Professional Information — Benzonatate 200 Mg

Indications and Usage

Benzonatate capsules 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, 150 mg or 200 mg capsule three times a day as needed for cough. If necessary to control cough, up to 600 mg daily in three divided doses may be given. B enzonatate capsules should be swallowed whole.Benzonatate capsules are not to be broken, chewed, dissolved, cut or crushed.

Contraindications

Hypersensitivity to benzonatate or related compounds.

Adverse Reactions

Potential Adverse Reactions to benzonatate capsules may include:

Hypersensitivity reactionsincluding 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.

Der m atologic:pruritus; skin eruptions.

Other:nasal congestion; sensation of burning in the eyes; vague “chilly” sensation; numbness of the chest; hypersensitivity.

Deliberate or accidental overdose has resulted in death, particularly in children.

Overdosage

Intentional and unintentional overdose may result in death, particularly in children.

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

The signs and symptoms of overdose of benzonatate have been reported within 15-20 minutes. If capsules are chewed or dissolved in the mouth, oropharyngeal anesthesia will develop rapidly, which may cause choking and airway compromise.

CNS stimulation may cause restlessness and tremors which may proceed to clonic convulsions followed by profound CNS depression. Convulsions, coma, cerebral edema and cardiac arrest leading to death have been reported within 1 hour of ingestion.

Treatment:

In case of overdose, seek medical attention immediately. 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.

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 benzonatate capsule USP contains:

Benzonatate, USP 100 mg

Each benzonatate capsule USP contains:

Benzonatate, USP 150 mg

Each benzonatate capsule USP contains:

Benzonatate, USP 200 mg

Benzonatate capsules USP also contain: bloom gelatin, glycerin, purified water, medium chain triglycerides, lecithin, isopropyl alcohol, nitrogen.

100 mg and 200 mg capsules also contain D&C Yellow No. 10.

150 mg capsules also contain FD&C Yellow No. 6 powder.

Each capsule also contains black iron oxide, propylene glycol, hypromellose as imprinting ink.

Clinical Pharmacology

Benzonatate capsules 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 capsules has no inhibitory effect on the respiratory center in recommended dosage.

How Supplied / Storage and Handling

Benzonatate Capsules, USP are available in 100 mg, 150 mg and 200 mg dosage strengths.

The 100 mg capsules are yellow round capsules containing clear to light yellow liquid, printed with ‘1’ sign in black ink.

NDC 85766-066-15 (repackaged from NDC 31722-956-XX) bottles of 15 capsules

NDC 85766-066-20 (repackaged from NDC 31722-956-XX) bottles of 20 capsules

NDC 85766-066-21 (repackaged from NDC 31722-956-XX) bottles of 21 capsules

NDC 85766-066-30 (relabeled from NDC 31722-956-30) bottles of 30 capsules

NDC 85766-066-60 (repackaged from NDC 31722-956-XX) bottles of 60 capsules

NDC 85766-066-90 (repackaged from NDC 31722-956-XX) bottles of 90 capsules

NDC 85766-066-01 (relabeled from NDC 31722-956-01) bottles of 100 capsules

NDC 85766-066-05 (relabeled from NDC 31722-956-05) bottles of 500 capsules

The 150 mg capsules are orange round capsules containing clear, light yellow to orange liquid, printed with ‘2’ sign in black ink.

NDC 85766-067-15 (repackaged from NDC 31722-957-XX) bottles of 15 capsules

NDC 85766-067-20 (repackaged from NDC 31722-957-XX) bottles of 20 capsules

NDC 85766-067-21 (repackaged from NDC 31722-957-XX) bottles of 21 capsules

NDC 85766-067-30 (relabeled from NDC 31722-957-30) bottles of 30 capsules

NDC 85766-067-60 (repackaged from NDC 31722-957-XX) bottles of 60 capsules

NDC 85766-067-90 (repackaged from NDC 31722-957-XX) bottles of 90 capsules

NDC 85766-067-01 (relabeled from NDC 31722-957-01) bottles of 100 capsules

NDC 85766-067-05 (relabeled from NDC 31722-957-05) bottles of 500 capsules

The 200 mg capsules are yellow round capsules containing clear to light yellow liquid, printed with ‘3’ sign in black ink.

NDC 85766-068-15 (repackaged from NDC 31722-958-XX) bottles of 15 capsules

NDC 85766-068-20 (repackaged from NDC 31722-958-XX) bottles of 20 capsules

NDC 85766-068-21 (repackaged from NDC 31722-958-XX) bottles of 21 capsules

NDC 85766-068-30 (relabeled from NDC 31722-958-30) bottles of 30 capsules

NDC 85766-068-60 (repackaged from NDC 31722-958-XX) bottles of 60 capsules

NDC 85766-068-90 (repackaged from NDC 31722-958-XX) bottles of 90 capsules

NDC 85766-068-01 (relabeled from NDC 31722-958-01) bottles of 100 capsules

NDC 85766-068-05 (relabeled from NDC 31722-958-05) bottles of 500 capsules

Store at 20°C to 25°C (68°F to77°F) [see USP Controlled Room Temperature].

Protect from light. Dispense in tight, light-resistant container as defined in the USP with a child-resistant closure.

Distributed by:

Sportpharm LLC

379 Van Ness Ave 1401,

Torrance, CA 90501

Relabeled and Repackaged by:

Enovachem PHARMACEUTICALS

Torrance, CA 9050