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Venlafaxine

Tablet 37.5 & 75 mg

Pharmacological class

Selective serotonin and norepinephrine uptake inhibitor (SSNRIs)


Indication

Depressive disorder, major (treatment), Anxiety (treatment), Panic disorder (treatment)


Pregnancy Category

FDA Pregnancy Category C

This drug should be used during pregnancy only if clearly needed.

Breast-feeding

Venlafaxine and ODV are distributed into breast milk and may cause un­wanted effects in the nursing infant. Because of the potential for se­rious adverse reactions in nursing infants from venlafaxine, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.


Precaution

Pediatrics

Safety and efficacy in children up to 18 years of age have not been es­tablished. Venlafaxine is not approved for use in treating any indica­tions in the pediatric population.

Geriatrics

Appropriate studies performed to date have not demonstrated geriatrics­ specific problems that would limit the usefulness of venlafaxine in the elderly. However, elderly patients are more likely to have age-related renal or hepatic impairment, which may require a dose reduction in patients receiving venlafaxine


Contraindication & Drug interaction

Contraindications

Except under special circumstances, this medication should not be used when the following medical problem exists:

Hypersensitivity to venlafaxine hydrochloride or to any excipients in the formulation

Risk-benefit should be considered when the following medical prob­lems exist:

Bipolar disorder or risk of ,Blood pressure problems or

Cardiac disease, Glaucoma. acute narrow-angle. risk of. or

Intraocular pressure, raised, Heart failure,Hyperthyroidism, Myocardial infarction, Hepatic function impairment, Mania, history of, Neurological impairment, including mental retardation, Renal function impairment, Cirrhosis of the liver, Seizures, history of, Volume-depleted, Weight loss


Drug interactions

Alcohol, Cimetidine, Clozapine, Diuretics, Haloperidol, Moclobemide, Monoamine oxidase (MAO) inhibitors, including furazolidone, procar­bazine, and selegiline, Phentermine, Other weight loss agents, Serotonergics or other medications or substances with serotonergic activity, Warfarin


Usual Adult Dose

Antidepressant -

Oral, initially 75 mg a day, administered in two or three divided doses and taken with food. The dosage may be increased, as needed and tolerated, in increments up to 75 mg a day at intervals of no less than four days, up to 225 mg a day. Although dosages over 225 mg a day have not been shown to be useful in moderately depressed outpatients, more severely depressed patients may re­spond to dosages of up to 375 mg a day, administered in three divided doses.

Note: Some clinicians recommend an initial dosage of 50 mg a day administered in two divided doses in the treatment of mild de­pression in order to minimize nausea.

In patients with moderate to severe hepatic function impair­ment-Dosage reductions of 50% or more are recommended.

In patients with renal function impairment-Mild to moderate:

Dosage reductions of 25% are recommended. Moderate to se­vere (CL cr < 30 ml/ min): Dosage should be reduced by 50%. The dose may be administered once a day because of the prolonged half-life. In dialysis patients: Total daily dose should be reduced by 50%, and administration withheld until dialysis treatment is completed.


Usual adult prescribing limits

375 mg per day.


Usual Pediatric Dose

Safety and efficacy in children up to 18 years of age have not been established.


Side Effects

Those indicating need for medical attention

Incidence more frequent:

Headache, hypertension, vision disturbances, including abnormal accommodation, and blurred vision

Incidence less frequent:

Cardiovascular effects, other, including chest pain, palpitation, and tachycardia, CNS effects, including abnormal thinking, agitation, confusion, depersonalization, and emotional lability, tinnitus

Incidence rare:

Dyspnea, edema, itching or skin rash, mania or hypomania, menstrual changes, orthoststic hypotension, seizures, trismus, urinary effects, including impaired urination, urinary frequency, urinary incontinence or urinary retention

Incidence not determined:

Agranulocytosis, anaphylaxis, aplastic anemia, atrial fibrillation, cardiac arrhythmias, catatonia, congenital anomalies, deep vein thrombophlebitis, delirium, dyskinesia, epidermal necrosis, erythema multiforme, eye hemorrhage, fatty liver, gastrointestinal hemorrhage, hemorrhage, involuntary movements, liver damage, liver failure, liver necrosis, neuroleptic malignant syndrome-like events, neutropenia, pan­creatitis, pancytopenia, panic; pulmonary eosinophilia, QT prolonga­tion, renal failure, rhabdomyolysis, serotonin syndrome, shock-­like electrical sensations; Stevens-Johnson syndrome, supraventricular tachycardia, syndrome of inappropriate antidiuretic hormone secretion, tardive dyskinesia, torsade de pointes, ventricular extrasystoles, ventricular fibrillation, ventricular tachycardia

Those indicating need for medical attention only if they continue or are bothersome

Incidence more frequent:

Abnormal dreams,anorexia,anxiety or nervous­ness, asthenia, chills, constipa­tion, diarrhea, dizziness, dryness of mouth, dyspepsia, increased sweating, insomnia, nausea, paresthesia, rhinitis, sexual dysfunction, including anorgasmia, de­creased libido; delayed ejaculation or impotence, somnolence, stomach pain or gas, tremor, vomiting, weight loss, yawning

Incidence less frequent:

Hypertonia, taste perversion

Incidence not determined:

Night sweats

Those indicating the need for medical attention if they occur after medication is discontinued

Agitation, anorexia, anxiety, asthenia, changes in dreaming, confusion, coordinatioth impaired

diarrhea, dizziness, dryness of mouth, dysphoric mood, emotional lability, fasciculation, fatigue

headache, hy­pomania, increased sweating, insom­nia, irritability, lethargy, nausea, nightmares, nervousness, seizures, sensory disturbances (including shock-like electrical sensations, somnolence, tin­nitus,tremor, vertigo, vomiting

Storage

Store below 30°C (86°F). Protect from light, moisture and keep the medicine in the box.


Packaging

Boxes of 100 Tablets Venlafaxine 37.5 & 75 mg

 

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