• Dosage of Zoledrex in details
• Zoledrex interactions
• Zoledrex reviews

Dosage of Zoledrex in details

Zoledrex Dosage

Generic name: Zoledrex 5mg in 100mL

Dosage form: injection, solution

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

2.1 Important Administration Instructions

Zoledrex injection must be administered as an intravenous infusion over no less than 15 minutes.

• Patients must be appropriately hydrated prior to administration of Zoledrex.

• Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

• Intravenous infusion should be followed by a 10 mL normal saline flush of the intravenous line.

• Administration of acetaminophen following Zoledrex administration may reduce the incidence of acute-phase reaction symptoms.

2.2 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.

2.3 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.

2.4 Osteoporosis in Men

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

2.5 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.

2.6 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.

Re-treatment of Paget’s Disease

After a single treatment with Zoledrex in Paget’s disease an extended remission period is observed. Specific re-treatment data are not available. However, re-treatment with Zoledrex may be considered in patients who have relapsed, based on increases in serum alkaline phosphatase, or in those patients who failed to achieve normalization of their serum alkaline phosphatase, or in those patients with symptoms, as dictated by medical practice.

2.7 Laboratory Testing and

Oral Examination Prior to Administration

• Prior to administration of each dose of Zoledrex, obtain a serum creatinine and creatinine clearance should be calculated based on actual body weight using Cockcroft-Gault formula before each Zoledrex dose. Zoledrex is contraindicated in patients with creatinine clearance less than 35 mL/min and in those with evidence of acute renal impairment. A 5 mg dose of Zoledrex administered intravenously is recommended for patients with creatinine clearance greater than or equal to 35 mL/min. There are no safety or efficacy data to support the adjustment of the Zoledrex dose based on baseline renal function. Therefore, no dose adjustment is required in patients with CrCl greater than or equal to 35 mL/min.
• A routine oral examination should be performed by the prescriber prior to initiation of Zoledrex treatment.

2.8 Calcium and Vitamin D Supplementation

• Instruct patients being treated for Paget’s disease of bone on the importance of calcium and vitamin D supplementation in maintaining serum calcium levels, and on the symptoms of hypocalcemia. All patients should take 1500 mg elemental calcium daily in divided doses (750 mg two times a day, or 500 mg three times a day) and 800 international units vitamin D daily, particularly in the 2 weeks following Zoledrex administration.
• Instruct patients being treated for osteoporosis to take supplemental calcium and vitamin D if their dietary intake is inadequate. An average of at least 1200 mg calcium and 800-1000 international units vitamin D daily is recommended.

2.9 Method of Administration

The Zoledrex infusion time must not be less than 15 minutes given over a constant infusion rate.

The i.v. infusion should be followed by a 10 mL normal saline flush of the intravenous line.

Zoledrex solution for infusion must not be allowed to come in contact with any calcium or other divalent cation-containing solutions, and should be administered as a single intravenous solution through a separate vented infusion line.

If refrigerated, allow the refrigerated solution to reach room temperature before administration. After opening, the solution is stable for 24 hours at 2°C-8°C (36°F-46°F).

More about Zoledrex (Zoledrex)

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Consumer resources

• Zoledrex
• Zoledrex (Advanced Reading)

• Other brands: Zometa, Aclasta

Professional resources

• Zoledrex (FDA)
• Zoledrex (AHFS Monograph)

Related treatment guides

• Osteoporosis
• Hypercalcemia of Malignancy
• Osteolytic Bone Lesions of Multiple Myeloma
• Osteolytic Bone Metastases of Solid Tumors
• Paget's Disease
• More (1) »

What other drugs will affect Zoledrex?

Zoledrex can harm your kidneys. This effect is increased when you also use other medicines harmful to the kidneys. You may need dose adjustments or special tests if you have recently used:

• a diuretic (water pill);
• lithium (Eskalith, Lithobid);
• methotrexate (Rheumatrex, Trexall);
• pain or arthritis medicines such as aspirin (Anacin, Excedrin), acetaminophen (Tylenol), ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Arthrotec, Cambia, Cataflam, Voltaren, Flector Patch, Pennsaid, Solareze), indomethacin (Indocin), meloxicam (Mobic), and others;
• medicines used to treat ulcerative colitis, such as mesalamine (Pentasa) or sulfasalazine (Azulfidine);
• medicine used to prevent organ transplant rejection, such as cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune) or tacrolimus (Prograf);
• IV antibiotics such as amphotericin B (Amphotec, AmBisome, Abelcet), amikacin (Amikin), bacitracin (Baci IM), capreomycin (Capastat), gentamicin (Garamycin), kanamycin (Kantrex), streptomycin, or vancomycin (Vancocin, Vancoled);
• antiviral medicines such as adefovir (Hepsera), cidofovir (Vistide), or foscarnet (Foscavir); or
• cancer medicine such as aldesleukin (Proleukin), carmustine (BiCNU, Gliadel), cisplatin (Platinol), ifosfamide (Ifex), oxaliplatin (Eloxatin), streptozocin (Zanosar), or tretinoin (Vesanoid).

This list is not complete and other drugs may interact with Zoledrex. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Zoledrex interactions

No in vivo drug interaction studies have been performed for Zoledrex. In vitro and ex vivo studies showed low affinity of Zoledrex for the cellular components of human blood. In vitro mean Zoledrex protein binding in human plasma ranged from 28% at 200 ng/mL to 53% at 50 ng/mL. In vivo studies showed that Zoledrex is not metabolized, and is excreted into the urine as the intact drug.

Aminoglycosides

Caution is advised when bisphosphonates, including Zoledrex, are administered with aminoglycosides, since these agents may have an additive effect to lower serum calcium level for prolonged periods. This effect has not been reported in Zoledrex clinical trials.

Loop Diuretics

Caution should also be exercised when Zoledrex is used in combination with loop diuretics due to an increased risk of hypocalcemia.

Nephrotoxic Drugs

Caution is indicated when Zoledrex is used with other potentially nephrotoxic drugs such as nonsteroidal anti-inflammatory drugs.

Drugs Primarily Excreted By The Kidney

Renal impairment has been observed following the administration of Zoledrex in patients with pre-existing renal compromise or other risk factors. In patients with renal impairment, the exposure to concomitant medications that are primarily renally excreted (e.g., digoxin) may increase. Consider monitoring serum creatinine in patients at risk for renal impairment who are taking concomitant medications that are primarily excreted by the kidney.

References

1. DailyMed. "ZOLEDRONIC ACID: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
2. FDA/SPL Indexing Data. "70HZ18PH24: The UNique Ingredient Identifier (UNII) is an alphanumeric substance identifier from the joint FDA/USP Substance Registration System (SRS).". https://www.fda.gov/ForIndustry/Data... (accessed September 17, 2018).
3. MeSH. "Bone Density Conservation Agents". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology