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Asenapine Maleate

Generic Medicine
Indications

Asenapine Maleate is indicated for:

  • Schizophrenia in adults.
  • Bipolar I disorder.
  • Acute treatment of manic or mixed episodes as monotherapy in adults and pediatric patients aged 10 to 17 years.
  • Adjunctive therapy with lithium or valproate in adults.
  • Maintenance monotherapy treatment in adults.
Pharmacology

The exact mechanism of action of Asenapine in schizophrenia and bipolar I disorder is not fully understood. However, its therapeutic effect is believed to be associated with antagonistic activity at dopamine D2 and serotonin 5-HT2A receptors, contributing to the regulation of mood and behavior.

Dosage Administration

Schizophrenia: adults:

  • Initial dose: 5 mg sublingually, twice daily
  • Recommended dose: 5 mg sublingually, twice daily
  • Maximum dose: 10 mg sublingually, twice daily

Schizophrenia maintenance treatment in adults.

  • Initial dose: 5 mg sublingually, twice daily
  • Recommended dose: 5-10 mg sublingually, twice daily
  • Maximum dose: 10 mg sublingually, twice daily

Bipolar mania in adults: acute and maintenance monotherapy.

  • Initial dose: 5-10 mg sublingually, twice daily
  • Recommended dose: 5-10 mg sublingually, twice daily
  • Maximum dose: 10 mg sublingually, twice daily

Bipolar mania in pediatric patients (10-17 years): monotherapy.

  • Initial dose: 2.5 mg sublingually, twice daily
  • Recommended dose: 2.5-10 mg sublingually, twice daily
  • Maximum dose: 10 mg sublingually, twice daily

Bipolar mania in adults: as an adjunct to lithium or valproate

  • Initial dose: 5 mg sublingually, twice daily
  • Recommended dose: 5-10 mg sublingually, twice daily
  • Maximum dose: 10 mg sublingually, twice daily

Sublingual tablets should not be swallowed. It should be placed under the tongue and left to dissolve completely. It will dissolve in saliva within seconds. Eating and drinking should be avoided for 10 minutes after administration.

Interactions

Asenapine Maleate should be used cautiously when co-administered with certain drugs. It may enhance the hypotensive effects of antihypertensive agents. Caution is also advised when used with paroxetine, a CYP2D6 substrate and inhibitor, as it may alter the metabolism of asenapine.

Contraindications

Asenapine is contraindicated in patients with severe hepatic impairment (Child-Pugh C) and in those with a known history of hypersensitivity to asenapine. Hypersensitivity reactions may include anaphylaxis, angioedema, hypotension, tachycardia, tongue swelling, dyspnea, wheezing, and rash.

Side Effects

Common adverse effects include akathisia, drowsiness, oral numbness, dizziness, extrapyramidal symptoms, nausea, increased appetite, fatigue, and weight gain.

Pregnancy & Lactation

Exposure during the third trimester of pregnancy may lead to extrapyramidal and/or withdrawal symptoms in newborns. There is insufficient data regarding the presence of asenapine in human milk, its effects on the breastfed infant, or its impact on milk production.

Precautions & Warnings

Caution is required when prescribing asenapine in elderly patients with dementia-related psychosis, as well as in patients at risk of QT prolongation, neuroleptic malignant syndrome, tardive dyskinesia, metabolic abnormalities, orthostatic hypotension, leukopenia, neutropenia, agranulocytosis, seizures, or cognitive and motor impairment.

Overdose Effects

There is no specific antidote for asenapine overdose. Management should include supportive care, maintenance of airway, oxygenation, and ventilation, along with symptomatic treatment. Anticholinergic agents may be used in cases of severe extrapyramidal symptoms. Continuous monitoring is required until recovery.

Storage Conditions

Store below 30°C, protected from light. Keep out of reach of children.

Common Questions

What is Asenapine Maleate for?

What does Asenapine Maleate do?

What are the side effects of Asenapine Maleate?

What happens if you take too much Asenapine Maleate?

Can Asenapine Maleate be taken during pregnancy?

Sublingual Tablet
Zukaria
Sublingual Tablet
5 mg
Incepta Pharmaceuticals Ltd.
Unit Price: ৳ 30.00
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