BENZONATATE- benzonatate capsule

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

Physicians Total Care, Inc.

Designación común internacional (DCI):

BENZONATATE

Composición:

BENZONATATE 100 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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

Resumen del producto:

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: Benzonatate capsules USP, 200 mg are light yellow-colored, round-shaped soft gelatin capsules, imprinted with "β" containing pale yellow-colored clear viscous liquid and are supplied as follows: Store at 20° - 25°C (68° - 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container.

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

BENZONATATE - BENZONATATE CAPSULE
PHYSICIANS TOTAL CARE, 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
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 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
a