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Mucosta

 

DESCRIPTION
1. Composition
MUCOSTA Tablets 100:
Each MUCOSTA Tablet contains 100 mg of rebamipide and the following inactive ingredients: microcrystalline cellulose, low substituted hydroxypropylcellulose, hydroxypropylcellulose, magnesium stearate, hydroxypropylmethylcellulose 2910, polyethylene glycol 6000, and titanium oxide.

2. Product Description
MUCOSTA Tablets 100 are white film-coated tablets.

Appearance

Diameter

(mm)

Thickness

(mm)

Weight

(mg)

Code

8.1

3.4

Approx.

175

OG33


INDICATION
- Gastric ulcers
- Treatment of gastric mucosal lesions (erosion, bleeding, redness and edema) in the following conditions: acute gastritis and acute exacerbation of chronic gastritis

 

CONTRAINDICATIONS

Patients with a history of hypersensitivity to any ingredient of this drug.


DOSAGE AND ADMINISTRATION
• Gastric ulcers The-usual adult dosage of rebamipide is 100 mg (1 MUCOSTA Tablet) taken by the oral route three times daily, in the
morning, in the evening, and before at bedtime.
• Treatment of gastric mucosal lesions (erosion, bleeding, redness, and edema) in the following conditions; acute gastritis and acute exacerbation of chronic gastritis: The usual adult dosage of rebamipide is 100 mg (1 MUCOSTA Tablet) three times daily taken by the oral route.


PRECAUTIONS
1. Adverse Reactions

Of 10,047 patients treated, adverse reactions, including abnormal laboratory findings, were reported in 54 patients (0.54%). Of 3,035
patients aged over 65 years, adverse reactions were noted in 18 patients (0.59%). The nature and incidence of adverse reactions were not different between the same in elderly and younger patients. The following summary of data includes adverse reactions voluntarily reported after marketing (Figures are total cases reported at the time of approval and at the completion of reexamination of MUCOSTA Tablets 100).
(1) Clinically significant adverse reactions
1) Shock, anaphylactoid reactions (incidence unknown*): 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.
2) Leukopenia (incidence <0.1%) and thrombocytopenia (incidence unknown*): 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.
3) Hepatic dysfunction (incidence <0.1%) and jaundice (incidence unknown*): 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 MUCOSTA Tablets. If abnormal laboratory findings are observed, the drug should be discontinued and appropriate measures taken.
 

(2) Other adverse reactions

Body system/

frequency

<0.1%

*Incidence unknown

Hypersensitivity

(note 1)

Rash, pruritus, drug-eruption-like

eczema, other symtpoms of

hypersensitivity

Urticaria

Neuro-psychiatric

 

Numbness,

dizziness,

sleepiness

Gastro-intestinal

Constipation, feeling of abdomen

enlarged, diarrhea, nausea, vomiting,

heartburn, abdominal pain, belching,

taste abnormality, etc.

Dry mouth

Hepatic (note 2)

Increased AST (GOT), ALT (GPT)

γ-GTP, alkaline phosphatase levels

 

Hematologic

Leukopenia, granulocytopenia, etc.

Thrombocytopenia

Other

Menstrual disorders, increased BUN

levels, edema, 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, alopecia

Note 1) If such symptoms of hypersensitivity occur, the drug should be discontinued.
Note 2) If transaminase levels are markedly increased or fever and rash develop, the drug should be discontinued and appropriate measures should be taken.
*The incidence rates of voluntarily reported adverse reactions are not known.


2. Drug Interactions
Rebamipide had little inhibitory effect on cytochrome P450 enzymes in vitro. Rebamipide is hardly metabolized in the liver and excreted in urine as an unchanged compound; thus, the drug has not much influence on metabolization of other drugs. Regarding the concomitant administration with other drugs with higher protein binding rate (H2 blocker and Warfarin), although Mucosta (rebamipide) has a high protein binding rate (95% or more), its blood concentration is as low as up to 200 ng/mL; therefore, this drug is considered less likely to increase the blood concentration in competition with other drugs. In addition, there have been reports that Mucosta (rebamipide) has not been influenced by (1) plasma salicylic acid concentration (human) at the time of aspirin administration, (2) serum indomethacin concentration (human) at the time of indomethacin administration, and (3) plasma and tumor tissue 5-FU concentration (rat) at the time of UFT administration. No drug interactions between rebamipide and other drugs are reported.


3. 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.


4. Use during Pregnancy, Delivery, or Lactation
(1) 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.)
(2) Nursing should be interrupted when this drug is administered to.
(Rat studies have shown that rebamipide is excreted in the breast milk.)


5. Pediatric Use
The safety of this drug in low birth weight infants, newborns, suckling infants, and children has not been established. (Clinical experience is insufficient.)


6. Precautions for Use
Patient's_ Instructions for Use

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.)


7. Overdose
In an efficacy study of gastric ulcer, one case of abdominal pain was reported among 81 patients who received rebamipide 900 mg/day (maximum dosage of the study). In postmarketing experience, there is limited information on overdose.


Treatment of overdose should be symptomatic. Close medical supervision and monitoring should continue until the patient recovering.


PHARMACOKINETICS
1. Plasma Concentrations
The table below shows the pharmacokinetic parameters of rebamipide following single oral administration of MUCOSTA Tablets 100 at the dose of 100 mg to 27 healthy male subjects in a fasted state.


Pharmacokinetic Parameters of Rebamipide

 

tmax

(hr)

Cmax

(ng/mL)

t1/2

(hr)

AUC24h

(ng•hr/mL)

MUCOSTA TABLETS 100

2.4±1.2

216±79

1.9±0.7

874±209

Mean value±SD, n=27, t1/2 calculated from values up to 12 hr


The absorption of rebamipide following single oral administration at a dose of 150 mg to 6 healthy subjects in a fed state tended to be slower than that in a fasted state.


However, food did not affect bioavailability of the drug in humans


Pharmacokinetic parameters obtained from patients with renal impairment after single oral administration of rebamipide at 100 mg revealed 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. Therefore, the drug was not considered to accumulate.
 

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