|
4. Drug Interactions
It has been reported that the hepatic enzyme cytochromes P4502C19 (CYP2C19) and 3A4 (CYP3A4) are involved in the metabolism of
PARIET. [See "PHARMACOKINETICS" section. ]
Precautions for coadministration (PARIET should be administered with care when coadministered with the following drugs.)
|
Drugs |
Signs, Symptoms, and
Treatment |
Mechanism and Risk
Factors |
|
Digoxin |
Blood concentration of
digoxin may increase. |
Absorption of digoxin is
promoted due to increasing gastric pH |
|
Phenytoin |
It has been reported that
an analogue compound (omeprazole) delays metabolism and excretion of
phenytoin. |
|
Antacid containing
aluminum hydroxide gel/magnesium hydroxide |
It has been reported that
the mena area under the plasma sodium rabeprazole concentration-time
curve (AUC) decreases by 8 and 6% after concomitant administration
of
PARIET and antacid, and administration of
PARIET at 1 hr after the antacid, respectively, compared
tot he administration of
PARIET alone. |
5. Adverse Reactions
Adverse reactions were reported in 22 of 1,244 patients
(1.77%), and abnormal laboratory test values were reported in
82 (6.59%). (At the time of approval)
(1) Clinically significant adverse reactions
i) Shock
It has been reported that anaphylactic reactions or shock occurred with analogue compounds (omeprazole and lansoprazole). If any such abnormality is observed, treatment should be discontinued and appropriate measures taken.
ii) Agranulocytosis, thrombocytopenia and pancytopenia
Agranulocytosis (incidence unknown), thrombocytopenia (5%>
≥0.1 %) or pancytopenia (incidence unknown) may occur. If any such abnormality is observed, treatment
should be discontinued and appropriate measures taken. It has been reported that hemolytic anemia occurred with
analogous compounds (omeprazole and lansoprazole).
iii) Hepatic function disorders
Hepatic function disorders (5%> ≥0.1%) or jaundice (incidence unknown) may occur. If any such abnormality
is observed, treatment should be discontinued and appropriate measures taken.
iv)Interstitial pneumonia
Interstitial pneumonia (incidence unknown) may occur. If symptoms such as fever, coughing, dyspnoea and abnormal lung sounds (crepitations) occur, thoracic radiography or other examination should be performed immediately. Administration should be discontinued, and appropriate measures should be taken, such as treatment with cortical steroid hormones.
5) Visual disturbance
Visual disturbance has been reported with an analogue compound (omeprazole).
(2) Other adverse reactions
| |
5%> ≥0.1 % |
<0.1% |
Incidence unknown |
| Hypersensitivity note 1) |
Rash and urticaria |
Itching |
|
| Hematologic note 2) |
Erythrocytopenia, leukopenia, leukocytosis, eosinophilia,
neutrophilia and lymphopenia |
|
Anemia |
| Hepatic note 3) |
Elevation of AST (GOT), ALT (GPT), Al-P, γ-GTP, LDH and total
bilirubin |
|
|
| Cardiovascular |
|
Palpitations |
|
| |
Constipation, diarrhea and feeling of enlarged
abdomen |
Nausea, lower abdominal pain and heavy feeling of
stomach |
|
| Psychoneurologic note 4) |
Headache |
Dizziness, sleepiness, weakness in the extremities,
hypoaesthesia, decreased grip strength, impaired tongue movement and
light headedness |
Delirium, coma and disorientation |
| Others |
Edema, elevation of total cholesterol, triglycerides
and BUN, and proteinuria |
Malaise and fever |
Blurred vision and shifting vision gynaecomastia |
Note
1) In the event of such symptoms, treatment should be discontinued.
2) It is advisable to conduct hematological tests periodically during administration of
PARIET. If any abnormality is observed, appropriate measures, such as discontinuation of the medication, should be taken.
3) It is advisable to conduct biochemical tests periodically during the administration of
PARIET. If any abnormality is observed, appropriate measures, such as discontinuation of the medication, should be taken.
4) Weakness in the extremities, hypoaesthesia, decreased grip strength, impaired tongue movement, light headedness, delirium, coma and disorientation have been reported in a patient with liver cirrhosis. Also, confusion and lethargy
have been reported in a patient with liver cirrhosis who had a history of hepatic encephalopathy.
(3) Post-Marketing Adverse Events
Additional adverse events reported from worldwide marketing experience with sodium rabeprazole are sudden death, coma and hyperammonemia, jaundice, rhabdomyolysis, disorientation and delirium, bullous and other drug eruptions of the skin, interstitial pneumonia, interstitial nephritis, and TSH elevations. In most instances, the relationship to sodium rabeprazole was unclear. In addition, agranulocytosis, hemolytic anemia, leukopenia, pancytopenia and thrombocytopenia have been reported. Increases in prothrombin time/INR in patients treated with concomitant warfarin have been reported.
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