Clonidine
Regulatory sources consulted
- aemps-spc-50669
- PubMed PMID:39394015 ↗
- PubMed PMID:38941125 ↗
- PubMed PMID:42342114 ↗
- CredibleMeds.org
- Clinical Pharmacist Knowledge Base
- RxNorm rxcui 2599 ↗
Approved indications
- Treatment of all forms of arterial hypertension. It can be administered alone or in combination with other antihypertensive agents.
- Clonidine suppression test for the differential diagnosis of pheochromocytoma. · off-label
- Treatment of symptoms of post-traumatic stress disorder (PTSD), particularly for improving sleep quality and reducing nightmares. · off-label
- Perioperative use to reduce blood loss and improve surgical field quality in functional endoscopic sinus surgery (FESS). · off-label
Contraindications
Absolute
- Hypersensitivity to the active substance or to any of the excipients.
- Severe bradycardia (< 50 beats per minute).
- Sick sinus syndrome or second or third degree AV block.
Clinical warnings
- Major warning · Abrupt discontinuation of treatment can cause rebound hypertensive crisis. Withdrawal should be gradual over 2-4 days. — AEMPS SPC
- Major warning · May cause sedation and drowsiness, which are enhanced by alcohol or other CNS depressants. Warn patients about driving or operating machinery. — AEMPS SPC
Drug interactions
- HighTricyclic antidepressants (e.g., Amitriptyline)N06AA
Mechanism: Pharmacodynamic antagonism at central alpha-2 adrenergic receptors, reducing or nullifying the hypotensive effect of clonidine.
Recommendation: Avoid combination or closely monitor blood pressure. A dose adjustment or an alternative antihypertensive may be necessary.
AEMPS SPC
- ModerateBeta-blockers (e.g., Propranolol)C07A
Mechanism: Potentiation of bradycardia. Risk of severe hypertensive crisis if the beta-blocker is withdrawn before clonidine.
Recommendation: If combined therapy must be discontinued, clonidine should be gradually withdrawn several days after the beta-blocker has been stopped.
AEMPS SPC
Adverse events
Common (≥1%)
dizziness · sedation · orthostatic hypotension · dry mouth
Rare but serious
bradycardia · AV block · syncope · rebound hypertension
Pregnancy and lactation
FDA category: C
Not recommended during pregnancy due to insufficient data. It is excreted in breast milk, so breastfeeding is not recommended.
Recent literature (PubMed)
Revisión sistemática de 10 estudios (N=569) sobre el uso de clonidina en TEPT. Aunque la evidencia es de baja calidad, muchos estudios reportaron mejoras en la calidad del sueño, reducción de pesadillas y de síntomas del TEPT. Se necesitan ECA de alta potencia para confirmar la eficacia.
Metaanálisis de 19 ECAs (N=1281) que muestra que la administración de clonidina en cirugía endoscópica funcional de senos paranasales se asocia con una menor pérdida de sangre y una mejor calidad del campo quirúrgico en comparación con placebo, con efectos comparables a la dexmedetomidina.
Revisión sobre el diagnóstico del feocromocitoma. Menciona que el test de supresión con clonidina puede ser útil para diferenciar la hipersecreción endógena de falsos positivos en casos de elevaciones moderadas de normetanefrina.