Controloc Special Precautions

Bone fracture: PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine. The risk of fracture was increased in patients who received high-doses; defined as multiple daily doses, and long-term PPI therapy (a year or longer).
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: 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 dose and shortest duration of PPI therapy appropriate to the condition being treated.
Hypomagnesemia: Has been rarely reported in patients treated with PPIs for at least three months (in most cases after a year of therapy). Serious consequences of hypomagnesemia such as fatigue, tetany, delirium, convulsions, dizziness, arrhythmia, and seizure 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 (and hypomagnesemia associated hypocalcemia and/or hypokalemia) improved after magnesium replacement and discontinuation of the PPI.
For patient expected to be on prolonged treatment or who take PPIs with medications such as digoxin or drugs that may cause hypomagnesemia (e.g. diuretics), healthcare professionals may consider measuring magnesium levels before starting PPI treatment and periodically during treatment.
Influence on vitamin B12 absorption: In patients with Zollinger-Ellison syndrome and other pathological hypersecretory conditions requiring long-term treatment (e.g., longer than 3 years), pantoprazole, as all acid-blocking medicines, may reduce the absorption of vitamin B12 (cyanocobalamin) due to hypo- or achlorhydria. This should be considered in patients with reduced body stores or risk factors for reduced vitamin B12 absorption on long-term therapy or if respective clinical symptoms are observed.
Interference with Laboratory Tests: Increased Chromogranin A (CgA) level may interfere with investigations for neuroendocrine tumours. To avoid this interference, proton pump inhibitor treatment should be stopped 14 days before CgA measurements.
Hepatic Impairment: In patients with severe liver impairment, the liver enzymes should be monitored regularly during treatment with pantoprazole, particularly on long-term use. In the case of a rise of the liver enzymes, the treatment should be discontinued.
HIV protease inhibitors: Co-administration of pantoprazole 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.
Methotrexate: Concomitant use with high dose methotrexate may elevate and prolong serum levels of methotrexate and/or its metabolite, possibly leading to methotrexate toxicities.
Gastric malignancy: Symptomatic response to pantoprazole does not preclude the presence of gastric malignancy.
Regular Surveillance: In long-term treatment, especially when exceeding a treatment period of 1 year, patients should be kept under regular surveillance.
Severe Cutaneous Adverse Reactions: Severe cutaneous adverse reactions, including erythema multiforme, Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP) have been reported in association with the use of PPIs (see Adverse Reactions). Discontinue pantoprazole 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 in rare cases with the occurrence 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.
Effects on the ability to drive and to use machines: Pantoprazole is not expected to adversely affect the ability to drive or use machines.
Adverse drug reactions such as dizziness and visual disturbances may occur. If affected, patients should not drive or operate machines.
Use in Pregnancy and Lactation: The limited data on the use of pantoprazole in pregnant women does not indicate foetal/neonatal toxicity. The potential risk for humans is unknown. Pantoprazole should not be used during pregnancy unless clearly necessary.
Animal studies have shown excretion of pantoprazole in breast milk. Excretion into human milk has been reported. Therefore, a decision on whether to continue/discontinue breastfeeding or to continue/discontinue therapy with pantoprazole should be made taking into account the benefit of breastfeeding to the child and the benefit of pantoprazole therapy to women.
20 mg and 40 mg tab: Studies in animals have shown reproductive toxicity.