Specification

ZOMETA 4mg Infusion 100ml

Zoledronic Acid 4 mg

ZOMETA 4MG contains Zoledronic Acid which belongs to the group of medicines called Bisphosphonates. ZOMETA 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 ZOMETA 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 ZOMETA 4MG your doctor might want you to take some diagnostic tests to understand the existing condition.
ZOMETA 4MG is not recommended for use in patients with severe kidney problems and hypocalcemia (low levels of calcium in the blood). ZOMETA 4MG is not recommended for use in pregnant and breastfeeding women. Consult your doctor before receiving ZOMETA 4MG.
ZOMETA 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 ZOMETA 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 ZOMETA 4MG

Treats osteoporosis or corticosteroid-induced osteoporosis (in post-menopausal women and adult men)

Treats Paget?s disease of the bone (in adults)
HOW ZOMETA 4MG WORKS
ZOMETA 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
ZOMETA 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 ZOMETA 4MG for you depending upon your age, body weight and disease condition.
SIDE EFFECTS OF ZOMETA 4MG

COMMON

Fever, chills

Pain in muscles, joints or bones

Headache, dizziness

Sickness, vomiting

Diarrhoea

Pain in back, arms or legs

Flu-like symptoms such as tiredness, fever, muscle pain

Lack of interest, weakness, feeling unwell

Pain

Swelling or pain at the infusion site

Low calcium levels in blood (signs include muscle spasms or numbness or tingling sensation)

UNCOMMON

Upper respiratory tract infections

Decreased red cell count (anaemia)

Loss of appetite, heartburn

Sleeplessness

Sleepiness associated with reduced alertness and awareness

Tingling sensation or numbness, flushing

Temporary loss of consciousness, trembling

Eye infection or irritation or inflammation with pain and redness

Spinning sensation (vertigo)

Increased blood pressure

Shortness of breath, cough

Abdominal pain, upset stomach, constipation

Dry mouth, thirst

Skin rash, itching, skin reddening

Excessive sweating

Stiffness in muscles, bones or joints

Shoulder or neck pain, muscle spasms

Pain in chest muscles and rib cage

Joint inflammation

Muscular weakness

Abnormal frequent urination

Extreme tiredness, swelling of hands, ankles or feet

Toothache

Taste disturbances

RARE

Low levels of phosphate in blood

Unusual fracture of thigh bone (symptoms such as pain, weakness or discomfort in thigh, hip or groin)
Consult your doctor if you experience any of the following side effects after receiving ZOMETA 4MG:
Irregular heart rhythm (atrial fibrillation)

Swelling, redness, pain and itching to the eyes or eye sensitivity to light

Osteonecrosis of the jaw (signs include any problems with your mouth or teeth such as loose teeth, pain or swelling, or non-healing of sores or discharge)

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

PREGNANCY
ZOMETA 4MG is not recommended for use in pregnant women. Consult your doctor before receiving ZOMETA 4MG.
BREASTFEEDING
ZOMETA 4MG is not recommended for use in breastfeeding women. Consult your doctor before receiving ZOMETA 4MG.
DRIVING AND USING MACHINES
Do not drive or operate any machines if you feel dizziness after receiving ZOMETA 4MG.
KIDNEY
ZOMETA 4MG is not recommended for use in patients with severe kidney disease and it should be used with caution in patients with other kidney problems. Consult your doctor before receiving ZOMETA 4MG.
ALLERGY
Do not receive ZOMETA 4MG if you are allergic to Zoledronic Acid or other bisphosphonate (such as alendronate) or any of the other ingredients of this medicine.
OTHERS
ZOMETA 4MG is not recommended for use if you:
Have hypocalcaemia (low levels of calcium in the blood)
Before receiving ZOMETA 4MG inform your doctor if you:
Are unable to take daily calcium supplements

Have had some or all of the parathyroid glands in neck surgically removed

Have had intestinal sections removed

Have any problems with mouth or teeth such as poor dental health or gum disease

Have not received routine dental care or have not had dental check-up for long time

Are smoker (increase the risk of dental problems)

Are under dental treatment or due to undergo dental surgery (Ex. tooth extractions)

Have cancer
Use in paediatrics:
ZOMETA 4MG is not recommended for use in children and adolescents (under 18 years of age). Consult child?s doctor for advice.
Use in geriatrics:
ZOMETA 4MG should be used with caution in elderly patients (aged 65 years and above). Consult your doctor before receiving ZOMETA 4MG.
INTERACTIONS
A. Drug ? Drug Interactions:
Before receiving ZOMETA 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)
ZOMETA 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 ZOMETA 4MG.
SYNOPSIS

Drug :?? Zoledronic Acid

Pharmacological Category :?? Bisphosphonates

Therapeutic Indication :?? Osteoporosis, Paget?s disease of the bone

Dosage Forms :?? Injection, Infusion

MORE INFORMATION

Store at room temperature

FAQs ABOUT ZOMETA 4MG
How long should I receive ZOMETA 4MG?
ZOMETA 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 ZOMETA 4MG for a longer duration. The exact duration will depend on the condition you are being treated for.
How is ZOMETA 4MG administered?
ZOMETA 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 ZOMETA 4MG for you depending upon your age, body weight and disease condition.
What are the lifestyle changes should I follow while receiving ZOMETA 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 ZOMETA 4MG cause constipation?
Yes, ZOMETA 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 ZOMETA 4MG safe to use in pregnant or breast-feeding women?
ZOMETA 4MG is not recommended for use in pregnant and breast-feeding women. Consult your doctor before receiving ZOMETA 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
PRODUCT DETAILS

Net Qty

1 N
Item Weight

120 g
Ingredient
Zoledronic Acid 4.264 MG
Hsn Code

30049049

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Additional information

Weight
120 g

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