Remasta

Each film-coated tablet contains Rebamipide 100 mg.
Physicochemistry: Nonproprietary name: Rebamipide (JAN).
Chemical name: (2RS)-2-(4-Chlorobenzoylamino)-3-(2-oxo-1,2- dihydroquinolin-4-yl) propanoic acid.
Molecular formula: C₁₉H₁₅CIN₂O₄.
Molecular weight: 370.79.

Pharmacology: Pharmacodynamics: The mechanism of rebamipide's anti-inflammatory and gastroprotective actions involves increased mucus secretion, enhanced generation of endogenous prostaglandin E2 (PGE2) in the gastric mucosa, inhibition of pro-inflammatory cytokine secretion by immune cells, inhibition of neutrophil activation, and scavenging of cytokine-induced reactive oxygen species.
Rebamipide is poorly absorbed into systemic circulation; thus, it exhibits only local activity at the target organ and essentially has no systemic activity.
The suppressive effect of rebamipide on nonsteroidal anti-inflammatory drug (NSAID) induced gastric mucosal injury can be attributed to reduced 15-hydroxyprostaglandin dehydrogenase expression, which increases the PEG2 concentration in the gastric tissue.
Pharmacokinetics: Following single oral administration of 100 mg in 12 healthy volunteers, the peak plasma concentration of rebamipide (210 ng/mL) was achieved in 2 hours with an elimination half-life of 1.94 hours. Repeated dose administration in humans revealed that rebamipide does not accumulate in the body.
Pharmacokinetic parameters of patients with renal impairment given a single oral dose of 100 mg rebamipide showed higher plasma concentrations and a longer elimination half-life compared with those in healthy subjects. At steady-state, rebamipide plasma concentrations observed in dialyzed renal patients following repeated administration were very close to the values simulated from single administration. Thus, rebamipide is not considered to accumulate in the body.
In 6 healthy volunteers, the absorption of rebamipide appears to be slow following an oral dose of 150 mg given after a meal. However, food did not affect the bioavailability of the drug.
Approximately 98.4 % to 98.6% of rebamipide is bound to plasma proteins when 0.05 to 5 mcg/mL was added to human plasma in vitro.
Rebamipide is primarily excreted in the urine as unchanged drug following a single oral dose of 600 mg to healthy male adults. Approximately 10% of the administer dose was excreted in the urine following a single oral dose of 100 mg.

Gastric ulcer.
Improvement of gastric mucosa lesion (erosion, flare and edema) of following diseases: Acute gastritis, acute aggravated period of chronic gastritis.

Gastric ulcer: Adults: It is usually administered orally a tablet (100 mg as rebamipide) as a single dose 3 times daily (morning, evening, and before bedtime).
Improvement of gastric mucosa lesion (erosion, flare and edema) of following diseases: Acute gastritis, acute aggravated period of chronic gastritis: Adults: It is usually administered orally a tablet (100 mg as rebamipide) as a single dose 3 times daily.

No information is available on the overdose of rebapimide. If more than the recommended dosage has been given, consult the physician right away.

Patients with history of hypersensitivity to any ingredients of the drug.

If symptoms of hypersensitivity (e.g. rash, pruritus) occur during use of rebamipide, the drug should be discontinued and the patient should immediately consult a physician.

Pregnancy category C. The safety of rebamipide in pregnant women has not been established. Thus, this drug should only be used in pregnant women if the potential benefit outweighs any potential risk.
Pre-clinical studies have shown that rebamipide is distributed into breast milk; thus, rebamipide is not recommended for use in breastfeeding women. If this medicine must be used, then breastfeeding should be discontinued.

Severe adverse effects: Shock, anaphylactic type: Shock, anaphylactic shock type may occur. If observed, discontinue the medicine and treatment. Decreasing white blood cell (rarely), decreasing platelet: Decreasing white blood cell (rarely), decreasing platelet may occur. If observed, discontinue the medicine and treatment.
Hepatic failure and jaundice: Hepatic failure accompany with increasing AST, ALT, y-GTP, ALP rarely and jaundice may occur. If observed, discontinue the medicine and treatment.
Others: Hypersensitivity: Hives and rarely rash, pruritus, drug exanthema eczema etc may occur. If observed, discontinue medicine and treat.
CNS: Paralysis, dizziness, sleepiness may occur.
GI: Thirst and rarely constipation, abdominal distension diarrhea, nausea, vomiting, heartburn, stomachache, belching, dysgeusia may occur.
Hepatic: Increasing markedly aminotransferase such as AST, ALT, y-GTP, ALP, fever and jaundice may occur. If observed, discontinue the medicine and treatment.
Blood: Decreasing platelets and rarely white blood cell fractionation, decreasing segmented leukocyte, increasing lymphocyte, rarely, decreasing white blood cell and granulocyte may occur.
Others: Mammary swelling, mastalgia, gynecomastia, lactation, palpitation, fever, hot flush, tongue paralysis, cough, dyspnea, alopecia or rarely menstrual disorder, BUN increase, edema, globus pharynges etc may occur.

There are no known drug interactions with the use of rebamipide. Before taking this medicine, tell the physician about any medicines you are taking, including food supplements and herbal medicines.

Store at temperatures not exceeding 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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