BENZONATATE- benzonatate capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Nucare Pharmaceuticals, Inc.

INN (International Name):

BENZONATATE

Composition:

BENZONATATE 100 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Benzonatate USP is indicated for the symptomatic relief of cough. Hypersensitivity to benzonatate or related compounds. Pediatric Use Safety and effectiveness in children below the age of 10 have not been established. Accidental ingestion resulting in death has been reported in children below age 10. Keep out of reach of children.

Product summary:

Benzonatate Capsules USP, 100 mg: Yellow soft gelatin capsules, imprinted “ASC” on one side and “105” on the other side. NDC 68071-3346-5 Bottles of 15 Store at 20° to 25° C (68° to 77°F). [See USP Controlled Room Temperature]. PROTECT FROM LIGHT. Manufactured by Intergel Division of IVC Industries, Inc. Irvington, NJ 07111 Manufactured for Ascend Laboratories, LLC Montvale, NJ 07645 Rev 10/14 210082

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BENZONATATE- BENZONATATE CAPSULE
NUCARE PHARMACEUTICALS, INC.
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BENZONATATE CAPSULES, USP
100 MG, 150 MG AND 200 MG
DESCRIPTION
Benzonatate, 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 soft gelatin capsule, for oral administration, contains 100 mg,
150 mg or 200 mg of benzonatate
USP. Benzonatate Capsules, USP also contain the following inactive
ingredients: D&C Yellow #10,
gelatin, glycerin, purified water, methylparaben, propylparaben 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.
INDICATIONS AND USAGE
Benzonatate USP is indicated for the symptomatic relief of cough.
CONTRAINDICATIONS
Hypersensitivity to benzonatate or related compounds.
WARNINGS
HYPERSENSITIVITY
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.
PSYCHIATRIC EFECTS
Isolated instances of bizarre behavior, including mental confusion and
visual hallucinations, have also
been reported in patients taking benzonatate in combination with other
prescribed drugs.
ACCIDENTAL INGESTION AND DEATH IN CHILDREN
Keep benzonatate capsules out of reach of children. Accidental
ingestion of benzonatate resulting in
death has been reported in children below age 10. Signs and symptoms
of overdose have been reported
within 15-20 minutes and death has been reported within one hour of
ingestion. If accidental ingestion