Pharmacy No. 84. Delivery of medicines to your home and office.

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Description of the dosage form

Chewing gum Fresh fruit in the form of a square pad, coated chewing gum Frosted mint chewing gum Fresh fruit Chewing gum Fresh mint patch transdermal Topical spray, colorless to light yellow, clear to slightly opalescent solution, with a minty odor. Sublingual tablets are white or almost white, round, flat, with beveled edges, with embossed inscriptions - “NIC” on one side and “2” on the other Transdermal therapeutic system (TTS) with a contact surface area of 10 cm2; is a rectangular patch with rounded edges, one side is light brown with the inscription “nicorette®”, the other side is adhesive, silver-white, covered with transparent synthetic Transdermal Therapeutic System (TTS) with a contact surface area of 20 cm2; is a rectangular patch with rounded edges, one side is light brown with the inscription “nicorette®”, the other side is adhesive, silver-white, covered with transparent synthetic Transdermal Therapeutic System (TTS) with a contact surface area of 30 cm2; is a rectangular patch with rounded edges, one side is light brown with the inscription “nicorette®”, the other side is adhesive, silver-white, covered with transparent synthetic material

Contraindications

- hypersensitivity to nicotine and other components of the drug. The drug should be used with caution and only after consultation with a doctor in patients with disorders of the cardiovascular system, incl. who have had a cardiovascular disease within 1 month before starting use (including stroke, myocardial infarction, unstable angina, arrhythmia, coronary artery bypass grafting, angioplasty), or with uncontrolled arterial hypertension. The drug should be prescribed with caution to patients with moderate or severe liver dysfunction, severe renal failure, exacerbation of gastric and duodenal ulcers. The drug should be used with caution in patients with uncontrolled hyperthyroidism, pheochromocytoma (due to the fact that nicotine entering the human body during replacement therapy or smoking causes the release of catecholamines from the adrenal medulla), as well as diabetes mellitus.

Special conditions

The use of Nicorette® is associated with less risk than smoking. Patients who wear removable dentures may have difficulty using Nicorette® chewing gum. Chewing gum can stick to dentures and, in rare cases, damage them. Patients with diabetes may need to reduce their insulin doses after stopping smoking. Minor digestive upsets that may occur with 4 mg nicotine gum can be managed by chewing the gum more slowly or by using 2 mg nicotine gum (at shorter intervals if necessary). The patient should be informed that he should carry Nicorette® chewing gum with him to use if he suddenly wants to smoke. Use in pediatrics The question of prescribing the drug to patients under the age of 18 years is decided by the doctor individually. Effect on the ability to drive vehicles and operate machinery. A negative effect on the ability to drive a vehicle and operate machinery has not been established.

Pharmacodynamics

Nicotine is an agonist of nicotinic receptors in the peripheral and central nervous system (CNS), and has a pronounced effect on the central nervous system and the cardiovascular system.
Abrupt cessation of smoking causes the development of a characteristic withdrawal syndrome, including cravings for smoking.

Clinical studies have shown that nicotine replacement therapy drugs help smokers abstain from smoking by easing withdrawal symptoms. A single-dose study in 200 healthy smokers demonstrated that using two doses of a 1 mg spray reduced the desire to smoke from the first minute after using the spray and to a significantly greater extent than using lozenges containing nicotine. Compared with nicotine gum chewing or lozenges, the absorption of nicotine from an oral spray is faster (see Pharmacokinetics section) and, based on accumulated experience with nicotine replacement therapy, it leads to a more rapid reduction in cravings and other symptoms.

Increased appetite is a well-known symptom of nicotine withdrawal, and weight gain often occurs after smoking cessation. An important symptom of withdrawal syndrome is also the desire to smoke.

Pharmacokinetics

The pharmacokinetics of nicotine are comparable when the patch is applied to the skin of the arm or thigh. Absorption After applying a nicotine patch to the skin of the arm or thigh, approximately 95% of the released nicotine enters the systemic circulation. The remaining part evaporates at the edges of the patch. All patches indicate the average amount of nicotine that is absorbed by the average patient within 16 hours. The Cmax of nicotine in the blood plasma after applying the patch is reached after 6-10 hours and after applying the 15 mg/16 hour patch is 9-15 ng/ml. If the 15 mg/16 hour patch is left on for 24 hours (rather than 16 hours), the nicotine concentration during the last 8 hours decreases from an average of 7.2 to 5.6 ng/ml. When using smaller patches, similar changes in plasma nicotine concentrations can be expected. When three patch doses were used, plasma nicotine concentrations differed slightly from the proportional increase in dose: as patch size increased, the corresponding increase in concentration was slightly lower than expected. The distribution of Vd of nicotine with intravenous administration is about 2-3 l/kg. The binding of nicotine to blood plasma proteins is less than 5%. In this regard, disturbances in the binding of nicotine during the simultaneous use of other drugs or changes in the amount of protein in plasma in various diseases should not have a significant effect on the kinetics of nicotine. When the patch is applied repeatedly, the nicotine concentration does not significantly exceed that after its single application. Metabolism Nicotine is metabolized in the liver, kidneys and lungs. More than 20 metabolites have been identified that are inferior in activity to nicotine. The concentration of the primary metabolite, cotinine, is 10 times higher than the concentration of nicotine. Excretion Excreted mainly by the liver. The average plasma clearance is about 70 l/h. T1/2 - about 2 hours. Mainly cotinine (15% of the dose, T1/2 - 15-20 hours) and trans-3-hydroxy-cotinine (45% of the dose) are excreted in the urine. 10-30% of the nicotine dose is excreted unchanged in the urine. Pharmacokinetics in special clinical situations Progressive deterioration of renal function is accompanied by a decrease in the overall clearance of nicotine. The pharmacokinetics of nicotine does not change significantly in patients with liver cirrhosis with mildly severe liver dysfunction (5 points on the Child-Pugh scale) and decreases in patients with cirrhosis with moderately severe liver dysfunction (7 points on the Child-Pugh scale). In smokers undergoing hemodialysis, an increase in the concentration of nicotine in the blood plasma was noted. In elderly patients, there is a slight decrease in the total clearance of nicotine, which does not require dose adjustment.

pharmachologic effect

N-cholinomimetic. Interacts with peripheral and central n-cholinergic receptors. In low concentrations it excites them, in high concentrations it blocks them. In ganglia, the first phase (excitation) is associated with depolarization of the membranes of ganglionic neurons, the second (inhibition) is associated with competitive antagonism with acetylcholine. In the central nervous system, it influences the content and modulates the release of acetylcholine, norepinephrine, serotonin and other mediators in the endings of neurons. Reduces the secretion of growth hormone and gonadotropins, increases the secretion of catecholamines and ADH. Promotes the release of endorphins. The effect on the central nervous system (excitation or depression) depends on the doses, the intervals between them and the psychological state of the person. Small doses excite the central nervous system, incl. vomiting center Nicotine can cause tremors and seizures. Stimulates the respiratory center (reflexively from the chemoreceptors of the sinocarotid zone, and directly). The effect on the cardiovascular system is due to the activation of sympathetic influences: tachycardia (ventricular extrasystole is possible), increased blood pressure, impaired blood supply to organs and tissues (vasoconstriction), hypernoradrenalinemia, increased glycogenolysis, etc. Nicotine increases cardiac output, cardiac function and increases myocardial oxygen consumption . Activation of the parasympathetic ganglia leads to increased secretion (of bronchial glands and acidic gastric juice) and tone of smooth muscles of the bronchi and gastrointestinal tract. Facilitates neuromuscular transmission. Increases the content of fatty acids in the blood and the adhesive ability of platelets. Addiction to nicotine gradually develops. Well absorbed from mucous membranes. The plasma half-life is 2 hours. Metabolic products and a small amount of unchanged alkaloid are excreted in the urine in the first 10-15 hours. Nicotine penetrates into mother's milk and can create high concentrations in it, sufficient for the development of intoxication, incl. respiratory arrest in a child. During pregnancy, the risk of spontaneous abortion (as a result of oxygen deficiency in the blood) and disturbances in the development of the placenta associated with a large amount of abnormal DNA in it increases.

Side effects

Most adverse reactions are observed during the first 3-4 weeks of use of the drug and are dose-dependent. At the beginning of treatment: sometimes - mild throat irritation and increased salivation; when swallowing an excessive amount of dissolved nicotine - hiccups. In case of excessive use of the drug by persons who are not accustomed to inhaling tobacco smoke: nausea, weakness, headache. From the digestive system: when using chewing gum containing nicotine 4 mg in patients predisposed to digestive disorders - indigestion, heartburn. Dizziness, headache, sleep disorders can be manifestations of withdrawal syndrome caused by quitting smoking. Quitting smoking may increase the incidence of aphthous stomatitis. When describing side effects, the following frequency criteria are used: very often (>1/10), often (>1/100 1/1000, 1/10,000)

Compound

1 tab. nicotine-?-cyclodextrin complex 17.1 mg, which corresponds to a nicotine content of 2 mg Excipients: ?-cyclodextrin (Betadex) - 69.55 mg, crospovidone - 2 mg, magnesium stearate - 0.9 mg, colloidal silicon dioxide - 0.45 mg. 1 ml nicotine 13.6 mg Excipients: propylene glycol - 150 mg, ethanol - 97 mg, trometamol - 40.5 mg, poloxamer - 40 mg, glycerol - 25 mg, sodium bicarbonate - 14.3 mg, levomenthol - 10 mg, mint flavor QL24245 - 4 mg , flavor Cooler 2 SN046680 - 3 mg, sucralose - 1.5 mg, acesulfame potassium - 1.5 mg, hydrochloric acid 10% - sufficient amount up to pH 9, water - sufficient amount up to 1 ml. 1 tab. nicotine-?-cyclodextrin complex 17.1 mg, which corresponds to a nicotine content of 2 mg Excipients: ?-cyclodextrin (Betadex) - 69.55 mg, crospovidone - 2 mg, magnesium stearate - 0.9 mg, colloidal silicon dioxide - 0.45 mg. nicotine 830 mcg/cm2 15 mg/dose Excipients: backing film, non-woven polyester, medium molecular weight polyisobutylene, low molecular weight polyisobutylene, polybutene, siliconized polyester. Nicotine 15.75 mg; Auxiliary ingredients: triglycerides, copolymer of basic butyl methacrylate Nicotine 323.62; Auxiliary ingredients: triglycerides, copolymer of basic butyl methacrylate Nicotine 39.37; Excipients: triglycerides, copolymer of basic butyl methacrylate nicotine 5 mg Excipients: support film, non-woven polyester, medium molecular weight polyisobutylene, low molecular weight polyisobutylene, polybutene, siliconized polyester. nicotine 10 mg Excipients: support film, non-woven polyester, medium molecular weight polyisobutylene, low molecular weight polyisobutylene, polybutene, siliconized polyester. nicotine-polymer complex 22 mg, which corresponds to nicotine content* 4 mg * nicotine content 4.4 mg, including 10% excess. Excipients: chewing gum base**, xylitol, peppermint oil, sodium carbonate, acesulfame potassium, levomenthol, magnesium oxide, quinoline yellow (E104). ** Chewing gum base: a mixture of various types of wax, resin and other hydrocarbons (about 60%) and calcium carbonate (up to 40%). Chewing gum shell: xylitol, peppermint oil, acacia gum, titanium dioxide, carnauba wax, quinoline yellow (E104). nicotine-polymer complex 11 mg, which corresponds to the nicotine content** 2 mg * - nicotine resinate containing 20% nicotine. ** — nicotine content 2.2 mg, including 10% excess. Excipients: chewing gum base (a mixture of various types of wax, resin and other hydrocarbons (about 60%) and calcium carbonate (up to 40%)), xylitol, peppermint oil, sodium carbonate, sodium bicarbonate, acesulfame potassium, levomenthol, magnesium oxide . Inner shell composition: Winterfresh flavor, hypromellose, sucralose, polysorbate 80. Outer shell composition: xylitol, pregelatinized starch, titanium dioxide, Winterfresh flavor, carnauba wax. nicotine-polymer complex* 11 mg, which corresponds to the nicotine content** 2 mg Excipients: chewing gum base (a mixture of various types of wax, resin and other hydrocarbons (about 60%) and calcium carbonate (up to 40%)), xylitol, oil peppermint, sodium carbonate, sodium bicarbonate, acesulfame potassium, levomenthol, magnesium oxide. Composition of the inner shell: tutti-frutti KuEl84441, hypromellose, sucralose, polysorbate 80. Composition of the outer shell: xylitol, acacia, titanium dioxide, tutti-frutti KuEl84441, carnauba wax. * - nicotine resinate containing 20% nicotine. ** — nicotine content 2.2 mg, including 10% excess. nicotine-polymer complex* 11 mg, which corresponds to the nicotine content** 4 mg Excipients: chewing gum base (a mixture of various types of wax, resin and other hydrocarbons (about 60%) and calcium carbonate (up to 40%)), xylitol, mint oil pepper, sodium carbonate, sodium bicarbonate, acesulfame potassium, levomenthol, magnesium oxide. Composition of the inner shell: tutti-frutti KuEl84441, hypromellose, sucralose, polysorbate 80. Composition of the outer shell: xylitol, acacia, titanium dioxide, tutti-frutti KuEl84441, carnauba wax. * - nicotine resinate containing 20% nicotine. ** — nicotine content 2.2 mg, including 10% excess. nicotine-polymer complex* 22 mg, which corresponds to the nicotine content** 4 mg * - nicotine resinate containing 20% nicotine. ** — nicotine content 4.4 mg, including 10% excess. Excipients: chewing gum base (a mixture of various types of wax, resin and other hydrocarbons (about 60%) and calcium carbonate (up to 40%)), xylitol, peppermint oil, sodium carbonate, acesulfame potassium, levomenthol, magnesium oxide, quinoline yellow (E104). Inner shell composition: Winterfresh flavor, hypromellose, sucralose, polysorbate 80. Outer shell composition: xylitol, pregelatinized starch, titanium dioxide, Winterfresh flavor, carnauba wax, quinoline yellow (E104). nicotine-polymer complex 11 mg, which corresponds to nicotine content * 2 mg * nicotine content 2.2 mg, including 10% excess. Excipients: chewing gum base**, xylitol, peppermint oil, sodium carbonate, sodium bicarbonate, acesulfame potassium, levomenthol, magnesium oxide. ** Chewing gum base: a mixture of various types of wax, resin and other hydrocarbons (about 60%) and calcium carbonate (up to 40%). Chewing gum shell: xylitol, peppermint oil, acacia gum, titanium dioxide, carnauba wax.