RISEDRONATE SODIUM tablet, film coated

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

RISEDRONATE SODIUM HEMI-PENTAHYDRATE (UNII: HU2YAQ274O) (RISEDRONIC ACID - UNII:KM2Z91756Z)

Commercializzato da:

Hangzhou Minsheng Binjiang Pharmaceutical CO., Ltd

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

Risedronate sodium tablets are indicated for the treatment and prevention of osteoporosis in postmenopausal women. In postmenopausal women with osteoporosis, risedronate sodium tablets 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 are indicated for treatment to increase bone mass in men with osteoporosis. Risedronate sodium tablets 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 are indicated for treatment of Pagets's disease of bone in men and women. The optimal duration of use has not been determined. The safety and

Dettagli prodotto:

Risedronate Sodium Tablets USP are available as follows: 35 mg orange film-coated, modified capsule-shaped tablets, one side debossed “041”, the other side is blank. NDC 60723-041-04 Blister pack of 4 tablets (1 × 4 unit-of-use) with child resistant package NDC 60723-041-12 Blister pack of 12 tablets (3 × 4 unit-of-use) with child resistant package Store at 20° to 25° C (68° to 77° F) [see USP Controlled Room Temperature].

Stato dell'autorizzazione:

Abbreviated New Drug Application

Foglio illustrativo

RISEDRONATE SODIUM- RISEDRONATE SODIUM TABLET, FILM COATED
Hangzhou Minsheng Binjiang Pharmaceutical CO., Ltd
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MEDICATION GUIDE
Medication Guide
Risedronate Sodium Tablets
(ris ed’ roe 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:
1. Esophagus problems
2. Low calcium levels in your blood (hypocalcemia)
3. Severe jaw bone problems (osteonecrosis)
4. Bone, joint, or muscle pain
5. Unusual thigh bone fractures
1. 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.
2. 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 y

Scheda tecnica

RISEDRONATE SODIUM- RISEDRONATE SODIUM TABLET, FILM COATED
HANGZHOU MINSHENG BINJIANG PHARMACEUTICAL CO., LTD
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
RISEDRONATE SODIUM
TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
RISEDRONATE SODIUM
TABLETS.
RISEDRONATE SODIUM TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1998
INDICATIONS AND USAGE
Risedronate sodium tablets are bisphosphonate indicated for:
• 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)
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:
• 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)
DOSAGE FORMS AND STRENGTHS
Tablets: 35 mg ( 3)
CONTRAINDICATIONS
• 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 30 minutes ( 4,
5.1)
• Hypocalcemia ( 4, 5.2)
• Known hypersensitivity to any component of this product ( 4, 6.2)
WARNINGS AND PRECAUTIONS
• _Products Containing Same Active Ingredient:_ Patients receiving
Atelvia should not be