Libexin® [Prenoxdiazine]
Hinoin Pharmaceutical and Chemical Product Plant
619 Items
2019-09-19
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Clinical Pharmacology
Libexin - cough suppressant.
Pharmacodynamics
Prenoxdiazine is an antitussive agent of peripheral action. The drug blocks the peripheral links of the cough reflex due to the following effects: local anesthetic action, which reduces the irritability of the peripheral sensory (cough) receptors of the respiratory tract; bronchodilatory action, due to which the suppression of stretching receptors involved in the cough reflex occurs; slight decrease in the activity of the respiratory center (without respiratory depression). The antitussive effect of the drug is approximately equal to that of codeine.
Prenoxdiazine is not addictive and drug dependent. In chronic bronchitis, the anti-inflammatory effect of prenoxdiazine is noted.
Prenoxdiazine does not affect the function of the central nervous system, with the exception of possible indirect anxiolytic action.
Pharmacokinetics
Prenoxdiazine is rapidly and largely absorbed from the gastrointestinal tract. Cmax Prenoxdiazine in plasma is reached 30 minutes after taking the drug, its therapeutic concentration is maintained for 6–8 hours. The association with plasma proteins is 55–59%. T1/2 is 2.6 hours. Most of the dose taken is metabolized in the liver, only about 1/3 of the dose taken is excreted unchanged, and the rest is metabolized (4 metabolites of prenoxdiazine are released). During the first 12 hours of metabolism of prenoxdiazine, the biliary excretion of its and its metabolites plays the most important role. 24 hours after administration, 93% of the drug is released. Within 72 hours after ingestion, 50–74% of the dose taken is excreted with feces and 26–50% with urine.
Indications
Cough (upper respiratory tract infection, acute or chronic bronchitis, bronchopneumonia, bronchial asthma, emphysema); bronchoscopy and bronchography (in combination with atropine).
Composition
1 tablet contains:
Active substance: prenoxdiazine hydrochloride 100 mg;
Excipients: glycerol (glycerol); magnesium stearate; talc; Povidone; corn starch; lactose monohydrate.
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Dosage and Administration
Administer the drug orally, regardless of the meal.
For relief of ventricular extrasystoles
0.25-1.0 g, then 0.25-0.5 g every 3-6 hours (if necessary, the dose can be increased to 3-4 g).
With paroxysmal atrial fibrillation
1.0-1.5 g (once). After 1 hour (in the absence of a therapeutic effect), another 0.5 g and then every 2 hours, 0.5-1.0 g (before stopping the paroxysm).
Adverse reactions
On the part of the nervous system: hallucinations, depression, myasthenia gravis, dizziness, headache, convulsions, psychotic reactions with productive symptoms, ataxia.
On the part of the digestive system: bitter taste in the mouth.
On the part of the blood-forming organs and the hemostatic system: with prolonged use, the inhibition of bone marrow hematopoiesis (leukopenia, thrombocytopenia, neutropenia, agranulocytosis, hypoplastic anemia), hemolytic anemia with a positive Coombs test.
From the sense organs: taste disorders.
On the part of the cardiovascular system: decrease in blood pressure, ventricular paroxysmal tachycardia. With rapid on / in the introduction of possible collapse, a violation of atrial or intraventricular conduction, asystole.
Allergic reactions: skin rash.
Others: with long-term use, drug-induced lupus erythematosus (in 30% of patients with a duration of therapy of more than 6 months).
Microbial infections, delayed healing processes and bleeding gums are likely due to the risk of leukopenia and thrombocytopenia.
Contraindications
Hypersensitivity to the drug.
Atrioventricular block 2 and 3 degrees.
Myocardial infarction.
Blockade of the bundle of His.
Arrhythmias associated with cardiac glycoside intoxication.
Severe heart failure.
Severe renal failure.
Hypotension.
Cardiogenic shock.
Pronounced atherosclerosis.
Systemic diseases of the connective tissue.
Bronchial asthma.
Myasthenia.
Drug interactions
Enhances the effect of antiarrhythmic, antihypertensive, anticholinergic and cytostatic drugs, muscle relaxants, side effects of Bretilium tosylate. With simultaneous use with antihistamine drugs, atropine-like effects may increase; with pimozodom - extension of the interval Q-T.
Reduces the activity of anti-myasthenic drugs.
Cimetidine reduces renal clearance of procainamide and lengthens T1 / 2.
With combination therapy with antiarrhythmic drugs (including quinidine, amiodarone, lidocaine) the risk of arrhythmogenic effect increases.
Strengthens the cardiodepressive effect of lidocaine.
The concentration of procainamide in plasma is increased by cimetidine, ranitidine, beta-blockers, amiodarone, trimethoprim, quinidine, ofloxacin.
Concurrent use with sparfloxacin is not recommended.
Drugs that inhibit bone marrow hematopoiesis, increase the risk of myelosuppression.
Pregnancy and Lactation
When using procainamide during pregnancy there is a potential risk of accumulation of the substance and the development of arterial hypotension in the mother, which can lead to uteroplacental insufficiency.
Special instructions
Take on an "empty" stomach (1 hour before meals or 2 hours after meals), drinking a glass of water for faster absorption with food or milk to prevent irritation of the gastric mucosa; for pills of prolonged action - swallow whole, do not crush, do not crush, do not chew.
Before using IV, it is necessary to dilute, inject at a speed not exceeding 50 mg / min; should be taken only in a hospital setting.
During therapy, it is necessary to monitor blood pressure, ECG, peripheral blood formulas, especially the number of leukocytes (every 2 weeks during the first 3 months of therapy, then with longer intervals).
After prolonged maintenance therapy, an increase in the titer of antinuclear antibodies is observed in approximately 80% of patients, most often 1-12 months after the start of therapy (therefore, when symptoms appear similar to SLE, it is necessary to periodically determine the antinuclear antibody titer).
Leukopenia is more likely when using dosage forms of prolonged action, especially after surgery on the heart or vessels. It is usually observed in the first 3 months of therapy (the blood formula is restored a few weeks after the cancellation).
When used in children, higher doses may be required to maintain therapeutic concentrations; in older people, hypotension is more likely to develop.
Care must be taken when interpreting laboratory results (possible effect on test results).
When prescribed during pregnancy there is a potential risk of developing hypotension in the mother, which can lead to uteroplacental insufficiency.
During the period of treatment, care must be taken when driving and engaging in other potentially hazardous activities that require increased concentration and psychomotor reactions.
Overdosage
Symptoms: confusion, decreased urination, severe dizziness or fainting, rapid or irregular heartbeat, nausea or vomiting.
Treatment: when the above symptoms of overdose occur, urgent medical consultation is required. Before the arrival of the doctor, it is recommended to drink a large amount of liquid (2-3 liters) and induce vomiting.
- Brand name: Libexin
- Active ingredient: Prenoxdiazine
- Dosage form: Pills
- Manufacturer: Hinoin Pharmaceutical and Chemical Product Plant
- Country of Origin: Hungary
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