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Indications:

Prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants in conjunction with adrenal corticosteroid therapy; may be used in the treatment of chronic rejection in patients previously treated with other immunosuppressive agents; increase tear production in patients whose tear production is presumed to be suppressed because of ocular inflammation associated with keratoconjunctivitis sicca (ophthalmic emulsion). In severe psoriasis or atopic dermatitis (eczema) and nephrotic syndrome> indicated for the treatment of patients with severe active, rheumatoid arthritis where the disease has not adequately responded to methotrexate.

Contraindications:

General :contraindicated in patients with a hypersensitivity to cyclosporine or to any of the ingredients of the formulation. Rheumatoid Arthritis Rheumatoid arthritis patients with abnormal renal function, uncontrolled hypertension, or malignancies should not receive cyclosporin. Psoriasis Psoriasis patients who are treated with cyclosporin should not receive concomitant PUVA or UVB therapy, methotrexate or other immunosuppressive agents, coal tar or radiation therapy. Psoriasis patients with abnormal renal function, uncontrolled hypertension, or malignancies should not receive this drug.

Adverse reactions:

Cardiovascular Hypertension (53%); chest pain (6%); arrhythmia (5%); abnormal heart sounds, cardiac failure, MI, peripheral ischemia (1% to less than 3%). CNS Tremor (55%); headache (25%); paresthesia (11%); dizziness (8%); depression, fatigue (6%); convulsions (5%); insomnia (4%); migraine (3%); anxiety, asthenia, confusion, decreased or increased libido, emotional lability, hypoesthesia, impaired concentration, malaise, nervousness, neuropathy, paranoia, somnolence, vertigo (1% to less than 3%); encephalopathy (postmarketing). Dermatologic Hirsutism (45%); hypertrichosis (19%); rash (12%); acne (6%); flushing (5%); alopecia, purpura (4%); abnormal pigmentation, angioedema, dermatitis, dry skin, eczema, folliculitis, increased sweating, keratosis, nail disorder, pruritus, skin disorder, skin malignancies, urticaria (1% to less than 3%); brittle fingernails (2% or less); bullous eruptions, skin ulcer (1%). EENT Ear disorder (5%); pharyngitis (4%); rhinitis (3%); abnormal vision, cataract, conjunctivitis, deafness, eye pain, taste perversion, tinnitus, vestibular disorder (1% to less than 3%); hearing loss (2% or less). Ophthalmic emulsion Ocular burning (17%); conjunctival hyperemia, discharge, epiphora, eye pain, foreign body sensation, pruritus, stinging, visual disturbances (1% to 5%). GI Nausea (23%); gum hyperplasia (16%); abdominal pain (15%); diarrhea (13%); dyspepsia (12%); nausea/vomiting (10%); vomiting (9%); abdominal discomfort, stomatitis (7%); flatulence (5%); GI disorder, gingivitis (4%); anorexia, rectal hemorrhage (3%); abdominal distension, constipation, dry mouth, dysphagia, enanthema, eructation, esophagitis, gastric ulcer, gastroenteritis, gingival bleeding, glossitis, peptic ulcer, salivary gland enlargement, tongue disorder, tooth disorder (1% to at least 3%); hiccups (2% or less). Genitourinary Renal dysfunction (38%); UTI (21%); nonprotein nitrogen increased (19%); gynecomastia, micturition frequency (4%); menstrual disorder (3%); abnormal urine, breast pain, breast fibroadenosis, hematuria, increased BUN, micturition urgency, nocturia, polyuria, pyelonephritis, renal abscess, urinary incontinence, uterine hemorrhage (1% to less than 3%); dysuria, leukorrhea (1%); glomerular capillary thrombosis; BK virus–associated nephropathy (postmarketing). Hematologic-Lymphatic Leukopenia, lymphoma (6%); anemia, bleeding and clotting disorders, epistaxis, lymphadenopathy, RBC disorders (1% to less than 3%); thrombocytopenia (2% or less). Hepatic Hepatotoxicity (7%); hyperbilirubinemia (1% to less than 3%). Lab Tests Increased creatinine (48%); elevated triglycerides (15%); elevated cholesterol (less than 3%). Metabolic-Nutritional Hypomagnesemia (6%); diabetes mellitus, hyperkalemia, hyperuricemia, hypoglycemia, increased or decreased weight (1% to less than 3%). Musculoskeletal Leg cramps/involuntary muscle contractions (12%); arthralgia (6%); arthropathy (5%); rigors (3%); bone fracture, bursitis, joint dislocation, myalgia, stiffness, synovial cyst, tendon disorder (1% to less than 3%); muscle pain (2% or less). Respiratory Upper respiratory tract infection (14%); respiratory infection (9%); sinusitis (7%); pneumonia (6%); bronchospasm, coughing, dyspnea (5%); bronchitis (3%); abnormal chest sounds, tonsillitis (1% to less than 3%). Miscellaneous Viral infection (16%); edema (14%); pain (13%); flu-like symptoms (10%); local fungal infection (8%); wound and skin infections (7%); cytomegalovirus infection, septicemia (5%); abscess, cramps (4%); fever (3%); bacterial infection, carcinoma, cellulitis, fungal infection, goiter, herpes simplex, herpes zoster, hot flushes, increased appetite, moniliasis, tumor, viral infection (1% to less than 3%); allergic reaction (2% or less).

Interactions:

Ciclosporin interacts with a large number of other medicines and this can interfere with your treatment. Tell your doctor or pharmacist if you are taking any of the following: • Medicines to treat heart problems or high blood pressure such as bosentan, diltiazem, nicardipine and verapamil. • Drugs containing potassium (your doctor will know which these are). • Medicines called NSAIDs used to treat pain and inflammation. (Some of these can be bought over-the-counter). • Medicines to treat infections including antibiotics (especially erythromycin and clarithromycin) and antifungal medicines (especially terbinafine and voriconazole). • Oral contraceptives. • Medicines for epilepsy. • Cholesterol lowering medicines (including statins). • Sleeping tablets. • Potassium supplements. • Diuretics or “water tablets” that affect the amount of urine you produce and might also affect the level of potassium in your blood. • Danazol (used to treat menstrual disorders, endometriosis or breast problems). • St John’s Wort: The herbal remedy St John’s Wort (Hypericum perforatum) should not be taken at the same time as this medicine. If you are already taking St John’s Wort consult your doctor before stopping the St John’s Wort preparation. • Octreotide (known as Sandostatin®). • Medicines to treat tuberculosis. • Medicines to treat gout. • Metoclopramide (used to stop sickness). • Melphalan (used to treat lymphomas or tumours). • Imatinib (used to treat leukaemia or tumours). • Orlistat (used to help weight loss). • Ticlopidine (used after a stroke). • Corticosteroids (used to treat conditions such as asthma, allergic conditions, inflammatory conditions including inflammatory bowel disease, adrenocortical insufficiency and rheumatic disease). • Ursodeoxycholic acid (used to treat gallstones). • Protease inhibitors (used to treat Human Immunodeficiency Virus (HIV)). • Tacrolimus, sirolimus and everolimus (other immunosuppressants). • Methotrexate (used to treat tumours, severe psoriasis and rheumatoid arthritis). • Etoposide (used to treat cancer). • Repaglinide (used to treat diabetes). Always tell your doctor or pharmacist about all the medicines you are taking. This means medicines you have bought yourself as well as medicines on prescription from your doctor.

Warnings:

The dose of this medicine needs to be carefully adjusted by your doctor. You will, therefore, have regular blood tests and visits to the hospital. This will give you the chance to talk to your doctor about your treatment and mention any problems you are having. • Ciclosporin can affect how the liver and kidneys work. It can also affect blood pressure, and the composition of the blood. Your doctor will want to perform tests from time to time while you are being treated with this medicine. • Because ciclosporin dampens down the immune system you are more prone to catch infections and they can become very serious. If you experience vision changes, loss of coordination, clumsiness, memory loss, difficulty speaking or understanding what others say, and muscle weakness, these can be the signs and symptoms of an infection of the brain called progressive multifocal leukoencephalopathy. Contact your doctor as soon as you feel unwell. • There have been very rare reports of people developing a condition called Benign Intracranial Hypertension when they are being treated with ciclosporin. Tell your doctor as soon as possible if you start to feel nauseous, develop tinnitus (ringing in your ears), or get pains in your head, neck or back, or problems with your sight, balance or memory. • Before giving you this medicine to treat psoriasis, the doctor will examine you to make sure that you do not have any skin cancers or pre-cancers. • You must not have light treatment (PUVA or other UV treatment) for psoriasis while you are taking this medicine. • Do not go out into the sun too much without protecting your skin. • You must not eat grapefruit or drink grapefruit juice in the hour before you take this medicine. • If you have recently had a vaccination or are planning to have any vaccinations make sure the doctor or nurse knows you are taking this medicine. • You must visit the dentist regularly while you are taking this medicine to make sure that your gums remain healthy.

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Consultants Corner

Dr. Faisal Dibsi

Dr. Faisal Dibsi Specialist of Otolaryngology - Head and Neck Surgery

Dr . Dirar Abboud

Dr . Dirar Abboud Hepatologist – Gastroenterologist

Dr. Hani Najjar

Dr. Hani Najjar Pediatrics, Neurology

Dr. Talal Sabouni

Dr. Talal Sabouni UROLOGY AND KIDNEY TRANSPLANT

Samir Moussa M.D.

Samir Moussa M.D. ENT Specialist

Yaser Habrawi , F.R.C.S.Ed

Yaser Habrawi , F.R.C.S.Ed Consultant Ophthalmologist

Dr. Tahsin Martini

Dr. Tahsin Martini Degree status: M.D. in Ophthalmology

Dr. Samer Al-Jneidy

Dr. Samer Al-Jneidy Pediatrician
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