Paracetamol/ Pseudoephedrine/ Diphenhydramine

Registered South African indications:

• Colds and flu

Contraindications

• Hypersensitivity to the active ingredients or any of the excipients in the combination product
• Severe renal impairment
• Severe hepatic impairment
• Cardiovascular disease 
• Hypertension 
• Hyperthyroidism 
• Phaeochromocytoma
• Closed-angle glaucoma
• Diabetes mellitus 
• Children younger than 10 years 
• Coadministration with sympathomimetic agents
• Coadministration with beta blockers 
• Coadministration with monoamine oxidase inhibitors or within 14 days of their use  

Cautions 

• Pregnancy 
• Breastfeeding
• Mild to moderate renal impairment
• Hepatic impairment 
• Elderly
• Chronic or persistent cough 
• Asthma
• Prostatic hypertrophy 
• Urinary retention
• Risk of angle-closure glaucoma

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

Symptomatic relief of colds and flu
- Coughing
- Headache
- Minor aches and pains
- Nasal congestion

Paracetamol/ Pseudoephedrine/ Diphenhydramine
500/22.5/12.5 (mg)

• Oral (tab): 2 tab, 6hrly; Max: 8 tab/24hrs

1000/45/25 (mg/20ml)

• Oral (liq): 20ml, 6hrly

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

Symptomatic relief of cold and flu
- Coughing
- Headache
- Minor aches and pains
- Nasal congestion

Paracetamol/ Pseudoephedrine/ Diphenhydramine
500/ 22.5/ 12.5 (mg)

• Younger than 6 years: Not indicated for use
• Between 6-12 years: 1 tab, 6hrly; Max: 4 tab/24hrs
• Older than 12 years: See adult dosage

1000/45/25 (mg/20ml) 

• Children older than 12 years: See adult dosage

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

Pregnancy

• FDA Pregnancy Category Not Rated (NR) (Pseudoephedrine)

Breastfeeding

• Caution, not recommended (Pseudoephedrine, Diphenhydramine)

Renal Impairment

• Mild to moderate: Caution; no dose adjustment recommended
• Severe: Contraindicated 

Hepatic Impairment

• Mild to moderate: Caution; no dose adjustment recommended
• Severe: Contraindicated 

Elderly

• Caution; no dose adjustment recommended

Central Nervous System Disorders

• Drowsiness
• Paradoxical stimulation
• Headache 
• Psychomotor impairment 
• Dizziness 
• Tremor 
• Seizures 
• Confusion 
• Depression
• Sleep disturbances 
• Irritability 
• Restlessness 
• Hallucinations
• Paranoid delusions

Cardiovascular Disorders

• Tachycardia
• Palpitations
• Arrhythmias
• Hypertension
• Hypotension

Respiratory Disorders

• Thickening of bronchial secretions

Gastrointestinal Disorders

• Dry mouth
• Nausea and vomiting

Hepatobiliary Disorders 

• Hepatic dysfunction

Genitourinary Disorders

• Urinary retention

Skin and Subcutaneous Tissue Disorders

• Rash

Immune, Blood and Lymphatic System Disorders

• Hypersensitivity 
• Agranulocytosis
• Thrombocytopaenia

• Central nervous system depressants
• Monoamine oxidase inhibitors 
• Moclobenide 
• Antihypertensives 
• Cardiac glycosides 
• Ergot alkaloids 
• Appetite suppressants 
• Oxytocin 
• Metoclopramide 
• Domperidone 
• Cholestyramine
• Anticholinergic agents 
• Warfarin
• CYP450 inducers 

None routine

Paracetamol
Paracetamol increases the pain threshold by inhibiting both isoforms of cyclooxygenase, COX-1, COX-2, and COX-3 enzymes involved in prostaglandin synthesis. It does not inhibit cyclooxygenase in peripheral tissues and, thus, has no peripheral anti-inflammatory affects.

Pseudoephedrine
Pseudoephedrine acts mainly on alpha- and also on beta adrenergic receptors. It produces vasoconstriction by acting on the alpha adrenergic receptors in the mucosa of the respiratory tract. This results in the decongestant properties of pseudoephedrine.

Diphenhydramine
Diphenhydramine is a histamine H1-receptor antagonist that competes with free histamine for binding at histamine receptors. In addition to its usual anti-allergy actions, it also has significant sedative and antimuscarinic properties.

COMBINATION PREPARATIONS

Paracetamol/ Pseudoephedrine/ Diphenhydramine

Tablet 500mg/22.5mg/12.5mg

• Benylin Four Flu (Johnson & Johnson)

Liquid (per 20ml) 1000mg/45mg/25mg

• Benylin Four Flu (Johnson & Johnson)