Sondelbay

Osteoporosis in postmenopausal women & in men at increased risk of fracture; associated w/ sustained systemic glucocorticoid therapy in women & men at increased risk for fracture.

Adult 20 mcg once daily by SC inj in thigh or abdomen. Max total duration of treatment: 24 mth.

Hypersensitivity. Pre-existing hypercalcaemia, metabolic bone diseases (including hyperparathyroidism & Paget's disease of bone) other than primary osteoporosis or glucocorticoid-induced osteoporosis. Unexplained elevations of alkaline phosphatase. Prior external beam or implant RT to skeleton. Exclude patients w/ skeletal malignancies or bone metastases from treatment. Severe renal impairment. Pregnancy & lactation.

Slight & transient elevations of serum Ca conc following administration; increased urinary Ca excretion. Caution in patients w/ active or recent urolithiasis. Isolated episodes of transient orthostatic hypotension. Do not repeat 24-mth course of treatment over patient's lifetime. Increased incidence of osteosarcoma w/ long-term administration. Do not exceed recommended treatment time of 24 mth until further clinical data become available. Advise patients experiencing transient orthostatic hypotension or dizziness to refrain from driving or use of machines. Hepatic impairment. Moderate renal impairment. Use effective methods of contraception during use in women of childbearing potential. Experience is limited & initiate treatment only if benefit clearly outweighs risks in younger adult population (>18-29 yr), including premenopausal women. Discontinue use if pregnancy occurs. Safety & efficacy has not been established in childn & adolescents <18 yr. Not to be used in paed patients <18 years, or young adults w/ open epiphyses.

Pain in limb. Anaemia; hypercholesterolaemia; depression; dizziness, headache, sciatica, syncope; vertigo; palpitations; hypotension; dyspnoea; nausea, vomiting, hiatus hernia, GERD; increased sweating; muscle cramps; fatigue, chest pain, asthenia, mild & transient inj site events including pain, swelling, erythema, localised bruising, pruritus & minor bleeding at inj site.

Transiently increases serum Ca, use w/ caution in patients taking digitalis.

Agents Affecting Bone Metabolism

H05AA02 - teriparatide ; Belongs to the class of parathyroid hormones and analogues. Used in the management of calcium homeostasis.

Rx