Venlafaxine

VENLAFAXINE- venlafaxine besylate monohydrate tablet, extended release
Almatica Pharma LLC

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WARNING: SUICIDAL THOUGHTS AND BEHAVIORS

Antidepressants increased the risk of suicidal thoughts and behavior in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and emergence of suicidal thoughts and behaviors [see Warnings and Precautions (5.1)].

Venlafaxine Extended-Release Tablets are not approved for use in pediatric patients [see Use in Specific Populations (8.4)].

1 INDICATIONS AND USAGE

Venlafaxine Extended-Release Tablets are indicated in adults for the treatment of:

  • Major depressive disorder (MDD)
  • Generalized Anxiety Disorder (GAD)

2 DOSAGE AND ADMINISTRATION

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 [see Dosage and Administration (2.6, 2.7, 2.8)]. 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 [see Dosage and Administration (2.2, 2.3)].

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 [see Clinical Pharmacology (12.3)]. 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 [see Dosage and Administration (2.1)].

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 [see Dosage and Administration (2.1)].

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 [see Warnings and Precautions (5.6)].

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 [see Use in Specific Populations (8.6)].

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 [see Dosage and Administration (2.1)].

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 [see Use in Specific Populations (8.7)].

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 [see Dosage and Administration (2.1)].

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 [see Dosage and Administration (2.1)]. Individualization of tapering may be necessary. In some patients, discontinuation may need to occur over a period of several months [see Warnings and Precautions (5.7)].

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 [see Contraindications (4), Warnings and Precautions (5.2), and Drug Interactions (7.1)].

3 DOSAGE FORMS AND STRENGTHS

Extended-release tablets: 112.5 mg, white, round, biconvex tablet, with “ALM” over “632” printed in black ink on one side, and plain on the other side.

4 CONTRAINDICATIONS

Venlafaxine Extended-Release Tablets are contraindicated in patients:

  • with known hypersensitivity to venlafaxine besylate, venlafaxine hydrochloride, desvenlafaxine succinate or to any excipients in Venlafaxine Extended-Release Tablets [see Adverse Reactions (6.2)].
  • taking, or within 14 days of stopping, MAOIs (including the MAOIs linezolid and intravenous methylene blue) because of increased risk of serotonin syndrome [see Dosage and Administration (2.9), Warnings and Precautions (5.2), Drug Interactions (7.1)].

5 WARNINGS AND PRECAUTIONS

5.1 Suicidal Thoughts and Behaviors in Adolescents and Young Adults

In pooled analyses of placebo-controlled trials of antidepressant drugs (SSRIs and other antidepressant classes) that included approximately 77,000 adult patients and 4,500 pediatric patients, the incidence of suicidal thoughts and behaviors in antidepressant-treated patients age 24 years and younger was greater than in placebo-treated patients. There was considerable variation in risk of suicidal thoughts and behaviors among drugs, but there was an increased risk identified in young patients for most drugs studied. There were differences in absolute risk of suicidal thoughts and behaviors across the different indications, with the highest incidence in patients with MDD. The drug-placebo differences in the number of cases of suicidal thoughts and behaviors per 1,000 patients treated are provided in Table 1.

Table 1: Risk Differences of the Number of Patients of Suicidal Thoughts and Behaviors in the Pooled Placebo-Controlled Trials of Antidepressants in Pediatric* and Adult Patients
*Venlafaxine Extended-Release Tablets are not approved for use in pediatric patients.
Age Range Drug-Placebo Difference in Number of Patients of Suicidal Thoughts and Behaviors per 1,000 Patients Treated
Increases Compared to Placebo
< 18 years old 14 additional patients
18–24 years old 5 additional patients
Decreases Compared to Placebo
25–64 years old 1 fewer patient
≥ 65 years old 6 fewer patients

It is unknown whether the risk of suicidal thoughts and behaviors in children, adolescents, and young adults extends to longer-term use, i.e., beyond four months. However, there is substantial evidence from placebo-controlled maintenance trials in adults with MDD that antidepressants delay the recurrence of depression and that depression itself is a risk factor for suicidal thoughts and behaviors.

Monitor all antidepressant-treated patients for any indication for clinical worsening and emergence of suicidal thoughts and behaviors, especially during the initial few months of drug therapy, and at times of dosage changes. Counsel family members or caregivers of patients to monitor for changes in behavior and to alert the healthcare provider. Consider changing the therapeutic regimen, including possibly discontinuing Venlafaxine Extended-Release Tablets, in patients whose depression is persistently worse, or who are experiencing emergent suicidal thoughts or behaviors.

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