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Why buffered Effervescent Alendronate sodium?
A buffered solution
BINOSTO is the first and only prescription medicine for the treatment of osteoporosis in postmenopausal women and treatment to increase bone mass in men with osteoporosis that gives you proven fracture protection in a buffered, effervescent solution. It is a treatment option when tablets just aren't the right choice--for any reason.
Important Limitations of Use: 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.
Proven fracture-risk reduction
Alendronate sodium has helped treat osteoporosis in postmenopausal women since 1995. For many years, it has been prescribed by doctors to build bone and protect from fractures at the hip and spine.
Fosamax® was the branded alendronate sodium approved by the US Food and Drug Administration (FDA) as being safe and effective. Generic alendronate sodium products became available to patients over time with the same alendronate sodium to help prevent and treat osteoporosis. Both Fosamax and the generic versions of the drug are available in a tablet that must be taken with 8 oz of water. Other conditions of use apply.
BINOSTO, once dissolved in 4 oz of water, forms a buffered effervescent solution. It is taken once weekly. The FDA approved BINOSTO and found it to be bioequivalent to Fosamax1, which means it works the same way.
BINOSTO is not a tablet that you swallow whole. It is an effervescent tablet that dissolves completely in water to become a strawberry-flavored, buffered solution.
- 1. Fosamax is a registered trademark of Merck & Co., Inc.
This material is intended to provide basic information and is not medical advice. All medical advice, diagnosis, and treatment should be obtained from your physician.
The product information provided in this site is intended for residents of the United States.
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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.
It is not known how long BINOSTO works for the treatment of osteoporosis. You should see your doctor regularly to determine if BINOSTO is still right for you.
BINOSTO is not for use in children.
Do not take BINOSTO if you:
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.
BINOSTO Effervescent Tablet can cause serious side effects, including:
Esophagus problems
Low calcium levels in your blood (hypocalcemia)
Bone, joint, or muscle pain
Severe jaw bone problems (osteonecrosis)
Unusual thigh bone fractures
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?” in the Medication Guide)
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.
Low calcium levels in your blood (hypocalcemia).
BINOSTO may lower the calcium levels in your blood. If you have low blood calcium, it must be treated before you take BINOSTO. 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
Bone, joint, or muscle pain.
Some people who take BINOSTO develop severe bone, joint, or muscle pain.
Severe jaw bone problems (osteonecrosis).
Severe jaw bone problems may happen when you take BINOSTO. Your doctor should examine your mouth or tell you to see your dentist before you start BINOSTO. It is important for you to practice good mouth care during treatment with BINOSTO.
Unusual thigh bone fractures.
Some people have developed unusual fractures in their thigh bone. Symptoms of a fracture may include new or unusual pain in your hip, groin, or thigh.
Call your doctor right away if you have any of these side effects.
Tell your doctor about all medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.
Especially tell your doctor if you take:
calcium
antacids
aspirin
Nonsteroidal Anti-Inflammatory (NSAID) medicines
The most common side effects of BINOSTO are:
Stomach area (abdominal) pain
Heartburn
Constipation
Diarrhea
Upset stomach
Pain in your bones, joints, or muscles
Nausea
You may get allergic reactions, such as hives, swelling of your face, lips, tongue, or throat.
Tell your doctor about any side effect that bothers you or that does not go away.
These are not all the side effects with BINOSTO. Ask your doctor or pharmacist for more information.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
For more information, go to BINOSTO.com, or call 1-855-778-0177.