caffeine citrate: clinical use

Prescribing considerations

• Initiate only under a clinician experienced in neonatal intensive care, with suitable surveillance and monitoring facilities.
• Confirm apnoea of prematurity as a diagnosis of exclusion and investigate infection, anaemia, metabolic disturbance, cardiopulmonary disease, neurological disease and obstruction where appropriate.
• Prescribe and communicate quantities consistently as caffeine citrate, not caffeine base; available products have different concentrations.
• Use caution with seizure disorders, significant cardiovascular disease, gastro-oesophageal reflux, and renal or hepatic impairment.
• Account for maternal caffeine exposure and previous theophylline treatment.

Contraindications and cautions

• Hypersensitivity to caffeine citrate or any product excipient.

Monitoring

• Frequency and severity of apnoea, bradycardia and oxygen desaturation
• Heart rate, rhythm and blood pressure
• Clinical response and signs of central nervous system or cardiovascular stimulation
• Feeding tolerance, abdominal findings and signs of necrotising enterocolitis
• Fluid balance, urine output, electrolytes, glucose, growth and nutritional needs
• Plasma caffeine where response is inadequate, toxicity is suspected, treatment is prolonged, interacting medicines are used, or renal or hepatic impairment is present

Clinical pharmacology

Caffeine citrate dissociates rapidly to caffeine and citrate. Caffeine antagonises adenosine receptors and stimulates respiratory drive. Premature newborns have limited hepatic metabolism and predominantly renal elimination, producing a much longer half-life and greater accumulation risk than adults.

Formulation and product differences

• Selected products include separate clear, colourless oral and injectable solutions containing 10 mg/mL caffeine citrate.
• Selected 20 mg/mL products include a combined infusion/oral solution and an infusion-labelled product whose SmPC also describes oral effectiveness.
• Caffeine citrate concentration is twice the equivalent caffeine-base concentration, creating a clinically important calculation and product-selection risk.
• Fenapin ampoules are preservative-free, single-use containers; unused solution must be discarded.

Solution for infusion

Route: Intravenous

Strengths: 20 mg/mL

Oral solution

Route: Oral

Strengths: 10 mg/mL, 20 mg/mL

Injection

Route: Parenteral

Strengths: 10 mg/mL