Pseudoephedrine/ Chlorphenamine/ Vitamin C

Registered South African indications:

• Symptomatic relief of colds and influenza associated with nasal, sinus and eustachian tube mucosal congestion

Pseudoephedrine/ chlorphenamine/ vitamin C may lead to drowsiness and impaired concentration that may be aggravated by the simultaneous intake of alcohol or other central nervous system depressants. Patients should be advised, particularly at the initiation of therapy, against taking charge of vehicles or machinery or performing potentially hazardous tasks where loss of concentration could lead to accidents.

Registered South African contraindications

• Hypersensitivity to the active ingredient or any of the excipients in this combination product
• Coronary disease and cardiovascular disease such as ischaemic heart disease, dysrhythmia or tachycardia
• Pregnancy
• Lactation
• Children less than 2 years old
• Patients sensitive to one antihistamine may be sensitive to others
• Patients receiving monoamine oxidase inhibitor treatment, or within 14 days of stopping such treatment

South African recommendations

• Renal impairment
• Hepatic impairment
• Elderly
• Patient should be reassessed if no relief is obtained
• Use for more than 7 days without medical evaluation

Chlorphenamine maleate

• Drowsiness and impaired concentration that may be aggravated by the simultaneous intake of alcohol or other central nervous system depressants
• Taking charge of vehicles or machinery or performing potentially hazardous tasks particularly at the initiation of therapy
• Prostatic hypertrophy
• Narrow angle glaucoma
• Emphysema or chronic bronchitis
• Porphyria
• Elderly & children
  - Risk of hyperexcitability, nervousness, insomnia
  - Elderly may experience dizziness, sedation, confusion, hypotension, dry mouth, and urinary retention
• Pyloroduodenal obstruction
• Epilepsy
• Severe cardiovascular disorders

Pseudoephedrine hydrochloride

• Tachyphylaxis
  - The product may lose effect after 5-7 days
• Symptom persistence
  - If symptoms don't improve or are accompanied by fever, patient should be advised to seek medical advice
• Excess dosage risks
  - Overdosage can cause nervousness, dizziness, sleeplessness, tremulousness, or cardiac dysrhythmia
• Sensitivity
  - Some individuals may experience side effects even at small doses
• Hypertension
• Hyperthyroidism
• Diabetes mellitus
• Closed-angle glaucoma
• Prostatic hypertrophy
• Phaeochromocytoma
• Occlusive vascular disease including arteriosclerosis, aneurysms
• Patients undergoing anaesthesia
  - With cyclopropane, halothane or other halogenated anaesthetics as they may induce ventricular fibrillation

 Vitamin C (ascorbic acid and sodium ascorbate)

• Patients with hyperoxaluria
• May impair ability to drive and operate machinery
  - Patients should be advised, particularly at the initiation of therapy, against taking charge of vehicles or machinery or performing potentially hazardous tasks

Excipients

• Contains sorbitol
  - May have a laxative effect
• Patients with the rare hereditary condition of sorbitol intolerance should not take this formulation

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

South African registered indications and dosages

Symptomatic relief of colds and influenza associated with nasal, sinus and eustachian tube mucosal congestion

Pseudoephedrine/ Chlorphenamine/ Vitamin C
25/2/50 (mg)

• Oral (syr): 10ml, 4 times a day

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

South African registered indications and dosages

Symptomatic relief of colds and influenza associated with nasal, sinus and eustachian tube mucosal congestion

Pseudoephedrine/ Chlorphenamine/ Vitamin C
25/2/50 (mg)

• Younger than 2 years: Contraindicated
• Between 2-5 years: Oral (syr): 2.5-5ml, 3 times a day
• Between 6-12 years: Oral (syr): 5-10ml, 3 times a day
• Older than 12 years: See adult dosage

Pregnancy

South African recommendations

• Contraindicated
• The safety of pseudoephedrine/ chlorphenamine/ vitamin C has not been established

Breastfeeding

South African recommendations

• Contraindicated
• The safety of pseudoephedrine/ chlorphenamine/ vitamin C has not been established

Fertility

• No information available

South African recommendations

• Caution; no information available

South African recommendations

• Caution; no information available

South African recommendations

• Caution; no dose adjustment recommended
  The elderly are more likely to exhibit anticholinergic and central nervous system stimulant effects and are prone to hypotension

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

Pseudoephedrine hydrochloride
Metabolism and Nutrition Disorders

• Reduced appetite
• Altered metabolism
• Disturbances of glucose metabolism

Psychiatric Disorders

• Fear
• Anxiety
• Restlessness
• Confusion
• Irritability
• Psychotic states
• Insomnia

Nervous System Disorders

• Tremor
• Headache (common)

Cardiac Disorders

• Vasoconstriction leading to hypertension
• Potential cerebral haemorrhage due to elevated blood pressure
• Potential pulmonary oedema due to elevated blood pressure
• Reflex bradycardia
• Stimulation of β1-adrenergic receptors potentially causing:
  • Tachycardia
  • Cardiac dysrhythmias
• Anginal pain
• Palpitations
• Cardiac arrest
• Hypotension, which might be accompanied by:
  • Dizziness
  • Fainting
  • Flushing
• Precipitated anginal pains in patients with angina pectoris

Respiratory, Thoracic and Mediastinal Disorders

• Dyspnoea

Gastrointestinal Disorders

• Nausea
• Vomiting
• Hypersalivation

Renal and Urinary Disorders

• Difficulty in micturition
• Urinary retention

General Disorders and Administrative Site Conditions

• Weakness
• Sweating

Chlorphenamine maleate
Blood and the Lymphatic System Disorders

• Agranulocytosis
• Leucopenia
• Haemolytic anaemia
• Thrombocytopenia

Immune System Disorders

• Hypersensitivity reactions (including bronchospasm, angioedema, and anaphylaxis)

Psychiatric Disorders

• Confusion
• Hallucinations
• Sleep disturbances
• Depression

Nervous System Disorders

• Sedation
• Drowsiness
• Convulsions
• Headache
• Dizziness
• Incoordination
• Fatigue
• Nervousness
• Insomnia
• Paresthesias
• Tingling
• Tremors
• Extrapyramidal effects (including muscle spasms and dystonia)
• Anticholinergic effects (with ataxia)

Eye Disorders

• Anticholinergic effects (with blurred vision)

Ear and Labyrinth Disorders

• Tinnitus

Cardiac Disorders

• Palpitation and dysrhythmias
• Hypertension
• Hypotension
• Tachycardia

Vascular Disorders

• Anticholinergic effects (with flushing)

Respiratory, Thoracic and Mediastinal Disorders

• Dryness of the mouth, throat, and respiratory passages
• Thickening of mucous
• Tightness of the chest

Gastrointestinal Disorders

• Nausea
• Vomiting
• Epigastric pain
• Diarrhoea
• Reduction in tone and motility of the gastrointestinal tract (leading to constipation and gastric reflux)

Skin and Subcutaneous Tissue Disorders

• Photosensitivity
• Skin rash
• Allergic dermatitis
• May cause rashes
• Hair loss

Musculoskeletal, Connective Tissue and Bone Disorders

• Myalgia
• Heaviness and weakness of the hands

Renal and Urinary Disorders

• Urinary retention or frequency
• Dysuria

General Disorders and Administrative Site Conditions

• Lassitude
• Drug fever
• Sweating

Vitamin C (ascorbic acid and sodium ascorbate)
Blood and the Lymphatic System Disorders

• Haemolysis in patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency (large doses )

Gastrointestinal Disorders

• Diarrhoea and other gastrointestinal disturbances (large doses)

Renal and Urinary Disorders

• Formation of renal calcium oxalate calculi (large doses)

General Disorders and Administrative Site Conditions

• Tolerance can develop with prolonged use of large doses

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

Pseudoephedrine hydrochloride

• Antihypertensive agents
• Alpha- and beta-blockers
• Tricyclic antidepressants
• Guanethidine
• Reserpine
• Alpha-methyldopa
• Digoxin
• Cyclopropane
• Halothane
• Other halogenated anaesthetics
• Cardiac glycosides
• Quinidine
• Aluminium hydroxide

Chlorphenamine maleate

• Sedatives
• Central nervous system depressants
• Barbiturates
• Hypnotics
• Opioid analgesics
• Anxiolytic sedatives
• Antipsychotics
• Tricyclic antidepressants
• Maprotiline
• Monoamine oxidase inhibitors

Other interactions

• Alcohol
• Positive skin test results (see additional prescribing points)

Vitamin C (ascorbic acid and sodium ascorbate)

• Desferrioxamine
• Hormonal contraceptives
• Fluphenazine
• Warfarin

None routine

Interactions (other)

• Antihistamines may suppress positive skin test results and should be stopped several days before the test

The pseudoephedrine/ chlorphenamine/ vitamin C combination product has antihistaminic and decongestant properties.

COMBINATION PREPARATIONS

Ascorbic acid/ Pseudoephedrine/ Chlorphenamine

Syrup (per 5ml) 50mg/25mg/2mg

• Flusin C (Pharmacare)