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Careful administration: (PREVACID FDT should be administered with caution to the following patients.): a) Patients with a past history of drug hypersensitivity.
b) Elderly patients (See Elderly under Dosage & Administration).
c) Patients with impaired renal and hepatic function (See Renal Impairment and Hepatic Impairment under Dosage & Administration).
d) The possibility of malignancy should be excluded when gastric ulcer is suspected, as symptoms may be alleviated and diagnosis delayed.
Regular Surveillance: Patients on proton pump inhibitor treatment (particularly those treated for long term) should be kept under regular surveillance.
Severe Cutaneous Adverse Reactions: Severe cutaneous adverse reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP) and erythema multiforme have been reported in association with the use of PPIs (see ADVERSE REACTIONS). Discontinue lansoprazole at the first signs or symptoms of severe cutaneous adverse reactions or other signs of hypersensitivity and consider further evaluation.
Subacute Cutaneous Lupus Erythematosus (SCLE): Proton pump inhibitors are associated with very infrequent cases of subacute cutaneous lupus erythematosus (SCLE). If lesions occur, especially in sun exposed areas of the skin, and if accompanied by arthralgia, the patient should seek medical help promptly and the healthcare professional should consider stopping the product. SCLE after previous treatment with a proton pump inhibitor may increase the risk of SCLE with other proton pump inhibitors.
Bone fracture: 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 recognized risk factors. Observational studies suggest PPI 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.
Clostridium difficile: Published observational studies suggest that PPI therapy may be associated with an increased risk of Clostridium difficile associated diarrhea, especially in hospitalized patients. This diagnosis should be considered for diarrhea that does not improve. Patients should use the lowest drug and shortest duration of PPI therapy appropriate to the condition being treated.
Hypomagnesemia: Severe hypomagnesaemia has been reported in patients treated with PPI like this product for at least three months, and in most cases for a year. Serious manifestations of hypomagenesia such as fatigue, tetany, delirium, convulsions, dizziness, arrhythmias and seizures can occur but they may begin insidiously and be overlooked. Hypomagnesemia may lead to hypocalcemia and/or hypokalemia (see Adverse Reactions). 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 PPI 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.
Influence on Vitamin B12 Absorption: Daily treatment with any acid-suppressing medications over a prolonged period of time (e.g. longer than 3 years) may lead to malabsorption of cyanocobalamin (vitamin B12) caused by hypo- or achlorhydria. Rare reports of cyanocobalamin deficiency occurring with acid-suppressing therapy have been reported in the literature. This diagnosis should be considered if clinical symptoms consistent with cyanocobalamin deficiency are observed. Cyanocobalamin deficiency should be considered in patients with Zollinger-Ellison syndrome and other pathological hypersecretory conditions requiring long-term treatment, individuals with reduced body stores or risk factors for reduced vitamin B12 absorption (such as the elderly) on long-term therapy or if relevant clinical symptoms are observed.
Interference with laboratory tests: Increased Chromogranin A (CgA) level may interfere with investigations for neuroendocrine tumours. If the patient(s) are due to have a test on Chromogranin A level, PREVACID FDT treatment should be stopped for at least 5 days before CgA measurements to avoid this interference (see Pharmacology: Pharmacodynamics under Actions). If CgA and gastrin levels have not returned to reference range after initial measurement, measurements should be repeated 14 days after cessation of proton pump inhibitor treatment.
HIV Protease Inhibitors: Co-administration of lansoprazole is not recommended with HIV protease inhibitors for which absorption is dependent on acidic intragastric pH such as atazanavir, nelfinavir; due to significant reduction in their bioavailability.
Pregnancy (Category B) and Lactation: Pregnancy: Lansoprazole should be administered to pregnant women with caution only if needed.
Lactation: It is unknown whether lansoprazole is excreted in human breast milk. During treatment with lansoprazole, nursing should be avoided if the administration of this drug is necessary for the mother.
Use in children: 12 to 17 years of age: In an uncontrolled, open-label, U.S. multicenter study, 87 adolescent patients (12-17 years of age) with symptomatic GERD were treated with PREVACID FDT for 8 to 12 weeks. Baseline upper endoscopies classified these patients into two groups: 64 (74%) nonerosive GERD and 23 (26%) erosive esophagitis (EE). The nonerosive GERD patients received PREVACID FDT 15mg q.d. for 8 weeks and the EE patients received PREVACID FDT 30mg q.d. for 8 to 12 weeks. At baseline, 89% of these patients had mild to moderate overall GERD symptoms (assessed by investigator interviews). During 8 weeks of PREVACID FDT treatment, adolescent patients experienced a 63% reduction in frequency and a 69% reduction in severity of GERD symptoms based on diary results.
Twenty-one of 22 (95.5%) adolescent erosive esophagitis patients were healed after 8 weeks of PREVACID FDT treatment. One patient remained unhealed after 12 weeks of treatment. (See table.)
Click on icon to see table/diagram/imageIn these 87 adolescent patients, increases in serum gastrin levels were similar to those observed in adult studies, median fasting serum gastrin levels increased 42% from 45pg/mL at baseline to 64pg/mL [interquartile range (25th - 75th percentile) of 44 - 88pg/mL] at the final visit. (Normal serum gastrin levels are 25 to 111pg/mL).
The safety of PREVACID FDT has been assessed in these 87 adolescent patients. Of the 87 adolescent patients with GERD, 6% (5/87) took PREVACID FDT for <6 weeks, 93% (81/87) for 6-10 weeks, and 1% (1/87) for >10 weeks.
The most frequently reported (at least 3%) treatment-related adverse events in these patients were headache (7%), abdominal pain (5%), nausea (3%) and dizziness (3%). Treatment-related dizziness, reported in this package insert as occurring in <1% of adult patients, was reported in this study by 3 adolescent patients with nonerosive GERD, who had dizziness concurrently with other events (such as migraine, dyspnea, and vomiting).
