Prosogan FD

Prosogan FD

lansoprazole

Manufacturer:

Takeda
Full Prescribing Info
Contents
Lansoprazole.
Action
Pharmacology: Mode of Action: Lansoprazole is effective in gastric acid secretion. Lansoprazole specifically inhibits the (H+/K+) ATPase (proton pump) of the parietal cells in the gastric mucosa.
Pharmacokinetics: Lansoprazole is rapidly absorbed and maximum serum levels are reached after approximately 1.5 hrs. The plasma protein-binding is 97%.
Lansoprazole exhibits high (80-90%) bioavailability from the 1st dose. As s result, effective acid inhibition is achieved rapidly. A single dose of 30 mg inhibits stimulated acid secretion by approximately 80%.
Toxicology: The long study in rats reported that gastric carcinoids, localized to the oxyntic mucosa, occurred. The changes have been related to sustained hypergastrinemia secondary to acid inhibition and not from a direct effect of any individual drug.
In the long study in rats, an increase in the frequency of retinal atrophy was observed. Retinal atrophy was not observed in mice as well as in toxicity studies in dogs or monkeys. Thus, these changes are considered to be specific to rats. There have not been sufficient experiences in long-term administration of lansoprazole and no such treatment-related changes in patients treated in a long-term period with lansoprazole.
Indications/Uses
Duodenal ulcer. Benign gastric ulcer. Reflux esophagitis. NSAID gastropathy.
Dosage/Direction for Use
Recommended Dose: Duodenal Ulcer: 30 mg once daily for 4 weeks.
Benign Gastric Ulcer: 30 mg once daily for 8 weeks.
Reflux Esophagitis: 30 mg once daily for 4 weeks.
NSAID Gastropathy: 30 mg once daily for 8 weeks.
Elderly: Dose adjustment is not required in the elderly. The normal daily dosage of 30 mg should be given.
Hepatic Impairment: Lansoprazole is metabolized substantially by the liver. Clinical trials in patients with liver disease indicate that metabolism of lansoprazole is prolonged in patients with severe hepatic impairment. However, no dose adjustment is necessary; the dose should not exceed 30 mg daily.
Renal Impairment: There is no need to alter the dosage in patients with impaired renal function.
Administration: Lansoprazole should be taken once daily to achieve the optimal acid inhibitory effect; hence, promote rapid healing and symptom relief. Lansoprazole should be administered in the morning before food.
Long-term treatment with lansoprazole cannot be recommended at this time since clinical experience is limited.
Overdosage
There are no reports of overdose with lansoprazole; however, lansoprazole has been given at doses up to 120 mg/day without any significant adverse effects.
In the event of overdosage, appropriate supportive treatment should be initiated according to the clinical signs and symptoms.
Contraindications
Hypersensitivity to lansoprazole.
Special Precautions
In common with other anti-ulcer therapies, the possibility of malignancy should be excluded when gastric ulcer is suspected, as symptoms may be alleviated and diagnosis delayed.
Use in pregnancy & lactation: There is insufficient evidence to recommend the use of lansoprazole in pregnancy. The use of lansoprazole in pregnany should be avoided. Animal studies do not reveal any teratogenic effect. Reproduction studies indicate slightly reduced litter survival and weights in rats and rabbits given very high doses of lansoprazole.
Animal studies indicate that lansoprazole is secreted into breast milk. There is no information on the secretion of lansoprazole into breast milk in humans. Breastfeeding should therefore be discontinued if the use of lansoprazole is considered essential.
Use in children: There is no experience with lansoprazole in children.
Use In Pregnancy & Lactation
There is insufficient evidence to recommend the use of lansoprazole in pregnancy. The use of lansoprazole in pregnany should be avoided. Animal studies do not reveal any teratogenic effect. Reproduction studies indicate slightly reduced litter survival and weights in rats and rabbits given very high doses of lansoprazole.
Animal studies indicate that lansoprazole is secreted into breast milk. There is no information on the secretion of lansoprazole into breast milk in humans. Breastfeeding should therefore be discontinued if the use of lansoprazole is considered essential.
Side Effects
A low incidence of events has been reported during clinical trials, including headache, diarrhoea, abdominal pain, dyspepsia, nausea, vomiting, dry mouth, constipation, flatulence, dizziness, fatigue, rash, urticaria and pruritus.
Increases in liver function test values have been observed. These events are generally transient and self-limiting. Its relationship to lansoprazole therapy has not been established. A few cases of arthralgia, peripheral oedema and depression were reported. Haematological changes (eg, thrombocytopenia, leucopenia) have been reported rarely.
Drug Interactions
Lansoprazole is hepatically metabolized and studies indicate that it is a weak inducer of cytochrome P-450. Accordingly, there is the possibility of interaction with drugs which are metabolized by the liver. In particular, caution should be exercised when oral contraceptives and preparations eg, phenytoin, carbamazepine, theophylline or warfarin are taken concomitantly with the administration of lansoprazole.
No clinical significant effects on NSAIDs or diazepam have been found.
Antacids and sucralfate may reduce the bioavailability of lansoprazole and should therefore not be taken within an hour of lansoprazole.
Storage
Store below 25°C.
ATC Classification
A02BC03 - lansoprazole ; Belongs to the class of proton pump inhibitors. Used in the treatment of peptic ulcer and gastro-oesophageal reflux disease (GERD).
Presentation/Packing
Tab (plain white to yellowish-white speckled with red-orange to dark brown) 15 mg x 2 x 14's. 30 mg x 2 x 14's.
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