BENZONATATE capsule, liquid filled

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BENZONATATE (UNII: 5P4DHS6ENR) (BENZONATATE - UNII:5P4DHS6ENR)

Available from:

Rebel Distributors Corp

INN (International Name):

BENZONATATE

Composition:

BENZONATATE 100 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. Hypersensitivity to benzonatate or related compounds.

Product summary:

Benzonatate Capsules, USP are available as: Soft gelatin capsules, 100 mg (oval, yellow) Imprint: A1.; bottle of 20 (NDC 42254-078-20) and bottle of 30 (42254-078-30 Store at 25°-25°C (68°-77°F) [See USP Controlled Room Temperature]. Dispense in tight, light-resistant container as defined in the USP. Manufactured by: Swiss Caps AG Hausenstrasse 35 CH-9533, Kirchberg, Switzerland Distributed by: Amneal Pharmaceuticals Glasgow, KY 42141 Rev. 09-2008 Repackaged by: Rebel Distributors Corp Thousand Oaks, CA 91320

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BENZONATATE- BENZONATATE CAPSULE, LIQUID FILLED
REBEL DISTRIBUTORS CORP
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BENZONATATE CAPSULES, USP
100 MG AND 200 MG
RX ONLY
DESCRIPTION
Benzonatate, a non-narcotic 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.
Benzonatate Capsules, USP contain 100 mg or 200 mg of benzonatate,
USP.
Benzonatate Capsules also contain: D&C Yellow No. 10, gelatin,
glycerin, methylparaben sodium and
propylparaben sodium.
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.
INDICATIONS AND USAGE
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.
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 capsule
instead of swallowing it. Severe reactions have required intervention
with vasopressor agents and
supportive measures.
PRECAUTIONS
Benzonatate is chemically related to anesthetic agents of the
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 THE PATIENT
Release of benzonatate from the capsule in th