Fosamax

DRUG DESCRIPTION

FOSAMAX (alendronate sodium) is a bisphosphonate that acts as a specific inhibitor of osteoclastmediated 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 empirical formula of alendronate sodium is C4H12NNaO7P2•3H2O and its formula weight is 325.12. The structural formula is:

FOSAMAX® (alendronate sodium) Structural Formula Illustration

Alendronate sodium is a white, crystalline, nonhygroscopic powder. It is soluble in water, very slightly soluble in alcohol, and practically insoluble in chloroform.

FOSAMAX tablets for oral administration contain 6.53, 13.05, 45.68, 52.21 or 91.37 mg of alendronate monosodium salt trihydrate, which is the molar equivalent of 5, 10, 35, 40 and 70 mg, respectively, of free acid, and the following inactive ingredients: microcrystalline cellulose, anhydrous lactose, croscarmellose sodium, and magnesium stearate. FOSAMAX 10 mg tablets also contain carnauba wax.

Each bottle of the oral solution contains 91.35 mg of alendronate monosodium salt trihydrate, which is the molar equivalent to 70 mg of free acid. Each bottle also contains the following inactive ingredients: sodium citrate dihydrate and citric acid anhydrous as buffering agents, sodium saccharin, artificial raspberry flavor, and purified water. Added as preservatives are sodium propylparaben 0.0225% and sodium butylparaben 0.0075%.

What are the possible side effects of alendronate (Fosamax)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using alendronate and call your doctor at once if you have any of these serious side effects:

  • chest pain;
  • difficulty or pain when swallowing;
  • pain or burning under the ribs or in the back;
  • new or worsening heartburn;
  • severe joint, bone, or muscle pain; or
  • jaw pain, numbness, or...

Read All Potential Side Effects and See Pictures of Fosamax »

What are the precautions when taking alendronate sodium (Fosamax)?

Before taking alendronate, tell your doctor or pharmacist if you are allergic to it; or to other bisphosphonates; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: disorders of the esophagus (such as esophageal stricture or achalasia), trouble swallowing, trouble standing or sitting upright for at least 30 minutes, low calcium levels, stomach/intestinal disorders (such as ulcers).

Infrequently, people taking bisphosphonates have had serious jawbone problems (osteonecrosis). Poor dental hygiene, poorly fitting dentures, or having certain dental work...

Read All Potential Precautions of Fosamax »


Fosamax Consumer (continued)

SIDE EFFECTS: Stomach pain, constipation, diarrhea, gas, or nausea may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if any of these unlikely but serious side effects occur: jaw pain, increased or severe bone/joint/muscle pain, swelling of joints/hands/ankles/feet, black/tarry stools, vomit that looks like coffee grounds.

This medication may infrequently cause serious irritation and ulcers of the esophagus. If you notice any of the following unlikely but very serious side effects, stop taking alendronate and talk to your doctor or pharmacist right away: new or worsening heartburn, chest pain, pain or difficulty when swallowing.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking alendronate, tell your doctor or pharmacist if you are allergic to it; or to other bisphosphonates; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: disorders of the esophagus (such as esophageal stricture or achalasia), trouble swallowing, trouble standing or sitting upright for at least 30 minutes, low calcium levels, stomach/intestinal disorders (such as ulcers).

Infrequently, people taking bisphosphonates have had serious jawbone problems (osteonecrosis). Poor dental hygiene, poorly fitting dentures, or having certain dental work (such as tooth removal, dental surgery) may increase your risk. Medical conditions (such as gum disease/infection, cancer, anemia) might also increase the risk. If you develop jaw pain, tell your doctor and dentist immediately.

Before having any surgery (especially dental procedures), tell your doctor and dentist about this medication and all other products you use (including prescription drugs, nonprescription drugs, and herbal products). Your doctor or dentist may tell you to stop taking alendronate before your surgery. Follow all instructions about stopping or starting this medication.

This drug is not recommended for use in children. Studies have shown that many children who took this drug had severe side effects such as vomiting, fever, and flu-like symptoms.

Caution is advised if you are pregnant or planning to become pregnant in the future. Alendronate may stay in your body for many years. Its effects on an unborn baby are unknown. Discuss the risks and benefits with your doctor before starting treatment with alendronate.

It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.


Fosamax Patient Information Including Side Effects

Brand Names: Fosamax

Generic Name: alendronate (Pronunciation: a LEN dro nate)

  • What is alendronate (Fosamax)?
  • What are the possible side effects of alendronate (Fosamax)?
  • What is the most important information I should know about alendronate (Fosamax)?
  • What should I discuss with my healthcare provider before taking alendronate (Fosamax)?
  • How should I take alendronate (Fosamax)?
  • What happens if I miss a dose (Fosamax)?
  • What happens if I overdose (Fosamax)?
  • What should I avoid while taking alendronate (Fosamax)?
  • What other drugs will affect alendronate (Fosamax)?
  • Where can I get more information?

What is alendronate (Fosamax)?

Alendronate is in the group of medicines called bisphosphonates (bis FOS fo nayts). It alters the cycle of bone formation and breakdown in the body. Alendronate slows bone loss while increasing bone mass, which may prevent bone fractures.

Alendronate is used to treat or prevent postmenopausal osteoporosis and steroid-induced osteoporosis. Alendronate is also used to treat Paget's disease of bone.

Alendronate may also be used for other purposes not listed in this medication guide.

What are the possible side effects of alendronate (Fosamax)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using alendronate and call your doctor at once if you have any of these serious side effects:

  • chest pain;
  • difficulty or pain when swallowing;
  • pain or burning under the ribs or in the back;
  • new or worsening heartburn;
  • severe joint, bone, or muscle pain; or
  • jaw pain, numbness, or swelling.

Less serious side effects may include:

  • mild heartburn or stomach upset;
  • diarrhea, gas, or constipation;
  • joint pain or swelling;
  • swelling in your hands or feet;
  • back pain; or
  • dizziness, weakness, or headache.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about alendronate (Fosamax)?

Do not take an alendronate tablet if you cannot sit upright or stand for at least 30 minutes. Alendronate can cause serious problems in the stomach or esophagus (the tube that connects your mouth and stomach). You will need to stay upright for at least 30 minutes after taking this medication.

Take the alendronate tablet first thing in the morning, at least 30 minutes before you eat or drink anything or take any other medicine.

Take each dose with a full glass (6 to 8 ounces) of water. Use only plain water (not mineral water) when taking an alendronate tablet.

For at least the first 30 minutes after taking an alendronate tablet, do not lie down or recline; do not eat or drink anything other than plain water; and do not take any other medicines including vitamins, calcium, or antacids.

Some people using medicines similar to alendronate have developed bone loss in the jaw, also called osteonecrosis of the jaw. Symptoms of this condition may include jaw pain, swelling, numbness, loose teeth, gum infection, or slow healing after injury or surgery involving the gums. You may be more likely to develop osteonecrosis of the jaw if you have cancer or have been treated with chemotherapy, radiation, or steroids. Other conditions associated with osteonecrosis of the jaw include blood clotting disorders, anemia (low red blood cells), and a pre-existing dental problem.

Alendronate is only part of a complete program of treatment that may also include diet changes, exercise, and taking calcium and vitamin supplements. Follow your diet, medication, and exercise routines very closely.

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