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ROCULAX

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    Komposisi:

    Rocuronium 10 mg/mL

    Bentuk sediaan:

    Cairan injeksi dalam ampul 5 mL

    Farmakologi:

    Mekanisme kerja: bersaing terhadap reseptor kolinergik pada motor end-plate. Pemulihan fungsi neuromuskuler baik. Mula kerja cepat sampai sedang tergantung dosisnya, dan lama kerjanya sedang. Terutama dieliminasi oleh hati.

    Indikasi:

    Sebagai tambahan pada anestesi umum untuk mempermudah intubasi endotrakea dan memberikan relaksasi otot rangka selama pembedahan.

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    Dosis:

    Dewasa:

    - Dosis awal intubasi endotrakeal : 0,6-1,2 mg/kgBB IV

    - Pemeliharaan : 0,1-0,2 mg/kgBB IV

    Anak-anak:

    - Dosis awal intubasi endotrakeal :0,6 mg/kgBB IV

    - Dosis pemeliharaan : 0,075-0,125 mg/kgBB IV

    Kontraindikasi:

    Hipersensitif terhadap rocuronium bromide atau ion bromide.

    Peringatan dan Perhatian:

    - Pemberiannya harus disertai dengan anestesi atau sedasi yang adekuat.

    - Penyakit hati/saluran empedu/ginjal, penyakit neuromuskuler, kelainan asam basa, usia lanjut, obesitas.

    - Ekstravasasi rocuronium dapat menyebabkan iritasi lokal. Ibu menyusui.

    Efek Samping:

    Mual, muntah, bronkospasme, reaksi alergi, edema pada lokasi injeksi, nyeri pada lokasi injeksi.

     

     

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    ROCULAX

     

    Composition:

    Each mL of injection contains rocuronium bromide 10 mg

    Presentation:

    Roculax 10 mg/mL : Box of 2 blisters @ 5 ampoules @ 5 mL

    Pharmacology:

    - Pharmacodynamics:Rocuronium bromide acts by competing for cholinergic receptors at the motor end-plate.The recovery of neuromuscular function is satisfactory. The neuromuscular blocking act ion of rocuronium bromide may be enhanced in the presence of potent inhalation anaesthetics. - Pharmacokinetics: Rocuronium is a nondepolarizing neuromuscular agent with rapid to intermediate onset depending on dose, and intermediate duration. The rapid distribution half-life is 1-2 minutes and the slower distribution half-life is 14-18 minutes. Rocuronium is approximately 30% bound to human plasma proteins. Rocuronium is eliminated primarily by the liver. The metabolite of rocuronium,17-desacetyl-rocuronium, has been rarely observed in the plasma or urine of humans administered single doses of 0.5-1 mg/kgBW with or without a subsequent infusion of rocuronium.

    Indications:

    Roculax is indicated as an adjunct to general anesthesia to facilitate endotracheal intubation, and to provide skeletal muscle relaxation during surgery.

    Contraindications:

    - Patients known to have hypersensitivity to rocuronium bromide or to bromide ion. - Pregnancy.

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    Dosage:

    As with other neuromuscular blocking agents, the dosage of Rocuronium bromide should be individualized to each patients. The method of anaesthesia, the expected duration of surgery, the possible interaction with other drugs that are administered before and/or during anaesthesia, and the condition of the patients should be taken into account when determining the dose. - Endotracheal intubation: The dose is 0.6 -1.2 mg/kgBW. The maintenance dose is 0.1 - 0.2 mg/kgBW. Use by continuous infusion: It is recommended to give loading dose of 0.6 mg ROCULAX®/kgBW, when neuromuscular block starts to recover, to start administration by infusion. In adults under i.v. anaesthesia, the infusion rate required to maintain neuromuscular block at this level ranges from 5 -10 mg/kgBW/min. Continuous monitoring of neuromuscular block is essential since infusion rate requirements vary from patient to patient and with the anaesthetic method used. - Pediatrics: The initial dose is 0.6 mg/kgBW. The maintenance dose is 0.075 - 0.125 mg/kgBW. A continuous infusion of ROCULAX® initiated at a rate of 0.012 mg/kgBW/min may also be used to maintain neuromuscular blockade in pediatric patients. There are no data to support the recommendation for the use of rocuronium bromide in neonates (0-3 months). - Geriatrics ( 65 years) and patients with hepatic and/or biliary tract disease and/or renal failure: The dose is 0.6 - 1.2 mg/kgBW. The maintenance dose is 0.075 - 0.1 mg/kgBW. The recommended infusion rate is 5-6 mg/kgBW/min. - Obese patients: When used in overweight or obese patients (defined as patients with a body weight of 30% or more above ideal body weight) doses should be reduced taking into account a lean body mass.

    Warning and Precautions:

    - ROCULAX® should be administered in carefully adjusted dosages under the supervision of experienced clinicians who are familiar with the drug's actions and the possible complications of its use. - ROCULAX® administration must be accompanied by adequate anaesthesia or sedation. - In patients with myasthenia gravis, small doses of nondepolarizing neuromuscular blocking agents may have profound effects. - ROCULAX®, which has an acid pH, should not be mixed with alkaline solutions (e.g. barbiturate solutions) in the same syringe or administered simultaneously during intravenous infusion through the same needle. - In the use of ROCULAX®, increases or decreases in MAP (Mean Arterial Pressure) and tachycardia may occurred. - Prolonged paralysis and/or skeletal muscle weakness may be noted during initial attempts to wean from the ventilator patients who have chronically received neuromuscular blocking drugs in the ICU. - ROCULAX® is not recommended for rapid induction in cesarean section patients. - ROCULAX® should be used with caution in patients with clinically significant hepatic disease because clinical duration and the recovery was moderately prolonged in these patients. - Both respiratory and metabolic acidosis prolonged the recovery time. The potency of ROCULAX® was significantly enhanced in metabolic acidosis and alkalosis, but was reduced in respiratory alkalosis. - Severe acid-base and/or electrolyte abnormalities may potentiate or cause resistance to the neuromuscular blocking action of ROCULAX®. - Extravasation of ROCULAX® may result signs or symptoms of local irritation; the injection or infusion should be terminated immediately and restarted in another vein. - Burns, disuse atrophy, denervation, direct muscle trauma, and cerebral palsy may result the development of resistance to nondepolarizing muscle relaxants. - Other nondepolarizing neuromuscular blocking agents exhibit profound neuromuscular blocking effects in cachectic or debilitated patients, patients with neuromuscular diseases, and patients with carcinomatosis. In these patients a decrease from the recommended initial dose should be considered. - ROCULAX® may be associated with increased pulmonary vascular resistance so caution in patients with pulmonary hypertension or valvular heart disease. - Anaphylactic reactions to neuromuscular blocking agents in general have been reported. - Because ROCULAX® is always used with other agents and because the occurrence of malignant hyperthermia during anaesthesia is possible, even in the absence of known triggering agents, clinicians should be familiar with early signs, confirmatory diagnosis and treatment of malignant hyperthermia prior to the start of any anaesthesia. - ROCULAX® should be used with caution in patients with clinically significant hepatic and/ or billiary tract diseases and/ or renal failure. - Conditions associated with prolonged circulation time such as cardiovascular disease, old age, and oedematous state resulting in an increased volume of distribution, may contribute to a slower onset of action. - Like other neuromuscular blocking agents, ROCULAX® should be used with extreme caution in patients with a neuromuscular disease or after poliomyelitis since the response to neuromuscular blocking agents may be considerably altered in these cases. - In surgery under hypothermic condition, the neuromuscular blocking effect of ROCULAX® is increased and the duration prolonged. - ROCULAX® may exhibit a prolonged duration and a prolonged spontaneous recovery in obese patients. - ROCULAX® should be given to lactating women only when the physician decides that the benefits outweigh the risk. - It is not recommended to use potentially dangerous machinery or drive a car within 24 hours after the full recovery from the neuromuscular blocking action of ROCULAX®.

    Adverse events:

    Prolonged neuromuscular block is associated with neuromuscular blockers. Adverse experiences with probable or unknown relationship: Cardiovascular: arrhythmia, abnormal electrocardiogram, tachycardia, hypotension, hypertension. Digestive: nausea, vomiting. Respiratory: asthma (bronchospasm, wheezing, or rhonchi), hiccup. Skin and appendages: allergic reactions (rash, pruritus, anaphylactic and anaphylactoid), injection site edema.

    Drugs Interaction:

    - If ROCULAX® is administered following administration of succinylcholine, it should not be given until recovery from succinylcholine has been observed. - Interactions have been observed between ROCULAX® and other nondepolarizing muscle relaxants if administered in succession. - Isoflurane and enflurane may also prolong the clinical duration and the spontaneous recovery time of initial and maintenance doses of ROCULAX® and decrease the average infusion requirement of ROCULAX® compared to opioid/N2O/O2 anaesthesia. - The use of propofol for induction and maintenance of anaesthesia does not alter the clinical duration or recovery characteristics following recommended doses of ROCULAX®. - If ROCULAX® is administered to patients chronically receiving anticonvulsant agents such as carbamazepine or phenytoin, shorter durations of neuromuscular block may occur and infusion rates may be higher. - If certain antibiotics (e.g., aminoglycosides; vancomycin; tetracyclines; bacitracin; polymyxins; colistin; and sodium colistimethate) are used in conjunction with ROCULAX®, the posibility of prolongation of neuromuscular block should be considered. - Magnesium salts, lithium, local anesthetics, procainamide, and quinidine have been shown to increase the duration of neuromuscular block and decrease infusion requirements of other neuromuscular blocking agents.

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