NORDITROPIN FLEXPRO 5MG/1.5ML
PRODUCT DESCRIPTION :
NORDITROPIN Flexpro is human growth hormone replacement therapy that can be used to help compensate for low levels of growth hormone. NORDITROPIN Flexpro is exactly like the natural growth hormone produced by the body’s pituitary gland.
Pediatric Patients :
NORDITROPIN is indicated for the treatment of pediatric patients with:
growth failure due to inadequate secretion of endogenous growth hormone (GH),
short stature associated with Noonan syndrome,
short stature associated with Turner syndrome,
short stature born small for gestational age (SGA) with no catch-up growth by age 2 years to 4 years of age,
Idiopathic Short Stature (ISS), height standard deviation score (SDS) <-2.25, and associated with growth rates unlikely to permit attainment of adult height in the normal range,
growth failure due to Prader-Willi syndrome (PWS).
Adult Patients :
NORDITROPIN flexpro is indicated for the replacement of endogenous GH in adults with growth hormone deficiency (GHD)
SIDE EFFECTS :
Headache, nausea, vomiting, fatigue, muscle pain, or weakness may occur. If these symptoms continue or become bothersome, inform your doctor or pharmacist promptly.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: development of a limp, persistent fatigue, unusual/unexplained weight gain, persistent cold intolerance, persistent slow heartbeat, fast heartbeat, ear pain/itching, hearing problems, joint/hip/knee pain, numbness/tingling, unusual increase in thirst or urination, swelling hands/ankles/feet, change in the appearance or size of any mole, persistent nausea/vomiting, severe stomach/abdominal pain.Get medical help right away if you have any very serious side effects, including: vision problems/changes, seizure, severe headache.Rare (possibly fatal) lung/breathing problems may be caused by this medication in children with Prader-Willi syndrome. Those at higher risk include males, severely overweight children, or those with serious lung/breathing problems ( e.g., sleep apnea, lung infections, lung disease). Children should be checked for certain breathing problems (upper airway obstruction) before and during treatment. Heavy snoring or irregular breathing during sleep (sleep apnea) are signs of airway obstruction. Tell the doctor right away if these signs occur. Also report any signs of lung infection, such as fever, persistent cough, or trouble breathing.Somatropin may increase your risk of getting a tumor or cancer. Discuss the details and the risks and benefits of this medication with your doctor.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any of the following symptoms of a serious allergic reaction: rash, itching/severe swelling (especially of the face/tongue/throat), dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
The dose for children depends on their body weight and body surface area. Later in life, the dose depends on your height, weight, gender, and growth hormone sensitivity and will be adjusted until you are on the right dose.
Children with low production or lack of growth hormone:
The usual dose is 0.025 to 0.035 mg per kg body weight per day or 0.7 to 1.0 mg per m2 body surface area per day
Children with Turner syndrome:
The usual dose is 0.045 to 0.067 mg per kg body weight per day or 1.3 to 2.0 mg per m2 body surface area per day.
Children with kidney disease:
The usual dose is 0.050 mg per kg body weight per day or 1.4 mg per m² body surface area per day
Children born small for gestational age (SGA):
The usual dose is 0.035 mg per kg body weight per day or 1.0 mg per m2 body surface area per day until final height is reached. (In clinical trials of short children born SGA doses of 0.033 and 0.067 mg per kg body weight per day have typically been used)
Adults with low production or lack of growth hormone:
If your growth hormone deficiency continues after completion of growth, treatment should be continued. The usual starting dose is 0.2 to 0.5 mg per day. Dose will be adjusted until you are on the right dose. If your growth hormone deficiency starts during adult life, the usual starting dose is 0.1 to 0.3 mg per day. Your doctor will increase this dose each month until you are getting the dose you need. The usual maximum dose is 1.0 mg per day.