Boniva is a bisphosphonate medicine that alters bone formation and breakdown in the body. This can slow bone loss and may help prevent bone fractures.

Boniva is prescription medicine used to treat or prevent osteoporosis in women after menopause. Ibandronate helps increase bone mass and helps reduce the chance of having a spinal fracture.

It is not known how long Boniva works for the treatment and prevention of osteoporosis. You should see your doctor regularly to determine if this medicine is still right for you.

Warnings

You should not use Boniva if you have severe kidney disease or low levels of calcium in your blood.

Do not take a tablet if you have problems with your esophagus, or if you cannot sit upright or stand for at least 60 minutes after taking the tablet.

Boniva tablets can cause serious problems in the stomach or esophagus. Stop taking Boniva and call your doctor at once if you have chest pain, new or worsening heartburn, or pain when swallowing.

Also call your doctor if you have muscle spasms, numbness or tingling (in hands and feet or around the mouth), new or unusual hip pain, or severe pain in your joints, bones, or muscles.

Boniva side effects

Get emergency medical help if you have signs of an allergic reaction to Boniva: hives; wheezing, difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using this medicine and call your doctor at once if you have:

• chest pain, new or worsening heartburn;
• difficulty or pain when swallowing;
• pain or burning under the ribs or in the back;
• severe heartburn, burning pain in your upper stomach, or coughing up blood;
• new or unusual pain in your thigh or hip;
• jaw pain, numbness, or swelling;
• severe joint, bone, or muscle pain; or
• low calcium levels – muscle spasms or contractions, numbness or tingly feeling (around your mouth, or in your fingers and toes).

Common Boniva side effects may include:

• heartburn, stomach pain, diarrhea;
• back pain, bone pain, muscle or joint pain;
• pain in your arms or legs;
• headache; or
• fever, chills, tiredness, flu-like symptoms.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

Before taking this medicine

You should not use Boniva if you are allergic to ibandronate, or if you have:

• severe kidney disease; or
• low blood levels of calcium (hypocalcemia).

Do not take an Boniva tablet if you have problems with your esophagus, or if you cannot sit upright or stand for at least 60 minutes. Ibandronate can cause serious problems in the stomach or esophagus. You must stay upright for at least 1 full hour after taking this medicine.

To make sure this medicine is safe for you, tell your doctor if you have ever had:

• trouble swallowing;
• problems with your stomach or digestion;
• hypocalcemia;
• a dental problem (you may need a dental exam before you begin using Boniva);
• kidney disease; or
• any condition that makes it hard for your body to absorb nutrients from food (malabsorption).

In rare cases, this medicine may cause bone loss (osteonecrosis) in the jaw. Symptoms include jaw pain or numbness, red or swollen gums, loose teeth, or slow healing after dental work. The longer you use Boniva, the more likely you are to develop this condition.

Osteonecrosis of the jaw may be more likely if you have cancer or received chemotherapy, radiation, or steroids. Other risk factors include blood clotting disorders, anemia (low red blood cells), and a pre existing dental problem.

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

It is not known whether ibandronate will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether ibandronate passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

How should I use Boniva?

Use Boniva exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Boniva tablets are taken once per month. The injection is given into a vein through an IV once every 3 months. The tablets can be taken at home, but a healthcare provider must give the injection.

Take the tablet first thing in the morning, at least 60 minutes before you eat or drink anything or take any other medicine. Take the medicine on the same day each month and always first thing in the morning.

Take the tablet with a full glass (6 to 8 ounces) of plain water. Do not use coffee, tea, soda, juice, or mineral water. Do not eat or drink anything other than plain water.

Do not crush, chew, or suck on a tablet. Swallow it whole.

For at least 60 minutes (1 full hour) after taking a tablet:

• Do not lie down or recline.
• Do not take any other medicine including vitamins, calcium, or antacids.

Pay special attention to your dental hygiene while using Boniva. Brush and floss your teeth regularly. Consult your dentist before starting Boniva to ensure that you don’t need dental work soon. If you need to have any dental work (especially surgery), tell the dentist ahead of time that you are using this medicine.

Boniva is only part of a complete program of treatment that may also include diet changes, exercise, bone mineral density testing, and taking calcium and vitamin supplements. Follow your doctor’s instructions very closely.

Store at room temperature away from moisture and heat.

Your doctor will determine how long to treat you with this medicine. Ibandronate is often given for only 3 to 5 years.

Dosing information

Usual Adult Dose for Osteoporosis:

Oral:
150 mg orally once a month on the same day each month

IV Injection:
3 mg by IV injection over 15 to 30 seconds every three months.

Comments:
-The IV injection should not be administered more frequently than once every 3 months.
-Obtain serum creatinine prior administration of each IV injection.
-Perform a routine oral examination prior administration of IV injection

Uses: Treatment and prevention of postmenopausal osteoporosis, to increase bone mineral density (BMD) and to reduce the incidence of vertebral fractures

Usual Adult Dose for Prevention of Osteoporosis:

Oral:
150 mg orally once a month on the same day each month

IV Injection:
3 mg by IV injection over 15 to 30 seconds every three months.

Comments:
-The IV injection should not be administered more frequently than once every 3 months.
-Obtain serum creatinine prior administration of each IV injection.
-Perform a routine oral examination prior administration of IV injection

Uses: Treatment and prevention of postmenopausal osteoporosis, to increase bone mineral density (BMD) and to reduce the incidence of vertebral fractures

What happens if I miss a dose?

Boniva tablets: If you forget to take a tablet first thing in the morning on your scheduled day, do not take it later in the day. Wait until the next morning to take the missed dose. Then return to your regular monthly schedule on your chosen dose day. If your next scheduled dose is less than 7 days away, wait until then and skip the missed dose. Do not take two (2) doses in one week.

Boniva injections: Call your doctor for instructions if you miss an appointment for your injection.

What happens if I overdose?

For Boniva tablets: Drink a full glass of milk and seek emergency medical attention or call the Poison Help line . Do not make yourself vomit and do not lie down.

Since the injections are given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

What to avoid

Avoid taking any other medicines for at least 60 minutes after taking Boniva. This includes vitamins, calcium, and antacids. Some medicines can make it harder for your body to absorb ibandronate.

Avoid smoking, or try to quit. Smoking can reduce your bone mineral density, making fractures more likely.

Avoid drinking large amounts of alcohol. Heavy drinking can also cause bone loss.

What other drugs will affect Boniva?

Tell your doctor about all your current medicines and any you start or stop using, especially:

• aspirin; or
• NSAIDs (nonsteroidal anti-inflammatory drugs) – ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.

This list is not complete. Other drugs may interact with ibandronate, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide. Talk with your doctor about the best dosing schedule for your other medicines.

What is Fosamax?

Fosamax is a bisphosphonate (bis FOS fo nayt) medicine that alters bone formation and breakdown in the body. This can slow bone loss and may help prevent bone fractures.

Fosamax is used in women to treat or prevent osteoporosis caused by menopause and in men and women to treat osteoporosis caused by taking steroids.

Fosamax is also used to increase bone mass in men who have osteoporosis, and to treat Paget’s disease of bone in men and women.

Warnings

You should not take Fosamax if you have problems with your esophagus, or low levels of calcium in your blood.

Do not take Fosamax if you cannot sit upright or stand for at least 30 minutes after taking the medicine.

Fosamax can cause serious problems in the stomach or esophagus. Stop using this medicine and call your doctor at once if you have chest pain, new or worsening heartburn, or pain when swallowing.

In rare cases, this medicine may cause bone loss (osteonecrosis) in the jaw or a broken leg bone called a femur fracture. Symptoms of osteonecrosis include jaw pain or numbness, red or swollen gums, loose teeth, or slow healing after dental work. Symptoms of a femur fracture include leg or groin pain.

Also call your doctor if you have muscle spasms, numbness or tingling (in hands and feet or around the mouth), new or unusual hip pain, or severe pain in your joints, bones, or muscles.

Before taking this medicine

You should not take Fosamax if you are allergic to alendronate, or if you have:

• low levels of calcium in your blood (hypocalcemia); or
• problems with the muscles in your esophagus (the tube that connects your mouth and stomach).

Do not take Fosamax if you cannot sit upright or stand for at least 30 minutes. Fosamax can cause serious problems in the stomach or esophagus. You must stay upright for at least 30 minutes after taking this medicine.

To make sure this medicine is safe for you, tell your doctor if you have ever had:

• trouble swallowing;
• problems with your stomach or digestion;
• low levels of calcium in your blood;
• a dental problem (you may need a dental exam before you begin taking Fosamax);
• kidney disease; or
• any condition that makes it hard for your body to absorb nutrients from food (malabsorption).

In rare cases, this medicine may cause bone loss (osteonecrosis) in the jaw. Symptoms include jaw pain or numbness, red or swollen gums, loose teeth, or slow healing after dental work. The longer you use Fosamax, the more likely you are to develop this condition.

Osteonecrosis of the jaw may be more likely if you have cancer or received chemotherapy, radiation, or steroids. Other risk factors include blood clotting disorders, anemia (low red blood cells), and a pre-existing dental problem.

Fosamax has also been reported to cause fractures, or broken bones, in the large bones of the leg. Tell your doctor if you have any leg or groin pain while using Fosamax.

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

It is not known whether Fosamax will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant. Stop using the medicine and tell your doctor right away if you become pregnant.

It is not known whether alendronate passes into breast milk or if it could harm a nursing baby. Ask your doctor about any risk.

How should I take Fosamax?

Take Fosamax exactly as prescribed by your doctor. Fosamax is taken either once daily or once per week. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Take Fosamax first thing in the morning, at least 30 minutes before you eat or drink anything or take any other medicine. If you take this medicine only once per week, take it on the same day each week and always first thing in the morning.

Take with a full glass (6 to 8 ounces) of plain water. Do not use coffee, tea, soda, juice, or mineral water. Do not eat or drink anything other than plain water.

Do not crush, chew, or suck on an Fosamax tablet. Swallow the tablet whole.

For at least 30 minutes after taking Fosamax:

• Do not lie down or recline.
• Do not take any other medicine including  vitamins, calcium, or antacids.

Pay special attention to your dental hygiene while taking Fosamax. Brush and floss your teeth regularly. If you need to have any dental work (especially surgery), tell the dentist ahead of time that you are using alendronate.

Fosamax is only part of a complete program of treatment that may also include diet changes, exercise, bone mineral density testing, and taking calcium and  vitamin  supplements. Follow your doctor’s instructions very closely.

Store at room temperature away from moisture and heat.

Your doctor will determine how long to treat you with this medicine. Fosamax is often given for only 3 to 5 years.

What happens if I miss a dose?

Once-daily dosing: If you forget to take Fosamax first thing in the morning, do not take it later in the day. Wait until the following morning and skip the missed dose. Do not take two (2) doses in one day.

Once-per-week dosing: If you forget to take Fosamax 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 2 doses in one day.

What happens if I overdose?

Drink a full glass of milk and seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Do not make yourself vomit and do not lie down.

What to avoid

Avoid taking any other medicines for at least 30 minutes after taking Fosamax. This includes vitamins, calcium, and antacids. Some medicines can make it harder for your body to absorb alendronate.

Avoid smoking, or try to quit. Smoking can reduce your bone mineral density, making fractures more likely.

Avoid drinking large amounts of alcohol. Heavy drinking can also cause bone loss.

Fosamax side effects

Get emergency medical help if you have signs of an allergic reaction to Fosamax: hives; wheezing, difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using Fosamax and call your doctor at once if you have:

• chest pain, new or worsening heartburn;
• difficulty or pain when swallowing;
• pain or burning under the ribs or in the back;
• severe heartburn, burning pain in your upper stomach, or coughing up blood;
• new or unusual pain in your thigh, hip or groin;
• jaw pain, numbness, or swelling;
• severe joint, bone, or muscle pain; or
• signs of low calcium levels – muscle spasms or contractions, numbness or tingly feeling (around your mouth, or in your fingers and toes).

Common Fosamax side effects may include:

• heartburn, upset stomach;
• stomach pain, nausea;
• diarrhea, constipation; or
• headaches; or
• bone pain, muscle or joint pain.

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 .

What other drugs will affect Fosamax?

Tell your doctor about all your current medicines and any you start or stop using, especially:

• aspirin; or
• NSAIDs (nonsteroidal anti-inflammatory drugs) – ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others; or
• calcium supplements and antacids

What is Reclast?

Reclast (sometimes called zoledronate) is a bisphosphonate medicine that alters bone formation and breakdown in the body. This can slow bone loss and may help prevent bone fractures.

Reclast is used to treat or prevent osteoporosis caused by menopause, or steroid use. This medicine also increases bone mass in men with osteoporosis. Reclast is for use when you have a high risk of bone fracture.

Reclast is also used to treat Paget’s disease of bone.

Zometa is another brand of zoledronic acid used to treat high blood levels of calcium caused by cancer (also called hypercalcemia of malignancy). This medicine also treats multiple myeloma (a type of bone marrow cancer) or bone cancer that has spread from elsewhere in the body. You should not use Reclast and Zometa at the same time.

Warnings

Zoledronic acid may harm an unborn baby. Do not use Reclast if you are pregnant. Use effective birth control, and ask your doctor how long to prevent pregnancy after you stop this medicine.

Reclast can cause serious kidney problems, especially if you are dehydrated, if you take diuretic medicine, or if you already have kidney disease. Call your doctor if you urinate less than usual, if you have swelling in your feet or ankles, or if you feel tired or short of breath.

Also call your doctor if you have muscle spasms, numbness or tingling (in hands and feet or around the mouth), new or unusual hip pain, or severe pain in your joints, bones, or muscles.

Your doctor may recommend you have a dental exam for preventive tooth and gum care before you start your treatment with zoledronic acid. This is especially important if you have cancer, if you are undergoing chemotherapy or using steroids, or if you have poor dental health.

Some people using medicines similar to Reclast 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 pre-existing dental problems.

Before taking this medicine

You should not be treated with Reclast if you are allergic to zoledronic acid.

You also should not receive Reclast if you have:

• low levels of calcium in your blood (hypocalcemia); or
• severe kidney disease.

You should not be treated with Reclast if are currently using any other bisphosphonate (such as alendronate, etidronate, ibandronate, pamidronate, risedronate, or tiludronate).

To make sure Reclast is safe for you, tell your doctor if you have ever had:

• kidney disease;
• hypocalcemia;
• thyroid or parathyroid surgery;
• surgery to remove part of your intestine;
• asthma caused by taking aspirin;
• any condition that makes it hard for your body to absorb nutrients from food (malabsorption);
• a dental problem (you may need a dental exam before you receive Reclast);
• if you are dehydrated; or
• if you take a diuretic or “water pill”.

Zoledronic acid can cause serious kidney problems, especially if you are dehydrated, if you take diuretic medicine, or if you already have kidney disease.

This medicine may cause jaw bone problems (osteonecrosis). The risk is highest in people with cancer, blood cell disorders, pre-existing dental problems, or people treated with steroids, chemotherapy, or radiation. Ask your doctor about your own risk.

You may need to have a negative pregnancy test before starting treatment with Reclast.

Do not use Reclast if you are pregnant. Zoledronic acid may harm an unborn baby or cause birth defects. Zoledronic acid can remain in your body for weeks or years after your last dose. Use effective birth control to prevent pregnancy while using this medicine. Talk with your doctor about the need to prevent pregnancy after you stop using Reclast.

This medicine may affect fertility (ability to have children) in women. However, it is important to use birth control to prevent pregnancy because zoledronic acid can harm an unborn baby.

You should not breastfeed while using Reclast.

How is Reclast given?

Reclast is given as an infusion into a vein. A healthcare provider will give you this injection.

Reclast is sometimes given as a single dose only one time. It may also be given once every 1 or 2 years. How often you receive Reclast will depend on why you are using this medicine. Follow your doctor’s instructions.

Drink at least 2 glasses of water within a few hours before your injection to keep from getting dehydrated.

You may need frequent medical tests to help your doctor determine how long to treat you with Reclast. Your kidney function may also need to be checked.

Pay special attention to your dental hygiene while using Reclast. Brush and floss your teeth regularly. If you need to have any dental work (especially surgery), tell the dentist ahead of time that you are using Reclast.

Reclast is only part of a complete program of treatment that may also include diet changes and taking calcium and vitamin supplements. Follow your doctor’s instructions very closely.

Your doctor will determine how long to treat you with this medicine. Reclast is often given for only 3 to 5 years.

Dosing information

Usual Adult Dose for Paget’s Disease:

5 mg IV infusion, at a constant infusion rate, over no less than 15 minutes

Calcium and vitamin D supplementation:
-Calcium: 750 mg elemental calcium orally twice a day, or 500 mg orally three times a day
-Vitamin D: 800 international units orally daily, especially in the 2 weeks following drug administration

Comments: Retreatment may be considered in patients who have relapsed, based on increases in serum alkaline phosphatase or failure to achieve normalization of serum alkaline phosphatase.

Uses: Paget’s disease of bone with elevations in serum alkaline phosphatase of two times or higher than upper limit of age- specific normal reference range

Usual Adult Dose for Osteoporosis:

5 mg IV infusion over no less than 15 minutes, once a year

Comments: An average of at least 1200 mg calcium and 800 to 1000 international units vitamin D daily is recommended.

Uses:
-Osteoporosis in postmenopausal women, diagnosed by bone mineral density or prevalent vertebral fracture (this drug reduces the incidence of fractures).
-To increase bone mass in men with osteoporosis.
-Treatment of glucocorticoid-induced osteoporosis in men and women who are either initiating or continuing systemic glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of prednisone and are expected to remain on glucocorticoids for at least 12 months.

Usual Adult Dose for Prevention of Osteoporosis:

5 mg IV infusion over no less than 15 minutes, every 2 years

Uses:
-Prevention of osteoporosis in postmenopausal women.
-Prevention of glucocorticoid-induced osteoporosis in men and women who are either initiating or continuing systemic glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of prednisone and are expected to remain on glucocorticoids for at least 12 months.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your Reclast injection.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while receiving Reclast?

Avoid smoking, or try to quit. Smoking can reduce your bone mineral density, making fractures more likely.

Avoid drinking large amounts of alcohol. Heavy drinking can also cause bone loss.

Reclast side effects

Get emergency medical help if you have signs of an allergic reaction to Reclast: hives; wheezing, chest tightness, trouble breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• new or unusual pain in your thigh or hip;
• jaw pain or numbness, red or swollen gums, loose teeth, or slow healing after dental work;
• severe joint, bone, or muscle pain;
• kidney problems – little or no urination, swelling in your feet or ankles, feeling tired;
• low red blood cells (anemia) – pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet; or
• low calcium levels – muscle spasms or contractions, numbness or tingly feeling (around your mouth, or in your fingers and toes).

Serious side effects on the kidneys may be more likely in older adults.

Common Reclast side effects may include:

• trouble breathing;
• nausea, vomiting, diarrhea, constipation;
• bone pain, muscle or joint pain;
• fever or other flu symptoms;
• tiredness;
• eye pain or swelling;
• pain in your arms or legs;
• headache; or
• anemia.

What is risedronate?

Risedronate is used to treat osteoporosis caused by menopause, or steroid use. risedronate is for use when you have a high risk of bone fracture due to osteoporosis.

Risedronate is also used to treat Paget’s disease of bone.

Risedronate may also be used for purposes not listed in this medication guide.

Risedronate side effects

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Risedronate may cause serious side effects. Stop using risedronate and call your doctor at once if you have:

• chest pain, new or worsening heartburn;
• difficulty or pain when swallowing;
• pain or burning under the ribs or in the back;
• severe heartburn, burning pain in your upper stomach, or coughing up blood;
• new or unusual pain in your thigh or hip;
• jaw pain, numbness, or swelling;
• severe joint, bone, or muscle pain; or
• low calcium levels–muscle spasms or contractions, numbness or tingly feeling (around your mouth, or in your fingers and toes).

Common side effects of risedronate may include:

• heartburn, diarrhea, indigestion;
• stomach pain;
• back pain, joint pain, muscle pain; or
• flu-like symptoms.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

Warnings

You should not take risedronate if you have problems with your esophagus, or low levels of calcium in your blood.

Do not take risedronate if you cannot sit upright or stand for at least 30 minutes after taking the medicine.

Risedronate can cause serious problems in the stomach or esophagus. Stop using risedronate and call your doctor at once if you have chest pain, new or worsening heartburn, or pain when swallowing.

Also call your doctor if you have muscle spasms, numbness or tingling (in hands and feet or around the mouth), new or unusual hip pain, or severe pain in your joints, bones, or muscles.

Before taking this medicine

You should not take risedronate if you are allergic to it, or if you have:

• low levels of calcium in your blood (hypocalcemia); or
• problems with the muscles in your esophagus (the tube that connects your mouth and stomach).

Do not take risedronate if you cannot sit upright or stand for at least 30 minutes. Risedronate can cause serious problems in the stomach or esophagus. You must stay upright for at least 30 minutes after taking risedronate.

Tell your doctor if you have ever had:

• trouble swallowing;
• problems with your stomach or digestion;
• hypocalcemia;
• a dental problem (you may need a dental exam before you begin taking risedronate);
• kidney disease; or
• any condition that makes it hard for your body to absorb nutrients from food (malabsorption).

This medicine may cause jaw bone problems (osteonecrosis). The risk is highest in people with cancer, blood cell disorders, pre-existing dental problems, or people treated with steroids, chemotherapy, or radiation. Ask your doctor about your own risk.

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

It is not known whether this medicine will harm an unborn baby. Stop taking risedronate and tell your doctor right away if you become pregnant, or think you may be pregnant.

You should not breastfeed while using risedronate.

Risedronate should not be given to a child younger than 18 years old.

How should I take risedronate?

Risedronate tablets come in different strengths (number of milligrams per pill) that are taken on different schedules. You may need to take a tablet once per day, once per week, once per month, or for 2 days in a row once per month.

Your dosing schedule will depend on why you are taking risedronate and in what tablet strength. If you change strengths, you may also need to change your schedule.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed. Risedronate is often given for only 3 to 5 years.

Take the Actonel tablet first thing in the morning with a full glass (6 to 8 ounces) of water, at least 30 minutes before you eat or drink anything or take any other medicine.

Take the Atelvia tablet just after breakfast, with at least 4 ounces of water.

Use only plain water when taking a risedronate tablet. Do not use coffee, tea, soda, juice, or mineral water.

Do not crush, chew, or suck on a risedronate tablet. Swallow it whole.

For at least 30 minutes after taking risedronate:

• Do not lie down or recline.
• Do not take any other medicine including vitamins, calcium, iron, antacids, or laxatives.

Take this medicine at the same time each day or on the same day each week or each month (depending on your dosing schedule).

Pay special attention to your dental hygiene while taking risedronate. Brush and floss your teeth regularly. If you need to have any dental work (especially surgery), tell the dentist ahead of time that you are using risedronate.

Risedronate is only part of a complete program of treatment that may also include diet changes, exercise, bone mineral density testing, and taking calcium and vitamin supplements. Follow your doctor’s instructions very closely.

Store at room temperature away from moisture and heat. Keep unused effervescent tablets in the foil blister pack.

What happens if I miss a dose?

Once-daily dosing: If you forget to take risedronate first thing in the morning, do not take it later in the day. Wait until the following morning and skip the missed dose. Do not take two (2) doses in one day.

Once-per-week or once-per-month dosing: If you forget to take risedronate 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 or monthly schedule on your chosen dose day. Do not take 2 doses in one day.

Call your doctor for instructions if you miss more than 2 doses in a month.

What happens if I overdose?

Drink a full glass of milk and seek emergency medical attention or call the Poison Help line

What should I avoid while taking risedronate?

Do not take two different brands or strengths of risedronate at the same time.

Avoid taking any other medicines for at least 30 minutes after taking risedronate. This includes vitamins, calcium, iron, antacids, or laxatives. Some medicines can make it harder for your body to absorb risedronate.

Avoid smoking, or try to quit. Smoking can reduce your bone mineral density, making fractures more likely.

Avoid drinking large amounts of alcohol. Heavy drinking can also cause bone loss.

What is alendronate?

Alendronate is used to treat osteoporosis caused by menopause, steroid use, or gonadal failure. alendronate is for use when you have a high risk of bone fracture due to osteoporosis.

Alendronate is also used to treat Paget’s disease of bone.

Alendronate may also be used for purposes not listed in this medication guide.

Alendronate side effects

Get emergency medical help if you have signs of an allergic reaction: hives; wheezing, difficulty breathing; swelling of your face, lips, tongue, or throat.

Alendronate may cause serious side effects. Stop using alendronate and call your doctor at once if you have:

• chest pain, new or worsening heartburn;
• difficulty or pain when swallowing;
• pain or burning under the ribs or in the back;
• severe heartburn, burning pain in your upper stomach, or coughing up blood;
• new or unusual pain in your thigh or hip;
• jaw pain, numbness, or swelling;
• severe joint, bone, or muscle pain; or
• low calcium levels–muscle spasms or contractions, numbness or tingly feeling (around your mouth, or in your fingers and toes).

Common side effects of alendronate may include:

• heartburn, upset stomach;
• stomach pain, nausea;
• diarrhea, constipation; or
• bone pain, muscle or joint pain.

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 .

Warnings

You should not take alendronate if you have problems with your esophagus, or low levels of calcium in your blood.

Do not take alendronate if you cannot sit upright or stand for at least 30 minutes after taking the medicine.

Alendronate can cause serious problems in the stomach or esophagus. Stop using alendronate and call your doctor at once if you have chest pain, new or worsening heartburn, or pain when swallowing.

Also call your doctor if you have muscle spasms, numbness or tingling (in hands and feet or around the mouth), new or unusual hip pain, or severe pain in your joints, bones, or muscles.

Before taking this medicine

You should not take alendronate if you are allergic to it, or if you have:

• low levels of calcium in your blood (hypocalcemia); or
• problems with the muscles in your esophagus (the tube that connects your mouth and stomach).

Do not take alendronate if you cannot sit upright or stand for at least 30 minutes. Alendronate can cause serious problems in the stomach or esophagus. You must stay upright for at least 30 minutes after taking alendronate.

Tell your doctor if you have ever had:

• trouble swallowing;
• problems with your stomach or digestion;
• hypocalcemia;
• a dental problem (you may need a dental exam before you begin taking alendronate);
• kidney disease; or
• any condition that makes it hard for your body to absorb nutrients from food (malabsorption).

The effervescent tablet contains a lot of sodium. Tell your doctor if you are on a low-salt diet before using this form of alendronate.

This medicine may cause jaw bone problems (osteonecrosis). The risk is highest in people with cancer, blood cell disorders, pre-existing dental problems, or people treated with steroids, chemotherapy, or radiation. Ask your doctor about your own risk.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or trying to become pregnant. Stop using the medicine and tell your doctor right away if you become pregnant.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

How should I take alendronate?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Alendronate is taken either once daily or once per week. Follow your doctor’s dosing instructions very carefully.

Take alendronate first thing in the morning, at least 30 minutes before you eat or drink anything or take any other medicine. If you take alendronate only once per week, take it on the same day each week and always first thing in the morning.

Take with a full glass (6 to 8 ounces) of plain water. Do not use coffee, tea, soda, juice, or mineral water. Do not eat or drink anything other than plain water.

Measure liquid medicine carefully. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

Do not crush, chew, or suck on an alendronate regular tablet. Swallow it whole.

Dissolve the effervescent tablet in at least 4 ounces of water (at room temperature, not hot or cold). Let the tablet dissolve for 5 minutes. Stir this mixture for 10 seconds and drink all of it right away. Add a little more water to the glass, swirl gently and drink right away.

For at least 30 minutes after taking alendronate:

• Do not lie down or recline.
• Do not take any other medicine including vitamins, calcium, or antacids.

Pay special attention to your dental hygiene while taking alendronate. Brush and floss your teeth regularly. If you need to have any dental work (especially surgery), tell the dentist ahead of time that you are using alendronate.

Alendronate is only part of a complete program of treatment that may also include diet changes, exercise, bone mineral density testing, and taking calcium and vitamin supplements. Follow your doctor’s instructions very closely.

Store at room temperature away from moisture and heat. Keep unused effervescent tablets in the foil blister pack.

Your doctor will determine how long to treat you with this medicine. Alendronate is often given for only 3 to 5 years.

What happens if I miss a dose?

Once-daily dosing: If you forget to take alendronate first thing in the morning, do not take it later in the day. Wait until the following morning and skip the missed dose. Do not take two (2) doses in one day.

Once-per-week dosing: If you forget to take alendronate 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 2 doses in one day.

What happens if I overdose?

Drink a full glass of milk and seek emergency medical attention or call the Poison Help line . Do not make yourself vomit and do not lie down.

What should I avoid while taking alendronate?

Avoid taking any other medicines for at least 30 minutes after taking alendronate. This includes vitamins, calcium, and antacids. Some medicines can make it harder for your body to absorb alendronate.

Avoid smoking, or try to quit. Smoking can reduce your bone mineral density, making fractures more likely.

Avoid drinking large amounts of alcohol. Heavy drinking can also cause bone loss.

What other drugs will affect alendronate?

Tell your doctor about all your other medicines, especially:

• aspirin; or
• NSAIDs (nonsteroidal anti-inflammatory drugs)–ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.

This list is not complete. Other drugs may affect alendronate, including prescription and over-the-counter medicines, vitamins, and herbal products.