Omepramix tablets contain omeprazole, clarithromycin, and amoxicillin. It is a triple combination therapy indicated for the eradication of H.pylori infection.

Omepramix (Omeprazole, clarithromycin, and amoxicillin) Uses:

• Helicobacter pylori eradication:

  • To reduce the risk of recurrent duodenal ulcers, H. pylori must be eradicated. pylori infection in persons who have a duodenal ulcer now or during the last year.

Omepramix Dose in Adults

Dose in the treatment of H. pylori eradication:

• P/O:
  • Amoxicillin 1,000 mg (two capsules), omeprazole 20 mg (one capsule), and clarithromycin 500 mg (one tablet) were administered concurrently twice daily for 10 days.

Note:

• If the individual has an existing duodenal ulcer at the moment of treatment beginning, omeprazole 20 mg once day for an additional 18 days is suggested.
• Omeprazole's bioavailability may be enhanced in people of Asian descent.
• Unless benefits outweigh risks, avoid use.
• Avoid using clarithromycin triple therapy in patients who have macrolide resistance risk factors, such as those who have previously used macrolides or who have local resistance rates to clarithromycin that is less than 15% or eradication rates with clarithromycin-based regimens that are less than 85%.

in Children:

Not indicated.

Pregnancy Risk Category: See individual agents

• Detrimental effects have been observed in animal reproduction research with clarithromycin as well as omeprazole.
• Refer to the individual monographs.

Use of clarithromycin, omeprazole and amoxicillin during lactation:

• Amoxicillin, clarithromycin, and omeprazole are all found in breast milk.
• It is not advised to breastfeed.
• Refer to the individual monographs.

Omepramix Dose in Kidney Disease:

• In the manufacturer's labeling, there are no specific dosage recommendations.
• Amoxicillin & clarithromycin pharmacokinetics are altered in renal impairment.
• In severe renal impairment, prolonged dosing intervals for clarithromycin may be appropriate, but no recommendations are available in regard to amoxicillin.

Omepramix Dose in Liver Disease:

• Avoid use.

• Frequencies noted pertain to experience with combo treatment.
• Moreover, view specific agents.

Side Effects of Omeprazole, clarithromycin, and amoxicillin:

• Gastrointestinal:

  • Diarrhea
  • Dysgeusia

• Central nervous system:

  • Headache

Contraindications to Omepramix (Omeprazole, clarithromycin, and amoxicillin):

• An allergic reaction known as hypersensitivity can result in anaphylaxis, anaphylactic shock, bronchospasm, interstitial nephritis, or any penicillin, clarithromycin, macrolide antibiotics, omeprazole, or formulation component.
• Use simultaneously with ergotamine, dihydroergotamine, and pimozide

Warnings and precautions

• Modified cardiac conduction

  Anaphylactoid reactions and hypersensitivity reactions

  • Macrolides have been linked to torsades de pointes, a ventricular arrhythmia, and rare QT prolongation.
  • Patients who are at a high risk for prolonged cardiac repolarization should be managed carefully.
  • It is best to steer clear of individuals who have untreated hypokalemia or hypomagnesemia, clinically severe bradycardia, and those who are on Class IA antiarrhythmic medications (such as quinidine, procainamide, sotalol, and dofetilide).
  • Patients receiving penicillin therapy have experienced severe and sometimes fatal hypersensitivity reactions (anaphylactoid).
  • This is especially true if they've previously had beta-lactam hypersensitivity, a history of numerous allergies, or IgE-mediated events like anaphylaxis or edoema.
  • With asthmatic individuals, exercise care.
  • Among the severe acute reactions that clarithromycin has (rarely) been linked to include anaphylaxis, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms (DRESS), and Henoch-Schonlein purpura (IgA vasculitis)
  • Stop all therapy immediately, then begin treatment.

• Clostridium difficile-associated diarrhea (CDAD), formerly Clostridium, is now Clostridioides

  • The risk of developing CDAD in hospitalised patients may be enhanced by the use of proton pump inhibitors (PPIs) (PPIs).
  • Consider CDAD diagnosis for people suffering from prolonged diarrhoea that doesn't improve.
  • The PPI therapy with the lowest dosage and the longest duration is the ideal one for your situation.

• Carcinoma

  • Omeprazole increased the number of stomach malignant tumours in rats during the course of long-term (2-year) research.
  • Despite the fact that endoscopic and histologic analyses of biopsy samples taken from human stomachs failed to find any evidence of a chance of contamination from short-term omeprazole exposure, more data is needed to determine whether there are any elevated risks for tumour development in patients receiving long-term treatment.

• Cutaneous and systemic Lupus Erythematosus

  • An autoimmune condition that already exists has been said to be exacerbated or to have just started.
  • Cultivar lupus erythematosus, or CLE, was present in the majority of cases. However, subacute CLE typically develops within weeks to years of ongoing therapy.
  • Less frequently, systemic lupus manifests itself in the early days to years of therapy. Although it often affects young individuals, it can also afflict patients who are older.
  • Refer to a specialist if you notice any signs or symptoms of CLE/SLE.
  • Most patients experience a significant improvement between 4-12 weeks after stopping omeprazole.

• Fractures

  Hypomagnesemia:

  • The lowest effective dose is recommended. Vitamin D and calcium supplements are also recommended. To lower the risk of fracture in patients at high risk, follow the recommended guidelines.
  • PPI medication may make osteoporosis-related hip, spine, or wrist fractures more likely.
  • It is important to examine patients on long-term or high-dose therapy.
  • Seldom ever reported. The majority of patients get therapy for longer than a year while using PPIs for more than three months.
  • It may or may not have symptoms.
  • You might want to consider getting blood magnesium levels before starting a long-term treatment programme. Additionally, later on, on occasion.
  • Omeprazole can be stopped, but hypomagnesemia can be managed with magnesium supplements.
  • Tetany, seizures, and cardiac arrhythmias can occur in severe instances.
  • If you are taking digoxin, diuretics, or any other medications that might result in hypomagnesemia,
  • Within a week, magnesium levels normally stabilise.

• Superinfection

  • Amoxicillin or clarithromycin usage over an extended period of time may lead to fungal or bacterial superinfection.
  • PPI users have been proven to get acute interstitial nephritis.
  • It can occur during treatment at any moment. Typically, an idiopathic allergic response is to blame.
  • If you get acute interstitial nephritis, stop using.
  • Diarrhoea caused by C. difficile and pseudomembranous colitis
  • Over two months were spent monitoring CDAD following antibiotic therapy..

• Coronary artery disease (CAD).

  • Clarithromycin was randomized to more smokers.
  • Patients with stable CAD have a greater risk of dying from short-term clarithromycin medication, according to a postmarketing safety study (vs. placebo).
  • The use of clarithromycin in CAD patients should be cautious.

• Vitamin B deficiency:

  • The dosage affects how severe the deficit is. When compared to younger people, women experience it more severely (30 years).
  • PPI use over a prolonged period of time (more than three years) may lead to vitamin B malabsorption and eventual vitamin B insufficiency.
  • After stopping, the disease's prevalence decreases.

• Gastric cancer:

  • Gastric malignancy can still be present despite symptoms being relieved.

• Infectious mononucleosis

  • Ampicillin-class antibiotics must not be administered in these instances.
  • Amoxicillin medication resulted in a significant percentage of infectious mononucleosis patients developing a rash.

• Renal impairment

  • Longer clarithromycin dose durations may be required for severe renal impairment
  • When treating individuals with renal impairment, exercise care.
  • Renal impairment affects the pharmacokinetics of clarithromycin and amoxicillin.

• Hepatic impairment

  • In chronic liver illness, bioavailability is much greater.
  • Avoid usage in people with hepatic impairment.

• Myasthenia gravis:

  • A return and aggravation of symptoms have occurred.
  • In individuals with myasthenia gravis, clarithromycin should be administered cautiously.

• Gastrointestinal infection (eg, Salmonella, Campylobacter):

  • These infections could be more likely if you use PPIs

Monitoring Parameters:

• In individuals who fail the H. pylori-eradication medical treatment, susceptibility testing is recommended.
• Hepatic function.

How to administer Omepramix (Omeprazole, clarithromycin, and amoxicillin)?

• Administer before meals in the morning and at night.
• Take tablets and capsules whole.
• Avoid crushing or chewing.

Mechanism of action of Omeprazole, clarithromycin, and amoxicillin:

Omeprazole:

• Proton pump inhibitors work by preventing the parietal cells' H+/K+ATP pump from secreting stomach acid.

Amoxicillin:

• It is an antibacterial substance that prevents bacteria from building cell walls.

Clarithromycin

• In susceptible microorganisms, an antibacterial substance binds to the 50s subunit and prevents protein synthesis.

Talk to individual agents.

International Brands of Omeprazole, clarithromycin, and amoxicillin:

• Omeclamox-Pak®
• Erradic
• GI Kit
• Heliclam
• Klacid Hp 7
• Klacid HP7
• Omepac
• Omepramix

Omeprazole, clarithromycin, and amoxicillin Brand Names in Pakistan:

No Brands Available in Pakistan.