Ventra

Ventra Special Precautions

esomeprazole

Manufacturer:

Ethypharm

Distributor:

International Med
Full Prescribing Info
Special Precautions
Talk to the doctor or pharmacist before taking Ventra: if the patient has severe liver problems; if the patient has severe kidney problems; if the patient has ever had a skin reaction after treatment with a medicine similar to Ventra that reduces stomach acid; if the patient is due to have a specific blood test (Chromogranin A).
If a rash on the skin develops, especially in areas exposed to the sun tell the doctor as soon as possible, as treatment with Ventra may need to be stopped. Remember to also mention any other ill-effects like pain in the joints.
Ventra may hide the symptoms of other diseases. Therefore, if any of the following happens before starting Ventra or while taking it, talk to the doctor straight away: A lot of weight loss for no reason and problems swallowing; stomach pain or indigestion; vomiting food or blood; passing black stools (blood-stained faeces).
Taking a proton pump inhibitor like Ventra, especially over a period of more than one year, may slightly increase the risk of fracture in the hip, wrist or spine. Tell the doctor if the patient has osteoporosis or is taking corticosteroids (which can increase the risk of osteoporosis).
If the patient has been prescribed Ventra "on demand", contact the doctor if the symptoms continue or change in character.
Talk to the doctor, pharmacist or nurse before taking Ventra.
Ventra contains sucrose and parahydroxybenzoates: Ventra contains sucrose, which is a type of sugar, propyl-p-hydroxybenzoate (E216) and methyl-p-hydroxybenzoate (E218): If the patient has an intolerance to some sugars, talk to the doctor before taking this medicine.
Parahydroxybenzoates may cause allergic reactions (possibly delayed).
Hypomagnesemia, symptomatic and asymptomatic, has been reported rarely in patients treated with PPIs for at least three months, in most cases after a year of therapy. Serious adverse events include tetany, arrhythmias, and seizures. In most patients, treatment of hypomagnesemia required magnesium replacement and discontinuation of the PPI. For patients expected to be on prolonged treatment or who take PPIs with medications such as digoxin or drugs that may cause hypomagnesemia (e.g., diuretics), health care professionals may consider monitoring magnesium levels prior to initiation of PPI treatment and periodically.
Esomeprazole is a CYP2C19 inhibitor. When starting or ending treatment with esomeprazole, the potential for interactions with drugs metabolised through CYP2C19 should be considered. An interaction is observed between clopidogrel and omeprazole. The clinical relevance of this interaction is uncertain. As a precaution, concomitant use of esomeprazole and clopidogrel should be discouraged.
Decreased gastric acidity due to any means, including proton pump inhibitors, increases gastric counts of bacteria normally present in the gastrointestinal tract. Treatment with proton pump inhibitors may lead to slightly increased risk of gastrointestinal infections such as Salmonella and Campylobacter and possibly Clostridium difficile.
Concomitant use of Proton Pump Inhibitors (PPIs) with Methotrexate: Literature suggests that concomitant use of PPIs with methotrexate (primarily at high dose) may elevate and prolong serum levels of methotrexate and/or its metabolite, possibly leading to methotrexate toxicities. A temporary withdrawal of the PPI may be considered in some patients receiving treatments with high dose methotrexate. Case reports, published population pharmacokinetic studies, and retrospective analyses suggest that concomitant administration of PPIs and methotrexate (primarily at high dose) may elevate and prolong serum levels of methotrexate and/or its metabolite hydroxymethotrexate. However, no formal drug interaction studies of methotrexate with PPIs have been conducted.
Long-term (a year or longer) and multiple daily dose PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist or spine. Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated.
Subacute cutaneous lupus erythematosus (SCLE): Proton pump inhibitors are associated with very infrequent cases of 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 VENTRA. SCLE after previous treatment with a proton pump inhibitor may increase the risk of SCLE with other proton pump inhibitors.
Driving and using machines: Ventra is not likely to affect the ability to drive or use any tools or machines. However, side effects such as dizziness and blurred vision may uncommonly or rarely occur (see Side Effects). If affected, do not drive or use machines.
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