Paracetamol/ Pseudoephedrine

Registered South African indications: 

• Allergic rhinitis 
• Colds and influenza

Contraindications

• Hypersensitivity to the active ingredient or any of the excipients in this combination product
• Severe hypertension
• Coronary artery disease
• Coadministration with monoamine oxidase inhibitors

Cautions

• Pregnancy
• Breastfeeding
• Moderate to severe renal impairment
• Severe hepatic impairment
• Mild to moderate hypertension
• Heart disease
• Diabetes
• Hyperthyroidism
• Elevated intraocular pressure
• Prostatic enlargement

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

Symptomatic relief of cold and influenza
Symptomatic relief of nasal and sinus congestion from 
-Sinusitis
-Hay fever

Paracetamol/ Pseudoephedrine
500/30 (mg)

• Oral (tab): 2 tab, 4-6hrly; Max: 8 tab/24hrs

500/60 (mg)

• Oral (tab): 1 tab, 8hrly

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

Symptomatic relief of cold and influenza
Symptomatic relief of nasal and sinus congestion from 
-Sinusitis
-Hay fever

Paracetamol/ Pseudoephedrine
500/30 (mg)

• Younger than 6 years: Not established for use
• Between 6-12 years: Oral (tab): 1/2-1 tab, 6hrly; Max: 4 tab/24hrs
• Older than 12 years: See adult dosage

500/60 (mg)

• Younger than 6 years: Not established for use
• Between 6-12 years: Oral (tab): 1/2 tab, 8hrly
• Older than 12 years: See adult dosage

160/15 (mg/5ml)

• Younger than 2 years: Not established for use
• Between 2-5 years: Oral (syr): 5ml, 4-6hrly; Max: 4 doses/24hrs
• Between 6-12 years: Oral (syr) 10ml, 4-6hrly; Max: 4 doses/24hrs
• Older than 12 years: Oral (syr) 20ml, 4-6hrly; Max: 4 doses/24hrs

Pregnancy

• Caution (Pseudoephedrine)
• Although pseudoephedrine has been in widespread use for many years without apparent ill consequence, there are no specific data on its use during pregnancy. Caution should therefore be exercised by balancing the potential benefit of treatment to the mother against any possible hazards to the developing foetus. Systemic administration of pseudoephedrine, up to 50 times the human daily dosage in rats and up to 35 times the human daily dosage in rabbits, did not produce teratogenic effects
• Epidemiological studies in human pregnancy have shown no ill effects due to paracetamol used in the recommended dosage, but patients should follow the advice of their doctor regarding its use

Breastfeeding

• Caution (Pseudoephedrine)
• Pseudoephedrine is excreted in breast milk in small amounts but the effect of this on breastfed infants is not known. It has been estimated that 0.5 to 0.7% of a single dose of pseudoephedrine ingested by a mother will be excreted in the breast milk over 24 hours
• Paracetamol is excreted in breast milk but not in a clinically significant amount. Available published data do not contraindicate breastfeeding

Renal Impairment

• Mild: No dose adjustment recommended
• Moderate to severe: Caution; no dose adjustment recommended

Hepatic Impairment

• Caution; no dose adjustment recommended

Elderly

• No dose adjustment recommended

Porphyria Information

• Not yet classified (NC)

Drugs in Sport

• Prohibited - In competition

Central Nervous System Disorders 

• Sleep disturbance
• Hallucinations

Hepatobiliary Disorders

• Chronic hepatic necrosis

Genitourinary Disorders

• Urinary retention

Skin and Subcutaneous Tissue Disorders 

• Skin rashes

Immune, Blood and Lymphatic System Disorders

• Thrombocytopenia
• Agranulocytosis

Others

• Papillary necrosis

• Tricyclic antidepressants
• Sympathomimetic agents
• Monoamine oxidase inhibitors
• Bretylium
• Betanidine
• Guanethedine
• Debrisoquine
• Methyldopa
• Alpha-adrenergic blocking agents
• Beta-adrenergic blocking agents
• Barbiturates
• Anticonvulsants
• Oral steroid contraceptives
• Metoclopramide
• Domperidone
• Colestyramine
• Warfarin and other coumarins

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. 

COMBINATION PREPARATIONS

Paracetamol/ Pseudoephedrine

Tablet 500mg/30mg

• Flusin Sinus (Pharmacare)
• Sinugesic (Pharmacare)
• Sinumax (Janssen)
• Sinutab Sinus Pain Non-Drowsy (Johnson & Jonson) originator

Tablet 500mg/60mg

• Sudafed Sinus Pain (Johnson & Jonson) originator

Syrup (per 5ml) 160mg/15mg

• Sinumax Ped (Janssen) originator