Zoledronic acid

  • Clastoz Banner

For more information please contact customer care:

+98 21 42593 Download leaflet
  • For more information, please download leaflet.

    • The brand name of your medication is Clastoz® and the generic name is Zoledronic acid.
    • Clastoz® is one of members of a drug family called bisphosphonate. This product increase bones density and lower risk of bone fracture in hip and spine.
    • This medication is available in 1 vial-containing 5mg per 100 mL solution.
    • Each 1 mL of Clastoz®contains 0.05 mg of zoledronic acid.

    1 Why is Clastoz® prescribed?

    Solution of Clastoz® is used in treatment of osteoporosis in men and women after menopause, also in prevention of osteoporosis in patients taking corticosteroids. Clastoz® is used in patients with Paget’s disease (kind of bone disease). using Clastoz® has not been approved in children.

    2 How is injection solution of Clastoz® given?

    Clastoz® is usually given as an injection at your doctor's office, hospital, or clinic. This medication is injected into a vein through an IV (infusion) by healthcare providers in 15 minutes. According to physician discretion, you may also receive other medications with Clastoz® like acetaminophen.

    3 What special precautions should you follow during your treatment with Clastoz®?

    • Clastoz® can change level of Calcium or Magnesium in blood. It may be having effect on kidneys, so it is recommended to have blood and urine test before every infusion.
    • At your appointment day, drink at least 2 glass of water before infusion to prevent your body from dehydration.
    • Drink liquids a lot during Clastoz® therapy, unless told to drink less liquid by your doctor. Use No caffeine drinks (like water) and prevent taking too much tea, coffee and Nescafe.
    • If you have Multiple Myeloma or you have metastasis in your bone because of cancer, doctor prescribes you some calcium supplements in combination of Vitamin D. take these supplements daily.
    • You may feel dizziness after Clastoz® infusion, for preventing this adverse effect, don’t change your body position suddenly. Stand slowly while you are sitting or lying down.
    • Clastoz® , like any other drug, can make you stomachache. Decrease volume of portion of each main meal, increase in number of food intake, using candy or free-sugar chewing gums may help.
    • Clastoz® rarely could cause jaw bone injury. This side effect appears by pain in jaw bone, face swelling, tingling in mouth, tooth loosing
    • or gum infection. Jaw bone problem will appear in patients who take Clastoz® for long time and also in following patients:
    • o Patients who do not have good dental care.

      o Patients with dental implants or artificial teeth.

      o Patients who undertake dental interventions like (tooth extraction or dental or gum surgery) during treatment with Clastoz®

      o Patients who have an injury in jaw bone area while taking Clastoz®

      o Patients who have radiotherapy or chemotherapy while taking Clastoz®

      o Patients who take corticosteroids while taking Clastoz®

      o Patients with problems in blood (like anemia or clot formation problems)

      So, It’s recommended to have a dental visit before starting of Clastoz®. If you need any dental intervention, start it before taking the medicine. Have a good hygiene habit and taking care of teeth and gums will help to prevent side effects.

    • In patients who take Clastoz and other drug in it’s family for a long time (more than 3-5 years), they could have some fractures in leg bone. Talk to your doctor If you feel any pain in your leg.
    • Talk to your doctor immediately if you feel sever joint or muscle pain. Your doctor may stop medication in such condition.
    • If you are a woman of childbearing potential, use birth control that you can trust to stop pregnancy while taking this medication.
    • Keep a list with you of all the medicines you use (including any prescription or nonprescription medicine, herbal preparation and vitamins) and show this list to any doctor or other healthcare provider who treats you.

    4 What are some side effects that you need to call your doctor about right away?

    • Clastoz® rarely could cause severe or life threatening allergic reactions that required immediate medical intervention. So tell your doctor immediately if you have these symptoms.
    • Other symptoms are:
    • Sever belly pain
    • Severe diarrhea
    • Sever joint pain
    • Sever pain in your legs
    • Feeling Burn or tingling in your mouth.
    • Numbness or tingling in your hands or feet.
    • Having problems in urine pass

    5 What is the storage condition of ALVOPEM®?

    Store Clastoz® at 15-30°C and away from light before opening (keep in original outer carton).

  • For more information, please download leaflet.

    • Zoledronic acid, is a bisphosphonic acid which is an inhibitor of osteoclastic bone resorption.
    • Clastoz 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.

    1 INDICATIONS AND USAGE

    1.1. Treatment of Osteoporosis in Postmenopausal Women:

    Zoledronic acid 5mg/100mL, solution for infusion, is indicated for treatment of osteoporosis in postmenopausal women. In postmenopausal women with osteoporosis, diagnosed by bone mineral density (BMD) or prevalent vertebral fracture, Zoledronic acid 5mg/100mL, 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, Zoledronic acid 5mg/100mL, reduces the incidence of new clinical fractures.

    1.2. Prevention of Osteoporosis in Postmenopausal Women:

    Zoledronic acid 5mg/100mL, is indicated for prevention of osteoporosis in postmenopausal women.

    1.3. Osteoporosis in Men:

    Zoledronic acid 5mg/100mL, is indicated for treatment to increase bone mass in men with osteoporosis.

    1.4. Glucocorticoid-Induced Osteoporosis:

    Zoledronic acid 5mg/100mL, is indicated for the treatment and prevention of glucocorticoid-induced osteoporosis in men and women who are either initiating or continuing systemic glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of prednisone and who are expected to remain on glucocorticoids for at least 12 months.

    1.5. Paget’s Disease of Bone:

    Zoledronic acid 5mg/100mL, is indicated for treatment of Paget’s disease of bone in men and women. Treatment is indicated in patients with Paget’s disease of bone with elevations in serum alkaline phosphatase of two times or higher than the upper limit of the age-specific normal reference range, or those who are symptomatic, or those at risk for complications from their disease.

    1.6. Important Limitations of Use:

    The safety and effectiveness of Zoledronic acid 5mg/100mL, for the treatment of osteoporosis is based on clinical data of three years duration. The optimal duration of use has not been determined. All patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis. Patients at low-risk for fracture should be considered for drug discontinuation after 3 to 5 years of use. Patients who discontinue therapy should have their risk for fracture re-evaluated periodically.

    2 DOSAGE AND ADMINISTRATION

    • 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.

    3 METHOD OF ADMINISTRATION:

    The Zoledronic acid 5mg/100mL, 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. Zoledronic acid 5mg/100mL, 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.

    4 COMPATIBILITY:

    Incompatible with calcium or other divalent cation-containing solutions (eg, Lactated Ringer).

    5 CONTRAINDICATIONS

    Zoledronic acid 5mg/100mL, is contraindicated in patients with the following conditions:

    • Hypocalcemia· Creatinine clearance less than 35 mL/min and in those with evidence of acute renal impairment due to an increased risk of renal failure.

    • Known hypersensitivity to Zoledronic acid or any components of Zoledronic acid 5mg/100mL Solution. Hypersensitivity reactions including urticaria, angioedema, and anaphylactic reaction/shock have been reported.

    6 USE IN SPECIAL POPULATIONS

      6.1. Pregnancy:

      Pregnancy Category: D

      ZOLEDRONIC ACID 5MG/100ML, SHOULD NOT BE USED DURING PREGNANCY.

      If the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus. Women of childbearing potential should be advised to avoid becoming pregnant while receiving Zoledronic acid5mg/100mL. Animal reproduction studies resulted in embryo toxicity and losses. Zoledronic acid should not be used during pregnancy; may cause fetal harm if administered to a pregnant woman. Bisphosphonates are incorporated into the bone matrix and gradually released over time. Theoretically, there may be a risk of fetal harm when pregnancy follows the completion of therapy. Based on limited case reports with pamidronate, serum calcium levels in the newborn may be altered if administered during pregnancy.

      6.2. NURSING MOTHERS:

      It is not known whether Zoledronic acid is excreted in human milk. Because many drugs are excreted in human milk, and because Zoledronic acid binds to bone long-term, Zoledronic acid 5mg/100mL, should not be administered to a nursing woman.

SIMILAR PRODUCTS