Risofos Tablets (Generic Risedronate Sodium Tablets)

Risofos Tablets (Generic Risedronate Sodium Tablets)
© The Swiss Pharmacy

Risofos (Generic Risedronate Sodium Tablets) is a
bisphosphonate and is used to prevent and treat
osteoporosis (thinning of the bone) in women after
menopause. Risedronate tablets may also be used to
increase bone mass in men who have osteoporosis, and in
men and women to prevent and treat osteoporosis caused
by long-term use of corticosteroids (cortisone-like
medicine). Risedronate tablets are also used to treat Paget's
disease of the bone.

Risofos Tablets are manufactured by Cipla Limited, India in
the strengths of 35 mg and 150 mg.

Chemical Structure

The active ingredient contained in Risofos tablets is
Risedronate Sodium.
Each Risofos tablet contains 35 mg or 150 mg of
Risedronate Sodium.

Uses of Risofos 35 mg and 150 mg Tablets:
Risofos (Generic Risedronate Sodium Tablets) is a bisphosphonate indicated
for treatment and prevention of postmenopausal osteoporosis, treatment to
increase bone mass in men with osteoporosis, treatment and prevention of
glucocorticoid-induced osteoporosis and treatment of Paget’s disease.
This medication helps to reduce bone pain and may prevent long-term
complications from this disease. Risedronate works by slowing bone loss to
help maintain strong bones and reduce the risk of broken bones (fractures).
Postmenopausal Osteoporosis: Risofos (Generic Risedronate Sodium
Tablets) is indicated for the treatment and prevention of osteoporosis in
postmenopausal women. In postmenopausal women with osteoporosis,
Risedronate reduces the incidence of vertebral fractures and a composite
endpoint of non-vertebral osteoporosis-related fractures.
URL: https://www.theswisspharmacy.com/product_info.php?info=p9477_Risedronate-Tablets.html

Uses of Risofos 35 mg and 150 mg Tablets:
Osteoporosis in Men: Risofos is indicated for treatment to increase
bone mass in men with osteoporosis.
Glucocorticoid-Induced Osteoporosis: Risofos is indicated for the
treatment and prevention of glucocorticoid-induced osteoporosis in
men and women who are either initiating or continuing systemic
glucocorticoid treatment (daily dosage of 7.5 mg or greater
Prednisone or equivalent) for chronic diseases. Patients treated with
glucocorticoids should receive adequate amounts of calcium and
vitamin D.
Paget’s Disease: Risofos is indicated for treatment of Paget’s disease
of the bone in men and women.

Recommended Adult Dosage
Risofos Tablets (Generic Risedronate Sodium Tablets) should
be taken at least 30 minutes before the first food or drink of the day
other than water and before taking any oral medication or
supplementation, including calcium, antacids, or vitamins to
maximize absorption and clinical benefit. The use of water with
supplements, including mineral water, should be avoided because
they may have a higher concentration of calcium. To facilitate
delivery to the stomach, Risofos Tablets should be swallowed while
the patient is in an upright position and with a full glass of plain
water (177 to 236 ml). Patients should not lie down for 30 minutes
after taking the medication.

The tablet should not be chewed or sucked because of a potential for
oropharyngeal ulceration. Patients should not eat or drink anything
except plain water or take other medications for at least 30 minutes
after taking Risofos Tablets. Patients should receive supplemental
calcium and vitamin D if dietary intake is inadequate.
Calcium supplements and calcium-, aluminium-, iron- and
magnesium-containing medications may interfere with the absorption
of Risofos Tablets and should be taken at a different time of the day.
Treatment of Postmenopausal Osteoporosis: The recommended
dosage is one 35 mg tablet orally, taken once-a-week OR one 150 mg
tablet orally, taken once-a-month.

Treatment to Increase Bone Mass in Men with Osteoporosis: The
recommended dosage is one 35 mg tablet orally, taken once-a-
week.
Treatment and Prevention of Glucocorticoid-Induced Osteoporosis:
The recommended dosage is one 35 mg tablet orally, taken weekly.
Paget’s Disease: The recommended treatment regimen is 30 mg
orally once daily for 2 months. Re-treatment may be considered
(following post-treatment observation of at least 2 months) if relapse
occurs, or if treatment fails to normalize serum alkaline phosphatase.
For re-treatment, the dose and duration of therapy are the same as
for initial treatment. No data are available on more than one course of
re-treatment.

Contraindications
➔
Risofos is contraindicated in patients with a known hypersensitivity to
Risedronate Sodium or any component of the tablet.
➔
Hypocalcaemia.
➔
Inability to stand or sit upright for at least 30 minutes.
➔
Abnormalities of the oesophagus, which delay oesophageal emptying,
such as stricture or achalasia.
➔
Severe renal impairment (creatinine clearance less than 30 mL/min).
➔
Pregnancy and lactation.

Storage Instructions
Risofos Tablets (Generic Risedronate Sodium Tablets have to be
stored at controlled room temperature i.e. from 20°C to 25°C (68°F to
77°F) with excursions permitted between 15° to 30°C (59° to 86°F).
Keep this as well as all other medicines away from children and pets.

Warnings
Upper gastrointestinal irritation may occur. Dosing instructions should
be followed. Discontinue use if new or worsening symptoms occur.
Hypocalcemia may worsen and must be corrected prior to use.
Osteonecrosis of the jaw has been reported rarely.
Severe bone, joint, or muscle pain may occur. Consider discontinuing
use if severe symptoms develop.
Before initiating treatment in patients with glucocorticoid-induced
osteoporosis, sex steroid hormonal status of both men and women
should be ascertained and appropriate replacement considered.
Bisphosphonates may interfere with bone-imaging agents.

Possible Side Effects
Most common Risedronate Sodium (Risofos tablets) side effects
with an incidence rate of greater than or equal to 10% and with a
higher frequency than placebo include back pain, arthralgia,
abdominal pain, and dyspepsia .
Hypersensitivity reactions (angioedema, generalized rash, bullous
skin reactions), and eye inflammation (iritis, uveitis) have been
reported rarely.

Possible Side Effects
The side effects from the Phase 3 postmenopausal osteoporosis
trials reported in greater than or equal to 5% of patients include
Infection, Back Pain, Accidental Injury, Pain, Abdominal Pain, Flu
Syndrome, Headache, Asthenia, Neck Pain, Chest Pain, Allergic
Reaction, Hypertension, Digestive System, Constipation, Diarrhea,
Dyspepsia, Nausea, Peripheral Edema, Arthralgia, Arthritis, Traumatic
Bone Fracture, Joint Disorder, Myalgia, Bone Pain, Dizziness,
Depression, Insomnia, Bronchitis, Sinusitis, Rhinitis, Pharyngitis,
Increased Cough, Rash, Cataract and Urinary Tract Infection.

Risofos Tablets Overdosage
Decreases in serum calcium and phosphorus following substantial
overdose may be expected in some patients. Signs and symptoms of
hypocalcemia may also occur in some of these patients.
Milk or antacids containing calcium should be given to bind
Risedronate and reduce absorption of the medicine.
In cases of substantial overdose, gastric lavage may be considered to
remove unabsorbed drug. Standard procedures that are effective for
treating hypocalcemia, including the administration of calcium
intravenously, would be expected to restore physiologic amounts of
ionized calcium and to relieve signs and symptoms of hypocalcemia.

Risofos Tablets During Pregnancy
Risedronate Sodium (Risofos tablets) has been classified by the US FDA
as Pregnancy Category C.
There are no adequate and well-controlled studies of Risedronate
Sodium in pregnant women. Risedronate should be used during
pregnancy only if the potential benefit justifies the potential risk to the
mother and foetus.
There are no data on fetal risk in humans. However, there is a theoretical
risk of fetal harm, predominantly skeletal, if a woman becomes pregnant
after completing a course of bisphosphonate therapy. The impact of
variables such as time between cessation of bisphosphonate therapy to
conception, the particular bisphosphonate used, and the route of
administration (intravenous versus oral) on this risk has not been studied.

Risofos Tablets (Generic Risedronate Sodium
Tablets) are manufactured by Cipla Limited, India.

Risofos Tablets (Generic Risedronate Sodium Tablets)

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