Aclasta drug infusion solution 5mg/100 ml indicated for postmenopausal osteoporosis, osteoporosis in men, prevention of clinical fractures after hip fractures in men & women, corticosteroid osteoporosis.
Aclasta medicine 5mg/100ml Zoledronic acid treatment of osteoporosis
- Active ingredient: A 100ml bottle of solution contains 5mg of Zoledronic acid (anhydrous), which corresponds to 5,330mg of zoledronic acid monohydrate.
- Excipients: Mannitol, sodium citrate, water for injection.
- Dosage form: Infusion solution. Aseptic solution, transparent and colorless.
- Manufacturer: Novartis
- Aclasta Drug Prices: COMMENT below for prices OR Click on the link: https://thuoclp.com/chatFB type “Aclasta”
Assign the drug Aclasta
- Treatment of osteoporosis in postmenopausal women to reduce the incidence of hip fractures, vertebral fractures, non-vertebral fractures and to increase bone mineral density.
- Prevention of clinical fractures after hip fractures in men and women.
- Treatment of Paget’s bone disease.
Dosage of Aclasta 5mg/100ml Zoledronic Acid
- Treatment of postmenopausal osteoporosis: To treat postmenopausal osteoporosis, the recommended dose is a single intravenous infusion of 5 mg Aclasta once a year.
- Prevention of clinical fractures after hip fractures: To prevent clinical fractures after hip fractures, the recommended dose is a single intravenous dose of 5 mg Aclasta once a year.
- Treatment of Paget’s bone disease: To treat Paget’s disease, Aclasta should only be prescribed by doctors who are experienced in treating Paget’s bone disease. The recommended dose is a single intravenous infusion of 5 mg Aclasta.
How to use Aclasta medicine
- Aclasta (5 mg in 100 ml available in infusion solution) is administered intravenously through an open vial with a constant infusion rate. Transmission time should not be less than 15 minutes. Supplement calcium and vitamin D before and after the infusion.
- Patients with renal impairment: Aclasta is not recommended for patients with creatinine clearance <35mL / min to ensure a sufficient safety level to avoid renal failure in patients taking drugs outside the test environment. No dose adjustment is necessary in patients with creatinine clearance> 35 ml / min.
- Hepatic impairment: No dose adjustment is necessary.
- Elderly (≥ 65 years): No dose adjustment is necessary because the bioavailability, distribution and elimination are the same between elderly patients and young people.
- Children and adolescents: Aclasta is not recommended for children and adolescents under 18 years of age due to lack of safety and efficacy data.
Contraindications to aclasta medicine
- Hypersensitivity to the active substance or to any component of the excipient or to all bisphosphonates.
- Pregnant and lactating women.
Report and exercise caution before using aclasta medication
- Read the manual carefully before use. If you need information, please consult your doctor.
- This medicine is for prescription only.
- Zoledronic acid dose of 5 mg must be infused over a period of at least 15 minutes.
- Aclasta has the same active ingredient as Zometa (Zoledronic acid) commonly used in cancer indications, and patients treated with Zometa must not take Aclasta.
- Patients must receive appropriate rehydration before taking Aclasta. This is especially important in the elderly and for patients taking diuretics.
- Pre-existing hypocalcemia must be treated with enough calcium and vitamin D before starting treatment with Aclasta. Other disorders of mineral metabolism must also be effectively treated (eg, decreased parathyroid hormone reserves, intestinal calcium malabsorption). Physicians should consider clinical monitoring in these patients.
- Renal impairment: Aclasta is not recommended for patients with renal impairment (creatinine clearance <35 ml / min) to ensure a sufficient level of safety to avoid renal failure in patients taking drugs outside the test environment. Patients should be measured serum creatinine before taking Aclasta.
- Treatment of postmenopausal osteoporosis: Adequate intake of calcium and vitamin D is important for women with osteoporosis if dietary intake is inadequate.
- Prevention of clinical fractures after hip fractures: Calcium and vitamin D supplements are recommended for patients treated to prevent clinical fractures after hip fractures.
- Musculoskeletal pain: Occasionally severe bone, joint and / or muscle pain has been reported and sometimes loss of function in patients receiving bisphosphonate, including Aclasta.
- Osteonecrosis of the jaw: Dental consideration should be considered with appropriate preventive dentistry prior to bisphosphonate treatment in patients with associated risk factors (e.g. cancer, chemotherapy, corticosteroids, oral hygiene least).
Drug interaction aclasta
- No studies have been conducted on specific drug interactions with zoledronic acid. Zoledronic acid is eliminated by renal excretion. Be careful while taking Aclata in combination with drugs that have a significant effect on renal function (e.g., aminoglycosides or diuretics that can cause loss of blood).
Pregnant and lactating women
- There are no data on the use of zoledronic acid in pregnant women.
Impact of drugs when driving and operating machinery
- There are no data on the use of Alasta that affects the ability to drive or use machines.
Undesirable effects when using Aclasta 5mg/100ml medicine
- As with intravenous bisphosphonates, Alasta is most often associated with the following symptoms when taking the drug: fever (18.1%), myalgia (9.4%), flu-like symptoms (7.8 %), joint pain (6.6%) and headache (6.5%), the majority of these symptoms occur within the first 3 days after using Alasta. Most of these symptoms are mild to moderate in nature and within three days of onset of symptoms. The incidence of these symptoms decreased markedly with the next dose of Alasta.
- The rate of symptoms after taking the drug within the first 3 days after taking Alasta can be reduced by about 50% when using paracetamol or ibuprofen early after taking Alasta.
- In a 3-year trial in postmenopausal osteoporosis women (horizon PFT trial), the overall incidence of fibrillation was low in 2.5% of patients (96 out of 3862 patients) in the Alasta group compared to with 1.9% of patients (75 of 3852 patients) in the placebo group. The low observed increase in this trial was not observed in other clinical trials using zoledronic acid.
Reaction in place
- In the HORIZON-PFT trial, there were reports of local infusion reactions such as redness, swelling and / or pain (0.7%) after administration of zoledronic acid.
- In the HORIZON-PFT trial, the incidence of side effects was the same in both Alasta and placebo treatments.
- In the HORIZON-PFT assay, there were no reports of osteonecrosis of the jaw.
- No cases of overdose have been reported. In the event of an overdose resulting in clinically significant hypocalcaemia, it may be reversible by supplementation with oral calcium and / or infusion of calcium gluconate.
Aclasta drug incompatibility
- Alasta infusion solution is not allowed to contact with any solution containing calcium.
Shelf life: 36 months.
Preservation of aclasta medicine
- Unopened bottles: do not store above 30oC.
- After opening: the solution is chemically stable for at least 24 hours at 2-8oC.
- Keep out of reach and sight of children.
- Do not use after the expiry date of Alasta marked “EXP” on the package.
Instructions for use and operation
- Do not mix Aclasta or intravenously with any other medicine and must pass the medicine through a separate line with openings with constant infusion rate. If kept in the refrigerator, allow the solution to return to room temperature before use. Aseptic techniques should be followed throughout the infusion.
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Conventional processes zoledronic acid 5mg/100ml
When identifying patients with osteoporosis, indicated treatment (aclasta infusion) patients need to be fully prepared with the following steps:
1. Tests to be done before infusion:
- The concentration of calcium in the blood.
- 25 – (OH) vitamin D in the blood.
- Bone-building marker BSAP, Osteocalcin. Bone fracture marker CTX.
- Creatinine clearance.
2. Examining and identifying patients without pathologies of teeth and jaw.
3. When the test results allow for infusion, the following steps are prepared:
- Explain the effects and therapeutic effects of the drug.
- Explain to patients the possible side effects (muscle aches, fever, headache, joint pain, etc.), how to prevent and treat them.
- Calcium supplementation (intravenous 0.5g calcium before infusion)
- Prepare an infusion with an isotonic infusion of 500 ml 1 bottle (5% glucose or 0.9% NaCl).
Implementing Aclasta Infusion Technique
Follow the sequence of the infusion technique:
- Set intravenous line with bottle of isotonic infusion fluid flow at a rate of 40 drops / minute, about 300ml flow (the purpose of the infusion is to rehydrate enough patients).
- Temporarily stop the isotonic bottle, switch to the Aclasta bottle to quickly flow 60 drops / minute. During this time monitor the patient’s blood pressure and pulse.
- After finishing the bottle, Aclasta transfers the bottle of isotonic fluid to the end (replenishes enough water for the patient), draws the needle for the patient lying down for 15 minutes, measures the blood pressure, and counting the pulse before returning the patient.
Instructing patients and relatives of patients
- Self-monitoring, detection of side effects of the drug: often painful ache all over the body, fatigue like the flu. Treatment: efferalgan 500mg 1 capsule x 3 times a day, drink plenty of water. This symptom will resolve after 2 to 3 days.
- Notify doctor for treatment as soon as other abnormal signs.
- Take calcium and vitamin D supplements by prescription. Eat enough protein, eat foods rich in Calcium and vitamin D.
- Sunbathing every day in the morning: expose the skin widely, expose directly in the sun for 20 to 30 minutes (do not let light shine directly into the eyes).
- Exercise exercises suitable to each condition of the patient.
- Re-examination on time.
- Instructions on how to daily activities in life, avoid falling:
- When walking, you can use a supportive stick, doing gentle and slow activities to avoid strong and unexpected impacts.
- Bathrooms must be dry, so there are handrails.
- No hammock, high bed.
- When falls, you should go to the hospital to have X-rays checked.
Create a monitoring program for treatment results
Phone monthly to visit patients and remind patients:
- Take medication (calcium and vitamin D) continuously and at the right dose.
- After 4-6 months of infusion, check bone maker again to monitor drug response.
- After each year of treatment, measure bone density for bone density recovery.
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Assoc.Prof.Dr. Tran Ngoc Anh is currently Hanoi Medical University Hospital, Associate Professor, Department of Internal Medicine, Gastroenterology and Head of Department of General-Uematology of Hanoi Medical University. Consulting doctor at ThuocLP Pharmacy.
Professional qualifications, Academic degrees – Education:
Graduated from General Practitioner System, Hanoi Medical University
Graduated with a Master degree in Internal Medicine, Hanoi Medical University
Graduated from the training program specialized in Gastrointestinal, Henri Mondor Institute Center, University of Paris 6, French Republic 1996-1997; 1999
Graduated from the training program specialized in Gastrointestinal, North Royal Sydney Hospital, Australia; 2002
Graduated from a training program specialized in chronic liver diseases, Pizza, Italy 2009
Graduated with a PhD in Gastrointestinal, Hanoi Medical University
Associate Professor, Gastroenterology, Hanoi Medical University
Training and Scientific Research:
Published more than 200 articles in domestic and international specialized journals
Editor of many monographs and participates in compiling 2 textbooks.
Guide many students and graduate students of Hanoi Medical University
Manager of many grassroots research projects
Certificate of Good Clinical Practice (GCP: 2012, 2015), Ministry of Health
Specialized certificates: General gastrointestinal endoscopy, Interventional gastrointestinal endoscopy, General gastrointestinal ultrasound, Interventional gastrointestinal ultrasound (Bach Mai BV), Chronic liver disease.