Actonel Once-a-Month/Actonel Once-a-Week

Actonel Once-a-Month/Actonel Once-a-Week

risedronic acid

Manufacturer:

Balkanpharma Dupnitsa AD

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Risedronate Na
Indications/Uses
Postmenopausal & established postmenopausal osteoporosis to reduce risk of vertebral & hip fractures, respectively. Actonel Once-a-Week Prevention of osteoporosis in postmenopausal women w/ increased risk of osteoporosis. To maintain or increase bone mass in postmenopausal women undergoing long-term (>3 mth) systemic corticosteroid treatment at doses of prednisone >7.5 mg/day or equiv. To increase bone mass in men w/ osteoporosis.
Dosage/Direction for Use
Osteoporosis Actonel Once-a-Month 1 tab once mthly, to be taken on the same date each mth. Actonel Once-a-Week 1 tab once wkly, to be taken on the same day each wk.
Administration
Should be taken on an empty stomach: To be taken at least 30 min before the 1st food/drink/medication of the day. Take w/ a full glass (≥120 mL) of plain water while in an upright position. Do not lie down for at least 30 min after taking. Swallow whole, do not chew/crush/suck.
Contraindications
Hypersensitivity. Hypocalcemia. Inability to stand or sit upright for at least 30 min. Actonel Once-a-Week Severe renal impairment (CrCl <30 mL/min). Pregnancy & lactation.
Special Precautions
Concomitant use w/ food, certain medication & beverages (except plain water). Patients w/ history of oesophageal disorders; upper GI disease or concomitant use of NSAIDs or aspirin. Correct hypocalcaemia; effectively treat bone & mineral metabolism dysfunction (eg, vit D deficiency & parathyroid abnormalities) prior to starting therapy. Supplemental Ca & vit D should be given if dietary intake is inadequate. May cause local irritation of the upper GI mucosa. Osteonecrosis of the jaw, generally associated w/ tooth extraction &/or local infection (including osteomyelitis) in patients w/ cancer receiving treatments including primarily intravenously administered bisphosphonates; chemotherapy & corticosteroids; patients w/ osteoporosis receiving oral bisphosphonates. Perform dental exam w/ appropriate preventive dentistry prior to treatment; avoid invasive dental procedures while on treatment. Atypical subtrochanteric & diaphyseal femoral fractures. Patient w/ a history of bisphosphonate exposure who presents w/ thigh or groin pain should be suspected of having an atypical fracture & should be evaluated to rule out a femur fracture. Known to interfere w/ the use of bone-imaging agents. Small asymptomatic decreases in serum Ca & P levels. Not recommended for use in patients w/ severe renal impairment (CrCl <30 mL/min). Pregnancy & lactation. Childn <18 yr.
Adverse Reactions
Abdominal & muscular pain. Actonel Once-a-Week Bone & joint pain, dyspepsia, nausea, headache.
Drug Interactions
Impaired absorption w/ polyvalent cations (eg, Ca, Mg, Fe, Al, antacids). Concomitant use w/ ≥2 bisphosphonates.
ATC Classification
M05BA07 - risedronic acid ; Belongs to the class of bisphosphonates. Used in the treatment of bone diseases.
Presentation/Packing
Form
Actonel Once-a-Week FC tab 35 mg
Packing/Price
4's
Form
Actonel Once-a-Month FC tab 150 mg
Packing/Price
1's
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