Rabimak (rabeprazole) coated tablets 10 mg. №14

Description

Rabimak (rabeprazole) coated tablets 10 mg. №14

Composition 

active ingredient: rabeprazole;

1 tablet contains rabeprazole sodium 10 mg or 20 mg;

excipients:

• tablets of 10 mg: mannitol (E 421), low-substituted hydroxypropylcellulose, heavy magnesium oxide, povidone, sodium hydroxide, talc, magnesium stearate, ethylcellulose, red iron oxide (E 172), titanium dioxide (E 171), methacrylate copolymer dispersion, triethylcitrate;
• 20 mg tablets: mannitol (E 421), low-substituted hydroxypropyl cellulose, heavy magnesium oxide, povidone, sodium hydroxide, talc, magnesium stearate, ethyl cellulose, iron oxide yellow (E 172), titanium dioxide (E 171), methacrylate copolymer dispersion, triethyl citrate .

Dosage form

Coated tablets, enteric.

Basic physical and chemical properties:

• 10 mg tablets: round, biconvex, film-coated tablets, enteric-soluble, pink, smooth on both sides;
• 20 mg tablets: round, biconvex, film-coated tablets, enteric-soluble, yellow, smooth on both sides.

Pharmacological group

Drugs that affect the digestive tract and metabolism. Preparations for the treatment of diseases associated with impaired acidity. Antiulcer drugs and drugs for the treatment of gastroesophageal reflux. proton pump inhibitors. Rabeprazole.
ATX code A02B C04.

Pharmacological properties

Rabimak tablets is a proton pump inhibitor, used to treat erosions, ulcers and other diseases of the gastrointestinal tract.

Indications

Rabimak tablets is used to treat peptic ulcers of the duodenum and stomach in the active stage, with erosive or ulcerative gastroesophageal reflux disease (GERD), Zollinger-Ellison syndrome. It is also used in complex treatment with appropriate antibacterial regimens for the eradication of Helicobacter pylori in patients with gastric and duodenal ulcers.

Rabeprazole sodium, which is the active ingredient of the drug, has the property of inhibiting gastric acid by specifically inhibiting certain gastric enzymes (acidic, proton pump). The effect of the drug is dose-dependent and causes inhibition of both basal and stimulated acid secretion, regardless of the stimulus.

It quickly disappears from both the gastric mucosa and their blood plasma. It is rapidly absorbed and concentrated in parietal cells. The main active ingredient of the drug, sodium rabeprazole, is converted into the active sulfanilamide form and thus reacts with the available cysteine ​​residues of the proton pump.

Has a noticeable antisecretory effect, which is observed 60 minutes after ingestion and reaches its peak in 3-4 hours. The effect of inhibition of the basal function is observed after 23 and after 48 hours. Regular daily intake enhances the antisecretory effect of the drug, however, stable inhibition of secretion is achieved 3 days after the first dose. After the end of the intake, the secretory activity is normalized after 2-3 days.

A decrease in the secretory activity of the stomach increases the number of bacteria in the gastrointestinal tract, which increases the occurrence of gastrointestinal infections – salmonellosis, campylobacter, clostridia.

Contraindications

Contraindicated in case of hypersensitivity to active and auxiliary substances that make up the drug.

Application during pregnancy and lactation

There is no data on the safety of taking the drug during pregnancy for both the mother and the fetus.

Method of administration and dosage

The drug Rabimak tablets is taken once a day, in the morning, on an empty stomach. The usual dose is 20 mg. In order for a duodenal ulcer and GERD to heal, usually 4-8 weeks are enough, a stomach ulcer – 6-12 weeks.

For long-term treatment, treatment of symptoms or prevention of exacerbations of GERD, 10 or 20 mg per day is sufficient, depending on the indication.

In the treatment of Zollinger-Ellison syndrome, the initial dose is 60 mg, which can be increased if necessary to 12 mg, divided into 2 doses. The duration of treatment is determined by the doctor.

Overdose

Overdoses were not recorded. With a maximum intake of 180 mg, no specific symptoms were identified.
The drug binds well to blood proteins, therefore it is poorly excreted during dialysis. In case of overdose, symptomatic treatment is recommended.

Side effects

Most often, adverse reactions were recorded in the form of flatulence, dry mouth, rashes, abdominal pain, diarrhea. They were usually mild and passed quickly.

May cause the development of anemia, eokinophilia, erythrocytopenia, lymphopenia, neutropenia, leukopenia, thrombocytopenia, leukocytosis.

Allergic reactions from the immune system are possible, including hives, swelling of the face, a drop in pressure, which disappear after stopping treatment.

Possible development of hypomagnesemia, hyponatremia, anorexia. The psyche, the nervous system can react with insomnia, depression, confusion, agitation of the nervous system, drowsiness, hypesthesia, numbness of the extremities, headaches.

Inflammatory processes from the respiratory system can develop – cough, pharyngitis, rhinitis, bronchitis, sinusitis, glossitis.

Thirst, alopecia may develop.