ALFATHROMB® 5 mcg Tablets

(Limaprost 5 mcg)

Medical Description

ALFATHROMB® contains limaprost, an orally active prostaglandin E1 (PGE1) analogue with vasodilatory and antiplatelet properties. It improves microvascular circulation by dilating peripheral blood vessels, enhancing tissue perfusion, reducing platelet aggregation, and improving oxygen delivery to ischemic tissues. Limaprost has been primarily studied and approved in several Asian countries for the management of thromboangiitis obliterans (Buerger's disease) and lumbar spinal canal stenosis (LSS) with neurogenic intermittent claudication.

Mechanism of Action

Limaprost exerts its effects by activating prostaglandin E (EP) receptors, leading to:

• Peripheral vasodilation and increased blood flow.
• Inhibition of platelet aggregation.
• Improvement of microcirculatory perfusion.
• Reduction of ischemia-related pain and cold sensation.
• Enhancement of nerve root blood supply, helping relieve symptoms associated with lumbar spinal stenosis.

Approved Therapeutic Uses

►Adults

Limaprost is indicated for:

• Thromboangiitis obliterans (Buerger's disease)
  • Improvement of ischemic symptoms including:
    • Rest pain
    • Coldness of the extremities
    • Ischemic ulcers
• Lumbar spinal canal stenosis
  • Improvement of:
    • Neurogenic intermittent claudication
    • Lower limb pain
    • Numbness
    • Walking ability
    • Functional status in selected patients with cauda equina or mixed-type stenosis.

►Pediatric Use

• Not recommended.
• Safety and efficacy have not been established in children or adolescents, and routine pediatric use is not advised.

Evidence-Based Clinical Benefits

Clinical studies have demonstrated that limaprost may:

• Improve peripheral blood circulation.
• Reduce ischemic pain and cold sensation.
• Improve walking distance in selected patients with lumbar spinal stenosis.
• Improve lower-limb numbness and neurological symptoms.
• Enhance quality of life in patients with lumbar spinal stenosis.
• Be generally well tolerated with a relatively favorable safety profile.

Dosage

The dosage should be individualized according to the approved indication and physician recommendation.

Typical regimens include:

• Peripheral ischemic disease (e.g., thromboangiitis obliterans):
  • 5 mcg orally three times daily (15 mcg/day).
• Lumbar spinal canal stenosis:
  • 5 mcg orally three times daily (15 mcg/day).

Tablets are usually taken after meals to reduce gastrointestinal discomfort.

Contraindications

Do not use in patients with:

• Hypersensitivity to limaprost or any component of the formulation.
• Active bleeding disorders.
• Conditions associated with an increased risk of hemorrhage unless the potential benefit outweighs the risk.

Warnings and Precautions

Use with caution in patients with:

• Bleeding tendency.
• Concomitant anticoagulant or antiplatelet therapy.
• Recent surgery.
• Severe hepatic or renal impairment.
• Pregnancy and breastfeeding (only if clearly indicated).

Patients should be monitored for signs of bleeding during treatment.

Common Side Effects

Most adverse effects are mild and transient.

They may include:

• Headache
• Flushing
• Dizziness
• Nausea
• Abdominal discomfort
• Diarrhea
• Skin rash
• Palpitations (uncommon)

Serious bleeding events are rare but require immediate medical attention.

Drug Interactions

Use cautiously with:

• Anticoagulants (e.g., warfarin, DOACs)
• Antiplatelet agents (e.g., aspirin, clopidogrel)
• Other vasodilators
• Antihypertensive medications

These combinations may increase the risk of bleeding or hypotension.

Storage

• Store below 25°C.
• Protect from moisture and direct sunlight.
• Keep in the original package.
• Keep out of reach of children.

Summary

ALFATHROMB® (Limaprost 5 mcg) is an oral prostaglandin E1 analogue that improves peripheral and neural microcirculation through vasodilation and inhibition of platelet aggregation. Evidence from randomized clinical trials and clinical practice guidelines supports its use for thromboangiitis obliterans and selected patients with lumbar spinal canal stenosis, particularly those with neurogenic intermittent claudication and cauda equina symptoms. It has demonstrated improvements in pain, numbness, walking ability, and quality of life while maintaining a favorable safety profile when used appropriately.

References

• Japanese Clinical Practice Guidelines for Lumbar Spinal Stenosis (2021).
• Harrison T, Plosker GL. Limaprost. Drugs. 2007 (PubMed).
• Matsudaira K, et al. Randomized controlled trial of limaprost in lumbar spinal stenosis. Spine. 2009.
• Systematic Review: Limaprost in Lumbar Spinal Stenosis. European Journal of Clinical Pharmacology. 2026.
• FDA Substance Registration (Limaprost).

Patient Disclaimer

This information is intended for educational purposes only and should not replace professional medical advice. ALFATHROMB® (Limaprost) should be used only under the supervision of a qualified healthcare professional. Do not start, stop, or change your medication without consulting your physician or pharmacist. Seek immediate medical attention if you experience severe allergic reactions, unusual bleeding, or worsening symptoms.

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