Country: United States
Language: English
Source: NLM (National Library of Medicine)
SOMATROPIN (UNII: NQX9KB6PCL) (SOMATROPIN - UNII:NQX9KB6PCL)
Physicians Total Care, Inc.
SOMATROPIN
SOMATROPIN 5 mg in 1.5 mL
SUBCUTANEOUS
PRESCRIPTION DRUG
Norditropin [somatropin (rDNA origin) injection] is indicated for the treatment of children with growth failure due to inadequate secretion of endogenous growth hormone (GH). Norditropin [somatropin (rDNA origin) injection] is indicated for the treatment of children with short stature associated with Noonan syndrome. Norditropin [somatropin (rDNA origin) injection] is indicated for the treatment of children with short stature associated with Turner syndrome. Norditropin [somatropin (rDNA origin) injection] is indicated for the treatment of children with short stature born small for gestational age (SGA) with no catch-up growth by age 2-4 years. Norditropin [somatropin (rDNA origin) injection] is indicated for the replacement of endogenous GH in adults with growth hormone deficiency (GHD) who meet either of the following two criteria: - Adult Onset (AO): Patients who have GHD, either alone or associated with multiple hormone deficiencies (hypopituitarism), as a result of pituitary disease, hypothalamic disease
Norditropin NordiFlex prefilled pens [somatropin (rDNA origin) injection] 5 mg/1.5 mL: Norditropin NordiFlex is individually cartoned in 5 mg/1.5 mL prefilled pens . Unused Norditropin NordiFlex pens must be stored at 2-8°C/36-46°F (refrigerator). Do not freeze. Avoid direct light. 5 mg/1.5 mL (orange) prefilled pens: After the initial injection, a Norditropin NordiFlex (5 mg/1.5 mL) prefilled pen may be EITHER stored in the refrigerator (2-8ºC/36-46ºF) and used within 4 weeks OR stored for up to 3 weeks at not more than 25ºC (77ºF). Discard unused portion. Storage Option 1 Storage Option 2 2-8 ºC/ 36-46 ºF 2-8 ºC/36-46 ºF Up to 25ºC/77ºF
New Drug Application
NORDITROPIN - SOMATROPIN INJECTION, SOLUTION PHYSICIANS TOTAL CARE, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE NORDITROPIN CARTRIDGES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR NORDITROPIN CARTRIDGES. NO RDITRO PIN CARTRIDGES [SOMATROPIN (RDNA ORIGIN) INJECTION], FOR SUBCUTANEOUS USE INITIAL U.S. APPROVAL: 1987 INDICATIONS AND USAGE Norditropin is a recombinant human growth hormone indicated for: _PEDIATRIC_: Treatment of children with growth failure due to growth hormone deficiency (GHD), short stature associated with Noonan syndrome, short stature associated with Turner syndrome and short stature born SGA with no catch-up growth by age 2-4 years (1.1) _ADULT_: Treatment of adults with either adult onset or childhood onset GHD (1.2) DOSAGE AND ADMINISTRATION Norditropin should be administered subcutaneously (2). _PEDIATRIC GHD: _0.024-0.034 mg/kg/day, 6-7 times a week (2.1) _NOONAN SYNDROME:_ Up to 0.066 mg/kg/day (2.1) _TURNER SYNDROME_: Up to 0.067 mg/kg/day (2.1) _SGA: _Up to 0.067 mg/kg/day (2.1) _ADULT GHD: _0.004 mg/kg/day to be increased as tolerated to not more than 0.016 mg/kg/day after approximately 6 weeks, or a starting dose of approximately 0.2 mg/day (range, 0.15-0.30 mg/day) increased gradually every 1-2 months by increments of approximately 0.1-0.2 mg/day (2.2) Norditropin cartridges must be used with their corresponding color-coded NordiPen delivery systems (2.3) Injection sites should always be rotated to avoid lipoatrophy (2.3) DOSAGE FORMS AND STRENGTHS Norditropin is preloaded in the Norditropin FlexPro or Norditropin NordiFlex pens, or cartridges for use with the corresponding NordiPens (3): 5 mg/1.5 mL (orange): FlexPro and NordiFlex pens, and cartridges 10 mg/1.5 mL (blue): FlexPro and NordiFlex pens 15 mg/1.5 mL (green): FlexPro and NordiFlex pens, and cartridges 30 mg/3 mL (purple): Norditropin NordiFlex pen only CONTRAINDICATIONS Acute Critical Illness (4.1, 5.1) Children with Prader-Willi sy Read the complete document