Reclast Solution For Injection 5Mg Drug Medication Dosage Information
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Reclast: Solution for injection (5mg)

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What is this Medicine?

ZOLEDRONIC ACID (ZOE le dron ik AS id) lowers the amount of calcium loss from bone. It is used to treat Paget's disease and osteoporosis in women.

In-Depth Information

Reclast 5mg/100ml Solution for Injection

NDC: 000780435
  • Prescription Required
  • Not a Controlled Drug
    (CSA Schedule)
  • FDA Approved




FDA approved for the following conditions:
Osteoporosis, Osteoporosis Prophylaxis, Paget's Disease

Storage Information
Refrigerated product should reach room temperature before administration
Store at 77 degrees F; excursions permitted to 59-86 degrees F
Opened product is stable in refrigerator (36 to 46 degrees F) for 24 hours
Reclast 5mg/100ml Solution for Injection

Reported Side Effects for Reclast 5mg/100ml Solution for Injection

Inflamed Iris (Eye) Incidence:
<1.1%*
Severity: MODERATE
Onset: DELAYED
Eye Inflammation Incidence:
<1.1%*
Severity: SEVERE
Onset: DELAYED
Low Magnesium Levels Incidence:
<11.0%*
Severity: MODERATE
Onset: DELAYED
Low Potassium Levels Incidence:
<15.0%*
Severity: MODERATE
Onset: DELAYED
Low Calcium Levels Incidence:
<22.0%*
Severity: MODERATE
Onset: DELAYED
Muscle And/Or Bone Pain Incidence:
0.4-12.4%*
Severity: MILD
Onset: EARLY
Back Pain Incidence:
0.6-2.0%*
Severity: MODERATE
Onset: DELAYED
Dehydration Incidence:
0.6-14.0%*
Severity: MODERATE
Onset: DELAYED
Irregular Heart Beat Incidence:
0.7-3.3%*
Severity: SEVERE
Onset: EARLY
Stomach Pain Incidence:
0.9-16.0%*
Severity: MILD
Onset: EARLY
Decreased Appetite Incidence:
1.0-22.0%*
Severity: MILD
Onset: DELAYED
Chest Pain Incidence:
1.3-9.9%*
Severity: MODERATE
Onset: EARLY
Balance Problems Incidence:
1.3-4.3%*
Severity: MILD
Onset: EARLY
Upset Stomach Incidence:
1.7-10.0%*
Severity: MILD
Onset: EARLY
Low Kidney Function Incidence:
2.0%*
Severity: SEVERE
Onset: DELAYED
Eye Pain Incidence:
2.0%*
Severity: MILD
Onset: EARLY
Vomiting Incidence:
2.0-32.0%*
Severity: MILD
Onset: EARLY
High Magnesium Level Incidence:
2.0%*
Severity: MODERATE
Onset: DELAYED
Paresthesias Incidence:
2.0-15.0%*
Severity: MILD
Onset: DELAYED
Skin Rash Incidence:
2.2-3.0%*
Severity: MILD
Onset: EARLY
Hypoesthesia Incidence:
2.2-12.0%*
Severity: MILD
Onset: DELAYED
Rapid Heart Rate Incidence:
2.6%*
Severity: MODERATE
Onset: EARLY
Excessive Sweating Incidence:
2.6%*
Severity: MILD
Onset: DELAYED
Bone Pain Incidence:
3.1-55.0%*
Severity: MODERATE
Onset: DELAYED
Back Pain Incidence:
4.0-18.2%*
Severity: MILD
Onset: DELAYED
Anemia Incidence:
4.4-33.0%*
Severity: MODERATE
Onset: DELAYED
Upset Stomach Incidence:
4.5-46.0%*
Severity: MILD
Onset: EARLY
Muscle Pain Incidence:
4.9-23.0%*
Severity: MILD
Onset: EARLY
Infection Incidence:
5.0-9.9%*
Severity: MILD
Onset: DELAYED
Joint Pain Incidence:
5.0-27.3%*
Severity: MILD
Onset: DELAYED
Pancytopenia Incidence:
5.0-9.9%*
Severity: SEVERE
Onset: DELAYED
Shortness Of Breath Incidence:
5.0-27.0%*
Severity: MODERATE
Onset: EARLY
Tiredness Incidence:
5.0%*
Severity: MILD
Onset: EARLY
Difficulty Swallowing Incidence:
5.0-9.9%*
Severity: MODERATE
Onset: DELAYED
Low Platelet Count Incidence:
5.0-9.9%*
Severity: MODERATE
Onset: DELAYED
High Blood Pressure Incidence:
5.1-12.7%*
Severity: MODERATE
Onset: EARLY
Loose Stools Incidence:
5.2-24.0%*
Severity: MILD
Onset: EARLY
Constipation Incidence:
6.0-31.0%*
Severity: MODERATE
Onset: DELAYED
Lightheadedness Incidence:
6.1-18.0%*
Severity: MILD
Onset: EARLY
Confusion Incidence:
7.0-13.0%*
Severity: MODERATE
Onset: EARLY
Flu Incidence:
7.0%*
Severity: MILD
Onset: DELAYED
Mouth Ulcers Incidence:
8.0%*
Severity: MODERATE
Onset: DELAYED
Sore Throat Incidence:
8.0%*
Severity: MILD
Onset: DELAYED
Low Blood Pressure Incidence:
11.0%*
Severity: MODERATE
Onset: RAPID
Nervousness Incidence:
11.0-14.0%*
Severity: MILD
Onset: DELAYED
Low Phosphate Level Incidence:
12.0-51.0%*
Severity: MODERATE
Onset: DELAYED
Low White Blood Cells Incidence:
12.0%*
Severity: MODERATE
Onset: DELAYED
Cough Incidence:
12.0-22.0%*
Severity: MILD
Onset: DELAYED
Hair Loss Incidence:
12.0%*
Severity: MILD
Onset: DELAYED
Distressed Incidence:
13.0%*
Severity: MILD
Onset: EARLY
Depression Incidence:
14.0%*
Severity: MODERATE
Onset: DELAYED
Inability To Sleep Incidence:
15.0-16.0%*
Severity: MILD
Onset: EARLY
Weight Loss Incidence:
16.0%*
Severity: MILD
Onset: DELAYED
*This is an approximate aggregated range of reported side effects from clinical studies performed on this drug. Your experience with this drug may be different.
Pregnancy & Lactation Information
First Trimester

Class D - Adequate well-controlled or observational studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy may outweigh the potential risk. For example, the drug may be acceptable if needed in a life-threatening situation or serious disease for which safer drugs cannot be used or are ineffective.

Second Trimester

Class D - Adequate well-controlled or observational studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy may outweigh the potential risk. For example, the drug may be acceptable if needed in a life-threatening situation or serious disease for which safer drugs cannot be used or are ineffective.

Third Trimester

Class D - Adequate well-controlled or observational studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy may outweigh the potential risk. For example, the drug may be acceptable if needed in a life-threatening situation or serious disease for which safer drugs cannot be used or are ineffective.

Lactation

Caution - Not enough information is available to rule out harm to infants when this drug is taken by nursing mothers.


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