Alendronate & Cholecalciferol
Alendronate & Cholecalciferol Overview
Alendronate/cholecalciferol is a prescription medication used to treat and prevent osteoporosis in men and women. It is a single tablet containing 2 medications. Alendronate belongs to a group of medications called bisphosphonates, which work by preventing bone breakdown and increasing bone density. Cholecalciferol, a form of vitamin D, is important for calcium absorption and bone health.
This medication comes in tablet form and is usually taken once a week. Always take alendronate/cholecalciferol on an empty stomach.
Common side effects include stomach pain, heartburn, and constipation.
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Uses of Alendronate & Cholecalciferol
Alendronate/cholecalciferol is a prescription medicine used to:
- treat osteoporosis in women after menopause
- increase bone mass in men with osteoporosis
This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.
Side Effects of Alendronate & Cholecalciferol
Alendronate/cholecalciferol may cause serious side effects.
- See "Drug Precautions".
The most common side effects include:
- stomach area (abdominal) pain
- heartburn
- constipation
- diarrhea
- upset stomach
- bone, joint, or muscle pain
- nausea
You may get allergic reactions, such as hives or, in rare cases, swelling of your face, lips, tongue, or throat.
Tell your doctor if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of alendronate/cholecalciferol. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Alendronate & Cholecalciferol Interactions
Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.
Especially tell your doctor if you take:
- antacids
- aspirin
- Nonsteroidal Anti-Inflammatory (NSAID) medicines
Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Certain medicines may affect how alendronate/cholecalciferol works.
Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist each time you get a new medicine.
Alendronate & Cholecalciferol Precautions
Alendronate/cholecalciferol can cause serious side effects including:
- Esophagus problems
- Low calcium levels in your blood (hypocalcemia)
- Bone, joint, or muscle pain
- Severe jaw bone problems (osteonecrosis)
- Unusual thigh bone fractures
Esophagus problems. Some people who take alendronate/cholecalciferol may develop problems in the esophagus (the tube that connects the mouth and the stomach). These problems include irritation, inflammation, or ulcers of the esophagus which may sometimes bleed.
- It is important that you take alendronate/cholecalciferol exactly as prescribed to help lower your chance of getting esophagus problems.
- Stop taking alendronate/cholecalciferol and call your doctor right away if you get chest pain, new or worsening heartburn, or have trouble or pain when you swallow.
Low calcium levels in your blood (hypocalcemia). Alendronate/cholecalciferol may lower the calcium levels in your blood. If you have low blood calcium before you start taking alendronate/cholecalciferol, it may get worse during treatment. Your low blood calcium must be treated before you take alendronate/cholecalciferol. Most people with low blood calcium levels do not have symptoms, but some people may have symptoms. Call your doctor right away if you have symptoms of low blood calcium such as:
- 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 alendronate/cholecalciferol. Take calcium and vitamin D as your doctor tells you to.
Bone, joint, or muscle pain. Some people who take alendronate/cholecalciferol develop severe bone, joint, or muscle pain.
Severe jaw bone problems (osteonecrosis). Severe jaw bone problems may happen when you take alendronate/cholecalciferol. Your doctor should examine your mouth before you start alendronate/cholecalciferol. Your doctor may tell you to see your dentist before you start alendronate/cholecalciferol. It is important for you to practice good mouth care during treatment with alendronate/cholecalciferol.
Unusual thigh bone fractures. Some people have developed unusual fractures in their thigh bone. Symptoms of a fracture may include new or unusual pain in your hip, groin, or thigh. Call your doctor right away if you have any of these side effects.
Inform MD
Before you start alendronate/cholecalciferol, be sure to talk to your doctor if you:
- Have problems with swallowing
- Have stomach or digestive problems
- Have low blood calcium
- Plan to have dental surgery or teeth removed
- Have kidney problems
- Have sarcoidosis, leukemia, lymphoma. These conditions may cause changes in vitamin D.
- Have been told you have trouble absorbing minerals in your stomach or intestines (malabsorption syndrome)
- Are pregnant or plan to become pregnant. It is not known if alendronate/cholecalciferol can harm your unborn baby.
- Are breastfeeding or plan to breastfeed. It is not known if alendronate/cholecalciferol passes into your milk and may harm your baby.
Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.
Alendronate & Cholecalciferol and Pregnancy
Tell your doctor if you are pregnant or plan to become pregnant.
The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.
This medication falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.
Alendronate & Cholecalciferol and Lactation
Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if alendronate/cholecalciferol passes into your milk and may harm your baby.
Alendronate & Cholecalciferol Usage
- Take alendronate/cholecalciferol exactly as your doctor tells you.
- Alendronate/cholecalciferol works only if taken on an empty stomach.
- Take 1 dose of alendronate/cholecalciferol 1 time a week, after you get up for the day and before taking your first food, drink, or other medicine.
- Take alendronate/cholecalciferol while you are sitting or standing.
- Take your alendronate/cholecalciferol tablet with a full glass (6-8 oz) of plain water.
- Do not chew or suck on a tablet of alendronate/cholecalciferol.
- Do not take alendronate/cholecalciferol with mineral water, coffee, tea, soda, or juice.
- Do not take alendronate/cholecalciferol at bedtime.
After swallowing alendronate/cholecalciferol, wait at least 30 minutes:
- Before you lie down. You may sit, stand or walk, and do normal activities like reading.
- Before you take your first food or drink except for plain water.
- Before you take other medicines, including antacids, calcium, and other supplements and vitamins.
Do not lie down for at least 30 minutes after you take alendronate/cholecalciferol and after you eat your first food of the day.
If you miss a dose of alendronate/cholecalciferol, do not take it later in the day. Take your missed dose on the next morning after you remember and then return to your normal schedule. Do not take 2 doses on the same day.
If you take too much alendronate/cholecalciferol, call your doctor. Do not try to vomit. Do not lie down.
Alendronate & Cholecalciferol Overdose
If you take too much alendronate/cholecalciferol, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.
If alendronate/cholecalciferol is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.
Other Requirements
- Store alendronate/cholecalciferol at room temperature, 68°F to 77°F (20°C to 25°C).
- Keep alendronate/cholecalciferol away from light.
- Keep alendronate/cholecalciferol package and tablets dry.
- Store alendronate/cholecalciferol in the original package.
- Keep alendronate/cholecalciferol and all medicines out of the reach of children.