Pronunciation:

a-LEN-droe-nate SOE-dee-um, koe-le-kal-SIF-er-ol

Brand Names:

• Fosamax Plus D

Dosage Forms:

• Tablet

Classifications:

Therapeutic—

Calcium Regulator

Pharmacologic—

Vitamin D

Chemical—

Alendronate

Uses of This Medicine:

Alendronate and cholecalciferol combination is used to treat osteoporosis (thinning of the bone) in women after menopause. This medicine may also be used to increase bone mass in men who have osteoporosis.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Use of alendronate and cholecalciferol combination is not indicated in children.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of alendronate and cholecalciferol combination in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Erdafitinib
• Parathyroid Hormone

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Dairy Food

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Anemia or
• Blood clotting problems or
• Cancer or
• Dental or tooth problems or
• Dental procedures (eg, dental implants, tooth extraction) or
• Infection or
• Poor oral hygiene or
• Surgery (eg, dental surgery)—May increase risk for severe jaw problems.

• Blood or bone marrow problems (eg, leukemia, lymphoma, sarcoidosis)—Use with caution. May cause changes in vitamin D.

• Esophagus (the tube that runs from your throat to your stomach) problems (eg, achalasia, stricture) or
• Hypocalcemia (low calcium in the blood) or
• Inability to stand or sit upright for at least 30 minutes or
• Kidney disease, severe or
• Trouble with swallowing—Should not be used in patients with these conditions.

• Stomach or bowel problems (eg, Barrett's esophagus, duodenitis, gastritis, heartburn, inflammation of the esophagus, or ulcers)—Use with caution. May make these conditions worse.

• Vitamin D deficiency—Should be treated first before using this medicine.

Proper Use of This Medicine:

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

Take this medicine with a full glass (6 to 8 ounces) of plain water 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 and cholecalciferol combination 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 and cholecalciferol combination.

Swallow the tablet whole. Do not suck or chew on the tablet because it may cause throat irritation.

Do not lie down for at least 30 minutes after taking this medicine and before having your first food for the day. This will help the medicine 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 this medicine. 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 (tablets):
  • For treatment of postmenopausal osteoporosis:
    • Adults—One tablet once a week at least 30 minutes before the first food or drink of the day other than water. Each tablet contains 70 milligrams (mg) of alendronate and 2800 international units of vitamin D3, or 70 milligrams (mg) of alendronate and 5600 international units of vitamin D3.
    • Children—Use is not recommended.
  • For treatment of osteoporosis in men:
    • Adults—One tablet once a week at least 30 minutes before the first food or drink of the day other than water. One tablet contains 70 milligrams (mg) of alendronate and 2800 international units of vitamin D3, or 70 milligrams (mg) of alendronate and 5600 international units of vitamin D3.
    • 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.

If you miss your regularly scheduled dose or you forget to take your medicine, take it the next morning after you remember. Resume your usual schedule taking the medicine on your chosen day the next week.

Storage—

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

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.

Precautions While Using This Medicine:

It is important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for any unwanted effects.

This medicine can irritate your esophagus. If you think this medicine has started to damage your esophagus, stop taking this medicine and call your doctor. Some symptoms of damage to the esophagus are heartburn (either new or worse than usual), pain when swallowing, pain in the center of your chest, trouble swallowing, or feeling that food gets stuck on the way to your stomach.

It is important that you tell all of your health care providers that you are taking alendronate and cholecalciferol combination. If you are having a dental procedure while taking this medicine, you may have an increased chance of having a severe problem with your jaw.

Make sure you tell your doctor about any new medical problems, especially with your teeth or jaws. Tell your doctor if you have severe bone, joint, or muscle pain while using this medicine.

This medicine could lower the amount of calcium in your blood. Call your doctor right away if you develop any signs of low calcium levels, such as muscle spasms or twitching, or numbness or tingling in your fingers, toes, or lips.

This medicine may increase your risk of developing fractures of the thigh bone. This may be more common if you use it for a long time. Check with your doctor right away if you have a dull or aching pain in the thighs, groin, or hips.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

Chest pain, discomfort, or burning

difficulty with swallowing

heartburn

muscle or bone pain

pain with swallowing

vomiting blood

Rare

Abdominal or stomach cramps

blistering, peeling, or loosening of the skin

bloating or swelling of the face, arms, hands, lower legs, or feet

chills

confusion

convulsions

cough

diarrhea

difficulty with breathing

fever

irregular heartbeats

itching

joint pain

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

mood or mental changes

muscle cramps in the hands, arms, feet, legs, or face

numbness and tingling around the mouth, fingertips, or feet

rapid weight gain

red skin lesions, often with a purple center

red, irritated eyes

shortness of breath

sore throat

sores, ulcers, or white spots in the mouth or on the lips

swelling of the neck

tremor

unusual tiredness or weakness

unusual weight gain or loss

vomiting

Incidence not known

Burning upper abdominal or stomach pain

difficulty with moving

heavy jaw feeling

loosening of a tooth

loss of appetite

muscle aching or cramping

muscle pains or stiffness

pain or burning in the throat

pain, swelling, or numbness in the mouth or jaw

severe bone, joint, or muscle pain

stomach bloating, burning, cramping, or pain

swollen joints

weight loss

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Acid or sour stomach

belching

constipation

excess air or gas in the stomach or intestines

full feeling

headache

indigestion

passing gas

pressure in the stomach

stomach discomfort, upset, or pain

swelling of the abdominal or stomach area

Rare

Blurred vision or other change in vision

decreased vision

eye pain

eye redness

eye tenderness

flushing or redness of the skin

increased tearing

rash

redness of the eye

sensitivity of the eye to light

severe eye pain

tearing

unusually warm skin

Incidence not known

Dizziness or lightheadedness

feeling of constant movement of self or surroundings

general feeling of discomfort or illness

hair loss

hives or welts

lack or loss of strength

sensation of spinning

thinning of the hair

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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