Trental 400mg Tablets
It is used to ease pain, numbness, and tingling in the legs.It is used to treat certain blood vessel problems.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Hemorheologic agent
Pharmacologic Class
Xanthine derivative
Pregnancy Category
Category C
FDA Approved
Aug 1984
DEA Schedule
Not Controlled
Overview
What is this medicine?
Pentoxifylline is a medication used to improve blood flow in people with a condition called intermittent claudication. This condition causes pain, cramping, or numbness in the legs during exercise due to poor circulation. Pentoxifylline works by making your blood less sticky and helping your red blood cells become more flexible, allowing them to pass more easily through narrow blood vessels.
How to Use This Medicine
Taking Your Medication
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. Take your medication with meals to help your body absorb it properly. Swallow the tablet whole - do not chew, break, or crush it. Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel better.
Storing and Disposing of Your Medication
Store your medication at room temperature, away from light and moisture. Keep it in a dry place, such as a closet or drawer, and avoid storing it in the bathroom. Keep all medications in a safe and secure location, out of the reach of children and pets. When your medication is no longer needed or has expired, dispose of it properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. Check with your pharmacist for guidance on the best way to dispose of your medication, and ask about any local drug take-back programs.
Missing a Dose
If you miss a dose, take it as soon as you remember, with a meal. However, if it's close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses to make up for a missed one.
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. Take your medication with meals to help your body absorb it properly. Swallow the tablet whole - do not chew, break, or crush it. Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel better.
Storing and Disposing of Your Medication
Store your medication at room temperature, away from light and moisture. Keep it in a dry place, such as a closet or drawer, and avoid storing it in the bathroom. Keep all medications in a safe and secure location, out of the reach of children and pets. When your medication is no longer needed or has expired, dispose of it properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. Check with your pharmacist for guidance on the best way to dispose of your medication, and ask about any local drug take-back programs.
Missing a Dose
If you miss a dose, take it as soon as you remember, with a meal. However, if it's close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses to make up for a missed one.
Lifestyle & Tips
- Take this medication exactly as prescribed, usually three times a day with meals to reduce stomach upset.
- Do not crush, chew, or break the extended-release tablets; swallow them whole.
- It may take 2 to 4 weeks to notice an improvement in your symptoms, and up to 8 weeks for the full effect. Continue taking the medication as directed even if you don't see immediate results.
- Smoking cessation is crucial for improving intermittent claudication and maximizing the benefits of this medication.
- Regular exercise, as tolerated and recommended by your doctor, can also help improve symptoms.
- Inform your doctor or dentist that you are taking pentoxifylline before any surgery or dental procedures, especially if you are also taking blood thinners.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
400 mg three times daily with meals
Dose Range:
400 - 1200 mg
Condition-Specific Dosing:
intermittent_claudication:
400 mg three times daily with meals. May reduce to 400 mg twice daily if GI or CNS side effects occur.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment, monitor for adverse effects.
Moderate:
Reduce dose to 400 mg twice daily or 400 mg once daily if creatinine clearance is <30 mL/min.
Severe:
Reduce dose to 400 mg twice daily or 400 mg once daily if creatinine clearance is <30 mL/min.
Dialysis:
Consider significant dose reduction (e.g., 400 mg once daily or less) due to accumulation of active metabolites; monitor closely.
Hepatic Impairment:
Mild:
No specific adjustment, monitor for adverse effects.
Moderate:
Consider dose reduction (e.g., 400 mg twice daily) due to impaired metabolism and increased plasma levels.
Severe:
Consider significant dose reduction (e.g., 400 mg once daily) due to impaired metabolism and increased plasma levels; monitor closely.
Pharmacology
Mechanism of Action
Pentoxifylline is a xanthine derivative that improves blood flow by decreasing blood viscosity and improving erythrocyte flexibility. It is thought to exert its hemorheologic effect by inhibiting phosphodiesterase, leading to increased intracellular cAMP in red blood cells, white blood cells, and vascular endothelial cells. This results in decreased blood viscosity, improved red blood cell deformability, reduced platelet aggregation, and decreased fibrinogen concentrations, ultimately enhancing microcirculatory blood flow and tissue oxygenation.
Pharmacokinetics
Absorption:
Bioavailability:
10-30%
Tmax:
1 hour (parent drug), 2-4 hours (metabolites)
FoodEffect:
Food delays absorption but does not significantly affect the extent of absorption.
Distribution:
Vd:
Not widely reported, but generally high due to extensive tissue distribution of metabolites.
ProteinBinding:
~45% (parent drug), metabolites are less protein bound.
CnssPenetration:
Limited
Elimination:
HalfLife:
0.4-0.8 hours (parent drug), 1-1.6 hours (active metabolites)
Clearance:
High systemic clearance due to extensive first-pass metabolism.
ExcretionRoute:
Primarily renal (95% as metabolites)
Unchanged:
<1%
Pharmacodynamics
OnsetOfAction:
Gradual, therapeutic effects may take 2-4 weeks.
PeakEffect:
Not a sharp peak for therapeutic effect; sustained improvement with continued dosing.
DurationOfAction:
Effects persist with continued dosing; requires chronic administration for benefit.
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Help Immediately
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Chest pain or pressure
Abnormal heartbeat
Severe dizziness or fainting
Unexplained bruising or bleeding
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only mild ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms that bother you or do not go away, contact your doctor:
Burping
Bloating
Gas
Upset stomach or vomiting
Dizziness or headache
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Chest pain or pressure
Abnormal heartbeat
Severe dizziness or fainting
Unexplained bruising or bleeding
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only mild ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms that bother you or do not go away, contact your doctor:
Burping
Bloating
Gas
Upset stomach or vomiting
Dizziness or headache
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Unusual bleeding or bruising
- Nosebleeds that don't stop easily
- Blood in urine or stools (black, tarry stools or bright red blood)
- Vomiting blood or material that looks like coffee grounds
- Severe headache or dizziness
- Chest pain or irregular heartbeat
- Signs of an allergic reaction (e.g., rash, itching, swelling of face/tongue/throat, severe dizziness, trouble breathing)
- Persistent or severe nausea, vomiting, or diarrhea
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction and its symptoms.
If you have recently experienced bleeding in your brain or retina.
* If you are unable to consume products containing theophylline, theobromine, or caffeine.
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other drugs and health issues. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction and its symptoms.
If you have recently experienced bleeding in your brain or retina.
* If you are unable to consume products containing theophylline, theobromine, or caffeine.
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other drugs and health issues. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Please note that it may take several weeks for the full effects of the drug to become apparent. If you are 65 years or older, exercise caution when using this medication, as you may be more susceptible to side effects. Additionally, if you are pregnant, planning to become pregnant, or are breastfeeding, consult your doctor to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Flushing
- Hypotension (low blood pressure)
- Convulsions
- Somnolence (drowsiness)
- Loss of consciousness
- Fever
- Agitation
- Reflex loss
What to Do:
Seek immediate medical attention or call a poison control center (1-800-222-1222). Treatment is generally supportive and symptomatic. Gastric lavage may be performed if ingestion is recent.
Drug Interactions
Major Interactions
Moderate Interactions
- Antihypertensive agents: Potentiation of hypotensive effect.
- Cimetidine: Increased plasma concentration of pentoxifylline and its metabolites.
- Ketorolac: Increased risk of bleeding.
Monitoring
Baseline Monitoring
Complete Blood Count (CBC) with differential
Rationale: To assess baseline hematologic status and identify potential risk factors for bleeding.
Timing: Prior to initiation of therapy.
Renal function (Serum Creatinine, eGFR)
Rationale: To assess kidney function, as pentoxifylline and its metabolites are primarily renally excreted, guiding dose adjustments.
Timing: Prior to initiation of therapy.
Liver function tests (ALT, AST, Bilirubin)
Rationale: To assess liver function, as pentoxifylline undergoes hepatic metabolism, guiding dose adjustments.
Timing: Prior to initiation of therapy.
Routine Monitoring
Symptoms of intermittent claudication (e.g., walking distance, pain-free walking distance)
Frequency: Every 2-4 weeks initially, then periodically (e.g., every 3-6 months) to assess therapeutic response.
Target: Improvement in walking distance and reduction in pain.
Action Threshold: Lack of improvement after 8 weeks may indicate non-response; consider alternative therapies.
Signs/symptoms of bleeding (e.g., bruising, petechiae, melena, hematemesis)
Frequency: Routinely, especially if co-administered with anticoagulants or antiplatelet agents.
Target: Absence of abnormal bleeding.
Action Threshold: Any signs of significant bleeding warrant immediate medical evaluation and potential discontinuation.
Blood pressure
Frequency: Periodically, especially if co-administered with antihypertensive agents.
Target: Within normal limits or patient's target range.
Action Threshold: Significant hypotension.
Symptom Monitoring
- Improvement in walking distance or pain-free walking distance
- Reduction in leg pain during exercise
- Headache
- Dizziness
- Nausea
- Vomiting
- Diarrhea
- Abdominal discomfort
- Flushing
- Signs of bleeding (e.g., unusual bruising, nosebleeds, blood in stool/urine, prolonged bleeding from cuts)
- Signs of allergic reaction (e.g., rash, itching, swelling, severe dizziness, trouble breathing)
Special Patient Groups
Pregnancy
Pentoxifylline is classified as Pregnancy Category C. Animal studies have shown adverse effects on the fetus at doses significantly higher than human therapeutic doses. There are no adequate and well-controlled studies in pregnant women. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity observed in animal studies at high doses; human data are lacking.
Second Trimester:
Limited human data; use only if clearly needed.
Third Trimester:
Limited human data; use only if clearly needed.
Lactation
Pentoxifylline and its metabolites are excreted into human breast milk. Due to the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. The LactMed database rates it as L3 (Moderately Safe), suggesting monitoring for adverse effects in the infant.
Infant Risk:
Potential for gastrointestinal upset (e.g., diarrhea), irritability, or other xanthine-related effects in the infant. Monitor infant for adverse effects.
Pediatric Use
Safety and efficacy in pediatric patients have not been established. Use is generally not recommended in this population.
Geriatric Use
No specific dose adjustment is typically required based solely on age. However, elderly patients may have age-related decreases in renal or hepatic function, which could necessitate dose adjustments as described under renal and hepatic impairment. Monitor elderly patients closely for adverse effects, particularly CNS and GI side effects, as they may be more sensitive to these effects.
Clinical Information
Clinical Pearls
- Pentoxifylline is not a cure for intermittent claudication but can improve symptoms and walking distance over time.
- Therapeutic effects are gradual and may take several weeks to become apparent. Patients should be advised to continue therapy for at least 8 weeks before assessing efficacy.
- Smoking cessation is the most important intervention for patients with intermittent claudication and significantly enhances the benefits of pentoxifylline.
- Take with food to minimize gastrointestinal side effects.
- Patients should be advised to report any signs of bleeding immediately, especially if they are on concomitant anticoagulant or antiplatelet therapy.
- Consider alternative therapies like cilostazol or supervised exercise therapy if pentoxifylline is ineffective or not tolerated.
Alternative Therapies
- Cilostazol (another phosphodiesterase inhibitor, often preferred due to greater efficacy)
- Supervised exercise therapy (first-line non-pharmacologic treatment)
- Revascularization procedures (e.g., angioplasty, bypass surgery) for severe cases
- Antiplatelet agents (e.g., Aspirin, Clopidogrel) to reduce cardiovascular event risk, not directly for claudication symptoms.
Cost & Coverage
Average Cost:
Varies widely, typically $10-$50 per 30 tablets (generic 400mg)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (generic), Tier 3 or higher (brand if available)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to facilitate prompt and effective treatment.