The mean baseline lumbar spine BMD Z-score of the patients was Treatment with Alendronate sodium did not reduce the risk of fracture. In Alendronate sodium-treated patients, bone histomorphometry data obtained at Month 24 demonstrated decreased bone turnover and delayed mineralization time; however, there were no mineralization defects.
There were no statistically significant differences between the Alendronate sodium and placebo groups in reduction of bone pain. The oral bioavailability in children was similar to that observed in adults. The overall safety profile of Alendronate sodium in osteogenesis imperfecta patients treated for up to 24 months was generally similar to that of adults with osteoporosis treated with Alendronate sodium. However, there was an increased occurrence of vomiting in osteogenesis imperfecta patients treated with Alendronate sodium compared to placebo.
During the month treatment period, vomiting was observed in 32 of These events, lasting no more than 2 to 3 days and responding to acetaminophen, are consistent with an acute-phase response that has been reported in patients receiving bisphosphonates, including Alendronate sodium. No overall differences in efficacy or safety were observed between these patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
Hepatic Impairment As there is evidence that Alendronate is not metabolized or excreted in the bile, no studies were conducted in patients with hepatic impairment. No dosage adjustment is necessary [see Clinical Pharmacology No specific information is available on the treatment of overdosage with Alendronate sodium. Hypocalcemia, hypophosphatemia, and upper gastrointestinal adverse events, such as upset stomach, heartburn, esophagitis, gastritis, or ulcer, may result from oral overdosage.
Milk or antacids should be given to bind Alendronate. Due to the risk of esophageal irritation, vomiting should not be induced and the patient should remain fully upright. Dialysis would not be beneficial. Bisphosphonates are synthetic analogs of pyrophosphate that bind to the hydroxyapatite found in bone. Alendronate sodium is chemically described as 4-aminohydroxybutylidene bisphosphonic acid monosodium salt trihydrate. The structural formula is: Alendronate sodium is a white, crystalline, nonhygroscopic powder.
It is soluble in water, very slightly soluble in alcohol, and practically insoluble in chloroform. Alendronate sodium tablets, USP, for oral administration contain Alendronate - Clinical Pharmacology Mechanism of Action Animal studies have indicated the following mode of action.
Fosamax 10mg should be taken once daily Fosamax Plus D 70mg should be taken once a week According to the medication insert, the recommended starting dosages are one 10 mg tablet once daily or a 70 mg tablet or oral solution once weekly. Because of how Fosamax works and is metabolized by the body, there are certain people who should not take the drug. Doctors should be cautious when prescribing Fosamax to patients with preexisting conditions. Fosamax and Fosamax Plus D are not approved for use in children.
People with the following condition should not use Fosamax: People with abnormalities or problems related to the esophagus People who cannot sit upright or stand for at least 30 minutes People with hypocalcemia low calcium in the blood People allergic to ingredients in Fosamax or Fosamax Plus D People at increased risk of aspiration, a condition where food or liquid is breathed into the airways, should not take liquid Fosamax.
Fosamax Drug Interactions Fosamax is known to interact with several common medications. Some make the drug less effective, while others can increase the risk of side effects. If it does, it may cause side effects in a child who is breastfed.
Talk to your doctor if you breastfeed your child. You may need to decide whether to stop breast-feeding or stop taking this medication. The kidneys of older adults may not work as well as they used to. This can cause your body to process drugs more slowly. As a result, more of a drug stays in your body for a longer time. This raises your risk of side effects. This dosage information is for alendronate oral tablet. All possible dosages and drug forms may not be included here.
Your dosage, drug form, and how often you take the drug will depend on: You should sit or stand. For at least the first 30 minutes after taking an alendronate tablet, do not lie down or recline; do not eat or drink anything other than plain water; and do not take any other medicines including vitamins, calcium, or antacids.
Some people using medicines similar to alendronate have developed bone loss in the jaw, also called osteonecrosis of the jaw. Symptoms may include jaw pain, swelling, numbness, loose teeth, gum infection, or slow healing after injury or surgery involving the gums. You may be more likely to develop osteonecrosis of the jaw if you have cancer or have been treated with chemotherapy, radiation, or steroids.
Other conditions associated with osteonecrosis of the jaw include blood clotting disorders, anemia low red blood cells , and a pre-existing dental problem. Gastric and duodenal ulceration may also occur.
Esophageal cancer , a meta-analysis concluded that bisphosphonate treatment is not significantly associated with excess risk of esophageal cancer.
In laboratory tests decreased calcium and phosphate values may be obtained but reflect action of the drug and are harmless. Osteonecrosis of the jaw deterioration of the temporomandibular joint or TMJ may occur while on this drug, if dental work of any kind is carried out.
At least half an hour should pass after intake of alendronate before taking the supplement or drug.
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