Asenapine 5 mg/1
ASENAPINE MALEATE · TABLET · Breckenridge Pharmaceutical, Inc.
Asenapine is a prescription medication taken as a sublingual tablet that is used to treat schizophrenia and bipolar disorder. The tablet dissolves under your tongue and should not be swallowed whole.
Key Facts
- Brand Name
- Asenapine
- Generic Name
- ASENAPINE MALEATE
- NDC Code (Product)
51991-358- Manufacturer
- Breckenridge Pharmaceutical, Inc.
- Strength
- 5 mg/1
- Dosage Form
- TABLET
- Route
- SUBLINGUAL
- Marketing Status
- Application #
- ANDA205960
- Marketing Start
- 03/08/2021
Recall History
SigmaPharm Laboratories LLC
Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent
SigmaPharm Laboratories LLC
Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent
Forest Laboratories, LLC
Labeling; Label Mixup; blister lidding foil and shell-pack labeled as 10 mg but package actually contains 5 mg tablets
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Asenapine is indicated for: • Bipolar I disorder [see Clinical Studies (14.2)] • Acute monotherapy of manic or mixed episodes, in pediatric patients 10 to 17 years of age • Adjunctive treatment to lithium or valproate in adults Asenapine is an atypical antipsychotic indicated for ( 1 ): Bipolar I disorder o Acute monotherapy treatment of manic or mixed episodes, in pediatric patients 10 to 17 years of age o Adjunctive treatment to lithium or valproate in adults
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Starting Dose Recommended Dose Maximum Dose Bipolar mania – pediatric patients (10 to 17 years): monotherapy ( 2.3 ) 2.5 mg sublingually twice daily 2.5 to 10 mg sublingually twice daily 10 mg sublingually twice daily Bipolar mania – adults: as an adjunct to lithium or valproate ( 2.3 ) 5 mg sublingually twice daily 5 to 10 mg sublingually twice daily 10 mg sublingually twice daily • Do not swallow tablet. Asenapine sublingual tablets should be placed under the tongue and left to dissolve completely. The tablet will dissolve in saliva within seconds. Eating and drinking should be avoided for 10 minutes after administration. ( 2.1 , 17 ) 2.1 Administration Instructions Asenapine is a sublingual tablet. To ensure optimal absorption, patients should be instructed to place the tablet under the tongue and allow it to dissolve completely. The tablet will dissolve in saliva within seconds. Asenapine sublingual tablets should not be split, crushed, chewed, or swallowed [see Clinical Pharmacology (12.3)]. Patients should be instructed to not eat or drink for 10 minutes after administration [see Clinical Pharmacology (12.3)]. 2.3 Bipolar I Disorder Acute Treatment…
Contraindications
4 CONTRAINDICATIONS Asenapine is contraindicated in patients with: Severe hepatic impairment (Child-Pugh C) [see Specific Populations (8.7), Clinical Pharmacology (12.3)] . A history of hypersensitivity reactions to asenapine. Reactions have included anaphylaxis, angioedema, hypotension, tachycardia, swollen tongue, dyspnea, wheezing and rash [see Warnings and Precautions (5.6), Adverse Reactions (6)] . • Severe hepatic impairment (Child-Pugh C). ( 8.7 , 12.3 ) • Known hypersensitivity to asenapine, or to any components in the formulation. ( 4 , 5.6 , 17 )
Drug Interactions
7 DRUG INTERACTIONS • Antihypertensive Drugs: Asenapine may cause hypotension. ( 5.7 , 7.1 , 12.3 ) • Paroxetine (CYP2D6 substrate and inhibitor): Reduce paroxetine by half when used in combination with asenapine. ( 7.1 , 12.3 ) 7.1 Drugs Having Clinically Important Drug Interactions with Asenapine Table 12: Clinically Important Drug Interactions with Asenapine Concomitant Drug Name or Drug Class Clinical Rationale Clinical Recommendation Antihypertensive Drugs Because of its α 1 -adrenergic antagonism with potential for inducing hypotension, asenapine may enhance the effects of certain antihypertensive agents [see Warnings and Precautions (5.7)] . Monitor blood pressure and adjust dosage of antihypertensive drug accordingly. Strong CYP1A2 Inhibitors (e.g., Fluvoxamine) Asenapine is metabolized by CYP1A2. Marginal increase of asenapine exposure was observed when asenapine is used with fluvoxamine at 25 mg administered twice daily [see Clinical Pharmacology (12.3)] . However, the tested fluvoxamine dose was suboptimal. Full therapeutic dose of fluvoxamine is expected to cause a greater increase in asenapine exposure. Dosage reduction for asenapine based on clinical response may be n…
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are discussed in more detail in other sections of the labeling: Use in Elderly Patients with Dementia-Related Psychosis [see Boxed Warning and Warnings and Precautions (5.1 and 5.2)] Neuroleptic Malignant Syndrome [see Warnings and Precautions (5.3)] Tardive Dyskinesia [see Warnings and Precautions (5.4)] Metabolic Changes [see Warnings and Precautions (5.5)] Hypersensitivity Reactions [see Contraindications, Warnings and Precautions (5.6)] Orthostatic Hypotension, Syncope, and other Hemodynamic Effects [see Warnings and Precautions (5.7)] Falls [see Warnings and Precautions (5.8)] Leukopenia, Neutropenia, and Agranulocytosis [see Warnings and Precautions (5.9)] QT Interval Prolongation [see Warnings and Precautions (5.10)] Hyperprolactinemia [see Warnings and Precautions (5.11)] Seizures [see Warnings and Precautions (5.12)] Potential for Cognitive and Motor Impairment [see Warnings and Precautions (5.13)] Body Temperature Regulation [see Warnings and Precautions (5.14)] Dysphagia [see Warnings and Precautions (5.15)] The most common adverse reactions (≥5% and at least twice the rate of placebo) reported during the adjunctive the…
Frequently Asked Questions
What is Asenapine used for?
Asenapine is a prescription medication taken as a sublingual tablet that is used to treat schizophrenia and bipolar disorder. The tablet dissolves under your tongue and should not be swallowed whole.
Is Asenapine a controlled substance?
Asenapine is not classified as a controlled substance by the DEA.
What is the generic name for Asenapine?
The generic name for Asenapine is ASENAPINE MALEATE. There are 3 other brand versions of ASENAPINE MALEATE.
What is the NDC code for Asenapine 5 mg/1?
The NDC (National Drug Code) for Asenapine 5 mg/1 is 51991-358, listed by Breckenridge Pharmaceutical, Inc..