Ampasse^® (Solution) Instructions for Use

Marketing Authorization Holder

Tavita, LLC (Russia)

Manufactured By

Ellara, LLC (Russia)

ATC Code

N06BX (Other psychostimulants and nootropic drugs)

Active Substance

Calcium hydroxynicotinoilglutamate (Grouping name)

Dosage Form

Ampasse®

Solution for intravenous administration 5 mg/1 ml: 1 ml, 2 ml or 5 ml ampoules 5, 10 or 15 pcs.

Dosage Form, Packaging, and Composition

Solution for intravenous administration transparent, colorless or with a yellowish tint.

Excipients : water for injections – up to 1 ml.

1 ml – ampoules of light-protective neutral glass (5) – contour cell packaging (1) – cardboard packs.
1 ml – ampoules of light-protective neutral glass (5) – contour cell packaging (2) – cardboard packs.
1 ml – ampoules of light-protective neutral glass (5) – contour cell packaging (3) – cardboard packs.
2 ml – ampoules of light-protective neutral glass (5) – contour cell packaging (1) – cardboard packs.
2 ml – ampoules of light-protective neutral glass (5) – contour cell packaging (2) – cardboard packs.
2 ml – ampoules of light-protective neutral glass (5) – contour cell packaging (3) – cardboard packs.
5 ml – ampoules of light-protective neutral glass (5) – contour cell packaging (1) – cardboard packs.
5 ml – ampoules of light-protective neutral glass (5) – contour cell packaging (1) – cardboard packs.
5 ml – ampoules of light-protective neutral glass (5) – contour cell packaging (1) – cardboard packs.

Clinical-Pharmacological Group

Nootropic drug

Pharmacotherapeutic Group

Psychoanaleptics; psychostimulants, agents used in attention deficit hyperactivity disorder, and nootropic agents; other psychostimulants and nootropic agents

Pharmacological Action

Nootropic agent. The neurochemical mechanism of action is mediated by interaction with the glutamatergic system at the level of AMPA receptor modulation.

It is effective in patients with chronic cerebrovascular accident due to arterial hypertension and/or atherosclerosis of the main arteries of the head.

Long-term use does not lead to effect accumulation, development of tolerance, or occurrence of adverse reactions. Discontinuation of the drug after long-term administration does not cause withdrawal syndrome.

It has low toxicity.

Pharmacokinetics

The values of the main pharmacokinetic parameters of hydroxynicotinoilglutamate after intravenous administration are characterized by high interindividual variability. The variability of pharmacokinetic parameters after intramuscular administration was small. Pharmacokinetic processes in the studied group of patients in the dose range of 10-50 mg with intravenous administration were nonlinear. The bioavailability of calcium hydroxynicotinoilglutamate after intramuscular administration to healthy volunteers was 1-3% of intravenous administration at the same dose.

Based on data obtained during clinical studies, the T_1/2 in humans is about 4 hours. The main route of elimination is renal excretion.

Indications

Chronic cerebrovascular accident.

ICD codes

Dosage Regimen

Administer intravenously as a slow bolus injection.

Use the standard adult dose of 25 mg once daily.

Prepare the injection using a 5 mg/ml solution; administer a total volume of 5 ml to achieve the 25 mg dose.

Administer the drug for a treatment course of 15 days.

Do not exceed the recommended duration of therapy.

Discontinue treatment if signs of hypersensitivity occur.

This drug is contraindicated in patients with renal impairment or hepatic impairment.

Do not administer to children or adolescents under 18 years of age.

Avoid use during pregnancy and breastfeeding.

Adverse Reactions

Nervous system disorders in rare cases – dizziness, mild drowsiness.

Other allergic reactions are possible.

Contraindications

Hypersensitivity to the components of the drug, pregnancy, breastfeeding period, age under 18 years, renal impairment, hepatic impairment.

Use in Pregnancy and Lactation

The use of the drug is contraindicated during pregnancy and breastfeeding.

Use in Hepatic Impairment

Contraindicated in hepatic impairment.

Use in Renal Impairment

Contraindicated in renal impairment.

Pediatric Use

Contraindicated for use in children and adolescents under 18 years of age.

Geriatric Use

The drug is approved for use in elderly patients according to indications.

Special Precautions

No cases of overdose have been reported.

Effect on ability to drive vehicles and operate machinery

The drug should not be used when engaging in these activities, as there are no data on the effect of the drug on the ability to drive vehicles and operate machinery.

Drug Interactions

Reduces the toxic effects of ethyl alcohol.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.