Ramiper

Rebamipide.

Each film-coated tablet contains Rebamipide 100 mg.

Pharmacology: Preventive or healing effects in gastric ulcer models: Rebamipide inhibited gastric mucosal injury of ulcers, including ulcers induced by water-immersion restraint stress, acetylsalicylic acid, indomethacin, histamine, serotonin, and pyloric ligation. Rebamipide also protected the mucosa from injury caused by other ulcerogenic condition. Rebamipide promoted healing of gastric ulcers and suppressed recurrence or relapse of ulcers even 120-140 days after ulcer induction production.
Preventive or healing effects in gastritis models: Rebamipide inhibited the occurrence of taurocholic acid induced gastritis and promoted healing of mucosal inflammation.
Prostaglandin-increasing effect: Rebamipide increased the endogenous prostaglandin E₂ (PGE₂) in the gastric mucosa. Rebamipide also increased the PGE₂ and PGI₂, as well as 15-keto-13,4-dihydro-PGE₂ (a metabolite of PGE₂) and PGI₂ in the gastric juice. Rebamipide revealed the effect of increasing the PGE₂ content in the gastric mucosa and protected the gastric mucosa from injury caused by ethanol loading.
Cytoprotective effect: Rebamipide exhibited a gastric cytoprotective effect to inhibit mucosal injury induced by ethanol, strong acid, and strong base.
Mucus-increasing effect: Rebamipide promoted gastric enzyme activity to synthesize high molecular weight glycoproteins, thickened the superficial mucous layer of gastric mucosa, and increased the amount of gastric surface mucus and soluble mucus. Endogenous PGs were not involved in the increase in soluble mucus.
Mucosal blood flow-increasing effect: Rebamipide increased gastric mucosal blood flow and improved impaired hemodynamics after blood loss.
Effect on mucosal barrier: Rebamipide did not ordinarily affect the gastric transmucosal potential difference, but did inhibit lowering of the potential difference by ethanol.
Effect on gastric alkaline secretion: Rebamipide promoted gastric alkaline secretion.
Effect on mucosal cell turnover: Rebamipide activated gastric mucosal cell proliferation and increased the number of gastric epithelial cells.
Effect on gastric mucosal repair: Rebamipide restored the bile acid- or hydrogen peroxide-induced retardation of artificial wound-repair in gastric epithelial cells.
Effect on gastric secretion: Rebamipide did not alter either basal secretion of gastric juice or secretagogue-stimulated acid secretion.
Effect on oxygen-free radicals: Rebamipide scavenged hydroxyl radicals directly and suppressed superoxide production by polymorphonuclear leukocytes. Rebamipide also protected the gastric mucosal cells against injury caused by oxygen-free radicals released. Rebamipide inhibited mucosal injury and reduced the content of lipid peroxide in the gastric mucosa treated with indomethacin under stressed conditions.
Effect on inflammatory cellular infiltration in the gastric mucosa: Rebamipide prevented inflammatory cellular infiltration of taurocholic acid-induced gastritis, NSAID-induced gastric mucosal damage, and ischemia-perfusion-induced gastric mucosal damage.
Effects on inflammatory cytokine released (interleukin-8) in the gastric mucosa: Rebamipide suppressed the increased production and released of interleukin-8 from human gastric mucosa. Rebamipide also inhibited the activation of NF-kB and suppressed the expression of interleukin-8 mRNA in epithelial cells.

Gastric ulcers in combination with offensive factor inhibitors (Proton Pump Inhibitors, anticholinergic, H₂ antagonist).
Gastritis.

Gastric ulcers: in combination with offensive factor inhibitors the usual adult dosage of RAMIPER tablets is one tablet (100 mg of Rebamipide) taken by the oral route three times daily, in the morning, in the evening, and before bedtime.
Gastritis: The usual adult dosage of RAMIPER Tablets is one tablet (100 mg Rebamipide) three times daily taken by the oral route.

Rebamipide is contraindicated in patient with a history of hypersensitivity to any ingredient of this drug.

Patients should be instructed not to ingest any portion of the press-through package (PTP). (There have been reports that the sharp edges of the sheet can cut or penetrate the esophageal mucosa if accidentally ingested, resulting in mediastinitis or other serious complications).
Use in Pregnancy & Lactation: This drug should be administered to pregnant or possibly pregnant women only if the anticipated therapeutic benefit is thought to outweigh any potential risk. (The safety of this drug in pregnant women has not been established).
Nursing should be interrupted when this drug is administered to a nursing woman.
Use in Children: The safety of this drug in children has not been established.
Use in the Elderly: Special care is required in elderly patients to minimize the risk of gastrointestinal disorders, because these patients may be physiologically more sensitive to this drug than younger patients.

This drug should be administered to pregnant or possibly pregnant women only if the anticipated therapeutic benefit is thought to outweigh any potential risk. (The safety of this drug in pregnant women has not been established).
Nursing should be interrupted when this drug is administered to a nursing woman.

Clinically significant adverse reactions: Shock, anaphylactoid reactions: Shock or anaphylactoid reactions may occur. Patients should therefore be closely monitored. If abnormal findings are observed, the drug should be discontinued and appropriate measures taken.
Leukopenia and thrombocytopenia: Leukopenia and thrombocytopenia may occur. Patient should therefore be closely monitored. If abnormal findings are observed, the drug should be discontinued and appropriate measures taken.
Hepatic dysfunction and jaundice: Hepatic dysfunction and jaundice, as indicated by increases in AST (GOT), ALT (GPT), γ-GTP, and alkaline phosphatase levels, have been reported in patients receiving Rebamipide. If abnormal laboratory findings are observed, the drug should be discontinued and appropriate measures taken.
Other adverse reactions: Hypersensitivity*: Rash, pruritus, drug-eruption like eczema, other symptoms of hypersensitivity and urticaria.
Neuropsychiatric: Numbness, dizziness, sleepiness.
Gastrointestinal: Constipation, feeling of abdomen enlarged, diarrhea, nausea, vomiting, heartburn, abdominal pain, belching, taste abnormality and dry mouth.
Hepatic**: Increased AST (GOT), ALT (GPT), γ-GTP, and alkaline phosphatase levels.
Hematologic: Leukopenia, granulocytopenia, and thrombocytopenia.
Other: Menstrual disorders, increased BUN levels, edema and feeling of a foreign body in the pharynx, breast swelling and pain, gynecomastia, induction of lactation, palpitations, fever, facial flushing, numbness of tongue, cough, respiratory distress and alopecia.
* If such symptoms of hypersensitivity occur, the drug should be discontinued.
** If transaminase levels are markedly increased or fever and rash develop, the drug should be discontinued and appropriate measures should be taken.

No study was done to evaluate drug interaction.

Store below 30°C.

Antacids, Antireflux Agents & Antiulcerants

A02BX14 - rebamipide ; Belongs to the class of other drugs used in the treatment of peptic ulcer and gastro-oesophageal reflux disease (GERD).

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