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Tessalon Capsules, Tessalon Perles (Forest)
DESCRIPTION
TESSALON, a non-narcotic oral antitussive agent, is 2, 5, 8, 11, 14, 17, 20, 23, 26-nonaoxaoctacosan-28-yl p-(butylamino) benzoate; with a molecular weight of 603.7.
Each TESSALON Perle contains:
Benzonatate, USP100 mg
Each TESSALON Capsule contains:
Benzonatate, USP200 mg
TESSALON Capsules also contain: D&C Yellow 10, gelatin, glycerin, methylparaben and propylparaben.
CLINICAL PHARMACOLOGY
TESSALON acts peripherally by anesthetizing the stretch receptors located in the respiratory passages, lungs, and pleura by dampening their activity and thereby reducing the cough reflex at its source. It begins to act within 15 to 20 minutes and its effect lasts for 3 to 8 hours. TESSALON has no inhibitory effect on the respiratory center in recommended dosage.
INDICATIONS AND USAGE
TESSALON is indicated for the symptomatic relief of cough.
CONTRAINDICATIONS
Hypersensitivity to benzonatate or related compounds.
WARNINGS
Severe hypersensitivity reactions (including bronchospasm, laryngospasm and cardiovascular collapse) have been reported which are possibly related to local anesthesia from sucking or chewing the perle instead of swallowing it. Severe reactions have required intervention with vasopressor agents and supportive measures.
Isolated instances of bizarre behavior, including mental confusion and visual hallucinations, have also been reported in patients taking TESSALON in combination with other prescribed drugs.
PRECAUTIONS
Benzonatate is chemically related to anesthetic agents of the para-amino-benzoic acid class (e.g., procaine; tetracaine) and has been associated with adverse CNS effects possibly related to a prior sensitivity to related agents or interaction with concomitant medication.
Information for Patients: Release of TESSALON from the capsule in the mouth can produce a temporary local anesthesia of the oral mucosa and choking could occur. Therefore, the capsules should be swallowed without chewing.
Usage in Pregnancy: Pregnancy Category C. Animal reproduction studies have not been conducted with TESSALON. It is also not known whether TESSALON can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. TESSALON should be given to a pregnant woman only if clearly needed.
Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk caution should be exercised when TESSALON is administered to a nursing woman.
Carcinogenesis, Mutagenesis, Impairment of Fertility : Carcinogenicity, mutagenicity, and reproduction studies have not been conducted with TESSALON.
Pediatric Use: Safety and effectiveness in children below the age of 10 has not been established.
ADVERSE REACTIONS
Potential Adverse Reactions to TESSALON may include:
Hypersensitivity reactions including bronchospasm, laryngospasm, cardiovascular collapse possibly related to local anesthesia from chewing or sucking the capsule.
CNS: sedation; headache; dizziness; mental confusion; visual hallucinations.
GI: constipation, nausea, GI upset.
Dermatologic: pruritus; skin eruptions.
Other: nasal congestion; sensation of burning in the eyes; vague "chilly" sensation; numbness of the chest; hypersensitivity.
Rare instances of deliberate or accidental overdose have resulted in death.
OVERDOSAGE
Overdose may result in death.
The drug is chemically related to tetracaine and other topical anesthetics and shares various aspects of their pharmacology and toxicology. Drugs of this type are generally well absorbed after ingestion.
Signs and Symptoms:
If capsules are chewed or dissolved in the mouth, oropharyngeal anesthesia will develop rapidly. CNS stimulation may cause restlessness and tremors which may proceed to clonic convulsions followed by profound CNS depression.
Treatment:
Evacuate gastric contents and administer copious amounts of activated charcoal slurry. Even in the conscious patient, cough and gag reflexes may be so depressed as to necessitate special attention to protection against aspiration of gastric contents and orally administered materials. Convulsions should be treated with a short-acting barbiturate given intravenously and carefully titrated for the smallest effective dosage. Intensive support of respiration and cardiovascular-renal function is an essential feature of the treatment of severe intoxication from overdosage.
Do not use CNS stimulants.
DOSAGE AND ADMINISTRATION
Adults and Children over 10: Usual dose is one 100 mg or 200 mg capsule t.i.d. as required. If necessary, up to 600 mg daily may be given.
HOW SUPPLIED
Perles, 100 mg (yellow); bottles of 100
NDC 0456-0688-01 Imprint: T.Perles, 100 mg (yellow); bottles of 500
NDC 0456-0688-02 Imprint: T.Capsules, 200 mg (yellow); bottles of 100
NDC 0456-0698-01 Imprint: 0698 .Capsules, 200 mg (yellow); bottles of 500
NDC 0456-0698-02 Imprint: 0698 .Store at 25°C (77°F); excursions permitted to 15-30°C
(59-86°F) [see USP Controlled Room Temperature].Rev. 3/03 (04)
Mfd by
Cardinal Health
St. Petersburg, Florida 33716
for
FOREST PHARMACEUTICALS, INC.
SUBSIDIARY OF Forest Laboratories, INC.
ST. LOUIS, MISSOURI 63045
©2003 Forest Laboratories, Inc.
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