Medicines - list and application. Medicines, medicines, drugs

Already in ancient times, people tried to save their lives using various natural medicinal substances. Most often these were plant extracts, but preparations were also used, which were obtained from raw meat, yeast and animal waste. Some medicinal substances are readily available accessible form in plant or animal raw materials, in connection with which medicine has successfully used since ancient times a large number of medicines of plant and animal origin (for example, castor bean, opium, sea onion, known in ancient Egypt; known to the ancient Hindus; foxglove, lily of the valley, adonis and many others widely used in folk medicine). Only with the development of chemistry did people become convinced that healing effect of such substances is the selective effect on the body of certain chemical compounds. Later, such compounds began to be obtained in laboratories by synthesis.

Advances in technology and the development of a number scientific disciplines(anatomy, physiology and especially chemistry) in the second half of the 19th century, firstly, made possible the synthesis significant amount substances that did not exist in a given combination or form, but possess therapeutic effect(antipyrine, pyramidon, plasmocid, aspirin and hundreds of others), and, secondly, they made it possible to make a scientific experiment the basis for studying the effects of drugs, as well as for researching new drugs. The experiment replaced various scientifically unsubstantiated theories (Paracelsus, Hahnemann, etc.) that had prevailed until that time in the treatment and pharmacology.

• plants (leaves, grass, flowers, seeds, fruits, bark, roots) and products of their processing (fatty and essential oils, juices, gums, resins);
• animal raw materials - animal glands and organs, lard, wax, cod liver, sheep wool fat and more;
• fossil organic raw materials - oil and products of its distillation, products of distillation of coal;
• inorganic minerals - mineral rocks and products of their processing by the chemical industry and metallurgy (metals);
• all kinds organic compounds- products of the large chemical industry.

Studying

Quantitative indicators for a medicinal product are established: lethal dose (usually calculated per 1 kg of live weight of an animal or human), tolerated (tolerated) dose and treatment dose. Tolerable doses (or slightly lower for caution) for many drugs are legalized as maximum doses. Attitude lethal dose to therapeutic is called the "therapeutic index" of the drug, since the larger this ratio, the more freely you can prescribe the drug.

Action

The action of drugs is carried out mainly by changing physical and chemical properties the environment in which the cellular elements of the body are located; in this case, the action may have the character of a chemical compound of the drug with the elements of the body and, in some cases, with a direct effect on the protoplasm of cells, be accompanied by complete destruction their. The physiological effect of the drug is either excitation or inhibition of the vital activity of cellular elements; dose plays an important role. medicinal substance because the same drug at different doses can cause miscellaneous action- excite in small doses and oppress (up to paralysis) in large doses.

An essential point is the phase of action of drugs: some drugs can show their effect at the moment of penetration into the body (the entry phase according to Kravkov), others - the majority - during the period of maximum concentration in the body (saturation phase), others - at the moment of concentration drop (exit phase). ); at the same time, the ability of some drugs to cumulation is extremely important, which manifests itself in a sharp increase, and sometimes even a distortion of their action upon repeated administration, which is explained by the accumulation of the drug in the body and the accumulation of the effect of its action.

The effect of the drug depends on age, sex, health status and individual characteristics body of the person taking it. A number of drugs in a correspondingly reduced dose have a much more strong action than on adults (often poisonous); women during menstruation, pregnancy, lactation react to drugs differently than usual; some people are affected by the drug in an abnormally strong way, which is explained hypersensitivity organism to certain substances(See: Idiosyncrasy).

Application methods

External use of drugs is considered to be their application to the skin and mucous membranes of the eyes, nose, ears, mouth, urinary tract(to the point of entry into the bladder and to the cervical canal of the uterus), on the mucous membrane of the rectum (to the location of the internal sphincter).

In the body, drugs are destroyed, changed and, entering into chemical compounds with its salts and liquids, lose their toxic properties (and sometimes, on the contrary, acquire them) and are excreted from the body in one form or another through the intestines, kidneys, Airways, sweat glands etc.

Prescription and non-prescription medicines

The state is gradually tightening control over the circulation of medicines. In particular, in June 2012, the Order of the Ministry of Health and Social Development of Russia No. 562n dated May 17, 2012 came into force on the approval of a new procedure for dispensing drugs containing precursors, including codeine-containing combined painkillers, which were popular with a large part of the population. In order to combat drug addiction, since July 2012, the above drugs have been dispensed according to 148-1 / y-88 form prescription.

In Russia, selling a drug without a prescription is punishable by a fine of 1-2 thousand rubles. If the situation repeats, the inspectors have the right to draw up a protocol already on entity, that is, on pharmacy organization, and in this case, the amount of the fine increases many times - up to 40-50 thousand rubles.

Homeopathic medicines

In a number of countries, these drugs are regulated differently - either as a category of "drugs", or as "food products and additives", or as "alternative medicine". At present, there is no consensus on this matter. international organizations agreed with national health authorities.

IN Russian Federation homeopathic preparations subject to the same legal regulation as conventional medicines. In 2010, work began on revising the status of certain types of medicines, in particular, homeopathic medicines.

Legislative regulation in the Russian Federation

The state strictly regulates the circulation of medicines. The main document regulating the circulation of medicines for 2011 is the federal law dated April 12, 2010 No. 61-FZ “On the circulation of medicines” (adopted by the State Duma of the Federal Assembly of the Russian Federation on March 24, 2010). In addition to the main law, subjects of drug circulation are subject to laws No. 3-FZ dated January 8, 1998 “On drugs ah and psychotropic substances ah”, No. 2300-1 “On Protection of Consumer Rights”, No. 122-FZ of 08.02.1995 “On Social Services for Elderly Citizens and the Disabled”, No. 128-FZ of 08.08.2001 “On Licensing certain types activities" and others.

The Law on Medicinal Products distinguishes between the concepts of “medicinal product” and “ medicine". According to the law, a "drug" is more than general concept, means also include substances. Medicinal preparations - medicines in the form dosage forms used for the prevention, diagnosis, treatment of a disease, rehabilitation, for the preservation, prevention or termination of pregnancy. All medicines used in Russia must be registered with the appropriate authorized federal executive body - Roszdravnadzor, which maintains the state register of medicines.

The production of authorized medicines must comply with the requirements of GOST, adopted in 2010. This GOST corresponds international standard GMP. All pharmaceutical companies Russia is obliged to switch to the requirements of this GOST by 2014.

The sale of medicines (as opposed to dietary supplements) is carried out only by pharmacies (pharmacies, pharmacy kiosks) that have the appropriate license.

The circulation of medicines is regulated by law and by-laws, including regularly updating the list of vital and most important medicines, etc.

Tax law

In Ukraine, there is a practice of returning excise duty for the use of alcohol in the manufacture of medicines, but only after they are sold.

State quality control bodies

The quality of medicines in Russia is controlled by the Federal Service for Surveillance in the Sphere of Health (Roszdravnadzor), subordinate to the Ministry of Health.

Most major cities Centers for quality control of medicines operate in Russia. Their main task is to check the organizations selling medicines (observance of numerous norms for the storage and sale of medicines), as well as selective (and in some regions even total) control of medicines. Based on data from regional centers Roszdravnadzor makes decisions on the rejection of a drug.

Rejected and counterfeit medicines are subject to withdrawal from the pharmacy network, information about them is available on the Roszdravnadzor website.

Turnover of narcotic medicines

According to regulatory documentation, narcotic drugs are medications and pharmaceutical substances containing narcotic drugs and included in the list of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation, in accordance with the legislation of the Russian Federation, international treaties of the Russian Federation, including the Single Convention on Narcotic Drugs of 1961.

From the list of narcotic drugs, drugs are related to:

• List II - narcotic drugs and psychotropic substances, the circulation of which in the Russian Federation is limited and for which control measures are established in accordance with the legislation of the Russian Federation and international treaties of the Russian Federation
• List III - psychotropic substances, the circulation of which in the Russian Federation is limited and for which the exclusion of certain control measures is allowed in accordance with the legislation of the Russian Federation and international treaties of the Russian Federation

The state reserves a monopoly on the production of Schedule II narcotic drugs. All enterprises involved in the circulation of narcotic and psychotropic substances are subject to compulsory licensing. Pharmacies that stock drugs in lists II and III are required to have licenses for the implementation of each list.

control government agency enterprises involved in the circulation of narcotic drugs, in addition to Roszdravnadzor, is the Federal Service of the Russian Federation for the Control of Drug Traffic. Because many doctors fear that patients will become addicted to the drug and are psychologically reluctant to accept it, due to confusing and conflicting and frequently changing legislation, doctors are wary of prescribing narcotic drugs, even to people who need it.

Original medicines, synonyms, "generics" and analogues

original A medicine is a drug that was previously unknown and first released to the market by a developer or patent holder. As a rule, the development and marketing of a new drug is a very expensive and time-consuming process. Of the many known compounds, as well as newly synthesized ones, by enumeration, on the basis of databases on their properties and computer modeling of the proposed biological activity, substances with the maximum target activity are identified and synthesized. After animal experiments, in the case positive result, limited clinical trials are being conducted on groups of volunteers. If the effectiveness is confirmed, and side effects insignificant - the drug goes into production, and based on the results of additional tests, possible features actions are revealed unwanted effects. Often the most harmful side effects found out in clinical practice.

Currently, almost all new drugs are patented. The patent legislation of most countries provides for patent protection not only for the method of obtaining a new drug, but also for the patent protection of the drug itself. In the Russian Federation, the term of a patent for an invention related to a medicinal product, the application of which requires obtaining permission in accordance with the procedure established by law, is extended by the federal executive body according to intellectual property at the request of the patent owner for a period calculated from the date of filing an application for an invention until the date of receipt of the first such permission for use, minus five years. At the same time, the period for which the validity of a patent for an invention is extended cannot exceed five years. After the expiration of the patent, other manufacturers can reproduce and put on the market a similar drug (so-called generic), if they prove the bioequivalence of the reproduced and original drugs. At the same time, the generic production technology can be any, but not subject to the existing patent protection in the country. The generic manufacturer cannot use the brand name for this medicine, but only the international non-proprietary name (INN) or some new one patented by him ( synonym).

From the point of view of chemistry, the active substance of the original drug and the generic is the same, but the production technology is different, it is possible varying degrees cleaning. There are other factors that affect the effectiveness of the drug. For example, for a long time different firms could not achieve the same effectiveness of acetylsalicylic acid for generics as Bayer, the manufacturer original drug"aspirin". It turned out that the matter was not only in the purity of the raw materials, but also in a special method of crystallization, which resulted in special, smaller crystals. The opposite result is also possible, when the generic is more successful than the original medicine.

Analog- substance-based drug excellent from the one used in the compared original and, therefore, with a different INN. Therefore, if the selection of a synonym or generic is the prerogative

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Oral hypoglycemic drug

Active substance

Alogliptin (alogliptin)

Release form, composition and packaging

yellow color, oval, biconvex, inked "TAK" and "ALG-12.5" on one side.

Excipients: core:- 96.7 mg, microcrystalline cellulose - 22.5 mg, hyprolose - 4.5 mg, croscarmellose sodium - 7.5 mg, magnesium stearate - 1.8 mg.

Compound film shell: hypromellose 2910 - 5.34 mg, titanium dioxide - 0.6 mg, iron dye yellow oxide - 0.06 mg, macrogol 8000 - trace amounts, gray ink F1 (shellac - 26%, iron dye black oxide - 10%, ethanol - 26%, butanol - 38%) - trace amounts.

Film-coated tablets light red, oval, biconvex, inked with "TAK" and "ALG-25" on one side.

Excipients: core: mannitol - 79.7 mg, microcrystalline cellulose - 22.5 mg, hyprolose - 4.5 mg, croscarmellose sodium - 7.5 mg, magnesium stearate - 1.8 mg.

The composition of the film shell: hypromellose 2910 - 5.34 mg, titanium dioxide - 0.6 mg, iron dye red oxide - 0.06 mg, macrogol 8000 - trace amounts, gray ink F1 (shellac - 26%, iron dye black oxide - 10%, ethanol - 26%, butanol - 38%) - trace amounts.

7 pcs. - aluminum blisters (4) - packs of cardboard.

pharmachologic effect

Hypoglycemic drug, a potent and highly selective inhibitor of dipeptidyl peptidase-4 (DPP-4). It is more than 10,000 times more selective for DPP-4 than other related enzymes, including DPP-8 and DPP-9. DPP-4 is the main enzyme involved in the rapid degradation of the hormones of the incretin family: glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP).

Hormones of the incretin family are secreted in the intestine, their concentration increases in response to food intake. GLP-1 and GIP increase insulin synthesis and secretion by pancreatic β-cells. GLP-1 also inhibits glucagon secretion and reduces hepatic production. Therefore, by increasing the concentration of incretins, alogliptin increases glucose-dependent insulin secretion and reduces glucagon secretion at elevated blood glucose concentrations. In patients with diabetes Type 2 with hyperglycemia, these changes in insulin and glucagon secretion lead to a decrease in concentration glycosylated hemoglobin HbA 1C and a decrease in the concentration of glucose in the blood both on an empty stomach and postprandial glucose.

Pharmacokinetics

The pharmacokinetics of alogliptin is similar in healthy individuals and in patients with type 2 diabetes.

Suction

The absolute bioavailability of alogliptin is approximately 100%. Simultaneous reception with food from high content fat had no effect on the AUC of alogliptin, so it can be taken with or without food. In healthy individuals, after a single oral dose of up to 800 mg of alogliptin, rapid absorption of the drug is observed with an average T max in the range of 1 to 2 hours from the moment of administration.

The AUC of alogliptin increases proportionally with a single dose over the therapeutic dose range of 6.25 mg to 100 mg. The coefficient of variability in the AUC of alogliptin among patients is small (17%). AUC (0-inf) of alogliptin after a single dose was similar to AUC (0-24) after taking the same dose 1 time / day for 6 days. This indicates no time dependence in the kinetics of alogliptin after repeated dosing.

Distribution

Plasma protein binding is approximately 20-30%. After a single intravenous injection of alogliptin at a dose of 12.5 mg in healthy volunteers, V d in the terminal phase was 417 liters, indicating that alogliptin is well distributed in tissues.

Neither in healthy volunteers nor in patients with type 2 diabetes, clinically significant accumulation of alogliptin was observed after multiple doses.

Metabolism

Alogliptin is not extensively metabolized; 60 to 70% of alogliptin is excreted unchanged by the kidneys.

After oral administration of 14 C-labeled alogliptin, two major metabolites were identified: N-demethylated alogliptin, M-I (<1% исходного вещества), и N-ацетилированный алоглиптин, М-II (<6% исходного вещества). М-I является активным метаболитом и высокоселективным ингибитором ДПП-4, схожим по действию с самим алоглиптином; М-II не проявляет ингибирующую активность по отношению к ДПП-4 или другим ДПП ферментам.

In vivo studies have shown that CYP2D6 and CYP3A4 are involved in the limited metabolism of alogliptin.

Also, in vitro studies show that alogliptin does not induce CYP1A2, CYP2C9, CYP2B6 and does not inhibit CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 or CYP3A4 at concentrations achieved with the recommended dose of alogliptin 25 mg. In vitro, alogliptin may slightly induce CYP3A4, but in vivo, alogliptin does not induce CYP3A4.

Alogliptin does not inhibit human renal organic anion transporters of the first (OAT1), third (OAT3) types and renal human organic cation transporters of the second (OST2) type.

Alogliptin exists predominantly as the (R)-enantiomer (>99%) and under in vivo conditions either in small amounts or does not undergo chiral transformation to the (S)-enantiomer. The (S) enantiomer is not detected when taking alogliptin at therapeutic doses.

breeding

After oral administration of 14 C-labeled alogliptin, 76% of the total radioactivity was excreted by the kidneys and 13% through the intestines. The mean renal clearance of alogliptin (170 ml/min) is greater than the mean glomerular filtration rate (about 120 ml/min), suggesting that alogliptin is partially eliminated by active renal excretion. The average terminal T 1/2 is approximately 21 hours.

Pharmacokinetics in selected groups of patients

Patients with renal insufficiency. A study of alogliptin at a dose of 50 mg/day was conducted in patients with varying degrees of severity of chronic kidney failure. The patients included in the study were divided into 4 groups in accordance with the Cockcroft-Gault formula: patients with mild (CC from 50 to 80 ml / min), medium degree severity (CC from 30 to 50 ml / min) and severe (CC less than 30 ml / min), as well as patients with terminal stage chronic renal failure requiring hemodialysis.

The AUC of alogliptin in patients with mild renal impairment was approximately 1.7-fold higher than in controls. However, this increase in AUC was within the tolerance for the control group, so dose adjustment of the drug in these patients is not required.

An increase in the AUC of alogliptin by approximately 2 times compared with the control group was observed in patients with moderate renal insufficiency. An approximately four-fold increase in AUC was observed in patients with severe renal failure, as well as in patients with end-stage chronic renal failure, compared with the control group. Patients with end-stage renal disease underwent hemodialysis immediately after taking alogliptin. About 7% of the dose was removed from the body during a 3-hour dialysis session.

Thus, in order to achieve a therapeutic plasma concentration of alogliptin similar to that in patients with normal renal function, dose adjustment is necessary in patients with moderate renal insufficiency. Alogliptin is not recommended for use in patients with severe renal impairment or in patients with end-stage renal disease requiring hemodialysis.

Patients with liver failure. In patients with moderate hepatic insufficiency, AUC and Cmax of alogliptin are reduced by approximately 10% and 8%, respectively, compared with patients with normal liver function. These values ​​are not clinically significant. Thus, dose adjustment of the drug for mild to moderate hepatic insufficiency (from 5 to 9 points on the Child-Pugh scale) is not required. There are no clinical data on the use of alogliptin in patients with severe hepatic insufficiency (more than 9 points on the Child-Pugh scale).

Other groups of patients. Age (65-81 years), gender, race, body weight of patients did not have a clinically significant effect on the pharmacokinetic parameters of alogliptin. Dose adjustment of the drug is not required.

Pharmacokinetics in children and adolescents under the age of 18 have not been studied.

Indications

Type 2 diabetes mellitus in adults to improve glycemic control when diet and exercise have failed:

- as monotherapy;

- in combination with other oral hypoglycemic agents or with insulin.

Contraindications

- hypersensitivity to alogliptin or any excipient, or a history of serious hypersensitivity reactions to any DPP-4 inhibitor, including anaphylactic reactions, anaphylactic shock and angioedema;

- type 1 diabetes mellitus;

- diabetic ketoacidosis;

- chronic insufficiency (FC class III-IV according to NYHA);

- severe liver failure (more than 9 points on the Child-Pugh scale) due to the lack of clinical data on the use;

- severe renal failure;

- pregnancy (due to the lack of clinical data on the use);

- the period of breastfeeding (due to the lack of clinical data on the use);

- children and adolescents under 18 years of age (due to the lack of clinical data on the use).

Carefully:

- acute pancreatitis in history;

- in patients with moderate renal insufficiency;

- in combination with a sulfonylurea derivative or insulin;

- taking a three-component combination of the drug Vipidia with metformin and thiazolidinedione.

Dosage

Taken inside.

Vipidia can be taken with or without food. The tablets should be swallowed whole, without chewing, with water.

The recommended dose of Vipidia is 25 mg 1 time / day as monotherapy or in addition to metformin, thiazolidinedione, sulfonylurea derivatives or insulin, or as a three-component combination with metformin, thiazolidinedione or insulin.

If a patient misses a dose of Vipidia, he should take the missed dose as soon as possible. It is unacceptable to take a double dose of Vipidia on the same day.

When prescribing Vipidia in addition to metformin or thiazolidinedione, the dose of the latter drugs should be left unchanged.

When combining the drug Vipidia with a sulfonylurea derivative or insulin, it is advisable to reduce the dose of the latter to reduce the risk of hypoglycemia.

Due to the risk of hypoglycemia, caution should be exercised when prescribing a three-component combination of Vipidia with metformin and thiazolidinedione. If hypoglycemia develops, a dose reduction of metformin or thiazolidinedione may be considered.

The efficacy and safety of alogliptin when taken in triple combination with metformin and a sulfonylurea have not been studied.

Patients with renal insufficiency

Patients with mild renal insufficiency (CC > 50 to ≤ 80 ml / min) dose adjustment of Vipidia is not required. In patients with moderate renal insufficiency (CC from ≥30 to ≤50 ml / min), the dose of Vipidia is 12.5 mg 1 time / day.

Alogliptin should not be used in patients with severe renal insufficiency and in patients with end-stage renal disease requiring hemodialysis (CC<30 мл/мин).

Patients with liver failure

Dose adjustment of Vipidia is not required in patients with mild to moderate hepatic insufficiency (from 5 to 9 points on the Child-Pugh scale). The drug has not been studied in patients with severe hepatic insufficiency (more than 9 points on the Child-Pugh scale), so it should not be used in this group of patients.

Patients over 65 years of age

Dose adjustment of Vipidia is not required in patients over 65 years of age. However, special care should be taken in dose selection of alogliptin due to the potential for decreased renal function in this group of patients.

Side effects

Determining the frequency of adverse reactions: very often (≥1/10), often (≥1/100 and<1/10), нечасто (≥1/1000 и <1/100), редко (≥1/10 000 и <1/1000), очень редко (<1/10 000, включая отдельные случаи), частота не установлена (данные постмаркетинговых наблюдений).

From the nervous system: often - headache.

From the digestive system: often - pain in the epigastric region, gastroesophageal reflux disease; frequency not established - acute pancreatitis.

From the side of the liver and biliary tract: frequency not established - impaired liver function, incl. liver failure.

From the skin and subcutaneous tissues: often - itching, rash; frequency not established - exfoliative skin diseases, including Stevens-Johnson syndrome, angioedema, urticaria.

From the respiratory system: often - infections of the upper respiratory tract, nasopharyngitis.

From the immune system: frequency not established - hypersensitivity reactions, including anaphylactic reaction.

Overdose

The maximum dose of alogliptin in clinical studies was 800 mg/day in healthy volunteers and 400 mg/day in patients with type 2 diabetes mellitus for 14 days. This is 32 and 16 times, respectively, the recommended daily dose of 25 mg of alogliptin. There were no serious adverse events when taking the drug at these doses.

Treatment: in case of overdose, gastric lavage and symptomatic treatment may be recommended. Alogliptin is poorly dialyzed. In clinical studies, only 7% of the dose was removed from the body during a 3-hour dialysis session. There are no data on the effectiveness of peritoneal dialysis of alogliptin.

drug interaction

Effects of other medicinal products on alogliptin

Alogliptin is mainly excreted unchanged by the kidneys, and is metabolized to a small extent by the CYP450 cytochrome enzyme system.

In interaction studies with other drugs, the pharmacokinetics of alogliptin did not have a clinically significant effect of the following drugs: gemfibrozil (CYP2C8 / 9 inhibitor), (CYP2C9 inhibitor), ketoconazole (CYP3A4 inhibitor), cyclosporine (P-glycoprotein inhibitor), α-glycosidase inhibitor , digoxin, metformin, cimetidine, pioglitazone or atorvastatin.

Effects of alogliptin on other medicinal products

In vitro studies have shown that alogliptin does not inhibit or induce CYP450 isoenzymes at concentrations achieved when taking alogliptin at the recommended dose of 25 mg. Interaction with CYP450 isoenzymes is not expected and has not been identified.

In vitro studies have shown that alogliptin is neither a substrate nor an inhibitor of OAT1, OAT3, and OCT2. In addition, data from clinical studies do not indicate an interaction with P-glycoprotein inhibitors or substrates.

In clinical drug interaction studies, alogliptin did not have a clinically significant effect on the pharmacokinetics of the following drugs: caffeine, (R)- and (S)-warfarin, pioglitazone, tolbutamide, dextromethorphan, atorvastatin, midazolam, oral contraceptives (norethindrone and ethinyl estradiol) , digoxin, fexofenadine, metformin or cimetidine. Based on these data, alogliptin does not inhibit the isoenzymes of the cytochrome system CYP1A2, CYP3A4, CYP2D6, CYP2C9, P-glycoprotein and OCT2.

Alogliptin did not affect the prothrombin index or MHO in healthy volunteers when taken with warfarin.

When taking alogliptin in combination with metformin, or pioglitazone (thiazolidinedione), or an α-glycosidase inhibitor, or glibenclamide (a sulfonylurea derivative), no clinically significant pharmacokinetic interaction was observed.

special instructions

Use with other hypoglycemic drugs

In order to reduce the risk of hypoglycemia, it is recommended to reduce the dose of sulfonylurea derivatives, insulin or a combination of pioglitazone (thiazolidinedione) with metformin while using Vipidia.

Unexplored Combinations

The efficacy and safety of Vipidia in combination with inhibitors of sodium-dependent glucose cotransporters 2 or analogues of the glucagon-like peptide and in triple combination with metformin and sulfonylurea derivatives have not been studied.

kidney failure

Because patients with moderate renal insufficiency require dose adjustment of Vipidia, it is recommended to evaluate renal function before starting and periodically during treatment.

Vipidia should not be used in patients with severe renal insufficiency, as well as in patients with end-stage chronic renal failure requiring hemodialysis.

Acute pancreatitis

The use of DPP-4 inhibitors is associated with a potential risk of developing acute pancreatitis. In a pooled analysis of 13 clinical trials of alogliptin 25 mg/day, 12.5 mg/day, comparator, and placebo, the incidence of acute pancreatitis was 3, 1, 1, or 0 cases per 1,000 patient-years in each arm, respectively. Patients should be informed of the characteristic symptoms of acute pancreatitis: persistent severe abdominal pain that may radiate to the back. If you suspect the development of acute pancreatitis, Vipidia is discontinued; with confirmation of acute pancreatitis, the drug is not resumed. There is no data on whether there is an increased risk of developing pancreatitis while taking Vipidia in patients with a history of pancreatitis. Therefore, when using the drug in patients with a history of pancreatitis, caution should be exercised.

Liver failure

There have been post-marketing reports of abnormal liver function, including liver failure, with alogliptin. Their connection with the use of the drug has not been established. However, patients should be carefully monitored for possible abnormal liver function. If abnormalities in liver function are found and an alternative etiology of their occurrence has not been established, the possibility of discontinuing treatment with the drug should be considered.

Influence on the ability to drive vehicles and control mechanisms

Vipidia has no or little effect on the ability to drive vehicles and mechanisms. However, the risk of hypoglycemia should be considered when using the drug in combination with other hypoglycemic drugs (sulfonylurea derivatives, insulin or combination therapy with pioglitazone and metformin) and caution should be exercised when driving vehicles and mechanisms.

Pregnancy and lactation

No studies have been conducted on the use of alogliptin in pregnant women. Experimental animal studies have not shown direct or indirect negative effects of alogliptin on the reproductive system. However, as a precaution, the use of Vipidia during pregnancy is contraindicated.

It is not known whether alogliptin is excreted in human breast milk. IN experimental studies animal studies have shown that alogliptin is excreted in breast milk, so the risk of side effects in infants cannot be excluded. In this regard, the use of the drug during breastfeeding is contraindicated.

Application in childhood

Due to the lack of clinical data on the use of the drug is contraindicated in children under the age of 18 years.

For impaired renal function

Patients with mild renal impairment (creatinine clearance > 50 to< 80 мл/мин) коррекции дозы препарата Випидия не требуется. У пациентов с почечной недостаточностью средней степени тяжести (клиренс креатинина от >30 to<50 мл/мин) доза препарата Випидия составляет 12,5 мг 1 раз в сутки.

Alogliptin should not be used in patients with severe renal insufficiency and in patients with end-stage renal disease requiring hemodialysis (creatinine clearance from< 30 мл/мин).

Terms of dispensing from pharmacies

The drug is dispensed by prescription.

Terms and conditions of storage

The drug should be stored out of the reach of children at a temperature not exceeding 25 ° C. Shelf life - 3 years.

Medications that reduce pain. Many of them have anti-inflammatory properties (see ANTI-INFLAMMATORY DRUGS) and reduce fever (see ANTIPYRETICS). There are three main groups. First, simple analgesics, which usually contain aspirin or paracetamol, are used for mild pain. Second: anti-inflammatory drugs used for muscle pain, arthritis. Third: narcotic analgesics, usually chemically related to morphine, used for severe pain.

Possible side effects: nausea, constipation, dizziness, dependence and development of drug resistance (only when using narcotic analgesics). For side effects of other groups, see ANTI-INFLAMMATORY DRUGS and ANTIPYRETICS.

Doses for children: Liquid paracetamol is one of the most harmless over-the-counter analgesics; it is recommended for pain and feverish symptoms in children. Another analgesic, aspirin, often used by adults, is no longer considered completely safe for children with certain viral infections. Its use can cause the development of Reye's syndrome, a rare and serious disease that affects the brain and liver. For severe pain, for example after surgery, narcotic analgesics (in particular, codeine) may be prescribed. Analgesics can cause drowsiness in a child, as well as transient constipation, nausea, and dizziness.

Substances (often derived from micro-organisms such as fungi or bacteria) that inhibit or kill bacteria in the body. Some of the newer antibiotics are synthetic derivatives of naturally occurring substances. Any type of antibiotic is only effective against certain strains of bacteria, although there are broad-spectrum antibiotics that work against a large number of bacterial infections. Sometimes microbes become resistant to a particular antibiotic. In such cases, the choice of drug should be based on laboratory data. Antibiotics are ineffective against viruses.

Possible side effects: nausea, vomiting, loose stools. Some people may be allergic to certain antibiotics. Its manifestations: rash, fever, joint pain, swelling, shortness of wheezing. When treated with broad-spectrum antibiotics, secondary fungal infections (thrush) may occur, for example, in the oral cavity or vagina.

Doses for children: The most commonly recommended antibiotics for children are ampicillin, amoxicillin, erythromycin, and penicillin. When prescribing antibiotics by a doctor, it is always necessary to complete the recommended course of treatment. Stopping treatment prematurely can lead to relapse and promote the emergence of resistant bacterial species. Antibiotics can have side effects, and some children are sensitive to penicillin and related antibiotics. Side effects: rash, nausea, vomiting, loose stools, shortness of breath. If you experience any adverse reactions to antibiotics, you should consult a doctor.

Warning: Complete the prescribed course of antibiotics. Otherwise, even after the symptoms disappear, a relapse of the infection may occur, which will be much more difficult to fight (due to the development of bacterial resistance to antibiotics).

Medications that prevent allergic reactions that occur when a substance called histamine is released in the body. These reactions may include a runny nose and watery eyes (allergic rhinitis), itching, and hives. Antihistamines are taken orally or in the form of ointments or aerosols applied to the skin at the site of the rash. They also affect the organs of balance located in the middle ear, and therefore are often used to prevent seasickness. The drugs have a calming effect, and they can be used to treat insomnia (on the advice of a doctor). They are also used as a means of drug preparation before surgery: they create a relaxed drowsy state in the patient before entering the operating room. Other antihistamines that affect the secretion of gastric juice are used to treat peptic ulcers.

Possible side effects: drowsiness, dry mouth, "veil" before the eyes.

Doses for children: In children, trimepraeine tartrate and promethazine hydrochloride are most commonly recommended. The main side effect is drowsiness, but in some children, on the contrary, unusual arousal occurs.

Warning: While taking antihistamines, it is recommended not to drive a car and avoid drinking alcoholic beverages.

Drugs to combat depression are divided into two main groups: tricyclics and their derivatives, as well as monoamine oxidase inhibitors (MAOIs). Because of the side effects, which can be quite serious, MAO inhibitors are prescribed only for those types of severe depression where tricyclic drugs are ineffective.

Possible side effects: drowsiness, dry mouth, "veil" before the eyes, constipation, difficulty urinating, fainting, sweating, trembling, rash, palpitations, headache.

Doses for children: In some cases, these drugs may be prescribed to older children suffering from depression. In addition, some doctors recommend antidepressants such as amitriptyline for bedwetting in children over 6 years of age (if other therapies fail). The feasibility of such treatment remains controversial. Side effects: deviations in behavior, disturbances in the frequency and rhythm of heart contractions.

Warning: In combination with certain drugs and foods, MAO inhibitors have the opposite effect, which can lead to a significant rise in blood pressure. Check with your doctor, he may recommend that you carry a warning card with you. When treating with antidepressants of both groups, alcohol intake should be limited. Ask your doctor if you can drive or use machines while taking antidepressants.

Drugs that prevent and/or dissolve blood clots (thrombi).

Possible side effects: increased tendency to bleeding from the nose, gums, as well as to the formation of subcutaneous hematomas (with bruises). There may be blood in the urine and stool.

Warning: Anticoagulants work more intensively in combination with some other drugs, including aspirin. Before taking any other medicines, check with your doctor to be sure that the effectiveness of anticoagulants will not be impaired. If you regularly take anticoagulants, you should carry a warning card with you.

Beta-adrenergic blocking agents (abbreviated as beta-blockers) reduce the heart's need for oxygen by lowering the heart rate. They are used both in the form of tablets and in the form of injections as ANTIHYPERTENSIVE and ANTIARRHYTHMIC MEDICINES, in the treatment of angina pectoris, as well as to reduce palpitations and tremors in patients in a state of excitation.

Possible side effects: nausea, insomnia, physical fatigue, loose stools.

Warning: An overdose may cause drowsiness and fainting. Stop therapy should be gradual. Beta-blockers are contraindicated in bronchial asthma and heart failure.

Drugs that expand the lumen of the bronchi, narrowed as a result of muscle spasm. Bronchial dilators, which make breathing easier in asthma-like conditions, are often used as aerosols, but are also available in tablet and liquid form, as well as suppositories. In emergency cases, such as a severe attack of bronchial asthma, drugs are administered intramuscularly or intravenously. The duration of action is usually 3-5 hours.

Possible side effects: palpitations, tremor, headache, dizziness.

Doses for children: In children, narrowing of the lumen of the bronchi usually occurs with asthma or respiratory infections (bronchitis and bronchiolitis). There are two groups of drugs for the primary treatment of bronchial asthma. The first includes drugs used to treat an acute attack (bronchodilators): terbutaline and theophyllines, used both inside and in the form of injections. The second group includes drugs whose action is aimed at preventing an attack (sodium chromoglycate). In the treatment of acute attacks, they are ineffective. CORTICOSTEROIDS (see ANTI-INFLAMMATORY DRUGS) are used to treat asthma resistant to the above medications. Children over 3 years of age can be taught how to use inhalers. Side effects of anti-asthma drugs include increased heart rate, trembling, and irritability.

Warning: Due to the possible effect on the heart, the prescribed doses should not be exceeded. If the recommended doses do not improve, emergency medical attention is needed.

Complex chemical compounds needed by the body in minimal quantities. Traditionally, they are often prescribed to infants and young children, especially with artificial feeding and prematurity. Apparently, healthy children and well-nourished adults do not need vitamins. Small doses of vitamin supplements are harmless, but exceeding the recommended daily doses is fraught with danger.

Medications that lower blood glucose levels. For the treatment of diabetes mellitus, which cannot be compensated only by dietary nutrition and does not require the administration of insulin, hypoglycemic drugs can be used orally.

Possible side effects: loss of appetite, nausea, indigestion, numbness and tingling in the skin, fever, rash.

Warning: At very low glucose levels, weakness, dizziness, pallor, sweating, increased salivation, palpitations, irritability, and trembling can be observed. If these symptoms appear a few hours after eating, this may indicate that the dose is too high. Report symptoms to your doctor.

Chemicals produced by the endocrine glands (pituitary, thyroid, adrenals, ovaries/testes, pancreas, and parathyroids). In the absence of hormone release (which may be due to a number of diseases), they can be replaced with natural or synthetic hormones. See SEX HORMONES

Possible side effects: there may be an increase in secondary sexual characteristics. So, in men, when taking estrogens, there is an increase in the mammary glands, and androgens in women can lead to increased hair growth on the body and a coarsening of the voice. Estrogens affect blood clotting and therefore can cause angina, stroke, or thrombosis of the vessels of the legs.

Doses for children: In some cases, hormonal preparations are prescribed for children with diseases of the endocrine glands to prevent a deficiency of a hormone produced in the body. The most common is the lack of thyroid-stimulating hormone, growth hormone and insulin (diabetes). If a child needs maintenance therapy with any of these hormones, it is advisable to check the correct dosage with repeated blood tests.

Drugs that prevent or impair the body's normal response to disease or foreign tissue. They are used to treat autoimmune diseases (in which the body's defenses are violated and attack its own tissues). They are also used to prevent rejection of transplanted organs.

Possible side effects: susceptibility to infections (especially pulmonary, fungal diseases of the oral cavity and skin, viral diseases). Some immunosuppressants cause nausea, vomiting, and damage to the bone marrow, leading to anemia.

For the treatment and/or prevention of skin diseases (eg infections or irritations) there are a large number of creams, ointments, lotions. They usually consist of a base to which various active ingredients are added. The following are widely used: antiseptic ointments (containing preparations such as cetrimide) - to prevent suppuration; soothing protective ointments, such as those containing zinc and castor oil, to prevent and treat diaper rash, ANTIBIOTIC ointments to treat skin infections, such as impetigo; CORTICOSTEROID ointments; ANTIFUNG ointments; acne remedies; local anesthetics and itch-relieving ointments containing calamine; ANTIHISTAMINS or local anesthetics such as benzocaine.

Doses for children: When choosing an ointment for the treatment of skin diseases in a child, be sure to consult a doctor.

A group of anti-inflammatory drugs (see ANTI-INFLAMMATORY DRUGS), similar in composition to hormones produced by the adrenal glands, which provide the body's response to stress. Corticosteroids can be taken by mouth, injected, applied as an ointment to the skin, or used by inhalation. Inhaled corticosteroids (eg, beclomethasone) may be recommended when other bronchodilators have failed. With such therapy for short periods of time, side effects are negligible. Corticosteroids such as prednisolone and hydrocortisone are taken orally or by injection for acute conditions (shock, severe allergic reactions, severe asthma). Corticosteroids are used for long-term therapy of a number of inflammatory diseases. They do not cure, but, significantly weakening the phenomena of inflammation, sometimes help the body cope with the disease. Corticosteroids are used in the treatment of certain types of cancer, as well as to compensate for the deficiency of the body's own hormones.

Possible side effects: weight gain, redness of the face, irritation of the gastric mucosa, mental disorders, excessive hairiness.

Doses for children: When prescribing corticosteroids to children, careful monitoring is necessary, since the drugs have side effects. These include fluid retention with the formation of excess weight, moon-shaped face, growth retardation.

Hormones responsible for the formation of secondary sexual characteristics and the regulation of the menstrual cycle. There are two main types of hormonal drugs: estrogens and progestogens. Estrogens are used to treat breast or prostate cancer; progestogens are used to treat endometriosis. Sex hormones can be used in the form of tablets, injections, and also implanted into muscles.

Possible side effects: nausea, weight gain, headache, depression, breast enlargement and tenderness, rashes and changes in skin pigmentation, changes in sexual behavior, blood clotting disorders leading to heart disease.

Warning: Estrogens are not recommended for use in circulatory and hepatic disorders; in persons with jaundice; in diabetes, epilepsy, kidney and heart disease, estrogen therapy should be carefully monitored. Treatment with progestogens is contraindicated in persons with liver disease, and in patients with asthma, epilepsy, kidney and heart disease should be carefully monitored.

Hormones (the most powerful of them is testosterone) responsible for the development of secondary male sexual characteristics. In very small quantities are produced in women. As medicines, male sex hormones are used to compensate for hormonal deficiency with a decrease in pituitary function or testicular disease. They can also be used to treat breast cancer in women, but their synthetic ones are more preferable: anabolic steroids with less pronounced side effects, as well as specific antiestrogen. Anabolic steroids increase lean body mass, which has led to their illegal use in competitive sports in both women and men. Male sex hormones are used in the form of tablets, injections or implanted into the muscles.

Possible side effects: swelling, weight gain, weakness, loss of appetite, drowsiness, nausea. Large doses in women can lead to the cessation of menstruation, an increase in the size of the clitoris, a deepening of the voice, a decrease in the mammary glands, hairiness or male pattern baldness.

Although there is no cure for a cold, aspirin or paracetamol can be alleviated with plenty of fluids. The most effective for the treatment of colds are drugs containing both of these compounds. To reduce the common cold and facilitate nasal breathing, there are a large number of drugs containing ANTIHISTAMINS and VASCULAR SUBSTANCES. However, these drugs are not effective when taken by mouth; only at a very high dose can they have some effect, negligible compared to the side effects.

Possible side effects: drowsiness, dizziness, headache, nausea, vomiting, sweating, thirst, palpitations, difficulty urinating, weakness, trembling, restlessness, insomnia.

Warning: Remedies for the treatment of colds are contraindicated in patients with angina pectoris, hypertension, diabetes, thyroid disease, and those taking monoamine oxidase inhibitors. It is not recommended to drive a car and work with potentially dangerous mechanisms after taking products containing antihistamines.

Drugs to fight viral infections. There is no effective drug treatment for most viral infections (particularly influenza and respiratory infections). However, for severe colds caused by the herpes simplex virus, you can lubricate the skin with idoxuridine ointment immediately after the onset of symptoms. The same ointment is used to treat shingles. Another antiviral drug, acicolvir, is taken orally or as an injection, as well as an ointment to treat the most severe types of herpes infection.

Possible side effects: antiviral drugs used to treat colds, genital herpes, and shingles can cause burning sensations, rashes, and sometimes loss of skin sensation.

Means used to treat the inflammatory process, which is manifested by redness, fever, swelling, pain, increased blood flow and is observed in infections and many chronic non-communicable diseases (rheumatoid arthritis, gout). Three main groups of drugs are used as anti-inflammatory drugs: ANALGESICS (eg, aspirin), CORTICOSTEROIDS, and non-steroidal anti-inflammatory drugs (eg, indomethacin, used especially for diseases of the muscles and joints). Corticosteroids can be applied topically as ointments or eye drops for skin or eye disorders, but are not always indicated for chronic rheumatic diseases, except in special cases.

Possible side effects: rash, stomach irritation with occasional bleeding, hearing loss, difficulty breathing.

Doses for children: For the treatment of children, two main groups of drugs are used: corticosteroids and non-steroidal anti-inflammatory drugs. Commonly used drugs in the second group include aspirin (although it is now used with caution in children - see ANALGESICS), ibuprofen, and mefenamic acid. These drugs can cause transient constipation and quite often minor indigestion.

Means for the treatment of fungal diseases, such as ringworm, athlete's foot, thrush and fungal diaper rash. They are applied either directly to the skin or taken orally for a long time. The main antifungal drug is griseofulvin. For direct action on the skin, clotrimazole and miconazole are used.

Possible side effects: when taking antifungal drugs by mouth, nausea, vomiting, loose stools and / or headaches may occur. When applied topically, irritation sometimes occurs.

Drugs that suppress nausea and vomiting. Most of them also reduce dizziness. The main groups of medicines in this category include a number of ANTIHISTAMINS (especially for nausea caused by seasickness and ear diseases), antispasmodics and tranquilizers. Antiemetics can make diagnosis difficult, so they are usually not given unless the cause of the vomiting is clear or if the vomiting lasts less than a day (as in gastroenteritis). During pregnancy, antiemetic drugs are prescribed only in severe cases.

Possible side effects: depend on the group of drugs used. Prolonged treatment with some tranquilizers can lead to involuntary contractions of the facial muscles. Antiemetic drugs are only used for a few days.

Warning: Many antiemetics cause drowsiness, so alcohol should be avoided. Ask your doctor if you can drive a car or work with dangerous machinery in these cases.

Drugs used to prevent and treat epileptic seizures. Usually taken at least twice a day. To reduce side effects, it is necessary to carefully select an individual dose. To monitor the concentration of drugs in the blood, blood or saliva is examined. Drugs are usually taken for a long time, until 2-4 years pass without seizures.

Possible side effects: drowsiness, rash, dizziness, headache, nausea, swollen gums.

Doses for children: The most commonly used drugs for the treatment of children with grand mal seizures are phenytoin, sodium valproate, and carbamazepine. Side effects include drowsiness, gastrointestinal disturbances, rashes, increased hair growth, swollen lymph glands, changes in blood composition, and abnormal liver function. Less often, children are prescribed phenobarbital, which causes behavioral disorders. For the treatment of small seizures, during which the child's gaze is fixed in space and it seems that he does not see or hear anything, sodium valproate and ethosuximide are used.

Warning: Alcohol, like ANTIHISTAMINS, increases the chance and severity of side effects and should therefore be avoided. If you need to work with potentially dangerous mechanisms, you should consult a doctor.

Specially formulated powders and solutions containing glucose and the necessary mineral salts in certain quantities. When boiled water is added, these remedies can be used to prevent and treat dehydration due to diarrhea or vomiting. Rehydration powders and solutions are also used for home treatment of infants and older children. Similar solutions can be administered intravenously in a hospital setting.

Possible side effects: a feeling of "hangover", dizziness, dry mouth and (especially in the elderly) clumsiness and confusion.

Doses for children: Sleeping pills for adults are not used to treat insomnia in children. A child who constantly wakes up at night can be given ANTIHISTAMINS, which cause drowsiness. Older children may, on rare occasions, be given sedatives to promote sleep during periods of psychological stress.

Warning: Sleeping pills are addictive, so they should be taken for a short time and canceled gradually. After discontinuation of the drug for several weeks, there may be intermittent sleep that does not bring a sense of rest, accompanied by vivid dreams. Until the effects of sleeping pills completely disappear, you should not drive a car, work with dangerous machinery, or drink alcohol.

Possible side effects: dry mouth, palpitations, difficulty urinating, constipation, "veil" before the eyes.

Used to treat diarrhea. There are two main groups: adsorbing excess water and toxins in the intestines (contain kaolin, bismuth compounds, chalk or coal) and inhibiting bowel contractions, which contributes to the reduction of stool. The second group includes codeine, mixtures of opium.

Possible side effects: constipation.

Warning: Remedies for diarrhea relieve symptoms but do not treat the underlying cause. They can prolong the course of a toxic or infectious disease accompanied by diarrhea. You should not take these medicines for more than a day without seeking medical attention. Drink plenty of fluids when treating diarrhea (see also REHYDRATING MEDICINES).

Sometimes called sedative anxiolytics, or minor tranquilizers. Reduce the feeling of anxiety, cause muscle relaxation. They can be used as sleeping pills and to alleviate premenstrual mood changes.

Possible side effects: drowsiness, dizziness, confusion, unsteadiness, loss of coordination.

Doses for children: These drugs are rarely used in children. For convulsions, intravenous diazepam is used as an emergency remedy. More modern drugs may sometimes be given to older children suffering from psychological distress. Side effects: confusion, drowsiness. These drugs may be habit-forming.

Warning: These drugs should not be used if you intend to drive or operate potentially dangerous machinery. Sedatives often increase the effects of alcohol. You can get used to them, so they should not be used for a long time.

Agents that damage or destroy proliferating cells. They are used to treat cancer, as well as immunosuppressants. Available in the form of tablets and liquid for intramuscular and intravenous injection. Some drugs with different types of action can be used in combination.

Possible side effects: nausea, vomiting, hair loss.

Doses for children: Cytotoxic drugs are used to treat certain childhood cancers, particularly leukemia. Being potent drugs, they require the mandatory control of specialists who calculate the maximum effective dose that gives a minimum of side effects.

Warning: Because of their cytotoxic effects on both cancerous and healthy cells, these drugs have dangerous side effects, such as the ability to destroy bone marrow and interfere with blood cell production, causing anemia, increased susceptibility to infection, and bleeding. During treatment with cytotoxic agents, regular blood tests should be done.

Medicines

Medicines (drugs, drugs)- substances or their combinations that come into contact with the human or animal body, penetrate the organs, tissues of the human or animal body, used for prevention, diagnosis (with the exception of substances or their combinations that are not in contact with the human or animal body), treatment of a disease, rehabilitation, for the preservation, prevention or termination of pregnancy and obtained from blood, blood plasma, organs, tissues of the human or animal body, plants, minerals by synthesis methods or using biological technologies. Medicinal products include pharmaceutical substances and drugs.

original medicinal product- a medicinal product containing a pharmaceutical substance obtained for the first time or a new combination of pharmaceutical substances, the efficacy and safety of which have been confirmed by the results of preclinical studies of medicinal products and clinical trials of medicinal products

Source: Federal Law of the Russian Federation of April 12, 2010 N 61-FZ

Medicine, medicinal product, medication, medicine(novolat. praeparatum medicinale, praeparatum pharmaceuticum, medication;) - a substance or mixture of substances of synthetic or natural origin in the form of a dosage form (tablets, capsules, solutions, ointments, etc.) used for the prevention, diagnosis and treatment of diseases.

Before being used in medical practice, medicinal products must undergo clinical trials and receive approval for use.

Original medicines and generics

An original drug is a drug that was previously unknown and first released to the market by a developer or patent holder. As a rule, the development and marketing of a new drug is a very expensive and time-consuming process. Of the many known compounds, as well as newly synthesized ones, by enumeration, on the basis of databases on their properties and computer modeling of the proposed biological activity, substances with the maximum target activity are identified and synthesized. After animal experiments, in the case of a positive result, limited clinical trials are carried out on groups of volunteers. If the effectiveness is confirmed, and side effects are insignificant, the drug goes into production, and based on the results of additional tests, possible features of the action are clarified, undesirable effects are revealed. Often the most harmful side effects are found in clinical use. Currently, almost all new drugs are patented. The patent legislation of most countries provides for patent protection not only for the method of obtaining a new drug, but also for the patent protection of the drug itself.

In the Russian Federation, the term of a patent for an invention related to a medicinal product, the application of which requires obtaining a permit in accordance with the procedure established by law, is extended by the federal executive authority for intellectual property at the request of the patent holder for a period calculated from the date of filing an application for an invention until the date of receipt of the first such permission to use, minus five years. At the same time, the period for which the validity of a patent for an invention is extended cannot exceed five years. After the expiration of the patent, other manufacturers can reproduce and put on the market a similar drug (the so-called generic), if they prove the bioequivalence of the reproduced and original drugs. At the same time, the generic production technology can be any, but not subject to the existing patent protection in the country. Of course, the generic manufacturer cannot use the brand name for this drug, but only the international non-proprietary name (INN), or some new patented by him (synonym). Despite the new name in their medicinal action, the drugs can be similar or very close.

Are original drugs and generics completely equivalent? From the point of view of chemistry, the active substance is the same. But the production technology is different, different degrees of purification are possible. There are other factors as well. For example, it is known that for a long time different companies could not achieve the same effectiveness of acetylsalicylic acid (for a generic) as Bayer AG, the manufacturer of the original drug "aspirin". It turned out that the matter was not only in the purity of the raw materials, but also in a special method of crystallization, which resulted in special, smaller crystals of acetylsalicylic acid. There can be many such nuances. The opposite result is also possible, when the generic is more successful than the original medicine.