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Reminyl

Reminyl
Reminyl is a cholinesterase inhibitor that is prescribed to reduce the symptoms of dementia (impairment of memory or judgment, abstract thinking, changes in personality) in patients suffering from Alzheimer’s disease.

Brand: Galantamine

Availability: In Stock
Average Delivery Time: 9 Days
Exp. Date: March 2024
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Reminyl 8 mg
90 pills - 8 mg
+ 12 free Viagra 100 mg, 7% discount for future orders
$331.99 $3.69 $45.98 Add to cart
60 pills - 8 mg
+ 8 free Viagra 100 mg, 5% discount for future orders
$227.55 $3.79 $24.43 Add to cart
30 pills - 8 mg
+ 4 free Viagra 100 mg, 3% discount for future orders
$125.99 $4.20 No Add to cart
Reminyl 4 mg
90 pills - 4 mg
+ 4 free Viagra 100 mg, 3% discount for future orders
$173.91 $1.93 $33.06 Add to cart
60 pills - 4 mg
+ 4 free Viagra 100 mg, 3% discount for future orders
$120.95 $2.02 $17.03 Add to cart
30 pills - 4 mg $68.99 $2.30 No Add to cart

Product description

Drug Title

Reminyl (Galantamine)

Pharmacological action

Galantamine, being a tertiary alkaloid, is a selective competitive and reversible inhibitor of acetylcholinesterase. In addition, galantamine enhances the inherent effect of acetylcholine on nicotinic receptors, apparently due to binding to the allosteric site of the receptor.


Due to increased activity of the cholinergic system, cognitive function may improve in patients with Alzheimer-type dementia.


Pharmacokinetics

Galantamine is characterized by slow clearance (plasma clearance is about 300 ml/min) and moderate Vd (mean steady state Vd is 175 L). The elimination of galantamine is biexponential and the final T1/2 is approximately 7-8 hours.


After a single oral dose of 8 mg galantamine, it is rapidly absorbed from the GI tract; its Cmax was reached after 1.2 h and was 43±13 ng/mL, and its AUC0-∞ is 427±102 ng h/mL. The absolute bioavailability of galantamine when taken orally is 88.5%. Galantamine intake with food slows down its absorption (Cmax is reduced by 25%), but does not affect the amount of absorbed drug (AUC).


After multiple doses of galantamine at a dose of 12 mg twice daily, mean end-dose concentrations and plasma Cmax ranged from 30 to 90 ng/ml. The pharmacokinetics of galantamine were linear in the dose range of 4-16 mg twice daily.


Within 7 days after a single oral dose of 4 mg of 3H-galantamine, 90-97% of the radioactivity was excreted in the urine and 2.2-6.3% in the feces. After oral administration, 18-22% of the dose was excreted as unchanged galantamine in the urine within 24 h, and renal clearance was about 65 ml/min, which is 20-25% of total plasma clearance.


The main metabolic pathways are N-oxidation, N-demethylation, O-demethylation, glucuronidation, and epimerization. In people with active CYP2D6 substrate metabolism, O-demethylation is the most important metabolic pathway. The amount of radioactive substances excreted in the urine and feces did not differ in people with fast and slow metabolism. In vitro studies showed that the main isoenzymes of the cytochrome P450 system involved in galantamine metabolism are 2D6 and 3A4.


In plasma of people with fast and slow metabolism the main part of radioactive substances is unchanged galantamine and its glucuronide. Glucuronide O-desmethylgalanthamine is also detected in the plasma of people with fast metabolism. After a single dose of galantamine, none of the active metabolites (norgalantamine, O-demethylgalantamine, and O-demethyl-norgalantamine) were present in the plasma of "fast and slow metabolizers" in an unconjugated form. Norgalantamine was detected in the plasma of patients after repeated administration of galantamine, but its amount was no more than 10% of galantamine levels.


The results of clinical trials have demonstrated that patients with Alzheimer's disease have plasma concentrations of galantamine that are 30-40% higher than those of young healthy individuals.


Pharmacokinetic parameters of galantamine in patients with mild hepatic impairment (5-6 points on the Child-Pugh scale) were similar to those in healthy subjects. In patients with moderate hepatic impairment (Childe-Pugh score 7-9) the AUC andT1/2 of galantamine were increased by approximately 30%.


The distribution of galantamine has been studied in young patients with varying degrees of renal impairment. Excretion of galantamine was attenuated as CK decreased. Patients with moderate renal impairment (CKR 52-104 mL/min) had a 38% increased plasma concentration of galantamine, and patients with severe impairment (CKR 9-51 mL/min) had a 67% increased plasma concentration compared with healthy subjects of the same age and weight (CKR >121 mL/min). A population pharmacokinetic study and analysis using a number of models showed that in patients with Alzheimer's disease and impaired renal function, the dose of galantamine need not be adjusted if their creatinine clearance is at least 9 ml/min, because galantamine clearance is reduced in patients with Alzheimer's disease.


Binding to plasma proteins: the degree of binding of galantamine to plasma proteins is low and is 17.7 ± 0.8%. In whole blood, galantamine is predominantly found in form cells (52.7%) and in plasma (39.0%), whereas its fraction bound to plasma proteins is only 8.4%. The ratio of galantamine blood/plasma concentrations is 1.17.

A comparative bioavailability study of Reminyl® in the form of sustained-release capsules taken in a dose of 24 mg once daily and in the form of immediate-release tablets taken in a dose of 12 mg twice daily showed bioequivalence of these doses by AUC0-24 h and Cmin values in equilibrium. The Cmax reached 4.4 hours after ingestion of the 12 mg once-daily capsules was approximately 24% less than after ingestion of the 12 mg twice-daily tablets. Food intake had no effect on the bioavailability of Reminyl® in the form of sustained-release capsules with the active ingredient in equilibrium. In a dose-dependent pharmacokinetic study of Reminyl® in sustained release capsule form in healthy elderly and young adults, the equilibrium concentration in plasma of both age groups was reached within 6 days in all doses (8, 16 or 24 mg). In both age groups, equilibrium pharmacokinetics was directly dose-dependent in the dose range studied (8-24 mg).

Contraindications to use

  • Severe renal insufficiency (CKR <9 ml/min);
  • severe hepatic function impairment;
  • Hypersensitivity to galantamine hydrobromide or to any excipient of this drug.

The drug should be used with caution during general anesthesia, in patients with bronchial asthma, COPD, bradycardia, AV-blockade, CCSU, unstable angina pectoris; concomitant therapy with drugs that slow the heart rate (digoxin, beta-adrenoblockers), gastric and duodenal ulcer, gastrointestinal obstruction, period after surgery on the gastrointestinal tract, epilepsy, urinary obstruction, in the period after surgery on the bladder.


Administration during pregnancy and lactation

No safety studies of using Reminil during pregnancy have been carried out. Reminyl® may be administered during pregnancy only in cases when the potential benefit to the mother outweighs the possible risk to the fetus.


It is not known whether galantamine is excreted with breast milk in humans. Women receiving Reminyl should refrain from breastfeeding.


Administration in patients with liver dysfunction

This drug is contraindicated in severe hepatic impairment (over 9 points on the Child-Pugh scale).

Administration in patients with kidney dysfunction

It is contraindicated in patients with severe renal impairment (CK values less than 9 ml/min).


Administration in children

Reminyl is not recommended for the treatment of children. There are no data on efficacy and safety of using Reminil in pediatric practice.

Indications for Reminyl

Mild to moderate dementia of Alzheimer's type, including chronic circulatory disorders of the brain.

Dosing regimen

Initial dosage


Reminyl in sustained release form should be taken orally once a day (in the morning), preferably with a meal. The recommended starting dose is 8 mg/day.


Patients already taking Reminil in other immediate-release forms (tablets) can switch to Reminil in sustained release capsules by taking the last dose of Reminil tablets in the evening and starting Reminil capsules once a day the next morning.


When changing from Reminil in the form of immediate-release tablets taken twice a day to Reminil® in the form of sustained-action capsules taken once a day, the total daily dose should remain unchanged.


Sufficient fluids should be taken during treatment.


Maintenance dose


The initial maintenance dose is 16 mg/day, patients should take this dose for at least 4 weeks.


Increasing the maintenance dose to the maximum recommended dose of 24 mg/day should be decided after a comprehensive evaluation of the clinical situation, in particular the effect achieved and tolerability.


There is no worsening of symptoms after abrupt withdrawal of Reminyl (e.g., in preparation for surgery). If the drug is interrupted for several days, the initial dose of Reminyl should be taken and then increased to the previous maintenance dose according to the above schedule.


There is no significant experience with Reminyl in children.


In patients with moderate to severe hepatic impairment, plasma concentrations of galantamine may be higher than in patients without such impairment. In patients with moderate hepatic impairment, the starting dose (based on pharmacokinetic data) should be 8 mg once daily in the morning for at least one week. Thereafter, patients may take 8 mg once daily for at least 4 weeks. The daily dose should not exceed 16 mg.


Patients with severe hepatic impairment (more than 9 points on the Child-Pugh scale) should not take Reminyl.


Reminyl is not recommended in patients with severe renal impairment (CKR less than 9 ml/min) (due to lack of data). In patients with a CKG greater than 9 ml/min, the dose of Reminyl does not need to be adjusted.


If a patient is receiving strong inhibitors of CYP2D6 or CYP3A4 coenzymes, it may be necessary to reduce the dose of Reminil.