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pms-Trazodone

pms-Trazodone

trazodone

Manufacturer:

Pharmascience

Distributor:

T-BOMA
Concise Prescribing Info
Contents
Trazodone HCl
Indications/Uses
Symptomatic relief of depressive illness.
Dosage/Direction for Use
Adult Initially 150-200 mg daily in 2 or 3 divided doses. May be increased by increments of 50 mg, usually up to 300 mg daily in divided doses. Once adequate response has been achieved, dose may be gradually reduced, w/ adjustment depending on therapeutic response.
Administration
Should be taken with food: Take shortly after a meal or light snack.
Special Precautions
Potential association w/ behavioural & emotional changes, including self-harm. Rigorous clinical monitoring for suicidal ideation or other indicators of potential for suicidal behaviour is advised, including monitoring for agitation-type emotional & behavioural changes. Gradual dose reduction is recommended due to risk of discontinuation symptoms. Not recommended for use during initial recovery phase of MI. Associated w/ QTc interval prolongation. May be arrhythmogenic. Rare cases of priapism. May cause hypotension including orthostatic hypotension & syncope. Carefully evaluate for history of drug abuse & observe for signs of misuse or abuse. Increased risk of bleeding events. Discontinue if WBC or ANC falls below normal. Risk of serotonin syndrome or NMS-like events. Consider discontinuation in patients w/ symptomatic hyponatremia. Caution in patients w/ cardiac disease; history of bleeding disorder or predisposing conditions (eg, thrombocytopenia); unstable epilepsy or history of seizures; history of mania/hypomania. Avoid concomitant use w/ drugs known to prolong QTc interval. Concomitant use w/ potent CYP3A4 inhibitors is discouraged. Co-administration w/ CYP3A4 inducers. Should not be used in combination w/ MAOIs or serotonin precursors (eg, L-tryptophan, oxitriptan) & should be used w/ caution in patients receiving other serotonergic drugs (eg, triptans, lithium, tramadol, St. John's wort, SSRIs, most TCAs) or neuroleptics/antipsychotics. Caution w/ alcohol, barbiturates & other CNS depressants. May impair mental or physical abilities required for performance of potentially hazardous tasks eg, operating an automobile or machinery. Caution in patients w/ hepatic or renal impairment. Should not be used in women of childbearing potential unless expected benefits justify potential risk to fetus. Carefully consider potential risks & benefits of treatment during later stages of pregnancy. Should not be administered to nursing mothers unless potential benefits justify possible risks to child. Not indicated in ped patients <18 yr. Caution in geriatric patients >65 yr. Elderly patients receiving antidepressants may be at increased risk of clinically significant hyponatremia.
Adverse Reactions
Headache, drowsiness, sedation, dry mouth, dizziness, nausea, fatigue, diarrhea, constipation, back pain, blurred vision.
Drug Interactions
Increased plasma conc w/ CYP3A4 inhibitors eg, ketoconazole, itraconazole, voriconazole, clarithromycin, erythromycin, atazanavir, indinavir, nelfinavir, ritonavir, saquinavir, amiodarone, grapefruit. Decreased plasma conc w/ CYP3A4 inducers eg, carbamazepine. Concomitant use w/ other QTc-prolonging drugs or drugs that can disrupt electrolyte levels is discouraged. Increased serum levels of digoxin or phenytoin. Increased risk of serotonin syndrome w/ MAOIs or other serotonergic drugs eg, tryptophan, triptans, SSRIs, lithium, fentanyl, tramadol, St. John's wort. Increased risk of bleeding w/ NSAIDs, aspirin, or other drugs that affect coagulation or bleeding. Reports of increased & decreased prothrombin time in warfarinized patients who take trazodone. May enhance response to alcohol & effects of barbiturates & other CNS depressants. Should be discontinued for as long as clinically feasible prior to elective surgery. Efficacy & safety of concurrent use w/ electroconvulsive therapy have not been studied.
MIMS Class
Antidepressants
ATC Classification
N06AX05 - trazodone ; Belongs to the class of other antidepressants.
Presentation/Packing
Form
pms-Trazodone tab 50 mg
Packing/Price
100's
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