Omnitrope 5 mg/1.5 ml (SC Injection)

1 Kit Pen: ৳ 20,809.68

Medicine Details

Category Details
Generic Somatropin
Company Sandoz a novartis division
Also available as

Indications

  • Treatment of pediatric patients with growth failure due to inadequate secretion of endogenous growth hormone (GH)
  • Treatment of pediatric patients with short stature associated with Noonan syndrome
  • Treatment of pediatric patients with 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
  • Results in intracellular signal transduction and pharmacodynamic effects
  • Produces IGF-I in the liver and locally (e.g., skeletal growth, protein synthesis)
  • Direct effects of somatropin (e.g., lipolysis)

Dosage & Administration

  • Administered subcutaneously
  • Injection sites should be rotated to avoid lipoatrophy
  • Specific dosages for pediatric growth hormone deficiency, Noonan Syndrome, Turner Syndrome, short stature born small for gestational age (SGA), and adult growth hormone deficiency

Interaction

  • Inhibition of 11-Hydroxysteroid Dehydrogenase Type 1 may require glucocorticoid replacement therapy
  • Glucocorticoid Replacement should be carefully adjusted
  • Monitor carefully when used with Cytochrome P450-Metabolized Drugs
  • Larger doses 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
  • No animal reproduction studies conducted with Somatropin
  • Caution when administered to a pregnant or nursing woman

Precautions & Warnings

  • Potential benefit of treatment continuation in Acute Critical Illness should be weighed against potential risk
  • Evaluation for signs of upper airway obstruction and sleep apnea in children with Prader-Willi Syndrome
  • Monitoring preexisting tumors for progression or recurrence
  • Unmasking of Impaired Glucose Tolerance and Diabetes Mellitus
  • Exclusion of preexisting papilledema for Intracranial Hypertension
  • Monitoring for reduced serum cortisol levels in Hypoadrenalism
  • Evaluating children for the onset of a limp or hip/knee pain to detect Slipped Capital Femoral Epiphysis
  • Considering pancreatitis in patients with persistent severe abdominal pain

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

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