Fluvoxamine Maleate

Registered South African indications:

• Depression
• Obsessive-compulsive disorder

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients 
• Coadministration with monamine oxidase inhibitors or within 14 days of their use (irreversible monoamine oxidase inhibitor)
• Coadministration with monamine oxidase inhibitors or within 1 day of their use (reversible monoamine oxidase inhibitor)
• Coadministration with tizanidine 

Cautions

• Pregnancy 
• Breastfeeding
• Renal impairment
• Hepatic impairment
• Elderly
• Children, except those with obsessive-compulsive disorder 
• History of suicide-related events
• Significant suicidal ideation
• Abrupt withdrawal 
• History of mania or hypomania 
• Seizure disorders 
• Diabetes mellitus 
• Increased intraocular pressure or those at risk of acute narrow angle glaucoma
• History or predisposing conditions for bleeding
• Post myocardial infarction 
• Electroconvulsive therapy

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

Major depressive episode

• Oral (tab): 100-200mg, dly at night; Max: 300mg/24hrs

Obsessive-compulsive disorder - Severe 

• Oral (tab): Initial: 50mg, dly at night for 3-4 days; Maintenance: 100-300mg/24hrs; Treatment duration: 10 weeks; Max: 300mg/24hrs

For responding patients, it is reasonable to consider treatment beyond 10 weeks

A total daily dose of more than 150mg should be given in 2-3 divided doses

Paed. forms avail. in SA and covered in this monograph: tab 

Obsessive-compulsive disorder

Younger than 8 years

• Not established for use

Between 8-18 years

• Oral (tab): Initial: 25mg, dly at night; Titrate by 25mg at 4-7 day intervals; Max: 200mg/24hrs

Older than 18 years

• See adult dosage 

A total daily dose of more than 50mg should be given in 2 divided doses, with the larger dose given at bedtime 

Pregnancy 

• Caution; not recommended
• Epidemiological data has suggested that the use of Selective Serotonin Reuptake Inhibitors (SSRIs) in pregnancy, particularly in late pregnancy, may increase the risk of perisistent pulmonary hypertension in the newborn (PPHN). The observed risk was approximately 5 cases per 1000 pregnancies. In the general population, 1 to 2 cases of PPHN per 1000 pregnancies occur
• Reproduction toxicity studies in animals revealed treatment-related increases in embryotoxicity (embryofoetal death, foetal eye abnormalaties). The relevance to humans is unknown
• The safety margin for reproductive toxicity is unknown
• Fluvoxamine should not be used during pregnancy unless the clinical condition of the woman requires treatment with fluvoxamine
• Isolated cases of withdrawal symptoms in the newborn child have been described after the use of fluvoxamine at the end of pregnancy
• Some newborns experience feeding and/or respiratory difficulties, seizures, temperature instability, hypoglycaemia, tremor, abnormal muscle tone, jitteriness, cyanosis, irritability, lethargy, somnolence, vomiting, difficulty in sleeping and constant crying after third-trimester exposure to SSRIs and may require prolonged hospitalization

Breastfeeding 

• Caution; not recommend 
• Fluvoxamine is excreted via human milk in small quantities. Therefore, the drug should not be used by women who breastfeed

Fertility

• Fluvoxamine should not be used in patients attempting to conceive unless the clinical condition of the patient requires treatment with fluvoxamine
• Reproductive toxicity studies in animals have shown that fluvoxamine impairs male and female fertility. The safety margin for this effect was not identified
• The relevance of these findings to humans is unknown
• Animal data has shown that fluvoxamine may affect sperm quality
• Human case reports with some SSRIs have shown that an effect on sperm quality is reversible. The impact on human fertility has not been observed so far

Renal Impairment

• Caution; dose adjustment recommended

Hepatic Impairment

• Caution; dose adjustment recommended

Elderly

• Caution; no dose adjustment recommended  

Porphyria Information

• Probably not porphyrinogenic (PNP) 

Central Nervous System Disorders

• Agitation
• Nervousness
• Anxiety
• Insomnia
• Somnolence
• Tremor
• Headache
• Dizziness
• Extrapyramidal disorder
• Ataxia
• Seizure
• Serotonin syndrome
• Neuroleptic malignant syndrome-like events
• Paresthesia
• Dysgeusia
• Psychomotor restlessness
• Asthenia
• Drug withdrawal syndrome
• Neonatal drug withdrawal syndrome

Cardiovascular Disorders

• Palpitations
• Tachycardia
• Orthostatic hypotension

Gastrointestinal Disorders

• Abdominal pain
• Constipation 
• Nausea and vomiting
• Dyspepsia
• Diarrhoea
• Dry mouth 

Hepatobiliary Disorders

• Abnormal hepatic function 

Genitourinary Disorders

• Abnormal ejaculation 
• Anorgasmia 
• Menstrual disorders 
• Urinary retention
• Urinary incontinence
• Pollakiuria
• Nocturia
• Enuresis

 Endocrine and Metabolic Disorders

• Hyperprolactinemia
• Inappropriate antidiuretic hormone secretion
• Galactorrhoea 
• Anorexia
• Hyponatraemia
• Increased weight
• Decreased weight 

Musculoskeletal Disorders

• Arthralgia
• Myalgia
• Fractures 

Skin and Subcutaneous Tissue Disorders

• Hyperhydrosis
• Cutaneous hypsensitivity reactions 
• Photosensitivity reactions

Sensory Disorders

• Glaucoma
• Mydriasis
• Dysgeusia

• Serotonergic agents
• Lithium 
• Tryptophan 
• Alcohol 
• Oral anticoagulants 
• Monoamine oxidase inhibitors 
• Thiorizidine
• Caffeine
• Terfenadine
• Astemizole
• Cisapride
• Sildenafil
• CYP1A2 inhibitors
• CYP2C19 inhibitors
• Tacrine
• Theophylline
• Methadone
• Mexiletine
• Phenytoin
• Carbamazepine 
• Cyclosporine
• Antidepressants
• Neuroleptics
• Benzodiazepines
• Ropinirole
• Propranalol
• Warfarin

None routine. Specific cases may require

• Hepatic function
• Renal function

The mechanism of action of fluvoxamine is thought to be related to selective serotonin reuptake inhibition in brain neurones, with minimum interference on noradrenergic processes. Fluvoxamine has negligible binding capacity to alpha adrenergic, beta adrenergic, histaminergic, cholinergic, dopaminergic or serotonergic receptors.

Tablet 100mg

• Faverin (Abbott) originator
• Fluvoxamine-Hexal (Sandoz)
• Fluvoxamine Oethmaan (Oethmaan)
• Luvox (Abbott)