BENZONATATE- benzonatate capsule

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

Bryant Ranch Prepack

INN (nemzetközi neve):

BENZONATATE

Összetétel:

BENZONATATE 100 mg

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

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

Termék összefoglaló:

Benzonatate Capsules USP, 100 mg: Yellow soft gelatin capsules, imprinted with “PA46”, available in bottles of 100’s and 500’s. Benzonatate Capsules USP, 200 mg: Yellow soft gelatin capsules, imprinted with “PA83”, available in bottles of 100’s. The capsules should be protected from light, moisture and humidity, and stored at controlled room temperature 20° to 25°C (68° to 77°F) [See USP]. Dispense in a tight, light-resistant container as defined in USP/NF. Manufactured by: BANNER PHARMACAPS INC.; High Point, NC 27265 Distributed by: TEVA PHARMACEUTICALS USA Sellersville, PA 18960 Revised February 2011

Engedélyezési státusz:

Abbreviated New Drug Application

Termékjellemzők

BENZONATATE- BENZONATATE CAPSULE
BRYANT RANCH PREPACK
----------
BENZONATATE CAPSULES USP, 100 MG AND 200 MG
RX ONLY
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 soft gelatin capsule, for oral administration, contains 100 mg or
200 mg benzonatate USP. In
addition, each capsule contains the following inactive ingredients:
D&C Yellow No. 10, gelatin,
glycerin, and purified water.
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.
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 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 15-20 minutes and death has been reported within one
hour of ingestion. If accidental
ingestion occurs, seek medical attention immediately (see OVERDOSAGE).
PRECAUTIONS
B