RISEDRONATE SODIUM tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Aurobindo Pharma Limited

INN (International Name):

RISEDRONATE SODIUM

Composition:

RISEDRONATE SODIUM 150 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 is 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 Paget’s disease of bone in men and women. The optimal duration of use has not been determined. The safety and effectiveness of risedronate sodium tablets for the treatment of osteoporosis are based on clinical data of three years 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 tablets are 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)] - Inability to stand or sit upright for at least 30 minutes [see Dosage and Administration (2), Warnings and Precautions (5.2)] - Hypocalcemia [see Warnings and Precautions (5.3)] - Known hypersensitivity to risedronate sodium tablets or any of its excipients. Angioedema, generalized rash, bullous skin reactions, Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported [see Adverse Reactions (6.2)] Risk Summary Available data on the use of risedronate in pregnant women are insufficient to inform a drug-associated risk of adverse maternal or fetal outcomes. Discontinue risedronate when pregnancy is recognized. In animal reproduction studies, daily oral administration of risedronate to pregnant rats during organogenesis decreased neonatal survival and body weight at doses approximately 5 and 26 times, respectively, the highest recommended human daily dose of 30 mg (based on body surface area, mg/m2 ). A low incidence of cleft palate was observed in fetuses of dams treated at doses approximately equal to the 30 mg human daily dose. Delayed skeletal ossification was observed in fetuses of dams treated at approximately 2.5 to 5 times the 30 mg human daily dose. Periparturient mortality due to maternal hypocalcemia occurred in dams and neonates upon daily oral administration of risedronate to pregnant rats during mating and/or gestation starting at doses equivalent to the 30 mg daily human dose. Bisphosphonates are incorporated into the bone matrix, from which they are gradually released over a period of years. The amount of bisphosphonate incorporated into adult bone and available for release into the systemic circulation is directly related to the dose and duration of bisphosphonate use. Consequently, based on the mechanism of action of bisphosphonates, there is a potential risk of fetal harm, predominantly skeletal, if a woman becomes pregnant after completing a course of bisphosphonate therapy. The impact of variables such as time between cessation of bisphosphonate therapy to conception, the particular bisphosphonate used, and the route of administration (intravenous versus oral) on this risk has not been studied. The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data In animal studies, pregnant rats received risedronate sodium during organogenesis at doses equivalent to 1 to 26 times the 30 mg human daily dose (based on body surface area, mg/m2 ). Survival of neonates was decreased in dams treated during gestation with oral doses approximately 5 times the human dose, and body weight was decreased in neonates of dams treated with approximately 26 times the human dose. A low incidence of cleft palate was observed in fetuses of dams treated with oral doses approximately equal to the human dose. The number of fetuses exhibiting incomplete ossification of sternebrae or skull of dams treated with approximately 2.5 times the human dose was significantly increased compared to controls. Both incomplete ossification and unossified sternebrae were increased in fetuses of dams treated with oral doses approximately 5 times the human dose. No significant ossification effects were seen in fetuses of rabbits treated with oral doses approximately 7 times the human dose (the highest dose tested). However, 1 of 14 litters were aborted and 1 of 14 litters were delivered prematurely. Periparturient mortality due to maternal hypocalcemia occurred in dams and neonates when pregnant rats were treated daily during mating and/or gestation with oral doses equivalent to the human dose or higher. Risk Summary There are no data on the presence of risedronate in human milk, the effects on the breastfed infant, or the effects on milk production. A small degree of lacteal transfer occurred in nursing rats. The concentration of the drug in animal milk does not necessarily predict the concentration of drug in human milk. However, when a drug is present in animal milk, it is likely that the drug will be present in human milk. The developmental and health benefits of breast-feeding should be considered along with the mother’s clinical need for risedronate and any potential adverse effects on the breast-fed child from risedronate or from the underlying maternal condition. Data Animal Data Risedronate was detected in neonates of lactating rats given a single oral dose of risedronate at 24-hours post-dosing, indicating a small degree of lacteal transfer. Risedronate is not indicated for use in pediatric patients. The safety and effectiveness of risedronate was assessed in a one-year, randomized, double-blind, placebo-controlled study of 143 pediatric patients (94 received risedronate) with osteogenesis imperfecta (OI). The enrolled population was predominantly patients with mild osteogenesis imperfecta (85% Type-I), aged 4 to less than 16 years, 50% male and 82% Caucasian, with a mean lumbar spine BMD Z-score of -2.08 (2.08 standard deviations below the mean for age-matched controls).  Patients received either a 2.5 mg (less than or equal to 30 kg body weight) or 5 mg (greater than 30 kg body weight) daily oral dose. After one year, an increase in lumbar spine BMD in the risedronate group compared to the placebo group was observed. However, treatment with risedronate did not result in a reduction in the risk of fracture in pediatric patients with osteogenesis imperfecta. In risedronate-treated subjects, no mineralization defects were noted in paired bone biopsy specimens obtained at baseline and month 12. The overall safety profile of risedronate in OI patients treated for up to 12 months was generally similar to that of adults with osteoporosis. However, there was an increased incidence of vomiting compared to placebo. In this study, vomiting was observed in 15% of children treated with risedronate and 6% of patients treated with placebo. Other adverse events reported in greater than or equal to 10% of patients treated with risedronate and with a higher frequency than placebo were: pain in the extremity (21% with risedronate versus 16% with placebo), headache (20% versus 8%), back pain (17% versus 10%), pain (15% versus 10%), upper abdominal pain (11% versus 8%), and bone pain (10% versus 4%). Of the patients receiving risedronate in postmenopausal osteoporosis studies [see Clinical Studies (14)] , 47% were between 65 and 75 years of age, and 17% were over 75. The corresponding proportions were 26% and 11% in glucocorticoid-induced osteoporosis trials, and 40% and 26% in Paget’s disease trials. No overall differences in efficacy between geriatric and younger patients were observed in these studies. In the male osteoporosis trial, 28% of patients receiving risedronate were between 65 and 75 years of age and 9% were over 75. The lumbar spine BMD response for risedronate compared to placebo was 5.6% for subjects less than 65 years and 2.9% for subjects greater than or equal to 65 years. No overall differences in safety between geriatric and younger patients were observed in the risedronate trials, but greater sensitivity of some older individuals cannot be ruled out. Risedronate is not recommended for use in patients with severe renal impairment (creatinine clearance less than 30 mL/min) because of lack of clinical experience. No dosage adjustment is necessary in patients with a creatinine clearance greater than or equal to 30 mL/min. No studies have been performed to assess risedronate’s safety or efficacy in patients with hepatic impairment. Risedronate is not metabolized in human liver preparations. Dosage adjustment is unlikely to be needed in patients with hepatic impairment. NDC 65862-870-11 Rx only Once-a-Month Risedronate Sodium Tablet, USP 150 mg AUROBINDO                  One-Month Supply (1 Tablet)                   NDC 65862-870-11 Rx only   Once-a-Month Risedronate Sodium Tablet, USP 150 mg PHARMACIST: Dispense the accompanying Medication Guide to each patient. AUROBINDO                                      One-Month Supply (1 Tablet)

Product summary:

Risedronate Sodium Tablets USP, 150 mg are blue colored, circular shaped, film-coated biconvex tablets debossed with ‘Z’ on one side and ‘43’ on the other side. Unit-of-use blister package of 1                           NDC 65862-870-11 Unit-of-use blister package of 3                           NDC 65862-870-03 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

RISEDRONATE SODIUM - RISEDRONATE SODIUM TABLET, FILM COATED
Aurobindo Pharma Limited
----------
MEDICATION GUIDE
Risedronate Sodium Tablets, USP
(ris'' e droe' nate soe' dee um)
Read the Medication Guide that comes with risedronate sodium tablets
before you start taking them 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 them.
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 you
have symptoms of low blood calci

Summary of Product characteristics

RISEDRONATE SODIUM - RISEDRONATE SODIUM TABLET, FILM COATED
AUROBINDO PHARMA LIMITED
----------
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 a 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: 150 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
Atelvia should not be treated with
risedronate sodium tablets (5.1)
_Upper Gastrointestinal Adverse