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Nolodatac instruction

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Indications for use

- Treatment of acute pain of mild to moderate intensity in adults.

Active substance, group

Flupirtine, an analgesic non-narcotic agent

Dosage form

capsules

Contraindications of Nolodatac

- Patients with a risk of developing hepatic encephalopathy and cholestasis (possibly development of encephalopathy or aggravation of already existing encephalopathy or ataxia);
- myasthenia gravis (due to the muscle relaxant effect of flupirtine);
- concomitant liver disease;
- Alcoholism;
- simultaneous application of flupirtine with other drugs that can have a hepatotoxic effect;
- Tinnitus (including recently healed);
- children and adolescence under 18;
- Hypersensitivity to the active substance or any other component of the drug.
Nolodact should not be used during pregnancy, except when the intended benefit to the mother exceeds the potential risk to the fetus. If it is necessary to use the drug during lactation it is necessary to stop breastfeeding.
Caution should be given to Nolodact in renal failure, hypoalbuminemia, patients older than 65 years.

Dosing and Administration (Instruction)

Inside. Capsule Nolodact should be swallowed whole, without chewing and washing down with a small amount of liquid (100 ml). If possible, take the drug in a sitting or standing position. In exceptional cases, the capsule can be opened and dissolved in water; neutralize the bitter taste of the contents of the capsule is recommended by eating food.
The dose is selected depending on the intensity of pain and individual sensitivity of the patient to the drug.
The recommended dose is 1 capsule 3-4 times a day at equal intervals between doses. At the expressed pains - on 2 capsules 3 times a day. The maximum daily dose is 600 mg (6 capsules).
The duration of therapy is determined by the attending physician and depends on the dynamics of the pain syndrome and the tolerability of Nolodatac. With prolonged use, the activity of hepatic transaminases should be monitored in order to identify early symptoms of hepatotoxicity. Duration of treatment should not exceed 2 weeks.
Patients over the age of 65 years at the beginning of treatment are prescribed 1 capsule 2 times a day (morning and evening). The dose may be increased to 300 mg, depending on the intensity of pain and the tolerability of the drug.
In patients with reduced liver function, the daily dose should not exceed 200 mg (2 capsules).
In patients with renal insufficiency, the concentration of creatinine in the blood plasma should be monitored. The maximum daily dose should not exceed 300 mg per day (3 capsules). In patients with mild to moderate renal failure, dose adjustment is not required. In patients with severe renal insufficiency or hypoalbuminemia, the maximum daily dose should not exceed 300 mg per day (3 capsules).
If Nolodatac is needed in higher doses, the patient's condition should be carefully monitored.

Pharmachologic effect

Flupirtine is a selective activator of neuronal potassium channels, a non-opioid analgesic of central action that does not cause addiction and addiction. In addition, it has a miorelaksiruyuschee effect. Flupirtine also blocks NMDA receptors, resulting in unfavorable conditions for clinically significant chronic pain, and in the case of previous chronic pain, to "erase" the pain memory by stabilizing the membrane potential, which leads to a reduction in pain sensitivity.

Side effects of Nolodact

The following undesirable events are distributed according to the frequency of occurrence and are classified according to the recommendations of the World Health Organization (WHO): very often (> 10%); often (> 1%, <10%); infrequently (> 0.1%, <1%); rarely (> 0.01%, <0.1%); very rarely (<0.01%, including individual messages); the frequency is not established - according to the available data, it is not possible to establish the frequency of occurrence.
On the part of the immune system: infrequently - hypersensitivity to the drug, allergic reactions (in some cases accompanied by fever, skin rash, urticaria, skin itching).
From the side of metabolism: often - lack of appetite.
From the nervous system: often - sleep disturbance, depression, anxiety / nervousness, dizziness, tremor, headache; infrequently - confused consciousness.
From the side of the organ of vision: infrequently - impaired vision.
From the gastrointestinal tract: often - dyspepsia, nausea, vomiting, pain in the epigastric region, constipation, abdominal pain, dryness of the oral mucosa, flatulence, diarrhea.
From the liver and bile ducts: very often - an increase in the activity of hepatic transaminases; frequency unknown - hepatitis, hepatic insufficiency.
From the skin and subcutaneous tissues: often - sweating.
Other: very often fatigue / weakness (in 15% of patients), especially at the beginning of treatment.
Side effects, in general, are dose-dependent (with the exception of allergic reactions). In many cases, they disappear by themselves as they take place or after the end of treatment.
There are reports of single cases of overdose with suicidal intentions.
When flupirtine was taken in a dose of 5 g, nausea, tachycardia, prostration, tearfulness, confusion, stupefaction, dry mouth were noted. After vomiting or using forced diuresis, reception of activated carbon and the introduction of electrolytes, the state of health was restored within 6-12 hours. No life-threatening conditions have been reported. In case of overdose or when signs of intoxication appear, one should remember about the possibility of occurrence of disorders from the side of the central nervous system, as well as manifestations of hepatotoxicity by the type of enhancement of metabolic disorders in the liver. It should be symptomatic treatment. The specific antidote is unknown.

Special instructions

Nolodatac should be used if treatment with other analgesics (eg, NSAIDs or opioids) is contraindicated.
In patients with tinnitus (including recently healed), the risk of an increase in hepatic transaminase activity with flupirtine is increased, and the use of the drug is contraindicated in such patients.
When using the drug in patients with reduced renal function should monitor the concentration of creatinine in the blood plasma.
In patients over the age of 65 years or with severe renal insufficiency or hypoalbuminemia, dose adjustment is necessary.
During treatment, Nolodatac should monitor the liver function once a week, because when flupirtin is used, an increase in hepatic transaminase activity, hepatitis and hepatic insufficiency may occur. If the results of a liver test deviate from the norm or if there are clinical symptoms that indicate liver damage, the drug should be discontinued.
Patients should be warned that during treatment with Nolodatac, attention should be paid to any symptoms of liver damage (eg, lack of appetite, nausea, vomiting, stomach pain, fatigue, dark urine, jaundice, pruritus). If these symptoms occur, stop taking the medication and consult the doctor as a matter of urgency.
In the treatment of flupirtin, false positive reactions of the test with diagnostic strips for bilirubin, urobilinogen and protein in the urine are possible. A similar reaction is possible with a quantitative determination of the concentration of bilirubin in the blood plasma.
When applying the drug in high doses, in some cases, the color of urine can be marked green, which is not a clinical sign of any pathology.
When using Nolodact, one should refrain from driving vehicles and controlling mechanisms, due to the fact that patients can develop drowsiness and dizziness, which can affect the concentration of attention and the speed of psychomotor reactions. It is especially important to remember this when using alcohol at the same time.

Interaction

Flupirtine enhances the effect of alcohol, sedatives and muscle relaxants.
Due to the fact that flupirtine binds to proteins, it should be taken into account that it can interact with other concurrent drugs (eg, acetylsalicylic acid, benzylpenicillin, digoxin, glibenclamide, propranolol, clonidine, warfarin and diazepam), which can be displaced by flupirtine from proteins, which can lead to an increase in their activity. Especially, this effect can be expressed by simultaneous application of flupirtine with warfarin or diazepam.
With simultaneous application of flupirtine and coumarin derivatives, it is recommended to monitor prothrombin time on a regular basis in order to timely adjust the dose of coumarin derivatives. There are no data on the interaction with other anticoagulants or antiplatelet agents (including acetylsalicylic acid).
With the simultaneous use of flupirtine with drugs that are metabolized in the liver, regular monitoring of hepatic transaminase activity is required. Combined use of flupirtine and drugs containing paracetamol and carbamazepine should be avoided.

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