Probitor 20 Capsule

✔️ Side Effects

Common Side Effects

Frequently reported adverse effects include:

• Headache
• Abdominal pain
• Diarrhea
• Nausea
• Vomiting
• Flatulence
• Dizziness
• Constipation
• Acid regurgitation
• Upper respiratory tract infection
• Cough
• Skin rash

Most side effects are mild and transient.

Less Common and Serious Adverse Effects

Rare but potentially serious reactions include:

• Osteoporosis-related fractures
• Hypomagnesemia
• Interstitial nephritis
• Hepatotoxicity
• Gastric polyps
• Pancreatitis
• Rhabdomyolysis
• Alopecia
• Taste disturbances
• Abnormal dreams
• Agranulocytosis
• Toxic epidermal necrolysis
• Severe allergic reactions, including anaphylaxis

Long-term use (more than one year) may increase the risk of fractures and mineral deficiencies.

✔️ Dosage & Administration

Adult Dosage

Peptic Ulcer

• Duodenal ulcer: 20–40 mg once daily for 4 weeks.
• Gastric ulcer: 20–40 mg once daily for 8 weeks.
• Maintenance therapy: 10–20 mg daily.

Gastroesophageal Reflux Disease (GERD)

• 20 mg once daily for 4 weeks.
• Treatment may be continued for an additional 4–8 weeks if required.
• Refractory esophagitis: 40 mg daily.
• Maintenance dose: 20 mg daily after healing; 10 mg daily for acid reflux.

Erosive Esophagitis

• 20 mg once daily for 4–8 weeks.
• Maintenance therapy: 20 mg daily for up to 12 months.

NSAID-Induced Ulcers

• 20 mg once daily in the morning.

Acid Dyspepsia

• 10–20 mg daily for 2–4 weeks.

Zollinger-Ellison Syndrome

• Initial dose: 60 mg once daily.
• Dose may be adjusted according to response.
• Total daily doses above 80 mg should be divided into two administrations.
• Dose range: 20–120 mg daily.

Prevention of Acid Aspiration During Surgery

• 40 mg the evening before surgery and another 40 mg 2–6 hours before the procedure.

H. pylori Eradication

Omeprazole is used in combination with antibiotics such as:

• Amoxicillin + Clarithromycin
• Clarithromycin + Metronidazole (or Tinidazole)
• Amoxicillin + Metronidazole

Treatment duration is generally 7–14 days.

✔️ Probitor 20 should not be used in individuals with:

• Known hypersensitivity to omeprazole or any component of the formulation.

✔️ Pregnancy & Lactation

Pregnancy

Available human data have not demonstrated an increased risk of major congenital malformations with first-trimester exposure. Animal studies showed embryo-fetal toxicity at high doses, although no teratogenic effects were observed. Use during pregnancy should be based on clinical necessity and physician assessment.

Breastfeeding

Small amounts of omeprazole may pass into breast milk. The benefits of breastfeeding and the mother's need for treatment should be carefully weighed against potential risks to the infant.

✔️ Omeprazole may interact with several medications:

Increased Effects or Toxicity

• Warfarin (increased INR and prothrombin time)
• Digoxin
• Diazepam and other benzodiazepines
• Clarithromycin
• Methotrexate
• Phenytoin
• Ciclosporin
• Cilostazol

Reduced Absorption

• Itraconazole
• Ketoconazole
• Posaconazole
• Dasatinib
• Iron salts

✔️ Precautions & Warnings

• Exclude gastric malignancy before initiating therapy, as symptom relief may delay diagnosis.
• Use cautiously in patients with severe liver impairment.
• Long-term treatment may lead to magnesium deficiency and reduced bone mineral density.
• Periodic monitoring of serum magnesium levels is recommended.
• Seek medical attention if persistent diarrhea, fever, abdominal pain, reduced urination, edema, lower back pain, rash, or unexplained fatigue develops, as these may indicate kidney-related complications.
• Do not discontinue therapy without consulting a physician.

✔️ Storage:

Keep out of reach of children. Store in a dry place, below 25˚C temperature and protected from light.