Phenylephrine/ Naphazoline

Registered South African indications:

• Colds
• Influenza
• Sinusitis
• Rhinitis
• Hayfever

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

Contraindications

• Hypersensitivity to the active ingredient or any of the excipients in this combination product
• Severe coronary disease
• Hypertension
• Cardiovascular disease
• Hyperthyroidism
• Patients being treated with monoamine oxidase inhibitors or within 14 days of stopping such treatment
• Pregnancy

Cautions

Use with caution in the following patient groups

• Breastfeeding
• Not recommended for children under the age of two years

Phenylephrine hydrochloride

Patients susceptible to sympathomimetic effects

• This combination product should be avoided or only used with great caution in patients susceptible to sympathomimetic effects particularly those with hyperthyroidism, cardiovascular disease such as ischaemic heart disease, arrhythmia or tachycardia, occlusive vascular disorders including arteriosclerosis, hypertension or aneurysms

Excessive use

• Excessive use can lead to rebound congestion as well as ventricular arrhythmias

Concomitant use with other agents

• It should be avoided in patients receiving tricyclic antidepressants. Patients receiving guanethidine and similar adrenergic neuron blocking agents are extremely sensitive to the hypersensitive (and mydriatic) effects of phenylephrine
• Phenylephrine may also markedly reverse the hypotensive effects of reserpine and methyldopa

Naphazoline nitrate

Children

• It should be used with special caution in children

Prolonged use

• If used for more than a few days severe rebound congestion and rhinorrhoea may occur

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

Colds
Influenza
Sinusitis
Rhinitis
Hayfever
- Causing nasal congestion

Phenylephrine/ Naphazoline
62.5/6.25 (mg/25ml)

• Nasal (dro): 2-3 drops per nostril, 8-24hrly; Max: 3 doses/24hrs

62.5/5.64 (mg/25ml)

• Nasal (nas): Apply 1-2 sprays per nostril, 4hrly; Max: 3 doses/24hrs

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See additional prescribing points for administration directions

Paed. forms avail. in SA and covered in this monograph: dro, nas 

Colds
Influenza
Sinusitis
Rhinitis
Hayfever
- Causing nasal congestion

Phenylephrine/ Naphazoline
62.5/6.25 (mg/25ml)

• Younger than 3 years: Not established for use
• Between 3-12 years: Nasal (dro): 1-2 drops per nostril, 8-24hrly; Max: 3 doses/24hrs
• Older than 12 years: See adult dosage

62.5/5.64 (mg/25ml)

• Younger than 2 years: Not established for use
• Older than 2 years: See adult dosage

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Use sparingly in children

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See additional prescribing points for administration directions

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

Pregnancy

• Contraindicated

Breastfeeding

• Caution; not recommended (Phenylephrine)

Renal Impairment

• No dose adjustment recommended (Phenylephrine, Naphazoline)

Hepatic Impairment

• No dose adjustment recommended (Phenylephrine, Naphazoline)

Elderly

• No dose adjustment recommended (Phenylephrine, Naphazoline)

Porphyria Information

• Not yet classified (NC)

Drugs in Sport

• Permitted - No warning

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

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 

Naphazoline
Central Nervous System Disorders

• Headache
• Coma

Cardiovascular Disorders

• Cardiac arrhythmias
• Hypertension
• Hypotension

Respiratory Disorders

• Respiratory depression

Endocrine and Metabolic Disorders

• Hyperhidrosis
• Hyperglycaemia
• Hypothermia

Skin and Subcutaneous Tissue Disorders

• Local irritation
• Redness
• Discomfort

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

Phenylephrine

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

Naphazoline

• Monoamine oxidase inhibitors

None routine

Administration directions

Drops

• Tilt the head back and instil the drops into each nostril. Then throw the head forward and down and maintain this position for at least 30 seconds. The first instillation prepares the way for deeper penetration by the second, which should be administered 2 to 3 minutes later. The effects will then last up to four hours

Spray

• Place the tip of the spray in the nostril, squeeze the plastic bottle quickly and firmly while breathing in, at the same time closing the other nostril. Treat the other nostril similarly. For lasting effects repeat in 2 to 3 minutes

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 alleviates nasal congestion. 

Naphazoline
Naphazoline is a vasoconstrictor, which acts by stimulating alpha-adrenergic receptors in arterioles. When applied topically to mucous membranes, naphazoline causes vasoconstriction that shrinks the mucous membranes, promotes drainage and improves ventilation.

COMBINATION PREPARATIONS

Phenylephrine/ Naphazoline

Nasal drops (per 25ml) 62.5mg/6.25mg

• ENT Nasal Drops (Adcock Ingram)
• Nasdro (Adcock Ingram)
• Rinol (Medicine Developers)

Nasal spray (per 25ml) 62.5mg/5.64mg

• ENT Nasal Spray (Adcock Ingram)