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Active ingredients
Citizin
Release form
Pills
Composition
Citizin 1.5 mg. Excipients: lactose monohydrate - 28 mg, microcrystalline cellulose - 67.5 mg, talc - 2 mg, magnesium stearate - 1 mg. The composition of the film shell: opadry II brown 85F26948 - 3 mg (polyvinyl alcohol partially hydrolyzed - 1.2 mg, titanium dioxide (E171) - 0.654 mg, macrogol 3350 - 0.606 mg, talc - 0.444 mg, iron oxide yellow (E172) - 0.062 mg, iron oxide red (E172) - 0.018 mg, iron oxide black (E172) - 0.016 mg).
Pharmacological effect
The drug for the treatment of nicotine addiction, n-cholinomimetic. Cyclozine alkaloid is the active ingredient of the drug, has an n-cholinomimetic effect. Its effects are expressed in the following: stimulates the ganglia of the autonomic nervous system, reflexively stimulates breathing, causes the release of adrenaline from the adrenal medulla, increases blood pressure. With a close resemblance to the mechanism of action of nicotine, cytisine has a much lower toxicity and a broader therapeutic index. Citizin competitively inhibits the interaction of nicotine with the corresponding receptors, which leads to a gradual decrease and disappearance of nicotine (tobacco) addiction.
Pharmacokinetics
Pharmacokinetic studies in humans have not been conducted.
Indications
- treatment of nicotine addiction (to alleviate smoking cessation). Physical and psychological dependence on nicotine is considered a specific type of disease, which leads to the inability to abstain from smoking, even with the understanding of its negative effects.
Contraindications
- hypersensitivity to the active or any of the excipients of the drug; - acute myocardial infarction; - unstable stenocardia; - cardiac arrhythmia; - recently suffered a stroke (within 1 month before starting the drug); - atherosclerosis; - severe arterial hypertension; - pregnancy - breastfeeding period; - age up to 18 years; - patients over 65 years; - lactase deficiency, galactosemia, glucose-galactose malabsorption syndrome (lactose is included in the preparation).
Precautionary measures
With caution should use the drug Tabex in other forms of coronary artery disease (stable angina, asymptomatic (silent) myocardial ischemia,vasospastic angina, X syndrome (microvascular angina)), heart failure, elevated blood pressure, diseases of the brain vessels, obliterative arterial diseases, hyperthyroidism, gastric ulcer, diabetes, renal or hepatic failure, in certain forms of schizophrenia, when the presence of chromaffin tumors of the adrenal glands, gastroesophageal reflux disease, persons with long periods of smoking and people older than 40-45 years. The use of the drug in patients with diseases indicated in the section with caution, is possible only after consulting a doctor.
Use during pregnancy and lactation
Tabex should not be used by women during pregnancy and during breastfeeding.
Dosage and administration
Tablets are taken internally, squeezed with a sufficient amount of liquid. Do not exceed recommended doses. It is advisable to start taking the drug after setting the patient to stop smoking. The drug should be used according to the following scheme: From 1 to 3 day - 1 tablet 6 times / day every 2 hours, gradually reducing the number of smoked cigarettes. The pill should be taken between episodes of smoking to lengthen the intervals between smoking cigarettes to minimize their consumption. Reception interval every 2 hours must be observed. If you can not achieve a reduction in daily consumption of cigarettes, treatment should be stopped and after 2-3 months you can start it again. With a good effect, the treatment is continued according to the following scheme: from 4th to 12th day of administration - 1 tablet 5 times / day, every 2.5 hours, from 13 to 16 day - 1 tablet 4 times / day, every 3 hours, from 17 to 20 day - 1 tablet 3 times / day, every 5 hours, from 21 to 25 days - 1-2 pills per day. It is strongly recommended to stop smoking no later than 5 days from the start of treatment. Combination of drug therapy with consultations, incl. with measures of psychological support of the patient, significantly increases the effectiveness of treatment.
Side effects
Conducted clinical studies and post-marketing observations show good tolerability of the drug. Observed adverse reactions are mild or moderate. Most of them occur at the beginning of treatment, and pass on their own.Most often they are associated with refusal of smoking and manifest dizziness, headache and insomnia. In the recommended doses, the drug Tabex does not cause serious adverse effects. The following side reactions are possible. Since the cardiovascular system: tachycardia, a slight increase in blood pressure, palpitations. From the side of the central nervous system: headache, dizziness, insomnia or drowsiness, irritability. On the part of the respiratory system: shortness of breath. On the part of the digestive tract: dry mouth, nausea, abdominal pain, constipation, diarrhea, changes in taste and appetite. From the musculoskeletal and connective tissue: muscle pain. On the part of metabolism and nutrition: weight loss, increased sweating. Other: pain in the chest.
Overdose
Symptoms: nausea, vomiting, dilated pupils, general weakness, tachycardia, clonic convulsions, respiratory paralysis. Symptoms of overdose occur in the case when the patient does not comply with the dosing regimen and takes the drug in doses several times higher than therapeutic. In case of overdose, you should immediately consult a doctor! Treatment: reception of activated carbon, gastric lavage, infusion of water-salt solutions, as well as 5% or 10% glucose solution, anticonvulsants, cardiotonics, respiratory analeptics and other symptomatic agents. Should monitor the work of the respiratory system, blood pressure and heart rate.
Interaction with other drugs
After cessation of tobacco smoking, the side effects of theophylline, ropinirole, clozapine, and olanzapine may increase. With simultaneous application Tabex with acetylcholine, carbachol, galantamine, pyridostigmine, rivastigmine, distigminom may increase nicotinic side effects (salivation, lacrimation, bronchial secretion with cough and the risk of an asthma attack, constriction of the pupil, cramps, nausea, vomiting, frequent urination, increased muscle tone or sudden muscle contractions). The use of Tabex at the same time with lovastatin, simvastatin, fluvastatin, pravastatin and others increases the risk of muscle pain. The simultaneous use of the drug Tabex with antihypertensive drugs (propranolol, etc.) may weaken their effect.
special instructions
The drug should be used only if the patient has a serious intention to quit smoking. Persons with a long period of smoking and persons older than 40-45 years, the drug Tabex should be used only after consulting a doctor. When using the drug should not exceed the recommended dose. Drug treatment and continued smoking can lead to increased side effects of nicotine (nicotine intoxication). The drug contains the excipient lactose. Patients with rare hereditary problems of intolerance to galactose, with lactase deficiency (Lapp) or glucose-galactose malabsorption should not use Tabex. Influence on the ability to drive vehicles and mechanisms: Although there was no negative effect on the ability to drive vehicles and work with mechanisms while using the drug, due to the possible occurrence of drowsiness and other adverse reactions, caution should be exercised in these situations.