Nimox® Infusion 10 mg/50 ml, each 50 ml contains : Nimodipine 10 mg.
Nimox® contains of Nimodipine as active ingredient is available in infusion 10 mg/50 ml.
Prophylaxis and treatment of ischaemic neurological deficits caused by cerebral vasospasm following subarachnoid haemorrhage of aneurismal origin.
DOSAGE AND ADMINISTRATIONS :
IV Infusion :
- At the beginning of treatment 1 mg/hour Nimodipine (= 5 ml Nimox® infusion solution/hour) for 2 hours (about 15 µg/kg body weight/hour).
- If this is well tolerated, and particularly if there is no marked reduction in blood pressure, the dose is increased after 2 hours to 2 mg/hour Nimodipine (= 10 ml Nimox® infusion solution/hour) about 30 µg/kg body weight/hour.
- Patients whose body weight is appreciably below 70 kg or who have labile blood pressure should be started with a dose of 0.5 mg/hour Nimodipine (= 2.5 ml Nimox® infusion solution/hour).
Intracisternal Installation :
- During surgery, a freshly prepared dilute solution of Nimox® (1 ml Nimox® infusion solution and 19 ml Ringer’s solution) warmed up to blood temperature may be instilled intracisternally.
- This dilute solution of Nimox® must be used immediately after preparation.
- Nimox® infusion solution is administered as a continuous IV infusion via a catheter using an infusion pump.
- Mannitol, human albumin or blood are also suitable for co-infusion.
- Nimox® solution must not be added to an infusion bag or bottle and must not be mixed with other drugs.
- Administration of Nimox® should be continued during anesthesia, surgery, and angiography.
Duration of Administration :
Prophylactic Use :
- IV therapy should be started not later than 4 days after the haemorrhage, and be continued during the period of maximum risk of vasospasm, i.e., up to 10 – 14 days after the subarachnoid haemorrhage.
- If during prophylactic administration of Nimox®, the source of the haemorrhage is treated surgically, IV treatment with Nimox® should be continued post-operatively for at least 5 days.
- After the end of the infusion therapy, it is advisable to continue with oral administration of 6 × 60 mg Nimodipine daily at 4-hourly intervals for about a further 7 days.
Therapeutic Use :
- If ischaemic neurological disturbances caused by vasospasm after aneurysmal subarachnoid haemorrhage are already present treatment should be started as early as possible and be continued for at least 5 days up to a maximum of 14 days.
- Thereafter, oral administration of 6 × 60 mg Nimodipine daily at 4-hourly intervals for 7 days is recommended.
- If during therapeutic administration of Nimox®, the source of the haemorrhage is treated surgically, IV treatment with Nimox® should be continued post-operatively for at least 5 days.
Symptoms of Overdosage :
Symptoms of acute overdosage to be anticipated are marked lowering of the blood pressure, tachycardia or bradicardia, and (after oral administration) gastrointestinal complaints and nausea.
Treatments of Overdosage :
- In the event of acute overdosage, treatment with Nimodipine must be discontinued immediately.
- Emergency measured should be governed by the symptoms.
- If the substance was ingested orally, gastric lavage with addition of charcoal should be considered as an emergency therapeutic measure.
- If there is a marked fall in blood pressure, Dopamine or Noradrenaline can be administered intravenously.
- Since no specific antidote is known, subsequent treatment for other side effects should be aimed at the most prominent symptoms.
Patients who have hypersensitivity to Nimodipine or other components contained in this product.
WARNINGS AND PRECAUTIONS :
- Although treatment with Nimodipine has not been shown to be associated with increases in intracranial pressure, close monitoring is recommended in these cases or when the water content of the brain tissue is elevated (generalized cerebral oedema).
- Caution is required in markedly hypotensive patients (systolic blood pressure < 100 mmHg).
- This medicinal product contains ethanol (alcohol). This may be harmful for those suffering from alcoholism or impaired alcohol metabolism and should be taken into account in pregnant or breast-feeding women, children, and high risk groups such as patients with liver disease, or epilepsy. The amount of alcohol in this medicinal product may alter the effects to other medicines.
- There are no adequate and well controlled studies in pregnant woman. If Nimodipine infusion solution is to be administered during pregnancy, the benefits and the potential risks must therefore be carefully weighted according to the severity of the clinical picture.
- Nimodipine and its metabolites have been shown to appear in human milk at concentrations of the same order of magnitude as corresponding maternal plasma concentrations. Nursing mothers are advised not to breastfeed their babies when taking the drug.
- In principle the ability to drive and use machines can be impaired in connection with possible occurrence of dizziness. In case of using Nimodipine infusion solution, this influence will not be of importance.
- In patients with unstable angina or within the first 4 weeks after acute myocardial infarction, physicians should consider the potential risk (e.g., reduced coronary artery perfusion and myocardial ischemia) versus the benefit (e.g., improvement of brain perfusion).
- Fertility : In single case of in vitro fertilization, calcium antagonists have been associated with reversible biochemical changes in the spermatozoa’s head section that may result in impaired sperm function.
Nimox® Infusion 10 mg/50 ml Box, 1 vial @ 50 ml Reg. No. DKL1402348749A1
STORE BELOW 25ºC AND DRY PLACE, PROTECT FROM LIGHT
ON MEDICAL PRESCRIPTION ONLY
Manufactured by :
Sidoarjo – Indonesia