INTRODUCTION

OSTEOMET 4MG contains Zoledronic Acid which belongs to the group of medicines called Bisphosphonates. OSTEOMET 4MG is used in post-menopausal women and adult men to treat osteoporosis or osteoporosis caused by treatment with corticosteroids and Paget’s disease of the bone in adults.

Osteoporosis is a bone disease that develops when bone mineral density and bone mass decreases or when the quality or structure of the bone changes. It usually occurs in women after the menopause and also occurs in adult men. Paget's disease of bone is a chronic bone disorder which disrupts the normal cycle of bone renewal, causing bones to become weakened and possibly deformed.

Along treatment with OSTEOMET 4MG your doctor might ask you to make some lifestyle changes such as eating balanced diet rich in calcium and vitamin D. Prior to starting the treatment with OSTEOMET 4MG your doctor might want you to take some diagnostic tests to understand the existing condition.

OSTEOMET 4MG is not recommended for use in patients with severe kidney problems and hypocalcemia (low levels of calcium in the blood). OSTEOMET 4MG is not recommended for use in pregnant and breastfeeding women. Consult your doctor before receiving OSTEOMET 4MG.

OSTEOMET 4MG is not recommended for use in children and adolescents (under 18 years of age) and should be used with caution in elderly patients. The most common side effects of receiving OSTEOMET 4MG are headache, dizziness, vomiting, diarrhoea, fever, chills, pain in muscles, joints or bones and pain in back, arms or legs. Inform your doctor if any of the symptom worsens.

USES OF OSTEOMET 4MG

• treats osteoporosis or corticosteroid-induced osteoporosis (in post-menopausal women and adult men)
• treats Paget’s disease of the bone (in adults)

HOW OSTEOMET 4MG WORKS

OSTEOMET 4MG works by suppressing the activity of osteoclasts, cells that cause destruction of bone. This strengthens the bones and minimizes the risk of fractures.

DIRECTIONS FOR USE

OSTEOMET 4MG 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 OSTEOMET 4MG for you depending upon your age, body weight and disease condition.

SIDE EFFECTS OF OSTEOMET 4MG

HOW TO MANAGE SIDE EFFECTS

Headache:

Drink ample amount of water and avoid skipping meals. Get adequate rest. Try to be relaxed and stress free. Apply pain relieving balm on your forehead if necessary. Inform your doctor if the symptom does not improve.

Vomiting:

Stick to simple meals. Avoid eating oily, fried or spicy foods. Do not lie down or sleep immediately after eating. Inform your doctor if the symptom does not improve.

Dizziness:

Lie down until 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.

Diarrhoea:

Drink lot of fluids such as water to keep yourself hydrated. Avoid eating high fat or spicy foods. Inform your doctor if the symptom gets worse.

Constipation:

Try to eat more high-fiber foods such as fresh fruit, vegetables, cereals, and drink plenty of water. If this does not help, inform your doctor for receiving alternate treatment for constipation.

Abdominal pain:

Try to rest and relax. Eat and drink slowly or try to have smaller and frequent meals. Keep a heat pad on your stomach. If the symptom does not improve, inform your doctor.

WARNING & PRECAUTIONS

INTERACTIONS

A. Drug – Drug Interactions:

Before receiving OSTEOMET 4MG, inform your doctor if you are taking any of the following medicines:

• aminoglycosides such as gentamicin (used to treat severe bacterial infections)
• diuretics (water pills) such as chlorthalidone, indapamide (used to treat high blood pressure or oedema)
• other bisphosphonates such as alendronate (used to treat or prevent bone disorders)
• corticosteroids such as prednisolone or dexamethasone (used to treat inflammation)

Overdosage:

OSTEOMET 4MG will be administered to you only by a doctor or a nurse in a hospital, and so it is unlikely to receive an overdose. However, consult your doctor or nurse if you experience any unusual symptoms after receiving OSTEOMET 4MG.

SYNOPSIS

MORE INFORMATION

• Store at room temperature

FAQs ABOUT OSTEOMET 4MG

How long should I receive OSTEOMET 4MG?

OSTEOMET 4MG should be received in the dose and duration as advised by your doctor. The medicine takes around 6 months to show its maximum benefits on bones. However, in some cases, the doctor may suggest OSTEOMET 4MG for a longer duration. The exact duration will depend on the condition you are being treated for.

How is OSTEOMET 4MG administered?

OSTEOMET 4MG 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 OSTEOMET 4MG for you depending upon your age, body weight and disease condition.

What are the lifestyle changes should I follow while receiving OSTEOMET 4MG?

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 improve bone health.

Can OSTEOMET 4MG cause constipation?

Yes, OSTEOMET 4MG may cause constipation in some individuals. To manage this effect, try to eat more high-fibre foods such as fresh fruit, vegetables, cereals and drink plenty of water. If this does not help, inform your doctor for receiving alternate treatment for constipation.

Is OSTEOMET 4MG safe to use in pregnant or breast-feeding women?

OSTEOMET 4MG is not recommended for use in pregnant and breast-feeding women. Consult your doctor before receiving OSTEOMET 4MG if you are pregnant or planning to 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. Ma Chao, Qin Hua, Zhou Yingfeng, Wan Guang, Shi Shufeng, Dong Yuzhen, Wang Wei, and Tan Haifeng. Study on the role of zoledronic acid in treatment of postmenopausal osteoporosis women. NIH: National Library of Medicine, National center of biotechnology Information, PMC Pubmed Central. December 2013 [Accessed on 7th June 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3905367/

3. Margaret Seton and Stephen M Krane. Use of zoledronic acid in the treatment of Paget’s disease. NIH: National Library of Medicine, National center of biotechnology Information, PMC, Pubmed Central. October 2007 [Accessed on 7th June 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2376069/

4. Sun Pharmaceutical Industries Europe B.V. Electronic Medicines Compendium (EMC). [Revised in October 2020] [Accessed on 7th June 2022] https://www.medicines.org.uk/emc/files/pil.5242.pdf

USEFUL DIAGNOSTIC TESTS

• Calcium Test
• Intact Parathyroid Hormone