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Omnitrope (1.5ml of 10mg/1.5ml cartridge) Growth failure in children due to inadequate endogenous GH secretion. Children with growth failure due to Prader-Willi Syndrome (PWS). Children with growth failure associated with Turner syndrome (TS). Children with growth failure born small for gestational age (SGA) with no catch-up growth by age 2yrs. Children with idiopathic short stature (ISS) whose epiphyses are not closed. Adults with childhood-onset or adult-onset GH deficiency.
Adult Dosage:
Rotate inj sites. Weight-based: Initially up to max 0.04mg/kg/week given as a daily SC inj; may increase at 4–8 week intervals to max 0.08mg/kg/week. Non-weight based: approx. 0.2mg/day (range: 0.15–0.3mg/day), may increase gradually every 1–2 months by increments of approx. 0.1–0.2mg/day.
Children Dosage:
Rotate inj sites. Weekly dose should be divided over 6 or 7 days of SC injections. GH deficient: 0.16–0.24mg/kg/week. PWS: 0.24mg/kg/week. SGA: up to 0.48mg/kg/week. TS: 0.33mg/kg/week. ISS: up to 0.47mg/kg/week.
OMNITROPE Contraindications:
Acute critical illness due to surgical complications or multiple accidental trauma or those with acute respiratory failure. Closed epiphyses. Active malignancy or growing intracranial tumors. Diabetic retinopathy. History of upper airway obstruction or sleep apnea, severe obesity, or severe respiratory impairment in PWS patients. RELATED PRODUCTS
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OMNITROPE Warnings/Precautions:
Increased mortality in those with acute critical illness (see Contraindications); weigh potential treatment benefit against the potential risk. PWS: evaluate baseline respiratory function; monitor weight and for respiratory infection; interrupt if signs of upper airway obstruction or sleep apnea occurs. History of GHD secondary to intracranial neoplasm: monitor routinely for tumor progression or recurrence. Increased risk of developing malignancies. Monitor for increased growth or malignant changes of preexisting nevi. Diabetes. Hypopituitarism. Hypothyroidism. Scoliosis. TS patients: evaluate for ear disorders (eg, otitis media); monitor for cardiovascular disorders (eg, stroke, aortic aneurysm/dissection, hypertension). Monitor thyroid function, glucose tolerance, and for intracranial hypertension (do baseline and periodic funduscopic exams). Hypoadrenalism: monitor for reduced serum cortisol levels. Elderly. Pregnancy (Cat.B). Nursing mothers.
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