Which company makes effexor

Dosing may vary, but the standard dose is 50 mg daily. Effexor is available in tablet form, and also as an extended-release capsule and extended-release tablet form. A typical dose is 75 or mg daily XR formulation.

Sign up for Pristiq price alerts and find out when the price changes! Get price alerts. Pristiq What is Pristiq? Sometimes, Pristiq is prescribed off-label for other uses. Effexor immediate-release is indicated to treat major depressive disorder. Effexor XR What is Effexor? A meta-analysis looked at the safety and efficacy of Pristiq and Effexor.

The researchers concluded that both drugs were similar in terms of efficacy in treating depression, as well as side effects. However, patients who took Pristiq had less nausea than patients who took Effexor. Consult your healthcare provider for medical advice. Only your healthcare provider can determine which medication is better for you, based on your medical condition s and history, as well as any medications you take that can interact with Pristiq or Effexor.

Get the pharmacy discount card. Insurance and Medicare Part D plans usually cover Pristiq. As insurance plans vary and are subject to change, contact your health insurance plan for current coverage information. The most common side effects of Pristiq are nausea, dizziness, insomnia, excess sweating, constipation, sleepiness, decreased appetite, anxiety, and male sexual problems. The most common side effects of Effexor XR are nausea, sleepiness, dry mouth, sweating, sexual problems, decreased appetite, and constipation.

Other side effects may occur. Consult your healthcare professional for a full list of adverse effects. Pristiq or Effexor must be separated from an MAOI by seven to 14 days, depending on which medication is stopped first. Pristiq or Effexor should not be taken with other medications that increase serotonin levels, like other SNRI or SSRI antidepressants, triptans for migraines, and opioids, for the same reason. Also, the cough suppressant dextromethorphan, which is found in Robitussin-DM as well as many other cough and cold products, should be avoided, as it can also cause serotonin syndrome when combined with Pristiq or Effexor.

Other drugs that may interact with Pristiq or Effexor include NSAIDs non-steroidal anti-inflammatory drugs such as aspirin or ibuprofen, and anticoagulants blood thinners like warfarin.

Avoid alcohol when taking Pristiq or Effexor. If Pristiq is taken with a medication that is metabolized by an enzyme called cytochrome P 2D6, the other medication may build up to levels that are too high and can become toxic. Teva's generic medications are available in most pharmacies across the United States, though not all pharmacies carry the same Teva medications. To find out if your medication is available as a Teva generic, contact your local pharmacy.

If the pharmacy doesn't regularly stock a certain medication from Teva, ask if it can be ordered for you at no additional cost. The product catalog provides you with a full listing of Teva's brand and generic product lines. The catalog displays all strengths and sizes along with the description, imprint code, NDC and photo for each product.

Effexor XR treatment for up to 12 weeks and up to 6 months in premarketing placebo-controlled Social Anxiety Disorder trials was associated with mean final on-therapy increases in serum cholesterol concentration of approximately 7. Effexor XR treatment for up to 12 weeks in premarketing placebo-controlled panic disorder trials was associated with mean final on-therapy increases in serum cholesterol concentration of approximately 5.

Patients treated with Effexor immediate release for at least 3 months in placebo-controlled month extension trials had a mean final on-therapy increase in total cholesterol of 9. This increase was duration dependent over the study period and tended to be greater with higher doses. Effexor XR was associated with mean final on-therapy increases in fasting serum triglycerides compared with placebo in premarketing clinical studies of SAD and PD up to 12 weeks pooled data and 6 months duration Table In general, the adverse reaction profile of venlafaxine in placebo-controlled clinical studies in children and adolescents ages 6 to 17 was similar to that seen for adults.

As with adults, decreased appetite, weight loss, increased blood pressure, and increased serum cholesterol were observed [see Warnings and Precautions 5. Particularly, the following adverse reactions were observed in pediatric patients: abdominal pain, agitation, dyspepsia, ecchymosis, epistaxis, and myalgia.

The following adverse reactions have been identified during postapproval use of Effexor XR. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure:. Cardiovascular system — QT prolongation, ventricular fibrillation, ventricular tachycardia including torsade de pointes , takotsubo cardiomyopathy. Respiratory system — Dyspnea, interstitial lung disease, pulmonary eosinophilia [see Warnings and Precautions 5.

Skin and appendages — Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme. Special senses — Angle-closure glaucoma [see Warnings and Precautions 5. The risk of using venlafaxine in combination with other CNS-active drugs has not been systematically evaluated. Based on the mechanism of action of Effexor XR and the potential for serotonin syndrome, caution is advised when Effexor XR is coadministered with other drugs that may affect the serotonergic neurotransmitter systems, such as triptans, SSRIs, other SNRIs, linezolid an antibiotic which is a reversible non-selective MAOI , lithium, tramadol, or St.

John's wort. If concomitant treatment with Effexor XR and these drugs is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases. The concomitant use of Effexor XR with tryptophan supplements is not recommended [see Dosage and Administration 2. Serotonin release by platelets plays an important role in hemostasis. The use of psychotropic drugs that interfere with serotonin reuptake is associated with the occurrence of upper gastrointestinal bleeding and concurrent use of an NSAID or aspirin may potentiate this risk of bleeding [see Warnings and Precautions 5.

Patients receiving warfarin therapy should be carefully monitored when Effexor XR is initiated or discontinued. The safety and efficacy of venlafaxine therapy in combination with weight loss agents, including phentermine, have not been established.

Coadministration of Effexor XR and weight loss agents is not recommended. Effexor XR is not indicated for weight loss alone or in combination with other products. False-positive urine immunoassay screening tests for phencyclidine PCP and amphetamine have been reported in patients taking venlafaxine.

This is due to lack of specificity of the screening tests. False positive test results may be expected for several days following discontinuation of venlafaxine therapy. Venlafaxine did not cause malformations in offspring of rats or rabbits given doses up to 2.

However, in rats, there was a decrease in pup weight, an increase in stillborn pups, and an increase in pup deaths during the first 5 days of lactation, when dosing began during pregnancy and continued until weaning. The cause of these deaths is not known. These effects occurred at 2. The no effect dose for rat pup mortality was 0. In reproductive developmental studies in rats and rabbits with O-desmethylvenlafaxine ODV , the major human metabolite of venlafaxine, evidence of teratogenicity was not observed at exposure margins of 13 in rats and 0.

There are no adequate and well-controlled studies in pregnant women. Effexor XR should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Such complications can arise immediately upon delivery.

Reported clinical findings have included respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying.

It should be noted, that in some cases the clinical picture is consistent with serotonin syndrome [see Warnings and Precautions 5. When treating a pregnant woman with Effexor XR during the third trimester, the physician should carefully consider the potential risks and benefits of treatment.

Venlafaxine and ODV have been reported to be excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from Effexor XR, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Two placebo-controlled trials in pediatric patients with MDD and two placebo-controlled trials in pediatric patients with GAD have been conducted with Effexor XR, and the data were not sufficient to support a claim for use in pediatric patients.

Anyone considering the use of Effexor XR in a child or adolescent must balance the potential risks with the clinical need [see Boxed Warning , Warnings and Precautions 5. Although no studies have been designed to primarily assess Effexor XR's impact on the growth, development, and maturation of children and adolescents, the studies that have been done suggest that Effexor XR may adversely affect weight and height [see Warnings and Precautions 5.

Should the decision be made to treat a pediatric patient with Effexor XR, regular monitoring of weight and height is recommended during treatment, particularly if treatment is to be continued long-term [see Warnings and Precautions 5.

The safety of Effexor XR treatment for pediatric patients has not been systematically assessed for chronic treatment longer than six months in duration. In the studies conducted in pediatric patients ages 6—17 , the occurrence of blood pressure and cholesterol increases considered to be clinically relevant in pediatric patients was similar to that observed in adult patients.

Consequently, the precautions for adults apply to pediatric patients [see Warnings and Precautions 5. No overall differences in effectiveness or safety were observed between geriatric patients and younger patients, and other reported clinical experience generally has not identified differences in response between the elderly and younger patients.

However, greater sensitivity of some older individuals cannot be ruled out. The pharmacokinetics of venlafaxine and ODV are not substantially altered in the elderly [see Clinical Pharmacology No dose adjustment is recommended for the elderly on the basis of age alone, although other clinical circumstances, some of which may be more common in the elderly, such as renal or hepatic impairment, may warrant a dose reduction [see Dosage and Administration 2.

A population pharmacokinetic analysis of Effexor-treated patients from two studies involving both twice daily and three times daily regimens showed that dose-normalized trough plasma levels of either venlafaxine or ODV were unaltered by age or gender differences. Dosage adjustment based on the age or gender of a patient is generally not necessary [see Dosage and Administration 2. While venlafaxine has not been systematically studied in clinical studies for its potential for abuse, there was no indication of drug-seeking behavior in the clinical studies.

Consequently, physicians should carefully evaluate patients for history of drug abuse and follow such patients closely, observing them for signs of misuse or abuse of venlafaxine e. Venlafaxine was not found to have any significant CNS stimulant activity in rodents. In primate drug discrimination studies, venlafaxine showed no significant stimulant or depressant abuse liability.

Discontinuation effects have been reported in patients receiving venlafaxine [see Dosage and Administration 2. Somnolence was the most commonly reported symptom. Among the other reported symptoms were paresthesia of all four limbs, moderate dizziness, nausea, numb hands and feet, and hot-cold spells 5 days after the overdose. In most cases, no signs or symptoms were associated with overdose.

The majority of the reports involved ingestion in which the total dose of venlafaxine taken was estimated to be no more than several-fold higher than the usual therapeutic dose. One patient who ingested 2. Mild sinus tachycardia was reported in two of the other patients.

Actions taken to treat the overdose included no treatment, hospitalization and symptomatic treatment, and hospitalization plus treatment with activated charcoal.

All patients recovered. The most commonly reported events in overdosage include tachycardia, changes in level of consciousness ranging from somnolence to coma , mydriasis, seizures, and vomiting. Electrocardiogram changes e. Published retrospective studies report that venlafaxine overdosage may be associated with an increased risk of fatal outcomes compared to that observed with SSRI antidepressant products, but lower than that for tricyclic antidepressants.

Epidemiological studies have shown that venlafaxine-treated patients have a higher preexisting burden of suicide risk factors than SSRI-treated patients.

The extent to which the finding of an increased risk of fatal outcomes can be attributed to the toxicity of venlafaxine in overdosage, as opposed to some characteristic s of venlafaxine-treated patients, is not clear. Consult a Certified Poison Control Center for up-to-date guidance and advice or www. In case of an overdose, provide supportive care, including close medical supervision and monitoring. Treatment should consist of those general measures employed in the management of overdosage with any drug.

Consider the possibility of multiple drug overdose. Ensure an adequate airway, oxygenation, and ventilation. Monitor cardiac rhythm and vital signs. Provide supportive and symptomatic measures. Effexor XR is an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, a SNRI. Its molecular weight is The structural formula is shown as follows:.

Its octanol:water 0. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Capsules contain venlafaxine hydrochloride equivalent to Inactive ingredients consist of cellulose, ethylcellulose, gelatin, hypromellose, iron oxide, and titanium dioxide. The exact mechanism of the antidepressant action of venlafaxine in humans is unknown, but is thought to be related to the potentiation of serotonin and norepinephrine in the central nervous system, through inhibition of their reuptake.

Non- clinical studies have demonstrated that venlafaxine and its active metabolite, ODV, are potent and selective inhibitors of neuronal serotonin and norepinephrine reuptake and weak inhibitors of dopamine reuptake.

Pharmacologic activity at these receptors is hypothesized to be associated with the various anticholinergic, sedative, and cardiovascular effects seen with other psychotropic drugs. The effect of venlafaxine on the QT interval was evaluated in a randomized, double-blind, placebo- and positive-controlled three-period crossover thorough QT study in 54 healthy adult subjects. No significant QT prolongation effect of venlafaxine mg was detected.

Steady-state concentrations of venlafaxine and ODV in plasma are attained within 3 days of oral multiple-dose therapy. Venlafaxine and ODV exhibited linear kinetics over the dose range of 75 to mg per day. Venlafaxine is well absorbed and extensively metabolized in the liver. ODV is the major active metabolite.

Administration of Effexor XR mg once daily generally resulted in lower C max and later T max values than for Effexor immediate release administered twice daily Table When equal daily doses of venlafaxine were administered as either an immediate-release tablet or the extended-release capsule, the exposure to both venlafaxine and ODV was similar for the two treatments, and the fluctuation in plasma concentrations was slightly lower with the Effexor XR capsule.

Therefore, Effexor XR provides a slower rate of absorption, but the same extent of absorption compared with the immediate-release tablet. Food did not affect the bioavailability of venlafaxine or its active metabolite, ODV. Venlafaxine is not highly bound to plasma proteins; therefore, administration of Effexor XR to a patient taking another drug that is highly protein-bound should not cause increased free concentrations of the other drug.

Following absorption, venlafaxine undergoes extensive presystemic metabolism in the liver, primarily to ODV, but also to N-desmethylvenlafaxine, N,O-didesmethylvenlafaxine, and other minor metabolites. Renal elimination of venlafaxine and its metabolites is thus the primary route of excretion.

Tumors were not increased by venlafaxine treatment in mice or rats. Plasma levels of the O-desmethyl metabolite ODV were lower in rats than in patients receiving the maximum recommended dose. O-desmethylvenlafaxine ODV , the major human metabolite of venlafaxine, administered by oral gavage to mice and rats for 2 years did not increase the incidence of tumors in either study. ODV was not clastogenic in the in vitro Chinese hamster ovary cell chromosomal aberration assay or in the in vivo chromosomal aberration assay in rats.

However, reduced fertility was observed in a study in which male and female rats were treated with O-desmethylvenlafaxine ODV , the major human metabolite of venlafaxine, prior to and during mating and gestation. In moderately depressed outpatients, the initial dose of venlafaxine was 75 mg per day. In both studies, Effexor XR demonstrated superiority over placebo on the primary efficacy measure defined as change from baseline in the HAM-D total score to the endpoint visit, Effexor XR also demonstrated superiority over placebo on the key secondary efficacy endpoint, the Clinical Global Impressions CGI Severity of Illness scale.

Examination of gender subsets of the population studied did not reveal any differential responsiveness on the basis of gender. The mean dose in completers was mg per day study 3. In a longer-term study, adult outpatients with MDD who had responded during an 8-week open-label study on Effexor XR 75, , or mg, once daily every morning were randomized to continuation of their same Effexor XR dose or to placebo, for up to 26 weeks of observation for relapse.

Patients receiving continued Effexor XR treatment experienced statistically significantly lower relapse rates over the subsequent 26 weeks compared with those receiving placebo study 4.

Patients receiving continued Effexor treatment experienced statistically significantly lower relapse rates over the subsequent 52 weeks compared with those receiving placebo study 5. The efficacy of Effexor XR as a treatment for Generalized Anxiety Disorder GAD was established in two 8-week, placebo-controlled, fixed-dose studies 75 to mg per day , one 6-month, placebo-controlled, flexible-dose study 75 to mg per day , and one 6-month, placebo-controlled, fixed-dose study However, the 75 and mg per day doses were not as consistently effective as the highest dose study 1.

A second 8-week study evaluating doses of 75 and mg per day and placebo showed that both doses were more effective than placebo on some of these same outcomes; however, the 75 mg per day dose was more consistently effective than the mg per day dose study 2.

A dose-response relationship for effectiveness in GAD was not clearly established in the 75 to mg per day dose range studied. Two 6-month studies, one evaluating Effexor XR doses of While there was also evidence for superiority over placebo for the There was no evidence for any greater effectiveness of the to mg per day group compared to the 75 mg per day group in the 6-month study.

Examination of subsets of the population studied did not reveal any differential responsiveness on the basis of gender. There was insufficient information to determine the effect of age or race on outcome in these studies.

Patients received fixed doses of 75 or mg per day in one study study 1 and 75 or mg per day in the other study study 2. Efficacy was assessed on the basis of outcomes in three variables: 1 percentage of patients free of full-symptom panic attacks on the Panic and Anticipatory Anxiety Scale PAAS ; 2 mean change from baseline to endpoint on the Panic Disorder Severity Scale PDSS total score; and 3 percentage of patients rated as responders much improved or very much improved on the Clinical Global Impressions CGI Improvement scale.

In these two studies, Effexor XR was statistically significantly more effective than placebo for each fixed dose on all three endpoints, but a dose-response relationship was not clearly established. In a longer term study study 3 , adult outpatients meeting DSM-IV criteria for PD who had responded during a week open phase with Effexor XR 75 to mg per day were randomly assigned to continue the same Effexor XR dose 75, , or mg or switch to placebo for observation for relapse under double-blind conditions.

Relapse during the double-blind phase was defined as having 2 or more full-symptom panic attacks per week for 2 consecutive weeks or having discontinued due to loss of effectiveness as determined by the investigators during the study. Randomized patients were in response status for a mean time of 34 days prior to being randomized. In the randomized phase following the week open-label period, patients receiving continued Effexor XR experienced a statistically significantly longer time to relapse.

Two placebo-controlled studies in pediatric patients with MDD and two placebo-controlled studies in pediatric patients with GAD have been conducted with Effexor XR, and the data were not sufficient to support a claim for use in pediatric patients. Prescribers or other healthcare professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with Effexor XR and should counsel them in its appropriate use.

The prescriber or healthcare 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 should be asked to alert their prescriber if these occur while taking Effexor XR.

Advise patients, their families and caregivers to look for the emergence of suicidality, worsening of depression, and other psychiatric symptoms anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia, psychomotor restlessness, hypomania, mania, other unusual changes in behavior , especially early during treatment and when the dose is adjusted up or down.