Acitac S

Description

Acitac S Tablet (Ranitidine)

Indications:

Acitac S Tablet is used for the treatment and management of various gastrointestinal conditions, including:

• Dyspepsia (indigestion)
• H. pylori infection (in conjunction with other therapies)
• Benign gastric and duodenal ulceration
• Gastro-oesophageal reflux disease (GERD)
• Acid aspiration during general anesthesia (prophylaxis)
• Prophylaxis against NSAID-induced ulcers
• Stress ulceration of the upper gastrointestinal tract
• Zollinger-Ellison syndrome
• Erosive oesophagitis

Dosage and Administration:

Acitac S Tablet can be taken with or without food.

Adult Dose:

• Benign Gastric and Duodenal Ulceration:
  • Initial: 300 mg once daily at bedtime or 150 mg twice daily for 4-8 weeks. For duodenal ulcers, 300 mg twice daily for 4 weeks may improve healing.
  • Maintenance: 150 mg once daily at bedtime.
  • Maximum: 300 mg twice daily.
• Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome):
  • Initial: 150 mg twice or three times daily, increased as needed.
  • Maximum: 6 grams daily.
• Gastro-oesophageal Reflux Disease (GERD):
  • 150 mg twice daily or 300 mg at bedtime for up to 8 weeks.
  • In severe cases, may increase to 150 mg four times daily for up to 12 weeks.
• Dyspepsia:
  • Chronic Episodic: 150 mg twice daily for up to 6 weeks.
  • Short-term Symptomatic Relief: 75 mg, repeated up to 4 doses daily if necessary. Maximum duration: 2 weeks of continuous use.
• Erosive Oesophagitis:
  • Treatment: 150 mg four times daily.
  • Maintenance: 150 mg twice daily.
• NSAID-Associated Ulceration:
  • Treatment: 150 mg twice daily or 300 mg at bedtime for 8-12 weeks.
  • Prevention: 150 mg twice daily.

Hepatic Impairment: Dosage adjustment is generally not necessary.

Child Dose (Oral):

• Benign Gastric and Duodenal Ulceration (1 month to 16 years):
  • 4-8 mg/kg daily in 2 divided doses. Maximum: 300 mg/day. Treatment duration: 4-8 weeks.
  • Maintenance: 2-4 mg/kg once daily. Maximum: 150 mg/day.
• Gastro-oesophageal Reflux Disease (1 month to 16 years):
  • 5-10 mg/kg daily in 2 divided doses. Maximum: 300 mg/day.
• Erosive Oesophagitis (1 month to 16 years):
  • 5-10 mg/kg daily in 2 divided doses. Maximum: 600 mg/day.

Renal Dose:

• Oral (CrCl < 50 mL/min): 150 mg daily at bedtime. Adjust dose cautiously if necessary.
• Parenteral: Individual doses may be reduced to 25 mg.

IV Administration:

• Direct Injection: 50 mg diluted to $\ge$20 mL with compatible IV infusion fluid and administered over $\ge$5 minutes (4 mL/min).
• Intermittent Infusion: 50 mg added to $\ge$100 mL of compatible IV solution and infused over 15-20 minutes.
• Continuous Infusion: 150 mg diluted in 250 mL of IV fluid and infused at 6.25 mg/hr for 24 hours.

Contraindications:

• Porphyria

Precautions:

• Before initiating therapy, the possibility of malignancy should be excluded, as Ranitidine may mask symptoms and delay the diagnosis of gastric malignancy.
• Use with caution in patients with difficulty swallowing.
• Exercise caution in patients with renal and hepatic impairment.
• Pregnancy and Lactation: Use with caution. The drug crosses into breast milk; consider discontinuing the drug or using caution during lactation.

Interactions:

• Propantheline Bromide: May cause delayed absorption and increased peak serum concentration of Ranitidine.
• Hepatic Metabolism: Ranitidine minimally inhibits the hepatic metabolism of coumarin anticoagulants, theophylline, diazepam, and propranolol.
• pH-dependent Drugs: May alter the absorption of pH-dependent drugs (e.g., ketoconazole, midazolam, glipizide).
• Antacids: May reduce Ranitidine’s bioavailability.

Adverse Effects:

• Common (1-10%): Headache (3%)
• Less Common (<1%): Abdominal pain, agitation, alopecia, confusion, constipation, diarrhea, dizziness, hypersensitivity reactions, nausea, vomiting.
• Frequency Not Defined (Rare): Anemia, necrotizing enterocolitis (in fetus or newborn), pancreatitis, thrombocytopenia, pancytopenia, agranulocytosis, acquired immune hemolytic anemia, arthralgia, myalgia.
• Potentially Fatal: Anaphylaxis, severe hypersensitivity reactions.

Mechanism of Action:

Ranitidine is a competitive antagonist at histamine H2-receptors on the gastric parietal cells. By blocking these receptors, it inhibits gastric acid secretion. It does not significantly affect pepsin secretion, pentagastrin-stimulated intrinsic factor secretion, or serum gastrin levels.

Note:

Acitac S 150mg Tablet is manufactured by G.D. Laboratories Pvt. Ltd. Its generic name is Ranitidine. Acitac S is available in Nepal. This information is for general knowledge and is not intended for diagnosis, medical advice, or treatment, nor is it a substitute for professional medical judgment.