Reboxetine

Registered South African indications:

• Depression

Contraindications 

• Hypersensitivity to the active ingredient or any of its excipients

Cautions 

• Pregnancy
• Breastfeeding
• Renal impairment
• Hepatic impairment
• Elderly
• Children
• History of seizures
• Bipolar patients
• History of suicide-related events or suicidal ideation
• Serious concomitant systemic illnesses
• Urinary retention
• Prostatic hypertrophy
• Glaucoma
• History of cardiovascular disease
• Increased intraocular pressure
• Risk factors for acute narrow angle glaucoma
• May impair ability to drive and operate machinery

Forms avail. in SA and covered in this monograph: tab

Acute treatment of depressive illness
Major depression

• Oral (tab): Initial: 4mg, 12hrly; Titrate at 3-4 week intervals to up to 10mg, dly, if needed; Max: 12mg/24hrs

Not established for use in children below 18 years

Pregnancy

• Caution
• No clinical trial data on exposure to reboxetine during pregnancy are available. However, postmarketing safety data on a very limited number of exposed pregnancies indicate no adverse effects of reboxetine on pregnancy or on the health of the foetus/newborn child
• Animal studies in general do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development or parturition. Some impairment of growth and development has been noted in rat neonates
• Reboxetine should only be used in pregnancy if the potential benefits of treatment to the mother outweigh the possible risks to the developing foetus

Breastfeeding

• Caution
• Reboxetine is known to be excreted in breast milk. The level of active substance transferred in breast milk is anticipated to be very low, however, there is insufficient information to exclude a risk to the nursing infant. The use of reboxetine during breastfeeding can be considered if the potential benefits outweigh the risk for the child

Fertility

• There is no clinical trial data on fertility. However, in animal studies no effect on fertility parameters were observed

Renal Impairment

• Caution; dose adjustment recommended
  Initial: 2mg, 12hrly; May be increased based on patient's tolerance

Hepatic Impairment

• Caution; dose adjustment recommended
  Initial: 2mg, 12hrly; May be increased based on patient's tolerance

Elderly

• Caution; no dose adjustment recommended
  Use is not recommended
  Limit use to a maximum of 4mg/24 hrs. Consider alternatives (SSRI or SNRI) in case of poor/no response

Porphyria Information

• Probably not porphyrinogenic (PNP)
  Very common and common side effects that can be potentially porphyrinogenic through reduction in carbohydrate intake and that also can be confused with an acute porphyria attack are decreased appetite, paresthesia, hypertension, tachycardia, constipation, nausea and vomiting. Other common side effects are headache, dizziness, agitation and anxiety

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Insomnia
• Agitation
• Anxiety
• Aggressive behaviour
• Hallucination
• Suicidal ideation or behaviour
• Dizziness
• Headache
• Paraesthesia
• Akathisia
• Irritability

Cardiovascular Disorders

• Tachycardia
• Palpitations
• Vasodilatation
• Hypotension
• Hypertension
• Peripheral coldness
• Raynaud's phenomenon

Gastrointestinal Disorders

• Dry mouth
• Constipation
• Nausea and vomiting

Genitourinary Disorders

• Sensation of incomplete bladder emptying
• Urinary tract infection
• Dysuria
• Urinary retention
• Erectile dysfunction
• Ejaculatory pain
• Ejaculatory delay
• Testicular pain

Endocrine and Metabolic Disorders

• Decreased appetite
• Hyponatraemia
• Chills

Skin and Subcutaneous Tissue Disorders

• Hyperhidrosis
• Rash
• Allergic dermatitis

Sensory Disorders

• Accommodation disorder
• Mydriasis
• Glaucoma
• Increased intraocular pressure
• Vertigo
• Dysgeusia

• Monoamine oxidase inhibitors
• Linezolid
• Methylene blue
• Antidepressants
• Lithium
• CYP3A4 inhibitors
• Ketoconazole
• Nefazodone
• Erythromycin
• Fluvoxamine
• CYP3A4 inducers 
• Phenobarbital
• Carbamazepine
• Phenytoin
• Rifampicin
• Lorazepam
• Ergot derivatives
• Potassium-depleting diuretics 
• Fluoxetine
• St John's wort
• Food

None routine

Reboxetine is a highly selective and potent inhibitor of noradrenaline reuptake. It has only a weak effect on the 5-HT reuptake and does not affect the uptake of dopamine. Noradrenaline reuptake inhibition and the consequent increase of noradrenaline availability in the synaptic cleft and modification of noradrenergic transmission, reportedly is among the most relevant mechanisms of action of known antidepressant drugs.

Tablet 4mg

• Edronax (Pfizer) originator