Rolitac Capsules (Hard Gelatin)

Tacrolimus
1mg
Sandoz GmbH
Pack size 100's (10's Blister x 10)
Dispensing mode POM
Source AUSTRIA
AgentALPHAMED CO. (AUH) LTD.
Retail Price 629.50 AED

Indications

Rolitac Capsules (Hard Gelatin) is used for: Prophylaxis of transplant rejection in liver, kidney or heart allograft recipients. Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products

Adult Dose

Consult specialist literature

Child Dose

Renal Dose

Administration

Contra Indications

Hypersensitivity to tacrolimus or other macrolides; Lactation

Precautions

Routinely monitor the following during the initial post-transplant period: blood pressure, ECG, neurological and visual status, fasting blood glucose levels, electrolytes (particularly potassium), liver and renal function tests, haematology parameters, coagulation values, and plasma protein determinations. Herbal preparations e.g. St. John’s wort (Hypericum perforatum) may reduce blood concentrations of tacrolimus. Diarrhoea episodes (monitor for changes in plasma concn of tacrolimus). Avoid co-administration of ciclosporin and tacrolimus. QT interval elongation. Monitor for increased risk of opportunistic infections (bacterial, fungal, viral and protozoal). Limit exposure to sunlight and UV light (wearing protective clothing and using a sunscreen with a high SPF). May cause visual disturbances. Pregnancy

Pregnancy-Lactation

Interactions

CYP3A4 inhibitors (e.g. ketoconazole, fluconazole, erythromycin, ritonavir may increase while the inducers (e.g. rifampicin, phenytoin or St. John’s Wort) may decrease plasma levels of tacrolimus. Corticosteroids may reduce tacrolimus blood levels. Tacrolimus is a CYP3A4 inhibitor may affect the metabolism of the substrates of this enzyme e.g. Ciclosporin, phenytoin, statins. May increase the nephrotoxic or neurotoxic effects of aminoglycosides, gyrase inhibitors, vancomycin, sulfamethoxazole+trimethoprim, NSAIDs, ganciclovir or aciclovir. May increase hyperkalaemia due to high potassium intake, or potassium-sparing diuretics (e.g., amiloride, triamterene, or spironolactone). Avoid concomitant use of live attenuated vaccines. May displace drugs with high affinity for plasma proteins (e.g., NSAIDs, oral anticoagulants, or oral antidiabetics).

Adverse Effects

Side effects of Tacrolimus : Diarrhoea, nausea, abdominal pains, dyspepsia, constipation, flatulence, bloating and distension; Tremor, headache, insomnia, anxiety, mood disorders, seizures, neuropathies, dizziness, other CNS disorders; Renal & hepatic impairment; Vision blurred, photophobia, eye disorders; Tinnitus; Dyspnoea, pharyngitis, cough, nasal congestion; Hyperglycaemia, diabetes mellitus, hyperkalaemia, electrolyte & lipid abnormalities, hyperuricaemia, appetite decreased, anorexia, metabolic acidoses; Hypertension, tachycardia, blood disorders; Pruritus, rash, alopecias, acne, sweating increased; Arthralgia, muscle cramps, pain in limb, back pain; Increased risk for infections; Primary graft dysfunction; Asthenia, febrile disorders, oedema, pain and discomfort, blood alkaline phosphatase increased, weight increased; Allergic and anaphylactoid reactions

Mechanism of Action

Note

Rolitac 1mg Capsules (Hard Gelatin) manufactured by Sandoz GmbH. Its generic name is Tacrolimus. Rolitac is availble in United Arab Emirates. Farmaco UAE drug index information on Rolitac Capsules (Hard Gelatin) is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.

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