Registered Botswana · BoMRA

NORDITROPIN® NORDIFLEX®

somatropin

BOT2304043 SOLUTION FOR INJECTION INN generic

What it does

Somatropin is a growth hormone used to treat growth disorders.

Commonly used for: growth hormone deficiency, chronic kidney disease, Turner syndrome, Prader-Willi syndrome

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Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Medicine sourcing is available in Kenya only. We don't sell or dispense medicines - licensed pharmacies do.

Sourcing - Kenya only

Registration & product details

Registration no.
BOT2304043
Registration date
2023-06-01
Expiry date
-
Status
Registered/Compliant
Active ingredient
somatropin
Strength
-
Pack size
-
Therapeutic class
-
Manufacturer / MAH
Novo Nordisk
Country of origin
Kenya

Source: Botswana Medicines Regulatory Authority · fetched 2026-04-15 20:42:50 · updated 2026-05-12 08:03:27

Drug Interactions

1
Check interactions

Unknown (1)

Somatropin - decreases effects

Corticosteroidsarepredictedtodecreasetheeffectsof somatropin.oTheoretical

Unknown Theoretical

Data from BNF 85 (British National Formulary). This is not a substitute for professional medical advice. Matched via: exact

Disclaimer: This information is sourced from Botswana Medicines Regulatory Authority (Botswana). Always consult a qualified healthcare professional before using any medication.

About this medicine

Somatropin is a growth hormone used to treat growth disorders.

What it treats

  • growth hormone deficiency
  • chronic kidney disease
  • Turner syndrome
  • Prader-Willi syndrome

How it works

Somatropin helps the body grow and develop by increasing the production of growth hormone.

Who it's for

It is for children and adults who have growth problems due to hormone deficiencies or certain medical conditions.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: Somatropin

BNF-referenced

Somatropin is a recombinant form of human growth hormone, primarily used to treat growth hormone deficiencies in children and adults. It stimulates growth and has metabolic effects, including promoting protein synthesis, increasing fat utilization, and influencing carbohydrate metabolism. Somatropin is also utilized in specific conditions like Turner syndrome and in patients with insufficient growth hormone levels due to pituitary gland disorders.

Indications

  • Growth hormone deficiency in children
  • Turner syndrome
  • Chronic kidney disease in children
  • Prader-Willi syndrome
  • Short stature due to other genetic conditions
  • Growth hormone deficiency in adults
  • Acromegaly (as adjunct therapy)
  • Cachexia associated with chronic diseases

Dosage

Children: For children, the recommended dose is generally 0.025 to 0.035 mg/kg/day, with specific adjustments based on individual growth patterns and clinical indications.

Adults: Initial dose is typically 0.2 to 0.5 mg/day, with adjustments made based on clinical response and serum IGF-1 levels.

Mechanism of action

Somatropin acts by mimicking the action of natural growth hormone released from the anterior pituitary gland. It binds to growth hormone receptors on target tissues, particularly in the liver, muscle, and fat, leading to increased production of insulin-like growth factor 1 (IGF-1). This process stimulates growth, enhances protein synthesis, and promotes lipolysis while reducing adiposity.

Pharmacodynamics

Somatropin exhibits anabolic effects on muscle and body composition, promoting growth in children. It increases the rate of protein synthesis and muscle mass while enhancing lipolysis and reducing fat mass. Additionally, it aids in maintaining normal blood glucose levels and influences the metabolism of carbohydrates and fats.

Pharmacokinetics

Somatropin is administered subcutaneously or intramuscularly, with peak plasma concentrations occurring approximately 12 hours post-injection. It has a half-life of about 20-30 minutes, although its metabolic effects persist due to the prolonged action of IGF-1. Somatropin is metabolized primarily in the liver and kidneys, with excretion occurring through urine. Variability in absorption and clearance can occur based on injection site and preparation used.

Contra-indications

  • Hypersensitivity to somatropin or any of its excipients
  • Active malignancy
  • Acute critical illness due to complications following open heart surgery, abdominal surgery, multiple accidental trauma or acute respiratory failure
  • Prader-Willi syndrome in patients with severe obesity or respiratory impairment
  • Idiopathic intracranial hypertension
  • Diabetic retinopathy
  • Severe obesity
  • Severe respiratory impairment

Adverse effects

  • Headache
  • Nausea
  • Vomiting
  • Myalgia
  • Oedema
  • Paraesthesia
  • Gynaecomastia
  • Hyperglycaemia
  • Hypothyroidism
  • Osteonecrosis of femur
  • Slipped capital femoral epiphysis
  • Pancreatitis
  • Intracranial hypertension
  • Visual problems
  • Papilloedema

Interactions

  • Corticosteroids may decrease the effects of somatropin
  • Insulin or oral hypoglycaemics may require dosage adjustments due to the effect of somatropin on glucose metabolism

Precautions

  • Monitor liver function tests prior to and during treatment, especially in children born small for corrected gestational age
  • Assess thyroid function periodically
  • Monitor serum IGF-I concentrations
  • Funduscopy recommended if severe headache or visual problems occur to rule out papilloedema
  • Use caution in patients with underlying conditions that may be exacerbated by fluid retention

Pregnancy

Discontinue if pregnancy occurs. No adequate studies are available in pregnant women, and animal studies have shown adverse effects.

Breast-feeding

No information available. It is unlikely to be excreted in breast milk, but caution is advised.

Storage

Store in a refrigerator (2°C to 8°C). Do not freeze. Protect from light. After reconstitution, the solution should be used immediately or stored in a refrigerator and used within a specified time frame as per manufacturer’s guidelines.

Formulations

  • Powder and solvent for solution for injection
  • Prefilled pens
  • Vials for injection
BNF 85 (British National Formulary) p.837 BNF for Children 2019-2020 p.514 PubChem / pathway

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

This drug in other countries

The same active ingredient registered across other registries we cover - including different brands.