GENERIC NAME: VENLAFAXINE HYDROCHLORIDE

Active ingredients: VENLAFAXINE HYDROCHLORIDE

 VENLAFAXINE HYDROCHLORIDE 37.5mg, 75mg, 150mg

ALSO AVIAL: SR TABLETS IN SAME. (Slow Release Tablets)

Pharmacology: Potentiates norepinephrine, serotonin, and dopamine neurotransmitter activity in the CNS by inhibiting their neuronal reuptake.

IDENTIFICATION:
Color: Light Orange

Shape: Circle

Pattern: Speckled ,SCORED

Generalized anxiety disorder; panic disorder.

Unlabeled Uses: Autism; binge eating disorder; hot flashes; pain; premenstrual dysphoric disorder; posttraumatic stress disorder; prevention of migraine.

Pharmacology: Potentiates norepinephrine, serotonin, and dopamine neurotransmitter activity in the CNS by inhibiting their neuronal reuptake.

Absorption:Absolute bioavailability is 45% and a single oral dose is well absorbed (at least 92%). Steady-state concentrations of venlafaxine and O-desmethylvenlafaxine (ODV) in plasma are attained within 3 days of oral dosing.

Metabolism: Extensively metabolized in the liver. The major metabolite is ODV, which is active.

Elimination:Renal elimination of venlafaxine and its metabolite is the primary route of excretion. Within 48 h, 87% is recovered in urine. Elimination half-life is 5 h (11 h for ODV).

Renal Function Impairment: Dosage adjustment is necessary with CrCl 10 to 70 mL/min. Venlafaxine elimination half-life was prolonged approximately 50% and Cl was reduced approximately 24%; ODV elimination half-life was prolonged 40% although Cl was unchanged.

Dialysis: Dose adjustment is necessary. Venlafaxine elimination half-life was prolonged approximately 180% and Cl was reduced approximately 57%. ODV elimination half-life was prolonged approximately 142% and Cl was reduced 56%.

Hepatic Function Impairment: In patients with hepatic cirrhosis, dosage adjustment is necessary. Venlafaxine elimination half-life was prolonged by approximately 30% and Cl decreased 50%; ODV elimination half-life was prolonged approximately 60% and Cl decreased 30%.

Elderly: Pharmacokinetics not altered by age.

Gender: Pharmacokinetics not altered by gender.

Poor/Extensive metabolizers:Venlafaxine plasma concentrations were higher in CYP2D6 poor metabolizers than in extensive metabolizers. AUC of venlafaxine and ODV were similar in poor and extensive metabolizers. No dosage adjustment is required.

Contraindications: Concomitant use with MAOIs; hypersensitivity to venlafaxine or any component in the formulation.

General Advice:

     * It is generally agreed that acute episodes of MDD require several months or longer of sustained pharmacological therapy beyond response to the acute episode.

    * Swallow venlafaxine capsules or tablets whole. Do not divide, crush, chew, or place in water.

    * For patients who have difficulty swallowing venlafaxine  capsules whole, the capsules may be opened and the contents sprinkled on a spoonful of applesauce. The drug/applesauce mixture should be swallowed immediately without chewing and followed with a glass of water. Do not prepare the mixture ahead of time and store. 
 

Adverse Reaction:

Major Depressive Disorder - Adverse events in short-term studies that occurred in at least 5% of the patients receiving venlafaxine extended-release capsules and at a rate at least twice that of the placebo group were abnormal ejaculation, gastrointestinal complaints (nausea, dry mouth, and anorexia), CNS complaints (dizziness, somnolence, and abnormal dreams), and sweating.

Dosing:

• Should be administered in a single dose with food either in the morning or in the evening at approximately the same time each day
• Each capsule should be swallowed whole with fluid and not divided, crushed, chewed, or placed in water, or it may be administered by carefully opening the capsule and sprinkling the entire contents on a spoonful of applesauce; this drug/food mixture should be swallowed immediately without chewing and followed with a glass of water to ensure complete swallowing of the pellets
• Flexibility in dosing for depression
  • Patients not responding to the initial dose of 75 mg/day may benefit from increases to a maximum of approximately 225 mg/day
  • When increasing the dosage, incremental increases of up to 75 mg/day should be made at intervals of no less than 4 days
  • Experience with doses higher than 225 mg/day is very limited
  • Dosing for special populations may vary.

Storage: Store between 68° and 77°F. Protect from moisture.Protect from Sunlight and Heat.

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