Clonidine

Registered South African indications:

• Prevention of migraine

Registered South African contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Porphyria
• Severe bradydysrhythmia resulting from either sick-sinus syndrome or AV block of 2nd or 3rd degree

Contraindications registered in other jurisdictions

• Hypersensitivity to the active ingredient or any of its excipients
• Severe bradyarrhythmia resulting from either sick-sinus syndrome or AV block of 2nd or 3rd degree
• Rare hereditary conditions that may be incompatible with an excipient of the product
  -  Galactose intolerance
  - Lapp lactase deficiency
  - Glucose-galactose malabsorption

• Pregnancy
• Breastfeeding
• Moderate to severe renal impairment (eGFR <50ml/min/1.73m²)
• Elderly
• Abrupt discontinuation
• Cerebrovascular disease
• Coronary insufficiency
• Cardiac failure
• Occlusive peripheral vascular disorders
• Constipation
• History of depression
• Cardiac conduction abnormalities
• Fructose intolerance (South African recommendations)
• Glucose-galactose malabsorption (South African recommendations)
• Sucrase-isomaltase insufficiency (South African recommendations)
• Patients who wear contact lenses

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

South African registered indications and dosages

Prevention of migraine

• Oral (tab): Initial: 25μg, twice daily (in the morning and evening); Increase to 75μg, twice daily if necessary 

The coated tablet should not be chewed because of bad taste

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

Paed. dosages below include:

• South African Standard Treatment Guidelines indications and dosages
• South African registered indications and dosages

South African Standard Treatment Guidelines indications and dosages

• Click here for the Pain Control Chapter (Standard Treatment Guidelines And Essential Medicines List For South Africa, Hospital Level, Paediatrics, 2023 Edition)
• Click here for the Anaesthetics Chapter (Standard Treatment Guidelines And Essential Medicines List For South Africa, Hospital Level, Paediatrics, 2023 Edition)

South African registered indications and dosages

• Not established for use in children below 18 years

Pregnancy

• Caution
• There are limited amount of data from the use of clonidine in pregnant women. Clonidine should only be used in pregnancy if considered essential. Careful monitoring of mother and child is recommended. Clonidine passes the placental barrier and may lower the heart rate of the foetus. Postpartum, a transient rise in blood pressure in the newborn cannot be excluded
• There is no adequate experience regarding the long-term effects of prenatal exposure. Non-clinical studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity

Breastfeeding

• Caution; not recommended
• Clonidine is excreted in human milk. However, there is insufficient information on the effect on newborns. The use of clonidine is therefore not recommended during breastfeeding

• eGFR ≥50ml/min/1.73m²: No dose adjustment recommended
• eGFR <50ml/min/1.73m²: Caution; dose adjustment recommended

• No dose adjustment recommended

• Caution; dose adjustment recommended
  Initiate at lower end of the dosage range: 25μg, 12hrly; Max: 50μg/24hrs

Central Nervous System Disorders

• Confusional state
• Delusional perception
• Depression
• Hallucination
• Decreased libido
• Nightmare
• Sleep disorder
• Dizziness
• Headache
• Paraesthesia
• Sedation
• Fatigue

Cardiovascular Disorders

• Atrioventricular block
• Bradyarrhythmia
• Sinus bradycardia
• Orthostatic hypotension
• Raynaud's phenomenon

Respiratory Disorders

• Nasal dryness

Gastrointestinal Disorders

• Colonic pseudo-obstruction
• Constipation
• Dry mouth
• Nausea and vomiting
• Salivary gland pain

Genitourinary Disorders

• Erectile dysfunction

Endocrine and Metabolic Disorders

• Gynaecomastia

Skin and Subcutaneous Tissue Disorders

• Alopecia
• Pruritus 
• Rash
• Urticaria

Sensory Disorders

• Accommodation disorder
• Decreased lacrimation

• Antihypertensive agents 
• Alpha-2 blockers
• Cardiac glycosides
• Tricyclic antidepressants  
• Central nervous system depressants

None routine. Specific cases may require

• Vital signs

Centrally acting alpha-2 adrenergic agonist. It diminishes the responsiveness of peripheral vessels to constrictor and dilator stimuli, thereby preventing the vascular changes associated with migraine.

Tablet 0.025mg

• Dixarit (Ingelheim) originator
• Menograine (Pharmacare)