BENZONATATE capsule

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

XLCare Pharmaceuticals, Inc.

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

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

Ürün özeti:

Benzonatate Capsules, USP are available in 100 mg, 150 mg and 200 mg dosage strengths. The 100 mg capsules are yellow round capsules containing clear to light yellow liquid, printed with ‘1’ sign in black ink. NDC 72865-117-30 bottles of 30 capsules NDC 72865-117-01 bottles of 100 capsules NDC 72865-117-05 bottles of 500 capsules The 150 mg capsules are orange round capsules containing clear, light yellow to orange liquid, printed with ‘2’ sign in black ink. NDC 72865-118-30 bottles of 30 capsules NDC 72865-118-01 bottles of 100 capsules NDC 72865-118-05 bottles of 500 capsules The 200 mg capsules are yellow round capsules containing clear to light yellow liquid, printed with ‘3’ sign in black ink. NDC 72865-119-30 bottles of 30 capsules NDC 72865-119-01 bottles of 100 capsules NDC 72865-119-05 bottles of 500 capsules Store at 20°C to 25°C (68°F to77°F) [see USP Controlled Room Temperature]. Protect from light. Dispense in tight, light-resistant container as defined in the USP with a child-resistant closure. Manufactured by: Ascent Pharmaceuticals, Inc. Central Islip, NY 11722 Manufactured for: XLCare Pharmaceuticals, Inc. 242 South Culver Street, Suite 202 Lawrenceville, GA 30046 Rev: 01/22

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

BENZONATATE- BENZONATATE CAPSULE
XLCARE PHARMACEUTICALS, INC.
----------
BENZONATATE CAPSULES
100 MG CAPSULES
150 MG CAPSULES
200 MG CAPSULES
(BENZONATATE, USP)
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.
Each benzonatate capsule USP contains:
Benzonatate, USP 100 mg
Each benzonatate capsule USP contains:
Benzonatate, USP 150 mg
Each benzonatate capsule USP contains:
Benzonatate, USP 200 mg
Benzonatate capsules USP also contain: bloom gelatin, glycerin,
purified water, medium
chain triglycerides, lecithin, isopropyl alcohol, nitrogen.
100 mg and 200 mg capsules also contain D&C Yellow No. 10.
150 mg capsules also contain FD&C Yellow No. 6 powder.
Each capsule also contains black iron oxide, propylene glycol,
hypromellose as imprinting
ink.
CLINICAL PHARMACOLOGY
Benzonatate capsules 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 capsules has no inhibitory
effect on the
respiratory center in recommended dosage.
INDICATIONS AND USAGE
Benzonatate capsules 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.
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 ING