Benzonatate is indicated for the symptomatic relief of cough.
Dosage and administration
Adults and Children over 10 years of age: Usual dose is one 100 mg or 200 mg capsule t.i.d. as required. If necessary, up to 600 mg daily may be given.
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.structural formula 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
CLINICAL PHARMACOLOGY SECTION
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
INDICATIONS & USAGE SECTION
Benzonatate is indicated for the symptomatic relief of cough.
CONTRAINDICATIONS
CONTRAINDICATIONS SECTION
Hypersensitivity to benzonatate or related compounds.
WARNINGS SECTION
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
PRECAUTIONS SECTION
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:
INFORMATION FOR PATIENTS SECTION
Release of benzonatate from the capsule in the mouth can produce a temporary
local anesthesia of the oral mucosa and choking could occur. Therefore, the
capsules should be swallowed without chewing.
Usage in Pregnancy:
PREGNANCY SECTION
Pregnancy Category C. Animal reproduction studies have not been conducted with
benzonatate. It is also not known whether benzonatate can cause fetal harm when
administered to a pregnant woman or can affect reproduction capacity.
Benzonatate should be given to a pregnant woman only if clearly needed.
Nursing Mothers:
NURSING MOTHERS SECTION
It is not known whether this drug is excreted in human milk. Because many
drugs are excreted in human milk caution should be exercised when benzonatate is
administered to a nursing woman.
Carcinogenesis, mutagenesis, impairment of fertility:
CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION
Carcinogenicity, mutagenicity, and reproduction studies have not been conducted
with benzonatate.
Pediatric Use:
PEDIATRIC USE SECTION
Safety and effectiveness in children below the age of 10 have not been
established.
ADVERSE REACTIONS
ADVERSE REACTIONS SECTION
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.
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
OVERDOSAGE SECTION
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.
DOSAGE AND ADMINISTRATION
DOSAGE & ADMINISTRATION SECTION
Adults and Children over 10 years of age: Usual dose is one 100 mg or 200 mg
capsule t.i.d. as required. If necessary, up to 600 mg daily may be given.
HOW SUPPLIED
HOW SUPPLIED SECTION
Benzonatate Capsules USP, 200 mg: Yellow soft gelatin capsules, imprinted
“ASC” on one side and “106” on the other side, available in bottles of 30 (NDC 67296-0822-1)
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
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