BENZONATATE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Cardinal Health 107, LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Benzonatate capsules are indicated for the symptomatic relief of cough. Hypersensitivity to benzonatate or related compounds.

Product summary:

Benzonatate capsules USP, 100 mg are light yellow-colored, round-shaped soft gelatin capsules, imprinted with "Z" containing pale yellow-colored clear viscous liquid and are supplied as follows: Overbagged with 10 Capsules per bag, NDC 55154-7995-0 Store at 20° - 25°C (68° - 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BENZONATATE- BENZONATATE CAPSULE
CARDINAL HEALTH 107, LLC
----------
BENZONATATE CAPSULES, USP
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 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.
CLINICAL PHARMACOLOGY
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.
INDICATIONS AND USAGE
Benzonatate capsules are 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
capsules in
combination with other prescribed drugs.
ACCIDENTAL INGESTION AND DEATH IN CHILDREN
Keep benzonatate capsules out of reach of children. Accidental
ingestion of benzonatate
capsules resulting in death has been reported in children below age
10. Signs and
symptoms of overdose have been reported within 15 to 20 minutes and
death has been
reported within one hour of ingestion. If accident