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MANNITOL 20% FIMA INTERNASIONAL

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    Komposisi:

    Mannitol 20%.

    Bentuk sediaan:

    Larutan infus 500 mL di dalam botol kaca.

    Farmakologi:

    Dapat menembus sawar darah otak, mencegah edema, dan memiliki efek diuresis.

    Indikasi:

    Terapi dan profilaksis oliguria pada gagal ginjal akut, edema otak, peningkatan tekanan intrakranial.

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    Dosis:

    Dewasa : 50-100 g (250-500 mL) dengan kecepatan infus 30-50 mL/jam.

    Penurunan TIK : 0,25-2 g/kgBB dengan infus selama 30-60 menit.

    Edema dan asites : 500 mL dengan infus selama 2-6 jam.

    Oliguria : 200 mg/kgBB dengan infus selama 90 menit.

    Peningkatan diuresis : 500 mL dengan infus selama 4-8 jam.

    Anak : 0,25-2 g/kgBB.

    Kontraindikasi:

    Gagal jantung, edema paru, dehidrasi.

    Peringatan dan Perhatian:

    Keseimbangan cairan, gangguan fungsi ginjal.

    Bila terbentuk kristal, hangatkan dalam pemanas air sampai kristal larut, kemudian dinginkan hingga sesuai dengan temperatur tubuh sebelum digunakan. Infus set berfilter harus digunakan jika menggunakan cairan infus yang mengandung mannitol 20% atau lebih. Jangan menginfuskan larutan mannitol jika terlihat adanya kristal.

    Efek Samping:

    Gangguan keseimbangan cairan dan elektrolit, haus, sakit kepala, mual, muntah, pusing, demam, sensasi rasa dingin, takikardi, hipertensi, nyeri dada, hiponatremi, dehidrasi.

     

     

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    MANNITOL 20% FIMA INTERNASIONAL

     

    Composition:

    Each 500 mL contains Mannitol 100 g, aqua for injection 400 g.

    Presentation:

    Mannitol for infusion is packed in 500 mL glass bottle.

    Pharmacology:

    Infusion solution containing 20% Mannitol in water for injection. Osmolarity 1098 mOsm/L.

    Indications:

    Mannitol is an osmotic diuretic for prevention and treatment of : - Oliguria in acute kidney failure to return its normal function. - Decrease pre and postoperative intracranial in patients undergoing neurosurgery. - Decrease cerebral edema/common edema (for example, intraocular, ascites). - Increase renal clearance in case of toxicity or overdose of barbiturate/others sedative agents.

    Contraindications:

    Mannitol cannot be given to patients with congestive heart failure, congestive pulmonary or pulmonary edema, intracranial hemorrhage (except during craniotomy), patients in dehydration state, patients with metabolic edema (the causes of edema are not from kidney, heart, or liver) in which associated with fragile capillaries/abnormal permeability. As well as patients with kidney failure, unless after the patient is given mannitol 0.2 gram/kg body weight infusion in 3 to 5 minutes infusion could produce urine output of minimum 40 mL/hour and the observation is done for 2 - 3 hours.

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    Dosage:

    Mannitol solution for injections is administered via intravenous infusion as an osmotic diuretic to protect kidney functions in acute kidney injury and as well as to decrease intracranial hypertension and intraocular pressure. The total dosage and rate of infusion are determined or could be adjusted according to a patient's conditions and age. - Common dosage for adults: 20 - 100 grams in 24 hours. Rate of infusion is adjusted to maintain the rate of urine output in minimum 30 - 50 mL/hour. - Dosage to decrease intracranial hypertension in patients undergoing neurosurgery or intraocular pressure : 1 - 2 grams/kg body weig ht infusion in 30 - 60 minutes - Therapy for edema and ascites : 500 mL mannitol infusion in 2 - 6 hours - Therapy of oliguria: 500 mL mannitol infusion in 90 minutes. - Dosage to increase diuresis in intoxication: 500 mL mannitol infusion in 4 - 8 hours. - Common dosage for children: 1 - 2 grams/kg body weight.

    Warning and Precautions:

    If crystals are formed, heat the product using water warmer until the crystals are dissolved, then cool down the product till it reaches body temperature before use. An administration set with a filter should be used for intravenous infusions of solutions containing 20% or more of mannitol. Do not infuse mannitol solution if crystals are visible. Preliminary test should be done prior using this product in patients with oliguria/anuria. Precaution should be taken while using solutions conta ining sodium ions in pat ients with congestive heart failure, severe renal insufficient and clinically static patients accompanied by edema caused by depletion of sodium. Administration via intravenous route could produce excess fluid due to dilution of serum electrolyte concentration, over hydration, congestive state, or accumulation of fluid in lung. The risk of the dilution is inversely to the concentration of the electrolyte solution given parenterally. Peripheral and accumulation of fluid in the Iungs is expressed directly proportional to the concentration of the electrolyte solution.

    Adverse events:

    Mannitol could cause fluid and electrolyte imbalance, therefore monitoring the fluid balance, electrolyte, kidney function, urine output, and other clinical symptoms is needed. Patients receiving intravenous mannitol infusion often feel thirst. If high dosage is administered rapidly, patients might experience headache, nausea, vomiting, dizziness, fever, tachyca rdia, hypotension, chest pain, hyponatre mia, and dehydration.

    Drugs Interaction:

    This product could have an interaction with other drugs, such as - Aminoglycosides : Mannitol potentiates their ototoxic effects. - Lithium : The renal excreation of lithium can be increased by administration of mannitol. - Neuromuscular-blocking drugs : Mannitol may enhance the effect of tubocurarine and other competitive or depolarizing neuromuscular-blocking drugs. - Oral anticoagulants : Mannitol may reduce the effect of oral anticoagulants by increasing concentration of clotting factors secondary to dehydration. - Digoxin : If hypokalemia follows mannitol treatment, there is increase risk of digoxin toxicity. - Cisplatin : Mannitol reduces the renal toxicity of cisplatin. - Potassium chloride, sodium chloride, other electrolytes, or other drugs should not be add ed to 20 or 25% mannitol solutions because of the likelihood of salting-out (precipitating) mannitol. - Adrenocorticotrophic hormone, barbiturates, norepinephrine, metaraminol, succinylcholine, cisplatin, or tetracycline should not be added to mannitol of any strength.

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