Please read the instructions carefully and use them under the guidance of a physician.
Common Name : Alendronate Vitamin D3 Tablets
Chinese Pinyin : ALunLinSuanNaWeiD3Pian
English name : Alendronate Sodium and Vitamin D3 Tablets
Product name : Familia
Ingredients: This product is a compound preparation, the components of which are alendronate sodium and vitamin D3.
Traits : This product is white or white-like shaped tablets.
Indications: This product is suitable for:
1. Treatment of postmenopausal women with osteoporosis to increase bone mass and reduce fracture incidence, including hip and vertebral fractures (vertebral compression fractures).
2. Treatment of male osteoporosis to increase bone mass.
Specifications : 70mg/2800IU*1 piece
Dosage: This product must be taken with white water for at least half an hour before eating, drinking or applying other drugs every day (see note: upper gastrointestinal side effects), because other beverages (including mineral water) , food and some drugs may reduce the absorption of thiram (see note: upper gastrointestinal side effects). Waiting for less than 30 minutes, or with food, drink (not white water) or other drugs, will reduce the effect of alendronate due to reduced absorption. In order to deliver the drug to the stomach as soon as possible to reduce the irritation to the esophagus, Fumiga should be served in a full cup of white water (175-250ml) in the morning, and at least 30 minutes after taking the drug and before the first meal on the day. Patients should avoid lying down, and Fumex should not be taken at bedtime and before getting up early in the morning. Otherwise, it will increase the risk of esophageal adverse events (see precautions for adverse reactions to the digestive tract).
If the calcium intake in the diet is insufficient, the patient may add additional calcium (see note: Mineral metabolism).
For high-risk patients with vitamin D deficiency (eg, older than 70 years of age, breastfeeding or chronic illness), in addition to taking thiram may require an increase in vitamin D supplementation. For patients with gastrointestinal malabsorption syndrome, higher doses of vitamin D may be required, and 25-hydroxyvitamin D levels may be considered. The recommended intake of vitamin D is 400 IU-800 IU per day. The purpose of alendronate sodium D3 tablets is to apply a weekly dose of vitamin D equivalent to 400 IU per day.
Dosage adjustment is not required for elderly or mild to moderate renal insufficiency (creatinine clearance 35-60 ml/min). The use of alendronate sodium D3 tablets in patients with more severe renal insufficiency (creatinine clearance <35 ml/min) is not recommended due to lack of relevant medication experience.
The recommended dose for the treatment of osteoporosis in postmenopausal women is thiram once a week, one tablet at a time.
The recommended dose for the treatment of osteoporosis in men to increase bone mass is thiram once a week, one tablet at a time.
Adverse reactions: Clinical studies A five-year clinical study of alendronate (FOSAMAX) has shown that adverse events associated with sodium alendronate (FOSAMAX) are generally mild and usually do not require treatment.
Systemic reactions: Allergic reactions, including urticaria and rare angioedema. It has been reported that transient myalgia, discomfort and fatigue symptoms occur after taking alendronate, and fever is rare, usually associated with initial treatment. Rare hypocalcemia occurs when there are incentive conditions. Rare peripheral edema.
Gastrointestinal tract: nausea, vomiting, esophagitis, esophageal erosion, esophageal ulcer, rare esophageal stricture or perforation, and oropharyngeal ulcer. Stomach or duodenal ulcers have been reported, some of which are more severe with complications.
Occasionally, localized osteonecrosis of the jaw may be reported, which may be related to delayed healing of the extraction and/or local infection (including osteomyelitis) (see [Precautions] Jaw Necrosis).
Musculoskeletal: bone, joint and/or muscle pain, rare and severe or disabling (see [Precautions]); joint swelling, musculoskeletal pain.
Nervous system: dizziness, dizziness, and taste disturbance.
Skin: rash (even with light allergy), itching, hair loss. Rare and severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis.
Special feeling: rare uveitis, scleritis or scleral inflammation.
Contraindications: 1. Esophageal abnormalities that cause delayed esophageal emptying, such as stenosis or relaxation.
2, can not stand or sit for at least 3 minutes. Hypocalcemia (see note mineral metabolism)
3. Those who are allergic to any of the ingredients in this product.
Note : Mineral metabolism
Hypocalcemia must be corrected before starting treatment with this product (see [Contraindications]). Effective treatment of other diseases that affect mineral metabolism, such as vitamin D deficiency. For these patients, the symptoms of serum calcium and hypocalcemia should be monitored during the treatment of this product.
It is speculated that it may be due to the increased bone density of alendronate, which may result in a decrease in mild asymptomatic serum calcium and phosphorus levels.
This product should not be used alone to treat vitamin D deficiency (usually defined as 25-hydroxyvitamin D levels below 9 ng/mL). Patients at high risk of vitamin D deficiency may need to supplement a higher dose of vitamin D supplement. For patients with gastrointestinal malabsorption syndrome, it may be necessary to supplement a higher dose of vitamin D and consider the level of 25-hydroxyvitamin D.
For patients with diseases associated with excessive production of 1,25 dihydroxyvitamin D (eg leukemia, lymphoma, sarcoidosis), vitamin D3 supplementation may aggravate hypercalcemia and/or hypercalciuria. In these patients, blood calcium and urinary calcium levels should be monitored.
According to post-marketing experience, severe bone, joint and/or muscle pain has occasionally occurred in patients who have used bisphosphonates (approved for the prevention and treatment of osteoporosis) (see [Adverse Reactions]). Among these drugs is alendronate sodium (FOSAMAX). Most patients are postmenopausal women. The time from the onset of the drug to the onset of symptoms ranges from 1 day to several months. If you have serious symptoms, you should stop using it. Most patients have reduced symptoms after stopping the drug. Some patients may reappear after re-use of the same drug or other bisphosphonates.
In a small number of patients who received long-term treatment with bisphosphonate (usually more than three years), low-energy fractures of the proximal femoral and femoral shaft were reported. Some are non-traumatic stress fractures (some reports are also called incomplete fractures). A few weeks before the complete fracture occurred, some patients experienced pre-existing pain in the affected area, often accompanied by imaging features of stress fractures. About one-third of patients have bilateral fractures, so the contralateral femur should be examined in patients who have had a femoral stress fracture. Stress fractures with clinical features also occur in patients who have not received bisphosphonate therapy. Patients with suspected stress fractures should be evaluated, including assessment of known causes and risk factors (eg vitamin D deficiency, malabsorption, glucocorticoid use, previous stress fractures, lower extremity arthritis or fractures, overactivity or activity) Increased amount, diabetes, long-term alcohol abuse), and need to receive appropriate corrective treatment. For patients with a stress fracture, discontinuation of bisphosphonate therapy should be carefully considered based on individual benefit/risk assessment before assessment.
Missing dose instructions
This product should be used on a fixed day of the week. The patient should be told that if a weekly dose is missed, one tablet should be taken the morning after the recording. Do not take two tablets on the same day, but plan on the date of their initial choice and still take one tablet per week.
This product is not recommended for use in patients with renal insufficiency (creatinine clearance <35 mL/min).
Drug interactions: 1. Calcium supplements / antacids
Calcium supplements, antacids, and certain oral medications are likely to interfere with the absorption of alendronate. Therefore, patients must take at least one and a half hours to take any other oral medication after taking this product.
In clinical studies, the incidence of adverse events in the upper gastrointestinal tract increased in patients who received a combination of alendronate sodium (FOSAMAX) (daily doses greater than 10 mg) and aspirin-containing drugs.
3. Non-steroidal anti-inflammatory drugs (NSAIDs)
Compound alendronate can be used in patients taking non-steroidal anti-inflammatory drugs. In a 3-year controlled clinical study (n=2027), most patients with non-steroidal anti-inflammatory drugs, patients with alendronate sodium (FOSAMAX) 5 or 10 mg/day had upper gastrointestinal dysfunction The event was similar to those taking a placebo. However, because the use of non-steroidal anti-inflammatory drugs is associated with gastrointestinal irritation, it must be warned during the use of this product.
4. Because non-steroidal anti-inflammatory drugs can cause gastrointestinal irritation, caution should be exercised when used with alendronate.
a drug that can interfere with the absorption of vitamin D3
Olestra (fat substitutes), mineral oil, orlistat and bile acid sequestrants (eg, cholestyramine, colestipol) can interfere with the absorption of vitamin D. Vitamin D supplementation should be considered at this time.
a drug that can increase the catabolism of vitamin D3
Anticonvulsants, cimetidines, and thiazides can increase the catabolism of vitamin D. Vitamin D supplementation should be considered at this time.
Pharmacology and Toxicology: 1. Alendronate
Animal studies have found that this product has the following mode of action. At the cellular level, alendronate has an affinity for osteoclast-mediated sites. Under normal circumstances, osteoclasts adhere to the surface of the bone but lack wrinkles, while the edges of the folds are a sign of active bone resorption. Alendronate does not affect the aggregation or adhesion of osteoclasts, but it does inhibit the activity of osteoclasts. Studies in vivo in mice with radioactive [3H] alendronate sodium at the site of action in the bone showed that the uptake of osteoclasts was 10 times greater than that of osteoblasts. The radioactive [3H] alendronate sodium was administered to rats for 6 days and mice for 49 days. After examination of the bone tissue, normal bone was formed on alendronate, which did not bind to the matrix. It has pharmacological activity, therefore, alendronate must be continuously administered to inhibit the newly formed absorption surface of osteoclasts. Histomorphometry of sputum and rats showed that alendronate reduced bone turnover (ie, the number of bone remodeling sites), and at these sites, bone formation exceeded bone resorption, resulting in a gradual increase in bone mass.
2. Vitamin D3
Vitamin D3 is a photochemical conversion of 7-dehydrocholesterol to a vitamin D3 precursor under the action of ultraviolet light, and then non-enzymatic isomerization to produce vitamin D3. In the absence of sufficient sunlight, vitamin D3 is mainly derived from the nutrients in the diet. Vitamin D3 (absorbed into chylomicrons) in the skin and diet is converted to 25-hydroxyvitamin D3 in the liver, and further converted to calcium-regulating activity in the kidney under the stimulation of parathyroid hormone and hypophosphatemia. - Dihydroxyvitamin D3 (calcitriol). The basic role of 1,25-dihydroxyvitamin D3 is to increase intestinal reabsorption of calcium and phosphorus, as well as to regulate serum calcium, renal calcium and phosphorus excretion, bone formation and bone resorption.
Vitamin D3 is required for normal bone formation. Vitamin D deficiency can occur when there is a lack of sunlight or malnutrition. Vitamin D deficiency is associated with negative calcium balance, loss of bone mass, and increased risk of fracture. In severe cases, vitamin D deficiency can cause secondary hyperparathyroidism, hypophosphatemia, proximal muscle weakness, and osteomalacia, further increasing the risk of falls and fractures in patients with osteoporosis.
Pregnancy and lactating women medication: Pregnant women are banned.
Drug use in elderly patients: In the fracture intervention trial (FIT), 71% of patients aged ≥65 years (n=2302) were treated with alendronate (FOSAMAX), and their age was ≥75 years old. %(n=550). In women and osteoporosis treatment studies in the United States and many countries and in the treatment of male osteoporosis [see clinical trials], patients aged 65 years or older who received alendronate sodium (FOSAMAX) were 45% and 54%, respectively. %. There was no overall difference in the effectiveness and safety observed between these patients and younger patients, but it did not rule out that some older individuals were more sensitive. The elderly have an increased demand for vitamin D3 in food.
Storage: Protect from moisture and light, and store at 30 °C.
Packing : Aluminum-plastic board, 1 piece per box.
Validity: 18 months
Approval number : Imported drug registration number: H20130840
Company Name : Merck Sharp&Dohme td.UK