Paracetamol/ Dextromethorphan/ Ephedrine/ Doxylamine

Registered South African indications:

• Relief of major symptoms associated with colds and influenza
  - Nasal congestion
  - Sniffing
  - Headache
  - Minor aches and pains
  - Coughing

This product 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
• Pregnancy
• Coadministration with monoamine oxidase inhibitors or within 14 days of their use

South African recommendations

• Breastfeeding
• Renal impairment (paracetamol)
• Hepatic impairment (paracetamol, dextromethorphan, doxylamine)
• Elderly
• Asthma (dextromethorphan)
• Epilepsy (doxylamine)
• Glaucoma (doxylamine)
• Prostatic hypertrophy (doxylamine)
• Most types of cardiovascular disease (ephedrine)
• Digitalised patients (ephedrine)
• Hypertension (ephedrine)
• Hyperthyroidism (ephedrine)
• Hyperexcitability (ephedrine)
• Pheochromocytoma (ephedrine)
• Closed-angle glaucoma (ephedrine)
• Prostatic enlargement (ephedrine)
• Exceeding recommended dose
• Continuous use for more than 10 days without doctor consultation
• Persistent symptoms after 5 days
• Drowsiness and impaired concentration
  -This medicine may lead to drowsiness and impaired concentration, which may be aggravated by simultaneous intake of alcohol, or other central nervous system depressant agents
• Coadministration with alcohol, or other central nervous system depressant agents
• Coadministration with chloroform, cyclopropane, halothane or other halogenated anaesthetics (ephedrine)
• May impair ability to drive and operate machinery

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

South African registered indications and dosages

Relief of major symptoms associated with colds and influenza
- Nasal congestion
- Sniffing
- Headache
- Minor aches and pains
- Coughing

Paracetamol/ Dextromethorphan/ Ephedrine/ Doxylamine
600/15/8/7.5 (mg/30ml)

• Oral (syr): 30ml, at bedtime

---

Do not exceed recommended dose

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

South African registered indications and dosages

Relief of major symptoms associated with colds and influenza
- Nasal congestion
- Sniffing
- Headache
- Minor aches and pains
- Coughing

Paracetamol/ Dextromethorphan/ Ephedrine/ Doxylamine
600/15/8/7.5 (mg/30ml)

• Younger than 12 years: Not recommended for use
• Older than 12 years: See adult dosage

---

Do not exceed recommended dose. Use in children under 12 years only under direction of a doctor

Pregnancy 

South African recommendations

• Contraindicated
• The safety of this preparation in pregnancy has not been established

Breastfeeding

South African recommendations

• Caution
• The safety of this preparation in lactation has not been established

Fertility

South African recommendations

• No information available

South African recommendations

• Caution; no dose adjustment recommended
  Patients suffering from kidney disease should take paracetamol under medical supervision

South African recommendations

• Caution; no dose adjustment recommended
  Patients suffering from liver disease should take paracetamol under medical supervision

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
Skin and Subcutaneous Tissue Disorders

• Sensitivity reactions resulting in reversible skin rash

Blood and Lymphatic System Disorders

• Blood disorders

Dextromethorphan Hydrobromide
Nervous System Disorders

• Drowsiness
• Dizziness
• Mental confusion

Psychiatric Disorders

• Excitation

Gastrointestinal Disorders

• Gastro-intestinal disturbances

Respiratory Disorders

• High doses cause respiratory depression

Doxylamine Succinate
Nervous System Disorders

• Sedation
• Slight drowsiness to deep sleep
• Dizziness
• Inability to concentrate
• Headache
• Muscle twitching
• Convulsions

Psychiatric Disorders

• Lassitude
• Elation or depression
• Irritability
• Nightmares
• Insomnia
• Nervousness

Cardiac Disorders

• Tachycardia

Gastrointestinal Disorders

• Nausea
• Vomiting
• Diarrhoea
• Constipation
• Epigastric pain

General Disorders and Administration Site Conditions

• Muscular weakness
• Incoordination

Vascular Disorders

• Hypotension

Eye Disorders

• Blurred vision

Ear and Labyrinth Disorders

• Tinnitus

Renal and Urinary Disorders

• Difficulty in micturition

Respiratory Disorders

• Tightness of the chest

Metabolism and Nutrition Disorders

• Anorexia

Musculoskeletal and Connective Tissue Disorders

• Tingling
• Heaviness
• Weakness of the hands

Skin and Subcutaneous Tissue Disorders

• Allergy and dermatological reactions

Blood and Lymphatic System Disorders

• Blood disorders including agranulocytosis and haemolytic anaemia

Ephedrine Sulphate
Nervous System Disorders

• Headache
• Tremors

Psychiatric Disorders

• Anxiety
• Restlessness
• Insomnia

Cardiac Disorders

• Tachycardia
• Palpitations
• Precordial pain

Gastrointestinal Disorders

• Nausea and vomiting

General Disorders and Administration Site Conditions

• Sweating
• Thirst
• Muscular weakness

Renal and Urinary Disorders

• Difficulty in micturition

Vascular Disorders

• Giddiness

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

• Monoamine oxidase inhibitors
• Central nervous system depressants
• Barbiturates
• Hypnotic analgesics
• Sedatives
• Tranquilizers
• Anticholinergic drugs
• Atropine
• Tricyclic antidepressants
• Halogenated anaesthetics
• Chloroform
• Cyclopropane
• Halothane
• Guanethidine
• Reserpine
• Methyldopa
• Tricyclic antidepressants
• Digitalis

Other interactions

• Alcohol

None routine. Specific cases may require

• Renal function
• Hepatic function

Paracetamol
Paracetamol has analgesic and antipyretic properties.

Dextromethorphan
Dextromethorphan hydrobromide has antitussive properties.

Ephedrine
Ephedrine sulphate has sympathomimetic properties causing vasoconstriction. It also has smooth muscle relaxant effects.

Doxylamine
Doxylamine succinate has antihistamine properties with a prolonged effect.

COMBINATION PREPARATIONS

Paracetamol/ Dextromethorphan/ Ephedrine/ Doxylamine

Syrup (per 30ml) 600mg/15mg/9mg/7.5mg

• Vicks Medinite (Procter & Gamble)