Venlafaxine Hcl Er
Generic Name: venlafaxine hcl er
Brand Names:
Venlafaxine Hcl Er
Venlafaxine hydrochloride extended-release capsule USP is an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride USP, a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the molecular formula of C17H27NO2HCl. Its molecular weight is 313.86.
Overview
Venlafaxine hydrochloride extended-release capsule USP is an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride USP, a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the molecular formula of C17H27NO2HCl. Its molecular weight is 313.86.
Uses
Venlafaxine hydrochloride extended-release capsules are indicated in adults for the treatment of: Major Depressive Disorder (MDD) [see CLINICAL STUDIES (14.1)] Generalized Anxiety Disorder (GAD) [see CLINICAL STUDIES (14.2)] Social Anxiety Disorder (SAD) [see CLINICAL STUDIES (14.3)] Panic Disorder (PD) [see CLINICAL STUDIES (14.4)]
Dosage
2.1 General Administration Information Administer venlafaxine hydrochloride extended-release capsules as 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)]. Swallow capsules whole with fluid. Do not divide, crush, chew, or place in water. The capsule may also be administered by carefully opening the capsule and sprinkling the entire contents on a spoonful of applesauce. This drug/food mixture should be swallowed immediately without chewing and followed with a glass of water to ensure complete swallowing of the pellets (spheroids).
Side Effects
The following adverse reactions are discussed in more detail in other sections of the labeling: Hypersensitivity [see CONTRAINDICATIONS (4)] Suicidal Thoughts and Behaviors in Adolescents and Young Adults [see WARNINGS AND PRECAUTIONS (5.1)] Serotonin Syndrome [see WARNINGS AND PRECAUTIONS (5.2)] Elevated Blood Pressure [see WARNINGS AND PRECAUTIONS (5.3)] Increased Risk of Bleeding [see WARNINGS AND PRECAUTIONS (5.4)] Angle Closure Glaucoma [see WARNINGS AND PRECAUTIONS (5.5)] Activation of Mania/Hypomania [see WARNINGS AND PRECAUTIONS (5.6)] Discontinuation Syndrome [see WARNINGS AND PRECAUTIONS (5.7)] Seizure [see WARNINGS AND PRECAUTIONS (5.8)] Hyponatremia [see WARNINGS AND PRECAUTIONS (5.9)] Weight and Height changes in Pediatric Patients [see WARNINGS AND PRECAUTIONS (5.10)] Appetit...
Interactions
7.1 Drugs Having Clinically Important Interactions with Venlafaxine Hydrochloride Extended-Release Capsules Table 15: Clinically Important Drug Interactions with Venlafaxine Hydrochloride Extended-Release Capsules Monoamine Oxidase Inhibitors (MAOI) Clinical Impact The concomitant use of SNRIs, including venlafaxine hydrochloride extended-release capsules, with MAOIs increases the risk of serotonin syndrome.
Warnings
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 hydrochloride extended-release capsules are not approved for use in pediatric patients [see USE IN SPECIFIC POPULATIONS (8.4)]. 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. Venlafaxine hydrochloride extended-release capsules are contraindicated in patients: with known hypersensitivity to venlafaxine hydrochloride, desvenlafaxine succinate or to any excipients in the formulation [see ADVERSE REACTIONS (6.2)].
Storage
Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]
Frequently Asked Questions
What is Venlafaxine Hcl Er used for?▼
Venlafaxine hydrochloride extended-release capsules are indicated in adults for the treatment of: Major Depressive Disorder (MDD) [see CLINICAL STUDIES (14.1)] Generalized Anxiety Disorder (GAD) [see CLINICAL STUDIES (14.2)] Social Anxiety Disorder (SAD) [see CLINICAL STUDIES (14.3)] Panic Disorder (PD) [see CLINICAL STUDIES (14.4)]
What are the side effects of Venlafaxine Hcl Er?▼
The following adverse reactions are discussed in more detail in other sections of the labeling: Hypersensitivity [see CONTRAINDICATIONS (4)] Suicidal Thoughts and Behaviors in Adolescents and Young Adults [see WARNINGS AND PRECAUTIONS (5.1)] Serotonin Syndrome [see WARNINGS AND PRECAUTIONS (5.2)] Elevated Blood Pressure [see WARNINGS AND PRECAUTIONS (5.3)] Increased Risk of Bleeding [see WARNINGS AND PRECAUTIONS (5.4)] Angle Closure Glaucoma [see WARNINGS AND PRECAUTIONS (5.5)] Activation of Mania/Hypomania [see WARNINGS AND PRECAUTIONS (5.6)] Discontinuation Syndrome [see WARNINGS AND PRECAUTIONS (5.7)] Seizure [see WARNINGS AND PRECAUTIONS (5.8)] Hyponatremia [see WARNINGS AND PRECAUTIONS (5.9)] Weight and Height changes in Pediatric Patients [see WARNINGS AND PRECAUTIONS (5.10)] Appetit...
What are the important warnings for Venlafaxine Hcl Er?▼
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 hydrochloride extended-release capsules are not approved for use in pediatric patients [see USE IN SPECIFIC POPULATIONS (8.4)]. 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. Venlafaxine hydrochloride extended-release capsules are contraindicated in patients: with known hypersensitivity to venlafaxine hydrochloride, desvenlafaxine succinate or to any excipients in the formulation [see ADVERSE REACTIONS (6.2)].
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.