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Alendronate/ cholecalciferol

Generic Name: alendronate/cholecalciferol (a-LEN-droe-nate/KOE-le-kal-SIF-er-ol)
Brand Name: Fosamax Plus D

Alendronate/ cholecalciferol is used for:

Treating osteoporosis in certain patients. It may also be used for other conditions as determined by your doctor.

Alendronate/cholecalciferol is a bisphosphonate and vitamin D combination. The bisphosphonate works by slowing bone loss. Vitamin D helps the body to form bone normally.

Do NOT use alendronate/ cholecalciferol if:

  • you are allergic to any ingredient in alendronate/cholecalciferol
  • you have certain esophagus problems (eg, narrowing, blockage)
  • you are unable to stand or sit upright for at least 30 minutes
  • you have low blood calcium levels or severe kidney problems

Contact your doctor or health care provider right away if any of these apply to you.

Slideshow: 2014 Update: First Time Brand-to-Generic Switches

Before using alendronate/ cholecalciferol:

Some medical conditions may interact with alendronate/cholecalciferol. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have a history of stomach or bowel problems (eg, inflammation, ulcer), esophagus problems (eg, heartburn, reflux disease, severe irritation), or kidney problems, or if you have difficult or painful swallowing
  • if you have high or low blood vitamin D levels, poor health, cancer (eg, leukemia, lymphoma), anemia, asthma, blood clotting problems, an infection, sarcoidosis, calcium metabolism problems, or nutrient absorption problems (eg, malabsorption syndrome), or you are unable to take calcium or vitamin D supplements
  • if you have poor dental hygiene or other dental problems, or you will be having a dental procedure (eg, tooth extraction)
  • if you smoke or drink alcohol
  • if you have had or will be having chemotherapy or radiation treatment
  • if you have a mental disorder or other condition that may decrease your ability to follow the dosing instructions for alendronate/cholecalciferol

Some MEDICINES MAY INTERACT with alendronate/cholecalciferol. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen) because the risk of side effects, such as esophagus or stomach irritation, may be increased
  • Corticosteroids (eg, prednisone) because the risk of jawbone problems may be increased
  • Anticonvulsants (eg, phenytoin), bile acid sequestrants (eg, cholestyramine, colestipol), cimetidine, mineral oil, olestra, orlistat, or thiazide diuretics (eg, hydrochlorothiazide) because they may decrease alendronate/cholecalciferol's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if alendronate/cholecalciferol may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use alendronate/ cholecalciferol:

Use alendronate/cholecalciferol as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Alendronate/cholecalciferol comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get alendronate/cholecalciferol refilled.
  • Swallow alendronate/cholecalciferol whole. Do not break, crush, chew, or suck on the tablet before swallowing.
  • Take alendronate/cholecalciferol by mouth on an empty stomach in the morning at least 30 minutes before your first food, drink, or other medicine of the day. Do NOT take alendronate/cholecalciferol at bedtime or before you get out of bed in the morning.
  • Take alendronate/cholecalciferol with a full glass (8 oz [240 mL]) of plain water. Do not take alendronate/cholecalciferol with mineral water, coffee, tea, or juice.
  • Do not lie down for 30 minutes after taking alendronate/cholecalciferol and until you eat your first food of the day.
  • Calcium, iron supplements, vitamins, antacids, or other products containing aluminum, calcium, or magnesium may interfere with the absorption of alendronate/cholecalciferol. Ask your doctor or pharmacist if you have questions about how to take any of these products with alendronate/cholecalciferol.
  • Alendronate/cholecalciferol is usually taken 1 time each week. Be sure you understand how to take alendronate/cholecalciferol. Contact your doctor or pharmacist if you have any questions.
  • Continue to take alendronate/cholecalciferol even if you feel well. Do not miss any doses.
  • If you miss a dose of alendronate/cholecalciferol, do not take it later in the day. Take it on the morning after you remember and go back to your regular dosing schedule. Do not take 2 doses within the same day.

Ask your health care provider any questions you may have about how to use alendronate/cholecalciferol.

Important safety information:

  • Alendronate/cholecalciferol may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use alendronate/cholecalciferol with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Talk with your doctor before you drink alcohol, smoke, or use other tobacco products while taking alendronate/cholecalciferol.
  • Follow the diet and exercise program given to you by your health care provider. Talk to your doctor about whether you should take a calcium and vitamin D supplement while you use alendronate/cholecalciferol.
  • Talk to your doctor about the use of weight-bearing exercises to help prevent weak bones.
  • Certain fractures of the thigh bone (femur) have been reported in patients using bisphosphonates. It is unknown if bisphosphonates contributed to the fractures. Contact your doctor right away if you experience hip, thigh, or groin pain. Discuss any questions or concerns with your doctor.
  • Products that have olestra in them may decrease the absorption of vitamin D. Talk with your doctor or pharmacist if you have questions about eating foods that contain olestra while you take alendronate/cholecalciferol.
  • Alendronate/cholecalciferol may cause jawbone problems in some patients. Your risk may be greater the longer you take alendronate/cholecalciferol or if you have cancer, poor dental hygiene, ill-fitting dentures, or certain other conditions (eg, anemia, blood clotting problems, dental problems, infection). Your risk may also be greater if you have certain dental procedures or you use certain medicines or therapies (eg, chemotherapy, corticosteroids, radiation). Talk to your doctor about having a dental exam before you start to use alendronate/cholecalciferol. Ask your doctor any questions you may have about dental treatment while you use alendronate/cholecalciferol.
  • Proper dental care is important while you are taking alendronate/cholecalciferol. Brush and floss your teeth and visit the dentist regularly.
  • Alendronate/cholecalciferol may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to alendronate/cholecalciferol. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
  • Certain dental procedures should be avoided if possible while you are using alendronate/cholecalciferol. Tell your doctor or dentist that you take alendronate/cholecalciferol before you receive any medical or dental care, emergency care, or surgery.
  • Worsening of asthma has been reported in patients taking medicines like this one. Discuss any questions or concerns with your doctor.
  • Lab tests, including bone density and blood calcium and vitamin D levels, may be performed while you use alendronate/cholecalciferol. These tests may be used to monitor your condition or check for side effects. Your doctor may also want to evaluate you periodically while you take alendronate/cholecalciferol to assess the need to continue treatment. Be sure to keep all doctor and lab appointments.
  • Alendronate/cholecalciferol should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using alendronate/cholecalciferol while you are pregnant. Alendronate/cholecalciferol is found in breast milk. If you are or will be breast-feeding while you use alendronate/cholecalciferol, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of alendronate/ cholecalciferol:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; gas; mild bone, muscle, or joint pain; mild stomach pain or upset; nausea; taste changes.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); black, tarry, or bloody stools; chest pain; coughing or vomiting blood; difficult or painful swallowing; mouth sores; new, worsening, or persistent heartburn; red, swollen, blistered, or peeling skin; severe bone, muscle, or joint pain (especially in the hip, groin, or thigh); severe or persistent sore throat or stomach pain; swelling of the hands, legs, or joints; swelling or pain in the jaw; symptoms of low blood calcium (eg, spasms, twitches, or cramps in your muscles; numbness or tingling in your fingers, toes, or around your mouth).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Drink a full glass (8 oz [240 mL]) of milk. Do not lie down for at least 30 minutes or as directed by your doctor. Do not try to vomit. Symptoms may include loss of appetite; painful swallowing; severe heartburn; sluggishness; stomach pain or upset; unusual weakness.

Proper storage of alendronate/cholecalciferol:

Store alendronate/cholecalciferol at 77 degrees F (25 degrees C) in the original blister package. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep alendronate/cholecalciferol out of the reach of children and away from pets.

General information:

  • If you have any questions about alendronate/cholecalciferol, please talk with your doctor, pharmacist, or other health care provider.
  • Alendronate/cholecalciferol is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take alendronate/cholecalciferol or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about alendronate/cholecalciferol. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to alendronate/cholecalciferol. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using alendronate/cholecalciferol.

Issue Date: July 2, 2014
Database Edition 14.3.1.001
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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