Patient Medication Safety Guidelines for Drugs Containing Bisphosphonates
Please read this medication safety guide carefully before starting to use Zhuoguta® Injection 4mg/100ml. If you have any questions, please ask your doctor or pharmacist. This medication safety guideline does not replace the doctor's professional consultation and advice on your condition or treatment. During medication, please be sure to follow the doctor's arrangements and return for regular check-ups.
Please maintain good personal oral hygiene while using Zhuo Guta® Injection 4 mg/100 ml, and visit the dental clinic regularly for follow-up. If invasive surgeries such as tooth extraction and dental implants are required, please inform the dentist that you are using bisphosphonates and the procedure can only be performed after being evaluated by the doctor.
1. Drug product names in Chinese and English:
Zoledronic Acid Monohydrate 4 mg/100ml (Zometa 4mg/100ml, Zoledronic Acid Monohydrate).2. "About Zhuo Gu® Information you must know":
- This drug is a bisphosphonate drug and can be used "1. In conjunction with standard cancer treatment, it is suitable for patients with multiple myeloma and solid tumors with bone metastasis. When used for bone metastasis in prostate cancer patients , should have received at least one type of hormonal therapy but continue to worsen. 2. Treatment of hypercalcemic complications of malignant tumors (HCM)."
- This drug must be prescribed by a physician and cannot be purchased by patients.
- During long-term use of this medicine, if you notice the following suspected symptoms, please consult your doctor immediately: • Continuous pain, swelling, suppuration in the mouth and gums, numbness of the lips or face, loose or falling teeth, With symptoms such as alveolar bone exposure and failure of tooth wounds to heal, you may be at risk of osteonecrosis of the jaw.
• If you experience persistent pain in your thigh, groin, or hip, you may be at risk for an atypical thigh bone fracture. - Regular follow-up visits should be requested to allow the doctor to evaluate the efficacy and demand for the drug.
- The safety and efficacy of this drug in children are unknown, and there are no special clinical needs or physician instructions. It is not recommended for use in children
- Circumstances in which this drug is not suitable to be used (professional clinical judgment is required):
Oral dosage forms
Injection dosage forms
Hypocalcemia
Allergic to DRAGONTA® or any of its ingredients. For a complete list of ingredients, please see the end of this Medication Information
Severe renal insufficiency
Having certain esophagus (the tube that connects the mouth to the stomach) or digestive problems
—
Unable to stand or sit upright for at least 30 minutes
—
3. Use Zhuo Gu He® and understand the following matters
▸ My oral condition has been confirmed by a physician, including no obvious gum bleeding, pain, or inflammation.
▸ We will proactively inform your doctor if:
▸ Are about to undergo or are undergoing invasive dental treatment such as dental surgery or tooth extraction.
▸ Any problems with your mouth or teeth.
▸ Have ever taken or are currently taking bisphosphonates or other anti-osteoporotic drugs.
▸ Currently taking steroid medicine or have diabetes.
▸ Smoking.
▸ Have had cancer.
▸ Pregnancy, breastfeeding.
4. Things to note when using Zhuo Gu He®
▸ Maintain the habit of brushing your teeth after meals and before going to bed every day to keep your mouth clean, and rinse your mouth frequently to keep your mouth moist.
▸ Use a mirror to check your oral gums every day. If you have symptoms such as gum pain, swelling, suppuration, numbness of the lips or face, loose or missing teeth, exposed alveolar bones, or tooth wounds that cannot heal, you should inform your doctor or dentist.
▸ Go to the dental clinic for regular oral examinations. If you need to undergo invasive surgeries such as tooth extraction or dental implants, proactively inform the dentist that you are currently using bisphosphonate-based drugs.
▸ If you have any persistent thigh, hip or groin pain, inform your physician.
5. This Patient Medication Safety Guide only provides the most important drug safety information. For more details, please refer to the package insert (package sheet) in the box, or consult your physician or pharmacist.
6. If you have any concerns about drug safety, please consult our company, consultation hotline: [02-2700-5238/0932796340].
If you suspect that a drug-related adverse reaction has occurred, please consult your physician or pharmacist as soon as possible, or report it to the National Adverse Drug Reaction Reporting Center. (02-2396-0100; https://adr.fda.gov.tw/Manager/WebLogin.aspx)