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Efexor XR

Efexor XR

venlafaxine

Manufacturer:

Viatris

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Venlafaxine HCl
Indications/Uses
Depression, including depression w/ associated anxiety; anxiety or generalized anxiety disorder, including long-term treatment; social anxiety disorder (social phobia); panic disorder w/ or w/o agoraphobia. Prevention of relapses or recurrence of depression.
Dosage/Direction for Use
Depression Initially 75 mg once daily. May be increased in increments of up to 75 mg daily at intervals not <4 days. Titrate up to 225 mg daily for moderate depression & 375 mg daily for severe depression. Generalized anxiety disorder Initially 75 mg daily. May be increased to max 150 mg or 225 mg daily at approx 2 wk intervals or more but not <4 days. Social anxiety disorder 75 mg daily as single dose. Panic disorder Initially 37.5 mg daily as single dose for 7 days followed by 75 mg daily & subsequent wkly dose increases of 75 mg up to max of 225 mg daily at increments of up to 75 mg daily w/ intervals not <7 days. Mild to moderate hepatic impairment Reduce total daily dose by 50%. Renal impairment w/ GFR 10-70 mL/min Reduce total daily dose by 25-50%. Hemodialysis patient Reduce total daily dose by 50%.
Administration
Should be taken with food: Swallow whole, do not divide/chew/crush or dissolve.
Contraindications
Hypersensitivity. Concomitant use w/ MAOIs.
Special Precautions
Discontinue treatment at least 7 days before starting any MAOI treatment. Not to initiate treatment at least 14 days after MAOI discontinuation. Not indicated for wt loss. Monitor & observe closely for clinical worsening & suicidality especially when initiating therapy or during any change in dose or dosage regimen. Increased risk of suicidality in childn, adolescents & young adults (18-24 yr) w/ major depression & other psychiatric disorders; bone fractures. Increased serum cholesterol. Bleeding abnormalities ranging from skin & mucous membrane bleeding & GI hemorrhage to life-threatening hemorrhage. Hyponatremia &/or SIADH secretion in vol-depleted or dehydrated patients. Aggression; mydriasis; convulsions; mania/hypomania. May cause sexual dysfunction symptoms. History of aggression; convulsions; recent MI or unstable heart disease. Personal or family history of bipolar disorder. Patients whose underlying conditions may be compromised by increases in BP & heart rate; w/ risk factors for QTc prolongation; predisposed to bleeding, including those on anti-coagulants & platelet inhibitors. Closely monitor patients w/ raised IOP or at risk for acute narrow angle glaucoma (angle closure glaucoma). Consider risk of suicide attempt in patients w/ depression. Periodically re-evaluate usefulness of long-term treatment for social anxiety/panic disorder. Gradually taper dose & monitor patients when discontinuing therapy. Measure serum cholesterol during long-term treatment; BP. Control pre-existing HTN before initiating treatment. Evaluate patients for history of drug abuse & closely observe for signs of misuse or abuse eg, development of tolerance, dose escalation or drug-seeking behaviour. Not recommended to use concomitantly w/ serotonin precursors eg, tryptophan supplements; wt loss agents including phentermine. Do not consume alcohol. Serotonin syndrome or NMS-like reactions w/ concomitant use of other serotonergic drugs including SSRIs, SNRIs, amphetamines & triptans, opioids (eg, fentanyl, dextromethorphan, tramadol, tapentadol, meperidine, methadone, pentazocine), w/ drugs impairing metabolism of serotonin including MAOIs, eg, methylene blue, or w/ antipsychotics or other dopamine antagonists. Observe patient during treatment initiation & dose increases if concomitant treatment w/ other agents affecting serotonergic &/or dopaminergic neurotransmitter systems is clinically warranted. May affect ability to drive or operate hazardous machinery. Increased risk for preeclampsia when exposed mid to late pregnancy; post partum haemorrhage when exposed near delivery. Pregnancy & lactation. Consider discontinuation of treatment in childn & adolescents experiencing sustained increase in BP. Measure serum cholesterol levels during long-term treatment; wt & BP in childn & adolescents. Childn & adolescents <18 yr. Elderly.
Adverse Reactions
Insomnia; headache, dizziness, sedation; nausea, dry mouth, constipation; hyperhidrosis. Decreased appetite; abnormal dreams, nervousness, decreased libido, agitation, anorgasmia; akathisia, tremor, paresthesia, dysgeusia; visual impairment, accommodation disorder, mydriasis; tinnitus; tachycardia, palpitations; HTN, hot flush; dyspnea, yawning; diarrhea, vomiting; rash, pruritus, night sweats; hypertonia; urinary hesitation & retention, pollakiuria; erectile dysfunction, ejaculation disorder; fatigue, asthenia, chills; decreased & increased wt. SJS, TEN, erythema multiforme.
Drug Interactions
Severe adverse reactions w/ MAOI. Concomitant use w/ other CNS-active drugs; agents affecting serotonergic neurotransmitter system including triptans, SSRIs, other SNRIs, amphetamines, lithium, sibutramine, opioids (eg, fentanyl and its analogues, tramadol, dextromethorphan, tapentadol, meperidine, methadone, pentazocine) or St. John's wort (Hypericum perforatum), drugs impairing serotonin metabolism eg, MAOIs, including linezolid & methylene blue, or w/ serotonin precursors eg, tryptophan supplements. Increased QTc prolongation &/or ventricular arrythmias w/ other drugs that prolong QTc interval eg, antipsychotics & antibiotics. Decreased AUC & Cmax of indinavir. CNS depressant effects w/ alcohol. Decreased total oral clearance, increased AUC & Cmax w/ haloperidol. Inhibited 1st-pass metabolism w/ cimetidine. Increased AUC, Cmax & Cmin of desipramine. Increased plasma conc w/ ketoconazole; CYP2D6 & CYP3A4 inhibitors. Increased plasma conc of metoprolol. Increased AUC of risperidone. False +ve urine immunoassay screening tests for PCP & amphetamine.
MIMS Class
Antidepressants
ATC Classification
N06AX16 - venlafaxine ; Belongs to the class of other antidepressants.
Presentation/Packing
Form
Efexor XR ER cap 150 mg
Packing/Price
2 × 14's
Form
Efexor XR ER cap 37.5 mg
Packing/Price
1 × 7's
Form
Efexor XR ER cap 75 mg
Packing/Price
2 × 14's
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