Index of drugs

Treatment of bone metastases (with predominance of lytic processes), multiple myeloma, hypercalcaemia in the course of cancer, Paget's disease of the bones.

One vial contains 60 mg or 90 mg of sterile lyophilized disodium pamidronate.

A strong inhibitor of osteoclast bone resorption.In vitro binds strongly to hydroxyapatite crystals and inhibits both the formation and dissolution of these crystals. Inhibition of osteoclast bone resorptionin vivo it may be at least partly dependent on the binding of the preparation to the mineral components of the bone tissue. Pamidronate inhibits the access of osteoclast precursors to the bone and prevents them from converting into mature osteoclasts. The main mode of action of the preparationin vitro andin vivo it depends on local and direct inhibition of resorption by bone-bound bisphosphonates. T_0,5 is about 0.8 h. The drug is probably not metabolised. After intravenous infusion, approximately 20-55% of the dose is excreted in the urine within 72 hours in unchanged form. The remaining part of the dose is retained in the body - due to the strong affinity of the drug for calcified tissues it is believed that they are the site of "visualization of elimination". The elimination of the drug in the urine takes place in two stages with apparent half-lives of 1.6 and 27 hours, respectively.

Hypersensitivity to pamidronate, other bisphosphonates or any of the excipients. Pregnancy and breastfeeding.

Do not use in patients with severe renal impairment (creatinine clearance <30 ml / min), except in cases of life-threatening hypercalcaemia in the course of cancer, when the potential benefits of treatment outweigh the risk of kidney damage. There are no data on the use of pamidronate in patients with severe hepatic impairment and in children. In patients with impaired cardiac function, especially in the elderly, additional salt supply may cause heart failure; fever (flu-like symptoms) may also cause the deterioration of these patients. Patients who have undergone thyroid surgery may be particularly susceptible to developing hypocalcemia caused by relative hypoparathyroidism.

Do not use during pregnancy and breast-feeding.

Very common: hypocalcaemia, hypophosphatemia, fever and flu-like symptoms, sometimes with malaise, chills, tiredness and sudden redness of the face. Common: anemia, thrombocytopenia, lymphocytopenia, symptomatic hypocalcemia (paresthesia, tetany), headache, insomnia, drowsiness, conjunctivitis, hypertension, nausea, vomiting, lack of appetite, abdominal pain, diarrhea, constipation, gastritis, rash, transient bone pain, arthralgia, muscle pain, generalized pain, reactions at the injection site (pain, redness, swelling, induration, phlebitis, thrombophlebitis), hypokalaemia, hypomagnesaemia, increased blood creatinine. Uncommon: allergic reactions including anaphylactoid reactions, bronchospasm / shortness of breath, Quincke's swelling (vasomotor), seizures, agitation, dizziness, lethargy, uveitis (iritis, iritis and iridocyclitis), hypotension, indigestion, pruritus, muscle cramps, acute renal failure, abnormal liver function tests, increased blood urea. Rare: focal segment glomerulosclerosis together with insufficiency, nephrotic syndrome. Very rare: virus makingHerpes simplex andHerpes zoster, leukopenia, anaphylactic shock, confusion, hallucinations, scleritis, episcleritis, vision of yellow color, left ventricular failure (shortness of breath, pulmonary edema), congestive heart failure (edema) due to fluid overload, worsening of existing kidney diseases, hematuria, hyperkalemia, hypernatremia. Atrial fibrillation was also observed.In the post-marketing period, osteonecrosis of the jaw was reported uncommonly - primarily in patients diagnosed with cancer, receiving chemotherapy and corticosteroids, signs of local infection (including osteomyelitis), tooth extraction or other dental procedures. Uncommon cases of severe bone, joint or muscle pain have been reported, which very rarely causes disability; in the majority of patients, these symptoms decreased after the end of treatment; some patients had recurrence of symptoms after restarting treatment with the same drug or other bisphosphate. There have been reports of very rare cases of orbital inflammation.

Intravenously. Adults (including elderly patients).Metastatic bone metastases (with predominance of lytic processes), multiple myeloma: 90 mg in a single infusion given every 4 weeks. In patients with bone metastases undergoing chemotherapy at 3-week intervals, the drug can be used in a dose of 90 mg every 3 weeks.Hypercalcemia in the course of cancer: depending on the Calcium concentration before treatment - calcium concentration up to 3 mmol / l - the recommended total dose of disodium pamidronate is 15-30 mg; 3.0-3.5 mmol / L - 30-60 mg; 3.5-4.0 mmol / L - 60-90 mg; > 4.0 mmol / l - 90 mg. The total dose can be given in one infusion as well as several infusions over 2-4 consecutive days. The maximum dose for a full course of treatment is 90 mg. This applies to both the first course of treatment and the Next courses of administration. If calcium levels are not normalized within 3-7 days after administration, further doses may be given. Patients should be hydrated with saline before or during treatment.Paget's disease of bones180-210 mg for one treatment cycle. It can be given as 6 single doses of 30 mg once a week or 3 individual doses of 60 mg every other week. If you use a single 60 mg dose, it is recommended to start treatment with an initial dose of 30 mg (the total dose is then 210 mg). Treatment can be repeated after 6 months and used until the remission of the disease and in case of recurrence of the disease.Impaired renal function. In patients with bone metastases or multiple myeloma who experience deterioration of renal function, treatment should be discontinued until renal function returns to approximately 10% of the normal value. No dosage adjustment is necessary for mild to moderate renal impairment (creatinine clearance ≥30 ml / min); infusion rate should not exceed 90 mg in 4 hours.Hepatic dysfunction. No dose adjustment is necessary in patients with moderate to moderate hepatic impairment.
The drug should be administered in a slow infusion, after dissolving the lyophilisate in an infusion fluid containing no calcium ions (eg 0.9% NaCl solution or 5% Glucose solution). The infusion rate should not exceed 60 mg / h (1 mg / min) and the concentration of pamidronate in the infusion fluid should not exceed 90 mg / 250 ml. The 90 mg dose should be given in 250 ml infusion fluid for 2 hours. However, in patients with multiple myeloma and in patients with hypercalcaemia in the course of neoplastic disease, a dose of more than 90 mg in 500 ml infusion is not recommended for infusion. 4 h. The drug should not be administered as a single, rapid injection.