Rabeprazol-Zdorovye (rabeprazole) coated enteric tablets 10 mg. №20

Description

Rabeprazol-Zdorovye (rabeprazole) coated enteric tablets 10 mg. №20

Composition 

active substance: rabeprazole;

1 tablet contains rabeprazole sodium 10 mg or 20 mg;

excipients: mannitol (E 421), microcrystalline cellulose, magnesium stearate, light magnesium oxide, sodium lauryl sulfate, crospovidone; dry mixture “Aquarius Prime” of white color, containing hypromellose, titanium dioxide (E 171), polyethylene glycol 400;

• dosage of 10 mg: dry mixture “Aquarius Control” of pink color, containing methacrylate copolymer (type C), talc, triethyl citrate, titanium dioxide (E 171), silicon dioxide, red magic (E 129), tartrazine (E 102), yellow west FCF (E 110);
• dosage of 20 mg: dry mixture “Aquarius Control” of green color, containing methacrylate copolymer (type C), talc, titanium dioxide (E 171), silicon dioxide, triethyl citrate, diamond blue (E 133), tartrazine (E 102), quinoline yellow (E 104).

Medicinal form

Film-coated tablets are enteric-soluble.

The main physicochemical properties: tablets covered with a film shell, with a biconvex surface, pink with an orange tint (dosage 10 mg) or green with a blue tint (dosage 20 mg) color. The cross section shows two layers.

Pharmacotherapeutic group

Means for the treatment of peptic ulcer and gastroesophageal reflux disease. Proton pump inhibitors.
Code ATX A02V C04.

Pharmacological properties

It is an agent that reduces the acidity of gastric juice. Its action is associated with the ability to block the proton pumps of the H + / K + -ATPase in the stomach. When active molecules enter the lumen of the canaliculi of parietal cells with an acidic environment, they are oxidized and converted into an active form. In this form, they bind the SH-groups of the H + / K + -ATPase, blocking this enzyme (irreversibly). This causes a disruption in the formation of hydrochloric acid, which is the main component of gastric juice.

Indications

Rabeprazol-Zdorovye tablets is prescribed:

• with NSAID-associated gastropathy (lesions of the stomach walls caused by treatment with non-steroidal anti-inflammatory drugs);
• with GERD (gastroesophageal reflux disease);
• with acute pancreatitis (to turn off the secretory activity of the gland);
• with peptic ulcer of the duodenum / stomach (for the purpose of treatment / prevention of relapse);
• with hypersecretory conditions (polyendocrine adenomatosis, systemic mastocytosis, Zollinger-Ellison syndrome, stress ulcers);
• for eradication therapy in patients infected with Helicobacter pylori.

Contraindications

You can not prescribe Rabeprazol-Zdorovye tablets if you are allergic to the components of the drug, substituted benzimidazoles.

Application during pregnancy and lactation

The USFDA fetal exposure category is C.
The use of Rabeprazol during these periods is possible only as directed by a doctor. The feeding is stopped.

Method of administration and dosage

Rabeprazol-Zdorovye tablets is administered orally, without crushing, with water.
To prevent the exacerbation of peptic ulcer disease – 10–20 mg x1 times / day – 2–4 weeks twice a year or continuously.

In case of exacerbation of peptic ulcer, 20 mg x1 times / day is prescribed for 2–4 weeks.
With NSAID gastropathy, exacerbation of GERD – 20 mg x1 times / day – 4-8 weeks.
In case of infection with Helicobacter pylorі – 20 mg x 2 times / day – 7-14 days (depending on the eradication scheme).

In Zollinger-Ellison syndrome, the dosage is selected depending on the level of gastric secretion. Usually start at 60 mg / day, if necessary, 80–120 mg / day in 2–3 divided doses.
The maximum dose is 120 mg per day.

Overdose

Overdose signs: tachycardia, vomiting, dry mouth, blurred vision, drowsiness, confusion, headache, arrhythmia.
Treatment: discontinuation, maintenance therapy.

Side effects:

• Blood test changes: agranulocytosis, anemia, thrombocytopenia, pancytopenia, leukopenia.
• Immune disorders: anaphylactic reactions, fever, Quincke’s edema, shock.
• Metabolic disorders: hypomagnesemia, hyponatremia, hypokalemia, hypocalcemia.
• Mental disorders: aggression, hallucinations, insomnia, confusion, anxiety, depression.
• Neurological disorders: paresthesias, taste disturbances, headache, dizziness, drowsiness.
• Perceptual impairment: vertigo, blurred vision.
• Respiratory disorders: bronchospasm.
• Digestive disorders: diarrhea / constipation, dry mouth, pain in the supragastric region, flatulence, nausea, stomatitis, microscopic colitis, candidiasis, increased ALT / AST levels, hepatitis, hepatic encephalopathy, jaundice, liver dysfunction.
• Skin changes: urticaria, alopecia, rash, dermatitis, pruritus, photosensitivity, erythema multiforme, Stevens-Johnson syndrome, cutaneous lupus erythematosus, toxic epidermonecrolysis.
• Genitourinary disorders: gynecomastia, interstitial nephritis.
• Musculoskeletal disorders: fracture (wrist, hip, spine), muscle weakness, pain in joints and / or muscles.
• General disorders: sweating, malaise, fever, swelling.