benzonatate
Benzonatate Capsules
FULL PRESCRIBING INFORMATION: CONTENTS*
- BENZONATATE DESCRIPTION
- CLINICAL PHARMACOLOGY
- BENZONATATE INDICATIONS AND USAGE
- BENZONATATE CONTRAINDICATIONS
- WARNINGS
- PRECAUTIONS
- Information for patients:
- Usage in Pregnancy:
- Nursing Mothers:
- Carcinogenesis, mutagenesis, impairment of fertility:
- Pediatric Use:
- BENZONATATE ADVERSE REACTIONS
- OVERDOSAGE
- BENZONATATE DOSAGE AND ADMINISTRATION
- HOW SUPPLIED
FULL PRESCRIBING INFORMATION
BENZONATATE 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 and C Yellow No. 10, gelatin, glycerin, purified water,
methylparaben, propylparaben and titanium dioxide.
CLINICAL PHARMACOLOGY
BENZONATATE INDICATIONS AND USAGE
BENZONATATE 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:
Usage in Pregnancy:
Nursing Mothers:
Carcinogenesis, mutagenesis, impairment of fertility:
Pediatric Use:
BENZONATATE ADVERSE REACTIONS
Potential Adverse Reactions to benzonatate may include:
Hypersensitivity reactions including bronchospasm, laryngospasm, cardiovascular collapse possibly related to local anesthesia from chewing or sucking the capsule.
CNS: sedation; headache; dizziness; mental confusion; visual hallucinations.
GI: constipation; nausea; GI upset.
Dermatologic: pruritus; skin eruptions.
Other: nasal congestion; sensation of burning in the eyes; vague “chilly” sensation; numbness of the chest; hypersensitivity.
Rare instances of deliberate or accidental overdose have resulted in
death.
OVERDOSAGE
Overdose may result in death.
The drug is chemically related to tetracaine and other topical anesthetics and shares various aspects of their pharmacology and toxicology. Drugs of this type are generally well absorbed after ingestion.
Signs and Symptoms:
If capsules are chewed or
dissolved in the mouth, oropharyngeal anesthesia will develop rapidly. CNS
stimulation may cause restlessness and tremors which may proceed to clonic
convulsions followed by profound CNS depression.
Treatment:
Evacuate gastric contents and
administer copious amounts of activated charcoal slurry. Even in the conscious
patient, cough and gag reflexes may be so depressed as to necessitate special
attention to protection against aspiration of gastric contents and orally
administered materials. Convulsions should be treated with a short-acting
barbiturate given intravenously and carefully titrated for the smallest
effective dosage. Intensive support of respiration and cardiovascular - renal
function is an essential feature of the treatment of severe intoxication from
overdosage.
Do not use CNS stimulants.
BENZONATATE DOSAGE AND ADMINISTRATION
HOW SUPPLIED
Store at controlled room temperature 20º - 25ºC (68º - 77ºF) [See USP].
API-01, 5/07
Mfd by
Intergel Division of IVC Industries, Inc.
Irvington, NJ
07111
benzonatatebenzonatate CAPSULE
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