Zonatuss

Vertical Pharmaceuticals, Inc.

FULL PRESCRIBING INFORMATION: CONTENTS*

• ZONATUSS DESCRIPTION
• CLINICAL PHARMACOLOGY
• ZONATUSS INDICATIONS AND USAGE
• ZONATUSS CONTRAINDICATIONS
• WARNINGS
• PRECAUTIONS
  • Information for Patients
  • Usage In Pregnancy
  • Nursing Mothers
  • Carcinogenesis, Mutagenesis, Impairment of Fertility
  • Pediatric Use
• ZONATUSS ADVERSE REACTIONS
• OVERDOSAGE
• ZONATUSS DOSAGE AND ADMINISTRATION
• HOW SUPPLIED
• PRINCIPAL DISPLAY PANEL

FULL PRESCRIBING INFORMATION

ZONATUSS 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 603.00 (av).

Each capsule, for oral administration, contains 150 mg of benzonatate.

In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, microcrystalline cellulose, and silicon dioxide. Capsule shell is composed of gelatin, titanium dioxide, FD&C Blue #1 and D&C Red #28. Imprinting ink is composed of black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac and strong ammonia solution.

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.

ZONATUSS INDICATIONS AND USAGE

ZONATUSS^TM (benzonatate capsules, USP) is indicated for the symptomatic relief of cough.

ZONATUSS CONTRAINDICATIONS

Hypersensitivity to benzonatate or related compounds.

WARNINGS

Hypersensitivity: 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 anesthetic agents of the para-amino-benzoic 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

Swallow Zonatuss^TM capsules whole. Do not break, chew, dissolve, cut, or crush Zonatuss^TM capsules. Release of benzonatate from the capsule in the mouth can produce a temporary local anesthesia of the oral mucosa and choking could occur. If numbness or tingling of the tongue, mouth, throat, or face occurs, refrain from oral ingestion of food or liquids until the numbness has resolved. If the symptoms worsen or persist, seek medical attention.

Keep benzonatate out of reach of children. Accidental ingestion resulting in death has been reported in children. Signs and symptoms of overdose have been reported within 15 to 20 minutes and death has been reported within one hour of ingestion. Signs and symptoms may include restlessness, tremors, convulsions, coma and cardiac arrest. If accidental ingestion occurs, seek medical attention immediately.

Overdosage resulting in death may occur in adults.

Do not exceed a single dose of 200 mg and a total daily dosage of 600 mg. If you miss a dose of benzonatate, skip that dose and take the next dose at the next scheduled time. Do not take 2 doses of benzonatate at one time.

Usage In Pregnancy

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

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

Carcinogenicity, mutagenicity, and reproduction studies have not been conducted with benzonatate.

Pediatric Use

Safety and effectiveness in children below the age of 10 have not been established. Accidental ingestion resulting in death has been reported in children below age 10. Keep out of reach of children.

ZONATUSS 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.

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 to 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.

ZONATUSS DOSAGE AND ADMINISTRATION

Adults and Children over 10 years of age: Usual dose is one 150 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. Zonatuss^TM capsules should be swallowed whole. Zonatuss^TM capsules are not to be broken, chewed, dissolved, cut or crushed.

HOW SUPPLIED

ZONATUSS^TM (benzonatate capsules USP, 150 mg) is supplied as opaque white body and opaque light blue cap imprinted "150" on the body and "ZON" on the cap, in black ink, in bottles of 100 capsules, NDC 68025-058-10 and in unit dose sample pouches for patient trial available only through physician offices, NDC 68025-058-01.

Store at 20º to 25º C (68º to 77ºF) [see USP Controlled Room Temperature].

Protect from light

Dispense in a tight, light-resistant container as defined in the USP. Keep tightly closed.

Manufactured for:

Vertical Pharmaceuticals, Inc.

Sayreville, NJ 08872

Manufactured by:

Mikart, Inc.

Atlanta, Georgia 30318

Code 1006C00

Rev. 08/11

PI058

PRINCIPAL DISPLAY PANEL