Efaxil XL

Company: Pinewood Healthcare.
Legal category: Prescription. GMS. Sport permitted.
Active ingredient: Venlafaxine (as hydrochloride) 75mg, 150mg.
Description: Respectively, flesh opaque/flesh opaque or scarlet opaque/scarlet opaque, size 0 or size 00 hard gelatine capsules containing two or three white round, biconvex film-coated tablets.
Presentation: 75mg-28, €22.15; 150mg-28, €37.35.
Indications: Treatment of depressive illness, including depression accompanied by anxiety. Following an initial response, for the prevention of relapses of the initial episode of depression or for the prevention of the recurrence of new episodes.

Pharmacology: The antidepressant action of venlafaxine in humans is believed to be associated with its potentiation of neurotransmitter activity in the central nervous system. Preclinical studies have shown that venlafaxine and its major metabolite, ODV, are potent inhibitors of serotonin and noradrenaline reuptake. Venlafaxine also weakly inhibits dopamine uptake.
Dosage: Swallow whole with food. Adult: 75mg once daily for initiation and maintenance. If after 2 weeks further clinical improvement is required, the dose may be increased to 150mg once daily. If needed the dose can be further increased up to 225mg once daily. Increase doses at intervals of 2 weeks or more but no less than 4 days. Discontinue if there is no evidence of clinical response after 8 weeks. Mild-moderate hepatic impairment: Reduce dose by 50%; further reduction may be required in some patients. Moderate renal impairment (GFR 10-30ml/minute): Reduce dose by 50%. Elderly: Caution, use lowest effective dose. Children: Under 18 years, not recommended.
Contraindications: Known hypersensitivity to venlafaxine or any other component of the product. Concomitant use with MAOIs, or within 14 days of their discontinuation.
Special precautions: Monitor for suicidality, especially in early treatment and following dose changes. Caution: History of bipolar disorder, aggression, MI or unstable heart disease, seizure (discontinue if occurs), moderate-severe renal impairment or hepatic cirrhosis, predisposition to bleeding. Monitor blood pressure; control pre-existing hypertension before treatment. Evaluate patients for drug abuse history. Increases in heart rate can occur (particularly at high doses). Postural hypotension may occur, warn patients (especially elderly). Consider hyponatraemia in patients who develop drowsiness, confusion or convulsions. Monitor patients with raised IOP or at a risk of narrow angle glaucoma. Long-term treatment (monitor serum cholesterol). Withdraw gradually. Driving/operating machines. Pregnancy (unless essential), lactation.
Drug interactions: Contra: MAOIs (or within 14 days of their discontinuation). Not recommended: Weight loss agents. Avoid alcohol. Caution: SSRIs, triptans, clozapine, warfarin, cimetidine (in elderly/hepatic dysfunction), indinavir, drugs inhibiting both CYP2D6 and CYP3A4, ECT.
Adverse drug reactions: Hypertension, palpitation, vasodilatation, GI disorders, anorexia, decreased appetite, chills, pyrexia, asthenia, headache, increased serum cholesterol (prolonged use, higher doses), weight gain or weight loss, arthralgia, myalgia, dizziness, insomnia, somnolence, nervousness, abnormal dreams, agitation, anxiety, confusion, hypertonia, paraesthesia, tremor, urinary frequency, abnormal ejaculation/orgasm, anorgasmia, erectile dysfunction, decreased libido, impotence, menstrual cycle disorders, dyspnoea, yawning, sweating (incl. night sweats), abnormal vision / accommodation, mydriasis.
Full prescribing information available from Pinewood Healthcare. Telephone: (052) 86000. Fax: (052) 36311. E-mail: info@pinewood.ie