Venlafaxine STELLA 37.5 mg

Rx

Indications

• Treatment of major depressive episodes (generalised anxiety, social anxiety disorder and panic disorder, with or without agoraphobia).
• For prevention of recurrence of major depressive episodes.

Dosage

• Major depressive episodes:
  Starting with 75 mg once daily, dose may be increased up to a maximum dose of 375 mg daily. Dosage increases can be made at intervals of 2 weeks or more.
  Generalised anxiety disorder: Starting with 75 mg once daily; dose may be increased up to a maximum dose of 225 mg daily. Dosage increases can be made at intervals of 2 weeks or more.
  Social anxiety disorder: Starting with 75 mg once daily; dose may be increased up to a maximum dose of 225 mg daily. Dosage increases can be made at intervals of 2 weeks or more.
  Panic disorder: 37.5 mg daily for 7 days, then be increased up to 75 mg daily; dose may be increased up to a maximum dose of 225 mg daily. Dosage increases can be made at intervals of 2 weeks or more.
• Prevention of recurrence of major depressive episodes:
  Longer term treatment may also be appropriate for prevention of recurrence of major depressive episodes (MDE). In most of the cases, the recommended dose in prevention of recurrence of MDE is the same as the one used during the current episode.

Usage

• Venlafaxine STELLA 37.5 mg is administered orally.

• Known hypersensitivity to any ingredient in the formulation.
• The high-risk cases of cardiac arrhythmias, uncontrolled hypertension.
• Children and adolescents under the age of 18 years.
• Pregnancy
• Venlafaxine must be discontinued for at least 7 days before starting treatment with an irreversible MAOI.
• Venlafaxine must not be initiated for at least 14 days after discontinuation of treatment with an irreversible MAOI.

Most frequently

• Nausea, headache, insomnia, somnolence, dry mouth, dizziness, constipation, sexual dysfunction, asthenia, sweating, and nervousness.

Other common adverse effects

• Anorexia, diarrhoea, dyspepsia, abdominal pain, anxiety, urinary frequently, visual disturbances, vasodilatation, vomiting, tremor, paraesthesia, chills or fever, palpitations, weight gain or loss, increase serum cholesterol, agitation, abnormal dreams, confusion, arthralgia, myalgia, tinnitus, pruritus, dyspnoea and skin rashes. Dose-related increases in blood pressure.

Caution should be exercised when use Venlafaxine STELLA 37.5 mg in:

• Patients with a recent history of myocardial infarction or whose condition might be exacerbated by an increase in heart rate. Due to the risk of dose-related increases in blood pressure, blood pressure measurement should be performed regularly during therapy. Measurement of serum-cholesterol levels should also be considered with long-term treatment.
• Patients with moderate to severe hepatic or renal impairment and dosage adjustment may be necessary.
• Patients with a history of bleeding disorders or of hypomania or mania.
• Patients with raised intra-ocular pressure or at risk of angle-closure glaucoma should be monitored closely.
• The elderly (risk of dizziness or unsteadiness due to orthostatic hypotension).
• Patients with a history of epilepsy.

Avoid Venlafaxine STELLA 37.5 mg in those with unstable disease; it should be stopped in any patient developing a seizure or if there is an increase in seizure frequency.

Patients who develop a rash, urticaria, or related allergic reaction with venlafaxine should be advised to contact their doctor.

Symptoms reported on abrupt withdrawal or dose reduction of venlafaxine include fatigue, somnolence, headache, nausea, vomiting, anorexia, palpitations, dizziness, dry mouth, diarrhoea, insomnia, agitation, anxiety, nervousness, confusion, hypomania, paraesthesia, sweating, and vertigo.

Venlafaxine STELLA 37.5 mg contains lactose and therefore should not take this medicine for patients with rare hereditary problems of galactose intolerance, the total lactase deficiency or glucose galactose malabsorption.

Venlafaxine STELLA 37.5 mg should be used during pregnancy only if clearly needed. A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Venlafaxine STELLA 37.5 mg may impair performance of skilled tasks and, if affected, patients should not drive or operate machinery.