Paracetamol/ Pseudoephedrine/ Triprolidine

Registered South African indications:

• Relief of symptoms of the common cold and influenza

Paracetamol/ pseudoephedrine/ triprolidine contains paracetamol which may be fatal in overdose. In the event of overdosage or suspected overdose and notwithstanding the fact that the person may be asymptomatic, the nearest doctor, hospital or poison centre must be contacted immediately.

Registered South African contraindications

• Hypersensitivity to the active ingredient or any of the excipients in this combination product
• Severe liver function impairment
• Patients using other sympathomimetic decongestants or beta-blockers
• Patients suffering from cardiovascular disease including ischaemic heart disease, occlusive vascular disease, and hypertension
• Thyrotoxicosis
• Diabetes
• Prostatism
• Bladder dysfunction
• Closed-angle glaucoma
• Phaeochromocytoma
• During an attack of asthma in asthmatic patients
• Patients being treated with monoamine oxidase inhibitors and within two weeks of stopping such treatment as a hypertensive response may result
• Children under 2 years of age
• Pregnancy
• Lactation

South African recommendations

• Renal impairment 
• Mild to moderate hepatic impairment
• Elderly 
• Organic cardiac disease
• Cardiac decompensation  
• Hyperthyroidism 
• Ischaemic heart disease 
• Dysrhythmia 
• Tachycardia 
• Arteriosclerosis 
• Aneurysms  
• Diabetes mellitus 
• Angina pectoris 
• Pulmonary insufficiency  
• Prostatic hypertrophy  
• Pyloroduodenal obstruction 
• Glaucoma 
• Urinary retention 
• Coadministration with digitalis  
• Patients requiring strict glycaemic control (some products contain sorbitol) 
• Prolonged use of >10 days 
• May impair ability to drive and operate machinery 

No specific recommendations provided for adults

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

South African registered indications and dosages

Relief of symptoms of the common cold and influenza
- Nasal congestion, sniffing and headache

Paracetamol/ Pseudoephedrine/ Triprolidine
125/15/0.625 (mg)

• Younger than 2 years: Contraindicated
• Between 2-6 years: Oral (syr): 5ml, 3 times daily 
• Between 6-12 years: Oral (syr): 5-10ml, 3 times daily 

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Do not exceed recommended dose

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A doctor should be consulted if no relief is obtained with the recommended dosage

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Not to be used continuously for longer than 10 days without consulting a doctor

Pregnancy

South African recommendations

• Contraindicated
• Safety in pregnancy has not been established
• Pseudoephedrine: There are limited data from the use of pseudoephedrine in pregnant women. It is advised that pseudoephedrine should be avoided during pregnancy, particularly during the first trimester, as defective closure of the abdominal wall (gastroschisis) has been reported very rarely in newborns after first trimester exposure
• Triprolidine: The safety of this combination product in pregnancy has not been established

Breastfeeding

South African recommendations

• Contraindicated
• Safety during lactation has not been established
• Pseudoephedrine: Pseudoephedrine has been detected in human milk with a small percentage of the total maternal dose potentially administered to the suckling infant. The use of pseudoephedrine should be avoided during breastfeeding as lactation may be suppressed, and irritability and disturbed sleep have been reported in breastfed infants
• Triprolidine: Triprolidine is distributed into breast milk

Fertility

South African recommendations

• No information available

South African recommendations

• Caution; no dose adjustment recommended

South African recommendations

• Mild to moderate: Caution; no dose adjustment recommended
• Severe: Contraindicated
  H₁ antagonists are eliminated more slowly in those with severe liver disease

South African recommendations

• Caution; no dose adjustment recommended
  This combination product should be used with care in the elderly who are more susceptible to many of the side effects

Central Nervous System Disorders

• Central nervous system depression
• Paradoxical stimulation
• Sleep disturbances
• Insomnia
• Nervousness
• Euphoria
• Irritability
• Tremors
• Nightmares
• Hallucinations
• Convulsions
• Sedation
• Dizziness
• Inability to concentrate
• Incoordination
• Headache
• Paraesthesias
• Lassitude
• Fear
• Anxiety
• Restlessness
• Confusion
• Psychotic states
• Fainting
• Depression
• Psychomotor impairment
• Extrapyramidal effects

Cardiovascular Disorders

• Tachycardia
• Palpitations
• Arrhythmias
• Hypertension
• Impaired circulation to the extremities
• Bradycardia  
• Hypotension
• Cerebral haemorrhage
• Pulmonary oedema
• Cardiac oedema
• Anginal pain
• Cardiac arrest

Respiratory Disorders

• Dry throat
• Dry nose
• Dyspnoea
• Nasal congestion
• Pharyngeal oedema
• Wheezing
• Thickened respiratory-tract secretions
• Tightness of the chest
• Bronchospasm

Gastrointestinal Disorders

• Dry mouth
• Tone and motility reduction of the gastrointestinal tract
• Constipation
• Increased gastric reflux
• Nausea and vomiting
• Diarrhoea
• Epigastric pain
• Hypersalivation
• Pancreatitis

Genitourinary Disorders

• Urinary difficulty and retention

Endocrine and Metabolic Disorders

• Reduced appetite
• Disturbances of glucose metabolism
• Sweating
• Flushing

Musculoskeletal Disorders

• Myalgia

Skin and Subcutaneous Tissue Disorders

• Diaphoresis
• Skin photosensitivity
• Skin rash
• Erythematous
• Urticaria
• Angioedema
• Alopecia

Immune, Blood and Lymphatic System Disorders

• Agranulocytosis
• Leucopenia
• Haemolytic anaemia  
• Thrombocytopenia
• Pancytopenia
• Neutropenia
• Allergic reactions
• Anaphylaxis

Sensory Disorders

• Blurred vision
• Tinnitus

Other

• Weakness

• Monoamine oxidase inhibitors
• Atropine
• Tricyclic antidepressants
• Sympathomimetic agents
• Decongestants
• Appetite suppressants
• Amphetamine-like psychostimulants
• Ototoxic agents
• Anticonvulsants
• Steroid contraceptives
• CNS depressants
• Alcohol
• Barbiturates
• Hypnotics
• Opioid analgesics
• Anxiolytic sedatives
• Antipsychotics  
• Anaesthesia
• Hypnotics
• Sedatives
• Phenothiazine
• Cyclopropane
• Halothane
• Halogenated anaesthetics
• Cardiac glycosides
• Quinidine
• Antihypertensive agents
• Furazolidone
• Guanethidine
• Reserpine
• Methyldopa

None routine

Interference with allergy tests

• Antihistamines such as triprolidine as contained in in this combination medicine, may suppress the cutaneous histamine response to allergen extracts and should be stopped several days before skin testing

Triprolidine and ototoxic agents

• Triprolidine could mask the warning signs of damage caused by ototoxic drugs such as aminoglycosides

Paracetamol/ pseudoephedrine/ triprolidine has decongestive, antipyretic, antihistamine and analgesic properties.

Paracetamol
Paracetamol is the active metabolite of phenacetin. Paracetamol has analgesic and antipyretic effects. However, it has weak anti-inflammatory effects, and has been thought to have a generally poor ability to inhibit cyclooxygenase (COX) in the presence of high concentrations of peroxides, as are found at sites of inflammation. COX inhibition might be disproportionately pronounced in the brain, explaining its antipyretic efficacy.

Pseudoephedrine
Pseudoephedrine is a direct and indirect acting sympathomimetic. It is a stereoisomer of ephedrine and has a similar action, but has been stated to have less pressor activity and fewer CNS effects. Pseudoephedrine is given for the symptomatic relief of nasal congestion.

Triprolidine
Triprolidine hydrochloride, an alkylamine derivative, is a sedating antihistamine with antimuscarinic and mild sedative effects. Antihistamines have potential anti-inflammatory properties because histamine releases inflammatory cytokines and eicosanoids. The anticholinergic effects may lead to lessen rhinorrhoea.

COMBINATION PREPARATIONS

Paracetamol/ Pseudoephedrine/ Triprolidine

Syrup (per 5ml) 125mg/15mg/0.625mg

• Adco-flupain (Adcock)
• Acuflu P (Pharmacare)
• Sinuclear Paed (Pharmacare)