Forteo20 mcg/80 mcl

Forteo 20 mcg/80 mcl is a parathyroid hormone analog, (PTH 1-34), indicated for: Treatment of postmenopausal women with osteoporosis at high risk for fracture. Increase of bone mass in men with primary or hypogonadal osteoporosis at high risk for fracture. Treatment of men and women with osteoporosis associated with sustained systemic glucocorticoid therapy at high risk for fracture.

Thyroid drugs & hormone

Endogenous 84-amino acid parathyroid hormone (PTH) is the primary regulator of calcium and phosphate metabolism in bone and kidney. Physiological actions of PTH include regulation of bone metabolism, renal tubular reabsorption of calcium and phosphate, and intestinal calcium absorption. The biological actions of PTH and Forteo 20 mcg/80 mcl are mediated through binding to specific high-affinity cell-surface receptors. Forteo 20 mcg/80 mcl and the 34 N-terminal amino acids of PTH bind to these receptors with the same affinity and have the same physiological actions on bone and kidney. Forteo 20 mcg/80 mcl is not expected to accumulate in bone or other tissues. The skeletal effects of Forteo 20 mcg/80 mcl depend upon the pattern of systemic exposure. Once-daily administration of Forteo 20 mcg/80 mcl stimulates new bone formation on trabecular and cortical (periosteal and/or endosteal) bone surfaces by preferential stimulation of osteoblastic activity over osteoclastic activity. In monkey studies, Forteo 20 mcg/80 mcl improved trabecular microarchitecture and increased bone mass and strength by stimulating new bone formation in both cancellous and cortical bone. In humans, the anabolic effects of Forteo 20 mcg/80 mcl manifest as an increase in skeletal mass, an increase in markers of bone formation and resorption, and an increase in bone strength. By contrast, continuous excess of endogenous PTH, as occurs in hyperparathyroidism, may be detrimental to the skeleton because bone resorption may be stimulated more than bone formation.

Treatment of Postmenopausal Women with Osteoporosis at High Risk for Fracture: The recommended dose is 20 mcg subcutaneously once a day. Increase of Bone Mass in Men with Primary or Hypogonadal Osteoporosis at High Risk for Fracture: The recommended dose is 20 mcg subcutaneously once a day. Treatment of Men and Women with Glucocorticoid-Induced Osteoporosis at High Risk for Fracture: The recommended dose is 20 mcg subcutaneously once a day.

Forteo 20 mcg/80 mcl should be administered as a subcutaneous injection into the thigh or abdominal wall. There are no data available on the safety or efficacy of intravenous or intramuscular injection of Forteo 20 mcg/80 mcl. Forteo 20 mcg/80 mcl should be administered initially under circumstances in which the patient can sit or lie down if symptoms of orthostatic hypotension occur Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Forteo 20 mcg/80 mcl is a clear and colorless liquid. Do not use if solid particles appear or if the solution is cloudy or colored. Patients and caregivers who administer Forteo 20 mcg/80 mcl should receive appropriate training and instruction on the proper use of the Forteo 20 mcg/80 mcl delivery device from a qualified health professional

Digoxin: A single Forteo 20 mcg/80 mcl dose did not alter the effect of digoxin on the systolic time interval (from electrocardiographic Q-wave onset to aortic valve closure, a measure of digoxin’s calcium-mediated cardiac effect). However, because Forteo 20 mcg/80 mcl may transiently increase serum calcium, Forteo 20 mcg/80 mcl should be used with caution in patients taking digoxinHydrochlorothiazide: The coadministration of hydrochlorothiazide 25 mg with Forteo 20 mcg/80 mcl did not affect the serum calcium response to Forteo 20 mcg/80 mcl 40 mcg. The effect of coadministration of a higher dose of hydrochlorothiazide with Forteo 20 mcg/80 mcl on serum calcium levels has not been studied Furosemide: Coadministration of intravenous furosemide (20 to 100 mg) with Forteo 20 mcg/80 mcl 40 mcg in healthy people and patients with mild, moderate, or severe renal impairment (CrCl 13 to 72 mL/min) resulted in small increases in the serum calcium (2%) and 24-hour urine calcium (37%) responses to Forteo 20 mcg/80 mcl that did not appear to be clinically important

Do not use Forteo 20 mcg/80 mcl in patients with hypersensitivity to Forteo 20 mcg/80 mcl or to any of its excipients. Reactions have included angioedema and anaphylaxis.

Most common adverse reactions include: arthralgia, pain, and nausea.

There are no available data on Forteo 20 mcg/80 mcl use in pregnant women to evaluate for drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Consider discontinuing Forteo 20 mcg/80 mcl when pregnancy is recognized. It is not known whether Forteo 20 mcg/80 mcl is excreted in human milk, affects human milk production, or has effects on the breastfed infant.

Patients with Paget’s disease of bone, pediatric and young adult patients with open epiphyses, and patients with prior external beam or implant radiation involving the skeleton: Should not be treated with Forteo 20 mcg/80 mcl Treatment duration: Use of Forteo 20 mcg/80 mcl for more than 2 years during a patient’s lifetime is not recommended. Patients with bone metastases, history of skeletal malignancies, metabolic bone diseases other than osteoporosis, or hypercalcemic disorders: Should not be treated with Forteo 20 mcg/80 mcl Laboratory alterations: Forteo 20 mcg/80 mcl may increase serum calcium, urinary calcium, and serum uric acid Urolithiasis: Use with caution in patients with active or recent urolithiasis because of risk of exacerbation Orthostatic hypotension: Transient orthostatic hypotension may occur with initial doses of Forteo 20 mcg/80 mcl.

The Forteo 20 mcg/80 mcl delivery device should be stored under refrigeration at 2 to 8°C at all times. Do not freeze. Do not use Forteo 20 mcg/80 mcl if it has been frozen.

Pediatric Use: The safety and efficacy of Forteo 20 mcg/80 mcl have not been established in any pediatric population. Hepatic Impairment: No studies have been performed in patients with hepatic impairment.

Thyroid drugs & hormone

Endogenous 84-amino acid parathyroid hormone (PTH) is the primary regulator of calcium and phosphate metabolism in bone and kidney. Physiological actions of PTH include regulation of bone metabolism, renal tubular reabsorption of calcium and phosphate, and intestinal calcium absorption. The biological actions of PTH and Forteo 20 mcg/80 mcl are mediated through binding to specific high-affinity cell-surface receptors. Forteo 20 mcg/80 mcl and the 34 N-terminal amino acids of PTH bind to these receptors with the same affinity and have the same physiological actions on bone and kidney. Forteo 20 mcg/80 mcl is not expected to accumulate in bone or other tissues. The skeletal effects of Forteo 20 mcg/80 mcl depend upon the pattern of systemic exposure. Once-daily administration of Forteo 20 mcg/80 mcl stimulates new bone formation on trabecular and cortical (periosteal and/or endosteal) bone surfaces by preferential stimulation of osteoblastic activity over osteoclastic activity. In monkey studies, Forteo 20 mcg/80 mcl improved trabecular microarchitecture and increased bone mass and strength by stimulating new bone formation in both cancellous and cortical bone. In humans, the anabolic effects of Forteo 20 mcg/80 mcl manifest as an increase in skeletal mass, an increase in markers of bone formation and resorption, and an increase in bone strength. By contrast, continuous excess of endogenous PTH, as occurs in hyperparathyroidism, may be detrimental to the skeleton because bone resorption may be stimulated more than bone formation.

There are no available data on Forteo 20 mcg/80 mcl use in pregnant women to evaluate for drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Consider discontinuing Forteo 20 mcg/80 mcl when pregnancy is recognized. It is not known whether Forteo 20 mcg/80 mcl is excreted in human milk, affects human milk production, or has effects on the breastfed infant.

Pediatric Use: The safety and efficacy of Forteo 20 mcg/80 mcl have not been established in any pediatric population. Hepatic Impairment: No studies have been performed in patients with hepatic impairment.