FOSAMAX PLUS D- alendronate sodium and cholecalciferol tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ALENDRONATE SODIUM (UNII: 2UY4M2U3RA) (ALENDRONIC ACID - UNII:X1J18R4W8P), CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41)

Available from:

Merck Sharp & Dohme Corp.

INN (International Name):

ALENDRONATE SODIUM

Composition:

ALENDRONIC ACID 70 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

FOSAMAX® PLUS D is indicated for the treatment of osteoporosis in postmenopausal women. In postmenopausal women, FOSAMAX PLUS D increases bone mass and reduces the incidence of fractures, including those of the hip and spine (vertebral compression fractures). [See Clinical Studies (14.1).] FOSAMAX PLUS D is indicated for treatment to increase bone mass in men with osteoporosis [see Clinical Studies (14.2)]. FOSAMAX PLUS D alone should not be used to treat vitamin D deficiency. The optimal duration of use has not been determined. The safety and effectiveness of FOSAMAX PLUS D for the treatment of osteoporosis are based on clinical data of four 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. FOSAMAX PLUS D is contraindicated in

Product summary:

No. 3870 — Tablets FOSAMAX PLUS D 70 mg/2800 international units 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 0006-0710-44 unit of use blister packages of 4. No. 6746 — Tablets FOSAMAX PLUS D 70 mg/5600 international units are white to off-white, modified rectangle-shaped tablets with code 270 on one side and an outline of a bone image on the other. They are supplied as follows: NDC 0006-0270-44 unit of use blister packages of 4 NDC 0006-0270-21 unit dose packages of 20. 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.

Authorization status:

New Drug Application

Patient Information leaflet

Merck Sharp & Dohme Corp.
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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 tablet?")
•
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 y

Summary of Product characteristics

FOSAMAX PLUS D- ALENDRONATE SODIUM AND CHOLECALCIFEROL TABLET
MERCK SHARP & DOHME CORP.
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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
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)
Limitations of use:
FOSAMAX PLUS D alone should not be used to treat vitamin D deficiency.
(1.3)
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. (1.3)
DOSAGE AND ADMINISTRATION
70 mg alendronate/2800 international units vitamin D or 70 mg
alendronate/5600 international units
vitamin D tablet once weekly. (2.1, 2.2)
Instruct patients to: (2.3)
Swallow tablets whole with 6-8 ounces plain water at least 30 minutes
before the first food, drink, or
medication of the day.
Not lie down for at least 30 minutes after taking FOSAMAX PLUS D and
until after food.
DOSAGE FORMS AND STRENGTHS
Tablets: 70 mg/2800 international units and 70 mg/5600 international
units (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
_Upper Gastrointestinal Adverse Reactions _can occur. Instruct
patients to follow dosing instructions.
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. (5.4)
_Atypical Femur Fractures _hav