Paracetamol/ Phenylpropanolamine/ Dextromethorphan

Registered South African indications:

• Relief of the symptoms associated with colds and influenza

Paracetamol/ phenylpropanolamine/ dextromethorphan 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 active ingredient or to any of the excipients in this combination product
• Asthma
• Sensitivity to small doses of sympathomimetic substances is manifested by sleeplessness, dizziness, light-headedness, weakness, tremulousness, or cardiac arrhythmia
• Liver damage
• Cardiovascular disease
• Hypertension
• Hyperthyroidism
• Hyperexcitability
• Phaeochromocytoma
• Closed-angle glaucoma
• Not recommended for children under the age of 6 years

South African recommendations

• Pregnancy
• Breastfeeding
• Renal impairment
• Hepatic impairment
• Elderly

Continuous use

• Patient should not use continuously for more than 10 days without consulting their doctor

Excipient cautions

• Contains sucrose, therefore patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine
• Contains liquid sorbitol non-crystallising, therefore patients with hereditary fructose intolerance (HFI) should not take/be given this medicine
• Contains small amounts of ethanol (ethanol) less than 100mg per dose
• Contains 31mg sodium per dosage unit equivalent to 1,55 % of the WHO recommended maximum daily intake of 2g sodium for an adult

Ability to drive and use machines

• Some patients may experience side effects such as dizziness, headaches and drowsiness
• Patients should be warned not to drive a motor vehicle, operate dangerous machinery or climb dangerous heights, as impaired decision making could lead to accidents

Paracetamol

Excess doses

• Dosages of this combination product in excess of those recommended may cause severe liver damage

Severe cutaneous adverse reactions (SCARs)

• SCARs such as toxic epidermal necrolysis (TEN), Steven-Johnson syndrome (SJS), acute generalised exanthematous pustulosis (AGEP), eosinophilia and systemic (DRESS)/Drug-induced hypersensitivity syndrome (DIHS) and fixed drug eruptions (FDE) have been reported in patients treated with paracetamol containing medicines
• If a patient develops SCAR, treatment with this combination product must immediately be discontinued and appropriate treatment instituted

Phenylpropanolamine hydrochloride

Patients with prostatic enlargement

• May cause difficulty in micturition in patients with prostatic enlargement

Coadministration cautions

• Phenylpropanolamine hydrochloride should be given with caution to patients receiving chloroform, cyclopropane, halothane or other halogenated anaesthetics
• The effect of phenylpropanolamine hydrochloride is diminished by guanethidine, reserpine, and methyldopa; and may be diminished or enhanced by tricyclic antidepressants
• It may diminish the effect of guanethidine and may increase the possibility of arrhythmias in digitalised patients

Prolonged use

• Prolonged use may lead to rebound congestion

Diabetic patients

• Use with caution in patients with diabetes

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

South African registered indications and dosages

Relief of the symptoms associated with colds and influenza
- Headache, minor aches and pains and coughing

Paracetamol/ Phenylpropanolamine/ Dextromethorphan
500/25/15 (mg/20ml) 

• Oral (syr): 20ml, 4hrly; Max: 4 doses/24hrs

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Do not exceed the recommended dose

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Patient should seek medical advice if symptoms persist

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

South African registered indications and dosages

Relief of the symptoms associated with colds and influenza
- Headache, minor aches and pains and coughing

Paracetamol/ Phenylpropanolamine/ Dextromethorphan
500/25/15 (mg/20ml) 

• Under 6 years: Contraindicated
• Between 6-12 years: Oral (syr): 10ml, 4hrly; Max: 4 doses/24hrs
• Older than 12 years: See adult dosage

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Do not exceed the recommended dose

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Patient should seek medical advice if symptoms persist

Pregnancy

South African recommendations

• Caution; not recommended
• The safety and efficacy of use during pregnancy has not been established. Therefore paracetamol/ phenylpropanolamine/ dextromethorphan syrup is not recommended during pregnancy

Breastfeeding

South African recommendations

• Caution; not recommended
• The safety and efficacy of use during lactation has not been established. Therefore paracetamol/ phenylpropanolamine/ dextromethorphan syrup is not recommended during lactation

Fertility

South African recommendations

• No information available

South African recommendations

• Caution; no information available

South African recommendations

• Caution; no information available
• Liver damage: Contraindicated

South African recommendations

• Caution; no information available

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

Paracetamol

Blood and the Lymphatic System Disorders

Frequency unknown

• Neutropenia
• Pancytopenia
• Leucopaenia

Skin and Subcutaneous Tissue Disorders

Frequency unknown

• Skin rashes (erythematous, urticarial or mucosal lesions)
• Risk of fixed drug eruptions and drug-induced hypersensitivity syndrome

General Disorders and Administrative Site Conditions

Frequency unknown

• Allergic reactions
• Drug fever

Phenylpropanolamine hydrochloride

Nervous System Disorders

Frequency unknown

• Dizziness
• Headache
• Tremor
• Anxiety
• Restlessness
• Insomnia

Musculoskeletal and connective tissue disorders

Frequency unknown

• Muscular weakness

Cardiac Disorders

Frequency unknown

• Tachycardia
• Precordial pain
• Palpitations
• Hypertension
• Ventricular arrhythmias

Gastrointestinal Disorders

Frequency unknown

• Nausea
• Vomiting

Renal and Urinary Disorders

Frequency unknown

• Sweating
• Thirst
• Difficulty micturition
• Prostatic enlargement

Dextromethorphan hydrobromide

Psychiatric Disorders

Frequency unknown

• Mental confusion

Nervous System Disorders

Frequency unknown

• Drowsiness
• Dizziness
• Excitation

Gastrointestinal Disorders

Frequency unknown

• Nausea
• Vomiting
• Diarrhoea

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

• Monoamine oxidase inhibitors
• Alcohol

Phenylpropanolamine hydrochloride

• Chloroform
• Cyclopropane
• Halothane or other halogenated anaesthetics
• Guanethidine
• Reserpine
• Methyldopa
• Tricyclic antidepressants
• Digitalis glycosides (such as digoxin)

None routine 

Paracetamol/ phenylpropanolamine/ dextromethorphan has analgesic, antipyretic, cough suppressant, and sympathomimetic properties.

COMBINATION PREPARATIONS

Paracetamol/ Phenylpropanolamine/ Dextromethorphan

Syrup (per 20ml) 500mg/25mg/15mg 

• Flustat (Be-tabs)
• Sinustat Flu (Goldex) originator