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Benzonatate capsules, USP, a non-narcotic oral antitussive agent, is 2,5,8,11,14,17,20,23,26-nonaoxaoctacosan-28-yl p-(butylamino) benzoate; with molecular weight of 603.7.
Each benzonatate capsule for oral administration contains 100 mg or 200 mg of benzonatate. In addition, each capsule also contains the following inactive ingredients: gelatin, glycerin, noncrystallising sorbitol solution, methylparaben, propylparaben and purified water.
Benzonatate capsules act 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. Benzonatate capsules have no inhibitory effect on the respiratory center in recommended dosage.
Severe hypersensitivity reactions (including bronchospasm, laryngospasm and cardiovascular collapse) have been reported which are possibly related to local anesthesia from sucking or chewing the capsule 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 benzonatate capsules in combination with other prescribed drugs.
Benzonatate is chemically related to anesthetic agents of para-aminobenzoic 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 patientsUsage in Pregnancy
Pregnancy Category C. Animal reproduction studies have not been conducted with benzonatate capsules. It is also not known whether benzonatate capsules can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Benzonatate capsules should be given to pregnant woman only if clearly needed.Nursing mothersCarcinogenesis, mutagenesis, impairment of fertilityPediatric Use
Potential Adverse Reactions to Benzonatate Capsules may include: Hypersensitivity reactions including bronchospasm, laryngospasm, cardiovascular collapse possibly related to local anesthesia from chewing or sucking the capsule.
Sedation; headache; dizziness; mental confusion; visual hallucinations.
Constipation; nausea; GI upset.
Pruritus; skin eruptions.
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.
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 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.
NDC 54868-3457-3 in bottle of 15 capsules
NDC 54868-3457-0 in bottle of 20 capsules
NDC 54868-3457-1 in bottle of 30 capsules
NDC 54868-3457-2 in bottle of 60 capsules
Benzonatate capsules USP, 200 mg are light yellow-colored, round-shaped soft gelatin capsules, imprinted with "β" containing pale yellow-colored clear viscous liquid and are supplied as follows:
NDC 54868-4482-0 in bottle of 20 capsules
NDC 54868-4482-1 in bottle of 30 capsules
NDC 54868-4482-2 in bottle of 90 capsules
Store at 20° - 25°C (68° - 77°F) [See USP Controlled Room Temperature].
Dispense in a tight, light-resistant container.
Cadila Healthcare Ltd.
Zydus Pharmaceuticals USA Inc.
Princeton, NJ 08540
Revision Date : 12/26/2009
Repackaging and Relabeling by:
PRINCIPAL DISPLAY PANEL
Benzonatate Capsules USP, 100 mg
Benzonatate Capsules USP, 200 mg
Revised: 05/2010 Physicians Total Care, Inc.
Reproduced with permission of U.S. National Library of Medicine
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