Pseudoephedrine/ Dextromethorphan/ Triprolidine

Registered South African indications:

• Cough

Contraindications

• Hypersensitivity to the active ingredients or any of the excipients in this combination product
• Younger than 2 years of age
• Cardiovascular disease (especially coronary insufficiency)
• Hypertension
• Prostatism
• Thyrotoxicosis
• Bladder dysfunction
• Narrow angle glaucoma
• Phaeochromocytoma
• Treatment with monoamine oxidase inhibitors and within two weeks of stopping such treatment
• Treatment with ephedrine and other sympathomimetic agents, as a hypertensive response may result
• Pregnancy
• Breastfeeding
• During an asthma attack
• Risk of developing respiratory failure

Cautions

• Moderate to severe renal impairment
• Hepatic impairment
• Elderly
• Porphyria
• Atopic children
• Epilepsy
• Aneurysms
• Cardiac disease
• Cardiac decompensation
• Angina
• Arrhythmia
• Tachycardia
• Acute or chronic asthma
• Persistent or chronic cough
• Chronic bronchitis
• Emphysema
• Cough accompanied by excessive secretions
• Pyloro-duodenal obstruction
• Diabetes mellitus
• Patients with thyroid disease receiving thyroid hormones
• Elevated intraocular pressure
• Susceptibility to angle closure glaucoma
• Occlusive vascular disorders
• Prostatic enlargement
• Liver disease
• Urinary retention
• Patients with a history of substance misuse disorder (including alcohol)
• Patients with a history of mental health disorders
• Sudden withdrawal
• Poor metabolizers of CYP2D6
• Patients receiving digitalis
• Fructose intolerance
• Glucose-galactose malabsorption
• Sucrase-isomaltase insufficiency
• May impair ability to drive and operate machinery

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

South African registered indications and dosages

Alleviation of cough

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

• Oral (sol): 10ml, 3 times daily

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The dosage must not be exceeded

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

South African registered indications and dosages

Alleviation of cough

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

Younger than 2 years

• Contraindicated

Between 2-5 years

• Oral (sol): 2.5ml, 3 times daily

Between 6-12 years

• Oral (sol): 5ml, 3 times daily

Older than 12 years

• See adult dosage

---

The dosage must not be exceeded

Pregnancy

• Contraindicated

Breastfeeding

• Contraindicated

Fertility

• No studies have been conducted in animals to determine whether triprolidine, pseudoephedrine or dextromethorphan have potential to impair fertility. There is no experience of the effect of pseudoephedrine/ dextromethorphan/ triprolidine on human fertility

Renal Impairment

• eGFR (>50-89ml/min/1.73m²): No dose adjustment recommended
• eGFR (>30-49ml/min/1.73m²): Caution; no dose adjustment recommended
  Closely monitor renal function. Discontinue if significant deterioration in CrCl observed
• eGFR (<29ml/min/1.73m²) and established renal failure: Contraindicated

Hepatic Impairment

• Caution; no dose adjustment recommended

Elderly

• Caution; no dose adjustment recommended

Porphyria Information

• Possibly porphyrinogenic (PSP)

Drugs in Sport

• Prohibited - In competition only (Pseudoephedrine)

Central Nervous System Disorders

• Central nervous system depression or excitation
• Paradoxial stimulation
• Sleep disturbances
• Nightmares
• Hallucinations
• Sedation
• Dizziness
• Incoordination
• Nervousness
• Convulsions
• Inability to concentrate
• Elation or depression
• Irritability
• Headache
• Psychomotor impairment
• Paraesthesias
• Tremor
• Confusion
• Deepening coma
• Extrapyramidal effects
• Tingling, heaviness, and weakness of the hands
• Seizures
• Fainting
• Anxiety
• Restlessness
• Giddiness
• Fear
• Psychotic states
• Weakness
• Toxic psychosis
• Euphoria
• Insomnia
• Paranoid delusions
• Irritability
• Excitability
• Stroke
• Posterior reversible encephalopathy syndrome (PRES)/ Reversible cerebral vasoconstriction syndrome (RCVS)
• Psychomotor hyperactivity

Cardiovascular Disorders

• Tachycardia
• Reflex bradycardia
• Hypotension
• Palpitations
• Dysrhythmias
• Hypertension
• Anginal pain
• Cardiac dysrhythmias
• Cardiac arrest
• Flushing
• Vasoconstriction  
• Myocardial infarction
• Myocardial ischaemia

Respiratory Disorders

• Dry throat
• Dry nose
• Mediastinal disorders
• Thickened respiratory tract secretions
• Tightness of the chest  
• Dyspnoea
• Pulmonary oedema
• Epistaxis

Gastrointestinal Disorders

• Gastrointestinal disturbances
• A reduction in tone and motility of the gastrointestinal tract
• Loss of appetite
• Dry mouth
• Nausea and vomiting
• Diarrhoea
• Constipation
• Increased gastric reflux
• Colic
• Epigastric pain
• Anorexia
• Abdominal pain
• Hypersalivation
• Ischaemic colitis
• Gastric reflux

Hepatobiliary Disorders

• Liver disorder

Genitourinary Disorders

• Urinary difficulty or retention
• Painful urination

Endocrine and Metabolic Disorders

• Flushing
• Thirst
• Disturbances of glucose metabolism

Musculoskeletal Disorders

• Muscle twitching
• Muscular weakness
• Myalgia

Skin and Subcutaneous Tissue Disorders

• Skin rash
• Photosensitivity
• Erythematous nummular patches
• Lichenoid skin eruption
• Hair loss
• Pallor
• Pruritis
• Urticaria
• Generalised exanthematous pustulosis (AGEP)
• Sweating

Immune, Blood and Lymphatic System Disorders

• Hypersensitivity reactions
• Anaphylactic reactions
• Blood dyscrasias
• Agranulocytosis
• Leucopenia
• Haemolytic anaemia
• Thrombocytopenia
• Angioedema

Sensory disorders

• Blurred vision
• Tinnitis
• Miosis
• Ischaemic optic neuropathy

Other

• Drug dependence
• Drug withdrawal syndrome
• Fatigue

• Monoamine oxidase inhibitors
• Reversible inhibitors of monoamine oxidase A (RIMAs)
• Moclobemide
• Antihypertensive agents
• Sympathomimetic agents 
• Decongestants
• Antimuscarinic agents
• Atropine
• Anticholinergic agents
• Tricyclic antidepressants
• Appetite suppressants
• Amphetamine-like psychostimulants
• Central nervous system depressants
• Alcohol
• Barbiturates
• Hypnotics
• Opioid analgesics
• Sedatives
• Antipsychotics
• Antihistamines
• Psychotropics
• CYP2D6 inhibitors
• Fluoxetine
• Paroxetine
• Quinidine
• Terbinafine
• Amiodarone
• Flecainide
• Anaesthesia
• Chloroform
• Cyclopropane
• Halothane
• Enflurane
• Isoflurane
• Halogenated anaesthetics
• Propafenone
• Sertraline
• Bupropion
• Methadone
• Cinacalcet
• Haloperidol
• Perphenazine
• Thioridazine
• Cardiac glycosides
• Quinidine
• Digitalis
• Ergot alkaloids
• Oxytocin
• Bretylium
• Betanidine
• Guanethidine
• Debrisoquine
• Methyldopa
• Beta-adrenergic blocking agents
• Adrenergic neurone blockers

None routine

Drug dependence, tolerance and potential for abuse

• For all patients, prolonged use of this product may lead to drug dependence (addiction), even at therapeutic doses. The risks are increased in individuals with current or past history of substance misuse disorder (including alcohol misuse) or mental health disorders
• Drug withdrawal syndrome may be experienced upon discontinuation of use

Pseudoephedrine
Pseudoephedrine has a direct and indirect sympathomimetic activity and is an effective upper respiratory decongestant. Pseudoephedrine is substantially less potent than ephedrine in producing both tachycardia and elevation of systolic blood pressure and considerably less potent in causing stimulation of the central nervous system.

Dextromethorphan
Dextromethorphan has an antitussive action. It controls coughs by depressing the medullary cough centre.

Triprolidine
Triprolidine provides symptomatic relief in conditions believed to depend wholly or partially 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 which may cause drowsiness.

COMBINATION PREPARATIONS

Pseudoephedrine/ Dextromethorphan/ Triprolidine

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

• Coryx Cough and Cold (Cipla Medpro)
• Medifed Cough Linctus (Cipla Medpro) 
• Sinuclear Cough Syrup (Pharmacare)