Actonel

 A prescription drug called Actonel is used to both treat and prevent osteoporosis. Bones become brittle and susceptible to breaking due to this condition. Actonel functions by facilitating the body's absorption of calcium, strengthening bones and lowering fracture risk.

This medication is taken once daily, with or without food, and comes in tablet form. Stomach pain, diarrhea, and nausea are typical side effects. Contact your doctor right away if you experience any severe side effects, such as bloody or tarry stools, excruciating stomach pain, or trouble breathing.

Why is Actonel prescribed?

Actonel belongs to the class of medications known as bisphosphonates, which helps to improve bone density and stop bone loss. In postmenopausal women, it is used to treat and prevent osteoporosis. Bones that have osteoporosis become fragile and break easily. The condition Paget's disease, which causes misshapen and easily breakable bones, can also be treated with actonel.

How should Actonel be used?

Actonel is taken once daily, with or without food, and comes in tablet form. It's crucial to take this medication exactly as your doctor has advised. Never take more or less than what is prescribed. Actonel should not be stopped without first consulting your doctor.

Pharmacokinetics

Actonel is administered orally and is quickly and completely absorbed. Risedronate's mean peak plasma concentration (Cmax) happens one to three hours after the dose (Tmax). About 60% of the risedronate in ACTONEL Tablets is bioavailable. Food reduces the amount of risedronate that is absorbed (AUC), but not the Cmax. As a result, you can take ACTONEL Tablets with or without food.

In normal healthy volunteers, 90% of the radioactivity given as a single 35 mg oral dose of 14C-risedronate was recovered in urine and feces over the course of 10 days, indicating that biliary excretion aids in the removal of risedronate. 62% of the dose is excreted through urine, and 28% is excreted through feces.

Metabolism and Excretion

Risedronate is not metabolized or excreted as an unchanged drug in animal studies. When 14C-labeled risedronate was administered to rats and dogs, the skeleton recovered the majority of the radioactivity, with small amounts also showing up in the kidney.

Particular Populations

Elderly Patients: Actonel's pharmacokinetics were comparable to those seen in younger subjects.

Children: The pharmacokinetics of Actonel have not been investigated in children.

Gender: The pharmacokinetics of Actonel in males and females are not significantly different.

Renal Impairment: 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), the pharmacokinetics of a single 35 mg oral dose of risedronate were examined. These results were compared to those in normal subjects (creatinine clearance 80 mL/min, n=8). The effects of renal impairment on pharmacokinetic differences were insignificant. As a result, Actonel dosage does not need to be changed for patients with renal impairment.

Hepatic Impairment: In order to compare the pharmacokinetics of a single 35 mg oral dose of risedronate with those of healthy subjects (creatinine clearance 80 mL/min, n=8), studies were conducted in subjects with mild (n=8) and moderate (n=8) hepatic impairment. Hepatic impairment did not significantly alter pharmacokinetics. As a result, Actonel dosage does not need to be changed.

Actonel is not advised for use in patients who have severe hepatic impairment because it has not been studied in those individuals.

Smoking: Risedronate's pharmacokinetics following a single 35 mg oral dose were examined in smokers (n = 8) and compared to nonsmokers (n = 8) in this study. Smoking-related variations in pharmacokinetics were not significant. As a result, patients who smoke do not require a dosage adjustment for Actonel.

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 Risedronate's bioavailability was unaffected by 1.25 g of calcium carbonate.

Cimetidine: There was no discernible difference in the bioavailability of risedronate when a single oral dose of 35 mg of risedronate was given along with 400 mg of cimetidine.

Risedronate's bioavailability was unaffected by the co-administration of an oral dose of furosemide (80 mg) and a single dose of risedronate (35 mg).

Hormone replacement therapy: There was no appreciable difference in the bioavailability of risedronate following the co-administration of a single 35 mg oral dose of risedronate with conjugated estrogens (0.625 mg) and medroxyprogesterone acetate (2.5 mg).

NSAIDs: The co-administration of a single 35 mg oral dose of risedronate with 800 mg of ibuprofen had no appreciable impact on the bioavailability of risedronate.

Oral contraceptives: Co-administration of a single 35 mg dose of risedronate with an oral contraceptive (ethinyl estradiol 33 mcg/norgestimate 150 mcg) had no appreciable impact on the bioavailability of risedronate.

Theophylline: The co-administration of a single oral risedronate dose of 35 mg with 300 mg of theophylline had no appreciable impact on the risedronate's bioavailability.

Tobacco: The oral administration of a single dose of 35 mg of risedronate had no appreciable impact on the drug's bioavailability.

Sucralfate: The bioavailability of risedronate was unaffected by the co-administration of a single 35 mg oral dose of sucralfate with risedronate.

Side Effects

Actonel's most typical side effects include

• Nausea
• Diarrhea
• discomfort in the stomach
• Headache
• muscle ache
• Dizziness

Contact your doctor right away if you experience any of the following severe side effects:

• Tarry or black stools
• intense stomach pain
• Having trouble breathing

There may be other, less severe side effects from taking Actonel. If you encounter any unusual issues while taking this medication, discuss them with your doctor.

People with the following conditions shouldn't use Actonel:

Some allergies, such as sensitivity to risedronate
kidney illness
stomach or esophageal ulcers
Tell your doctor if you have or have ever had kidney disease, esophageal or stomach ulcers, or any other health issues before taking Actonel. If you are pregnant, you should also let your doctor know.

Actonel and other drugs may interact. Make sure to disclose to your doctor all prescription and non-prescription drugs you take. Antiacids and minerals like calcium, iron, or magnesium shouldn't be taken along with actonel. Your body may have a harder time absorbing Actonel if you use these products.

What special precautions should I follow when taking Actonel?

Make sure to follow your doctor's instructions for taking this medication exactly. Never take more or less than what is prescribed.

Never stop taking Actonel without first consulting your physician.

Overdose

For a risedronate sodium overdose, there is no specific antidote. Symptomatic treatment and general supportive measures should be used in the event of an overdose. Hemodialysis does not remove risedronate sodium.