Drugs Details

Drugs Info of Benzonatate
Drugs Details
  • Drugs Type  : FDA
  • Date : 5th Jan 2015 02:08 am
  • Brand Name : Benzonatate
  • Generic Name : (Soft Gelatin Capsules)
Descriptions

Benzonatate (benzonatate softgels) , a nonnarcotic oral antitussive agent, is 2,5,8,11,14,17,20, 23,26- nonaoxaoctacosan-28-yl-p-(butylamino) benzoate; with an average molecular weight of 603.7. The chemical formula is C30H53NO11, structural formula is:

Each softgel (soft gelatin capsule), for oral administration, contains 100 mg benzonatate (benzonatate softgels) . In addition, each capsule contains the following inactive ingredients: D&C Yellow No. 10, gelatin, glycerin, methylparaben, propylparaben and purified water.

This monograph has been modified to include the generic and brand name in many instances.

Indications

Benzonatate (benzonatate softgels) is indicated for the symptomatic relief of cough.

Dosage Administration

Adults and children over 10 years of age: Usual dose is one 100 mg softgel t.i.d. as required. If necessary, up to 6 softgels daily may be given.

How Supplied

Each yellow softgel contains 100 mg of benzonatate (benzonatate softgels) and is available in bottles of 100's and 500's.

The softgels should be protected from light, moisture and humidity, and stored at controlled room temperature 15°-30°C (59°-86°F). Dispense in a tight, light-resistant container as defined in USP/NF.

Caution: Federal law prohibits dispensing without prescription.

This monograph has been modified to include the generic and brand name in many instances.

Side Effects

Potential Adverse Reactions to benzonatate (benzonatate softgels) may include: Hypersensitivity reactions including bronchospasm, laryngospasm, cardiovascular collapse possibly related to local anesthesia from chewing or sucking the softgel.

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. Rare instances of deliberate or accidental overdose have resulted in death.

Read the Benzonatate (benzonatate softgels) Side Effects Center for a complete guide to possible side effects

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Interactions

No information provided.

This monograph has been modified to include the generic and brand name in many instances.

Warnings

Severe hypersensitivity reactions (including bronchospasm, laryngospasm and cardiovascular collapse) have been reported which are possibly related to local anesthesia from sucking or chewing the softgel 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 (benzonatate softgels) in combination with other prescribed drugs.

Precautions

Benzonatate (benzonatate softgels) 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.

Usage in Pregnancy

Pregnancy Category C. Animal reproduction studies have not been conducted with benzonatate (benzonatate softgels) . It is also not known whether benzonatate (benzonatate softgels) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Benzonatate (benzonatate softgels) 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 (benzonatate softgels) is administered to a nursing woman.

Carcinogenesis, Mutagenesis, Impairment of Fertility

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

Pediatric Use

Safety and effectiveness in children below the age of 10 has not been established.

This monograph has been modified to include the generic and brand name in many instances.

OverDose

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 softgels 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 overdose.

Do not use CNS stimulants.

ContrainDications

Hypersensitivity to benzonatate (benzonatate softgels) or related compounds.

This monograph has been modified to include the generic and brand name in many instances.

Clinical Pharamacology

Benzonatate (benzonatate softgels) 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 (benzonatate softgels) has no inhibitory effect on the respiratory center in recommended dosage.

This monograph has been modified to include the generic and brand name in many instances.

Patient Information

Release of benzonatate (benzonatate softgels) from the softgel in the mouth can produce a temporary local anesthesia of the oral mucosa and choking could occur. Therefore, the softgels should be swallowed without chewing.

See WARNINGS, CONTRAINDICATIONS, and PRECAUTIONS.

This monograph has been modified to include the generic and brand name in many instances.

Consumer Overview Uses

No Information Available!

Consumer Overview Side Effect

No Information Available!

Consumer Overview Missed Dose

No Information Available!

Patient Detailed Side Effect

No Information Available!

Patient Detailed How Take

No Information Available!

Patient Detailed Avoid Taking

No Information Available!

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