Acifix 20 mg (Capsule (Enteric Coated))

Indications

• Active duodenal ulcer
• Active benign gastric ulcer
• Symptomatic erosive or ulcerative gastro-esophageal reflux disease (GERD)
• Gastro-esophageal Reflux Disease Long-term Management (GERD Maintenance)
• Symptomatic treatment of moderate to very severe gastro-esophageal reflux disease (symptomatic GERD)
• Zollinger-Ellison Syndrome
• In combination with appropriate antibacterial therapeutic regimens for the eradication of Helicobacter pylori in patients with peptic ulcer disease

Pharmacology

• Suppresses gastric acid secretion by inhibiting the gastric H+/K+-ATPase at the secretory surface of the gastric parietal cell

Dosage

• 20 mg once daily in the morning for active duodenal ulcer and active benign gastric ulcer
• 20 mg once daily for four to eight weeks for erosive or ulcerative gastro-esophageal reflux disease (GERD)
• 20 mg or 10 mg once daily for GERD maintenance
• 10 mg once daily for symptomatic treatment of moderate to very severe GERD
• 5 mg or 10 mg once daily for 12 weeks in pediatric patients
• 60-120 mg once daily for Zollinger-Ellison Syndrome
• Combination therapy for H. pylori eradication

Administration

• Tablets should be taken in the morning before eating and swallowed whole

Interaction

• Potential interaction with ketoconazole, itraconazole, and atazanavir

Contraindications

• Hypersensitivity to the active substance or excipients
• Contra-indicated in pregnancy and during breastfeeding

Side Effects

• Headache
• Diarrhoea
• Abdominal pain
• Vomiting
• Constipation
• Dry mouth
• Increased or decreased appetite
• Muscle pain
• Drowsiness
• Dizziness

Pregnancy & Lactation

• US FDA pregnancy category 'C'
• No adequate and well-controlled studies in pregnant women
• Likely excreted in human milk

Precautions & Warnings

• Monitor for presence of gastric or oesophageal malignancy
• Regular surveillance for long-term treatment patients
• Possible increase in risk of hip, wrist, and spine fracture
• Risk of cross-hypersensitivity reactions
• Caution in hepatic impairment
• Avoid co-administration with atazanavir
• Possible increase in risk of gastrointestinal infections
• Hypomagnesaemia and vitamin B12 absorption effects
• Association with subacute cutaneous lupus erythematosus (SCLE)
• Interference with laboratory tests

Use in Special Populations

• No dosage adjustment for renal or hepatic impairment
• Not recommended for use in children due to lack of data on safety and efficacy

Overdose Effects

• Maximum established exposure up to 60-160 mg daily
• Effects are generally minimal and reversible

Therapeutic Class

• Proton Pump Inhibitor

Storage Conditions

• Keep below 30°C, away from light and moisture, out of the reach of children

Chemical Structure

• Molecular Formula: C18H21N3O3S

Common Questions about Acifix 20 mg Capsule

• Proton pump inhibitor (PPI) that suppresses gastric acid secretion
• Used to treat duodenal ulcer, gastric ulcer, GERD, Zollinger-Ellison Syndrome, Helicobacter pylori eradication
• Common side effects include diarrhea, constipation, nausea, vomiting, headache, dizziness, rash, and dry mouth
• Take with food, not recommended for use during pregnancy or breastfeeding, potential for bone problems with long-term use, quick tips provided

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