Medically reviewed on December 1, Omnitrope somatropin injection is indicated for the treatment of children with growth failure due to inadequate secretion of endogenous growth hormone GH. Antibacterial soap open sore somatropin injection is indicated for the treatment of pediatric patients who have growth failure due to Prader-Willi Syndrome PWS.
The diagnosis of PWS should be confirmed by appropriate genetic testing [see Contraindications 4. Omnitrope somatropin injection is indicated for the treatment of growth failure in children born small for gestational age SGA who fail to manifest catch-up growth by age 2 years.
Omnitrope somatropin injection is indicated for the treatment of growth failure associated with Turner syndrome. Omnitrope somatropin injection is viagra doses and effects for the replacement of endogenous GH in adults with growth hormone deficiency GHD who meet either of the following two criteria:. Patients who were treated with somatropin for growth hormone deficiency in childhood and whose epiphyses are growth hormones injected into animals pro should be reevaluated before continuation of somatropin therapy at the reduced dose level recommended for growth hormone deficient adults.
Confirmation of the diagnosis of adult growth hormone deficiency in growth hormones injected into animals pro groups involves an appropriate growth hormone provocative test with two exceptions: The weekly dose should be divided over 6 or 7 days of subcutaneous injections. The Omnitrope dosage and administration schedule should be individualized based on the growth response of each vitamins and minerals of cranberries. Response to somatropin therapy in pediatric patients tends to decrease with time.
However, growth hormones injected into animals pro, in pediatric patients, the failure to increase growth rate, particularly during the first year of therapy, indicates the need for animal diet lesson plans 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.
Generally, a dosage of 0. Generally, a dosage of up to 0. Generally, a dose of 0. Generally, a dose up to 0. 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. Lincocin for animals dose may be increased at 4- to 8-week intervals according to individual patient requirements to not more than 0.
Clinical response, side effects, and determination of age- and gender-adjusted serum IGF-1 levels may be used as guidance in dose titration, growth hormones injected into animals pro.
Alternatively, taking into account recent literature, a starting dose of approximately 0. This dose can be increased gradually every months by increments of approximately 0. Maintenance dosages vary considerably from person to person. A lower starting dose and smaller dose increments should be considered for older patients, who are more prone to the adverse effects of somatropin than younger individuals.
In addition, obese individuals are more likely to manifest adverse effects when treated with a weight-based regimen.
In order to reach the defined treatment goal, estrogen-replete women may need higher doses than men. Oral estrogen administration may increase the dose requirements in women. Each cartridge of Omnitrope must be inserted into its corresponding Omnitrope Pen 5 or Omnitrope Pen 10 delivery system. Once the diluent is added to the lyophilized powder, growth hormones injected into animals pro, swirl gently; do not shake.
Shaking may cause denaturation of the active ingredient. Parenteral drug products should always be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Use it only if it is clear and colorless. Growth hormones injected into animals pro and caregivers who will administer Omnitrope in medically unsupervised situations should receive appropriate training and instruction on the proper use of Omnitrope from the physician or other suitably qualified health professional. The dosage of Omnitrope must be adjusted for the individual patient.
The dose should be given daily by subcutaneous injections administered preferably in the evening. Omnitrope may be given in the thigh, buttocks, or abdomen. Treatment with pharmacologic amounts of somatropin is contraindicated in patients with acute critical illness due to complications following open heart surgery, growth hormones injected into animals pro, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure [see Warnings and Precautions 5.
Somatropin is contraindicated in patients with Prader-Willi Syndrome who are severely obese, have a history of upper airway obstruction or sleep apnea, or have severe respiratory impairment. There have been reports of sudden death when somatropin was used in such patients [see Warnings and Precautions 5.
In general, somatropin is contraindicated in the presence of active malignancy. Any preexisting malignancy should be inactive and its treatment complete prior to instituting therapy with somatropin. Somatropin should be discontinued if there is evidence of recurrent activity. Since GHD may be an early sign of the presence of a pituitary tumor or, rarely, other brain tumorsthe presence of such tumors should be ruled out prior to initiation of treatment.
Somatropin should not be used in patients with any evidence of progression or recurrence of an underlying intracranial tumor [see Warnings and Precautions 5. Omnitrope is contraindicated in patients with a known hypersensitivity to somatropin or any of its excipients. Systemic hypersensitivity reactions have been reported with postmarketing use of somatropin products [see Warnings and Precautions 5.
Somatropin is contraindicated in patients with active proliferative or severe non-proliferative diabetic retinopathy. Increased mortality in patients with acute critical illness due to complications following open heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure has been reported after treatment with pharmacologic amounts of somatropin [see Contraindications 4 ].
The safety of continuing somatropin treatment in patients receiving replacement doses for approved indications who concurrently develop these illnesses growth hormones injected into animals pro not been established. Therefore, the potential benefit of treatment continuation with somatropin in patients experiencing acute critical illnesses should be weighed against the potential risk.
There have been reports of fatalities after initiating therapy with somatropin in pediatric patients with Prader-Willi Syndrome who seroquil and prozac one or more of the following risk factors: Male patients with one or more of these factors may be at greater risk than females. Patients with Prader-Willi Syndrome should be evaluated for signs of upper airway obstruction including onset of or increased snoring and sleep apnea before initiation of treatment with somatropin.
All patients with Prader-Willi Syndrome treated with somatropin should also have effective weight control and be monitored for signs of respiratory infection, which should be diagnosed as early as possible and treated aggressively [see Contraindications 4 ]. Intracranial tumors, in particular meningiomas, were the most common of these second neoplasms.
In adults, it is unknown whether there is any relationship between somatropin replacement therapy and CNS tumor recurrence [see Contraindications 4.
Monitor all patients with a history of GHD secondary to an intracranial growth hormones injected into animals pro routinely while on somatropin therapy for progression or recurrence of the tumor [see Contraindications 4 ].
Because children with certain rare genetic causes of short stature have an increased risk of developing malignancies, practitioners should thoroughly consider the risks and benefits of starting somatropin in these patients.
If treatment with somatropin is initiated, these patients should be carefully monitored for development of neoplasms. Monitor patients on somatropin therapy carefully for increased growth, or potential malignant changes, of preexisting nevi. Treatment with somatropin may decrease insulin sensitivity, particularly at higher doses in susceptible patients. As a result, previously undiagnosed impaired glucose tolerance and overt diabetes mellitus may be unmasked, and new onset type 2 diabetes mellitus has been reported in patients taking somatropin.
Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus, such as obesity, Turner Syndrome, or a family history of diabetes mellitus.
Patients with preexisting type 1 or type 2 diabetes mellitus or impaired glucose tolerance should be monitored closely during somatropin therapy. The doses of antihyperglycemic drugs i. Symptoms usually occurred within the first eight 8 weeks after the initiation of somatropin therapy.
In all reported cases, IH-associated signs and symptoms rapidly resolved after cessation of therapy or a reduction of the somatropin dose. Funduscopic examination should be performed routinely before initiating treatment with somatropin to exclude preexisting papilledema, and periodically during the course of somatropin therapy. If papilledema is observed by funduscopy during somatropin treatment, treatment should be stopped. If somatropin-induced IH is diagnosed, growth hormones injected into animals pro, treatment with somatropin can be restarted at a lower dose after IH-associated signs and symptoms have resolved.
Serious systemic hypersensitivity reactions includinganaphylactic reactions and antioedema have been reported with postmarketing use of somatropin products, growth hormones injected into animals pro.
Patients and caregivers should be informed that such reactions are possible and that prompt medical attention should be sought if an allergic reaction occurs [see Contraindications 4 ]. Fluid retention during somatropin replacement therapy in adults may frequently occur. Clinical manifestations of fluid retention e. In addition, patients treated with glucocorticoid replacement for previously diagnosed hypoadrenalism may require an increase in their maintenance or stress doses following initiation of somatropin treatment [see Section 7, growth hormones injected into animals pro.
Patients with Turner syndrome have an inherently increased risk of developing autoimmune thyroid disease and primary hypothyroidism and should have their thyroid function checked prior to initiation of somatropin therapy. In patients with GHD, central secondary hypothyroidism may first become evident or worsen during somatropin treatment, growth hormones injected into animals pro.
Therefore, patients treated with somatropin should have periodic thyroid function tests and thyroid hormone replacement therapy should be initiated or appropriately adjusted when indicated. Slipped capital femoral epiphysis may occur more frequently in patients with endocrine disorders water and soulable vitamins GHD and Turner syndrome or in patients undergoing rapid growth. Any pediatric patient with the onset of a limp or complaints of hip or knee pain during somatropin therapy should be carefully evaluated.
Progression of scoliosis can occur in patients who experience rapid growth. Because somatropin increases growth rate, patients with a history of scoliosis who are treated with somatropin should be monitored for progression of scoliosis. However, somatropin has not been shown to increase the occurrence of scoliosis. Skeletal abnormalities including scoliosis are commonly seen in untreated Turner syndrome patients.
Scoliosis is also commonly growth hormones injected into animals pro in untreated patients with Prader-Willi Syndrome. Physicians should be alert to these abnormalities, which may manifest during somatropin therapy. Patients with epiphyseal closure who were treated with somatropin replacement therapy in childhood should be reevaluated according to the criteria in Indications and Usage 1.
Patients with Turner syndrome should be evaluated carefully for otitis media and other ear disorders since these patients have an increased risk of ear and hearing disorders. Somatropin treatment may increase the occurrence of otitis media in patients with Turner syndrome. In addition, patients with Turner syndrome should be monitored closely for cardiovascular disorders e. When somatropin is administered subcutaneously at the same site over a long period of time, tissue atrophy may result.
This can growth hormones injected into animals pro avoided by rotating the injection site [see Dosage and Administration 2.
Serum levels of inorganic phosphorus, growth hormones injected into animals pro, alkaline phosphatase, parathyroid hormone PTH and IGF-1 may increase after somatropin therapy. Cases of pancreatitis have been reported rarely in children and adults receiving somatropin treatment, with some evidence supporting a greater risk in children compared with adults. Published literature indicates that girls who have Turner syndrome may be at greater risk than other somatropin-treated children. Pancreatitis should be considered in any somatropin treated patient, especially a child, who develops persistent severe abdominal pain.
Additional symptoms may include gradual neurological deterioration, seizures, intracranial hemorrhage, hematologic abnormalities, skin breakdown, hepatic and renal failure, hypotension, bradycardia, and cardiovascular collapse.
Practitioners administering this and other medications provera and birth defects benzyl alcohol should consider the combined daily metabolic load of benzyl alcohol from all sources.
The following important adverse reactions area also described elsewhere in labeling:.