Neoral 50mg Capsule

Uses of Neoral 50mg Capsule

• Organ Transplant - Rejection Prophylaxis
• Rheumatoid Arthritis
• Psoriasis

How does Neoral 50mg Capsule work?

• Neoral 50mg Capsule works by blocking the cytokine genes in the T cells that are activated. It forms a complex with Cyclophilin and inhibits the activity of Calcineurin which helps regulate nuclear translocation. It also blocks the pathways that are triggered by antigens.

Side Effects of Neoral 50mg Capsule

Common Side Effects:

• High blood pressure
• Headache and shakiness
• Nausea, vomiting, loss of appetite, stomach pain, diarrhea
• Acne, hot flushes, fever, tiredness
• Excessive facial hair
• Elevated blood cholesterol and sugar levels
• Tingling sensation in the body
• Muscle spasms, swollen gums
• Elevated levels of uric acid or potassium
• Low levels of magnesium in the blood

Uncommon Side Effects:

• Insomnia (lack of sleep)
• Edema and weight gain

Rare Side Effects:

• Inflammation of the pancreas, severe upper stomach pain
• Menstrual irregularities, breast enlargement in men

Serious Side Effects (Stop Taking and Contact Your Doctor Immediately):

• Signs of infection (fever or sore throat)
• Signs of brain infection known as progressive multifocal leukoencephalopathy (vision changes, loss of coordination, memory loss, etc.)
• Brain-related problems (seizures, confusion, paralysis, etc.)
• Swelling at the back of the eye with blurred vision
• Signs of liver problems (yellow skin/eyes, nausea, dark urine)
• Low urine output, kidney issues
• Low red blood cells or platelet levels (pale skin, fatigue, breathlessness, bruising/bleeding, confusion, kidney problems)

These are potential side effects associated with Neoral 50mg Capsule. If you experience any of the serious side effects, consult your doctor immediately.

Quick Suggestions:

• Consume foods rich in quercetin (e.g., apples, cherries, broccoli, spinach, blueberries), a flavonoid with potential anti-allergic properties.
• Incorporate foods rich in probiotics to support the immune system against allergies.
• Limit intake of potential allergy triggers like dairy products, soy, eggs, and nuts.
• Avoid excessive sugar consumption to prevent inflammation flare-ups.
• Ciclosporin is used to prevent organ rejection in transplant patients.
• It treats various immune-related conditions involving the eyes, lungs, muscles, skin, nerves, and blood vessels.
• The medication might take several months to show its full effects; continue taking it as prescribed.
• Regular blood tests may be performed to monitor blood cell levels.
• Report any unusual symptoms such as bruising, bleeding, sore throat, mouth ulcers, fever, or general illness to your doctor.
• Kidney function should be monitored; stay hydrated by drinking 8 to 10 glasses of water daily.
• Never stop taking Ciclosporin without consulting your doctor.
• Opt for a diet rich in fruits, vegetables, whole grains, healthy fats, and fish.
• Manage stress and maintain a consistent sleep schedule.
• Avoid harsh soaps, detergents, and rough fabrics that could irritate the skin.

Indication

Organ Transplant Rejection: After receiving a new organ through transplantation, the body's immune system may identify it as foreign and attempt to attack and reject it. This occurs because the transplanted organ's antigens are different from the recipient's own antigens. To prevent this rejection, immunosuppressant drugs like cyclosporine are administered. These drugs suppress the immune response, reducing the chances of the body attacking the newly transplanted organ.

Rheumatoid Arthritis: Rheumatoid arthritis is an autoimmune disorder where the body's immune system mistakenly targets and attacks its own joint tissues. This leads to inflammation, pain, swelling, and damage to the joints. The symptoms can result in difficulty moving and reduced joint function.

Psoriasis: Psoriasis is a chronic inflammatory skin condition characterized by the development of itchy and red patches on the skin. Although not contagious, it often has a genetic predisposition. The immune system plays a role in triggering excessive skin cell growth, causing the buildup of patches and scales on the skin's surface.

Pharmacology

Cyclosporine binds to a protein called cyclophilin. This complex goes on to inhibit calcineurin, which is a key enzyme responsible for activating the transcription of interleukin 2 (IL-2), an important cytokine involved in immune responses. By inhibiting calcineurin, Cyclosporine prevents the production of IL-2 and also hinders the release of other immune-signaling molecules.

Dosage & Administration of

Adult Dose:

• For organ transplantation: Initial doses vary (10-15 mg/kg/day), followed by maintenance doses (2-6 mg/kg/day).
• Severe atopic dermatitis and psoriasis: Initial dose (2.5 mg/kg/day) in divided doses, with adjustments based on response.
• Rheumatoid arthritis: 2.5 mg/kg/day in divided doses, with potential dose increase.
• Nephrotic syndrome: 5 mg/kg daily in divided doses.

Child Dose:

• Nephrotic syndrome in children: 6 mg/kg daily in divided doses.

Administration:

• Cyclosporine can be taken with or without food. Consistency in timing and relation to meals is important.
• Grapefruit juice should be avoided.

Interaction

Medications that Increase Cyclosporine Levels:

• Diltiazem, doxycycline, erythromycin, ketoconazole, methylprednisolone (high doses), nicardipine, verapamil, and oral contraceptives can increase Cyclosporine levels in the body.

Medications that Reduce Cyclosporine Levels:

• Carbamazepine, isoniazid, phenobarbitone, phenytoin, and rifampicin can decrease Cyclosporine levels.

Interaction with Methylprednisolone:

• Concurrent use of high-dose methylprednisolone with Cyclosporine can increase the risk of convulsions.

Potentially Fatal Interactions (Additive Nephrotoxicity):

• Cyclosporine use in combination with aminoglycosides, amphotericin B, ciprofloxacin, colchicine, melphalan, co-trimoxazole, and NSAIDs can lead to additive nephrotoxicity, potentially causing serious kidney damage.

Contraindications

Hypersensitivity to Cyclosporine or to any of the excipients of Cyclosporine.

Pregnancy & Lactation

Pregnancy: There are no adequate and well-controlled studies in pregnant women and, therefore, Cyclosporine should not be used during pregnancy unless the potential benefit to the mother justifies the potential risk to the fetus.

Lactation: Cyclosporine passes into breast milk. Mothers receiving treatment with Cyclosporine should not breastfeed.

Precautions & Warnings

• Cyclosporine increases the risk of developing lymphomas and other malignancies, especially skin cancers. Patients should avoid excessive ultraviolet light exposure and take measures to protect their skin.
• Cyclosporine may lead to bacterial, fungal, parasitic, and viral infections. Long-term immunosuppressive strategies are important to manage the risk of infections.
• A reversible increase in serum creatinine and urea might occur initially and often responds to dose reduction. Elderly patients, in particular, require careful renal function monitoring.
• Blood pressure should be regularly monitored during Cyclosporine therapy. If hypertension develops, appropriate antihypertensive treatment should be administered.
• Cyclosporine enhances the risk of hyperkalemia, especially in patients with renal dysfunction. Caution is advised when co-administered with potassium-sparing drugs. It also affects magnesium clearance, necessitating potential supplementation.
• Care should be taken when treating patients with hyperuricemia (elevated uric acid levels in the blood).
• During Cyclosporine treatment, the efficacy of vaccinations may be reduced, and live-attenuated vaccines should be avoided.
• Non-transplant patients with impaired renal function, uncontrolled hypertension, uncontrolled infections, or any kind of malignancy should not receive Cyclosporine.
• Contraindications include renal and hepatic impairment, hyperuricemia, history of allergic reactions, anaphylaxis, pregnancy, and lactation.
• Cyclosporine is excreted in breast milk; nursing should be avoided.

Storage Conditions

Store in a cool and dry place away from sunlight