Pamidronate Disodium

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Overview

What is Pamidronate Disodium?

Pamidronate Disodium Injection is a bone resorption inhibitor available in 30 mg and 90 mg sterile vials for intravenous administration.

Each mL of the 30 mg vials contains 3 mg of pamidronate disodium; 47 mg of mannitol USP and water for injection q.s.; phosphoric acid and/or sodium hydroxide have been added to adjust pH 6 to 7.

Each mL of the 90 mg vials contains 9 mg of pamidronate disodium; 37.5 mg of mannitol USP and water for injection q.s.; phosphoric acid and/or sodium hydroxide have been added to adjust pH 6 to 7.

The pH of a 1% solution of pamidronate disodium in distilled water is approximately 8.3. Pamidronate disodium, a member of the group of chemical compounds known as bisphosphonates, is an analog of pyrophosphate. Pamidronate disodium is designated chemically as disodium dihydrogen (3-amino-1-hydroxypropylidene) diphosphonate, and its structural formula is:

Pamidronate disodium is a white-to-practically-white powder. It is soluble in water and in 2N sodium hydroxide, sparingly soluble in 0.1N hydrochloric acid and in 0.1N acetic acid, and practically insoluble in organic solvents. Its molecular formula is CHNOPNaand its molecular weight is 279.1.

What does Pamidronate Disodium look like?

What are the available doses of Pamidronate Disodium?

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

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How should I use Pamidronate Disodium?

Pamidronate disodium in conjunction with adequate hydration, is indicated for the treatment of moderate or severe hypercalcemia associated with malignancy, with or without bone metastases. Patients who have either epidermoid or non-epidermoid tumors respond to treatment with pamidronate disodium. Vigorous saline hydration, an integral part of hypercalcemia therapy, should be initiated promptly and an attempt should be made to restore the urine output to about 2 L/day throughout treatment. Mild or asymptomatic hypercalcemia may be treated with conservative measures (i.e., saline hydration, with or without loop diuretics). Patients should be hydrated adequately throughout the treatment, but overhydration, especially in those patients who have cardiac failure, must be avoided. Diuretic therapy should not be employed prior to correction of hypovolemia. The safety and efficacy of pamidronate disodium in the treatment of hypercalcemia associated with hyperparathyroidism or with other non-tumor-related conditions has not been established.

Consideration should be given to the severity of as well as the symptoms of hypercalcemia. Vigorous saline hydration alone may be sufficient for treating mild, asymptomatic hypercalcemia. Overhydration should be avoided in patients who have potential for cardiac failure. In hypercalcemia associated with hematologic malignancies, the use of glucocorticoid therapy may be helpful.

What interacts with Pamidronate Disodium?

Pamidronate disodium is contraindicated in patients with clinically significant hypersensitivity to pamidronate disodium or other bisphosphonates.

What are the warnings of Pamidronate Disodium?

Codeine or other narcotics may obscure signs on which to judge the diagnosis or clinical course of patients with acute abdominal conditions.

Deterioration in Renal Function

Bisphosphonates, including pamidronate disodium, have been associated with renal toxicity manifested as deterioration of renal function and potential renal failure.

Focal segmental glomerulosclerosis (including the collapsing variant) with or without nephrotic syndrome, which may lead to renal failure, has been reported in pamidronate disodium-treated patients, particularly in the setting of multiple myeloma and breast cancer. Some of these patients had gradual improvement in renal status after pamidronate disodium was discontinued.

Patients who receive pamidronate disodium should have serum creatinine assessed prior to each treatment. Patients treated with pamidronate disodium for bone metastases should have the dose withheld if renal function has deteriorated (see

PREGNANCY: PAMIDRONATE DISODIUM SHOULD NOT BE USED DURING PREGNANCY

Pamidronate disodium may cause fetal harm when administered to a pregnant woman (see , .)

There are no studies in pregnant women using pamidronate disodium. 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.

Studies conducted in young rats have reported the disruption of dental dentine formation following single- and multi-dose administration of bisphosphonates. The clinical significance of these findings is unknown.

What are the precautions of Pamidronate Disodium?

General Precautions

Standard hypercalcemia-related metabolic parameters, such as serum levels of calcium, phosphate, magnesium, and potassium, should be carefully monitored following initiation of therapy with pamidronate disodium. Cases of asymptomatic hypophosphatemia (12%), hypokalemia (7%), hypomagnesemia (11%), and hypocalcemia (5% to 12%), were reported in pamidronate disodium-treated patients. Rare cases of symptomatic hypocalcemia (including tetany) have been reported in association with pamidronate disodium therapy. If hypocalcemia occurs, short-term calcium therapy may be necessary. In Paget’s disease of bone, 17% of patients treated with 90 mg of pamidronate disodium showed serum calcium levels below 8 mg/dL.

Patients with a history of thyroid surgery may have relative hypoparathyroidism that may predispose to hypocalcemia with pamidronate disodium.

Renal Insufficiency

Pamidronate disodium is excreted intact primarily via the kidney, and the risk of renal adverse reactions may be greater in patients with impaired renal function. Patients who receive pamidronate disodium should have serum creatinine assessed prior to each treatment. In patients receiving pamidronate disodium for bone metastases, who show evidence of deterioration in renal function, pamidronate disodium treatment should be withheld until renal function returns to baseline (see and

In clinical trials, patients with renal impairment (serum creatinine >3 mg/dL) have not been studied. Limited pharmacokinetic data exist in patients with creatinine clearance <30 mL/min (see .)

Osteonecrosis of the Jaw

Osteonecrosis of the jaw (ONJ) has been reported predominantly in cancer patients with intravenous bisphosphonates, including pamidronate sodium. Many of these patients were also receiving chemotherapy and corticosteroids which may be risk factors of ONJ. Postmarketing experience and the literature suggest a greater frequency of reports of ONJ based on tumor type (advanced breast cancer, multiple myeloma), and dental status (dental extraction, periodontal disease, local trauma including poorly fitting dentures). Many reports of ONJ involved patients with signs of local infection including osteomyelitis.

Cancer patients should maintain good oral hygiene and should have a dental examination with preventive dentistry prior to treatment with bisphosphonates.

While on treatment, these patients should avoid invasive dental procedures if possible. For patients who develop ONJ while on bisphosphonate therapy, dental surgery may exacerbate the condition. For patients requiring dental procedures, there are no data available to suggest whether discontinuation of bisphosphonate treatment reduces the risk of ONJ. Clinical judgment of the treating physician should guide the management plan of each patient based on individual benefit/risk assessment (see ).

Musculoskeletal Pain

In post marketing experience, severe and occasionally incapacitating bone, joint, and/or muscle pain has been reported in patients taking bisphosphonates. However, such reports have been infrequent. This category of drugs includes pamidronate disodium. The time to onset of symptoms varied from one day to several months after starting the drug. Most patients had relief of symptoms after stopping. A subset had recurrence of symptoms when rechallenged with the same drug or another bisphosphonate.

Laboratory Tests

Patients who receive pamidronate disodium should have serum creatinine assessed prior to each treatment. Serum calcium, electrolytes, phosphate, magnesium, and CBC, differential, and hematocrit/hemoglobin must be closely monitored in patients treated with pamidronate disodium. Patients who have preexisting anemia, leukopenia, or thrombocytopenia should be monitored carefully in the first 2 weeks following treatment.

What are the side effects of Pamidronate Disodium?

Clinical Studies

Transient mild elevation of temperature by at least 1°C was noted 24 to 48 hours after administration of pamidronate disodium in 34% of patients in clinical trials. In the saline trial, 18% of patients had a temperature elevation of at least 1°C 24 to 48 hours after treatment.

Drug-related local soft-tissue symptoms (redness, swelling or induration and pain on palpation) at the site of catheter insertion were most common in patients treated with 90 mg of pamidronate disodium. Symptomatic treatment resulted in rapid resolution in all patients.

Rare cases of uveitis, iritis, scleritis, and episcleritis have been reported, including one case of scleritis, and one case of uveitis upon separate rechallenges.

Five of 231 patients (2%) who received pamidronate disodium during the four U.S. controlled hypercalcemia clinical studies were reported to have had seizures, 2 of whom had preexisting seizure disorders. None of the seizures were considered to be drug-related by the investigators. However, a possible relationship between the drug and the occurrence of seizures cannot be ruled out. It should be noted that in the saline arm 1 patient (4%) had a seizure.

There are no controlled clinical trials comparing the efficacy and safety of 90 mg pamidronate disodium over 24 hours to 2 hours in patients with hypercalcemia of malignancy. However, a comparison of data from separate clinical trials suggests that the overall safety profile in patients who received 90 mg pamidronate disodium over 24 hours is similar to those who received 90 mg pamidronate disodium over 2 hours. The only notable differences observed were an increase in the proportion of patients in the pamidronate disodium 24 hour group who experienced fluid overload and electrolyte/mineral abnormalities.

At least 15% of patients treated with pamidronate disodium for hypercalcemia of malignancy also experienced the following adverse events during a clinical trial:

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Many of these adverse experiences may have been related to the underlying disease state.

The following table lists the adverse experiences considered to be treatment-related during comparative, controlled U.S. trials.

**Treatment-Related Adverse Experiences Reported in Three U.S. Controlled Clinical Trials**
	Pamidronate Disodium	Etidronate Disodium	Saline
	60 mg over 4 hr	60 mg over 24 hr	90 mg over 24 hr	7.5 mg/kg x 3 days
	n=23	n=73	n=17	n=35	n=23
General
Edema	0	1	0	0	0
Fatigue	0	0	12	0	0
Fever	26	19	18	9	0
Fluid overload	0	0	0	6	0
Infusion-site reaction	0	4	18	0	0
Moniliasis	0	0	6	0	0
Rigors	0	0	0	0	4
Gastrointestinal
Abdominal pain	0	1	0	0	0
Anorexia	4	1	12	0	0
Constipation	4	0	6	3	0
Diarrhea	0	1	0	0	0
Dyspepsia	4	0	0	0	0
Gastrointestinal hemorrhage	0	0	6	0	0
Nausea	4	0	18	6	0
Stomatitis	0	1	0	3	0
Vomiting	4	0	0	0	0
Respiratory
Dyspnea	0	0	0	3	0
Rales	0	0	6	0	0
Rhinitis	0	0	6	0	0
Upper respiratory infection	0	3	0	0	0
CNS
Anxiety	0	0	0	0	4
Convulsions	0	0	0	3	0
Insomnia	0	1	0	0	0
Nervousness	0	0	0	0	4
Psychosis	4	0	0	0	0
Somnolence	0	1	6	0	0
Taste perversion	0	0	0	3	0
Cardiovascular
Atrial fibrillation	0	0	6	0	4
Atrial flutter	0	1	0	0	0
Cardiac failure	0	1	0	0	0
Hypertension	0	0	6	0	4
Syncope	0	0	6	0	0
Tachycardia	0	0	6	0	4
Endocrine
Hypothyroidism	0	0	6	0	0
Hemic and Lymphatic
Anemia	0	0	6	0	0
Leukopenia	4	0	0	0	0
Neutropenia	0	1	0	0	0
Thrombocytopenia	0	1	0	0	0
Musculoskeletal
Myalgia	0	1	0	0	0
Urogenital
Uremia	4	0	0	0	0
Laboratory Abnormalities
Hypocalcemia	0	1	12	0	0
Hypokalemia	4	4	18	0	0
Hypomagnesemia	4	10	12	3	4
Hypophosphatemia	0	9	18	3	0
Abnormal liver function	0	0	0	3	0

Transient mild elevation of temperature >1°C above pretreatment baseline was noted within 48 hours after completion of treatment in 21% of the patients treated with 90 mg of pamidronate disodium in clinical trials.

Drug-related musculoskeletal pain and nervous system symptoms (dizziness, headache, paresthesia, increased sweating) were more common in patients with Paget’s disease treated with 90 mg of pamidronate disodium than in patients with hypercalcemia of malignancy treated with the same dose. Adverse experiences considered to be related to trial drug, which occurred in at least 5% of patients with Paget’s disease treated with 90 mg of pamidronate disodium in two U.S. clinical trials, were fever, nausea, back pain, and bone pain.

At least 10% of all pamidronate disodium-treated patients with Paget’s disease also experienced the following adverse experiences during clinical trials:

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Most of these adverse experiences may have been related to the underlying disease state.

The most commonly reported (>15%) adverse experiences occurred with similar frequencies in the pamidronate disodium and placebo treatment groups, and most of these adverse experiences may have been related to the underlying disease state or cancer therapy.

Of the toxicities commonly associated with chemotherapy, the frequency of vomiting, anorexia, and anemia were slightly more common in the pamidronate disodium patients whereas stomatitis and alopecia occurred at a frequency similar to that in placebo patients. In the breast cancer trials, mild elevations of serum creatinine occurred in 18.5% of pamidronate disodium patients and 12.3% of placebo patients. Mineral and electrolyte disturbances, including hypocalcemia, were reported rarely and in similar percentages of pamidronate disodium-treated patients compared with those in the placebo group. The reported frequencies of hypocalcemia, hypokalemia, hypophophatemia, and hypomagnesemia for pamidronate disodium-treated patients were 3.3%,10.5%,1.7%, and 4.4%, respectively, and for placebo-treated patients were 1.2%,12%,1.7%, and 4.5%, respectively In previous hypercalcemia of malignancy trials, patients treated with pamidronate disodium (60 or 90 mg over24 hours) developed electrolyte abnormalities more frequently (see ).

Arthralgias and myalgias were reported slightly more frequently in the pamidronate disodium group than in the placebo group (13.6% and 26% vs 10.8% and 20.1%, respectively).

In multiple myeloma patients, there were five pamidronate disodium-related serious and unexpected adverse experiences. Four of these were reported during the 12 month extension of the multiple myeloma trial. Three of the reports were of worsening renal function developing in patients with progressive multiple myeloma or multiple myeloma-associated amyloidosis. The fourth report was the adult respiratory distress syndrome developing in a patient recovering from pneumonia and acute gangrenous cholecystitis. One pamidronate disodium-treated patient experienced an allergic reaction characterized by swollen and itchy eyes, runny nose, and scratchy throat within 24 hours after the sixth infusion.

In the breast cancer trials, there were four pamidronate disodium-related adverse experiences, all moderate in severity, that caused a patient to discontinue participation in the trial. One was due to interstitial pneumonitis, another to malaise and dyspnea. One pamidronate disodium patient discontinued the trial due to a symptomatic hypocalcemia. Another pamidronate disodium patient discontinued therapy due to severe bone pain after each infusion, which the investigator felt was trial-drug-related.

**Commonly Reported Adverse Experiences in Three U.S. Controlled Clinical Trials**

General
Asthenia	16.1	17.1	25.6	19.2	22.2	18.5
Fatigue	31.7	28.3	40.3	28.8	37.2	29
Fever	38.5	38	38.1	32.1	38.5	34
Metastases	1	3	31.3	24.4	20.5	17.5
Pain	13.2	11.8	15	18.1	14.3	16.1
Digestive System
Anorexia	17.1	17.1	31.1	24.9	26	22.3
Constipation	28.3	31.7	36	38.6	33.2	35.1
Diarrhea	26.8	26.8	29.4	30.6	28.5	29.7
Dyspepsia	17.6	13.4	18.3	15	22.6	17.5
Nausea	35.6	37.4	63.5	59.1	53.5	51.8
Pain Abdominal	19.5	16	24.3	18.1	22.6	17.5
Vomiting	16.6	19.8	46.3	39.1	35.7	32.8
Hemic and Lymphatic
Anemia	47.8	41.7	39.5	36.8	42.5	38.4
Granulocytopenia	20.5	15.5	19.3	20.5	19.8	18.8
Thrombocytopenia	16.6	17.1	12.5	14	14	15
Musculoskeletal System
Arthralgias	10.7	7	15.3	12.7	13.6	10.8
Myalgia	25.4	15	26.4	22.5	26	20.1
Skeletal Pain	61	71.7	70	75.4	66.8	74
CNS
Anxiety	7.8	9.1	18	16.8	14.3	14.3
Headache	24.4	19.8	27.2	23.6	26.2	22.3
Insomnia	17.1	17.2	25.1	19.4	22.2	19
Respiratory System
Coughing	26.3	22.5	25.3	19.7	25.7	20.6
Dyspnea	22	21.4	35.1	24.4	30.4	23.4
Pleural Effusion	2.9	4.3	15	9.1	10.7	7.5
Sinusitis	14.6	16.6	16.1	10.4	15.6	12
Upper Respiratory Tract Infection	32.2	28.3	19.6	20.2	24.1	22.9
Urogenital System
Urinary Tract Infection	15.6	9.1	20.2	17.6	18.5	15.6

Renal Toxicity

In a study of the safety and efficacy of pamidronate disodium 90 mg (2 hour infusion) versus Zometa 4 mg (15 minute infusion) in bone metastases patients with multipe myeloma or breast cancer, renal deterioration was defined as an increase in serum creatinine of 0.5 mg/dL for patients with normal baseline creatinine (<1.4 mg/dL) or an increase of 1 mg/dL for patients with an abnormal baseline creatinine (≥1.4 mg/dL). The following are data on the incidence of renal deterioration in patients in this trial. See Table below.

Incidence of Renal Function Deterioration in Multiple Myeloma and Breast Cancer Patients with Normal and Abnormal Serum Creatinine at Baseline*
Patient Population/Baseline Creatinine	Pamidronate Disodium 90 mg/2 hours	Zometa 4 mg/15 minutes
	n/N	(%)	n/N	(%)
Normal	20/246	(8.1%)	23/246	(9.3%)
Abnormal	2/22	(9.1%)	1/26	(3.8%)
Total	22/268	82%	24/272	(8.8%)

Post-Marketing Experience

The following adverse reactions have been reported in post-marketing use:

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CNS:

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Skin:

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Special senses:

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Renal:

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Laboratory abnormalities:

Rare instances of allergic manifestations have been reported, including hypotension, dyspnea, or angioedema, and very rarely, anaphylactic shock. Pamidronate disodium is contraindicated in patients with clinically significant hypersensitivity pamidronate disodium or other bisphosphonates (see ).

Cases of osteonecrosis (primarily involving the jaw) have been reported predominantly in cancer patients treated with intravenous bisphosphonates, including pamidronate disodium. Many of these patients were also receiving chemotherapy and corticosteroids which may be risk factors for ONJ. Data suggest a greater frequency of reports of ONJ in certain cancers, such as advanced breast cancer and multiple myeloma. The majority of the reported cases are in cancer patients following invasive dental procedures, such as tooth extraction. It is therefore prudent to avoid invasive dental procedures as recovery may be prolonged (see .)

What should I look out for while using Pamidronate Disodium?

Pamidronate disodium is contraindicated in patients with clinically significant hypersensitivity to pamidronate disodium or other bisphosphonates.

Deterioration in Renal Function

Bisphosphonates, including pamidronate disodium, have been associated with renal toxicity manifested as deterioration of renal function and potential renal failure.

DUE TO THE RISK OF CLINICALLY SIGNIFICANT DETERIORATION IN RENAL FUNCTION, WHICH MAY PROGRESS TO RENAL FAILURE, SINGLE DOSES OF PAMIDRONATE DISODIUM SHOULD NOT EXCEED 90 MG (see

for appropriate infusion durations). Renal deterioration, progression to renal failure, and dialysis have been reported in patients after the initial or a single dose of pamidronate disodium.

Focal segmental glomerulosclerosis (including the collapsing variant) with or without nephrotic syndrome, which may lead to renal failure, has been reported in pamidronate disodium-treated patients, particularly in the setting of multiple myeloma and breast cancer. Some of these patients had gradual improvement in renal status after pamidronate disodium was discontinued.

Patients who receive pamidronate disodium should have serum creatinine assessed prior to each treatment. Patients treated with pamidronate disodium for bone metastases should have the dose withheld if renal function has deteriorated (see

What might happen if I take too much Pamidronate Disodium?

There have been several cases of drug maladministration of intravenous pamidronate disodium in hypercalcemia patients with total doses of 225 mg to 300 mg given over 2 1/2 to 4 days. All of these patients survived, but they experienced hypocalcemia that required intravenous and/or oral administration of calcium. Single doses of pamidronate disodium should not exceed 90 mg and the duration of the intravenous infusion should be no less than 2 hours (see ).

In addition, one obese woman (95 kg) who was treated with 285 mg of pamidronate disodium/day for 3 days experienced high fever (39.5°C), hypotension (from 170/90 mmHg to 90/60 mmHg), and transient taste perversion, noted about 6 hours after the first infusion. The fever and hypotension were rapidly corrected with steroids.

If overdosage occurs, symptomatic hypocalcemia could also result; such patients should be treated with short-term intravenous calcium.

How should I store and handle Pamidronate Disodium?

Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP] .Pamidronate Disodium Injection is supplied as follows:30 mg in 10 mL; single dose, flip-top vials as a clear-colorless solution containing pamidronate disodium 3 mg/mL. , individually boxed.90 mg in 10 mL; single dose, flip-top vials as a clear-colorless solution containing pamidronate disodium 9 mg/mL. , individually boxed.Store at 20° to 25°C (68° to77°F) [see USP controlled room temperature].*Zometa is a registered trademark of Novartis Pharmaceuticals Corporation.Manufactured for:GeneraMedix Inc.150 Allen RoadLiberty Corner, NJ 07938Manufactured by:Mustafa Nevzat İlaç Sanayii A.Ş.Saatçi Bayırı, Prof. Dr. Bülent Tarcan Sokak, # 5/134349 Gayrettepe / İstanbul -TurkeyJanuary 2009PI30600.01Pamidronate Disodium Injection is supplied as follows:30 mg in 10 mL; single dose, flip-top vials as a clear-colorless solution containing pamidronate disodium 3 mg/mL. , individually boxed.90 mg in 10 mL; single dose, flip-top vials as a clear-colorless solution containing pamidronate disodium 9 mg/mL. , individually boxed.Store at 20° to 25°C (68° to77°F) [see USP controlled room temperature].*Zometa is a registered trademark of Novartis Pharmaceuticals Corporation.Manufactured for:GeneraMedix Inc.150 Allen RoadLiberty Corner, NJ 07938Manufactured by:Mustafa Nevzat İlaç Sanayii A.Ş.Saatçi Bayırı, Prof. Dr. Bülent Tarcan Sokak, # 5/134349 Gayrettepe / İstanbul -TurkeyJanuary 2009PI30600.01Pamidronate Disodium Injection is supplied as follows:30 mg in 10 mL; single dose, flip-top vials as a clear-colorless solution containing pamidronate disodium 3 mg/mL. , individually boxed.90 mg in 10 mL; single dose, flip-top vials as a clear-colorless solution containing pamidronate disodium 9 mg/mL. , individually boxed.Store at 20° to 25°C (68° to77°F) [see USP controlled room temperature].*Zometa is a registered trademark of Novartis Pharmaceuticals Corporation.Manufactured for:GeneraMedix Inc.150 Allen RoadLiberty Corner, NJ 07938Manufactured by:Mustafa Nevzat İlaç Sanayii A.Ş.Saatçi Bayırı, Prof. Dr. Bülent Tarcan Sokak, # 5/134349 Gayrettepe / İstanbul -TurkeyJanuary 2009PI30600.01Pamidronate Disodium Injection is supplied as follows:30 mg in 10 mL; single dose, flip-top vials as a clear-colorless solution containing pamidronate disodium 3 mg/mL. , individually boxed.90 mg in 10 mL; single dose, flip-top vials as a clear-colorless solution containing pamidronate disodium 9 mg/mL. , individually boxed.Store at 20° to 25°C (68° to77°F) [see USP controlled room temperature].*Zometa is a registered trademark of Novartis Pharmaceuticals Corporation.Manufactured for:GeneraMedix Inc.150 Allen RoadLiberty Corner, NJ 07938Manufactured by:Mustafa Nevzat İlaç Sanayii A.Ş.Saatçi Bayırı, Prof. Dr. Bülent Tarcan Sokak, # 5/134349 Gayrettepe / İstanbul -TurkeyJanuary 2009PI30600.01Pamidronate Disodium Injection is supplied as follows:30 mg in 10 mL; single dose, flip-top vials as a clear-colorless solution containing pamidronate disodium 3 mg/mL. , individually boxed.90 mg in 10 mL; single dose, flip-top vials as a clear-colorless solution containing pamidronate disodium 9 mg/mL. , individually boxed.Store at 20° to 25°C (68° to77°F) [see USP controlled room temperature].*Zometa is a registered trademark of Novartis Pharmaceuticals Corporation.Manufactured for:GeneraMedix Inc.150 Allen RoadLiberty Corner, NJ 07938Manufactured by:Mustafa Nevzat İlaç Sanayii A.Ş.Saatçi Bayırı, Prof. Dr. Bülent Tarcan Sokak, # 5/134349 Gayrettepe / İstanbul -TurkeyJanuary 2009PI30600.01Pamidronate Disodium Injection is supplied as follows:30 mg in 10 mL; single dose, flip-top vials as a clear-colorless solution containing pamidronate disodium 3 mg/mL. , individually boxed.90 mg in 10 mL; single dose, flip-top vials as a clear-colorless solution containing pamidronate disodium 9 mg/mL. , individually boxed.Store at 20° to 25°C (68° to77°F) [see USP controlled room temperature].*Zometa is a registered trademark of Novartis Pharmaceuticals Corporation.Manufactured for:GeneraMedix Inc.150 Allen RoadLiberty Corner, NJ 07938Manufactured by:Mustafa Nevzat İlaç Sanayii A.Ş.Saatçi Bayırı, Prof. Dr. Bülent Tarcan Sokak, # 5/134349 Gayrettepe / İstanbul -TurkeyJanuary 2009PI30600.01Pamidronate Disodium Injection is supplied as follows:30 mg in 10 mL; single dose, flip-top vials as a clear-colorless solution containing pamidronate disodium 3 mg/mL. , individually boxed.90 mg in 10 mL; single dose, flip-top vials as a clear-colorless solution containing pamidronate disodium 9 mg/mL. , individually boxed.Store at 20° to 25°C (68° to77°F) [see USP controlled room temperature].*Zometa is a registered trademark of Novartis Pharmaceuticals Corporation.Manufactured for:GeneraMedix Inc.150 Allen RoadLiberty Corner, NJ 07938Manufactured by:Mustafa Nevzat İlaç Sanayii A.Ş.Saatçi Bayırı, Prof. Dr. Bülent Tarcan Sokak, # 5/134349 Gayrettepe / İstanbul -TurkeyJanuary 2009PI30600.01Pamidronate Disodium Injection is supplied as follows:30 mg in 10 mL; single dose, flip-top vials as a clear-colorless solution containing pamidronate disodium 3 mg/mL. , individually boxed.90 mg in 10 mL; single dose, flip-top vials as a clear-colorless solution containing pamidronate disodium 9 mg/mL. , individually boxed.Store at 20° to 25°C (68° to77°F) [see USP controlled room temperature].*Zometa is a registered trademark of Novartis Pharmaceuticals Corporation.Manufactured for:GeneraMedix Inc.150 Allen RoadLiberty Corner, NJ 07938Manufactured by:Mustafa Nevzat İlaç Sanayii A.Ş.Saatçi Bayırı, Prof. Dr. Bülent Tarcan Sokak, # 5/134349 Gayrettepe / İstanbul -TurkeyJanuary 2009PI30600.01Pamidronate Disodium Injection is supplied as follows:30 mg in 10 mL; single dose, flip-top vials as a clear-colorless solution containing pamidronate disodium 3 mg/mL. , individually boxed.90 mg in 10 mL; single dose, flip-top vials as a clear-colorless solution containing pamidronate disodium 9 mg/mL. , individually boxed.Store at 20° to 25°C (68° to77°F) [see USP controlled room temperature].*Zometa is a registered trademark of Novartis Pharmaceuticals Corporation.Manufactured for:GeneraMedix Inc.150 Allen RoadLiberty Corner, NJ 07938Manufactured by:Mustafa Nevzat İlaç Sanayii A.Ş.Saatçi Bayırı, Prof. Dr. Bülent Tarcan Sokak, # 5/134349 Gayrettepe / İstanbul -TurkeyJanuary 2009PI30600.01Pamidronate Disodium Injection is supplied as follows:30 mg in 10 mL; single dose, flip-top vials as a clear-colorless solution containing pamidronate disodium 3 mg/mL. , individually boxed.90 mg in 10 mL; single dose, flip-top vials as a clear-colorless solution containing pamidronate disodium 9 mg/mL. , individually boxed.Store at 20° to 25°C (68° to77°F) [see USP controlled room temperature].*Zometa is a registered trademark of Novartis Pharmaceuticals Corporation.Manufactured for:GeneraMedix Inc.150 Allen RoadLiberty Corner, NJ 07938Manufactured by:Mustafa Nevzat İlaç Sanayii A.Ş.Saatçi Bayırı, Prof. Dr. Bülent Tarcan Sokak, # 5/134349 Gayrettepe / İstanbul -TurkeyJanuary 2009PI30600.01Pamidronate Disodium Injection is supplied as follows:30 mg in 10 mL; single dose, flip-top vials as a clear-colorless solution containing pamidronate disodium 3 mg/mL. , individually boxed.90 mg in 10 mL; single dose, flip-top vials as a clear-colorless solution containing pamidronate disodium 9 mg/mL. , individually boxed.Store at 20° to 25°C (68° to77°F) [see USP controlled room temperature].*Zometa is a registered trademark of Novartis Pharmaceuticals Corporation.Manufactured for:GeneraMedix Inc.150 Allen RoadLiberty Corner, NJ 07938Manufactured by:Mustafa Nevzat İlaç Sanayii A.Ş.Saatçi Bayırı, Prof. Dr. Bülent Tarcan Sokak, # 5/134349 Gayrettepe / İstanbul -TurkeyJanuary 2009PI30600.01Pamidronate Disodium Injection is supplied as follows:30 mg in 10 mL; single dose, flip-top vials as a clear-colorless solution containing pamidronate disodium 3 mg/mL. , individually boxed.90 mg in 10 mL; single dose, flip-top vials as a clear-colorless solution containing pamidronate disodium 9 mg/mL. , individually boxed.Store at 20° to 25°C (68° to77°F) [see USP controlled room temperature].*Zometa is a registered trademark of Novartis Pharmaceuticals Corporation.Manufactured for:GeneraMedix Inc.150 Allen RoadLiberty Corner, NJ 07938Manufactured by:Mustafa Nevzat İlaç Sanayii A.Ş.Saatçi Bayırı, Prof. Dr. Bülent Tarcan Sokak, # 5/134349 Gayrettepe / İstanbul -TurkeyJanuary 2009PI30600.01Pamidronate Disodium Injection is supplied as follows:30 mg in 10 mL; single dose, flip-top vials as a clear-colorless solution containing pamidronate disodium 3 mg/mL. , individually boxed.90 mg in 10 mL; single dose, flip-top vials as a clear-colorless solution containing pamidronate disodium 9 mg/mL. , individually boxed.Store at 20° to 25°C (68° to77°F) [see USP controlled room temperature].*Zometa is a registered trademark of Novartis Pharmaceuticals Corporation.Manufactured for:GeneraMedix Inc.150 Allen RoadLiberty Corner, NJ 07938Manufactured by:Mustafa Nevzat İlaç Sanayii A.Ş.Saatçi Bayırı, Prof. Dr. Bülent Tarcan Sokak, # 5/134349 Gayrettepe / İstanbul -TurkeyJanuary 2009PI30600.01Pamidronate Disodium Injection is supplied as follows:30 mg in 10 mL; single dose, flip-top vials as a clear-colorless solution containing pamidronate disodium 3 mg/mL. , individually boxed.90 mg in 10 mL; single dose, flip-top vials as a clear-colorless solution containing pamidronate disodium 9 mg/mL. , individually boxed.Store at 20° to 25°C (68° to77°F) [see USP controlled room temperature].*Zometa is a registered trademark of Novartis Pharmaceuticals Corporation.Manufactured for:GeneraMedix Inc.150 Allen RoadLiberty Corner, NJ 07938Manufactured by:Mustafa Nevzat İlaç Sanayii A.Ş.Saatçi Bayırı, Prof. Dr. Bülent Tarcan Sokak, # 5/134349 Gayrettepe / İstanbul -TurkeyJanuary 2009PI30600.01Pamidronate Disodium Injection is supplied as follows:30 mg in 10 mL; single dose, flip-top vials as a clear-colorless solution containing pamidronate disodium 3 mg/mL. , individually boxed.90 mg in 10 mL; single dose, flip-top vials as a clear-colorless solution containing pamidronate disodium 9 mg/mL. , individually boxed.Store at 20° to 25°C (68° to77°F) [see USP controlled room temperature].*Zometa is a registered trademark of Novartis Pharmaceuticals Corporation.Manufactured for:GeneraMedix Inc.150 Allen RoadLiberty Corner, NJ 07938Manufactured by:Mustafa Nevzat İlaç Sanayii A.Ş.Saatçi Bayırı, Prof. Dr. Bülent Tarcan Sokak, # 5/134349 Gayrettepe / İstanbul -TurkeyJanuary 2009PI30600.01

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Clinical Information

Chemical Structure

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Clinical Pharmacology

Cancer patients (n=24) who had minimal or no bony involvement were given an intravenous infusion of 30, 60, or 90 mg of pamidronate disodium over 4 hours and 90 mg pamidronate disodium over 24 hours (Table 1).

Non-Clinical Toxicology

Pamidronate disodium is contraindicated in patients with clinically significant hypersensitivity to pamidronate disodium or other bisphosphonates.

Deterioration in Renal Function

Bisphosphonates, including pamidronate disodium, have been associated with renal toxicity manifested as deterioration of renal function and potential renal failure.

DUE TO THE RISK OF CLINICALLY SIGNIFICANT DETERIORATION IN RENAL FUNCTION, WHICH MAY PROGRESS TO RENAL FAILURE, SINGLE DOSES OF PAMIDRONATE DISODIUM SHOULD NOT EXCEED 90 MG (see

for appropriate infusion durations). Renal deterioration, progression to renal failure, and dialysis have been reported in patients after the initial or a single dose of pamidronate disodium.

Focal segmental glomerulosclerosis (including the collapsing variant) with or without nephrotic syndrome, which may lead to renal failure, has been reported in pamidronate disodium-treated patients, particularly in the setting of multiple myeloma and breast cancer. Some of these patients had gradual improvement in renal status after pamidronate disodium was discontinued.

Patients who receive pamidronate disodium should have serum creatinine assessed prior to each treatment. Patients treated with pamidronate disodium for bone metastases should have the dose withheld if renal function has deteriorated (see

Standard hypercalcemia-related metabolic parameters, such as serum levels of calcium, phosphate, magnesium, and potassium, should be carefully monitored following initiation of therapy with pamidronate disodium. Cases of asymptomatic hypophosphatemia (12%), hypokalemia (7%), hypomagnesemia (11%), and hypocalcemia (5% to 12%), were reported in pamidronate disodium-treated patients. Rare cases of symptomatic hypocalcemia (including tetany) have been reported in association with pamidronate disodium therapy. If hypocalcemia occurs, short-term calcium therapy may be necessary. In Paget’s disease of bone, 17% of patients treated with 90 mg of pamidronate disodium showed serum calcium levels below 8 mg/dL.

Patients with a history of thyroid surgery may have relative hypoparathyroidism that may predispose to hypocalcemia with pamidronate disodium.

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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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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72

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Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).

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