BENZONATATE capsule, liquid filled

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

REMEDYREPACK INC.

INN (국제 이름):

BENZONATATE

구성:

BENZONATATE 100 mg

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

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

제품 요약:

Benzonatate Capsules, USP are available as: 100 mg (oval, yellow) soft gelatin capsules with imprint “A1”. Bottles of 100: NDC 65162-536-10 Bottles of 500: NDC 65162-536-50 200 mg (oblong, yellow) soft gelatin capsules with imprint “A2”. Bottles of 100: NDC 65162-537-10 Bottles of 500: NDC 65162-537-50 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Dispense in tight, light-resistant container as defined in the USP. Distributed by: Amneal Pharmaceuticals Bridgewater, NJ 08807 Rev. 09-2015-00

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

BENZONATATE- BENZONATATE CAPSULE, LIQUID FILLED
REMEDYREPACK INC.
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BENZONATATE CAPSULES, USP
100 MG AND 200 MG
DESCRIPTION
Benzonatate, a non-narcotic 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.
Benzonatate Capsules, USP contain 100 mg or 200 mg of benzonatate,
USP.
Benzonatate Capsules also contain: D&C Yellow No. 10, gelatin,
glycerin, methylparaben sodium and
propylparaben sodium.
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 is indicated for the symptomatic relief of cough.
CONTRAINDICATIONS
Hypersensitivity to benzonatate or related compounds.
BOXED WARNING
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 in combination with
other prescribed drugs.
ACCIDENTAL INGESTION AND DEATH IN CHILDREN
Keep benzonatate 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 to 20 minutes and death has been reported within one hour of
ingestion. If accidental
ingestion occurs, seek medical attention immediately (see OVERDOSAGE).
PRECAUTIONS
Benzonatate is chemically re