Paracetamol/ Phenylpropanolamine

Registered South African indications:

• Symptomatic relief of nasal, sinus and eustachian tube mucal congestion and associated pain and fever due to colds and influenza

Paracetamol/ phenylpropanolamine contains paracetamol which may be fatal in overdose. In the event of overdosage or suspected overdose 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 
• Patients whose sensitivity to small doses of sympathomimetic substances is manifested by sleeplessness, dizziness, light-headedness, weakness, tremulousness or cardiac dysrhythmia
• Cardiovascular disease
• Hypertension
• Hyperthyroidism
• Hyperexcitability
• Phaeochromocytoma
• Closed-angle glaucoma
• Pregnancy
• Lactation
• Children younger than 6 years
• Concomitant use with any monoamine-oxidase inhibitors for depression (e.g. tranylcypromine), or within 14 days of stopping such a treatment

South African recommendations

• Renal impairment
• Hepatic impairment
• Elderly

Continuous use

• Patient should not use for more then 7 days without seeking medical advice

Excess doses

• Dosages in excess of those recommended may cause severe liver or kidney damage

Overdose

• The hazards of overdose are greater in those with non-cirrhotic alcoholic liver disease

Intracranial haemorrhage

• Severe hypertensive episodes that could lead to intracranial haemorrhage have been noted after phenylpropanolamine ingestion
• Overdose increases the risk of hypertensive crisis and haemorrhagic stroke
• Not recommended for patients with cardiovascular disease, hypertension, or hyperthyroidism

Aggravation of conditions

• May worsen diabetes, glaucoma, or prostatic enlargement
• Not suitable for patients on monoamine oxidase inhibitors

Prostatic enlargement

• May cause difficulty in micturition

Diabetes

• Caution advised for patients with diabetes

Skin reactions

• Paracetamol may lead to severe skin reactions such as AGEP. Discontinue use and seek medical attention for skin abnormalities

Effects on ability to drive and use machines

• Paracetamol/phenylpropanolamine may moderately impair the ability to drive and operate machinery
• Due to potential adverse reactions like dizziness, headache, and muscular weakness, patients should not engage in tasks requiring concentration until they are certain of paracetamol/phenylpropanolamine's effects

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

South African registered indications and dosages

Symptomatic relief of nasal, sinus and eustachian tube mucal congestion and associated pain and fever due to colds and influenza
- Temporary therapy

Paracetamol/ Phenylpropanolamine
325/18 (mg) 

• Oral (cap): 1 cap, 6hrly; Max: 5 cap/24hrs

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Recommended dose should not to be exceeded

No specific recommendations provided. Contraindicated in children younger than 6 years

Pregnancy

South African recommendations

• Contraindicated
• Epidemiological studies on neurodevelopment in children exposed to paracetamol, as contained in this combination product, in utero show inconclusive results. The use of paracetamol during the last trimester of pregnancy may lead to a risk of premature closure of the foetal ductus arteriosus

Breastfeeding

South African recommendations

• Contraindicated
• Paracetamol, as contained in this combination product, is excreted in breast milk but not in a clinically significant amount

Fertility

South African recommendations

• No information available

South African recommendations

• Caution; no information available
  Dosages in excess of those recommended may cause severe kidney damage

South African recommendations

• Caution; no information available
  Dosages in excess of those recommended may cause severe liver damage

South African recommendations

• Caution; no information available

Paracetamol/ Phenylpropanolamine
Infections and infestations

• Fever

Blood and the lymphatic system disorders

• Blood dyscrasias
• Thrombocytopenia
• Purpura
• Methaemoglobinaemia
• Agranulocytosis

Metabolism and nutrition disorders

• Altered metabolism including disturbances of glucose metabolism
• Reduced appetite

Psychiatric disorders

• Psychotic state
• Confusion

Nervous system disorders

• Irritability

Cardiac disorders

• Ventricular dysrhythmias
• Haemorrhagic stroke

Vascular disorders

• Hypotension with dizziness
• Fainting and flushing may occur

Respiratory, thoracic and mediastinal disorders

• Dyspnoea

Gastrointestinal disorders

• Hypersalivation

Skin and subcutaneous tissue disorders

• Usually erythematous or urticarial

Renal and urinary disorders

• Urinary retention

General disorders and administrative site conditions

• Weakness

Paracetamol

Blood and the lymphatic system disorders

• Neutropenia
• Pancytopenia
• Leukopenia

Respiratory, thoracic and mediastinal disorders

• Rebound congestion

Skin and subcutaneous tissue disorders

• Skin rashes
• Medicine fever and mucosal lesions
• Other allergic reactions

Phenylpropanolamine hydrochloride
Infections and infestations

• Sweating

Blood and the lymphatic system disorders

• Intracranial haemorrhage

Psychiatric disorders

• Alteration of mental status

Nervous system disorders

• Insomnia
• Restlessness
• Anxiety
• Tremors
• Headache
• Giddiness
• Agitation

Eye disorders

• Blurred vision

Cardiac disorders

• Tachycardia
• Precordial pain
• Palpitations

Vascular disorders

• Vasoconstriction which results in hypertension

Gastrointestinal disorders

• Nausea
• Vomiting

Musculoskeletal and connective tissue disorders

• Muscular weakness

Renal and urinary disorders

• Difficulty in micturition

General disorders and administrative site conditions

• Thirst

Paracetamol/ Phenylpropanolamine

• Monoamine-oxidase inhibitors
• Tranylcypromine
• Metoclopramide
• Domperidone
• Chloramphenicol

Paracetamol

• Colestyramine
• Warfarin
• Other coumarins

Phenylpropanolamine

• Bromocriptine
• Chloroform
• Cyclopropane
• Halothane
• Other halogenated anaesthetics
• Amantadine
• Antivirals
• Triple-medicine HIV prophylactic regimen
• Non-steroidal anti-inflammatory drugs
• Indomethacin
• Guanethidine
• Reserpine
• Methyldopa
• Tricyclic antidepressants

None routine

Paracetamol/ Phenylpropanolamine
Paracetamol/ phenylpropanolamine has analgesic, antipyretic and decongestant properties.

Paracetamol
Paracetamol may act predominantly by inhibiting prostaglandin synthesis in the central nervous system (CNS) and to a lesser extent, through a peripheral action by blocking pain impulse generation. The peripheral action may also be due to inhibition of prostaglandin synthesis or to inhibition of the synthesis or actions of other substances that sensitise pain receptors to mechanical or chemical stimulation. Paracetamol produces antipyresis by acting centrally on the hypothalamic heat-regulation centre to produce peripheral vasodilation resulting in increased blood flow through the skin, sweating and heat loss. The central action involves inhibition of prostaglandin synthesis in the hypothalamus.

Phenylpropanolamine
Phenylpropanolamine is a mainly indirect-acting sympathomimetic.

COMBINATION PREPARATIONS

Paracetamol/ Phenylpropanolamine

Capsule 325mg/18mg

• Sinuclear (Pharmacare)
• Sinustat (Litha Pharma) originator