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Nootropil

Brand Names: Nootropil, Qropi, Myocalm, Dinagen, Synaptine
Generic Name:
Piracetam
Manufacturer: ucb


PHARMACOLOGY
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.
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.

PHARMACOKINETICS
When given by mouth, in either solution or tablet form, NOOTROPIL is rapidly and almost totally absorbed in the gut. Bioavailability is high.
When given as a single 2 g dose, the peak blood level of 40 to 60 µg/ml is attained after 30 minutes. In the cerebrospinal fluid the peak concentration is achieved at 2 to 8 hours post-dosage. The apparent volume of distribution is in the region of 0.6 l/kg.
Plasma half-life is 4 to 5 hours, while the half-life in the cerebro-spinal fluid is 6 to 8 hours. The half-life is increased in cases of renal insufficiency. NOOTROPIL does not bind to plasma proteins and is eliminated unchanged principally via the kidney. Renal excretion is almost complete, i.e. over 95% after 30 hours. Renal clearance of NOOTROPIL in healthy volunteers is 86 ml/minute. NOOTROPIL will diffuse into all types of tissue and can cross both the bloodbrain barrier and the placenta, as well as the membranes employed in renal dialysis. NOOTROPIL is active in its unchanged form and is not metabolised by any of the animal species tested. NOOTROPIL is concentrated  in the cerebral cortex, in the frontal, parietal and occipital lobes, in the cerebellum and in the basal ganglia.

Indication Dosage and administration

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.

CONTRAINDICATIONS
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.

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.

PRECAUTIONS
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:


Group

Creatinine clearance (ml/min)


Posology and frequency

Normal
Mild
Moderate
Severe
End-Stage Renal Disease

>80
50-79
30-49
<30

Usual daily dose.2 to 4 sub-doses
2/3 usual daily dose,  2 or 3 sub-doses
1/3 usual daily dose,  2 sub-doses
1/6 usual daily dose, I single intake contra-indicated

Abrupt discontinuation of treatment should be avoided in myoclonic patients as this may induce sudden relapse or withdrawal seizures. For sickle cell indication, d dose lower than 160 mg/kg/ day or irregular intake may result in relapse of arises.

INCOMPATIBILITY
None reported to date.

PREGNANCY AND BREASTFEEDING
NOOTROPIL should not be prescribed during pregnancy or when breastfeeding, except under
exceptional circumstances. NOOTROPIL is able to cross the placenta.

DRUG INTERACTIONS  
           
The classical treatment for alcoholism,  i.e. vitamins and sedatives, may continue to be prescribed during cures for alcoholism, in cases where there is a known vitamin deficiency or severe excitability. Only one case of interaction has been reported, where NOOTROPIL and thyroid extract (T3 & T4) were given together:  confusion, irritability and sleep disturbances were later ob­served. No other drug interactions have been described.

OVERDOSAGE
NOOTROPIL appears to have very low toxicity even at maximal doses of 12 g/day, no reaction of intoxications have been observed

STORAGE
All dosage forms of the product should be stored in a dry place at room temperature (15-25ºC).

STABILITY
The expiry date should be checked. This is indicated on the package after the word “Exp”,  the four figures given indicating th month, as trom the first day, and the year after which the product will be time-expired.

  HOW SUPPLIED

Oral preparations: Preparations for injection
20 and 60 Capsules of NOOTROPIL 400 mg 12 Ampoules of NOOTROPIL 1g/5ml
30 Film-coated tablets of NOOTROPIL 800 mg  4 Ampoules of NOOTROPIL 3g/15ml
20 Film-coated tablets of NOOTROPIL 1200 mg Vial for intravenous infusion of NOOTROPIL
60 ml of 20% solution (1 ml=200 mg piracetam)  12g/60ml

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