Fosamax tablet 70mg

Instruct patients to drink at least 2 ounces a quarter of a cup of water after taking FOSAMAX oral solution, to facilitate gastric emptying. Instruct patients not to lie down for at least 30 minutes and until after their first food of the day. Patients should be informed that failure to follow these instructions may increase their risk of esophageal problems. Instruct patients that if they develop symptoms of esophageal disease such as difficulty or pain upon swallowing, retrosternal pain or new or worsening heartburn they should stop taking FOSAMAX and consult their physician.

They should not take two doses on the same day but should return to taking one dose once a week, as originally scheduled on their chosen day. These doses are equivalent to approximately 0.

The relevance of this finding to humans is unknown. Alendronate was not genotoxic in the in vitro microbial mutagenesis assay with and without metabolic activation, in an in vitro mammalian cell mutagenesis assay, in an in vitro alkaline elution assay in rat hepatocytes, and in an in vivo chromosomal aberration assay in mice. In an in vitro chromosomal aberration assay in Chinese hamster ovary cells, however, alendronate gave equivocal results. FOSAMAX should be used during pregnancy only if the potential benefit justifies the potential risk to the mother and fetus.

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 hence, the amount available for release back into the systemic circulation , is directly related to the dose and duration of bisphosphonate use. The alendronic acid derivative was eluted with methanol. The calibration curve for alendronic acid was linear within the range of 0. In method validation, dilution test was performed to assess the reliability of the method at concentration levels outside the calibration range.

Based on the results, a fivefold dilution of human plasma samples containing alendronic acid above the upper limit of quantification ULOQ was considered acceptable. In an analysis of unknown samples with concentrations higher than ULOQ, they were reassayed after appropriate dilution.

Pharmacokinetic analyses Pharmacokinetic parameters were calculated using standard non-compartmental methods. The Cmax and the time to reach Cmax tmax were derived from the plasma concentration—time curves. Phoenix WinNonlin software version 6.

Statistical analysis The protocol was prespecified using the method recommended by the FDA for assessing bioequivalence. EMA method was performed in a post hoc manner to detect any differences in bioequivalence between the two methods. The sequence effect was tested using the subject-within sequence effect as error term.

The treatment and period effects were tested against the residual mean square error. CVWR was calculated by using analysis of variance ANOVA on the reference data only, with sequence, subject-within sequence, and study period as fixed effects. For Cmax, a scaled average bioequivalence method can be used. This method was based on CVWR. Results Background characteristics of the volunteers A total of 36 Chinese males were enrolled and completed this study.

These transverse or short oblique, fractures can occur anywhere along the femur from just below the lesser trochanter to just above the supracondylar flare. These fractures occur after minimal or no trauma and some patients experience thigh or groin pain, often associated with imaging features of stress fractures, weeks to months before presenting with a completed femoral fracture.

Fractures are often bilateral; therefore the contralateral femur should be examined in bisphosphonate-treated patients who have sustained a femoral shaft fracture. Poor healing of these fractures has also been reported. Discontinuation of bisphosphonate therapy in patients suspected to have an atypical femur fracture should be considered pending evaluation of the patient, based on an individual benefit risk assessment.

During bisphosphonate treatment patients should be advised to report any thigh, hip or groin pain and any patient presenting with such symptoms should be evaluated for an incomplete femur fracture. Skin reactions In post-marketing experience, there have been rare reports of severe skin reactions including Stevens Johnson syndrome and toxic epidermal necrolysis.

They should not take two tablets on the same day but should return to taking one tablet once a week, as originally scheduled on their chosen day. Bone and mineral metabolism Causes of osteoporosis other than oestrogen deficiency and ageing should be considered. Hypocalcaemia must be corrected before initiating therapy with alendronate see section 4.

Other disorders affecting mineral metabolism such as vitamin D deficiency and hypoparathyroidism should also be effectively treated. Due to the positive effects of alendronate in increasing bone mineral, decreases in serum calcium and phosphate may occur especially in patients taking glucocorticoids in whom calcium absorption may be decreased.

These are usually small and asymptomatic. However, there have been rare reports of symptomatic hypocalcaemia, which have occasionally been severe and often occurred in patients with predisposing conditions e. In animals, IV alendronate is excreted into milk. It is not known whether alendronate is excreted in human milk, but the manufacturer indicates that alendronate should be used with caution in women who are breast-feeding their infants. If alendronate is excreted into human breast milk, the amount to which the infant is exposed is expected to be low due to the drug's low oral bioavailability and short elimination half-life.

Once the mother has discontinued alendronate, secretion into the breast milk is still possible due to the long elimination of alendronate from the bone; however, the amount secreted into the milk should be even lower than when the mother was actively taking alendronate.

The effects of alendronate on the nursing infant are not known. Very limited data state that pamidronate, a parenteral bisphosphonate with very low oral bioavailability, has been used in a breast-feeding mother with no detectable concentrations in breast milk.

Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally ingested drug, healthcare providers are encouraged to report the adverse effect to the FDA.

By binding to calcium salts, alendronate blocks the transformation of calcium phosphate into hydroxyapatite and inhibits the formation, aggregation, and dissolution of hydroxyapatite crystals in bone. While inhibition of hydroxyapatite crystals may lead to the inhibition of bone mineralization seen at high doses, it does not explain alendronate's effects on bone resorption. The mechanism of inhibition of bone resorption by bisphosphonates is not known.

Alendronate is preferentially localized to the site of resorption; however, alendronate does not interfere with the recruitment and attachment of osteoclasts. Alendronate is internalized by osteoclasts causing disruption of osteoclast cytoskeleton, loss of the ruffled border, which may lead to the loss of ability to resorb bone.

The exact molecular mechanisms of these effects are not known. In addition, macrophages and osteoblasts may mediate the antiresorptive effects of bisphosphonates.

Continuous administration of alendronate is necessary to maintain osteoclast suppression on newly-formed resorption surfaces. In patients with Paget's disease, alendronate directly decreases bone resorption, resulting in a significant decrease in serum alkaline phosphatase and urinary markers of bone collagen degradation.

Alendronate also slightly increases parathyroid hormone levels. Alendronate significantly increases bone mineral density in women with postmenopausal osteoporosis. Increases in bone mass of the spine and hip are evident after three months, and do not occur at the expense of other skeletal bone. Continuous therapy is necessary to maintain increases in bone mass. Histological examination after at least one year's therapy, reveals that bone formation is of normal structure and mineral content.

In a short trial, alendronate decreased serum alkaline phosphatase up to 12 weeks post treatment and serum osteocalcin up to 30 weeks post treatment. Follow all instructions about stopping or starting this medication. This drug is not recommended for use in children. Studies have shown that many children who took this drug had severe side effects such as vomiting , fever , and flu -like symptoms. Caution is advised if you are pregnant or planning to become pregnant in the future.

Alendronate may stay in your body for many years. Its effects on an unborn baby are unknown. Discuss the risks and benefits with your doctor before starting treatment with alendronate. It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

Quick GuideWhat Is Osteoporosis? See also How to Use section.

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