BENZONATATE capsule

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Pharmasource Meds, LLC

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Benzonatate capsules, USP are indicated for the symptomatic relief of cough. Hypersensitivity to benzonatate or related compounds.

Produkt oppsummering:

Benzonatate Capsules USP, 200 mg are clear yellow, oval-shaped softgel capsules imprinted with “PC15” and are supplied as follows: NDC 82982-031-30 in bottle of 30 capsules Store at 20˚ to 25˚ C (68˚ to 77˚ F) [see USP Controlled Room Temperature]. PROTECT FROM LIGHT Dispense in tight (USP), child-resistant containers. Rx Only Manufactured by: Humanwell PuraCap Pharmaceutical Wuhan, Hubei 430206, China Distributed by: Epic Pharma, LLC Laurelton, NY 11413 Rev. 10-2018-00 PI-EBEN-00 Repackaged by: Pharmasource Meds, LLC Tigard OR 97223

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

BENZONATATE- BENZONATATE CAPSULE
PHARMASOURCE MEDS, LLC
----------
BENZONATATE CAPSULES, USP
DESCRIPTION
Benzonatate capsules, USP, a non-narcotic oral antitussive agent, is
2, 5, 8, 11, 14, 17,
20, 23, 26- onaoxaoctacosan-28-ylp-(butylamino) benzoate; with a
molecular weight of
603.7.
Each benzonatate capsules, USP for oral administration contains 100 mg
or 200 mg
benzonatate, USP. In addition, each capsule contains the following
inactive ingredients:
D&C Yellow #10, gelatin, glycerin, lecithin, light mineral oil,
propylene glycol, purified
water, shellac glaze, titanium dioxide, and white edible ink.
CLINICAL PHARMACOLOGY
Benzonatate capsules act 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 capsules have no inhibitory
effect on the
respiratory center in recommended dosage.
INDICATIONS AND USAGE
Benzonatate capsules, USP are 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
capsules in
combination with other prescribed drugs.
ACCIDENTAL INGESTION AND DEATH IN CHILDREN
Keep benzonatate capsules out of reach of children. Accidental
ingestion of benzonatate
capsules 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
ha