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Rx Item-Effexor XR 150Mg Cap 90 By Pfizer Pharma

NDC 00008-0836-22 UPC/GTIN No.3-00080-83622-4 Mfg.Part No.83622BRAND: EFFEXOR-XR NDC: 00008-0836-22,8083622 UPC: 3-00080-83622-4,300080836224 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scopWant to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.comVisit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.

Rx Item-Effexor XR 150Mg Cap 90 By Pfizer Pharma

$2147.03$1999.99

Item No.:RX039166 NDC No.8083622 UPC No.:300080836224 NDC No. 00008-0836-22 UPC/GTIN No. 3-00080-83622-4 MPN 83622 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,ResearchCo.,Uni.,VA,Vet & Wholesalers in scope of practice can order this RX Item. Rx Item No. Rx039166 Effexor XR 150mg Cap 90 by Pfizer Pharm Item No. 3039166 NDC No. 00008083622 UPC No. 300080836224 Other Name Venlafaxine.Effexo

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EFFEXOR XR- venlafaxine hydrochloride capsule, extended release
Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc.
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS

Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a reduction in risk with antidepressant use in patients aged 65 and older [see Warnings and Precautions (5.1)].



In patients of all ages who are started on antidepressant therapy monitor closely for clinical worsening and emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber [see Warnings and Precautions (5.1) and Patient Counseling Information (17)].

1 INDICATIONS AND USAGE

1.1 Major Depressive Disorder
Effexor XR (venlafaxine hydrochloride) extended-release capsules are indicated for the treatment of major depressive disorder (MDD). Efficacy was established in three short-term (4, 8, and 12 weeks) and two long-term, maintenance trials.

1.2 Generalized Anxiety Disorder
Effexor XR is indicated for the treatment of Generalized Anxiety Disorder (GAD). Efficacy was established in two 8-week and two 26-week placebo-controlled trials.

1.3 Social Anxiety Disorder
Effexor XR is indicated for the treatment of Social Anxiety Disorder (SAD), also known as social phobia. Efficacy was established in four 12-week and one 26-week, placebo-controlled trials.

1.4 Panic Disorder
Effexor XR is indicated for the treatment of Panic Disorder (PD), with or without agoraphobia. Efficacy was established in two 12-week placebo-controlled trials.

2 DOSAGE AND ADMINISTRATION

Effexor XR should be administered in a single dose with food, either in the morning or in the evening at approximately the same time each day [see Clinical Pharmacology (12.3) ]. Each capsule should be swallowed whole with fluid and not divided, crushed, chewed, or placed in water or it may be administered by carefully opening the capsule and sprinkling the entire contents on a spoonful of applesauce. This drug/food mixture should be swallowed immediately without chewing and followed with a glass of water to ensure complete swallowing of the pellets (spheroids).

2.1 Major Depressive Disorder
For most patients, the recommended starting dose for Effexor XR is 75 mg per day, administered in a single dose. For some patients, it may be desirable to start at 37.5 mg per day for 4 to 7 days to allow new patients to adjust to the medication before increasing to 75 mg per day. Patients not responding to the initial 75 mg per day dose may benefit from dose increases to a maximum of 225 mg per day. Dose increases should be in increments of up to 75 mg per day, as needed, and should be made at intervals of not less than 4 days, since steady-state plasma levels of venlafaxine and its major metabolites are achieved in most patients by day 4 [see Clinical Pharmacology (12.3) ]. In the clinical studies establishing efficacy, upward titration was permitted at intervals of 2 weeks or more.

It should be noted that, while the maximum recommended dose for moderately depressed outpatients is also 225 mg per day for Effexor (immediate-release), more severely depressed inpatients in one study of the development program for that product responded to a mean dose of 350 mg per day (range of 150 to 375 mg per day). Whether or not higher doses of Effexor XR are needed for more severely depressed patients is unknown; however, the experience with Effexor XR doses higher than 225 mg per day is very limited.

2.2 Generalized Anxiety Disorder
For most patients, the recommended starting dose for Effexor XR is 75 mg per day, administered in a single dose. For some patients, it may be desirable to start at 37.5 mg per day for 4 to 7 days to allow new patients to adjust to the medication before increasing to 75 mg per day. Patients not responding to the initial 75 mg per day dose may benefit from dose increases to a maximum of 225 mg per day. Dose increases should be in increments of up to 75 mg per day, as needed, and should be made at intervals of not less than 4 days, since steady-state plasma levels of venlafaxine and its major metabolites are achieved in most patients by day 4 [see Clinical Pharmacology (12.3) ].

2.3 Social Anxiety Disorder (Social Phobia)
The recommended dose is 75 mg per day, administered in a single dose. There was no evidence that higher doses confer any additional benefit.

2.4 Panic Disorder
The recommended starting dose is 37.5 mg per day of Effexor XR for 7 days. Patients not responding to 75 mg per day may benefit from dose increases to a maximum of approximately 225 mg per day. Dose increases should be in increments of up to 75 mg per day, as needed, and should be made at intervals of not less than 7 days.

2.5 Switching Patients from Effexor Tablets
Depressed patients who are currently being treated at a therapeutic dose with Effexor (immediate release) may be switched to Effexor XR at the nearest equivalent dose (mg per day), e.g., 37.5 mg venlafaxine twice a day to 75 mg Effexor XR once daily. However, individual dosage adjustments may be necessary.

2.6 Specific Populations
Patients with Hepatic Impairment

The total daily dose should be reduced by 50% in patients with mild (Child-Pugh=5�6) to moderate (Child-Pugh=7�9) hepatic impairment. In patients with severe hepatic impairment (Child-Pugh=10�15) or hepatic cirrhosis, it may be necessary to reduce the dose by 50% or more [See Use in Specific Populations ( 8.7) ].

Patients with Renal Impairment

The total daily dose should be reduced by 25% to 50% in patients with mild (CLcr= 60�89 mL/min) or moderate (CLcr= 30�59 mL/min) renal impairment. In patients undergoing hemodialysis or with severe renal impairment (CLcr < 30 mL/min), the total daily dose should be reduced by 50% or more. Because there was much individual variability in clearance between patients with renal impairment, individualization of dosage may be desirable in some patients [see Use in Specific Populations ( 8.7) ].

2.7 Maintenance Treatment
There is no body of evidence available from controlled studies to indicate how long patients with MDD, GAD, SAD, or PD should be treated with Effexor XR.

It is generally agreed that acute episodes of MDD require several months or longer of sustained pharmacological therapy beyond response to the acute episode. Effexor XR/Effexor have demonstrated continuation of response in clinical studies up to 52 weeks, at the same dose at which patients responded during the initial treatment [see Clinical Studies (14.1) ]. It is not known whether or not the dose of Effexor XR needed for maintenance treatment is identical to the dose needed to achieve an initial response. Patients should be periodically reassessed to determine the need for maintenance treatment and the appropriate dose for such treatment.

In patients with GAD and SAD, Effexor XR has been shown to be effective in 6-month clinical studies. The need for continuing medication in patients with GAD and SAD who improve with Effexor XR treatment should be periodically reassessed.

In a clinical study for PD, patients continuing Effexor XR at the same dose at which they responded during the initial 12 weeks of treatment experienced a statistically significantly longer time to relapse than patients randomized to placebo [see Clinical Studies (14.4) ]. The need for continuing medication in patients with PD who improve with Effexor XR treatment should be periodically reassessed.

2.8 Discontinuing Effexor XR
A gradual reduction in the dose, rather than abrupt cessation, is recommended whenever possible. In clinical studies with Effexor XR, tapering was achieved by reducing the daily dose by 75 mg at one-week intervals. Individualization of tapering may be necessary [see Warnings and Precautions (5.7) ].
OVERDOSAGE

10.1 Human Experience
During the premarketing evaluations of Effexor XR (for MDD, GAD, SAD, and PD) and Effexor (for MDD), there were twenty reports of acute overdosage with Effexor (6 and 14 reports in Effexor XR and Effexor patients, respectively), either alone or in combination with other drugs and/or alcohol.

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 2.75 g of venlafaxine was observed to have two generalized convulsions and a prolongation of QTc to 500 msec, compared with 405 msec at baseline. 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.

In postmarketing experience, overdose with venlafaxine has occurred predominantly in combination with alcohol and/or other drugs. 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.g., prolongation of QT interval, bundle branch block, QRS prolongation), ventricular tachycardia, bradycardia, hypotension, rhabdomyolysis, vertigo, liver necrosis, serotonin syndrome, and death have been reported.

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. Prescriptions for Effexor XR should be written for the smallest quantity of capsules consistent with good patient management, in order to reduce the risk of overdose.
DESCRIPTION

Effexor XR is an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, a serotonin and norepinephrine reuptake inhibitor (SNRI).

Venlafaxine is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (�)-1-[?- [(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17 H27 NO2 HCl. Its molecular weight is 313.86.
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.

Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of cellulose, ethylcellulose, gelatin, hypromellose, iron oxide, and titanium dioxide.

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action
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.

NDC 00008-0836-22 UPC/GTIN No.3-00080-83622-4 Mfg.Part No.83622
RX ITEM-Effexor XR 150Mg Cap 90 By Pfize
NDC 00008-0836-22 UPC/GTIN No.3-00080-83622-4 Mfg.Part No.83622

BRAND: EFFEXOR-XR NDC: 00008-0836-22,8083622 UPC: 3-00080-83622-4,300080836224
Effexor XR 150Mg Cap 90 By Pfizer Pharma
BRAND: EFFEXOR-XR NDC: 00008-0836-22,8083622 UPC: 3-00080-83622-4,300080836224

Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop
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Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.
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Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.