Company: Rowex Ltd.
Legal category: Prescription. GMS. Sport permitted.
Active ingredient: Escitalopram (oxalate) 5mg, 10mg, 15mg, 20mg.
Description: All: White, film-coated tablets. 5mg: Round. 10mg: Oval with breaking notch on one side. 15mg: Oval with two breaking notches on both sides. 20mg: Round with cross breaking notch on both sides.
Presentation: 5mg-28, €4.24; 10mg-28, €7.92; 15mg-28, €11.58; 20mg-28, €14.06.
Indications: Treatment of major depressive episodes, panic disorder with or without agoraphobia, social anxiety disorder (SAD), generalised anxiety disorder (GAD), obsessive-compulsive disorder (OCD).
Pharmacology: Escitalopram is a selective inhibitor of serotonin (5-HT) re-uptake with high affinity for the primary binding site.
Dosage: Adult: Depression: Usually 10mg once daily, may increase to maximum 20mg daily. After symptoms resolve (usually 2-4 weeks), continue for at least 6 months. Panic disorder: Initially 5mg for first week, then 10mg daily. May increase to maximum 20mg daily. Maximum effect reached after 3 months. SAD: Usually 10mg once daily. Relief of symptoms 2-4 weeks. Depending on response may decrease to 5mg or increase to maximum 20mg daily. Duration, 12 weeks. Treatment for 6 months may be considered to prevent relapse; re-evaluate regularly. GAD: Initially 10mg once daily, may increase to maximum 20mg daily. Long-term treatment (at least 6 months), re-evaluate regularly. OCD: Initially 10mg once daily, may increase to maximum 20mg daily; treat for sufficient period to ensure patient is symptom free; re-evaluate regularly. Hepatic impairment: Mild to moderate, initially 5mg for first 2 weeks, may increase to 10mg daily. Severe, caution (titrate dose carefully). Poor metabolisers of CYP2C19: Initially 5mg daily for first 2 weeks, may increase to 10mg daily. Elderly: Over 65 years, initially 5mg once daily, may increase to 10mg daily. SAD: Efficacy not studied. Children: Under 18 years, not recommended.
Contraindications: Hypersensitivity to the active ingredient or to any of the excipients. QT-interval prolongation or congenital long QT syndrome. Pregnancy (unless clearly necessary), lactation.
Special precautions: Caution: Severe renal impairment, history of mania/hypomania (discontinue if entering a manic phase), patients at risk of hyponatraemia (elderly, cirrhosis), bleeding tendencies, electroconvulsive therapy, coronary heart disease, significant bradycardia, recent acute myocardial infarction or uncompensated heart failure, angle-closure glaucoma or history of glaucoma. Increased anxiety may occur in patients with panic disorder at treatment initiation (use low starting dose). Discontinue if seizures develop (or if seizure frequency increases). Unstable epilepsy (avoid); controlled epilepsy (monitor closely). Diabetes (may alter glycaemic control). Supervise patients closely for suicide-related events, particularly those at high risk, during treatment (especially early treatment and following dose changes). Akathisia may develop (do not increase dose). Discontinue immediately if serotonin syndrome develops. Withdraw gradually over at least 1-2 weeks. Correct electrolyte disturbances (such as hypokalaemia and hypomagnesaemia) before treatment. Stable cardiac disease (consider ECG review before treatment). If signs of cardiac arrhythmia occur, withdraw treatment and perform ECG. May affect sperm quality. Driving/using machines. Contains lactose.
Drug interactions: Contraindicated: Monoamine oxidase inhibitors (e.g. moclobemide, linezolid, selegiline), drugs prolonging QT-interval. Caution: Serotonergics (e.g. tramadol, sumatriptan and other triptans), drugs lowering seizure threshold, lithium, tryptophan, St. John’s Wort, oral anticoagulants, drugs affecting platelet function, drugs inducing hypokalaemia/hypomagnesaemia, CYP2C19 inhibitors, cimetidine, CYP2D6 substrates (with a narrow therapeutic index or some CNS-acting drugs), CYP2C19 substrates, drugs inducing hyponatraemia. Avoid alcohol.
Adverse drug reactions: Decreased appetite, increased appetite, increased weight, anxiety, restlessness, abnormal dreams, decreased libido (male and female), anorgasmia (female), headache, insomnia, somnolence, dizziness, paraesthesia, tremor, sinusitis, yawning, GI upset, increased sweating, arthralgia, myalgia, ejaculation disorder (male), impotence (male), fatigue, pyrexia.
Full prescribing information and references available from Rowex Ltd. Telephone: 1800 304400. Fax: (027) 50417. E-mail: rowex@rowa-pharma.ie