Pharmacology is a science that studies the effect of drugs on the human body and methods for obtaining new drugs. Also in Ancient Greece and in India, in the tundra and at the southernmost tip of Africa, people tried to find a way to combat the disease. This became, in a sense, their obsession, a dream worth striving for.

Pharmacological terminology

Medicines are substances or combinations thereof that are used to treat a disease or as a preventive measure.

A medicinal product is a medicinal product that is ready for use.

Exist various shapes medicines. This is done for ease of use and ability individual approach to the treatment of patients. In addition, due to the variety of release forms, the drug can be delivered to the body in several ways. This makes it easier to work with patients unconscious, as well as with people who have suffered injuries and burns.

List A and B

All medications are divided into three groups:

List A (poisons);

List B ( potent drugs, including analgesics);

Medicines available without a prescription.

Class A and B drugs require increased attention, therefore, to obtain them in a pharmacy network you need special recipe. In addition, you need to know where and how to properly store these medications. Since they may well decompose into sunlight or acquire additional toxic properties. And some drugs, such as morphine, are subject to strict reporting. Therefore, each ampoule is handed over by nurses at the end of the work shift and recorded in the appropriate journal. Some more are being registered medicines: antipsychotics, anesthesia drugs, vaccines.

Recipes

A prescription is a written request from a doctor to a pharmacist or pharmacist with a request to sell a medicine to a patient, indicating the form, dose and method and frequency of use. The form immediately performs the functions of a medical, legal and monetary document if medications are issued to the patient on a preferential basis or without payment.

There is a legislative act that regulates various specialties and positions held by doctors.

A medicine is not only a substance that can eliminate a disease or its manifestations, but also a poison, so the doctor must correctly indicate the dosage when writing a prescription.

Doses

It is written on the prescription form Arabic numerals quantity medicinal substance in mass or volumetric units of the decimal system. Whole grams are separated by a comma, for example 1.0. If the medicine contains drops, their quantity is indicated in Roman numerals. Some antibiotics are calculated in international (IU) or biological units (BI).

Medicines are substances that can be in solid, liquid or gaseous form. Liquids and gases in prescriptions are indicated in milliliters; in the case of inhalation, the doctor can only note the dose of dry medicine.

At the end of the prescription the signature and personal seal of the doctor is placed. In addition, the patient’s passport data, such as last name, initials, and age, is indicated. The date the prescription was issued and its validity period must be indicated. There are special forms for recording prescriptions for discounted medications, narcotic substances, sleeping pills, antipsychotics and painkillers. They are signed not only by the attending physician, but also chief physician hospital, certifies with its seal, and on top puts the round seal of the medical institution.

It is prohibited to prescribe ether for anesthesia, fentanyl, chloroethane, ketamine and other sedatives in the outpatient clinic. In most countries, prescriptions are written in Latin, and only recommendations for use are written in a language that the patient understands. For narcotic and toxic substances, the validity period of a sales permit is limited to five days, for medical alcohol- ten, the rest can be purchased within two months from the date of issuing the prescription.

General classification

In modern realities, when the most unusual medicines exist, classification is simply necessary in order to navigate their diversity. To do this, several conditional guides are used:

1. Therapeutic use - groups of drugs used to treat one disease are formed.
2. Pharmacological action is the effect that a medicine produces in the body.
3. Chemical structure.
4. Nosological principle. It is similar to therapeutic, only the distinction is even narrower.

Classification by groups

At the dawn of the development of medicine, doctors tried to systematize medicines themselves. The classification as such appeared through the efforts of chemists and pharmacists, compiled according to the principle of the point of application. It included the following categories:

1. Psychotropic drugs and those acting on the central nervous system drugs (tranquilizers, neuroleptics, sedatives, antidepressants, antiepileptics, anti-inflammatory).

2. Medicines acting on the peripheral nervous system (ganglionic blockers, anticholinergics)

3. Local anesthetics.

4. Drugs that change vascular tone.

5. Diuretics and choleretic agents.

6. Medicines affecting organs internal secretion and metabolism.

7. Antibiotics and antiseptics.

8. Antitumor medications.

9. Diagnostic agents (dyes, contrast agents, radionuclides).

This and similar divisions help young doctors better study existing drugs. Classification into groups helps to intuitively understand the mechanism of action of a particular drug and remember the dosage.

Classification by chemical structure

This sign is most suitable for the classification of antiseptic and antimicrobials. There are bactericidal and bacteriostatic drugs. The classification by covers both of these groups. The chemical structure of a substance reflects the mechanism of action of the drug and its name.

1. Halides. At their core they have chemical element halogen group: chlorine, fluorine, bromine, iodine. For example, antiformin, chloramine, pantocid, iodoform and others.
2. Oxidizing agents. It is not difficult to guess that their mechanism of action is aimed at the formation of a large amount of free oxygen. These include hydrogen peroxide, hydroperite, and potassium permanganate crystals.
3. Acids. They are used in medicine in large quantities. The most famous of them are salicylic and boric.
4. Alkalis: sodium borate, bicarmint, ammonia.
5. Aldehydes. The mechanism of action is based on the ability to remove water from tissues, making them more rigid. Representatives - formalin, formidron, lysoform, methenamine, urosal, ethyl alcohol.
6. Salts heavy metals: sublimate, mercury ointment, calomel, lapis, collargol, lead plaster, zinc oxide, Lassar paste, etc.
7. Phenols. They have an irritating and cauterizing effect. The most common of them are carbolic acid and Lysol.
8. Dyes. Used in diagnostic procedures and as a local irritant and antibacterial agent. These include methylene blue, brilliant green, fucorcin.
9. Tars and resins, for example, Vishnevsky balsam, ichthyol, paraffin, naphthalene, sulsen. Improves local blood supply to tissues.

Solid drugs

These drugs have the following representatives: tablets, dragees, powders, capsules and granules and other drugs. Determining the form of release is not difficult, since you can determine with the naked eye what exactly is in front of you.

Tablets are prepared by shaping a powder consisting of active substance and auxiliary. This is usually done under pressure.

Dragees are active and auxiliary substances arranged in layers, pressed around granules.

Powders have several uses. You can drink them, sprinkle them on wounds, dilute them with saline solution and inject intramuscularly or intravenously. There are non-dosed and dosed powders, which, in turn, are simple and complex.

Capsules are gelatin shells that contain liquid, granular, powder, or paste medication.

Granules are most often found in homeopathic medicines, have the appearance of small particles (no more than half a millimeter in size).

Liquid forms

This method of preparing the drug includes solutions, galenic and new galenic preparations, balms, collodions and other liquid and semi-liquid options.

Solutions are formed after mixing the drug and a solvent, such as water or alcohol.

They consist only of plant extracts obtained by heating.

Infusions and decoctions are prepared from dry plants. Each of these is written down on the prescription, including the amount of solvent the pharmacist should use.

Infusion and extract are, on the contrary, alcohol-containing liquids. They can be either pure, alcohol-based or alcohol-ether. New galenic preparations differ from conventional, galenic, high degree purification of raw materials and finished product.

Special forms of drugs

Balms are oily liquids that have deodorizing and antiseptic properties. Collodion is a solution of nitrocellulose with alcohol and ether in a one-to-six combination. For external use only. Creams have a semi-liquid consistency and contain plant extracts mixed with a base such as glycerin, wax, paraffin, etc. Lemonades and syrups are intended to make it easier for children to take medications. This helps to get people interested without any extra effort. little patient process of treatment.

Suitable for injection are sterile aqueous and oil solutions. They can be both simple and complex. When writing a prescription, always indicate the dose of the substance and the volume in one ampoule, as well as recommendations on where exactly the drug should be administered.

Soft forms

If fatty or fat-like substances are used as a base, soft medicines are obtained. Definition, classification, manufacturing process - all these issues are studied perfectly by chemists and pharmacists, but the doctor only needs to know the dose and indications for use.

So, ointments must contain at least twenty-five percent dry matter. The appropriate consistency can be achieved by mixing the powders with animal fat, wax, vegetable oils, Vaseline or polyethylene glycol. The same criteria apply to pastes, but they must be more viscous. Liniments, on the contrary, should be more liquid, and before use they need to be shaken so that the settled powder is evenly distributed within the solvent. Candles or suppositories have a solid form, but when they enter the body they quickly melt and become liquid. The patches are also solid at room temperature, but on the skin they melt and stick, forming a tight contact.

Medicines are substances primarily plant origin, which have undergone chemical or physical treatment so that the patient’s body absorbs them better.

Oral hypoglycemic drug

Active substance

Alogliptin

Release form, composition and packaging

yellow color, oval, biconvex, with ink inscriptions "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 oxide yellow dye - 0.06 mg, macrogol 8000 - trace amounts, gray ink F1 (shellac - 26%, black iron oxide dye - 10%, ethanol - 26%, butanol - 38%) - trace amounts.

Film-coated tablets light red, oval, biconvex, with ink inscriptions "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.

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

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

pharmachologic effect

A hypoglycemic drug, a potent and highly selective inhibitor of dipeptidyl peptidase-4 (DPP-4). Its selectivity for DPP-4 is more than 10,000 times greater than its selectivity for other related enzymes, including DPP-8 and DPP-9. DPP-4 is the main enzyme involved in the rapid destruction of the incretin family hormones: 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 production by the liver. 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 mellitus Type 2 with hyperglycemia, these changes in insulin and glucagon secretion lead to decreased concentrations 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 mellitus.

Suction

The absolute bioavailability of alogliptin is approximately 100%. Simultaneous use with food with high content fat did not affect the AUC of alogliptin, so it can be taken regardless of food intake. In healthy individuals, after a single oral dose of up to 800 mg of alogliptin, rapid absorption of the drug is observed, reaching an average Tmax in the range of 1 to 2 hours from the moment of administration.

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

Distribution

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

Neither healthy volunteers nor patients with type 2 diabetes mellitus experienced clinically significant accumulation of alogliptin after repeated dosing.

Metabolism

Alogliptin is not subject to extensive metabolism; 60 to 70% of alogliptin is excreted unchanged by the kidneys.

After oral administration of 14 C-labeled alogliptin, two main 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 revealed that CYP2D6 and CYP3A4 are involved in the limited metabolism of alogliptin.

Also, in vitro studies indicate that alogliptin does not induce CYP1A2, CYP2C9, CYP2B6 or inhibit CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, or CYP3A4 at concentrations achieved at the recommended dose of 25 mg alogliptin. In vitro, alogliptin may induce CYP3A4 to a small extent, but in vivo, alogliptin does not induce CYP3A4.

Alogliptin does not inhibit human renal transporters of organic anions 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, in vivo, undergoes little or no chiral conversion to the (S)-enantiomer. The (S)-enantiomer is not detected when alogliptin is taken in therapeutic doses.

Removal

After oral administration of 14 C-labeled alogliptin, 76% of the total radioactivity was excreted by the kidneys and 13% by 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 T1/2 is approximately 21 hours.

Pharmacokinetics in selected patient groups

Patients with renal failure. A study of alogliptin at a dose of 50 mg/day was conducted in patients with varying degrees of severity of chronic renal failure. Patients included in the study were divided into 4 groups according to the Cockroft-Gault formula: patients with mild (creatinine clearance from 50 to 80 ml/min), medium degree severity (creatinine clearance from 30 to 50 ml/min) and severe degree (creatinine clearance 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 failure increased approximately 1.7-fold compared to the control group. However, this increase in AUC was within the acceptable deviation for the control group, so dosage adjustment is not required in such patients.

An approximately 2-fold increase in the AUC of alogliptin compared to the control group was observed in patients with moderate renal failure. An approximately fourfold increase in AUC was observed in patients with severe renal impairment and in patients with end-stage chronic renal failure compared with controls. 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, to achieve therapeutic plasma concentrations of alogliptin similar to those in patients with normal renal function, dose adjustment is necessary in patients with moderate renal impairment. Alogliptin is not recommended for use in patients with severe renal failure, as well as with end-stage renal failure requiring hemodialysis.

Patients with liver failure. In patients with moderate hepatic impairment, the AUC and Cmax of alogliptin are reduced by approximately 10% and 8%, respectively, compared to patients with normal hepatic function. These values ​​are not clinically significant. Thus, dose adjustment of the drug for mild to moderate liver failure (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 liver failure (more than 9 points on the Child-Pugh scale).

Other patient groups. Age (65-81 years), gender, race, and body weight of patients did not have a clinically significant effect on the pharmacokinetic parameters of alogliptin. No dose adjustment is required.

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

Indications

Type 2 diabetes mellitus in adults to improve glycemic control when diet therapy and exercise are ineffective:

- as monotherapy;

- in combination with other oral hypoglycemic agents or insulin.

Contraindications

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

— diabetes mellitus type 1;

- diabetic ketoacidosis;

— chronic failure (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 use;

- severe renal failure;

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

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

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

Carefully:

- history of acute pancreatitis;

- in patients with moderate renal failure;

- in combination with a sulfonylurea derivative or insulin;

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

Dosage

Taken orally.

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 the patient misses a dose of Vipidia, he should take the missed dose as quickly 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 the three-component combination of Vipidia with metformin and thiazolidinedione. If hypoglycemia develops, it may be possible to consider reducing the dose of metformin or thiazolidinedione.

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

Patients with kidney failure

Patients with mild renal failure (creatinine clearance from >50 to ≤80 ml/min) do not require dose adjustment of Vipidia. In patients with moderate renal failure (creatinine clearance ≥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 impairment or in patients with end-stage renal disease requiring hemodialysis (HD).<30 мл/мин).

Patients with liver failure

No dose adjustment of Vipidia is required in patients with mild to moderate liver failure (from 5 to 9 points on the Child-Pugh scale). The drug has not been studied in patients with severe hepatic impairment (Child-Pugh score greater than 9), so it should not be used in this group of patients.

Patients over 65 years of age

No dose adjustment of Vipidia is required in patients over 65 years of age. However, the dose of alogliptin should be adjusted with particular care due to the potential for decreased renal function in this group of patients.

Side effects

Determination of 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 liver and biliary tract: frequency not established - liver dysfunction, incl. liver failure.

For 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 - upper respiratory tract infections, nasopharyngitis.

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

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 dialyzable. 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 with alogliptin.

Drug interactions

Effect of other drugs on alogliptin

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

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

Effect of alogliptin on other drugs

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. Interactions with CYP450 isoenzymes are not expected and have not been identified.

In vitro studies revealed that alogliptin is neither a substrate nor an inhibitor of OAT1, OAT3 and OCT2. In addition, clinical trial data do not indicate interactions with P-gp 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 cytochrome isoenzymes CYP1A2, CYP3A4, CYP2D6, CYP2C9, P-glycoprotein and OCT2.

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

When alogliptin was co-administered 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 the combination of pioglitazone (thiazolidinedione) with metformin when used simultaneously with Vipidia.

Unexplored combinations

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

Kidney failure

Because Patients with moderate renal failure require dose adjustment of Vipidia; it is recommended to assess renal function before starting and periodically during treatment.

Vipidia should not be used in patients with severe renal failure, 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 studies 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 1000 patient-years in each group, respectively. Patients should be informed of the characteristic symptoms of acute pancreatitis: persistent severe abdominal pain that may radiate to the back. If the development of acute pancreatitis is suspected, stop taking Vipidia; If acute pancreatitis is confirmed, the drug should not be 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, caution should be used when using the drug in patients with a history of pancreatitis.

Liver failure

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

Impact on the ability to drive vehicles and operate machinery

Vipidia does not have or has an insignificant effect on the ability to drive vehicles and machines. However, the risk of hypoglycemia should be taken into account when using the drug in combination with other hypoglycemic drugs (sulfonylurea derivatives, insulin or combination therapy with pioglitazone and metformin) and use caution when driving vehicles and machinery.

Pregnancy and lactation

There have been no studies of the use of alogliptin in pregnant women. Experimental studies in animals 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 unknown 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.

Use in childhood

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

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 impairment and patients with end-stage renal disease requiring hemodialysis (creatinine clearance from< 30 мл/мин).

Conditions for dispensing from pharmacies

The drug is available with a prescription.

Storage conditions and periods

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

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 that were obtained from raw meat, yeast and animal waste. Some medicinal substances are available in easily accessible form in plant or animal raw materials, and therefore medicine has successfully used since ancient times a large number of drugs of plant and animal origin (for example castor bean , opium , onion, known back in ancient Egypt; , known to the ancient Hindus; digitalis , lily of the valley , Adonis and many others, widely used traditional medicine) . Only with the development of chemistry did people become convinced that the therapeutic effect of such substances consists of selective effects 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 of scientific disciplines ( anatomy , physiology and especially chemistry) in the second half of the 19th century, firstly, they made it possible to synthesize a significant amount of substances that did not exist in a given combination or form, but had a therapeutic effect ( antipyrine , pyramidon, plasmacide, aspirin and hundreds of others), and, secondly, they made it possible to make scientific experiment the basis for studying the effects of drugs, as well as the search for new drugs. The experiment replaced the various scientifically unsubstantiated theories that had dominated until that time in treatment and medicine ( Paracelsus , Hahnemann and etc.) .

• 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 its distillation products, coal distillation products;
• inorganic minerals - mineral rocks and products of their processing by the chemical industry and metallurgy (metals);
• all kinds of organic compounds are products of the large chemical industry.

Studying

Quantitative indicators for a drug are established: a lethal dose (usually calculated per 1 kg of live weight of an animal or person), a tolerable (tolerable) dose and a therapeutic dose. Tolerable doses (or slightly less to be cautious) for many drugs are legislated as maximum doses. The ratio of the lethal dose to the therapeutic dose is called the “therapeutic index” of the drug, since the higher this ratio, the more freely the drug can be prescribed.

Action

The action of drugs is carried out mainly by changing the physicochemical properties of the environment in which the cellular elements of the body are located; in this case, the effect may have the nature of a chemical combination 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 their complete destruction. The physiological effect of the drug is either stimulation or inhibition of the vital activity of cellular elements; In this case, the dose of the medicinal substance plays a huge role, since the same medicine in different doses can cause different effects - excite in small doses and depress (up to paralysis) in large doses.

An important point is the phase of action of drugs: some drugs can manifest their effect at the moment of penetration into the body (phase of entry into Kravkov), others - the majority - during the period of maximum concentration in the body (saturation phase), others - at the moment of falling concentration (excretion phase); At the same time, the ability of some drugs to cumulation, manifested in a sharp increase and sometimes distortion of their action upon repeated administration, which is explained by the accumulation of the drug in the body and the accumulation of its effect.

The effect of the medicine depends on the age, gender, health status and individual characteristics of the body of the person taking it. A number of drugs in a correspondingly reduced dose have a much stronger effect on children than on adults (often poisonous); women during menses , pregnancy , lactation react to medications differently than usual; For some people, the medicine has an abnormally strong effect, which is explained by the body’s increased sensitivity to certain substances (see: Idiosyncrasy) .

Methods of application

External use of medicines is considered to be their application to the skin and mucous membranes eyes, nose, ears, oral cavity, genitourinary tract (to the point of entry into bladder and up to 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 in one form or another are eliminated from the body through the intestines, kidneys, respiratory tract, sweat glands, etc.

Prescription and over-the-counter drugs

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

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 for a legal entity, that is, a 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 “medicines” or as “medicines”. food products and supplements", or as "means alternative medicine" Currently, there is no established opinion of international organizations on this matter, agreed upon with national health authorities.

In the Russian Federation, homeopathic medicines are subject to the same legislative regulation as conventional medicines. In 2010, work began to review the status of certain types of drugs, in particular homeopathic drugs.

Legislative regulation in the Russian Federation

The state regulates the circulation of medicines quite strictly. The main document regulating the circulation of medicines for 2011 is the Federal Law of 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 basic law, subjects of drug circulation are subject to laws No. 3-FZ of 01/08/1998 “On narcotic drugs and psychotropic substances”, No. 2300-1 “On the protection of consumer rights”, No. 122-FZ of 08/02/1995 “On social services for elderly citizens and disabled people”, No. 128-FZ dated 08.08.2001 “On licensing of certain types of activities” and others.

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

The production of approved medicines must comply with the requirements of GOST, adopted in 2010. This GOST complies with the international standard GMP. All pharmaceutical enterprises in Russia are required to switch to the requirements of this GOST by 2014.

Sale of medicines (as opposed to biological active supplements) is carried out only by pharmacies ( pharmacies, pharmacy kiosks) with appropriate license.

The circulation of medicines is regulated by law and regulations, including regularly updating the list vital and essential drugs, and etc.

Tax law

In Ukraine there is a return practice excise duty for use alcohol in the production of medicines, but only after their sale.

State quality control bodies

Controls the quality of medicines in Russia Federal Service for supervision in the sphere of healthcare(Roszdravnadzor), subordinate Ministry of Health.

In most large cities of Russia there are quality control centers for medicines. Their main task is to check organizations selling medicines (compliance with numerous standards for the storage and sale of medicines), as well as selective (and in some regions, total) control of medicines. Based on data from regional centers, Roszdravnadzor makes decisions on rejecting a particular medicine.

Rejected and falsified medicines are subject to withdrawal from the pharmacy network; information about them is posted on the Roszdravnadzor website.

Trafficking in narcotic drugs

According to regulatory documentation, narcotic drugs are drugs and pharmaceutical substances containing narcotic drugs and included in 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 the following are related to medicinal products:

• List II - narcotic drugs and psychotropic substances, the circulation of which in the Russian Federation is limited and in respect of 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 in respect of which certain control measures may be excluded 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 drugs. All enterprises associated with the trafficking of narcotic and psychotropic substances are subject to mandatory licensing. Pharmacies, which have in their assortment medicinal products of lists II and III, are required to have licenses for the sale of each list.

The control state body of enterprises related to the circulation of narcotic drugs, in addition to Roszdravnadzor, is Federal Service of the Russian Federation for control of drug traffic. Since many doctors fear the development of drug dependence in patients and psychologically do not accept it, due to confusing, as well as contradictory and frequently changing legislation, doctors are wary of prescribing narcotic drugs even to those people who need it.

Original medicines, synonyms, “generics” and analogues

Original A drug is a drug that was previously unknown and first released onto the market by the developer or patent holder. As a rule, the development and marketing of a new drug is a very expensive and lengthy process. From a variety of known compounds, as well as newly synthesized ones, substances with maximum target activity are identified and synthesized using the brute force method, based on databases of their properties and computer modeling of their expected biological activity. After animal experiments, in case of a positive result, limited clinical trials are carried out on groups of volunteers. If the effectiveness is confirmed and the side effects are insignificant, the medicine goes into production, and based on the results of additional tests, possible features of the action are clarified and undesirable effects are identified. Often the most harmful side effects are revealed during clinical use.

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

From a chemical point of view active substance original medicine and generic the same thing, but the production technology is different, different degrees of purification are possible. There are other factors that influence the effectiveness of the drug. For example, for a long time different firms could not achieve the same efficiency acetylsalicylic acid for generics, like the company Bayer- manufacturer of the original drug " aspirin" It turned out that the matter is not only in the purity of the raw materials, but also in the special method of crystallization, which results in special, smaller crystals. The opposite result is also possible, when the generic drug turns out to be more successful than the original medicine.

Analogue- a medicine based on substances excellent from that used in the compared original and therefore with another INN. Therefore, if the selection of a synonym or generic is the prerogative

What does the word medicine mean?

Thank you

All people, without exception, encounter one or another pathological condition. And it doesn’t matter what kind of disease we are talking about. In this case, the person may have either the most banal headache or a terrible illness called cancer or such a common pathology as diabetes mellitus. When any pathological condition develops, we immediately rush to purchase one or another medication, hoping that it will help us cope with the existing illness, and in a fairly short period of time.
Do you know what the word medications actually means? No?
Read this article.

Definition of the concept

Historical facts

Our ancestors tried to heal from various ailments using various substances of exclusively natural origin. In most cases these were plant extracts.
Some ancient healers also invented drugs that could be obtained from animal waste, raw meat or yeast. Even then, people realized that in many living organisms there is an accumulation of certain components that can help overcome various pathologies. A little later, scientists were able to establish that the effect of such components lies in the selective effect of various chemical compounds on the human body. A few years later, they learned how to obtain such compounds in laboratories by synthesis. Already in 1891, the German chemist and bacteriologist Paul Ehrlich developed the theory of using such compounds to treat infectious diseases.

Existing classifications

• pharmacological action: in this case we are talking about the therapeutic effects that certain drugs tend to have. So, for example, analgesics help reduce pain irritation, but vasodilators tend to dilate blood vessels;
• nosological principle: a list of various medicines that are used to treat a strictly defined disease. This can be either bronchial asthma or myocardial infarction, angina pectoris, etc.;
• therapeutic use: let's say drugs for the treatment of malignant neoplasms, antimicrobial agents or medications to lower blood pressure;
• chemical structure: This group includes medications that are similar in structure. These are salicylates, the main component of which is acetylsalicylic acid. The list of salicylates includes both aspirin and methyl salicylate, as well as salicylamide, etc.

• synthetic: they are obtained by chemical synthesis;
• mineral: they are obtained from mineral compounds such as silver nitrate and magnesium sulfate;
• natural: They are made from plant extracts, as well as animal tissues and organs.

Dose and concentration

Routes of administration

The list of enteral routes includes:

• oral ( inside);
• rectal ( into the rectum);
• sublingual ( under the tongue);
• buccal ( by the cheek);
• through a probe into the duodenum.

• subcutaneous;
• inhalation;
• intravenous;
• subarachnoid ( under the membranes of the brain);
• intramuscular;
• intraperitoneal;
• intra-arterial;
• intranasal ( through the nose);
• intrasternal ( into the sternum);
• transdermal ( into the pleural cavity, into the body, urethra, cervix, etc.).

Types of action

2. resorptive effect: observed after absorption of the drug into the blood and is characterized by the interaction of its components with tissues and organs;
3. direct action: represents the direct effect of a chemical on a target organ. This action is primary in all cases. A manifestation of the direct action of drugs is considered to be a selective action, during which the therapeutic effect is exerted on a limited group of cells or organs;
4. reversible and irreversible actions: if the changes resulting from the action of the drug disappear without a trace after a certain period of time, then we are talking about a reversible effect. If this does not happen, then the effect on the face is irreversible. An irreversible effect in most cases is observed when dosages or concentrations are exceeded, in case of individual intolerance to the drug by the body, as well as with prolonged use.

Prescription and over-the-counter drugs

The list of medicines that are allowed to be dispensed without a prescription is established by order of the Ministry of Health. This is done for a reason. The thing is that both irrational use and uncontrolled use of certain drugs can have a detrimental effect on the general health of people. Dispensing some drugs without a prescription can lead to distribution and addiction.

Best before date

Storage Features

Concerning drugs of the first group, which are represented by poisonous and narcotic drugs, they must be stored in a safe locked with a separate lock.

Drugs of the second group containing potent medications should be stored in locked medical cabinets.

Medical drugs of the third group, which can be dispensed without a prescription, may be stored in open cabinets.

The patient's course of therapy depends on the correct storage of medications. If the rules are violated for any reason, this may lead to a decrease in the therapeutic effect of a particular drug. In some cases, improper storage causes a person to feel even worse after a course of therapy with one or another drug.

First Aid Medicines

And here is a list of well-known medicines that must be present in every home medicine cabinet:

• Suprastin: taken for allergic reactions;
• Loperamide: treats acute and chronic diarrhea;
• Validol: used for hysteria, neurosis and angina;
• Paracetamol or Aspirin: has antipyretic, analgesic and anti-inflammatory effects;
• Analgin or Pentalgin: taken for headaches, toothaches, fever, pain syndrome, pain from injuries or burns;
• Valocordin: neuroses with increased irritability, tachycardia and insomnia;
• Donormil or Phenazepam: sleeping pills;
• Activated carbon: used for food intoxication, diarrhea, allergic diseases, poisoning with chemical compounds or salts of heavy metals, alcohol withdrawal syndrome. It is recommended to take this drug at the rate of 1 tablet per 5 – 10 kg of weight;
• Albucid: 20% eye drops endowed with bacteriostatic and antimicrobial effects, which can be used to treat both conjunctivitis and blepharitis ( inflammation of the eyelid margins), as well as some other eye pathologies. They can also be instilled as a preventive measure when a foreign body such as dirt or sand gets into the eyes;
• Phthalazole: an antimicrobial drug used for the treatment of enterocolitis, dysentery, gastroenteritis, colitis and other pathologies of the gastrointestinal tract of an infectious-inflammatory nature.

Free medications for pregnant women

How to get such medicines?
First of all, you need to make an appointment with an obstetrician-gynecologist, who will examine you and write a prescription for free medications. With this prescription, you go to a pharmacy that has an agreement with a medical institution to provide free services to expectant mothers, and receive the medicine you need. Everything is quite easy and simple.

Free medications for children under 1 year of age

This same drug can also cause Reye's syndrome, which is characterized by acute hepatic encephalopathy.
Against the background of this pathology, damage occurs to both internal organs and the central nervous system. This syndrome is very rare in medical practice, but no parent can know in advance whether their child is predisposed to it or not. Given this fact, it is best not to give aspirin to children under 12 years of age. The list of drugs that are strictly prohibited for use at elevated temperatures includes phenazone, analgin, and pyramidon. These drugs are best replaced with ibuprofen or paracetamol. Other prohibited drugs for children are considered to be boric alcohol and chloramphenicol, which are intended for the treatment of otitis media. Some mothers still treat ear diseases with alcohol preparations. In fact, such treatment is at least unwise, since these drugs can provoke the development of a burn.

Various painkillers for abdominal pain are also contraindicated for children. Complaints of abdominal pain may indicate both the most common indigestion and appendicitis. Self-medication in such cases is unacceptable. By giving your baby a painkiller, you will only eliminate the pain, but the problem will still remain unresolved. In such cases, the best way out of the situation is to call emergency doctors to your home. In case of diarrhea, it is strictly forbidden to give fixative medications. If diarrhea occurs due to infection, taking such drugs will only worsen the general situation.

Antibiotics, which are used without the prescription of a specialist, are also considered prohibited drugs for children. Each antibiotic is a strong medicine, the irrational use of which can cause the development of various side effects and complications. Hormonal pills and homeopathic medicines are also prohibited from being given to children, since all these drugs can have an unpredictable effect on the growing body.

Remember once and for all - never treat your child with strong pharmaceuticals yourself and do not use the methods that your neighbor used. If this or that medicine helped your neighbor’s child, it is not a fact that your baby’s body will react to it the same way.

Allergy to drugs

With the development of a drug allergy, the patient may complain of diarrhea, difficulty breathing, vomiting, nausea, runny nose, conjunctivitis, tissue swelling, burning, etc. Repeated use of the drug that provoked the development of such a reaction will only increase the severity of its manifestation. Drug allergies are often classified as side effects that develop extremely rarely. Patients often confuse the side effects of the drug, which most often manifest themselves in a mild form, with an allergic reaction, which can even result in the death of the patient.

Diagnosis and treatment of drug allergies

To diagnose such immediate reactions, skin tests are often taken from patients. As for the direct treatment of drug allergies, it most often involves the treatment of pain and itching. If the medicine that causes an allergic reaction is vital and cannot be stopped, then patients will have to put up with all the unpleasant symptoms that they experience.

Weight loss medications and their side effects

If we talk directly about the medications that are used in the fight against obesity, then all of them involve, first of all, appetite suppression. Such medications are sold both in tablet and capsule form. By influencing the body, they seem to deceive it, as a result of which a person does not experience hunger. They also tend to reduce appetite by increasing the amount of catecholamines - chemical components of the brain that have a direct effect on both appetite and mood. Fat absorption inhibitors, which are part of such pharmaceuticals, prevent the absorption of fats that enter the body along with food. Undigested fat is, in turn, excreted from the body through feces.

It is also important to note the fact that these medications tend to cause the development of various side effects.

The list of adverse reactions can include:

• insomnia;
• anxiety;
• headache;
• increased sweating;
• increased heart rate;
• dry mouth;
• increased blood pressure;
• nasal congestion;
• excessive thirst;
• drowsiness;
• cramping abdominal pain;

Drugs for the treatment of psoriasis

Biologics are another group of medications that are increasingly used in the fight against this disease. Biologics are medications that resemble or are identical to proteins produced by the human body. The list of such drugs includes etanercept and alefacept, which tend to block the negative reaction of the human immune system, which causes signs of this pathology.

If topical medications do not have the desired therapeutic effect, then patients are prescribed medications that should be taken orally. These drugs include methotrexate, cyclosporine and retinoids such as acitretin.

Drug treatment of gout

Arcoxia is a non-steroidal anti-inflammatory drug that can also be used to treat this disease. This drug also has analgesic and antipyretic effects.

Ambene - this drug is intended for short-term treatment of critical situations with gout.

Drugs for the treatment of spinal osteochondrosis

• reduce the severity of pain in the back;
• eliminate inflammation;
• restore regeneration of cartilage and connective tissue of the intervertebral disc;
• prevent further development of the disease;
• functionally rehabilitate the patient.

Often, the course of therapy includes the use of antidepressants, such as fluoxetine or amitriptyline. The thing is that such drugs tend not only to balance the psyche, but also to have a fairly pronounced analgesic effect. Studies have shown that it is with the help of antidepressants that it is possible to achieve better control over pain and significantly shorten the course of therapy.

Medicines to improve memory

Another fairly well-known drug that is used directly to improve memory is a medication called glycine. This drug is available only in tablet form, but in terms of effectiveness it is in no way inferior to nootropil. With its help, it is possible to reduce irritability and aggressiveness, normalize sleep, make it easier to fall asleep, as well as increase performance and significantly improve memory. As for side effects, only allergic reactions can develop against the background of its use.

Akatinol memantine is also considered to be a very effective means of improving memory, which tends to improve the process of nerve impulse transmission, normalize membrane potential and increase learning ability. This medicine is produced in the form of tablets, the active components of which are absorbed into the blood in a fairly short period of time.

Medicines to relieve alcohol dependence

Veritrol is one of the newest drugs that helps even when previous treatment for alcoholism, for one reason or another, did not have the desired therapeutic effect. This drug is recommended to be administered in two doses, the interval between which is about half an hour. After such a procedure, the patient will need to take Finlepsin and Lucetam for a month. This approach makes it possible to enhance the effectiveness of encoding and minimize the craving for alcoholic beverages.

All of the above drugs have one common property. If a patient coded with one of these drugs begins to drink alcohol, then the drug forms a toxic compound with alcohol, which endangers both the organs and systems of the body, and sometimes even the life of the patient.