Composition, form of production and packaging
Tablets and capsules set.
The tablets covered with a film membrane of light yellow color, are oval.
clarithromycin 500 mg
Excipients: croscarmellose sodium - 65.6 mg, microcrystalline cellulose - 183.9 mg, silicon dioxide - 12 mg, povidone - 25.5 mg, stearic acid - 21 mg, magnesium stearate 12.6 mg, talc - 29.4 mg.
Composition of the film membrane: hypromellose 22.1 mg, giprolose 1.7 mg, propylene glycol 14.62 mg, sorbitan oleate 1.7 mg, titanium dioxide 5.1 mg, sorbic acid 0.94 mg, vanillin 0.94 mg, quinoline yellow dye 0.07 mg.
Capsules hard gelatinous, size 1, with a body and a lid of pink color; the contents of the capsules are pellets of white or almost white color.
lansoprazole (in the composition of pellets 8.8%) 30 mg
Excipients: mannitol 189 mg, lactose monohydrate 26 mg, sucrose 52 mg.
The composition of the pellet shell: povidone - 14.9 mg, hypromellose phthalate - 34.3 mg, cetyl alcohol - 3.8 mg.
The composition of the capsule shell: 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 (Ponso 4R) 0.0078 mg, water 6.815 mg; lid gelatin 24.0376 mg, gatriya 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.
Capsules gelatinous, the size в„–0, with the case of yellow color and a cover of red color; the contents of the capsules - granular powder from white to light yellow color, it is allowed to have a pressed cylinder of powder, which when pressed with a glass rod turns into a free-flowing powder.
amoxicillin (in the form of amoxicillin trihydrate) 500 mg
Excipients: magnesium stearate - 9.2 mg, microcrystalline cellulose PH102 - 26.9 mg.
The composition of the capsule shell: titanium dioxide - 2.5866 mg, dye quinoline yellow - 0.5335 mg, dye Azorubin 0.4081 mg, Krustiel Crimson (Ponso 4R) 0.2974 mg, iron oxide yellow oxide 0.0008 mg, gelatin 97 mg.
Tab. clarithromycin (2 pcs.) + caps. lansoprazole (2 pcs.) + caps. amoxicillin (4 pcs.) - blisters (7) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2012.
For lansoprazole, clarithromycin, and amoxicillin, activity has been demonstrated for most strains of Helicobacter pylori both in vitro and in clinical settings.
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. The rate and degree of inhibition of basal and stimulated secretion of hydrochloric acid are dose-dependent: the pH begins to grow 2-3 hours after taking 30 mg; 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 admission. After discontinuation of the intake, the acidity for 39 hours remains below 50% of the basal value, there is no "ricochet" increase in secretion. Secretory activity is restored 3-4 days after the end of the drug. In patients with Zollinger-Ellison syndrome, it is more prolonged. Increases the concentration of pepsinogen in the blood serum 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. Effective in the treatment of peptic ulcer of the stomach and duodenum, resistant to blockers of histamine H 2 -receptors. Provides rapid healing of ulcerative defects in the duodenum (85% of duodenal ulcers heal after 4 weeks of treatment with a dose of 30 mg / day).
Antibacterial bactericidal acid-resistant broad spectrum agent from the group of semisynthetic penicillins. Inhibits the transpeptidase of bacteria involved in the synthesis of the bacterial cell wall; violates the synthesis of peptidoglycan (supporting cell wall protein) in the period of division and growth; causes bacterial lysis.
It is active against aerobic gram-positive bacteria: Staphylococcus spp. (with the exception of strains producing penicillinase), Streptococcus spp. and aerobic Gram-negative bacteria: Neisseria gonorrhoeae, Neisseria meningitidis, Escherichia coli, Shigella spp., Salmonella spp., Klebsiella spp. The microorganisms producing penicillinase are resistant to the action of amoxicillin.
Clarithromycin is a semisynthetic antibiotic in the macrolide group and has an antibacterial effect by interacting with the 50S ribosomal subunit and suppressing protein synthesis of bacteria sensitive to it.
Clarithromycin is highly effective in vitro for both standard laboratory strains of bacteria and isolated in patients in clinical practice. It is highly active against a wide range of aerobic and anaerobic, gram-positive and gram-negative microorganisms. The minimum inhibitory concentrations (MPC) of clarithromycin for most pathogens are less than the erythromycin MPC.
In vitro studies have shown that clarithromycin is highly active against Legionella pneumophila, Mycoplasma pneumoniae, but Enterobacteriaceae, Pseudomonas spp. and other non-fermenting lactose, gram-negative microorganisms, are immune to the action of clarithromycin. Clarithromycin has antibacterial action against Helicobacter pylori; the effect is enhanced at neutral and acidic pH values.
The activity of clarithromycin against most strains of the microorganisms listed below has been proven both in vitro, and in clinical practice for the diseases listed in the section "Indications for Use".
Aerobic Gram-positive microorganisms (Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus pyogenes).
Aerobic Gram-negative microorganisms (Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, Legionella pneumophila).
Other microorganisms (Mycoplasma pneumoniae, Chlamydia pneumoniae).
Mycobacterium (Mycobacterium kansasii, Mycobacterium chelonae, Mycobacterium fortuitum, Mycobacterium avium complex (MAC) - complex, including: Mycobacterium avium and Mycobacterium intracellulare).
Beta-lactamases do not affect the activity of clarithromycin. Most strains of staphylococcus aureus resistant to methicillin and oxacillin are resistant to clarithromycin.
The sensitivity of Helicobacter pylori to clarithromycin was studied on Helicobacter pylori isolates isolated from 104 patients, before the drug was started. In 4 of them, resistant strains of Helicobacter pylori, in 2 - strains with intermediate resistance, in the remaining 98 patients Helicobacter pylori were sensitive to clarithromycin.
Clarithromycin in vitro exhibits activity against most strains of the following microorganisms: aerobic Gram-positive microorganisms (Streptococcus agalactiae, Streptococcus spp., Group C, F, G, Streptococcus spp., Viridans, Listeria monocytogenes); aerobic gram-negative microorganisms (Bordetella pertussis, Pasteurella multocida, Neisseria gonorrhoeae); anaerobic Gram-positive microorganisms (Clostridium perfringens, Peptococcus niger, Propionibacterium acnes); anaerobic gram-negative microorganisms (Bacteroides melaninogenicus); spirochetes (Borrelia burgdorferi, Treponema pallidum); Campylobacter jejuni; Mycobacterium(Mycobacterium leprae).
The main metabolite of clarithromycin in the human body is the microbiologically active 14 (R) -hydroxy-clarithromycin (14-OH-clarithromycin), which is twice as active against the Naemophillus influenzae as the original compound. The parent compound (clarithromycin) and its metabolite in combination can have both additive and synergistic effects on Haemophilus influenzae in vitro and in vivo , depending on the strain of the bacterium.
Pharmacokinetics with the simultaneous use of all three components of the combined Heliotrix В® package has not been investigated. With simultaneous administration of clinically significant interaction between lansoprazole and amoxicillin, as well as between lansoprazole and clarithromycin was not noted. There is also no information on the concentrations of lansoprazole, amoxicillin and clarithromycin in the gastric mucosa during joint administration. The following data on systemic pharmacokinetics were obtained from the study of individual drugs.
Suction and distribution
Lansoprazole capsules contain lansoprazole granules coated with an enteric coating. Absorption of lansoprazole begins only after the granules of the drug enter the duodenum. The drug is characterized by rapid absorption, the average value of C max of lansoprazole in plasma was noted after approximately 1.7 hours. C max and AUC of lansoprazole were approximately proportional to a single oral administration of the drug at doses of 15 to 60 mg. For lansoprazole, cumulation is not characteristic; repeated administration does not affect its pharmacokinetics. The absolute bioavailability of lansoprazole is 80%. When taking the drug 30 minutes after eating, there was a decrease in C max and AUC in comparison with the administration of the drug on an empty stomach. The intake of the drug before meals did not have a significant effect on the pharmacokinetics.
97% of lansoprazole binds to plasma proteins. The binding of lansoprazole to plasma proteins was noted at concentrations ranging from 0.05 to 5.0 Ојg / ml.
Metabolism and excretion
Lansoprazole is characterized by a pronounced metabolism in the liver. In quantities above the detection threshold, 2 of its metabolites were identified in the plasma: hydroxylated sulfinyl- and sulphonated derivatives of lansoprazole. The antisecretory activity of these metabolites was very low or absent. The transformation of lansoprazole into two active forms, which are not present in the systemic blood flow, inhibiting the H + -K + -ATPase and the secretion of H + ions in parietal cells is proposed.
In healthy subjects, the mean T 1/2 was 1.5 (В± 1.0) h. T 1/2 of lansoprazole did not affect the duration of its effect on the secretion of hydrochloric acid in the stomach.Thus, T 1/2 of lansoprazole from plasma is less than 2 hours, while the duration of action on gastric secretion exceeds 24 hours. Lansoprazole is excreted predominantly by the intestine.
Pharmacokinetics in specific patient groups
In elderly patients there is a decrease in clearance of lansoprazole, while an increase in T 1/2 of 50-100% is noted. Due to the fact that the average value of T 1/2 in elderly patients remains at 1.9-2.9 h, re-taking the drug does not lead to its cumulation. For elderly patients, an increase in plasma concentrations of lansoprazole is not typical.
In patients with severe renal failure, when lansoprazole was taken in a dose of 60 mg, the binding of lansoprazole to plasma proteins was decreased by 1.0-1.5%. For patients with renal insufficiency, a decrease in T 1/2 and the total value of AUC (free and bound lansoprazole). However, the values вЂ‹вЂ‹of AUC for free lansoprazole in plasma did not correspond to the degree of renal dysfunction, with the values вЂ‹вЂ‹of C max and T max not different from those observed in patients without renal involvement.
In patients with chronic liver diseases of varying degrees, an increase in the mean T 1/2 lansoprazole from 1.5 h to 3.2-7.2 h. In patients with hepatic insufficiency in a stable state, the AUC values вЂ‹вЂ‹increased to 500% compared with healthy subjects. In patients with severe hepatic insufficiency, the possibility of reducing the dose of the drug should be considered.
The mean AUC values вЂ‹вЂ‹obtained for lansoprazole in patients from Asia exceeded those obtained in patients from the United States; However, there was a high variability in individual patients. Also comparable values вЂ‹вЂ‹of C max were obtained.
Suction and distribution
Amoxicillin maintains stability in the presence of hydrochloric acid of gastric juice, in addition it can be taken regardless of food intake. With oral intake, rapid absorption of amoxicillin is noted. When oral capsules containing 500 mg of amoxicillin, C max amoxicillin in plasma is 5.5 to 7.5 Ојg / ml 1-2 hours after taking the drug.
Amoxicillin binds to plasma proteins by 20%. Amoxicillin is characterized by rapid entry into most biological fluids and tissues except for the brain and cerebrospinal fluid (except for cases of meningitis).
T 1/2 amoxicillin is 61.3 minutes. Approximately 60% of amoxicillin for oral administration is excreted by the kidneys within 6-8 hours. Most of the amoxicillin is excreted by the kidneys unchanged; with the concomitant administration of probenecid, a decrease in the excretion of amoxicillin is possible.
Suction and distribution
Absolute bioavailability is about 50%. With repeated intake of a dose of cumulation is not found, and the nature of metabolism in the human body has not changed.
Eating directly before taking clarithromycin increases the bioavailability of clarithromycin by 25%. In general, this increase is insignificant and has little clinical significance with the correct intake of the recommended dose. Thus, clarithromycin can be taken with or without food.
In vitro studies showed that on average about 70% of clarithromycin binds to human serum proteins at concentrations of 0.45-4.5 Ојg / ml. When the concentration increased to 45.0 Ојg / ml, the binding of clarithromycin decreased to 41%, which may indicate saturation of the binding sites. This phenomenon was observed only at concentrations of clarithromycin, significantly exceeding therapeutic.
When clarithromycin was administered at a dose of 500 mg 2 times / day, Css max of clarithromycin and 14-hydroxyclarithromycin in plasma were achieved after taking the 5th dose and averaged 2.7-2.9 Ојg / ml and 0.88-0.83 Ојg / ml, respectively.
Clarithromycin and 14-hydroxyclarithromycin are widely distributed in tissues and body fluids. After oral administration of clarithromycin, its content in the cerebrospinal fluid remains low (at normal permeability of the BBB 1-2% of the value in the blood serum). The content in the tissues is usually several times larger than the content in the serum.
Metabolism and excretion
Clarithromycin is metabolized in the cytochrome P450 3A system (isoenzyme CYP 3A) of the liver.
In the equilibrium state, the concentration of 14-hydroxyclarithromycin does not increase in proportion to the doses of clarithromycin, while T 1/2 of clarithromycin and its main metabolite increase with increasing doses. The non-linear nature of the pharmacokinetics of clarithromycin is associated with a decrease in the formation of 14-hydroxylated and N-demethylated metabolites with higher doses, which indicates the non-linearity of clarithromycin metabolism when taking high doses.
T 1/2 of clarithromycin and its main metabolite were 4.5-4.8 h and 6.9-8.7 h, respectively,
The kidneys excreted about 37.9% after taking 250 mg and 46% after taking 1200 mg of clarithromycin, through the intestines - about 40.2% and 29.1%, respectively.
Pharmacokinetics in specific patient groups
In patients with moderate and severe impairment of the functional state of the liver, but with preserved renal function, correction of the dose of clarithromycin is not required. C ss in the blood plasma and the systemic clearance of clarithromycin is not different in patients of this group and healthy patients. The equilibrium concentration of 14-hydroxyclarithromycin in people with impaired liver function is lower than in healthy people.
If the renal function is impaired, the minimum and maximum content of clarithromycin in the blood plasma, T 1/2 , AUC of clarithromycin and the 14-OH metabolite increases. The elimination constant and excretion in the urine are reduced. The degree of changes in these parameters depends on the degree of impaired renal function.The decreased excretion of the 14-hydroxylated metabolite was partially compensated by the increased excretion of clarithromycin by the kidneys, as a result of which the C ss of clarithromycin differed insignificantly in the two groups. These studies show that for patients with moderate and severe impairment of liver function, but with healthy kidneys, dose adjustment is not needed.
After repeated use in elderly patients, the concentration of clarithromycin and its 14-OH metabolite in the blood is higher, and excretion is slower than in a group of young people. Changes in pharmacokinetics in elderly patients are associated primarily with changes in QC and functional state of the kidneys, and not with the age of patients.
- eradication Helicobacter pylori to reduce the recurrence rate of duodenal ulcers.
The drug should be taken orally before meals. It is necessary to swallow each pill and capsule in its entirety.
Recommended dose for adults : clarithromycin 500 mg (1 tab.), Amoxicillin 1000 mg (2 caps.), Lansoprazole 30 mg (1 caps.) 2 times / day (morning and evening) for 7-14 days.
The most common side effects observed in clinical trials with simultaneous administration of all three components of the drug for 14 days were diarrhea, headache, and taste disorders.
The following side effects reflect the side effects of each drug combination packaging Helitriks В® .
Cardio-vascular system: angina, arrhythmias, bradycardia, cerebrovascular accident / stroke, raising and lowering of blood pressure, migraine, myocardial infarction, shock (circulatory failure), syncope, tachycardia, vasodilatation, ventricular tachycardia, including type "pirouette", atrial and ventricular fibrillation, an increase in the QT interval on the electrocardiogram.
From the digestive system:nausea, abdominal pain, bloating, vomiting, diarrhea, dyspepsia, dysphagia, enteritis, regurgitation, stenosis of the esophagus, constipation, anorexia, dry mouth, thirst, esophageal ulcers, esophagitis, changes in stool color, bloating, discoloration of teeth, bezoar formation, cardia spasm, increased liver enzymes, acute pancreatitis, colitis (including ulcerative, hemorrhagic / pseudomembranous), gastric nodules / fundus gland polyps, gastritis, gastroenteritis, gastrointestinal abnormalities, perianal itch, gastrointestinal diseases , color change dental, gastro-intestinal bleeding, bleeding gums, vomiting of blood, increased appetite, hypersalivation, tarry stools, oral ulcers, the pathology of the rectum, rectal bleeding, tenesmus, language disorders, glossitis, stomatitis (including ulcerative), candidiasis oral mucosa,discoloration tongue and teeth, hepatotoxicity, liver failure, hepatitis, cholelithiasis, cholestatic hepatitis, cytolytic hepatitis, hepatocellular and cholestatic jaundice, liver function abnormalities. In very rare cases have been reported cases of hepatic failure with a fatal outcome is mainly against the background of severe concomitant diseases and / or concomitant medication.
The respiratory system: asthma, bronchitis, cough increased, dyspnea, epistaxis, hemoptysis, hiccups, throat tumors, pharyngitis, pleural disease, pneumonia, respiratory pathology, inflammation / upper respiratory tract infection, rhinitis, sinusitis, wheezing.
From a metabolism (metabolism disorders and nutrition): gout, dehydration, peripheral edema, hyperglycemia / hypoglycemia, increase / decrease in body weight.
From endocrine system: diabetes, goiter, hypothyroidism.
With the genitourinary system:interstitial nephritis, breast enlargement, breast pain, breast sensitivity, dysmenorrhea, dysuria, gynecomastia, impotence, nephrolithiasis, leucocyturia, menorrhagia, penis disorders, polyuria, testicular disease, pain in the urethra, frequent urination, urinary tract infection, urinary incontinence, impaired urination, vaginitis, crystalluria.
On the part of the musculoskeletal system: arthralgia, arthritis, bone disease, joint disease, lower limb spasms, musculoskeletal pain, myalgia, myositis, myasthenia, synovitis.
From the nervous system:headaches, psychotic disorders, dizziness, anxiety, insomnia, nightmares, ringing in the ears, depersonalization, hallucinations, confusion, depression, seizures, psychosis, agitation, reversible hyperactivity, amnesia, apathy, confusion, double vision, emotional lability, hemiplegia, increased aggressiveness, hyperkinesia, hypoesthesia, decrease / increase in libido, nervousness, neurosis, paresthesia, sleep disturbance, drowsiness, abnormal thinking, tremor.
From the senses:deafness, vertigo, loss of smell, distortion of the olfactory sensations, blurred vision, blurred vision, conjunctivitis, dry eye, the organ of hearing disorders, eye pain, otitis media, parosmiya, photophobia, retinal degeneration, distortion or loss of taste, lack of taste perception, ringing in the ears.
Skin: acne, alopecia, contact dermatitis, dry skin, hair diseases, nail diseases, itching, skin cancer, skin diseases, increased sweating.
Allergic reactions:hypersensitivity reactions (serum sickness, and similar reactions, maculopapular rash, erythema multiforme, Stevens-Johnson syndrome, exfoliative dermatitis, acute generalized exanthematous pustulosis, vasculitis, hypersensitivity and urticaria, toxic epidermal necrolysis (sometimes fatal), anaphylactic reactions.
General : asthenia, candidiasis, back pain, chest pain (unspecified), fever, edema, fever, flu-like syndrome, halitosis, an infection (unspecified) is not domogany, neck pain, stiffness in the neck muscles, pain (unspecified), pain in the pelvic region.
From the laboratory parameters:increase in ACT and ALT activity, increased ALP activity, increasing concentrations of globulin, anemia (including aplastic, hemolytic), hemolysis, lymphadenopathy, thrombocytopenia, increased creatinine in blood, hypoglycemia (while taking hypoglycemic drugs), agranulocytosis, neutropenia , pancytopenia, anemia and thrombocytopenic purpura, increased GGT activity, increase / decrease / violation leukocytes ratio change albumin / globulin ratio, changing the content of erythro itov, hyperbilirubinemia, eosinophilia, hyperlipidemia, increase / decrease in the level of electrolytes, the increase / decrease in the concentration of cholesterol, the increase in the content of glucocorticoids, increased LDH activity, increase / decrease / presence of abnormal platelet increasing the concentration of gastrin.It was also reported cases of violations of the composition of the urine in the form of albuminuria, glycosuria, and hematuria. In addition, there are reports of changes in certain laboratory parameters.
AIDS patients and other immunocompromised patients received clarithromycin increased doses for a long time for the treatment of mycobacterial infections. It was often difficult to distinguish adverse effects possibly associated with taking clarithromycin, from the main symptoms of HIV disease and accidental. For adult patients who received a total of 1000 mg clarithromycin per day, the most common side effects were nausea, vomiting, dysgeusia, abdominal pain, diarrhea, rash, flatulence, headache, constipation, hearing impairment, increased ACT activity and ALT. We met the following side effects: shortness of breath, insomnia, dry mouth, a significant reduction in the number of white blood cells and platelets, increasing concentrations of urea in blood.
- allergic diathesis, bronchial asthma, hay fever;
- Infectious mononucleosis;
- lymphocytic leukemia;
- simultaneous reception of the following drugs: astemizole, cisapride, pimozide, terfenadine, ergotamine, dihydroergotamine (see "Interaction with other drugs.");
- simultaneous reception of the following drugs: alprazolam, midazolam, triazolam (oral dosage form);
- severe renal impairment (creatinine clearance less than 30
mL / min);
- gastrointestinal malignancies;
- lactose intolerance, lactase deficiency, glucose-galactose malabsorption, fructose intolerance, lack of sucrase / isomaltase;
- age under 18 years (effectiveness and safety not established);
- I trimester of pregnancy;
- the period of breastfeeding;
- installed hypersensitivity to any component of the drug combination packaging drugs macrolide, penicillins, cephalosporins, carbapenems.
With caution should be prescribed for violations of liver function, kidney function disorders of moderate and severe, patients of advanced age (over 65 years), since there may be asymptomatic disorders of the liver and kidneys, in myasthenia gravis (possibly increased symptoms), bleeding history during II and III trimester of pregnancy, simultaneous administration with drugs that are metabolized by the liver (see. "Interaction with other drugs").
PREGNANCY AND LACTATION
Application in I trimester of pregnancy is contraindicated.
Application in II and III trimester of pregnancy is possible only if the potential benefit to the mother outweighs the potential risk to the fetus and / or no safer alternative therapy drugs.
If pregnancy occurs during use of the drug, the drug should be discontinued.
It is known that clarithromycin is excreted in breast milk. During the period of lactation should be discontinued breastfeeding.
APPLICATION FOR FUNCTIONS OF THE LIVER
Is contraindicated in severe renal failure (creatinine clearance less than 30 mL / min). With caution should appoint a drug in renal impairment moderate and severe.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
With caution should be given the drug in the human liver.
APPLICATION FOR CHILDREN
Contraindicated in children and adolescents under 18 years.
APPLICATION IN ELDERLY PATIENTS
With care should be prescribed to elderly patients (over 65 years), as there may be asymptomatic human liver and kidneys.
In the course of treatment should take into account the possibility of fungal or bacterial superinfection. In the event of superinfection should stop taking the drug Helitriks В® and start appropriate therapy.
Improvement of clinical symptoms while taking the drug does not indicate the absence of cancer process in the stomach. Clinical improvement when using the drug in the absence of confirmed or suspected on the basis of objective evidence of bacterial infection and also for the prevention unlikely; In addition, while there is an increase risk of antibiotic-resistant strains.
In applying the drug Helitriks В®Patients should be advised of the need for the full course of antibiotic treatment, despite repeated improvements in the early antibiotic therapy. Skipping ingestion or incompleteness of the full course of treatment can reduce the efficiency and increase the probability of occurrence of strains resistant to the drug Helitriks В® and the other antibiotics.
can be expected that, as the reception of other penicillins, the majority of adverse events will be presented to the phenomena of hypersensitivity. Most often these phenomena have been reported in patients with previous hypersensitivity to penicillins were recorded, as well as in patients with allergic diseases, bronchial asthma, hay fever or a history of urticaria.
Control hypersensitivity reactions (see. The section "Side effects") can be achieved by administering an antihistamine and optionally systemic glucocorticoids. If you have any of these reactions require the cancellation of amoxicillin, except in cases where, in the opinion of the physician, the patient's condition is life-threatening and is effective only with amoxicillin therapy.
There are reports of severe and fatal (rare) cases of hypersensitivity reactions (anaphylaxis) in patients treated with drugs penicillin, despite the fact that anaphylactic reactions tend to occur upon parenteral administration, they have been reported in patients treated with drugs penicillin orally.
These reactions are more frequent in patients with hypersensitivity to the drug penicillin in history and / or in patients with polyvalent allergy.
There are reports of the development of severe hypersensitivity reactions occurring in patients treated with cephalosporins with hypersensitivity to penicillins history. Before initiation of therapy should be to conduct a thorough survey of previous hypersensitivity reactions induced by administration of penicillins, cephalosporins, as well as exposure to other allergens. If you experience an allergic reaction, discontinue use of the drug and begin the appropriate therapy.
With the development of severe anaphylactic reactions requiring emergency treatment with epinephrine, oxygen, on / in the glucocorticoids when indicated should conduct airway, including with intubation.
the possibility of cross resistance between clarithromycin and other macrolide drugs group, as well as lincomycin and clindamycin.
Long-term use of clarithromycin, like other antibiotics, can cause colonization with increasing number of refractory bacteria and fungi. Adequate therapy should be instituted with the appearance of secondary infection.
In the treatment of nearly all antibacterial agents are described cases of pseudomembranous colitis, the severity of which can range from mild to life-threatening. One of the symptoms of pseudomembranous colitis is diarrhea caused by Clostridium difficile. Therefore, the appearance of diarrhea should be considered the possibility of this disease after use 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.
Infections caused by Mycobacterium avium
The equilibrium concentrations of clarithromycin and 14 hydroxyclarithromycin obtained for adult patients with HIV infection when receiving 500 mg every 12 hours, similar to those obtained for uninfected patients. However, at higher doses, which may be required for the treatment of infections caused by Mycobacterium avium, clarithromycin concentrations were significantly higher than in normal doses. In adult patients with HIV infection who received 1000 and 2000 mg / day, divided into 2 intakes, the values C ss max clarithromycin was varied from 2 to 4 mg / ml and 5 to 10 mg / ml, respectively. It was found that T 1/2increased at higher doses as compared to conventional doses in normal conditions. These higher concentrations of plasma and increased half-life obtained for these dosage confirm the known data on the nonlinearity in the pharmacokinetics of clarithromycin.
Impact on the ability to drive vehicles and manage mechanisms
During the period of treatment must be careful when driving and occupation of other potentially hazardous activities that require high concentration and speed of psychomotor reactions, because the drug can cause dizziness and other side effects that may affect these abilities.
Research ability to drive vehicles and management mechanisms are not carried out.
In case of overdose, the patient should seek medical help from a doctor. Pharmacological background, as well as studies indicating increased toxicity drug combination compared with the individual components are absent.
Lansoprazole is not removed from the bloodstream by means of