Trade Name: PENTOXIFYLLINE

Following information is meant for : Wholesalers, Suppliers, Exporters, Doctors, CROs, Comparator Supplies, Hospitals, MOH Tender Supplies, Generic, Brand, Cooperate Sourcing, India, Institutional Buyers.

Manufacturer: NuCare Pharmaceuticals, Inc.

Presentation: TABLET, EXTENDED RELEASE, HUMAN PRESCRIPTION DRUG

Strength: 400 mg/1

Storage and handling

PENTOXIFYLLINE Blood Viscosity Reducer [EPC],Hematologic Activity Alteration [PE]

Disclaimer:
  1. These products are NOT FOR SALE in US territories. We offer them for Exports outside of US Territories to Trade Professionals or patients with a valid prescription.
  2. Trademark shown are property of their respective owners and GNH India does not lay any claim on them.
  3. Read more
  • No data
  • Pentoxifylline extended-release tablets, USP for oral administration contain 400 mg of the active drug and the following inactive ingredients: colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, and titanium dioxide in an extended-release formulation. Pentoxifylline is a tri-substituted xanthine derivative designated chemically as 3,7-Dihydro-3,7-dimethyl-1-(5-oxohexyl)-1H-purine-2,6-dione 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. The molecular formula is Cn n n Hn n n Nn n n On n n and its molecular weight is 278.31.n nn
  • The chemical structure is:
  • USP Dissolution Test 9
  • No data
  • 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 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.
  • Pentoxifylline 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.
  • No data
  • Clinical trials were conducted using either extended-release pentoxifylline tablets for up to 60 weeks or immediate-release pentoxifylline capsules for up to 24 weeks. Dosage ranges in the tablet studies were 400 mg bid to tid and in the capsule studies, 200 to 400 mg tid. The table summarizes the incidence (in percent) of adverse reactions considered drug related, as well as the numbers of patients who received extended-release pentoxifylline tablets, immediate-release pentoxifylline capsules, or the corresponding placebos. The incidence of adverse reactions was higher in the capsule studies (where dose related increases were seen in digestive and nervous system side effects) than in the tablet studies. Studies with the capsule include domestic experience, whereas studies with the extended-release tablets were conducted outside the U.S.
  • The table indicates that in the tablet studies few patients discontinued because of adverse effects.
  • Pentoxifylline has been marketed in Europe and elsewhere since 1972. In addition to the above symptoms, the following have been reported spontaneously since marketing or occurred in other clinical trials with an incidence of less than 1%; the causal relationship was uncertain:
  • Cardiovascular
  • Digestive
  • Nervous
  • Respiratory
  • Skin and Appendages
  • Special Senses
  • Miscellaneous
  • A few rare events have been reported spontaneously worldwide since marketing in 1972. Although they occurred under circumstances in which a causal relationship with pentoxifylline could not be established, they are listed to serve as information for physicians. Cardiovascular - angina, arrhythmia, tachycardia. Digestive - hepatitis, jaundice, cholestasis, increased liver enzymes; and Hemic and Lymphatic - decreased serum fibrinogen, pancytopenia, aplastic anemia, leukemia, purpura, thrombocytopenia. Immune system disorders - anaphylactic reaction, anaphylactoid reaction, anaphylactic shock.
  • Overdosage with pentoxifylline 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-releaseu00a0u00a0tablets 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.
  • 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 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 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.
  • Pentoxifylline extended-release tablets, USP are available for oral administration as 400 mg white, oval, unscored, film coated tablets, imprinted u201cAPO 033u201d on one side and plain on the other side; supplied in bottles of 30 (NDC 66267-710-30), bottles of 60 (NDC 66267-710-60), bottles of 90 (NDC 66267-710-90).
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [see Controlled Room Temperature].
  • Dispense in a tight, light-resistant container [see USP].
  • APOTEX INC.n- PENTOXIFYLLINE EXTENDED-RELEASE TABLETS, USP n- 400mg
  • Manufactured by Manufactured for
  • Revised: May 2016 n n
  • Rev. 7
  • No data

Ask for Quote

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler, Supplier, Exporters from India of PENTOXIFYLLINE (PENTOXIFYLLINE) which is also known as PENTOXIFYLLINE and Manufactured by NuCare Pharmaceuticals, Inc.. It is available in strength of 400 mg/1.

PENTOXIFYLLINE (PENTOXIFYLLINE) 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.

Browse Our Services And Processes

Name Patient Supply

Name Patient Supply

Validated Cold Chain Shipment

Validated Cold Chain Shipment

Comparator Sourcing for Clinical Trials

Comparator Sourcing for Clinical Trials

Our Process - The Gnh Way

Our Process - The Gnh Way

Other Pharmaceutical Products

Succinylcholine Chloride (Quelicin)

Succinylcholine Chloride (Quelicin)

Liposomal Amphotericin - B for Injection IP (AmBisome)

Liposomal Amphotericin - B for Injection IP (AmBisome)

Edatate Calcium Disodium Injection USP 200mg/ml (Cal-Rsodate)

Edatate Calcium Disodium Injection USP 200mg/ml (Cal-Rsodate)

Melphalan Injection IP 50mg (Alkacel)

Melphalan Injection IP 50mg (Alkacel)

Monobenzone Cream USP 20% (Albaquin)

Monobenzone Cream USP 20% (Albaquin)

Beclomethasone Dipropionate and Levosalbutamol Inhaler (Aerocort)

Beclomethasone Dipropionate and Levosalbutamol Inhaler (Aerocort)

Are you an existing customer or a vendor of GNH India? Log in here to