Tuesday 6 September 2016

Pentoxifylline



Class: Hemorrheologic Agents
VA Class: CV900
Molecular Formula: C13H18N4O3
CAS Number: 6493-05-6
Brands: Pentoxil, Trental

Introduction

Hemorrheologic agent; a synthetic xanthine derivative.1 2 3 4


Uses for Pentoxifylline


Peripheral Vascular Disease


Used for the symptomatic treatment of intermittent claudication associated with peripheral vascular disease (i.e., chronic occlusive arterial disease of the extremities).1 2 4 6 7 8 9 13 14 16 18 21 27 32 52 56 57 58 59 60 61 62 63 64 65 66 67 68 69 70 71 120 121 May improve function of the extremities and symptoms of the disease1 2 4 6 7 8 9 13 14 16 18 21 27 32 52 56 57 58 59 60 61 62 63 64 65 66 67 68 69 70 71 103 120 121 (e.g., improvement in walking distance and duration;2 4 6 7 8 13 14 27 32 35 52 57 59 60 61 62 63 64 65 68 69 71 119 120 121 reductions in severity and occurrence of paresthesia6 7 8 57 59 62 63 64 68 121 and trophic ulcers6 7 8 109 110 121 ). Does not affect other symptoms associated with claudication such as cramping, tiredness, tightness, and pain during exercise.57 59 62 63 64 68 Pentoxifylline should not replace more definitive therapy for peripheral vascular disease such as smoking cessation, weight loss, exercise therapy,18 103 107 108 121 or surgical bypass or removal of arterial obstructions when indicated.1


Cerebrovascular Disease


Also has been used for the management of acute73 76 81 83 121 and chronic cerebrovascular insufficiency†73 74 75 77 78 79 80 81 82 83 84 85 86 87 121 . Improves psychopathologic symptoms74 81 87 121 (e.g., those associated with aging, stroke, TIAs), including memory loss, disorientation, constructional apraxia, impaired practical reasoning, motor impairment, and dizziness.74 81 87 Reduces the incidence of recurrence of TIAs.87 121


Male Infertility


Used in a limited number of patients for the treatment of male fertility disorders†, including asthenospermia†90 92 121 and idiopathic oligospermia†.91 92 121 Increases the duration of activity of ejaculated spermatozoa.90 95


Pentoxifylline Dosage and Administration


Administration


Administration


Administer orally, preferably with meals.1


An aluminum and magnesium hydroxides antacid can be administered concomitantly to reduce intolerable GI effects.117


Dosage


Adults


Peripheral Vascular Disease

Oral

400 mg 3 times daily.1 2 4 8 13 18 59 60 61 63 64 65 68 69 71 Continue for at least 8 weeks to determine efficacy.1 Reduce dosage to 400 mg twice daily if adverse GI and/or CNS effects develop.1 Discontinue if adverse effects persist at this lower dosage.1 Efficacy was demonstrated in clinical studies of 6-months duration.1


Cautions for Pentoxifylline


Contraindications



  • History of intolerance to pentoxyphylline or to xanthine derivatives such as caffeine, theophylline, or theobromine.1




  • Recent cerebral and/or retinal hemorrhage.1



Warnings/Precautions


General Precautions


Cardiovascular Effects

Other manifestations of arteriosclerotic disease may be exhibited frequently in patients with chronic occlusive arterial disease.1 Angina, hypotension, and arrhythmia reported occasionally in patients with concomitant coronary artery and/or cerebrovascular disease; consider the possibility that such effects may occur.1


Hematologic Effects

Periodic examination for signs of bleeding (e.g., hemoglobin and hematocrit determinations) recommended in patients who have risk factors potentially complicated by hemorrhage (e.g., recent surgery, peptic ulceration, cerebral and/or retinal bleeding).1


Specific Populations


Pregnancy

Category C.1


Lactation

Distributed into milk.1 102 104 Discontinue nursing or the drug, taking into account the importance of the drug to the woman.1


Pediatric Use

Safety and efficacy not established.a


Common Adverse Effects


Dyspepsia, nausea, dizziness.1


Interactions for Pentoxifylline


Specific Drugs




































Drug



Interaction



Comments



Antacids



Potential pharmacokinetic interaction (reduced bioavailability of several metabolites)117



Interaction not clinically important; concomitant administration may reduce intolerable GI effects117



Antiarrhythmic agents



Interaction not observeda



Anticoagulants, oral (warfarin)



Possible bleeding an/or prolonged PT1



Determine prothrombin time more frequently during concomitant therapy1



Antidiabetic agents



Interaction not observed1



Antihypertensive agents



Possible additive antihypertensive effect1



Periodic monitoring of systemic blood pressure recommended;1 if required, reduce antihypertensive dosage 1



β-Adrenergic blocking agents



Interaction not observed1



Cardiac Glycosides



Interaction not observed1



Diuretics



Interaction not observed1



Platelet-aggregation inhibitors



Possible bleeding and/or prolonged PT



Theophylline



Possible increased theophylline levels and possible theophylline toxicitya



Closely monitor and adjust theophylline dosage as needed1


Pentoxifylline Pharmacokinetics


Absorption


Bioavailability


Rapidly and almost completely absorbed following oral administration,1 2 3 4 53 54 55 with peak plasma concentrations usually attained within 1 hour.1


Mean absolute bioavailability is 33% in healthy men.122


Onset


Symptomatic relief may occur within 2–4 weeks following initiation of therapy.1 The therapeutic effects result principally from an action on newly formed erythrocytes rather than on circulating mature erythrocytes.3 Allow at least 8 weeks to determine full therapeutic efficacy.1


Food


Food increases mean peak plasma concentrations and mean AUC.a


Special Populations


Peak plasma concentrations and mean absolute bioavailability were substantially increased, and time to peak concentration was prolonged in adults with hepatic cirrhosis.122


Increased AUC in patients 60–68 years of age, compared to younger adults.1


Distribution


Extent


Not known whether pentoxifylline or its metabolites cross the placenta.102 103 Pentoxifylline and its metabolites are distributed into milk.102 104


Elimination


Metabolism


Extensively metabolized in erythrocytes and the liver to active metabolites3 4 53 , principally via reduction, oxidation, and demethylation.3 4 53 55


Elimination Route


Eliminated in urine (95%) 3 4 53 55 and feces (4%), principally as metabolites.1 3 4 53 55


Half-life


0.4–0.8 hours.1 53 55


Special Populations


Prolonged elimination in adults with hepatic cirrhosis.122


Decreased elimination rate in patients 60–68 years of age, compared with younger adults.1


Stability


Storage


Oral


Tablets

Tight, light-resistant containers at 15–30°C.1


Actions and SpectrumActions



  • Increases erythrocyte flexibility (deformability)1 2 3 4 6 7 8 9 10 11 12 13 18 19 20 21 and reduces the viscosity of whole blood, which decreases total systemic vascular resistance,3 4 improves blood flow,1 2 3 18 and increases tissue oxygenation1 2 3 4 6 7 8 9 10 11 12 13 14 15 in patients with peripheral vascular disease.1 2 3 4 6 7 16 17 20 21




  • Affects the electrolyte balance of erythrocytes which may improve erythrocyte flexibility and blood flow.6 7 29




  • May improve poststenotic blood flow in relatively poorly perfused tissue.6 7 26 27 30 31 32 Improves resting blood flow and reactive hyperemia.26 31 Increases peak flow of reactive hyperemia in the extremities indicating an increase in reserve blood flow which is associated with some increase in walking distance.31




  • Improves regional and hemispheric cerebral blood flow, particularly in ischemic areas where microcirculation is impaired.73 74 75 76 77 78 79 81 82 83 84 85 86 87 Increases oxygen and glucose supply, eliminates or reduces perivascular edema, and enhances cellular function in some patients with cerebrovascular insufficiency.77 82 87 121



Advice to Patients



  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.1




  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1




  • Importance of informing patients of other important precautionary information. (See Cautions.)



Preparations


Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.


* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name























Pentoxifylline

Routes



Dosage Forms



Strengths



Brand Names



Manufacturer



Oral



Tablets, extended-release, film-coated



400 mg*



Pentoxifylline Extended-release Tablets



Biovail, Clonmel, Impax, Mylan, Pliva, Purepac, Teva, Torpharm, Watson



Pentoxil



Upsher-Smith



Trental (with povidone)



Sanofi-Aventis


Comparative Pricing


This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.


Pentoxifylline CR 400MG Controlled-release Tablets (TEVA PHARMACEUTICALS USA): 100/$24.99 or 300/$49.98


TRENtal 400MG Controlled-release Tablets (SANOFI-AVENTIS U.S.): 60/$84.29 or 180/$229.85



Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.


The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions July 2006. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.


† Use is not currently included in the labeling approved by the US Food and Drug Administration.




References



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29. Porsche E, Stefanovich V, Grigoleit H. Inhibition of K+ leakage from human red blood cells by pentoxifylline. IRCS Med Sci: Libr Compend. 1977; 5:484-8.



30. Ehrly AM, Schroeder W, Dannhof S. The effect of pentoxifylline on the oxygen pressure of ischemic muscle tissue in patients with chronic arterial occlusions. IRCS Med Sci: Libr Compend. 1977; 5:411-7.



31. Heidrich H, Witt D, Witt E. Plethysmographic studies in the influence of intravenous long-term therapy with pentoxifylline in arterial occlusive disease. IRCS Med Sci: Libr Compend. 1977; 5:487-95.



32. Komarov FI, Olbinskaja LI, Severova TM. Pentoxifylline in the treatment of peripheral vascular disease. Pharmatherapeutica. 1978; 2(Suppl 1):82-9.



33. Seiffge D. Effect of pentoxifylline on red cell aggregation. IRCS Med Sci: Libr Compend. 1982; 8:727-34.



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35. Gorbatschova FE, Turaschwili GA, Kvassov VT et al. The circulatory and clinical effects of pentoxifylline. Pharmatherapeutica. 1978; 2:100-7.



36. Stefanovich V, Jarvis P, Grigoleit HG. The effect of pentoxifylline on the 3′,5′-cyclic AMP-system in bovine platelets. Int J Biochem. 1977; 8:359-63.



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38. Zinzadse KI, Gulischwili LN, Tavchelidse TD et al. The effect of pentoxifylline on the flow properties of blood in experimental atherosclerosis in rabbits. Pharmatherapeutica. 1978; 2:118-23.



39. Weithmann KU. The influence of pentoxifylline on interactions between blood vessel wall and platelets. IRCS Med Sci: Libr Compend. 1980; 8:293-300.



40. Matzky R, Darius H, Schrör K. The release of prostacyclin (PGI2) by pentoxifylline from human vascular tissue. Arzneimittelforschung. 1982; 32:1315-8. [PubMed 6817760]



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52. Völker D. Haemorheological investigations in patients with vascular disease undergoing treatment with pentoxifylline. Pharmatherapeutica. 1978; 1:154-9.



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57. Bollinger A, Frei C. Double-blind study of pentoxifylline against placebo in patients with intermittent claudication. Pharmatherapeutica. 1977; 1:557-62.



58. Coffman JD. Medical therapy of chronic obstructive arterial disease. Drug Ther. 1982; 12:53-67.



59. Porter JM, Cutler BS, Lee BY et al. Pentoxifylline efficacy in the treatment of intermittent claudication: multicenter controlled double-blind trial with objective assessment of chronic occlusive arterial disease patients. Am Heart J. 1982; 104:66-72. [IDIS 154447] [PubMed 7046409]



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88. Stennert E. Bell’s palsy: a new concept of treatment. Arch Oto-Rhino-Laryngol. 1979; 225:265-8.



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90. Marsiglia EAP, Santillan EJ. Pentoxifylline treatment of asthenozoospermia. Andrologia. 1983; 15:571-2. [IDIS 190308] [PubMed 6666863]



91. Wang C, Chan CW, Wong KK et al. Comparison of the effectiveness of placebo, clomiphene citrate, mesterolone, pentoxifylline, and testosterone rebound therapy for the treatment of idiopathic oligospermia. Fertil Steril. 1983; 40:358-65. [IDIS 175877] [PubMed 6411497]



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102. Roney JV (Hoechst-Roussel Pharmaceuticals, Inc., Somerville, NJ): Personal communication; 1985 Mar 29.



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