BENZONATATE capsule

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

Epic Pharma LLC

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

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

Ürün özeti:

Benzonatate Capsules USP, 100 mg are clear yellow, oval-shaped softgel capsules imprinted with “PC14” and are supplied as follows: NDC 42806-714-01 in bottle of 100 capsules NDC 42806-714-05 in bottle of 500 capsules Benzonatate Capsules USP, 200 mg are clear yellow, oval-shaped softgel capsules imprinted with “PC15” and are supplied as follows: NDC 42806-715-01 in bottle of 100 capsules NDC 42806-715-05 in bottle of 500 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

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

BENZONATATE- BENZONATATE CAPSULE
EPIC PHARMA 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
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 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 has bee