Inspago 25 mg film-coated tablets
Film-coated tablet [tablet].
Treatment of major depressive episodes in adults
The recommended dose is 25 mg once daily taken orally at bedtime.
After two weeks of treatment, if there is no improvement of symptoms, the dose may be increased to 50 mg once daily, i.e. two 25 mg tablets, taken together at bedtime.
Liver function tests should be performed in all patients: at initiation of treatment, and then periodically after around six weeks (end of acute phase), twelve weeks and twenty four weeks (end of maintenance phase) and thereafter when clinically indicated Patients with depression should be treated for a sufficient period of at least 6 months to ensure that they are free of symptoms.
Inspago tablets may be taken with or without food.
Children and adolescents:
Inspago is not recommended for use in children and adolescents below 18 years of age due to a lack of data on safety and efficacy (see section 4.4).
Efficacy has not been clearly demonstrated in the elderly ( 65 years). Only limited clinical data is available on the use of Inspago in elderly patients 65 years old with major depressive episodes. Therefore, caution should be exercised when prescribing Inspago to these patients
Patients with renal impairment:
No relevant modification in agomelatine pharmacokinetic parameters in patients with severe renal impairment has been observed. However, only limited clinical data on the use of Inspago in depressed patients with severe or moderate renal impairment with major depressive episodes is available. Therefore, caution should be exercised when prescribing Inspago to these patients.
Patients with hepatic impairment:
Inspago is contra-indicated in patients with hepatic impairment
No dosage tapering is needed on treatment discontinuation.
Potential interactions affecting agomelatine:
Agomelatine is metabolised mainly by cytochrome P450 1A2 (CYP1A2) (90%) and by CYP2C9/19 (10%). Medicinal products that interact with these isoenzymes may decrease or increase the bioavailability of agomelatine.
Fluvoxamine, a potent CYP1A2 and moderate CYP2C9 inhibitor markedly inhibits the metabolism of agomelatine resulting in a 60-fold (range 12-412) increase of agomelatine exposure.
Consequently, co-administration of Inspago with potent CYP1A2 inhibitors (e.g. fluvoxamine, ciprofloxacin) is contra-indicated.
Combination of agomelatine with oestrogens (moderate CYP1A2 inhibitors) results in a several fold increased exposure of agomelatine. While there was no specific safety signal in the 800 patients treated in combination with oestrogens, caution should be exercised when prescribing agomelatine with other moderate CYP1A2 inhibitors (e.g. propranolol, grepafloxacin, enoxacin) until more experience has been gained
Potential for agomelatine to affect other medicinal products:
In vivo, agomelatine does not induce CYP450 isoenzymes. Agomelatine inhibits neither CYP1A2 in vivo nor the other CYP450 in vitro. Therefore, agomelatine will not modify exposure to medicinal products metabolised by CYP 450.
Medicinal products highly bound to plasma protein:
Agomelatine does not modify free concentrations of medicinal products highly bound to plasma proteins or vice versa.
Other medicinal products:
No evidence of pharmacokinetic or pharmacodynamic interaction with medicinal products which could be prescribed concomitantly with Inspago in the target population was found in phase I clinical trials: benzodiazepines, lithium, paroxetine, fluconazole and theophylline.
The combination of Inspago and alcohol is not advisable.
Electroconvulsive therapy (ECT):
There is no experience of concurrent use of agomelatine with ECT. Animal studies have not shown proconvulsant properties (see section 5.3). Therefore, clinical consequences of ECT concomitant treatment with Inspago are considered to be unlikely.
For agomelatine, no clinical data on exposed pregnancies are available. Caution should be exercised when prescribing to pregnant women.
It is not known whether agomelatine is excreted into human milk. Agomelatine or its metabolites are excreted in the milk of lactating rats. Potential effects of agomelatine on the breast-feeding infant have not been established. If treatment with Inspago is considered necessary, breast-feeding should be discontinued.
However, considering that dizziness and somnolence are common adverse reactions patients should be cautioned about their ability to drive a car or operate machinery.
The active substance is agomelatine. Each tablet contains 25 mg of agomelatine.
The inactive ingredients are:
lactose monohydrate, maize starch, povidone, sodium starch glycolate type A, magnesium stearate, colloidal anhydrous silica, Hypromellose, Polyethylene glycol 6000, Purified talc, Titanium dioxid, Iron Oxide Yellow.