$100.00
CLINICAL PHARMACOLOGY. UNITROPIN (somatropin [rDNA origin] for injection
Product description by Mighty Alex. MANUFACTURED BY : UNIGEN. PACKAGE : 45 iu (3 x 15 iu boxes) or 150 iu (10 x 15 iu boxes). Unitropin has been sold on the international market since the November 20th 2010, and has been added to our catalog in June 2011. Unitropin is presented as a single 5mg multi-dose vial
Buy Unitropin online
DESCRIPTION
Best place to Buy Unitropin online |UNITROPIN lyophilized powder contains somatropin [rDNA origin], which is a polypeptide hormone of recombinant DNA origin. It has 191 amino acid residues and a molecular weight of 22,124 daltons. The amino acid sequence of the product is identical to that of human growth hormone (HGH) of pituitary origin (somatropin). UNITROPIN is synthesized in a strain of Escherichia coli that has been modified by the addition of the gene for human growth hormone (rHGH).UNITROPIN is a sterile white lyophilized powder intended for subcutaneous injection.
INDICATIONS AND USAGE
UNITROPIN is a recombinant human growth hormone indicated for:
Pediatric: Treatment of children with growth failure due to growth hormone deficiency (GHD), Prader-Willi syndrome, Small for Gestational Age, Turner syndrome, and Idiopathic Short Stature.
Adult: Treatment of adults with either adult onset or childhood onset GHD
DOSAGE AND ADMINISTRATION (SUMMARY)
UNITROPIN should be administered subcutaneously:
Pediatric GHD: 0.16 to 0.24 mg/kg/week
Prader-Willi Syndrome: 0.24 mg/kg/week
Small for Gestational Age: Up to 0.48 mg/kg/week
Turner Syndrome: 0.33 mg/kg/week
Idiopathic Short Stature: up to 0.47 mg/kg/week
Adult GHD: Either a non-weight based or a weight based dosing regimen may be followed, with dose adjustment based on treatment response and serum IGF-I assay. (See Dosing of Adult Patients)
DOSAGE FORM AND STRENGTHS
Where can Buy Unitropin online?|Unitropin lyophilized powder in a multi-dose vial. One vial of lyophilized powder product contains 5mg of Somatropin USP (15 IU approx.), Mannitol BP 45mg (buffer). Sodium Phosphate monobasic and dibasic 1.7mg (preservative), and Glycine 1.7mg.
After reconstitution, each UNITROPIN vial delivers 5mg (approx. 15 IU). Each package includes an ampule of bacteriostatic water as a solvent (2ml).
WARNINGS AND PRECAUTIONS
Acute Critical Illness: Potential benefit of treatment continuation should be weighed against the potential risk.
Prader-Willi syndrome in Children: Evaluate for signs of upper airway obstruction and sleep apnea before initiation of treatment. Discontinue treatment if these signs occur.
Neoplasm: Monitor patients with preexisting tumors for progression or recurrence. Increased risk of a second neoplasm in childhood cancer survivors treated with somatropin–in particular meningiomas in patients treated with radiation to the head for their first neoplasm
Impaired Glucose Tolerance and Diabetes Mellitus: May be unmasked. Periodically monitor glucose levels in all patients. Doses of concurrent antihyperglycemic drugs in diabetics may require adjustment.
Intracranial Hypertension: Exclude preexisting papilledema. May develop and is usually reversible after discontinuation or dose reduction.
Fluid Retention (i.e., edema, arthralgia, carpal tunnel syndrome –especially in adults): May occur frequently. Reduce dose as necessary.
Hypopituitarism: Closely monitor other hormone replacement therapies.
Hypothyroidism: May first become evident or worsen.
Slipped Capital Femoral Epiphysis: May develop. Evaluate children with the onset of a limp or hip/knee pain.
Progression of Preexisting Scoliosis: May develop.
ADULT PATIENTS
UNITROPIN is indicated for replacement of endogenous growth hormone in adults with growth hormone deficiency who meet either of the following two criteria:
Adult Onset (AO): Patients who have growth hormone deficiency, either alone or associated with multiple hormone deficiencies (hypopituitarism), as a result of pituitary disease, hypothalamic disease, surgery, radiation therapy, or trauma; or
Childhood Onset (CO): Patients who were growth hormone deficient during childhood as a result of congenital, genetic, acquired, or idiopathic causes.
Patients who were treated with somatropin for growth hormone deficiency in childhood and whose epiphyses are closed should be reevaluated before continuation of somatropin therapy at the reduced dose level recommended for growth hormone deficient adults.
DOSAGE AND ADMINISTRATION
The weekly dose should be divided into 6 or 7 subcutaneous injections. UNITROPIN must not be injected intravenously.
Dosing of Pediatric Patients
General Pediatric Dosing Information
UNITROPIN dosage and administration schedules should be individualized based on the growth response of each patient.
Response to somatropin therapy in pediatric patients tends to decrease with time.
Treatment with UNITROPIN for short stature should be discontinued when the epiphyses are fused.
Pediatric Growth Hormone Deficiency (GHD)
Generally, a dose of 0.16 to 0.24 mg/kg body weight/week is recommended.
Prader-Willi Syndrome
Generally, a dose of 0.24 mg/kg body weight/week is recommended.
Turner Syndrome Generally, a dose of 0.33 mg/kg body weight/week is recommended.
Idiopathic Short Stature
Generally, a dose up to 0.47 mg/kg body weight/week is recommended.
Small for Gestational Age: Generally, a dose of up to 0.48 mg/kg body weight/week is recommended.
Dosing of Adult Patients
Adult Growth Hormone Deficiency (GHD)
Either of two approaches to UNITROPIN dosing may be followed: a non-weight based regimen or a weight based regimen.
Non-weight based– based on published consensus guidelines, a starting dose of approximately 0.2 mg/day (range, 0.15-0.30 mg/day) may be used without consideration of body weight. This dose can be increased gradually every 1-2 months by increments of approximately 0.1-0.2 mg/day, according to individual patient requirements based on the clinical response and serum insulin-like growth factor I (IGF-I) concentrations. The dose should be decreased as necessary on the basis of adverse events and/or serum IGF-I concentrations above the age- and gender-specific normal range.
Weight based–the recommended dosage at the start of treatment is not more than 0.04 mg/kg/week. The dose may be increased according to individual patient requirements to not more than 0.08 mg/kg/week at 4–8 week intervals. Clinical response, side effects, and determination of age- and gender-adjusted serum IGF-I concentrations should be used as guidance in dose titration.
A lower starting dose and smaller dose increments should be considered for older patients, who are more prone to the adverse effects of somatropin than younger individuals. In addition, obese individuals are more likely to manifest adverse effects when treated with a weight-based regimen. In order to reach the defined treatment goal, estrogen-replete women may need higher doses than men. Oral estrogen administration may increase the dose requirements in women.
Preparation and Administration
UNITROPIN is provided in 5 mg vials (approx. 15 IU).
Parenteral drug products should always be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. UNITROPIN MUST NOT BE INJECTED if the solution is cloudy or contains particulate matter. Use it only if it is clear and colorless.
UNITROPIN may be given in the thigh, buttocks, or abdomen; the site of SC injections should be rotated daily to help prevent lipoatrophy.
CONTRAINDICATIONS
Acute Critical Illness
Treatment with pharmacologic amounts of somatropin is contraindicated in patients with acute critical illness due to complications following open heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure.
Prader-Willi Syndrome in Children
Somatropin is contraindicated in patients with Prader-Willi syndrome who are severely obese, have a history of upper airway obstruction or sleep apnea, or have severe respiratory impairment. There have been reports of sudden death when somatropin was used in such patients.
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