BINOSTO- alendronate sodium tablet, effervescent

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ALENDRONATE SODIUM (UNII: 2UY4M2U3RA) (ALENDRONIC ACID - UNII:X1J18R4W8P)

Available from:

Mission Pharmacal Company

INN (International Name):

alendronate sodium

Composition:

ALENDRONIC ACID 70 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

BINOSTO effervescent tablet 70 mg is indicated for the treatment of osteoporosis in postmenopausal women. For the treatment of osteoporosis, alendronate sodium increases bone mass and reduces the incidence of fractures, including those of the hip and spine (vertebral compression fractures). [See Clinical Studies ( 14.1).] BINOSTO is indicated for treatment to increase bone mass in men with osteoporosis [see Clinical Studies ( 14.2)] . The optimal duration of use has not been determined. The safety and effectiveness of BINOSTO 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. BINOSTO i

Product summary:

BINOSTO effervescent tablets are round, flat faced, white to off-white tablets with beveled edges and “M” debossed on one side. BINOSTO effervescent tablets, 70 mg are provided in blisters made of aluminum foil composite, as follows: NDC 0178-0101-02 carton containing 4 units of use blisters Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F), [See USP Controlled Room Temperature.] Protect from moisture. Store tablets in original blister package until use.

Authorization status:

New Drug Application

Patient Information leaflet

Mission Pharmacal Company
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Medication Guide
BINOSTO ® (BIN -oss-tow )
(alendronate sodium)
Effervescent Tablets
Read the Medication Guide that comes with BINOSTO ® 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.
What is the most important information I should know about BINOSTO
Effervescent Tablet?
BINOSTO Effervescent Tablet 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 BINOSTO 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 BINOSTO exactly as prescribed to
help lower your chance of
getting esophagus problems. (See the section “How should I take
BINOSTO?”)
● Stop taking BINOSTO 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).
BINOSTO may lower the calcium levels in your blood. If you have low
blood calcium before you
start taking BINOSTO, it may get worse during treatment. Your low
blood calcium must be
treated before you take BINOSTO. 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 your
blood, while you take BINOSTO. Take calcium and vitamin D as your
doctor tells you to.
3.
Bone, joint, or mus

Summary of Product characteristics

BINOSTO- ALENDRONATE SODIUM TABLET, EFFERVESCENT
MISSION PHARMACAL COMPANY
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BINOSTO SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR BINOSTO.
BINOSTO (ALENDRONATE SODIUM) EFFERVESCENT TABLETS FOR ORAL SOLUTION
INITIAL U.S. APPROVAL: 1995
INDICATIONS AND USAGE
BINOSTO is a bisphosphonate indicated for:
Treatment of osteoporosis in postmenopausal women ( 1.1)
Treatment to increase bone mass in men with osteoporosis ( 1.2)
Limitation 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. ( 1.3)
DOSAGE AND ADMINISTRATION
70 mg BINOSTO effervescent tablet once weekly. ( 2.1, 2.2)
Instruct patients to: ( 2.3)
Dissolve one tablet of BINOSTO in approximately half a glass of plain
room temperature water (4 oz). Wait at least 5
minutes after the effervescence stops, stir the solution for
approximately 10 seconds and consume contents.
Swallow solution _at least _30 minutes before the first food,
beverage, or medication of the day.
Avoid lying down for at least 30 minutes after taking BINOSTO and
until after the first food of the day.
DOSAGE FORMS AND STRENGTHS
Effervescent tablets, 70 mg ( 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)
Increased risk of aspiration. ( 4)
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_ have