Nimodipine Infusion 10 mg/50 ml, each 50 ml contains : Nimodipine 10 mg.
Nimodipine contains 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 aneurysmal origin.
DOSAGE AND ADMINISTRATIONS :
IV Infusion :
At the beginning of treatment 1 mg/hour Nimodipine (= 5 ml Nimodipine 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 Nimodipine 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 Nimodipine infusion solution/hour).
Intracisternal Installation :
During surgery a freshly prepared dilute solution of Nimodipine (1 ml Nimodipine infusion solution and 19 ml Ringer’s solution) warmed up to blood temperature may be instilled intracisternally.
This dilute solution of Nimodipine must be used immediately after preparation.
Nimodipine infusion solution is administered as a continuous IV infusion via a catheter using an infusion pump.
Mannitol, human albumin, or blood is also suitable for co-infusion.
Nimodipine solution must not be added to an infusion bag or bottle and must not be mixed with other drugs.
Administration of Nimodipine should be continued during anesthesia, surgery, and angiography.
Duration of Administration :
Prophylactic Use :
IV therapy should be started no 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 Nimodipine, the source of the haemorrhage is treated surgically, IV treatment with Nimodipine 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 Nimodipine, the source of the haemorrhage is treated surgically, IV treatment with Nimodipine 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.
Treatment 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 to any of the excipient.
WARNING 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.
DRUG INTERACTIONS :
The steady state concomitant administration of Nimodipine with the antidepressant Fluoxetine led to about 50% higher Nimodipine plasma concentrations. Fluoxetine exposure was markedly decreased, while its active metabolite nonfluoxetine was not affected.
The steady state concomitant administration of Nimodipine and Nortriptyline led to a slight decreased in Nimodipine exposure with unaffected Nortriptyline plasma concentrations.
Nimodipine may increase the blood pressure lowering effect of concomitant applied anti-hypertensive, such as : Diuretics, α-Blockers, ACE Inhibitors, A1-Antagonists, other Calcium Antagonists, α-Adrenergic Blockers, PDE5 Inhibitors, α-Methyldopa. However, if a combination of this type proves unavoidable particularly careful monitoring of the patient is necessary.
Simultaneous IV administration of β-Blockers may lead to mutual potentiation of negative inotropic action going as far as decompensated heart failure.
Renal function can deteriorate if potentially nephrotoxic drugs (e.g., Aminoglycosides, Cephalosporins, and Furosemide) are given simultaneously, and also in patients whose renal function is already impaired. Renal function must be monitored carefully in such cases, and if a deterioration is found discontinuation of the treatment should be considered.
Simultaneous administration of Anti-HIV drug Zidovudine IV and Nimodipine bolus IV resulted for Zidovudine in significantly higher AUC, whereas the distribution volume and clearance were significantly reduced.
Since Nimodipine infusion solution contains Alcohol, interactions with Alcohol incompatible drugs should be taken into consideration (see : WARNING AND PRECAUTIONS).
ADVERSE REACTIONS :
Blood and Lymphatic System Disorders :
Thrombocytopenia is uncommon.
Immune System Disorders :
Acute hypersensitivity reactions include uncommonly occurring mild to moderate allergic reaction. Associated clinical symptoms related to skin (uncommon rash).
Nervous System Disorders :
Unspecific cerebrovascular symptoms include uncommonly occurring headache.
Cardiac Disorders :
Unspecific cardiac arrhythmias : Tachycardia is uncommon while bradycardia is rare.
Vascular Disorders :
Unspecific cardiovascular symptoms, such as hypotension and vasodilatation are uncommon.
Gastrointestinal Disorders :
Unspecific gastrointestinal and abdominal symptom, include uncommonly occurring nausea. Rarely ileus has been reported.
Hepatobiliary Disorders :
Liver reactions include a rarely occurring transient increase in liver enzymes (include increase in transaminase, alkaline phosphatase and Y-GT).
General Disorders and Administration Site Conditions :
Infusion and injection site reactions are rare, including infusion site thrombophlebitis.
Nimodipine Infusion 10 mg/50 ml Box, 1 vial @ 50 ml Reg. No. GKL1402348649A1
STORE BELOW 25ºC AND DRY PLACE.
PROTECT FROM DIRECT SUNLIGHT IF THE BOTTLE IS REMOVED FROM THE BOX.
ON MEDICAL PRESCRIPTION ONLY
Manufactured by :
Sidoarjo – Indonesia