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Serlift

Ranbaxy Nigeria Limited
24, Abimbola street, Abimbola House, Isolo, Lagos.
Tel: 234-1-7932744, 7913002
Fax: 234 1 7913003, 4526371

Brand Name

Serlift

Manufacturer

Ranbaxy Lab. Ind., Area 3 Dewas 455001 Madhya Pradesh, India.

Therapeutic Class

Antidepressants and mood stabilisers

Dosage Form, Composition & NAFDAC Registration Number (NRN)

Tablet 25 mg (NRN: 04-2795): Sertraline HCl equiv. to Sertraline 25 mg.

 

How to identify the Product: Film-coated tablet.

 

Pack: Blister strip of 10’s; Box of 10 x 10’s.

 

 

Tablet 50 mg (NRN: 04-2794): Sertraline HCl equiv. to Sertraline 50 mg.

 

How to identify the Product: Film-coated tablet.

 

Pack: Blister strip of 10’s; Box of 10 x 10’s.

Pharmacology

Mechanism of Action:

Sertraline is a potent and selective inhibitor of neuronal serotonin (5-HT) reuptake. It has only a weak effect on neuronal uptake of norepinephrine and dopamine.

Sertraline’s inhibition of serotonin reuptake enhances serotonergic transmission. In vitro studies have shown that sertraline has no significant affinity for adrenergic, muscarinic, cholinergic, gamma aminobutyric acid (GABA), dopaminergic, serotonergic (5HT1A, 5HT1B, 5HT2) histaminergic or benzodiazepine receptors.

Pharmacokinetics:

The GI absorption of sertraline is slow but consistent. Sertraline undergoes extensive first-pass metabolism in the liver. The bioavailability is slightly increased if sertraline is taken with food. Mean peak plasma concentrations of about 20 - 55 mcg/L occur between 4.5 - 8.4 hours after administration of a single 100 mg dose.

Sertraline is approximately 98% bound to plasma proteins. Both sertraline and its metabolites are extensively distributed into tissues. The metabolite N-desmethylsertraline exhibits only about 1/8 of its activity. It does not contribute to the antidepressant activity or toxicity of the parent compound.

Both sertraline and its metabolite undergo oxidative deamination and subsequent reduction, hydroxylation and glucuronide conjugation. Only 0.2% of the unchanged drug is excreted through the kidneys. The elimination half-life of sertraline is 24 to 26 hours. The pharmacokinetics of sertraline in elderly patients are similar to younger adults.

Indications

Treatment of symptoms of depressive illness including accompanying symptoms of anxiety; Preventing relapse of the initial episode of depression or recurrence of further depressive episodes including accompanying symptoms of anxiety; Treatment of obsessions and compulsions in patients with obsessive-compulsive disorder; Manic disorder with or without agoraphobia

Contra-indications

Avoid co-administration with MAOIs. While switching from an MAOI to sertraline or vice-versa, a washout period of at least 14 days should elapse. Hypersensitivity to sertraline.

Precautions/Warnings

General:

Hepatic impairment; Cirrhosis of the liver, a lower dose or a lower frequency of dosing should be employed. Since sertraline is extensively metabolised in the liver, renal route is a minor route of elimination. However, caution is advised in patients with severe renal impairment, until more data becomes available.

Sertraline should be introduced with care in patients with seizure disorders. No clinical studies have been performed on the risks/benefits of combining sertraline therapy with electroconvulsive therapy. Careful supervision of depressed patients with suicidal tendencies is recommended especially during the early treatment phase.

Concomitant use of alcohol with Serlift should be avoided. Although adverse interactions with lithium have not been reported it is recommended that plasma lithium levels be monitored following initiation of Serlift therapy with appropriate adjustments of the lithium dose. Tricyclic antidepressants, propafenone or flecainide may require lower doses if given concurrently with Serlift (see Interactions).

Warnings:

Serlift should not be used in combination with an MAOI, or within 14 days of discontinuing treatment with an MAOI. As with other antidepressants, activation of mania/hypomania has been reported in a small proportion of patients.

Pregnancy: No teratogenic effects were demonstrated in rats and rabbits receiving 20 and 10 times the maximum daily human mg/kg dose, respectively. Adequate and well-controlled studies in humans have not been done. Serlift should be used during pregnancy only if clearly needed.

Lactation: There is no data available on the secretion of sertraline in breast milk, hence use in nursing mothers is not recommended.

Paediatrics:

The safety and efficacy of sertraline for the treatment of obsessive compulsive disorder has been demonstrated in a 12 week, multicentre, placebo-controlled study with 187 out patients ages 6-17 years. The risks, if any, that may be associated with sertraline’s extended use in children and adolescents with OCD have not been systematically assessed.

Safety and effectiveness in paediatric patients below the age of 6 have not been established. Effectiveness of sertraline in paediatric patients with depression or manic disorder has not been established.

Interactions

Concurrent use of IV diazepam with sertraline may reduce the clearance and prolong the half-life of diazepam.

Caution is recommended during concurrent use of digitoxin and warfarin with sertraline because of possible displacement of either medication from protein binding sites. This may lead to increased plasma concentrations and increased risk of adverse effects. Prothrombin time should be carefully monitored when sertraline therapy is initiated or stopped in patients taking warfarin.

Drugs metabolised by cytochrome P450 2D6:

Sertraline inhibits the biochemical activity of the drug metabolising isozyme P450 2D6, and, thus may increase the plasma concentration of co-administered drugs (which are metabolised by P450 2D6) such as tricyclic antidepressants and Type 1C antiarrhythmics, propafenone and flecainide: dose reduction may be required.

In a placebo controlled trial in normal volunteers, it has been reported that administration of two doses of sertraline did not significantly alter steady-state lithium levels or the renal clearance of lithium. Nonetheless, it is recommended that plasma lithium levels be monitored following initiation of sertraline therapy with appropriate adjustments to the lithium dose.

Adverse Effects

Nausea, diarrhoea, vomiting, anorexia, abdominal cramps, tremor, anxiety, agitation, dizziness, nervousness, blurred vision, dryness of mouth and palpitations. Other adverse effects rarely reported with sertraline include fever, rash, weight loss, decreased sexual drive, delayed ejaculation, mania and insomnia.

Dosage & Administration

Dosage for adults:

Depression: Initially 50 mg per day as a single daily dose. The daily dose may be increased after several weeks with increments of 50 mg made at intervals of at least 1 week, as needed and tolerated, upto a maximum dose of 200 mg once daily. In elderly individuals, a lower initiation dose (12.5 to 25 mg) may be used.

Obsessive - Compulsive DisorderSerlift should be administered at a dose of 50 mg. The daily dose may be increased if required at intervals of atleast one week, upto 200 mg.

Manic Disorder: Serlift treatment should be initiated with a dose of 25 mg once daily. After one week, the dose should be increased to 50 mg once daily. Further increments may be made up to a dose of 200 mg/day.

Dosage for children and adolescents (age >6 years):

Obsessive Compulsive DisorderSertraline treatment should be initiated with a dose of 25 mg once daily in children (ages 6-12) and at a dose of 50 mg once daily in adolescents (ages 13-17).

Patients not responding to an initial dose of 25 or 50 mg/day may benefit from dose increases up to maximum of 200 mg/day. For children with OCD, their generally lower body weights compared to adults should be taken into consideration in advancing the dose, in order to avoid excess dosing. Given the 24 hour elimination half-life of sertraline, dose changes should not occur at intervals of less than 1 week.

Serlift tablets should be administered once daily, either in the morning or evening.

Overdosage

Signs and symptoms of overdosage with sertraline may include somnolence, nausea, vomiting, tachycardia, anxiety, ECG changes and dilated pupils. There is no specific antidote for sertraline. Treatment of overdosage involves establishing and maintaining airway, oxygenation and ventilation. Activated charcoal may be used with sorbitol. Cardiac and vital signs monitoring is recommend along with general symptomatic and supportive measures.

Storage/Handling Recommendations

Store below 25oC.    

Review Date

2016-04-12 12:00:01