Lanzofutal   Capsules   

 

Lanzofutal 30 mg SR tablets

 

Usage and indications:

  • Treatment of duodenal ulcer 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 (see section 4.2) requiring continued therapy.
  • Symptomatic gastroesophageal reflux disease.
  • Zollinger-Ellison syndrome

 

Dosage and administration:

For optimal effect, Lansoprazole should be taken once daily in the morning except when used for H. pylori eradication when treatment should be twice a day, once in the morning and once in the evening.

Lansoprazole should be taken at least 30 minutes before food. Capsules should be swallowed whole with liquid.

For patients with difficulty swallowing; studies and clinical practice suggest that the capsules may be opened and the granules mixed with a small amount of water, apple/tomato juice or sprinkled onto a small amount of soft food (e.g. yoghurt, apple puree) to ease administration. Capsules may also be opened and granules mixed with 40 ml of apple juice for administration through a nasogastric tube. After preparing the suspension or mixture, the drug should be administered immediately.

Treatment of duodenal ulcer:

The recommended dose is 30 mg once daily for 2 weeks. In patients not fully healed within this time, the medicinal product should be continued at the same dose for another two weeks.

Treatment of gastric ulcer:

The recommended dose is 30 mg once daily for 4 weeks. The ulcer usually heals within 4 weeks, but in patients not fully healed within this time, the medicinal product should be continued at the same dose for another 4 weeks.

Treatment of reflux oesophagitis:

The recommended dose of lansoprazole is 30 mg once daily for 4 weeks. In patients not fully healed within this time, the treatment may be continued at the same dose for another 4 weeks.

Prophylaxis of reflux oesophagitis:

15 mg once daily. The dose may be increased up to 30 mg daily as necessary.

Eradication of Helicobacter pylori:

When selecting appropriate combination therapy consideration should be given to official local guidance regarding bacterial resistance, duration of treatment, (most commonly 7 days but sometimes up to 14 days), and appropriate use of antibacterial agents.

The recommended dose is 30 mg of lansoprazol twice daily for 7 days in combination with one of the following:

Clarithromycin 250-500 mg twice daily + amoxicillin 1 g twice daily.

Clarithromycin 250 mg twice daily + metronidazole 400-500 mg twice daily.

H. pylori eradication rates of up to 90%, are obtained when clarithromycin is combined with lansoprazol and amoxicillin or metronidazole.

Six months after successful eradication treatment, the risk of re-infection is low and relapse is therefore unlikely.

Use of a regimen including lansoprazole 30 mg twice daily, amoxicillin 1 g twice daily and metronidazole 400-500 mg twice daily has also been examined. Lower eradication rates were seen using this combination than in regimens involving clarithromycin. It may be suitable for those who are unable to take clarithromycin as part of an eradication therapy, when local resistance rates to metronidazole are low.

Treatment of NSAID-associated benign gastric and duodenal ulcers in patients requiring continued NSAID treatment:

30 mg once daily for four weeks. In patients not fully healed the treatment may be continued for another four weeks. For patients at risk or with ulcers that are difficult to heal, a longer course of treatment and/or a higher dose should be considered.

Prophylaxis of NSAID-associated gastric and duodenal ulcers in patients at risk (such as age >65 or history of gastric or duodenal ulcer) requiring prolonged NSAID treatment:

15 mg once daily. If the treatment fails the dose 30 mg once daily should be used.

Symptomatic gastro-oesophageal reflux disease:

The recommended dose is 15 mg or 30 mg daily. Relief of symptoms is obtained rapidly. Individual adjustment of dosage should be considered. If the symptoms are not relieved within 4 weeks with a daily dose of 30 mg, further examinations are recommended.

Zollinger-Ellison syndrome:

The recommended initial dose is 60 mg once daily. The dose should be individually adjusted and the treatment should be continued for as long as necessary. Daily doses of up to 180 mg have been used. If the required daily dose exceeds 120 mg, it should be given in two divided doses.

Dosing in special population

Impaired hepatic or renal function:

There is no need to change the dose in patients with impaired renal function.

Patients with moderate or severe liver disease should be kept under regular supervision and a 50% reduction of the daily dose is recommended.

Elderly:

Due to reduced clearance of Lansoprazole in the elderly an adjustment of the dose may be necessary based on individual requirements. A daily dose of 30 mg should not be exceeded in the elderly unless there are compelling clinical indications.

Children:

The use of Lansoprazole is not recommended in children as clinical data are limited. Treatment of small children below one year of age should be avoided as available data have not shown beneficial effects in the treatment of gastro-oesophageal reflux disease.

Undesirable effects:

Blood and lymphatic system disorders:

Uncommon: Thrombocytopenia, eosinophilia, leucopenia.

Rare: Anaemia.

Very rare: Agranulocytosis, pancytopenia.

Metabolism and nutritional disorders:

Not known: Hypomagnesaemia

Psychiatric disorders:

Uncommon: depression

 

Nervous system disorders:

Common: Headache, dizziness.

Rare: Restlessness, vertigo and paraesthesia, somnolence, tremor.

Eye disorders:

Rare: visual disturbances.

Gastrointestinal disorders:

Common: Nausea, diarrhoea, stomach ache, constipation, vomiting, flatulence and dry mouth or throat.

Rare: Glossitis, candidiasis of the oesophagus, pancreatitis, taste disturbances.

Very rare: Colitis, stomatitis.

Hepatobiliary disorders:

Common: Increase in liver enzyme levels.

Rare: Hepatitis and jaundice.

Skin and subcutaneous tissue disorders:

Common: Urticaria, itching, rash

Rare: Petechia, purpura, hair loss, erythema multiforme, photosensitivity.

Very rare: Stevens-Johnson syndrome and toxic epidermal necrolysis.

Musculoskeletal and connective tissue disorders:

Uncommon: Athralgia, myalgia, fracture of the hip, wrist or spine.

Renal and urinary disorders:

Rare: Interstitial nephritis.

Reproductive system and breast disorders:

Rare: Gynaecomastia.

General disorders and administration site conditions:

Common: Fatigue.

Uncommon: Oedema.

Rare: Fever, hyperhidrosis, anorexia, impotence and angioedema.

Very rare: Anaphylactic shock.

Investigations:

Very rare: Increase in cholesterol and triglyceride levels, hyponatremia.

Warnings and precautions:

In common with other anti-ulcer therapies, the possibility of malignant gastric tumour should be excluded when treating gastric ulcers with lansoprazole, because lansoprazole can mask the symptoms and delay the diagnosis.

Lansoprazole should be used with caution in patients with moderate to severe hepatic dysfunction.

Decreased gastric acidity due to lansoprazole might be expected to increase gastric counts of bacteria normally present in the gastrointestinal tract. Treatment with lansoprazole may lead to a slightly increased risk of gastrointestinal infections such as Salmonella and Campylobacter.

In patients suffering from gastro-duodenal ulcers, the possibility of H. pylori infection as an etiological factor should be considered.

If lansoprazole is used in combination with antibiotics for eradication therapy of H.pylori, then the instructions for the use of these antibiotics should also be followed.

Because of limited safety data for patients on maintenance treatment for longer than 1 year, regular review of the treatment and a thorough benefit risk assessment should regularly be performed in these patients.

Very rarely cases of colitis have been reported in patients taking Lansoprazole.                           Therefore, in the case of severe and/or persistent diarrhoea, discontinuation of therapy should be considered.

The treatment for the prevention of peptic ulceration of patients in need of continuous NSAID treatment should be restricted to high risk patients (e.g. previous gastrointestinal bleeding, perforation or ulcer, advanced age, concomitant use of medication known to increase the likelihood of upper GI adverse events [e.g. corticosteroids or anticoagulants],    the presence of a serious co-morbidity factor or the prolonged use of NSAID maximum recommended doses).

Proton pump inhibitors, especially if used in high doses and over long durations (>1 year), may modestly increase the risk of hip, wrist and spine fracture, predominantly in the elderly or in presence of other recognised risk factors. Observational studies suggest that proton pump inhibitors may increase the overall risk of fracture by 10–40%. Some of this increase may be due to other risk factors. Patients at risk of osteoporosis should receive care according to current clinical guidelines and they should have an adequate intake of vitamin D and calcium.

Hypomagnesaemia

Severe hypomagnesaemia has been reported in patients treated with PPIs like lansoprazole for at least three months, and in most cases for a year. Serious manifestations of hypomagnesaemia such as fatigue, tetany, delirium, convulsions, dizziness and ventricular arrhythmia can occur but they may begin insidiously and be overlooked. In most affected patients, hypomagnesaemia improved after magnesium replacement and discontinuation of the PPI.

For patients expected to be on prolonged treatment or who take PPIs with digoxin or drugs that may cause hypomagnesaemia (e.g., diuretics), health care professionals should consider measuring magnesium levels before starting PPI treatment and periodically during treatment.

As Lansoprazole contains sucrose, patients with rare hereditary problems of fructose intolerance, glucose-galactosemalabsorption or sucrase-isomaltase insufficiency should not take this medicine.

Pack:

Carton box containing a plastic bottle of 10 Capsules.

Or

Carton box containing a plastic bottle of 14 Capsules.

 

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