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Venlafaxine Hydrochloride (Venlafaxine Hydrochloride)

Trade Name : Venlafaxine Hydrochloride

Mylan Pharmaceuticals Inc.

TABLET

Strength 25 mg/1

VENLAFAXINE HYDROCHLORIDE Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Venlafaxine Hydrochloride (Venlafaxine Hydrochloride) which is also known as Venlafaxine Hydrochloride and Manufactured by Mylan Pharmaceuticals Inc.. It is available in strength of 25 mg/1 per ml. Read more

Venlafaxine Hydrochloride (Venlafaxine Hydrochloride) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • (Each 25 mg, 37.5 mg, 50 mg, 75 mg and 100 mg tablet contains venlafaxine hydrochloride, USP equivalent to 25 mg, 37.5 mg, 50 mg, 75 mg or 100 mg venlafaxine, respectively)
  • Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of venlafaxine tablets or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Venlafaxine tablets are not approved for use in pediatric patients. (See , and .)
  • Venlafaxine hydrochloride is a structurally novel antidepressant for oral administration. It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (u00b1)-1-[u03b1-[(Dimethylamino)methyl]--methoxybenzyl] cyclohexanol hydrochloride and has the molecular formula of CHNO HCl. Its molecular weight is 313.87. The structural formula is shown below.
  • Venlafaxine hydrochloride, USP is a white to off-white crystalline solid with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43.
  • Each tablet contains venlafaxine hydrochloride equivalent to 25 mg, 37.5 mg, 50 mg, 75 mg, or 100 mg venlafaxine. Inactive ingredients consist of D&C Yellow No. 10 Aluminum Lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, sodium lauryl sulfate and sodium starch glycolate (potato).
  • No data
  • The efficacy of venlafaxine hydrochloride as a treatment for major depressive disorder was established in five placebo-controlled, short-term trials. Four of these were 6-week trials in adult outpatients meeting DSM-III or DSM-III-R criteria for major depression: two involving dose titration with venlafaxine hydrochloride in a range of 75 to 225 mg/day (t.i.d. schedule), the third involving fixed venlafaxine hydrochloride doses of 75, 225, and 375 mg/day (t.i.d. schedule), and the fourth involving doses of 25, 75, and 200 mg/day (b.i.d. schedule). The fifth was a 4-week study of adult inpatients meeting DSM-III-R criteria for major depression with melancholia whose venlafaxine hydrochloride doses were titrated in a range of 150 to 375 mg/day (t.i.d. schedule). In these five studies, venlafaxine was shown to be significantly superior to placebo on at least two of the following three measures: Hamilton Depression Rating Scale (total score), Hamilton depressed mood item, and Clinical Global Impression-Severity of Illness rating. Doses from 75 to 225 mg/day were superior to placebo in outpatient studies and a mean dose of about 350 mg/day was effective in inpatients. Data from the two fixed-dose outpatient studies were suggestive of a dose-response relationship in the range of 75 to 225 mg/day. There was no suggestion of increased response with doses greater than 225 mg/day.
  • While there were no efficacy studies focusing specifically on an elderly population, elderly patients were included among the patients studied. Overall, approximately 2/3 of all patients in these trials were women. Exploratory analyses for age and gender effects on outcome did not suggest any differential responsiveness on the basis of age or sex.
  • 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 mg, 150 mg, 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 u2264 3 and a HAM-D-21 total score of u2264 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 u2265 4 (moderately ill), (2) two consecutive CGI Severity of Illness item scores of u2265 4, or (3) a final CGI Severity of Illness item score of u2265 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 depression, recurrent type, who had responded (HAM-D-21 total score u2264 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 u2265 20; (2) no more than 2 HAM-D-21 total scores > 10; and (3) no single CGI Severity of Illness item score u2265 4 (moderately ill)] during an initial 26 weeks of treatment on venlafaxine hydrochloride (100 to 200 mg/day, on a b.i.d. schedule) were randomized to continuation of their same venlafaxine dose or to placebo. The follow-up period to observe patients for relapse, defined as a CGI Severity of Illness item score u2265 4, was for up to 52 weeks. Patients receiving continued venlafaxine treatment experienced significantly lower relapse rates over the subsequent 52 weeks compared with those receiving placebo.
  • Venlafaxine tablets are indicated for the treatment of major depressive disorder.
  • The efficacy of venlafaxine tablets in the treatment of major depressive disorder was established in 6-week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III or DSM-III-R category of major depression and in a 4-week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see ).
  • A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least four of the following eight symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation.
  • The efficacy of venlafaxine hydrochloride extended-release capsules in maintaining an antidepressant response for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of venlafaxine tablets in maintaining an antidepressant response in patients with recurrent depression who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see ). Nevertheless, the physician who elects to use venlafaxine tablets/venlafaxine hydrochloride extended-release capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.
  • Hypersensitivity to venlafaxine hydrochloride or to any excipients in the formulation.
  • The use of MAOIs intended to treat psychiatric disorders with venlafaxine or within 7 days of stopping treatment with venlafaxine is contraindicated because of an increased risk of serotonin syndrome. The use of venlafaxine within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated (see and ).
  • Starting venlafaxine in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome (see and ).
  • No data
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  • Venlafaxine Tablets, USP are available containing venlafaxine hydrochloride, USP equivalent to 25 mg, 37.5 mg, 50 mg, 75 mg or 100 mg of venlafaxine.
  • The 25 mg tablets are yellow, round, scored tablets debossed with above the score and below the score on one side of the tablet and on the other side. They are available as follows:
  • NDC 0378-4881-01bottles of 100 tablets
  • The 37.5 mg tablets are yellow, round, scored tablets debossed with above the score and below the score on one side of the tablet and on the other side. They are available as follows:
  • NDC 0378-4882-01bottles of 100 tablets
  • The 50 mg tablets are yellow, round, scored tablets debossed with above the score and below the score on one side of the tablet and on the other side. They are available as follows:
  • NDC 0378-4883-01bottles of 100 tablets
  • The 75 mg tablets are yellow, round, scored tablets debossed with above the score and below the score on one side of the tablet and blank on the other side. They are available as follows:
  • NDC 0378-4884-01bottles of 100 tablets
  • The 100 mg tablets are yellow, round, scored tablets debossed with above the score and below the score on one side of the tablet and blank on the other side. They are available as follows:
  • NDC 0378-4885-01bottles of 100 tablets
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F). [See USP Controlled Room Temperature.]
  • Protect from moisture.
  • Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
  • PHARMACIST:
  • Venlafaxine Tablets, USPn- (ven'' la fax' een)n- 25 mg, 37.5 mg, 50 mg, 75 mg and 100 mg
  • Read the Medication Guide that comes with venlafaxine tablets before you start taking them and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment. Talk with your healthcare provider if there is something you do not understand or want to learn more about.
  • What is the most important information I should know about venlafaxine tablets?
  • Venlafaxine tablets and other antidepressant medicines may cause serious side effects, including:
  • 1. Suicidal thoughts or actions:
  • Keep all follow-up visits with your healthcare provider and call between visits if you are worried about symptoms.
  • Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency, especially if they are new, worse, or worry you:
  • Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency. Venlafaxine tablets may be associated with these serious side effects:
  • 2. Serotonin Syndrome
  • This condition can be life threatening and may include:
  • 3. Changes in blood pressure.
  • 4. Enlarged pupils (mydriasis).
  • 5. Anxiety and insomnia.
  • 6. Changes in appetite or weight.
  • 7. Manic/hypomanic episodes:
  • 8. Low salt (sodium) levels in the blood.
  • 9. Seizures or convulsions.
  • 10. Abnormal bleeding
  • 11. Elevated cholesterol.
  • 12. Lung disease and pneumonia
  • 13. Severe allergic reactions:
  • 14. 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.
  • Do not stop venlafaxine tablets without first talking to your healthcare provider.
  • Stopping venlafaxine tablets too quickly or changing from another antidepressant too quickly may cause serious symptoms including:
  • What are venlafaxine tablets?
  • Venlafaxine tablets are a prescription medicine used to treat depression. It is important to talk with your healthcare provider about the risks of treating depression and also the risks of not treating it. You should discuss all treatment choices with your healthcare provider.
  • Talk to your healthcare provider if you do not think that your condition is getting better with venlafaxine tablet treatment.
  • Who should not take venlafaxine tablets?
  • Do not take venlafaxine tablets if you: n n
  • What should I tell my healthcare provider before taking venlafaxine tablets? Ask if you are not sure.
  • Before starting venlafaxine tablets, tell your healthcare provider if you:
  • Tell your healthcare provider about all the medicines that you take,
  • Your healthcare provider or pharmacist can tell you if it is safe to take venlafaxine tablets with your other medicines. Do not start or stop any medicine while taking venlafaxine tablets without talking to your healthcare provider first.
  • How should I take venlafaxine tablets?
  • What should I avoid while taking venlafaxine tablets?
  • Venlafaxine tablets can cause sleepiness or may affect your ability to make decisions, think clearly or react quickly. You should not drive, operate heavy machinery, or do other dangerous activities until you know how venlafaxine tablets affect you. Do not drink alcohol while using venlafaxine tablets.
  • What are the possible side effects of venlafaxine tablets?
  • Venlafaxine tablets may cause serious side effects, including:
  • Common possible side effects in people who take venlafaxine tablets includen
  • Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of venlafaxine tablets. For more information, ask your healthcare provider or pharmacist.
  • Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
  • How should I store venlafaxine tablets?
  • Keep venlafaxine tablets and all medicines out of the reach of children.
  • General information about venlafaxine tablets
  • Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use venlafaxine tablets for a condition for which they were not prescribed. Do not give venlafaxine tablets to other people, even if they have the same condition. They may harm them.
  • This Medication Guide summarizes the most important information about venlafaxine tablets. If you would like more information, talk with your healthcare provider. You may ask your healthcare provider or pharmacist for information about venlafaxine tablets that is written for healthcare professionals.
  • For more information, call Mylan at 1-877-446-3679 (1-877-4-INFO-RX).
  • What are the ingredients in venlafaxine tablets?
  • Active ingredient: venlafaxine hydrochloride
  • Inactive ingredients: D&C Yellow No. 10 Aluminum Lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, sodium lauryl sulfate and sodium starch glycolate (potato)
  • The brands mentioned in this Medication Guide are registered trademarks of their respective owners.
  • This Medication Guide has been approved by the U.S. Food and Drug Administration for all antidepressants.
  • Mylan Pharmaceuticals Inc.
  • Revised: 1/2019VNLA:R13m/MG:VNLA:R5m
  • PRINCIPAL DISPLAY PANEL - 25 mg
  • NDC 0378-4881-01
  • Venlafaxinen- Tablets, USPn- 25 mg
  • PHARMACIST: Dispense the accompanyingn- Medication Guide to each patient.
  • Rx only 100 Tablets
  • Each tablet contains venlafaxine hydrochloride, USP equivalent to 25 mg of venlafaxine.
  • Dispense in a tight, light-resistantcontainer as defined in the USPusing a child-resistant closure.
  • Keep container tightly closed.
  • Keep this and all medicationn- out of the reach of children.
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F).n- [See USP Controlled Roomn- Temperature.]
  • Protect from moisture.
  • Usual Dosage:
  • Mylan Pharmaceuticals Inc.
  • Mylan.com
  • RM4881A5
  • PRINCIPAL DISPLAY PANEL - 37.5 mg
  • NDC 0378-4882-01
  • Venlafaxinen- Tablets, USPn- 37.5 mg
  • PHARMACIST: Dispense the accompanyingn- Medication Guide to each patient.
  • Rx only 100 Tablets
  • Each tablet contains venlafaxine hydrochloride, USP equivalent to 37.5 mg of venlafaxine.
  • Dispense in a tight, light-resistantcontainer as defined in the USPusing a child-resistant closure.
  • Keep container tightly closed.
  • Keep this and all medicationn- out of the reach of children.
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F).n- [See USP Controlled Roomn- Temperature.]
  • Protect from moisture.
  • Usual Dosage:
  • Mylan Pharmaceuticals Inc.
  • Mylan.com
  • RM4882A5
  • PRINCIPAL DISPLAY PANEL - 50 mg
  • NDC 0378-4883-01
  • Venlafaxinen- Tablets, USPn- 50 mg
  • PHARMACIST: Dispense the accompanyingn- Medication Guide to each patient.
  • Rx only 100 Tablets
  • Each tablet contains venlafaxinehydrochloride, USP equivalent to 50 mg of venlafaxine.
  • Dispense in a tight, light-resistantcontainer as defined in the USPusing a child-resistant closure.
  • Keep container tightly closed.
  • Keep this and all medicationn- out of the reach of children.
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F).n- [See USP Controlled Roomn- Temperature.]
  • Protect from moisture.
  • Usual Dosage:
  • Mylan Pharmaceuticals Inc.
  • Mylan.com
  • RM4883A5
  • PRINCIPAL DISPLAY PANEL - 75 mg
  • NDC 0378-4884-01
  • Venlafaxinen- Tablets, USPn- 75 mg
  • PHARMACIST: Dispense the accompanyingn- Medication Guide to each patient.
  • Rx only 100 Tablets
  • Each tablet contains venlafaxine hydrochloride, USP equivalent to75 mg of venlafaxine.
  • Dispense in a tight, light-resistantcontainer as defined in the USPusing a child-resistant closure.
  • Keep container tightly closed.
  • Keep this and all medicationn- out of the reach of children.
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F).n- [See USP Controlled Roomn- Temperature.]
  • Protect from moisture.
  • Usual Dosage:
  • Mylan Pharmaceuticals Inc.
  • Mylan.com
  • RM4884A5
  • PRINCIPAL DISPLAY PANEL - 100 mg
  • NDC 0378-4885-01
  • Venlafaxinen- Tablets, USPn- 100 mg
  • PHARMACIST: Dispense the accompanyingn- Medication Guide to each patient.
  • Rx only 100 Tablets
  • Each tablet contains venlafaxine hydrochloride, USP equivalent to 100 mg of venlafaxine.
  • Dispense in a tight, light-resistantcontainer as defined in the USPusing a child-resistant closure.
  • Keep container tightly closed.
  • Keep this and all medicationn- out of the reach of children.
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F).n- [See USP Controlled Roomn- Temperature.]
  • Protect from moisture.
  • Usual Dosage:
  • Mylan Pharmaceuticals Inc.
  • Mylan.com
  • RM4885A5

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