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|Nefazodone Hydrochloride |
Drugs search, click the first letter of a drug name: | A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U | V | W | X | Y | Z | 1 | 2 | 3 | 4 | 5 | 6 | 8 | 9 Home Nefazodone HydrochloridePronouncation: (neff-AZE-oh-dohn HIGH-droe-KLOR-ide)Class: Antidepressant Trade Names: Mechanism of ActionPharmacologyUndetermined; inhibits neuronal uptake of serotonin and norepinephrine; antagonizes alpha-1 adrenergic receptors. PharmacokineticsAbsorptionAbsorbtion is rapid and complete. Absolute bioavailability is approximately 20%, T max is about 1 hr, and steady state is 4 to 5 days (parent and metabolite). Food delays absorption and decreases bioavailability. DistributionNefazodone is widely distributed in body tissues, including CNS, and exhibits nonlinear kinetics for dose and time. Nefazodone Vd is 0.22 to 0.87 L/kg and plasma protein binding is more than 99%. MetabolismNefazodone is extensively metabolized in the liver by n-dealkylation and aliphatic and aromatic hydroxylation. Three active metabolites are hydroxynefazodone (HO-NEF), meta-chlorophenylpiperazine (mCPP), and triazole-dione. EliminationNefazodone is eliminated in urine (less than 1% excreted as unchanged) and feces. The t ½ is 2 to 4 hr (parent compound), 1.5 to 4 hr (HO-NEF), 4 to 8 hr (mCPP), and 18 hr (triazole-dione). Special PopulationsElderlyC max and AUC for nefazodone and HO-NEF were twice as high. Initiate at half the dose, especially in elderly women. GenderNefazodone has a higher C max and AUC in women in single dose, but no difference after multiple doses. Liver CirrhosisAUC for nefazodone and HO-NEF at steady state were approximately 25% greater. Indications and UsageTreatment of depression. ContraindicationsCoadministration with carbamazepine, cisapride, or pimozide; hypersensitivity to nefazodone or other phenylpiperazine antidepressants (eg, trazodone). Dosage and AdministrationAdultsPO 100 mg bid initially; increase by 100 to 200 mg increments q wk (max, 600 mg/day). Elderly and Debilitated PatientsPO 50 mg bid initially; increase by 100 mg increments q wk (max, 600 mg/day). General Advice
Storage/StabilityStore tablets at controlled room temperature (59° to 86°F). Drug InteractionsBenzodiazepinesIncreased plasma concentrations and effects of alprazolam and triazolam. BuspironeElevated buspirone concentrations and decreased buspirone metabolite plasma concentrations. CarbamazepineElevated serum carbamazepine concentrations with possible increase in side effects may occur. CisaprideIncreased cisapride plasma concentrations with cardiotoxicity may occur. DigoxinIncreased plasma levels of digoxin. HaloperidolDecreased haloperidol clearance; may need to adjust haloperidol dose. HMG-CoA reductase inhibitors (eg, simvastatin)The risk of rhabdomyolysis occurrence may be increased. MAOIsDo not use nefazodone concurrently or within 14 days of discontinuing an MAOI; do not start MAOIs within 1 wk of stopping nefazodone. PimozideIncreased plasma concentrations of pimozide may occur associated with QT prolongation and rare cases of serious cardiovascular adverse events, including death, principally caused by ventricular tachycardia of the torsades de pointes type. PropranololNefazodone may decrease propranolol serum concentration; propranolol may interfere with nefazodone metabolism. St. John"s wortIncreased sedative-hypnotic effects may occur. Sibutramine, sumatriptan, trazodoneSerotonin syndrome, including irritability, increased muscle tone, shivering, myoclonus, and altered consciousness may occur. Laboratory Test InteractionsNone well documented. Adverse ReactionsCardiovascularPostural hypotension, vasodilation (4%); hypotension (2%); sinus bradycardia (1.5%). CNSHeadache (36%); somnolence (28%); dizziness (22%); asthenia, insomnia (11%); lightheadedness (10%); confusion (8%); memory impairment, paresthesia (4%); abnormal dreams, decreased concentration (3%); ataxia, incoordination, psychomotor retardation, tremor (2%); hypertonia, decreased libido (1%); convulsions (postmarketing). DermatologicPruritus, rash (2%); Stevens-Johnson syndrome (postmarketing). EENTAbnormal vision (10%); blurred vision (9%); pharyngitis (6%); tinnitus (3%); taste perversion, visual field defect (2%). GIDry mouth (25%); nausea (23%); constipation (17%); dyspepsia (9%); diarrhea (8%); increased appetite (5%); nausea and vomiting (2%); gastroenteritis (at least 1%). GenitourinaryUrinary frequency, UTI, urinary retention, vaginitis (2%); breast pain (1%); impotence (at least 1%); gynecomastia (male), priapism (postmarketing). HematologicThrombocytopenia (postmarketing). HepaticLiver necrosis, liver failure (postmarketing). Lab TestsDecreased hematocrit (3%). MetabolicPeripheral edema (3%); thirst (1%); galactorrhea, hyponatremia, increased prolactin (postmarketing). MusculoskeletalArthralgia (1%). RespiratoryIncreased cough (3%); dyspnea, bronchitis (at least 1%). MiscellaneousInfection (8%); flu-like syndrome (3%); chills, fever (2%); neck rigidity (1%); anaphylactic reactions, angioedema, serotonin syndrome (postmarketing). Precautions
PregnancyCategory C . LactationUndetermined. ChildrenSafety and efficacy not established. ElderlyInitiate treatment at half the usual dose. Dosage range same as younger patients. BradycardiaSinus bradycardia reported in 1.5% of patients; use with caution in patients with recent MI or unstable heart disease. Mania/HypomaniaMay activate mania/hypomania; use with caution in patients with history of mania. Postural hypotensionUse with caution in patients with known cardiovascular or cerebrovascular disease that could be exacerbated by hypotension (eg, history of MI, angina, ischemic stroke) and conditions that would predispose to hypotension (eg, dehydration, hypovolemia, treatment with antihypertensive medications). PriapismPriapism (eg, prolonged, painful, inappropriate penile erection) has been reported with closely related antidepressants. Discontinuation of therapy is necessary. SeizuresRare cases of petit mal and grand mal seizures reported. SuicideClosely monitor patients at risk, and do not give them access to excessive quantities. Visual disturbancesVisual disturbances, including blurred vision, scotoma, and visual trails reported. OverdosageSymptomsNausea, vomiting, somnolence. Patient Information
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