Pseudoephedrine/ Triprolidine

Registered South African indications:

• Colds and flu

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

Pseudoephedrine
Contraindications

• Hypersensitivity to the active ingredient or any of the excipients in this combination product
• Cardiovascular disease
• Children younger than 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

• Breastfeeding
• Moderate to severe renal impairment
• Severe hepatic impairment
• Elderly
• Enlarged prostate
• Bladder dysfunction
• Seizure disorders

Triprolidine
Contraindications

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

Cautions

• Pregnancy 
• Breastfeeding
• Children
• Pulmonary insufficiency
• Prostatic hypertrophy  
• Glaucoma
• May impair ability to drive and operate machinery

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

Symptomatic relief of colds and flu 

Pseudoephedrine/ Triprolidine
30/1.25 (mg)
30/1.25 (mg/5ml)

• Oral (tab): 1-2 tab, 8hrly
• Oral (syr): 5-10ml, 8hrly

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

Symptomatic relief of cold and flu 

Pseudoephedrine/ Triprolidine
30/1.25 (mg)
30/1.25 (mg/5ml)

Younger than 6 years :

• Not established for use

Between 6-12 years

• Oral (tab): 1/2-1 tab, 8hrly
• Oral (syr): 5ml, 8hrly

Older than 12 years

• See adult dosage

Pregnancy

• Caution
• Although pseudoephedrine and triprolidine have been in widespread use for many years without apparent ill consequence, there are no specific data on their 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 triprolidine in rats and rabbits up to 75 times the human dose did not produce teratogenic effectsSystemic 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

Breastfeeding

• Caution
• Pseudoephedrine and triprolidine are excreted in breast milk in small amounts but the effect of this on breastfed infants is not known. It has been estimated that approximately 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

Renal Impairment

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

Hepatic Impairment

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

Elderly

• Caution; no dose adjustment recommended

Porphyria Information

• Possibly porphyrinogenic (PSP)

Drugs in Sport

•  Prohibited - In competition

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

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

• Closed angle glaucoma
• Blurred vision
• Diplopia
• Tinnitus

Triprolidine 

• No information available 

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

Pseudoephedrine

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

Triprolidine

• Central nervous system depressants
• Anticholinergic agents
• Azelastine 
• Secretin 

None routine

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. 

Triprolidine
Triprolidine provides symptomatic relief in conditions believed to depend wholly or partly upon the triggered release of histamine. It is a potent competitive histamine H1-receptor antagonist of the pyrrolidine class with mild central nervous system depressant properties.

COMBINATION PREPARATIONS

Pseudoephedrine/ Triprolidine

Tablet 30mg/1.25mg

• Actifed Cold (GSK) originator
• Decofed Tablets (Litha Pharma)

Syrup (per 5ml) 30mg/1.25mg

• Actifed Cold (GSK) originator
• Betafed Syrup (Ranbaxy Pharmaceuticals)
• Decofed Syrup (Litha Pharma)