MedPath

Pentoxifylline

Generic Name
Pentoxifylline
Drug Type
Small Molecule
Chemical Formula
C13H18N4O3
CAS Number
6493-05-6
Unique Ingredient Identifier
SD6QCT3TSU

Overview

Pentoxifylline (PTX) is a synthetic dimethylxanthine derivative that modulates the rheological properties of blood and also has both anti-oxidant and anti-inflammatory properties. Although originally developed to treat intermittent claudication, a form of exertion-induced leg pain common in patients with peripheral arterial disease, PTX has been investigated for its possible use in diverse conditions, including osteoradionecrosis, diabetic kidney disease, and generally any condition associated with fibrosis. More recently, PTX has been suggested as a possible treatment for COVID-19-induced pulmonary complications due to its ability to regulate the production of inflammatory cytokines. Pentoxifylline has been marketed in Europe since 1972; PTX extended-release tablets sold under the trade name TRENTAL by US Pharm Holdings were first approved by the FDA on Aug 30, 1984, but have since been discontinued. A branded product, PENTOXIL, marketed by Upsher-Smith Laboratories, and generic forms marketed by Valeant Pharmaceuticals and APOTEX have been available since the late 1990s.

Background

Pentoxifylline (PTX) is a synthetic dimethylxanthine derivative that modulates the rheological properties of blood and also has both anti-oxidant and anti-inflammatory properties. Although originally developed to treat intermittent claudication, a form of exertion-induced leg pain common in patients with peripheral arterial disease, PTX has been investigated for its possible use in diverse conditions, including osteoradionecrosis, diabetic kidney disease, and generally any condition associated with fibrosis. More recently, PTX has been suggested as a possible treatment for COVID-19-induced pulmonary complications due to its ability to regulate the production of inflammatory cytokines. Pentoxifylline has been marketed in Europe since 1972; PTX extended-release tablets sold under the trade name TRENTAL by US Pharm Holdings were first approved by the FDA on Aug 30, 1984, but have since been discontinued. A branded product, PENTOXIL, marketed by Upsher-Smith Laboratories, and generic forms marketed by Valeant Pharmaceuticals and APOTEX have been available since the late 1990s.

Indication

Pentoxifylline is indicated for the treatment of intermittent claudication in patients with chronic occlusive arterial disease. Pentoxifylline may improve limb function and reduce symptoms but cannot replace other therapies such as surgical bypass or removal of vascular obstructions.

Associated Conditions

  • Intermittent Claudication
  • Venous Leg Ulcer (VLU)
  • Severe alcoholic liver disease

FDA Approved Products

Pentoxifylline
Manufacturer:State of Florida DOH Central Pharmacy
Route:ORAL
Strength:400 mg in 1 1
Approved: 2010/05/31
NDC:53808-0758
Pentoxifylline
Manufacturer:Aphena Pharma Solutions - Tennessee, LLC
Route:ORAL
Strength:400 mg in 1 1
Approved: 2016/06/15
NDC:43353-123
PENTOXIFYLLINE
Manufacturer:Direct_Rx
Route:ORAL
Strength:400 mg in 1 1
Approved: 2019/08/02
NDC:72189-025
PENTOXIFYLLINE
Manufacturer:Direct_Rx
Route:ORAL
Strength:400 mg in 1 1
Approved: 2019/08/02
NDC:72189-025
PENTOXIFYLLINE
Manufacturer:REMEDYREPACK INC.
Route:ORAL
Strength:400 mg in 1 1
Approved: 2024/01/31
NDC:70518-1285

Singapore Approved Products

TRENLIN 400 SR TABLET 400 mg
Manufacturer:DUOPHARMA MANUFACTURING (BANGI) SDN.BHD.
Form:TABLET, FILM COATED
Strength:400 mg
Online:Yes
Approved: 1999/02/08
Approval:SIN10727P

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