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  • Cinacalcet Trima
    / Trima


    Active Ingredient
    Cinacalcet 30, 60, 90 mg

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Film Coated Tablets

    28 X 30 mg

    partial basket chart 32088 9888

    Film Coated Tablets

    28 X 60 mg

    partial basket chart 32090 9889

    Film Coated Tablets

    28 X 90 mg

    partial basket chart 32092 9890

    Related information


    Dosage

    Children under the age of 18 must not take this drug. 
    Usual starting dose of Cinacalcet  is 30 mg (one tablet of 30 mg), once per day.
    Parathyroid cancer or primary hyperparathyroidism: The usual starting dose is 30 mg (one tablet of 30 mg), twice per day. Do not exceed the recommended dose. The tablets must be taken whole and are not to be divided, orally with or shortly after food.
    Accidental intake of higher dosage, or if a child has accidentally swallowed the medicine, immediately refer to a doctor or proceed to a hospital emergency room and bring the package of the medicine with you. Possible signs of overdose include numbness or tingling around the mouth, muscle aches or cramps and seizures.


    Indications

    Treatment of secondary hyperparathyroidism (HPT) in patients with end-stage renal disease (ESRD) on maintenance dialysis therapy.
    As part of a therapeutic regimen including phosphate binders and/or vitamin D sterols, as appropriate.
    Reduction of hypercalcaemia in patients with: Parathyroid carcinoma Primary HPT for whom parathyroidectomy would be indicated on the basis of serum calcium levels (as defined by relevant treatment guidelines), but in whom parathyroidectomy is not clinically appropriate or is contraindicated.


    Contra-Indications

    Known hypersensitivity to the active substance or any other constituent.


    Special Precautions

    Before treatment tell your doctor if you are suffering from Seizures, Liver problems Heart failure, Life-threatening events and death associated with low calcium levels (hypocalcemia) have been reported in patients treated with this drug. Low calcium levels can affect heart rhythm. Patients with arrhythmia or patients under anti-arrhythmic therapy should be carefully monitored.
    Please refer to the license holder for further details.


    Side Effects

    Very common: may affect more than 1 in 10 people. nausea and vomiting, these side effects are normally quite mild and do not last for long.
    Common: may affect up to 1 in 10 people dizziness numbness or tingling sensation (paraesthesia) loss (anorexia) or decrease of appetite muscle pain (myalgia) weakness (asthenia), rash, reduced testosterone levels, high potassium levels in the blood (hyperkalaemia), allergic reactions (hypersensitivity), headache, seizures (convulsions or fits), low blood pressure (hypotension), upper respiratory infection, breathing difficulties (dyspnoea), cough, indigestion (dyspepsia), diarrhoea, abdominal pain, abdominal pain – upper, constipation muscle spasms, back pain, low calcium levels in the blood (hypocalcaemia).
    Not known: frequency cannot be estimated from available data: Hives (urticaria), Swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing (angioedema), Unusually fast or pounding heart beat which may be associated with low levels of calcium in your blood (QT prolongation and ventricular arrhythmia secondary to hypocalcaemia).


    Drug interactions

    Initiation/ discontinuation of smoking, may affect the way this drug works.
    Medicines that can affect the activity of Cinacalcet: Ketokonazole, Itraconazole and Voriconazole. Telithromycin, Rifampicin, Ciprofloxacin. Ritonavir Fluvoxamine.
    Cinacalcet may affect the activity of the following medicines: Amitrptyline, Desipramine, Nortriptyline, Clomipramine. Flecainide, Propafenone. Metoprolol.


    Pregnancy and Lactation

    Pregnancy: Cinacalcet has not been tested in pregnant women. In case of pregnancy, the doctor may decide to modify your treatment, as Cinacalcet might harm the unborn baby.
    Lactation: It is not known whether Cinacalcet is excreted in breast milk. The doctor will discuss with you if you should discontinue either breastfeeding or treatment with Cinacalcet.
    Please refer to the license holder for further details.


    Overdose

    Please refer to the license holder for further details.


    Manufacturer
    Trima Israel Pharmaceutical Products Maabarot Ltd. Israel
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