Reboxetine Full Prescribing Information

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Brand Name: Edronax
Generic Name: Roboxetine

Reboxetine (Endronax) is an antidepressant drug used in the treatment of clinical depression, panic disorder and ADHD. Uses, dosage, side-effects of Reboxetine.

Other Brand Names: Norebox, Prolift, Solvex, Davedax, Vestra

Contents:

Description
Indications
Precautions
Drug Interactions
Adverse Reactions
Overdose
Dosage
How Stored

Description

Reboxetine (Edronax) is used for the treatment of depression.

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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.

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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 bipolar 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.

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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.

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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.

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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.

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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.

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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.

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How Stored

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.


The information in this monograph is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects. This information is generalized and is not intended as specific medical advice. If you have questions about the medicines you are taking or would like more information, check with your doctor, pharmacist, or nurse. Last updated 3/03.

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