Composition, form of production and packaging
Tablets and capsules set
Blister contains:
The tablets covered with a film cover of yellow color, oval form, with risk from one side; Color of tablets on a break - white (2 pieces in a blister).
1 tab.
clarithromycin 500 mg
Additives: microcrystalline cellulose 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.
The composition of the film shell: hypromellose 20.65 mg, titanium dioxide 4.75 mg, propylene glycol 3.2 mg, quinoline yellow color 0.195 mg, vanilla flavor 1.2 mg.
Capsules hard gelatinous, the case of yellow color, the lid of dark red color; 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 в„–0 (4 pieces in the strip).
1 caps.
amoxicillin 500 mg
which corresponds to the content of amoxicillin trihydrate 588 mg
Excipients: magnesium stearate 5 mg, talc 8 mg, sodium lauryl sulfate 3 mg.
Composition of the cap of the capsule: propyl parahydroxybenzoate 0.2 mg, methylparahydroxybenzoate 0.8 mg, water 14-15 mg, gelatin qs, titanium dioxide 0.8132 mg, dye diamond blue 0.0062 mg, dye sunset yellow 0.0495 mg.
The composition of the capsule body: propyl parahydroxybenzoate 0.2 mg, methyl parahydroxybenzoate 0.8 mg, water 14-15 mg, gelatin qs, titanium dioxide 1.6266 mg, iron oxide dye yellow 0.9999 mg.
The composition of black ink: ethanol 29-33%, isopropanol 9-12%, butanol 4-7%, shellac 24-28%, iron dye oxide black 24-28%, ammonia water 1-3%, propylene glycol 0.5-2%.
Intestinal-soluble hard gelatin capsules, No. 1, with pink body and cap and black "MICRO / MICRO" inscription; the contents of capsules - pellets of white or almost white color (2 pieces in a strip).
1 caps.
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, carmellose calcium 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 phthalate 8.11 mg, sodium hydroxide 0.44 mg.
The composition of the capsule body: 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 (Ponso 4R) 0.0078 mg, water 6.815 mg.
The capsule capsule 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 (Ponso 4R) 0.0048 mg, water 4.205 mg.
8 pcs. - blisters (7) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2015.
PHARMACHOLOGIC EFFECT
Triple therapy, including clarithromycin, amoxicillin and lansoprazole, allows a high percentage of eradication of Helicobacter pylori (85-94%).
Clarithromycin is a bacteriostatic antibiotic from the macrolide group, a semisynthetic derivative of erythromycin A. The antibacterial effect of clarithromycin is due to the binding of the 50S subunit of the ribosome membrane of the microbial cell 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 14 (R) -hydroxyclarithromycin formed in the body also has a pronounced antimicrobial activity.
Amoxicillin is a semisynthetic penicillin, has a bactericidal action, has a wide spectrum 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 with respect to Helicobacter pylori. The resistance of Helicobacter pylori to amoxicillin is rare. The combination of amoxicillin and clarithromycin has a potentiated antimicrobial effect against Helicobacter pylori.
Lansoprazole is a specific inhibitor of the proton pump (H + / K + -ATPase); is metabolized in parietal cells of the stomach to active sulfonamide derivatives, which inactivate H + / K + -ATPase. 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 secretion of hydrochloric acid are dose-dependent: the pH begins to grow after 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. It promotes the formation in the gastric mucosa of specific IgA to Helicobacter pylori, suppressing their growth, increases the anti-Helicobacter pylori 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 peptic ulcer of the stomach and duodenum resistant to blockers of H2-histamine 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
Kparitromycin
When administered orally, clarithromycin is rapidly 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 (C max ) are recorded. 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 (TCmax ) with a single administration of 500 mg of clarithromycin - 2-3 hours.
Clarithromycin is metabolized in the cytochrome P450 system with the participation of the CYP3A isoenzyme, is an inhibitor of the CYP3A4, CYP3A5, CYP3A7 isoenzymes. After ingestion, 20% of the dose is rapidly hydroxylated in the liver to form the main metabolite -14 (R) -hydroxyclarithromycin.
At equilibrium, the concentration of 14 (R) -hydroxyclarithromycin does not increase in proportion to the doses of clarithromycin, and the half-life (T 1/2 ) of clarithromycin and its main metabolite increases with increasing dose. The non-linear nature of the pharmacokinetics of clarithromycin is associated with a decrease in the formation of 14 (R) -hydroxyclarithromycin and N-demethylated 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 (C ss ) of the unchanged drug and its main metabolite in blood plasma are -2.7-2.9 Ојg / ml and 0.83-0.88 Ојg / ml, respectively; the half-life (T 1/2 ) is 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. The time to reach the maximum concentration (TC max ) is 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 is found in blood plasma, sputum, bronchial secretion (in the purulent bronchial secretion is weak), pleural and peritoneal fluid, urine, skin blisters, lung tissue, intestinal mucosa, female genital organs, prostate gland , 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 (T 1/2 ) 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. The pharmacokinetics of lansoprazole, such as the maximum plasma concentration ( Cmax ) 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%. The time to reach the maximum concentration (TC max ) after oral intake of 30 mg is 1.5-2.0 hours, the maximum concentration (Cmax ) is 0.75-1.15 mg / l. Lansoprazole penetrates well into tissues, including the lining 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 CYP2C19 isoenzyme. The CYP3A4 isozyme can also be involved 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 two active substances, but not detectable in the systemic circulation.
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 period (T 1/2 ) is 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 Helicobacter pylori infection).
DOSING MODE
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 В® 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 EFFECT
The undesirable phenomena listed below 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 from the blood and lymphatic system: infrequently - leukopenia, neutropenia, thrombocythemia, eosinophilia; frequency unknown - agranulocytosis, thrombocytopenia.
Disorders from the immune system: 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).
Mental disorders: often - insomnia; infrequently - anxiety, nervousness; frequency is 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.
Disturbances from the organ of hearing and labyrinthine disturbances: infrequently -verting, hearing impairment, noise, ringing in the ears; frequency unknown - hearing loss (passing after withdrawal of the drug).
Heart disorders: infrequent - prolongation of QT interval on electrocardiogram, palpitation; frequency unknown - ventricular tachycardia of the type "pirouette", ventricular tachycardia, flutter and fibrillation of the ventricles.
Violations from the vessels: the frequency is 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.
Disorders from the liver and biliary tract: often - an atypical functional test of the liver; infrequently - cholestasis, hepatitis, increased ALT activity, increased ACT activity, increased GGT activity; 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.
Disorders from the 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, kidney failure, interstitial nephritis.
General disorders and disorders at the injection site: infrequently - malaise, fever, asthenia, chest pain, chills, weakness.
Laboratory indicators: infrequently - increased activity of alkaline phosphatase, increased activity of LDH of blood; very rarely hypercreatininaemia; 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.
Violations from the blood and lymphatic system: rarely-eosinophilia, hemolytic anemia; very rarely - leukopenia, neutropenia, graylulocytopenia, thrombocytopenia, pancytopenia, anemia, myelosuppression, agranulocytosis, reversible increase in prothrombin time and bleeding time.
Disorders from the immune system: rarely - laryngeal edema, serum sickness, allergic purpura, anaphylactic reaction.
Disorders from the nervous system: infrequently - headache; seldom-excitement, 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 biliary tract: infrequently - a reversible increase in the activity of "liver" transaminases; rarely - hepatitis, cholestatic jaundice.
Violations of the skin and subcutaneous tissue disorders: often - skin rash, pruritus, urticaria; rarely - angioedema (Quincke's edema), polymorphic erythema, acute generalized exanthematous pustulosis, toxic epidermal necrolysis (Lyell's syndrome), malignant exudative erythema (Stevens-Johnson syndrome), exfoliative dermatitis and bullous.
Violations by the kidneys: rarely - acute interstitial nephritis, crystalluria.
General disorders and at the injection site: seldom - a drug fever.
Lansoprazole
Violations of the blood and lymphatic system: rarely - thrombocytopenia, eosinophilia, leukopenia; rarely - anemia; very rarely - agranulocytosis, pancytopenia.
Disorders of immune system: very rarely - anaphylactic shock.
Violations by the Metabolism and nutrition: rarely - anorexia; the frequency is unknown - hypomagnesemia.
Mental disorders: rarely - depression; rarely - insomnia, hallucinations, confusion.
Disorders of the nervous system: often - headache, dizziness; rare - anxiety, vertigo and paresthesia, somnolence, tremor.
Violations by the organ of vision: rarely - visual disturbances.
Disorders of the gastrointestinal tract:often - nausea, diarrhea, abdominal pain, constipation, vomiting, flatulence, dry mouth or throat; rarely - glossitis, candidiasis of the esophagus, pancreatitis, impaired perception of flavor; very rarely - colitis, stomatitis.
Violations of the liver and biliary tract: often - increased activity of "liver" transaminases; rarely - hepatitis, jaundice; very rarely - hyperbilirubinemia.
On the part of the respiratory system: rarely - cough, pharyngitis, rhinitis, upper respiratory tract infection, flu-like syndrome.
Violations of the skin and subcutaneous tissue disorders: often - urticaria, pruritus, rash; rarely - petechiae, purpura, alopecia, angioedema (Quincke's edema), polymorphic erythema, photosensitization; rarely -zlokachestvennaya erythema multiforme (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome).
Violations of the musculoskeletal and connective tissue disorders: rarely - arthralgia, myalgia, fracture of the hip, wrist or spine.
Violations by the kidneys and urinary tract: rarely - interstitial nephritis.
Violations by the genitals and breast: rare - a gynecomastia, impotence.
General disorders and the site of injection:often - weakness; Infrequent - edema rarely - fever, increased sweating.
Laboratory findings: very rarely - increased cholesterol and triglyceride levels, hyponatremia.
CONTRAINDICATIONS
- hypersensitivity to any component of drugs (base material and / or auxiliary components), a macrolide, a penicillin, cephalosporin, carbapenems;
- concomitant use of clarithromycin with the following medicines: astemizole, cisapride, pimozide, terfenadine; with ergot alkaloids, for example ergotamine, dihydroergotamine; with midazolam for oral use;
- simultaneous reception of clarithromycin with inhibitors of HMG-CoA reductase inhibitors (statins), which largely metabolized isoenzyme CYP3A4 (lovastatin, simvastatin), due to an increased risk of myopathy, including rhabdomyolysis;
- concomitant use of clarithromycin with colchicine in patients with impaired liver and kidney function;
- presence in patients with a history lengthening QT interval,
ventricular fibrillation or ventricular tachycardia type "pirouette";
- patients with hypokalemia (risk lengthening QT interval);
- patients with severe hepatic insufficiency, to run concurrently with renal insufficiency;
- patients with cholestatic jaundice / history of hepatitis, which developed when using clarithromycin;
- with porphyria;
- during pregnancy and breastfeeding;
- patients with atopic dermatitis, bronchial asthma, hay fever, infectious mononucleosis, lymphocytic leukemia, hepatic insufficiency, gastrointestinal diseases in history (especially colitis associated with the use of antibiotics),
- children's age till 18 years;
- the presence of sucrase / isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption.
Carefully
Renal failure secondary to severe liver failure secondary to severe, myasthenia gravis (possibly increased symptoms), simultaneous with drugs that are metabolized isoenzyme CYP3A (e.g., carbamazepine, cilostazol, cyclosporine, disopyramide, methylprednisolone, omeprazole, oral anticoagulants (e.g. , warfarin), quinidine, rifabutin, sildenafil, tacrolimus, vinblastine); simultaneous with drugs that induce isoenzyme CYP3A4 (e.g., rifampicin, phenytoin, carbamazepine, phenobarbital, St. John's wort); simultaneous with benzodiazepines, such as alprazolam, triazolam, midazolam for intravenous administration; simultaneous with calcium channel blockers that are metabolized isoenzyme CYP3A4 (e.g., verapamil, amlodipine, diltiazem);Patients with coronary heart disease (CHD), severe cardiac insufficiency, hypomagnesemia, severe bradycardia (less than 50 beats / min) and patients taking concomitant antiarrhythmics IA class drugs (quinidine, procainamide) and IIIklassa (dofetilide, amiodarone, sotalol) older age, a history of bleeding, allergic reactions (including history), concomitant therapy with clopidogrel.
PREGNANCY AND LACTATION
The drug Lantsid В® Kit is contraindicated in pregnancy and during breastfeeding.
APPLICATION FOR FUNCTIONS OF THE LIVER
To use caution in patients with renal failure, moderate and severe.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
To use caution in hepatic failure secondary to severe.
APPLICATION FOR CHILDREN
Do not use this drug in children under the age of 18 years.
APPLICATION IN ELDERLY PATIENTS
Precautions should use the drug in elderly patients.
SPECIAL INSTRUCTIONS
Before therapy is necessary to exclude the presence of malignant process (especially gastric ulcer), as well as treatment, masking symptoms, may delay the correct diagnosis.
Clarithromycin
Long-term use of antibiotics can lead to the formation of colonies with increased amounts of non-susceptible bacteria and fungi. By superinfection necessary to assign appropriate therapy.
In the application of clarithromycin reported hepatic dysfunctions (hepatic enzyme increase in concentration in blood plasma, hepatocellular and / or cholestatic hepatitis with jaundice or without). Hepatic dysfunction may be severe, but is usually reversible. There are cases of liver failure fatal, mainly due to the presence of serious opportunistic diseases and / or simultaneous use of other drugs. If signs and symptoms of hepatitis, such as anorexia. jaundice, dark urine, tenderness on palpation of the abdomen, you must immediately discontinue therapy with clarithromycin.
In the presence of chronic liver disease must regularly monitor blood plasma enzymes.
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.
Antibacterials can change the normal intestinal flora, which can lead to the growth of Clostridium difficile. Pseudomembranous colitis caused by Clostridium difficile, is necessary at all suspect patients experiencing diarrhea appearance after application of antibacterial agents. After a course of antibiotic therapy requires careful medical supervision of the patient. Described cases of pseudomembranous colitis after 2 months after taking antibiotics.
Clarithromycin should be used with caution in patients with coronary heart disease (CHD), severe cardiac insufficiency, hypomagnesemia, severe bradycardia (less than 50 beats / min), and while the use of antiarrhythmic IA class drugs (quinidine, procainamide) and Class III ( dofetilide, amiodarone, sotalol). Under these conditions and at the same time taking clarithromycin with these drugs should be regularly monitoring the electrocardiogram for increasing the interval QT.
Perhaps the development of cross-resistance to clarithromycin and other macrolide antibiotics, as well as lincomycin and clindamycin.
In case of acute hypersensitivity reactions, such as anaphylaxis, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms (DRESS-syndrome), Henoch-Schonlein, you must immediately stop taking clarithromycin and start appropriate therapy.
In patients taking clarithromycin, reported an exacerbation of symptoms of myasthenia gravis.
In the case of joint use with warfarin or other indirect anticoagulants is necessary to monitor the prothrombin time MHOi.
amoxicillin
Before taking amoxicillin is necessary to collect detailed history concerning previous hypersensitivity reactions to penicillins, cephalosporins, or other allergens. Described serious, and sometimes fatal hypersensitivity reactions (anaphylaxis) to penicillin. The risk of such reactions is highest in patients who have a history of hypersensitivity to penicillins. In the case of allergic reactions should stop taking amoxicillin and begin antibiotic treatment of the other group. In severe hypersensitivity reactions should take appropriate measures immediately. It may also require administration of epinephrine, oxygen, intravenous corticosteroids and airway management, including intubation.
You must refrain from the use of amoxicillin in cases of suspected infectious mononucleosis, because patients with this disease can amoxicillin cause a rash morbilliform, difficult to diagnose.
Prolonged treatment with amoxicillin alone sometimes results in excessive propagation of microorganisms insensitive.
During application of amoxicillin to periodically evaluate the function of the kidneys, liver and hematopoiesis. Amoxicillin should be used with caution in patients with impaired hepatic function. Monitor liver function should be implemented on a regular basis. In patients with impaired renal function, the dose of amoxicillin should be reduced according to the degree violations.
Amoxicillin can induce nonspecific binding of immunoglobulins and albumins from erythrocyte membrane, which may cause false positive reaction in the test Coombs.
In patients with reduced urine output crystalluria occur very rarely. During the amoxicillin therapy are of utmost importance and adequate fluid intake to maintain adequate urine output.
Patients with cholangitis, cholecystitis or antibiotics can be administered only under mild flow conditions in the absence of cholestasis. During treatment with amoxicillin 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.
With continuing severe diarrhea should be suspected pseudomembranous colitis caused by antibiotics, which may endanger the patient's life (watery feces mixed with blood and mucus common obtuse or colicky abdominal pain, fever, sometimes tenesmus). In such cases, amoxicillin should be lifted immediately and assign specific with respect to the causal treatment, such as vancomycin. At the same time lowering agents perilstatiku gastrointestinal tract, are contraindicated. Excretion of Amoxicillin results in its high content in the urine, which can lead to false positive results in the determination of glucose in urine (e.g., sample Benedict, Fehling test). In this case it is recommended to use the glucose oxidase method for determining the concentration of glucose in the urine.
If necessary, the simultaneous use of amoxicillin with anticoagulants, prothrombin time and INR should be monitored closely in the appointment or revocation of amoxicillin.
With simultaneous use of estrogensoderjath oral contraceptives and amoxicillin should be possible to use other or additional contraceptive methods.
Particular caution is recommended that the patients with atopic diathesis or bronchial asthma, diseases of the gastrointestinal tract in history (in particular, colitis caused by antibiotic treatment).
Chronic administration of amoxicillin should appoint a Nystatin, Levorinum or other antifungals.
During treatment is not recommended to drink alcohol.
lansoprazole
It is recommended to avoid the combined use of proton pump inhibitors and clopidogrel. If concomitant use increases the risk of recurrent myocardial infarction, hospitalization for heart attack or unstable angina, stroke, repeat revascularization. When the absolute necessity of a joint appointment, patients should be monitored carefully.
It is recommended to avoid the combined use of proton pump inhibitors and antiretroviral agents in HIV-infected patients. If necessary, concomitant use with atazanavir / ritonavir is recommended that the 12-hour interval between doses of lansoprazole and these preparations, and does not exceed a dose of 30 mg lansoprazole.
When combined with the use of antiretroviral drugs (indinavir, nelfinavir, atazanavir) and ketoconazole, itraconazole, posaconazole, cefpodoxime, cefuroxime and ampicillin requires monitoring their performance and appearance of resistance.
The combined use of imatinib may increase the risk of adverse reactions (potential interaction via CYP3A4), especially in patients with severe allergic reactions in the anamnesis.
