Drug Name

Nootropil

Drug Uses

Nootropil will reduce the duration of vestibular nystagmus. Nootropil will improve regional oxygen and glucose uptake in the brain in patients suffering from dementia subsequent to multiple infarcts. Nootropil will inhibit the increased aggregation of activated platelets and, in conditions where there is abnormal rigidity of the red blood cell, it can restore deformability and the ability to pass through the microvasculature.

How to use

1. Loss of memory, vertigo, lack of concentration or alertness, personal negligence, change of mood, dete­rioration in behaviour. - Tablet 800 mg 3 times/day orally, or tablet 1200 mg 2 times/day, morning and evening for 6 weeks conti­nuously. After improvement of symptom, take capsule 400 mg 3 times/day as the maintenance dose.
Solution 20%-Adults: 5 ml 3 times/day orally.

2 Treatment of alcoholism and withdrawal symptom after stop drinking. - In the initial period: by injection the dose of 6-12 g in four divided doses. After improvement of symptom, fol­lowed by dose of 2.4 g/day orally in 2-3 divided doses before or after meal.

3. Treatment of sickle cell anaemia. - Severe symptoms Infuse 80 mq/kg in 300 ml of glucose solution every 8 hours for 3 days. Maintenance therapy (Adult) by intramuscular injec­tion of 1 g/day continuously for 6 months. After impro­vement of symptom, followed by dose of 1.2 g orally every 8 hours.
(Children) 600 mg 3 times/day orally.

4. Treatment of cognitive deficit as a result of cerebrovascular diseases or head injury. - Initially by infusion or intravenous injection dose of 6-12 g/day until recovery. Maintenance therapy: 800 mg 3 times/day orally, or Solution 20% :5 ml 3 times/day orally.

5. Cortical myoclonus, alone or in combination.
Initial dosage: Initial dose is 72g/day, increasing the dose by 4.8 g every 3-4 days, up to the maximum dose of 24 g/day in two or three sub-doses. In case of a weak or no response, the administration of 24 g/day will be continued until the 7th day. If it becomes active then reducing the dose by 1.2 g every other day until myoclonus appear again to determine the mean active dose. If there is still no response, treatment will be discontinued on the 7th day. Treatment with other, anti-myocfonus drug will be maintained or reduced depending on the obtained clinical benefit. The treat­ment with Nootropil will be maintained as long as the cerebral pathology persists. An attempt to decrease or to discontinue the drug therapy will be made every 6 months. Treatment will be discontinued by reducing the dose of Nootropil by 1.2 g every other day.

6. The administration Nootropil together with improving remedial teaching to treat children with learning difficulties in reading which cannot be explained by intel­lectual backwardness, inadequate education or by family environment.
Children 8-13 years old: total dose 3.3 g/day in two sub-doses.
Solution 20%: 8 ml 2times/day. It may be given in fruit juice or in some other drinks. Treatment should be continued throughout the school year.

Drug Class and Mechanism

Nootropil is a “nootrope “ that is to say it is a psychotropic agent which acts directly on the brain to improve the efficacy of the telencephalon in both normal subjects and those suffering from some functional deficit. This area of the brain is involved in cognition and also has a role to play in teaming and memory, in alertness and in consciousness. Nootropil does not produce either sedation or stimulation. Nootropil can act on the Central Nervous System in a variety of ways. It will modify neurotransmission within the brain, and can help to improve the metabolic environ­ment essential for good neuronal function. It is also a ha emorrheo logical agent and can improve microcirculation without producing vasodilation. When given as acute or long term treatment for patients suffering from a tunctional CNS deficit, or after cerebral trauma such as hypoxia or intoxi­cation, and after electroshock therapy, it will heighten alertness and increase cognitive function. These changes are seen as a significant increase in the alpha and beta activity, with a reduction in delta activity on an EEG trace.

Missed Dose

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

Storage

Store this medicine at room temperature in a tightly-closed container, away from heat and light.

Warnings/Precautions

Hypersensitivity to Nootropil or other pyrrolidone derivatives or any of the excipients. Nootropil is contra-indicated in patients with cerebral haemorrhage. Nootropil is contra-indicated in End Stage Renal Disease patients.

Due to the effect of Nootropil on platelet aggregation, caution is recommended in patients with underlying disorders of haemostasis, major surgery or severe haemorrhage. As Nootropil is almost exclusively eliminated by the kidney, precautions should be taken when treating patients suffering from renal insufficiency, and in whom it is wise to check the renal function. The half-life time is increased in direct proportion to the loss of renal function and the creatinine clearance; this is equally true in elderly patients, in whom the excretion of creatinine is dependant on age. For this reason, the dosage will be changed according to the table below:

Possible Side Effects

The side effects reported in connection with Nootropil include nervousness, agitation, irritability, anxiety and sleep disturbances. The incidence of these during clinical trials was 5% or less and they were more often noted in the older patients taking more than 2.4 g daily. In the majority of cases a dose reduction sufficed to make these symptoms disappeared. Some patients may complain of fati­gue or drowsiness. Gastro-intestinal problems such as nausea, vomiting, diarrhoea and stomacha­che have also been reported, but their Incidence during clinical trials was 2% or less. Other symptoms, such as vertigo, headaches, trembling and sexual stimulation have occasionally been reported.

More Information

Nootropil should not be prescribed during pregnancy or when breastfeeding.