Roly
Roly Uses, Dosage, Side Effects, Food Interaction and all others data.
Roly Sodium is an antiulcerant drug in the class of Proton Pump Inhibitors. Roly Sodium is a substituted benzimidazole which suppresses gastric acid secretion by inhibiting the gastric H+/K+-ATPase enzyme at the secretory surface of the gastric parietal cell. It is an enteric coated tablet, because of its coated formulation it is highly stable in stomach and because of higher pKa value of Roly Sodium it provides faster onset of action. It blocks the final step of gastric acid secretion.
After oral administration of 20 mg, Roly is absorbed and can be detected in plasma by 1 hour. The effects of food on the absorption of Roly have not been evaluated. Roly is 96.3% bound to human plasma proteins. Roly is primarily metabolized in the liver by Cytochrome P-450 3A (Sulphone metabolite) and 2C19 (Desmethyl Roly). Following a single 20 mg oral dose of Roly, approximately 90% of the drug is eliminated in the urine.The remainder of the dose is excreted in the feaces.
Roly prevents the production of acid in the stomach. It reduces symptoms and prevents injury to the esophagus or stomach in patients with gastroesophageal reflux disease (GERD) or ulcers. Roly is also useful in conditions that produce too much stomach acid such as Zollinger-Ellison syndrome. Roly may also be used with antibiotics to get rid of bacteria that are associated with some ulcers. Roly is a selective and irreversible proton pump inhibitor, suppresses gastric acid secretion by specific inhibition of the H+, K+ -ATPase, which is found at the secretory surface of parietal cells. In doing so, it inhibits the final transport of hydrogen ions (via exchange with potassium ions) into the gastric lumen.
| Trade Name | Roly |
| Availability | Prescription only |
| Generic | Rabeprazole |
| Rabeprazole Other Names | Clofezone, Rabeprazole |
| Related Drugs | amoxicillin, omeprazole, famotidine, pantoprazole, metronidazole, Nexium, Pepcid, Protonix, esomeprazole, sucralfate |
| Type | Tablet |
| Formula | C18H21N3O3S |
| Weight | Average: 359.443 Monoisotopic: 359.130362243 |
| Protein binding | 96.3% (bound to human plasma proteins) |
| Groups | Approved, Investigational |
| Therapeutic Class | Proton Pump Inhibitor |
| Manufacturer | Floreat Medica Pvt Ltd |
| Available Country | India |
| Last Updated: | September 19, 2023 at 7:00 am |
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.
Roly 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 Roly works
Roly 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. Roly 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
Roly 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-
- Roly 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 Roly 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 Roly Sodium for up to one year.
Side Effects
Roly Sodium may sometimes cause headache, diarrhoea, abdominal pain, vomiting, constipation, dry mouth, increased or decreased appetite, muscle pain, drowsiness and dizziness.
Precaution
Administration of Roly 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
Roly is metabolized by the Cytochrome P-450 (CYP-450) drug metabolizing enzyme system. Roly 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 Roly 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.
Roly 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
Roly 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
Roly is FDA Pregnancy Category B. No data is available on administration of Roly to pregnant women. However this drug should be used during pregnancy, only if clearly needed. There are no data on the excretion of Roly 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
Roly Sodium is contraindicated in patient with known hypersensitivity to Roly or to any component in the product.
Special Warning
Use in pediatric patients: The safety and effectiveness of Roly in pediatric patients have not been established.
Acute Overdose
There has been no experience with large overdoses with Roly. No specific antidote for Roly is known. Roly 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
You find simplified version here Roly
Roly contains Rabeprazole see full prescribing information from innovator Roly Monograph, Roly MSDS, Roly FDA label
FAQ
What is Roly used for?
Roly used for heartburn, acid reflux and gastro-oesophageal reflux disease when you keep getting acid reflux. Roly is also taken to prevent and treat stomach ulcers. Roly reduces the amount of acid your stomach makes.
How safe is Roly?
Roly is efficacious in gastro-esophageal reflux disease (GERD) and other acid-related diseases. Long-term use of Roly was confirmed to be safe in studies of two to five-year maintenance therapy for GERD.
What are side effects of Roly?
Common side effects may include:
- infection;
- pain;
- sore throat;
- headache;
- nausea, vomiting;
- gas, diarrhea, constipation; or.
- stomach pain.
Is Roly taken empty stomach?
Roly can be taken either before or after food, although taking it before food is preferable. If you forget to take a dose at your usual time, you can generally take it when you remember.
Is Roly safe for my kidneys?
Roly can cause kidney problems.If you have blood in your urine. Diarrhea may be a sign of a new infection.
Is Roly safe during pregnancy?
Roly isn't usually recommended during pregnancy as there's no firm evidence it's safe. if you're pregnant, it's better to try to treat symptoms of acid reflux and heartburn without taking a medicine.
Is Roly safe to take while breastfeeding?
The SPC advises to avoid the use of rabeprazole during lactation.levels for both drugs are low, and in addition a large proportion of any of the drug ingested by the infant is likely to be destroyed by the acid in the stomach.
Does Roly work right away?
Roly starts doing its job within an hour of taking the first dose, you may not feel that your symptoms have improved for several days. This is because Roly has to “turn off” the proton pumps of the acid-producing cells in the stomach, and it is not able to turn off all proton pumps immediately.
How long Roly can be taken?
Roly is for short-term use only, usually 4 to 8 weeks. Your doctor may recommend a second course of treatment if you need additional healing time.
Is Roly good for gastritis?
Roly may good to treat: Reflux oesophagitis. Peptic ulcers. Chronic Gastritis.
Can Roly cause liver problems?
Roly therapy is associated with a low rate of transient and asymptomatic serum aminotransferase elevations and is a rare cause of clinically apparent liver injury.
Is Roly safe long term?
The drug is efficacious in gastro-esophageal reflux disease (GERD) and other acid-related diseases. Long-term use of Roly was confirmed to be safe in studies of two to five-year maintenance therapy for GERD.
What happens when you stop taking Roly?
Stopping the Roly suddenly could make your stomach produce a lot more acid, and make your symptoms return.you can stop taking rabeprazole without reducing the dose first. If you've taken Roly for a long time, speak to your doctor before you stop taking Roly.
Is Roly an antifungal?
Proton pump inhibitors, such as Roly act as agents with antifungal activity or reverse-acquired resistance to azoles.
Is Roly a controlled substance?
Roly 20 mg is not a controlled substance under the Controlled Substances Act (CSA).
What class of drug is Roly?
Roly is in a class of medications called proton-pump inhibitors.
Can you take Tylenol with Roly?
No interactions were found between Roly and Tylenol. This does not necessarily mean no interactions exist. Always consult your healthcare provider.
How many Roly Can I take a day?
Adults can take Roly 20 milligrams (mg) once a day for up to 4 weeks. Your doctor may adjust your dose as needed. Children 12 years of age and older take Roly 20 mg once a day for up to 8 weeks. Your child's doctor may adjust the dose as needed.
