NIKP-Rabeprazole

NIKP-Rabeprazole

rabeprazole

Manufacturer:

Nichi-Iko

Distributor:

DKSH
Concise Prescribing Info
Contents
Rabeprazole Na
Indications/Uses
Duodenal, gastric, stomal ulcer; reflux esophagitis; Zollinger-Ellison syndrome. GERD long-term management. Symptomatic treatment of moderate to very severe GERD. Eradication of H. pylori in patients w/ PUD in combination w/ appropriate antibacterial therapeutic regimens.
Dosage/Direction for Use
Adult & elderly Duodenal, gastric, stomal ulcer & reflux esophagitis 10 mg once daily for 8 wk (gastric & stomal ulcer, reflux esophagitis), or 6 wk (duodenal ulcer). May be increased up to 20 mg once daily. GERD maintenance 10 or 20 mg once daily depending on patient's response. Symptomatic GERD 10 mg once daily. Zollinger-Ellison syndrome Initially 60 mg daily, up to 100 mg once daily. Or 60 mg bd. Eradication of H. pylori 20 mg bd for 7 days in combination w/ clarithromycin 500 mg bd & amoxicillin 1 g bd.
Administration
May be taken with or without food: Swallow whole, do not chew/crush.
Contraindications
Hypersensitivity to rabeprazole Na or substituted benzimidazoles. Pregnancy & lactation.
Special Precautions
Exclude possibility of malignancy prior to treatment. Associated w/ very infrequent cases of subacute cutaneous lupus erythematosus (SCLE). Hypomagnesemia. Monitor Mg levels prior to treatment initiation & periodically thereafter in patients expected to be on prolonged use or concomitantly taking digoxin or drugs that may cause hypomagnesemia. Increased risk of GI infections eg, Salmonella & Campylobacter, & possibly Clostridium difficile. Prolonged use may cause increased risk of osteoporosis-related fractures of the hip, wrist or spine. Caution in patients w/ hepatic dysfunction. Avoid driving & operating complex machinery if alertness is impaired. Not recommended for use in childn.
Adverse Reactions
Headache, diarrhoea & nausea. Infection; neutropenia, leucopenia, thrombocytopenia, leucocytosis; acute systemic allergic reactions; anorexia; insomnia, nervousness, somnolence, depression; dizziness; visual disturbance; cough, pharyngitis, rhinitis, bronchitis, sinusitis; vomiting, abdominal pain, constipation, flatulence, dyspepsia, dry mouth, eructation, gastritis, stomatitis, taste disturbance; hepatitis, jaundice, hepatic encephalopathy; rash, erythema, pruritis, sweating, bullous reactions, erythema multiforme, toxic epidermal necrolysis, Stevens-Johnson syndrome; non-specific pain/back pain, myalgia, leg cramps, arthralgia; UTI, interstitial nephritis; asthenia, flu-like syndrome, chest pain, chills, fever; increased hepatic enzymes; wt gain.
Drug Interactions
Interaction w/ compd w/ pH-dependent absorption. Decreased ketoconazole plasma levels. Increased digoxin plasma levels. May elevate & prolong serum levels of methotrexate &/or its metabolite (hydroxymethotrexate) at high dose.
MIMS Class
Antacids, Antireflux Agents & Antiulcerants
ATC Classification
A02BC04 - rabeprazole ; Belongs to the class of proton pump inhibitors. Used in the treatment of peptic ulcer and gastro-oesophageal reflux disease (GERD).
Presentation/Packing
Form
NIKP-Rabeprazole EC tab 10 mg
Packing/Price
10 × 10's
Form
NIKP-Rabeprazole EC tab 20 mg
Packing/Price
10 × 10's
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