failure, peripheral edema, or orthostatic hypotension. Care should be exercised when administering Symmetrel to patients with a history of recurrent eczematoid rash, or to patients with psychosis or severe psychoneurosis not controlled by chemotherapeutic agents.

Serious bacterial infections may begin with influenza-like symptoms or may coexist with or occur as complications during the course of influenza. Amantadine HCl (Symmetrel) tablets and syrup has not been shown to prevent such complications.

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