Cyclophil Me Capsule (Cyclosporine)
Cyclophil Me Capsule contains Cyclosporine, a potent calcineurin inhibitor and immunosuppressant used to prevent organ rejection following kidney, liver, and heart transplantation, and to treat severe autoimmune conditions including rheumatoid arthritis, psoriasis, and nephrotic syndrome.
Product Overview
Cyclophil Me Capsule is an advanced immunosuppressant medication containing Cyclosporine in a microemulsion formulation. Cyclophil Me Capsule used to prevent organ transplant rejection and treat autoimmune conditions such as psoriasis, rheumatoid arthritis and nephrotic syndrome.This specialized delivery system ensures consistent and predictable drug absorption, making it a cornerstone therapy for preventing organ transplant rejection. By selectively modulating the immune system, it allows the body to accept foreign tissue while also serving as a powerful treatment for severe autoimmune disorders that do not respond to standard inflammatory therapies.
Product Composition
- Cyclosporine (USP/BP): The active immunosuppressive agent, a cyclic polypeptide that specifically inhibits T-lymphocyte activity.
- Ethanol: Acts as a solubilizing agent within the microemulsion system to maintain the stability of the active ingredient.
- Corn Oil-Mono-Di-Triglycerides: Essential lipid components that facilitate the formation of the microemulsion upon contact with gastric fluids.
- Polyoxyl 40 Hydrogenated Castor Oil: A high-grade surfactant that improves the bioavailability and solubility of the drug.
- DL-Alpha-Tocopherol: Added as an antioxidant to protect the pharmaceutical formulation from oxidative degradation.
Product Specification
| Feature | Details |
| Therapeutic Class | Calcineurin Inhibitor / Immunosuppressant |
| Dosage Form | Soft Gelatin Capsule (Microemulsion) |
| Bioavailability | Enhanced and consistent compared to traditional formulations |
| Protein Binding | 90% to 98% (primarily to lipoproteins) |
| Metabolism | Extensively Hepatic (via Cytochrome P450 3A4) |
| Excretion | Primarily Biliary (Feces); minimal Renal excretion |
Mechanism of Action
- Cyclophil Me works by binding to a specific intracellular protein called cyclophilin, forming a complex that inhibits the enzyme calcineurin.
- The inhibition of calcineurin prevents the dephosphorylation of the nuclear factor of activated T-cells (NF-AT).
- This blockade stops the transcription of interleukin-2 (IL-2) and other cytokines essential for the activation and proliferation of T-lymphocytes.
- By suppressing the production of these inflammatory signals, the medication prevents the immune system from mounting an antigen-specific attack against a transplanted organ.
- The microemulsion technology ensures that this process begins reliably by reducing the drug's dependence on bile for absorption in the gut.
Key Benefits
- Significantly increases graft survival rates in patients receiving kidney, liver, or heart transplants.
- Provides a predictable pharmacokinetic profile, allowing for more precise therapeutic drug monitoring and dosage adjustments.
- Highly effective in treating severe rheumatoid arthritis by reducing joint destruction and systemic inflammation.
- Offers a potent solution for recalcitrant psoriasis when topical treatments and phototherapy have failed.
- Utilized in managing nephrotic syndrome to induce and maintain remission in patients with minimal change disease.
- The microemulsion form reduces the intra-patient variability in drug levels, lowering the risk of sudden toxicity or rejection episodes.
Precautions
| General Precaution | Details |
|---|---|
| Use only on prescription | Take Cyclophil Me Capsule only as directed by a doctor |
| Regular monitoring required | Blood tests may be needed during treatment |
| Do not stop suddenly | Abrupt discontinuation may worsen condition |
| Take at the same time daily | Helps maintain consistent drug levels |
| Avoid self-medication | Incorrect use may increase serious risks |
Medical Supervision
- Use only under specialist medical guidance
- Inform your doctor about all existing medical conditions
- Share history of kidney, liver or blood pressure problems
Health Condition Precautions
- Use carefully in kidney or liver disease patients
- Monitor blood pressure regularly during treatment
- Increased risk of infections due to lowered immunity
During Treatment Care
- Avoid exposure to infections whenever possible
- Maintain regular follow-up appointments and lab tests
- Report fever, unusual swelling or reduced urine output immediately
Pregnancy and Breastfeeding
- Use only if clearly prescribed by a doctor
- Consult doctor before breastfeeding during treatment
Safety Advice
- Avoid grapefruit or grapefruit juice during therapy
- Do not receive live vaccines without medical advice
- Store in a cool and dry place away from moisture and heat
Usage
The administration of Cyclosporine microemulsion must be highly standardized to ensure stable blood trough levels and long-term graft stability.
Administration
Consistency is Key: Take the capsules at the same time every day (e.g., 8 AM and 8 PM) to maintain a steady immunosuppressive state.
Dietary Uniformity: You may take the medication with or without food, but you must choose one method and stay consistent to ensure stable drug absorption.
Grapefruit Interaction: Strictly avoid grapefruit and grapefruit juice, as they significantly increase cyclosporine levels in the blood, leading to potential kidney toxicity.
Capsule Integrity: Swallow the capsules whole with a glass of water; do not chew, crush, or open them, as this destroys the microemulsion delivery system.
Monitoring Protocol: Regular blood tests are mandatory to check creatinine levels, blood pressure, and drug concentration to ensure the dosage remains safe and effective.
Clinical Management Summary
| Factor | Requirement |
| Dosing Frequency | Twice daily (Every 12 hours) |
| Fluid Restriction | Avoid grapefruit juice entirely |
| Storage | Keep in the original blister pack until use to protect from moisture |
| Key Safety Check | Monitor blood pressure and renal function (Kidney tests) regularly |
Uses
Prophylaxis of organ rejection in patients receiving allogeneic kidney, liver, and heart transplants.
Treatment of graft-versus-host disease (GVHD) in bone marrow transplant recipients.
Management of severe active rheumatoid arthritis in patients who have not responded adequately to methotrexate.
Treatment of recalcitrant plaque psoriasis where other systemic therapies or PUVA are contraindicated or ineffective.
Induction and maintenance of remission in nephrotic syndrome caused by glomerular diseases like minimal change disease or focal segmental hyalinosis.
Off-label use in severe cases of atopic dermatitis and certain types of autoimmune uveitis that threaten vision.
Side Effects
Common Side Effects
- Headache
- Nausea
- Tremors
- Increased hair growth
- Gum swelling
Less Common Side Effects
- High blood pressure
- Fatigue
- Abdominal discomfort
- Muscle cramps
- Loss of appetite
Serious Side Effects
| Serious Side Effect | Details |
|---|---|
| Kidney damage | Reduced urination or abnormal kidney function |
| Severe infections | Increased risk due to weakened immunity |
| Liver problems | Yellowing of skin or abnormal liver tests |
| High blood pressure | May become severe if untreated |
| Neurological effects | Confusion, seizures or severe tremors |
When to Seek Medical Help
- If fever or signs of infection occur
- If swelling, reduced urination or severe weakness develops
- If yellowing of skin or eyes appears
- If severe headache, confusion or seizures occur
FAQs
Q: What are Cyclophil Me Capsules used for?
A: Cyclophil Me Capsules are used to prevent organ rejection after kidney, liver, and heart transplantation, and to treat severe autoimmune conditions including rheumatoid arthritis, psoriasis, and nephrotic syndrome.
Q: How do Cyclophil Me Capsules work?
A: Cyclosporine works by inhibiting calcineurin, a protein essential for T-lymphocyte activation, thereby suppressing the immune response and preventing the body from attacking transplanted organs or healthy tissues.
Q: What is the recommended dose of Cyclophil Me Capsules?
A: The dose varies depending on the condition being treated, the patient's body weight, and blood Cyclosporine levels. The doctor will determine and regularly adjust the appropriate dose based on therapeutic drug monitoring.
Q: Should Cyclophil Me Capsules be taken with food?
A: Cyclophil Me Capsules can be taken with or without food, but should always be taken consistently at the same time each day in relation to meals to maintain stable blood levels.
Q: How long should I take Cyclophil Me Capsules?
A: For transplant patients, Cyclosporine is typically a lifelong therapy. For autoimmune conditions, the duration is determined by the doctor based on clinical response and tolerability.
Q: What are the common side effects?
A: Common side effects include increased blood pressure, kidney dysfunction, tremors, headache, excessive hair growth, gum overgrowth, nausea, and increased susceptibility to infections.
Q: Can Cyclophil Me Capsules cause kidney damage?
A: Yes, nephrotoxicity is a significant concern with long-term Cyclosporine use. Regular monitoring of kidney function and blood Cyclosporine levels is essential throughout treatment.
| Manufacturer | : | Eris Lifesciences Ltd |
| Trade Name | : | Neoral |
| Generic Search | : | Cyclosporine |
| Strength | : | 25mg, 50mg, 100mg |
Latest Products
