Instructions for use Ritmokor capsules blister No. 48
Composition
active ingredients: 1 capsule contains 2,3,4,5,6-pentahydroxycaproic acid magnesium salt, calculated as 100% substance 300 mg;
2,3,4,5,6-pentahydroxycaproic acid potassium salt in terms of 100% substance 60 mg;
excipients: colloidal anhydrous silicon dioxide, calcium stearate.
Dosage form
Capsules.
Main physicochemical properties: hard gelatin capsules of cylindrical shape with hemispherical ends of white-green color (with the inscription "FarKoS" or without the inscription). The contents of the capsule are white or almost white odorless powder.
Pharmacotherapeutic group
Mineral supplements. Magnesium preparations. ATX code A12C C.
Pharmacological properties
Pharmacodynamics
RYTMOKOR is a combined drug that exhibits metabolic, antioxidant, membrane-stabilizing and antiarrhythmic effects. The metabolic activity of RYTMOKOR is due to the activation of redox enzymes of cells, increasing the level of adenosine triphosphoric acid (ATP) and creatine phosphate. The indicated effects of the drug contribute to the optimization of the functioning of ion pumps of cells. Due to the indicated effects and the content of magnesium and potassium ions, the drug exhibits antiarrhythmic effects and potentiates the clinical effectiveness of antiarrhythmic drugs.
Pharmacokinetics
After oral administration, the maximum concentration in the blood is determined after 1–1.5 hours. Within 48 hours, 95% of the drug is metabolized, and the metabolic products are excreted by the kidneys.
Indication
Diseases and conditions accompanied by hypomagnesemia and hypokalemia (in complex treatment regimens):
ischemic heart disease; heart rhythm disorders (atrial and ventricular extrasystolic arrhythmia); vegetative-vascular dystonia; myocardiopathy; electrolyte metabolism disorders (to correct the level of magnesium and potassium ions); chronic fatigue syndrome.
Contraindication
Hypersensitivity to the components of the drug. Atrioventricular block of the III degree. Cardiogenic shock (with systolic blood pressure in adults below 90 mm Hg). Coma states of unknown etiology. Decompensated forms of diabetes mellitus. Acute and chronic renal failure of the II–IV degree. Addison's disease. Hyperkalemia and hypermagnesemia.
Interaction with other medicinal products and other types of interactions
When using RITMOKOR simultaneously with antiarrhythmic and hypotensive agents, a mutual enhancement of the activity of the drugs is observed. When used simultaneously with potassium-sparing diuretics and angiotensin-converting enzyme inhibitors, it is necessary to monitor the level of potassium and magnesium in the blood serum. When used simultaneously with cardiac glycosides, the risk of developing their toxic effect on the heart is reduced.
Application features
During treatment with RITMOKOR, it is necessary to monitor the level of potassium and magnesium in the blood serum. Particular attention should be paid to patients with a high risk of developing hypermagnesemia and hyperkalemia. Hypermagnesemia and hyperkalemia may manifest as paresthesia, decreased tendon reflexes, tremor, and respiratory depression. Calcium preparations should be used to reduce hypermagnesemia.
With prolonged use, constant monitoring of ECG data is necessary. It should be used with caution in patients with myasthenia gravis; in conditions that may lead to hyperkalemia, such as acute dehydration, extensive tissue damage, in particular, severe burns.
In patients with diabetes, it is necessary to take into account the possibility of determining a falsely elevated glucose level when using the orthotoluidine method due to the presence of gluconic (pentahydroxycaproic) acid in the preparation.
1 capsule of the drug contains 0.03 g of bread units.
Ability to influence reaction speed when driving vehicles or other mechanisms
Usually has no effect, but the possibility of dizziness associated with the effect of the first dose should be considered.
Use during pregnancy or breastfeeding
There is no experience of use.
Method of administration and doses
In each case, the duration and dosage of RITMOKOR is determined by the doctor. Capsules should be taken orally 10–15 minutes before meals, washing down a single dose with a small amount of water.
Adults should take 1–2 capsules 3–4 times a day. In more severe cases, 3 capsules 3 times a day may be used. When a therapeutic effect is achieved (usually after 5–7 days), the dose of the drug should be reduced to 1 capsule 3 times a day. The duration of the course of treatment is determined individually by the doctor.
If it is necessary to quickly achieve a treatment effect, start with the use of the injectable form of the drug RITMOCOR.
For chronic fatigue syndrome, the drug is taken 1 capsule 3 times a day for 3–6 months.
Children aged 6 to 12 years should be prescribed 1 capsule 3 times a day, and those aged 12 and over should be prescribed the same as adults.
Children
The drug in this dosage form should be used in children aged 6 years and older.
Overdose
Cases of overdose have not been registered. Since the drug contains magnesium and potassium ions, in case of overdose, ECG changes are possible, which are characteristic of hypermagnesemia and hyperkalemia. Hyperkalemia and hypermagnesemia can manifest as paresthesia, decreased tendon reflexes, tremor, respiratory depression. Symptoms of hyperkalemia: nausea, vomiting, diarrhea, abdominal pain, metallic taste in the mouth, bradycardia, weakness, disorientation, muscle paralysis; hypermagnesemia: facial flushing, thirst, arterial hypotension, impaired neuromuscular transmission, arrhythmia, convulsions; ECG changes. Calcium preparations are used to reduce the manifestations of hyperkalemia.
Adverse reactions
The drug is well tolerated, adverse reactions develop very rarely.
Skin and subcutaneous tissue disorders: skin rash, urticaria, itching, skin hyperemia.
Respiratory system: respiratory depression.
Musculoskeletal system: paresthesia, hyporeflexia, convulsions.
From the cardiovascular system: myocardial conduction disorders, decreased blood pressure, AV block.
Gastrointestinal: nausea, vomiting, diarrhea, abdominal pain, discomfort or burning sensation in the epigastric region, gastrointestinal bleeding, ulcers of the digestive tract mucosa, dry mouth, dyspeptic phenomena (very rare).
From the vestibular system: dizziness (very rare), associated with the effect of the first dose.
Vascular: feeling of heat.
On the part of the immune system: allergic reactions, including rash, itching, urticaria, feeling of heat, skin hyperemia. In case of allergic manifestations, desensitization therapy is prescribed.
Expiration date
3 years.
The drug should not be used after the expiration date indicated on the package.
Storage conditions
Store in the original packaging out of the reach of children at a temperature not exceeding 25 °C.
Packaging
12 capsules in a blister. 4 blisters in a box.
Vacation category
Without a prescription.
Producer
LLC "Pharmaceutical Company "FarKoS".
Location of the manufacturer and its business address
Ukraine, 03162, Kyiv, Zodchykh St., 50-A.
