Benzonatate - Benzonatate capsule prescribing information
INDICATIONS AND USAGE
Benzonatate capsules USP are indicated for the symptomatic relief of cough.
DOSAGE AND ADMINISTRATION
Adults and Children over 10 years of age: Usual dose is one 100 mg or 200 mg capsule three times a day as needed for cough. If necessary to control cough, up to 600 mg daily in three divided doses may be given. Benzonatate capsules USP should be swallowed whole. Benzonatate capsules USP are not to be broken, chewed, dissolved, cut or crushed.
CONTRAINDICATIONS
Hypersensitivity to benzonatate or related compounds.
ADVERSE REACTIONS
Potential Adverse Reactions to benzonatate 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.
Deliberate or accidental overdose has resulted in death, particularly in children.
Call your doctor for medical advice about side effects. You may report side effects to Strides Pharma Inc. at 1-877-244-9825 or go to www.strides.com
DESCRIPTION
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 a molecular weight of 603.7.
Each benzonatate capsule USP, 100 mg contains:
Benzonatate USP 100 mg
Each benzonatate capsule USP, 200 mg contains:
Benzonatate USP 200 mg
Benzonatate capsules USP also contain: D&C Yellow 10, gelatin, glycerin, methylparaben, propylparaben and purified water.
Ingredients of the imprinting ink are: Propylene glycol, shellac resins, sodium lauryl sulphate, isopropyl alcohol and titanium dioxide.
CLINICAL PHARMACOLOGY
Benzonatate 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. Benzonatate has no inhibitory effect on the respiratory center in recommended dosage.
HOW SUPPLIED
Benzonatate capsules USP, 100 mg are available as yellow colored, oval shaped soft gelatin capsules, imprinted as '705' in white ink and containing clear, pale yellow viscous liquid.
NDC 64380-712-06 in bottles of 100 capsules.
NDC 64380-712-07 in bottles of 500 capsules.
Benzonatate capsules USP, 200 mg are available as yellow colored, oval shaped soft gelatin capsules, imprinted as '704' in white ink and containing clear, pale yellow viscous liquid.
NDC 64380-713-06 in bottles of 100 capsules.
NDC 64380-713-07 in bottles of 500 capsules.
Store at 20° to 25°C (68° to 77°F); excursions permitted to 15-30°C (59-86°F) [See USP controlled room temperature].
PROTECT FROM LIGHT
Dispense in a tight (USP), child-resistant containers.
