Chlorpheniramine/ Pseudoephedrine/ Paracetamol/ Caffeine

Registered South African indications:

• Colds and influenza

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

Chlorpheniramine
Contraindications

• Hypersensitivity to the active ingredient or any of the excipients in this combination product
• Premature infants 
• Neonates 
• Coadministration with monoamine oxidase inhibitors or within 14 days of their use 

Cautions

• Breastfeeding
• Renal impairment 
• Hepatic impairment 
• Elderly
• Narrow angle glaucoma 
• Urinary retention 
• Prostatic hypertrophy 
• Severe hypertension and cardiovascular disease 
• Bronchitis 
• Bronchiectasis 
• Asthma 
• Fructose intolerance
• Epilepsy 
• Acute exacerbation of asthma 
• May impair ability to drive and operate machinery 

Pseudoephedrine
Contraindications

• Hypersensitivity to the active ingredient or any of the excipients in this combination product
• Severe renal impairment
• Cardiovascular disease
• Children < 12 years
• Phaeochromocytoma
• Diabetes mellitus
• Hyperthyroidism
• Closed angle glaucoma
• Coadministration with monoamine oxidase inhibitors or within 14 days of their use
• Coadministration with other sympathomimetic decongestants
• Coadministration with beta-blockers

Cautions

• Pregnancy
• Breastfeeding
• Mild to moderate renal impairment
• Severe hepatic impairment
• Elderly
• Enlarged prostate
• Bladder dysfunction
• Seizure disorders

Paracetamol
Contraindications

• Hypersensitivity to the active ingredient or any of the excipients in this combination product
• Severe hepatic impairment

Cautions

• Pregnancy
• Renal impairment
• Mild to moderate hepatic impairment

Caffeine
Contraindications 

• Hypersensitivity to the active ingredient or any of the excipients in this combination product

Cautions 

• Pregnancy
• Breastfeeding
• Renal impairment
• Hepatic impairment
• Anxiety 
• Cardiovascular disease
• History of peptic ulcer
• Gastroesophageal reflux
• History of seizure disorder
• Neonates
• Concommitant use with transcutaneous electrical nerve stimulation

Additional contraindications for this combination product

• Children < 2 years
• Coadministration with halothane or other halogenated anaesthetics

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

Symptomatic relief of colds and influenza

Chlorphenamine/ Pseudoephedrine/ Paracetamol/ Caffeine
2/25/300/20 (mg)

• Oral (cap): 2 cap, 6hrly

Paed. forms avail. in SA and covered in this monograph: cap

Symptomatic relief of colds and influenza

Chlorphenamine/ Pseudoephedrine/ Paracetamol/ Caffeine
2/25/300/20 (mg)

Younger than 6 years

• Not established for use

Between 6-12 years

• Oral (cap): 1 cap, 6-8hrly

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)

Renal impairment

• Mild to moderate: Caution; no dose adjustment recommended (Chlorpheniramine, Pseudoephedrine, Paracetamol, Caffeine)
• Severe: Contraindicated (Pseudoephedrine)

Hepatic impairment

• Mild to moderate: Caution; no dose adjustment recommended (Chlorpheniramine, Pseudoephedrine, Paracetamol, Caffeine)
• Severe: Contraindicated (Paracetamol)

Elderly

• Caution; dose adjustment recommended (Chlorpheniramine, Pseudoephedrine)

Drugs in Sport

• Prohibited - In competition

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

Chlorpheniramine
Central Nervous System Disorders 

• Sedation
• Seizures
• Disturbances in attention
• Abnormal co-ordination
• Dizziness
• Headache
• Depression
• Nightmares
• Paradoxical stimulation

Cardiovascular Disorders 

• Palpitations
• Tachycardia
• Arrhythmias
• Hypotension

Respiratory Disorders 

• Thickening of bronchial secretions
• Tight chest

Gastrointestinal Disorders 

• Nausea and vomiting
• Dry mouth
• Abdominal pain
• Diarrhoea
• Constipation
• Dyspepsia

Hepatobiliary Disorders

• Hepatitis 
• Jaundice

Genitourinary Disorders 

• Urinary retention
• Dysuria

Endocrine and Metabolic Disorders 

• Anorexia
• Increased appetite

Musculoskeletal Disorders 

• Muscle twitching
• Muscle weakness

Skin and Subcutaneous Tissue Disorders 

• Exfoliative dermatitis
• Rash
• Urticaria
• Photosensitivity

Immune, Blood and Lymphatic System Disorders 

• Haemolytic anaemia
• Blood dyscrasias
• Allergic reaction
• Angioedema
• Anaphylactic reactions

Sensory Disorders 

• Blurred vision
• Tinnitis

Pseudoephedrine
Central Nervous System Disorders

• Hallucinations
• Insomnia
• Anxiety
• Restlessness
• Irritability
• Psychosis
• Headache
• Seizures
• Vertigo
• Ataxia
• Fatigue 
• Tremor

Cardiovascular Disorders

• Tachycardia
• Palpitations
• Arrhythmias
• Hypertension
• Impaired circulation to the extremities

Respiratory Disorders

• Dry throat
• Dry nose
• Dyspnoea
• Nasal congestion
• Pharyngeal oedema
• Thickening of bronchial secretions
• Wheezing

Gastrointestinal Disorders

• Dry mouth
• Nausea and vomiting
• Anorexia
• Constipation
• Diarrhoea
• Ischemic colitis

Genitourinary Disorders

• Urinary retention
• Dysuria

Skin and Subcutaneous Tissue Disorders

• Diaphoresis
• Skin photosensitivity
• Skin rash
• Urticaria

Immune, Blood and Lymphatic System Disorders

• Anaphylaxis
• Agranulocytosis
• Haemolytic anaemia
• Thrombocytopaenia

Sensory Disorders

• Angle closure glaucoma
• Blurred vision
• Diplopia
• Tinnitus

Paracetamol
Respiratory Disorders

• Bronchospasm

Hepatobiliary Disorders

• Hepatic dysfunction

Immune, Blood and Lymphatic System Disorders

• Anaphylaxis
• Cutaneous hypersensitivity reactions 
• Angioedema
• Stevens Johnson syndrome
• Thrombocytopenia 
• Agranulocytosis
• Methaemoglobinaemia

Caffeine
Central Nervous System Disorders

• Agitation
• Delirium
• Dizziness
• Hallucination
• Headache
• Insomnia
• Irritability
• Psychosis
• Restlessness

Cardiovascular Disorders

• Angina
• Chest pain
• Flushing
• Palpitations
• Sinus tachycardia
• Supraventricular tachycardia
• Vasodilation
• Ventricular arrhythmia

Gastrointestinal Disorders

• Oesophageal motility disorder
• Gastritis

Genitourinary Disorders

• Diuresis

Musculoskeletal Disorders

• Fasciculations

Skin and Subcutaneous Tissue Disorders

• Urticaria

Sensory Disorders

• Increased intraocular pressure
• Miosis

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

Chlorpheniramine

• Phenytoin 
• Monoamine oxidase inhibitors 
• Anticholinergic agents 
• Antihistamines 
• Central nervous system depressants 

Pseudoephedrine

• Sympathomimetic agents
• Antihypertensive agents
• Monoamine oxidase inhibitors
• Volatile anaesthetics
• Cardiac glycosides
• Anticholinergic agents
• Antidepressants
• Antipsychotics 
• Doxapram 
• Oxytocin
• Aluminium oxide 

Paracetamol

• Metoclopramide 
• Domperidone
• Cholestyramine
• Oral anticoagulants
• Chloramphenicol

Caffeine

• Adenosine
• Cocaine
• CYP1A2 inhibitors 
• Linezolid 
• Xanthines

None routine. Specific cases may require

• Hepatic function  

Chlorpheniramine
Chlorpheniramine acts as a competitive antagonist at H1-receptors. These histamine receptors are present in the respiratory tract, gastrointestinal tract and blood vessels thus allowing chlorpheniramine to perform its role in modulating the immune response and as a decongestant. 

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. 

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.

Caffeine
Caffeine is a nonspecific adenosine receptor antagonist and acts as a central nervous system stimulant. 

COMBINATION PREPARATIONS

Chlorphenamine/ Pseudoephedrine/ Paracetamol/ Caffeine

Capsule 2mg/ 25mg/ 300mg/ 20mg

• Flusin capsule (Pharmacare)