Source: Health Products Regulatory Authority (ZA) Revision Year: 2020 Publisher: CIPLA MEDPRO (PTY) LTD, Building 9, Parc du Cap, Mispel Street, Belville, 7530, RSA Company Contact Details: Phone: +27 21 943 4200 Customer Care: 080 222 6662, E-mail: info@cipla.com
DEPVEN XL extended release tablets are indicated for the treatment of major depressive disorder (MDD).
The recommended adult dose of DEPVEN XL for the treatment of major depressive disorder is 50 mg daily, with or without food, with a maximum dose of 100 mg daily. The dose should be increased gradually and should be at an interval of not less than 7 days.
The recommended starting dose of DEPVEN XL in patients with severe renal impairment (24-hr CrCl <30 mL/min) or end-stage renal disease (ESRD) is 50 mg every other day.
Because the clearance may vary in these patients, individualisation of dosage may be ideal. Supplemental doses should not be given to patients after dialysis (see section 5.2).
No dosage adjustment of DEPVEN XL is necessary for patients with hepatic impairment (see section 5.2).
No dosage adjustment is required solely on the basis of age; however, possible reduced renal clearance of DEPVEN XL should be considered when determining dose (see section 5.2).
Safety and efficacy in patients less than 18 years of age has not been established.
Symptoms associated with the discontinuation of serotonin-norepinephrine reuptake inhibitors (SNRI’s) and selective serotonin reuptake inhibitors (SSRI’s) may occur when discontinuing DEPVEN. It is recommended that the dose be gradually reduced instead of abruptly stopping treatment.
If intolerable symptoms occur following a dose reduction or upon discontinuation of treatment, resuming the previously prescribed dose may be considered. Subsequently, the medical practitioner may continue decreasing the dose but at a more gradual rate.
Discontinuation symptoms may occur when switching patients from other antidepressants, including venlafaxine, to DEPVEN XL. Tapering of the initial dose may be necessary to minimise discontinuation symptoms.
DEPVEN XL is for oral administration and should be swallowed whole.
There is limited clinical experience with DEPVEN XL overdosage in humans.
No specific antidotes for DEPVEN XL are known. Induction of emesis is not recommended. Because of the moderate volume of distribution of this medicine, forced diuresis, dialysis, haemoperfusion, and exchange transfusion are unlikely to be of benefit.
Treatment should consist of general measures taken when managing overdose with an SSRI/SNRI. Adequate airway, oxygenation and ventilation should be ensured. Cardiac rhythm and vital signs should be monitored. General supportive and symptomatic measures are recommended. Activated charcoal should be administered.
36 months.
Store at or below 30°C in the original container to protect from moisture.
This medicine does not require any special storage conditions.
DEPVEN XL Extended Release Tablets are packed in Blister and HPDE bottle pack(s). Such blisters and/or HDPE bottles are further packed in a Carton along with Pack Insert.
No special requirements.
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