BENZONATATE capsule

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Major Pharmaceuticals, Inc.

INN (Nome Internazionale):

BENZONATATE

Composizione:

BENZONATATE 100 mg

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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

Dettagli prodotto:

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: Bottle of 100 capsules, NDC 0904-6564-60 Carton of 100 capsules (10 capsules each blister pack x 10), NDC 0904-6564-61 Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container.

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

BENZONATATE- BENZONATATE CAPSULE
MAJOR PHARMACEUTICALS, INC.
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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 accid