Generic Name and Formulations:
Triptorelin pamoate 22.5mg; lyophilized microgranules for ext-rel IM inj after reconstitution; contains mannitol.
Arbor Pharmaceuticals, LLC
Indications for TRIPTODUR:
Treatment of central precocious puberty.
<2yrs: not established. Give as IM inj in buttock or thigh. ≥2yrs: 22.5mg once every 24 weeks. Discontinue at appropriate time point for onset of puberty. Consider switching to alternative GnRH agonist if Triptodur dose is inadequate.
Use aseptic technique. Must administer under physician supervision. Initial transient rise in gonadotropins and sex steroids may result in increased signs/symptoms of puberty. Monitor LH and sex steroid levels at 1–2 months after treatment initiation, during, and with each subsequent dose. Assess height every 3–6 months and bone age periodically. Monitor for psychiatric symptoms. History of seizures/epilepsy, cerebrovascular disorders, CNS anomalies or tumors: risk of convulsions. Renal or hepatic impairment. Discontinue if overdosage occurs. Nursing mothers.
Concomitant hyperprolactinemic drugs: not recommended. Caution with concomitant drugs that are associated with convulsions (eg, bupropion, SSRIs). May interfere with pituitary gonadotropic and gonadal function tests.
Inj site reactions, menstrual bleeding, hot flush, headache, cough, infections (eg, bronchitis, gastroenteritis, influenza, nasopharyngitis, otitis externa, pharyngitis, sinusitis, upper respiratory tract infection); psychiatric events, convulsions.
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