Each bottle (75 mL solution) contains:

Alendronate sodium trihydrate………………………… 91.35 mg
(equivalent to 70 mg alendronic acid)

Inactive ingredients:

Sodium citrate, Citric acid, Sodium methylparaben, Sodium propylparaben, Saccharin sodium,
Tuttifriutti flavor, & Purified water.

Pharmacological action:

At the cellular level, alendronate shows preferential localization to sites of bone resorption,
specifically under osteoclasts. The osteoclasts adhere normally to the bone surface but lack
the ruffled border that is indicative of active resorption. Alendronate does not interfere with
osteoclast recruitment or attachment, but it does inhibit osteoclast activity. Studies in mice on
the localization of radioactive [3H] alendronate in bone showed about 10-fold higher uptake
on osteoclast surfaces than on osteoblast surfaces. Bones examined 6 and 49 days after [3H]
alendronate administration in rats and mice, respectively, showed that normal bone was formed
on top of the alendronate, which was incorporated inside the matrix. While incorporated in bone
matrix, alendronate is not pharmacologically active. Thus, alendronate must be continuously
administered to suppress osteoclasts on newly formed resorption surfaces. Histomorphometry in
baboons and rats showed that alendronate treatment reduces bone turnover (i.e., the number of
sites at which bone is remodeled). In addition, bone formation exceeds bone resorption at these
remodeling sites, leading to progressive gains in bone mass.
As there is evidence that alendronate is not metabolized or excreted in the bile, no studies were
conducted in patients with hepatic insufficiency. No dosage adjustment is necessary.

Indications:

• Treatment and prevention of osteoporosis in postmenopausal women.
• For the treatment of osteoporosis, Borgalendro increases bone mass and reduces the
incidence of fractures, including those of the hip and spine (vertebral compression fractures).
Osteoporosis may be confirmed by the finding of low bone mass (for example, at least 2
Vomiting.

Dosage & administration:

• Borgalendro must be taken at least one-half hour before the first food, beverage, or
medication of the day with plain water only. Other beverages (including mineral water), food,
and some medications are likely to reduce the absorption of Borgalendro. Waiting less than
30 minutes, or taking Borgalendro with food, beverages (other than plain water) or other
medications will lessen the effect of Borgalendro by decreasing its absorption into the body.
• Borgalendro should only be taken upon arising for the day. To facilitate delivery to the
stomach and thus reduce the potential for esophageal irritation. To facilitate gastric
emptying Borgalendro oral solution should be followed by at least a quarter of a cup of water.
Patients should not lie down for at least 30 minutes and until after their first food of the day.
Borgalendro should not be taken at bedtime or before arising for the day. Failure to follow
these instructions may increase the risk of esophageal adverse experiences.
• Patients should receive supplemental calcium and vitamin D, if dietary intake is inadequate.
• No dosage adjustment is necessary for the elderly or for patients with mild-to-moderate renal
insufficiency (creatinine clearance 35 to 60 mL/min). Borgalendro is not recommended for
patients with more severe renal insufficiency (creatinine clearance of experience.
Treatment of osteoporosis in postmenopausal women.
The recommended dosage is one bottle of 70 mg oral solution once weekly.
Treatment to increase bone mass in men with osteoporosis
The recommended dosage is one bottle of 70 mg oral solution once weekly.
Retreatment of Paget’s disease
In clinical studies in which patients were followed every six months, relapses during the 12
months following therapy occurred in 9% (3 out of 32) of patients who responded to treatment
with FOSAMAX. Specific retreatment data are not available, although responses to FOSAMAX
were similar in patients who had received prior bisphosphonate therapy and those who had
not. Retreatment with Borgalendro may be considered, following a six-month post-treatment
evaluation period in patients who have relapsed, based on increases in serum alkaline
phosphatase, which should be measured periodically. Retreatment may also be considered in
those who failed to normalize their serum alkaline phosphatase.

Pregnancy and Lactation:

Pregnancy

Pregnancy Category C:

Patient information:

General

– Physicians should instruct their patients to read the patient package insert before starting
therapy with Borgalendro and to reread it each time the prescription is renewed.
– Patients should be instructed to take supplemental calcium and vitamin D, if daily dietary
intake is inadequate. Weight-bearing exercise should be considered along with the
modification of certain behavioral factors, such as cigarette smoking and/or excessive
alcohol consumption, if these factors exist.
Dosing Instructions
– Patients should be instructed that the expected benefits of Borgalendro may only be
obtained when it is taken with plain water the first thing upon arising for the day at least 30
minutes before the first food, beverage, or medication of the day. Even dosing with orange
juice or coffee has been shown to markedly reduce the absorption of alendronate sodium.
– To facilitate gastric emptying patients should drink at least 2 oz (a quarter of a cup) of water
after taking Borgalendro oral solution. Patients should be instructed not to lie down for at
least 30 minutes and until after their first food of the day. Patients should be specifically
instructed not to take Borgalendro at bedtime or before arising for the day. Patients should
be informed that failure to follow these instructions may increase their risk of esophageal
problems. Patients should be instructed 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 Borgalendro and consult their physician.
– Patients should be instructed that if they miss a dose of once weekly Borgalendro, they
should take one dose on the morning after they remember. 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.
Package & Storage:
– Carton box containing an ogival amber glass (type III) bottle of

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