COMPOSITION :
Lansoprazole Delayed release capsule 30 mg, each delayed release capsule contains : Lansoprazole pellets equivalent to Lansoprazole 30 mg.
DESCRIPTIONS :
Lansoprazole contains Lansoprazole as active ingredient available in delayed release capsule 30 mg.
INDICATIONS :
- Duodenal ulcer.
- Benign gastric reflux.
- Reflux esophagitis.
- Treatment of gastric ulcers due to NSAID use.
DOSAGE AND ADMINISTRATIONS :
-
- Duodenal ulcer and reflux esophagitis : 30 mg once daily for 4 weeks.
- Benign gastric reflux : 30 mg once daily for 8 weeks.
- Treatment of gastric ulcers due to the use of NSAID : 30 mg once daily for 8 weeks.
- Elderly : No dosage adjustment necessary. Normal dosage can be administered.
- Liver and kidney impairment : Lansoprazole delayed release capsule basically metabolized by the liver. Clinical research in liver impairment patient showed that Lansoprazole metabolism prolonged in 30 mg once daily dose in liver impairment patient. Therefore it is recommended dose adjustment for severe liver disease individual dose 15 mg or 30 mg once daily. Patient should be well monitored and dosage should not more than 30 mg daily.
- No necessary dosage modification in mild to moderate liver disease or kidney disfunction.
Administration :
Lansoprazole should be taken once daily to achieve the optimal acid inhibitory effect, promote rapid healing and symptom relief. Lansoprazole should be administered in the morning before meal, the capsule should be swallowed whole, do not crush or chew. Long-term treatment with Lansoprazole is not recommended.
OVERDOSAGE :
There are no reports of overdose, however administration dose of Lansoprazole up to 120 mg a day without any significant adverse effects. In the event of overdosage, symptomatic and supportive treatment should be initiated.
CONTRAINDICATIONS :
Patients with known hypersensitivity to the component of drug.
WARNINGS AND 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.
- Caution in patients with severe liver dysfunction. Patients should be well monitored, and the dose should not exceed 30 mg daily.
- Treatment with acid secretion inhibitors may potentially lead to slightly increase the risk of gastrointestinal infections such as Salmonella and Campylobacter.
- Lansoprazole usage should be avoided in pregnant women. The use of Lansoprazole during breastfeeding should be avoided, unless considered essential.
DRUG INTERACTIONS :
- There is a possibility of interactions with drugs which are metabolized in the liver. Monitoring to the patient should be made on the administration of Lansoprazole with oral contraceptives and preparations such as Phenytoin, Carbamazepine, Theophylline or Warfarin.
- 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.
ADVERSE REACTIONS :
- Most commonly reported adverse effects are : Headache, dizziness, fatigue and discomfort feeling.
- Gastrointestinal effects including diarrhea, constipation, abdominal pain, nausea, vomiting, flatulence, mouth and throat dry and sore.
- As with other proton pump inhibitors, although very rare, case of colitis has been reported. In the case severe diarrhea and/or persistent, drug discontinuation should be considered. In most cases these symptoms can be resolved with discontinuation of therapy.
- Changes in liver function tests and, although very rare, icterus or hepatitis has been reported.
- Dermatologic reactions including skin rash, urticaria and pruritus. In general, improved with discontinuation of therapy. Serious dermatological reactions are rare but have been reported such as Steven-Johnson syndrome, toxic epidermal necrolysis and erythematous or blistered skin, including erythema multiforme. Cases of hair loss and photosensitivity have also been reported.
- Hypersensitivity reactions include angioedema, wheezing, and anaphylaxis are very rare. Cases of interstitial nephritis has been reported which sometimes may cause renal impairment.
- Hematologic effects (thrombocytopenia, agranulocytosis, eosinophilia, leucopenia, and pancytopenia) are rare. Also been reported bruising, purpura and petechiae.
- Other reactions such as arthralgia, myalgia, depression, peripheral oedema and, rarely, paresthesia, blurred vision, impaired sense of taste, vertigo, confusion and hallucinations. Gynecomastia and impotence reported rarely.
PRESENTATIONS :
Lansoprazole Delayed release capsule 30 mg Box, 10 strips @ 10 delayed release capsule
Reg. No. GKL0502337403A1
STORAGE :
STORE BELOW 25ºC AND DRY PLACE, PROTECT FROM LIGHT
ON MEDICAL PRESCRIPTION ONLY
Manufactured by :
BERNOFARM
Sidoarjo – Indonesia
