Binosto

Generic name: alendronate
Brand names: Binosto, Fosamax
Drug class: Bisphosphonates

Medically reviewed by  A Ras MD.

What is Binosto?

Binosto is a prescription medicine that is used to prevent or treat soft, brittle bones (osteoporosis). It is used to treat Paget’s disease. Binosto may be given to you for other reasons.

Description

BINOSTO (alendronate sodium) is a bisphosphonate that acts as a specific inhibitor of osteoclast-mediated bone resorption. Bisphosphonates are synthetic analogs of pyrophosphate that bind to the hydroxyapatite found in bone.

Alendronate sodium is chemically described as (4 amino-1-hydroxybutylidene) bisphosphonic acid, monosodium salt, trihydrate. The molecular formula of alendronate sodium is C 412NNaO 72 • 3H 2O and its molecular weight is 325.12. The structural formula of alendronate sodium is

 

alendronate sodium 11 description

Alendronate sodium is a white or almost white crystalline powder that is soluble in water, very slightly soluble in methanol, and practically insoluble in methylene chloride.

BINOSTO for oral administration is an effervescent tablet formulation that must be dissolved in water before use. Each individual tablet contains 91.37 mg of alendronate sodium, which is equivalent to 70 mg of free alendronic acid. Each tablet also contains the following inactive ingredients: monosodium citrate anhydrous, citric acid anhydrous, sodium hydrogen carbonate, and sodium carbonate anhydrous as buffering agents, strawberry flavor, acesulfame potassium, and sucralose.

Once the effervescent tablet is dissolved in water, the alendronate sodium is present in a citrate-buffered solution of pH 4.8 to 5.4.

Mechanism of Action

Animal studies have indicated the following mode of action. 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. Studies in mice on the localization of radioactive [ 3H]alendronate in bone showed about 10-fold higher uptake on osteoclast surfaces than on osteoblast surfaces.

Bones examined 6 and 49 days after [ 3H]alendronate administration in rats and mice, respectively, showed that normal bone was formed on top of the alendronate, which was incorporated inside the matrix. While incorporated in bone matrix, alendronate is not pharmacologically active. Thus, alendronate must be continuously administered to suppress osteoclasts on newly formed resorption surfaces. Histomorphometry in baboons and rats showed that alendronate treatment reduces bone turnover (i.e., the number of sites at which bone is remodeled). In addition, bone formation exceeds bone resorption at these remodeling sites, leading to progressive gains in bone mass.

Before taking Binosto, tell your doctor:

  • If you are allergic to Binosto; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
  • If you have any of these health problems: A swallowing tube (esophagus) that is not normal, low calcium levels, kidney disease, or trouble swallowing.
  • If you are not able to stand or sit up for 30 minutes.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Binosto with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Binosto?

  • Tell all of your health care providers that you take Binosto. This includes your doctors, nurses, pharmacists, and dentists.
  • Very bad swallowing tube (esophagus) problems like irritation, swelling, ulcers, and bleeding have happened with Binosto. Talk with the doctor.
  • Worsening of asthma has happened in people taking drugs like this one. Talk with the doctor.
  • This medicine may raise the chance of a broken leg. Talk with the doctor.
  • Have a bone density test as you have been told by your doctor. Talk with your doctor.
  • This medicine works best when used with calcium/vitamin D and weight-bearing workouts like walking or PT (physical therapy).
  • Follow the diet and workout plan that your doctor told you about.
  • Have a dental exam before starting Binosto.
  • Take good care of your teeth. See a dentist often.
  • Talk with your doctor before you drink alcohol.
  • If you smoke, talk with your doctor.
  • If you are on a low-sodium or sodium-free diet, talk with your doctor. Some of these products have sodium.
  • This medicine is not approved for use in children. However, the doctor may decide the benefits of taking Binosto outweigh the risks. If your child has been given Binosto, ask the doctor for information about the benefits and risks. Talk with the doctor if you have questions about giving Binosto to your child.
  • If you are pregnant or you get pregnant while taking Binosto, call your doctor right away.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is Binosto best taken?

Use Binosto as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • Take on an empty stomach before breakfast.
  • Take at least 30 minutes before the first food, drink, or drugs of the day.
  • Do not lie down for at least 30 minutes after taking Binosto and until you eat your first food of the day.
  • Keep taking Binosto as you have been told by your doctor or other health care provider, even if you feel well.
  • Dissolve the effervescent tablet in 1/2 cup of water. Do not swallow the tablet whole.
  • When the water stops bubbling, wait at least 5 more minutes then stir for about 10 seconds and drink.
  • Take with plain water only. Avoid taking with mineral water, milk, or other drinks.

What do I do if I miss a dose?

  • Take the missed dose on the next morning after you think about it and then go back to your normal time.
  • Do not take 2 doses on the same day.

What are the side effects of Binosto that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of low calcium levels like muscle cramps or spasms, numbness and tingling, or seizures.
  • Black, tarry, or bloody stools.
  • Chest pain.
  • Coughing up blood.
  • Heartburn.
  • Trouble swallowing.
  • Very bad pain when swallowing.
  • Sore throat.
  • Throwing up blood or throw up that looks like coffee grounds.
  • Very bad bone, joint, or muscle pain.
  • Any new or strange groin, hip, or thigh pain.
  • Mouth sores.
  • This medicine may cause jawbone problems. The risk may be higher with longer use, cancer, dental problems, ill-fitting dentures, anemia, blood clotting problems, or infection. It may also be higher if you have dental work, chemo, radiation, or take other drugs that may cause jawbone problems. Many drugs can do this. Talk with your doctor if any of these apply to you, or if you have questions. Call your doctor right away if you have jaw swelling or pain.

What are some other side effects of Binosto?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Binosto?

  • Store at room temperature.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
  • Store in original container.

 

Label

PRINCIPAL DISPLAY PANEL

Binosto ® 70 mg Carton
4 Effervescent Tablets
NDC 17139–400–04

Binosto 70mg Carton 4 Tablets
 

Imprint M - Binosto 70 mg

PRINCIPAL DISPLAY PANEL

Binosto ® 70 mg
Label Effervescent Tablet
NDC 17139–400–00

Binosto 70mg Label

Imprint M - Binosto 70 mg

SRC: NLM .

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