Reventa Special Precautions

General: Causes of osteoporosis other than estrogen deficiency, aging and glucocorticoid use should be considered.
Hypocalcemia must be corrected before initiating therapy with alendronate.
Other disorders affecting mineral metabolism (eg, vitamin D deficiency) should also be treated. Patients with these conditions, serum calcium and symptoms of hypocalcemia should be monitored during therapy.
Ensuring adequate calcium absorption and vitamin D intake is especially important in patients with Paget's disease of bone and in patients receiving glucocorticoids, as small asymptomatic decreases in serum calcium and phosphate may occur with alendronate treatment.
Gastrointestinal: Physicians should be alert to symptoms signalling a possible esophageal reaction including dyaphasis, odynophagia, retrosternal pain or new/worsening heartburn. Patients should be instructed to discontinue alendronate.
Because of possible irritant effects of alendronate on the upper gastrointestinal mucosa and a potential for worsening of the underlying disease, caution should be used when alendronate is given to patients with active upper gastrointestinal problems.
Renal Insufficiency: Alendronate is not recommended for patients with severe renal insufficiency (creatinine clearance <35 mL/min) due to lack of experience in renal failure.
Glucocorticoid-induced Osteoporosis: The risk versus benefit of alendronate for treatment at daily dosages of glucocorticoids <7.5 mg of prednisone or equivalent has not been established. Before initiating treatment, the hormonal status of both men and women should be ascertained and appropriate replacement considered. A bone mineral density measurement should be made at the initiation of therapy and repeated after 6-12 months of combined alendronate and glucocorticoid treatment.
Use in pregnancy: There are no studies in pregnant women. Alendronate should be used during pregnancy only if the potential benefit justifies the potential risk to the mother and fetus.
Use in lactation: It is not known whether alendronate is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when alendronate is administered to nursing women.
Use in children: Safety and effectiveness in pediatric patients have not been established.