RISEDRONATE SODIUM tablet, delayed release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Zydus Pharmaceuticals USA Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 empt

Product summary:

Risedronate Sodium Delayed-Release Tablets, 35 mg are yellow colored, round, biconvex, bevel edge coated tablets with '75' debossed on one side and plain on other side and are supplied as follows: NDC 68382-075-73 in unit-dose blister carton of 4 (1 x 4) unit-dose tablets Storage Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Zydus Pharmaceuticals USA Inc.
----------
Medication Guide
Risedronate Sodium
(ris ed' 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, 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
symptoms, bu

Summary of Product characteristics

RISEDRONATE SODIUM - RISEDRONATE SODIUM TABLET, DELAYED RELEASE
ZYDUS PHARMACEUTICALS USA INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
RISEDRONATE SODIUM
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
RISEDRONATE SODIUM.
RISEDRONATE SODIUM DELAYED-RELEASE TABLETS
INITIAL U.S. APPROVAL: 1998
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 tablet 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 tablet (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)
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 (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 (5.3)
_Osteonecrosis of the Jaw_ has been reported (5.4)
_Severe Bone, Joint, Muscle Pain may occur._ Discontinue use if severe
symptoms develop (5.5, 6.2)
_Atypical Femur Fractures_ have been re