NUTROPIN therapy does not apply to:
Patients with severe complications after open heart surgery, abdominal surgery, severe damage to multiple body systems, or life-threatening respiratory problems.Deaths have been reported in this case
Children with prader-willi syndrome (PWS) who are overweight or have a history of severe respiratory problems.Children with PWS have been reported to be overweight, have a history of upper airway obstruction, sleep apnea (sleep apnea), or other severe respiratory problems
Patients with active cancer.Because somatropin deficiency can be an early sign of certain tumors in the brain or pituitary gland, doctors should rule out these types of tumors before starting treatment with nodopin
Patients who are allergic to growth hormone, which is the active ingredient in the treatment, or the inactive ingredient in the treatment
An adult or child with some type of eye disease caused by diabetes
Bones grow out in children and adolescents
What should you tell your doctor before starting treatment?
If you’re taking cyclosporine, hormone replacement therapy, insulin or other diabetes medications, steroid-containing medications, or epilepsy medications.These drugs may need to be adjusted during Nutropin’s treatment
If you had cancer as a child.Patients treated with notrepine have been reported to have an increased risk of developing new tumors, especially some brain tumors.If you have a pre-existing tumor or abnormal tissue in the brain caused by a growth hormone deficiency, you should keep an eye out for deterioration or recurrence
If you have diabetes, risk factors for diabetes, or impaired glucose tolerance.If so, your doctor should monitor your blood sugar closely during treatment.New cases of type 2 diabetes have been reported in patients taking notrepine
If you have a pituitary hormone deficiency (the pituitary gland doesn’t produce enough hormones) or an adrenal hormone deficiency (the adrenal gland doesn’t produce enough hormones, mainly cortisol).When you are treated with notrepine, your doctor may further closely monitor your hormone levels or hormone replacement therapy
If you are pregnant, lactating, or planning to become pregnant.It is not clear whether notrepine is excreted in breast milk.Notrepine should be used during pregnancy only when it is clearly needed
If you experience any of the following, please contact your doctor immediately:
Changes in upper airway obstruction (including increased or increased snoring) and/or new sleep apnea in PWS patients.These patients should also keep their weight under control and have their doctors monitor them for signs of respiratory infection
Vision change, headache, nausea, vomiting or no vomiting.This could be a sign of increased stress in the brain
Any allergic reaction after the injection of notripine
Claudication or pain in the hip or knee
Hip bulb fractures can occur in children with endocrine problems and in children with rapid growth
Children with growth failure due to chronic kidney disease should be regularly examined for signs of bone mineral loss.These children should undergo a hip X-ray before receiving notrepine treatment
The progression of scoliosis (curvature of the spine) may occur in rapidly growing children.Notrepine treatment did not show an increase in this condition
Elevated serum levels of inorganic phosphorus, alkaline phosphatase, parathyroid hormone (PTH) or igf-1 were detected in the laboratory
Abdominal pain.Few cases of pancreatitis (inflammation of the pancreas) have been reported in children and adults treated with notrepine
Other important information about notripine
Adults can retain water during Nutropin therapy.This may be transient, but may increase with higher doses of notrepine
Thyroid function should be regularly checked during notripine therapy.Thyroid hormone therapy may require initiation or adjustment
Patients should be injected each time at a different recommended location in the body to avoid tissue rupture.A doctor or nurse should provide injection training and supervise the first injection
Notrepine has not been studied in patients over the age of 65.Older patients may be more sensitive to notripine treatment and may have more side effects
Patients with Turner syndrome should be closely monitored for ear infections and cardiovascular problems during treatment with notripine
What are the common side effects of notrepine treatment?
Common side effects of notrepine therapy in adults and children include injection-site reactions.Other common side effects in adults include swelling, joint pain and carpal tunnel syndrome.
You can report side effects to the FDA through (800) fda-1088 or www.FDA.gov/med
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