Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include decreased urination; irregular heartbeat; mental or mood changes; muscle cramps; numbness or tingling (especially around the mouth).
Proper storage of Zolako:
Zolako is usually handled and stored by a health care provider. If you are using Zolako at home, store Zolako as directed by your pharmacist or health care provider. Keep Zolako out of the reach of children and away from pets.
Overdose of Zolako in details
When a dose is taken in higher dose than the recommended doses, it is called Overdose. Overdose always needs a clinical supervision. Any medicine or drug when consumed in Overdose produces untoward side effects on one or various organs in the body. A medicine is excreted in the kidney or metabolized in the liver most of the times. This process goes without any hurdles when taken in normal dose, but when taken in an overdose, the body is not able to metabolize it or send it out properly which causes the effects of anoverdose.
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Clinical experience with acute overdosage of Zolako injection is limited. Two patients received Zolako injection 32 mg over 5 minutes in clinical trials. Neither patient experienced any clinical or laboratory toxicity. Overdosage may cause clinically significant 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.
In an open-label study of Zolako 4 mg in breast cancer patients, a female patient received a single 48-mg dose of Zolako in error. Two days after the overdose, the patient experienced a single episode of hyperthermia (38°C), which resolved after treatment. All other evaluations were normal, and the patient was discharged seven days after the overdose.
A patient with non-Hodgkin’s lymphoma received Zolako 4 mg daily on four successive days for a total dose of 16 mg. The patient developed paresthesia and abnormal liver function tests with increased GGT (nearly 100U/L, each value unknown). The outcome of this case is not known.
In controlled clinical trials, administration of Zolako injection 4 mg as an intravenous infusion over 5 minutes has been shown to increase the risk of renal toxicity compared to the same dose administered as a 15-minute intravenous infusion. In controlled clinical trials, Zolako injection 8 mg has been shown to be associated with an increased risk of renal toxicity compared to Zolako injection 4 mg, even when given as a 15-minute intravenous infusion, and was not associated with added benefit in patients with hypercalcemia of malignancy [see.
What should I avoid while taking Zolako?
Avoid having any type of dental surgery while you are being treated with Zolako. It may take longer than normal for you to recover.
Zolako warnings
Warnings are a mix of Precautions. Contraindications and interactions and serious harmful effects associated with the medicine intake. A diabetic or Hypertensive patient need to be warned about few drug interactions. A known hypersensitivity patient needs to be careful about the reactions or anaphylactic shock. A pregnant woman or a breastfeeding woman should be warned of certain medications. A Hepatitis [liver disease] patient or a cardiac patient should avoid few drugs.
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Drugs with Same Active Ingredient or in the Same Drug Class
Zolako contains the same active ingredient as found in Zolako® (Zolako). Patients being treated with Zolako should not be treated with Zolako or other bisphosphonates.
Hydration and Electrolyte Monitoring
Patients with hypercalcemia of malignancy must be adequately rehydrated prior to administration of Zolako. Loop diuretics should not be used until the patient is adequately rehydrated and should be used with caution in combination with Zolako in order to avoid hypocalcemia. Zolako should be used with caution with other nephrotoxic drugs.
Standard hypercalcemia-related metabolic parameters, such as serum levels of calcium, phosphate, and magnesium, as well as serum creatinine, should be carefully monitored following initiation of therapy with Zolako. If hypocalcemia, hypophosphatemia, or hypomagnesemia occur, short-term supplemental therapy may be necessary.
Renal Impairment
Zolako is excreted intact primarily via the kidney, and the risk of adverse reactions, in particular renal adverse reactions, may be greater in patients with impaired renal function. Safety and pharmacokinetic data are limited in patients with severe renal impairment and the risk of renal deterioration is increased. Preexisting renal insufficiency and multiple cycles of Zolako and other bisphosphonates are risk factors for subsequent renal deterioration with Zolako. Factors predisposing to renal deterioration, such as dehydration or the use of other nephrotoxic drugs, should be identified and managed, if possible.
Zolako treatment in patients with hypercalcemia of malignancy with severe renal impairment should be considered only after evaluating the risks and benefits of treatment. In the clinical studies, patients with serum creatinine greater than 400 µmol/L or greater than 4.5 mg/dL were excluded.
Zolako treatment is not recommended in patients with bone metastases with severe renal impairment. In the clinical studies, patients with serum creatinine greater than 265 µmol/L or greater than 3.0 mg/dL were excluded and there were only 8 of 564 patients treated with Zolako 4 mg by 15-minute infusion with a baseline creatinine greater than 2 mg/dL. Limited pharmacokinetic data exists in patients with creatinine clearance less than 30 mL/min.
Osteonecrosis of the Jaw
Osteonecrosis of the jaw (ONJ) has been reported predominantly in cancer patients treated with intravenous bisphosphonates, including Zolako. Many of these patients were also receiving chemotherapy and corticosteroids which may be risk factors for ONJ. The risk of ONJ may increase with duration of exposure to bisphosphonates.
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.
Musculoskeletal Pain
In postmarketing experience, severe and occasionally incapacitating bone, joint, and/or muscle pain has been reported in patients taking bisphosphonates, including Zolako. The time to onset of symptoms varied from one day to several months after starting the drug. Discontinue use if severe symptoms develop. Most patients had relief of symptoms after stopping. A subset had recurrence of symptoms when rechallenged with the same drug or another bisphosphonate.
Atypical Subtrochanteric and Diaphyseal Femoral Fractures
Atypical subtrochanteric and diaphyseal femoral fractures have been reported in patients receiving bisphosphonate therapy, including Zolako. These fractures can occur anywhere in the femoral shaft from just below the lesser trochanter to just above the supracondylar flare and are transverse or short oblique in orientation without evidence of comminution. These fractures occur after minimal or no trauma. Patients may experience thigh or groin pain weeks to months before presenting with a completed femoral fracture. Fractures are often bilateral; therefore the contralateral femur should be examined in bisphosphonate-treated patients who have sustained a femoral shaft fracture. Poor healing of these fractures has also been reported. A number of case reports noted that patients were also receiving treatment with glucocorticoids (such as prednisone or dexamethasone) at the time of fracture. Causality with bisphosphonate therapy has not been established.
Any patient with a history of bisphosphonate exposure who presents with thigh or groin pain in the absence of trauma should be suspected of having an atypical fracture and should be evaluated. Discontinuation of Zolako therapy in patients suspected to have an atypical femur fracture should be considered pending evaluation of the patient, based on an individual benefit risk assessment. It is unknown whether the risk of atypical femur fracture continues after stopping therapy.
Patients with Asthma
While not observed in clinical trials with Zolako, there have been reports of bronchoconstriction in aspirin-sensitive patients receiving bisphosphonates.
Hepatic Impairment
Only limited clinical data are available for use of Zolako to treat hypercalcemia of malignancy in patients with hepatic insufficiency, and these data are not adequate to provide guidance on dosage selection or how to safely use Zolako in these patients.
Use in Pregnancy
Bisphosphonates, such as Zolako, are incorporated into the bone matrix, from where they are gradually released over periods of weeks to years. There may be a risk of fetal harm (e.g., skeletal and other abnormalities) if a woman becomes pregnant after completing a course of bisphosphonate therapy.
Zolako may cause fetal harm when administered to a pregnant woman. In reproductive studies in pregnant rats, subcutaneous doses equivalent to 2.4 or 4.8 times the human systemic exposure resulted in pre- and post-implantation losses, decreases in viable fetuses and fetal skeletal, visceral, and external malformations. There are no adequate and well-controlled studies in pregnant women. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus.
Hypocalcemia
Hypocalcemia has been reported in patients treated with Zolako. Cardiac arrhythmias and neurologic adverse events (seizures, tetany, and numbness) have been reported secondary to cases of severe hypocalcemia. In some instances, hypocalcemia may be life-threatening. Caution is advised when Zolako is administered with drugs known to cause hypocalcemia, as severe hypocalcemia may develop,. Serum calcium should be measured and hypocalcemia must be corrected before initiating Zolako. Adequately supplement patients with calcium and vitamin D.
What should I discuss with my healthcare provider before taking Zolako?
You should not receive this medication if you are allergic to Zolako or similar medicine such as alendronate (Fosamax), etidronate (Didronel), ibandronate (Boniva), pamidronate (Aredia), risedronate (Actonel), or tiludronate (Skelid).
You should also not receive Zolako if you have:
low levels of calcium in your blood; or
if you are pregnant or breast-feeding.
Zolako and Zolako are two different brands of Zolako. You should not be treated with Zolako if you are already receiving Zolako. Before receiving a Zolako injection, tell your doctor if you are already being treated with Zolako.
Do not use Zolako if you have severe kidney disease.
To make sure you can safely use Zolako, tell your doctor if you have any of these other conditions:
aspirin-sensitive asthma;
a thyroid or parathyroid disorder;
malabsorption syndrome (an inability to absorb food and nutrients properly);
a history of surgical removal of part of your intestine;
bone cancer;
kidney disease; or
if you are dehydrated.
Your doctor may recommend you have a dental exam for preventive tooth and gum care before you start your treatment with Zolako. This is especially important if you have cancer, if you are undergoing chemotherapy or using steroids, or if you have poor dental health.
Some people using medicines similar to Zolako have developed bone loss in the jaw, also called osteonecrosis of the jaw. Symptoms of this condition may include jaw pain, swelling, numbness, loose teeth, gum infection, or slow healing after injury or surgery involving the gums.
You may be more likely to develop osteonecrosis of the jaw if you have cancer or have been treated with chemotherapy, radiation, or steroids. Other conditions associated with osteonecrosis of the jaw include blood clotting disorders, anemia (low red blood cells), and dental surgery or pre-existing dental problems.
FDA pregnancy category D. Do not use Zolako if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment.
Zolako can pass into breast milk and may harm a nursing baby. Do not receive this medication without telling your doctor if you are breast-feeding a baby.
Serious side effects on the kidneys may be more likely in older adults using Zolako.
Zolako precautions
Certain people who are very sick or very old or who are sensitive show an exacerbation of side effect of the drug which can turn dangerous at times. So, it is very important to remember the precautions while taking the medicine. Pregnancy and Breastfeeding are also special categories wherein extra care or precaution is needed when taking a drug. Few patients may have a hypersensitivity reaction to few medications, and that can be life-threatening rarely. Penicillin hypersensitivity is one example. Diarrhea, rashes are few other symptoms which need a watch. A patient with other co-existing diseases like liver disease, heart disease, kidney disease should take special precautions.
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The 5-mg dose of Zolako must be administered over at least 15 min.
Zolako is not recommended for patients with severe renal impairment (creatinine clearance <30 mL/min) due to lack of adequate clinical experience in this population. Patients should have serum creatinine measured before receiving Zolako.
Patients must be appropriately hydrated prior to administration of Zolako. This is especially important for patients receiving diuretic therapy.
Preexisting hypocalcemia must be treated by adequate intake of calcium and vitamin D before initiating therapy with Zolako. Other disturbances of mineral metabolism must also be effectively treated (eg, diminished parathyroid reserve; intestinal calcium malabsorption). Physicians should consider clinical monitoring for these patients.
Elevated bone turnover is characteristic of Paget's disease of bone. It is strongly advised that patients with Paget's disease receive the recommended daily allowance of supplemental calcium and vitamin D and this should be ensured during the initial 10 days following Zolako administration. Patients should be informed about symptoms of hypocalcemia. Physicians should consider clinical monitoring for patients at risk.
Adequate calcium and vitamin D intake is important in women with osteoporosis if dietary intake is inadequate.
Severe and occasionally incapacitating bone, joint and/or muscle pain have been infrequently reported in patients taking bisphosphonates, including Zolako.
Zolako contains the same active ingredient found in Zolako (Zolako), used for oncology indications, and a patient being treated with Zolako should not be treated with Zolako.
Osteonecrosis of the Jaw (ONJ): Osteonecrosis of the jaw has been reported predominantly in cancer patients treated with bisphosphonates, including Zolako. Many of these patients were also receiving chemotherapy and corticosteroids. The majority of reported cases have been associated with dental procedures eg, tooth extraction. Many had signs of local infection including osteomyelitis. A dental examination with appropriate preventive dentistry should be considered prior to treatment with bisphosphonates in patients with concomitant risk factors (eg, cancer, chemotherapy, corticosteroids, poor oral hygiene). While on treatment, these patients should avoid invasive dental procedures if possible. For patients who develop osteonecrosis of the jaw 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 osteonecrosis of the jaw. The clinical judgement of the treating physician should guide the management plan of each patient based on individual benefit/risk assessment.
Effects on the Ability to Drive or Operate Machinery: There are no data to suggest that Zolako affects the ability to drive or use machines.
What happens if I miss a dose of Zolako?
When you miss a dose, you should take it as soon as you remember, but you should take care that it should be well spaced from the next dose. You should not take an extra dose at the time of the second dose as it will become a double dose. The double dose can give unwanted side effects, so be careful. In chronic conditions or when you have a serious health issue, if you miss a dose, you should inform your health care provider and ask his suggestion.
Call your doctor for instructions if you miss an appointment for your Zolako injection.
References
DailyMed. "ZOLEDRONIC ACID: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
