The following information is a summary about Edronax. It is not intended to replace a doctor's instructions.
Description
Reboxetine (Edronax) is used for the treatment of depression.
Indications
Reboxetine is indicated for the treatment of depressive illness and for maintaining the
clinical improvement in patients initially responding to treatment.
The remission of the acute phase of the depressive illness is associated with an improvement in the
patient's quality of life in terms of social adaptation.
Precautions
Since rare cases of seizures have been reported in
clinical studies, reboxetine should be given under close supervision to
subjects with a history of convulsive disorders and it should be discontinued
if the patient develops seizures.
Combined usage of MAO inhibitors and reboxetine should be
avoided.
As with all antidepressants, switches to mania - hypomania have occurred. Close supervision of patients is recommended.
The risk of a suicidal attempt is inherent in depression and may persist until significant
remission occurs; close patient supervision during initial drug therapy is
recommended.
Caution is recommended in patients with current evidence
of urinary retention and glaucoma.
Orthostatic hypotension has been observed with greater
frequency at doses higher than the maximum recommended. Close supervision is
recommended when administering reboxetine with other drugs known to lower blood
pressure.
Pregnancy and Lactation
There are no adequate and well-controlled studies in pregnant women. Reboxetine
should be used during pregnancy only if the potential benefit justifies the
potential risk to the fetus. While no information on the excretion of
reboxetine in maternal milk in humans is available, reboxetine administration
is not recommended in women who are breast feeding.
Drug Interactions
BEFORE USING THIS MEDICINE: INFORM YOUR DOCTOR OR
PHARMACIST of all prescription and over-the-counter medicine that you are
taking.
Combined usage of MAO inhibitors and reboxetine should be
avoided.
Contraindicated for those with hypersensitivity to
reboxetine or any other components of the product.
Close supervision is recommended when administering
reboxetine with other drugs known to lower blood pressure.
Adverse Reactions
Side Effects
Dry mouth, constipation, insomnia, increased sweating,
tachycardia, vertigo, urinary hesitance/retention and impotence. Impotence was
mainly observed in patients treated with doses greater than 8 mg/day.
Overdose
In a few cases during clinical trials, doses higher than
that recommended were administered to patients (12 to 20 mg/day) for a period
ranging from a few days to a few weeks during clinical studies.
Treatment-emergent adverse events included postural hypotension, anxiety and
hypertension.
Two cases of self-overdosing with up to 52 mg of
reboxetine have been reported. No serious adverse events were observed.
Treatment: In the case of overdose, close
supervision including monitoring of cardiac function and vital signs is
recommended.
Dosage
HOW TO USE THIS MEDICINE:
The onset of the clinical effect is generally seen after
14 days from start of treatment.
Use in adults
The recommended therapeutic dose is 4 mg BID (8 mg/day) administered orally.
After 3 weeks, the dose can be increased up to 10 mg/day in case of incomplete
clinical response.
Use in the elderly (age greater than 65)
The recommended therapeutic dose is 2 mg BID (4 mg/day) administered orally.
This dose can be increased up to 6 mg/day in case of incomplete clinical
response after 3 weeks from starting reboxetine.
Use in children
There are no data available on the use of reboxetine in children.
Use in patients with renal or hepatic
insufficiency
The starting dose in patients with renal or moderate to severe hepatic
insufficiency should be 2 mg BID which can be increased based on patient
tolerance.
Storage
Keep out of the reach of children in a container that
small children cannot open.
Store at room temperature between 15 and 30°C (59
and 86°F). Throw away any unused medicine after the expiration date.
NOTE: This information is not intended to cover
all possible uses, precautions, interactions, or adverse effects for this drug.
If you have questions about the drug(s) you are taking, check with your health
care professional.
