Actilyse 50mg Injection (Alteplase): Complete Medicine Guide
Clinical Reference Standards: CDSCO (Central Drugs Standard Control Organisation), Indian Pharmacopoeia (IP) & WHO | Last Updated: September 2026
When to Call Your Doctor IMMEDIATELY
- Sudden severe headache, confusion, or loss of consciousness
- Vomiting blood or passing black tarry stools
- Severe abdominal or back pain
- Difficulty breathing or swelling of the face, lips, or throat
- Sudden weakness or numbness on one side of the body
- Bleeding that does not stop after applying pressure
- Chest pain or irregular heartbeat
If experiencing severe symptoms, call emergency services immediately.
What is actilyse 50mg injection used for?
This medicine is a clot-dissolving injection containing alteplase 50 mg. It is used in hospitals for emergency conditions such as acute ischemic stroke, heart attack, and massive pulmonary embolism. It works by converting plasminogen to plasmin, which breaks down blood clots. It is given only by intravenous infusion under strict medical supervision because of a high risk of serious bleeding.
- Generic Name: Alteplase
- Manufacturer: Boehringer Ingelheim
- Form: Allopathy
- Pregnancy Category: Consult doctor
- Prescription Required: Yes
🇮🇳 actilyse 50mg injection के बारे में (Hindi Summary)
उपयोग: यह दवा एक शक्तिशाली क्लॉट-भंग करने वाली इंजेक्शन है जिसमें एल्टेप्लेज 50 मिलीग्राम होता है। इसका उपयोग अस्पताल में आपातकालीन स्थितियों जैसे दिमाग की नस में खून का थक्का जमने (इस्केमिक स्ट्रोक), दिल का दौरा, और फेफड़ों की धमनी में खतरनाक थक्के के इलाज के लिए किया जाता है। यह दवा खून के थक्के को घोलकर रक्त प्रवाह बहाल करती है। इसे केवल डॉक्टर की देखरेख में नस के माध्यम से दिया जाता है। घर पर इसका उपयोग बिल्कुल न करें।
साइड इफेक्ट्स: इस दवा का सबसे गंभीर दुष्प्रभाव खून बहना है, जो इंजेक्शन लगाने की जगह, पेट, आंत, मूत्र मार्ग या दिमाग में हो सकता है। हल्के दुष्प्रभावों में मसूड़ों से खून आना, नाक से खून आना, जी मिचलाना, उल्टी, कम रक्तचाप, बुखार या ठंड लगना शामिल हैं। दिमाग में खून बहना एक गंभीर लेकिन दुर्लभ दुष्प्रभाव है। अगर सांस लेने में तकलीफ, चेहरे या गले में सूजन, तेज सिरदर्द, भ्रम, या बोलने में कठिनाई हो तो तुरंत डॉक्टर को बताएं।
सुरक्षा सलाह: यह दवा केवल अस्पताल में योग्य डॉक्टर द्वारा दी जानी चाहिए, घर पर कभी नहीं। इलाज से पहले अपने डॉक्टर को सभी दवाओं के बारे में बताएं, खासकर खून पतला करने वाली दवाएं, दर्द निवारक दवाएं, और हर्बल सप्लीमेंट। हाल की सर्जरी, चोट, रक्तस्राव की समस्या, स्ट्रोक, ब्रेन ट्यूमर, प्रेग्नेंसी या अनियंत्रित उच्च रक्तचाप के बारे में जरूर बताएं। इलाज के बाद चोट लगने वाली गतिविधियों से बचें और असामान्य खून बहना, चोट के निशान, तेज सिरदर्द, कमजोरी या बोलने में कठिनाई होने पर तुरंत डॉक्टर को सूचित करें। डॉक्टर की अनुमति के बिना गाड़ी न चलाएं।
💊 actilyse 50mg injection Uses & Benefits
[{"condition":"Acute ischemic stroke","description":"Used within a carefully selected time window to dissolve the clot and restore blood flow to the brain, reducing disability when given to eligible patients.","evidence":"Well-established"},{"condition":"Acute myocardial infarction (heart attack)","description":"Used to dissolve coronary artery clots and restore blood flow to the heart muscle when primary percutaneous coronary intervention is not immediately available.","evidence":"Well-established"},{"condition":"Massive pulmonary embolism","description":"Used in life-threatening pulmonary embolism with haemodynamic instability to dissolve clots in the pulmonary arteries.","evidence":"Well-established"},{"condition":"Occluded central venous catheters","description":"Instilled locally into a blocked catheter to restore patency when other measures fail.","evidence":"Well-established"},{"condition":"Acute peripheral arterial occlusion","description":"Used in selected patients with sudden limb-threatening arterial blockage to restore blood flow.","evidence":"Established in selected patients"}]
Off-label uses: [{"condition":"Intraventricular haemorrhage with intraventricular clot","description":"Sometimes used off-label in selected neurosurgical patients to help dissolve intraventricular blood clots.","evidence":"Limited"},{"condition":"Retinal artery occlusion","description":"Occasionally used off-label in specialised centres for sudden loss of vision due to retinal artery clot.","evidence":"Limited"},{"condition":"Frostbite","description":"Rarely used off-label in severe frostbite to improve blood flow in affected tissues.","evidence":"Limited"}]
Primary treatment for: Acute ischemic stroke, acute myocardial infarction, and massive pulmonary embolism
Also treats: Occluded central venous catheters, Acute peripheral arterial occlusion
📋 Drug Information
| Generic Name(s) | Alteplase |
| Brand Name | Actilyse |
| Manufacturer | Boehringer Ingelheim |
| Packaging / Form | Varies by brand (Allopathy) |
| Therapeutic Class | CARDIAC |
| Action Class | Plasminogen Activators- Thrombolytics |
| Route of Administration | Intravenous (IV) infusion, and in some cases intra-arterial infusion for local clot dissolution. It is also used locally for occluded catheters |
| Storage | Store the lyophilised powder at 2°C to 25°C. Protect from light. After reconstitution, use immediately or store as directed by the manufacturer and institutional policy. Do not freeze. |
| Shelf Life | Refer to the product label for the exact shelf life. Typically 24 to 36 months from the date of manufacture when stored as directed. |
| WHO Guideline | Not established from the available information. |
| ICMR Guideline | Not established from the available information. |
👨⚕️ Doctor's Practical Tips
Evidence-based practical advice from experienced clinicians
🔍 Is This Medicine Right for Your Symptom?
Educational reference. Always consult a doctor for diagnosis.
🔬 How This Medicine Works (Pharmacology)
Pharmacokinetics
How It Works
This medicine is a recombinant form of human tissue plasminogen activator. It binds to fibrin in a blood clot and converts clot-bound plasminogen into plasmin. Plasmin then breaks down the fibrin network that holds the clot together, leading to clot dissolution and restoration of blood flow. Because it preferentially activates plasminogen bound to fibrin, its action is relatively clot-selective, but it can still cause systemic bleeding by generating plasmin in the circulation.
Mechanism Steps
💡 How to Take actilyse 50mg injection
Strength: Lyophilised powder for solution for injection or infusion, 50 mg per vial.
Dosage Information
| Adult Dosage | The dose of this medicine depends on the condition being treated and must be individualised by a qualified clinician. For acute ischemic stroke, a common regimen is a total dose based on body weight, given as a bolus followed by an infusion over 60 minutes. For acute myocardial infarction, a weight-based accelerated infusion regimen is often used. For massive pulmonary embolism, a weight-based dose is given over 2 hours. For occluded catheters, a small local dose is instilled. Dose must be individualised by a qualified clinician based on indication, age, weight, renal and hepatic function, and bleeding risk. |
| Pediatric Dosage | Pediatric dosing is not established from available information. Consult a pediatrician. |
| Elderly Dosage | Elderly patients have a higher risk of bleeding, especially intracranial haemorrhage. The dose is generally the same as for younger adults, but the decision to use this medicine must carefully weigh the benefits against the risks. Close monitoring is essential. |
| Renal Impairment | No specific dose adjustment is established for renal impairment, but use with caution in patients with severe kidney disease because of an increased risk of bleeding. |
| Hepatic Impairment | No specific dose adjustment is established for hepatic impairment, but use with caution in patients with severe liver disease because of an increased risk of bleeding. |
| Maximum Daily Dose | The maximum dose depends on the indication and is determined by the treating clinician. Do not exceed the prescribed dose. |
Dosage Timeline
🍽️ Food Timing Guide
⏰ What to Do If You Miss a Dose
⚠️ Side Effects of actilyse 50mg injection
✅ Common Side Effects
🚨 Serious Side Effects
⚠️ Rare Side Effects
Consult your doctor if you experience any unusual symptoms.
🔬 Drug Interactions
| Drug | Severity | Effect |
|---|---|---|
| Warfarin | Major | |
| Heparin | Major | |
| Aspirin | Major | |
| Clopidogrel | Major | |
| Rivaroxaban | Major | |
| Apixaban | Major | |
| Dabigatran | Major | |
| Ibuprofen | Major | |
| ACE inhibitors | Moderate | |
| Nitroglycerin | Moderate |
🚨 Major Interactions
- Warfarin and other vitamin K antagonists
- Heparin, low molecular weight heparin, and fondaparinux
- Direct oral anticoagulants (apixaban, rivaroxaban, dabigatran, edoxaban)
- Antiplatelet agents (aspirin, clopidogrel, ticagrelor, prasugrel)
- Non-steroidal anti-inflammatory drugs (NSAIDs)
⚡ Moderate Interactions
- Angiotensin-converting enzyme inhibitors
- Nitroglycerin
- Cephalosporins with methylthiotetrazole side chain
🍷 Alcohol Interaction
Alcohol can increase the risk of bleeding and may worsen liver function. Avoid alcohol during treatment and for as long as your doctor advises.
🔎 Check Your Other Medicines
Educational tool. Always confirm with your doctor or pharmacist.
🛡️ Safety & Warnings
🚫 Contraindications
["Active internal bleeding","History of intracranial haemorrhage","Known bleeding diathesis","Recent major surgery or trauma","Severe uncontrolled hypertension","Recent stroke or brain surgery","Intracranial neoplasm, arteriovenous malformation, or aneurysm","Suspected aortic dissection","Acute pericarditis","Severe liver disease","Pregnancy or recent childbirth, except in life-threatening situations"]
⚠️ Warnings & Precautions
["This medicine must be given only in a hospital setting with access to emergency care and blood products.","The risk of bleeding is high, and patients must be monitored closely.","Avoid invasive procedures such as arterial punctures during treatment whenever possible.","Use with caution in elderly patients, who have a higher risk of bleeding.","Use with caution in patients with severe kidney or liver disease.","Do not use in patients with known hypersensitivity to alteplase or any component of the formulation.","Reconstituted solution should be used promptly and handled according to institutional protocols."]
🤱 Lactation Safety
It is not known whether this medicine passes into breast milk. Because it is given in emergency situations, breastfeeding should be discussed with the treating doctor. In many cases, breastfeeding may need to be interrupted temporarily.
💊 Overdose Management
Overdose with this medicine can cause severe bleeding. There is no specific antidote, but treatment includes stopping the infusion immediately, applying local pressure to bleeding sites, and giving blood products such as fresh frozen plasma, cryoprecipitate, or platelets as needed. Antifibrinolytic agents such as tranexamic acid may be considered in severe cases. Supportive care and close monitoring are essential.
⏰ Missed Dose
This medicine is given as a single course or short infusion in a hospital setting, so missed doses are not applicable. If a dose is interrupted, the medical team will decide whether to continue or restart based on the clinical situation.
Additional Safety Advice
This medicine must be given only by a qualified clinician in a hospital or emergency setting, never at home. Before treatment, tell the medical team about all medicines you take, especially blood thinners such as warfarin, heparin, low molecular weight heparin, direct oral anticoagulants, antiplatelet drugs, and non-steroidal anti-inflammatory drugs. Inform them about any recent surgery, trauma, bleeding problems, stroke, brain tumour, pregnancy, or uncontrolled high blood pressure. After treatment, avoid activities that could cause injury or bleeding, and report any unusual bruising, bleeding gums, nosebleeds, blood in urine or stool, severe headache, confusion, weakness, or difficulty speaking immediately. Do not drive or operate machinery until your doctor confirms it is safe. Keep all follow-up appointments for monitoring and imaging. Do not take any new medicine, including over-the-counter painkillers, without asking your doctor first.
👴 Special Considerations for Elderly
💡 For Patients Above 65
Elderly patients have a higher risk of bleeding, especially intracranial haemorrhage, after receiving this medicine. The decision to use it must carefully weigh the benefits against the risks. Close monitoring and dose adjustment as per protocol are essential.
🤰 Pregnancy Planning (TTC)
This medicine is used only in life-threatening emergencies during pregnancy. If you are planning pregnancy or are pregnant, inform your doctor immediately. The risks and benefits will be discussed by the specialist team.
🏥 Post-Surgery Considerations
This medicine is generally avoided after recent surgery because of the high risk of bleeding. If surgery is planned, inform your surgeon if you have received this medicine recently. The timing of surgery after treatment will be decided by your doctor.
🦷 Dental Procedures
Inform your dentist if you have recently received this medicine. Dental procedures that cause bleeding may need to be postponed until your doctor confirms it is safe. Good oral hygiene is important to prevent gum bleeding.
💚 Lifestyle Tips for Better Results
🏋️ Exercise Considerations
Avoid strenuous exercise and activities that could cause injury or bleeding for at least a few days after treatment, or as advised by your doctor. Gradually resume activity under medical guidance.
🥗 Diet Recommendations
💼 Impact on Daily Work & Life
After receiving this medicine, you will need time to recover in hospital and at home. Do not drive or operate machinery until your doctor confirms it is safe. Depending on your condition, you may need rehabilitation before returning to work. Discuss your work schedule with your doctor.
🛑 When to Stop This Medicine
This medicine is given as a short course in hospital, so you do not decide when to stop it. The medical team will stop the infusion based on your clinical response and any complications. After discharge, follow your doctor's advice on other medicines and lifestyle changes.
📅 Long-Term Use Effects
This medicine is usually given as a short course in an emergency setting, so long-term effects are not common. However, patients who survive a stroke or heart attack may need long-term rehabilitation and preventive medicines. The risk of bleeding can persist for some time after treatment, so follow-up monitoring is important. Regular check-ups with your doctor are recommended to manage the underlying condition and prevent future clots.
🌿 Non-Medicine Approaches
These can complement medicine but do not replace prescribed treatment.
A procedure to remove the clot physically in selected stroke patients.
Evidence: Well-establishedAngioplasty and stenting to open blocked coronary arteries in heart attack.
Evidence: Well-establishedUse of blood thinners to prevent further clots in some conditions.
Evidence: Well-established💉 Vaccination Considerations
💉 If You're Getting Vaccinated
There are no specific vaccine interactions reported with this medicine. However, if you have recently received a live vaccine or are due for one, inform your doctor. Vaccination should be planned according to your overall medical condition.
📦 Storage Guide
✅ DO
Store the lyophilised powder at 2°C to 25°C.
❌ DON'T
Do not freeze the product.
✅ DO
Protect the vial from light.
❌ DON'T
Do not use if the solution is discoloured or contains particles.
✅ DO
Use the reconstituted solution promptly as directed.
❌ DON'T
Do not store reconstituted solution for long periods unless specified.
✈️ Traveling with This Medicine
This medicine is given only in a hospital setting, so travel advice is mainly for patients who have received it. Carry a copy of your discharge summary and prescription, especially if you are travelling soon after treatment. Avoid long journeys immediately after treatment because of the risk of bleeding and the need for follow-up. If you must travel, inform your doctor and carry enough of any other prescribed medicines in their original packaging. Keep a list of your medicines and allergies with you at all times. Follow up with a doctor at your destination if you experience any bleeding or unusual symptoms.
💰 Cost Analysis & Savings
👥 Real Patient Stories
Educational, anonymized scenarios. Individual results may vary.
💬 Questions Patients Often Ask
A: This medicine starts dissolving the clot during the infusion, and clinical effects can be seen within minutes to hours depending on the site and size of the clot.
A: No. This medicine is given only in a hospital setting by a qualified clinician because of the high risk of serious bleeding.
A: The most serious side effect is severe bleeding, including bleeding in the brain, gastrointestinal bleeding, and allergic reactions. Seek immediate medical help if you notice any signs of bleeding.
A: It should not be given to patients with active internal bleeding, recent major surgery, severe uncontrolled high blood pressure, a history of bleeding in the brain, certain brain tumours, or a recent stroke.
🤔 Common Patient Concerns
🛑 Myths vs. Facts
- Myth: This medicine can be taken as a tablet at home.
Fact: This medicine is an injection given only in a hospital setting by a qualified clinician. - Myth: This medicine is safe for everyone with a blood clot.
Fact: It is contraindicated in many conditions, especially those with a high risk of bleeding. - Myth: This medicine has no serious side effects.
Fact: The most serious side effect is severe bleeding, including bleeding in the brain.