Sirolimus (1.0mg)..

Introduction

Sirolimus 1 mg, the active ingredient in SIROLIME 1, is an immunosuppressive agent primarily used to prevent organ rejection in patients undergoing renal (kidney) transplantation. It belongs to a class of drugs known as mTOR inhibitors (mammalian target of rapamycin inhibitors), which modulate immune function by blocking T-cell activation and proliferation.

Sirolimus 1 mg Tablet Uses

SIROLIME 1 is prescribed for the following medical conditions:

• Prevention of Kidney Transplant Rejection (usually in combination with other immunosuppressants such as cyclosporine and corticosteroids)

• Lymphangioleiomyomatosis (LAM) – a rare lung disease (off-label or FDA-approved indication in some countries)

• Investigational/off-label uses in:

  • Certain cancers (e.g., Kaposi sarcoma, renal cell carcinoma)

  • Autoimmune disorders

  • Coronary stent coating (as a drug-eluting agent)

How Sirolimus 1 mg Works

Sirolimus works by:

• Inhibiting the mTOR pathway, which is essential for T-cell proliferation.

• Blocking immune responses that lead to graft rejection after organ transplantation.

• Reducing inflammation and preventing fibrosis in some off-label conditions like LAM.

Its immunosuppressive effect prevents the immune system from attacking the transplanted organ, thereby increasing graft survival.

Dosage & Administration of Sirolimus 1 mg Tablet

• Initial Dose (Kidney Transplant): Usually 6 mg orally as a loading dose, followed by 2 mg once daily.

• Maintenance Dose: Adjusted to maintain target blood levels (typically 4–12 ng/mL, depending on indication and combination therapy).

• Administration:

  • Take consistently with or without food.

  • Do not crush or chew the tablet.

  • Monitor blood sirolimus levels regularly.

 Note: Dose adjustment is required based on drug levels, kidney function, and co-medications.

Sirolimus Side Effects

Like all potent immunosuppressants, sirolimus can have side effects:

Common Side Effects

• High blood cholesterol and triglycerides

• High blood pressure

• Diarrhea, constipation, abdominal pain

• Headache

• Acne or skin rashes

• Joint pain

• Mouth ulcers (stomatitis)

Serious Side Effects

• Increased risk of infections (e.g., CMV, fungal, bacterial)

• Anemia, leukopenia, or thrombocytopenia

• Interstitial lung disease (ILD)

• Hepatic artery thrombosis (especially in liver transplant recipients – not recommended)

• Delayed wound healing

• Kidney impairment (especially when combined with cyclosporine)

Seek medical help if you notice fever, unusual bruising, breathlessness, or yellowing of skin.

Precautions Before Using Sirolimus

• Avoid live vaccines while on sirolimus therapy.

• Inform your doctor if you have a history of liver or lung disease.

• Requires frequent blood monitoring for drug levels, kidney/liver function, and complete blood counts.

• May affect fertility in both men and women (reversible in most cases).

• Pregnancy Category C – Use only if clearly needed; consult your doctor for risks.

• Avoid grapefruit juice, as it may increase sirolimus blood levels dangerously.

Drug Interactions

Sirolimus may interact with:

• Cyclosporine (requires careful dose adjustment)

• Ketoconazole, erythromycin, ritonavir (increase sirolimus levels)

• Rifampin, carbamazepine, phenytoin (decrease sirolimus levels)

• Other immunosuppressants or nephrotoxic drugs

Storage Instructions

• Store at a temperature below 30°C.

• Protect from moisture and direct sunlight.

• Keep out of reach of children.

FAQs – Sirolimus 1 mg Tablet (SIROLIME 1)

1. What is Sirolimus used for?

Sirolimus is used to prevent rejection in kidney transplant patients and for certain rare lung diseases like LAM.

2. Is Sirolimus a steroid?

No, Sirolimus is an mTOR inhibitor, not a corticosteroid, though it is used in combination with steroids for transplant protocols.

3. Can I stop taking Sirolimus suddenly?

No. Stopping sirolimus suddenly can lead to organ rejection. Always consult your physician before making any changes.

4. How long should Sirolimus be taken after a transplant?

It’s usually taken life-long, but the dosage and combinations may change over time based on graft health and lab results.

5. Does Sirolimus affect fertility or pregnancy?

Yes, it may temporarily reduce fertility. It is not recommended during pregnancy or breastfeeding unless advised by a specialist.

Conclusion

SIROLIME 1, containing Sirolimus 1 mg, is a life-saving immunosuppressant for transplant recipients, ensuring long-term graft survival. With proper monitoring and compliance, it significantly reduces the risk of rejection. As a high-potency therapy, its usage should always be under strict medical supervision with regular monitoring.

About The Company

Steris Healthcare Pvt Ltd, widely recognized as Sterispharma, was established in February 2018 by a team of seasoned experts from the pharmaceutical sector. Based in Navi Mumbai, the company is proudly certified by WHO, GMP, and ISO, underscoring its unwavering commitment to quality and patient safety. Sterispharma is driven by a mission to make affordable, premium-quality medicines accessible throughout India, adhering strictly to WHO-recommended standards. Through its user-friendly online pharmacy platforms, customers can effortlessly order medications with home delivery services.

Sterispharma boasts an extensive portfolio of healthcare solutions, ranging from treatments for rare diseases to essential everyday healthcare needs. Their comprehensive product lineup addresses multiple therapeutic areas including Cardiology, Asthma, Respiratory Disorders, Nasal Care, Diabetes, Endocrinology, Gastroenterology, Orthopedics, Anti-infective/Antibiotic Therapy, General Medicine, Urology, Neurology, Nephrology, Oncology, Gynecology, Pediatrics, Dental Care, and Dermatology. Medications are easily available for online purchase through their official websites — Sterisonline, Sterisindia, and Sterispharma — offering a seamless and reliable healthcare experience.

For further information 

Email: info@sterispharma.com / contact@sterispharma.com

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