RISEDRONATE SODIUM tablet, film coated

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

RISEDRONATE SODIUM (UNII: OFG5EXG60L) (RISEDRONIC ACID - UNII:KM2Z91756Z)

Commercializzato da:

Proficient Rx LP

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

Risedronate sodium tablets, USP are indicated for the treatment and prevention of osteoporosis in postmenopausal women. In postmenopausal women with osteoporosis, risedronate sodium tablets, USP reduce the incidence of vertebral fractures and a composite endpoint of nonvertebral osteoporosis-related fractures [see Clinical Studies (14.1, 14.2) ]. Risedronate sodium tablets, USP are indicated for treatment to increase bone mass in men with osteoporosis. Risedronate sodium tablets, USP are 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 greater than or equal to 7.5 mg of prednisone or equivalent) for chronic diseases. Patients treated with glucocorticoids should receive adequate amounts of calcium and vitamin D. Risedronate sodium tablets, USP are indicated for treatment of Paget’s disease of bone in men and women. The optimal duration of use has not been determined. The

Dettagli prodotto:

Risedronate Sodium Tablets, USP are available as follows:  35 mg film-coated, round, orange biconvex tablet, engraved ‘APO’ on one side, ‘RIS’ over ‘35’ on the other side NDC 71205-714-04 dose pack of 4 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

Stato dell'autorizzazione:

Abbreviated New Drug Application

Foglio illustrativo

RISEDRONATE SODIUM- RISEDRONATE SODIUM TABLET, FILM COATED
Proficient Rx LP
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MEDICATION GUIDE
Risedronate Sodium Tablets, USP
(ris-e-drone-nate soe-dee-um)
Read the Medication Guide that comes with risedronate sodium tablets
before you start taking it and each
time you get a refill. There may be new information. This Medication
Guide does not take the place of
talking with your doctor about your medical condition or your
treatment. Talk to your doctor if you have any
questions about risedronate sodium tablets, there may be new
information about it.
What is the most important information I should know about risedronate
sodium tablets?
Risedronate sodium tablets can cause serious side effects including:
Esophagus problems
Low calcium levels in your blood (hypocalcemia)
Severe jaw bone problems (osteonecrosis)
Bone, joint, or muscle pain
Unusual thigh bone fractures
Esophagus problems.
Some people who take risedronate sodium tablets may develop problems
in the esophagus (the tube
that connects the mouth and the stomach). These problems include
irritation, inflammation, or ulcers of
the esophagus which may sometimes bleed.
It is important that you take risedronate sodium tablets exactly as
prescribed to help lower your
chance of getting esophagus problems. (See the section “How should I
take risedronate sodium
tablets?”)
Stop taking risedronate sodium tablets and call your doctor right away
if you get chest pain, new
or worsening heartburn, or have trouble or pain when you swallow.
Low calcium levels in your blood (hypocalcemia).
Risedronate sodium tablets may lower the calcium levels in your blood.
If you have low blood calcium
before you start taking risedronate sodium tablets, it may get worse
during treatment. Your low blood
calcium must be treated before you take risedronate sodium tablets.
Most people with low blood
calcium levels do not have symptoms, but some people may have
symptoms. Call your doctor right
away if you have symptoms of low blood calcium such as:
Spasms, twitches, or cramps in yo

Scheda tecnica

RISEDRONATE SODIUM- RISEDRONATE SODIUM TABLET, FILM COATED
PROFICIENT RX LP
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
RISEDRONATE SODIUM
TABLETS, USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR RISEDRONATE
SODIUM TABLETS, USP.
RISEDRONATE SODIUM TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1998
INDICATIONS AND USAGE
Risedronate sodium tablets, USP are a bisphosphonate indicated for:
•
•
Limitations of Use
Optimal duration of use has not been determined. For patients at
low-risk for fracture, consider drug
discontinuation after 3 to 5 years of use. (1.5)
DOSAGE AND ADMINISTRATION
Treatment of Postmenopausal Osteoporosis: 5 mg daily, 35 mg
once-a-week, 75 mg two consecutive days
each month, 150 mg once-a-month (2.1)
Prevention of Postmenopausal Osteoporosis: 5 mg daily, 35 mg
once-a-week (2.2)
Men with Osteoporosis: 35 mg once-a-week (2.3)
Glucocorticoid-Induced Osteoporosis: 5 mg daily (2.4)
Paget's Disease: 30 mg daily for 2 months (2.5)
Instruct patients to:
•
•
•
DOSAGE FORMS AND STRENGTHS
Tablets: 35, 75, and 150 mg (3)
CONTRAINDICATIONS
WARNINGS AND PRECAUTIONS
•
•
ADVERSE REACTIONS
Most common adverse reactions reported in greater than 10% of patients
treated with risedronate sodium
tablets and with a higher frequency than placebo are: back pain,
arthralgia, abdominal pain, and dyspepsia
Treatment and prevention of postmenopausal osteoporosis (1.1)
Treatment to increase bone mass in men with osteoporosis (1.2)
Treatment and prevention of glucocorticoid-induced osteoporosis (1.3)
Treatment of Paget's disease (1.4)
Swallow tablet whole with 6 to 8 ounces of plain water, at least 30
minutes before the first food,
beverage, or medication of the day.
Avoid lying down for 30 minutes (2)
Take supplemental calcium and vitamin D if dietary intake is
inadequate (2.7)
Abnormalities of the esophagus which delay esophageal emptying such as
stricture or achalasia (4,
5.1)
Inability to stand or sit upright for at least 3