If they experience any oral symptoms, they should immediately report them to their physician or dentist. Adequate calcium and vitamin D intake is important in patients with osteoporosis and the current recommended daily intake of calcium is 1200 mg and vitamin D is 800 international units – 1000 international units daily. All patients should be instructed on the importance of calcium and vitamin D supplementation in maintaining serum calcium levels. After getting Reclast it is strongly recommended patients with Paget’s disease take calcium in divided doses (for example, 2 to 4 times a day) for a total of 1500 mg calcium a day to prevent low blood calcium levels. This is especially important for the two weeks after getting Reclast [see WARNINGS AND PRECAUTIONS].
- No clinical data are available for use of Reclast in patients with hepatic impairment.
- At the end of the year the accountants need to appropriately allocate payroll expenses, plus taxes due and payable.
- This might be necessary if an entry is made without complete information.
- A subset had recurrence of symptoms when rechallenged with the same drug or another bisphosphonate [see ADVERSE REACTIONS].
- All osteoporosis patients should be instructed on the importance of calcium and vitamin D supplementation in maintaining serum calcium levels [see DOSAGE AND ADMINISTRATION, ADVERSE REACTIONS, PATIENT INFORMATION].
For young athletes, graduating a year earlier frees them to start their college sports career, with the hope of playing professionally sooner.[1][2] On the other hand, an athlete repeating a grade and delaying graduation is allowed an extra year to mature. In most cases, a student who reclassified to graduate earlier also previously repeated a grade. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Data sources include IBM Watson Micromedex (updated 5 Nov 2023), Cerner Multum™ (updated 24 Oct 2023), ASHP (updated 11 Oct 2023) and others.
Basic Classification FAQs
Reclast significantly decreased the incidence of new vertebral fractures at one, two, and three years as shown in Table 5. The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. There have been reports of bronchoconstriction in aspirin-sensitive patients receiving bisphosphonates, including Reclast. Before being given Reclast, patients should tell their doctor if they are aspirin-sensitive.
- Allergic reactions with intravenous zoledronic acid including anaphylactic reaction/shock, urticaria, angioedema, Stevens-Johnson syndrome, toxic epidermal necrolysis, and bronchoconstriction have been reported.
- The research designations will be separated from the Basic Classification, becoming additional listings for those institutions that meet the definitions.
- Although about 90 to 95% of jobs that are formally submitted for reclassification review are upwardly reclassified, the ones that are denied can cause frustration for the employees involved.
- However, changes in BMD in individual patients with severe osteogenesis imperfecta did not necessarily correlate with the risk for fracture or the incidence or severity of chronic bone pain.
- If you notice other effects not listed above, contact your doctor or pharmacist.
- Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products.
In the postmenopausal osteoporosis trial, Study 1, in 7736 patients, after initiation of therapy, symptoms consistent with ONJ occurred in one patient treated with placebo and one patient treated with Reclast. Both cases resolved after appropriate treatment [see WARNINGS AND PRECAUTIONS]. No reports of osteonecrosis of the jaw were reported in either treatment group in Study 2. Adverse reactions reported in at least 2% of patients with osteoporosis and more frequently in the Reclast-treated patients than placebo-treated patients in either osteoporosis trial are shown below in Table 1. After a single treatment with Reclast in Paget’s disease an extended remission period is observed.
However, adverse reactions seen more commonly in pediatric patients included pyrexia (61%), arthralgia (26%), hypocalcemia (22%) and headache (22%). These reactions, excluding arthralgia, occurred most frequently within three days after the first infusion and became less common with repeat dosing. Because of long-term retention in bone, Reclast should only be used in children if the potential benefit outweighs the potential risk. Concomitant osteoporosis therapies excluding other bisphosphonates and parathyroid hormone were allowed. Reclast was administered once a year as a single 5 mg dose in 100 mL solution, infused over at least 15 minutes.
What is Reclast?
They may be bilateral and many patients report prodromal pain in the affected area, usually presenting as dull, aching thigh pain, weeks to months before a complete fracture occurs. A number of reports note that patients were also receiving treatment with glucocorticoids (e.g., prednisone) at the time of fracture. While on treatment, patients with concomitant risk factors should avoid invasive dental procedures if possible.
Reclassification is a dynamic process that helps maintain the accuracy and integrity of financial reporting. Accountants and financial professionals must stay up-to-date with accounting standards and company policies to ensure the proper classification and reclassification of transactions. By considering these reasons for reclassification, businesses can provide transparent and reliable financial information to stakeholders, fostering trust and facilitating effective decision-making. Reclassification, as the term suggests, refers to the act of changing the classification or category of a financial transaction or account.
Sign up for our newsletter to keep up to date with the latest accounting news and resources
It is not known how long Reclast works for the treatment and prevention of osteoporosis. You should see your doctor regularly to determine if Reclast is still right for you. Your doctor may tell you to see your dentist before you start Reclast.
Pre-existing hypocalcemia and disturbances of mineral metabolism (e.g., hypoparathyroidism, thyroid surgery, parathyroid surgery; malabsorption syndromes, excision of small intestine) must be effectively treated before initiating therapy with Reclast. Clinical monitoring of calcium and mineral rv insurance policy for your rv or travel trailer levels (phosphorus and magnesium) is highly recommended for these patients [see CONTRAINDICATIONS]. Cases of osteonecrosis of other bones (including femur, hip, knee, ankle, wrist and humerus) have been reported; causality has not been determined in the population treated with Reclast.
Report Problems to the Food and Drug Administration
Bone biopsy results showed bone of normal quality with no evidence of impaired bone remodeling and no evidence of mineralization defect. Reclast demonstrated superiority to placebo in reducing the incidence of all clinical fractures, clinical (symptomatic) vertebral and non-vertebral fractures (excluding finger, toe, facial, and clinical thoracic and lumbar vertebral fractures). All clinical fractures were verified based on the radiographic and/or clinical evidence. The pharmacokinetics of zoledronic acid was not affected by age in patients with cancer and bone metastases whose age ranged from 38 years to 84 years. There are no data on the presence of zoledronic acid in human milk, the effects on the breastfed infant, or the effects on milk production.
In animal studies, less than 3% of the administered intravenous dose was found in the feces, with the balance either recovered in the urine or taken up by bone, indicating that the drug is eliminated intact via the kidney. The combined osteoporosis trials included 4863 Reclast-treated patients who were at least 65 years of age, while 2101 patients were at least 75 years old. No overall differences in efficacy or safety were observed between patients under 75 years of age with those at least 75 years of age, except that the acute phase reactions occurred less frequently in the older patients. Cases of iritis/uveitis/episcleritis/conjunctivitis have been reported in patients treated with bisphosphonates, including zoledronic acid. In the osteoporosis prevention trial, 4 (1.1%) patients treated with Reclast and 0 (0%) patients treated with placebo developed iritis/uveitis. In the osteoporosis trials, 1 (less than 0.1%) to 9 (0.2%) patients treated with Reclast and 0 (0%) to 1 (less than 0.1%) patient treated with placebo developed iritis/uveitis/episcleritis.
Commodity Price Risk: Definition, Calculation, And Main Risks
Mean Cmax and AUC(0-last) was 167 ng/mL and 220 ng.h/mL respectively. The plasma concentration time profile of zoledronic acid in pediatric patients represent a multi-exponential decline, as observed in adult cancer patients at an approximately equivalent mg/kg dose. Bisphosphonates are incorporated into the bone matrix, from which they are gradually released over a period of years. The amount of bisphosphonate incorporated into adult bone, and available for release into the systemic circulation is directly related to the dose and duration of bisphosphonate use. Consequently, based on the mechanism of action of bisphosphonates, there is a potential risk of fetal harm, predominantly skeletal, if a woman becomes pregnant after completing a course of bisphosphonate therapy. The impact of variables such as time between cessation of bisphosphonate therapy to conception, the particular bisphosphonate used, and the route of administration (intravenous versus oral) on the risk has not been studied.
We have also discussed the impact of reclassification on financial statements and highlighted the importance of proper reclassification in accounting. Proper reclassification requires a solid understanding of accounting principles, attention to detail, and adherence to professional standards. It is crucial for accountants and financial professionals to stay updated with changes in accounting standards and internal policies to ensure accurate and transparent financial reporting.
You should not receive Reclast if you are already receiving Zometa. Administration of acetaminophen following Reclast administration may reduce the incidence of these symptoms. Before being given Reclast, patients should tell their doctor if they have kidney problems and what medications they are taking. Reclast contains the same active ingredient found in Zometa, used for oncology indications, and a patient being treated with Zometa should not be treated with Reclast. Caution is indicated when Reclast is used with other potentially nephrotoxic drugs such as nonsteroidal anti-inflammatory drugs.
The threshold for R2 will continue to be defined as institutions with at least 20 doctoral research degrees that also have at least $5 million in total research expenditures (as reported through the NSF HERD Survey). There will not be a cap on the number of institutions that can be in this category. Starting with the 2025 Carnegie Classifications, the Basic Classification will move to multidimensional labels that more accurately describe the richness and multifaceted nature of today’s colleges and universities and their learners.