Norditropin SimpleXx 5 mg/1.5 ml (SC Injection)
1.5 ml cartridge: ৳ 10,440.00
Medicine Details
| Category | Details |
|---|---|
| Generic | Somatropin |
| Company | Novo nordisk pharma pvt ltd |
Indications
- 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
- Treatment of pediatric patients with short stature born small for gestational age (SGA) with no catch-up growth by age 2 to 4 years
- Replacement of endogenous GH in adults with growth hormone deficiency (GHD)
Pharmacology
- Somatropin binds to a dimeric GH receptor in the cell membrane of target cells
- Results in intracellular signal transduction and pharmacodynamic effects
- Effects primarily mediated by IGF-I produced in the liver and locally
Dosage & Administration
- Administered subcutaneously
- Injection sites should be rotated to avoid lipoatrophy
- Dosage varies based on condition (e.g., Pediatric growth hormone deficiency, Noonan Syndrome, Turner Syndrome, Short stature born small for gestational age (SGA), Adult growth hormone deficiency)
Interaction
- Inhibition of 11â-Hydroxysteroid Dehydrogenase Type 1 may require glucocorticoid replacement therapy
- Glucocorticoid Replacement should be carefully adjusted
- Cytochrome P450-Metabolized Drugs should be monitored carefully if used with Norditropin SimpleXx
- Larger doses of Norditropin SimpleXx may be required in women using Oral Estrogen
- Insulin and/or Oral/Injectable Hypoglycemic Agents may require adjustment
Contraindications
- Acute Critical Illness
- Children with Prader-Willi syndrome who are severely obese or have severe respiratory impairment
- Active Malignancy
- Hypersensitivity to somatropin or excipients
- Active Proliferative or Severe Non-Proliferative Diabetic Retinopathy
- Children with closed epiphyses
Side Effects
- Headaches
- Muscle pain
- Joint stiffness
- High blood sugar (hyperglycemia)
- Sugar in urine (glucosuria)
Pregnancy & Lactation
- Pregnancy Category C
- Not known whether Somatropin can cause fetal harm when administered to a pregnant woman
- Not known whether Somatropin is excreted in human milk
Precautions & Warnings
- Acute Critical Illness should be weighed against potential risk
- Evaluate for signs of upper airway obstruction and sleep apnea in children with Prader-Willi Syndrome
- Monitor patients with preexisting tumors for progression or recurrence
- Increased risk of a second neoplasm in childhood cancer survivors treated with Norditropin SimpleXx
- May unmask impaired glucose tolerance and diabetes mellitus
- Periodically monitor glucose levels in all patients
- Exclude preexisting papilledema for Intracranial Hypertension
- Reduce dose for Fluid Retention (edema, arthralgia, carpal tunnel syndrome- especially in adults)
- Monitor patients for reduced serum cortisol levels and/or need for glucocorticoid dose increases in those with known hypoadrenalism
- May first become evident or worsen Hypothyroidism
- Evaluate children with the onset of a limp or hip/knee pain for Slipped Capital Femoral Epiphysis
- May develop in Progression of Preexisting Scoliosis
- Consider pancreatitis in patients with persistent severe abdominal pain for Pancreatitis
Therapeutic Class
- Drugs for Growth failure
Storage Conditions
- Store at 2-8°C
- Do not freeze
- Avoid direct light
- Keep out of reach of children