Azgovanc IR-Omeprazole 20mg/40mg

Forms : Hard gelatin capsules .

A02BC01-Azgovanc
A02BC01-Azgovanc

Azgovanc Price in EGYPT

  • 20 mg 14 capsules for 16.8 L.E.
  • 20 mg 7 capsules for 19 L.E.
  • 40 mg 7 capsules for 27 L.E.

COMPANY

Advanced Pharmaceutical Industries Co (APIC).

Generic Name

Hard gelatin capsule: Omeprazole 20 or 40mg + Sodium bicarbonate 1100 mg.

Pharmaceutical form

Azgovanc 20 mg and 40 mg hard gelatin capsules.

Clinical Pharmacology

Omeprazole is acid labile and thus rapidly degraded by gastric acid.

Azgovanc is immediate-release formulations that contain sodium bicarbonate which raises the gastric pH and thus protects omeprazole from acid degradation.

Omeprazole belongs to a class of antisecretory compounds, the substituted benzimidazoles, that do not exhibit anticholinergic or H2 histamine antagonistic but that suppress gastric acid secretion by specific inhibition of H+/K+ ATPase  enzyme system at the secretory surface of the gastric parietal cell. Because this enzyme system is regarded as the acid (proton) pump within the gastric mucosa, omeprazole has been characterized as a gastric acid-pump inhibitor, in that it blocks the final step of acid production.

This effect is dose related and leads to inhibition of both basal and stimulated acid secretion irrespective of the stimulus.

Repeated single daily oral doses of Azgovanc 20 mg and 40 mg have produced nearly 100% inhibition of 24-hours integrated gastric acidity in some subjects.

A02BC01-Azgovanc01
A02BC01-Azgovanc01

Pharmacokinetics

Absorption:

Azgovanc is administered on an empty stomach 1 hour prior to a meal.

The absorption of omeprazole is rapid, time to peak of approximately 30 minutes (range 10-90 min) after a single-dose or repeated-dose administration.

When Azgovanc is administered 1 hour after a meal, the omeprazole AUC is reduced by approximately 24% relative to administration 1 hour prior to a meal.

Distribution:

Omeprazole is bound to plasma proteins. Protein binding is approximately 95%..

Metabolism:

This implies a significant biliary excretion of the metabolites of omeprazole.

Three metabolites have been identified in plasma the sulfide and sulfone derivatives of omeprazole, and hydroxyomeprazole.

These metabolites have very little or no antisecretory activity.

Excretion:

Following single-dose oral administration of omeprazole, the majority of the dose (about 77%) is eliminated in urine as at least six metabolites.

Two metabolites have been identified as hydroxyomeprazole and the corresponding carboxylic’acid. The remainder of the dose was recoverable in feces.

Little if any unchanged drug is excreted in urine.

The mean plasma omeprazole half-life in healthy subjects is approximately 1 hour.

Indications and Usage

  1. Duodenal Ulcer:

Azgovanc is indicated for short-term treatment of active duodenal ulcer. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.

  1. Gastric Ulcer:

Azgovanc is indicated for short-term treatment (4-8 weeks) of active benign gastric ulcer.

  1. Treatment of Gastro Esophageal Reflux Disease (GERD(

 Azgovanc is indicated for the treatment of heartburn and other symptoms associated with GERD.

  1. Erosive Esophagitis:

Azgovanc is indicated for the short-term treatment (4-8 weeks) of erosive esophagitis which has been diagnosed by endoscopy .

The efficacy of Azgovanc used for longer than 8 weeks in these patients has not been established. In the rare instance of a patient not responding to 8 weeks of treatment, it may be helpful to give up to an additional 4 weeks of treatment.

If there is recurrence of erosive esophagitis or GERD symptoms ( e.g. heartburn ),additional (4-8 weeks ) courses of omeprazole may be considered.

  1. Maintenance of Healing of Erosive Esophagitis:

Azgovanc is indicated to maintain healing of erosive esophagitis.

Dosage and Administration

Azgovanc should be taken on an empty stomach at least one hour before a meal.

Recommended doses of Azgovanc by indication for adults 18 years and older are as follows:

Indication Recommended dose Frequency
 
Short-Term Treatment of Active Duodenal Ulcer 20 mg Once daily for 4 weeks
Benign Gastric Ulcer 40 mg Once daily for 4-8 weeks

Gastroesophageal Reflux Disease (GERD)    
Symptomatic GERD 20 mg Once daily for up to 4 weeks
(with no esophageal erosions)
Erosive Esophagitis 20 mg Once daily for up to 4-8 weeks
Maintenance of Healing of Erosive Esophagitis 20 mg Once daily

Administration of hard gelatin capsules:

Azgovanc hard gelatin capsules should be swallowed intact with water. Do not use other liquids. Do not open capsule and sprinkle content into food.

Contraindications

Azgovanc is contraindicated in patients with known hypersensitivity to any components of the formulation.

Adverse Reactions

Rarely:

Fever, pain, fatigue, malaise, abdominal swelling, tachycardia, bradycardia, palpitation, pancreatitis, anorexia, irritable colon, dry mouth, stomatitis and marked elevations of liver function tests. Muscle cramps, myalgia, muscle weakness, depression, hallucinations, confusion, insomnia, nervousness, tremors, somnolence, anxiety, vertigo, tinnitus, taste perversion and blurred vision.

Post marketing reports:

Musculoskeletal: bone fracture.

Drug Interactions

Omeprazole can prolong the elimination of diazepam, warfarin and phenytoin, or other drugs that are metabolized by oxidation in the liver.

There have been reports of increased prothrombin time in patients receiving proton pump inhibitors, including omeprazole, and warfarin concomitantly.

Administration of omeprazole and atazanavir has been reported to reduce the plasma levels of atazanavir.

Administration of omeprazole and tacrolimus may increase the serum levels of tacrolimus.

Co-administration of omeprazole and clarithromycin has resulted in increases of plasma levels of omeprazole, clarithromycin, and 14-hydroxy-clarithromycin.

Pregnancy & Nursing Mothers

There are no adequate and well-controlled studies on the use of omeprazole in pregnant women.

Chronic use of sodium bicarbonate may lead to systemic alkalosis and increased sodium intake  can produce edema and weight increase .

Omeprazole concentrations have been measured in breast milk of a woman. A decision should be taken to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

In addition, sodium bicarbonate should be used with caution in nursing mothers.

Precautions & Warnings

Symptomatic response to therapy with omeprazole does not preclude the presence of gastric malignancy.

Azgovanc is not to be used for patients who asked to reduce sodium intake.

Sodium bicarbonate is contraindicated in patients with metabolic alkalosis and hypocalcemia.

Sodium bicarbonate should be used with caution in patients with Bartter’s syndrome, hypokalemia, respiratory alkalosis, and problems with acid-base balance.

Long-term administration of bicarbonate with calcium or milk can cause milk-alkali syndrome.

Bone fracture: Several published observational studies suggest that proton pump inhibitor (PPI) therapy may be associated with an increased risk for osteoporosis-related fractures of hip, wrist, or spine. The risk of fracture was increased in patients who received high-dose, defined as multiple daily doses, and long-term PPI therapy (a year or longer).

Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated.

Patients at risk for osteoporosis-related fractures should be managed according to the established treatment guidelines.

Prescription proton pump inhibitor (PPI) drugs may cause low serum magnesium levels (hypomagnesemia) if taken for prolonged periods of time (in most cases, longer than one year), magnesium supplementation alone did not improve low serum magnesium levels and the PPI had to be discontinued.

Low serum magnesium levels can result in serious adverse events including muscle spasm (tetany), irregular heart beat (arrhythmias), and convulsions )seizures); however, patients do not always have these symptoms.

Treatment of hypomagnesemia generally requires magnesium supplements treatment in patient taking a PPI and who have hypomagnesemia may also require stopping the PPI.

This product contains aspartam which is a source of phenylalanine and is harmful for patients with phenylketonuria.

Storage

  • Keep out of reach of children.
  • Store at a temperature not exceeding 30°C in a dry place .

Instructions for patients

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, please refer to your doctor or pharmacist.
  • Azgovanc hard gelatin capsules should be swallowed intact with water.
  • Do not use other liquids.
  • Do not open the capsule and sprinkle its content on food.

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