Sporium 100 mg/ml (Syrup)
Medicine Details
| Category | Details |
|---|---|
| Generic | Cyclosporine oral |
| Company | Incepta pharmaceuticals ltd |
Indications
- Solid organ transplantation
- Bone marrow transplantation
- Endogenous uveitis
- Nephrotic syndrome
- Rheumatoid arthritis
- Psoriasis
- Atopic dermatitis
Pharmacology
Cyclosporine is a cyclic polypeptide consisting of 11 amino acids. It is a potent immunosuppressive agent, which prolongs survival of allogeneic transplants of skin, heart, kidney, pancreas, bone marrow, small intestine, or lung.
Dosage & Administration
- Solid organ transplantation: Initial dose 10 to 15 mg/kg, maintenance dose 2 to 6 mg/kg
- Bone marrow transplantation: Initial dose 12.5 to 15 mg/kg, maintenance dose 12.5 mg/kg
- Endogenous uveitis: Initial dose 5 mg/kg, maintenance treatment at lowest effective level
- Nephrotic syndrome: Initial dose 5 mg/kg for adults, 6 mg/kg for children, maintenance treatment at lowest effective level
- Rheumatoid arthritis: Recommended dose 3 mg/kg for the first 6 weeks, maintenance treatment titrated individually
- Psoriasis & Atopic dermatitis: Initial dose 2.5 mg/kg, maintenance treatment titrated individually
Interaction
- Drugs that decrease Sporium levels:
- Barbiturates
- Carbamazepine
- Phenytoin
- Rifampicin
- Orlistat
- Ticlopidine
- Drugs that increase Sporium levels:
- Macrolide antibiotics
- Ketoconazole
- Fluconazole
- Oral contraceptives
- Allopurinol
- Amiodarone
- Other relevant drug interactions:
- Sporium may reduce the clearance of digoxin, colchicine, prednisolone, and statins
Contraindications
- Hypersensitivity to ciclosporin
- Kidney failure (except in patients with nephrotic syndrome)
- Uncontrolled hypertension
- Uncontrolled infection
- History of malignancy
Side Effects
- Renal dysfunction
- Hypertension
- Tremor
- Headache
- Anorexia
- Nausea
- Diarrhoea
- Muscle cramps
- Hypertrichosis
Pregnancy & Lactation
Sporium should not be used during pregnancy unless the potential benefit to the mother justifies the potential risk to the fetus. Cyclosporine passes into breast milk; mothers receiving treatment with Sporium should not breast-feed.
Precautions & Warnings
Sporium increases the risk of developing lymphomas and other malignancies, particularly those of the skin. Patients should avoid excess ultraviolet light exposure. Sporium may develop bacterial, fungal, parasitic, and viral infections.
Overdose Effects
Renal dysfunction may occur, which resolve following drug withdrawal. Elimination can be achieved by nonspecific measures.
Therapeutic Class
Immunosuppressant, Vaccines, Anti-sera & Immunoglobulin
Storage Conditions
Sporium oral solution should be used within 2 months of opening the bottle and be stored between 15 to 30°C.