BENZONATATE capsule

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Major Pharmaceuticals

INN (mednarodno ime):

benzonatate

Sestava:

benzonatate 100 mg

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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.

Povzetek izdelek:

Benzonatate Capsules USP, 100 mg: Yellow soft gelatin capsules, imprinted "105", available in bottles of 100’s (NDC 0904-6657-60) 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 Distributed By: Major® Pharmaceuticals Livonia, MI 48152 REFER TO PACKAGE LABEL FOR DISTRIBUTOR’S NDC NUMBER Rev 03/17 210082

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

BENZONATATE- BENZONATATE CAPSULE
MAJOR PHARMACEUTICALS
----------
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,
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.
30
53
11
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 been reported within 15-20 minutes and death has been
reported within
one hour of ingestion. If accidental