BENZONATATE capsule

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

Alembic Pharmaceuticals Inc.

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

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

ملخص المنتج:

Benzonatate Capsules, USP are available as: 100 mg (oval, yellow) soft gelatin capsules with imprint “A5”. NDC 62332-426-31 Bottles of 100 NDC 62332-426-71 Bottles of 500 200 mg (oblong, yellow) soft gelatin capsules with imprint “A6”. NDC 62332-427-31 Bottles of 100 NDC 62332-427-71 Bottles of 500 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. To report SUSPECTED ADVERSE REACTIONS, contact Alembic Pharmaceuticals Limited at 1-866-210-9797 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch Manufactured by: Swiss Caps AG Kirchberg, Switzerland Manufactured for: Alembic Pharmaceuticals, Inc. Bedminster, NJ 07921, USA Revised: 08/2021

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

BENZONATATE - BENZONATATE CAPSULE
ALEMBIC PHARMACEUTICALS INC.
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BENZONATATE CAPSULES, USP
100 MG AND 200 MG
RX ONLY
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
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 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 chemicall