FOSAMAX PLUS D- alendronate sodium and cholecalciferol tablet

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

alendronate sodium (UNII: 2UY4M2U3RA) (alendronic acid - UNII:X1J18R4W8P), cholecalciferol (UNII: 1C6V77QF41) (cholecalciferol - UNII:1C6V77QF41)

Beszerezhető a:

Physicians Total Care, Inc.

INN (nemzetközi neve):

alendronate sodium

Összetétel:

alendronic acid 70 mg

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

FOSAMAX® PLUS D is indicated for: For the treatment of osteoporosis, FOSAMAX PLUS D increases bone mass and reduces the incidence of fractures, including those of the hip and spine (vertebral compression fractures). FOSAMAX PLUS D alone should not be used to treat vitamin D deficiency. The safety and effectiveness of FOSAMAX PLUS D for the treatment of osteoporosis are based on clinical data of four years duration. The optimal duration of use has not been determined. All patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis. - 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 30 minutes [see Dosage and Administration (2.3), Warnings and Precautions (5.1)] - Hypocalcemia [see Warnings and Precautions (5.2)] - Hypersensitivity to any component of this product. Hypersensitivity reactions including urticaria and angioedema have

Termék összefoglaló:

No. 3870 — Tablets FOSAMAX PLUS D 70 mg/2800 IU are white to off-white, modified capsule-shaped tablets with code 710 on one side and an outline of a bone image on the other. They are supplied as follows: NDC 54868-5480-0           unit of use blister packages of 4. Storage Store at 20-25°C (68-77°F), excursions between 15-30°C (59-86°F) are allowed. [See USP Controlled Room Temperature.] Protect from moisture and light. Store tablets in the original blister package until use.

Engedélyezési státusz:

New Drug Application

Betegtájékoztató

Physicians Total Care, Inc.
----------
MEDICATION GUIDE
FOSAMAX® PLUS D (FOSS-ah-max PLUS D)
(alendronate sodium/cholecalciferol)
Tablets
Read the Medication Guide that comes with FOSAMAX® PLUS D 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 treatment.
Talk to your doctor if you have any
questions about FOSAMAX PLUS D.
What is the most important information I should know about FOSAMAX
PLUS D?
FOSAMAX PLUS D can 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 FOSAMAX PLUS D 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 FOSAMAX PLUS D exactly as prescribed to
help lower your
chance of getting esophagus problems. (See the section “How should I
take FOSAMAX
PLUS D?”)
•
Stop taking FOSAMAX PLUS D 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).
FOSAMAX PLUS D may lower the calcium levels in your blood. If you have
low blood calcium
before you start taking FOSAMAX PLUS D, it may get worse during
treatment. Your low blood
calcium must be treated before you take FOSAMAX PLUS D. 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 D to help prevent low
calcium levels in yo

Termékjellemzők

FOSAMAX PLUS D - ALENDRONATE SODIUM AND CHOLECALCIFEROL TABLET
PHYSICIANS TOTAL CARE, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FOSAMAX PLUS D SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING INFORMATION FOR FOSAMAX PLUS D.
FOSAMAX PLUS D
(ALENDRONATE SODIUM/CHOLECALCIFEROL) TABLETS
INITIAL U.S. APPROVAL: 2005
RECENT MAJOR CHANGES
Indications and Usage, Limitations of Use (1.3) 01/2011
Warnings and Precautions, Femoral Fractures (5.5) 01/2011
INDICATIONS AND USAGE
FOSAMAX PLUS D is a combination of a bisphosphonate and vitamin D
indicated for:
Treatment of osteoporosis in postmenopausal women (1.1)
Treatment to increase bone mass in men with osteoporosis (1.2)
FOSAMAX PLUS D alone should not be used to treat vitamin D deficiency.
(1.3)
The optimal duration of use has not been determined. Patients should
have the need for continued therapy re-evaluated on
a periodic basis.
DOSAGE AND ADMINISTRATION
Must be taken with plain water (6 to 8 oz) at least 30 minutes before
the first food or drink of the day; do not lie down for 30
minutes. (2.3)
70 mg alendronate/2800 IU vitamin D or 70 mg alendronate/5600 IU
vitamin D tablet once weekly. (2.1, 2.2, 2.3, 2.4)
DOSAGE FORMS AND STRENGTHS
Tablets: 70 mg/2800 IU and 70 mg/5600 IU (3)
CONTRAINDICATIONS
Abnormalities of the esophagus which delay emptying such as stricture
or achalasia (4, 5.1)
Inability to stand/sit upright for at least 30 minutes (4, 5.1)
Hypocalcemia (4, 5.2)
Hypersensitivity to any component of this product (4, 6.2)
WARNINGS AND PRECAUTIONS
Severe irritation of upper gastrointestinal mucosa can occur. Follow
dosing instructions. Use caution in patients with
active upper GI disease. Discontinue if new or worsening symptoms
occur. (5.1)
Hypocalcemia can worsen and must be corrected prior to use. (5.2)
Severe bone, joint, muscle pain may occur. Discontinue use if severe
symptoms develop. (5.3)
Osteonecrosis of the jaw has been reported rarely. (5.4)
Atypical femur fractures have been re