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Somatropin information from DrugsUpdate  

See Available Brands of Somatropin in India

P - Caution when used during pregnancy

Growth hormone (GH) is a protein-based peptide hormone. It stimulates growth, cell reproduction and regeneration in humans and other animals. Growth hormone is a 191-amino acid, single-chain polypeptide which is synthesized, stored, and secreted by the somatotroph cells within the lateral wings of the anterior pituitary gland. Somatotropin refers to the growth hormone produced natively and naturally in animals, whereas the term somatropin refers to growth hormone produced by recombinant DNA technology, and is abbreviated "HGH" in humans.

Pharmacodynamics

Mimics actions of naturally occurring growth hormone (GH) to stimulate linear and skeletal growth; increases number and size of skeletal muscle cells; increases RBC mass and internal organ size; increases cellular protein synthesis; reduces body fat stores and lipid mobilization, and increases plasma fatty acids.

Pharmacokinetics

Absorption
Somatropin C max with concentrations of 5.3 mg/mL is approximately 23 ng/mL. C max with concentrations of 1.3 mg/mL is approximately 17.4 ng/mL. Following a 0.03 mg/kg subcutaneous injection of Genotropin 1.3 mg/mL, about 80% was systemically available compared with that available following IV dosing.
Norditropin
Following a subcutaneous injection of 0.024 mg/kg, the C max was 13.8 ng/mL 4 to 5 h postdose.
Omnitrope
Following a subcutaneous injection of a single dose of 5 mg, the C max and T max are 74 mcg/L and 4 h, respectively.
Distribution
Vd is approximately 1.3 L/kg.
Metabolism
Somatropin undergoes classical protein catabolism in both liver and kidneys.
Elimination
The half-life is approximately 0.4 h (IV) and approximately 3 h (subcutaneous). Mean Cl of subcutaneous administration is about 0.3 L/h/kg.

Somatropin Indications / Somatropin Uses

Information Not Available

Somatropin Adverse Reactions / Somatropin Side Effects

Cardiovascular
Hypertension (8%); tachycardia, vasodilatation (1% to less than 10%); dependent edema (1% to less than 5%).
CNS
Headache (18%); paresthesia (17%); dizziness, hypoesthesia (7%); asthenia, fatigue, hypesthesia (6%); insomnia, phantom pain (1% to less than 10%); anorexia, anxiety, hypertonia, somnolence, peripheral neuropathy (1% to less than 5%); intracranial hypertension; intracranial tumors, particularly meningiomas; malaise.
Dermatologic
Acne (6%); alopecia, bullous eruption, skin disorder (1% to less than 10%); maculopapular rash, rash, verruca (1% to less than 5%); growth of existing nevi (rare); pruritus.
EENT
Otitis media (86%); ear disorders (18%); pharyngitis (14%); visual field defect (1% to less than 10%); conjunctivitis (1% to less than 5%); diabetic retinopathy, ear or hearing symptoms.
GI
Nausea (9%); gastroenteritis (8%); melena, mouth disorder, rectal hemorrhage, steatorrhea (1% to less than 10%); abdominal pain, constipation, dyspepsia, vomiting (1% to less than 5%); acute pancreatitis, dry mouth, flatulence, hemorrhoids, pancreatitis in children, tenesmus (postmarketing).
Genitourinary
Gynecomastia (8%); gastritis (6%); abnormal urine, breast enlargement, dysuria, UTI, vaginal fungal infection (1% to less than 10%); male breast neoplasm, renal calculus (1% to less than 5%); female breast pain; gynecomastia in children (postmarketing).
Hematologic-Lymphatic
Eosinophilia (12%); decreased prothrombin, purpura (1% to less than 10%); lymphadenopathy (1% to less than 5%); leukemia (postmarketing).
Local
Injection-site inflammation, injection-site pain (1% to less than 10%); lipoatrophy, rash.
Metabolic-Nutritional
Hypothyroidism (16%); hyperlipidemia (8%); abnormal glucose tolerance (6%); hypertriglyceridemia (5%); hypomagnesemia (1% to less than 10%); hyperglycemia, periorbital edema (1% to less than 5%); dehydration, fluid retention.
Musculoskeletal
Arthralgia (36%); myalgia (30%); arthralgia and joint disorders (27%); scoliosis (19%); pain in the extremities (15%); arthrosis, back pain, skeletal pain (11%); stiffness in the extremities (8%); leg pain (5%); hip pain (3%); arthropathy, bursitis, cramps (1% to less than 10%); carpal tunnel syndrome, musculoskeletal pain, rigors (1% to less than 5%); progression of preexisting scoliosis in children.
Respiratory
Upper respiratory tract infection (16%); rhinitis (14%); bronchitis (9%); bronchospasm, dyspnea (7%); increased cough, respiratory disorder (6%); respiratory tract infection (1% to less than 10%); pneumonia, sinusitis (1% to less than 5%).
Miscellaneous
Surgical procedures (45%); peripheral edema (42%); edema (41%); flu-like symptoms (23%); peripheral swelling (18%); leg edema (15%); pain (14%); infection (13%); increased nevi (11%); hematoma (9%); increased sweating (8%); generalized edema (6%); fungal infection, periorbital edema (1% to less than 10%); accident, chest pain, face edema, fever, flu-like symptoms, herpes simplex, moniliasis, night sweats, viral infection (1% to less than 5%); bacterial infection; fluid retention, including peripheral swelling; sepsis; slipped capital femoral epiphysis in children; sudden death in children with Prader-Willi syndrome.

Precautions

Monitor
Be alert for signs of acromegaly. Monitor glucose levels periodically. Routinely monitor patients with preexisting tumors or GHD secondary to an intracranial lesion for progression or recurrence of the underlying disease process. Monitor patients with a history of scoliosis for progression of the condition. Monitor standard hormonal replacement therapy closely when administering somatropin to patients with hypopituitarism. Carefully monitor patients for any malignant transformation of skin lesions. Monitor patients with Turner syndrome for CV disorders (eg, stroke). Monitor thyroid function tests and signs of respiratory infection.

Special Precautions

Information Not Available

Other Drug Interactions

Corticosteroids
Somatropin may interfere with the metabolic conversion of cortisol and cortisone to their active metabolites. Glucocorticoids may inhibit growth-promoting effects of somatropin.
CYP-450 substrates (eg, anticonvulsants, cyclosporine)
Somatropin may alter the Cl of drugs metabolized by CYP liver enzymes.
Insulin, oral hypoglycemic agents
Because somatropin decreases insulin sensitivity, diabetic patients receiving drug therapy may require adjustments in the insulin or oral hypoglycemic dosage when somatropin is started or stopped.
Oral estrogens
Larger doses of somatropin may be required in women receiving oral estrogens.

Other Interactions

Information Not Available

Dosage

Information Not Available

Food(before/after)

Information Not Available

List of Contraindications

Somatropin and Pregnancy

Caution when used during pregnancy

Somatropin and Lactation

Undetermined

Somatropin and Children

Some diluents may contain benzyl alcohol, which can cause gasping syndrome in premature infants.

Somatropin and Geriatic

Information Not Available

Somatropin and Other Contraindications

Active proliferative or severe nonproliferative diabetic retinopathy; acute critical illness caused by complications following open heart surgery, abdominal surgery, or multiple accidental trauma; acute respiratory failure; closed epiphyses in children when used for growth promotion; Prader-Willi syndrome in children who are severely obese, have a history of upper airway obstruction or sleep apnea, or have severe respiratory impairment; evidence of tumor activity or active neoplasm; sensitivity to benzyl alcohol ( Nutropin , Omnitrope , Saizen , Serostim , Tev-Tropin , Zorbtive diluent), or glycerin or M-cresol ( Humatrope diluent); hypersensitivity to any component of the product. Intracranial lesion must be inactive and antitumor therapy complete prior to instituting therapy.

Storage

Store refrigerated at 36° to 46°F. Avoid freezing and shaking. Once opened, discard after 14 days.

Lab interference

Store refrigerated at 36° to 46°F. Avoid freezing and shaking. Once opened, discard after 14 days.

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