Reboxetine Mesylate indications
Acute 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.
The onset of the clinical effect is seen after 14 days from the start of treatment.
Uses of Reboxetine Mesylate in details
Reboxetine Mesylate is used to treat depressive illness including major depression.
Reboxetine Mesylate description
Reboxetine Mesylate is an antidepressant drug used in the treatment of clinical depression, panic disorder and ADD/ADHD. Its mesylate (i.e. methanesulfonate) salt is sold under tradenames including Edronax, Norebox, Prolift, Solvex, Reboxetine Mesylate or Vestra. Reboxetine Mesylate has two chiral centers, but it only exists as two enantiomers, (R,R)-(-)- and (S,S)-(+)-Reboxetine Mesylate.
Reboxetine Mesylate dosage
Oral
Depression
Adult: 4 mg bid, may increase to 10 mg daily after 3-4 wk if necessary. Max: 12 mg daily.
Elderly: 2 mg bid, may increase dose to 6 mg/day after 3 ww if required.
Renal impairment: Initiate with lower doses: 2 mg bid; may increase gradually according to tolerance.
Hepatic impairment: Initiate with lower doses: 2 mg bid; may increase gradually according to tolerance.
Reboxetine Mesylate interactions
In vitro and in vivo studies have shown that Reboxetine Mesylate is not metabolized by CYP-450 2D6. Therefore, no special precautions are necessary for individuals deficient in this enzyme. Likewise, inhibitors of this enzyme eg, fluoxetine and paroxetine, are unlikely to have an effect on Reboxetine Mesylate pharmacokinetics.
In vitro studies have shown that Reboxetine Mesylate does not inhibit the activity of the following CYP-450 isozymes: CYP1A2, CYP2C9, CYP2C19 and CYP2E1. At high concentrations, Reboxetine Mesylate inhibits CYP2D6, but the clinical significance of this observation is unknown. In vitro studies show that Reboxetine Mesylate is a very weak inhibitor of CYP3A4.
In vitro metabolism studies indicate that Reboxetine Mesylate is metabolized by the CYP3A4 isozyme of CYP-450. Therefore, compounds which modulate the activity of this isozyme, would be expected to increase plasma concentrations of Reboxetine Mesylate.
Reboxetine Mesylate side effects
Adverse effects in Reboxetine Mesylate-treated patients appear early, tend to diminish with time and are of mild to moderate severity.
In placebo-controlled studies, adverse events were reported in approximately 70% of Reboxetine Mesylate-treated patients and in approximately 60% of placebo-treated patients. Discontinuation rates for adverse events were similar between Reboxetine Mesylate- and placebo-treated patients and were <10%.
Adverse events that occurred with statistically greater frequency in Reboxetine Mesylate-treated patients than in placebo-treated patients include: Dry mouth, constipation, insomnia, increased sweating, tachycardia, vertigo, urinary hesitancy/retention and impotence. Impotence was mainly observed in patients treated with doses >8 mg/day.
The most relevant between gender difference in adverse event rate was related to the frequency of urinary hesitancy/retention which occurred more often in male patients.
The overall frequency (approximately 1%) of serious adverse events in adult Reboxetine Mesylate-treated patients was not different from that found in the placebo-treated population.
The only modification in vital signs was an increase in heart rate upon standing. Apart from tachycardia, no consistent changes in electrocardiogram (ECG) tracings were observed during Reboxetine Mesylate treatment in adult patients. In the elderly population, newly observed rhythm disorders (mainly tachycardia) and conduction disorders were apparent in the ECG in approximately 15% of cases.
In studies of longer than 8 weeks, newly emergent adverse events were reported in approximately 30% of the Reboxetine Mesylate-treated patients and approximately 25% of the placebo-treated patients. These adverse events were associated with discontinuation rates of 4% and 1%, respectively.
Constipation was the only event which was observed more commonly in the Reboxetine Mesylate-treated group.
Discontinuation emergent adverse events were infrequent and occurred in approximately 4% of the Reboxetine Mesylate-treated patients and approximately 6% of placebo-treated patients.
Reboxetine Mesylate contraindications
Hypersensitivity to the constituents of this medicine.
Active ingredient matches for Reboxetine Mesylate:
Reboxetine Mesylate
List of Reboxetine Mesylate substitutes (brand and generic names) | Sort by popularity |
| Unit description / dosage (Manufacturer) | Price, USD |
| Rebodex 4 | |
| Reboxetine 4 | |
References
- PubChem. "Reboxetine". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
- DrugBank. "Reboxetine". http://www.drugbank.ca/drugs/DB00234 (accessed September 17, 2018).
- MeSH. "Adrenergic Uptake Inhibitors". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
Reviews
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Information checked by Dr. Sachin Kumar, MD Pharmacology
