Reclast 3 dosage forms and strengths 4 contraindications 4.1 highlights of prescribing information these.Warning (see full prescribing information for details). Information obtained from Reclast (zoledronic acid). Microsoft Word - Reclast (zoledronic acid intravenous).doc. Side Effects, Interactions, Warning, Dosage & Uses. What are the possible side effects of zoledronic acid (Reclast, Zometa)? Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as: urinating less than usual or not at all; drowsiness, confusion, mood changes, increased thirst, loss of appetite, nausea and vomiting; swelling, weight gain, feeling short of breath; muscle spasms, numb or tingly feeling (especially around your mouth); fever, chills, body aches, flu.. Read All Potential Side Effects and See Pictures of Reclast »What are the precautions when taking zoledronic acid injection (Reclast)? Before using zoledronic acid, tell your doctor or pharmacist if you are allergic to it; or to other bisphosphonates such as alendronate or risedronate; or if you have trouble breathing (wheezing) after taking aspirin; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Reclast Approved for Osteoporosis Treatment in Postmenopausal Women. In August 2. 00. 7, the Food and Drug Administration approved zoledronic acid (Reclast) with a new indication for osteoporosis treatment in postmenopausal women. Reclast, an intravenous bisphosphonate from Novartis Pharmaceuticals, was previously indicated for treatment of Paget's disease of bone, a metabolic bone disease that causes accelerated bone remodeling and excessive bone resorption followed by excessive abnormal bone formation, often resulting in bone deformity. Fifty percent of women and 2. Osteoporosis is responsible for more than 1. In clinical studies of postmenopausal women with osteoporosis, Reclast was found to reduce the incidence of fractures (hip, vertebral, and nonvertebral osteoporosis- related fractures). Indications. Reclast is indicated for treatment of osteoporosis in postmenopausal women. The efficacy and safety of Reclast in the treatment of postmenopausal osteoporosis was demonstrated in a randomized, double- blind, placebo- controlled, multinational study of 7,7. Mechanism of Action. Reclast is a bisphosphonate and acts primarily on bone as an inhibitor of osteoclast- mediated bone resorption. The selective action of zoledronic acid on bone is based on its high affinity for mineralized bone. Zoledronic acid administered intravenously rapidly partitions to bone and localizes at sites of high bone turnover. The main molecular target of zoledronic acid is the enzymatic activity in osteoclasts. Because of its high binding affinity to bone mineral, zoledronic acid has a relatively long duration of action. Drug Metabolism. Pharmacokinetic properties of Reclast are not based on studies with osteoporotic postmenopausal women or patients with Paget's disease of the bone. Information related to drug distribution, metabolism, and elimination is derived from animal studies and from the use of zoledronic acid in patients with cancer and bone metastases. Zoledronic acid is administered by intravenous infusion and shows a rapid decrease in plasma concentration after distribution. Less than 1% of the drug is detectable after 2. Zoledronic acid has a low affinity for blood components and has only moderate protein binding in human plasma. Zoledronic acid does not inhibit cytochrome P4. The drug is either taken up by bone or eliminated unchanged in the feces and urine, which suggests that zoledronic acid is not metabolized. Excretion of zoledronic acid unbound to bone appears to be predominantly through the kidneys and seems to be partially dependent on a patient's kidney function as measured by creatinine clearance. Contraindications. Reclast is contraindicated in patients with any history of hypersensitivity reactions to zoledronic acid. The drug is also contraindicated for any patient with current hypocalcemia. Oncology patients receiving Zometa, another form of zoledronic acid, should not receive Reclast. Patients with preexisting hypocalcemia and disturbances of mineral metabolism (hypoparathyroidism, thyroid surgery, parathyroid surgery; malabsorption syndromes, excision of small intestine) must be effectively treated before initiating therapy with Reclast. Monitoring calcium, phosphorus, and magnesium levels is highly recommended for these patients. Because the drug is excreted through the kidney, Reclast is not recommended for use in patients with severe renal impairment (creatinine clearance lower than 3. L/ minute) due to lack of adequate clinical trials in this population. Patients (especially those on diuretics) should also be appropriately hydrated prior to administration of Reclast and used cautiously with concomitant use of other nephrotoxic drugs. Monitoring serum creatinine before each Reclast dose is recommended. Race, hepatic function, and age do not appear to be characteristics requiring special monitoring. Reclast is a pregnancy Category D drug and has a potential for alterations to fetal bone development; therefore, it is contraindicated in pregnant women or those who wish to become pregnant. It is unknown whether Reclast is excreted in breast milk, but the manufacturer suggests that this drug not be administered to nursing women. The drug has not been studied in the pediatric population. Adverse Reactions. The Reclast clinical trial lasted 3 years with 3,8. All women in the study also received 1,0. D supplementation daily. The incidence of serious adverse events was 2. Reclast group and 3. Table: . Withdrawal from the study due to adverse events was 5. Reclast and placebo groups, respectively. The most common adverse reactions in the treatment group, significantly different than the placebo group, included pyrexia, myalgia, headache, arthralgia, and pain in extremity. Osteonecrosis of the jaw has been reported in patients treated with bisphosphonates, including zoledronic acid. A dental examination should be considered before treatment with bisphosphonates in patients with a history of concomitant risk factors (cancer, chemotherapy, corticosteroids, poor oral hygiene). Although they occurred more than a month after treatment, the potentially significant adverse event of atrial fibrillation was seen in 1. Reclast- treated group (versus 0. Although it is not known if there is a causal association between atrial fibrillation and bisphosphonate therapy. Dosage and Administration. For postmenopausal women with osteoporosis, Reclast is administered as a 5 mg once- a- year intravenous infusion. The room temperature solution should be inspected for particulate matter or discoloration, and the infusion should be given over at least 1. To moderate possible acute- phase reaction symptoms (fever, headache, muscle aches), patients should receive appropriate doses of acetaminophen or ibuprofen following Reclast infusion. In addition, to minimize potential renal impairment, patients should be adequately hydrated prior to initiation of therapy. Patients receiving Reclast for osteoporosis treatment should maintain an adequate intake of calcium (1,2. D (4. 00 to 8. 00 international units daily) either through diet or supplements. Hypocalcemia is a potential risk in patients receiving bisphosphonate treatment. Reclast is a pregnancy Category D drug and should not be used in pregnant women or in nursing mothers. No precautions are needed for administration of Reclast specifically due to advanced age. However, renal function commonly declines in the elderly and practitioners are advised to monitor renal function. The cost for once- yearly Reclast infusion is approximately $1,3. This is compared to the other intravenous bisphosphonate, ibandronate (Boniva), given once every 3 months for an approximate annual cost of $2,0. The oral bisphosphonate risedronate (Actonel), with a new twice- a- month dosing, costs approximately $1,1. Special Instructions. Patients receiving Reclast should advise their practitioner of medications and supplements they are taking, especially those that may impact renal function. Female patients should be warned not to become pregnant or to breastfeed while receiving Reclast therapy. Patients should hydrate themselves adequately (at least two glasses of fluid such as water) a few hours before expected drug infusion. Adequate calcium and vitamin D intake is important in women with osteoporosis, and patients should be instructed on the importance of calcium and vitamin D supplementation in maintaining serum calcium levels. Acetaminophen or ibuprofen is recommended after receiving Reclast to moderate possible infusion reaction. If flu- like symptoms persist more than a week, patients should contact their provider. Persistent pain or new mouth or jaw symptoms should also be reported due to a potential, albeit low, risk of osteonecrosis of the jaw associated with zoledronic acid use.
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