Venlafaxine Hydrochloride (Page 10 of 11)
14.4 Panic Disorder
The efficacy of venlafaxine hydrochloride extended-release capsules as a treatment for Panic Disorder (PD) was established in two double-blind, 12-week, multicenter, placebo-controlled studies in adult outpatients meeting DSM-IV criteria for PD, with or without agoraphobia. Patients received fixed doses of 75 or 150 mg per day in one study (study 1) and 75 or 225 mg per day in the other study (study 2).
Efficacy was assessed on the basis of outcomes in three variables: (1) percentage of patients free of full-symptom panic attacks on the Panic and Anticipatory Anxiety Scale (PAAS); (2) mean change from baseline to endpoint on the Panic Disorder Severity Scale (PDSS) total score; and (3) percentage of patients rated as responders (much improved or very much improved) on the Clinical Global Impressions (CGI) Improvement scale. In these two studies, venlafaxine hydrochloride extended-release capsules were statistically significantly more effective than placebo (for each fixed dose) on all three endpoints, but a dose-response relationship was not clearly established.
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.
In a longer term study (study 3), adult outpatients meeting DSM-IV criteria for PD who had responded during a 12-week open phase with venlafaxine hydrochloride extended-release capsules (75 to 225 mg per day) were randomly assigned to continue the same venlafaxine hydrochloride extended-release capsules dose (75, 150, or 225 mg) or switch to placebo for observation for relapse under double-blind conditions. Response during the open phase was defined as ≤ 1 full-symptom panic attack per week during the last 2 weeks of the open phase and a CGI Improvement score of 1 (very much improved) or 2 (much improved). Relapse during the double-blind phase was defined as having 2 or more full-symptom panic attacks per week for 2 consecutive weeks or having discontinued due to loss of effectiveness as determined by the investigators during the study. Randomized patients were in response status for a mean time of 34 days prior to being randomized. In the randomized phase following the 12-week open-label period, patients receiving continued venlafaxine hydrochloride extended-release capsules experienced a statistically significantly longer time to relapse.
a Odds ratio (drug to placebo) in terms of probability of free of full-symptom panic attacks based on logistic regression model. 95% CI: 95% confidence interval without adjusting for multiple dose arms. * Doses statistically significantly superior to placebo. | |||||||||||||||||||||||||||||||||||
Study Treatment Group Number | Primary Efficacy Measure: Whether Free of Full-symptom Panic Attacks | ||||||||||||||||||||||||||||||||||
Percent of Patients Free of Full Symptom Panic Attack | Adjusted Odds Ratio a to Placebo | Adjusted Odds Ratio a 95% Confidence Interval | |||||||||||||||||||||||||||||||||
Study 1 | Venlafaxine Hydrochloride Extended-Release Capsules 75 mg * | 54.1% (85/157) | 2. 268 | (1.43, 3.59) | |||||||||||||||||||||||||||||||
Venlafaxine Hydrochloride Extended-Release Capsules 150 mg * | 61.4% (97/158) | 3.035 | (1.91, 4.82) | ||||||||||||||||||||||||||||||||
Placebo | 34.4% (53/154) | — | — | ||||||||||||||||||||||||||||||||
Study 2 | Venlafaxine Hydrochloride Extended-Release Capsules 75 mg * | 64.1% (100/156) | 2.350 | (1.46, 3.78) | |||||||||||||||||||||||||||||||
Venlafaxine Hydrochloride Extended-Release Capsules 225 mg * | 70% (112/160) | 2.890 | (1.80, 4.64) | ||||||||||||||||||||||||||||||||
Placebo | 46.5% (73/157) | — | — |
16 HOW SUPPLIED/STORAGE AND HANDLING
Venlafaxine Hydrochlorid e Extended-Release Capsules USP , 37.5 mg are white to off white spherical to oval pellets filled in empty hard gelatin capsule shell (size ‘3’) of opaque grey color cap and opaque peach color body imprinted with “E” on cap and “73” on the body with edible black ink.
Bottles of 15 NDC 76420-630-15 (relabeled from NDC 65862-527-47)
Bottles of 30 NDC 76420-630-30 (repackaged from NDC 65862-527-xx)
Bottles of 60 NDC 76420-630-60 (repackaged from NDC 65862-527-xx)
Bottles of 90 NDC 76420-630-90 (repackaged from NDC 65862-527-xx)
Bottles of 100 NDC 76420-630-01 (relabeled from NDC 65862-527-01)
Venlafaxine Hydrochlorid
e Extended-Release Capsules USP , 75 mg are white to off white spherical to oval pellets filled in empty hard gelatin capsule shell (size ‘1’) of opaque peach color cap and opaque peach color body imprinted with “E” on cap and “74” on the body with edible black ink.
Bottles of 15 NDC 76420-631-15 (relabeled from NDC 65862-528-47)
Bottles of 30 NDC 76420-631-30 (repackaged from NDC 65862-528-xx)
Bottles of 60 NDC 76420-631-60 (repackaged from NDC 65862-528-xx)
Bottles of 90 NDC 76420-631-90 (repackaged from NDC 65862-528-xx)
Bottles of 10 NDC 76420-631-01 (relabeled from NDC 65862-528-01)
Venlafaxine Hydrochlorid
e Extended-Release Capsules USP , 150 mg are white to off white spherical to oval pellets filled in empty hard gelatin capsule shell (size ‘0’) of opaque dark orange color cap and opaque dark orange color body imprinted with “E” on cap and “89” on the body with edible black ink.
Bottles of 15 NDC 76420-632-15 (relabeled from NDC 65862-697-47)
Bottles of 30 NDC 76420-632-30 (repackaged from NDC 65862-697-xx)
Bottles of 60 NDC 76420-632-60 (repackaged from NDC 65862-697-xx)
Bottles of 90 NDC 76420-632-90 (repackaged from NDC 65862-697-xx)
Bottles of 100 NDC 76420-632-01 (relabeled from NDC 65862-697-01)
Store at
20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling ( Medication Guide).
Suicidal Thoughts and Behaviors
Advise patients and caregivers to look for the emergence of suicidality, especially early during treatment and when the dose is adjusted up or down, and instruct them to report such symptoms to the healthcare provider [see Boxed Warningand Warnings and Precautions (5.1)] .
Concomitant Medication
Instruct patients not to take venlafaxine hydrochloride extended-release capsules with an MAOI or within 14 days of stopping an MAOI [see Contraindications (4)].
Serotonin Syndrome
Caution patients about the risk of serotonin syndrome, particularly with the concomitant use of venlafaxine hydrochloride extended-release capsules with other serotonergic drugs including triptans, tricyclic antidepressants, opioids, lithium, tryptophan, buspirone, amphetamines, St. John’s Wort, and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid). Instruct patients to contact their healthcare provider or report to the emergency room if they experience signs or symptoms of serotonin syndrome [see Warnings and Precautions (5.2)and Drug Interactions (7.1)].
Elevated Blood Pressure
Advise patients that they should have regular monitoring of blood pressure when taking venlafaxine hydrochloride extended-release capsules [see Warnings and Precautions (5.3)] .
Increased Risk of Bleeding
Inform patients about the concomitant use of venlafaxine hydrochloride extended-release capsules with NSAIDs, aspirin, other antiplatelet drugs, warfarin, or other drugs that affect coagulation because the combined use has been associated with an increased risk of bleeding. Advise patients to inform their health care providers if they are taking or planning to take any prescription or over-the-counter medications that increase the risk of bleeding [see Warnings and Precautions (5.4)] .
Activation of Mania/Hypomania
Advise patients, their families and caregivers to observe for signs of activation of mania/hypomania and instruct them to report such symptoms to the healthcare provider [see Warnings and Precautions (5.6)] .
Cardiovascular/Cerebrovascular Disease
Caution is advised in administering venlafaxine hydrochloride extended-release capsules to patients with cardiovascular, cerebrovascular, or lipid metabolism disorders [see Adverse Reactions (6.1)] .
Serum Cholesterol and Triglyceride Elevation
Advise patients that elevations in total cholesterol, LDL and triglycerides may occur and that measurement of serum lipids may be considered [see Adverse Reactions (6.1)] .
Discontinuation Syndrome
Advise patients not to abruptly stop taking venlafaxine hydrochloride extended-release capsules without talking first with their healthcare provider. Patients should be aware that discontinuation effects may occur when stopping venlafaxine hydrochloride extended-release capsules and they should monitor for discontinuation symptoms [see Warnings and Precautions (5.7) and Adverse Reactions (6.1)] .
Sexual Dysfunction
Advise patients that use of venlafaxine hydrochloride extended-release capsules may cause symptoms of sexual dysfunction in both male and female patients. Inform patients that they should discuss any changes in sexual function and potential management strategies with their healthcare provider [see Warnings and Precautions (5.13)].
Interference with Cognitive and Motor Performance
Caution patients about operating hazardous machinery, including automobiles, until they are reasonably certain that venlafaxine hydrochloride extended-release capsules therapy does not adversely affect their ability to engage in such activities.
Alcohol
Advise patients to avoid alcohol while taking venlafaxine hydrochloride extended-release capsules [see Drug Interactions (7.2)] .
Allergic Reactions
Advise patients to notify their healthcare provider if they develop allergic phenomena such as rash, hives, swelling, or difficulty breathing [see Contraindications (4) and Adverse Reactions (6.2)] .
Pregnancy
Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with venlafaxine hydrochloride extended-release capsules. Advise patients that venlafaxine hydrochloride extended-release capsules use during mid to late pregnancy may lead to an increased risk for preeclampsia and may increase the risk for neonatal complications requiring prolonged hospitalization, respiratory support, and tube feeding. Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to venlafaxine hydrochloride extended-release capsules during pregnancy [see Use in Specific Populations (8.1)] .
Residual Spheroids
Venlafaxine hydrochloride extended-release capsule contains spheroids, which release the drug slowly into the digestive tract. The insoluble portion of these spheroids is eliminated, and patients may notice spheroids passing in the stool or via colostomy. Patients should be informed that the active medication has already been absorbed by the time the patient sees the spheroids.
Dispense with Medication Guide available at:
www.aurobindousa.com/medication-guides
Brands listed are trademarks of their respective owners. Relabeled and Repackaged by:
Enovachem PHARMACEUTICALS
Torrance, CA 90501
MEDICATION GUIDE Venlafaxine Hydrochloride Extended-Release Capsules, USP (ven” la fax’ een hye” droe klor’ ide) |
What is the most important information I should know about venlafaxine hydrochloride extended-release capsules? Venlafaxine hydrochloride extended-release capsules may cause serious side effects, including:
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What are venlafaxine hydrochloride extended-release capsules? Venlafaxine hydrochloride extended-release capsules are a prescription medicine used to treat adults with:
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Do not take venlafaxine hydrochloride extended-release capsules if you:
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Before taking venlafaxine hydrochloride extended-release capsules tell your healthcare provider about all your medical conditions, including if you:
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How should I take venlafaxine hydrochloride extended-release capsules?
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What should I avoid while taking venlafaxine hydrochloride extended-release capsules?
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What are the possible side effects of venlafaxine hydrochloride extended-release capsules? Venlafaxine hydrochloride extended-release capsules may cause serious side effects, including:
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How should I store venlafaxine hydrochloride extended-release capsules?
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General information about the safe and effective use of venlafaxine hydrochloride extended-release capsules. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use venlafaxine hydrochloride extended-release capsules for a condition for which it was not prescribed. Do not give venlafaxine hydrochloride extended-release capsules to other people, even if they have the same symptoms that you have. They may harm them. You can ask your healthcare provider or pharmacist for information about venlafaxine hydrochloride extended-release capsules that is written for healthcare professionals. |
What are the ingredients in venlafaxine hydrochloride extended-release capsules? Active ingredient: Venlafaxine hydrochloride
Inactive ingredients : Ethyl cellulose, hypromellose, sugar spheres, and talc. The empty hard gelatin capsule shells contain iron oxide red, gelatin, titanium dioxide, and sodium lauryl sulphate. In addition, the 37.5 mg empty hard gelatin capsule shells contain iron oxide black. The capsules are printed with edible ink containing black iron oxide and shellac.
Relabeled and Repackaged by: Enovachem PHARMACEUTICALS Torrance, CA 90501 |
This Medication was approved by the U.S. Food and Drug Administration.
Revised: 09/2023
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