EFFEXOR XR Extended-release capsule (2020)

Βιβλιογραφική αναφορά

Συγγραφείς

PD-Rx Pharmaceuticals, Inc.

Λέξεις κλειδιά

55289-277

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BOXED WARNING SECTION

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did ...

1. Indications and Usage

1.1 Major Depressive Disorder Effexor XR (venlafaxine hydrochloride) extended-release capsules are indicated for the treatment of major depressive disorder (MDD). Efficacy was established in three short-term ...

2. Dosage and Administration

Effexor XR should be administered in a single dose with food, either in the morning or in the evening at approximately the same time each day [see Clinical Pharmacology (12.3)]. Each capsule should ...

3. Dosage Forms and Strengths

Effexor XR (venlafaxine hydrochloride) extended-release capsules are available in the following strengths: 37.5 mg capsules (grey cap/peach body with W and Effexor XR on the cap and 37.5 on the body) ...

4. Contraindications

4.1 Hypersensitivity Hypersensitivity to venlafaxine hydrochloride, desvenlafaxine succinate or to any excipients in the formulation. 4.2 Concomitant Use with Monoamine Oxidase Inhibitors (MAOIs) The use ...

5. Warnings and Precautions

5.1 Suicidal Thoughts and Behaviors in Children, Adolescents, and Young Adults Patients with major depressive disorder (MDD), both adult and pediatric, may experience worsening of their depression and/or ...

6. Adverse Reactions

The following adverse reactions are discussed in greater detail in other sections of the label: Hypersensitivity [see Contraindications (4.1)] Suicidal Thoughts and Behaviors in Children, Adolescents, ...

6.1. Clinical Trials Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of ...

7. Drug Interactions

7.1 Central Nervous System (CNS)-Active Drugs The risk of using venlafaxine in combination with other CNS-active drugs has not been systematically evaluated. Consequently, caution is advised when Effexor ...

8. Use in Specific Populations

8.6 Age and Gender A population pharmacokinetic analysis of 404 Effexor-treated patients from two studies involving both twice daily and three times daily regimens showed that dose-normalized trough plasma ...

8.1. Pregnancy

Teratogenic Effects – Pregnancy Category C Venlafaxine did not cause malformations in offspring of rats or rabbits given doses up to 2.5 times (rat) or 4 times (rabbit) the maximum recommended human daily ...

8.2. Labor and Delivery

The effect of venlafaxine on labor and delivery in humans is unknown.

8.3. Nursing Mothers

Venlafaxine and ODV have been reported to be excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from Effexor XR, a decision should be made whether to discontinue ...

8.4. Pediatric Use

Two placebo-controlled trials in 766 pediatric patients with MDD and two placebo-controlled trials in 793 pediatric patients with GAD have been conducted with Effexor XR, and the data were not sufficient ...

8.5. Geriatric Use

The percentage of patients in clinical studies for Effexor XR for MDD, GAD, SAD, and PD who were 65 years of age or older are shown in Table 15. Table 15. Percentage (and Number of Patients Studied) ...

9.1. Controlled Substance

Effexor XR is not a controlled substance.

9.2. Abuse

While venlafaxine has not been systematically studied in clinical studies for its potential for abuse, there was no indication of drug-seeking behavior in the clinical studies. However, it is not possible ...

9.3. Dependence

In vitro studies revealed that venlafaxine has virtually no affinity for opiate, benzodiazepine, phencyclidine (PCP), or N-methyl-D-aspartic acid (NMDA) receptors. Venlafaxine was not found to ...

10. Overdosage

10.1 Human Experience During the premarketing evaluations of Effexor XR (for MDD, GAD, SAD, and PD) and Effexor (for MDD), there were twenty reports of acute overdosage with Effexor (6 and 14 reports in ...

11. Description

Effexor XR is an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated ...

12.1. Mechanism of Action

The exact mechanism of the antidepressant action of venlafaxine in humans is unknown, but is thought to be related to the potentiation of serotonin and norepinephrine in the central nervous system, through ...

12.2. Pharmacodynamics

Venlafaxine and ODV have no significant affinity for muscarinic-cholinergic, H1-histaminergic, or α1-adrenergic receptors in vitro. Pharmacologic activity at these receptors ...

12.3. Pharmacokinetics

Steady-state concentrations of venlafaxine and ODV in plasma are attained within 3 days of oral multiple-dose therapy. Venlafaxine and ODV exhibited linear kinetics over the dose range of 75 to 450 mg ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis Tumors were not increased by venlafaxine treatment in mice or rats. Venlafaxine was given by oral gavage to mice for 18 months at doses up to 120 mg/kg per day, which was 1.7 times the maximum ...

14. Clinical Studies

14.1 Major Depressive Disorder The efficacy of Effexor XR (venlafaxine hydrochloride) extended-release capsules as a treatment for Major Depressive Disorder (MDD) was established in two placebo-controlled, ...

16.1. How Supplied

Effexor XR (venlafaxine hydrochloride) extended-release capsules are available as follows: 75 mg, peach cap and body with W and Effexor XR on the cap and 75 on the body. NDC 55289-277-30, bottle of 30 ...

16.2. Storage and Handling

Store at controlled room temperature, 20° to 25°C (68° to 77°F). The unit-of-use package is intended to be dispensed as a unit. The appearance of these capsules is a trademark of Wyeth Pharmaceuticals. ...

17. Patient Counseling Information

See FDA-approved patient labeling (Medication Guide). Prescribers or other healthcare professionals should inform patients, their families, and their caregivers about the benefits and risks associated ...