Binosto

What is Binosto?

Binosto is a bisphosphonate indicated for:

• Treatment of osteoporosis in postmenopausal women
• Treatment to increase bone mass in men with osteoporosis

What are the uses of this medicine?

BINOSTO is a prescription medicine used to:

• Treat thinning of your bones (osteoporosis) in women after menopause. BINOSTO helps reduce the chance of having a hip or spinal fracture (break).
• Increase bone mass in men who have osteoporosis.

How does this medicine work?

• At the cellular level, alendronate shows preferential localization to sites of bone resorption, specifically under osteoclasts.
• The osteoclasts adhere normally to the bone surface but lack the ruffled border that is indicative of active resorption.
• Alendronate does not interfere with osteoclast recruitment or attachment, but it does inhibit osteoclast activity.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• Have certain problems with your esophagus, the tube that connects your mouth with your stomach
• Cannot stand or sit upright for at least 30 minutes
• Have trouble swallowing liquids
• Have low levels of calcium in your blood
• Are allergic to BINOSTO or any of its ingredients.

What drug interactions can this medicine cause?

• Co-administration of BINOSTO and calcium, antacids, or oral medications containing multivalent cations will interfere with absorption of BINOSTO. Therefore, instruct patients to wait at least one-half hour after taking BINOSTO before taking any other oral medications.
• The incidence of upper gastrointestinal adverse events was increased in patients receiving concomitant therapy with daily doses of alendronate sodium greater than 10 mg and aspirin-containing products. Use caution when co-prescribing aspirin.
• BINOSTO may be administered to patients taking NSAIDs. However, since NSAID use is associated with gastrointestinal irritation, caution should be used during concomitant use with BINOSTO.
• The bioavailability of alendronate was slightly decreased when BINOSTO and levothyroxine were co-administered to healthy subjects.

Is this medicine FDA approved?

• Initial U.S. Approval: 1995

How should this medicine be used?

Recommended dosage: Treatment of Osteoporosis in Postmenopausal Women

• The recommended dosage is one 70 mg effervescent tablet once weekly.

Treatment to Increase Bone Mass in Men With Osteoporosis

• The recommended dosage is one 70 mg effervescent tablet once weekly.

Administration:

• Take BINOSTO exactly as your doctor tells you.
• BINOSTO is taken 1 time each week. Choose the day of the week that best fits your schedule, then take BINOSTO on the same day every week.
• BINOSTO works only if you take it on an empty stomach.
• Take BINOSTO after you get up for the day and 30 minutes before taking your first food, drink, or other medicine.
• Take BINOSTO while you are sitting or standing.
• Do not swallow, chew or suck on a BINOSTO tablet.

Do not dissolve BINOSTO in: mineral or flavored water coffee tea soda juice You must dissolve your BINOSTO effervescent tablet in plain water at room temperature before you take it. To prepare your BINOSTO liquid medicine:

• Step 1. Place the BINOSTO tablet in about a half glass (4 ounces) of plain water. The water should not be cold or hot, and should be at room temperature.
• Step 2. Wait at least 5 minutes after the bubbling (effervescence) stops for the BINOSTO tablet to completely dissolve in the water.
• Step 3. Stir the liquid medicine for about 10 seconds.
• Step 4. Drink all of the BINOSTO liquid medicine in the glass.

After you take BINOSTO, wait at least 30 minutes before you:

• lie down. You may sit, stand or walk, and do normal activities like reading.
• take your first food or drink, except for plain water.
• take other medicines, including antacids, calcium, and other supplements and vitamins.
• Do not lie down until after you eat your first food of the day.
• If you miss a dose of BINOSTO, do not take it later in the day. Take your missed dose on the next morning after you remember and then return to your normal schedule. Do not take 2 doses on the same day.
• If you think you took more than your prescribed dose of BINOSTO, drink a full glass of milk and call your doctor right away. Do not try to vomit. Do not lie down.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Effervescent tablets, 70 mg

This medicine is available in fallowing brand namesː

• BINOSTO , Fosamax

What side effects can this medication cause?

The most common side effects of this medicine include:

• Stomach area (abdominal) pain
• Heartburn
• Constipation
• Diarrhea
• Upset stomach
• Pain in your bones, joints, or muscles
• Nausea

BINOSTO may cause serious side effects:

• Esophagus problems
• Low calcium levels in your blood (hypocalcemia)
• Bone, joint, or muscle pain
• Severe jaw bone problems (osteonecrosis)
• Unusual thigh bone fractures

What special precautions should I follow?

• Upper Gastrointestinal Adverse Reactions can occur with BINOSTO. Instruct patients to follow dosing instructions. Discontinue if new or worsening symptoms occur.
• Hypocalcemia can worsen and must be corrected prior to use of BINOSTO.
• Severe Bone, Joint, Muscle Pain may occur with BINOSTO. Discontinue use if severe symptoms develop.
• Osteonecrosis of the Jaw has been reported with BINOSTO.
• Atypical, low-energy, or low trauma fractures of the femoral shaft have been reported in bisphosphonate-treated patients. Patients with new thigh or groin pain should be evaluated to rule out a femoral fracture.
• Each tablet contains 650 mg sodium, equivalent to 1650 mg NaCl. Use caution in patients on sodium restriction.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• Hypocalcemia, hypophosphatemia, and upper gastrointestinal adverse events, such as upset stomach, heartburn, esophagitis, gastritis, or ulcer, may result from oral overdosage.

Treatment of overdosage:

• Milk or antacids should be given to bind alendronate. Due to the risk of esophageal irritation, vomiting should not be induced and the patient should remain fully upright.
• Dialysis would not be beneficial.

Can this medicine be used in pregnancy?

• There are no studies in pregnant women.
• BINOSTO should be used during pregnancy only if the potential benefit justifies the potential risk to the mother and fetus.

Can this medicine be used in children?

• BINOSTO is not indicated for use in pediatric patients.

What are the active and inactive ingredients in this medicine?

• Active ingredient: alendronate sodium
• Inactive ingredients: monosodium citrate anhydrous, citric acid anhydrous, sodium hydrogen carbonate, sodium carbonate anhydrous, strawberry flavor, acesulfame potassium, and sucralose.

Who manufactures and distributes this medicine?

• Manufactured for:

Mission Pharmacal Company San Antonio

What should I know about storage and disposal of this medication?

• Store BINOSTO at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep BINOSTO tablets in their original blister pack until you use them.
• Protect BINOSTO from moisture.

• Dailymed label info on Binosto
• FDA Binosto

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