Lancid Kit, pills and capsules, 56 pcs.

Composition

Tablets

Active ingredient:

clarithromycin 500 mg;

Auxiliary substances: 

microcrystalline cellulose 31.5 mg,

corn starch 8.9 mg,

sorbic acid 1.1 mg,

sorbitan a oleate 2 mg,

povidone 30 mg,

colloidal silicon dioxide 8 mg,

magnesium stearate 11 mg,

talc 24 mg,

croscarmellose sodium 55 mg,

stearic acid 20 mg;

Composition of the film shell:

hypromellose 20.65 mg, titanium dioxide 4.75 mg, propylene glycol 3.2 mg, quinoline yellow dye 0.195 mg, vanilla flavor 1.2 mg;

Capsules

Active ingredient:

amoxicillin 500 mg;

Auxiliary substances:

magnesium stearate 5 mg,

talc 8 mg,

sodium lauryl sulfate 3 mg.

Capsule cap composition:

propyl parahydroxybenzoate 0.2 mg, methyl parahydroxybenzoate 0.8 mg, water 14-15 mg, gelatin q. s., titanium dioxide 0.8132 mg, diamond blue dye 0.0062 mg, sunset yellow dye 0.0495 mg;

Capsule body composition:

propyl parahydroxybenzoate 0.2 mg, methyl parahydroxybenzoate 0.8 mg, water 14-15 mg, gelatin q. s., titanium dioxide 1.6266 mg, iron oxide yellow dye 0.9999 mg;

Black ink composition:

ethanol 29-33%, isopropanol 9-12%, butanol 4-7%, shellac 24-28%, iron oxide black dye 24-28%, water ammonia 1-3%, propylene glycol 0.5-2%;

Enteric capsules

Active ingredient:

lansoprazole 30 mg;

Auxiliary substances:

mannitol 41.11 mg,

sucrose 123.22 mg,

povidone 1.09 mg

microspheres from sucrose 38.19 mg,

sodium hydrogen phosphate 2.08 mg,

calcium carmellose 10.41 mg,

magnesium hydroxycarbonate 5.3 mg,

Polysorbate 80 0.99 mg,

hypromellose 25.58 mg,

titanium dioxide 2.19 mg,

methacrylic acid polymer 65.78 mg,

talc 8.77 mg,

diethyl 8.11 mg,

sodium hydroxide 0.44 mg;

Capsule body composition:

gelatin 38.9575 mg, sodium lauryl sulfate 0.0376 mg, propyl parahydroxybenzoate 0.376 mg, methyl parahydroxybenzoate 0.094 mg, titanium dioxide 0.712 mg, crimson dye (Ponceau 4R) 0.0078 mg, water 6.815 mg;

Capsule cap composition:

gelatin 24.0376 mg, sodium lauryl sulfate 0.0232 mg, propyl parahydroxybenzoate 0.058 mg, methyl parahydroxybenzoate 0.232 mg, titanium dioxide 0.4393 mg, crimson dye (Ponceau 4R) 0.0048 mg, water 4.205 mg;

Pharmacological action

Lancid is an anti-ulcer agent.

It inhibits H+ – K+ATPase (proton pump) of parietal cells, blocks the final stage of hydrochloric acid formation, and suppresses basal and stimulated secretion.

Pharmacodynamics

Having high lipophilicity, it easily penetrates into the parietal cells of the stomach, concentrates in them, has a cytoprotective effect, increases the secretion of bicarbonates. Inhibition of the formation of hydrochloric acid at a dose of 30 mg is 80-97%.

It does not affect the motility of the gastrointestinal tract. The inhibitory effect increases in the first four days of administration. Secretory activity is restored 3-4 days after discontinuation of the drug.

Pharmacokinetics

Absorption is high. Cmax after oral administration at a dose of 30 mg is reached in 1.5-2.2 hours and is 0.75-1.15 mg/l. Binding to plasma proteins is 98%. T1/2 — 1,3–1,7 h (increases with impaired renal function and in the elderly).

It is actively metabolized during its primary passage through the liver. It is excreted by the kidneys in the form of metabolites (14-23%), as well as by the intestines.

Indications

Peptic ulcer of the stomach and duodenum (treatment and eradication therapy of Helicobacter pylori infection)

Contraindications

• hypersensitivity to any component of the drug (the base material and/or auxiliary components) to macrolides, penicillin, cephalosporins, carbapenems;
• concomitant use of clarithromycin with the following drugs: astemizole, cisapride with pimozide, terfenadine; with ergot alkaloids, for example, ergotamine, dihydroergotamine with; with midazolam for oral administration;
• concomitant use of clarithromycin with inhibitors of HMG-COA reductase (statins), which are largely metabolized by CYP3A4 (lovastatin, simvastatin), in connection with the increased risk of myopathy, including rhabdomyolysis;
• concomitant use of clarithromycin and colchicine in patients with impaired liver function and kidney;
• patients with history of QT prolongation,
• ventricular fibrillation or ventricular tachycardia type “pirouette”;
• patients with hypokalaemia (risk of QT interval prolongation);
• patients with severe hepatic insufficiency occurring simultaneously with renal failure;
• patients with cholestatic jaundice/hepatitis in history, which developed in the application of clarithromycin;
• porphyria;
• in lactation and pregnancy;
• patients with atopic dermatitis, bronchial asthma, hay fever, infectious mononucleosis, lymphatic leukemia, liver disease, diseases of the gastrointestinal disease (especially colitis associated with antibiotic use),
• children’s age up to 18 years of age;
• in the presence of deficiency of sucrase/isomaltase, fructose intolerance, glucose-galactose malabsorption.

Side effects

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.

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

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

Metabolic and nutritional disorders: infrequently – anorexia, decreased appetite; frequency unknown-hypoglycemia (including when taking hypoglycemic medications at the same time).

Mental disorders: often – insomnia; infrequently-anxiety, nervousness; frequency unknown-psychosis, confusion, depersonalization, depression, disorientation, hallucinations, “nightmare” dreams, mania.

Nervous system disorders: often-changes in taste (dysgeusia), headache; infrequently-dizziness, loss of consciousness, drowsiness, tremor; frequency unknown-convulsions, loss of taste sensations, impaired sense of smell, loss of smell, paresthesia.

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

Cardiac disorders: infrequently-prolongation of the QT interval on the electrocardiogram, palpitation sensation; frequency unknown-ventricular tachycardia of the “pirouette” type, ventricular tachycardia, fluttering and flickering of the ventricles.

Vascular disorders: frequency unknown-unusual bleeding, hemorrhage.

Respiratory, thoracic and mediastinal disorders: infrequently-nosebleeds.

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

Liver and biliary tract disorders: often – atypical liver function test; infrequently-cholestasis, hepatitis, increased ALT activity, increased AST activity, increased GGT activity; frequency unknown-liver failure, hepatocellular jaundice.

Skin and subcutaneous tissue disorders: often-rash, increased sweating; infrequently-pruritus, urticaria, maculopapular rash; frequency unknown-malignant exudative erythema (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell’s syndrome), drug rash with eosinophilia and systemic manifestations, acne, Schonlein-Henoch purpura.

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

Kidney and urinary tract disorders: very rarely -renal failure, interstitial nephritis.

General disorders and disorders at the injection site: infrequently – malaise, fever, asthenia, chest pain, chills, weakness.

Laboratory parameters: infrequently-increased alkaline phosphatase activity, increased blood LDH activity; very rarely-hypercreatininemia; frequency unknown-increased international normalized ratio( MHO), increased prothrombin time, change in urine color, increased bilirubin concentration.

Amoxicillin

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

Disorders of the blood and lymphatic system: rarely -eosinophilia, hemolytic anemia; very rarely-leukopenia, neutropenia, graiulocytopenia, 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.

Nervous system disorders: infrequently-headache; rarely-agitation, anxiety, insomnia, ataxia, confusion, hyperkinesia, behavior changes, depression, peripheral neuropathy, dizziness, seizures (in patients with impaired renal function, epilepsy or meningitis).

Disorders of 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.

Liver and biliary tract disorders: infrequently-reversible increase in the activity of “hepatic” transaminases; rarely-hepatitis, cholestatic jaundice.

Skin and subcutaneous tissue disorders: often – skin rashes, pruritus, urticaria; 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 injection site: rarely-drug fever.

Lansoprazole

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

Immune system disorders: very rarely – anaphylactic shock.

Metabolic and nutritional disorders: rarely – anorexia; frequency unknown-hypomagnesemia.

Mental disorders: infrequently-depression; rarely-insomnia, hallucinations, confusion.

Nervous system disorders: often – headache, dizziness; rarely-restlessness, vertigo and paresthesia, drowsiness, tremor.

Visual disturbances: rarely-visual impairment.

Disorders of 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.

Liver and biliary tract disorders: often-increased activity of “hepatic” transaminases; rarely-hepatitis, jaundice; very rarely-hyperbilirubinemia.

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

Skin and subcutaneous tissue disorders: often – urticaria, pruritus, rash; rarely-petechiae, purpura, alopecia, angioedema (Quincke’s edema), erythema polymorphic, photosensitization; very rarely-malignant exudative erythema (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell’s syndrome).

Musculoskeletal and connective tissue disorders: infrequently-arthralgia, myalgia, hip, wrist, or spine fracture.

Kidney and urinary tract disorders: rarely-interstitial nephritis.

Genital and breast disorders: rarely-gynecomastia, impotence.

General disorders and disorders at the injection site: often – weakness; infrequently-edema; rarely-fever, increased sweating.

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

Interaction

Clarithromycin

Concomitant administration of clarithromycin and drugs primarily metabolized by CYP3A isoenzymes may lead to a mutual increase in their concentrations, which may increase or prolong both therapeutic and side effects. Concomitant administration with astemizole, cisapride, pimozide, terfenadine, ergotamine and other ergot alkaloids, alprazolam, midazolam, triazolam is contraindicated.

Cautiously prescribed 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 isoenzymes cytochrome P 450). 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, an increase in the concentration of the latter in blood plasma, prolongation of the QT interval and the development of cardiac arrhythmias, including ventricular paroxysmal tachycardia, fibrillation, flutter or ventricular fibrillation, polymorphic ventricular tachycardia of the “pirouette” type is possible (see the section “Contraindications”). A similar mechanism of interaction is observed when using drugs that are metabolized by another cytochrome P450 isoenzyme – phenytoin, theophylline, and valproic acid. With the simultaneous administration of the above drugs, monitoring of their concentration in blood plasma and ECG is required.

Clarithromycin may decrease the clearance of triazolam and thus increase its pharmacological effects with the development of drowsiness and confusion.

For benzodiazepines whose elimination does not depend on CYP3A4 isoenzymes (temazepam, nitrazepam, lorazepam), a clinically significant interaction with clarithromycin is unlikely.

There have been reports of increased plasma digoxin concentrations in patients treated with digoxin and clarithromycin concomitantly. Blood plasma digoxin levels should be constantly monitored to avoid digitalis intoxication and the development of potentially fatal arrhythmias.

Concomitant use with ergotamine and dihydroergotamine (ergot derivatives) can lead to acute ergotamine intoxication, which is manifested by severe peripheral vasospasm, ischemia of the extremities and other tissues, including the central nervous system, and perverted sensitivity.

Rare cases of rhabdomyolysis have been reported when clarithromycin is co-administered with HMG-CoA reductase inhibitors lovastatin and simvastatin.

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

Concomitant administration of fluconazole at a dose of 200 mg and clarithromycin at a dose of 1 g / day may increase the steady-state concentration and AUC of clarithromycin by 33% and 18%, respectively. No dose adjustment of clarithromycin is required.

Attention should be paid to the possibility of cross-resistance between clarithromycin and other macrolide antibiotics, as well as lincomycin and clindamycin.

Concomitant administration of clarithromycin and zidovudine in adult HIV-infected patients may lead to a decrease in the steady-state concentration of zidovudine. The dosage of clarithromycin and zidovudine should be selected.

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

When taking clarithromycin and itraconazole together, a mutual increase in the concentration of drugs in the blood plasma is possible. Patients taking itraconazole and clarithromycin concomitantly should be closely monitored for possible increased or prolonged pharmacological effects of these drugs.

Concomitant administration of clarithromycin (1 g / day) and saquinavir (in soft gelatin capsules,1200 mg 3 times a day) may increase the AUC and steady-state concentration of saquinavir by 177% and 187%, respectively, and clarithromycin by 40%. When these two drugs are co-administered for a limited time in the doses/dosage forms indicated above, no dose adjustment is required. Since the co-administration of colchicine, which is a substrate for CYP3A and P-glycoprotein, and clarithromycin, as well as other macrolide inhibitors of CYP3A and P – glycoprotein, inhibition can lead to an increase in the effect of colchicine, patients should be carefully monitored for symptoms of toxic effects of colchicine. When using clarithromycin with tolterodine in patients with low activity of the CYP2D6 isoenzyme, it may be necessary to reduce the dose of tolterodine in the presence of clarithromycin (an inhibitor of CYP3A isoenzymes).

When clarithromycin is co-administered with verapamil, it is possible to reduce blood pressure, bradyarrhythmia and lactic acidosis.

When using etravirine, the concentration of clarithromycin decreases, but the concentration of the active metabolite 14(R)-hydroxyclarithromycin increases.

When clarithromycin is co-administered with oral hypoglycemic agents and / or insulin, severe hypoglycemia may occur. When clarithromycin is co-administered with certain glucose-lowering drugs, such as nateglinide, pioglitazone, repaglinide, and rosiglitazone, inhibition of the CYP3A isoenzyme by clarithromycin may occur, resulting in hypoglycemia. Careful monitoring of glucose concentrations is recommended.

Amoxicillin

Antacids, glucosamine, laxatives, aminoglycosides, food slow 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) have a synergistic effect; bacteriostatic drugs (macrolides, chloramphinecol, lincosamides, tetracyclines, sulfonamides) have an antagonistic effect.

When taking amoxicillin in combination with metronidazole, nausea, vomiting, anorexia, diarrhea, constipation, epigastric pain, digestive disorders, in rare cases jaundice, interstitial nephritis, hematopoiesis disorders are observed.

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

Amoxicillin decreases the clearance and increases the toxicity of methotrexate, probably due to the competitive inhibition of renal tubular secretion of methotrexate by amoxicillin. In patients receiving concomitant treatment with amoxicillin and methotrexate, plasma concentrations of the latter should be carefully monitored. It is possible to increase the time of digoxin absorption during amoxicillin therapy. If necessary, adjust the dose of digoxin.

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

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

Lansoprazole

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

Reduces theophylline clearance by 10%.

It slows down the pH-dependent absorption of drugs belonging to the weak acid groups and accelerates the absorption of drugs belonging to the base groups.

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

Lansoprazole slows down the absorption of cyanocobalamin.

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

Antacids should be given 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, there was a 90% decrease in the AUC and Cmax of the latter. Lansoprazole should not be administered concomitantly with atazanavir.

Ritonavir (a substrate and inhibitor of CYP2C19) can variably affect the AUC of lansoprazole (increase or decrease). If concomitant therapy is necessary, it is recommended to monitor therapeutic and possible side effects, as well as adjust the dose of lansoprazole.

Simultaneous administration of lansoprazole and tacrolimus (a substrate of the CYP3A4 isoenzyme and P-glycoprotein) leads to an increase in the plasma concentration of the latter (up to 81%). Tacrolimus plasma concentrations should be monitored when administered concomitantly with lansoprazole.

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

Rifampicin and St. John’s wort (induces CYP2C19 and CYP3A4 isoenzymes) can significantly reduce plasma concentrations of lansoprazole.

How to take, course of administration and dosage

Inside. Take 500 mg (1 tablet) of clarithromycin,1000 mg of amoxicillin (2 capsules) and 30 mg of lansoprazole (1 capsule), twice a day in the morning and in the evening before meals.

Tablets and capsules should not be broken or chewed, they should be swallowed whole. The duration of treatment is 7 days, if necessary, it can be extended to 14 days.

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

Overdose

Clarithromycin

Symptoms: abdominal pain, nausea, vomiting, diarrhea, possible headache, confusion.

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

Amoxicillin

Symptoms: nausea, vomiting, diarrhea, impaired water and electrolyte balance (as a result of vomiting and diarrhea), crystalluria.

Treatment: gastric lavage, activated charcoal, saline laxatives, preparations for maintaining water and electrolyte balance; hemodialysis.

Special instructions

Before starting therapy, it is necessary to exclude the presence of a malignant process (especially with a stomach ulcer), since treatment, masking the symptoms, can delay 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. In case of superinfection, appropriate therapy should be prescribed.

Hepatic dysfunction (increased plasma concentrations of hepatic enzymes, hepatocellular and/or cholestatic hepatitis with or without jaundice) has been reported with clarithromycin. Hepatic dysfunction can be severe, but is usually reversible. There are cases of liver failure with a fatal outcome, mainly associated with the presence of serious concomitant diseases and/or the simultaneous use of other medications. When signs and symptoms of hepatitis appear, such as anorexia. jaundice, darkening of the urine, abdominal pain on palpation, clarithromycin therapy should be stopped immediately.

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

Cases of pseudomembranous colitis, the severity of which can range from mild to life-threatening, have been reported with virtually all antibacterial agents, including clarithromycin.

Antibacterial drugs can alter the normal intestinal microflora, which can lead to the growth of Clostridium difficile. Pseudomembranous colitis caused by Clostridium difficile should be suspected in all patients experiencing diarrhea after the use of antibacterial agents. After the course of antibiotic therapy, careful medical supervision of the patient is necessary. Cases of pseudomembranous colitis were described 2 months after taking antibiotics.

Clarithromycin should be used with caution in patients with coronary heart disease( CHD), severe heart failure, hypomagnesemia, severe bradycardia (less than 50 beats/min), as well as when used simultaneously with Class IA antiarrhythmic drugs (quinidine, procainamide) and Class III antiarrhythmic drugs (dofetilide, amiodarone, sotalol). In these conditions and when clarithromycin is co-administered with these drugs, the electrocardiogram should be regularly monitored for an increase in the QT interval.

It is possible to develop cross-resistance to clarithromycin and other macrolide antibiotics, as well as 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), Schonlein-Henoch purpura, it is necessary to immediately stop taking clarithromycin and start appropriate therapy.

Worsening of myasthenia gravis symptoms has been reported in patients taking clarithromycin.

If co-administered with warfarin or other indirect anticoagulants, multiple prothrombin times should be monitored.

Amoxicillin

Before taking amoxicillin, you should collect a detailed medical history of previous hypersensitivity reactions to penicillins, cephalosporins, or other allergens. Serious and sometimes fatal hypersensitivity reactions (anaphylactic reactions) to penicillins have been described. The risk of such reactions is highest in patients with a history of hypersensitivity reactions to penicillins. In case of allergic reactions, it is necessary to stop taking amoxicillin and start therapy with an antibiotic of a different 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 if infectious mononucleosis is suspected, since in patients with this disease, amoxicillin can cause a crust-like skin rash that makes diagnosis difficult.

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

During the use of amoxicillin, it is recommended to periodically evaluate the function of the kidneys, liver and hematopoiesis. Amoxicillin should be used with caution in patients with impaired liver function. Liver function should be monitored on a regular basis. In patients with impaired renal function, the dose of amoxicillin should be reduced accordingly to the degree of impairment.

Amoxicillin can provoke non-specific binding of immunoglobulins and albumins to the red blood cell membrane, which can cause a false positive reaction in the Coombs test.

Crystalluria is very rare in patients with reduced diuresis. Adequate fluid intake and maintenance of adequate diuresis are essential for amoxicillin therapy.

In patients with cholangitis or cholecystitis, antibiotics can only be prescribed if the disease is mild and there is no cholestasis. During amoxicillin therapy, you should be aware of the possible development of superinfection (usually caused by bacteria of the genus Pseudomonas spp. or fungi of the genus Candida). In this case, amoxicillin therapy should be discontinued and / or appropriate treatment should be prescribed.

If severe diarrhea persists, pseudomembranous colitis caused by antibiotics should be suspected, which may pose a threat to the patient’s life (watery feces with an admixture of blood and mucus; dull, widespread or colicky abdominal pain; fever, sometimes tenesmus). In such cases, amoxicillin should be discontinued immediately and a pathogen-specific treatment, such as vancomycin, should be prescribed. At the same time, drugs that reduce perilstatics of the gastrointestinal tract are contraindicated. Elimination 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, the Fehling test). In this case, it is recommended to use the glucose oxidase method for determining the concentration of glucose in the urine.

If concomitant use of amoxicillin with anticoagulants is necessary, prothrombin time or INR should be carefully monitored when prescribing or discontinuing amoxicillin.

If possible, other or additional methods of contraception should be used when using estrogen-containing oral contraceptives and amoxicillin at the same time.

Special care should be taken in patients with allergic diathesis or bronchial asthma, or a history of gastrointestinal diseases (in particular, colitis caused by antibiotic treatment).

If you are taking amoxicillin for a long time, you should simultaneously prescribe nystatin, levorin or other antifungal drugs.

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 used together, the risk of recurrent myocardial infarction, hospitalization for a heart attack or unstable angina, stroke, and repeated revascularization increases. If co-administration is absolutely necessary, patients should be closely monitored.

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

When co-administered with antiretroviral drugs (indinavir, nelfinavir, atazanavir), as well as ketoconazole, itraconazole, posaconazole, cefpodoxime, cefuroxime and ampicillin, monitoring of their effectiveness and the appearance of resistance is necessary.

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

Due to the increased risk of myotoxicity, patients taking atorvastatin, lovastatin or simvastatin should be carefully monitored during concomitant use of lansoprazole.

Monitoring of prothrombin time and MHO should be performed in patients taking warfarin concomitantly.

Prolonged use of proton pump inhibitors increases the risk of infection (including Salmonella, Campylobacter, Clostridium difficile). The benefits of preventing upper gastrointestinal bleeding should be weighed against the potential risk of developing ventilator-associated pneumonia.

Long-term use of proton pump inhibitors increases the risk of fractures in menopausal women.

During the treatment period, you should avoid drinking alcoholic beverages.

Pharmacogenetic factor. The effectiveness of the drug depends on the genetic polymorphism of CYP2C19. In patients classified as “slow metabolizers” (RM-type), the effectiveness is higher, and Helicobacte rpylori eradication is significantly more often achieved compared to “fast metabolizers” (homEM-type), even against the background of clarithromycin resistance.

“Withdrawal syndrome “or” acid rebound ” in compliance with the recommendations for the duration of use for lansoprazole is not typical.

Influence on the ability to drive mechanisms and a car

During treatment, caution should be exercised when driving vehicles and engaging in other potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions, as the drug can cause weakness, drowsiness and dizziness.

Form of production

tablets + capsules

Storage conditions

In a dry place protected from light, at a temperature not exceeding 25 °C.

Shelf life

3 years

Active ingredient

Amoxicillin, Clarithromycin, Lansoprazole

Conditions of release from pharmacies

By prescription

Dosage form

of capsule

Weight

Weight: 100 gr.