Zoledronic Acid (Reclast)

Trade Name : Reclast

Novartis Pharmaceuticals Corporation

INJECTION, 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 (Reclast) which is also known as Reclast and Manufactured by Novartis Pharmaceuticals Corporation. It is available in strength of 5 mg/100mL per ml. Read more

Zoledronic Acid (Reclast) 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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No data

Reclast is a bisphosphonate indicated for:
Limitations of UseOptimal duration of use has not been determined. For patients at low-risk for fracture, consider drug discontinuation after 3 to 5 years of use ()

Treatment and prevention of postmenopausal osteoporosisu00a0(, )n
Treatment to increase bone mass in men with osteoporosis ()n
Treatment and prevention of glucocorticoid-induced osteoporosis ()n
Treatment of Pagetu2019s disease of bone in men and women ()

Infusion given intravenously over no less than 15 minutes:

Treatment of postmenopausal osteoporosis (); treatment to increase bone mass in men with osteoporosis (): treatment and prevention of glucocorticoid-induced osteoporosis (): 5 mg once a year n
Prevention of postmenopausal osteoporosis: 5 mg once every 2 years ()n
Treatment of Pagetu2019s disease of bone: a single 5 mg infusion.u00a0u00a0Patients should receive 1500 mg elemental calcium and 800 international units vitamin D daily ()

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

Reclast is contraindicated in patients with the following conditions:

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 Reclast (, )

No data

Products Containing Same Active Ingredient:
Hypocalcemia may worsen during treatment.
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 Reclast.n 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.

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 ()

Nursing Mothers: Reclast should not be given to nursing women ()
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 (Reclast) 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.
Single doses of Reclast should not exceed 5 mg and the duration of the intravenous infusion should be no less than 15 minutes [].u00a0

Reclast 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:
Zoledronic acid monohydrate is a white crystalline powder. Its molecular formula is CHNOP u2022 HO and a molar mass of 290.1u00a0g/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 Reclast solution for infusion is approximately 6.0 u2013 7.0.
Reclast Injection is available as a sterile solution in bottles for intravenous infusion. One bottle with 100 mL solution contains 5.330u00a0mg of zoledronic acid monohydrate, equivalent to 5 mg zoledronic acid on an anhydrous basis.n
Inactive Ingredients

No data

No data

No data

Each bottle contains 5 mg per 100 mL. NDC 0078-0435-61
Handling
After opening the solution, it is stable for 24 hours at 2u00b0Cu20138u00b0C (36u00b0F-46u00b0F).
If refrigerated, allow the refrigerated solution to reach room temperature before administration.
Storage
Store at 25u00b0C (77u00b0F); excursions permitted to 15u00b0C-30u00b0C (59u00b0F-86u00b0F) [see USP Controlled Room Temperature].

See FDA-Approved Medication Guide
Information for Patients
Patients should be made aware that Reclast contains the same active ingredient (zoledronic acid) found in Zometa, and that patients being treated with Zometa should not be treated with Reclast.
Reclast is contraindicated in patients with creatinine clearance less than 35 mL/min [].
Before being given Reclast, patients should tell their doctor if they have kidney problems and what medications they are taking.
Reclast should not be given if the patient is pregnant or plans to become pregnant, or if she is breast-feeding [n n ].n
There have been reports of bronchoconstriction in aspirin-sensitive patients receiving bisphosphonates, including Reclast. Before being given Reclast, patients should tell their doctor if they are aspirin-sensitive.
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.
Reclast 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.
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 Reclast.
After getting Reclast it is strongly recommended patients with Pagetu2019s 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 Reclast [].
Adequate calcium and vitamin D intake is important in patients with osteoporosis and the current recommended daily intake of calcium is 1200 mg and vitamin D is 800 international units u2013 1000 international units daily. All patients should be instructed on the importance of calcium and vitamin D supplementation in maintaining serum calcium levels.
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 Reclast. 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 Reclast.
Administration of acetaminophen following Reclast administration may reduce the incidence of these symptoms.
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.
Severe and occasionally incapacitating bone, joint, and/or muscle pain have been infrequently reported in patients taking bisphosphonates, including Reclast. Consider withholding future Reclast treatment if severe symptoms develop.
Atypical femur fractures in patients on bisphosphonate therapy have been reported;u00a0patients with thigh or groin pain should be evaluated to rule out a femoral fracture.
T2017-76July 2017

MEDICATION GUIDE
Reclastu00ae (RE-clast)
(zoledronic acid)
Injection
Read the Medication Guide that comes with Reclast 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 Reclast.
What is the most important information I should know about Reclast?
You should not receive Reclast if you are already receiving Zometa. Both Reclast and Zometa n- contain zoledronic acid.
Reclast can cause serious side effects including:
1. .
Reclast may lower the calcium levels in your blood. If you have low blood calcium before you start taking Reclast, it may get worse during treatment. Your low blood calcium must be treated before you take Reclast. 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:
Your doctor may prescribe calcium and vitamin D to help prevent low calcium levels in your blood, while you take Reclast. Take calcium and vitamin D as your doctor tells you to.
2. n
Severe kidney problems may happen when you take Reclast. Severe kidney problems may lead to hospitalization or kidney dialysis and can be life-threatening. Your risk of kidney problems is higher if you:
You should drink at least 2 glasses of fluid within a few hours before receiving Reclast to reduce the risk of kidney problems.
3. n
Severe jaw bone problems may happen when you take Reclast. Your doctor should examine your mouth before you start Reclast. Your doctor may tell you to see your dentist before you start Reclast. It is important for you to practice good mouth care during treatment with Reclast.
4. n
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.
5. n
Reclast should not be used if you are pregnant.
6. n
Some people who take bisphosphonates develop severe bone, joint, or muscle pain.
Call your doctor right away if you have any of these side effects.
What is n- Reclastn- ?
Reclast is a prescription medicine used to:
It is not known how long Reclast works for the treatment and prevention of osteoporosis. You should see your doctor regularly to determine if Reclast is still right for you.
Reclast is not for use in children.
Who should not take Reclast?
Do not take Reclast if you:
What should I tell my doctor before taking Reclast?
Before you start Reclast, be sure to talk to your doctor if you:
Tell your doctor about all the medicines you take,
Especially tell your doctor if you are taking:
Ask your doctor or pharmacist for a list of these medicines, if you are not sure.
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.
How will I receive Reclast?
What are the possible side effects of Reclast?
Reclast may cause serious side effects.
The most common side effects of Reclast included:
Talk to your doctor about things you can do to help decrease some of these side effects that might happen with a Reclast infusion. u00a0
You may get allergic reactions, such as hives, swelling of your face, lips, tongue, or throat.
Tell your doctor if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of Reclast. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA atu00a01-800-FDA-1088.
General information about safe and effective use of Reclast.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide.
This Medication Guide summarizes the most important information about Reclast. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Reclast that is written for health professionals.
For more information, go to: or call 1-888-669-6682.
What are the ingredients in Reclast?
Active ingredient: zoledronic acid monohydrate.
Inactive ingredients: mannitol and sodium citrate.
Distributed by:Novartis Pharmaceuticals CorporationEast Hanover, New Jersey 07936
This Medication Guide has been approved by the U.S. Food and Drug Administration.
u00a9 Novartis
T2015-32January 2015

PRINCIPAL DISPLAY PANEL
Package Label u2013 n- 5n- mgn- / 100 n- mL
Rx Onlynttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0ntNDC 0078-0435-61
Reclastu00ae
(zoledronic acid) injection
5 mg / 100 mL
Solution for Intravenous Infusion
Dispense the accompanying Medication Guide to each patient.
1 bottle u2013 Sterile Solution
Do not mix with calcium-containing solutions. Administer as a single intravenous solution through a separate vented infustion line.

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Zoledronic Acid (Reclast)

Trade Name : Reclast

INJECTION, 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

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Zoledronic Acid (Reclast)

Trade Name : Reclast

INJECTION, 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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