Omnitrope HGH 5.8mg is a recombinant somatropin Human Growth Hormone manufactured by Sandoz Pharmaceuticals, US. It is mainly prescribed by doctors to adults with growth hormone deficiency (AGHD) and elderly patients with age-related hormone imbalance for anti-aging purposes.
In paediatrics, Omnitrope hgh is prescribed for children with growth failure due to growth hormone deficiency (GHD) and Prader-Willi syndrome (diagnosed by genetic testing). It is also indicated for the treatment of SGA – growth failure in children born small for gestational age, failing to catch-up growth by the age of 2, as well as for children that do not grow due to idiopathic short stature (with no known cause) and ones suffering from Turner Syndrome (females with only a single X chromosome). In adults, Omnitrope is used to treat adult onset or childhood onset growth hormone deficiency.
- Omnitrope hgh is contraindicated in children:
- – With acute critical illnesses,
- – With respiratory failure,
- – With cancer/ active malignancy,
- – With active proliferative or non-proliferative diabetic retinopathy,
- – With known hypersensitivity to somatropin,
- – With closed epiphyseal plates,
- – Who are severely obese or with respiratory impairment with Prader-Willi Syndrome,
- – After trauma,
- – Post-surgery.
Before prescribing Omnitrope, doctor should look out for the following:
– Signs of upper airway obstruction and sleep apnoea in children with Prader-Willi Syndrome; if any symptoms arise – treatment should be discontinued;
– Neoplasm: patients with pre-existing tumours should be monitored for progression or recurrence; childhood cancer survivors if treated with somatropin, hold the increased risk of a second neoplasm, especially meningiomas in those treated with radiation to the head for their first neoplasm;
– Glucose levels should be monitored in all patients; in diabetic patients, dosage of concurrent anti-hyperglycaemic may require adjustment as impaired glucose tolerance and diabetes mellitus may get unmasked;
– Intracranial Hypertension may develop; can be reversed by reducing the dose or terminating the treatment;
– Fluid retention – frequent in adults, like oedema, arthralgia or carpal tunnel syndrome. Dose reduction is required in such cases;
– Other hormone replacement therapies should be monitored closely due to an increased risk for hypopituitarism;
– Hypothyroidism can become evident or get worse;
– Children with the onset of a limp or hip/knee pain should be evaluated for slipped capital femoral epiphysis
– Pre-existing scoliosis may worsen
– Pancreatitis should be considered in patients with persistent severe abdominal pain;
Formulations containing BA (benzyl alcohol) should not be used in premature babies or neonates (e.g., 5 mg/1.5 mL Omnitrope + Bacteriostatic Water diluent for the Omnitrope 5.8 mg vial). Once the treatment is started, risks of continuing Omnitrope should be considered if the child has any of the following: scoliosis, diabetes, cancer, hormone deficiencies, trauma, complains about hip or knee pains, limping, or difficulty breathing. Tests for child’s blood glucose and funduscopic examination (an eye test for intracranial hypertension) must be performed before starting the treatment and periodically afterwards. Parents of children, who are treated for Prader-Willi syndrome and start having difficulty breathing, start snoring or their snoring increases, should seek medical advice.
Side effects that may arise after the treatment with Omnitrope hgh include headaches, loss of fatty tissue under the skin (lipoatrophy) or rash at the injection sites.
Drug interaction And Dosage
The weekly dose should be divided over 6 or 7 days of subcutaneous injections.
Therapy with Omnitrope should be supervised by a physician who is experienced in the diagnosis and management of pediatric patients with short stature associated with GHD, Prader-Willi Syndrome (PWS), Turner syndrome (TS), those who were born small for gestational age (SGA), Idiopathic Short Stature (ISS) and adult patients with either childhood onset or adult onset GHD.
2.1 Dosing of Pediatric Patients
General Pediatric Dosing Information
The Omnitrope dosage and administration schedule should be individualized based on the growth response of each patient.
Response to somatropin therapy in pediatric patients tends to decrease with time. However, in pediatric patients, the failure to increase growth rate, particularly during the first year of therapy, indicates the need for close assessment of compliance and evaluation for other causes of growth failure, such as hypothyroidism, undernutrition, advanced bone age and antibodies to recombinant human GH (rhGH).
Treatment with Omnitrope for short stature should be discontinued when the epiphyses are fused.
Pediatric Growth Hormone Deficiency (GHD)
Generally, a dosage of 0.16 to 0.24 mg/kg body weight /week is recommended. The weekly dose should be divided over 6 or 7 days of subcutaneous injections.
Prader-Willi Syndrome (PWS)
Generally, a dosage of 0.24 mg/kg body weight/week is recommended. The weekly dose should be divided over 6 or 7 days of subcutaneous injections.
Small for Gestational Age (SGA)
Generally, a dosage of up to 0.48 mg/kg body weight/week is recommended. The weekly dose should be divided over 6 or 7 days of subcutaneous injections.
Turner Syndrome (TS)
Generally, a dose of 0.33 mg/kg body weight/week is recommended. The weekly dose should be divided over 6 or 7 days of subcutaneous injections.
Idiopathic Short Stature (ISS)
Generally, a dose up to 0.47 mg/kg of body weight/week is recommended. The weekly dose should be divided over 6 or 7 days of subcutaneous injections.
2.2 Dosing of Adult Patients
Adult Growth Hormone Deficiency (GHD)
Based on the weight-based dosing utilized in clinical studies with another somatropin product, the recommended dosage at the start of therapy is not more than 0.04 mg/kg/week given as a daily subcutaneous injection. The dose may be increased at 4- to 8-week intervals according to individual patient requirements to not more than 0.08 mg/kg/week. Clinical response, side effects, and determination of age- and gender-adjusted serum IGF-1 levels may be used as guidance in dose titration.
Store this medication in a refrigerator at 36°F to 46°F (2°C to 8°C). Keep all medicines out of the reach of children. Throw away any unused medicine after the beyond use date. Do not flush unused medications or pour down a sink or drain.