BENZONATATE capsule
Country: United States
Language: English
Source: NLM (National Library of Medicine)
Summary of Product characteristics
(SPC)
25-10-2017
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Active ingredient:
BENZONATATE (UNII: 5P4DHS6ENR) (BENZONATATE - UNII:5P4DHS6ENR)
Available from:
Marlex Pharmaceuticals Inc
INN (International Name):
BENZONATATE
Composition:
BENZONATATE 200 mg
Administration route:
ORAL
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
Benzonatate is indicated for the symptomatic relief of cough. Hypersensitivity to benzonatate or related compounds.
Product summary:
Benzonatate Capsules, USP are available as: 200 mg (oblong, yellow) soft gelatin capsules with imprint “A2”. Bottles of 500: NDC 10135-0632-05 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Dispense in tight, light-resistant container as defined in the USP. Manufactu red for and Distributed by: Marlex Pharmaceuticals New Castle, DE 19720 Rev. 10/2017AN
Authorization status:
Abbreviated New Drug Application
Summary of Product characteristics
BENZONATATE- BENZONATATE CAPSULE
MARLEX PHARMACEUTICALS INC
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BENZONATATE CAPSULES
BENZONATATE CAPSULES, USP 100 MG AND 200 MG
RX ONLY
DESCRIPTION
Benzonatate, a non-narcotic 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.
Benzonatate Capsules, USP contain 100 mg or 200 mg of benzonatate,
USP.
Benzonatate Capsules also contain: D&C Yellow No. 10, gelatin,
glycerin, methylparaben sodium and
propylparaben sodium.
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
to 20 minutes and death has been reported within one hour of
ingestion. If accidental ingestion occurs,
seek medical attention immediately (see OVERDOSAGE).
PRECAUTIONS
Benzonata
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