IBANDRONATE SODIUM tablet, film coated

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

IBANDRONATE SODIUM (UNII: J12U072QL0) (IBANDRONIC ACID - UNII:UMD7G2653W)

Предлага се от:

Aurobindo Pharma Limited

INN (Международно Name):

IBANDRONATE SODIUM

Композиция:

IBANDRONIC ACID 150 mg

Начин на приложение:

ORAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

Ibandronate sodium tablets are indicated for the treatment and prevention of osteoporosis in postmenopausal women. Ibandronate sodium tablets increase bone mineral density (BMD) and reduce the incidence of vertebral fractures. The optimal duration of use has not been determined. The safety and effectiveness of ibandronate 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. Ibandronate 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 [5.1]) - Inability to stand or sit upright for at least 60 minutes (see Dosage and Administration [2.2], and Warnings and Precautions [5.1]) - Hypocalcemia (see Warnings and Precautions [5.2]) - Known hypersensitivity to ibandronate sodium tablets or to any of its excipients. Cases of anaphylaxis have been reported (see Adverse Reactions [6.2]). Risk Summary Ibandronate sodium is not indicated for use in women of reproductive potential. There are no data with ibandronate sodium use in pregnant women to inform any drug-associated risks. In reproductive toxicity studies in the rat, ibandronate sodium caused post-implantation loss and obstruction of labor with maternal and fetal periparturient mortality at greater than or equal to 3 times human exposure at the recommended 2.5 mg daily oral dose, or at greater than or equal to 1 times human exposure at the recommended 150 mg once-monthly oral dose. In pregnant rats, kidney developmental toxicity occurred in offspring at greater than or equal to 30 times the daily 2.5 mg human dose or at greater than or equal to 9 times the once-monthly 150 mg human dose. In rat reproductive studies, impaired pup neuromuscular development was observed at 45 times the daily 2.5 mg dose and 13 times the once-monthly 150 mg dose. In reproductive studies in the rabbit, ibandronate sodium caused maternal mortality at greater than or equal to 8 times the daily 2.5 mg dose and greater than or equal to 4 times the once-monthly 150 mg dose (see Data ). Data Animal Data In female rats given ibandronate at oral doses greater than or equal to 3 times human exposure at the recommended daily oral dose of 2.5 mg or greater than or equal to 1 times human exposure at the recommended once-monthly oral dose of 150 mg beginning 14 days before mating and continuing through lactation, maternal deaths were observed at the time of delivery in all dose groups. Perinatal pup loss in dams given doses producing 45 times human exposure at the recommended daily dose and 13 times human exposure at the recommended once-monthly dose was likely related to maternal dystocia. Calcium supplementation did not completely prevent dystocia and periparturient mortality in any of the treated groups at greater than or equal to 16 times the recommended daily dose and greater than or equal to 4.6 times the recommended once-monthly dose. A low incidence of postimplantation loss was observed in rats treated from 14 days before mating throughout lactation or during gestation, only at doses causing maternal dystocia and periparturient mortality. In pregnant rats dosed orally from gestation day 17 through lactation day 21 (following closure of the hard palate through weaning), maternal toxicity, including dystocia and mortality, fetal perinatal and postnatal mortality, were observed at doses equivalent to human exposure at the recommended daily dose and greater than or equal to 4 times the recommended once-monthly dose. Periparturient mortality has also been observed with other bisphosphonates and appears to be a class effect related to inhibition of skeletal calcium mobilization resulting in hypocalcemia and dystocia. Exposure of pregnant rats during the period of organogenesis resulted in an increased fetal incidence of RPU (renal pelvis ureter) syndrome at oral doses producing 30 times human exposure at the recommended daily oral dose of 2.5 mg and greater than or equal to 9 times human exposure at the recommended once-monthly oral dose of 150 mg. Impaired pup neuromuscular development (cliff avoidance test) was observed at 45 times human exposure at the daily dose and 13 times the once-monthly dose. In pregnant rabbits treated orally with ibandronate during gestation at doses greater than or equal to 8 times the recommended human daily oral dose of 2.5 mg and greater than or equal to 4 times the recommended human once-monthly oral dose of 150 mg, dose-related maternal mortality was observed in all treatment groups. The deaths occurred prior to parturition and were associated with lung edema and hemorrhage. No significant fetal anomalies were observed. Exposure multiples for the rat studies were calculated for the recommended daily oral dose of 2.5 mg or once-monthly dose of 150 mg based on area under the curve (AUC) comparison. Exposure multiples for the rabbit study were calculated for the recommended human daily oral dose of 2.5 mg or once-monthly dose of 150 mg based on dose/body surface area comparison. Doses used in pregnant animals were 1, 4, 5, 6, 16, 10, 20, 30, 60 or 100 mg/kg/day in rats, and 1, 4 or 20 mg/kg/day in rabbits. Risk Summary Ibandronate sodium is not indicated for use in women of reproductive potential. There is no information on the presence of ibandronate in human milk, the effects of ibandronate on the breastfed infant, or the effects of ibandronate on milk production. Ibandronate is present in rat milk (see Data). The clinical relevance of these data is unclear. Data Animal Data In lactating rats treated with intravenous doses of 0.08 mg/kg, ibandronate was present in breast milk from 2 to 24 hours after dose administration. Concentrations in milk averaged 1.5 times plasma concentrations. Safety and effectiveness in pediatric patients have not been established. Of the patients receiving ibandronate sodium 2.5 mg (ibandronate) daily in postmenopausal osteoporosis studies, 52% were over 65 years of age, and 10% were over 75 years of age. Of the patients receiving ibandronate sodium 150 mg (ibandronate) once-monthly in the postmenopausal osteoporosis 1-year study, 52% were over 65 years of age, and 9% were over 75 years of age. No overall differences in effectiveness or safety were observed between these patients and younger patients but greater sensitivity in some older individuals cannot be ruled out. Ibandronate sodium is not recommended for use in patients with severe renal impairment (creatinine clearance less than 30 mL/min).

Каталог на резюме:

Ibandronate Sodium Tablets, 150 mg ( ibandronate) are white to off-white, film-coated, caplet shaped, biconvex tablets debossed with ‘X’ on one side and ‘78’ on the other side.       Carton of 1 Blister Pack Containing 3 Tablets         NDC 65862-237-03 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Статус Оторизация:

Abbreviated New Drug Application

Листовка

IBANDRONATE SODIUM - IBANDRONATE SODIUM TABLET, FILM COATED
Aurobindo Pharma Limited
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MEDICATION GUIDE
Ibandronate Sodium Tablets
(eye-BAN-droe-nate SOE-dee-um)
Read the Medication Guide that comes with ibandronate 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 ibandronate sodium tablets.
What is the most important information I should know about ibandronate
sodium tablets?
Ibandronate sodium tablets may cause serious side effects including:
1.
Esophagus problems
2.
Low calcium levels in your blood (hypocalcemia)
3.
Bone, joint or muscle pain
4.
Severe jaw bone problems (osteonecrosis)
5.
Unusual thigh bone fractures
1. Esophagus problems.
Some people who take ibandronate 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 ibandronate sodium tablets exactly as
prescribed to help lower your
chance of getting esophagus problems (see the section “How should I
take ibandronate sodium
tablets?”).
•
Stop taking ibandronate 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).
Ibandronate sodium tablets may lower the calcium levels in your blood.
If you have low blood calcium
before you start taking ibandronate sodium tablets, it may get worse
during treatment. Your low blood
calcium must be treated before you take ibandronate 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 calcium such as:
•
Spasms, twitches, or cramps in yo

Данни за продукта

IBANDRONATE SODIUM - IBANDRONATE SODIUM TABLET, FILM COATED
AUROBINDO PHARMA LIMITED
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
IBANDRONATE SODIUM
TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
IBANDRONATE SODIUM
TABLETS.
IBANDRONATE SODIUM TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2003
INDICATIONS AND USAGE
Ibandronate sodium is a bisphosphonate indicated for the treatment and
prevention of postmenopausal
osteoporosis. (1.1)
Limitations of Use
The 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
Take one 150 mg tablet once monthly on the same day each month (2.1)
Instruct patient to: (2.2)
Swallow whole tablet with 6 to 8 oz of plain water only, at least 60
minutes before the first food,
beverage, or medication of day. Avoid lying down for at least 60
minutes after taking ibandronate
sodium tablets.
Do not eat, drink (except for water), or take other medication for 60
minutes after taking
ibandronate sodium tablets.
Take supplemental calcium and vitamin D if dietary intake inadequate
(2.3)
DOSAGE FORMS AND STRENGTHS
Tablets: 150 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 60 minutes. (4, 5.1)
Hypocalcemia. (4)
Hypersensitivity to ibandronate sodium tablets. (4)
WARNINGS AND PRECAUTIONS
_Upper gastrointestinal Adverse Reactions_ can occur. Instruct
patients to follow dosing instructions and
discontinue use if new or worsening symptoms occur. (5.1)
_Hypocalcemia_ may worsen during treatment. Correct hypocalcemia
before use. (5.2)
_Severe Bone, Joint, and Muscle Pain_ may occur. Consider
discontinuing use if symptoms develop. (5.3)
_Osteonecrosis of the Jaw_ has been reported. (5.4)
_Atypical Femur Fractures_ have been reported. Patients with new thigh
or groin pa