Venlafaxine Hydrochloride (Venlafaxine Hydrochloride)

Trade Name : Venlafaxine Hydrochloride

Teva Pharmaceuticals USA, 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 Teva Pharmaceuticals USA, 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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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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  • Suicidality and Antidepressant Drugs
  • 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 WARNINGS, Clinical Worsening and Suicide Risk; PRECAUTIONS, Information for Patients; and PRECAUTIONS, Pediatric Use).
  • Venlafaxine hydrochloride, USP is a structurally novel antidepressant for oral administration. It is designated (/)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (u00b1)-1-[u03b1-[(dimethylamino)methyl]--methoxybenzyl]cyclohexanol hydrochloride. The structural formula is shown below.
  • CHNOu2022HCl M.W. 313.87
  • 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.
  • Compressed tablets contain venlafaxine hydrochloride, USP equivalent to 25 mg, 37.5 mg, 50 mg, 75 mg, or 100 mg venlafaxine. Inactive ingredients consist of colloidal silicon dioxide, ferric oxide yellow, ferric oxide red, lactose monohydrate, magnesium stearate, and sodium starch glycolate.
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  • The efficacy of venlafaxine hydrochloride as a treatment for major depressive disorder was established in 5 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 5 studies, venlafaxine hydrochloride was shown to be significantly superior to placebo on at least 2 of the following 3 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 2 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, 150, or 225 mg, qAM) were randomized to continuation of their same venlafaxine hydrochloride extended-release capsule 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) 2 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 capsule 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 hydrochloride 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 hydrochloride treatment experienced significantly lower relapse rates over the subsequent 52 weeks compared with those receiving placebo.
  • Venlafaxine tablets USP are indicated for the treatment of major depressive disorder.
  • The efficacy of venlafaxine tablets USP 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 4 of the following 8 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 USP 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 USP/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 hydrochloride or within 7 days of stopping treatment with venlafaxine hydrochloride is contraindicated because of an increased risk of serotonin syndrome. The use of venlafaxine hydrochloride within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated (see and ).
  • Starting venlafaxine hydrochloride 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 ).
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  • Venlafaxine tablets USP are available as follows:
  • 25 mg - mottled peach, round, flat beveled tablet, on one side scored and debossed u201c9u201d on one side of the score and u201c3u201d on the other side of the score. Debossed with u201c199u201d on the opposite side of the tablet. It is available in bottles of 100 (NDC 0093-0199-01).
  • 37.5 mg - mottled peach, round, flat beveled tablet, on one side scored and debossed u201c9u201d on one side of the score and u201c3u201d on the other side of the score. Debossed with u201c7380u201d on the opposite side of the tablet. It is available in bottles of 100 (NDC 0093-7380-01).
  • 50 mg - mottled peach, round, flat beveled tablet, on one side scored and debossed u201c9u201d on one side of the score and u201c3u201d on the other side of the score. Debossed with u201c7381u201d on the opposite side of the tablet. It is available in bottles of 100 (NDC 0093-7381-01).
  • 75 mg - mottled peach, round, flat beveled tablet, on one side scored and debossed u201c9u201d on one side of the score and u201c3u201d on the other side of the score. Debossed with u201c7382u201d on the opposite side of the tablet. It is available in bottles of 100 (NDC 0093-7382-01).
  • 100 mg - mottled peach, round, flat beveled tablet, on one side scored and debossed u201c9u201d on one side of the score and u201c3u201d on the other side of the score. Debossed with u201c7383u201d on the opposite side of the tablet. It is available in bottles of 100 (NDC 0093-7383-01).
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [See USP Controlled Room Temperature] in a dry place.
  • Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
  • KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
  • Manufactured In Israel By:
  • Teva Pharmaceutical Ind. Ltd.
  • Jerusalem, 9777402, Israel
  • Manufactured For:
  • Teva Pharmaceuticals USA, Inc.
  • North Wales, PA 19454
  • Rev. Q 9/2016
  • Venlafaxine (ven la fax een) Tablets USP
  • 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. Venlafaxine tablets
  • 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.
  • Elderly people may be at greater risk for this. Symptoms may include:
  • 9. Seizures or convulsions.
  • 10. Abnormal bleeding: Venlafaxine tablets
  • 11. Elevated cholesterol.
  • 12. Lung disease and pneumonia: Venlafaxine tablets
  • 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.n- venlafaxine tablets
  • What are venlafaxine tablets?
  • Venlafaxine tablets
  • Talk to your healthcare provider if you do not think that your condition is getting better with treatment.
  • Who should not take venlafaxine tablets?
  • Do not take if you:
  • People who take venlafaxine tablets close in time to an MAOI may have serious or even life-threatening side effects. Get medical help right away if you have any of these symptoms:
  • What should I tell my healthcare provider before taking venlafaxine tablets? Ask if you are not sure.
  • Before starting , tell your healthcare provider if you:
  • Tell your healthcare provider about all the medicines that you take, n- Venlafaxine tablets
  • Your healthcare provider or pharmacist can tell you if it is safe to take with your other medicines. Do not start or stop any medicine while taking without talking to your healthcare provider first.
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