Fosamax Plus D

Generic Name: alendronate and cholecalciferol (a LEN dro nate and KOL e cal SIF er ol)
Brand Names: Fosamax Plus D

What is Fosamax Plus D?

Fosamax Plus D contains a combination of alendronate and cholecalciferol. Alendronate belongs to a group of medicines called bisphosphonates. 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.

Cholecalciferol is a form of vitamin D, and is important for the absorption of calcium from the stomach and for the functioning of calcium in the body.

Fosamax Plus D is used to treat and prevent osteoporosis.

Fosamax Plus D may also be used for other purposes.

Important information about Fosamax Plus D

Do not take an Fosamax Plus D tablet if you cannot sit upright or stand for at least 30 minutes. This medicine 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 the medicine.

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

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

For at least the first 30 minutes after taking Fosamax Plus D, 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.

If you need to have any dental work (especially surgery), tell the dentist ahead of time that you are using Fosamax Plus D. You may need to stop using the medicine for a short time.

Talk with your doctor about the risks and benefits of using this medication.

Before taking Fosamax Plus D

Do not take an Fosamax Plus D tablet if you cannot sit upright or stand for at least 30 minutes. This medicine 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 the medicine.

To make sure you can safely take Fosamax Plus D, tell your doctor if you have any of these other conditions:

• low blood calcium (hypocalcemia);

• a cancer such as sarcoidosis, leukemia, lymphoma;

• a vitamin D deficiency;

• kidney disease; or

• an ulcer in your stomach or esophagus.

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 dental surgery or pre-existing dental problems.

Talk with your doctor about the risks and benefits of using Fosamax Plus D.

FDA pregnancy category C. It is not known whether Fosamax Plus D will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether alendronate passes into breast milk or if it could harm a nursing baby. Do not use Fosamax Plus D without telling your doctor if you are breast-feeding a baby.

See also: Fosamax Plus D pregnancy and breastfeeding warnings (in more detail)

How should I take Fosamax Plus D?

Take Fosamax Plus D exactly as it was prescribed for you. Do not use the medication in larger amounts or for longer than recommended by your doctor.

Fosamax Plus D tablets are taken once each week. Choose the day of the week that best fits your schedule. Every week, take one Fosamax Plus D tablet on your chosen day.

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

Take the tablet with a full glass (6 to 8 ounces) of water. Use only plain water (not mineral water) when taking this medicine. Do not crush, chew, or suck the tablet. Swallow the pill whole.

After taking an Fosamax Plus D tablet, carefully follow these instructions:

• Do not lie down or recline for at least 30 minutes after taking Fosamax Plus D.
• Do not eat or drink anything other than plain water.
• Do not take any other medicines including vitamins, calcium, or antacids for at least 30 minutes after taking Fosamax Plus D. It may be best to take your other medicines at a different time of the day. Talk with your doctor about the best dosing schedule for your other medicines.

To be sure Fosamax Plus D is helping your condition, your bone mineral density will need to be tested on a regular basis. You may not need to take alendronate and cholecalciferol for longer than 3 to 5 years if you take it for osteoporosis. Visit your doctor regularly.

If you need to have any dental work (especially surgery), tell the dentist ahead of time that you are using Fosamax Plus D. You may need to stop using the medicine for a short time.

Fosamax Plus D 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.

Store Fosamax Plus D at room temperature away from moisture and heat.

What happens if I miss a dose?

If you forget to take Fosamax Plus D 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.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Drink a full glass of milk and call your local poison control center or emergency room right away. Do not make yourself vomit and do not lie down.

Overdose symptoms may include severe forms of some of the side effects listed in this medication guide. Overdose may also cause muscle cramps, numbness or tingling, tight muscles in your face, seizure (convulsions), irritability, and unusual thoughts or behavior.

What should I avoid while taking Fosamax Plus D?

Do not take any other medicines including vitamins, calcium, or antacids for at least 30 minutes after taking Fosamax Plus D. Do not lie down for at least 30 minutes after you take this medicine.

Fosamax Plus D side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Fosamax Plus D: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using Fosamax Plus D and call your doctor at once if you have a serious side effect such as:

• 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;

• new or unusual pain in your thigh or hip; or

• jaw pain, numbness, or swelling.

Less serious Fosamax Plus D side effects may include:

• mild heartburn, stomach upset;

• diarrhea, gas, constipation;

• mild joint or back pain; or

• headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Fosamax Plus D side effects (in more detail)

What other drugs will affect Fosamax Plus D?

Antacids, supplements, or medicines that contain aluminum, calcium, magnesium, or other minerals can interfere with how your body absorbs Fosamax Plus D. If you use these other medicines, do not that take them for at least 30 minutes after taking an Fosamax Plus D tablet.

Before using Fosamax Plus D, tell your doctor if you also use aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs) such as ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Arthrotec, Cambia, Cataflam, Voltaren, Flector Patch, Pennsaid, Solareze), indomethacin (Indocin), meloxicam (Mobic), and others.

This list is not complete and other drugs may interact with Fosamax Plus D. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

• Your pharmacist can provide more information about Fosamax Plus D.

What does my medication look like?

Alendronate and cholecalciferol is available with a prescription under the brand name Fosamax Plus D. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

• Fosamax Plus D 70 mg/2800 IU - white, capsule shaped tablets.