Mucosta

Mucosta

rebamipide

Manufacturer:

Otsuka
Full Prescribing Info
Contents
Rebamipide.
Action
Anti-inflammatory and anti-free radical.
Pharmacokinetics: Plasma Concentrations: Following single 100-mg oral administration to 12 healthy subjects, plasma concentrations of rebamipide peaked (at 210 ng/mL) at 2 hrs. The elimination half-life in plasma was about 1.5 hrs. Repeated administration studies have shown that rebamipide does not accumulate in humans.
The absorption of rebamipide tended to be slow when the drug was administered orally at a dose of 150 mg to 6 healthy subjects after a meal. However, food did not affect bioavailability of rebamipide in humans.
Excretion: Approximately 10% of the administered dose was excreted in the urine when rebamipide was administered as a single oral dose to healthy adult males at 100 mg.
Protein-Binding: Rebamipide at 0.05-5 mcg/mL was added to human plasma in vitro, and 98.4-98.6% of the drug was bound to plasma proteins.
Clinical Studies: Clinical Efficacy in Gastric Ulcer: Mucosta tablets were studied in patients with gastric ulcer, using endoscopy for objective drug evaluation. In the final endoscopic assessment, Mucosta achieved complete healing in 60% (200/335) of the patients studied and near-complete healing in 67% (224/335). The clinical usefulness of rebamipide, based on efficacy and safety was demonstrated in a double-blind study. Six-month follow-up of 67 patients who showed healing at a daily dose of 300 mg revealed that recurrence occurred in only 4 patients (approximately 6%).
Clinical Efficacy in Acute Gastritis and Acute Exacerbation of Chronic Gastritis: Mucosta tablets were studied in patients with acute gastritis or acute exacerbation of chronic gastritis. Mucosta achieved an 80% (370/461) global efficacy rate in the patients evaluated, with 76% (351/461) showing moderate or marked improvement. Its clinical usefulness was found to be reproducible in a double-blind study.
Indications/Uses
Gastritis.
Gastric Ulcers: In combination with offensive factor inhibitors (proton-pump inhibitors, anticholinergic, H2-antagonist).
Dosage/Direction for Use
Adults: Gastric Ulcers: In combination with offensive factor inhibitors, the usual dosage is 1 tab (rebamipide 100 mg) orally 3 times daily (morning, evening and before bedtime).
Gastritis: Usual Dosage: 1 tab (rebamipide 100 mg) orally 3 times daily.
Contraindications
Patients with a history of hypersensitivity to any ingredient of Mucosta.
Special Precautions
Use in pregnancy & lactation: Mucosta should be administered to pregnant women only if the anticipated therapeutic benefit is thought to outweigh any potential risk.
Nursing should be interrupted when Mucosta is administered to a nursing woman.
Use in children: The safety of Mucosta in children has not been established.
Use in the elderly: Special care is required in elderly patients.
Use In Pregnancy & Lactation
Mucosta should be administered to pregnant women only if the anticipated therapeutic benefit is thought to outweigh any potential risk.
Nursing should be interrupted when Mucosta is administered to a nursing woman.
Adverse Reactions
Of 10,047 patients treated, adverse reactions including abnormal laboratory findings were reported in 54 patients (0.54%). Of 3035 patients >65 years, adverse reactions were noted in 18 patients (0.59%). The incidence of the following adverse reactions is <0.1%: Hypersensitivity (rash, pruritus), gastrointestinal (constipation, feeling of enlarged abdomen).
Storage
Store at room temperature (25°-30°C).
ATC Classification
A02BX - Other drugs for peptic ulcer and gastro-oesophageal reflux disease (GORD) ; Used in the treatment of peptic ulcer and gastro-oesophageal reflux disease (GERD).
Presentation/Packing
FC tab 100 mg x 10 x 10's.
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