Rabelock, lyophilizate 20 mg

Rabelok is an antiulcer drug, an inhibitor of H+-K+-ATPase (proton pump).

The mechanism of action is associated with inhibition of the enzyme H+-K+-ATPase in the parietal cells of the stomach, which leads to blocking the final stage of hydrochloric acid formation.

This action is dose-dependent and results in inhibition of both basal and stimulated hydrochloric acid secretion regardless of the nature of the stimulus.

Indications

Peptic ulcer of the stomach and duodenum in the acute phase;
peptic ulcer of the stomach and duodenum associated with Helicobacter pylori (in combination with antibiotics);
gastroesophageal reflux.

Pharmacological effect

Rabeloc is an antiulcer agent, an inhibitor of H+-K+-ATPase (proton pump).

The mechanism of action is associated with inhibition of the enzyme H+-K+-ATPase in the parietal cells of the stomach, which leads to blocking the final stage of hydrochloric acid formation.

This effect is dose-dependent and leads to inhibition of both basal and stimulated secretion of hydrochloric acid, regardless of the nature of the stimulus.

Special instructions

Before starting therapy, it is necessary to exclude malignant neoplasms of the stomach, because the use of rabeprazole may mask symptoms and delay correct diagnosis.

No dosage adjustment is required in patients with hepatic or renal impairment; however, rabeprazole should be used with caution in patients with severe hepatic impairment.

When used simultaneously with rabeprazole, the doses of ketoconazole and digoxin should be adjusted.

Experimental studies have not established the carcinogenic effect of rabeprazole, however, when studying mutagenicity, ambiguous results were obtained. Tests on lymphoma cells in mice were positive, while the in vivo micronucleus test and the in vivo and in vitro DNA repair test were negative.

Active ingredient

Rabeprazole

Composition

Active ingredient:

rabeprazole sodium 20 mg;

Excipients:

mannitol 75 mg,

sodium hydroxide to pH 11.0.

Pregnancy

Rabeprazole is contraindicated for use during pregnancy and lactation.

Experimental studies have found that rabeprazole penetrates the placental barrier in small quantities, but no fertility disorders or fetal developmental defects have been observed; excreted in the milk of lactating rats.

There is no clinical experience with the use of rabeprazole in children, so use is not recommended.

Contraindications

Pregnancy, lactation (breastfeeding), hypersensitivity to rabeprazole sodium or substituted benzimidazoles.

Side Effects

From the digestive system: diarrhea, nausea, abdominal pain, vomiting, flatulence, constipation; rarely – dry mouth, dyspepsia, belching; in isolated cases – anorexia, gastritis, stomatitis, increased activity of liver transaminases.

From the central nervous system and peripheral nervous system: headache, asthenia, dizziness, insomnia; rarely – nervousness, drowsiness; in isolated cases – depression, visual and taste disturbances.

From the respiratory system: possible – rhinitis, pharyngitis, cough; rarely – sinusitis, bronchitis.

Allergic reactions: rarely – skin rash; in isolated cases – itching.

Other: back pain, flu-like syndrome; rarely – myalgia, chest pain, chills, calf muscle cramps, urinary tract infection, arthralgia, fever; in isolated cases – increased body weight, increased sweating, leukocytosis.

Interaction

When used simultaneously with digoxin, an increase (from small to moderate) in the concentration of digoxin in the blood plasma is possible.

When used simultaneously with ketoconazole, its bioavailability decreases.

Storage conditions

In a place protected from light, at a temperature not exceeding 25 °C.

Shelf life

2 years

Manufacturer

Cadila Pharmaceuticals Ltd, India