Drugplain

Venlafaxine Hydrochloride ER 37.5 mg/1

Venlafaxine Hydrochloride · CAPSULE, EXTENDED RELEASE · Advanced Rx Pharmacy of Tennessee, LLC

No Recall History
Plain English

Venlafaxine Hydrochloride ER is a capsule, extended release containing venlafaxine hydrochloride at 37.5 mg/1, taken oral. Manufactured by Advanced Rx Pharmacy of Tennessee, LLC.

Key Facts

Brand Name
Venlafaxine Hydrochloride ER
Generic Name
Venlafaxine Hydrochloride
NDC Code (Product)
80425-0290
Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC
Strength
37.5 mg/1
Dosage Form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Marketing Status
Application #
ANDA214654
Marketing Start
03/24/2023

Recall History

No Recall History

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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. 1.4 Panic Disorder Venlafaxine Hydrochloride Extended-Release Capsules are indicated for the treatment of Panic Disorder (PD), with or without agoraphobia. Efficacy was established in two 12-week placebo-controlled trials.

Dosage & Administration

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). 2.1 Major Depressive Disorder For most patients, the recommended starting dose for venlafaxine hydrochloride extended-release capsules is 75 mg per day, administered in a single dose. For some patients, it may be desirable to start at 37.5 mg per day for 4 to 7 days to allow new patients to adjust to the medication before increasing to 75 mg per day. Patients not responding to the initial 75 mg per day dose may benefit from dose increases to a maximum of 225 mg per day. Dose increases should be in increments of up to 75 mg per day, as needed, and should …

Contraindications

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 Venlafaxine Hydrochloride Extended-Release Capsules is contraindicated because of an increased risk of serotonin syndrome. The use of Venlafaxine Hydrochloride Extended-Release Capsules within 14 days of discontinuing treatment with an MAOI (intended to treat psychiatric disorders) is also contraindicated [see Dosage and Administration ( 2.9), Warnings and Precautions ( 5.2), and Drug Interactions ( 7.2) ]. Starting Venlafaxine Hydrochloride Extended-Release Capsules in a patient who is being treated with an MAOI such as linezolid or intravenous methylene blue is also contraindicated, because of an increased risk of serotonin syndrome [see Dosage and Administration ( 2.9), Warnings and Precautions ( 5.2), and Drug Interactions ( 7.3) ].

Drug 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. 7.2 Monoamine Oxidase Inhibitors Adverse reactions, some of which were serious, have been reported in patients who have recently been discontinued from an MAOI and started on antidepressants with pharmacological properties similar to venlafaxine hydrochloride extended-release capsules (SNRIs or SSRIs), or who have recently had SNRI or SSRI therapy discontinued prior to initiation of an MAOI [see Dosage and Administration ( 2.9), Contraindications ( 4.2), and Warnings and Precautions ( 5.2) ]. 7.3 Serotonergic Drugs Based on the mechanism of action of venlafaxine hydrochloride extended-release capsules and the potential for serotonin syndrome, caution is advised when venlafaxine hydrochloride extended-release capsules are coadministered with other drugs that may affect the serotonergic neurotransmitter systems, such as triptans, SSRIs, other SNRIs, linezolid (an ant…

Adverse Reactions

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 Pediatric Patients [see Warnings and Precautions ( 5.10) ] Appetite Changes in Pediatric Patients [see Warnings and Precautions ( 5.11) ] Interstitial Lung Disease and Eosinophilic Pneumonia [see Warnings and Precautions ( 5.12) ] Sexual Dysfunction [see Warnings and Precautions ( 5.13)] 6.1 Clinical Studies Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates obse…

Frequently Asked Questions

What is Venlafaxine Hydrochloride ER used for?

Venlafaxine Hydrochloride ER contains Venlafaxine Hydrochloride. It is a capsule, extended release taken oral. Consult your doctor for specific uses.

Is Venlafaxine Hydrochloride ER a controlled substance?

Venlafaxine Hydrochloride ER is not classified as a controlled substance by the DEA.

What is the generic name for Venlafaxine Hydrochloride ER?

The generic name for Venlafaxine Hydrochloride ER is Venlafaxine Hydrochloride. There are 11 other brand versions of Venlafaxine Hydrochloride.

What is the NDC code for Venlafaxine Hydrochloride ER 37.5 mg/1?

The NDC (National Drug Code) for Venlafaxine Hydrochloride ER 37.5 mg/1 is 80425-0290, listed by Advanced Rx Pharmacy of Tennessee, LLC.

Product NDC

80425-0290

Package NDC

80425-0290-1

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)