Reminyl capsules 16 mg №28

Indications and usage

Dementia of Alzheimer's type of mild or moderate degree, incl. with concomitant cerebral circulatory failure.

Contraindications

- pronounced impaired renal function (CC less than 9 ml / min);
- severe liver dysfunction (more than 9 points on the Child-Pugh scale);
- Hypersensitivity to galantamine or other components of the drug.

Pregnancy and Breastfeeding

Reminyl can be prescribed during pregnancy only in cases where the potential benefits of treatment for the mother outweigh the possible risk to the fetus.
If necessary, the use of the drug during lactation breastfeeding should be discontinued.

Dosage and administration

Reminyl should be taken 2 times / day, preferably during breakfast and dinner.
Initial dose makes 8 mg / days (on 4 mg 2 times / days), it should be accepted within 4 weeks.
Maintenance dose is 16 mg / day (8 mg 2 times / day), it should also be taken at least 4 weeks. The question of increasing the maintenance dose to the maximum recommended 24 mg / day (12 mg 2 times / day) should be addressed after a comprehensive assessment of the clinical situation, in particular, the achieved effect and tolerability.

Adverse reactions

Gastrointestinal: in clinical trials, nausea, vomiting, abdominal pain, dyspepsia, and anorexia were often observed (> = 5% or with a frequency of twice the frequency of patients receiving placebo). Nausea, vomiting and anorexia were more common in women.
From the side of the central nervous system: during clinical trials, often (> = 5% or with a frequency of twice the frequency of patients receiving placebo) showed weakness, dizziness, headache, drowsiness; also described (> = 5% or with a frequency of occurrence> = frequency in patients receiving placebo) confusion, sudden falls, insomnia; rarely - tremor, fainting.
Other: often - weight loss, trauma, rhinitis, urinary tract infections; rarely severe bradycardia.

Special notes

Alzheimer's patients often have a decrease in their body weight.The use of acetylcholinesterase inhibitors, including Reminyl, may also be accompanied by a decrease in body weight. Therefore, during treatment with Reminyl, it is necessary to monitor changes in the patient's body weight.
Like other cholinomimetics, Reminyl should be used with caution in diseases of the cardiovascular system, since Due to its pharmacological action, cholinomimetics can cause vagotonic effects on the heart (for example, bradycardia). With extreme caution, the drug should be prescribed to patients with SSSU and other supraventricular conduction disorders, as well as to patients who simultaneously receive heart-lowering drugs, such as Digoxin or beta-blockers.
In patients with an increased risk of erosive and ulcerative lesions of the gastrointestinal tract, for example, having a peptic ulcer disease in history, it is necessary to monitor the patient's condition in order to early identify the relevant symptoms. It should be noted that during clinical trials in patients receiving Reminyl, there was no increase in the frequency of occurrence of peptic ulcers and bleeding from the gastrointestinal tract compared with patients receiving placebo. Reminyl is not recommended for use in patients with gastrointestinal obstruction, as well as in patients who have recently undergone surgery on the digestive organs.
It is believed that cholinomimetics have a certain ability to cause generalized seizures.It should be remembered, however, that seizure activity may be a manifestation of Alzheimer's disease itself. In clinical trials, there was no increase in seizure frequency in patients taking Reminyl compared with patients receiving placebo.
With caution Reminyl prescribed to patients with severe bronchial asthma or chronic obstructive pulmonary disease due to the cholinomimetic activity of the drug.
Reminyl is not recommended for use in patients with obstruction of the urinary tract, as well as in persons who have recently undergone bladder surgery.
After a sharp reversal of Reminyl (for example, when preparing for an operation), the symptoms do not worsen.
Most of the undesirable side effects occur on the background of a gradual increase in the dose of Reminyl. Nausea and vomiting (the most common phenomena) in most cases lasted less than 1 week and / or occurred once. In such cases, antiemetic drugs and heavy drinking can be used.
With simultaneous use of Reminyl with drugs that are active inhibitors of CYP2D6 or CYP3A4, the frequency of cholinergic adverse events, mainly nausea and vomiting, may increase. In these situations, depending on the tolerance of therapy to a specific patient, a reduction in the dose of Reminyl may be required.
Use in pediatrics
Reminyl is not recommended for the treatment of children.There are no data on the efficacy and safety of the use of Reminyl in pediatric practice.
Influence on ability to drive motor transport and control mechanisms
Alzheimer's disease can impair the ability to drive a car and work with machinery. In addition, against the background of the use of Reminyl, especially in the first weeks of its use, drowsiness and dizziness may occur, which also impair the ability to concentrate and have a negative effect on driving a car and working with mechanisms.

Drug Interactions

When applied simultaneously, Reminyl enhances the effect of other cholinomimetics, therefore this combination is not recommended.
Galantamine is an antagonist of anticholinergic blocking agents.
With the simultaneous use of Reminyl enhances the effect of drugs that reduce heart rate (eg, digoxin and beta-blockers).
Being cholinomimetic, Reminyl may enhance the effect of peripheral myoreclamps of depolarizing type (for example, suxametonium) during anesthesia.
Pharmacokinetic interactions
In vitro studies have shown that CYP2D6 and CYP3A4 isoenzymes play a major role in the metabolism of galantamine.
Drugs that are strong inhibitors of the isoenzymes CYP2D6 and CYP3A4, can increase the AUC of galantamine. Pharmacokinetic studies with repeated intake of drugs showed that galantamine AUC increased by 30 and 40%, while simultaneously using it with Ketoconazole and paroxetine.When used concurrently with Erythromycin, which is also an inhibitor of the CYP3A4 isoenzyme, galantamine AUC increases by only about 10%. Pharmacokinetic studies in patients with Alzheimer's disease showed that the clearance of galantamine decreased by about 25-33% while using this drug with such known inhibitors of the CYP2D6 isoenzyme as Amitriptyline, Fluoxetine, fluvoxamine, paroxetine or quinidine.
Inhibition of the secretion of gastric juice does not violate the absorption of galantamine.
Therapeutic doses of galantamine (12 mg 2 times / day) did not affect the kinetics of digoxin and Warfarin. Galantamine did not affect the increase in prothrombin time caused by warfarin.

Overdosage

Symptoms: muscular weakness, fasciculation, some or all of the symptoms of a cholinergic crisis (severe nausea, vomiting, cramping abdominal pain, increased salivation, tearing, incontinence of urine and feces, excessive sweating, bradycardia, hypotension, collapse, convulsions) are possible. Severe muscle weakness in combination with hypersecretion of the mucous membrane of the trachea and bronchospasm can be fatal.
Treatment: if necessary, conduct symptomatic therapy. In severe cases, atropine is administered as an antidote in / in (an initial dose of 0.5–1 mg; the frequency of administration and the magnitude of subsequent doses depend on the dynamics of the patient’s clinical condition).

The drug should be stored out of reach of children at a temperature of 15 ° to 30 ° C.