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INTRODUCTION
STOPLOS ONE contain zoledronic acid which belongs to a group of medicine called bisphosphonates. It is used to treat osteoporosis in post-menopausal women and adult men, osteoporosis caused by treatment with corticosteroid used to treat inflammation and Paget’s disease of the bone in adult. Osteoporosis is a disease that involve the thinning and weakening of the bone and is common in women after the menopause but can also occur in men.
At the menopause, woman ovary stops producing the female hormone oestrogen, which help keep bone healthy. This makes the become weaker and break more easily leading to bone loss. Osteoporosis could also occur in men and women due to long-term use of steroid, which can affect the strength of bones. In both women and men, STOPLOS ONE strengthens the bone and therefore makes it less likely to break.
Normally old bone is removed and is replaced with new bone material. This process is called remodelling. In Paget’s disease, this process is too fast and new bones formation occurs in a disordered manner resulting in weakened and fragile bones. It works by bringing the remodelling process to normal and helps in the formation of normal bone, thus restoring strength to the bone. It is strictly not recommended for use in children and adolescents under 18 years of age. Before taking this medicine tell your doctor if you have ever had kidney disease, heart disease, liver problems. Pregnant and breastfeeding women should consult their doctor before taking this medicine.
USES OF STOPLOS ONE
- Treat osteoporosis in post-menopausal women and adult men
- Treat osteoporosis caused by treatment with corticosteroid used to treat inflammation
- Treat paget’s disease of the bone in adult
HOW STOPLOS ONE WORKS
STOPLOS ONE works by suppressing the activity of osteoclasts, cells that cause destruction of bone. This strengthens the bones and minimizes the risk of fractures. In Paget’s disease, this medicine works by returning the bone remodelling process to normal thus securing formation of normal bone and restores strength of the bone.
DIRECTIONS FOR USE
STOPLOS ONE will be given as an infusion into your vein administered by a doctor or nurse. Your doctor will decide the dose and frequency depending on your condition.
SIDE EFFECTS OF STOPLOS ONE
COMMON
- fever, chills
- pain in the muscles or joints, pain in the back, arms, or legs
- headache
- irregular heart rhythm (atrial fibrillation)
- dizziness, sickness
- diarrhoea, vomiting
- flu-like symptoms such as tiredness
- lack of interest
- pain, weakness
- feeling unwell
- swelling and/or pain at the infusion site
- low blood calcium, such as muscle spasms, or numbness, or tingling sensation especially in the area around the mouth
RARE
- unusual fracture of the thigh bone
- discomfort in your thigh, hip
- low levels of phosphate in the blood
HOW TO MANAGE SIDE EFFECTS
Headache:
Apply hot or cold-water bag on your head. Take rest in a quiet and dark room. Drink tea or coffee.
Dizziness:
Get up and move around to feel awake, take small naps to edge off the sleepiness. Give your eyes a break to avoid fatigue and eat a healthy food to boost energy.
Vomiting:
Try taking this medicine with, or just after, a meal or snack and stick to simple meals and do not eat rich or spicy food.
Diarrhoea:
Drink lot of fluid such as water or squash, to avoid dehydration. Do not take any other medicines without talking to a doctor.
WARNING & PRECAUTIONS
PREGNANCY
STOPLOS ONE is not recommended for use in pregnant women unless necessary. Discuss the risks and benefits with your doctor.
BREASTFEEDING
STOPLOS ONE is not recommended for use in breastfeeding women unless necessary. Discuss the risks and benefits with your doctor.
DRIVING AND USING MACHINES
Do not drive or operate any machine while taking this medicine as it may cause dizziness.
ALCOHOL
Consumption of alcohol is not recommended during treatment with STOPLOS ONE.
KIDNEY
STOPLOS ONE is not recommended in patients with active kidney diseases. Before taking this medicine consult your doctor.
ALLERGY
Do not take STOPLOS ONE if you are allergic (hypersensitive) to zoledronic acid or any other ingredients in this medicine.
OTHERS
Tell your doctor, if you:
- have hypocalcaemia (this mean that the level of calcium in your blood are too low)
- are unable to take daily calcium supplements
- have had some or all of the parathyroid gland in your neck surgically removed
- have had sections of your intestine removed
- do not receive routine dental care or have not had a dental check-up for a long time
- are a smoker (as this may increase the risk of dental problem)
- have cancer
- should maintain good oral hygiene (including regular teeth brushing) and receive routine dental check-ups
- wear denture you should make sure these fit properly
- are under dental treatment or are due to undergo dental surgery (e.g., tooth extraction)
INTERACTIONS
Talk to your doctor if you are taking,
- aminoglycosides
- diuretics (waterpills)
SYNOPSIS
| Drug | : | Zoledronic acid |
| Pharmacological Category | : | Bisphosphonate Derivative |
| Therapeutic Indication | : | Bone complications |
| Dosage Forms | : | Injection |
MORE INFORMATION
Store below 20-25°C and keep out of reach of children.
FAQs ABOUT STOPLOS ONE
Does STOPLOS ONE safe while driving?
No, do not drive or operate any machine while taking this medicine as it may cause dizziness.
Can STOPLOS ONE be given in children and adolescents?
No, it is strictly not recommended for use in children and adolescents under 18 years of age.
Does STOPLOS ONE cause bone pain?
It can cause bone, joint and/or muscle pain that can be severe. This may occur from 1 day to several months after starting the medication. Inform these symptoms to your doctor, who can advise you on strategies to relieve the pain.
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. E Michael Lewiecki. Intravenous zoledronic acid for the treatment of osteoporosis: The evidence of its therapeutic effect. US National Library of Medicines, National Institutes of Health. 15 Jun 2010. [Accessed 21 Dec 2020] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2899787/
3. Dennis M Black 1, Pierre D Delmas, Richard Eastell, Ian R Reid, Steven Boonen, Jane A Cauley, Felicia Cosman, Péter Lakatos, Ping Chung Leung, Zulema Man, Carlos Mautalen, Peter Mesenbrink, Huilin Hu, John Caminis, Karen Tong, Theresa Rosario-Jansen, Joel Krasnow, Trisha F Hue, Deborah Sellmeyer, Erik Fink Eriksen, Steven R Cummings, HORIZON Pivotal Fracture Trial. Once-yearly zoledronic acid for treatment of postmenopausal osteoporosis. NIH: National Library of Medicine, National center of biotechnology Information Pubmed.gov. 3 May 2007. [Accessed 21 Dec 2020] https://pubmed.ncbi.nlm.nih.gov/17476007/
4. Dr. Reddy’s Laboratories (UK) Ltd; Electronic Medicines Compendium (EMC); [Revised on Jan 2020] [Accessed 21 Dec 2020] https://www.medicines.org.uk/emc/files/pil.3623.pdf
USEFUL DIAGNOSTIC TESTS
- Calcium
- Intact Parathyroid Hormone
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