Venlafaxine Hcl
Generic Name: venlafaxine hcl
Brand Names:
Venlafaxine Hcl Er
11. Description Venlafaxine hydrochloride extended-release capsules USP are an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, a SNRI. Venlafaxine is designated Cyclohexanol,1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl]-, hydrochloride or (±)-1-[α-[(dimethylamino)methyl]-p-methoxybenzyl]cyclohexanol hydrochloride and has the empirical formula of C 17H 27NO 2 HCl. Its molecular weight is 313.9.
Overview
11. Description Venlafaxine hydrochloride extended-release capsules USP are an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, a SNRI. Venlafaxine is designated Cyclohexanol,1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl]-, hydrochloride or (±)-1-[α-[(dimethylamino)methyl]-p-methoxybenzyl]cyclohexanol hydrochloride and has the empirical formula of C 17H 27NO 2 HCl. Its molecular weight is 313.9.
Uses
1. Indications and Usage 1.1 Major Depressive Disorder Venlafaxine hydrochloride extended-release capsules are indicated for the treatment of major depressive disorder (MDD). Efficacy was established in three short-term (4, 8, and 12 weeks) and two long-term, maintenance trials. 1.2 Generalized Anxiety Disorder Venlafaxine hydrochloride extended-release capsules are indicated for the treatment of Generalized Anxiety Disorder (GAD). Efficacy was established in two 8-week and two 26-week placebo-controlled trials. 1.3 Social Anxiety Disorder Venlafaxine hydrochloride extended-release capsules are indicated for the treatment of Social Anxiety Disorder (SAD), also known as social phobia. Efficacy was established in four 12-week and one 26-week, placebo-controlled trials.
Dosage
2. Dosage and Administration Venlafaxine hydrochloride extended-release capsules 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 be swallowed whole with fluid and not divided, crushed, chewed, or placed in water or it may 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
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, and Adults [see Warnings and Precautions ( 5.1)] • Serotonin Syndrome [see Warnings and Precautions ( 5.2)] • Elevations in Blood Pressure [see Warnings and Precautions ( 5.3)] • Abnormal 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 Pediatri...
Interactions
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 venlafaxine hydrochloride extended-release capsules are taken in combination with other CNS-active drugs.
Warnings
Boxed Warning 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 not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a reduction in risk with antidepressant use in patients aged 65 and older [see Warnings and Precautions ( 5.1)]. 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 the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. Suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide. 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 of MAOIs (intended to treat psychiatric disorders) concomitantly with venlafaxine hydrochloride extended-release capsules or within 7 days of discontinuing treatment with venla...
Storage
16. How Supplied/Storage and Handling Venlafaxine hydrochloride extended-release capsules USP, 150 mg are white to off white colored, round to oval shaped pellets filled in size '0' hard Gelatin capsules with orange opaque cap imprinted with 'V' in black color, white opaque body imprinted with '11' in black color.
Frequently Asked Questions
What is Venlafaxine Hcl used for?▼
1. Indications and Usage 1.1 Major Depressive Disorder Venlafaxine hydrochloride extended-release capsules are indicated for the treatment of major depressive disorder (MDD). Efficacy was established in three short-term (4, 8, and 12 weeks) and two long-term, maintenance trials. 1.2 Generalized Anxiety Disorder Venlafaxine hydrochloride extended-release capsules are indicated for the treatment of Generalized Anxiety Disorder (GAD). Efficacy was established in two 8-week and two 26-week placebo-controlled trials. 1.3 Social Anxiety Disorder Venlafaxine hydrochloride extended-release capsules are indicated for the treatment of Social Anxiety Disorder (SAD), also known as social phobia. Efficacy was established in four 12-week and one 26-week, placebo-controlled trials.
What are the side effects of Venlafaxine Hcl?▼
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, and Adults [see Warnings and Precautions ( 5.1)] • Serotonin Syndrome [see Warnings and Precautions ( 5.2)] • Elevations in Blood Pressure [see Warnings and Precautions ( 5.3)] • Abnormal 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 Pediatri...
What are the important warnings for Venlafaxine Hcl?▼
Boxed Warning 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 not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a reduction in risk with antidepressant use in patients aged 65 and older [see Warnings and Precautions ( 5.1)]. 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 the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. Suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide. 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 of MAOIs (intended to treat psychiatric disorders) concomitantly with venlafaxine hydrochloride extended-release capsules or within 7 days of discontinuing treatment with venla...
Related Medications
Brodalumab
brodalumab
Dosage form: INJECTION. Active ingredients: BRODALUMAB (210 mg/1). Category: DRUG FOR FURTHER PROCESSING.
Propylene Glycol,arginine,lactic Acid,salicylic Acid,glycolic Acid
propylene glycol,arginine,lactic acid,salicylic acid,glycolic acid
Reduce acne scars and blemishes Even skin tone Refine and smooth the skin’s surface Leave the skin more radiant
American Red Cross 6 Oz, 3% Hydrogen Peroxide Spray
american red cross 6 oz, 3% hydrogen peroxide spray
USES First aid to help prevent the risk of infection in minor cuts, scrapes and burns
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.