Registered Kenya · PPB

MIREL

RETEPLASE

H2015/CTD4067/555 18 MG/10 ML INN generic

What it does

Reteplase is a medication used to dissolve blood clots in the body.

Commonly used for: heart attack (myocardial infarction), pulmonary embolism

Read more in plain English ↓

Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

Ask about this medicine

Answers come only from this medicine's registration record, BNF monograph and interaction data - not medical advice.

Hard to find? We help patients in Kenya source rare medicines. We don't sell or dispense medicines - licensed pharmacies do.

Source this medicine

Registration & product details

Registration no.
H2015/CTD4067/555
Registration date
-
Expiry date
-
Status
Registered
Active ingredient
RETEPLASE
Dosage form
18 MG/10 ML
Strength
-
Pack size
-
Therapeutic class
-
Manufacturer / MAH
Galaxy Pharmaceutical
Applicant / LTR
-
Country of origin
FOREIGN
Manufacturer location
PRQC+GJ5, 3rd Parklands Ave, Nairobi, Kenya

Source: Pharmacy and Poisons Board · fetched 2026-01-28 20:40:53 · updated 2026-07-26 11:31:24

Disclaimer: This information is sourced from Pharmacy and Poisons Board (Kenya). Always consult a qualified healthcare professional before using any medication.

About this medicine

Reteplase is a medication used to dissolve blood clots in the body.

What it treats

  • heart attack (myocardial infarction)
  • pulmonary embolism

How it works

Reteplase works by breaking down clots in the blood vessels, helping to restore normal blood flow.

Who it's for

This medication is generally used for adults experiencing conditions related to severe blood clots.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: reteplase

Reteplase is a recombinant tissue plasminogen activator (rtPA) used primarily in the management of acute myocardial infarction (AMI). It facilitates the breakdown of fibrin in blood clots, promoting thrombolysis. Reteplase is a form of the natural enzyme plasminogen, which is activated to plasmin, leading to the degradation of fibrin mesh within clots. Its fast onset of action makes it suitable for emergency situations.

Indications

  • Acute myocardial infarction
  • Pulmonary embolism
  • Thrombotic stroke

Dosage

Children: Refer to the BNF for Children for specific dosing guidance.

Adults: Refer to the BNF for specific dosing guidance.

Mechanism of action

Reteplase works by binding to fibrin in a thrombus (blood clot) and converting plasminogen to plasmin, which is an active proteolytic enzyme that breaks down fibrin, thus dissolving the clot. This process restores blood flow to the affected area, which is critical in the treatment of ischemic conditions such as myocardial infarction.

Pharmacodynamics

Reteplase exhibits a rapid onset of action, with peak thrombolytic activity occurring within 30 minutes of administration. The drug has a relatively short half-life, necessitating its use in a hospital setting where monitoring can occur. Its efficacy in dissolving clots is influenced by factors such as the size and age of the clot, as well as patient-specific variables.

Pharmacokinetics

After intravenous administration, reteplase has a rapid distribution phase followed by a slower elimination phase. It is primarily cleared from the circulation through hepatic metabolism. The half-life of reteplase is approximately 13 to 16 minutes. Renal excretion plays a minor role in its elimination, thus liver function is a more critical factor in its clearance.

Contra-indications

  • Active internal bleeding
  • History of cerebrovascular accident within the last 6 months
  • Severe uncontrolled hypertension
  • Recent surgery or trauma
  • Allergy to reteplase or any component of the formulation

Adverse effects

  • Hemorrhage
  • Nausea
  • Vomiting
  • Hypotension
  • Arrhythmias
  • Anaphylaxis
  • Reperfusion injury

Interactions

  • Anticoagulants may increase the risk of bleeding
  • Antiplatelet agents may enhance the risk of hemorrhage
  • Other thrombolytics used concurrently can increase the risk of adverse effects

Precautions

  • Use with caution in patients with a history of gastrointestinal bleeding
  • Monitor closely for signs of bleeding or bruising
  • Assess renal and hepatic function before use
  • Patients with recent surgery should be evaluated carefully

Pregnancy

Reteplase should only be used in pregnancy if clearly needed, as safety has not been established.

Breast-feeding

It is not known whether reteplase is excreted in human milk; use caution when administering to nursing mothers.

Storage

Store in a refrigerator at 2-8 degrees Celsius. Do not freeze. Protect from light.

Formulations

  • Reteplase powder for solution for injection

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.