Venlafaxine (Venlafaxine)

Trade Name : venlafaxine

NorthStar RxLLC

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 (Venlafaxine) which is also known as venlafaxine and Manufactured by NorthStar RxLLC. It is available in strength of 25 mg/1 per ml. Read more

Venlafaxine (Venlafaxine) 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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About GNH

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Venlafaxine hydrochloride USP 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-[u26d9-[(dimethyl-amino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of CHNOHCl. Its molecular weight is 313.87.
The structural formula is shown below.
Venlafaxine hydrochloride USPu00a0is 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 USPu00a0equivalent to 25 mg, 37.5 mg, 50 mg, 75 mg, or 100 mg venlafaxine. Inactive ingredients consist of cellulose, iron oxide red, iron oxide yellow,lactose monohydrate, magnesium stearate and crospovidone.

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The efficacy of venlafaxineu00a0 tablets 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 tablets in a range of 75 to 225 mg/day (t.i.d. schedule), the third involving fixed venlafaxineu00a0tablets 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 venlafaxineu00a0tablets doses were titrated in a range of 150 to 375 mg/day (t.i.d. schedule). In these 5 studies, venlafaxine tablets were 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.u00a0n 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.n 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 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 u22643 and a HAM-D-21 total score of u226410 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 u22654 (moderately ill), (2) 2 consecutive CGI Severity of Illness item scores of u22654, or (3) a final CGI Severity of Illness item score of u22654 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.u00a0u00a0In 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 u226412 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 u226520; (2) no more than 2 HAM-D-21 total scores >10; and (3) no single CGI Severity of Illness item score u22654 (moderately ill)] during an initial 26 weeks of treatment on venlafaxine tablets (100 to 200 mg/day, on a b.i.d. schedule) were randomized to continuation of their same venlafaxine tablet dose or to placebo. The follow-up period to observe patients for relapse, defined as a CGI Severity of Illness item score u22654, was for up to 52 weeks. Patients receiving continued venlafaxine tablet treatment experienced significantly lower relapse rates over the subsequent 52 weeks compared with those receiving placebo.

Venlafaxineu00a0tablets are indicated for the treatment of major depressive disorder.u00a0n The efficacy of venlafaxineu00a0tablets 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 ).n 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.n 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 venlafaxineu00a0tablets 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 (seeu00a0). Nevertheless, the physician who elects to use venlafaxineu00a0tablets/ 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 tablets or within 7 days of stopping treatment with venlafaxine tablets is contraindicated because of an increased risk of serotonin syndrome. The use of venlafaxine tabletswithin 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated (see and ).n Starting venlafaxine 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 (see and ).

Clinical Worsening and Suicide Risk
No suicides occurred in any of the pediatric trials. There were suicides in the adult trials, but the number was not sufficient to reach any conclusion about drug effect on suicide.u00a0n It is unknown whether the suicidality risk extends to longer-term use, i.e., beyond several months. However, there is substantial evidence from placebo-controlled maintenance trials in adults with depression that the use of antidepressants can delay the recurrence of depression.n n n n The following symptoms, anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, and mania, have been reported in adult and pediatric patients being treated with antidepressants for major depressive disorder as well as for other indications, both psychiatric and nonpsychiatric. Although a causal link between the emergence of such symptoms and either the worsening of depression and / or the emergence of suicidal impulses has not been established, there is concern that such symptoms may represent precursors to emerging suicidality.u00a0n Consideration should be given to changing the therapeutic regimen, including possibly discontinuing the medication, in patients whose depression is persistently worse, or who are experiencing emergent suicidality or symptoms that might be precursors to worsening depression or suicidality, especially if these symptoms are severe, abrupt in onset, or were not part of the patient's presenting symptoms.u00a0n If the decision has been made to discontinue treatment, medication should be tapered, as rapidly as is feasible, but with recognition that abrupt discontinuation can be associated with certain symptoms (see and n , for a description of the risks of discontinuation of venlafaxineu00a0tablets).u00a0n n Prescriptions for venlafaxineu00a0tablets should be written for the smallest quantity of tablets consistent with good patient management, in order to reduce the risk of overdose.u00a0n n n A major depressive episode may be the initial presentation of bipolar disorder. It is generally believed (though not established in controlled trials) that treating such an episode with an antidepressant alone may increase the likelihood of precipitation of a mixed/manic episode in patients at risk for bipolar disorder. Whether any of the symptoms described above represent such a conversion is unknown. However, prior to initiating treatment with an antidepressant, patients with depressive symptoms should be adequately screened to determine if they are at risk for bipolar disorder; such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder, and depression. It should be noted that venlafaxine tablets are not approved for use in treating bipolar depression.n The development of a potentially life-threatening serotonin syndrome has been reported with SNRIs and SSRIs, including venlafaxine tablets, alone but particularly with concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, and 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 and intravenous methylene blue).Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, delirium, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular symptoms (e.g., tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). Patients should be monitored for the emergence of serotonin syndrome.The concomitant use of venlafaxine tablets with MAOIs intended to treat psychiatric disorders is contraindicated. Venlafaxine tablets should also not be started in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue. All reports with methylene blue that provided information on the route of administration involved intravenous administration in the dose range of 1 mg/kg to 8 mg/kg. No reports involved the administration of methylene blue by other routes (such as oral tablets or local tissue injection) or at lower doses. There may be circumstances when it is necessary to initiate treatment with a MAOI such as linezolid or intravenous methylene blue in a patient taking venlafaxine tablets. Venlafaxine tablets should be discontinued before initiating treatment with the MAOI (see If concomitant use of venlafaxine tablets with other serotonergic drugs, including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, buspirone, tryptophan, and St. John's Wort is clinically warranted, patients should be made aware of a potential increased risk of serotonin syndrome, particularly during treatment initiation and dose increases.Treatment with venlafaxine tablets and any concomitant serotonergic agents should be discontinued immediately if the above events occuru00a0and supportive symptomatic treatment should be initiated.n n The pupillary dilation that occurs following use of many antidepressant drugs including venlafaxine tablets may trigger an angle closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy.n n Venlafaxine treatment is associated with sustained increases in blood pressure in some patients. (1) In a premarketing study comparing three fixed doses of venlafaxine (75, 225, and 375 mg/day) and placebo, a mean increase in supine diastolic blood pressure (SDBP) of 7.2 mm Hg was seen in the 375 mg/day group at week 6 compared to essentially no changes in the 75 and 225 mg/day groups and a mean decrease in SDBP of 2.2 mm Hg in the placebo group. (2) An analysis for patients meeting criteria for sustained hypertension (defined as treatment-emergent SDBP u226590 mm Hg u226510 mm Hg above baseline for 3 consecutive visits) revealed a dose-dependent increase in the incidence of sustained hypertension for venlafaxine:
An analysis of the patients with sustained hypertension and the 19 venlafaxine patients who were discontinued from treatment because of hypertension (<1% of total venlafaxine-treated group) revealed that most of the blood pressure increases were in a modest range (10 to 15 mm Hg, SDBP). Nevertheless, sustained increases of this magnitude could have adverse consequences. Cases of elevated blood pressure requiring immediate treatment have been reported in post marketing experience. Pre-existing hypertension should be controlled before treatment with venlafaxine. It is recommended that patients receiving venlafaxine have regular monitoring of blood pressure. For patients who experience a sustained increase in blood pressure while receiving venlafaxine, either dose reduction or discontinuation should be considered.u00a0

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Associated with Discontinuation of Treatment
* Percantage based on the number of males-- Less than 1%n n n Commonly Observed Adverse Events in Controlled Clinical TrialsThe most commonly observed adverse events associated with the use of venlafaxineu00a0tablets (incidence of 5% or greater) and not seen at an equivalent incidence among placebo-treated patients (ie, incidence for venlafaxineu00a0tablets at least twice that for placebo), derived from the 1% incidence table below, were asthenia, sweating, nausea, constipation, anorexia, vomiting, somnolence, dry mouth, dizziness, nervousness, anxiety, tremor, and blurred vision as well as abnormal ejaculation/orgasm and impotence in men.n Adverse Events Occurring at an Incidence of 1% or More Among venlafaxine tablets-Treated Patients n The table that follows enumerates adverse events that occurred at an incidence of 1% or more, and were more frequent than in the placebo group, among venlafaxineu00a0tablets-treated patients who participated in short-term (4- to 8-week) placebo-controlled trials in which patients were administered doses in a range of 75 to 375 mg/day. This table shows the percentage of patients in each group who had at least one episode of an event at some time during their treatment. Reported adverse events were classified using a standard COSTART-based Dictionary terminology.n The prescriber should be aware that these figures cannot be used to predict the incidence of side effects in the course of usual medical practice where patient characteristics and other factors differ from those which prevailed in the clinical trials. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses and investigators. The cited figures, however, do provide the prescribing physician with some basis for estimating the relative contribution of drug and nondrug factors to the side effect incidence rate in the population studied.n n n
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Adaptation to Certain Adverse EventsOver a 6-week period, there was evidence of adaptation to some adverse events with continued therapy (eg, dizziness and nausea), but less to other effects (eg, abnormal ejaculation and dry mouth).n Vital Sign ChangesVenlafaxineu00a0tablet treatment (averaged over all dose groups) in clinical trials was associated with a mean increase in pulse rate of approximately 3 beats per minute, compared to no change for placebo. In a flexible-dose study, with doses in the range of 200 to 375 mg/day and mean dose greater than 300 mg/day, the mean pulse was increased by about 2 beats per minute compared with a decrease of about 1 beat per minute for placebo.u00a0n In controlled clinical trials, venlafaxineu00a0tablets were associated with mean increases in diastolic blood pressure ranging from 0.7 to 2.5 mm Hg averaged over all dose groups, compared to mean decreases ranging from 0.9 to 3.8 mm Hg for placebo. However, there is a dose dependency for blood pressure increase (see ).n Laboratory ChangesOf the serum chemistry and hematology parameters monitored during clinical trials with venlafaxine tablets, a statistically significant difference with placebo was seen only for serum cholesterol. In premarketing trials, treatment with venlafaxineu00a0tablets was associated with a mean final on-therapy increase in total cholesterol of 3 mg/dL.n Patients treated with venlafaxineu00a0tablets for at least 3 months in placebo-controlled 12-month extension trials had a mean final on-therapy increase in total cholesterol of 9.1 mg/dL compared with a decrease of 7.1 mg/dL among placebo-treated patients. This increase was duration dependent over the study period and tended to be greater with higher doses. Clinically relevant increases in serum cholesterol, defined as 1) a final on-therapy increase in serum cholesterol u226550 mg/dL from baseline and to a value u2265261 mg/dL or 2) an average on-therapy increase in serum cholesterol u226550 mg/dL from baseline and to a value u2265261 mg/dL, were recorded in 5.3% of venlafaxine-treated patients and 0.0% of placebo-treated patients (seeu00a0n ).n ECG ChangesIn an analysis of ECGs obtained in 769 patients treated with venlafaxineu00a0tablets and 450 patients treated with placebo in controlled clinical trials, the only statistically significant difference observed was for heart rate, ie, a mean increase from baseline of 4 beats per minute for venlafaxineu00a0 tablets. In a flexible-dose study, with doses in the range of 200 to 375 mg/day and mean dose greater than 300 mg/day, the mean change in heart rate was 8.5 beats per minute compared with 1.7 beats per minute for placebo (see n ).n n n During its premarketing assessment, multiple doses of venlafaxineu00a0tablets were administered to 2897 patients in Phase 2 and Phase 3 studies. In addition, in premarketing assessment of venlafaxine hydrochloride extended release capsules, multiple doses were administered to 705 patients in Phase 3 major depressive disorder studies and venlafaxineu00a0 tablets wereadministered to 96 patients. During its premarketing assessment, multiple doses of venlafaxine hydrochloride extended release capsuleswere also administered to 1381 patients in Phase 3 GAD studies and 277 patients in Phase 3 Social Anxiety Disorder studies. The conditions and duration of exposure to venlafaxine in both development programs varied greatly, and included (in overlapping categories) open and double-blind studies, uncontrolled and controlled studies, inpatient (venlafaxine tablets only) and outpatient studies, fixed-dose and titration studies. Untoward events associated with this exposure were recorded by clinical investigators using terminology of their own choosing. Consequently, it is not possible to provide a meaningful estimate of the proportion of individuals experiencing adverse events without first grouping similar types of untoward events into a smaller number of standardized event categories.u00a0n In the tabulations that follow, reported adverse events were classified using a standard COSTART-based Dictionary terminology. The frequencies presented, therefore, represent the proportion of the 5356 patients exposed to multiple doses of either formulation of venlafaxine who experienced an event of the type cited on at least one occasion while receiving venlafaxine. All reported events are included except those already listed in Table 2 and those events for which a drug cause was remote. If the COSTART term for an event was so general as to be uninformative, it was replaced with a more informative term. It is important to emphasize that, although the events reported occurred during treatment with venlafaxine, they were not necessarily caused by it.n Events are further categorized by body system and listed in order of decreasing frequency using the following definitions: adverse events are defined as those occurring on one or more occasions in at least 1/100 patients; adverse events are those occurring in 1/100 to 1/1000 patients; events are those occurring in fewer than 1/1000 patients.n Body as a whole -accidental injury, chest pain substernal, neck pain; face edema, intentional injury, malaise, moniliasis, neck rigidity, pelvic pain, photosensitivity reaction, suicide attempt, withdrawal syndrome; appendicitis, bacteremia, carcinoma, cellulitis.n Cardiovascular system - migraine; angina pectoris, arrhythmia, extrasystoles, hypotension, peripheral vascular disorder (mainly cold feet and/or cold hands), syncope, thrombophlebitis; aortic aneurysm, arteritis, first-degree atrioventricular block, bigeminy, bradycardia, bundle branch block, capillary fragility, cardiovascular disorder (mitral valve and circulatory disturbance), cerebral ischemia, coronary artery disease, congestive heart failure, heart arrest, mucocutaneous hemorrhage, myocardial infarct, pallor.n Digestive system - eructation; bruxism, colitis, dysphagia, tongue edema, esophagitis, gastritis, gastroenteritis, gastrointestinal ulcer, gingivitis, glossitis, rectal hemorrhage, hemorrhoids, melena, oral moniliasis, stomatitis, mouth ulceration; cheilitis, cholecystitis, cholelithiasis, duodenitis, esophageal spasm, hematemesis, gastrointestinal hemorrhage, gum hemorrhage, hepatitis, ileitis, jaundice, intestinal obstruction, parotitis, periodontitis, proctitis, increased salivation, soft stools, tongue discoloration.n Endocrine system - goiter, hyperthyroidism, hypothyroidism, thyroid nodule, thyroiditis.n Hemic and lymphatic system - ecchymosis; anemia, leukocytosis, leukopenia, lymphadenopathy, thrombocythemia, thrombocytopenia; basophilia, bleeding time increased, cyanosis, eosinophilia, lymphocytosis, multiple myeloma, purpura.n Metabolic and nutritional - edema, weight gain; alkaline phosphatase increased, dehydration, hypercholesteremia, hyperglycemia, hyperlipemia, hypokalemia, SGOT (AST) increased, SGPT (ALT) increased, thirst; alcohol intolerance, bilirubinemia, BUN increased, creatinine increased, diabetes mellitus, glycosuria, gout, healing abnormal, hemochromatosis, hypercalcinuria, hyperkalemia, hyperphosphatemia, hyperuricemia, hypocholesteremia, hypoglycemia, hyponatremia, hypophosphatemia, hypoproteinemia, uremia.n Musculoskeletal system - arthritis, arthrosis, bone pain, bone spurs, bursitis, leg cramps, myasthenia, tenosynovitis; pathological fracture, myopathy, osteoporosis, osteosclerosis, plantar fasciitis, rheumatoid arthritis, tendon rupture.n Nervous system - trismus, vertigo; akathisia, apathy, ataxia, circumoral paresthesia, CNS stimulation, emotional lability, euphoria, hallucinations, hostility, hyperesthesia, hyperkinesia, hypotonia, incoordination, libido increased, manic reaction, myoclonus, neuralgia, neuropathy, psychosis, seizure, abnormal speech, stupor; akinesia, alcohol abuse, aphasia, bradykinesia, buccoglossal syndrome, cerebrovascular accident, loss of consciousness, delusions, dementia, dystonia, facial paralysis, feeling drunk, abnormal gait, Guillain-Barre Syndrome, hyperchlorhydria, hypokinesia, impulse control difficulties, neuritis, nystagmus, paranoid reaction, paresis, psychotic depression, reflexes decreased, reflexes increased, suicidal ideation, torticollis.n Respiratory system - bronchitis, dyspnea; asthma, chest congestion, epistaxis, hyperventilation, laryngismus, laryngitis, pneumonia, voice alteration; atelectasis, hemoptysis, hypoventilation, hypoxia, larynx edema, pleurisy, pulmonary embolus, sleep apnea.n Skin and appendages - acne, alopecia, brittle nails, contact dermatitis, dry skin, eczema, skin hypertrophy, maculopapular rash, psoriasis, urticaria; erythema nodosum, exfoliative dermatitis, lichenoid dermatitis, hair discoloration, skin discoloration, furunculosis, hirsutism, leukoderma, petechial rash, pustular rash, vesiculobullous rash, seborrhea, skin atrophy, skin striae.n Special senses - abnormality of accommodation, abnormal vision; cataract, conjunctivitis, corneal lesion, diplopia, dry eyes, eye pain, hyperacusis, otitis media, parosmia, photophobia, taste loss, visual field defect; blepharitis, chromatopsia, conjunctival edema, deafness, exophthalmos, angle-closure glaucoma, retinal hemorrhage, subconjunctival hemorrhage, keratitis, labyrinthitis, miosis, papilledema, decreased pupillary reflex, otitis externa, scleritis, uveitis.n Urogenital system - metrorrhagia*, prostatic disorder (prostatitis and enlarged prostate)*, vaginitis*; albuminuria, amenorrhea*, cystitis, dysuria, hematuria, leukorrhea*, menorrhagia*, nocturia, bladder pain, breast pain, polyuria, pyuria, urinary incontinence, urinary urgency, vaginal hemorrhage*; abortion*, anuria, balanitis*, breast discharge, breast engorgement, breast enlargement, endometriosis*, fibrocystic breast, calcium crystalluria, cervicitis*, ovarian cyst*, prolonged erection*, gynecomastia (male)*, hypomenorrhea*, kidney calculus, kidney pain, kidney function abnormal, female lactation*, mastitis, menopause*, oliguria, orchitis*, pyelonephritis, salpingitis*, urolithiasis, uterine hemorrhage*, uterine spasm*, vaginal dryness*.u00a0n * Based on the number of men and women as appropriate.n n Voluntary reports of other adverse events temporally associated with the use of venlafaxine that have been received since market introduction and that may have no causal relationship with the use of venlafaxine include the following: agranulocytosis, anaphylaxis, angioedema, aplastic anemia, catatonia, congenital anomalies, impaired coordination and balance, CPK increased, deep vein thrombophlebitis, delirium, EKG abnormalities such as QT prolongation; cardiac arrhythmias including atrial fibrillation, supraventricular tachycardia, ventricular extrasystole, and rare reports of ventricular fibrillation and ventricular tachycardia, including torsade de pointes; toxic epidermal necrosis/Stevens-Johnson Syndrome, erythema multiforme, extrapyramidal symptoms (including dyskinesia and tardive dyskinesia), angle-closure glaucoma, hemorrhage (including eye and gastrointestinal bleeding), hepatic events (including GGT elevation; abnormalities of unspecified liver function tests; liver damage, necrosis, or failure; and fatty liver), interstitial lung disease, involuntary movements, LDH increased, neutropenia, night sweats, pancreatitis, pancytopenia, panic, prolactin increased, renal failure, rhabdomyolysis,u00a0shock-like electrical sensations or tinnitus (in some cases, subsequent to the discontinuation of venlafaxine or tapering of dose), and syndrome of inappropriate antidiuretic hormone secretion (usually in the elderly).u00a0n u00a0There have been reports of elevated clozapine levels that were temporally associated with adverse events, including seizures, following the addition of venlafaxine. There have been reports of increases in prothrombin time, partial thromboplastin time, or INR when venlafaxine was given to patients receiving warfarin therapy.

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Venlafaxine Tablets USP are available containing 25 mg, 37.5 mg, 50 mg, 75 mg or 100 mg of venlafaxine.u00a025 mg, peach colored, round shape, flat, beveled edge, uncoated tablets debossed with u2018175u2019 on one side and breakline on other side.NDC 16714-311-02, bottle of 30 tablets.NDC 16714-311-01, bottle of 100 tablets.NDC 16714-311-03, bottle of 1000 tablets.n 37.5 mg, peach colored, round shape, flat, beveled edge, uncoated tablets debossed with u2018176u2019 on one side and breakline on other side.n NDC 16714-312-02, bottle of 30 tablets.NDC 16714-312-01, bottle of 100 tablets.NDC 16714-312-03, bottle of 1000 tablets.n 50 mg, peach colored, round shape, flat, beveled edge, uncoated tablets debossed with u2018L177u2019 on one side and breakline on other side.n NDC 16714-313-02, bottle of 30 tablets.NDC 16714-313-01, bottle of 100 tablets.NDC 16714-313-03, bottle of 1000 tablets.n 75 mg, peach colored, round shape, flat, beveled edge, uncoated tablets debossed with u2018L178 on one side and breakline on other side. n NDC 16714-314-02, bottle of 30 tablets.NDC 16714-314-01, bottle of 100 tablets.NDC 16714-314-03, bottle of 1000 tablets.n n 100 mg, peach colored, round shape, flat, beveled edge, uncoated tablets debossed with u2018L179u2019 on one side and breakline on other side.n NDC 16714-315-02, bottle of 30 tablets.NDC 16714-315-01, bottle of 100 tablets.NDC 16714-315-03, bottle ofu00a01000 tablets.n n n n n n n n
Medication Guide available at n or call 1-800-206-7821.
Manufactured for: Northstar Rx LLCMemphis, TN 38141Toll free: 1-800-206-7821
Manufactured by: Alembic Pharmaceuticals Limited(Formulation Division),Village Panelav, P. O. Tajpura, Near Baska,Taluka-Halol, Panchmahal, Gujarat, India.
Product of India.
Revision Date: 10/2016

Venlafaxine (ven-la-fax-een)Tablets, USPn- u00a0
Read the Medication Guide that comes with venlafaxine tablets before you start taking it 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.n
What is the most important information I should know about venlafaxine tablets?
Venlafaxine tablets n- Array
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:
u00a0:
u00a0u00a0u00a0u00a0u00a0u00a0u00a0 n
u00a0u00a0u00a0u00a0u00a0u00a0 :
u00a0u00a0u00a0u00a0u00a0 3.u00a0Changes in blood pressure
u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 n
u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0n
u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0n
u00a0u00a0u00a0u00a0u00a0 6. Changes in appetite or weight.
u00a0u00a0u00a0u00a0u00a0 7. Manic/hypomanic episodes:
u00a0u00a0u00a0u00a0u00a0 8. Low salt (sodium) levels in the blood.
Elderly people may be at greater risk for this. Symptoms may include:
u00a0u00a0u00a0u00a0u00a0u00a0 9. Seizures or convulsions
10.u00a0 n- Abnormal bleedingn- venlafaxine tablets n- Array
11.u00a0 n- Elevated cholesterol.
12.u00a0 n- Lung disease and pneumonian- Venlafaxine tablets may cause rare lung problems. Symptoms include:
13.u00a0 n- Severe allergic reactions:
14. Visual problemsn
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 n- venlafaxine tablets
What is venlafaxine tablets?
Venlafaxine tablets
Talk to your healthcare provider if you do not think that your condition is getting better with venlafaxine tabletsu00a0treatment.n n n
Do not take if you:
u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0See the end of this Medication Guide for a complete list of ingredients in .
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 venlafaxine tabletswithout talking to your healthcare provider first.
u00a0n
u00a0n
Venlafaxine tabletscan 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 affects you. Do not drink alcohol while using venlafaxine tablets.
u00a0n n
Venlafaxine tablets
u00a0Common possible side effects in people who take venlafaxine tabletsincluden
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 . 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 tabletsu00a0
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use venlafaxine tabletsfor a condition for which it was not prescribed. Do not give to other people, even if they have the same condition. It may harm them.
This Medication Guide summarizes the most important information about . If you would like more information, talk with your healthcare provider. You may ask your healthcare provider or pharmacist for information about that is written for healthcare professionals.
For more information about venlafaxine tabletscall .
What are the ingredients in venlafaxine tablets?
Active ingredient: (venlafaxine)
Inactive ingredients:
This Medication Guide has been approved by the U.S. Food and Drug Administration for all antidepressants.u00a0
The brands listed are the registered trademarks of their respective owners.
u00a0Medication Guide available at or call 1-800-206-7821.
Manufactured for:
Northstar Rx LLC
Memphis, TN 38141
Toll free: 1-800-206-7821
Product of India.n Revision Date : 10/2016

Venlafaxineu00a0Tablets USPu00a025 mg - 30 Tablets HDPE Bottle PackEach uncoated tablet contains venlafaxine hydrochloride USPu00a0equivalent to 25 mg of venlafaxine16714-311-02
u00a0 u00a0

Venlafaxine Tablets USP 37.5 mg - 30 Tablets HDPE Bottle PackEach uncoated tablet contains venlafaxine hydrochloride USP equivalent to 37.5 mg of venlafaxine16714-312-02

Venlafaxine Tablets USP 50 mg - 30 Tablets HDPE Bottle PackEach uncoated tablet contains venlafaxine hydrochloride USP equivalent to 50 mg of venlafaxine16714-313-02

Venlafaxine Tablets USP 75 mg - 30 Tablets HDPE Bottle PackEach uncoated tablet contains venlafaxine hydrochloride USP equivalent to 75 mg of venlafaxine16714-314-02

Venlafaxine Hydrochloride Tablets 100 mg - 30 Tablets HDPE Bottle PackEach uncoated tablet contains venlafaxine hydrochloride USP equivalent to 100 mg of venlafaxine16714-315-02

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Venlafaxine (Venlafaxine)

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