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ETC / RX - Alimentary system drugs - Rabera

COMPOSITIONS:

RABERA® 10 mg: Each capsule contains:

Active ingredient: Rabeprazole 10 mg (as Rabeprazole sodium pellets 6,25% (w/w))

RABERA® 20 mg: Each capsule contains:

Active ingredient: Rabeprazole 20 mg (as Rabeprazole sodium pellets 13,33% (w/w))


PHARMACODYNAMICS:

Rabeprazole inhibits gastric acid secretion by the recoverable inhibition of the H+/K+ Adenosine triphosphatase enzyme (the proton pump) at the secretory surface of the gastric parietal cell.


PHARMACOKINETICS:

After oral administration, absolute bioavailability is approximately 52%, peak plasma concentrations of rabeprazole occur over a range of 2.0 to 5.0 hours. Rabeprazole is highly bound to plasma protein (96.3%) and is extensively metabolized in the liver to desmethyl rabeprazole. The plasma half-life of rabeprazole ranges from 1 to 2 hours. Approximately 90% of the drug is eliminated in the urine. Plasma concentration of Rabeprazole is increased in the elderly and in patients with hepatic disease.


INDICATIONS:

  • Gastroesophageal Reflux Disease (GERD).
  • Duodenal ulcer, gastric ulcer.
  • Combination with antibiotics for helicobacter pylori eradication.
  • Zollinger-Ellison Syndrome.

ADMINISTRATION AND DOSAGE:

For Adults:

Gastroesophageal Reflux Disease (GERD):

20 mg to be taken once daily for four to eight weeks.

For long term management up to 12 months, a maintenance dose of Rabeprazole 10 mg or 20 mg once daily can be used.

Active Duodenal Ulcer and Active Benign Gastric Ulcer:

20 mg to be taken once daily in the morning.

Most patients with active duodenal ulcer heal within four weeks. Some may respond to Rabeprazole 10 mg to be taken once daily in the morning.

Most patients with active benign gastric ulcer heal within six weeks.

Eradication of Helicobacter Pylori:

Rabeprazole is indicated for H. Pylori-positive duodenal ulcers, in combination with appropriate antibiotics.

  • Rabeprazole 20 mg
  • Amoxicillin 1000 mg
  • Clarithromycin 500 mg

All three medications should be taken twice daily with the morning and evening meals for 7 days.

For Zollinger-Ellison syndrome:

Initially, 60 mg to be taken once daily. Dosage requirements vary and should be continued as clinically indicated. Doses up to 100 mg to be taken once daily and 60 mg to be taken twice daily have been administered.

For children:

Rabeprazole is not recommended for use in children, as there is no experience of its use in this group.


CONTRAINDICATIONS:

  • Hypersensitivity to any components of this product.

WARNINGS AND PRECAUTIONS:

  • Symptomatic response to therapy with Rabeprazole does not preclude the presence of gastric or oesophageal malignancy.
  • Patients with severe hepatic disease.
  • Pregnancy: Category B. This drug should be used during pregnancy only if clearly needed.
  • Lactation: It is not known if rabeprazole is excreted in human breast milk. A decision should be made to discontinue nursing or discontinue the drug.

SIDE EFFECTS:

Headache, abdominal pain, diarrhea, dry mouth, dizziness, peripheral edema, hepatic enzyme increase, hepatitis, myalgia and arthralgia.

In case of an unexpected reaction, consult your physician.


INTERACTIONS:

Rabeprazole may reduce the absorption of drugs where an acid gastric pH enhances their bioavailability (ketoconazole, itraconazole, ampicilline esters, and iron salts).

Co-administration of rabeprazole may result in increase in Digoxin levels.


OVERDOSAGE:

There has been no experience with large overdoses with rabeprazole. The maximum reported overdose was 80 mg. There were no clinical signs or symptoms associated with any reported overdose. Patients with Zollinger-Ellison syndrome have been treated with up to 120 mg rabeprazole once daily. No specific antidote for rabeprazole is known. Rabeprazole is extensively protein bound and is not readily dialyzable. In the event of overdosage, treatment should be symptomatic and supportive.


PRESENTATION:

Box of 2 blisters x 7 capsules

Box of 3 blisters x 6 capsules

Storage: Store at temperature from 150C to 300C.

Shelf-life: 36 months from manufacturing date. Do not use after expiry date.