Generic Fosamax for Treatment of Osteoporosis and Paget's Disease

Generic Fosamax Tablets
Generic Fosamax (Osteofos Tablets) is used to
prevent osteoporosis in postmenopausal women,
and to treat Paget's disease of the bone.
Generic Fosamax is also used to treat or prevent
osteoporosis in men, premenopausal women and
postmenopausal women using oestrogen who are
receiving corticosteroid medicines, such as
prednisone and dexamethasone.
© The Swiss Pharmacy, Geneva Switzerland

Chemical Structure

Indications
Generic Fosamax (Osteofos Tablets) is
used to treat the following indications:
In postmenopausal women for the
treatment of osteoporosis to prevent
fractures, including those of the hip and
spine (vertebral compression fractures).
In postmenopausal women who are at risk
of developing osteoporosis Generic
Fosamax is indicated for the prevention of
osteoporosis to reduce the risk of future
fracture.

Indications
For the treatment of osteoporosis in men
to prevent fractures.
For the treatment and prevention of
glucocorticoid-induced osteoporosis in
men, premenopausal women and
postmenopausal women receiving
oestrogen.
For treatment of Paget’s disease of bone
in men and women.

Active Ingredient
The active pharmaceutical ingredient
contained in Generic Fosamax (Osteofos
Tablets) is Alendronate Sodium.

Recommended Dosage
Generic Fosamax must be taken at
least one half hour before the first food,
beverage, or medication of the day with
plain water only. To facilitate delivery to
the stomach and thus reduce the
potential for oesophageal irritation,
Generic Fosamax should only be
swallowed upon arising for the day with
a full glass of water and patients should
not lie down for at least 30 minutes and
until after their first food of the day.

Recommended Dosage
The recommended dosage of Generic Fosamax
(Alendronate Tablets) for the treatment of various
indications is given below:
➔Treatment of Osteoporosis in Postmenopausal
Women and in Men: The recommended dosage of
Generic Fosamax is one 70 mg tablet taken orally
once weekly.
➔Prevention of Osteoporosis in Postmenopausal
Women: The recommended dose of Generic
Fosamax is one 5 mg tablet taken orally once a
day.

Recommended Dosage
➔Treatment and Prevention of Glucocorticoid-
Induced Osteoporosis in Men, Premenopausal
Women and Postmenopausal Women Receiving
Oestrogen: The recommended dosage of Generic
Fosamax is one 5 mg tablet taken orally once a
day.
➔Paget’s Disease of Bone in Men and Women:
The recommended treatment regimen is 40 mg
once a day for six months.

Contraindications
Generic Fosamax (Osteofos Tablets) is
contraindicated in patients with the following
conditions:
➔Hypersensitivity to Alendronate Sodium, or
any inactive component of this medication.
➔Abnormalities of the oesophagus which delay
oesophageal emptying such as stricture or
achalasia.
➔Inability to stand or sit upright for at least 30
minutes.
➔Hypocalcaemia

Side Effects of Generic Fosamax
The following upper gastrointestinal side
effects were reported in 1% or more of
patients treated with Generic Fosamax
10 mg/day and at a greater incidence than
in patients treated with placebo: abdominal
pain, dyspepsia, oesophageal ulcer,
dysphagia and abdominal distention.
Rarely, rash and erythema have occurred.

Side Effects of Generic Fosamax
Additionally, the following side effects were
also reported in 1% or more of patients
treated with Generic Fosamax 10 mg/day
and at a greater incidence than in patients
treated with placebo: musculoskeletal
(bone, muscle or joint) pain, constipation,
diarrhoea, flatulence, and headache.

Warnings And Precautions
➔Generic Fosamax like other orally administered
bisphosphonates, may cause local irritation of the upper
gastrointestinal mucosa. Because of these possible irritant
effects and a potential for worsening of the underlying
disease, caution should be used when Generic Fosamax
is given to patients with active upper gastrointestinal
problems (such as known Barrett's esophagus, dysphagia,
other esophageal diseases, gastritis, duodenitis, or
ulcers).
➔The risk of severe esophageal side effects appears to be
greater in patients who lie down after taking oral
bisphosphonates including Generic Fosamax and/or who
fail to swallow oral bisphosphonates including Generic
Fosamax with the recommended full glass (180 to 250
ml) of water.

➔Hypocalcemia must be corrected before initiating therapy
with Generic Fosamax. Other disorders affecting mineral
metabolism (such as vitamin D deficiency) should also be
effectively treated.
➔Severe and occasionally incapacitating bone, joint, and/or
muscle pain has been reported in patients taking
bisphosphonates (including Generic Fosamax
(Alendronate))that are approved for the prevention and
treatment of osteoporosis.
➔Osteonecrosis of the jaw (ONJ), which can occur
spontaneously, is generally associated with tooth
extraction and/or local infection with delayed healing, and
has been reported in patients taking bisphosphonates,
including Generic Fosamax.

➔Atypical, low-energy, or low trauma fractures of the
femoral shaft have been reported in bisphosphonate-treated
patients.
➔Generic Fosamax is not recommended for patients
with creatinine clearance <35 mL/min
➔The risk versus benefit of Generic Fosamax for
treatment at daily dosages of glucocorticoids less
than 7.5 mg of prednisone or equivalent has not been
established. Before starting treatment, the gonadal
hormonal status of both men and women should be
ascertained and appropriate replacement considered.

Overdose Symptoms
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.

Osteofos Tablets manufactured
by Cipla Ltd., India
For more information click here

Generic Fosamax for Treatment of Osteoporosis and Paget's Disease

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Generic Fosamax for Treatment of Osteoporosis and Paget's Disease