Fosamax

Fosamax and Drug Interactions

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Certain medicines may affect how Fosamax works. Especially tell your doctor if you take any of the following:

• Antacids
• Aspirin
• Non-steroidal anti-inflammatory drugs (NSAIDs)

GENERIC AVAILABLE: Yes

Yes

Fosamax is part of the drug class:

• Bisphosphonates

Fosamax can cause serious side effects including:

1. Esophagus problems. It is important that you take Fosamax exactly as prescribed to help lower your chance of getting esophagus problems.

• Stop taking Fosamax and call your doctor right away if you get chest pain, new or worsening heartburn, or have trouble or pain when you swallow.

• 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 Fosamax. Take calcium and vitamin D as your doctor tells you to.

Call your doctor right away if you have any of these side effects.

Do not take Fosamax 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 low levels of calcium in your blood.
• Are allergic to Fosamax or any of its ingredients.
• Do not take Fosamax oral solution if you have trouble swallowing liquids.

Tell your doctor if you are breastfeeding or planning to breastfeed. It is not known if Fosamax is excreted in human breast milk or if it will harm your nursing baby.

• Store Fosamax at room temperature.
• Keep Fosamax in a tightly closed container.
• Keep Fosamax tablets in their original blister pack until you use them.
• Protect Fosamax from moisture.
• Keep Fosamax and all medicines out of the reach of children.

This medicine comes with a Medication Guide and a patient information insert. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Take the medicine on an empty stomach. It should be taken as soon as you get out of bed in the morning and at least 30 minutes before any food, beverage, or other medicines. Food and beverages (eg, mineral water, coffee, tea, or juice) will decrease the amount of alendronate absorbed by the body. Waiting longer than 30 minutes will allow more of the drug to be absorbed. Medicines such as antacids, calcium, or vitamin supplements will also decrease the absorption of alendronate.

If you are using alendronate oral liquid, drink at least 2 ounces (a quarter of a cup) of water immediately after taking the medicine. This will allow the medicine to reach your intestines and be absorbed by the body more quickly.

Swallow the tablet whole with a full glass (6 to 8 ounces) of plain water. Do not suck or chew on the tablet because it may cause throat irritation.

If you are taking alendronate effervescent tablet, dissolve it in 4 ounces of room temperature plain water only (not mineral water or flavored water). Wait at least 5 minutes after the effervescence stops and then stir the solution for 10 seconds and drink it.

Do not lie down for at least 30 minutes after taking alendronate and before having your first food for the day. This will help alendronate reach your stomach faster. It will also help prevent irritation to your esophagus.

It is important that you eat a well-balanced diet with adequate amounts of calcium and vitamin D (found in milk or other dairy products). However, do not take any foods, beverages, or calcium supplements within 30 minutes or longer after taking the alendronate. To do so may keep this medicine from working properly.

Follow your dosing instructions given to you by your doctor closely. It may affect the way this medicine works if you do not. Do not stop using this medicine suddenly without asking your doctor.

Tell your doctor if you do weight-bearing exercises, smoke or drink excessively. Your doctor will need to take these into consideration in deciding your dose.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (effervescent tablets):
  • For treatment of osteoporosis in men:
    • Adults—70 milligrams (mg) once a week at least 30 minutes before the first food or drink of the day other than water.
    • Children—Use is not recommended.
  • For treatment of postmenopausal osteoporosis:
    • Adults—70 milligrams (mg) once a week at least 30 minutes before the first food or drink of the day other than water.
    • Children—Use is not recommended.
• For oral dosage forms (liquid or tablets):
  • For treatment of corticosteroid-induced osteoporosis:
    • Adults—5 milligrams (mg) once a day at least 30 minutes before the first food or drink of the day other than water. In postmenopausal women not receiving estrogen, the dose is 10 mg once a day.
    • Children—Use is not recommended.
  • For treatment of Paget's disease of bone:
    • Adults—40 milligrams (mg) once a day for 6 months. Your doctor may tell you to repeat this dose.
    • Children—Use is not recommended.
  • For treatment of osteoporosis in men:
    • Adults—10 milligrams (mg) once a day or 70 mg once a week at least 30 minutes before the first food or drink of the day other than water.
    • Children—Use is not recommended.
  • For treatment of postmenopausal osteoporosis:
    • Adults—10 milligrams (mg) once a day or 70 mg once a week at least 30 minutes before the first food or drink of the day other than water.
    • Children—Use is not recommended. .
  • For prevention of postmenopausal osteoporosis:
    • Adults—5 milligrams (mg) once a day or 35 mg once a week at least 30 minutes before the first food or drink of the day other than water.
    • Children—Use is not recommended.

Missed Dose

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

For patients taking the medicine each day: If you miss a dose or forget to use your medicine in the morning, skip the missed dose and take your medicine the next morning. Do not take two tablets on the same day. Return to your regular schedule the next day.

If you are on a weekly schedule and miss a dose of this medicine, take it the next morning after you remember. Resume your usual schedule taking the medicine on your chosen day the next week.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Protect the effervescent tablet from moisture and do not remove from the blister pack until you are ready to use it.

Calcium Supplements/Antacids

Co-administration of Fosamax and calcium, antacids, or oral medications containing multivalent cations will interfere with absorption of Fosamax. Therefore, instruct patients to wait at least one-half hour after taking Fosamax before taking any other oral medications.

Aspirin

In clinical studies, the incidence of upper gastrointestinal adverse events was increased in patients receiving concomitant therapy with daily doses of Fosamax greater than 10 mg and aspirin-containing products.

Nonsteroidal Anti-Inflammatory Drugs

Fosamax may be administered to patients taking nonsteroidal anti-inflammatory drugs (NSAIDs). In a 3-year, controlled, clinical study (n=2027) during which a majority of patients received concomitant NSAIDs, the incidence of upper gastrointestinal adverse events was similar in patients taking Fosamax 5 or 10 mg/day compared to those taking placebo. However, since NSAID use is associated with gastrointestinal irritation, caution should be used during concomitant use with Fosamax.

Fosamax (alendronate) belongs to a 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.

Fosamax is used in women to treat or prevent osteoporosis that is caused by menopause and in men and women to treat osteoporosis caused by taking steroids.

Fosamax is also used to increase bone mass in men who have osteoporosis, and to treat Paget's disease of bone in men and women.

If you take Fosamax once daily: If you forget to take this medicine first thing in the morning, do not take it later in the day. Wait until the following morning to take the medicine and skip the missed dose. Do not take two (2) tablets in one day.

If you take Fosamax once a week: If you forget to take your dose on your scheduled day, take it first thing in the morning on the day after you remember the missed dose. Then return to your regular weekly schedule on your chosen dose day. Do not take two (2) tablets in one day.

Applies to alendronate: oral solution, oral tablet, oral tablet effervescent

General

Generally, this drug has been well tolerated. Adverse effects usually have been mild when patients adhered to prescribing instructions.[Ref]

Musculoskeletal

Very common (10% or more): Bone, muscle or joint pain (sometimes severe)
Common (1% to 10%): Muscle cramp, joint swelling
Rare (less than 0.1%): Osteonecrosis of the jaw, atypical subtrochanteric and diaphyseal femoral fractures
Postmarketing reports: Myalgia, low-energy femoral shaft and subtrochanteric fractures[Ref]

Dermatologic

Common (1% to 10%): Alopecia, pruritus
Uncommon (0.1% to 1%): Rash, erythema
Rare (less than 0.1%): Rash with photosensitivity, severe skin reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis[Ref]

Gastrointestinal

Common (1% to 10%): Abdominal pain, dyspepsia, acid regurgitation, nausea, abdominal distension, constipation, diarrhea, flatulence, esophageal ulcer, gastritis, gastroesophageal reflux
Uncommon (0.1% to 1%): Gastric ulcer, esophagitis, esophageal erosions, melena, dysphagia, vomiting
Rare (less than 0.1%): Esophageal stricture, oropharyngeal ulceration, upper gastrointestinal PUB (perforation, ulcers, bleeding)
Postmarketing reports: Localized osteonecrosis of the jaw, generally associated with tooth extraction and/or local infection with delayed healing[Ref]

Nervous system

Common (1% to 10%): Headache, dizziness
Uncommon (0.1% to 1%): Dysgeusia[Ref]

Other

Common (1% to 10%): Vertigo, asthenia, peripheral edema
Uncommon (0.1% to 1%): Transient symptoms of myalgia, malaise and rarely, typically in association with initiation of treatment[Ref]

Ocular

Uncommon (0.1% to 1%): Eye inflammation (uveitis, scleritis, episcleritis)[Ref]

Metabolic

Rare (less than 0.1%): Symptomatic hypocalcemia (often in association with predisposing conditions)[Ref]

Hypersensitivity

Rare (less than 0.1%): Urticaria, angioedema[Ref]

Respiratory

Postmarketing reports: Acute asthma exacerbations[Ref]

Some side effects of Fosamax may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.