Katadolon is a non-opioid analgesic of central action.
Release form and composition
The dosage form of Katadolon is hard gelatin capsules (10 each in blisters, 1, 3 or 5 blisters in a carton box).
The active ingredient of the drug is flupirtin maleate: 100 mg in 1 capsule.
Auxiliary components: copovidone, colloidal silicon dioxide, calcium hydrogen phosphate dihydrate, magnesium stearate.
The composition of the shell: gelatin, sodium lauryl sulfate, titanium dioxide, purified water and iron dye red oxide (E172).
Indications for use
Katadolon used for the relief of acute pain, mild to moderate severity.
- Tinnitus (including recently cured);
- Risk of developing hepatic encephalopathy and cholestasis;
- Liver disease;
- Chronic alcoholism;
- Myasthenia gravis;
- Age up to 18 years;
- The need to use drugs that have a hepatotoxic effect;
- Hypersensitivity to any component of the drug.
Particularly careful monitoring during treatment is required for people over 65, as well as for patients with renal insufficiency and hypoalbuminemia.
In experimental animal studies, it was found that flupirtine has a negative effect on reproductive function, but has no teratogenic effect. However, the experience of using Catadolone during pregnancy is not enough, so the drug can be administered only in extreme cases, if the expected benefit to the woman outweighs the potential risks to the fetus.
Breastfeeding at the time of treatment is recommended to stop.
Dosing and Administration
Katadolon should be taken orally, swallowing the capsule whole, without breaking and chewing, drinking plenty of water. If possible, take the drug while standing upright.
In some cases, the capsule can be opened, and its contents can be taken or introduced through a probe. You can neutralize the bitter taste with a meal, such as a banana.
The dose is selected individually depending on the intensity of pain and tolerability of the drug. As a rule, adult patients are prescribed 1 capsule 3-4 times a day, optimally - with equal intervals. For severe pain, the dose can be increased to 2 capsules 3 times a day. The maximum permissible daily dose is 6 capsules (600 mg of flupirtin maleate).
Katadolon is recommended to be prescribed in the minimum effective dose for the shortest possible period. The duration of treatment should not exceed 2 weeks.
Older people are prescribed 1 capsule 2 times a day (morning and evening), patients with hypoalbuminemia and severe renal failure - no more than 1 capsule 3 times a day.
If it is necessary to use higher doses of Katadolon, careful observation is established for the patient.
Adverse reactions are classified as follows:
- Very often - in more than 1 patient out of 10;
- Often, more than 10, but less than 100 patients;
- Infrequently - more than 100, but less than 1000 patients.
Possible side effects:
- Immune system: infrequently - hypersensitivity to the drug and allergic reactions, in some cases accompanied by skin rash, itching, urticaria, fever;
- Nervous system: often: dizziness, anxiety or nervousness, tremor, sleep disturbance, headache, depression; infrequently - confused consciousness;
- The digestive system: often: nausea, vomiting, constipation or diarrhea, pain in the abdomen and in the stomach, flatulence, dryness of the oral mucosa;
- Organ of vision: infrequently - visual impairment;
- Liver and biliary tract: very often - increased activity of hepatic transaminases; frequency is unknown - liver failure, hepatitis;
- Metabolism: often - sweating;
- Other: very often - weakness or fatigue (especially at the beginning of therapy), lack of appetite.
The described side effects are mainly dose-dependent in nature (with the exception of allergic reactions), often go away on their own with continued treatment or after it ends.
When taking 5 g of flupirtine (20 capsules), dryness of the oral mucosa, nausea, tearfulness, stunning, prostration, confusion, tachycardia were noted. Cases of development of life-threatening conditions are unknown. There is no specific antidote. It is recommended to induce vomiting or carry out forced diuresis, prescribe activated carbon, inject electrolytes. As a rule, after these events the state of health is restored within 6-12 hours. If necessary, conduct symptomatic therapy.
Katadolon should be used only if other painkillers (for example, nonsteroidal anti-inflammatory) are contraindicated.
Once a week throughout the entire period of treatment, it is necessary to monitor the state of the liver function, since when taking flupirtine, transaminase activity may increase, there is a likelihood of developing hepatitis and liver failure. Katadolon should be canceled if according to test results there are abnormal liver functions or clinical symptoms appear that indicate liver damage, such as lack of appetite, pain in the stomach, dark urine, nausea, vomiting, fatigue, itching, jaundice. Patients should be informed that in the event of such symptoms, you should immediately consult a doctor.
For violations of the kidney during the treatment period, in addition, regular monitoring of the concentration of creatinine in the blood is necessary.
Flupirtine can cause a false-positive test with diagnostic strips for the determination of bilirubin, urobilinogen and protein in the urine, as well as a test for the concentration of bilirubin in the blood plasma.
When taking Katadolona in high doses, it is possible to stain urine in green. This reaction does not indicate the presence of any pathology.
Drowsiness and dizziness are quite frequent side effects of the drug, which may affect the speed of psychophysical reactions and concentration. For this reason, during the period of treatment, it is recommended to refrain from performing potentially dangerous types of slaves, including driving vehicles.
Since flupirtin binds to proteins, one should take into account the possibility of its interaction with any other drugs taken simultaneously, especially with warfarin, diazepam, glibenclamide, digoxin, propranolol, benzylpenicillin and clonidine, because may increase their activity.
Flupirtine enhances the action of ethanol, muscle relaxants and sedatives.
The combined use of Katadolone with drugs containing carbamazepine or paracetamol should be avoided.
With the simultaneous appointment of coumarin derivatives, it is necessary to regularly monitor the prothrombin index, since may require correction of their dose.
Terms and conditions of storage
To store at a temperature up to 25 ºС in the place, inaccessible for children.
Shelf life - 5 years.