Actonel is a prescription medication used to treat and prevent osteoporosis. This condition causes bones to become weak and break easily. Actonel works by helping to strengthen bones and decrease the risk of fractures.

Actonel is a prescription medication used to treat and prevent osteoporosis. This condition causes bones to become weak and break easily. Actonel works by helping the body to absorb calcium, which helps to strengthen bones and decrease the risk of fractures.

This medication comes in tablet form and is taken once a day, with or without food. Common side effects include nausea, diarrhea, and stomach pain. If you experience any serious side effects, such as black or tarry stools, severe abdominal pain, or difficulty breathing, contact your doctor immediately.

Actonel

Why is Actonel prescribed?

Actonel is a bisphosphonate, a class of drugs that helps to prevent bone loss and improve bone density. It is used to treat and prevent osteoporosis in postmenopausal women. Osteoporosis is a condition in which bones become weak and break easily. Actonel can also be used to treat Paget’s disease, a condition in which bones become misshapen and break easily.

How should Actonel be used?

Actonel comes in tablet form and is taken once a day, with or without food. It is important to take this medication exactly as prescribed by your doctor. Do not take more or less than directed. Do not stop taking Actonel without first talking to your doctor.

Pharmacokinetics

Actonel is rapidly and completely absorbed following oral administration. The mean peak plasma concentration (Cmax) of risedronate occurs 1 to 3 hours post-dose (Tmax). Bioavailability of risedronate from ACTONEL Tablets is approximately 60%. Food decreases the extent of absorption (AUC), but not the Cmax, of risedronate. Therefore, ACTONEL Tablets may be taken with or without food.

After a single 35 mg oral dose of 14C-risedronate in normal healthy volunteers, approximately 90% of the administered radioactivity was recovered in urine and feces over 10 days, indicating that biliary excretion contributes to the elimination of risedronate. Urinary excretion represents 62% of the dose with fecal excretion representing 28% of the dose.

Metabolism and Excretion

In animal studies, risedronate is not metabolized or excreted as unchanged drug. In rats and dogs administered 14C-labeled risedronate, radioactivity was primarily recovered in the skeleton with small amounts of radioactivity also appearing in the kidney.

Special Populations

Geriatric Patients: The pharmacokinetics of Actonel were similar to those observed in younger subjects.

Pediatric Patients: The pharmacokinetics of Actonel have not been studied in pediatric patients.

Gender: There is no significant difference between the pharmacokinetics of Actonel in males and females.

Renal Impairment: The pharmacokinetics of a single 35 mg oral dose of risedronate were studied in subjects with varying degrees of renal impairment (creatinine clearance 30 to < 80 mL/min, n=8; creatinine clearance 10 to < 30 mL/min, n=8) and compared with those in normal subjects (creatinine clearance ≥ 80 mL/min, n=8). Pharmacokinetic differences due to renal impairment were not significant. Consequently, no dosage adjustment for Actonel is necessary in patients with renal impairment.

Hepatic Impairment: The pharmacokinetics of a single 35 mg oral dose of risedronate were studied in subjects with mild (n=8) and moderate hepatic impairment (n=8) and compared with those in normal subjects (creatinine clearance ≥ 80 mL/min, n=8). Pharmacokinetic differences due to hepatic impairment were not significant. Consequently, no dosage adjustment for Actonel is necessary in patients with mild or moderate hepatic impairment.

Actonel has not been studied in subjects with severe hepatic impairment and is not recommended for use in these patients.

Smoking: The pharmacokinetics of a single 35 mg oral dose of risedronate were studied in smokers (n=8) and compared with those in nonsmokers (n=8). Pharmacokinetic differences due to smoking were not significant. Consequently, no dosage adjustment for Actonel is necessary in patients who smoke.

Drug-Drug Interactions

Antacids: The co-administration of a single 35 mg oral dose of risedronate with an antacid ( aluminum hydroxide/magnesium hydroxide) had no significant effect on the bioavailability of risedronate.

Calcium: The co-administration of a single 35 mg oral dose of risedronate with calcium carbonate (1.25 g) had no significant effect on the bioavailability of risedronate.

Cimetidine: The co-administration of a single 35 mg oral dose of risedronate with cimetidine (400 mg) had no significant effect on the bioavailability of risedronate.

Furosemide: The co-administration of a single 35 mg oral dose of risedronate with furosemide (80 mg) had no significant effect on the bioavailability of risedronate.

Hormone Replacement Therapy: The co-administration of a single 35 mg oral dose of risedronate with conjugated estrogens (0.625 mg) plus medroxyprogesterone acetate (2.5 mg) had no significant effect on the bioavailability of risedronate.

Nonsteroidal Anti-inflammatory Drugs: The co-administration of a single 35 mg oral dose of risedronate with ibuprofen (800 mg) had no significant effect on the bioavailability of risedronate.

Oral Contraceptives: The co-administration of a single 35 mg oral dose of risedronate with an oral contraceptive product (ethinyl estradiol 33 mcg/norgestimate 150 mcg) had no significant effect on the bioavailability of risedronate.

Theophylline: The co-administration of a single 35 mg oral dose of risedronate with theophylline (300 mg) had no significant effect on the bioavailability of risedronate.

Tobacco: The co-administration of a single 35 mg oral dose of risedronate with tobacco had no significant effect on the bioavailability of risedronate.

Sucralfate: The co-administration of a single 35 mg oral dose of risedronate with sucralfate (1 g) had no significant effect on the bioavailability of risedronate.

Side Effects

The most common side effects of Actonel include

  • Nausea
  • Diarrhea
  • Stomach pain or discomfort
  • Headache
  • Muscle pain
  • Dizziness

If you experience any of the following serious side effects, contact your doctor immediately:

  • Black or tarry stools
  • Severe abdominal pain
  • Difficulty breathing

Actonel may also cause other less serious side effects. Talk to your doctor if you experience any unusual problems while taking this medication.

Actonel should not be used by people with the following conditions:

  • Certain allergies (including hypersensitivity to risedronate)
  • Kidney disease
  • Ulcers of the esophagus or stomach

Before taking Actonel, tell your doctor if you have or have ever had kidney disease, ulcers of the esophagus or stomach, or any other medical conditions. You should also tell your doctor if you are pregnant or breastfeeding.

Actonel may interact with other medications. Be sure to tell your doctor about all the prescription and over-the-counter medications you use. Actonel should not be taken with antacids or minerals such as calcium, iron, or magnesium. These products can make it harder for your body to absorb Actonel.

What special precautions should I follow when taking Actonel?

Be sure to take this medication exactly as prescribed by your doctor. Do not take more or less than directed.

Do not stop taking Actonel without first talking to your doctor

Overdose

There is no specific antidote for overdose with risedronate sodium. In the event of an overdose, symptomatic treatment and general supportive measures should be employed. Risedronate sodium is not removed by hemodialysis.