Venlafaxinedosage

Do not initiate treatment with Venlafaxine Extended-Release Tablets. Use another venlafaxine extended-release product for initial dosage, titration, and dosages below 112.5 mg once daily. Take once daily with food. Swallow tablets whole with fluid. Do not divide, crush, chew, or place in water. Venlafaxine Extended-Release Tablets can be initiated at 112.5 mg once daily in patients who have received at least 75 mg of another venlafaxine extended-release product for at least 4 days. Maximum recommended dosage is 225 mg once daily. When discontinuing treatment, reduce the dose gradually. Gradual dosage reduction will require the use of another venlafaxine extended-release product.

Hepatic and Renal impairment: Maximum recommended dosage of Venlafaxine Extended-Release Tablets is 112.5 mg once daily. Switch to another venlafaxine extended-release product if doses lower than 112.5 mg are needed.

2.1 Important

Dosing and Administration Information Do not initiate venlafaxine treatment, titrate by doses less than 112.5 mg, or taper treatment with Venlafaxine Extended-Release Tablets, as dosing is not possible in these scenarios because Venlafaxine Extended-Release Tablets are only available in a 112.5 mg strength. Use another venlafaxine extended-release product for dosage initiation, titration, administration of dosages below 112.5 mg once daily, and to taper during discontinuation. Refer to the Prescribing Information of other venlafaxine extended-release products for the recommended dosage of those products in these dosing scenarios. Venlafaxine Extended-Release Tablets can be initiated in patients who have received at least 75 mg per day of another venlafaxine extended-release product for at least 4 days. Administer Venlafaxine Extended-Release Tablets as once daily with food, either in the morning or in the evening at approximately the same time each day. Swallow tablets whole with fluid. Do not divide, crush, chew, or place in water.

2.2 Recommended

Dosage for the Treatment of Major Depressive Disorder Initiate Venlafaxine Extended-Release Tablets at a dosage of 112.5 mg once daily in patients who have received at least 75 mg per day of another venlafaxine extended-release product for at least 4 days. Patients not responding to their current venlafaxine dosage may benefit from dose increases to a maximum of 225 mg per day. Increase the dosage in increments of up to 75 mg per day, as needed, using another venlafaxine extended-release product at intervals of 4 days or more.

2.3 Recommended

Dosage for the Treatment of Generalized Anxiety Disorder Initiate Venlafaxine Extended-Release Tablets at a dosage of 112.5 mg once daily in patients who have received at least 75 mg per day of another venlafaxine extended-release product for at least 4 days. Patients not responding to their current venlafaxine dosage may benefit from dose increases to a maximum of 225 mg per day. Increase the dosage in increments of up to 75 mg per day, as needed, using another venlafaxine extended-release product at intervals of 4 days or more.

2.4 Screen for

Bipolar Disorder Prior to Starting Venlafaxine Extended-Release Tablets Prior to initiating treatment with Venlafaxine Extended-Release Tablets, screen patients for a personal or family history of bipolar disorder, mania, or hypomania.

2.5 Switching

Patients from Venlafaxine Tablets (Immediate-Release Formulation) Patients who are currently receiving venlafaxine tablets (immediate-release formulation) may be switched to Venlafaxine Extended-Release Tablets at the nearest equivalent dose (mg per day) if the total daily dosage is either 112.5 mg or 225 mg once daily.

2.6 Dosage Recommendations in

Patients with Hepatic Impairment Reduce the total daily dose of venlafaxine by 50% in patients with mild (Child-Pugh Class A) to moderate (Child-Pugh Class B) hepatic impairment. In patients with severe hepatic impairment (Child-Pugh Class C) or hepatic cirrhosis, it may be necessary to reduce the dose by 50% or more. The maximum recommended dosage of Venlafaxine Extended-Release Tablets in patients with hepatic impairment is 112.5 mg once daily. If the total daily dosage of venlafaxine is less than 112.5 mg per day, use another venlafaxine extended-release product.

2.7 Dosage Recommendations in

Patients with Renal Impairment Reduce the total daily dose of venlafaxine by 25% to 50% in patients with mild (CLcr = 60-89 mL/min) or moderate (CLcr = 30-59 mL/min) renal impairment. In patients undergoing hemodialysis or with severe renal impairment (CLcr < 30 mL/min), the total daily dose should be reduced by 50% or more. The maximum recommended dosage of Venlafaxine Extended-Release Tablets in patients with renal impairment is 112.5 mg once daily. If the total daily dosage of venlafaxine is less than 112.5 mg per day, use another venlafaxine extended-release product.

2.8 Discontinuing

Treatment with Venlafaxine Extended-Release Tablets A gradual reduction in the dose, rather than abrupt cessation, is recommended whenever possible when discontinuing Venlafaxine Extended-Release Tablets. In clinical studies with venlafaxine extended-release capsules, tapering was achieved by reducing the daily dosage by 75 mg at one-week intervals. Given that dosage strengths of Venlafaxine Extended-Release Tablets are not available below 112.5 mg, use another venlafaxine extended-release product for discontinuation. Individualization of tapering may be necessary. In some patients, discontinuation may need to occur over a period of several months.

2.9 Switching

Patients to or from a Monoamine Oxidase Inhibitor (MAOI) Antidepressant At least 14 days must elapse between discontinuation of an MAOI (intended to treat psychiatric disorders) and initiation of therapy with Venlafaxine Extended-Release Tablets. In addition, at least 7 days should be allowed after stopping Venlafaxine Extended-Release Tablets before starting an MAOI intended to treat psychiatric disorders.