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zoledronic acid

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Overview

What is Reclast?

Reclast contains zoledronic acid, a bisphosphonic acid which is an inhibitor of osteoclastic bone resorption. Zoledronic acid is designated chemically as (1-Hydroxy-2-imidazol-1-yl-phosphonoethyl) phosphonic acid monohydrate and its structural formula is:

Zoledronic acid monohydrate is a white crystalline powder. Its molecular formula is CHNOP • HO and a molar mass of 290.1 g/Mol. Zoledronic acid monohydrate is highly soluble in 0.1N sodium hydroxide solution, sparingly soluble in water and 0.1N hydrochloric acid, and practically insoluble in organic solvents. The pH of the Reclast solution for infusion is approximately 6.0 – 7.0.

Reclast Injection is available as a sterile solution in bottles for intravenous infusion. One bottle with 100 mL solution contains 5.330 mg of zoledronic acid monohydrate, equivalent to 5 mg zoledronic acid on an anhydrous basis.

Inactive Ingredients



What does Reclast look like?



What are the available doses of Reclast?

5 mg in a 100 mL ready-to-infuse solution ()

What should I talk to my health care provider before I take Reclast?

Nursing Mothers: Reclast should not be given to nursing women ()

Pediatric Use: Not indicated for use in pediatric patients ()

Geriatric Use: Special care to monitor renal function ()

How should I use Reclast?

Reclast is indicated for treatment of osteoporosis in postmenopausal women. In postmenopausal women with osteoporosis, diagnosed by bone mineral density (BMD) or prevalent vertebral fracture, Reclast reduces the incidence of fractures (hip, vertebral and non-vertebral osteoporosis-related fractures). In patients at high risk of fracture, defined as a recent low-trauma hip fracture, Reclast reduces the incidence of new clinical fractures [].

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


What interacts with Reclast?

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What are the warnings of Reclast?

Sorry No Records found


What are the precautions of Reclast?

Sorry No Records found


What are the side effects of Reclast?

Sorry No records found


What should I look out for while using Reclast?

Reclast is contraindicated in patients with the following conditions:


What might happen if I take too much Reclast?

Clinical experience with acute overdosage of zoledronic acid (Reclast) solution for intravenous infusion is limited. Patients who have received doses higher than those recommended should be carefully monitored. Overdosage may cause clinically significant renal impairment, hypocalcemia, hypophosphatemia, and hypomagnesemia. 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.

Single doses of Reclast should not exceed 5 mg and the duration of the intravenous infusion should be no less than 15 minutes []. 


How should I store and handle Reclast?

Store at 20° to 25° C (68° to 77° F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Store at 20° to 25° C (68° to 77° F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Each bottle contains 5 mg per 100 mL. NDC 0078-0435-61HandlingAfter opening the solution, it is stable for 24 hours at 2°C–8°C (36°F-46°F). If refrigerated, allow the refrigerated solution to reach room temperature before administration.StorageStore at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature].Each bottle contains 5 mg per 100 mL. NDC 0078-0435-61HandlingAfter opening the solution, it is stable for 24 hours at 2°C–8°C (36°F-46°F). If refrigerated, allow the refrigerated solution to reach room temperature before administration.StorageStore at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature].Each bottle contains 5 mg per 100 mL. NDC 0078-0435-61HandlingAfter opening the solution, it is stable for 24 hours at 2°C–8°C (36°F-46°F). If refrigerated, allow the refrigerated solution to reach room temperature before administration.StorageStore at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature].Each bottle contains 5 mg per 100 mL. NDC 0078-0435-61HandlingAfter opening the solution, it is stable for 24 hours at 2°C–8°C (36°F-46°F). If refrigerated, allow the refrigerated solution to reach room temperature before administration.StorageStore at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature].Each bottle contains 5 mg per 100 mL. NDC 0078-0435-61HandlingAfter opening the solution, it is stable for 24 hours at 2°C–8°C (36°F-46°F). If refrigerated, allow the refrigerated solution to reach room temperature before administration.StorageStore at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature].Each bottle contains 5 mg per 100 mL. NDC 0078-0435-61HandlingAfter opening the solution, it is stable for 24 hours at 2°C–8°C (36°F-46°F). If refrigerated, allow the refrigerated solution to reach room temperature before administration.StorageStore at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature].


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Reclast is a bisphosphonate and acts primarily on bone. It is an inhibitor of osteoclast-mediated bone resorption.

The selective action of bisphosphonates on bone is based on their high affinity for mineralized bone. Intravenously administered zoledronic acid rapidly partitions to bone and localizes preferentially at sites of high bone turnover. 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.

Non-Clinical Toxicology
Reclast is contraindicated in patients with the following conditions:

In controlled trials, terazosin has been added to diuretics, and several beta-adrenergic blockers; no unexpected interactions were observed. Terazosin has also been used in patients on a variety of concomitant therapies; while these were not formal interaction studies, no interactions were observed. Terazosin has been used concomitantly in at least 50 patients on the following drugs or drug classes: 1) analgesic/anti-inflammatory (e.g., acetaminophen, aspirin, codeine, ibuprofen, indomethacin); 2) antibiotics (e.g., erythromycin, trimethoprim and sulfamethoxazole); 3) anticholinergic/sympathomimetics (e.g., phenylephrine hydrochloride, phenylpropanolamine hydrochloride, pseudoephedrine hydrochloride); 4) antigout (e.g., allopurinol); 5) antihistamines (e.g., chlorpheniramine); 6) cardiovascular agents (e.g., atenolol, hydrochlorothiazide, methyclothiazide, propranolol); 7) corticosteroids; 8) gastrointestinal agents (e.g., antacids); 9) hypoglycemics; 10) sedatives and tranquilizers (e.g., diazepam).

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.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Interactions

Interactions

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