In some cases, although not all, these urges were reported to have stopped when the dose was reduced or the medication was discontinued. The no-effect dose for embryofetal developmental toxicity in rats (5 mg/kg/day) is approximately 20 times the maximum recommended human dose (MRHD) of 2.5 mg/day on a mg/mIn rabbits administered selegiline orally (5, 30, and 60 mg/kg/day) throughout the period of organogenesis, embryolethality was observed at the highest dose tested and reduced fetal body weight was observed at the mid and high doses.
Effect of CYP3A inhibitor itraconazole: Itraconazole (200 mg QD) did not affect the pharmacokinetics of selegiline (single 10 mg oral, swallowed dose).Although adequate studies to investigate the effect of CYP3A4-inducers on selegiline have not been performed, drugs that induce CYP3A4 (e.g., phenytoin, carbamazepine, nafcillin, phenobarbital, and rifampin) should be used with caution. (See Infrequently, DDAVP has produced transient headache, nausea, mild abdominal cramps and vulval pain. Most common adverse reactions causing discontinuation of treatment included dizziness, chest pain, accidental injury, and myasthenia.Treatment-emergent adverse reactions for certain events were reported at a higher frequency by patients ≥65 years of age compared to patients <65 years [seeNo consistent differences in the incidences of adverse reactions were observed between male and female patients.There were insufficient data to assess the impact of race on the incidence of adverse reactions.Serious, sometimes fatal reactions have been reported in patients treated with concomitant meperidine (e.g., Demerol and other tradenames) and MAO inhibitors including selective MAO-B inhibitors [seeThe combination of MAO inhibitors and dextromethorphan has been reported to cause brief episodes of psychosis or bizarre behavior.
Prescribers should ask patients about the development of new or increased gambling urges, sexual urges or other urges while being treated with ZELAPAR.
at any time during treatment, they should not drive or participate in potentially dangerous activities until they have contacted their physician. DDAVP is contraindicated in patients with moderate to severe renal impairment (defined as a creatinine clearance below 50 mL/min). Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.. 0187-0453-02, The incidence of dyskinesia causing study discontinuation was greater on ZELAPAR than on placebo.In controlled trials, hallucination was reported by 4% of ZELAPAR-treated patients and 2% in placebo-treated patients. An increase in tyramine sensitivity for blood pressure responses appears to begin at a dose of 5 mg ZELAPAR daily [see Reports of hypertensive reactions have occurred in patients who ingested tyramine-containing consumables (i.e., food or drink) while receiving swallowed selegiline at the recommended dose (a dose believed to be relatively selective for MAO-B).The safe use of ZELAPAR at doses above 2.5 mg daily without dietary tyramine restrictions has not been established. Explain the risk of using higher daily doses of ZELAPAR and provide a brief description of the hypertensive tyramine reaction provided. Signs and symptoms of central nervous system stimulation, including convulsions, should be treated with diazepam, given slowly intravenously. Both treatment groups had an average of 7 hours per day of “OFF” time at baseline. A pharmacodynamic study showed increased tyramine sensitivity for increasing blood pressure and decreased selectivity for MAO-B with dosing above the recommended level (2.5 mg daily) [seeUncontrolled hypertension has been reported when taking the recommended dose of swallowed selegiline and a sympathomimetic medication (ephedrine). In most cases, there is no need for dietary tyramine restriction in patients prescribed ZELAPAR [seeReports of hypertensive reactions have occurred in patients who ingested tyramine-containing consumables (i.e., food or drink) while receiving swallowed selegiline at the recommended dose (a dose believed to be relatively selective for MAO-B). Compare DDAVP vs Imipramine head-to-head with other drugs for uses, ratings, cost, side effects, interactions and more. There is insufficient information to establish whether dose reduction will eliminate episodes of falling asleep while engaged in activities of daily livingCase reports suggest that patients can experience intense urges to gamble, increased sexual urges, intense urges to spend money, binge eating, and/or other intense urges, and the inability to control these urges while taking one or more of the medications, including ZELAPAR, that increase central dopaminergic tone and that are generally used for the treatment of Parkinson’s disease.