Fardole

Uses

Short-term treatment in healing and symptomatic relief of duodenal ulcers and erosive or ulcerative Gastroesophageal Reflux Disease (GERD).

Maintaining healing and reducing relapse rates of heartburn symptoms in patients with GERD.

Treatment of daytime and night time heartburn and other symptoms associated with GERD.

Long-term treatment of pathological hypersecretory conditions, including Zollinger Ellison Syndrome.

In combination with Amoxicillin and Clarithromycin to eradicate Helicobacter pylori.

Fardole is also used to associated treatment for these conditions: Duodenal Ulcer, Gastric Ulcer, Gastro-esophageal Reflux Disease (GERD), Heartburn, Helicobacter Pylori Infection, NSAID Associated Gastric Ulcers, Non-erosive Reflux Esophagitis Disease (NERD), Vomiting, Zollinger-Ellison Syndrome, Erosive reflux esophagitis

How Fardole works

Fardole belongs to a class of antisecretory compounds (substituted benzimidazole proton-pump inhibitors) that do not exhibit anticholinergic or histamine H2-receptor antagonist properties, but suppress gastric acid secretion by inhibiting the gastric H⁺/K⁺ATPase (hydrogen-potassium adenosine triphosphatase) 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. Fardole blocks the final step of gastric acid secretion. In gastric parietal cells, rabeprazole is protonated, accumulates, and is transformed to an active sulfenamide. When studied in vitro, rabeprazole is chemically activated at pH 1.2 with a half-life of 78 seconds.

Dosage

Fardole dosage

Healing of Erosive or Ulcerative Gastroesophageal Reflux Disease (GERD): 20 mg to be taken once daily for 4 to 8 weeks. For those patients who have not healed after 8 weeks of treatment, an additional 8 week course may be considered.

Maintenance of Healing of Erosive or Ulcerative Gastroesophageal Reflux Disease (GERD Maintenance): The recommended adult oral dose is 20 mg once daily.

Treatment of Symptomatic Gastroesophageal Reflux Disease (GERD):The recommended adult oral dose is 20 mg once daily for 4 weeks. If symptoms do not resolve completely after 4 weeks, an additional course of treatment may be considered.

Healing of Duodenal Ulcers:The recommended adult oral dose is 20 mg once daily after the morning meal for a period up to four weeks. Most patients with duodenal ulcer heal within four weeks. A few patients may require additional therapy to achieve healing.

Helicobacter pylori Eradication:To Reduce the Risk of Duodenal Ulcer Recurrence-

• Fardole Sodium 20 mg Twice Daily for 7 Days
• Amoxicillin 1000 mg Twice Daily for 7 Days
• Clarithromycin 500 mg Twice Daily for 7 Days

All three medications should be taken twice daily with the morning and evening meals. It is important that patients comply with the full 7-day regimen.

Treatment of Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome: The dosage of Fardole Sodium in patients with pathologic hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose is 60 mg once a day. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Some patients may require divided doses. Doses up to 100 mg QD and 60 mg BID have been administered. Some patients with Zollinger-Ellision syndrome have been treated continuously with Fardole Sodium for up to one year.

Side Effects

Fardole Sodium may sometimes cause headache, diarrhoea, abdominal pain, vomiting, constipation, dry mouth, increased or decreased appetite, muscle pain, drowsiness and dizziness.

Precaution

Administration of Fardole Sodium to patients with mild to moderate liver impairment resulted in increased exposure and decreased elimination. Caution should be exercised in patients with severe hepatic impairment.

Interaction

Fardole is metabolized by the Cytochrome P-450 (CYP-450) drug metabolizing enzyme system. Fardole does not have clinically significant interactions with other drugs metabolized by the CYP-450 system,such as Warfarin and Theophylline given as single oral dose, Diazepam as a single intravenous dose, and Phenytoin given as a single intravenous dose. In normal subjects, co-administration of Fardole 20 mg QD resulted in an approximately 30% decrease in the bioavailability of Ketoconazole and increase in the AUC and Cmax for digoxin of 90% and 29% respectively.

Food Interaction

• Take with or without food. Food delays drug absorption, but not to a clinically significant extent.

Fardole Drug Interaction

Major: clopidogrelModerate: levothyroxineMinor: aspirin, aspirin, duloxetine, cyanocobalaminUnknown: celecoxib, rosuvastatin, apixaban, omega-3 polyunsaturated fatty acids, atorvastatin, pregabalin, metoprolol, metoprolol, acetaminophen, budesonide / formoterol, ascorbic acid, cholecalciferol, bupropion, cetirizine

Fardole Disease Interaction

Major: C. diffModerate: bone fractures, hypomagnesemia, liver disease

Elimination Route

Absolute bioavailability is approximately 52%.

Half Life

1-2 hours (in plasma)

Elimination Route

Following a single 20 mg oral dose of 14C-labeled rabeprazole, approximately 90% of the drug was eliminated in the urine, primarily as thioether carboxylic acid; its glucuronide, and mercapturic acid metabolites.

Pregnancy & Breastfeeding use

Fardole is FDA Pregnancy Category B. No data is available on administration of Fardole to pregnant women. However this drug should be used during pregnancy, only if clearly needed. There are no data on the excretion of Fardole into the breast milk. A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the benefit of the drug to the mother.

Contraindication

Fardole Sodium is contraindicated in patient with known hypersensitivity to Fardole or to any component in the product.

Special Warning

Use in pediatric patients: The safety and effectiveness of Fardole in pediatric patients have not been established.

Acute Overdose

There has been no experience with large overdoses with Fardole. No specific antidote for Fardole is known. Fardole is extensively protein bound and is not readily dialyzable. In the event of overdosage, treatment should be symptomatic and supportive.

Storage Condition

Store below 25°C, protected from light and moisture. Keep all medicines out of the reach of the children.

Innovators Monograph

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