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.

Table 21: Primary Efficacy Results for Studies in Panic Disorder in Adults (Studies 1 and 2)
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:
  • Increased risk of suicidal thoughts and actions. Venlafaxine hydrochloride extended-release capsules and other antidepressant medicines may increase suicidal thoughts and actions in some children, adolescents, and young adults, especially within the first few months of treatment or when the dose is changed. Venlafaxine hydrochloride extended-release capsules are not for use in children.
    • Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions.
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 your healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings.
  • Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you have concerns about symptoms.
Call your healthcare provider or get emergency help right away if you or a family member have any of the following symptoms, especially if they are new, worse, or worry you:
  • attempts to commit suicide
  • acting aggressive, being angry, or violent
  • new or worse depression
  • panic attacks
  • new or worse irritability
  • an extreme increase in activity or talking (mania)
  • thoughts about suicide or dying
  • acting on dangerous impulses
  • new or worse anxiety
  • feeling very agitated or restless
  • trouble sleeping
  • other unusual changes in behavior or mood
What are venlafaxine hydrochloride extended-release capsules? Venlafaxine hydrochloride extended-release capsules are a prescription medicine used to treat adults with:
  • a certain type of depression called Major Depressive Disorder (MDD)
  • Generalized Anxiety Disorder (GAD)
  • Social Anxiety Disorder (SAD)
  • Panic Disorder (PD)
It is not known if venlafaxine hydrochloride extended-release capsules are safe and effective for use in children.
Do not take venlafaxine hydrochloride extended-release capsules if you:
  • are allergic to venlafaxine hydrochloride, desvenlafaxine succinate, or any of the ingredients in venlafaxine hydrochloride extended-release capsules. See the end of this Medication Guide for a complete list of ingredients in venlafaxine hydrochloride extended-release capsules.
  • take a Monoamine Oxidase Inhibitor (MAOI)
  • have stopped taking an MAOI in the last 14 days
  • are being treated with the antibiotic linezolid or intravenous methylene blue
Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including MAOIs such as linezolid or intravenous methylene blue. Do not start taking an MAOI for at least 7 days after you stop treatment with venlafaxine hydrochloride extended-release capsules.
Before taking venlafaxine hydrochloride extended-release capsules tell your healthcare provider about all your medical conditions, including if you:
  • have, or have a family history of suicide, bipolar disorder, depression, mania or hypomania
  • have high blood pressure
  • have heart problems
  • have cerebrovascular problems or had a stroke
  • have or have had bleeding problems
  • have high pressure in the eye (glaucoma)
  • have high cholesterol or high triglycerides
  • have kidney or liver problems
  • have or had seizures or convulsions
  • have low sodium levels in your blood
  • have lung problems
  • drink alcohol
  • are pregnant or plan to become pregnant. Venlafaxine hydrochloride extended-release capsules may harm your unborn baby. Talk to your healthcare provider about the risk to you and your unborn baby if you take venlafaxine hydrochloride extended-release capsules during pregnancy.
    • Tell your healthcare provider if you become pregnant or think you are pregnant during treatment with venlafaxine hydrochloride extended-release capsules.
    • Pregnancy Exposure Registry. There is a pregnancy registry for women who are exposed to venlafaxine hydrochloride extended-release capsules during pregnancy. The purpose of the registry is to collect information about the health of you and your baby. If you become pregnant during treatment with venlafaxine hydrochloride extended-release capsules, talk to your healthcare provider about registering with the National Pregnancy Registry for Antidepressants. You can register by calling 1-844-405-­6185 or by visiting online at https://womensmentalhealth.org/research/pregnancyregistry/antidepressants.
  • are breastfeeding or plan to breastfeed. Venlafaxine hydrochloride passes into your breast milk and may harm your baby. Talk to your healthcare provider about the best way to feed your baby during treatment with venlafaxine hydrochloride extended-release capsules.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Venlafaxine hydrochloride extended-release capsules and other medicines may affect each other causing possible serious side effects. Venlafaxine hydrochloride extended-release capsules may affect the way other medicines work and other medicines may affect the way venlafaxine hydrochloride extended-release capsules work. Especially tell your healthcare provider if you take:
  • medicines to treat migraine headaches known as triptans
  • tricyclic antidepressants
  • lithium
  • tramadol, fentanyl, meperidine, methadone, or other opioids
  • tryptophan
  • buspirone
  • amphetamines
  • St. John’s Wort
  • phentermine
  • other medicines containing desvenlafaxine or venlafaxine
  • medicines that can affect blood clotting such as aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), warfarin
Ask your healthcare provider if you are not sure if you are taking any of these medicines. Your healthcare provider can tell you if it is safe to take venlafaxine hydrochloride extended-release capsules with your other medicines. Do not start or stop any other medicines during treatment with venlafaxine hydrochloride extended-release capsules without first talking to your healthcare provider. Stopping venlafaxine hydrochloride extended-release capsules suddenly may cause you to have serious side effects. See “What are the possible side effects of venlafaxine hydrochloride extended-release capsules?” Know the medicines you take. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine.
How should I take venlafaxine hydrochloride extended-release capsules?
  • Take venlafaxine hydrochloride extended-release capsules exactly as your healthcare provider tells you to. Do not change your dose or stop taking venlafaxine hydrochloride extended-release capsules without first talking to your healthcare provider.
  • Your healthcare provider may need to change the dose of venlafaxine hydrochloride extended-release capsules until it is the right dose for you.
  • Take venlafaxine hydrochloride extended-release capsules 1 time each day with food.
  • Venlafaxine hydrochloride extended-release capsules may be taken either in the morning or in the evening, but take it the same way each time.
  • Swallow venlafaxine hydrochloride extended-release capsules whole with fluid. Do not divide, crush, chew, or dissolve venlafaxine hydrochloride extended-release capsules.
  • If you cannot swallow venlafaxine hydrochloride extended-release capsules whole, the venlafaxine hydrochloride extended-release capsules may be opened and the entire contents sprinkled on a spoonful of applesauce.
    • Swallow the venlafaxine hydrochloride extended-release capsules and applesauce mixture right away without chewing.
    • Follow with a glass of water to make sure you have swallowed all of the venlafaxine hydrochloride extended-release pellets.
  • If you take too much venlafaxine hydrochloride, call your healthcare provider or poison control center at 1-800-222-1222 or go to the nearest hospital emergency room right away.
What should I avoid while taking venlafaxine hydrochloride extended-release capsules?
  • Do not drive, or operate heavy machinery, or do other dangerous activities until you know how venlafaxine hydrochloride extended-release capsules affect you. Venlafaxine hydrochloride extended-release capsules can make you drowsy.
  • You should not drink alcohol during treatment with venlafaxine hydrochloride extended-release capsules. Drinking alcohol during treatment with venlafaxine hydrochloride extended-release capsules can increase your risk of having serious side effects.
What are the possible side effects of venlafaxine hydrochloride extended-release capsules? Venlafaxine hydrochloride extended-release capsules may cause serious side effects, including:
  • See “What is the most important information I should know about venlafaxine hydrochloride extended-release capsules?”
  • Serotonin syndrome. Taking venlafaxine hydrochloride extended-release capsules can cause a potentially life-threatening problem called serotonin syndrome. The risk of developing serotonin syndrome is increased when venlafaxine hydrochloride extended-release capsules are taken with certain other medicines. See “Do not take venlafaxine hydrochloride extended-release capsules if you:” Stop taking venlafaxine hydrochloride extended-release capsules and call your healthcare provider or go to the nearest hospital emergency room right away if you have any of the following signs and symptoms of serotonin syndrome:
    • agitation
    • confusion
    • fast heartbeat
    • dizziness
    • flushing
    • tremors, stiff muscles, or muscle twitching
    • seizures
    • seeing or hearing things that are not real (hallucinations)
    • coma
    • changes in blood pressure
    • sweating
    • high body temperature (hyperthermia)
    • loss of coordination
    • nausea, vomiting, diarrhea
  • Increases in blood pressure. Your healthcare provider should check your blood pressure before starting treatment and regularly during treatment with venlafaxine hydrochloride extended-release capsules. If you have high blood pressure, it should be controlled before you start treatment with venlafaxine hydrochloride extended-release capsules.
  • Increased risk of bleeding. Taking venlafaxine hydrochloride extended-release capsules with aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), or blood thinners may add to this risk. Tell your healthcare provider right away about any unusual bleeding or bruising.
  • Eye problems (angle-closure glaucoma). Venlafaxine hydrochloride extended-release capsules may cause a certain type of eye problem called angle-closure glaucoma. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are. Call your healthcare provider if you have eye pain, changes in your vision, or swelling or redness in or around the eye.
  • Manic episodes. Manic episodes may happen in people with bipolar disorder who take venlafaxine hydrochloride extended-release capsules. Symptoms may include:
    • greatly increased energy
    • racing thoughts
    • unusually grand ideas
    • talking more or faster than usual
    • severe trouble sleeping
    • reckless behavior
    • excessive happiness or irritability
  • Discontinuation syndrome. Suddenly stopping venlafaxine hydrochloride extended-release capsules may cause you to have serious side effects. Your healthcare provider may want to decrease your dose slowly. Symptoms may include:
    • dizziness
    • irritability and agitation
    • anxiety
    • sweating
    • seizures
    • ringing in your ears (tinnitus)
    • nausea
    • problems sleeping
    • tiredness
    • confusion
    • electric shock sensation (paresthesia)
    • headache
    • diarrhea
    • abnormal dreams
    • changes in your mood
    • hypomania
  • Seizures (convulsions).
  • Low sodium levels in your blood (hyponatremia). Low sodium levels can happen during treatment with venlafaxine hydrochloride extended-release capsules. Low sodium levels in your blood may be serious and may cause death. Elderly people may be at greater risk for this. Signs and symptoms of low sodium levels in your blood may include:
    • headache
    • difficulty concentrating
    • memory changes
    • confusion
    • weakness and unsteadiness on your feet which can lead to falls
In severe or more sudden cases, signs and symptoms include:
  • hallucinations (seeing or hearing things that are not real)
  • fainting
  • seizures
  • coma
  • respiratory arrest
  • Lung problems. Some people who have taken the medicine venlafaxine, which is the same kind of medicine as the medicine in venlafaxine hydrochloride extended-release capsules, have had lung problems. Symptoms of lung problems include difficulty breathing, cough, or chest discomfort. Tell your healthcare provider right away if you have any of these symptoms.
  • Sexual problems (dysfunction). Taking selective serotonin reuptake inhibitors (SNRIs), including venlafaxine hydrochloride extended-release capsules, may cause sexual problems.
Symptoms in males may include:
  • delayed ejaculation or inability to have an ejaculation
  • decreased sex drive
  • problems getting or keeping an erection
Symptoms in females may include:
  • decreased sex drive
  • delayed orgasm or inability to have an orgasm
Talk to your healthcare provider if you develop any changes in your sexual function or if you have any questions or concerns about sexual problems during treatment with venlafaxine hydrochloride extended-release capsules. There may be treatments your healthcare provider can suggest. Your healthcare provider may tell you to stop taking venlafaxine hydrochloride extended-release capsules if you develop serious side effects during treatment with venlafaxine hydrochloride extended-release capsules. The most common side effects of venlafaxine hydrochloride extended-release capsules include:
  • nausea
  • dry mouth
  • male and female sexual problems
  • loss of appetite (anorexia)
  • sleepiness
  • sweating
  • constipation
These are not all the possible side effects of venlafaxine hydrochloride extended-release capsules. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store venlafaxine hydrochloride extended-release capsules?
  • Store venlafaxine hydrochloride extended-release capsules at room temperature between 20° to 25°C (68° to 77°F).
  • Keep venlafaxine hydrochloride extended-release capsules in a dry place.
Keep venlafaxine hydrochloride extended-release capsules and all medicines out of the reach of children.
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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