Pentoxifylline 400 mg Tablet, Extended Release, 100-count — NDC 60505-0033-6 (Billing 60505-0033-06)
This is a package of 100 tablets of Pentoxifylline 400 mg Tablet, Extended Release from Apotex Corp., marketed since Jun 1999 and currently FDA-listed; retail pharmacies pay about $0.2273 per tablet (NADAC).
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 006573
- GCN: 11800
- HICL (First Databank): 002819
- AHFS class code: 20:24.00.00
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
Clinical
Pentoxifylline is used to improve blood flow in patients with circulation problems to reduce aching, cramping, and tiredness in the hands and feet. It works by decreasing the thickness (viscosity) of blood. This change allows your blood to flow more easily, especially in the small blood vessels of the hands and feet. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
Read the full MedlinePlus article ↗- Pentoxifylline extended-release tablets treat intermittent claudication. That is leg pain when walking caused by long-term blocked arteries in the limbs. It can improve symptoms an...
- Swallow the tablet by mouth with meals, usually three times a day, as your prescriber directs. Give it time. You might notice a difference in 2 to 4 weeks, but treatment is recomme...
- Some people get an upset stomach, nausea, dizziness or headache. If these bother you, call your doctor, since lowering the dose may help. Call right away for bleeding, chest pain,...
- Tell me about everything you take. Blood thinners like warfarin and NSAIDs can raise bleeding concerns. Theophylline levels can rise, and some antibiotics and antidepressants like...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Pentoxifylline — tap one for details:
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.227 | $22.73 / 100 tablets |
| Medicaid paysCMS SDUD · 12 mo | $0.3563 | $35.63 / 100 tablets |
| Medicare drug plans payPart D · Q2 2026 | $0.3020 | $30.20 / 100 tablets |
Where does this data come from?
- CMS NADAC weekly file · file of Sep 30, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Marketing end | Status |
|---|---|---|---|---|---|---|
| 60505-0033-06 You're viewing this | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE | $0.2273 / ea | $22.73 | 1999-06-10 | — | Active |
| 60505-0033-07 60505-0033-7 Main listing | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE | $0.2273 / ea | $113.64 | 1999-06-10 | — | Active |
| 60505-0033-08 60505-0033-8 | 5500 TABLET, EXTENDED RELEASE in 1 BOTTLE | $0.2767 / ea | $1,522.02 | 1999-06-10 | — | Discontinued by firm |
| 60505-0033-09 60505-0033-9 | 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE | — | — | 1999-06-10 | — | Discontinued by firm |
You're viewing the smallest of 4 pack sizes for this product.
This pack has the lowest per-ea cost of the 3 priced pack sizes ($0.2273 NADAC).
This pack accounts for about 43% of this product's recent Medicaid fills; most go to the 500 tablets pack. See all packs ↓
Pack size FAQ
What quantity is in this package?
How does this package differ from NDC 60505-0033-07?
What NDC number is used to bill for this package of Pentoxifylline 400 mg Tablet, Extended Release?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Pentoxifylline 400 mg 00904-5448-61 | Major | 1 tablet | $0.227 | AB | Availability likely | — |
| Pentoxifylline 400 mg 16571-0856-01 | Rising | 100 tablets | $0.227 | AB | Availability likely | — |
| Pentoxifylline 400 mgthis 60505-0033-06 | Apotex | 100 tablets | $0.227 | AB | Availability likely | — |
| Pentoxifylline 400 mg 70954-0668-10 | ANI | 100 tablets | $0.227 | AB | Availability likely | — |
| Pentoxifylline 400 mg 00615-8511-39 | NCS | 30 tablets | — | AB | FDA listed | — |
| Pentoxifylline 400 mg 63629-2910-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Pentoxifylline 400 mg 71335-2586-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file · file of Sep 30, 2026
Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
- FDA Orange Book · refreshed Oct 3, 2026
What it looks like
Where does this data come from?
- FDA label on DailyMed · label index refreshed Oct 1, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII RFW2ET671P
Hydroxypropyl cellulose is a plant-derived thickening agent made from cellulose. It acts as a binder to hold tablet ingredients together and as a film-former to coat tablets or control how fast the medicine releases.
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UNII 3NXW29V3WO
Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
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UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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UNII Q662QK8M3B
Polyethylene glycol 8000 is a synthetic polymer made from ethylene oxide. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and add bulk to the medicine.
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UNII ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
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UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
6 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 1, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
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 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.
⏱️ Dosage and Administration ▾
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 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.
⛔ Contraindications ▾
CONTRAINDICATIONS 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.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS 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.
INCIDENCE (%) OF SIDE EFFECTS Extended-Release Tables Immediate-Release Capsules Commercially Available Used Only For Controlled Clinical Trials Pentoxifylline Placebo Pentoxifylline Placebo (Number of Patients at Risk) (321) (128) (177) (138) Discontinued for Side Effect 3.1 0 9.6
7.2CARDIOVASCULAR SYSTEM Angina/Chest Pain 0.3 - 1.1
2.2Arrhythmia/Palpitation - - 1.7
0.7Flushing - - 2.3
0.7DIGESTIVE SYSTEM Abdominal Discomfort - - 4.0
1.4Belching/Flatus/Bloating 0.6 - 9.0
3.6Diarrhea - - 3.4
2.9Dyspepsia 2.8 4.7 9.6
2.9Nausea 2.2 0.8 28.8
8.7Vomiting 1.2 - 4.5
0.7NERVOUS SYSTEM Agitation/Nervousness - - 1.7
0.7Dizziness 1.9 3.1 11.9
4.3Drowsiness - - 1.1
5.8Headache 1.2 1.6 6.2
5.8Insomnia - - 2.3
2.2Tremor 0.3 0.8 - - Blurred Vision - - 2.3
1.4Pentoxifylline 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 - dyspnea, edema, hypotension. Digestive - anorexia, cholecystitis, constipation, dry mouth/thirst.
Nervous - anxiety, confusion, depression, seizures, aseptic meningitis. Respiratory - epistaxis, flu-like symptoms, laryngitis, nasal congestion. Skin and Appendages - brittle fingernails, pruritus, rash, urticaria, angioedema.
Special Senses - blurred vision, conjunctivitis, earache, scotoma. Miscellaneous - bad taste, excessive salivation, leukopenia, malaise, sore throat/swollen neck glands, weight change. 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.
🔄 Drug Interactions ▾
Drug Interactions Bleeding has been reported in patients treated with pentoxifylline with or without concomitant NSAIDs, anticoagulants, or platelet aggregation inhibitors. Increased prothrombin time has been reported in patients concomitantly treated with pentoxifylline and vitamin K antagonists. Monitoring of anticoagulant activity in these patients is recommended when pentoxifylline is introduced or the dose is changed.
Concomitant administration of pentoxifylline and theophylline-containing drugs leads to increased theophylline levels and theophylline toxicity in some individuals. Monitor theophylline levels when starting pentoxifylline or changing dose. Concomitant administration of strong CYP1A2 inhibitors (including e.g. ciprofloxacin or fluvoxamine) may increase the exposure to pentoxifylline (see ADVERSE REACTIONS ).
Pentoxifylline has been used concurrently with antihypertensive drugs, beta blockers, digitalis, diuretics, and antiarrhythmics, without observed problems. Small decreases in blood pressure have been observed in some patients treated with pentoxifylline plus nifedipine or captopril; periodic systemic blood pressure monitoring is recommended for patients receiving concomitant antihypertensive therapy. If indicated, dosage of the antihypertensive agents should be reduced.
Postmarketing cases of increased anticoagulant activity have been reported in patients concomitantly treated with pentoxifylline and vitamin K antagonists. Monitoring of anticoagulant activity in these patients is recommended when pentoxifylline is introduced or the dose is changed. Concomitant administration with cimetidine is reported to increase the average steady state plasma concentration of pentoxifylline (~25%) and the Metabolite I (~30%).
🤰 Pregnancy ▾
Pregnancy Category C. Teratogenicity studies have been performed in rats and rabbits using oral doses up to 576 and 264 mg/kg, respectively. On a weight basis, these doses are 24 and 11 times the maximum recommended human daily dose (MRHD); on a body-surface-area basis, they are 4.2 and 3.5 times the MRHD.
No evidence of fetal malformation was observed. Increased resorption was seen in rats of the 576 mg/kg group. There are no adequate and well controlled studies in pregnant women.
Pentoxifylline should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Category C. Teratogenicity studies have been performed in rats and rabbits using oral doses up to 576 and 264 mg/kg, respectively. On a weight basis, these doses are 24 and 11 times the maximum recommended human daily dose (MRHD); on a body-surface-area basis, they are 4.2 and 3.5 times the MRHD.
No evidence of fetal malformation was observed. Increased resorption was seen in rats of the 576 mg/kg group. There are no adequate and well controlled studies in pregnant women.
Pentoxifylline should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
🧒 Pediatric Use ▾
Pediatric Use Safety and effectiveness in pediatric patients have not been established.
🆘 Overdosage ▾
OVERDOSAGE 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-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.
🧬 Clinical Pharmacology ▾
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. Following oral administration of aqueous solutions containing 100 to 400 mg of pentoxifylline, the pharmacokinetics of the parent compound and Metabolite I are dose-related and not proportional (non-linear), with half-life and area under the blood-level time curve (AUC) increasing with dose.
The elimination kinetics of Metabolite V are not dose-dependent. The apparent plasma half-life of pentoxifylline varies from 0.4 to 0.8 hours and the apparent plasma half-lives of its metabolites vary from 1 to 1.6 hours. There is no evidence of accumulation or enzyme induction (Cytochrome P450) following multiple oral doses.
Excretion is almost totally urinary; the main biotransformation product is Metabolite V. Essentially no parent drug is found in the urine. Despite large variations in plasma levels of parent compound and its metabolites, the urinary recovery of Metabolite V is consistent and shows dose proportionality.
Less than 4% of the administered dose is recovered in feces. Food intake shortly before dosing delays absorption of an immediate-release dosage form but does not affect total absorption. The pentoxifylline AUC was increased and elimination rate decreased in an older population (60 to 68 years, n=6) compared to younger individuals (22 to 30 years, n=6) (see PRECAUTIONS , Geriatric Use ).
After administration of the 400 mg extended-release pentoxifylline tablet, plasma levels of the parent compound and its metabolites reach their maximum within 2 to 4 hours and remain constant over an extended period of time. Coadministration of pentoxifylline extended-release tablets with meals resulted in an increase in mean AUC and C max of about 1.1 and 1.3 fold for pentoxifylline, respectively. C max for Metabolite I also increased about 1.2 fold.
The extended release of pentoxifylline from the tablet eliminates peaks and troughs in plasma levels for improved gastrointestinal tolerance. Patients with Hepatic Impairment In patients with mild to moderate liver impairment AUC and C max of pentoxifylline increased 6.5 and 7.5 fold, respectively, after a single 400 mg dose of pentoxifylline extended-release tablet AUC and C max of the active Metabolite I also increased 6.9 and 8.2 fold, respectively, in hepatic impaired subjects. Pentoxifylline extended-release tablet has 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… [Excerpted — this section continues on DailyMed.]
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Pentoxifylline extended-release tablets, USP are available for oral administration as 400 mg white, oval, unscored, film coated tablets, imprinted “APO 033” on one side and plain on the other side; supplied in bottles of 100 (NDC 60505-0033-6), bottles of 500 (NDC 60505-0033-7), bottles of 1,000 (NDC 60505-0033-9) and bottles of 5,500 (NDC 60505-0033-8). Store at 20° to 25°C (68° to 77°F) [see Controlled Room Temperature]. Dispense in a tight, light-resistant container [see USP].
APOTEX INC. PENTOXIFYLLINE EXTENDED-RELEASE TABLETS, USP 400mg Manufactured by Manufactured for Apotex Inc. Apotex Corp.
Toronto, Ontario Weston, Florida Canada M9L 1T9 33326 Revised: May 2016 Rev. 7
📋 Description ▾
DESCRIPTION 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 C 13 H 18 N 4 O 3 and its molecular weight is 278.31. The chemical structure is: USP Dissolution Test 9
⚠️ Precautions ▾
PRECAUTIONS General At the first sign of anaphylactic/anaphylactoid reaction, pentoxifylline must be discontinued. Patients with chronic occlusive arterial disease of the limbs frequently show other manifestations of arteriosclerotic disease. Pentoxifylline has been used safely for treatment of peripheral arterial disease in patients with concurrent coronary artery and cerebrovascular diseases, but there have been occasional reports of angina, hypotension, and arrhythmia.
Controlled trials do not show that pentoxifylline causes such adverse effects more often than placebo, but, as it is a methylxanthine derivative, it is possible some individuals will experience such responses. Patients on warfarin should have more frequent monitoring of prothrombin times, while patients with other risk factors complicated by hemorrhage (e.g., recent surgery, peptic ulceration, cerebral and/or retinal bleeding) should have periodic examinations for bleeding including, hematocrit and/or hemoglobin. In patients with hepatic or renal impairment, the exposure to pentoxifylline and/or active metabolites is increased.
The consequences of the increase in drug exposure are not known (see Pharmacokinetics and Metabolism and DOSAGE AND ADMINISTRATION ). Drug Interactions Bleeding has been reported in patients treated with pentoxifylline with or without concomitant NSAIDs, anticoagulants, or platelet aggregation inhibitors. Increased prothrombin time has been reported in patients concomitantly treated with pentoxifylline and vitamin K antagonists.
Monitoring of anticoagulant activity in these patients is recommended when pentoxifylline is introduced or the dose is changed. Concomitant administration of pentoxifylline and theophylline-containing drugs leads to increased theophylline levels and theophylline toxicity in some individuals. Monitor theophylline levels when starting pentoxifylline or changing dose.
Concomitant administration of strong CYP1A2 inhibitors (including e.g. ciprofloxacin or fluvoxamine) may increase the exposure to pentoxifylline (see ADVERSE REACTIONS ). Pentoxifylline has been used concurrently with antihypertensive drugs, beta blockers, digitalis, diuretics, and antiarrhythmics, without observed problems. Small decreases in blood pressure have been observed in some patients treated with pentoxifylline plus nifedipine or captopril; periodic systemic blood pressure monitoring is recommended for patients receiving concomitant antihypertensive therapy.
If indicated, dosage of the antihypertensive agents should be reduced. Postmarketing cases of increased anticoagulant activity have been reported in patients concomitantly treated with pentoxifylline and vitamin K antagonists. Monitoring of anticoagulant activity in these patients is recommended when pentoxifylline is introduced or the dose is changed.
Concomitant administration with cimetidine is reported to increase the average steady state plasma concentration of pentoxifylline (~25%) and the Metabolite I (~30%). Carcinogenesis, Mutagenesis and Impairment of Fertility Long-term studies of the carcinogenic potential of pentoxifylline were conducted in mice and rats by dietary administration of the drug at doses up to 450 mg/kg (approximately 19 times the maximum recommended human daily dose (MRHD) in both species when based on body weight; 1.5 times the MRHD in the mouse and 3.3 times the MRHD in the rat when based on body surface area).
In mice, the drug was administered for 18 months, whereas in rats, the drug was administered for 18 months followed by an additional 6 months without drug exposure. In the rat study, there was a statistically significant increase in benign mammary fibroadenomas in females of the 450 mg/kg group. The relevance of this finding to human use is uncertain.
Pentoxifylline was devoid of mutagenic activity in various strains of Salmonella (Ames test) and in cultured mammalian cells (unscheduled DNA synthesis test) when tested in the presence and absence of me… [Excerpted — this section continues on DailyMed.]
🍼 Nursing Mothers ▾
Nursing Mothers Pentoxifylline and its metabolites are excreted in human milk. Because of the potential for tumorigenicity shown for pentoxifylline in rats, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
Carcinogenesis, Mutagenesis and Impairment of Fertility Long-term studies of the carcinogenic potential of pentoxifylline were conducted in mice and rats by dietary administration of the drug at doses up to 450 mg/kg (approximately 19 times the maximum recommended human daily dose (MRHD) in both species when based on body weight; 1.5 times the MRHD in the mouse and 3.3 times the MRHD in the rat when based on body surface area). In mice, the drug was administered for 18 months, whereas in rats, the drug was administered for 18 months followed by an additional 6 months without drug exposure.
In the rat study, there was a statistically significant increase in benign mammary fibroadenomas in females of the 450 mg/kg group. The relevance of this finding to human use is uncertain. Pentoxifylline was devoid of mutagenic activity in various strains of Salmonella (Ames test) and in cultured mammalian cells (unscheduled DNA synthesis test) when tested in the presence and absence of metabolic activation.
It was also negative in the in vivo mouse micronucleus test.
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL - 400 mg BOTTLE APOTEX CORP. NDC 60505-0033-6 Pentoxifylline Extended-Release Tablets, USP 400 mg Rx 100 count