Prescription Drug Information: VENLAFAXINE HYDROCHLORIDE (Page 8 of 8)

14 CLINICAL STUDIES

14.1 Major Depressive Disorder

The efficacy of venlafaxine hydrochloride extended-release capsules as a treatment for major depressive disorder was established in two placebo-controlled, short-term, flexible-dose studies in adult outpatients meeting DSM-III-R or DSM-IV criteria for major depressive disorder.

A 12-week study utilizing venlafaxine hydrochloride extended-release capsules doses in a range 75 to 150 mg/day (mean dose for completers was 136 mg/day) and an 8-week study utilizing venlafaxine hydrochloride extended-release capsules doses in a range 75 to 225 mg/day (mean dose for completers was 177 mg/day) both demonstrated superiority of venlafaxine hydrochloride extended-release capsules over placebo on the HAM-D total score, HAM-D Depressed Mood Item, the MADRS total score, the Clinical Global Impressions (CGI) Severity of Illness item, and the CGI Global Improvement item. In both studies, venlafaxine hydrochloride extended-release capsules were also significantly better than placebo for certain factors of the HAM-D, including the anxiety/somatization factor, the cognitive disturbance factor, and the retardation factor, as well as for the psychic anxiety score.

A 4-week study of inpatients meeting DSM-III-R criteria for major depressive disorder with melancholia utilizing venlafaxine hydrochloride immediate-release tablets in a range of 150 to 375 mg/day (t.i.d. schedule) demonstrated superiority of venlafaxine hydrochloride immediate-release tablets over placebo. The mean dose in completers was 350 mg/day.

Examination of gender subsets of the population studied did not reveal any differential responsiveness on the basis of gender.

In one longer-term study, adult outpatients meeting DSM-IV criteria for major depressive disorder who had responded during an 8-week open trial on venlafaxine hydrochloride extended-release capsules (75, 150, or 225 mg, qAM) were randomized to continuation of their same venlafaxine hydrochloride extended-release capsules dose or to placebo, for up to 26 weeks of observation for relapse.

Response during the open phase was defined as a CGI Severity of Illness item score of ≤3 and a HAM-D-21 total score of ≤10 at the day 56 evaluation. Relapse during the double-blind phase was defined as follows: (1) a reappearance of major depressive disorder as defined by DSM-IV criteria and a CGI Severity of Illness item score of ≥4 (moderately ill), (2) 2 consecutive CGI Severity of Illness item scores of ≥4, or (3) a final CGI Severity of Illness item score of ≥4 for any patient who withdrew from the study for any reason. Patients receiving continued venlafaxine hydrochloride extended-release capsules treatment experienced significantly lower relapse rates over the subsequent 26 weeks compared with those receiving placebo.

In a second longer-term trial, adult outpatients meeting DSM-III-R criteria for major depressive disorder, recurrent type, who had responded (HAM-D-21 total score ≤12 at the day 56 evaluation) and continued to be improved [defined as the following criteria being met for days 56 through 180: (1) no HAM-D-21 total score ≥20; (2) no more than 2 HAM-D-21 total scores >10, and (3) no single CGI Severity of Illness item score ≥4 (moderately ill)] during an initial 26 weeks of treatment on venlafaxine hydrochloride immediate-release tablets (100 to 200 mg/day, on a b.i.d. schedule) were randomized to continuation of their same dose of venlafaxine hydrochloride immediate-release tablets or to placebo. The follow-up period to observe patients for relapse, defined as a CGI Severity of Illness item score ≥4, was for up to 52 weeks. Patients receiving continued treatment with venlafaxine hydrochloride immediate-release tablets experienced significantly lower relapse rates over the subsequent 52 weeks compared with those receiving placebo.

14.2 Social Anxiety Disorder (Social Phobia)

The efficacy of venlafaxine hydrochloride extended-release capsules as a treatment for Social Anxiety Disorder (also known as Social Phobia) was established in two double-blind, parallel group, 12-week, multicenter, placebo-controlled, flexible-dose studies in adult outpatients meeting DSM-IV criteria for Social Anxiety Disorder. Patients received doses in a range of 75 to 225 mg/day. Efficacy was assessed with the Liebowitz Social Anxiety Scale (LSAS). In these two trials, venlafaxine hydrochloride extended-release capsules were significantly more effective than placebo on change from baseline to endpoint on the LSAS total score.

Examination of subsets of the population studied did not reveal any differential responsiveness on the basis of gender. There was insufficient information to determine the effect of age or race on outcome in these studies.

16 HOW SUPPLIED/STORAGE AND HANDLING

Venlafaxine extended-release tablets 37.5 mg are white to off white, film coated, round biconvex tablets printed with “392” in black ink. They are supplied as follows:

Unit of Use Bottles of 30 Tablets NDC 68001-496-04

Unit of Use Bottles of 90 Tablets NDC 68001-496-05

Venlafaxine extended-release tablets 75 mg are white to off white, film coated, round biconvex tablets printed with “393” in black ink. They are supplied as follows:

Unit of Use Bottles of 30 Tablets NDC 68001-497-04

Unit of Use Bottles of 90 Tablets NDC 68001-497-05

Venlafaxine extended-release tablets 150 mg are white to off white, film coated, round biconvex tablets printed with “394” in black ink. They are supplied as follows:

Unit of Use Bottles of 30 Tablets NDC 68001-498-04

Unit of Use Bottles of 90 Tablets NDC 68001-498-05

Venlafaxine extended-release tablets 225 mg are white to off white, film coated, round biconvex tablets printed with “395” in black ink. They are supplied as follows:

Unit of Use Bottles of 30 Tablets NDC 68001-499-04

Unit of Use Bottles of 90 Tablets NDC 68001-499-05

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Protect from moisture and humidity.

17 PATIENT COUNSELING INFORMATION

See FDA-approved Medication Guide (17.9)

Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with venlafaxine extended-release tablets and should counsel them in its appropriate use. A patient Medication Guide about “Antidepressant Medicines, Depression and Other Serious Mental Illness, and Suicidal Thoughts or Actions” is available for venlafaxine extended-release tablets. The prescriber or health professional should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents. Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have. The complete text of the Medication Guide is reprinted at the end of this document.

Patients should be advised of the following issues and asked to alert their prescriber if these occur while taking venlafaxine extended-release tablets.

17.1 Clinical Worsening and Suicide Risk

Patients, their families, and their caregivers should be encouraged to be alert to the emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, mania, other unusual changes in behavior, worsening of depression, and suicidal ideation, especially early during antidepressant treatment and when the dose is adjusted up or down. Families and caregivers of patients should be advised to look for the emergence of such symptoms on a day-to-day basis, since changes may be abrupt. Such symptoms should be reported to the patient’s prescriber or health professional, especially if they are severe, abrupt in onset, or were not part of the patient’s presenting symptoms. Symptoms such as these may be associated with an increased risk for suicidal thinking and behavior and indicate a need for very close monitoring and possibly changes in the medication.

17.2 Interference with Cognitive and Motor Performance

Clinical studies were performed to examine the effects of venlafaxine on behavioral performance of healthy individuals. The results revealed no clinically significant impairment of psychomotor, cognitive, or complex behavior performance. However, since any psychoactive drug may impair judgment, thinking, or motor skills, patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that venlafaxine therapy does not adversely affect their ability to engage in such activities.

17.3 Concomitant Medication

Patients should be advised to inform their physicians if they are taking, or plan to take, any prescription or over-the-counter drugs, including herbal preparations and nutritional supplements, since there is a potential for interactions.

Patients should be cautioned about the risk of serotonin syndrome with the concomitant use of venlafaxine extended-release tablets and triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, amphetamines, tryptophan, buspirone, and St. John’s Wort supplements or other serotonergic agents [ see Warnings and Precautions (5.2) and Drug Interactions (7.10) ].

Patients should be cautioned about the concomitant use of venlafaxine extended-release tablets and NSAID’s, aspirin, warfarin, or other drugs that affect coagulation since combined use of psychotropic drugs that interfere with serotonin reuptake and these agents has been associated with an increased risk of bleeding [ see Warnings and Precautions (5.13) and Drug Interactions (7.11) ].

17.4 Alcohol

Although venlafaxine has not been shown to increase the impairment of mental and motor skills caused by alcohol, patients should be advised to avoid alcohol while taking venlafaxine.

17.5 Allergic Reactions

Patients should be advised to notify their physician if they develop a rash, hives, or a related allergic phenomenon.

17.6 Pregnancy

Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during therapy.

17.7 Nursing

Patients should be advised to notify their physician if they are breast-feeding an infant.

17.8 Angle Closure Glaucoma

Patients should be advised that taking venlafaxine can cause mild pupillary dilation, which in susceptible individuals, can lead to an episode of angle closure glaucoma. Pre-existing glaucoma is almost always open-angle glaucoma because angle closure glaucoma, when diagnosed, can be treated definitively with iridectomy. Open-angle glaucoma is not a risk factor for angle closure glaucoma. Patients may wish to be examined to determine whether they are susceptible to angle closure, and have a prophylactic procedure (e.g., iridectomy), if they are susceptible. [see Warnings and Precautions (5.4)]

17.9 FDA-Approved Medication Guide

Manufactured by:

Ascent Pharmaceuticals, Inc.

Central Islip, NY 11722

For:

Blue Point Laboratories

RevIsion: 03/21

MEDICATION GUIDE

Venlafaxine Extended-Release Tablets

(ven-luh-fak-seen)

Antidepressant Medicines, Depression and Other Serious Mental Illnesses, and Suicidal Thoughts or Actions

Read the Medication Guide that comes with your or your family member’s antidepressant medicine. This Medication Guide is only about the risk of suicidal thoughts and actions with antidepressant medicines. Talk to your, or your family member’s, healthcare provider about:

  • all risks and benefits of treatment with antidepressant medicines
  • all treatment choices for depression or other serious mental illness

Who should not take venlafaxine extended-release tablets?

  • take a monoamine oxidase inhibitor (MAOI). Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including the antibiotic linezolid.
  • Do not take an MAOI within 7 days of stopping venlafaxine extended-release tablets unless directed to do so by your physician.
  • Do not start venlafaxine extended-release tablets if you stopped taking an MAOI in the last 2 weeks unless directed to do so by your physician.

What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions?

1. Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment.

2. Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a particularly high risk of having suicidal thoughts or actions. These include people who have (or have a family history of) bipolar illness (also called manic-depressive illness) or suicidal thoughts or actions.

3. How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member?

  • Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed.
  • Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings.
  • Keep all follow-up visits with the healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms.

Call a healthcare provider right away if you or your family member has any of the following symptoms, especially if they are new, worse, or worry you:

Symptoms Table
(click image for full-size original)

What else do I need to know about antidepressant medicines?

  • Never stop an antidepressant medicine without first talking to a healthcare provider.

Stopping an antidepressant medicine suddenly can cause other symptoms.

  • Visual Problems. Only some people are at risk for these problems. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are.
  • Antidepressants are medicines used to treat depression and other illnesses. It is important to discuss all the risks of treating depression and also the risks of not treating it. Patients and their families or other caregivers should discuss all treatment choices with the healthcare provider, not just the use of antidepressants.
  • Antidepressant medicines have other side effects. Talk to the healthcare provider about the side effects of the medicine prescribed for you or your family member.
  • Antidepressant medicines can interact with other medicines. Know all of the medicines that you or your family member takes. Keep a list of all medicines to show the healthcare provider. Do not start new medicines without first checking with your healthcare provider.
  • Not all antidepressant medicines prescribed for children are FDA approved for use in children. Talk to your child’s healthcare provider for more information.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Medication Guide available at http://camberpharma.com/medication-guides

This Medication Guide has been approved by the U.S. Food and Drug Administration for all antidepressants.

Manufactured by:

Ascent Pharmaceuticals, Inc.

Central Islip, NY 11722

Manufactured for:

Blue Point Laboratories

Rev: 03/21

37.5 mg 30 count

37.5 mg 30 count
(click image for full-size original)

75 mg 30 count

75mg 30 count
(click image for full-size original)

150 mg 30 count

150mg 30 count
(click image for full-size original)

225 mg 30 count

225mg 30 count
(click image for full-size original)
VENLAFAXINE HYDROCHLORIDE
venlafaxine tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68001-496
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VENLAFAXINE HYDROCHLORIDE (VENLAFAXINE) VENLAFAXINE 37.5 mg
Inactive Ingredients
Ingredient Name Strength
MANNITOL
MICROCRYSTALLINE CELLULOSE
POVIDONE
POLYETHYLENE GLYCOL 400
POLYETHYLENE GLYCOL 8000
POLYETHYLENE GLYCOL 3350
SILICON DIOXIDE
MAGNESIUM STEARATE
CELLULOSE ACETATE
HYPROMELLOSES
TITANIUM DIOXIDE
TALC
PROPYLENE GLYCOL
FERROSOFERRIC OXIDE
Product Characteristics
Color white Score no score
Shape ROUND Size 6mm
Flavor Imprint Code 392
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68001-496-04 30 TABLET, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:68001-496-05 90 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA214419 04/30/2021
VENLAFAXINE HYDROCHLORIDE
venlafaxine tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68001-497
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VENLAFAXINE HYDROCHLORIDE (VENLAFAXINE) VENLAFAXINE 75 mg
Inactive Ingredients
Ingredient Name Strength
MANNITOL
MICROCRYSTALLINE CELLULOSE
POVIDONE
POLYETHYLENE GLYCOL 400
SILICON DIOXIDE
MAGNESIUM STEARATE
CELLULOSE ACETATE
HYPROMELLOSES
POLYETHYLENE GLYCOL 3350
TITANIUM DIOXIDE
TALC
FERROSOFERRIC OXIDE
PROPYLENE GLYCOL
POLYETHYLENE GLYCOL 8000
Product Characteristics
Color white Score no score
Shape ROUND Size 7mm
Flavor Imprint Code 393
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68001-497-04 30 TABLET, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:68001-497-05 90 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA214419 04/30/2021
VENLAFAXINE HYDROCHLORIDE
venlafaxine tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68001-498
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VENLAFAXINE HYDROCHLORIDE (VENLAFAXINE) VENLAFAXINE 150 mg
Inactive Ingredients
Ingredient Name Strength
MANNITOL
MICROCRYSTALLINE CELLULOSE
POVIDONE
POLYETHYLENE GLYCOL 400
SILICON DIOXIDE
MAGNESIUM STEARATE
CELLULOSE ACETATE
HYPROMELLOSES
POLYETHYLENE GLYCOL 3350
POLYETHYLENE GLYCOL 8000
TITANIUM DIOXIDE
TALC
FERROSOFERRIC OXIDE
PROPYLENE GLYCOL
Product Characteristics
Color white Score no score
Shape ROUND Size 9mm
Flavor Imprint Code 394
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68001-498-04 30 TABLET, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:68001-498-05 90 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA214419 04/30/2021
VENLAFAXINE HYDROCHLORIDE
venlafaxine tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68001-499
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VENLAFAXINE HYDROCHLORIDE (VENLAFAXINE) VENLAFAXINE 225 mg
Inactive Ingredients
Ingredient Name Strength
MANNITOL
MICROCRYSTALLINE CELLULOSE
POVIDONE
POLYETHYLENE GLYCOL 400
POLYETHYLENE GLYCOL 3350
POLYETHYLENE GLYCOL 8000
SILICON DIOXIDE
MAGNESIUM STEARATE
CELLULOSE ACETATE
HYPROMELLOSES
TITANIUM DIOXIDE
TALC
FERROSOFERRIC OXIDE
PROPYLENE GLYCOL
Product Characteristics
Color white Score no score
Shape ROUND Size 10mm
Flavor Imprint Code 395
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68001-499-04 30 TABLET, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:68001-499-05 90 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA214419 04/30/2021
Labeler — BluePoint Laboratories (985523874)
Establishment
Name Address ID/FEI Operations
Ascent Pharmaceuticals, Inc. 080938961 analysis (68001-496), analysis (68001-497), analysis (68001-498), analysis (68001-499), manufacture (68001-496), manufacture (68001-497), manufacture (68001-498), manufacture (68001-499), pack (68001-496), pack (68001-497), pack (68001-498), pack (68001-499), label (68001-496), label (68001-497), label (68001-498), label (68001-499)

Revised: 05/2021 BluePoint Laboratories

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