Uses
What is Fosamax Plus D used for?
Fosamax Plus D is commonly used for the following conditions.
- Treatment of osteoporosis in women after menopause. Osteoporosis is a condition where your bones become thin and weak and may break more easily.
- Treatment of osteoporosis in men
Fosamax Plus D may also be used for other conditions as determined by your healthcare provider.
How does Fosamax Plus D work (mechanism of action)?
Fosamax Plus D contains two main ingredients: alendronate and cholecalciferol (also known as vitamin D3). Alendronate slows the natural breakdown of your bones. This helps them stay stronger and reduces the risk for bone fractures. Cholecalciferol helps your body absorb calcium and phosphate from the food you eat. This helps your body build and maintain healthy bones.
How is Fosamax Plus D supplied (dosage forms)?
Fosamax Plus D is available in the following dosage forms that are taken by mouth.
- 70 mg alendronate/2800 IU cholecalciferol oral tablets
- 70 mg alendronate/5600 IU cholecalciferol oral tablets
How should I store Fosamax Plus D?
Fosamax Plus D should be stored at room temperature, between 68 F to 77 F (20 C to 25 C). It can be exposed to temperatures between 59 F to 86 F (15 C to 30 C) for shorter periods of time, such as when transporting it. Each tablet should be kept in the original blister pack until ready to use. Store in a cool, dry place. Protect from light and moisture.
Side Effects
What are the most common side effects of Fosamax Plus D?
The most common side effects of Fosamax Plus D are listed below. Tell your healthcare provider if you have any of these side effects that bother you.
- Stomach pain
- Heartburn
- Constipation
- Diarrhea
- Upset stomach or indigestion
- Bone, joint, or muscle pain (see below)
- Nausea
There may be other side effects of Fosamax Plus D that are not listed here. Contact your healthcare provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.
What are the serious side effects of Fosamax Plus D?
While less common, the most serious side effects of Fosamax Plus D are described below, along with what to do if they happen.
Severe Allergic Reactions. Fosamax Plus D may cause allergic reactions, which can be serious. Stop taking Fosamax Plus D and get help right away if you have any of the following symptoms of a serious allergic reaction.
- Breathing problems or wheezing
- Racing heart
- Fever or general ill feeling
- Swollen lymph nodes
- Swelling of the face, lips, mouth, tongue, or throat
- Trouble swallowing or throat tightness
- Itching, skin rash, or pale red bumps on the skin called hives
- Nausea or vomiting
- Dizziness, feeling lightheaded, or fainting
- Stomach cramps
- Joint pain
Esophagus Problems. Taking Fosamax Plus D by mouth may irritate the esophagus or upper part of your gastrointestinal (GI) tract. This irritation can be worse in people who already have stomach or esophagus problems. In some cases, it can lead to problems such as ulcers, bleeding, or tears in the esophagus, which may require hospitalization. To reduce the risk of these problems, it is important to take a Fosamax Plus D tablet with a full glass of plain water and stay upright after taking it. Stop taking Fosamax Plus D and call your healthcare provider right away if you have any of the following symptoms.
- Trouble or pain while swallowing
- Chest pain
- New or worsening heartburn
Low Calcium Level (Hypocalcemia). Fosamax Plus D can cause low calcium levels, also known as hypocalcemia, which can be serious. Decreased calcium levels can cause a rare dangerous heart rhythm problem called QT prolongation and torsade de pointes. Some people have a higher risk of this, including people who are older, have other people in their family who have had these conditions, have low potassium or magnesium, or who take some medicines for other heart rhythm problems. Call your healthcare provider if you have any of the following symptoms.
- Changes in your heart rate or rhythm, such as fast or skipping heartbeat
- Fainting
- Numbness, tingling, or burning sensation in your arms, feet, or face (paresthesia)
- Muscle pain, spasms, twitching, or cramps
- Seizures
Severe Pain in the Bones, Joints, or Muscles. Fosamax Plus D may cause severe pain in the bones, joints, or muscles (musculoskeletal pain). The pain can be severe enough that it could be difficult to carry out normal activities. Call your healthcare provider if you experience severe pain while on Fosamax Plus D.
Severe Jawbone Problems (Osteonecrosis). Fosamax Plus D can rarely cause severe jawbone problems, also called osteonecrosis of the jaw. In this condition, your jawbone may get damaged due to reduced blood flow. You may be at higher risk if you are undergoing certain dental procedures (such as a tooth extraction or dental implants), if you have poor oral health, or if you have cancer or certain other conditions. You may be told to see a dentist before starting Fosamax Plus D and to practice good mouth care. Call your healthcare provider right away if you experience any of the following symptoms of jaw osteonecrosis.
- Jaw pain or discomfort
- Mouth sores
- Loose teeth
Unusual Thigh Bone Fractures. Fosamax Plus D may cause an increased risk for fractures in your thigh bone, even with a light force. Call your healthcare provider if you experience new or unusual pain in your thigh, hip, or groin.
Warnings & Precautions
Who should not use Fosamax Plus D?
Allergies to Ingredients. People who are allergic to any of the following should not take Fosamax Plus D.
- Fosamax Plus D
- Fosamax
- Alendronate
- Cholecalciferol
- Vitamin D3
- Any of the ingredients in the specific product dispensed
Your pharmacist can tell you all of the ingredients in Fosamax Plus D.
Esophagus Problems. Fosamax Plus D should not be taken if you have problems with your esophagus. Alendronate can cause irritation, inflammation, or sores in your esophagus if you already have esophagus problems.
Unable to Sit Upright or Stand. Fosamax Plus D is not recommended if you cannot sit upright or stand for at least 30 minutes. You need to be able to sit upright or stand for this long to reduce your risk of irritation of the esophagus.
Low Calcium Levels (Hypocalcemia). Alendronate can cause low calcium levels, also known as hypocalcemia. It should not be used if you have low blood calcium levels.
Kidney Problems. Alendronate should not be taken if your kidneys are not working as well as they should be. If there is a concern about the health of your kidneys, your healthcare provider may do tests to determine if they are working well enough for you to take this medicine.
What should I know about Fosamax Plus D before using it?
Do not take Fosamax Plus D unless it has been prescribed to you by a healthcare provider. Take it as prescribed.
Do not share Fosamax Plus D with other people, even if they have the same condition as you. It may harm them.
Keep Fosamax Plus D out of the reach of children.
Take the Fosamax Plus D tablet after you get up for the day. Take it on an empty stomach, at least 30 minutes before the first food or drink (other than plain water) of the day and before taking any other medicines or supplements. Fosamax Plus D will work only if it is taken on an empty stomach.
Do not eat, drink anything except plain water, or take other medicines for at least 30 minutes after taking a Fosamax Plus D tablet. Do not take it with mineral water, coffee, tea, soda, or juice. These may make Fosamax Plus D not work as well. See the Interactions section for more details.
Swallow the tablet whole with a full glass (6 to 8 ounces) of plain water to lower the risk of irritation of the esophagus. Sit upright or stand when you take a Fosamax Plus D tablet and afterwards. Do not lie down for at least 30 minutes after you take it. You may sit, stand, walk, or do other activities where you are upright (like reading).
Do not chew or suck on Fosamax Plus D tablets. This could lead to irritation or sores in the mouth or throat.
Your healthcare provider may tell you to take calcium and/or additional vitamin D supplements while using Fosamax Plus D. Wait at least 30 minutes after taking your Fosamax Plus D tablet before taking any other medicines or supplements by mouth.
Your healthcare provider may recommend that you have a dental exam before starting treatment with Fosamax Plus D.
Talk with your healthcare provider about how long you should use Fosamax Plus D.
What should I tell my healthcare provider before using Fosamax Plus D?
Tell your healthcare provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Fosamax Plus D is right for you.
In particular, make sure that you discuss any of the following.
Problems Absorbing Nutrients. Tell your healthcare provider if you have been told that you have malabsorption syndrome, a condition where you have trouble absorbing minerals in the stomach or intestines. Fosamax Plus D may increase the risk of side effects if you already have this condition.
Esophagus, Stomach, or Intestine Problems. Tell your healthcare provider if you have any problems in your upper digestive tract, including Barrett’s esophagus (a condition where the lining of your esophagus thickens), stomach ulcers, or any inflammation. Fosamax Plus D can irritate your digestive tract and worsen these conditions.
Planned Dental Surgery. Tell your healthcare provider if you are planning to undergo any dental treatments, such as tooth extraction or dental implant surgery, while using alendronate. Certain dental procedures may increase the risk of osteonecrosis of the jaw.
Conditions Related to Vitamin D. Tell your healthcare provider if you have any condition that can affect the body’s regulation of vitamin D (such as leukemia, lymphoma, sarcoidosis). Cholecalciferol (vitamin D3) in Fosamax Plus D may worsen some of the symptoms of these conditions.
Other Current and Past Health Conditions. Tell your healthcare provider if you have any of the following.
- Trouble swallowing
- Low calcium levels (hypocalcemia)
- Kidney problems
- Poor oral health or dental problems (including use of dentures)
- Cancer
- Blood disorders
Other Medicines and Supplements. Fosamax Plus D may interact with other medicines and supplements. Before using alendronate, tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.
Pregnancy. It is not known if or how Fosamax Plus D could affect pregnancy or harm an unborn baby. Tell your healthcare provider if you are or plan to become pregnant. If you become pregnant while taking Fosamax Plus D, stop taking it right away and contact your healthcare provider.
Breastfeeding. Fosamax Plus D consists of two drugs: alendronate and cholecalciferol (vitamin D3). It is not known if alendronate passes into breast milk, but cholecalciferol does. Tell your healthcare provider if you are breastfeeding or plan to breastfeed. Your healthcare provider will advise you if you should take alendronate while breastfeeding.
How can I get more information about Fosamax Plus D?
For more information about Fosamax Plus D, you can visit the manufacturer’s website at www.organon.com or call them at 844-674-3200.
Interactions
Does Fosamax Plus D interact with foods or drinks?
Avoid eating food or drinking beverages (including mineral water, coffee, tea, soda, juice, or milk) other than plain water within 30 minutes of taking Fosamax Plus D, because this may decrease the amount of medicine your body absorbs and make it not work as well.
Olestra (also known as Olean), a fat substitute that may be used in certain food products, can decrease the amount of cholecalciferol absorbed into the body.
It is unknown if drinking alcohol will affect Fosamax Plus D.
Does Fosamax Plus D interact with other medicines (drug interactions)?
Always tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.
In particular, make sure that you discuss if you are using any of the following before using Fosamax Plus D.
- An antacid, supplement, or vitamin containing calcium, aluminum, magnesium, or iron
- A nonsteroidal anti-inflammatory drug (NSAIDs) such as aspirin, ibuprofen, naproxen, and others, which are contained in many prescription and OTC products for pain, swelling, and fever
- A bile acid sequestrant, such as cholestyramine or colestipol, which is a medicine for high cholesterol
- Mineral oil, which is a laxative used to treat constipation
- Orlistat, which is a weight loss medicine
- A corticosteroid, which is a medicine for certain inflammatory conditions
- Chemotherapy or radiation for treating cancer
This may not be a complete list of medicines that can interact with Fosamax Plus D. Always check with your healthcare provider.
Overdose/Missed Dose
What should I do if I accidentally use too much Fosamax Plus D?
If you or someone else has used too much Fosamax Plus D, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222. Do not try to vomit. Do not lie down.
What should I do if I miss a dose of Fosamax Plus D?
If you miss a dose of Fosamax Plus D, do not take it later in the day. Take the missed dose the morning after the day you remember, and then return to your normal schedule. Do not take 2 doses on the same day.
Are you currently using Fosamax Plus D (alendronate/cholecalciferol)?
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