BENZONATATE capsule

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

benzonatate (UNII: 5P4DHS6ENR) (benzonatate - UNII:5P4DHS6ENR)

Disponible desde:

Preferred Pharmaceuticals Inc

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Benzonatate USP is indicated for the symptomatic relief of cough. Hypersensitivity to benzonatate or related compounds. Pediatric Use Safety and effectiveness in children below the age of 10 have not been established. Accidental ingestion resulting in death has been reported in children below age 10. Keep out of reach of children.

Resumen del producto:

Benzonatate Capsules USP, 200 mg: Yellow soft gelatin capsules, imprinted “106”, available in bottles of; Bottles of 15’s (NDC 68788-7087-1) Bottles of 200’s (NDC 68788-7087-2) Bottles of 30’s (NDC 68788-7087-3) Bottles of 60’s (NDC 68788-7087-6) Store at 20° to 25° C (68° to 77°F). [See USP Controlled Room Temperature]. PROTECT FROM LIGHT. Manufactured by Intergel Division of IVC Industries, Inc. Irvington, NJ 07111 Manufactured for Ascend Laboratories, LLC Parsippany, NJ 07054 Rev 03/18 210082 Repackaged By: Preferred Pharmaceuticals Inc.

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

BENZONATATE- BENZONATATE CAPSULE
PREFERRED PHARMACEUTICALS INC
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BENZONATATE CAPSULES, USP
100 MG, 150 MG AND 200 MG
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,
150 mg or 200 mg
of benzonatate USP. Benzonatate Capsules, USP also contain the
following inactive
ingredients: D&C Yellow #10, gelatin, glycerin, purified water,
methylparaben,
propylparaben and titanium dioxide
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 USP 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 capsules 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 ingesti