Risedronate sodium

What is Risedronate sodium?

• Risedronate sodium is a bisphosphonate used to treat postmenopausal osteoporosis, to increase bone mass in men with osteoporosis, and Paget’s disease.

Risedronate

What are the uses of this medicine?

Risedronate sodium tablets are a prescription medicine used to:

• Treat or prevent osteoporosis in women after menopause. Risedronate sodium tablets help increase bone mass and help reduce the chance of having a spinal or non-spinal fracture (break).
• Increase bone mass in men with osteoporosis.
• Treat or prevent osteoporosis in either men or women who are taking corticosteroid medicines.
• Treat certain men and women who have Paget's disease of the bone.

Limitations of Use:

• It is not known how long risedronate sodium tablets work for the treatment and prevention of osteoporosis.
• You should see your doctor regularly to determine if risedronate sodium tablets are still right for you.
• Risedronate sodium tablets are not for use in children.

How does this medicine work?

• Risedronate has an affinity for hydroxyapatite crystals in bone and acts as an antiresorptive agent.
• At the cellular level, risedronate inhibits osteoclasts.
• The osteoclasts adhere normally to the bone surface, but show evidence of reduced active resorption (for example, lack of ruffled border).

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• Have certain problems with your esophagus, the tube that connects your mouth with your stomach
• Cannot stand or sit upright for at least 30 minutes
• Have low levels of calcium in your blood
• Are allergic to risedronate sodium tablets or any of their ingredients.

What drug interactions can this medicine cause?

• Calcium, antacids, or oral medications containing divalent cations interfere with the absorption of risedronate.

Is this medicine FDA approved?

• It was patented in 1984 and approved for medical use in 1998.

How should this medicine be used?

Recommended dosage: Treatment of Postmenopausal Osteoporosis:

• 5 mg daily, 35 mg once-a-week, 75 mg two consecutive days each month, 150 mg once-a-month

Prevention of Postmenopausal Osteoporosis:

• 5 mg daily, 35 mg once-a-week

Men with Osteoporosis:

• 35 mg once-a-week

Glucocorticoid-Induced Osteoporosis:

• 5 mg daily

Paget’s Disease:

• 30 mg daily for 2 months

Administration:

• Risedronate sodium tablets work only if taken on an empty stomach.
• Take 1 risedronate sodium tablet, after you get up for the day and before taking your first food, drink, or other medicine.
• Take risedronate sodium tablets while you are sitting or standing.
• Do not chew or suck on a tablet of risedronate sodium.
• Swallow risedronate sodium tablet with a full glass (6 to 8 ounces) of plain water only.
• Do not take risedronate sodium tablets with mineral water, coffee, tea, soda, or juice.

After swallowing risedronate sodium tablet, 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 risedronate sodium tablets and after you eat your first food of the day.
• If you miss a dose of risedronate sodium tablets, do not take it later in the day. Take your missed dose the next morning and then return to your normal schedule. Do not take 2 doses at the same time.
• If you miss more than 2 doses of risedronate sodium tablets in a month, call your doctor for instructions.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Tablets: 5, 30, and 35 mg

This medicine is available in fallowing brand namesː

• Actonel, Atelvia, Benet

What side effects can this medication cause?

The most common side effects of this medicine include:

• pain, including back and joint pain
• stomach area (abdominal) pain
• heartburn
• allergic reactions, such as hives, swelling of your face, lips, tongue, or throat

Risedronate sodium tablets may cause serious side effects:

• Esophagus problems
• Low calcium levels in your blood (hypocalcemia)
• Severe jaw bone problems (osteonecrosis)
• Bone, joint, or muscle pain
• Unusual thigh bone fractures

What special precautions should I follow?

• Risedronate, like other bisphosphonates administered orally, may cause local irritation of the upper gastrointestinal mucosa. Instruct patients to follow dosing instructions. Discontinue use if new or worsening symptoms occur.
• Hypocalcemia has been reported in patients taking risedronate. Instruct patients to take supplemental calcium and vitamin D if their dietary intake is inadequate.
• Osteonecrosis of the jaw (ONJ), which can occur spontaneously, is generally associated with tooth extraction and/or local infection with delayed healing, and has been reported in patients taking bisphosphonates, including risedronate. For patients requiring invasive dental procedures, discontinuation of bisphosphonate treatment may reduce the risk for ONJ.
• In postmarketing experience, there have been reports of severe and occasionally incapacitating bone, joint, and/or muscle pain in patients taking bisphosphonates. Consider discontinuing use if severe symptoms develop.
• Severe Bone, Joint, Muscle Pain may occur. Discontinue use if severe symptoms develop.
• Atypical Femur Fractures have been reported. Patients with new thigh or groin pain should be evaluated to rule out a femoral fracture.
• Risedronate is not recommended for use in patients with severe renal impairment (creatinine clearance less than 30 mL/min).
• Bisphosphonates are known to interfere with the use of bone-imaging agents. Specific studies with risedronate have not been performed.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• hypocalcemia
• Decreases in serum calcium and phosphorus

Management of overdosage:

• Milk or antacids containing calcium should be given to bind risedronate and reduce absorption of the drug.
• In cases of substantial overdose, gastric lavage may be considered to remove unabsorbed drug.
• Standard procedures that are effective for treating hypocalcemia, including the administration of calcium intravenously, would be expected to restore physiologic amounts of ionized calcium and to relieve signs and symptoms of hypocalcemia.

Can this medicine be used in pregnancy?

• Available data on the use of risedronate sodium tablets in pregnant women are insufficient to inform a drug-associated risk of adverse maternal or fetal outcomes.
• Discontinue risedronate sodium tablets when pregnancy is recognized.

Can this medicine be used in children?

• Risedronate is not indicated for use in pediatric patients.

What are the active and inactive ingredients in this medicine?

Active ingredient: risedronate sodium Inactive ingredients: colloidal silicon dioxide, corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, pregelatinized corn starch, sodium stearyl fumarate, and titanium dioxide. Additionally, the 5 mg tablets contain D&C yellow #10 lake, iron oxide yellow, and polysorbate 80; the 30 mg tablets contain polysorbate 80; and the 35 mg tablets contain FD&C yellow #6 aluminum lake, iron oxide yellow, iron oxide red, and polysorbate 80.

Who manufactures and distributes this medicine?

Manufactured In Israel By: Teva Pharmaceutical Ind. Ltd. Jerusalem, 9777402, Israel

Manufactured For: Teva Pharmaceuticals USA, Inc. North Wales, PA

What should I know about storage and disposal of this medication?

• Store risedronate sodium tablets at room temperature, (68° to 77°F) 20° to 25°C.

• Dailymed label info on Risedronate sodium
• FDA Risedronate sodium

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