Abbreviated Prescribing Information
Zoton FasTab* Presentation:
Oro-dispersible tablet containing 30 mg or 15 mg of lansoprazole.
White to yellowish-white, circular flat bevelled-edge oro-dispersibletablet containing orange to dark brown microgranules.
Indications
Treatment of duodenal and gastric ulcer. Treatment of reflux oesophagitis. Prophylaxis of reflux oesophagitis. Eradication of Helicobacter pylori (H. pylori) concurrently given with appropriate antibiotic therapy for treatment of H. pylori-associated ulcers. Treatment of NSAID-associated benign gastric and duodenal ulcers in patients requiring continued NSAID treatment. Prophylaxis of NSAID-associated gastric ulcers and duodenal ulcers in patients at risk requiring continued therapy. Symptomatic gastroesophageal reflux disease (GORD). Zollinger-Ellison syndrome.
Dosage and Administration
| Duodenal ulcer: | 30 mg daily for 2 weeks. If not fully healed within 2 weeks, then 30 mg daily for a further 2 weeks. |
| Gastric ulcer: | 30 mg daily for 4 weeks. If not fully healed within 4 weeks, then 30 mg daily for a further 4 weeks. |
| Reflux oesophagitis: | 30 mg daily for 4 weeks. If not fully healed within 4 weeks, then 30 mg daily for a further 4 weeks. |
| Prophylaxis of reflux oesophagitis: | 15 mg or 30 mg daily. |
| Eradication of H. pylori (both regimens twice daily for 7 days): | 30 mg plus: |
| Treatment of NSAID- associated benign gastric and duodenal ulcers: | 30 mg daily for 4 weeks. If not fully healed after 4 weeks, then 30 mg for a further 4 weeks. Use higher dose and/or longer duration in patients at risk or with ulcers difficult to heal. |
| Prophylaxis of NSAID- associated gastric and duodenal ulcers: | 15 mg daily. 30 mg daily if treatment fails. |
| Symptomatic GORD: | 15 mg or 30 mg daily for 4 weeks. |
| Zollinger-Ellison syndrome: | Initially 60 mg daily, then adjust individually. |
For most rapid healing and symptom relief, Zoton FasTab should be taken in the morning before food. Zoton FasTab can be placed on the tongue and gently sucked or, if preferred, swallowed whole with a drink of water. Zoton FasTab can also be dispersed in a small amount of water and administered via a nasogastric tube or oral syringe.
No dosage adjustment is necessary in patients with impaired renal function. 50% reduction of the daily dose is recommended in patients with moderate or severe liver disease. A daily dose of 30 mg should not be exceeded in the elderly. The use of Zoton FasTab in children is not recommended.
Contra-indications
Hypersensitivity to any of the ingredients. Zoton FasTab should not be administered with atazanavir.
Precautions
Exclude the possibility of malignancy when treating a gastric ulcer. Use with caution in patients with moderate to severe hepatic dysfunction. Decreased gastric acidity may increase gastric counts of endogenous bacteria. Treatment may lead to a slightly increased risk of gastrointestinal infections (e.g. Salmonella, Campylobacter). In patients with gastro-duodenal ulcers, consider the possibility of H. pylori as an etiological factor. Cases of colitis have very rarely been reported in patients taking lansoprazole. Treatment for prevention of peptic ulceration of patients in need of continuous NSAID treatment should be restricted to those at high risk. Zoton FasTab contains lactose.
Pregnancy and Lactation
Avoid in pregnancy. Avoid during breast feeding unless essential.
Interactions
| Medicinal products with pH dependent absorption: | Lansoprazole may interfere with the absorption of drugs where gastric pH is critical to bioavilability. Lansoprazole should not be co-administered with atazanavir, ketoconazole and itraconazole. As co-administration of lansoprazole and digoxin may lead to increased plasma levels, plasma level monitoring is recommended. |
| Medicinal products metabolised by P450 enzymes: | Lansoprazole may increase plasma concentrations of drugs that are metabolised by CYP3A4. Caution is advised when combining lansoprazole with drugs which are metabolised by this enzyme and have a narrow therapeutic window, such as theophylline or tacrolimus. |
| Medicinal products transported by P-glycoprotein: | Lansoprazole has been observed to inhibit the transport protein P-glycoprotein (P-gp) in vitro. The clinical relevance of this is unknown. |
| Drugs which inhibit CYP2C19: | A dose reduction may be considered when combining lansoprazole with fluvoxamine. A study shows that the plasma concentrations of lansoprazole increase up to 4-fold. |
| Drugs which induce CYP2C19 & CYP3A4: | Enzyme inducers affecting CYP2C19 and CYP3A4, such as rifampicin and St John’s wort, can markedly reduce the plasma concentrations of lansoprazole. |
| Others: | Sucralfate / antacids may decrease the bioavailability of lansoprazole. Therefore lansoprazole should be taken at least 1 hour after taking these drugs. |
No clinically significant interactions of lansoprazole with NSAIDs have been demonstrated, although no formal interactions studies have been performed.
Side Effects
The most common side effects include headache, dizziness, nausea, diarrhoea, stomach ache, constipation, vomiting, flatulence, dry mouth or throat, fatigue, urticaria, itching, rash, and increase in liver enzyme levels. Uncommon side effects include depression, thrombocytopenia, eosinophilia, leucopenia, arthralgia, myalgia, and oedema. Anaemia, insomnia, hallucinations, confusion, restlessness, vertigo, paraesthesia, somnolence, tremor, visual disturbances, glossitis, candidiasis of the oesophagus, pancreatitis, taste disturbances, hepatitis, jaundice, petechiae, purpura, hair loss, erythema multiforme, photosensitivity, interstitial nephritis, gynaecomastia, fever, hyperhidrosis, angioedema, anorexia and impotence have been reported rarely. Very rarely agranulocytosis, pancytopenia, colitis, stomatitis, Steven-Johnson syndrome, toxic epidermal necrolysis, anaphylactic shock, increase in cholesterol and triglyceride levels, and hyponatraemia have been reported.
Legal Category
POM
Package Quantities
30 mg Zoton FasTab: Blister packs of 28, 14 and 7 (hospitals only) tablets.
15 mg Zoton FasTab: Blister packs of 28 tablets.
Marketing Authorisation Numbers
30 mg Zoton FasTab: PL 00011/0289
15 mg Zoton FasTab: PL 00011/0290
Cost
30 mg Zoton FasTab: £ 2.74 (1x7, hospitals only)
£ 5.47 (1x14)
£ 11.00 (1x28)
15 mg Zoton FasTab: £ 5.97 (1x28)
Marketing Authorisation Holder: John Wyeth & Brother Limited, t/a Wyeth Pharmaceuticals, Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH
For full prescribing information and details of other side effects see Summary of Product Characteristics.
Full prescribing information is available on request from:
Wyeth Pharmaceuticals, Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, UK.
Telephone: 01628 415330.
Date of Prescribing Information: 4 May 2007Code no. ZAPI050. Doc ID 42897.
- * Trademark of, and under licence agreement with, Takeda Pharmaceutical Company Limited, Japan.
www.wyeth.co.uk
ZZOT4370 Date of Preparation: August 2007