BENZONATATE- 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:

Lake Erie Medical DBA Quality Care Products LLC

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 are available as: 100 mg (oval, yellow) soft gelatin capsules with imprint “A1”. 200 mg (oblong, yellow) soft gelatin capsules with imprint “A2”. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Dispense in tight, light-resistant container as defined in the USP.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BENZONATATE- BENZONATATE CAPSULE, LIQUID FILLED
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
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BENZONATATE CAPSULES, USP
100 MG AND 200 MG
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 is indicated for the symptomatic relief of cough.
CONTRAINDICATIONS
Hypersensitivity to benzonatate or related compounds.
BOXED WARNING
HYPERS ENS ITIVITY
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 to 20 minutes and death has been reported within one hour of
ingestion. If accidental
ingestion occurs, seek medical attention immediately (see OVERDOSAGE).
PRECAUTION