Pilobact NEO oral combination set coated tablets + capsules №42

Description

Pilobact NEO composition
active substances:

• amoxicillin tablets – 1 film-coated tablet contains amoxicillin trihydrate equivalent to amoxicillin 1000 mg;
• clarithromycin tablets – 1 film-coated tablet contains clarithromycin 500 mg;
• omeprazole capsules – 1 capsule contains omeprazole 20 mg;

excipients:

• amoxicillin tablets: microcrystalline cellulose, sodium starch glycolate, colloidal anhydrous silica, talc, magnesium stearate; shell composition: hydroxypropylmethylcellulose, titanium dioxide (E 171), parmasil, dye yellow west FCF (E 110), polyethylene glycol;
• clarithromycin tablets: microcrystalline cellulose, povidone, magnesium stearate, stearic acid, talc, colloidal anhydrous silica, croscarmellose sodium; shell composition: hydroxypropylmethylcellulose, hydroxypropylcellulose, propylene glycol, sorbitan oleate, titanium dioxide (E 171), quinoline yellow dye (E 104), vanillin, opacod (black) contains: (shellac, iron oxide black, propyl);
• omeprazole capsules: starch, dextrin, powdered sugar, talc, cane sugar, carboxymethyl sodium starch, sodium carboxymethylcellulose, disodium hydrogen phosphate, sodium sulfite anhydrous, hypromellose, titanium dioxide (polythane dioxide) granules non-parel, empty hard gelatin capsule size “2” contains: (diamond blue, carmoisin, gelatin, methylparaben, propylparaben).

Dosage form:

• Amoxicillin – coated tablets;
• Clarithromycin – coated tablets;
• Omeprazole – capsules.

Pharmacological properties
Pilobact NEO is a combination kit containing omeprazole, clarithromycin and amoxicillin. Pilobact Neo is a triple scheme of the first line of eradication therapy of Helicobacter rulori (H. pylori), designed for 7 days of treatment.
Omeprazole is a proton pump inhibitor. Omeprazole reduces the secretion of hydrochloric acid in the stomach by inhibiting the activity of H + -K + -ATPase, which blocks the final stage of hydrochloric acid secretion. This leads to a decrease in the level of basal and stimulated secretion, regardless of the nature of the stimulus. The duration of inhibition of hydrochloric acid secretion in the stomach is more than 24 hours. Omeprazole raises the pH level in the stomach, thereby providing an optimal environment for antimicrobial activity. Omeprazole significantly reduces the volume of gastric juice and thus increases the concentrations of clarithromycin and amoxicillin in the gastric mucosa.
Clarithromycin is a macrolide antibiotic that exhibits antibacterial activity against many aerobic and anaerobic gram-positive and gram-negative microorganisms, including H. pylori. Clarithromycin has an antibacterial effect by inhibiting protein synthesis by binding to the 50s subunit of ribosome-sensitive bacteria. The minimum inhibitory concentration (MIC90) of clarithromycin and its active metabolite 14-hydroxyclarithromycin relative to H. pylori is 0.03 μg / ml and 0.06 μg / ml, respectively. Clarithromycin is resistant to the acidic environment of the stomach. Amoxicillin is a broad-spectrum penicillin antibiotic with a broad spectrum of bactericidal activity, associated with the ability to inhibit bacterial cell wall synthesis. Amoxicillin-resistant strains of H. pylori active against H. pylori have not yet been identified.

Indication
Pilobact NEO is used for the eradication of Helicobacter rulori in patients with gastric and duodenal ulcers.

Use during pregnancy or breastfeeding
Pilobact Neo is contraindicated during pregnancy or breastfeeding.

Method of application and dosage
Pilobact Neo is a combination kit containing omeprazole, clarithromycin and amoxicillin. Pilobact Neo is a triple scheme of the first line of eradication therapy of H. pylori, designed for 7 days of treatment.
1 blister containing 2 capsules of omeprazole, 2 tablets of clarithromycin and 2 tablets of amoxicillin, designed for the 1st day of treatment of adults. Take 1 capsule of omeprazole in the morning and 1 tablet of clarithromycin and amoxicillin, repeat the administration of these drugs in the evening.
The total duration of therapy is 7 days.

Children
Contraindicated for children under 16 years.

Overdose:

• Omeprazole
  Symptoms: nausea, vomiting, dizziness, abdominal pain, diarrhea, headache. In addition, in some cases, apathy, depression and confusion may occur. All symptoms associated with omeprazole overdose are reversible.
  Treatment: specific antidote unknown. Symptomatic and supportive therapy.
• Amoxicillin
  Symptoms: nausea, vomiting, diarrhea; vomiting and diarrhea can result in water-electrolyte imbalance. In isolated cases – crystalluria.
  Cases of crystalluria have been reported, sometimes leading to renal failure.
  Treatment: vomiting or gastric lavage should be instituted, followed by charcoal and an osmotic laxative. It is necessary to maintain water and electrolyte balance.
  Amoxicillin is not removed by hemodialysis. The specific antidote is unknown.
• Clarithromycin
  Symptoms: There are reports that an overdose of clarithromycin may cause gastrointestinal symptoms. One patient with a history of bipolar psychosis who received 8 grams of clarithromycin developed changes in mental status, paranoid behavior, hypokalemia, and hypoxemia.
  Treatment: gastric lavage. Symptomatic therapy.

Side effects
Drugs that are part of the combined set are well tolerated, and adverse reactions are usually mild and reversible.
Amoxicillin:

• From the central and peripheral nervous system: rarely – hyperkinesia, dizziness and convulsions. Seizures may occur in patients with impaired renal function or in persons receiving high doses of amoxicillin.
• From the digestive system: nausea, vomiting, diarrhea, flatulence, stomach pain, soft stools, itching in the anus; in some cases – pseudomembranous and hemorrhagic colitis, enanthema (especially on the oral mucosa), dry mouth, taste disturbances, intestinal candidiasis, tooth discoloration, tongue discoloration in black (these side effects are mostly not severe and pass or pass during treatment, or immediately after the end of therapy, the occurrence of such phenomena can be prevented if you use amoxicillin with food).
• From the hepatobiliary system: hepatitis, cholestatic jaundice, moderate and short-term increase in the concentration of liver enzymes (ACT, ALT).
• From the skin and subcutaneous tissue: skin rash, exanthema, toxic epidermal necrolysis, bullous or exfoliative dermatitis and acute generalized exanthematous pustulosis.
• Allergic reactions: skin reactions, mainly in the form of specific maculopapular rash; very rare – pruritus, urticaria, erythema multiforme, Stevens-Johnson syndrome, anaphylactic shock and angioneurotic edema, severe allergic reactions including anaphylaxis, serum sickness, allergic vasculitis, laryngeal edema. The sudden onset of urticaria indicates an allergic reaction to amoxicillin and requires immediate discontinuation of therapy.
• From the urinary system: rarely – the development of interstitial nephritis, crystalluria.
• From the blood and lymphatic system: hemolytic anemia, thrombocytopenia, leukopenia, eosinophilia, severe neutropenia, pancytopenia, myelosuppression, granulocytopenia, agranulocytosis, as well as prolonged bleeding and prothrombin time.

Clarithromycin:

• From the central nervous system: headache, taste changes, convulsions, dizziness, ageusia, anosmia, parosmia, anxiety, insomnia, confusion, hallucinations, vertigo, anxiety, insomnia, bad dreams, ringing in the ears, disorientation, psychosis depersonalization, hearing loss, which usually recovered after discontinuation of therapy; nervousness, screaming; mania, loss of consciousness, dyskinesia, drowsiness, tremor; paresthesia, hearing impairment
• From the digestive system: diarrhea, nausea, abdominal pain, dyspepsia, vomiting, anorexia, loss of appetite, gastroenteritis, acute pancreatitis, glossitis, stomatitis, discoloration of the tongue, discoloration of the teeth (discoloration of the teeth is usually eliminated by professional dental cleaning), oral candidiasis, olfactory disorders, usually in combination with changes in taste, pseudomembranous colitis, oral candidiasis, gastroesophageal reflux disease, gastritis, proctalgia, bloating, constipation, dry mouth, belching, belching, belching.
• From the hepatobiliary system: liver failure, hepatitis, cholestatic hepatitis, cholestatic jaundice, hepatocellular jaundice, liver dysfunction, cholestasis.
• From the skin and subcutaneous tissue: Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria, minor skin rashes, bullous dermatitis, itching, maculopapular rash; drug skin reaction accompanied by eosinophilia and systemic manifestations (DRESS), acne, Shenlein-Henoch disease, erysipelas, erythrasma.
• From the musculoskeletal system and connective tissue: muscle spasms, musculoskeletal rigidity, myalgia; rhabdomyolysis (in some reports of rhabdomyolysis, clarithromycin has been used in combination with other drugs known to be associated with rhabdomyolysis (such as statins, fibrates, colchicine or allopurinol)), myopathy.
• From the urinary system: interstitial nephritis, renal failure, discoloration of urine.
• From the blood and lymphatic system: leukopenia, thrombocytopenia, neutropenia, thrombocythemia, eosinophilia; agranulocytosis, increased blood urea, increased levels of lactate dehydrogenase in the blood, changes in the ratio of albumin-globulin, increased levels of alkaline phosphatase in the blood.
• From the immune system: anaphylactic reactions (angioneurotic edema to anaphylaxis), hypersensitivity.
• Metabolic disorders: hypoglycemia, hyperhidrosis.
• Mental disorders: psychosis, hallucinations, disorientation, depression, anxiety, insomnia, nightmares.
• From the organs of hearing and labyrinth: hearing loss (usually recovered after discontinuation of therapy), dizziness, tinnitus.
• From the cardiovascular system: pirouette ventricular tachycardia (torsade de pointes), QT prolongation, ventricular tachycardia, cardiac arrest, atrial fibrillation, ecstasy, palpitations; vasodilation; hemorrhage.
• From the respiratory system: asthma, epistaxis, pulmonary embolism, chest pain.
• Laboratory tests: increased activity of liver enzymes, increased blood creatinine, increased international normalized ratio, increased prothrombin time, urine discoloration.
• Others: cellulite, infection, vaginal infection, malaise, fever, asthenia, chills, fatigue.

Omeprazole:

• From the central and peripheral nervous system: headache; dizziness, paresthesia, drowsiness, insomnia, vertigo, fatigue, weakness, sleep disturbances; in isolated cases – reversible confusion, agitation, depression or hallucinations, slight disorientation, aggression, agitation, visual impairment, mainly in critically ill patients. Seizures may occur in patients with impaired renal function.
• From the digestive tract: diarrhea, nausea, vomiting, constipation, abdominal pain, flatulence; in some cases – dry mouth, stomatitis and candidiasis of the gastrointestinal tract, microscopic colitis.
• From the hepatobiliary system: rarely – increased levels of liver enzymes; in some cases – encephalopathy in severe liver disease, hepatitis, accompanied or not accompanied by jaundice, liver failure.
• Endocrine disorders: in some cases – gynecomastia.
• From the blood and lymphatic system: leukopenia, thrombocytopenia, agranulocytosis and pancytopenia, hypomagnesemia, hypocalcemia, hypokalemia.
• From the skin and subcutaneous tissue: rash, itching, erythema multiforme, Stevens-Johnson syndrome, alopecia, photosensitivity, dermatitis, redness, toxic epidermal necrolysis.
• From the musculoskeletal system and connective tissue: symptoms of arthritis and myalgia, muscle weakness, joint and muscle pain, arthralgia.
• Others: rarely – general weakness, hypersensitivity reactions, including anaphylactic reaction, urticarial rash, Quincke’s edema, fever, bronchospasm, interstitial nephritis, anaphylactic shock); in some cases – increased sweating, peripheral edema, blurred vision, taste disturbances, decreased sodium levels in the blood, impotence, malaise.

Expiration date
2 years.

Storage conditions
Store Pilobact NEO in its original packaging at a temperature not exceeding 25 ° C, out of the reach of children.