BENZONATATE capsule

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

benzonatate (UNII: 5P4DHS6ENR) (benzonatate - UNII:5P4DHS6ENR)

Disponible depuis:

H.J. Harkins Company, Inc.

DCI (Dénomination commune internationale):

benzonatate

Composition:

benzonatate 100 mg

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

Benzonatate is indicated for the symptomatic relief of cough. Hypersensitivity to benzonatate or related compounds. Safety and effectiveness in children below the age of 10 have not been established.

Descriptif du produit:

Benzonatate Capsules USP, 100 mg: Yellow soft gelatin capsules, imprinted “ASC” on one side and “105” on the other side, available in bottles of 100’s (NDC 67877-105-01), 500’s (NDC 67877-105-05) and 1000’s (NDC 67877-105- 10). Benzonatate Capsules USP, 200 mg: Yellow soft gelatin capsules, imprinted “ASC” on one side and “106” on the other side, available in bottles of 100’s (NDC 67877-106-01) and 500’s (NDC 67877-106-05). Store at controlled room temperature 20º - 25ºC (68º - 77ºF) [See USP]. 10/11 Mfd by Intergel Division of IVC Industries, Inc. Irvington, NJ 07111 for ASCEND LABORATORIES, LLC MONTVALE, NJ 07645 Repacked by: H.J. Harkins Company, Inc. Nipomo, CA 93444

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

BENZONATATE - BENZONATATE CAPSULE
H.J. HARKINS COMPANY, INC.
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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 of benzonatate USP.
Benzonatate Capsules, USP also contain the following inactive
ingredients: D&C Yellow # 10, gelatin,
glycerin, purified water, methylparaben, propylparaben and titanium
dioxide.
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
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.
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.
PRECAUTIONS
Benzonatate is chemically related to anesthetic agents of the
para-aminobenzoic acid class (e.g.
procaine; tetracaine) and has been associated with adverse CNS effects
possibly related to a prior
sensitivity to related agents or interaction with concomitant
medication.
INFORMATION FOR PATIENTS:
Release of benzonatate from the capsule in the mouth can produce a
temporary local anesthesia of the
oral mucosa and choking could occur.