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 Cymbalta
1. NAME OF THE MEDICINAL PRODUCT
CYMBALTA 30 mg hard gastro-resistant capsules
CYMBALTA 60 mg hard gastro-resistant capsules
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
The active ingredient in CYMBALTA is duloxetine.
Each Cymbalta 30 mg & 60 mg capsule contains 30 mg & 60 mg of duloxetine as
duloxetine hydrochloride respectively.
For excipients. see section 6.1.
3. PHARMACEUTICAL FORM
Hard gastro-resistant capsule.
The CYMBALTA 30 mg capsule has an opaque white body, imprinted with '30 mg'
and an opaque blue cap, imprinted with '9543'.
The CYMBALTA 60 mg capsule
has an opaque green body, imprinted with '60 mg' and an opaque blue cap,
imprinted with '9542'.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Treatment of major depressive disorder.
Management of neuropathic pain associated with diabetic peripheral
neuropathy in adults.
Treatment of generalized anxiety disorder.
4.2 Posology and method of administration
For oral use.
Major Depressive Disorder
The starting and recommended maintenance dose is 60 mg once daily with or
without food. Dosages above 60 mg once daily, up to a maximum dose of 120 mg
per day administered in evenly divided doses, have been evaluated from a
safety perspective in clinical trials. However, there is no clinical
evidence suggesting that patients not responding to the initial recommended
dose may benefit from dose up-titrations.
Therapeutic response is usually seen after 2-4 weeks of treatment.
After consolidation of the antidepressive response, it is recommended to
continue treatment for several months, in order to avoid relapse.
Diabetic Peripheral Neuropathic Pain
Cymbalta should be administered at a dose of 60 mg once daily with or
without food. Dosages above 60 mg once daily, up to a maximum dose of 120 mg
per day administered in evenly divided doses, have been evaluated from a
safety perspective in clinical trials. The plasma concentration of
duloxetine displays large inter-individual variability (see section 5.2).
Hence, some patients that respond insufficiently to 60 mg may benefit from a
higher dose.
The medicinal product response should be evaluated after 2 months' of
treatment. Additional response after this time is unlikely (see section
5.1).
The therapeutic benefit should regularly (at least every three months) be
reassessed.
Generalized Anxiety Disorder
Duloxetine should be administered at a dose of 60 mg once daily without
regard to meals.
For some patients, it may be desirable to start at 30 mg once daily for one
week to allow patients to adjust to medication before increasing to 60 mg
once daily. While a 120 mg once daily was shown to be effective, there is no
evidence that doses greater than 60 mg/day confer additional benefit.
Nevertheless, if a decision is made to increase the dose beyond 60 mg once
daily. dose increases should be in increments of 30 mg once daily. The
safety of doses above 120 mg once daily has not been adequately evaluated.
Special Populations and General Information:
Hepatic impairment
CYMBALTA should not be used in patients with liver disease resulting in
hepatic impairment (see sections 4.3 and 5.2).
Renal insufficiency
No dosage adjustment is necessary for patients with mild or moderate renal
dysfunction (creatinine clearance 30 to 80 ml, min). See section 4.3 for
severe renal impairment.
Elderly
Major Depressive Disorder: Depression may have different features in the
elderly which make it difficult to extrapolate efficacy and safety data from
a younger population. Only limited clinical data on the use of CYMBALTA in
elderly patients with major depressive disorders is available. Therefore,
caution should be exercised when treating the elderly. Until more efficacy
data are available the use of CYMBALTA in the very elderly population (>75
years) is not recommended. (see sections 4.4 and 5.2).
Diabetic Peripheral Neurophatic Pain:
No dosage adjustment is recommended for elderly patients
solely on the basis of age. However, caution should be exercised when
treating the elderly (see section 5.2)
Children and adolescents
The safety and efficacy of duloxetine in these age groups have not been
studied. Therefore, administration of CYMBALTA to children and adolescents
is not recommended (see section 4.4).
Discontinuation of treatment
Abrupt discontinuation should be avoided. When stopping treatment with
CYMBALTA the dose should be gradually reduced over a period of at least one
to two weeks in order to reduce the risk of withdrawal reactions (see
sections 4.4 and 4.8). If intolerable symptoms occur following a decrease in
the dose or upon discontinuation of treatment, then resuming the previously
prescribed dose may be considered. Subsequently. the physician may continue
decreasing the dose, but at a more gradual rate.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients.
Concomitant use of CYMBALTA with nonselective, irreversible Monoamine
Oxidase Inhibitors (MAOIs) is contraindicated (see section 4.5).
Liver disease resulting in hepatic impairment (see section 5.2).
CYMBALTA should not be used in combination with fluvoxamine. ciprofloxacin
or enoxacine (i.e. potent CYP1A2 inhibitors) since the combination results
in elevated plasma concentrations of duloxetine (see section 4.5).
Severe renal impairment (creatinine clearance <30 ml/min).
In clinical trials. Cymbalta use was associated with an increased risk of
mydriasis; therefore, its use should be avoided in patients with
uncontrolled narrow-angle glaucoma.
The initiation of treatment with CYMBALTA is contraindicated in patients
with uncontrolled hypertension that could expose patients to a potential
risk of hypertensive crisis (see sections 4.4 and 4.8).
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