ZOLTONAR
(Zoledronic acid)




COMPOSITION

1 vial of the solution contains:

Active substance: zoledronic acid (as zoledronic acid monohydrate) 5 mg.

Excipients: mannitol, sodium citrate, water for injections.

THERAPEUTIC INDICATIONS

- treatment of osteoporosis in postmenopausal women (to reduce the risk of femoral fractures, vertebral fractures and extraspinal fractures, to increase bone mineral density);

- prevention of osteoporosis in postmenopausal women;

- osteoporosis in men;

- prevention and treatment of osteoporosis, caused by the use of glucocorticosteroids;

- Paget’s disease.

CONTRAINDICATIONS

- hypersensitivity to the components of the drug or to other bisphosphonates;

- severe renal impairment with creatinine clearance less than 35 ml/min;

- hypocalcemia;

- pregnancy and lactation.

ADVERSE EFFECTS

Cardiovascular system: sometimes –increase of arterial pressure.

Hematopoietic system: sometimes - anemia.

Peripheral nervous system and CNS: often – headache, dizziness; rarely – lethargy.

Visual organ: sometimes - conjunctivitis; rarely – uveitis, episcleritis.

Respiratory system: sometimes - dyspnea.

Digestive system: often - nausea, diarrhea; sometimes - constipation, abdominal pain, dyspepsia.

Dermatological reactions: sometimes – rash, itching, erythema.

Musculoskeletal system: often – extremities pain, myalgia, arthralgia, bone pain; sometimes – shoulder pain, musculoskeletal pain.

Urinary system: sometimes – renal dysfunction.

Laboratory tests: very often - hypophosphatemia; sometimes - hypomagnesemia, hypokalemia.

General disorders and local reactions: very often – pyrexia; often – chill, flu-like symptoms fatigability, asthenia, illness, reaction at the injection site (pain, irritation, edema, infiltrate formation).

DOSAGE AND ADMINISTRATION

Zoltonar administered intravenously as an infusion. Infusion must last not less than 15 minutes.

In treatment of osteoporosis in postmenopausal women, osteoporosis in men, prevention and treatment of osteoporosis, caused by the use of glucocorticosteroids, the recommended dose of preparation is 5 mg intravenously once yearly. Patients must receive supplemental calcium and vitamin D. Such patients required an average 1200 mg of calcium daily and 800-1000 IU of vitamin D daily.

In prevention of osteoporosis in postmenopausal women: recommended dose is 5 mg intravenously once every 2 years. Patients must receive supplemental calcium and vitamin D. Postmenopausal women require 1200 mg of calcium daily and 800-1000 IU of vitamin D daily.

In Paget’s disease recommended dose of preparation is 5 mg intravenously. To reduce the risk for hypocalcemia, patients should receive 1500 mg of calcium daily and 800 IU of vitamin D daily for at least 2 weeks following Zoltonar administration. Retreatment with Zoltonar may be considered after one or more years after first dose of drug if relapse occurs based on serum alkaline phosphatase level assessment, increase its level, as well as clinical response to therapy.

Dose regimen correction for renal impairment patients with creatinine clearance of ≥ 35 ml/min is not required.

Dose regimen correction for hepatic impairment patients is not required.

Dose regimen correction for geriatric (65 years of age or older) patients is not required, since bioavailability, distribution and elimination of zoledronic acid are similar in older and younger patients.

The dose of the drug in case of a single intravenous infusion must not exceed 5 mg.

Rules for administration of solution for infusion

Preparation should be used immediately after opening of vial. The solution which has not been used immediately can be stored in the refrigerator at 2°С-8°С and use during 24 hours. Before infusion keep the solution indoors until it reaches room temperature.

Zoltonar should not be mixed with any other drugs. Zoltonar must be administered intravenously in a separate infusion system with stable rate of infusion. After administration injection of 10 ml of saline solution is recommended.

DRUG INTERACTIONS

Zoledronic acid does not essentially bind to plasma proteins and does not inhibit cytochrome P450 system enzymes.

Exercise caution in case of concomitant use of bisphosphonates and aminoglycosides, as parallel action of these drugs manifests itself in increase of plasma calcium decrease prolongation.

Exercise caution in parallel administration of Zoltonar and drugs with potential nephrotoxic action.

Concomitant prescription of zoledronic acid and loop diuretics increases risk of hypocalcemia development.

In patients with impaired renal function concomitant administration Zoltonar and drugs that eliminate primarily by the kidneys, may increase the systemic effects of these drugs.

SPECIAL INDICATIONS

Patients under treatment with zoledronic acid must undergo monitoring of hemoglobin level and hematocrit, as well as serum calcium, phosphor, and magnesium levels.

Before Zoltonar administration should be treated disorders of mineral metabolism (occurring after operations on the thyroid and parathyroid glands, in hypoparathyroidism or decrease of calcium intestinal absorption) and ensure regular monitoring of patients with hypocalcaemia.

Creatinine clearance in patients must be evaluated before each infusion of the drug.

The drug should be prescribed with caution in patients with medical history of mild and moderate renal impairment, severe dehydration, and aspirin-induced bronchial asthma.

Adequate hydration of the organism must be ensured before infusion of zoledronic acid, which especially important for patients undergoing therapy with diuretics. Avoid hyperhydration in patients with risk of heart failure development.

Before prescription of bisphosphonates patients should undergo stomatological examination and perform corresponding preventive procedures, and be recommended to closely observe the rules of oral hygiene. During treatment the patients should possibly avoid stomatological operations.

The drugs Zoltasta concentrate for preparation of solution for infusion and Zoltonar solution for infusion are not interchangeable and should not be administered concomitantly.

PREGNANCY AND LACTATION

The drug is contraindicated in pregnancy and lactation.

MANUFACTURED FORM AND PACKAGE

Solution for intravenous infusion in a 100 ml colourless glass vial siliconized inside, with a bromobutyl rubber stopper covered with PTFE underneath, and a combined aluminum Flip off cap.

1 vial together with a leaflet in a carton box.

Alimentary Tract and Metabolism

All Products
Choludexan
Cocarnit
Coledan
D-Calcin
Dialin
Doprokin
Doprokin-S
Duskonal
Emfetal
Gold Ray
Kercavit
Lacidofil
Listora
Medulac
Metacartin
Panivit
Polijen
Reytoil
Silarsil
Simalgel
Sunovit
Ulsepan
Yodofol

Home      |      Site Map      |      Terms of Use      |      Privacy Policy

2015 WORLD MEDICINE. All Rights Reserved.