BENZONATATE capsule

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Proficient Rx LP

INN (Διεθνής Όνομα):

BENZONATATE

Σύνθεση:

BENZONATATE 200 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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

Περίληψη προϊόντος:

Benzonatate Capsules USP, 200 mg are available as yellow, oval soft gelatin capsules with ‘2’ imprinted in white ink. Store at 20° to 25°C (68° to 77°F) excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. PROTECT FROM LIGHT

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

BENZONATATE- BENZONATATE CAPSULE
PROFICIENT RX LP
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BENZONATATE CAPSULES USP, 200 MG
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 Capsules USP contains:
Benzonatate, USP 200 mg
Benzonatate Capsules USP also contain: D&C Yellow 10, gelatin,
glycerin, methylparaben,
propylparaben and titanium dioxide.
CLINICAL PHARMACOLOGY
Benzonatate Capsule 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 Capsule has no inhibitory
effect on the
respiratory center in recommended dosage.
INDICATIONS AND USAGE
Benzonatate Capsule 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
Capsule 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 been reported within one hour of ingestion. If accidental
ingestion occurs, seek
medical attention immediately (see OVERDOSAGE).
PRECAUTIONS
Benzonatate i