When gastric ulcer is suspected, the possibility of malignancy should be excluded before treatment with Omilock is instituted, as treatment may alleviate symptoms and delay diagnosis.
Risk-benefit should be considered when the following medical problems exist: Hepatic disease, chronic, current or history of (dosage reduction may be required due to increased half-life in chronic hepatic disease).
High risk groups: Fertility: In a rat fertility and general reproductive performance test, omeprazole, in a dose 35 to 345 times the human dose, was not toxic or deleterious to the reproductive performance of parental animals.
Use in Pregnancy: Adequate and well-controlled studies in humans have not been done and the drug is not recommended.
Studies in pregnant rats did not show omeprazole to have any teratogenic potential at doses 345 times the human dose. Omeprazole produced dose-related increases in embryo-lethality, fetal resorptions, and pregnancy disruptions in rabbits receiving 17 to 172 times the human dose.
In rats, dose-related embryo/fetal toxicity and postnatal developmental toxicity were observed in offspring resulting from parents treated with 35 to 345 times the human dose.
FDA Pregnancy Category C.
Use in Lactation: It is not known whether omeprazole is distributed into human breast milk. However, because omeprazole has been shown to cause tumorigenic and carcinogenic effects in animals, a decision should be made on whether nursing should be discontinued or the medication withdrawn, taking into account the importance of the omeprazole to the mother.
Neonates: There are no data and the drug is not recommended for neonates.
Use in Children: Appropriate studies on the relationship of age to the effects of omeprazole have not been performed in the pediatric population and the drug is not recommended.
Use in Elderly: No information is available on the relationship of age to the effects of omeprazole in geriatric patients. However, a somewhat decreased rate of elimination and an increased bioavailability are more likely to occur in geriatric patients taking omeprazole.
Regular Surveillance: Patients on proton pump inhibitor treatment (particularly those treated for long term) should be kept under regular surveillance.
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 health care professional should consider stopping omilock. SCLE after previous treatment with a proton pump inhibitor may increase the risk of SCLE with other proton pump inhibitors.
Hypomagnesaemia: Severe hypomagnesaemia has been reported in patients treated with PPI like omilock for at least three months, and in most cases for a year. Serious manifestations of hypomagnesaemia such as fatigue, tetany, delirium, convulsion, 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 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.
Fracture: Proton pump inhibitors, especially if used in high doses and over long duration (>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 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.
Clostridium Difficile Diarrhea: Published observational studies suggest that PPI therapy may be associated with an increased 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 dose and shortest duration of PPI therapy appropriate to the condition being treated.
Vitamin B12 Deficiency: Daily treatment with any acid-suppressing medications over a long period of time (e.g.,longer than 3 years) may lead to malabsorption of cyanocobalamin deficiency occurring with -suppressing therapy have been reported in the literature. This diagnosis should be considered if clinical symptoms consistent with cyanocobalamin deficiency are observed.