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Safiya

Safiya

Manufacturer:

Inventia Healthcare

Distributor:

Kaufmann
Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Warnings Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing
Concise Prescribing Info
Contents
Per 20 mg/150 mg MR cap Rabeprazole Na 20 mg, itopride HCl 150 mg
Indications/Uses
Management of symptoms of burning in various acid peptic disorders associated w/ nausea &/or vomiting. GERD, reflux esophagitis, non-ulcer dyspepsia, gastroparesis & idiopathic hiccup, or any other acid peptic disease accompanied by nausea &/or vomiting like acute gastritis, including that induced by NSAIDs.
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Dosage/Direction for Use
Moderate to severe/unresponsive GERD/reflux esophagitis 1 cap once daily in the morning for 4-8 wk. Prevention of aspiration pneumonitis 1 cap once in the evening before surgery & repeated on the morning of surgery. Other indication Adult 1 cap daily in the morning. Maintenance 1 cap once daily in the morning or at bedtime.
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Overdosage
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Administration
Should be taken on an empty stomach: Take 15-30 min before food. Swallow whole, do not open/chew/crush.
Contraindications
Hypersensitivity to rabeprazole Na, itopride HCl, or substituted benzimidazoles.
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Warnings
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Special Precautions
Should be used during pregnancy only if potential benefit justifies probable risks involved. Discontinue nursing or the drug taking into account the importance of therapy to the mother. Safety & efficacy in childn have not been established. Rabeprazole: Symptomatic response to rabeprazole does not preclude presence of gastric malignancy. Atrophic gastritis has been noted occasionally in gastric corpus biopsies from patients treated long-term w/ benzimidazole. Potential to cause gastric carcinoids.
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Use In Pregnancy & Lactation
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Adverse Reactions
Rabeprazole: Asthenia, fever, allergic/photosensitivity reactions, chills, malaise, musculoskeletal pain & aches, CV signs, digestive system complaints, thyroid abnormalities, hemopoietic changes, edema, wt change, sleep disturbances & other central nervous symptoms, decreased libido, resp features, sight & hearing difficulties, dysuria, genital system affections & skin lesions. Itopride: Diarrhea/constipation, increased salivation, abdominal pain, other GI disturbances, hypersensitivity, headache.
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Drug Interactions
Rabeprazole: Inhibited metabolism of cyclosporine. May interfere w/ absorption of drugs wherein gastric pH is an important determinant of bioavailability eg, ketoconazole. Itopride: May have reduced action w/ anticholinergic agents.
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Storage
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Description
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Action
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MIMS Class
Antacids, Antireflux Agents & Antiulcerants
ATC Classification
A02BC54 - rabeprazole, combinations ; Belongs to the class of proton pump inhibitors. Used in the treatment of peptic ulcer and gastro-oesophageal reflux disease (GERD).
Regulatory Classification
Rx
Presentation/Packing
Form
Safiya 20 mg/150 mg MR cap
Packing/Price
30's