Katadolon

Katadolon – not opioid analgetic, a muscle relaxant of the central action.

Form of release and structure

Katadolon release in the form of capsules: size No. 2, gelatinous firm, opaque, lid and case of red-brown color; contents of capsules – white color powder with a light yellow, grayish-yellow or light green shade (on 10 pieces in blisters from polyvinylchloride / aluminum foil, on 1, 3 or 5 blisters in a cardboard pack).

Structure of 1 capsule:

• Active ingredient: a flupirtina a maleate – 100 mg;
• Auxiliary components: magnesium stearate, коповидон, silicon dioxide colloid, hydrophosphate calcium dihydrate;
• Capsule case: gelatin, titanium dioxide, dye ferrous oxide red (E172), sodium lauryl sulfate, the water purified.

Indications to use

Katadolon appoint the adult for therapy and stopping of attacks of chronic and acute pain easy and moderate severity, namely:

• Headaches of various genesis;
• Muscular spasms (fibromyalgia, arthropathies, skeletal and muscular dorsodynias and neck);
• Pains at malignant new growths;
• Posttraumatic pains;
• Pain syndrome at orthopedic/traumatologic operations and interventions;
• Dysmenorrhea.

Contraindications

• Cholestasia and risk of development of hepatic encephalopathy (as the probability of development or progressing and aggravation of already available encephalopathy or an ataxy is high);
• Abnormal liver functions;
• Alcoholism;
• Myasthenia (myasthenia gravis) (because of myorelaxation action of a flupirtin);
• Tinnitus (a ring in ears), including recently cured;
• Simultaneous use with other drugs of a hepatotoxic action;
• Age up to 18 years;
• Hypersensitivity to drug components.

With care drug is used at a hypoalbuminemia, a renal failure, and also at advanced age (of 65 years).

There are no data on Katadolon's use for pregnant women. During the experiments on animals reproductive toxicity, but not teratogenecity of a flupirtin was revealed. For the person the potential risk of therapy is unknown therefore Katadolon pregnant women cannot accept, except those cases when the advantage for mother is much higher than potential risk for a fruit.

By results of researches флупиртин gets into breast milk in insignificant quantity. Katadolon during breastfeeding is applied only in urgent cases, breastfeeding for this time should be stopped.

Route of administration and dosage

Katadolon accept inside, washing down with a small amount of water and not chewing (it is desirable to be at the same time in vertical position).

By way of exception, if the patient cannot swallow the capsule, it can be opened and entered via the probe, or to accept inside only contents. Bitter taste of a flupirtin at the same time can be neutralized food, for example, having eaten banana.

The recommended standard mode of dosing: on 1 capsule (100 mg) 3-4 times a day, maintaining, whenever possible, equal intervals between receptions. In case of the expressed pains – on 2 capsules (200 mg) 3 times a day. The maximum daily dose – 6 capsules (600 mg).

The dose is selected depending on individual portability of Katadolon and from intensity of pain. In the therapeutic purposes it is necessary to apply a minimal effective dose throughout the shortest interval of time. The maximum course of treatment should not exceed 2 weeks.

At elderly patients at the age of 65 years treatment is also more senior begin with 2 capsules (200 mg) a day accepted in the morning and in the evening.

At a heavy renal failure or a hypoalbuminemia control of concentration of creatinine in a blood plasma is necessary. The maximum daily dose for such patients should not exceed 3 capsules (300 mg). If higher dose is necessary, then for patients continuous monitoring has to be carried out.

In case of a slight and moderate renal failure dose adjustment is not necessary, but control of concentration of creatinine in a blood plasma is required.

Side effects

Side effects from systems and bodies depending on manifestation frequency (≥1/10 – it is very frequent; ≥1/100-<1/10 – it is frequent; ≥1/1000-<1/100 – infrequently; ≥1/10 000-<1/1000 – it is rare; <1/10 000 – it is extremely rare; unknown frequency – is not present an opportunity to carry out assessment on the basis of the obtained data):

• Gepatobiliarny system: very often – increase in activity of hepatic transaminases; unknown frequency – hepatitis, a liver failure;
• Digestive tract: often – nausea, vomiting, dyspepsia, gastric pains, a lock, dryness of a mucous oral cavity, an abdominal pain, a meteorism, diarrhea;
• Immune system: infrequently – hypersensitivity to drug, allergic answers (sometimes followed by skin rash, the small tortoiseshell raised by the body temperature, a skin itch);
• Skin and hypodermic fabrics: often – a hyperhidrosis (perspiration);
• Nervous system: often – a depression, a sleep disorder, concern/nervousness, a tremor, a headache, dizziness; infrequently – confusion of consciousness;
• Metabolism: often – decrease or lack of appetite;
• Organ of sight: infrequently – vision disorders;
• Others: very often (in 15% of cases, especially at the beginning of therapy) – weakness/fatigue.

Side effects, except for allergic reactions, in most cases dozozavisimy, and often take place independently in the course of carrying out or after the end of therapy.

Symptoms of overdose are: tachycardia, nausea, a condition of prostration, confusion of consciousness, tearfulness, dryness in a mouth. It is recommended to carry out symptomatic therapy – an artificial diuresis, a gastric lavage, administration of electrolytes and absorbent carbon. The specific antidote for a flupirtin does not exist.

Special instructions

At patients with reduced function of kidneys or a liver it is necessary to control the content of creatinine in urine and activity of liver enzymes.

At the age of 65 years is also more senior, at the expressed symptoms of a liver and/or renal failure, and also at a hypoalbuminemia dose adjustment is required.

At therapy flupirtiny false positive reactions of tests for bilirubin, protein in urine and urobilinigen are possible. Similar reaction can be at quantitative determination of level of bilirubin in a blood plasma.

Use of drug in high doses in some cases can cause coloring of urine in green color that is not a clinical sign of any disease.

Considering Katadolon's ability to weaken attention and to slow down speed of response, during treatment it is recommended to abstain from driving of transport and occupations potentially dangerous types of activity.

Medicinal interaction

At simultaneous use of a flupirtin with some medicines there can be following effects:

• Alcohol, muscle relaxants, sedatives: their action amplifies;
• Acetylsalicylic acid, benzylpenicillin, digoxin, Glibenclamidum, propranolol, clonidine, warfarin and diazepam: because of possible replacement of these substances flupirtiny of communication with proteins their activity can amplify (it is especially expressed for diazepam and warfarin in a combination with Katadolon);
• Coumarin derivatives: regular control of a prothrombin ratio is required in time to correct a coumarin dose;
• Anticoagulants or antiagregant: there are no data on interaction;
• The drugs which are metabolized liver: regular control of level of liver enzymes is necessary;
• The medicines containing carbamazepine and paracetamol: it is necessary to avoid the combined use with Katadolon.

Terms and storage conditions

To store in the place, unavailable to children, at a temperature not above 25 °C.

Period of validity – 5 years.