BENZONATATE

Main information

  • Trade name:
  • BENZONATATE- benzonatate capsule
  • Composition:
  • BENZONATATE 100 mg
  • Administration route:
  • ORAL
  • Prescription type:
  • PRESCRIPTION DRUG
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • BENZONATATE- benzonatate capsule
    United States
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • Benzonatate capsules are indicated for the symptomatic relief of cough. Hypersensitivity to benzonatate or related compounds.
  • Product summary:
  • Benzonatate capsules USP, 100 mg are light yellow-colored, round-shaped soft gelatin capsules, imprinted with "Z" containing pale yellow-colored clear viscous liquid and are supplied as follows: NDC 68788-6357-9 in bottle of 9 capsules NDC 68788-6357-5 in bottle of 15 capsules NDC 68788-6357-2 in bottle of 20 capsules NDC 68788-6357-3 in bottle of 30 capsules NDC 68788-6357-6 in bottle of 60 capsules Store at 20° - 25°C (68° - 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container.

Status

  • Source:
  • DailyMed - NLM - National Library of Medicine
  • Authorization status:
  • Abbreviated New Drug Application
  • Authorization number:
  • 68788-6357-1, 68788-6357-2, 68788-6357-3, 68788-6357-6, 68788-6357-9
  • Last update:
  • 26-05-2019

Summary of Product characteristics: dosage, interactions, side effects

BENZONATATE- benzonatate capsule

Preferred Pharmaceuticals Inc.

----------

Benzonatate Capsules, USP

DESCRIPTION

Benzonatate capsules, USP, 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 for oral administration contains 100 mg or 200 mg of benzonatate. In addition,

each capsule also contains the following inactive ingredients: gelatin, glycerin, noncrystallising

sorbitol solution, methylparaben, propylparaben and purified water. The 200 mg capsule is printed with

black pharmaceutical ink which contains following ingredients: ammonium hydroxide, ferrosoferric

oxide, ethanol, isopropyl alcohol, polyethylene glycol, polyvinyl acetate phthalate, propylene glycol

and purified water.

CLINICAL PHARMACOLOGY

Benzonatate capsules act 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

have no inhibitory effect on the respiratory center in recommended dosage.

INDICATIONS AND USAGE

Benzonatate capsules are indicated for the symptomatic relief of cough.

CONTRAINDICATIONS

Hypersensitivity to benzonatate or related compounds.

WARNINGS

Hypers ens itivity

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 capsules in combination with other prescribed drugs.

Accidental Ingestion and Death in Children

Keep benzonatate capsules out of reach of children. Accidental ingestion of benzonatate capsules

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 benzonatate capsules whole. Do not break, chew, dissolve, cut, or crush benzonatate

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 capsules 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 capsules, skip that dose and take the next dose at the next scheduled time. Do not take 2

doses of benzonatate capsules at one time.

Usage in Pregnancy

Pregnancy Category C. Animal reproduction studies have not been conducted with benzonatate capsules.

It is also not known whether benzonatate capsules can cause fetal harm when administered to a pregnant

woman or can affect reproduction capacity. Benzonatate capsules 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 capsules are administered to a nursing woman.

Carcinogenesis, mutagenesis, impairment of fertility

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

capsules.

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.

ADVERSE REACTIONS

Potential Adverse Reactions to Benzonatate Capsules 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 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.

DOSAGE AND ADMINISTRATION

Adults and Children over 10 years of age: Usual dose is one 100 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. Benzonatate Capsules should be swallowed whole. Benzonatate Capsules are not to be

broken, chewed, dissolved, cut or crushed.

HOW SUPPLIED

Benzonatate capsules USP, 100 mg are light yellow-colored, round-shaped soft gelatin capsules,

imprinted with "Z" containing pale yellow-colored clear viscous liquid and are supplied as follows:

NDC 68788-6357-9 in bottle of 9 capsules

NDC 68788-6357-5 in bottle of 15 capsules

NDC 68788-6357-2 in bottle of 20 capsules

NDC 68788-6357-3 in bottle of 30 capsules

NDC 68788-6357-6 in bottle of 60 capsules

Store at 20° - 25°C (68° - 77°F) [See USP Controlled Room Temperature].

Dispense in a tight, light-resistant container.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-

800-FDA-1088.

Manufactured by:

Cadila Healthcare Ltd.

Ahmedabad, India.

Distributed by:

Zydus Pharmaceuticals USA Inc.

Pennington, NJ 08534

Rev.: 08/16

Revision Date : 27/08/2016

Repackaged By: Preferred Pharmaceuticals Inc.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68788-6357

Benzonatate Capsules USP, 100 mg

R only

Repackaged By: Preferred Pharmaceuticals Inc.

BENZONATATE

benzonatate capsule

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:6 8 78 8 -6 357(NDC:6 8 38 2-247)

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

BENZO NATATE (UNII: 5P4DHS6 ENR) (BENZONATATE - UNII:5P4DHS6 ENR)

BENZONATATE

10 0 mg

Inactive Ingredients

Ingredient Name

Stre ng th

GLYCERIN (UNII: PDC6 A3C0 OX)

METHYLPARABEN (UNII: A2I8 C7HI9 T)

PRO PYLPARABEN (UNII: Z8 IX2SC1OH)

SO RBITO L (UNII: 50 6 T6 0 A25R)

WATER (UNII: 0 59 QF0 KO0 R)

GELATIN, UNSPECIFIED (UNII: 2G8 6 QN327L)

Product Characteristics

Color

YELLOW (LIGHT YELLOW)

S core

no sco re

S hap e

ROUND (ROUND)

S iz e

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 8 78 8 -6 357-9

9 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 3/0 1/20 16

Preferred Pharmaceuticals Inc.

2

NDC:6 8 78 8 -6 357-1

15 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 3/0 1/20 16

3

NDC:6 8 78 8 -6 357-2

20 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 3/0 1/20 16

4

NDC:6 8 78 8 -6 357-3

30 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 3/0 1/20 16

5

NDC:6 8 78 8 -6 357-6

6 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 3/0 1/20 16

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 40 59 7

0 3/0 1/20 16

Labeler -

Preferred Pharmaceuticals Inc. (791119022)

Registrant -

Preferred Pharmaceuticals Inc. (791119022)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Preferred Pharmaceuticals Inc.

79 1119 0 22

REPACK(6 8 78 8 -6 357)

Revised: 3/2018