BENZONATATE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Golden State Medical Supply, Inc.

INN (International Name):

Benzonatate

Composition:

Benzonatate 100 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

BENZONATATE is indicated for the symptomatic relief of cough. Hypersensitivity to benzonatate or related compounds.

Product summary:

Benzonatate Capsules USP, 100 mg: Yellow soft gelatin capsules, imprinted with "PA46", available in bottles of 30's (NDC 60429-927-30), 100's (NDC 60429-927-01) and 500's (NDC 60429-927-05). Benzonatate Capsules USP, 200 mg: Yellow soft gelatin capsules, imprinted with "PA83", available in bottles of 100's (NDC 60429-914-01). The capsules should be protected from light, moisture and humidity, and stored at controlled room temperature 20° to 25°C (68° to 77°F) [See USP]. Dispense in a tight, light-resistant container as defined in USP/NF. Manufactured for: Bionpharma Inc., 600 Alexander Road, Princeton, NJ 08540, USA Rev. 05/2020 Marketed by: GSMS, Inc. Camarillo, CA 93012 USA

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BENZONATATE- BENZONATATE CAPSULE
GOLDEN STATE MEDICAL SUPPLY, INC.
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BENZONATATE CAPSULES USP, 100 MG AND 200 MG
RX ONLY
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 or
200 mg
benzonatate USP. In addition, each capsule contains the following
inactive ingredients:
D&C Yellow No. 10, gelatin, glycerin, and purified water.
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 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 EFFECTS
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 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 occurs, seek medical
attention immediately
(see OVERDOSAGE).
PR