Reclast

What is Reclast?

• Reclast (Zoledronic acid) is a bisphosphonate used to treat a number of bone diseases.

Zoledronic acid

Zoledronic-acid-from-xtal-2003-3D-balls

What are the uses of this medicine?

Reclast (Zoledronic acid) is a prescription medicine used to:

• Treat or prevent osteoporosis in women after menopause. Reclast helps reduce the chance of having a hip or spinal fracture (break).
• Increase bone mass in men with osteoporosis.
• Treat or prevent osteoporosis in either men or women who will be taking corticosteroid medicines for at least one year.
• Treat certain men and women who have Paget’s disease of the bone.

How does this medicine work?

• Reclast is a bisphosphonate and acts primarily on bone. It is an inhibitor of osteoclast-mediated bone resorption.
• The main molecular target of zoledronic acid in the osteoclast is the enzyme farnesyl pyrophosphate synthase.
• The relatively long duration of action of zoledronic acid is attributable to its high binding affinity to bone mineral.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• Have low levels of calcium in your blood.
• Have kidney problems.
• Are allergic to zoledronic acid or any of its ingredients.

What drug interactions can this medicine cause?

• Caution is advised when bisphosphonates, including zoledronic acid, are administered with aminoglycosides.
• Caution should also be exercised when Reclast is used in combination with loop diuretics due to an increased risk of hypocalcemia.
• Caution is indicated when Reclast is used with other potentially nephrotoxic drugs, such as nonsteroidal anti-inflammatory drugs (NSAIDs).
• Consider monitoring serum creatinine in patients at risk for renal impairment who are taking concomitant medications that are primarily excreted by the kidney (e.g., digoxin).

Especially tell your doctor if you are taking:

• An antibiotic. Certain antibiotic medicines called aminoglycosides may increase the effect of Reclast in lowering your blood calcium for a long period of time.
• A diuretic or “water pill”.
• Non-steroidal anti-inflammatory medicines (NSAIDS).

Is this medicine FDA approved?

• Initial U.S. Approval: 2001

How should this medicine be used?

Recommended dosage: Treatment of Osteoporosis in Postmenopausal Women:

• The recommended regimen is a 5 mg infusion once a year given intravenously over no less than 15 minutes.

Prevention of Osteoporosis in Postmenopausal Women:

• The recommended regimen is a 5 mg infusion given once every 2 years intravenously over no less than 15 minutes.

Osteoporosis in Men:

• The recommended regimen is a 5 mg infusion once a year given intravenously over no less than 15 minutes.

Treatment and Prevention of Glucocorticoid-Induced Osteoporosis:

• The recommended regimen is a 5 mg infusion once a year given intravenously over no less than 15 minutes.

Treatment of Paget’s Disease of Bone:

• The recommended dose is a 5 mg infusion. The infusion time must not be less than 15 minutes given over a constant infusion rate.

Administration:

• Reclast is given by infusion into your vein (intravenously). Your infusion should last at least 15 minutes.
• Before you receive Reclast, drink at least 2 glasses of fluid (such as water) within a few hours as directed by your doctor.
• You may eat before your treatment with Reclast.
• If you miss a dose of Reclast, call your doctor or healthcare provider to schedule your next dose.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As 5 mg in a 100 mL ready-to-infuse solution

This medicine is available in fallowing brand namesː

• Reclast

What side effects can this medication cause?

The most common side effects of this medicine include:

• Fever
• Pain in your bones, joints or muscles
• Pain in your arms and legs
• Headache
• Flu-like illness (fever, chills, bone, joint, or muscle pain, fatigue)
• Nausea
• Vomiting
• Diarrhea

Reclast can cause serious side effects, including:

• hypocalcemia
• Severe kidney problems
• osteonecrosis
• Unusual thigh bone fractures
• Bone, joint, or muscle pain

What special precautions should I follow?

• Reclast contains the same active ingredient found in Zometa, used for oncology indications, and a patient being treated with Zometa should not be treated with Reclast.
• Hypocalcemia following Reclast administration is a significant risk in Paget’s disease. Patients must be adequately supplemented with calcium and vitamin D.
• A single dose should not exceed 5 mg and the duration of infusion should be no less than 15 minutes. Renal toxicity may be greater in patients with underlying renal impairment or with other risk factors, including advanced age or dehydration. Monitor creatinine clearance before each dose.
• Osteonecrosis of the Jaw (ONJ) has been reported. All patients should have a routine oral exam by the prescriber prior to treatment.
• Atypical Femur Fractures have been reported. Patients with thigh or groin pain should be evaluated to rule out a femoral fracture.
• Severe Bone, Joint, and Muscle Pain may occur. Withhold future doses of Reclast if severe symptoms occur. Most patients had relief of symptoms after stopping. A subset had recurrence of symptoms when rechallenged with the same drug or another bisphosphonate.
• Use Reclast with caution in aspirin-sensitive patients.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• renal impairment
• hypocalcemia
• hypophosphatemia
• hypomagnesemia

Treatment of overdosage:

• Clinically relevant reductions in serum levels of calcium, phosphorus, and magnesium should be corrected by intravenous administration of calcium gluconate, potassium or sodium phosphate, and magnesium sulfate, respectively.

Can this medicine be used in pregnancy?

• Available data on the use of Reclast in pregnant women are insufficient to inform a drug-associated risk of adverse maternal or fetal outcomes.
• Discontinue Reclast when pregnancy is recognized.

Can this medicine be used in children?

• Reclast is not indicated for use in children.
• Because of long-term retention in bone, Reclast should only be used in children if the potential benefit outweighs the potential risk.

What are the active and inactive ingredients in this medicine?

• Active ingredient: zoledronic acid monohydrate.
• Inactive ingredients: mannitol and sodium citrate.

Who manufactures and distributes this medicine?

Distributed by: Novartis Pharmaceuticals Corporation East Hanover, New Jersey

What should I know about storage and disposal of this medication?

• Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F to 86°F).

• Dailymed label info on Reclast
• FDA Reclast

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