RISEDRONATE SODIUM- risedronate sodium tablet, delayed release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

RISEDRONATE SODIUM HEMI-PENTAHYDRATE (UNII: HU2YAQ274O) (RISEDRONIC ACID - UNII:KM2Z91756Z), RISEDRONATE SODIUM MONOHYDRATE (UNII: F67L43UT5C) (RISEDRONIC ACID - UNII:KM2Z91756Z)

Available from:

Actavis Pharma, Inc.

INN (International Name):

RISEDRONATE SODIUM HEMI-PENTAHYDRATE

Composition:

RISEDRONATE SODIUM ANHYDROUS 30.1 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Risedronate sodium is 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 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 is contraindicated in patients with the following conditions: - Abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia [see Warnings and Precautions (5.2) ] -

Product summary:

Risedronate sodium delayed-release tablets are: 35 mg, yellow, oval-shaped, and engraved with EC 35 on one side. NDC 0591-3876-04       Dose pack of 4 tablets Store at controlled room temperature 20° to 25° C (68° to 77° F) [see USP].

Authorization status:

New Drug Application

Patient Information leaflet

Actavis Pharma, Inc.
----------
Medication Guide
Risedronate sodium
delayed-release tablets
Read this Medication Guide that comes with Risedronate sodium 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?
Risedronate sodium 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 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 exactly as prescribed
to help lower your chance
of getting esophagus problems. (See the section “How should I take
Risedronate sodium?”)
•
Stop taking Risedronate sodium 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 may lower the calcium levels in your blood. If you
have low blood calcium before
you start taking Risedronate sodium , it may get worse during
treatment. Your low blood calcium must be
treated before you take Risedronate sodium . 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 your muscles
•
Numbness or tingling in your fingers, toes, or around your mouth
Your doctor may prescribe calcium and vitamin

Summary of Product characteristics

RISEDRONATE SODIUM- RISEDRONATE SODIUM TABLET, DELAYED RELEASE
ACTAVIS PHARMA, INC.
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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
RECENT MAJOR CHANGES
Contraindications (4) 03/2015
Warnings and Precautions (5.4) 04/2015
INDICATIONS AND USAGE
Risedronate sodium is 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 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 (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_ ha