BENZONATATE capsule

Country: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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

Доступно од:

AiPing Pharmaceutical, Inc.

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

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.

Резиме производа:

Benzonatate Capsules USP, 100 mg: Yellow soft gelatin capsules, imprinted " "with white ink, available in bottles of 100’s (NDC 11788-028-01), and 500’s (NDC 11788-028-05). Benzonatate Capsules USP, 150 mg: Yellow soft gelatin capsules, imprinted " "with white ink, available in bottles of 100's (NDC 11788-029-01), and 500’s (NDC 11788-029-05). Benzonatate Capsules USP, 200 mg: Yellow soft gelatin capsules, imprinted " "with white ink, available in bottles of 100’s (NDC 11788-027-01) and 500’s (NDC 11788-027-05). Store at 20° to 25° C (68° to 77°F). [See USP Controlled Room Temperature]. PROTECT FROM LIGHT. Dispense in a tight, light-resistant container as defined in the USP. Manufactured for AiPing Pharmaceutical, Inc. Hauppauge, NY 11788 USA Manufactured by Anshi Pharmaceutical (Zhongshan) Inc., P.R. China Rev 03/18

Статус ауторизације:

Abbreviated New Drug Application

Карактеристике производа

BENZONATATE- BENZONATATE CAPSULE
AIPING PHARMACEUTICAL, 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.
C
H
NO
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 and
propylparaben. Imprinting ink is composed of isopropyl alcohol,
n-butyl alcohol,
propylene glycol, shellac, 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.
30
53
11
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 EFECTS
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 bee