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Eutropin S Pen Injection

Eutropin S Pen Injection

somatropin

Manufacturer:

LG Chem Ltd

Distributor:

DKSH

Marketer:

LG Chem Life Sciences
Concise Prescribing Info
Contents
Recombinant human somatropin
Indications/Uses
Short stature in childn due to inadequate secretion of endogenous growth hormone (GH deficiency); w/ Turner syndrome; born small for gestational age (SGA).
Dosage/Direction for Use
SC Individualized dosage. Short stature in childn due to GH deficiency 0.5-0.6 IU (0.17-0.21 mg)/kg/wk or 12 IU (4 mg)/m2/wk, divided into 3-6 inj. Short stature in childn w/ Turner syndrome 1 IU (0.33 mg)/kg/wk, divided into 6-7 inj. Short stature in childn born SGA 1.44 IU (0.48 mg)/kg/wk, divided into 6-7 inj.
Contraindications
Hypersensitivity. DM. Malignant tumor. Closed epiphyses. Short stature due to brain tumor which induces hypopituitarism & hyposecretion of GH. Acute critical illness w/ complications following open heart & abdominal surgery, multiple accidental trauma. Acute resp failure.
Special Precautions
Local or systemic allergic reactions. Discontinue treatment if papilledema is observed by funduscopy during treatment; Ab to human GH is formed & effect is decreased. Not to be administered if overt diabetes occurs. Not recommended to initiate treatment near onset of puberty. Possible loss of obtained height gain in short childn born SGA if stopped before final height is reached. Increased risk of 2nd neoplasm (intracranial tumors particularly meningiomas) in childhood cancer survivors; intracranial HTN, developing autoimmune thyroid disease & primary hypothyroidism in patients w/ Turner syndrome. Hyperglycemia, ketosis & induced insulin resistance; hypoglycemia. Closely monitor patients w/ pre-existing type 1 or 2 DM or impaired glucose tolerance; hypothyroidism (lacking in multiple pituitary hormones) for HRT during therapy; Turner syndrome for CV disorders (eg, stroke, aortic aneurysm/dissection, HTN). Intracranial HTN w/ papilledema, visual changes, headache, nausea &/or vomiting. May induce overfiltration w/ increasing renal plasma flow & GFR. Undiagnosed/untreated hypothyroidism particularly in childn. Skeletal abnormalities. Tissue atrophy if administered at same site over prolonged period. May increase serum levels of inorganic P, alkaline phosphatase, parathyroid hormone & IGF-I during therapy. Patients w/ heart & kidney disease; familial history of & previously diagnosed DM; hypopituitarism on standard replacement therapy. Monitor patients w/ history of scoliosis for progression of scoliosis. Rule out other medical reasons or treatments for growth disturbance in short childn born SGA before starting treatment. Measure fasting insulin & blood glucose prior to treatment & annually thereafter; IGF-I level prior to treatment & twice yrly thereafter in SGA childn. Perform oral glucose tolerance testing in patients w/ increased risk for DM (eg, familial history of DM, obesity, severe insulin resistance, acanthosis nigricans); funduscopic exam routinely before initiating treatment & periodically during therapy. Regularly examine patients w/ signs of developing malignancies & GHD secondary to intracranial lesion for progression or recurrence of underlying disease prior to therapy. Carefully monitor skin lesions for increased growth or potential malignant changes; standard HRT if used in patients w/ panhypopituitarism. Monitor glucose levels periodically especially those w/ risk factors for DM; thyroid function. Periodically conduct urine glucose test. Evaluate any ped patient w/ onset of limp or complaints of hip or knee pain during therapy; patients w/ Turner syndrome for otitis media & other ear disorders. Determine Abs to GH periodically. Not to be used in pregnant women or women of childbearing potential. Lactation.
Adverse Reactions
Hypothyroidism; papilloedema, dysopia; pancreatitis, vomiturition, abdominal pain, vomiting accompanied by intracranial HTN, nausea; mild, transient peripheral or generalized edema, bruising, bleeding, itching, hives at inj site, loss of SC fat, edema; hypersensitivity; increased creatine phosphokinase, leukocyte count, plasma fatty acids, P serum level, myoglobin, elevated ALT, AST & alkaline phosphatase; arthralgia, exostosis, osteonecrosis, scoliosis, calcaneal apophysitis; carpal tunnel syndrome, seizure, periodical acroparalysis in association w/ growth, headache; proteinuria, microscopic hematuria, gynecomastia; acne.
Drug Interactions
Inhibited expected effects w/ excessive glucocorticoid treatment. Altered clearance of CYP450-metabolized drugs (eg, corticosteroids, sex steroids, anticonvulsants, cyclosporine). Inhibition of 11 β-hydroxysteroid dehydrogenase type 1 & reduced serum cortisol conc. Concomitant use w/ oral estrogen; insulin &/or oral/injectable hypoglycemic agents.
MIMS Class
Trophic Hormones & Related Synthetic Drugs
ATC Classification
H01AC01 - somatropin ; Belongs to the class of somatropin and somatropin agonists. Used in anterior pituitary lobe hormone and analogue preparations.
Presentation/Packing
Form
Eutropin S Pen Injection soln for inj 36 IU
Packing/Price
1's
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