Naphazoline/ Phenylephrine/ Chlorobutanol

Registered South African indications:

• Nasal congestion

Contraindications

• Hypersensitivity to the active ingredient or any of the excipients in this combination product
• Coadministration with monoamine oxidase inhibitors or within 14 days of their use
• Presence of high blood pressure
• Thyrotoxicosis
• Patients with cardiovascular disease

Cautions

Caution in the following patient groups

• Pregnancy 
• Breastfeeding
• Children

Excessive or prolonged use

• May lead to rebound congestion or rhinorrhoea

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

Nasal congestion

Naphazoline/ Phenylephrine/ Chlorobutanol
5/50/100 (mg/20ml)

• Nasal (dro): 2 drops in each nostril, 4hrly

---

Excessive or prolonged use may lead to rebound congestion or rhinorrhoea

Use with special precaution in children

Recommendations for this combination product as per highest risk category when comparing individual active ingredients

Pregnancy

• FDA Pregnancy Category C (Naphazoline, Phenylephrine)

Breastfeeding

• Caution; not recommended (Phenylephrine)

Renal Impairment

• No dose adjustment recommended (Naphazoline, Phenylephrine)

Hepatic Impairment

• No dose adjustment recommended (Naphazoline, Phenylephrine)

Elderly

• No dose adjustment recommended (Naphazoline, Phenylephrine)

Combination products may have additional pharmacological effects not accounted for by the action of the individual ingredients

Naphazoline

Central Nervous System Disorders

• Headache

Gastrointestinal Disorders

• Nausea

Sensory Disorders

• Rebound congestion
• Rhinorrhoea

Phenylephrine
Central Nervous System Disorders

• Headache 
• Anxiety 
• Restlessness 
• Tremor 
• Insomnia 
• Confusion 
• Irritability 
• Weakness 
• Psychotic states 
• Cerebral haemorrhage 

Cardiovascular Disorders

• Hypertension 
• Palpitations 
• Reflex bradycardia 
• Cardiac arrest 
• Angina 
• Hypotension 

Respiratory Disorders

• Rhinitis medicamentosa 
• Pulmonary oedema 
• Dyspnoea

Gastrointestinal Disorders

• Vomiting 
• Reduced appetite 

Genitourinary Disorders

• Difficulty with micturition 
• Urinary retention 

Endocrine and Metabolic Disorders

• Altered glucose metabolism 

Skin and Subcutaneous Tissue Disorders

• Nasal irritation

Others

• Sweating 
• Hypersalivation

Combination products may have additional pharmacological effects not accounted for by the action of the individual ingredients

Naphazoline

• Halothane

Phenylephrine

• Monoamine oxidase inhibitors 
• Tricyclic antidepressants 
• Adrenergic neuron-blocking agents 
• Centrally acting antiadrenergic agents

None routine

Naphazoline
Naphazoline is an alpha adrenoreceptor agonist which causes vasoconstriction in the arterioles of the nasal passages.

Phenylephrine
Phenylephrine is a sympathomimetic amine that acts agonistically at alpha-1 adrenoreceptors. Binding at these receptors causes vasoconstriction and decreases nasal blood flow which results in alleviation of nasal congestion.

Chlorobutanol
This ingredient has no pharmacological effect.

COMBINATION PREPARATIONS

Naphazoline/ Phenylephrine/ Chlorobutanol

Nasal drops (per 20ml) 5mg/50mg/100mg 

• Nazo-Ezze nose drops (Pharma Q)
• Nitro nose drops (Thebe Medicare)
• Sinucon nasal drops (Akacia)