Edronax (Tablets) Instructions for Use

ATC Code

N06AX18 (Reboxetine)

Active Substance

Reboxetine (Rec.INN WHO registered)

Clinical-Pharmacological Group

Antidepressant

Pharmacotherapeutic Group

Antidepressant

Pharmacological Action

Antidepressant. The antidepressant effect develops within 2 weeks after the start of treatment. It improves work capacity and social adaptation of patients.

Reboxetine highly selectively inhibits the reuptake of norepinephrine by presynaptic nerve endings, promotes the accumulation of neurotransmitters in the synaptic cleft and enhances noradrenergic transmission. It has no affinity for neurotransmitter receptors.

Indications

• Depressive states for the management of the acute phase and for maintenance therapy.

This includes the treatment of major depressive episodes and recurrent depressive disorders as classified by standard diagnostic codes.

The therapeutic objective is the resolution of depressive symptoms and the prevention of relapse in susceptible patients.

ICD codes

Dosage Regimen

Administer orally without regard to meals. The standard initial adult dosage is 4 mg taken twice daily, resulting in a total daily dose of 8 mg.

If the clinical response is insufficient after a minimum of three weeks, the dose may be increased to a maximum of 10 mg per day.

For elderly patients over 65 years of age and for patients with renal impairment or moderate hepatic impairment, initiate therapy at a reduced dose of 2 mg twice daily (4 mg/day). The dose may be increased to a maximum of 6 mg per day after three weeks if necessary and tolerated.

Adverse Reactions

Common adverse reactions include insomnia, dizziness, dry mouth, constipation, increased sweating, and tachycardia.

Difficulty with urination (urinary hesitation or retention) may occur. Sexual dysfunction, such as impotence, is more frequently reported at doses exceeding 8 mg per day.

Monitor for these effects, particularly during the initial phase of treatment and following dose adjustments.

Contraindications

• Hypersensitivity to reboxetine or to any of the excipients in the formulation.

• Concomitant use with monoamine oxidase inhibitors (MAOIs) is contraindicated due to the risk of serious reactions. A sufficient washout period must be observed when switching between these therapies.

Use is not recommended in patients with severe hepatic impairment or severe urinary retention.

Use in Pregnancy and Lactation

Use during pregnancy is possible if the expected therapeutic effect outweighs the potential risk to the fetus.

Use during breastfeeding is not recommended, because there are no data on safety of use in nursing women.

Use in Renal Impairment

Use with caution in patients with severe renal insufficiency.

Pediatric Use

Reboxetine should be used with caution in children (safety and efficacy of use have not been established).

Special Precautions

Use with caution in patients with a history of seizures (if a seizure develops during treatment, administration should be discontinued), with bipolar affective disorder, severe renal insufficiency, urinary retention, glaucoma, arterial hypotension.

Should not be used concomitantly with MAO inhibitors.

Drug Interactions

No clinically significant pharmacokinetic interactions have been identified with fluoxetine, paroxetine, or lorazepam.

Concomitant use with other antidepressants, including tricyclic antidepressants, MAO inhibitors, and serotonin reuptake inhibitors, as well as with lithium salts, has not been systematically studied in clinical trials; exercise caution.

Use with drugs that inhibit the CYP3A4 isoenzyme (e.g., ketoconazole) may increase reboxetine plasma concentrations. Avoid concomitant use with potent CYP3A4 inhibitors.

Overdose

Symptoms of overdose are primarily related to excessive pharmacological effects and may include severe hypertension, tachycardia, insomnia, and anxiety.

General supportive and symptomatic measures are recommended. There is no specific antidote. Ensure adequate hydration and monitor cardiac function and vital signs.

Gastric lavage may be considered if performed soon after ingestion. Activated charcoal can be administered to reduce absorption.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.