RISEDRONATE SODIUM- risedronate sodium hemi-pentahydrate tablet, delayed release

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

Impax Generics

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Risedronate sodium delayed-release tablets are indicated for the treatment of osteoporosis in postmenopausal women. In postmenopausal women, risedronate sodium has been shown to reduce the incidence of vertebral fractures and a composite endpoint of nonvertebral osteoporosis-related fractures [see Clinical  Studies (14.1) ]. The optimal duration of use has not been determined. The safety and effectiveness of risedronate sodium delayed-release tablets for the treatment of osteoporosis are based on clinical data of one year duration. All patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis. Patients at low-risk for fracture should be considered for drug discontinuation after 3 to 5 years of use. Patients who discontinue therapy should have their risk for fracture re-evaluated periodically. Risedronate sodium delayed-release tablets are contraindicated in patients with the following conditions: - Abnormalities of the esophagus which delay esophageal emp

Resumen del producto:

Risedronate sodium delayed-release tablets are light orange oval film coated tablets, debossed with “AG” on one side and blank on the other side. Store at 20°C to 25°C (68°F to 77° F) [see USP Controlled Room Temperature].

Estat d'Autorització:

Abbreviated New Drug Application

Informació per a l'usuari

Impax Generics
----------
Medication Guide
Risedronate Sodium
(rih-SED-roe-nate SOE-dee-um)
Delayed-Release Tablets
Read this Medication Guide that comes with risedronate sodium
delayed-release 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
delayed-release tablets, there may be new
information about it.
What is the most important information I should know about risedronate
sodium delayed-release tablets?
Risedronate sodium delayed-release 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 delayed-release 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 delayed-release
tablets exactly as prescribed to
help lower your chance of getting esophagus problems. (See the section
"How should I take
risedronate sodium delayed-release tablets?")
•
Stop taking risedronate sodium delayed-release 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 delayed-release tablets may lower the calcium
levels in your blood. If you have low
blood calcium before you start taking risedronate sodium
delayed-release tablets, it may get worse during
treatment. Your low blood calcium must be treated before you take
risedronate sodium delayed-release
tablets. Most people with low blood calcium levels do not have
sympt

Fitxa tècnica

RISEDRONATE SODIUM- RISEDRONATE SODIUM HEMI-PENTAHYDRATE TABLET,
DELAYED RELEASE
IMPAX GENERICS
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
RISEDRONATE SODIUM DELAYED-RELEASE
TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
RISEDRONATE SODIUM DELAYED-RELEASE
TABLETS.RISEDRONATE SODIUM DELAYED-RELEASE TABLETS FOR ORAL
USE.INITIAL U.S. APPROVAL: 1998
RECENT MAJOR CHANGES
Contraindications (4)
03/2015
Warnings and Precautions (5.4)
04/2015
INDICATIONS AND USAGE
Risedronate sodium delayed-release tablets are a bisphosphonate in a
delayed-release formulation and is indicated for
treatment of postmenopausal osteoporosis (1.1)
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 (1.2)
DOSAGE AND ADMINISTRATION
One 35 mg delayed-release tablet once-a-week (2.1)
Instruct patients to:
• Take risedronate sodium delayed-release tablets in the morning
immediately _following breakfast _with at least 4 ounces of
plain water (2.2)
• Avoid lying down for 30 minutes after taking risedronate sodium
delayed-release tablets (2.2)
• Take supplemental calcium and vitamin D if dietary intake is
inadequate (2.3)
DOSAGE FORMS AND STRENGTHS
Delayed-release tablets: 35 mg (3) (3)
CONTRAINDICATIONS
Abnormalities of the esophagus which delay esophageal emptying such as
stricture or achalasia (4, 5.2)
Inability to stand or sit upright for at least 30 minutes (4, 5.2)
Hypocalcemia (4, 5.3)
Known hypersensitivity to any component of this product (4, 6.2)
WARNINGS AND PRECAUTIONS
_Products Containing Same Active Ingredient:_ Patients receiving
Actonel should not be treated with risedronate sodium
delayed-release tablets (5.1)
_Upper Gastrointestinal Adverse Reactions_ can occur. Instruct
patients to follow dosing instructions. Discontinue use if
new or worsening symptoms occur (5.2)
_Hypocalcemia_ may worsen and must be corrected prior to use