Lanzid® Kit (Lancid® Kit)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Dosage form: & nbsptablets and capsules set
Composition:

CLARITHROMYCIN, film-coated tablets, 500 mg:

One tablet, film-coated, contains:

active substance: clarithromycin 500 mg;

Excipients: cellulose microcrystalline 31.5 mg, corn starch 8.9 mg, sorbic acid 1.1 mg, sorbitan oleate 2 mg, povidone 30 mg, silicon dioxide colloid 8 mg, magnesium stearate 11 mg, talc 24 mg, croscarmellose sodium 55 mg, stearic acid 20 mg;

film coating: hypromellose 20.65 mg, titanium dioxide (E171) 4.75 mg, propylene glycol 3.2 mg, dye quinoline yellow (E104) 0.195 mg, vanilla flavor 1.2 mg.

Amoxicillin, capsules, 500 mg:

One capsule contains:

active substance: amoxicillin 500 mg (in the form of amoxicillin trihydrate 588 mg);

Excipients: magnesium stearate 5 mg, talc 8 mg, sodium lauryl sulfate 3 mg;

composition of the capsule shell: cap - propyl parahydroxybenzoate 0.2 mg, methyl parahydroxybenzoate 0.8 mg, water 14-15 mg, gelatin qs, titanium dioxide (E171) 0.8132 mg, blue diamond dye (E133) 0.0062 mg, dye sunset yellow (E110) 0.0495 mg; housing: propyl parahydroxybenzoate 0.2 mg, methyl parahydroxybenzoate 0.8 mg, water 14-15 mg, gelatin q.s., titanium dioxide (E171) 1.6266 mg, iron oxide yellow oxide (E172) 0.9999 mg;

black ink composition: ethanol 29-33%, isopropanol 9-12%, butanol 4-7%, shellac 24-28%, iron dye black oxide (E172) 24-28%, ammonia water 1-3%, propylene glycol 0.5-2% .

Lansoprazole, enteric-solution capsules, 30 mg:

One capsule is enteric-soluble:

active substance: lansoprazole 30 mg;

Excipients: mannitol 41.11 mg, sucrose 123.22 mg, povidone 1.09 mg, sucrose microspheres 38.19 mg, sodium hydrogen phosphate 2.08 mg, carmellose calcium 10.41 mg, magnesium hydroxycarbonate 5.3 mg, polysorbate 80 0 , 99 mg, hypromellose 25.58 mg, titanium dioxide (E171) 2.19 mg, methylacrylic acid copolymer (type A) 65.78 mg, talc 8.77 mg, diethyl phthalate 8.11 mg, sodium hydroxide 0.44 mg ;

Capsule shell composition: body - gelatin 38.9575 mg, sodium lauryl sulfate 0.0376 mg, propyl parahydroxybenzoate 0.376 mg, methyl parahydroxybenzoate 0.094 mg, titanium dioxide (E171) 0.712 mg, crimson dye [Ponso 4R] (E124) 0.0078 mg, water 6.815 mg; cap - gelatin 24,0376 mg, sodium lauryl sulfate 0.0232 mg, propyl parahydroxybenzoate 0.058 mg, methyl parahydroxybenzoate 0.232 mg, titanium dioxide (E171) 0.4393 mg, dye crimson [Ponso 4R] (E124) 0.0048 mg, water 4.205 mg;

black ink composition: Ethanol 29-33%, isopropanol 9-12%, butanol 4-7%, shellac 24-28%, iron dye oxide black (E172) 24-28%, Ammonia water 1-3%, propylene glycol 0.5-2%.

Description:

CLARITHROMYCIN, film-coated tablets, 500 mg:

Yellow, film-coated tablets, oval, with a risk on one side. The color of the tablets at the break is white.

Amoxicillin, capsules, 500 mg:

Hard gelatin capsules; the case is yellow, the lid is dark red; on the body there is an inscription "500", on the cap there is an inscription "AMOXI", Executed in black ink. The size of the capsule is No. 0. The contents of the capsule are crystalline powder of white or almost white color.

Lansoprazole, enteric-solution capsules, 30 mg:

Hard gelatin capsules No. 1 with a pink-colored case and lid and an inscription in black "MICRO/MICRO"The contents of capsules are pellets of white or almost white color.

Pharmacotherapeutic group:Peptic ulcer treatment
ATX: & nbsp
  • Lansoprazole, amoxicillin and clarithromycin
    • Pharmacodynamics:

    Triple therapy, which includes clarithromycin, amoxicillin and lansoprazole, allows you to achieve a high percentage of eradication Helicobacter pylori (85-94%).

    Clarithromycin - a bacteriostatic antibiotic from the macrolide group, a semisynthetic derivative of erythromycin A. The antibacterial effect of clarithromycin is due to binding 50S subunit membrane ribosome microbial cells and suppression of protein synthesis of microorganisms. It is highly effective against many aerobic and anaerobic Gram-positive and Gram-negative microorganisms, including Helicobacter pylori. The metabolite formed in the body 14 (R) -hydroxyclarithromycin also has a pronounced antimicrobial activity.

    Amoxicillin - semi-synthetic penicillin, has a bactericidal action, has a wide range of action. It inhibits transpeptidase, breaks the synthesis of peptidoglycan (the supporting protein of the cell wall) in the period of division and growth, causes bacterial lysis. Has a pronounced activity in relation to Helicobacter pylori. Resistance Helicobacter pylori to amoxicillin is rare. The combination of amoxicillin and clarithromycin has a potentiated antimicrobial effect in relation to Helicobacter pylori.

    Lansoprazole is a specific inhibitor of the proton pump (H+/TO+-ATPase); is metabolized in parietal cells of the stomach to active sulfonamide derivatives that inactivate H+/TO+-ATP-ase. It blocks the final stage of hydrochloric acid secretion, reducing basal and stimulated secretion, regardless of the nature of the stimulus.Possessing high lipophilicity, it easily penetrates into the parietal cells of the stomach, concentrates in them and has a cytoprotective effect, increasing oxygenation of the gastric mucosa and increasing the secretion of bicarbonate. The rate and extent of inhibition of basal and stimulated hydrochloric acid secretion are dose-dependent: the pH begins to rise in 1-2 hours and 2-3 hours after administration of 15 mg and 30 mg of lansoprazole, respectively; inhibition of production of hydrochloric acid at a dose of 30 mg is 80-97%. Does not affect the motility of the gastrointestinal tract. Inhibitory effect increases in the first 4 days of lansoprazole. After discontinuation, acidity for 39 hours remains below 50% basal level; "ricochet" increase in secretion is not noted. Secretory activity is normalized 3-4 days after the end of the drug intake. In patients with Zollinger-Ellison syndrome, it is more prolonged. Promotes the formation of gastric mucosa specific IgA to Helicobacter pylori, suppressing their growth, increases the anti-Helicobacter activity of other drugs. Increases the concentration of pepsinogen in the blood plasma and inhibits the production of pepsin.Oppression of secretion is accompanied by an increase in the number of nitrosobacteria and an increase in the concentration of nitrates in the gastric secretion. Lansoprazole is effective in the treatment of stomach ulcer and duodenal ulcer resistant to blockers H2-gistaminovyh receptors. Provides faster healing of ulcerative defects in the duodenum (85% of duodenal ulcers heal after 4 weeks of treatment at a dose of 30 mg / day).

    Pharmacokinetics:

    Clarithromycin

    Ingestion clarithromycin quickly and well absorbed. Absolute bioavailability is about 50%. Food slows down absorption, without significantly affecting bioavailability. With repeated intake of cumulation drug is not found, and the nature of metabolism in the human body does not change. The connection with blood plasma proteins is about 80%. After a single dose, 2 peaks of maximum concentration (CmOh). The second peak is due to the ability of clarithromycin to accumulate in the gallbladder, followed by a gradual or rapid intake into the intestine and absorption. Time to reach the maximum concentration (TCmOh) with a single administration of 500 mg of clarithromycin - 2-3 hours.

    Clarithromycin is metabolized in the cytochrome P450 system with the participation of isoenzyme CYP3A, is an inhibitor of isoenzymes CYP3A4, CYP3A5, CYP3A7. After oral administration, 20% of the dose is rapidly hydroxylated in the liver to form the main metabolite - 14 (R) -hydroxyclamirithromycin.

    At equilibrium, the concentration of 14 (R) -hydroxyclarithromycin does not increase in proportion to the doses of clarithromycin, and the half-life (T1/2) of clarithromycin and its main metabolite increase with increasing dose. The non-linear nature of the pharmacokinetics of clarithromycin is associated with a decrease in education

    14(R) -hydroxyclamirithromycin and N-detylated metabolites when higher doses are used, which indicates the non-linearity of clarithromycin metabolism when taken in high doses.

    With a regular intake of 500 mg / day, the equilibrium concentrations (Css) unchanged drug and its main metabolite in blood plasma - 2.7-2.9 μg / ml and 0.83-0.88 μg / ml, respectively; half-life (T1/2) - 4.8-5 hours and 6.9-8.7 hours respectively. In therapeutic concentrations, it accumulates in the lungs, skin and soft tissues (concentrations 10 times higher than in blood plasma).

    Excreted by the kidneys and intestines (20-30% - in unchanged form, the rest - in the form of metabolites).

    Amoxicillin

    Absorption is fast, high. Eating does not affect absorption. Does not degrade in the acidic environment of the stomach. Absolute bioavailability of amoxicillin is dose dependent and ranges from 75% to 90%. As a result of oral administration of amoxicillin in a single dose of 500 mg, the concentration of the drug in the blood plasma is 6-11 mg / l. Time to reach the maximum concentration (TCmOh) - 1-2 hours. The connection with plasma proteins is 17%.

    Passes histohematological barriers, except for unchanged blood-brain; has a large volume of distribution: in high concentrations found in blood plasma, sputum, bronchial secretions (in purulent bronchial secretions distribution weak), pleural and peritoneal fluid, urine, content of skin blisters, lung tissue, the intestinal mucosa, the female genital organs, prostate , fluid of the middle ear (with its inflammation), bone, adipose tissue, gall bladder (with normal liver function). Amoxicillin penetrates the placenta and in small amounts is found in breast milk. With increasing dose, the concentration in organs and tissues increases proportionally.Concentration in the bile is 2-4 times higher than the concentration in the blood plasma. In amniotic fluid and vessels of the umbilical cord, the concentration of amoxicillin is 25-30% of the concentration in the blood plasma of a pregnant woman. Poor penetration of the blood-brain barrier, with inflammation of the meninges (meningitis), the concentration of amoxicillin in the cerebrospinal fluid is about 20% of the level in the blood plasma.

    About 7-25% of the dose is metabolized with the formation of inactive penicillic acid.

    The half-life (T1/2) is 1-1.5 hours. It is excreted by 50-70% kidneys in unchanged form by tubular secretion (80%) and glomerular filtration (20%), liver - 10-20%. In small amounts excreted in breast milk. If the kidney function is impaired (creatinine clearance <15 ml / min), the elimination half-life increases to 5-20 hours. Amoxicillin is removed during hemodialysis.

    Lansoprazole

    Absorption is high, bioavailability is 80-90%; food intake reduces absorption and bioavailability (by 50%), but the inhibitory effect on gastric secretion remains the same regardless of food intake. With cirrhosis of the liver, absorption may be delayed.

    Such indicators of pharmacokinetics lansoprazole a, as the maximum concentration in the blood plasma (CmOh) and the area under the concentration-time curve (AUC) are approximately proportional. If the drug is taken 30 minutes after eating, both pharmacokinetic indicators are reduced by 50%.

    Food does not have any significant effect if the drug is taken before meals. Connection with blood plasma proteins - 97%; in patients with impaired renal function, binding can be reduced by 1-1.5%. Time to reach the maximum concentration (TCmOh) after oral intake of 30 mg - 1,5-2,0 hours, the maximum concentration (CmOh) - 0,75-1,15 mg / l. Lansoprazole well penetrates into tissues, including in the lining cells of the stomach. The volume of distribution is 0.5 l / kg.

    It is actively metabolized at the "first passage" through the liver with the participation of the isoenzyme CYP2C19. Isozyme CYP3A4 can also participate in metabolism. In significant amounts in the blood plasma, two metabolites (sulfinyl hydroxide and sulfone derivative) are found which are inactive. In the acidic environment of the tubules of parietal cells lansoprazole is transformed into 2 active substances, but not detectable in the systemic blood stream.

    The beginning of the action.After the first dose of lansoprazole at a dose of 30 mg, the pH of the gastric juice increases after 1-2 hours. When taking the drug several times a day (30 mg each), the pH of the gastric juice is increased in the first hour after administration.

    The duration of the action is more than 24 hours. Restoration of the level of secretion of hydrochloric acid to normal occurs gradually in the period from 2 to 4 days after taking several doses of the drug.

    The half-life (T1/2) - 1-2 hours, in elderly patients - 1.9-2.9 hours, with a violation of liver function - 3.2-7.2 hours.

    It is excreted from the body in the form of lansoprazole sulfone and hydroxylansoprazole with bile (2/3), kidneys - 14-23% (renal failure for speed and clearance is not significantly affected).

    Indications:

    Stomach ulcer and duodenal ulcer (treatment and eradication therapy of infection Helicobacter pylori).

    Contraindications:

    Hypersensitivity to any component of drugs (the main substance and / or auxiliary components), to macrolides, to penicillins, cephalosporins, carbapenems; simultaneous reception of clarithromycin with the following drugs: astemizole, cisapride, pimozide, terfenadine; with ergot alkaloids, for example, ergotamine,dihydroergotamine; with midazolam for oral administration; with inhibitors of HMG-CoA reductase (statins), which are largely metabolized by the isoenzyme CYP3A4 (lovastatin, simvastatin), due to the increased risk of myopathy, including rhabdomyolysis; with colchicine in patients with impaired liver and kidney function; patients with a history of lengthening the interval QT, ventricular arrhythmia or ventricular tachycardia of the "pirouette" type; patients with hypokalemia (risk of lengthening the interval QT); patients with severe hepatic insufficiency, which occurs simultaneously with renal insufficiency; patients with cholestatic jaundice / hepatitis in history, developed with the use of clarithromycin; with porphyria; in the period of breastfeeding and pregnancy; patients with atopic dermatitis, bronchial asthma, pollinosis, infectious mononucleosis, lymphocytic leukemia, liver failure, history of gastrointestinal disease (especially colitis associated with the use of antibiotics), children under 18 years of age, with a deficiency of sugar / isomaltase, intolerance to fructose, glucose- galactose malabsorption.

    Carefully:

    Renal failure of medium and severe degree, hepatic insufficiency of moderate and severe degree, myasthenia gravis gravis (possibly increased symptoms), simultaneous use with drugs that are metabolized by the isoenzyme CYP3A (eg, carbamazepine, cilostazol, ciclosporin, disopyramide, methylprednisolone, omeprazole, indirect anticoagulants (for example, warfarin), quinidine, rifabutin, sildenafil, tacrolimus, vinblastine); simultaneous reception with drugs that induce isoenzyme CYP3A4 (e.g., rifampicin, phenytoin, carbamazepine, phenobarbital, St. John's wort pitted); simultaneous administration with benzodiazepines, such as alprazolam, triazolam, midazolam for intravenous use; simultaneous reception with calcium channel blockers, which are metabolized by isoenzyme CYP3A4 (e.g., verapamil, amlodipine, diltiazem); patients with coronary heart disease (CHD), severe heart failure, hypomagnesemia, severe bradycardia (less than 50 beats per minute), as well as patients taking antiarrhythmic drugs at the same time IA class (quinidine, procainamide) and III class (dofetilide, amiodarone, sotalol), elderly age, history of bleeding, allergic reactions (including history), concomitant therapy with clopidogrel.

    Pregnancy and lactation:

    The drug Lantis® Kit is contraindicated in pregnancy and during breastfeeding.

    Dosing and Administration:

    Inside. Take 500 mg (1 tablet) of clarithromycin, 1000 mg of amoxicillin (2 capsules) and 30 mg of lansoprazole (1 capsule), twice daily in the morning and evening before meals. Tablets and capsules can not be broken and chewed, they should be swallowed whole.

    Duration of treatment 7 days, if necessary, can be increased to 14 days.

    Each blister of the drug Lanzid® Kit contains two tablets of clarithromycin (500 mg), four capsules of amoxicillin (500 mg) and 2 capsules of lansoprazole (30 mg) and is calculated for one day of treatment. One package contains 7 blisters and is designed for one course of treatment.

    Side effects:

    The following undesirable phenomena are distributed according to the frequency of occurrence in accordance with the following gradation: very often (≥ 1/10), often (from ≥ 1/100 to <1/10), infrequently (from ≥ 1/1000 to <1/100) , rarely (from ≥ 1/10000 to <1/1000), very rarely (<1/10000).

    Clarithromycin

    Infectious and parasitic diseases: infrequently - candidiasis, gastroenteritis, development of superinfection (with prolonged or repeated use of clarithromycin), vaginal infections; frequency unknown - pseudomembranous colitis, erysipelas, erythrasma.

    Violations of the blood and lymphatic system: infrequently - leukopenia, neutropenia, thrombocythemia, eosinophilia; frequency unknown - agranulocytosis, thrombocytopenia.

    Immune system disorders: infrequently - hypersensitivity; frequency unknown - anaphylactic reactions.

    Disorders from the metabolism and nutrition: infrequently - anorexia, decreased appetite; the frequency is unknown - hypoglycemia (including the simultaneous use of hypoglycemic drugs).

    Disorders of the psyche: often - insomnia; infrequently - anxiety, nervousness; frequency unknown - psychosis, confusion, depersonalization, depression, disorientation, hallucinations, "nightmarish" dreams, mania.

    Disturbances from the nervous system: often - a change in taste (dysgeusia), headache; infrequently - dizziness, loss of consciousness, drowsiness, tremor; the frequency is unknown - convulsions, loss of taste sensations, impaired sense of smell, loss of smell, paresthesia.

    Hearing disorders and labyrinthine disturbances: infrequently - vertigo, hearing impairment, noise, ringing in the ears; frequency unknown - hearing loss (passing after withdrawal of the drug).

    Heart Disease: infrequent - lengthening of the interval QT on electrocardiogram, palpitation; frequency unknown - ventricular tachycardia of the type "pirouette", ventricular tachycardia, flutter and fibrillation of the ventricles.

    Vascular disorders: frequency unknown - unusual bleeding, hemorrhage.

    Disturbances from the respiratory system, chest and mediastinal organs: infrequently - epistaxis.

    Disorders from the gastrointestinal tract: often - diarrhea, vomiting, dyspepsia, nausea, abdominal pain; infrequently - gastroesophageal reflux disease, gastritis, procalgia, stomatitis, glossitis, bloating, constipation, dry mouth, eructation, flatulence; frequency unknown - acute pancreatitis, discoloration of the tongue and teeth.

    Disturbances from the liver and bile ducts: often - an atypical functional test of the liver; infrequently - cholestasis, hepatitis, increased activity of alanine aminotransferase, increased activity of aspartate aminotransferase, increased activity of gamma-glutamyltransferase; frequency unknown - hepatic insufficiency, hepatocellular jaundice.

    Disturbances from the skin and subcutaneous tissues: often - a rash, increased sweating; infrequently - itching, urticaria, spotted-papular rash; frequency unknown - malignant exudative erythema (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), drug rash with eosinophilia and systemic manifestations, acne, purpura Shenlaine-Genocha.

    Disturbances from musculoskeletal and connective tissue: infrequently - muscle spasm, myalgia; frequency unknown - rhabdomyolysis, myopathy, increased symptoms of myasthenia gravis.

    Disorders from the kidneys and urinary tract: very rarely - renal failure, interstitial nephritis.

    General disorders and disorders at the site of administration: infrequently - malaise, fever, asthenia, chest pain, chills, weakness.

    Laboratory indicators: infrequently - increased activity of alkaline phosphatase, increased blood lactate dehydrogenase activity; very rarely hypercreatininaemia; frequency unknown - increased international normalized ratio (INR), increased prothrombin time, change in urine color, increased bilirubin concentration.

    Amoxicillin

    Infectious and parasitic diseases: infrequently, the development of superinfections, candidiasis of the oral mucosa, vaginal candidiasis.

    Violations of the blood and lymphatic system: rarely - eosinophilia, hemolytic anemia; very rarely - leukopenia, neutropenia, granulocytopenia, thrombocytopenia, pancytopenia, anemia, myelosuppression, agranulocytosis, reversible increase in prothrombin time and bleeding time.

    Immune system disorders: rarely - laryngeal edema, serum sickness, allergic purpura, anaphylactic reaction.

    Disturbances from the nervous system: infrequently - a headache; rarely - agitation, anxiety, insomnia, ataxia, confusion, hyperkinesia, behavior change, depression, peripheral neuropathy, dizziness, convulsions (in patients with impaired renal function, epilepsy or meningitis).

    Disorders from the gastrointestinal tract: often - nausea, loss of appetite, vomiting, flatulence, soft stools, diarrhea, rash on the oral mucosa, dry mouth, distortion of taste perception; rarely - darkening of tooth enamel; very rarely - pseudomembranous colitis, black "hairy" tongue.

    Disorders from the liver and bile ducts: infrequently - a reversible increase in the activity of "liver" transaminases; rarely - hepatitis, cholestatic jaundice.

    Disturbances from the skin and subcutaneous tissues: often - skin rashes, itching, hives; rarely angioedema (Quincke's edema), polymorphic exudative erythema, acute generalized exanthematous pustulosis, toxic epidermal necrolysis (Lyell's syndrome), malignant exudative erythema (Stevens-Johnson syndrome), bullous and exfoliative dermatitis.

    Kidney disorders: rarely acute interstitial nephritis, crystalluria.

    General disorders and disorders at the site of administration: rarely - drug fever.

    Lansoprazole

    Violations from the blood and lymphatic system: infrequently - thrombocytopenia, eosinophilia, leukopenia; rarely anemia; very rarely - agranulocytosis, pancytopenia.

    Immune system disorders: very rarely - anaphylactic shock.

    Disorders from the metabolism and nutrition: rarely anorexia; frequency is unknown - hypomagnesemia.

    Disorders of the psyche: infrequently - depression; rarely - insomnia, hallucinations, confusion.

    Disturbances from the nervous system: often a headache, dizziness; rarely - anxiety, vertigo and paresthesia, drowsiness, tremor.

    Disturbances on the part of the organ of sight: rarely - a vision disorder.

    Disorders from the gastrointestinal tract: often - nausea, diarrhea, abdominal pain, constipation, vomiting, flatulence, dry mouth or throat; rarely - glossitis, esophageal candidiasis, pancreatitis, impaired taste perception; very rarely - colitis, stomatitis.

    Disturbances from the side of baked and bile ducts: often - increased activity of "liver" transaminases; rarely - hepatitis, jaundice; very rarely - hyperbilirubinemia.

    From the respiratory system: rarely - cough, pharyngitis, rhinitis, upper respiratory tract infection, flu-like syndrome.

    Disturbances from the skin and subcutaneous tissues: often - hives, itching, rash; rarely - petechia, purpura, alopecia, angioedema (Quincke's edema), polymorphic erythema, photosensitivity; very rarely - malignant exudative erythema (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome).

    Disturbances from the musculoskeletal and connective tissue: infrequently - arthralgia, myalgia, fracture of the thigh, wrist or spine.

    Disorders from the kidneys and urinary tract: rarely interstitial nephritis.

    Violations of the genitals and breast: rarely - gynecomastia, impotence.

    General disorders and disorders at the site of administration: often - weakness; infrequently - swelling; rarely - fever, increased sweating.

    Laboratory indicators: very rarely - increased cholesterol and triglycerides, hyponatremia.

    Overdose:

    Clarithromycin

    Symptoms: abdominal pain, nausea, vomiting, diarrhea, possibly a headache, confusion.

    Treatment: gastric lavage, maintenance therapy. It is not removed during hemo- or peritoneal dialysis.

    Amoxicillin

    Symptoms: nausea, vomiting, diarrhea, disturbance of water-electrolyte balance (as a consequence of vomiting and diarrhea), crystalluria.

    Treatment: gastric lavage, Activated carbon, salt laxatives, preparations for maintaining the water-electrolyte balance; hemodialysis.

    Lansoprazole

    Cases of an overdose of lansoprazole have not been described.

    Interaction:

    Clarithromycin

    With the joint administration of clarithromycin and drugs, primarily metabolized by isoenzymes CYP3A, there may be a mutual increase in their concentrations, which may enhance or prolong both the therapeutic and side effects.

    Contraindicated joint administration with astemizole, cisapride, pimozide, terfenadine, ergotamine and other ergot alkaloids, alprazolam, midazolam, triazolam.

    Carefully prescribe with carbamazepine, cilostazol, cyclosporine, disopyramide, lovastatin, methylprednisolone, omeprazole, indirect anticoagulants (including warfarin), quinidine, rifabutin, sildenafil, simvastatin, tacrolimus, vinblastine, phenytoin, theophylline and valproic acid (metabolized through other cytochrome P450 isoenzymes ). It is necessary to adjust the dose of drugs and control the concentration in the blood plasma.

    When combined with cisapride, pimozide, terfenadine and astemizole, it is possible to increase the concentration of the latter in the blood plasma, lengthening the interval QT and the development of cardiac arrhythmias, including ventricular paroxysmal tachycardia, fibrillation,flutter or fibrillation of the ventricles, polymorphic ventricular tachycardia of the type "pirouette" (see section "Contraindications"). A similar mechanism of interaction is noted when using drugs metabolized by another isoenzyme of the cytochrome P450 system - phenytoin, theophylline and valproic acid. With the simultaneous administration of the above drugs, monitoring of their concentration in the blood plasma and ECG is required.

    Clarithromycin can reduce the clearance of triazolam and, thus, increase its pharmacological effects with the development of drowsiness and confusion.

    For benzodiazepines, the excretion of which does not depend on isoenzymes CYP3A4 (temazepam, nitrazepam, lorazepam), clinically significant interaction with clarithromycin is unlikely.

    There are reports of an increase in the concentration of digoxin in the blood plasma of patients receiving concomitantly digoxin and clarithromycin. It is necessary to constantly monitor the digoxin content in the blood plasma in order to avoid digitalis intoxication and the development of potentially lethal arrhythmias.

    Joint application with ergotamine and dihydroergotamine (ergot derivatives) maylead to acute ergotamine intoxication, manifested by severe peripheral vasospasm, ischemia of limbs and other tissues, including the central nervous system, and perverted sensitivity.

    With the simultaneous administration of clarithromycin with HMG-CoA reductase inhibitors-lovastatin and simvastatin-rare cases of rhabdomyolysis have been described.

    Efavirenz, nevirapine, rifampicin, rifabutin and rifapentin (inducers of cytochrome P450) reduce the concentration of clarithromycin in the blood plasma and weaken its therapeutic effect, and at the same time increase the concentration of 14 (R) -hydroxyclamirithromycin.

    With the simultaneous administration of fluconazole at a dose of 200 mg and clarithromycin at a dose of 1 g / day, an increase in the equilibrium concentration and AUC clarithromycin by 33% and 18%, respectively. Correction of the dose of clarithromycin is not required.

    It is necessary to pay attention to the possibility of cross-resistance between clarithromycin and other antibiotics from the macrolide group, as well as lincomycin and clindamycin.

    Simultaneous reception of clarithromycin and zidovudine in adult HIV-infected patients may lead to a decrease in the equilibrium level of zidovudine concentration. It is necessary to select doses of clarithromycin and zidovudine.

    With the simultaneous administration of clarithromycin and ritonavir, atazanavir, or other protease inhibitors, plasma concentrations like clarithromycin increase, which in this case should not be administered at a dose greater than 1 g / day, or a protease inhibitor.

    With the joint administration of clarithromycin and itraconazole, a mutual increase in the concentration of drugs in the blood plasma is possible. For patients who simultaneously take itraconazole and clarithromycin, careful monitoring is necessary because of the possible enhancement or extension of the pharmacological effects of these drugs.

    With concurrent administration of clarithromycin (1 g / day) and saquinavir (in soft gelatin capsules, 1200 mg 3 times a day), an increase AUC and the equilibrium concentration of saquinavir by 177% and 187%, respectively, and clarithromycin by 40%. When co-prescribing these two medicines for a limited time in the doses / dosage forms indicated above, dose adjustment is not required. Since cochriction, which is a substrate for CYP3A and P-glycoprotein, and clarithromycin, as well as other macrolides - inhibitors CYP3A and P-glycoprotein, inhibition can lead to an increase in the effect of colchicine, patients should be carefully monitored in order to identify symptoms of the toxic effects of colchicine. When using clarithromycin with tolterodine in patients with low isoenzyme activity CYP2D6, a dose reduction of tolterodine in the presence of clarithromycin (an inhibitor of isoenzymes CYP3A).

    With the joint administration of clarithromycin with verapamil it is possible to lower blood pressure, bradyarrhythmia and lactic acidosis.

    With the use of etravirine, the concentration of clarithromycin decreases, but the concentration of the active metabolite increases 14 (R) -hydroxy-clarithromycin.

    With the combined use of clarithromycin and oral hypoglycemic agents and / or insulin, pronounced hypoglycemia can be observed. Against the background of simultaneous reception of clarithromycin and some drugs that reduce the concentration of glucose, such as nateglinide, pioglitazone, repaglinide and rosiglitazone, there may be an inhibition of the isoenzyme CYP3A clarithromycin, which may result in hypoglycemia. Careful monitoring of glucose concentration is recommended.

    Amoxicillin

    Antacids, glucosamine, laxatives, aminoglycosides, food slow down and reduce the absorption of amoxicillin; ascorbic acid increases absorption.

    Probenecid reduces the excretion of amoxicillin by the kidneys and increases the concentration of amoxicillin in bile and blood plasma.

    Bactericidal antibiotics (including aminoglycosides, cephalosporins, vancomycin, rifampicin) - a synergistic effect; bacteriostatic drugs (macrolides, chloramfinekol, lincosamides, tetracyclines, sulfonamides) - antagonistic.

    When taking amoxicillin in combination with metronidazole, nausea, vomiting, anorexia, diarrhea, constipation, epigastric pain, digestive disorders, in rare cases jaundice, interstitial nephritis, violations of hemopoiesis.

    Amoxicillin improves the effectiveness of indirect anticoagulants (suppressing the intestinal microflora, reduces the synthesis of vitamin K and prothrombin index), which leads to an extension of the clotting time. If necessary, adjust the dose of indirect anticoagulants. Simultaneous use of amoxicillin and allopurinol increases the risk of skin rash.

    Amoxicillin reduces clearance and increases the toxicity of methotrexate, probably because of competitive inhibition of tubular renal secretion of methotrexate with amoxicillin. Patients receiving concomitantly amoxicillin and methotrexate, the plasma concentrations of the latter should be carefully monitored.

    It is possible to increase the absorption time of digoxin against amoxicillin therapy. If necessary, adjust the dose of digoxin.

    Diuretics, allopurinol, oxyphenbutazone, phenylbutazone, non-steroidal anti-inflammatory drugs and other drugs that block tubular secretion, increase the concentration of amoxicillin in the blood plasma.

    Amoxicillin reduces the concentration of estrogens and progesterones in the blood plasma, which can lead to a loss of contraceptive effect of oral contraceptives. During treatment with amoxicillin, additional nonhormonal methods of contraception should be used.

    Lansoprazole

    Lansoprazole slows down the elimination of drugs metabolized in the liver by microsomal oxidation (including diazepam, phenytoin, indirect anticoagulants).

    Reduces the clearance of theophylline by 10%.

    Slows pH-dependent absorption of drugs belonging to weak acid groups, and accelerates the absorption of drugs belonging to the groups of bases.

    Prevents the absorption of ketoconazole, itraconazole, ampicillin, iron salts, digoxin.

    Lansoprazole slows the absorption of cyanocobalamin.

    Compatible with ibuprofen, indomethacin, diazepam, propranolol, warfarin, oral contraceptives, phenytoin, prednisolone. Sucralfate reduces the bioavailability of lansoprazole by 30%, so it is necessary to observe the interval between taking these medicines 30-40 minutes.

    Antacids should be prescribed 1 hour before or 1-2 hours after taking lansoprazole, as they slow down and reduce its absorption.

    In volunteers who simultaneously received 60 mg of lansoprazole and 400 mg of atazanavir per day, a decrease of 90% AUC and CmOh the latter. Lansoprazole should not be administered simultaneously with atazanavir.

    Ritonavir (substrate and inhibitor CYP2C19) can have a variable effect on AUC lansoprazole (increase or decrease). If necessary, concomitant therapy is recommended to control the therapeutic and possible side effects, as well as dose adjustment of lansoprazole.Simultaneous reception of lansoprazole and tacrolimus (substrate isoenzyme CYP3A4 and P-glycoprotein) leads to an increase in the plasma concentration of the latter (up to 81%). The concentration of tacrolimus in the blood plasma should be monitored while concomitant administration with lansoprazole.

    Simultaneous administration of fluvoxamine (inhibitor of isoenzyme CYP2C19) and lansoprazole leads to a fourfold increase in the concentration of the latter in blood plasma.

    Rifampicin and St. John's Wort (perforated isozymes CYP2C19 and CYP3A4) can significantly reduce plasma concentrations of lansoprazole.

    Special instructions:

    Before the start of therapy, it is necessary to exclude the presence of a malignant process (especially with a stomach ulcer), as treatment, masking the symptoms, can delay the establishment of the correct diagnosis.

    Clarithromycin

    Long-term use of antibiotics can lead to the formation of colonies with an increased number of insensitive bacteria and fungi. When superinfection is necessary to appoint appropriate therapy.

    When applying clarithromycin, hepatic dysfunction was reported (increased concentration of hepatic enzymes in the blood plasma, hepatocellular and / or cholestatic hepatitis with or without jaundice).Hepatic dysfunction can be severe, but is usually reversible. There are cases of hepatic insufficiency with a fatal outcome, mainly associated with the presence of serious concomitant diseases and / or simultaneous use of other medications. When signs and symptoms of hepatitis such as anorexia, jaundice, darkening of the urine, tenderness of the abdomen during palpation, it is necessary to immediately stop the treatment with clarithromycin.

    In the presence of chronic liver diseases, regular monitoring of plasma enzymes is necessary.

    In the treatment of nearly all antibacterial agents, including clarithromycin, described cases of pseudomembranous colitis, the severity of which can range from mild to life-threatening. Antibiotic drugs can change the normal intestinal microflora, which can lead to growth Clostridium difficile. Pseudomembranous colitis caused by Clostridium difficile, It is necessary to suspect all patients experiencing the appearance of diarrhea after using antibacterial agents. After the course of antibiotic therapy, careful medical supervision is necessaryfor the patient. Cases of pseudomembranous colitis after 2 months after taking antibiotics were described.

    Clarithromycin should be used with caution in patients with ischemic heart disease (CHD), severe heart failure, hypomagnesemia, severe bradycardia (less than 50 beats / min), and also with simultaneous use with antiarrhythmic drugs IA class (quinidine, procainamide) and III class (dofetilide, amiodarone, sotalol). With these conditions and with simultaneous reception of clarithromycin with these drugs, the electrocardiogram should be monitored regularly to increase the interval QT.

    It is possible to develop cross-resistance to clarithromycin and other antibiotics of the macrolide group, as well as to lincomycin and clindamycin.

    In case of acute hypersensitivity reactions, such as anaphylactic reaction, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms (DRESS-syndrome), purpura Shenlaine-Henoch, it is necessary to immediately stop taking clarithromycin and begin appropriate therapy.

    In patients receiving clarithromycin, reported worsening of myasthenia gravis symptoms gravis.

    In the case of combined use with warfarin or other indirect anticoagulants, it is necessary to monitor INR and prothrombin time.

    Amoxicillin

    Before starting amoxicillin, you need to collect a detailed history of previous hypersensitivity reactions to penicillins, cephalosporins or other allergens. Serious and sometimes lethal hypersensitivity reactions (anaphylactic reactions) to penicillins are described. The risk of occurrence of such reactions is highest in patients who have a history of hypersensitivity reactions to penicillins. In case of allergic reactions, it is necessary to stop taking amoxicillin and begin therapy with an antibiotic of another group. In case of serious hypersensitivity reactions, appropriate measures should be taken immediately. Epinephrine, oxygen therapy, intravenous glucocorticosteroids, and airway patency, including intubation, may also be required.

    It is necessary to refrain from using amoxicillin in case of suspected infectious mononucleosis, since in patients with this disease amoxicillin can cause a skinlike skin rash that makes diagnosis difficult.

    Long-term treatment with amoxicillin sometimes leads to excessive reproduction of insensitive microorganisms.

    During the application of amoxicillin it is recommended to periodically evaluate the function of the kidneys, liver and hematopoiesis. Amoxicillin Use with caution in patients with impaired hepatic function. Monitoring of liver function should be performed on a regular basis. In patients with impaired renal function, the dose of amoxicillin should be reduced accordingly.

    Amoxicillin can provoke non-specific binding of immunoglobulins and albumins to the erythrocyte membrane, which may be the cause of a false positive reaction in the Coombs sample.

    In patients with reduced diuresis, crystalluria is very rare. In carrying out therapy with amoxicillin, adequate fluid intake and maintaining a sufficient diuresis are extremely important. Patients with cholangitis or cholecystitis can be prescribed antibiotics only with mild disease and in the absence of cholestasis.

    During therapy with amoxicillin, it is necessary to remember the possible development of superinfection (usually caused by bacteria of the genus Pseudomonas spp. or fungi of the genus Candida). In this case, therapy with amoxicillin should be discontinued and / or appropriate treatment should be prescribed.

    With persistent severe diarrhea, pseudomembranous colitis due to antibiotics should be suspected, which may pose a threat to the life of the patient (watery feces with an admixture of blood and mucus, dull common or colicky abdominal pains, fever, sometimes, tenesmus). In such cases amoxicillin should immediately be abolished and a treatment specific for the causative agent, for example, vancomycin. In this case, the drugs that reduce the perelstatics of the gastrointestinal tract are contraindicated.

    Excretion of amoxicillin leads to its high content in the urine, which can lead to false positive results in the determination of glucose in the urine (for example, the Benedict test, Feeling's test). In this case, it is recommended to use a glucose oxidase method to determine the concentration of glucose in the urine.

    If it is necessary to simultaneously use amoxicillin with anticoagulants,prothrombin time or INR should be carefully monitored when amoxicillin is prescribed or withdrawn.

    When using estrogen-containing oral contraceptives and amoxicillin concomitantly, other or additional methods of contraception should be used whenever possible.

    Particular care is recommended for patients with allergic diathesis or bronchial asthma, gastrointestinal diseases in history (in particular, colitis caused by antibiotic treatment).

    With prolonged use of amoxicillin should be simultaneously prescribed nystatin, levorin or other antifungal agents.

    During treatment, it is not recommended to drink alcohol.

    Lansoprazole

    It is recommended to avoid the combined use of proton pump inhibitors and clopidogrel. When combined, the risk of repeated myocardial infarction, hospitalization for a heart attack or unstable angina, stroke, repeated revascularization increases. With the unconditional need for co-administration, patients should be carefully monitored.

    It is recommended to avoid the joint use of proton pump inhibitors and antiretroviral drugs in HIV-infected patients. If it is necessary to use together with atazanavir / ritonavir, it is recommended to observe a 12-hour interval between taking lansoprazole and these drugs, as well as not to exceed the dose of lansoprazole 30 mg.

    When combined with antiretroviral drugs (indinavir, nelfinavir, atazanavir), as well as ketoconazole, itraconazole, posaconazole, cefpodoxime, cefuroxime and ampicillin, it is necessary to monitor their effectiveness and the appearance of resistance.

    Co-administration with imatinib may increase the risk of adverse reactions (potential interaction through CYP3A4), especially in persons with severe allergic reactions in the history.

    In connection with an increased risk of myotoxicity, patients taking atorvastatin, lovastatin or simvastatinshould be carefully observed during the concomitant use of lansoprazole.

    In patients who simultaneously take warfarin, it is necessary to monitor prothrombin time and INR.

    Prolonged use of proton pump inhibitors increases the risk of infection (including Salmonella, Campylobacter, Clostridium difficile).

    The use of bleeding prevention from the upper gastrointestinal tract should be correlated with the potential risk of developing a ventilator-associated pneumonia.

    Prolonged use of proton pump inhibitors increases the risk of fractures in women during menopause.

    During the treatment should avoid the use of alcoholic beverages.

    Pharmacogenetic factor. The effectiveness of the drug depends on genetic polymorphism CYP2C19. In patients belonging to the "slow metabolizers" (PM-type), the efficacy is higher, eradication is achieved more reliably Helicobacter pylori compared with "fast metabolizers" (homEMtype), even against a background of resistance to clarithromycin.

    The "withdrawal syndrome" or "acid rebound", while observing the recommended duration of application for lansoprazole, is not typical.

    Effect on the ability to drive transp. cf. and fur:

    During the treatment period, care must be taken when driving vehicles and engaging in other potentially dangerous activities that require increased attention and speed of psychomotor reactions, since the drug may cause weakness, drowsiness and dizziness.

    Form release / dosage:

    Tablets and capsules set (clarithromycin - film coated tablets, 500 mg, amoxicillin capsules 500 mg, lansoprazole - capsules enteric-soluble 30 mg).

    Packaging:

    2 tablets of clarithromycin, 4 capsules of amoxicillin and 2 capsules of lansoprazole in one blister of PVC film / aluminum foil.

    The blister is divided into two parts (morning / evening) with a perforated line.

    For 7 blisters together with instructions for use in a cardboard bundle.

    Storage conditions:

    In dry, dark place at a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    3 years.

    Do not use after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:LP-002364
    Date of registration:10.02.2014
    Expiration Date:10.02.2019
    Date of cancellation:2019-02-10
    The owner of the registration certificate:Micro Labs LimitedMicro Labs Limited India
    Manufacturer: & nbsp
    Representation: & nbspMICRO LABS LIMITED MICRO LABS LIMITED India
    Information update date: & nbsp15.02.2018
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