Actonel with Calcium

DRUG DESCRIPTION

Actonel® with Calcium (risedronate sodium with calcium carbonate) is a co-package product containing Actonel® (risedronate sodium tablets, 35 mg) for once weekly dosing and calcium carbonate tablets, USP (1250 mg, equivalent to 500 mg elemental calcium) for daily dosing for the remaining 6 days of the week. Each package contains a 28-day course of therapy.

Actonel

Actonel (risedronate sodium tablets) is a pyridinyl bisphosphonate that inhibits osteoclast-mediated bone resorption and modulates bone metabolism. Each Actonel tablet in the Actonel with Calcium (risedronate sodium with calcium carbonate) co-package contains the equivalent of 35 mg of anhydrous risedronate sodium in the form of the hemi-pentahydrate with small amounts of monohydrate. The empirical formula for risedronate sodium hemi-pentahydrate is C7H10NO7P2Na •2.5 H2O. The chemical name of risedronate sodium is [1-hydroxy-2-(3-pyridinyl)ethylidene]bis[phosphonic acid] monosodium salt. The chemical structure of risedronate sodium hemi-pentahydrate is the following:

Actonel®
 (risedronate sodium with calcium carbonate) Structural Formula Illustration

Molecular Weight:
Anhydrous: 305.10
Hemi-pentahydrate: 350.13

Risedronate sodium is a fine, white to off-white, odorless, crystalline powder. It is soluble in water and in aqueous solutions, and essentially insoluble in common organic solvents.

Calcium

The empirical formula for calcium carbonate is CaCO3 and the molecular weight is 100.09.

Calcium carbonate is supplied as a calcium carbonate tablet, USP containing 1250 mg calcium carbonate (equivalent to 500 mg elemental calcium). Calcium carbonate is a fine, white, odorless, tasteless powder. It is stable and non-hygroscopic.

Calcium carbonate is formulated per USP standards to meet disintegration or dissolution, weight, purity, and potency requirements.

Inactive Ingredients

Actonel

Crospovidone, ferric oxide red, ferric oxide yellow, hydroxypropyl cellulose, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, titanium dioxide.

Calcium

Pregelatinized starch, sodium starch glycolate, FD&C Blue #2, magnesium stearate, polyethylene glycol 3350, hypromellose, Opaspray Light Blue, polysorbate 80.

What are the possible side effects of calcium carbonate and risedronate (Actonel with Calcium)?

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

Stop using calcium carbonate and risedronate and call your doctor at once if you have any of these serious side effects:

  • 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; or
  • ...

Read All Potential Side Effects and See Pictures of Actonel with Calcium »

What are the precautions when taking risedronate sodium with calcium carbonate (Actonel with Calcium)?

Before taking risedronate with calcium, tell your doctor or pharmacist if you are allergic to either of these drugs; or to other bisphosphonates (e.g., alendronate, etidronate, pamidronate); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This product should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have the following conditions: low or high blood calcium levels (hypocalcemia or hypercalcemia), inability to sit upright or stand for at least 30 minutes, severe kidney disease.

Before using this product, tell your doctor or pharmacist your medical history, especially...

Read All Potential Precautions of Actonel with Calcium »


Actonel with Calcium Consumer (continued)

SIDE EFFECTS: Upset stomach, nausea, constipation, gas, bloating, or headache may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: increased or severe bone/joint/muscle pain, jaw pain, eye/vision problems, symptoms of a kidney stone (e.g., lower abdominal/back/side pain, frequent urination, blood in the urine, fever/chills).

Risedronate may infrequently cause irritation and ulcers in your stomach or esophagus. Seek immediate attention if any of these serious side effects occur: new/severe/worsening heartburn, chest pain, difficult or painful swallowing, severe stomach/abdominal pain, black/tarry stools, vomit that looks like coffee grounds.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking risedronate with calcium, tell your doctor or pharmacist if you are allergic to either of these drugs; or to other bisphosphonates (e.g., alendronate, etidronate, pamidronate); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This product should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have the following conditions: low or high blood calcium levels (hypocalcemia or hypercalcemia), inability to sit upright or stand for at least 30 minutes, severe kidney disease.

Before using this product, tell your doctor or pharmacist your medical history, especially of: esophagus problems (e.g., esophageal stricture, achalasia), difficult or painful swallowing, kidney problems (e.g., kidney stones), stomach/intestinal disorders (e.g., ulcers).

Infrequently, people taking this class of medication (bisphosphonates) have had serious jawbone problems (osteonecrosis). Lack of proper dental hygiene, poorly fitting dentures, or certain dental procedures (such as tooth extraction, dental surgery) may increase your risk. Medical conditions (such as gum disease/infection, cancer, anemia) might also increase the risk. If you develop jaw pain, tell your doctor and dentist immediately.

Before having any surgery (especially dental procedures), tell your doctor and dentist about this medication and all other products you use (including prescription drugs, nonprescription drugs, and herbal products). Your doctor or dentist may tell you to stop taking this medication before your surgery. Ask for specific instructions about stopping or starting this medication.

Caution is advised if you are pregnant or planning to become pregnant in the future. Risedronate may stay in your body for many years. Its effects on an unborn baby are not known. Discuss the risks and benefits with your doctor before starting treatment with risedronate.

It is not known if risedronate passes into breast milk. Consult your doctor before breast-feeding.


Actonel with Calcium Patient Information Including Side Effects

Brand Names: Actonel with Calcium

Generic Name: calcium carbonate and risedronate (Pronunciation: KAL see um KAR bo nate and RYE e droe nate)

  • What is calcium carbonate and risedronate (Actonel with Calcium)?
  • What are the possible side effects of calcium carbonate and risedronate (Actonel with Calcium)?
  • What is the most important information I should know about calcium carbonate and risedronate (Actonel with Calcium)?
  • What should I discuss with my healthcare provider before taking calcium carbonate and risedronate (Actonel with Calcium)?
  • How should I take calcium carbonate and risedronate (Actonel with Calcium)?
  • What happens if I miss a dose (Actonel with Calcium)?
  • What happens if I overdose (Actonel with Calcium)?
  • What should I avoid while taking calcium carbonate and risedronate (Actonel with Calcium)?
  • What other drugs will affect calcium carbonate and risedronate (Actonel with Calcium)?
  • Where can I get more information?

What is calcium carbonate and risedronate (Actonel with Calcium)?

Risedronate is in the group of medicines called bisphosphonates (bis FOS fo nayts). It alters the cycle of bone formation and breakdown in the body. Risedronate slows bone loss while increasing bone mass, which may prevent bone fractures.

Calcium is a mineral that is needed for many functions of the body, especially bone formation and maintenance.

Risedronate is used to treat or prevent postmenopausal and steroid-induced osteoporosis. Risedronate is also used to treat Paget's disease of bone.

Calcium carbonate is used to prevent and to treat calcium deficiencies.

Calcium carbonate and risedronate may also be used for other purposes not listed in this medication guide.

What are the possible side effects of calcium carbonate and risedronate (Actonel with Calcium)?

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

Stop using calcium carbonate and risedronate and call your doctor at once if you have any of these serious side effects:

  • 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; or
  • jaw pain, numbness, or swelling.

Less serious side effects may include:

  • mild heartburn, nausea, or stomach upset;
  • diarrhea, gas, or constipation;
  • muscle, joint, or back pain;
  • pain or burning with urination;
  • mild skin rash; or
  • headache or depressed mood.

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. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about calcium carbonate and risedronate (Actonel with Calcium)?

Actonel with Calcium is packaged as two separate medicines: 4 risedronate tablets and 24 calcium tablets. Take a risedronate tablet one day per week, first thing in the morning, at least 30 minutes before you eat or drink anything or take any other medicine. Take a calcium tablet with food every day for the 6 days in between your risedronate doses. Only the calcium tablet should be taken with food. Risedronate must be taken on an empty stomach.

Do not take a risedronate tablet if you cannot sit upright or stand for at least 30 minutes. Risedronate 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 this medication.

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

For at least the first 30 minutes after taking a risedronate tablet, 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 risedronate 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.

Calcium carbonate and risedronate is only part of a complete program of treatment that may also include diet changes, exercise, and taking vitamin supplements. Follow your diet, medication, and exercise routines very closely.

Take only the amount of calcium that your doctor recommends. Do not use other calcium supplements unless your doctor has told you to.

Related Drug Centers
  • Actonel with Calcium


Related Drugs Index: