Ruling Capsule

Photography by Syed Najam Abbas Rizvi (Social media influencer, Pharmacist)

Ruling capsule 20mg/40mg is a prescription medicine.

Manufacturer: HIGH-Q

Ruling capsule 20mg (14 capsules box) price: 366.67

Ruling capsule 40mg (14 capsules box) price: 480.00

Omeprazole, available in the form of Ruling capsules, is a widely used proton pump inhibitor (PPI) that works to reduce gastric acid production. Commonly prescribed for the management of conditions associated with excessive stomach acid, Omeprazole helps relieve symptoms and promote healing in patients with acid-related disorders. Below, we will explore the detailed aspects of Ruling capsules, including their description, composition, mechanism of action, pharmacokinetics, application in special populations, and therapeutic indications.

Description of ruling capsule

Ruling (Omeprazole) capsules are designed for oral administration, typically containing omeprazole in a delayed-release form. The capsules are usually available in 20 mg and 40 mg doses. Omeprazole itself is a substituted benzimidazole that inhibits gastric acid secretion. The capsule’s enteric coating allows it to bypass the stomach, ensuring that the medication is released in the intestine, where it can be absorbed effectively without being broken down by stomach acid.

Qualitative and Quantitative Composition:

Each Ruling capsule contains omeprazole as the active ingredient. Other components, which may vary by manufacturer, often include inactive ingredients such as magnesium oxide, Hypromellose, and other agents that enhance the stability and absorption of omeprazole. A typical qualitative composition of Ruling capsules includes:

• Active Ingredient:

Omeprazole

• Excipients:

Sucrose, magnesium carbonate, sodium lauryl sulfate, Hypromellose, and an enteric coating of methacrylic acid copolymers. The quantitative concentration varies based on dosage strength, ensuring that patients receive the correct amount for therapeutic efficacy.

Clinical Pharmacology (Mechanism of action):

Omeprazole operates as a proton pump inhibitor, which blocks the hydrogen-potassium ATPase enzyme system of gastric parietal cells. This enzyme system, known as the "proton pump," is the terminal stage in the production of gastric acid. By binding irreversibly to the proton pump, omeprazole suppresses both basal and stimulated gastric acid secretion. This inhibition is dose-dependent and can achieve up to 24-hour control over gastric acid secretion, which is beneficial for patients with acid reflux, ulcers, and other acid-related conditions.

Pharmacokinetics:

After oral administration, omeprazole is absorbed in the small intestine. The absorption is generally rapid, with peak plasma levels occurring within 0.5 to 3.5 hours. The bioavailability of omeprazole increases upon repeated doses, achieving around 60% bioavailability after several days of continuous dosing.

• Absorption:

Omeprazole’s absorption is pH-dependent and can be reduced in highly acidic environments.

• Distribution:

The drug is widely distributed throughout the body, with high binding to plasma proteins (approximately 95%).

• Metabolism:

Omeprazole undergoes extensive hepatic metabolism, primarily by the CYP2C19 and CYP3A4 enzymes, and is converted to inactive metabolites.

• Elimination:

Most of the metabolites are excreted in the urine, with a small portion also found in the feces. The half-life of omeprazole in plasma is approximately 1-1.5 hours, but its effects on acid suppression last much longer due to the irreversible binding to the proton pump.

Special Population:

1. Elderly:

In elderly patients, the bioavailability of omeprazole may increase slightly, but no dose adjustment is typically necessary.

2. Renal Impairment:

Omeprazole’s clearance may decrease in patients with renal impairment, yet significant accumulation does not generally occur, making dose adjustment unnecessary.

3. Hepatic Impairment:

Due to reduced clearance, patients with severe liver dysfunction may require a lower dosage.

4. Pregnancy and Lactation:

Omeprazole is classified as Pregnancy Category C, and should only be used if clearly needed. Lactating mothers are generally advised to avoid omeprazole, as it may be excreted in breast milk.

Therapeutic Indications:

Ruling (Omeprazole) capsules are primarily indicated for the following conditions:

• Gastroesophageal Reflux Disease (GERD):

Used for the treatment of erosive esophagitis and relief of symptoms associated with GERD.

• Peptic Ulcer Disease:

Includes treatment for both gastric and duodenal ulcers, promoting healing by reducing gastric acid secretion.

• Zollinger-Ellison Syndrome:

Prescribed for long-term management in patients with this rare condition characterized by excessive gastric acid production.

• Helicobacter pylori Infection:

Used in combination with antibiotics to eradicate H. pylori, reducing the risk of duodenal ulcer recurrence.

Dosage and Administration:

• For adults, the recommended dose to treat gastro-oesophageal reflux disease (GERD) without oesophagitis is 20mg OD for upto 4 weeks.

• For adults, the recommended dose to treat erosive oesophagitis is 20mg OD for 4-8 weeks. This medicine can also treat accompanying symptoms with GERD.

• For adults, for maintenance of healing of erosive oesophagitis is 20mg OD.

• For GERD, recommended dose in children is 0.7/1.4 mg/kg, upto a maximum of 40mg daily for 4-12 weeks.

• To treat duodenal and gastric ulcer, 20 mg OD or 40 mg OD in severe cases.

  For duodenal ulcer: 4 weeks

  For gastric ulcer: 8 weeks

• 20mg OD is given to treat NSAID associated ulceration.

• To eradicate H-pylori in peptic ulceration, 40mg is given with antibacterials.

• To treat zollinger-ellison syndrome,initial dose is 60mg OD. Further, 120mg dose can be given daily in 3 divided doses.

• 10-20mg OD for acid-related dyspepsia, 2-4 weeks.

• For prophylaxis of acid aspiration during general anaesthesia, 40mg evening before surgery and a further 40mg 2-6 hrs before procedure.

• Maximum of 20mg OD is given in patient who have improper liver functions.

  
  

  Adverse Effects:

  Adverse effects are generally mild and reversible.

• Common:

  Central nervous system:

• Diarrhea

• Constipation

• Abdominal pain

• Nausea and vomiting

• Flatulence

• Un-Common:

  Central nervous system:

• Dizziness

• Paraesthesia

• Somnolence

• Insomnia

• Vertigo

Hepatic:

Increased liver enzymes

• Skin:

• Rash/pruritis

• Urticaria

  
  

  Other:

  Malaise

  
  

  Rare:

  Central and peripheral nervous system:

• Reversible mental confusion

• Agitation

• Aggression

• Depression and hallucinations predominantly in severely ill patients.

Endocrine:

Gynecomastia

Gastro-Intestinal:

• Dry mouth

• Stomatitis

• G.I. candidiasis.

Hematological:

• Leukopenia

• Thrombocytopenia

• Agranulocytosis

• Pancytopenia

• G.I. carcinoids have been reported in patients with Zollinger-Ellison syndrome in long- term treatment with omeprazole.

Contra-Indications:

Omeprazole is contra-indicated in patients who are hypersensitive to any component of this drug or to substituted benzimidazoles.

Precautions:

• If there are chances of gastric ulcer to be indicated, don't give this drug as it can make diagnosis difficult and delayed.

• Before treatment, doctor should check if the patient is hypersensitive to penicillin, macrolides and other antibiotics.

• The reduced dose should be given in patirnts with abnormal liver functions.

• No studies for pregnancy. It can only be used if benefits are greater than risk to the fetus.

• Discontinue the drug in nursing mothers.

Instructions:

• Store below 30 degree celcius.

• Protect from light and moisture.

• Keep all medicines out of reach of children.

Counselling points:

• Take this medicine with water by swallowing.

• It is taken 30 minutes before meal.

Drug Interactions:

• Omeprazole can interact with ketoconazole and itraconazole and can decrease activity.

• This drug can increase plasma concentration of diazepam, citalopram, imipramine, clomipramine, phenytoin etc.