BENZONATATE

Main information

  • Trade name:
  • BENZONATATE- benzonatate capsule
  • Composition:
  • BENZONATATE 200 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 is indicated for the symptomatic relief of cough. Hypersensitivity to benzonatate or related compounds.
  • Product summary:
  • Benzonatate Capsules, USP are available as: 200 mg (oblong, yellow) soft gelatin capsules with imprint “A2”. Bottles of 500: NDC 10135-0632-05 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Dispense in tight, light-resistant container as defined in the USP. Manufactu red for and Distributed by: Marlex Pharmaceuticals New Castle, DE 19720 Rev. 10/ 2017AN

Status

  • Source:
  • DailyMed - NLM - National Library of Medicine
  • Authorization status:
  • Abbreviated New Drug Application
  • Authorization number:
  • 10135-632-05
  • Last update:
  • 15-06-2019

Summary of Product characteristics: dosage, interactions, side effects

BENZONATATE- benzonatate capsule

Marlex Pharmaceuticals Inc

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Benzonatate Capsules

Benzonatate Capsules, USP 100 mg and 200 mg

Rx Only

DESCRIPTION

Benzonatate, a non-narcotic 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.

Benzonatate Capsules, USP contain 100 mg or 200 mg of benzonatate, USP.

Benzonatate Capsules also contain: D&C Yellow No. 10, gelatin, glycerin, methylparaben sodium and

propylparaben sodium.

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.

INDICATIONS AND USAGE

Benzonatate is 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 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 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 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 dose 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 has 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 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 refluxes

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 should be

swallowed whole. Benzonatate Capsules are not to be broken, chewed, dissolved, cut or crushed.

HOW SUPPLIED

Benzonatate Capsules, USP are available as:

200 mg (oblong, yellow) soft gelatin capsules with imprint “A2”.

Bottles of 500: NDC 10135-0632-05

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP

Controlled Room Temperature]. Dispense in tight, light-resistant container as defined in the USP.

Manufactured for and Distributed by:

Marlex Pharmaceuticals

New Castle, DE 19720

Rev. 10/2017AN

PRINCIPAL DISPLAY PANEL

Benzonatate

Capsules, USP

200 mg

500 CAPSULES

Rx Only

BENZONATATE

benzonatate capsule

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:10 135-6 32

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

20 0 mg

Inactive Ingredients

Ingredient Name

Stre ng th

D&C YELLO W NO . 10 (UNII: 35SW5USQ3G)

GELATIN (UNII: 2G8 6 QN327L)

GLYCERIN (UNII: PDC6 A3C0 OX)

Marlex Pharmaceuticals Inc

METHYLPARABEN SO DIUM (UNII: CR6 K9 C2NHK)

PRO PYLPARABEN SO DIUM (UNII: 6 25NNB0 G9 N)

Product Characteristics

Color

YELLOW

S core

no sco re

S hap e

CAPSULE (So ft Gelatin Capsules)

S iz e

16 mm

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:10 135-6 32-0 5

50 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

10 /20 /20 17

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 40 6 8 2

10 /20 /20 17

Labeler -

Marlex Pharmaceuticals Inc (782540215)

Revised: 10/2017