Bioprazole – composition, dosage, indications, contraindications. How does Bioprazole work?

Proven content

Bioprazole is a drug that inhibits the production of hydrochloric acid in the stomach, containing a proton pump inhibitor. The preparation is used: in the treatment of gastric ulcer, duodenal ulcer, esophageal reflux, indigestion or a history of damaged gastric and duodenal mucosa. Read how Bioprazole works and how it should be used.

Bioprazole – composition and mechanism of action

Bioprazole is a drug that is used to treat gastric and duodenal ulcers, indigestion, damaged gastric and duodenal mucosa, and esophageal reflux. The active substance of Bioprazole is omeprazole, and the excipients are:

1. sucrose, grains (containing sucrose and corn starch),
2. hypromeloza 2910,
3. talk,
4. titanium dioxide (E 171),
5. disodium phosphate dihydrate,
6. methacrylic acid and ethyl acrylate copolymer (1: 1), dispersion 30% (containing additives: sodium lauryl sulfate, polysorbate 80),
7. triethyl citrate.

Omeprazole is a racemic mixture of two active enantiomers. It is a selective inhibitor of the proton pump in the parietal cells of the stomach and reduces the secretion of hydrochloric acid in the stomach.. The action of the drug is quick, and when given in one dose a day, it relieves the symptoms of the disease.

See: What is the treatment and diet for bile reflux?

Bioprazole – indications for use

Bioprazole is a drug with a broad spectrum of action. It is indicated for use in the case of:

1. gastric or duodenal ulcer, also coexisting with Helicobacter pylori infection,
2. reflux oesophagitis
3. symptomatic treatment of gastro-esophageal reflux disease (burning sensation in the esophagus – heartburn),  Zollinger-Ellison syndrome,
4. as a prophylaxis of aspiration pneumonia before general anesthesia in people at risk of gastric acid aspiration,
5. when there are acid indigestion symptoms, 
6. treatment and prophylaxis of mild gastric ulcer and duodenal ulcer and erosions caused by the use of non-steroidal anti-inflammatory drugs (NSAIDs) in people with a history of gastric and duodenal damage who require NSAID treatment.

Also read: Diet for gastric and duodenal ulcers

Bioprazole – dosage

The dosage of Bioprazole will depend on the disease and the age of the person taking the preparation. The dosage of Bioprazole for each disease will be characterized in detail below.

Dosage of Bioprazole in the case of peptic ulcer disease

The recommended dose of omeprazole is 20 mg once daily. Conditions usually resolve quickly, and most patients heal within four weeks. In people with refractory peptic ulcer disease, omeprazole 40 mg once a day should be used – the healing process takes about eight weeks.

Omeprazole 20 mg once daily is recommended to prevent relapse of gastric ulcers. The dose can be increased to 40 mg once daily if needed.

Dosage of Bioprazole in the case of Helicobacter pylori

The regimens recommended for the treatment of Helicobacter pylori infection include the three-component and two-component methods.

The three-component method – three drugs are administered simultaneously according to one of the following three schedules:

1. twice daily dosed with 20 mg omeprazole, 1 g amoxicillin and 500 mg clarithromycin for one week,
2. Omeprazole 20 mg, clarithromycin 250 mg and metronidazole 400 mg (or tinidazole 500 mg) twice daily for one week,
3. Omeprazole 40 mg once daily and amoxicillin 500 mg and metronidazole 400 mg three times a day for one week.

Two-component method – two drugs are administered simultaneously according to one of the following two schedules:

1. in divided doses, 40 mg of omeprazole and 1,5 g of amoxicillin are administered daily for two weeks. In clinical trials, daily doses of amoxicillin ranging from 1,5 to 3,0 g were used.
2. Omeprazole 40 mg once daily and clarithromycin 500 mg three times a day for two weeks.

Dosage of Bioprazole in the case of duodenal ulcer

People who struggle with an active duodenal ulcer should take omeprazole 20 mg once a day. Patients with refractory duodenal ulcer should be administered omeprazole 40 mg once daily.

The regimens recommended for the treatment of Helicobacter pylori infection coexisting with gastric or duodenal ulcer disease are also based on the three- and two-component method.

The three-component method – three drugs are administered simultaneously according to one of the following three schedules:

1. Omeprazole 20 mg, amoxicillin 1 g and clarithromycin 500 mg twice daily for one week.
2. Omeprazole 20 mg, clarithromycin 250 mg and metronidazole 400 mg (or tinidazole 500 mg) twice daily for one week,
3. Omeprazole 40 mg once daily and amoxicillin 500 mg and metronidazole 400 mg three times a day for one week.

Two-component method – two drugs are administered simultaneously according to one of the following two schedules:

1. in divided doses, 40 mg of omeprazole and 1,5 g of amoxicillin are administered daily for two weeks. In clinical trials, daily doses of amoxicillin ranging from 1,5 to 3,0 g were used.
2. Omeprazole 40 mg once daily and clarithromycin 500 mg three times a day for two weeks. 

Dosage of Bioprazole in reflux oesophagitis

For adults, the recommended dose is omeprazole 20 mg once a day. Bioprazole is also administered at a dose of 40 mg daily in patients with severe reflux oesophagitis. In long-term treatment of patients, after resolution of reflux oesophagitis, omeprazole 10 mg once daily is recommended. If necessary, the dose can be increased to 20-40 mg once daily.

In children, Bioprazole should not be used in children under three years of age. Children from three years of age can take Bioprazole according to the following schedule: 

1. children weighing from 10 kg to 20 kg – 10 mg, 
2. children weighing more than 20 kg – 20 mg.

Dosage of Bioprazole for symptomatic treatment of gastro-oesophageal reflux disease:

1. The recommended dose of omeprazole ranges from 10 to 20 mg daily – the dosage should be determined individually in each case.

Bioprazole dosage for Zollinger-Ellison syndrome

In people with Zollinger-Ellison syndrome, the dose of Bioprazole should be adjusted individually. The recommended starting dose is omeprazole 60 mg once daily. Treatment is continued as long as clinically indicated. In patients with severe symptoms who do not respond poorly to other treatments, maintenance treatment with doses of 20 to 120 mg per day is usually effective. Omeprazole above 80 mg daily should be administered in two divided doses.

Bioprazole 20 mg once daily can also be used for the following diseases and symptoms:

1. acid indigestion
2. treatment of gastric and duodenal ulcers and erosions caused by the use of non-steroidal anti-inflammatory drugs,
3. prophylaxis of gastric and duodenal ulcers and erosions caused by the use of non-steroidal anti-inflammatory drugs.

Bioprazole – side effects

Bioprazole, like all medicines, may cause certain side effects. In the leaflet of Bioprazole, undesirable effects that are common, uncommon, rare and of an unknown frequency are listed.

Common side effects are:

1. diarrhea
2. constipation
3. flatulence
4. epigastric pain,
5. nausea,
6. vomiting,
7. flatulence with gas,
8. fundus polyps (benign),
9. headaches.

Uncommon side effects include:

1. dizziness,
2. paresthesia,
3. sensitivity to light,
4. bad mood,
5. somnolence,
6. insomnia,
7. disorders of the liver and bile ducts,
8. increased liver enzymes
9. skin and subcutaneous tissue disorders rash,
10. dermatitis and / or itching
11. hives.

The editorial board recommends: Sleep rhythm disturbances after 50, or why does our sleep quality decline with age?

Bioprazole – precautions

It should be remembered that decreased gastric acidity from any cause, including proton pump inhibitors (Bioprazole), increases the amount of bacteria normally present in the gastrointestinal tract. Treatment with drugs that reduce gastric acidity may lead to an increased risk of Salmonella and Campylobacter infections.

For the treatment of seriously ill children who require long-term therapy with Bioprazole and whose vitamin B12 levels are borderline or very low, monitoring of serum vitamin B12 levels may be advised.

Proton pump inhibitors, especially when used in high doses and in long-term treatment (over 1 year), may slightly increase the risk of fracture in the hip, wrist and spine, especially in the elderly or in people with known risk factors.

Severe hypomagnesaemia has been reported in people treated with proton pump inhibitors like omeprazole for at least three months and most of those taking PPIs for one year. Severe symptoms of hypomagnesaemia such as fatigue, tetany, delirium, dizziness and ventricular arrhythmias can occur, but they may start unnoticed and go unnoticed. In the most affected patients, hypomagnesaemia decreased after magnesium supplementation and withdrawal of proton pump inhibitors.

Bioprazole contains sucrose. People with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicinal product.

Bioprazole – interactions with other drugs

Before taking Bioprazole, inform your doctor or pharmacist about any medications you are taking on a permanent basis, as some of them may cause some side effects. Particular care should be taken when taking:

1. warfarin (an anti-clotting drug), 
2. phenytoin (an anti-epileptic drug), 
3. diazepam,
4. hexabarbital (sedatives and sleeping pills),
5. atazanavir (medicine to treat HIV infection),
6. tacrolimus (a medicine used during organ transplantation and to treat atopic dermatitis)
7. digoxin (a medicine used to treat heart failure and fast ventricular atrial fibrillation)
8. cilostazol (a medicine used to treat the symptoms of cramp pains in the legs when walking),
9. antidepressants such as citalopram, imipramine, clomipramine,
10. anti-fungal and anti-yeast drugs (e.g. ketoconazole, itraconazole, voriconazole).