Pseudoephedrine/ Codeine/ Triprolidine

Registered South African indications:

• Alleviation of cough

Registered South African contraindications

• Hypersensitivity to the active ingredient or any of the excipients in this combination product
  - Persons who have previously exhibited intolerance to this product or to any of its constituents
• Patients suffering from cardiovascular disease (especially coronary insufficiency)
• Hypertension
• Prostatism
• Thyrotoxicosis
• Bladder dysfunction
• Narrow-angle glaucoma
• Phaeochromocytoma
• In patients with prostatic enlargement, it may increase difficulty with micturition
• Patients being treated with monoamine oxidase inhibitors and within two weeks of stopping such treatment; ephedrine and other sympathomimetic agents as a hypertensive response may result
• Acute alcoholism
• During an acute attack of bronchial asthma
• In patients with head injuries or where the intracranial pressure is raised
• In heart failure secondary to chronic lung disease
• In case of respiratory depression, especially in the presence of cyanosis and excessive bronchial secretion

South African recommendations

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

Drowsiness and impaired concentration

• Can cause drowsiness and concentration issues, worsened by alcohol or CNS depressants
• Patients should not drive, climb dangerous heights or operate machinery as impaired decision-making and impaired mental alertness could lead to accidents

Pseudoephedrine usage

• Use cautiously in patients with organic heart diseases, cardiac decompensation, angina of effort, or those on digitalis.

Epilepsy concerns

• High doses may trigger seizures in individuals with epilepsy

Effects in children and infants

• May act as a cerebral stimulant; not recommended for children under 2 years

Risk of dependence

• Overdosing or prolonged use can lead to addiction and dependence

Should be used cautiously in the following conditions:

• Use with caution in diabetes, occlusive vascular disorders like arteriosclerosis, aneurysms, and in patients with myasthenia gravis or renal impairment

Elderly and debilitated patients

• Care is needed in administering to elderly and debilitated individuals

Specific medication cautions

• Should not be administered with cardiac glycosides
• Avoid use with quinidine
• Do not use concurrently with tricyclic antidepressants

Impact on diabetes patients

• Contains liquid glucose, which may affect blood sugar control in patients with diabetes mellitus

Sucrose content

• Not suitable for patients with rare hereditary conditions like fructose intolerance, glucose-galactose malabsorption, or sucrose-isomaltase insufficiency

Sorbitol intolerance

• Patients with a rare hereditary condition of sorbitol intolerance should not use this combination product

Codeine

Should be used cautiously in following patient groups:

• Hypothyroidism
• Adrenal insufficiency
• Impaired liver function
• Prostatic hypertrophy
• Shock
• Inflammatory or obstructive bowel disorders
• Elderly and debilitated dose adjustment may be needed

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

South African registered indications and dosages

Alleviation of cough

Pseudoephedrine/ Codeine/ Triprolidine
30/10/1.25 (mg/5ml)

• Oral (syr): 5-10ml, 3 times dly as needed

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

South African registered indications and dosages

Alleviation of cough

Pseudoephedrine/ Codeine/ Triprolidine
30/10/1.25 (mg)

• Younger than 2 years: Not recommended for use
• Between 2-5 years: Oral (syr): 2.5ml, 3 times dly as needed
• Between 6-12 years: Oral (syr): 5ml, 3 times dly as needed
• Older than 12 years: See adult dosage

Pregnancy

South African recommendations

• Caution
• Safety in pregnancy has not been established

Breastfeeding

South African recommendations

• Caution
• Safety in lactation has not been established

Fertility

South African recommendations

• No information available

South African recommendations

• Caution; no dose adjustment recommended

South African recommendations

• Caution; no dose adjustment recommended

South African recommendations

• Caution; dose adjustment recommended
  The dosage should be reduced in elderly and debilitated patients

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

Pseudoephedrine

Central Nervous System Disorders

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

Cardiovascular Disorders

• Tachycardia
• Precordial pain
• Palpitations
• Hypertension potentially leading to intracranial haemorrhage

Gastrointestinal Disorders

• Nausea
• Vomiting
• Thirst

Genitourinary Disorders

• Difficulty in micturition
  - Increased difficulty in micturition in patients with prostatic enlargement

Musculoskeletal Disorders

• Muscular weakness

Skin and Subcutaneous Tissue Disorders

• Fixed drug eruption, taking the form of erythematous nummular patches
• Sweating

Codeine

Central Nervous System Disorders

• Drowsiness
• Confusion
• Vertigo
• Restlessness
• Changes of mood
• Agitation
• Psychotic states
• Loss of appetite
• Fear
• Irritability
• Dizziness
• Raised intracranial pressure

Cardiovascular Disorders

• Bradycardia
• Palpitation
• Orthostatic hypotension
• Hyperthermia
• Circulatory failure
• Reflex bradycardia
• Cardiac arrhythmias
• Cardiac arrest
• Fainting

Respiratory Disorders

• Respiratory depression
• Dyspnoea

Gastrointestinal Disorders

• Nausea
• Vomiting
• Constipation
• Dry mouth

Genitourinary System Disorders

• Difficulty in micturition
• Ureteric or biliary spasm
• Antidiuretic effect

Endocrine and Metabolic Disorders

• Disturbance of glucose metabolism

Musculoskeletal Disorders

• Muscle rigidity

Skin and Subcutaneous Tissue Disorders

• Sweating
• Facial flushing
• Pruritus
• Urticaria

Sensory Disorders

• Miosis

Others

Weakness

Triprolidine

Central Nervous System Disorders

• Sedation (ranging from slight drowsiness to deep sleep)
• Inability to concentrate
• Lassitude
• Dizziness
• Incoordination
• Headache
• Elation or depression
• Irritability
• Nightmares
• Anorexia
• Tingling, heaviness, and weakness of the hands
• Insomnia
• Nervousness
• Tremors
• Convulsions (large doses may precipitate fits in epileptics)
• Cerebral stimulant (in infants and children)

Cardiovascular Disorders

• Tightness of the chest
• Tachycardia
• Hypotension

Gastrointestinal Disorders

• Nausea
• Vomiting
• Diarrhoea or constipation
• Colic
• Epigastric pain
• Dryness of the mouth

Genitourinary Disorders

• Difficulty in micturition

Musculoskeletal Disorders

• Muscle twitching
• Muscular weakness

Skin and Subcutaneous Tissue Disorders

• Lichenoid skin eruption
• Dermatological reactions

Immune, Blood and Lymphatic System Disorders

• Allergy
• Anaphylaxis
• Blood dyscrasias
• Agranulocytosis
• Haemolytic anaemia

Sensory Disorders

• Blurred vision
• Tinnitus

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

Pseudoephedrine/ Codeine/ Triprolidine

• Central nervous system depressant agents
• Sympathomimetic agents
• Decongestants
• Appetite suppressants
• Amphetamine-like psychostimulants
• Monoamine oxidase inhibitors (MAOIs) (largely because of interaction with pseudoephedrine)
• Quinidine

Other interactions

• Alcohol

Pseudoephedrine

• Chloroform
• Cyclopropane
• Halothane and other halogenated anaesthetics
• Guanethidine
• Reserpine
• Methyldopa
• Tricyclic antidepressants
• Digitalis glycosides (such as digoxin)
• Agents which interfere with sympathetic activity
• Bretylium
• Bethanidine
• Guanethidine
• Debrisoquine
• Methyldopa
• Beta-adrenergic blocking agents

Codeine

• Central nervous system depressants
• Anaesthetics
• Hypnotics
• Sedatives
• Phenothiazines

Other interactions

• Alcohol

Triprolidine

• Central nervous system depressants
• Barbiturates
• Hypnotics
• Narcotic analgesics
• Sedatives
• Tranquilizers
• Anticholinergic agents
• Atropine
• Tricyclic antidepressants
• Agents that are metabolised in the liver

Other interactions

• Alcohol

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.

Codeine
Codeine is a centrally acting weak analgesic. It exerts its effect through mu opioid receptors. It resembles morphine in its pharmacodynamic actions although much weaker in its effects.

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/ Codeine/ Triprolidine

Syrup (per 5ml) 30mg/10mg/1.25mg

• Actifed Dry cough Regular (GSK) originator
• Adco-Tussend (Adcock)