Lancid Kit, a set of tablets and capsules 56 pcs.

Lancid is an antiulcer.

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

Pharmacodynamics

With high lipophilicity, easily penetrates into the parietal cells of the stomach, concentrates in them, has cytoprotective effect, increases bicarbonate secretion. Inhibition of hydrochloric acid formation 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. The secretory activity is restored in 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 h and is 0.75-1.15 mg/L. Binding to plasma proteins is 98%. T1/2 – 1.3-1.7 h (increases in renal dysfunction and elderly).

It is actively metabolized by primary passage through the liver. It is excreted by the kidneys as metabolites (14-23%) and by the intestine.

Indications

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

Active ingredient

Composition

Tablets

The active ingredient:

clarithromycin 500 mg;

Associates:

Microcrystalline cellulose 31.5 mg,

Corn starch 8.9 mg,

sorbic acid 1.1 mg,

sorbitan a oleate 2 mg,

povidone 30 mg,

p> colloidal silicon dioxide 8 mg,

magnesium stearate 11 mg,

talc 24 mg,

croscarmellose sodium 55 mg,

stearic acid 20 mg;

Composition of the film coating:

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

Capsules

Active substanceant:

amoxicillin 500 mg;

Associates:

magnesium stearate 5 mg,

talc 8 mg,

sodium lauryl sulfate 3 mg.

Capsule cap composition:

propylparahydroxybenzoate 0.2 mg, methylparahydroxybenzoate 0.8 mg, water 14-15 mg, gelatin q.s, titanium dioxide 0.8132 mg, brilliant 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;

Composition of black ink:

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

Capsules enteric soluble

Active ingredient:

lansoprazole 30 mg;

Supplementary substances:

Mannitol 41.11 mg,

sucrose 123.22 mg,

povidone 1.09 mg,

sucrose microspheres 38.19 mg,

sodium hydrophosphate 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 phthalate 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;

How to take, the dosage

Ingestion. Take 500 mg (1 tablet) of clarithromycin, 1000 mg of amoxicillin (2 capsules), and 30 mg of lansoprazole (1 capsule), twice daily, morning and evening before meals.

The tablets and capsules must not be crushed or chewed, they should be swallowed whole. The duration of treatment is 7 days; if necessary, it may be increased up to 14 days.

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

Interaction

Clarithromycin

The co-administration of clarithromycin and drugs that are primarily metabolized by CYP3A isoenzymes may result in increased concentrations, which may increase or prolong both therapeutic and adverse effects. Co-administration with astemizole, cisapride, pimozide, terfenadine, ergotamine and other ergot alkaloids, alprazolam, midazolam, triazolam is contraindicated.

. Use with caution with carbamazepine, cilostazol, cyclosporine, disopyramide, lovastatin, methylprednisolone, omeprazole, indirect anticoagulants (including warfarin), quinidine, rifabutin, sildenafil, simvastatin, tacrolimus, vinblastine, phenytoin, theophylline and valproic acid (metabolized through other cytochrome P450 isoenzymes). Correction of the dose of drugs and monitoring of plasma concentrations is necessary.

Special Instructions

Before starting therapy, malignancy must be ruled out (especially with gastric ulcers), because treatment, by masking symptoms, can delay a correct diagnosis.

Clarithromycin

Long-term antibiotic use may lead to colonies with increased numbers of insensitive bacteria and fungi. Appropriate therapy should be prescribed if superinfection occurs.

Hepatic dysfunction (increased plasma hepatic enzyme concentrations, hepatocellular and/or cholestatic hepatitis with or without jaundice) has been reported with clarithromycin. Liver dysfunction can be severe, but is usually reversible. There are cases of hepatic failure with fatal outcome, mainly associated with the presence of serious comorbidities and/or concomitant use of other drugs. In case of signs and symptoms of hepatitis, such as anorexia. jaundice, darkened urine, abdominal pain on palpation, clarithromycin therapy should be stopped immediately.

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

In treatment with virtually all antibacterials, including clarithromycin, there have been cases of pseudomembranous colitis, which can range in severity from mild to life-threatening.

Antibiotic drugs can change the normal gut microflora, which can lead to growth of Clostridium difficile. Pseudomembranous colitis caused by Clostridium difficile should be suspected in all patients who experience diarrhea after using antibiotics. After a course of antibiotic therapy, careful medical follow-up of the patient is necessary. Cases of pseudomembranous colitis have been described 2 months after antibiotic treatment.

Clarithromycin should be used with caution in patients with coronary heart disease (CHD), severe heart failure, hypomagnesemia, severe bradycardia (less than 50 bpm), and concomitant use with class IA (quinidine, procainamide) and class III (dofetilide, amiodarone, sotalol) antiarrhythmic drugs. In these conditions and when concomitant administration of clarithromycin with these drugs, regular monitoring of electrocardiogram for QT interval prolongation should be performed.

Cross-resistance to clarithromycin and other macrolide antibiotics and to lincomycin and clindamycin may develop.

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), Schoenlein-Henoch purpura, clarithromycin should be stopped immediately and appropriate therapy initiated.

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

In case of co-administration with warfarin or other indirect anticoagulants, the INR and prothrombin time should be monitored.

Amoxicillin

Before starting amoxicillin administration, a detailed history should be taken regarding 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, amoxicillin should be discontinued and therapy with antibiotic of other group should be started. In severe hypersensitivity reactions, appropriate measures should be taken immediately. Epinephrine, oxygen therapy, intravenous glucocorticosteroids, and airway support, including intubation, may also be required.

The use of amoxicillin should be withheld if infectious mononucleosis is suspected, since in patients with this disease amoxicillin may cause a rash of the skin, making diagnosis difficult.

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

When using amoxicillin, it is recommended to periodically assess the function of the kidneys, liver and hematopoiesis. Amoxicillin should be used with caution in patients with liver dysfunction. Monitoring of liver function should be carried out on a regular basis. In patients with impaired renal function the dose of amoxicillin should be reduced according to the degree of impairment.

Amoxicillin may provoke nonspecific binding of immunoglobulins and albumin to the red blood cell membrane, which may cause false positive reaction in Coombs test.

In patients with decreased diuresis, crystalluria is very rare. Adequate fluid intake and maintenance of adequate diuresis are extremely important during therapy with amoxicillin.

Patients with cholangitis or cholecystitis can be treated with antibiotics only if the disease is mild and there is no cholestasis. During therapy with amoxicillin it is necessary to remember about possible development of superinfection (usually caused by bacteria of Pseudomonas spp. or Candida fungi). In this case the therapy with amoxicillin should be discontinued and/or appropriate treatment should be prescribed.

In case of persistent severe diarrhea pseudomembranous colitis caused by antibiotics should be suspected, which may be life-threatening for the patient (watery stool with a mixture of blood and mucus; blunt widespread or colic-like abdominal pain; fever, sometimes tenesmus). In such cases, amoxicillin should be immediately discontinued and treatment specific to the pathogen, such as vancomycin, should be prescribed. At the same time, agents that reduce gastrointestinal peristalsis are contraindicated. Excretion of amoxicillin leads to its high content in the urine, which may lead to false-positive results in the determination of glucose in the urine (e.g., Benedict test, Feling test). In this case it is recommended to use glucose oxidase method to determine the concentration of glucose in urine.

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

When concomitant use of estrogen-containing oral contraceptives and amoxicillin, other or additional methods of contraception should be used if possible.

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

In case of long-term use of amoxicillin, nystatin, levorin or other antifungal drugs should be prescribed simultaneously.

Alcohol consumption is not recommended during treatment.

Lansoprazole

The co-administration of proton pump inhibitors and clopidogrel is recommended to be avoided. Co-administration increases the risk of recurrent myocardial infarction, hospitalization for heart attack or unstable angina, stroke, and repeat revascularization. Patients should be closely monitored if co-prescribing is absolutely necessary.

The co-administration of proton pump inhibitors and antiretroviral drugs in HIV-infected patients should be avoided. If coadministration with atazanavir/ritonavir is necessary, a 12-hour interval between administration of lansoprazole and these drugs is recommended, and the dose of lansoprazole 30 mg should not be exceeded.

When co-administered with antiretrovirals (indinavir, nelfinavir, atazanavir) as well as ketoconazole, itraconazole, posaconazole, cefpodoxime, cefuroxime and ampicillin, their effectiveness and appearance of resistance should be monitored.

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

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

In patients taking warfarin concomitantly, prothrombin time and MHO should be monitored.

Long-term use of proton pump inhibitors increases the risk of infection (including Salmonella, Campylobacter, Clostridium difficile). The benefit of upper gastrointestinal bleeding prophylaxis must be weighed against the potential risk of ventilator-associated pneumonia.

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

Alcoholic beverages should be avoided during treatment.

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

“Withdrawal syndrome” or “acid ricochet” is not characteristic of lansoprazole if the duration of use recommendations are followed.

Impact on ability to operate machinery and motor transport

At the time of treatment it is necessary to exercise caution while driving motor transport and engaging in other potentially dangerous activities requiring increased concentration and rapid psychomotor reactions, because the drug may cause weakness, drowsiness and dizziness.

Contraindications

Side effects

Clarithromycin

Infectious and parasitic diseases: infrequent – candidiasis, gastroenteritis, development of superinfection (with prolonged or repeated use of clarithromycin), vaginal infections; frequency unknown – pseudomembranous colitis, rye, erythrasis.

Blood and lymphatic system disorders: infrequent – leukopenia, neutropenia, thrombocythemia, eosinophilia; frequency unknown – agranulocytosis, thrombocytopenia.

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

Metabolic and nutritional disorders: infrequent anorexia, decreased appetite; frequency unknown – hypoglycemia (including concomitant use of hypoglycemic drugs).

Psychiatric disorders: frequent – insomnia; infrequent – anxiety, nervousness; frequency unknown – psychosis, confusion, depersonalization, depression, disorientation, hallucinations, “nightmare” dreams, mania.

Nervous system disorders: frequently – change in taste (dysgeusia), headache; infrequently – dizziness, loss of consciousness, somnolence, tremor; frequency unknown – seizures, loss of taste sensation, olfactory disorders, loss of sense of smell, paresthesias.

Hearing and labyrinth disorders: infrequent – vertigo, hearing disorders, tinnitus, tinnitus; frequency unknown – hearing loss (resolving after discontinuation of the drug).

Chronic disorders: infrequent – prolongation of QT interval on electrocardiogram, palpitations; frequency unknown – ventricular tachycardia such as “pirouette”, ventricular tachycardia, ventricular flutter and fibrillation.

Vascular disorders: frequency unknown – unusual bleeding, hemorrhage.

Respiratory system, thorax and mediastinum disorders: infrequent – nasal bleeding.

Gastrointestinal disorders: frequent – diarrhea, vomiting, dyspepsia, nausea, abdominal pain; infrequent – gastroesophageal reflux disease, gastritis, proctalgia, stomatitis, glossitis, bloating, constipation, dry mouth, belching, flatulence; frequency unknown – acute pancreatitis, discoloration of tongue and teeth.

Hepatic and biliary tract disorders: frequently – atypical liver function test; infrequent – cholestasis, hepatitis, increased ALT activity, increased AST activity, increased GGT activity; frequently unknown – liver failure, hepatocellular jaundice.

Skin and subcutaneous tissue disorders: frequent – rash, increased sweating; infrequent – itching, urticaria, patchy-papular rash; frequency unknown – malignant exudative erythema (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell syndrome), drug rash with eosinophilia and systemic manifestations, acne, Schoenlein-Henoch purpura.

Muscular and connective tissue disorders: infrequent – muscle spasm, myalgia; frequency unknown – rhabdomyolysis, myopathy, increased symptoms of myasthenia gravis.

Renal and urinary tract disorders: very rare – renal failure, interstitial nephritis.

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

Laboratory parameters: infrequent – increased alkaline phosphatase activity, increased blood LDH activity; very rare – hypercreatinemia; frequency unknown – increased international normalized ratio (MHO), increased prothrombin time, changes in urine color, increased bilirubin concentration.

Amoxicillin

Infectious and parasitic diseases: infrequent – development of superinfection, oral candidiasis, vaginal candidiasis.

Blood and lymphatic system disorders: rarely – eosinophilia, hemolytic anemia; very rarely – leukopenia, neutropenia, grayulocytopenia, thrombocytopenia, pancytopenia, anemia, myelosuppression, agranulocytosis, reversible increase of prothrombin time and bleeding time.

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

Nervous system disorders: infrequent – headache; rare – agitation, anxiety, insomnia, ataxia, confusion, hyperkinesia, altered behavior, depression, peripheral neuropathy, dizziness, seizures (in patients with renal disorders, epilepsy or meningitis).

Gastrointestinal disorders: frequently – nausea, loss of appetite, vomiting, flatulence, soft stools, diarrhea, oral mucosa rash, dry mouth, distortion of taste perception; rarely – darkening of tooth enamel; very rarely – pseudomembranous colitis, black “hairy” tongue.

Hepatic and biliary tract disorders: infrequent – reversible increase in “hepatic” transaminase activity; rare – hepatitis, cholestatic jaundice.

Skin and subcutaneous tissue disorders: frequent – skin rashes, itching, 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.

Repnal disorders: rarely – acute interstitial nephritis, crystalluria.

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

Lansoprazole

Blood and lymphatic system disorders: infrequent – thrombocytopenia, eosinophilia, leukopenia; rare – anemia; very rare – agranulocytosis, pancytopenia.

Immune system disorders: very rare – anaphylactic shock.

Disorders of metabolism and nutrition: rare – anorexia; frequency unknown – hypomagnesemia.

Psychiatric disorders: infrequent – depression; rare – insomnia, hallucinations, confusion.

Nervous system disorders: often – headache, dizziness; rarely – anxiety, vertigo and paresthesia, somnolence, tremor.

Visual organ disorders: rare – visual disturbances.

Gastrointestinal disorders: frequently – nausea, diarrhea, abdominal pain, constipation, vomiting, flatulence, dry mouth or throat; rarely – glossitis, oesophageal candidiasis, pancreatitis, violation of sense of taste; very rarely – colitis, stomatitis.

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

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

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

Muscular and connective tissue disorders: infrequent – arthralgia, myalgia, fracture of the hip, wrist or spine.

Repnal and urinary tract disorders: rarely – interstitial nephritis.

Gender and mammary gland disorders: rarely – gynecomastia, impotence.

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

Laboratory measures: very rarely – increase in cholesterol and triglycerides, hyponatremia.

Overdose

Clarithromycin

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

Treatment: gastric lavage, supportive therapy. Not removed by hemo- or peritoneal dialysis.

Amoxicillin

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

Treatment: gastric lavage, activated charcoal, saline laxatives, drugs to maintain water-electrolyte balance; hemodialysis.