Midantan (Tablets) Instructions for Use

Marketing Authorization Holder

Borisov Plant Of Medical Preparations, PJSC (Republic Of Belarus)

ATC Code

N04BB01 (Amantadine)

Active Substance

Amantadine (Rec.INN registered by WHO)

Dosage Form

Midantan

Film-coated tablets, 100 mg: 50 or 100 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets yellow in color, round, biconvex; a cross-section shows two layers.

Excipients: lactose monohydrate, starch 1500, partially pregelatinized corn starch, croscarmellose sodium, talc, stearic acid, potato starch, Opadry II series 85F32554 (yellow).

Composition of Opadry II series 85F32554: partially pregelatinized polyvinyl alcohol, macrogol 3350 (polyethylene glycol), coloring pigment (titanium dioxide (E171), quinoline yellow aluminum lake (E104), yellow iron oxide (E172)).

10 pcs. – blister packs (5) – cardboard boxes.
10 pcs. – blister packs (10) – cardboard boxes.

Clinical-Pharmacological Group

Antiparkinsonian drug – glutamate NMDA receptor blocker

Pharmacotherapeutic Group

Antiparkinsonian agent

Pharmacological Action

Amantadine exerts an indirect agonistic effect on striatal dopamine receptors.

It increases the extracellular concentration of dopamine by both enhancing its production and blocking the reuptake of dopamine by presynaptic neurons.

At therapeutic concentrations, Amantadine slows the production of acetylcholine and thus has an anticholinergic effect.

Pharmacokinetics

After oral administration, it is well absorbed in the gastrointestinal tract.

C_max in blood plasma is reached after 5 hours; T_1/2 of amantadine sulfate is 12-13 hours, of amantadine hydrochloride is 30 hours.

It is excreted by the kidneys unchanged.

Indications

• Parkinsonism syndrome;
• Idiopathic Parkinson’s disease.

ICD codes

Dosage Regimen

Orally, after meals.

For Parkinson’s disease, the initial dose is 100 mg/day at 6-hour intervals (the last dose before dinner) for 3 days; from day 4 to day 7 – 200 mg/day; for 2 weeks – 300 mg/day; from the 3rd week, depending on the patient’s condition – 300-400 mg/day.

The maximum dose is 600 mg/day.

In case of renal impairment, the dose should be reduced and the intervals between doses increased: with a glomerular filtration rate of 80-60 ml/min – 100 mg every 12 hours, 60-50 ml/min – doses of 200 mg and 100 mg are alternated every other day, 30-20 ml/min – 200 mg 2 times/week, 20-10 ml/min – 100 mg 3 times/week, less than 10 ml/min – 200 mg once/week and 100 mg every other week.

In elderly patients, reduced doses should be used.

Adverse Reactions

Nervous system disorders: motor or mental agitation, convulsions, headache, dizziness, irritability, insomnia, tremor, mental disorders accompanied by visual hallucinations.

Cardiovascular system disorders: heart failure, tachycardia, orthostatic hypotension, arrhythmogenic effect.

Digestive system disorders: dry mouth, nausea, anorexia, dyspepsia.

Urinary system disorders: acute urinary retention in patients with prostatic hyperplasia, polyuria, nocturia.

Other: dermatosis, appearance of a bluish discoloration of the skin of the upper and lower extremities, decreased visual acuity.

Contraindications

• Hypersensitivity to any component of the drug;
• Severe congestive heart failure of class IV;
• Cardiomyopathy;
• Myocarditis;
• Second and third degree AV block;
• Bradycardia with heart rate <55 beats/min;
• QT interval prolongation greater than 420 ms;
• Ventricular arrhythmia (including ventricular flutter);
• Hypokalemia, hypomagnesemia;
• Concomitant use with drugs that prolong the QT interval;
• Severe renal failure (creatinine clearance <10 ml/min);
• Children under 18 years of age;
• Psychosis (in history);
• Hereditary galactose intolerance, lactase deficiency, glucose-galactose malabsorption; sucrase-isomaltase deficiency, hereditary fructose intolerance;
• Phenylketonuria;
• Pregnancy;
• Breastfeeding period.

With caution

Prostatic hyperplasia, closed-angle glaucoma, renal failure of varying severity (there is a risk of drug accumulation), agitation, delirium, CNS depression, exogenous psychosis (including in history), concomitant use with memantine, hydrochlorothiazide/triamterene.

Use in Pregnancy and Lactation

Contraindicated during pregnancy and breastfeeding, as Amantadine crosses the placental barrier and is found in breast milk.

Use in Hepatic Impairment

Contraindicated in hepatic insufficiency.

Use in Renal Impairment

Contraindicated in chronic renal failure.

In case of renal impairment, the dose should be reduced and the intervals between doses increased: with a glomerular filtration rate of 80-60 ml/min – 100 mg every 12 hours, 60-50 ml/min – doses of 200 mg and 100 mg are alternated every other day, 30-20 ml/min – 200 mg 2 times/week, 20-10 ml/min – 100 mg 3 times/week, less than 10 ml/min – 200 mg once/week and 100 mg every other week.

Pediatric Use

Contraindicated in children and adolescents under 18 years of age.

Geriatric Use

Use with caution in elderly patients; dose reduction is necessary.

Special Precautions

Data on efficacy in the treatment of extrapyramidal disorders during treatment with antipsychotic drugs (drug-induced parkinsonism) are contradictory.

Therapy should not be discontinued abruptly, as a sharp exacerbation of the disease is possible.

Consumption of ethanol while taking the drug is contraindicated.

Effect on the ability to drive vehicles and operate machinery

During treatment, it is necessary to refrain from driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Drug Interactions

CNS stimulants and ethanol increase the risk of adverse effects.

It enhances the effect of levodopa and psychostimulants.

It is compatible with central anticholinergics and other antiparkinsonian drugs.

Storage Conditions

The drug should be stored in a dry place, at a temperature not exceeding 25°C (77°F). Keep out of reach of children.

Shelf Life

The shelf life of the drug is 3 years. Do not use after the expiration date printed on the packaging.

Dispensing Status

The drug is dispensed by prescription.

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.