Dosulepin

Registered South African indications: 

• Depression

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients 
• Acute phase of myocardial infarction 
• Heart block
• Pregnancy < 12 weeks

Cautions

• Pregnancy > 12 weeks
• Renal impairment 
• Hepatic impairment 
• Elderly 
• Children
• Porphyria 
• Hyperthyroidism 
• Epilepsy 
• Closed angle glaucoma
• Urinary retention 
• Prostatic hypertrophy 
• Constipation
• Diabetes mellitus 
• May impair ability to drive and operate machinery 

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

Depression 

• Oral (cap, tab): Initial: 25mg, 8hrly; Maintenance: 75-150mg, dly

Maintenance dose can be given as a single dose at night or in 3 divided doses

No information available 

Pregnancy

• FDA Pregnancy Category Not Rated (NR)

Breastfeeding

• Compatible

Renal Impairment

• Caution; no information available

Hepatic Impairment

• Caution; no dose adjustment recommend 

Elderly 

• Caution; dose adjustment recommended

Porphyria Information

• Not yet classified (NC)

Drugs in Sport

• Permitted - No warning

Central Nervous System Disorders

• Drowsiness
• Insomnia
• Nervousness
• Headache
• Peripheral neuropathy 
• Tremor
• Dizziness
• Ataxia
• Fatigue
• Seizures
• Speech difficulty 
• Confusion 
• Delirium 

Cardiovascular Disorders

• Palpitations
• Tachycardia 
• Orthostatic hypotension
• Hypertension 
• Conduction defects
• Cardiac arrhythmias
• Sudden death

Gastrointestinal Disorders

• Dry mouth
• Constipation 
• Paralytic ileus 
• Stomatitis 
• Nausea and vomiting
• Gastric irritation

Hepatobiliary Disorders

• Cholestatic jaundice  

Genitourinary Disorders

• Urinary retention
• Impotence 

Endocrine and Metabolic Disorders

• Anorexia
• Increased weight
• Decreased weight
• Inappropriate appetite

Musculoskeletal Disorders

• Weakness 

Skin and Subcutaneous Tissue Disorders

• Allergic skin reactions
• Photosensitivity 

Immune, Blood and Lymphatic System Disorders

• Eosinophilia 
• Bone marrow depression 
• Thrombocytopaenia
• Leucopaenia 
• Agranulocytosis 

Sensory Disorders

• Sour or metallic taste 
• Blurred vision
• Disturbances in accommodation 

• Central nervous system depressants 
• Monoamine oxidase inhibitors 
• Local anaesthetics 
• Sympathomimetic agents 
• Anticholinergics 
• Antihypertensives
• Neuroleptics
• Cimetidine
• Antiepileptics 
• Barbiturates 
• Methylphenidate
• Oral contraceptives
• Oestrogens 
• Thyroid preparations 
• Clonidine
• Guanethidine
• Bethanidine 
• Debrisoquine

None routine 

Dosulepin binds to the noradrenaline and serotonin transporter in an equipotent manner and inhibits the reuptake activity, thereby increasing the free levels of noradrenaline and serotonin at the synaptic cleft.

Capsule 25mg

• Prothiaden (Abbott) originator
• Thaden (Pharmacare)

Tablet 75mg

• Sandoz Dothiepin (Sandoz)
• Thaden (Pharmacare)