Finix 20

Generic

Rabeprazole Sodium.

 

Indications

Rabeprazole is indicated in Duodenal ulcer Healing of erosive or ulcerative Gastroesophageal Reflux Disease (GERD). Treatment of symptomatic GERD. Maintenance of healing of erosive or ulcerative GERD Zollinger-Ellison Syndrome. Helicobacter pylori eradication to Reduce the Risk of Duodenal Ulcer Recurrence.

 

Pharmacology

Finix 20 suppresses gastric acid secretion by inhibiting the gastric H+/K+-ATPase at the secretory surface of the gastric parietal cell. Because this enzyme is regarded as the acid (proton) pump within the parietal cell, rabeprazole has been characterized as a gastric proton-pump inhibitor.

 

Dosage

Active Duodenal Ulcer and Active Benign Gastric Ulcer: The recommended oral dose for both bioactive duodenal ulcer and active benign gastric ulcer is 20 mg to be taken once daily in the morning. Most patients with active duodenal ulcers heal within four weeks. However, a few patients may require an additional four weeks of therapy to achieve healing. Most patients with active benign gastric ulcers heal within six weeks. However, again a few patients may require an additional six weeks of therapy to achieve healing.

Erosive or Ulcerative Gastro-Esophageal Reflux Disease (GERD): The recommended oral dose for this condition is 20 mg to be taken once daily for four to eight weeks.

Gastro-Esophageal Reflux Disease Long-term Management (GERD Maintenance): For long-term management, a maintenance dose of rabeprazole sodium 20 mg or 10 mg once daily can be used depending upon patient response. Symptomatic treatment of moderate to very severe Gastro-Esophageal Reflux Disease (symptomatic GERD): 10 mg once daily in patients without oesophagitis. If symptom control has not been achieved during four weeks, the patient should be further investigated. Once symptoms have resolved, subsequent symptom control can be achieved using an on-demand regimen taking 10 mg once daily when needed.

Zollinger-Ellison Syndrome: The recommended adult starting dose is 60 mg once a day. The dose may be titrated upwards of 120 mg/day based on individual patient needs. Single daily doses up to 100 mg/day may be given. 120 mg dose may require divided doses, 60 mg twice daily. Treatment should continue for as long as clinically indicated.

Eradication of H. pylori: Patients with H. pylori infection should be treated with eradication therapy. The following combination given for 7 days is recommended. Rabeprazole sodium 20 mg twice daily, clarithromycin 500 mg twice daily and amoxicillin 1g twice daily.

 

Administration

For signs requiring once-daily treatment Finix 20 tablets ought to be taken within the morning, sometimes recently eating; and in spite of the fact that not one or the other the time of day nor nourishment admissions were appeared to have any impact on rabeprazole sodium movement, this regimen will encourage treatment compliance. Patients ought to be cautioned that the Finix 20 tablets ought to not be chewed or pulverized, but ought to be gulped entirety.

 

Interaction

Rest produces a significant and long-lasting restraint of gastric corrosive discharge. An interaction with a compound whose assimilation is pH subordinate may happen. Co-administration of rabeprazole sodium with ketoconazole or itraconazole may result in a critical diminish in antifungal plasma levels. Hence person patients may get to be observed to decide in the event that a measurement alteration is vital when ketoconazole or itraconazole are taken concomitantly with Break. No interaction with fluid stomach settling agents was watched. The assimilation of atazanavir is pH-dependent. Subsequently, PPIs, counting rabeprazole, ought to not be co-administered with atazanavir.

 

Contraindications

Hypersensitivity to the active ingredient or any excipient. Rabeprazole is not recommended during pregnancy or nursing.

 

Side Effects

Rabeprazole is generally well-tolerated in both short and long-term studies. Headache, diarrhea, abdominal discomfort, vomiting, constipation, dry mouth, increased or decreased hunger, muscle soreness, sleepiness, and dizziness are all possible side effects of rabeprazole.

 

Pregnancy & Lactation

US FDA pregnancy category 'C'. Thinks about have been performed in creatures and have uncovered no prove of impeded ripeness or hurt to the embryo due to Rabeprazole. There are, be that as it may, no satisfactory and well-controlled ponders in pregnant ladies. Rabeprazole is likely to be excreted in the human brain, a choice ought to be made whether to suspend nursing or to suspend the sedate, taking into consideration the significance of the sedate to the mother.

 

Precautions & Warnings

• Symptomatic response to therapy with Rabeprazole does not preclude the presence of gastric or oesophageal malignancy, therefore the possibility of malignancy should be excluded prior to commencing treatment with Rabeprazole 20 mg Gastro-resistant Tablets.
• Patients on long-term treatment (particularly those treated for more than a year) should be kept under regular surveillance.
• Proton pump inhibitors, especially if used in high doses and over long durations (>1 year), may modestly increase the risk of hip, wrist, and spine fracture, predominantly in the elderly or in presence of other recognized risk factors. Observational studies suggest that proton pump inhibitors may increase the overall risk of fracture by 10–40%. Some of this increase may be due to other risk factors. Patients at risk of osteoporosis should receive care and they should have an adequate intake of vitamin D and calcium.
• A risk of cross-hypersensitivity reactions with another proton pump inhibitor or substituted benzimidazoles cannot be excluded.
• Patients should be cautioned that Rabeprazole gastro-resistant tablets should not be chewed or crushed, but should be swallowed whole.
• There have been post-marketing reports of blood dyscrasias (thrombocytopenia and neutropenia). In the majority of cases where an alternative etiology cannot be identified, the events were uncomplicated and resolved on discontinuation of rabeprazole.
• Hepatic enzyme abnormalities have been seen in clinical trials and have also been reported since market authorization. In the majority of cases where an alternative etiology cannot be identified, the events were uncomplicated and resolved on discontinuation of rabeprazole.
• No evidence of significant drug-related safety problems was seen in a study of patients with mild to moderate hepatic impairment versus normal age and sex-matched controls. However, because there are no clinical data on the use of rabeprazole in the treatment of patients with severe hepatic dysfunction the prescriber is advised to exercise caution when treatment with Rabeprazole 20mg Gastro-resistant. Tablets are first initiated in such patients.
• Co-administration of atazanavir with Rabeprazole is not recommended.
• Treatment with proton pump inhibitors, including rabeprazole, may possibly increase the risk of gastrointestinal infections such as Salmonella, Campylobacter, and Clostridium difficile.

Hypomagnesaemia: Severe hypomagnesemia has been reported in patients treated with PPIs like rabeprazole for at least three months, and in most cases for a year. Serious manifestations of hypomagnesemia such as fatigue, tetany, delirium, convulsions, dizziness, and ventricular arrhythmia can occur but they may begin insidiously and be overlooked. In most affected patients, hypomagnesemia improved after magnesium replacement and discontinuation of the PPI. For patients expected to be on prolonged treatment or who take PPIs with digoxin or drugs that may cause hypomagnesemia (e.g., diuretics), health care professionals should consider measuring magnesium levels before starting PPI treatment and periodically during treatment.

Influence on vitamin B12 absorption: Rabeprazole sodium, as all acid-blocking medicines, may reduce the absorption of vitamin B12 (cyanocobalamin) due to hypo- or a- chlorhydria. This should be considered in patients with reduced body stores or risk factors for reduced vitamin B12 absorption on long-term therapy or if respective clinical symptoms are observed.

Subacute cutaneous lupus erythematosus (SCLE): Proton pump inhibitors are associated with very infrequent cases of SCLE. If lesions occur, especially in sun-exposed areas of the skin, and if accompanied by arthralgia, the patient should seek medical help promptly and the health care professional should consider stopping Rabeprazole. SCLE after previous treatment with a proton pump inhibitor may increase the risk of SCLE with other proton pump inhibitors.

Interference with laboratory tests: Increased Chromogranin A (CgA) level may interfere with investigations for neuroendocrine tumors. To avoid this interference, Rabeprazole 20mg Gastro-resistant Tablets treatment should be stopped for at least 5 days before CgA measurements. If CgA and gastrin levels have not returned to the reference range after initial measurement, measurements should be repeated 14 days after cessation of proton pump inhibitor treatment.

 

Therapeutic Class

Proton Pump Inhibitor

 

Storage Conditions

Even if the canister appears to be empty, it should not be punctured, broken, or incinerated. Avoid storing in direct sunlight or in a hot environment. Keep it below 30°C. Keep your distance from the eyes. Keep your distance from youngsters.

 

Pharmaceutical Name

Opsonin Pharma Ltd.

 

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