Nootropil 800 mg Tablet

Nootropil 800 mg Tablet

"* Capsules

Each capsule contains:

Active ingredient : Piracetam 400 mg .

Inactive ingredients:  Silicon Colloidal anhydrous ,Macrogol 6000 ,Magnesium stearate ,Lactose 

Capsule shell:* Cap: Gelatin, Titanium dioxide , Sunset yellow , Erythrosine, Quinoline yellow
* Body:Gelatin ,Titanium dioxide
* Film coated tablets

Each tablet contains :Active ingredient: Piracetam 800 mg . 

Inactive ingredients:

Core: 

Macrogol 6000 , Colloidal anhydrous Silica or Aerosil , Magnesium Stearate , Sodium croscarmellose
Film coating: Opadry white or orange ,Opadry OY-S29019 clear , Purified water
* Oral solution

Each 1 ml contains: Active ingredient:
Piracetam 200 mg .
Inactive ingredients: Glycerol. ( 85%) ,sod . Saccharin , sod . acetas , Methyl parahydroxybenzoat., Arom. Abricot 52247/A (Firmenich) ,Arom. Caramel 52939/A ( Firmenich) , Propyl parahydroxy benzoat. , Acid. acetic, purified water
* Ampoules

Each 5 ml ampoule contains: Active ingredient:
Piracetam 1 gm .
Inactive ingredients: Sodium acetate ,Acetic acid., Water for injection

Company Name

CID/Glaxo

Therapeutic Group

NOOTROPICS

Pharmaceutical form

Tablet

Nootropil Package

Nootropil 800 mg Tablets : Carton box contains 3 blister strips (Alum .PVC ) each of 10 tablets . Nootropil 400 mg capsule : Carton box contains 3 Blister strips (Alum .PVC ) each of 10 capsule. Nootropil Oral Solution : Bottles of 120 ml drinkable solution .

Nootropil Ampoules :
Carton Boxes of 6 ampoules each of 5 ml .

Nootropil Indications

NOOTROPIL is indicated for patients suffering from myoclonus of cortical origin, irrespective of aetiology, and should be used in combination with other anti-myoclonic therapies.

Nootropil Warning & Precautions

"Due to the effect of piracetam on platelet aggregation, caution is recommended in patients with underlying disorders of haemostasis, major surgery or severe haemorrhage. Abrupt discontinuation of treatment should be avoided as this may induce myoclonic or generalised seizures in some myoclonic patients. As piracetam is almost exclusively excreted by the kidneys caution should be exercised in treating patients with known renal impairment. In renally impaired and elderly patients an increase in terminal half-life is directly related to renal function as measured by creatinine clearance. The daily dose must be individualized according to renal function. Refer to the following table and adjust the dose as indicated. To use this dosing table, an estimate of the patient's creatinine clearance (CLcr) in ml/min is needed. The CLcr in ml/min may be estimated from serum creatinine (mg/dl) determination using the following formula: CLcr = [140-age (years)] × weight (kg)/72×serum creatinine(mg/dl) (× 0.85 for women) When Creatinine clearance is normal (> 80 ml/min), the dose will be as usual daily dose , 2 to 4 sub-doses. When Creatinine clearance is mild (50-79 ml/min), the dose will be 2/3 usual daily dose, 2 to 3 sub-doses. When Creatinine clearance is moderate (30-49 ml/min), the dose will be 1/3 usual daily dose, 2 sub-doses. When Creatinine clearance is severe (< 30 ml/min), the dose will be 1/6 usual daily dose, 1 single intake. When Creatinine clearance is (< 20 ml/min), the drug is contraindicated Warnings related to the excipients: • Lactose: patients with rare hereditary problems of galactose intolerance. The lapp lactase deficiency or glucose-galactose malabsorpton should not take the medicine. • Aspartam (E951): Contains a source of phenylalanine equivalent to 50 mg for a dose of 2.4g piracetam. May be harmful for people with phenylketonuria. • Methyl parahydroxybenzoate and propylparahydroxybenzoate: May cause allergic reactions (possibly delayed). • Glycerol: May cause headache, stomach upset and diarrhoea. • Sodium: Piracetam 800 mg film-coated tablets: This product contains about 2 mmol (or about 46 mg) sodium per 24 g piracetam. Piracetam 200 mg/ml oral solution: This product contains about 3.5 mmol (or about 80.5 mg) sodium per 24 g piracetam. Piracetam 1g/5ml ampoule: This product contains less than 1 mmol (23mg) sodium per 24 g piracetam.. To be taken into consideration by patients on a controlled sodium diet.


Product Type
human

Nootropil Dosage

"Adults :
Oral administration
The dosage regime shows important interindividual variability, requiring an individualised dose finding approach. A reasonable protocol would be to introduce piracetam at a dosage of 7.2 g/day, increasing by 4.8 g/day every 3 to 4 days up to a maximum of 20g/day, given in either 2 or 3 divided doses while keeping other antimyoclonic drugs unchanged at their optimal dosage. If possible, depending on clinical benefit, an attempt should be made to subsequently reduce the dosage of other antimyoclonic drugs.
Parentrally :
the average dosage shall be : 1 ampoule scored at 1 gm t . i. d . intravenously . In an initial stage parenteral administration may reach up to 10 and even 15 gm daily , depending on the severity of the case.
Children :
Between 30 and 50 mg / kg / day.

Adverse Reactions

"A. Clinical studies
Double-blind placebo-controlled clinical or pharmacoclinical trials, of which quantified safety data are available (extracted from the UCB Documentation Data Bank on June 1997), included more than 3000 subjects receiving piracetam, regardless of indication, dosage form, daily dosage or population characteristics.
When adverse events are grouped together according to WHO System Organ Classes, the following classes were found to be related to a statistically significantly higher occurrence under treatment with piracetam: psychiatric disorders, central and peripheral nervous system disorders, metabolic and nutritional disorders, body as a whole - general disorders.
Following adverse experiences were reported for piracetam with a statistically significantly higher incidence than placebo. Incidences are given for piracetam versus placebo treated patients.
WHO System Organ Class Common Uncommon
(> 1 %, 10 %) (> 0.1 %, 1 %)
Central and peripheral nervous Hyperkinesia
system disorders (1.72 versus 0.42 %)
Metabolic and nutritional disorders Weight increase
(1.29 versus 0.39 %)
Psychiatric disorders Nervousness Somnolence
(1.13 versus 0.25 %) (0.96 versus 0.25 %)
Depression
(0.83 versus 0.21 %)
Body as a whole - Asthenia
general disorders (0.23 versus 0.00 %)
B. Post-marketing experience
From the post-marketing experience, the following adverse drug reactions have been reported (sorted according to MedDRA System Organ Classes). Data are insufficient to support an estimate of their incidence in the population to be treated.
- Ear and labyrinth disorders:
vertigo
- Gastrointestinal disorders:
abdominal pain, abdominal pain upper, diarrhoea, nausea, vomiting
- Immune system disorders:
anaphylactoid reaction, hypersensitivity
- Nervous system disorders:
ataxia, balance impaired, epilepsy aggravated, headache, insomnia, somnolence
- Psychiatric disorders:
agitation, anxiety, confusion, hallucination
- Skin and subcutaneous tissue disorders:
angioneurotic oedema, dermatitis, pruritus, urticaria, rash.

Contra Indications

"Piracetam is contra-indicated in patients with severe renal impairment (renal creatinine clearance of less than 20 ml per minute), hepatic impairment and to those under 16 years of age. It is also contraindicated in patients with cerebral haemorrhage and in those with hypersensitivity to piracetam, other pyrrolidone derivatives or any of the excipients .

Drug Interactions

"In a single case, confusion, irritability and sleep disorders were reported in concomitant use with thyroid extract (T3 + T4). At present although based on a small number of patients, No interaction has been found with the following anti-epileptic medications: clonazepam, carbamazepine, phenytoin, phenobarbitone and sodium valproate.
In a published single-blind study on patients with severe recurrent venous thrombosis, piracetam 9.6 g/day did not modify the doses of acenocoumarol necessary to reach INR 2.5 to 3.5, but compared with the effects of acenocoumarol alone, the addition of piracetam 9.6 g/day significantly decreased platelet aggregation, β-thromboglobulin release, levels of fibrinogen and von Willebrand's factors (VIII : C; VIII : vW : Ag; VIII : vW : RCo) and whole blood and plasma viscosity.
To date, there are no known interactions with other drugs.

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