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RX ITEM-Pentoxifylline 400Mg Tab 100 By Teva Pharma

NDC 00093-5116-01 UPC/GTIN No.3-00935-11601-3 Mfg.Part No.511601BRAND: PENTOXIFYLLIN NDC: 00093-5116-01,93511601 UPC: 3-00935-11601-3,300935116013 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-Pentoxifylline 400Mg Tab 100 By Teva Pharma

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item No.:RX774018 NDC No.93511601 UPC No.:300935116013 NDC No. 00093-5116-01 UPC/GTIN No. 3-00935-11601-3 MPN 511601 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. Rx774018 Pentoxifylline 400mg Tab 100 by TTeva Pharma Item No. 3774018 NDC No. 00093511601 UPC No. 300935116013 Other Name Trental,Pen

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PENTOXIFYLLINE- pentoxifylline tablet, film coated, extended release
Mylan Pharmaceuticals Inc.

DESCRIPTION

Pentoxifylline extended-release tablets, USP for oral administration contain 400 mg of the active drug and the following inactive ingredients: D&C Red No. 30 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, hydroxyethylcellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, titanium dioxide and triacetin in an extended-release formulation. Pentoxifylline extended-release tablets are a tri-substituted xanthine derivative designated chemically as 1-(5-oxohexyl)-3,7-dimethylxanthine that, unlike theophylline, is a hemorrheologic agent, i.e., an agent that affects blood viscosity. Pentoxifylline is soluble in water and ethanol, and sparingly soluble in toluene.
Meets USP Dissolution Test 6.

CLINICAL PHARMACOLOGY

Mode of Action
Pentoxifylline and its metabolites improve the flow properties of blood by decreasing its viscosity. In patients with chronic peripheral arterial disease, this increases blood flow to the affected microcirculation and enhances tissue oxygenation. The precise mode of action of pentoxifylline and the sequence of events leading to clinical improvement are still to be defined. Pentoxifylline administration has been shown to produce dose-related hemorrheologic effects, lowering blood viscosity, and improving erythrocyte flexibility. Leukocyte properties of hemorrheologic importance have been modified in animal and in vitro human studies. Pentoxifylline has been shown to increase leukocyte deformability and to inhibit neutrophil adhesion and activation. Tissue oxygen levels have been shown to be significantly increased by therapeutic doses of pentoxifylline in patients with peripheral arterial disease.

Pharmacokinetics and Metabolism
After oral administration in aqueous solution pentoxifylline is almost completely absorbed. It undergoes a first-pass effect and the various metabolites appear in plasma very soon after dosing. Peak plasma levels of the parent compound and its metabolites are reached within 1 hour. The major metabolites are Metabolite I (1-[5-hydroxyhexyl]-3,7-dimethylxanthine) and Metabolite V (1-[3-carboxypropyl]-3,7-dimethylxanthine), and plasma levels of these metabolites are 5 and 8 times greater, respectively, than pentoxifylline.
Patients with Hepatic Impairment
In patients with mild to moderate liver impairment AUC and Cmax of pentoxifylline increased 6.5 and 7.5 fold, respectively, after a single 400 mg dose of pentoxifylline extended-release tablets. AUC and Cmax of the active Metabolite I also increased 6.9 and 8.2 fold, respectively, in hepatic impaired subjects.

Pentoxifylline extended-release tablets have not been studied in patients with severe hepatic failure.

Patients with Renal Impairment
In patients with mild, moderate, or severe renal impairment the exposure to pentoxifylline and its active Metabolite I are not increased. In contrast, AUC0-tss and Cmax of the active Metabolite V in patients with mild to moderate renal impairment increased 2.4 and 2.1 fold, respectively, with a 400 mg TID regimen of pentoxifylline extended-release tablets. In severe renal impairment AUC0-tss and Cmax of the active Metabolite V increased 12.9 and 10.6 fold, respectively, with a 400 mg pentoxifylline extended-release tablets TID regimen. The increase in exposure to Metabolite V is only slightly smaller in both renal impairment groups if pentoxifylline extended-release tablets are administered BID.

INDICATIONS AND USAGE

Pentoxifylline extended-release tablets are indicated for the treatment of patients with intermittent claudication on the basis of chronic occlusive arterial disease of the limbs. Pentoxifylline extended-release tablets can improve function and symptoms but is not intended to replace more definitive therapy, such as surgical bypass, or removal of arterial obstructions when treating peripheral vascular disease.

CONTRAINDICATIONS

Pentoxifylline extended-release tablets should not be used in patients with recent cerebral and/or retinal hemorrhage or in patients who have previously exhibited intolerance to this product or methylxanthines such as caffeine, theophylline, and theobromine.

PRECAUTIONS

General
At the first sign of anaphylactic/anaphylactoid reaction, pentoxifylline extended-release tablets must be discontinued.
OVERDOSAGE

Overdosage with pentoxifylline extended-release tablets has been reported in pediatric patients and adults. Symptoms appear to be dose related. A report from a poison control center on 44 patients taking overdoses of enteric-coated pentoxifylline extended-release tablets noted that symptoms usually occurred 4 to 5 hours after ingestion and lasted about 12 hours. The highest amount ingested was 80 mg/kg; flushing, hypotension, convulsions, somnolence, loss of consciousness, fever, and agitation occurred. All patients recovered. In addition to symptomatic treatment and gastric lavage, special attention must be given to supporting respiration, maintaining systemic blood pressure, and controlling convulsions. Activated charcoal has been used to absorb pentoxifylline in patients who have overdosed.

DOSAGE AND ADMINISTRATION



The usual dosage of pentoxifylline in extended-release tablet form is one tablet (400 mg) three times a day with meals.

While the effect of pentoxifylline extended-release tablets may be seen within 2 to 4 weeks, it is recommended that treatment be continued for at least 8 weeks. Efficacy has been demonstrated in double-blind clinical studies of 6 months duration.

Digestive and central nervous system side effects are dose related. If patients develop these effects it is recommended that the dosage be lowered to one tablet twice a day (800 mg/day). If side effects persist at this lower dosage, the administration of pentoxifylline extended-release tablets should be discontinued.

In patients with severe renal impairment (creatinine clearance below 30 mL/min) reduce dose to 400 mg once a day.

Dosing information cannot be provided for patients with hepatic impairment.

NDC 00093-5116-01 UPC/GTIN No.3-00935-11601-3 Mfg.Part No.511601
RX ITEM-Pentoxifylline 400Mg Tab 100 By
NDC 00093-5116-01 UPC/GTIN No.3-00935-11601-3 Mfg.Part No.511601

BRAND: PENTOXIFYLLIN NDC: 00093-5116-01,93511601 UPC: 3-00935-11601-3,300935116013
Pentoxifylline 400Mg Tab 100 By Teva Pha
BRAND: PENTOXIFYLLIN NDC: 00093-5116-01,93511601 UPC: 3-00935-11601-3,300935116013

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
Click above for all Pentoxyfylline
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.