Χώρα: Ηνωμένες Πολιτείες
Γλώσσα: Αγγλικά
Πηγή: NLM (National Library of Medicine)
BENZONATATE (UNII: 5P4DHS6ENR) (BENZONATATE - UNII:5P4DHS6ENR)
AvKARE
BENZONATATE
BENZONATATE 100 mg
ORAL
PRESCRIPTION DRUG
Benzonatate is indicated for the symptomatic relief of cough. Hypersensitivity to benzonatate or related compounds.
Benzonatate Capsules, USP are available as: 100 mg (oval, yellow) soft gelatin capsules with imprint “A1”. Bottles of 100: NDC 42291-164-01 Bottles of 500: NDC 42291-164-50 200 mg (oblong, yellow) soft gelatin capsules with imprint “A2”. Bottles of 100: NDC 42291-165-01 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.
Abbreviated New Drug Application
BENZONATATE- BENZONATATE CAPSULE, LIQUID FILLED AVKARE ---------- BENZONATATE CAPSULES, USP 100 MG AND 200 MG 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. BOXED WARNING 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 Benzonatate is chemically related to an Διαβάστε το πλήρες έγγραφο