Ciclosporin


Generic Medicine Info
Administration
May be taken with or without food. Take consistently w/ regard to time of day & relation to meals. Avoid grapefruit juice.
Contraindications
Non-transplant indications: Abnormal renal function (except in nephrotic syndrome), uncontrolled hypertension, malignant neoplasms, uncontrolled infections. Psoriasis; atopic dermatitis: Patient receiving psoralen and ultraviolet A (PUVA) photochemotherapy, ultraviolet B (UVB) irradiation, or other radiation therapy. Concomitant use with coal tar, methotrexate or other immunosuppressive agents (in psoriatic patient). Lactation. Ophthalmic: Active or suspected ocular or peri-ocular infection, malignancies or premalignant conditions.
Special Precautions
Patients with hyperuricaemia; on K-rich diet; history of ocular herpes, glaucoma (ophthalmic). Hepatic impairment. Children. Pregnancy. Patient taking substrates of P-glycoprotein (P-gp) or organic anion transporter proteins (OATP) and products containing St. John's wort. Avoid immunisation with live vaccines. Patient Counselling Do not switch between brands or dosage forms unless instructed by your doctor. Avoid excessive exposure to sunlight or artificial UV light, use protective measures (e.g. sunscreen, protective clothing). Ophthalmic: Ciclosporin eye drops may cause blurred vision or other visual disturbances, if affected, do not drive or operate machinery. Remove contact lenses before administration and allow a 15-minute interval before reinserting lenses. Monitoring Parameters Perform physical and dermatological examination prior to treatment in patients with psoriasis or atopic dermatitis. Monitor plasma ciclosporin concentrations (particularly in transplant patients receiving conventional formulation), renal (serum BUN and creatinine) and liver function, serum glucose, serum lipids (prior to and after 1st month of therapy), blood pressure, uric acid, serum electrolytes (e.g. K, Mg) periodically or as clinically indicated. Assess for hypersensitivity reactions for 30 minutes after IV administration; hepatotoxicity, nephrotoxicity, secondary malignancy, infection, diabetes mellitus, progressive cognitive or motor deficits. Ophthalmic: Perform regular eye examination or reassess treatment every 6 months.
Adverse Reactions
Significant: Infections (bacterial, fungal, parasitic, viral), gingival hyperplasia, nephrotoxicity (e.g. renal dysfunction, increased serum creatinine and urea), seizures, encephalopathy (including posterior reversible encephalopathy syndrome), hypertension, microangiopathic haemolytic anaemia, thrombocytopenia, hyperkalaemia, hyperuricaemia; anaphylactoid reactions (IV). Blood and lymphatic system disorders: Anaemia, leucopenia. Cardiac disorders: MI. Eye disorders: Eye pain, burning or foreign body sensation in the eye, visual disturbance, conjunctival hyperemia, blepharitis, epiphora, eye discharge, eye irritation. Gastrointestinal disorders: Nausea, vomiting, diarrhoea, abdominal pain/discomfort, dyspepsia, flatulence, tongue and tooth disorders, constipation, dysphagia, eructation, esophagitis, peptic ulcer, gastritis, gastroenteritis, glossitis, salivary gland enlargement, pancreatitis. General disorders and administration site conditions: Pyrexia, fatigue, increased sweating, asthenia. Immune system disorders: Angioedema. Metabolism and nutrition disorders: Decreased or increased weight, anorexia, hyperglycaemia, hyperlipidaemia, hypomagnesaemia. Musculoskeletal and connective tissue disorders: Muscle cramps, arthralgia, myalgia. Nervous system disorders: Tremor, headache, paraesthesia, neuropathy. Psychiatric disorders: Anxiety, confusion. Renal and urinary disorders: Haematuria, UTI, micturition urgency. Reproductive system and breast disorders: Gynaecomastia, menstrual disorder. Respiratory, thoracic and mediastinal disorders: Bronchospasm, upper respiratory tract infections, dyspnoea, rhinitis, cough. Skin and subcutaneous tissue disorders: Hirsutism/hypertrichosis, rash, abnormal pigmentation, dermatitis, dry skin, eczema, pruritus, urticaria, acne, nail disorder. Vascular disorders: Flushing.
Potentially Fatal: Polyoma virus infections (e.g. JC virus-associated progressive multifocal leucoencephalopathy, polyoma virus-associated nephropathy due to BK virus), lymphomas and other malignancies (particularly of the skin), hepatotoxicity (usually manifested as increased hepatic enzymes and bilirubin) and liver injury (e.g. cholestasis, jaundice, hepatitis, liver failure).
Drug Interactions
Decreased plasma concentrations with inducers of CYP3A4 and/or P-gp (e.g. carbamazepine, nevirapine, phenytoin, phenobarbital, rifampicin, bosentan, orlistat). Increased plasma concentrations with CYP3A4 inhibitors (e.g. ketoconazole, azithromycin, ritonavir, delavirdine). Concomitant use with HMG-CoA reductase inhibitors (statins) may potentiate the risk of myopathy and rhabdomyolysis. May increase risk of gingival hyperplasia with nifedipine or amlodipine. May increase risk of hyperkalaemia with K-sparing diuretics, angiotensin II receptor antagonists, ACE inhibitors, K-containing products. May diminish efficacy of live vaccines. May increase plasma concentrations of substrates of CYP3A4, P-gp (e.g. aliskiren, dabigatran) and OATP. May increase risk of nephrotoxicity with aminoglycosides (e.g. gentamicin, tobramycin), amphotericin B, ciprofloxacin, vancomycin, trimethoprim and sulfamethoxazole, fibric acid derivatives (e.g. fenofibrate, bezafibrate), NSAIDs (e.g. naproxen), melphalan, H2-receptor blockers (e.g. cimetidine), methotrexate, tacrolimus, everolimus.
ATC Classification
L04AD01 - ciclosporin ; Belongs to the class of calcineurin inhibitors. Used as immunosuppressants.
S01XA18 - ciclosporin ; Belongs to the class of other ophthalmologicals .
Disclaimer: This information is independently developed by CIMS based on ciclosporin from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to CIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, CIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2021 CIMS. All rights reserved. Powered by CIMSAsia.com
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