- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Sublingual tablets containing asenapine
Treatment of manic episodes associated with bipolar disorder
Treatment of moderate to severe manic episodes associated with bipolar I disorder in adults.
Initially 10 mg twice daily with one dose taken in the morning and one dose in the evening.
The dose may be reduced to 5 mg twice daily according to clinical assessment.
Initially 5 mg twice daily with one dose taken in the morning and one dose in the evening.
The dose may be increased to 10 mg twice daily depending on the clinical response and tolerability.
Children under 18 years
Renal impairment - creatinine clearance below 15ml/minute
Severe hepatic impairment
Precautions and Warnings
Family history of long QT syndrome
Patients over 65 years
Predisposition to hypotension
History of seizures
Moderate hepatic impairment
Patients at risk of suicide should be closely supervised
Advise ability to drive/operate machinery may be affected by side effects
Advise patients not eat immediately after a dose
Monitor ECG in patients at risk of QT prolongation
Monitor patients with existing or tendency towards diabetes mellitus
Neonate exposed in utero: Monitor neonate for adverse effects
Advise patient to report unexplained fever, sore throat, bruising, bleeding
Consider discontinuation if signs of tardive dyskinesia occur
Dysphagia & aspiration:caution in patients at risk for aspiration pneumonia
May cause postural hypotension especially in elderly
May impair ability to reduce core body temperature
Discontinue if patient develops neuroleptic malignant syndrome
Advise patient to avoid alcohol during treatment
Elderly patients with psychosis related to dementia, treated with antipsychotic substances, are at an increased risk of death.
Patients with Parkinson's disease or dementia with Lewy Bodies are at increased risk of Neuroleptic Malignant Syndrome and increased sensitivity to antipsychotics.
Pregnancy and Lactation
Use asenapine with caution in pregnancy.
Use of asenapine during pregnancy is recommended by the manufacturer only if the benefits to the mother outweigh the potential risk to the foetus. There are no adequate data from the use of asenapine in pregnant women.
In animal studies asenapine did not impair fertility in rats and was not found to be teratogenic in rats and rabbits. Embryotoxic effects were, however, found in reproduction toxicology studies using rats and rabbits and asenapine caused mild maternal toxicity and slight retardation of foetal skeletal development.
Neonates exposed to antipsychotics during the third trimester of pregnancy are at risk of adverse reactions. Monitor neonates carefully for extrapyramidal and/or withdrawal symptoms.
The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14-17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Asenapine is contraindicated while breastfeeding.
Studies in rats have shown asenapine to be excreted in milk during lactation. It is not known if asenapine or its metabolites are excreted in human milk.
Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1
The sublingual tablet should be placed under the tongue and allowed to dissolve completely. The tablet will dissolve in saliva within seconds. The sublingual tablets should not be crushed, chewed or swallowed.
Advise the patient to avoid eating and drinking for 10 minutes after administration.
If using in combination with other medication then asenapine should be taken last.
Advise the patient to avoid alcohol.
Advise patient to report unexplained fever, sore throat, bruising or bleeding.
Advise the patient not to drive or operate machinery if affected by certain side effects of asenapine such as sleepiness.
Bundle branch block
Exacerbation of diabetes
Increases in hepatic enzymes
Neuroleptic malignant syndrome
Oral mucosal blistering
Prolongation of QT interval
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Last Full Review Date: June 2013
British National Formulary, 65th Edition (March - September 2013) Pharmaceutical Press, London.
Martindale: The Complete Drug Reference, 37th edition (2011) ed. Sweetman, S. Pharmaceutical Press, London.
Summary of Product Characteristics: Sycrest 5mg sublingual tablets & Sycrest 10mg sublingual tablets. Lundbeck. Revised February 2013.
Already a member? Log in
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.