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INTRODUCTION ABOUT STOPLOS ONE INFUSION
STOPLOS ONE INFUSION contains Zoledronic Acid, which belongs to the group of medicines called Bisphosphonates. It is used to manage bone complications such as fractures and bone metastases (cancer that has spread from the original (primary) tumour to the bone) in adult patients and helps to reduce the amount of calcium in the blood in adult patients (tumour-induced hypercalcaemia (TIH)).
Along with management with STOPLOS ONE INFUSION, your doctor might ask you to make some lifestyle changes, such as eating a balanced diet rich in calcium and vitamin D. Prior to starting management with STOPLOS ONE INFUSION, your doctor might want you to take some diagnostic tests to understand the existing condition.
Before receiving STOPLOS ONE INFUSION, inform your doctor if you have had or have pain, swelling or numbness of the jaw, a feeling of heaviness in the jaw or loosening of teeth, kidney disease, are having dental management, or are due to undergo dental surgery.
STOPLOS ONE INFUSION is not recommended for use in pregnant and breast-feeding women. STOPLOS ONE INFUSION is not recommended for use in children and adolescents (under 18 years of age) and should be used with caution in elderly patients (aged 65 years and above). Consult your doctor before receiving STOPLOS ONE INFUSION.
The most common side effects of receiving STOPLOS ONE INFUSION are headache, nausea, vomiting, loss of appetite, conjunctivitis, and anemia (a low number of red blood cells). Inform your doctor if any of the symptoms worsen.
USES OF STOPLOS ONE INFUSION
Used in adult patients to:
- Manage bone complications such as fractures and bone metastases
- Helps to reduce the amount of calcium in the blood (tumour-induced hypercalcaemia (TIH))
HOW STOPLOS ONE INFUSION WORKS
STOPLOS ONE INFUSION works by suppressing the activity of osteoclasts, cells that cause the destruction of bones. This strengthens the bones and minimizes the risk of fractures.
DIRECTIONS FOR USE
STOPLOS ONE INFUSION will be given to you only by a doctor or a nurse into a vein (intravenously). Your doctor will decide the correct dose and duration of STOPLOS ONE INFUSION for you depending upon your age, body weight, and disease condition.
SIDE EFFECTS OF STOPLOS ONE INFUSION
COMMON
- Headache
- Flu-like symptoms such as fever, fatigue, weakness, drowsiness, chills, and bone, joint, or muscle pain
- Gastrointestinal reactions such as nausea, vomiting, and loss of appetite
- Conjunctivitis
- Low level of phosphate in the blood
- Low level of red blood cells (anemia)
UNCOMMON
- Allergic reactions
- High or low blood pressure, chest pain
- Rash, itching, redness, and swelling at the infusion site
- Shortness of breath
- Dizziness, anxiety
- Sleep disturbances
- Taste disturbances
- Trembling
- Tingling or numbness of the hands or feet
- Diarrhea, constipation, and abdominal pain
- Dry mouth
- Weight gain
- Increased sweating
- Sleepiness
- Blurred vision, tearing of the eye, and eye sensitivity to light
- Sudden coldness with fainting, limpness, or collapse
- Difficulty breathing with wheezing or coughing
- Urticaria
RARE
- Slow heartbeat
- Confusion
- Unusual fracture of the thigh bone (symptoms such as pain, weakness, or discomfort in the thigh, hip, or groin)
- Interstitial lung disease (inflammation of the tissue around the air sacs of the lungs)
- Joint swelling
- Painful redness and/or swelling of the eye
Consult your doctor if you experience any of the following side effects after receiving STOPLOS ONE INFUSION:
- Severe kidney impairment (signs include nausea, vomiting, fluid retention, and decreased or increased urination)
- Low levels of calcium in the blood (hypocalcaemia) (symptoms such as muscle cramps, dry skin, burning sensations, irregular heartbeat, seizures, spasms, and twitching (tetany))
- Bone damage in the jaw (osteonecrosis) (symptoms such as pain in the mouth, teeth, and/or jaw, swelling or non-healing sores inside the mouth or jaw, discharge, numbness or feeling of heaviness in the jaw or loosening of a tooth)
- Irregular heart rhythm (atrial fibrillation)
- Severe allergic reaction (symptoms such as shortness of breath and swelling mainly of the face and throat)
HOW TO MANAGE SIDE EFFECTS
Constipation
Try to eat more high-fiber foods, such as fresh fruit, vegetables, and cereals, and drink plenty of water. If this does not help, inform your doctor about receiving alternate management for constipation.
Dizziness Or Drowsiness
Lie down until the dizziness is gone, then get up slowly. Move slowly and carefully, do not hurry. Get adequate rest. Drink plenty of water and other fluids. Inform your doctor if the symptom gets worse.
Headache
Drink an ample amount of water and avoid skipping meals. Get adequate rest. Try to be relaxed and stress-free. Apply a pain-relieving balm to your forehead if necessary. Inform your doctor if the symptom does not improve.
Nausea And Vomiting
Stick to simple meals. Avoid eating oily, fried, or spicy foods. Do not lie down or go to sleep immediately after eating. Inform your doctor if the symptom does not improve.
Stomach Pain
Try to rest and relax. Eat and drink slowly or try to have smaller and more frequent meals. Keep a heat pad on your stomach. If the symptom does not improve, inform your doctor.
WARNING & PRECAUTIONS
PREGNANCY
ContraindicatedSTOPLOS ONE INFUSION is not recommended for use by pregnant women. Consult your doctor before receiving STOPLOS ONE INFUSION.
BREASTFEEDING
ContraindicatedSTOPLOS ONE INFUSION is not recommended for use by breastfeeding women. Consult your doctor before receiving STOPLOS ONE INFUSION.
DRIVING AND USING MACHINES
ContraindicatedDo not drive or operate any machines if you feel drowsiness and sleepiness after receiving STOPLOS ONE INFUSION.
KIDNEY
Use with CautionSTOPLOS ONE INFUSION should be used with caution in patients with kidney problems. Consult your doctor before receiving STOPLOS ONE INFUSION.
ALLERGY
ContraindicatedDo not receive STOPLOS ONE INFUSION if you are allergic to Zoledronic Acid, other bisphosphonates (such as alendronate), or any of the other ingredients of this medicine.
USE IN PEDIATRICS
ContraindicatedSTOPLOS ONE INFUSION is not recommended for use in children and adolescents (under 18 years of age). Consult the child’s doctor for advice.
USE IN GERIATRICS
Use with CautionSTOPLOS ONE INFUSION should be used with caution in elderly patients (aged 65 years and above). Consult your doctor before receiving STOPLOS ONE INFUSION.
OTHERS
Before receiving STOPLOS ONE INFUSION, inform your doctor if you:
- Had or have pain, swelling, or numbness of the jaw, a feeling of heaviness in the jaw, or a loosening of teeth
- Are having dental management or are due to undergo dental surgery
INTERACTIONS
A. Drug-Drug interactions:
Before receiving STOPLOS ONE INFUSION, inform your doctor if you have received, are receiving, or are taking any of the following medicines:
- Aminoglycosides such as gentamicin
- Calcitonin
- Loop diuretics such as chlorthalidone and indapamide
- Other calcium-lowering medicines
- Anticancer agents like thalidomide
- Any other bisphosphonates, such as risedronate
- Anti-angiogenic medicines such as bevacizumab and axitinib
Overdosage:
STOPLOS ONE INFUSION will be given to you only by a doctor or nurse in a hospital, and so it is unlikely to receive an overdose. However, if you experience any unusual symptoms, such as serum electrolyte abnormalities (Ex. abnormal levels of calcium, phosphorus, and magnesium) and/or changes in kidney function, including severe kidney impairment, consult your doctor immediately.
SYNOPSIS
| Drug | : | Zoledronic Acid |
| Pharmacological Category | : | Bisphosphonates |
| Therapeutic Indication | : | To manage fractures and bone metastases, reduce the amount of calcium in the blood |
| Dosage Forms | : | Injection, Infusion |
MORE INFORMATION
STORAGE
- Keep out of reach of children
- Store STOPLOS ONE INFUSION below 25°C. Do not freeze
FAQs ABOUT STOPLOS ONE INFUSION
Q: What precautions should be taken before using STOPLOS ONE INFUSION?
A: Inform your doctor if you have any kidney problems, low calcium levels, or any other medical conditions. Ensure adequate hydration before the infusion. Calcium and vitamin D supplements may be recommended to prevent low calcium levels.
Q. Can STOPLOS ONE INFUSION interact with other medications?
A: Yes, STOPLOS ONE INFUSIONcan interact with medications such as aminoglycosides (which can also affect kidney function) and other drugs that may affect calcium levels. Always inform your doctor about all medications you are taking.
Q. How should STOPLOS ONE INFUSIONbe stored?
A: STOPLOS ONE INFUSION should be stored in a refrigerator (2-8°C) and protected from light. It should not be frozen.
Q. What should I do if I experience side effects?
A: Report any side effects to your healthcare provider. Immediate medical attention may be needed for severe reactions.
Q. Is STOPLOS ONE INFUSION safe for long-term use?
A: Your doctor will evaluate the benefits and risks of long-term use based on your specific condition. Regular monitoring of kidney function and other parameters will be necessary during treatment. For any further questions or concerns, always consult your healthcare provider for personalized advice.
Q: How long should I receive STOPLOS ONE INFUSION?
A: STOPLOS ONE INFUSION should be received in the dose and duration as advised by your doctor. The medicine takes around 6 months to show its maximum benefits for bones. However, in some cases, the doctor may suggest STOPLOS ONE INFUSION for a longer duration. The exact duration will depend on the condition you are being managed for.
Q: How is STOPLOS ONE INFUSION administered?
A: STOPLOS ONE INFUSION will be given to you only by a doctor or a nurse into a vein (intravenously). Your doctor will decide the correct dose and duration of STOPLOS ONE INFUSION for you depending upon your age, body weight, and disease condition.
Q: What are the lifestyle changes I should follow while receiving STOPLOS ONE INFUSION?
A: To get maximum benefit from this medicine, there are certain lifestyle changes that you must adhere to. Include some calcium- or vitamin-D-rich foods for bone strength. Try to spend more time in sunlight to get natural vitamin D. Quit smoking and reduce alcohol consumption, as they may harm your bones. You can take up an exercise regime such as walking and low-impact aerobics, as they are good for your bones. Similarly, you can try strength-training exercises where you use your own body weight, which in turn improves bone health.
Q: Can STOPLOS ONE INFUSION cause constipation?
A: Yes, STOPLOS ONE INFUSION may cause constipation in some individuals. To manage this effect, try to eat more high-fiber foods such as fresh fruit, vegetables, and cereals, and drink plenty of water. If this does not help, inform your doctor about receiving alternate management for constipation.
Q: Is STOPLOS ONE INFUSION safe to use in pregnant or breast-feeding women?
A: STOPLOS ONE INFUSION is not recommended for use in pregnant and breast-feeding women. Consult your doctor before receiving STOPLOS ONE INFUSION if you are pregnant, planning to be pregnant, or breast-feeding.
REFERENCES
1. Briggs GG, Freeman RK, editors. A Reference Guide to Fetal and Neonatal Risk: Drugs in Pregnancy and Lactation. 10th ed. Philadelphia, PA: Wolters Kluwer Health; 2015. Page - 4229-4231.
2. R Berenson. Zoledronic acid in cancer patients with bone metastases: results of Phase I and II trials. NIH: National Library of Medicine, National center of biotechnology Information Pubmed.gov. April 2001. [Accessed on 8th July 2024] https://pubmed.ncbi.nlm.nih.gov/11346862/
3. Ali Haidar, Morten Jonler, Troels B Folkmar, Lars Lund. Bisphosphonate (zoledronic acid)-induced osteonecrosis of the jaw. NIH: National Library of Medicine, National center of biotechnology Information Pubmed.gov. 2009. [Accessed on 8th July 2024] https://pubmed.ncbi.nlm.nih.gov/19903091/
4. Seacross Pharmaceuticals Ltd. Electronic Medicines Compendium (EMC). [Revised in November 2021] [Accessed on 8th July 2024] https://www.medicines.org.uk/emc/files/pil.7205.pdf
USEFUL DIAGNOSTIC TESTS
- Calcium
- Vitamin D 1,25 Dihydroxy
- Extended Arthritis Care
- Comprehensive Arthritis Care
- Basic Bone Care
- Advance Bone Care
- Comprehensive Bone Care
- Esr Automated
- Phosphorus-Inorganic, Serum
- Basic Arthritis Care Plan
- Bone Strength Package
- Arthritis Profile-Basic
- Arthritis Profile-Advanced
- Pth-Intact Molecule Parathyroid Hormone
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