Zoton Capsule (Enteric Coated) 30 mg

Zoton Capsule (Enteric Coated)

Generic Name: Lansoprazole

Strength: 30 mg

Dosage Form: Capsule (Enteric Coated)

Manufacturer: General Pharmaceuticals Ltd

Indications

Zoton is indicated for:

• Short term treatment of active duodenal ulcer
• Maintenance of healed duodenal ulcers
• Short term treatment of active benign gastric ulcers
• Short term treatment of active erosive esophagitis
• Maintenance of healing of erosive esophagitis
• Pathological hypersecretory conditions including Zollinger-Ellison Syndrome
• H. pylori eradication to reduce the risk of duodenal ulcer recurrence

Pharmacology

Lansoprazole is a substituted benzimidazole, and is also known as PPI due to its property to block the final step of acid secretion by inhibiting H⁺/K⁺ ATPase enzyme system in gastric parietal cell. Both basal and stimulated acid are inhibited.

Dosage Information

Benign gastric ulcer: 30 mg daily in the morning for 8 weeks.

Duodenal ulcer: 30 mg daily in the morning for 4 weeks; maintenance 15 mg.

NSAID-associated duodenal or gastric ulcer: 15-30 mg daily for 4 weeks, followed by a further 4 weeks if not fully healed.

Zollinger-Ellison syndrome (and other hypersecretory conditions): Initially 60 mg once daily adjusted according to response; daily doses of 120 mg or more is given in two divided doses.

Gastroesophageal reflux disease: 30 mg daily in the morning for 4 weeks, followed by a further 4 weeks if not fully healed; maintenance 15-30 mg daily.

Acid-related dyspepsia: 15-30 mg daily in the morning for 2-4 weeks.

Side Effects

Severe or irreversible adverse effects: The possible induction of carcinoid tumors by profound acid suppression, and a rise in serum gastrin may occur. There is a rise in serum gastrin levels in the first 3 months of treatment, which are then maintained though at a lower level than those found in pernicious anaemia. Long term treatment with a proton pump inhibitor in patients with Helicobacter pylori infection may accelerate the development of atrophic gastritis.

Symptomatic adverse effect: Dose dependent diarrhoea occurs with an incidence of about 4% at 30 mg per day, rising to 8% at 60 mg per day. Headache occurs in 2-3% of treated patients

Precautions

Gastric malignancy should be ruled out. Hepatic impairment. Pregnancy and lactation.

Benign gastric ulcer: 30 mg daily in the morning for 8 weeks.

Duodenal ulcer: 30 mg daily in the morning for 4 weeks; maintenance 15 mg.

NSAID-associated duodenal or gastric ulcer: 15-30 mg daily for 4 weeks, followed by a further 4 weeks if not fully healed.

Zollinger-Ellison syndrome (and other hypersecretory conditions): Initially 60 mg once daily adjusted according to response; daily doses of 120 mg or more is given in two divided doses.

Gastroesophageal reflux disease: 30 mg daily in the morning for 4 weeks, followed by a further 4 weeks if not fully healed; maintenance 15-30 mg daily.

Acid-related dyspepsia: 15-30 mg daily in the morning for 2-4 weeks.

Severe or irreversible adverse effects: The possible induction of carcinoid tumors by profound acid suppression, and a rise in serum gastrin may occur. There is a rise in serum gastrin levels in the first 3 months of treatment, which are then maintained though at a lower level than those found in pernicious anaemia. Long term treatment with a proton pump inhibitor in patients with Helicobacter pylori infection may accelerate the development of atrophic gastritis.

Symptomatic adverse effect: Dose dependent diarrhoea occurs with an incidence of about 4% at 30 mg per day, rising to 8% at 60 mg per day. Headache occurs in 2-3% of treated patients

Lansoprazole should be avoided in pregnancy unless there are compelling reasons.

Gastric malignancy should be ruled out. Hepatic impairment. Pregnancy and lactation.

Neonates:There is no relevant human data. The drug is not recommended for use with neonates.

Children: The youngest person to have received Zoton in clinical trials was 13 years old.

The Elderly: No problems have been encoun- tered in clinical use and there has been no increase in adverse drug reaction in the elderly.