Zoledronic Acid (Zoledronic Acid)

Trade Name : Zoledronic Acid

Akorn, Inc.

SOLUTION

Strength 5 mg/100mL

ZOLEDRONIC ACID Diphosphonates [CS],Bisphosphonate [EPC]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Zoledronic Acid (Zoledronic Acid) which is also known as Zoledronic Acid and Manufactured by Akorn, Inc.. It is available in strength of 5 mg/100mL per ml. Read more

Zoledronic Acid (Zoledronic Acid) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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About GNH

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Zoledronic acid injection 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 [].n
Zoledronic acid injection is a bisphosphonate indicated for:n

Treatment of Paget's disease of bone in men and women ()n

Infusion given intravenously over no less than 15 minutes:n

Treatment of Paget's disease of bone: a single 5 mg infusion. Patients should receive 1500 mg elemental calcium and 800 international units vitamin D daily. ()n

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

Zoledronic acid injection is contraindicated in patients with the following conditions:n

Hypocalcemia ()n
Patients with creatinine clearance less than 35 mL/min and in those with evidence of acute renal impairment (, )n
Hypersensitivity to any component of zoledronic acid injection (, )n

No data

Products Containing Same Active Ingredient:
Hypocalcemia
Renal Impairment:
Osteonecrosis of the Jaw (ONJ)
Atypical Femur Fractures
Pregnancy:
Severe Bone, Joint, and Muscle Pain

The most common adverse reactions (greater than 10%) were pyrexia, myalgia, headache, arthralgia, pain in extremity (). Other important adverse reactions were flu-like illness, nausea, vomiting, diarrhea (), and eye inflammation (). n

No drug interaction studies have been performed for zoledronic acid injection. and studies showed low affinity of zoledronic acid for the cellular components of human blood. mean zoledronic acid protein binding in human plasma ranged from 28% at 200 ng/mL to 53% at 50 ng/mL. studies showed that zoledronic acid is not metabolized, and is excreted into the urine as the intact drug.n

Aminoglycosides: May lower serum calcium for prolonged periods ()n
Loop diuretics: May increase risk of hypocalcemia ()n
Nephrotoxic drugs: Use with caution. ()n
Drugs primarily excreted by the kidney: Exposure may be increased with renal impairment. Monitor serum creatinine in patients at risk. ()n

Nursing Mothers: Zoledronic acid injection should not be given to nursing women.n
()n
Pediatric Use: Not indicated for use in pediatric patients () Geriatric Use: Special care to monitor renal function ()n

Clinical experience with acute overdosage of zoledronic acid injection 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.n
Single doses of zoledronic acid injection should not exceed 5 mg and the duration of the intravenous infusion should be no less than 15 minutes [].n

Zoledronic acid injection 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:n
Zoledronic acid monohydrate is a white crystalline powder. Its molecular formula is CHNOP u2022 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 zoledronic acid injection solution for infusion is approximately 6.0 to 7.0.n
Zoledronic acid injection is available as a plastic IV bag for intravenous infusion. One IV bag with 100 mL solution contains 5.330 mg of zoledronic acid monohydrate, equivalent to 5 mg zoledronic acid on an anhydrous basis.n
Inactive Ingredients:

No data

No data

Zoledronic acid injection was studied in male and female patients with moderate to severe Paget's disease of bone, defined as serum alkaline phosphatase level at least twice the upper limit of the age-specific normal reference range at the time of study entry. Diagnosis was confirmed by radiographic evidence.n
The efficacy of one infusion of 5 mg zoledronic acid injection vs. oral daily doses of 30 mg risedronate for 2 months was demonstrated in two identically designed 6-month randomized, double blind trials. The mean age of patients in the two trials was 70. Ninety-three percent (93%) of patients were Caucasian. Therapeutic response was defined as either normalization of serum alkaline phosphatase (SAP) or a reduction of at least 75% from baseline in total SAP excess at the end of 6 months. SAP excess was defined as the difference between the measured level and midpoint of normal range.n
In both trials zoledronic acid injection demonstrated a superior and more rapid therapeutic response compared with risedronate and returned more patients to normal levels of bone turnover, as evidenced by biochemical markers of formation (SAP, serum N-terminal propeptide of type I collagen [P1NP]) and resorption (serum CTx 1 [cross-linked C-telopeptides of type I collagen] and urine u03b1-CTx).n
The 6-month combined data from both trials showed that 96% (169/176) of zoledronic acid injection-treated patients achieved a therapeutic response as compared with 74% (127/171) of patients treated with risedronate. Most zoledronic acid injection patients achieved a therapeutic response by the Day 63 visit. In addition, at 6 months, 89% (156/176) of zoledronic acid injection-treated patients achieved normalization of SAP levels, compared to 58% (99/171) of patients treated with risedronate (p<0.0001) (see ).n
Figure 2. Therapeutic Response/Serum Alkaline Phosphatase (SAP) Normalization Over Time
The therapeutic response to zoledronic acid injection was similar across demographic and disease-severity groups defined by gender, age, previous bisphosphonate use, and disease severity. At 6 months, the percentage of zoledronic acid injection-treated patients who achieved therapeutic response was 97% and 95%, respectively, in each of the baseline disease severity subgroups (baseline SAP less than 3xULN, greater than or equal to 3xULN) compared to 75% and 74%, respectively, for the same disease severity subgroups of risedronatetreated patients.n
In patients who had previously received treatment with oral bisphosphonates, therapeutic response rates were 96% and 55% for zoledronic acid injection and risedronate, respectively. The comparatively low risedronate response was due to the low response rate (7/23, 30%) in patients previously treated with risedronate. In patients nau00efve to previous treatment, a greater therapeutic response was also observed with zoledronic acid injection (98%) relative to risedronate (86%). In patients with symptomatic pain at screening, therapeutic response rates were 94% and 70% for zoledronic acid injection and risedronate respectively. For patients without pain at screening, therapeutic response rates were 100% and 82% for zoledronic acid injection and risedronate respectively.n
Bone histology was evaluated in 7 patients with Paget's disease 6 months after being treated with zoledronic acid injection 5 mg. Bone biopsy results showed bone of normal quality with no evidence of impaired bone remodeling and no evidence of mineralization defect.n

Zoledronic acid injection is supplied as follows:n

See FDA-Approved n
Information for Patients
Patients should be made aware that zoledronic acid injection contains the same active ingredient (zoledronic acid) found in Zometa, and that patients being treated with Zometa should not be treated with zoledronic acid injection.n
Zoledronic acid injection is contraindicated in patients with creatinine clearance less than 35 mL/min [].n
Before being given zoledronic acid injection, patients should tell their doctor if they have kidney problems and what medications they are taking.n
Zoledronic acid injection should not be given if the patient is pregnant or plans to become pregnant, or if she is breast-feeding [].n
There have been reports of bronchoconstriction in aspirin-sensitive patients receiving bisphosphonates, including zoledronic acid injection. Before being given zoledronic acid injection, patients should tell their doctor if they are aspirinsensitive.n
If the patient had surgery to remove some or all of the parathyroid glands in their neck, or had sections of their intestine removed, or are unable to take calcium supplements they should tell their doctor.n
Zoledronic acid injection is given as an infusion into a vein by a nurse or a doctor, and the infusion time must not be less than 15 minutes.n
On the day of treatment the patient should eat and drink normally, which includes drinking at least 2 glasses of fluid such as water within a few hours prior to the infusion, as directed by their doctor, before receiving zoledronic acid injection.n
After getting zoledronic acid injection it is strongly recommended patients with Paget's disease take calcium in divided doses (for example, 2 to 4 times a day) for a total of 1500 mg calcium a day to prevent low blood calcium levels. This is especially important for the two weeks after getting zoledronic acid injection [].n
Patients should be aware of the most commonly associated side effects of therapy. Patients may experience one or more side effects that could include: fever, flu-like symptoms, myalgia, arthralgia, and headache. Most of these side effects occur within the first 3 days following the dose of zoledronic acid injection. They usually resolve within 3 days of onset but may last for up to 7 to 14 days. Patients should consult their physician if they have questions or if these symptoms persist. The incidence of these symptoms decreased markedly with subsequent doses of zoledronic acid injection.n
Administration of acetaminophen following zoledronic acid injection administration may reduce the incidence of these symptoms.n
Physicians should inform their patients that there have been reports of persistent pain and/or a non-healing sore of the mouth or jaw, primarily in patients treated with bisphosphonates for other illnesses. During treatment with zoledronic acid, patients should be instructed to maintain good oral hygiene and undergo routine dental check-ups. If they experience any oral symptoms, they should immediately report them to their physician or dentist.n
Severe and occasionally incapacitating bone, joint, and/or muscle pain have been infrequently reported in patients taking bisphosphonates, including zoledronic acid injection. Consider withholding future zoledronic acid injection treatment if severe symptoms develop.n
Atypical femur fractures in patients on bisphosphonate therapy have been reported; patients with thigh or groin pain should be evaluated to rule out a femoral fracture.n
Zometa is a registered trademark of Novartis.n
AKORN
Manufactured for: Lake Forest, IL 60045n
Made in Norway
FKZL00Nu00a0 u00a0 u00a0 u00a0Rev. 07/17n

MEDICATION GUIDEZoledronic Acid Injectionn n- (ZOE-le-DRON-ik AS-id)
Read the Medication Guide that comes with zoledronic acid injection before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking with your doctor about your medical condition or treatment. Talk to your doctor if you have any questions about zoledronic acid injection.n
What is the most important information I should know about zoledronic acid injection?
You should not receive zoledronic acid injection if you are already receiving Zometa. Both zoledronic acid injection and Zometa contain zoledronic acid.
Zoledronic acid injection can cause serious side effects including:
1. Low calcium levels in your blood (hypocalcemia).
Zoledronic acid injection may lower the calcium levels in your blood. If you have low blood calcium before you start taking zoledronic acid injection, it may get worse during treatment. Your low blood calcium must be treated before you take zoledronic acid injection. Most people with low blood calcium levels do not have symptoms, but some people may have symptoms. Call your doctor right away if you have symptoms of low blood calcium such as:n
Your doctor may prescribe calcium and vitamin D to help prevent low calcium levels in your blood, while you take zoledronic acid injection. Take calcium and vitamin D as your doctor tells you to.n
2. Severe kidney problems.
Severe kidney problems may happen when you take zoledronic acid injection. Severe kidney problems may lead to hospitalization or kidney dialysis and can be life-threatening. Your risk of kidney problems is higher if you:n
You should drink at least 2 glasses of fluid within a few hours before receiving zoledronic acid injection to reduce the risk of kidney problems.n
3. Severe jaw bone problems (osteonecrosis).
Severe jaw bone problems may happen when you take zoledronic acid injection. Your doctor should examine your mouth before you start zoledronic acid injection. Your doctor may tell you to see your dentist before you start zoledronic acid injection. It is important for you to practice good mouth care during treatment with zoledronic acid injection.n
4. Unusual thigh bone fractures.
Some people have developed unusual fractures in their thigh bone. Symptoms of a fracture may include new or unusual pain in your hip, groin, or thigh.n
5. Possible harm to your unborn baby.
Zoledronic acid injection should not be used if you are pregnant.
6. Bone, joint, or muscle pain.
Some people who take bisphosphonates develop severe bone, joint, or muscle pain.n
Call your doctor right away if you have any of these side effects.
What is zoledronic acid injection?
Zoledronic acid injection is a prescription medicine used to:n
Zoledronic acid injection is not for use in children.n
Who should not take zoledronic acid injection?
Do not take zoledronic acid injection if you:n
What should I tell my doctor before taking zoledronic acid injection?
Before you start zoledronic acid injection, be sure to talk to your doctor if you:
Tell your doctor about all the medicines you take,
Certain medicines may affect how zoledronic acid injection works.n
Especially tell your doctor if you are taking:
Ask your doctor or pharmacist for a list of these medicines, if you are not sure.n
Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist each time you get a new medicine.n
How will I receive zoledronic acid injection?
What are the possible side effects of zoledronic acid injection?
Zoledronic acid injection may cause serious side effects.n
The most common side effects of zoledronic acid injection included:n
Talk to your doctor about things you can do to help decrease some of these side effects that might happen with a zoledronic acid injection infusion.n
You may get allergic reactions, such as hives, swelling of your face, lips, tongue, or throat.n
Tell your doctor if you have any side effect that bothers you or that does not go away.n
These are not all the possible side effects of zoledronic acid injection. For more information, ask your doctor or pharmacist.n
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.n
General information about safe and effective use of zoledronic acid injection.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. This Medication Guide summarizes the most important information about zoledronic acid injection. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about zoledronic acid injection that is written for health professionals.n
For more information, go to www.akorn.com or call 1-800-932-5676.n
What are the ingredients in zoledronic acid injection?
Active ingredient: zoledronic acid monohydrate Inactive ingredients: mannitol, sodium citrate, and 100 mL water for injection, USPn
This Medication Guide has been approved by the U.S. Food and Drug Administration.n
Zometa is a registered trademark of Novartis.n
Rx onlyn
AKORNn n- Akorn, Inc.n
Made in Norway
FKZL00Nu00a0 u00a0 u00a0 u00a0Rev. 07/17n

Principal Display Panel Text for Container Label:n
Rx only NDC 17478-324-91n
Zoledronic Acid Injectionn
5 mg/100 mL (0.05 mg/mL)n
Sterile Solution for Intravenous Infusionn

Principal Display Panel Text for Carton Label:n
NDC 17478-324-91n
Zoledronic Acid Injectionn
5 mg/100 mLn
(0.05 mg/mL)n
Sterile Solution for Intravenous Infusionn
One 100 mL Single-Dose Plastic Containern
Do not mix with calcium-containing solutions.n
Administer as a single intravenous solutionn
through a separate vented infusion line.n
PHARMACIST:n
Dispense the accompanying Medication Guiden
to each patient.n
Rx only Akorn Logon

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Zoledronic Acid (Zoledronic Acid)

Trade Name : Zoledronic Acid

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Zoledronic Acid (Zoledronic Acid)

Trade Name : Zoledronic Acid

SOLUTION

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

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Browse from other international pharmaceuticals

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