IBANDRONATE SODIUM tablet

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Alvogen Inc.

INN (International Name):

IBANDRONATE SODIUM

Sammensetning:

IBANDRONIC ACID 150 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Ibandronate Sodium Tablets are indicated for the treatment and prevention of osteoporosis in postmenopausal women. Ibandronate sodium increases bone mineral density (BMD) and reduces 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 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 [5.1]) • Inability to stand or sit upright for at least 60 minutes (see Dosage

Produkt oppsummering:

Ibandronate Sodium Tablets: supplied as yellow colored capsule shaped film-coated tablets debossed with “ID” on one side and “150” on the other side. Carton of 1 Blister Pack containing 3 tablets NDC 47781-103-21 Store at 25°C (77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature].

Autorisasjon status:

Abbreviated New Drug Application

Informasjon til brukeren

IBANDRONATE SODIUM- IBANDRONATE SODIUM TABLET
Alvogen Inc.
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MEDICATION GUIDE
Ibandronate (eh-BAN-drow-nate) Sodium Tablets
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 your muscles
• Numbness or tingling in

Preparatomtale

IBANDRONATE SODIUM- IBANDRONATE SODIUM TABLET
ALVOGEN INC.
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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 Tablets are a bisphosphonate indicated for the
treatment and prevention of post-
menopausal 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 as ibandronic acid 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 as ibandronic acid (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 (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