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Venlafaxine Hydrochloride (Venlafaxine Hydrochloride)

Trade Name : Venlafaxine Hydrochloride

Trigen Laboratories, LLC

TABLET, EXTENDED RELEASE

Strength 37.5 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 Trigen Laboratories, LLC. It is available in strength of 37.5 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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  • No data
  • WARNING: 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 Extended Release 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 Extended Release Tablets are not approved for use in pediatric patients. []
  • WARNING: Suicidality and Antidepressants
  • See full prescribing information for complete boxed warning.
  • Venlafaxine Extended Release Tablets are a selective serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for:
  • Major Depressive Disorder (MDD) ()
  • Social Anxiety Disorder (SAD) ()
  • Venlafaxine Extended Release Tablets should be administered in a single dose with food either in the morning or in the evening at approximately the same time each day. Each tablet should be swallowed whole with fluid and not divided, crushed, chewed, or placed in water.
  • u2022u00a0 Initial Treatment ()
  • Venlafaxine extended-release tablets should be taken as a single daily dose with food in either the morning or evening at the same time each day. ()
  • Discontinuation: Gradual; individualized as necessary. () u00a0
  • Venlafaxine Extended Release Tablets are available as: -u00a0u00a0u00a0u00a0u00a0u00a0 37.5 mg tablets (round, biconvex, white coated tablets with OS301 printed on one side) -u00a0u00a0u00a0u00a0u00a0u00a0 75 mg tablets (round, biconvex, white coated tablets with OS302 printed on one side) -u00a0u00a0u00a0u00a0u00a0u00a0 150 mg tablets (round, biconvex, white coated tablets with OS303 printed on one side) -u00a0u00a0u00a0u00a0u00a0u00a0 225 mg tablets (round, biconvex, white coated tablets with OS304 printed on one side)u00a0
  • 37.5 mg, 75mg, 150 mg, and 225 mg tablets ()
  • The use of MAOIu2019s intended to treat psychiatric disorders with Venlafaxine Extended Release Tablets or within 7 days of stopping treatment with Venlafaxine Extended Release Tablets is contraindicated because of an increased risk of serotonin syndrome.u00a0 The use of Venlafaxine Extended Release Tablets within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated. [].
  • Starting Venlafaxine Extended Release Tablets 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 [].
  • Serotonin Syndrome and MAOIs:u00a0 Do not use MAOIu2019s intended to treat psychiatric disorders with Venlafaxine Extended Release Tablets or within 7 days of stopping treatment with Venlafaxine Extended Release Tablets.u00a0 Do not use Venlafaxine Extended Release Tablets within 14 days of stopping an MAOI intended to treat psychiatric disorders.u00a0 In addition, do not start Venlafaxine Extended Release Tablets in a patient who is being treated with u00a0linezolid or intravenous methylene blue ().
  • No data
  • Serotonin Syndrome: Sertotonin syndrome has been reported with SSRIs and SNRIs, including Venlafaxine Extended Release Tablets, both when taken alone, but especially when co-administered with other serotonergic agents (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, and St. John's Wort).u00a0u00a0 If such symptoms occur, discontinue Venlafaxine Extended-Release tablets and initiate supportive treatment. If concomitant use of Venlafaxine Extended Release Tablets with other serotonergic drugs is clinically warranted, patients should be made aware of a potential increased risk for serotonin syndrome, particularly during treatment initiation and dose increases. ().u00a0
  • Suicidality: Monitor for clinical worsening and suicide risk. ()
  • Sustained hypertension may occur. Blood pressure monitoring recommended. ()
  • Angle Closure Glaucoma: Angle closure glaucoma has occurred in patients with untreated anatomically narrow angles treated with antidepressants. ()
  • Abrupt discontinuation or dose reduction: Discontinuation symptoms may occur (generally self-limiting; serious symptoms possible). Dose reduction recommended to be gradual. ()
  • Activation of Mania/Hypomania has occurred. ()
  • Symptomatic hyponatremia may occur. ()
  • Seizures have been reported. Use with caution in patients with seizure history. ()
  • Abnormal bleeding (most commonly ecchymosis) has been reported. ()
  • Serum cholesterol: Clinically relevant cholesterol increases may occur. Cholesterol measurements should be considered during long-term therapy. ()
  • Interstitial lung disease and eosinophilic pneumonia have been reported. ()
  • Major Depressive Disorder - Adverse events in short-term studies that occurred in at least 5% of the patients receiving venlafaxine extended-release capsules and at a rate at least twice that of the placebo group were abnormal ejaculation, gastrointestinal complaints (nausea, dry mouth, and anorexia), CNS complaints (dizziness, somnolence, and abnormal dreams), and sweating.
  • Social Anxiety Disorder - Adverse events in short-term studies that occurred in at least 5% of the patients receiving venlafaxine extended-release capsules and at a rate at least twice that of the placebo group were asthenia, gastrointestinal complaints (anorexia, dry mouth, nausea), CNS complaints (anxiety, insomnia, libido decreased, nervousness, somnolence, dizziness), abnormalities of sexual function (abnormal ejaculation, orgasmic dysfunction, impotence), yawn, sweating, and abnormal vision.
  • To report SUSPECTED ADVERSE REACTIONS, contact Trigen Laboratories, LLC at 1-888-9-TRIGEN (1-888-987-4436) or FDA at 1-800-FDA-1088 or n
  • No data
  • MAOIu2019s: concomitant use contraindicated ().u00a0 Avoid MAOIu2019s 14 days before starting venlafaxine and 7 days after stopping venlafaxine ().
  • Cimetidine: Caution in patients with pre-existing hypertension, in elderly patients and patients with hepatic dysfunction. ()
  • Haloperidol: Increase in Haloperidol AUC and Cmax. ()
  • Ketoconazole: Increase in venlafaxine and O-desmethylvenlafaxine AUC and Cmax. Caution when using venlafaxine with substances that inhibit both CYP2D6 and CYP3A4. ()
  • Metoprolol: Possibly reduced blood-pressure lowering effect despite increased metoprolol plasma levels. Caution should be exercised with co-administration of venlafaxine and metoprolol. ()
  • CNS-active drugs:u00a0 Caution when using venlafaxine with such drugs. ()
  • Serotonergic drugs (e.g., triptans, SSRIs, other SNRIs, linezolid, lithium, tramadol, or St. John's Wort): Potential for serotonin syndrome. Careful patient observation advised. ()
  • Tryptophan supplements: Concomitant use not recommended. ()
  • No data
  • No data
  • No data
  • Venlafaxine Extended Release Tablets (venlafaxine hydrochloride) are extended-release tablets for oral administration that contain venlafaxine hydrochloride, a structurally novel antidepressant. Venlafaxine hydrochloride is a selective serotonin and norepinephrine reuptake inhibitor (SNRI). It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (u00b1)-1-[u03b1- [(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2 u00a0HCl. Its molecular weight is 313.87. The structural formula is shown below.n
  • Venlafaxine hydrochloride 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.
  • Venlafaxine Extended Release Tablets are formulated as extended-release tablet for once-a-day oral administration. Venlafaxine Extended Release Tablets use osmotic pressure to deliver venlafaxine hydrochloride at a controlled rate over approximately 24 hours. The system, which resembles a conventional tablet in appearance, comprises an osmotically active core surrounded by a semipermeable membrane. The unitary tablet core is composed of the drug and excipients (including the osmotically active components). There is a precision-laser drilled orifice in the semipermeable membrane on the side of the tablet. In an aqueous environment, such as the gastrointestinal tract, water permeates through the membrane into the tablet core, causing the drug to dissolve and the osmotic components to expand. This expansion pushes the drug out through the orifice. The semipermeable membrane controls the rate at which water permeates into the tablet core, which in turn controls the rate of drug delivery. The controlled rate of drug delivery into the gastrointestinal lumen is thus independent of pH or gastrointestinal motility. The function of Venlafaxine Extended Release Tablets depends on the existence of an osmotic gradient between the contents of the core and the fluid in the gastrointestinal tract. Since the osmotic gradient remains constant, drug delivery remains essentially constant. u00a0
  • The biologically inert components of the tablet remain intact during gastrointestinal transit and are eliminated in the feces as an insoluble shell.
  • Tablets contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, 150 mg, or 225 mg venlafaxine. Inactive ingredients consist of mannitol, povidone, microcrystalline cellulose, polyethylene glycol, colloidal silicon dioxide, magnesium stearate, cellulose acetate, hypromellose lactose, titanium dioxide, triacetin, black iron oxide, and propylene glycol.
  • No data
  • Carcinogenesis
  • Venlafaxine was given by oral gavage to mice for 18 months at doses up to 120 mg/kg per day, which was 1.7 times the maximum recommended human dose on a mg/m basis. Venlafaxine was also given to rats by oral gavage for 24 months at doses up to 120 mg/kg per day. In rats receiving the 120 mg/kg dose, plasma concentrations of venlafaxine at necropsy were 1 times (male rats) and 6 times (female rats) the plasma concentrations of patients receiving the maximum recommended human dose. Plasma levels of the O-desmethyl metabolite were lower in rats than in patients receiving the maximum recommended dose. Tumors were not increased by venlafaxine treatment in mice or rats.
  • Mutagenesis
  • Venlafaxine and the major human metabolite, O-desmethylvenlafaxine (ODV), were not mutagenic in the Ames reverse mutation assay in Salmonella bacteria or the Chinese hamster ovary/HGPRT mammalian cell forward gene mutation assay. Venlafaxine was also not mutagenic or clastogenic in the in vitro BALB/c-3T3 mouse cell transformation assay, the sister chromatid exchange assay in cultured Chinese hamster ovary cells, or in the in vivo chromosomal aberration assay in rat bone marrow. ODV was not clastogenic in the in vitro Chinese hamster ovary cell chromosomal aberration assay, but elicited a clastogenic response in the in vivo chromosomal aberration assay in rat bone marrow.
  • Impairment of Fertility
  • Reproduction and fertility studies in rats showed no effects on male or female fertility at oral doses of up to 2 times the maximum recommended human dose on a mg/m basis.
  • No data
  • Venlafaxine Extended Release Tablets 37.5 mg are round, biconvex, white coated tablets with OS301 printed on one side. They are supplied as follows: u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Unit of Use Bottles of 30 Tablets NDC 13811-712-30 u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Unit of Use Bottles of 90 Tablets NDC 13811-712-90
  • Venlafaxine Extended Release Tablets 75 mg are round, biconvex, white coated tablets with OS302 printed on one side. They are supplied as follows: u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Unit of Use Bottles of 30 Tablets NDC 13811-713-30 u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Unit of Use Bottles of 90 Tablets NDC 13811-713-90
  • Venlafaxine Extended Release Tablets 150 mg are round, biconvex, white coated tablets with OS303 printed on one side. They are supplied as follows: u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Unit of Use Bottles of 30 Tablets NDC 13811-714-30 u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Unit of Use Bottles of 90 Tablets NDC 13811-714-90
  • Venlafaxine Extended Release Tablets 225 mg are round, biconvex, white coated tablets with OS304 printed on one side. They are supplied as follows: u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Unit of Use Bottles of 30 Tablets NDC 13811-715-30 u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Unit of Use Bottles of 90 Tablets NDC 13811-715-90
  • Store at 25u00b0C (77u00b0F); excursions permitted to 15-30u00b0C (59-86u00b0F)
  • See FDA-approved u00a0(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 u201cAntidepressant Medicines, Depression and Other Serious Mental Illness, and Suicidal Thoughts or Actionsu201d 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.
  • Medication Guide
  • Antidepressant Medicines, Depression and Other Serious Mental Illnesses, and Suicidalu00a0n- Thoughts or Actions
  • Read the Medication Guide that comes with your or your family memberu2019s antidepressant medicine. This Medication Guide is only about the risk of suicidal thoughts and actions with antidepressant medicines.u00a0n
  • Who should not take Venlafaxine Extended Release Tablets?
  • 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.u00a0
  • 3. How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member?
  • 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:
  • _____________________________________________________________________________
  • _____________________________________________________________________________
  • What else do I need to know about antidepressant medicines?
  • u00a0
  • Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
  • This Medication Guide has been approved by the U.S. Food and Drug Administration for all antidepressants.
  • Marketed by:
  • Bridgewater, NJ 08807
  • Rev. 10/2017
  • 70035845
  • PRINCIPAL DISPLAY PANEL - 37.5 mg 30 Tablet Bottle Label
  • NDC 13811-712-30
  • VenlafaxineExtended Release Tablets
  • 37.5 mg*
  • *present as venlafaxine hydrochloride
  • Rx only
  • Note to authorizeddispenser:
  • Unit of Use30 tablets
  • PRINCIPAL DISPLAY PANEL - 37.5 mg 90 Tablet Bottle Label
  • NDC 13811-712-90
  • VenlafaxineExtended Release Tablets
  • 37.5 mg*
  • *present as venlafaxine hydrochloride
  • Rx only
  • Note to authorizeddispenser:
  • Unit of Use90 tablets
  • PRINCIPAL DISPLAY PANEL - 75 mg 30 Tablet Bottle Label
  • NDC 13811-713-30
  • VenlafaxineExtended Release Tablets
  • 75 mg*
  • *present as venlafaxine hydrochloride
  • Rx only
  • Note to authorizeddispenser:
  • Unit of Use30 tablets
  • PRINCIPAL DISPLAY PANEL - 75 mg 90 Tablet Bottle Label
  • NDC 13811-713-90
  • VenlafaxineExtended Release Tablets
  • 75 mg*
  • *present as venlafaxine hydrochloride
  • Rx only
  • Note to authorizeddispenser:
  • Unit of Use90 tablets
  • PRINCIPAL DISPLAY PANEL - 150 mg 30 Tablet Bottle Label
  • NDC 13811-714-30
  • VenlafaxineExtended Release Tablets
  • 150 mg*
  • *present as venlafaxine hydrochloride
  • Rx only
  • Note to authorizeddispenser:
  • Unit of Use30 tablets
  • PRINCIPAL DISPLAY PANEL - 150 mg 90 Tablet Bottle Label
  • NDC 13811-714-90
  • VenlafaxineExtended Release Tablets
  • 150 mg*
  • *present as venlafaxine hydrochloride
  • Rx only
  • Note to authorizeddispenser:
  • Unit of Use90 tablets
  • PRINCIPAL DISPLAY PANEL - 225 mg 30 Tablet Bottle Label
  • NDC 13811-715-30
  • Extended Release Tablets
  • 225 mg*
  • *present as venlafaxine hydrochloride
  • Rx only
  • Note to authorizeddispenser:
  • Unit of Use30 tablets
  • PRINCIPAL DISPLAY PANEL - 225 mg 90 Tablet Bottle Label
  • NDC 13811-715-90
  • VenlafaxineExtended Release Tablets
  • 225 mg*
  • *present as venlafaxine hydrochloride
  • Rx only
  • Note to authorizeddispenser:
  • Unit of Use90 tablets

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