Levare: Dosages and Ingredients | Full Prescribing Info

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Full Prescribing Info

Contents

Levodropropizine.

Description

Each tablet contains: Levodropropizine 60 mg.
Levodropropizine (Levare) 60 mg is a white, round tablet.

Action

Pharmacology: Pharmacodynamics: Levodropropizine, the S-isomer of dropropizine, has a predominant peripheral antitussive action which acts by inhibiting the sensory C-fiber activation and the release of neuropeptides. It is a cough sedative with bronchial muscle relaxant action, thus improving pulmonary ventilation. However, it is exempted from secondary reactions of central antitussive action.
Pharmacokinetics: Levodropropizine is rapidly absorbed after oral administration and peak plasma concentration occurred within 40 minutes. The bioavailability of levodropropizine is more than 75%.
Levodropropizine is 11 to 14% bound to plasma proteins.
It is unknown whether levodropropizine is metabolized in the liver.
The plasma elimination half-life of levodropropizine is 1 to 2 hours. Approximately 35% of levodropropizine is excreted unchanged in the urine within 48 hours.

Indications/Uses

For the symptomatic relief of cough.

Dosage/Direction for Use

Adults and Children 12 years and older: 1 tablet. Or, as prescribed by a physician.
Levodropropizine should be taken orally, 3 times a day with at least 6-hour intervals, in between meals.
This medicine should not be taken for more than 7 days. If symptoms persist after this period, the treatment should be stopped and a physician should be consulted.

Overdosage

There is limited information on levodropropizine overdose. No significant side effects have been reported after a single dose administration of up to 240 mg and multiple administration (thrice a day) of up to 120 mg for 8 consecutive days.
In cases of overdose, symptomatic and supportive treatment should be given.

Contraindications

Hypersensitivity to levodropropizine or to any component of the product.
Patients with bronchorrhea and reduced mucociliary function (e.g., Kartagener syndrome or bronchial cilia dyskinesia).
Severe hepatic impairment.
Pregnancy.
Breastfeeding.

Special Precautions

Coexisting Conditions: Levodropropizine should be administered with caution in patients with severe heart failure, diabetes, and severe renal impairment (creatinine clearance < 35 mL/min).
Effects on Ability to Drive and Use Machines: Levodropropizine may cause somnolence, dizziness, and vertigo. Patients should exercise caution when driving vehicles or operating machinery.
Use in Children: The safety and efficacy of levodropropizine have not been established in children below 2 years old.

Use In Pregnancy & Lactation

Pregnancy: There are no adequate and well-controlled studies in pregnant women. Levodropropizine should not be used during pregnancy.
Lactation: Levodropropizine is excreted in breast milk. Therefore, it is not recommended in breastfeeding women.

Adverse Reactions

The most frequently reported adverse effect with levodropropizine is somnolence.
Immune system disorders: Allergic skin reaction, angioedema, hypersensitivity reaction.
Metabolism and nutrition disorders: Generalized edema, hypoglycemia.
Psychiatric disorders: Depersonalization, nervousness, stupor.
Nervous system disorders: Coma, clouding of consciousness, dizziness, epilepsy, faint, headache, hypoglycemic coma, impaired consciousness, paresthesia, tremors, vertigo.
Eye disorders: Bilateral blindness, mydriasis, palpebral edema, temporary loss of vision.
Cardiac disorders: Arrhythmia, palpitations, tachycardia.
Vascular disorders: Hypotension.
Respiratory, thoracic and mediastinal disorders: Cough, dyspnea, pulmonary edema.
Gastrointestinal disorders: Abdominal distress, abdominal discomfort, aphthous fever, diarrhea, dyspepsia, glossitis, heartburn, nausea, vomiting.
Hepatobiliary disorders: Cholestatic hepatitis.
Skin and subcutaneous tissue disorders: Epidermolysis, erythema, exanthema, itching, urticaria.
Musculoskeletal and connective tissue disorders: Hypotonia.
General disorders and administration site conditions: Asthenia, exhaustion, fatigue, malaise, irritability, weakness.

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Drug Interactions

Benzodiazepines: No interaction has been observed between benzodiazepines (e.g., alprazolam, diazepam, clonazepam) and levodropropizine. However, caution should be exercised when concomitantly administered in sensitive patients.

Storage

Store at temperatures not exceeding 30°C.

MIMS Class

Cough & Cold Preparations

ATC Classification

R05DB27 - levodropropizine ; Belongs to the class of other cough suppressants.

Regulatory Classification

Presentation/Packing

Form

Levare tab 60 mg

Packing/Price

100's

Levare

levodropropizine

Manufacturer:

UNILAB, Inc

Distributor:

UNILAB, Inc