What are the recommended recombinant tissue plasminogen activator (rTPA) brands in India for thrombolysis in acute ischemic stroke?

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rTPA Brands Available in India for Acute Ischemic Stroke

I cannot provide specific brand names of rTPA available in India from the evidence provided, as none of the guidelines or research studies contain information about pharmaceutical brands marketed specifically in the Indian market.

What the Evidence Does Support

The evidence strongly supports using recombinant tissue plasminogen activator (r-tPA) at a dose of 0.9 mg/kg (maximum 90 mg) for acute ischemic stroke within 3 hours of symptom onset (Grade 1A), with weaker support for the 3-4.5 hour window (Grade 2C). 1, 2

Generic Drug Information

The active pharmaceutical ingredient discussed in all guidelines is:

  • Alteplase (recombinant tissue plasminogen activator) - This is the generic name for the thrombolytic agent approved for acute ischemic stroke 1, 3
  • Standard dosing: 0.9 mg/kg IV (maximum 90 mg) 2
  • Alternative agent mentioned in recent literature: Tenecteplase (TNK) - a genetically modified tPA with higher fibrin specificity and longer half-life, though evidence is still emerging 4

Time-Based Treatment Protocol

  • 0-3 hours from symptom onset: Strongly recommend IV r-tPA (Grade 1A evidence), with 154 more favorable events per 1,000 patients treated 1, 2
  • 3-4.5 hours from symptom onset: Suggest IV r-tPA (Grade 2C evidence), with 69 more favorable events per 1,000 patients 1, 2, 3
  • Beyond 4.5 hours: Recommend against IV r-tPA (Grade 1B) 1

Critical Safety Considerations

  • Risk of symptomatic intracranial hemorrhage increases 10-fold (6.4% vs 0.6% in placebo) 1
  • Blood pressure must be maintained at <185/110 mm Hg 1
  • Exclude patients with early CT changes involving more than one-third of the MCA territory 1

To Find India-Specific Brands

You would need to consult:

  • Indian pharmaceutical databases
  • Local hospital formularies
  • The Central Drugs Standard Control Organisation (CDSCO) approved drug list
  • Indian pharmaceutical company websites that manufacture or distribute alteplase

The clinical efficacy and safety data apply regardless of the specific brand, as long as the product contains alteplase at the appropriate concentration and is administered according to the established protocol 1, 2.

References

Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

Guideline

Thrombolytic Therapy for Acute Ischemic Stroke

Praxis Medical Insights: Practical Summaries of Clinical Guidelines, 2025

Research

Thrombolysis with alteplase 3 to 4.5 hours after acute ischemic stroke.

The New England journal of medicine, 2008

Research

Alteplase or tenecteplase for thrombolysis in ischemic stroke: An illustrated review.

Research and practice in thrombosis and haemostasis, 2022

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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