mopral 10 mg Uses, Dosage, Side Effects, Precautions & Warnings

mopral 10 mg Generic drug of the Therapeutic class: Gastro-Entero-Hepatology
active ingredients: Omeprazole

Important to know about mopral 10 mg ?

MOPRAL 10 mg hard gastro-resistant capsule is used to treat the following conditions:

In adults:

• gastroesophageal reflux disease (GERD). The stomach acid rises to the level of the esophagus (the tube that connects the throat to the stomach) causing pain, inflammation and burns.
• ulcers of the upper part of your intestine (duodenal ulcer) or of your stomach (gastric ulcer).
• ulcers infected with a bacterium called Helicobacter pylori. In this case, your doctor may also prescribe antibiotics that treat the infection and heal the ulcer.
• stomach ulcers associated with taking nonsteroidal anti-inflammatory drugs (NSAIDs). MOPRAL 10 mg, gastro-resistant capsule can also be used for the prevention of these if you take NSAIDs.
• an excess of acid in the stomach due to pancreatic size (Zollinger-Ellison syndrome)

In children:

Children over one year of age and with a body weight ≥ 10 kg

• gastroesophageal reflux disease (GERD). The stomach acid rises to the level of the esophagus (the tube that connects the throat to the stomach) causing pain, inflammation and burns.

Symptoms in children may include upset stomach contents (regurgitation), vomiting, and limited weight gain.

Children over 4 years old and teenagers

• ulcers infected with bacteria called Helicobacter pylori . In this case, the doctor may also prescribe antibiotics to your child that will treat the infection and cure the ulcer.

MOPRAL indication and Uses :

MOPRAL Dosage

The MOPRAL cells are indicated in:

Adults:

• Treatment of duodenal ulcers.
• Preventing recurrence of duodenal ulcers.
• Treatment of gastric ulcers.
• Prevention of relapsing gastric ulcers.

 In combination with appropriate antibiotics, eradication of Helicobacter pylori ( H. pylori ) in gastroduodenal ulcer disease.

Treatment of gastric and duodenal ulcers associated with the use of non-steroidal anti-inflammatory drugs (NSAIDs).

 Prevention of gastric and duodenal ulcers associated with the use of non-steroidal anti-inflammatory drugs (NSAIDs) in patients at risk.

• Treatment of reflux esophagitis.
• Maintenance treatment of patients after healing of reflux oesophagitis.
• Treatment of symptomatic gastro-oesophageal reflux.
• Treatment of Zollinger-Ellison Syndrome.

Pediatric use :

Children from one year and Â³ to 10 kg

• Treatment of reflux esophagitis.
• Symptomatic treatment of heartburn and acid reflux in patients with gastroesophageal reflux.

Children over 4 years old and adolescents

• In combination with antibiotics, treatment of duodenal ulcer secondary to infection with H. pylori.

Contraindications

How it works MOPRAL

Pharmacotherapeutic group: Drugs for acidity disorders, proton pump inhibitors. ATC Code: A02BC01

Action mechanism

• Omeprazole is a racemic mixture of two enantiomers reducing gastric acid secretion by a specifically targeted mechanism of action. It is a specific inhibitor of the proton pump in the parietal cell. It acts quickly and leads to a control of the gastric acid secretion by a reversible inhibition, with a daily catch.
• Omeprazole is a weak base. It is concentrated and converted into an active form in the highly acidic environment of the intracellular canaliculi of parietal cells, where it inhibits the enzyme H + K + -ATPase (the proton pump). This final step in the process of formation of gastric acidity is dose-dependent and results in significant inhibition of both basal acid secretion and stimulated acid secretion irrespective of the stimulus.

Pharmacodynamic effects

• All the observed pharmacodynamic effects can be explained by the effect of omeprazole on acid secretion.

Effect on gastric acid secretion

• Oral administration of omeprazole once daily results in rapid and effective inhibition of gastric acid secretion over 24 hours with maximum effect achieved after 4 days of treatment. With omeprazole 20 mg, an average decrease of at least 80% in 24-hour intragastric acidity is maintained in patients with duodenal ulcer, with an average decrease of approximately 70% in the acid flow peak after stimulation. by pentagastrin 24 hours after taking.
• Oral administration of omeprazole 20 mg maintains an intragastric pH > 3 for an average of 17 hours over a 24-hour period in patients with duodenal ulcer.
• Reduction of acid secretion and intragastric acidity results in dose-dependent reduction / normalization of acid exposure of the esophagus in patients with gastroesophageal reflux. The inhibition of acid secretion is related to the area under the omeprazole plasma concentration (AUC) curve, and not to the actual plasma concentration at a given time.
• Tachyphylaxis was not observed during treatment with omeprazole.

Effect on H. pylori

• H. pylori is associated with gastroduodenal ulcer disease including gastric ulcer and duodenal ulcer. H. pylori is an important factor in the development of gastritis. H. pylori and gastric acid are important factors in the development of peptic ulcer disease. H. pylori is an important factor in the development of atrophic gastritis, associated with an increased risk of developing gastric cancer.
• The eradication of H. pylori by omeprazole combined with antimicrobials is associated with high rates of healing and long-term remission of peptic ulcers.
• Dual therapies were tested and found to be less effective than triple therapies. However, dual therapy may be considered when there is known hypersensitivity preventing the use of triple therapies.

Other effects related to acid inhibition

• During long-term treatment, gastric glandular cysts were observed with a slightly increased frequency. These changes are a physiological consequence of a pronounced inhibition of acid secretion: they are benign and reversible.
• La diminution de l’acidité gastrique, quelle qu’en soit l’origine y compris l’utilisation des inhibiteurs de la pompe à protons, favorise le développement de bactéries intra-gastriques normalement présentes dans le tractus gastro-intestinal. Un traitement entraînant la diminution de l’acidité peut conduire à un risque légèrement augmenté d’infections gastro-intestinales, telles que les infections par Salmonella et par Campylobacter.
• During anti-secretory treatment, serum gastrin concentration increases in response to decreased acid secretion. Chromogram A (CgA) also increases because of decreased gastric acidity. Increased CgA concentration may interfere with investigations for neuroendocrine tumors. Literature data indicate that treatment with a proton pump inhibitor should be stopped at least 5 days prior to measurement of CgA. If CgA and gastrin levels are not normalized after 5 days, dosing should be repeated 14 days after stopping omeprazole treatment.
• An increase in the number of ECL cells in relation to the increase in serum gastrin concentrations has been observed in some patients (both adults and children) treated with omeprazole in the long term. The results are considered to be non-clinically significant.

Pediatric population

• In a non-controlled study in children (1 to 16 years) with severe reflux esophagitis, omeprazole at doses between 0.7 and 1.4 mg / kg improved the stage of esophagitis in 90% of cases and significantly decreased reflux symptoms. In a single-blind study, children aged 0 to 24 months with a clinical diagnosis of gastroesophageal reflux disease were treated with 0.5 mg, 1 mg or 1.5 mg d omeprazole / kg. The frequency of vomiting / regurgitation episodes decreased by 50% after 8 weeks of treatment regardless of dose.

Eradication of H. pylori in children

• A randomized double-blind clinical study (Heliot study) concluded that omeprazole and two antibiotics (amoxicillin and clarithromycin) are both effective and well tolerated in the treatment of H. pylori infections in children aged 4 years. years and older with gastritis: H. pylori eradication rate : 74.2% (23/31 patients) with omeprazole + amoxicillin + clarithromycin versus 9.4% (3/32 patients) with amoxicillin + clarithromycin. Nevertheless, no evidence has been provided regarding the clinical benefit of dyspeptic symptoms. This study does not provide any information about children under 4 years old.

MOPRAL Side Effects

Summary of the security profile

• The most common side effects (1-10% of patients) are headache, abdominal pain, constipation, diarrhea, flatulence and nausea / vomiting.

Table of adverse effects

• The following side effects have been reported or suspected in the clinical trials of omeprazole and since its launch. None of the effects were dose-dependent.
• Adverse effects are classified by frequency and system organ class. Frequency is defined by the following convention: very common ( > 1/10), frequent ( > 1/100 to < 1/10),frequent p ( > 1/1000 to <1/100), rare ( > 1/10 000 to < 1/1 000), very rare (<1 / 10,000), frequency not known (can not be estimated from the available data).

Frequency and class of organ system	Undesirable effect
Blood and lymphatic system disorders
Rare:	Leukopenia, thrombocytopenia
Very rare :	Agranulocytosis, pancytopenia
Immune system disorders
Rare:	Hypersensitivity reactions such as fever, angioedema and anaphylactic reaction / shock
Metabolism and nutrition disorders
Rare:	hyponatremia
Undetermined:	Hypomagnesemia; severe hypomagnesemia can lead to hypocalcemia. Hypomagnesemia may also be associated with hypokalemia.
Psychiatric disorders
Rare :	Insomnia
Rare:	Agitation, confusion, depression
Very rare :	Aggressiveness, hallucinations
Nervous system disorders
Frequent	headaches
Rare :	Dizziness, paresthesia, drowsiness
Rare:	Taste disorders
Eye disorders
Rare:	Blurry vision
Affections of the ear and labyrinth
Rare :	Dizziness
Respiratory, thoracic and mediastinal disorders
Rare:	bronchospasm
Gastrointestinal disorders
Frequent	Abdominal pain, constipation, diarrhea, flatulence, nausea / vomiting, fundic gland polyps (benign)
Rare:	Oral dryness , stomatitis, gastrointestinal candidiasis
indeterminate	Microscopic colitis
Hepatobiliary disorders
Rare :	Increased liver enzymes
Rare:	Hepatitis with or without jaundice
Very rare :	Hepatic insufficiency, encephalopathy in patients with pre-existing hepatic impairment
Skin and subcutaneous tissue disorders
Rare :	Dermatitis, pruritus, rash, urticaria
Rare:	Alopecia, photosensitivity
Very rare :	Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis
Undetermined:	Subcutaneous Lupus Skin Erythematosus (see section 4.4).
Musculoskeletal and systemic disorders
Rare :	Fracture of the hip, wrist or vertebrae
Rare:	Arthralgia, myalgia
Very rare :	Muscle weakness
Renal and urinary disorders
Rare:	Interstitial nephritis
Disorders of reproductive organs and breast
Very rare :	gynecomastia
General disorders and administration site abnormalities
Rare :	Malaise, peripheral edema
Rare:	Increased sweating

Pediatric population:

• The safety of omeprazole was evaluated in 310 children aged 0 to 16 years with gastric acid related diseases.
• Long-term use data are limited and come from 46 children who received omeprazole maintenance therapy in a clinical trial in severe erosive osteoarthritis lasting up to 749 days.
• The pattern of adverse events was generally similar to that seen in adults, both in short- and long-term treatments. There is no long-term evidence regarding the effects of omeprazole treatment on puberty and growth.

MOPRAL Interactions

Effects of omeprazole on the pharmacokinetics of other active substances

Active substances whose absorption is dependent on pH

The decrease in intragastric acidity during treatment with omeprazole may decrease or increase the absorption of active substances whose absorption is dependent on pH.

Nelfinavir, atazanavir

• Plasma concentrations of atazanavir and nelfinavir decrease when co-administered with omeprazole.
• Co-administration of omeprazole with nelfinavir is contraindicated.
• Concomitant administration of omeprazole (40 mg once daily) resulted in a decrease in mean nelfinavir exposure of 40% and a decrease in mean exposure of its pharmacologically active metabolite M8. 75-90%. The interaction could also result in inhibition of CYP2C19.
• Concomitant administration of omeprazole with atazanavir is not recommended (see Warnings and Precautions ).
• Omeprazole (40 mg once daily) in combination with atazanavir 300 mg plus ritonavir 100 mg in healthy volunteers resulted in a 75% decrease in exposure. Atazanavir. The increase in dosage of atazanavir to 400 mg did not offset the impact of omeprazole on exposure to atazanavir. The combination of omeprazole (20 mg once daily) with atazanavir 400 mg / ritonavir 100 mg in healthy volunteers decreased exposure to atazanavir by approximately 30% compared to observed with atazanavir 300 mg / ritonavir 100 mg once daily.

digoxin

• Concomitant treatment with omeprazole (20 mg daily) and digoxin in healthy subjects increases the bioavailability of digoxin by 10%. The toxicity of digoxin is rarely reported. However, caution should be exercised in elderly patients when omeprazole is administered in high doses.
• Therapeutic monitoring of digoxin should be strengthened.

clopidogrel

• The results of studies in healthy subjects showed a pharmacokinetic (PK) / pharmacodynamic (PD) interaction between clopidogrel (loading dose of 300mg / followed by a maintenance dose of 75 mg / day) and omeprazole (80 mg / day orally) resulting in an average 46% decrease in exposure to active metabolite of clopidogrel and resulting in a decrease in maximum inhibition of platelet mediation (ADP-induced) by an average of 16%.
• Contradictory data on the clinical consequences of a PK / PD interaction of omeprazole in terms of major cardiovascular events have been reported both in the observational and clinical studies. As a precautionary measure, concomitant use of omeprazole with clopidogrel should be discouraged (see Warnings and Precautions ).

Other active substances

• Absorption of posaconazole, erlotinib, ketoconazole and itraconazole is significantly reduced and clinical efficacy may be impaired. The concomitant combination of posaconazole and erlotinib with omeprazole should be avoided.

Active substances metabolised by CYP2C19

• Omeprazole is a moderate inhibitor of CYP2C19, the major metabolizing enzyme of omeprazole. Therefore, when administered concomitantly with active substances metabolized by CYP2C19, metabolism may be decreased and systemic exposure of these substances increased. Examples of such drugs are R-warfarin and other anti-vitamin K, cilostazol, diazepam and phenytoin.

cilostazol

• Oprazazole given at a dose of 40 mg to healthy subjects in a cross-over study, increased Cmax and AUC for cilostazol by 18% and 26% respectively, and for ‘one of its active metabolites 29% and 69% respectively.

saquinavir

• The concomitant administration of omeprazole with saquinavir / ritonavir results in an increase in plasma concentrations of approximately 70% for saquinavir, which is associated with good tolerability in patients with HIV infection.

tacrolimus

• Concomitant administration of omeprazole increases the serum concentrations of tacrolimus. Enhanced monitoring of tacrolimus and renal function (clearance of creatinine) should be performed as well as adjustment of tacrolimus dosage if necessary.
• An increase in methotrexate concentrations has been observed in some patients when concomitant administration of methotrexate with proton pump inhibitors (PPIs). When administering high doses of methotrexate, a temporary discontinuation of omeprazole therapy may be necessary.

Effects of other active substances on the pharmacokinetics of omeprazole

Inhibitors of CYP2C19 and / or CYP3A4

1. Since omeprazole is metabolized by CYP2C19 and CYP3A4, active substances known to inhibit CYP2C19 or CYP3A4 (such as clarithromycin and voriconazole) may lead to increased serum levels of omeprazole by decrease in metabolism.
2. Concomitant administration of voriconazole resulted in more than a doubling of exposure to omeprazole. High dose omeprazole has been well tolerated, dose adjustment of omeprazole is usually not necessary.
3. However, a dose adjustment may Be necessary in patients with severe hepatic insufficiency and if long-term treatment is indicated.

Inducers of CYP2C19 and / or CYP3A4

1. Active substances known to induce CYP2C19 or CYP3A4 or both (such as rifampicin and St. John’s Wort) may cause a decrease in plasma concentrations of omeprazole by increasing its metabolism.

MOPRAL Warnings and Precautions

• In the presence of any alarming symptoms (such as significant and involuntary weight loss, repeated vomiting, dysphagia, haematemesis or melena) and in case of suspicion or presence of a gastric ulcer, the possibility of a malignant lesion should be ruled out because treatment can alleviate symptoms and delay diagnosis.
• Concomitant use of atazanavir with proton pump inhibitors is not recommended (see section 4.5 ). If the combination of atazanavir with a proton pump inhibitor is considered essential, close clinical monitoring (eg viral load monitoring) is recommended together with a dose increase of atazanavir 400 mg with 100 mg ritonavir; a maximum dose of 20 mg omeprazole should not be exceeded.
• Omeprazole, like all acidic gastric anti-secretory drugs, can reduce the absorption of vitamin B12 (cyanocobalamin), due to hypo- or achlorhydria. This should be taken into account during long-term treatment in patients with reduced reserves or with risk factors for reduced absorption of vitamin B12.
• Omeprazole is an inhibitor of CYP2C19. At the beginning and end of treatment with omeprazole, the risk of interactions with products metabolized by CYP2C19 should be considered. An interaction between clopidogrel and omeprazole has been observed (see section Interactions with other medicinal products and other forms of interaction ). The clinical relevance of this interaction is uncertain. As a precaution, the concomitant use of omeprazole and clopidogrel should be discouraged.
• Cases of severe hypomagnesemia have been reported in patients treated with proton pump inhibitors (PPIs) such as omeprazole for at least three months and in most cases for one year. Hypomagnesemia can manifest as severe clinical signs such as fatigue, tetany, delirious flushes, convulsions, dizziness, ventricular arrhythmia, but it can start insidiously and go unnoticed. In most patients, hypomagnesemia improved after magnesium supplementation and discontinuation of PPI.
• In patients requiring prolonged treatment or in combination of PPIs with digoxin or with drugs that may induce hypomagnesaemia (eg diuretics), blood magnesium levels should be considered by health professionals before start treatment with IPP and then regularly during treatment.
• Proton pump inhibitors, particularly if used in high doses over a prolonged period (> 1 year), may increase the risk of hip, wrist and vertebral fracture, mainly in patients aged or in the presence of other identified risk factors. Observational studies suggest that proton pump inhibitors can increase the overall risk of fracture by 10-40%. This increase may be due in part to other risk factors. Patients at risk for osteoporosis should be managed according to the recommendations in force, and receive appropriate vitamin D and calcium intake.

Interference with laboratory tests

• An increase in Chromogranin A (CgA) concentration may interfere with investigations for neuroendocrine tumors. To avoid this interference, treatment with omeprazole should be stopped for at least 5 days before the determination of CgA.
• Some children with chronic conditions may require long-term treatment, although this is not recommended.
• MOPRAL contains lactose. Patients with rare hereditary problems of galactose intolerance, LAPP lactase deficiency or glucose-galactose malabsorption should not take this medicine.
• Treatment with proton pump inhibitors may slightly increase the risk of gastrointestinal infections, such as infection with Salmonella and Campylobacter .
• As in all long-term treatments, especially when the treatment period is greater than one year, regular monitoring of patients is necessary.

Drive and use machines:

• MOPRAL 10 mg, gastro-resistant capsule has no effect or negligible effect on the ability to drive and use machines.
• Adverse effects such as dizziness and visual disturbances may occur . If this is the case, patients should not drive motor vehicles or operate machinery.

MOPRAL and PREGNANCY / BREAST FEEDING / FERTILITY

Pregnancy

• The results of three prospective epidemiological studies (more than 1,000 exposure results) indicate that there are no adverse effects of omeprazole during pregnancy or on the health of the fetus / newborn.
•  Omeprazole can be used during pregnancy.

Breastfeeding

• Omeprazole is excreted in breast milk, but probably has no influence on the child if used therapeutically.

Fertility

• Animal studies with a racemic mixture of omeprazole administered orally do not indicate effects on fertility.

What should I do if I miss a dose?

If you forget to take MOPRAL 10 mg, gastro-resistant capsule:

• If you miss a dose, take it as soon as you think about it. However, if you are close to taking the next dose, do not take the dose you have missed.
• Do not take a double dose to make up for the dose you have forgotten to take.

What happens if I overdose from MOPRAL ?

If you take more MOPRAL 10 mg, gastro-resistant capsule than you should:

• If you take more MOPRAL 10 mg gastro-resistant capsules than prescribed by your doctor, tell your doctor or pharmacist immediately.

What is  Forms and Composition MOPRAL ?

• 10 mg gastro-resistant capsule (opaque pink body marked “10” and pink opaque head marked “A / OS”) containing gastroresistant granules: Flasks   of 14, 28 and 30. 20 mg gastroresistant capsule (opaque pink body) marked with “20” and opaque red brown head marked “A / OM”) containing gastro-resistant granules:   Vials of 7, 14, 28 and 30.

• Excipients (common): disodium phosphate dihydrate, hydroxypropylcellulose, hypromellose, lactose anhydrous, magnesium stearate, mannitol, methacrylic acid-ethyl acrylate copolymer (1: 1) dispersion 30%, microcrystalline cellulose, macrogol (polyethylene glycol 400), sodium laurilsulfate.
• Capsule shell : red iron oxide (E 172), titanium dioxide (E 171), gelatin, magnesium stearate, sodium laurilsulfate, ink (containing lacquer, ammonia, potassium hydroxide and black iron oxide (E172), anhydrous colloidal silica, liquid paraffin. Calibration: No. 3 (gel 10 mg); No. 2 (gel 20 mg).
• Excipient with known effect: Each capsule contains: 4 mg lactose (gel 10 mg) or 8 mg lactose (gel 20 mg).

NOT’s

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general information:

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Additional information:

• General explanation about dealing with the medicine: how to take the medicine, the doses and times of it, the start and duration of its effectiveness, the recommended diet during the period of taking the medicine, the method of storage and storage, recommendations in cases for forgetting the dose and instructions to stop taking the drug and take additional doses.

Special warnings:

• For pregnant and breastfeeding women, the elderly, boys and drivers, and use before surgery.

Side effects:

• It treats possible side effects and drug interactions that require attention and its effect on continuous use.
• The information contained in this medicine is based on medical literature, but it is not a substitute for consulting a doctor.