Clemastine Syrup

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Change in balance.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Feeling sleepy.
• Dizziness.
• Belly pain.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• Store at room temperature.
• Protect from light.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

Antihistamines are contraindicated in patients hypersensitive to the drug or to other antihistamines of similar chemical structure (see PRECAUTIONS-Drug Interactions).

Antihistamines should not be used in newborn or premature infants. Because of the higher risk of antihistamines for infants generally and for newborns and prematures in particular, antihistamine therapy is contraindicated in nursing mothers (see PRECAUTIONS-Nursing Mothers).

Antihistamine overdosage reactions may vary from central nervous system depression to stimulation. In children, stimulation predominates initially in a syndrome which may include excitement, hallucinations, ataxia, incoordination, muscle twitching, athetosis, hyperthermia, cyanosis convulsions, tremors, and hyperreflexia followed by postictal depression and cardio-respiratory arrest. Convulsions in children may be preceded by mild depression. Dry mouth, fixed dilated pupils, flushing of the face, and fever are common. In adults, CNS depression, ranging from drowsiness to coma, is more common. The convulsant dose of antihistamines lies near the lethal dose. Convulsions indicate a poor prognosis.

In both children and adults, coma and cardiovascular collapse may occur. Deaths are reported especially in infants and children.

There is no specific therapy for acute overdosage with antihistamines. The latent period from ingestion to appearance of toxic effects is characteristically short (1/2-2 hours). General symptomatic and supportive measures should be instituted promptly and maintained for as long as necessary.

Since overdoses of other classes of drugs (i.e. tricyclic antidepressants) may also present anticholinergic symptomatology, appropriate toxicological analysis should be performed as soon as possible to identify the causative agent.

In the conscious patient, vomiting should be induced even though it may have occurred spontaneously. If vomiting cannot be induced, gastric lavage is indicated. Adequate precautions must be taken to protect against aspiration, especially in infants and children. Charcoal slurry or other suitable agents should be instilled into the stomach after vomiting or lavage. Saline cathartics or milk of magnesia may be of additional benefit.

In the unconscious patient, the airway should be secured with a cuffed endotracheal tube before attempting to evacuate the gastric contents. Intensive supportive and nursing care is indicated, as for any comatose patient.

If breathing is significantly impaired, maintenance of an adequate airway and mechanical support of respiration is the most effective means of providing adequate oxygenation.

Hypotension is an early sign of impending cardiovascular collapse and should be treated vigorously. Although general supportive measures are important, specific treatment with intravenous infusion of a vasopressor titrated to maintain adequate blood pressure may be necessary.

Do not use with CNS stimulants.

Convulsions should be controlled by careful administration of diazepam or a short-acting barbiturate, repeated as necessary. Physostigmine may also be considered for use in controlling centrally mediated convulsions.

Ice packs and cooling sponge baths, not alcohol, can aid in reducing the fever commonly seen in children. A more detailed review of antihistamine toxicology and overdose management is available in Gosselin, R.E., et. al., "Clinical Toxicology of Commercial Products."

Clemastine Fumarate Syrup: clemastine 0.5 mg/5 mL (present as clemastine fumarate 0.67 mg/5 mL). A clear, colorless liquid with a citrus flavor, in 120 mL bottle.

Store at controlled room temperature, between 20° and 25°C (68° and 77°F) (see USP).

Manufactured By:

TEVA PHARMACEUTICALS USA

Sellersville, PA 18960

Rev. I 4/2003