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DBID
Registration ID: 176322642
Trade License: TRAD/DNCC/040904/2023

Incepta Pharmaceuticals Ltd. · Sublingual Tablet
/ Piece
Detailed scientific information regarding the indications, dosage, potential side effects, and guidelines for use during pregnancy of Zukaria or the Asenapine Maleate group is provided below. Always consult a specialist physician before taking any medication.
Asenapine is indicated for:
Schizophrenia in adults
Bipolar I disorder
Acute monotherapy for manic or mixed episodes in adults and pediatric patients 10 to 17 years of age
Adjunctive treatment to lithium or valproate in adults.
Maintenance monotherapy treatment in adults
The mechanism of action of asenapine, in schizophrenia and bipolar I disorder, is unknown. It has been suggested that the efficacy of asenapine in schizophrenia could be mediated through a combination of antagonist activity at D2 and 5-HT 2A receptors.
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.
Asenapine should be used with caution in combination with:
Antihypertensive, as it may cause hypotension
Paroxetine (CYP2D6 substrate and inhibitor)
The most common adverse reactions to asenapine are akathisia, somnolence, oral hypoesthesia, dizziness, extrapyramidal symptoms, nausea, increased appetite, fatigue, and increased weight.
May cause extrapyramidal and/or withdrawal symptoms in neonates with third trimester exposure. Lactation studies have not been conducted to assess the presence of asenapine in human milk, the effects of asenapine on the breastfed infant, or the effects of asenapine on milk production.
Caution should be exercised when asenapine is prescribed in elderly patients with dementia-related psychosis, QT prolongation, neuroleptic malignant syndrome, tardive dyskinesia, metabolic changes, orthostatic hypotension, leukopenia, neutropenia, agranulocytosis, seizures, and the potential for cognitive and motor impairment.
Do not store above 30°C. Keep away from light and out of the reach of children.
The information provided on All Samadhan is intended for general informational purposes only and is prepared based on our best practices. It is not a substitute for professional medical advice, diagnosis, or treatment. While we strive to keep the information accurate and up to date, we do not guarantee its completeness or accuracy. The absence of specific information or warnings about any medicine or service should not be considered as an assurance or endorsement by All Samadhan. All Samadhan shall not be held responsible for any consequences arising from the use of this information. We strongly recommend consulting a qualified healthcare professional or physician for any medical concerns, questions, or clarifications.All Samadhan is a digital healthcare software platform operated by MS Genius Experts. We provide technology solutions for pharmacies and healthcare providers; we are not a direct seller or dispenser of prescription medicines