Chlorpheniramine/ Pseudoephedrine/ Dextromethorphan/ Ascorbic Acid

Registered South African indications: 

• Colds and influenza

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

Chlorpheniramine
Contraindications

• Hypersensitivity to the active ingredient or any of the excipients in this combination product  
• Premature infants 
• Neonates 
• Coadministration with monoamine oxidase inhibitors or within 14 days of their use 

Cautions

• Breastfeeding
• Renal impairment 
• Hepatic impairment 
• Elderly
• Narrow angle glaucoma 
• Urinary retention 
• Prostatic hypertrophy 
• Severe hypertension and cardiovascular disease 
• Bronchitis 
• Bronchiectasis 
• Asthma 
• Epilepsy
• Acute exacerbation of asthma 
• Fructose intolerance
• May impair ability to drive and operate machinery

Pseudoephedrine
Contraindications

• Hypersensitivity to the active ingredient or any of the excipients in this combination product 
• Severe renal impairment
• Cardiovascular disease
• Children younger than 12 years
• Phaeochromocytoma
• Diabetes mellitus
• Hyperthyroidism
• Closed angle glaucoma
• Coadministration with monoamine oxidase inhibitors or within 14 days of their use
• Coadministration with other sympathomimetic decongestants
• Coadministration with beta blockers

Cautions

• Pregnancy
• Breastfeeding
• Mild to moderate renal impairment
• Severe hepatic impairment
• Elderly
• Enlarged prostate
• Bladder dysfunction
• Seizure disorders

Dextromethorphan
Contraindications

• Hypersensitivity to the active ingredient or any of the excipients in this combination product
• Current or risk factors for respiratory failure
• Coadministration with monoamine oxidase inhibitors or within 14 days of their use
• Coadministration with selective serotonin reuptake inhibitors

Cautions

• Pregnancy
• Breastfeeding
• Renal impairment
• Hepatic impairment
• Chronic cough
• Asthma
• History of substance abuse
• Slow metabolisers of CYP2D6
• Atopic children
• Epilepsy

Ascorbic acid
Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Hyperoxaluria

Cautions

• Pregnancy
• Breastfeeding
• Renal impairment
• Diabetes mellitus
• Glucose-6-phosphate dehydrogenase deficiency
• Haemachromatosis
• High doses

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

Colds and influenza
Nasal, sinus and eustachian tube mucosal congestion 

Chlorpheniramine/ Pseudoephedrine/ Dextromethorphan/ Ascorbic acid
2/25/7.5/50 (mg/5ml)

• Oral (syr): 10ml, 6hrly

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

Colds and influenza
Nasal, sinus and eustachian tube mucosal congestion 

Chlorpheniramine/ Pseudoephedrine/ Dextromethorphan/ Ascorbic acid
2/25/7.5/50 (mg/5ml)

• Younger than 2 years: Not established for use 
• Between 2-5 years: Oral (syr): 2.5-5ml, 8hrly 
• Between 6-12 years: Oral (syr): 5-10ml, 8hrly 
• Older than 12 years: See adult dosage 

Recommendations for this combination product as per highest risk category when comparing individual active ingredients

Pregnancy

• FDA Pregnancy Category Not Rated (NR) (Pseudoephedrine) 

Breastfeeding

• Caution; not recommended (Pseudoephedrine, Dextromethorphan)

Renal Impairment

• Mild to moderate: Caution; no information available (Dextromethorphan)
• Severe: Contraindicated (Pseudoephedrine)

Hepatic Impairment

• Caution; no information available (Dextromethorphan)

Elderly

• Caution; dose adjustment recommended (Chlorpheniramine, Pseudoephedrine)  

Drugs in Sport

• Prohibited - In competition

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

Chlorpheniramine 
Central Nervous System Disorders 

• Sedation
• Seizures
• Disturbances in attention
• Abnormal coordination
• Dizziness
• Headache
• Depression
• Nightmares
• Paradoxical stimulation

Cardiovascular Disorders 

• Palpitations
• Tachycardia
• Arrhythmias
• Hypotension

Respiratory Disorders 

• Thickening of bronchial secretions
• Tight chest

Gastrointestinal Disorders

• Nausea and vomiting
• Dry mouth
• Abdominal pain
• Diarrhoea
• Constipation
• Dyspepsia 

Hepatobiliary Disorders

• Hepatitis 
• Jaundice

Genitourinary Disorders 

• Urinary retention
• Dysuria

Endocrine and Metabolic Disorders 

• Anorexia
• Increased appetite

Musculoskeletal Disorders 

• Muscle twitching
• Muscle weakness

Skin and Subcutaneous Tissue Disorders

• Exfoliative dermatitis
• Rash
• Urticaria
• Photosensitivity

Immune, Blood and Lymphatic System Disorders 

• Haemolytic anaemia
• Blood dyscrasias
• Allergic reaction
• Angioedema
• Anaphylactic reactions

Sensory Disorders 

• Blurred vision
• Tinnitis

Pseudoephedrine
Central Nervous System Disorders

• Hallucinations
• Insomnia
• Anxiety
• Restlessness
• Irritability
• Psychosis
• Headache
• Seizures
• Vertigo
• Ataxia
• Fatigue 
• Tremor

Cardiovascular Disorders

• Tachycardia
• Palpitations
• Arrhythmias
• Hypertension
• Impaired circulation to the extremities

Respiratory Disorders

• Dry throat
• Dry nose
• Dyspnoea
• Nasal congestion
• Pharyngeal oedema
• Thickening of bronchial secretions
• Wheezing

Gastrointestinal Disorders

• Dry mouth
• Nausea and vomiting
• Anorexia
• Constipation
• Diarrhoea
• Ischemic colitis

Genitourinary Disorders

• Urinary retention
• Dysuria

Skin and Subcutaneous Tissue Disorders

• Diaphoresis
• Skin photosensitivity
• Skin rash
• Urticaria

Immune, Blood and Lymphatic System Disorders

• Anaphylaxis
• Agranulocytosis
• Haemolytic anaemia
• Thrombocytopaenia

Sensory Disorders

• Angle closure glaucoma
• Blurred vision
• Diplopia
• Tinnitus

Dextromethorphan
Central Nervous System Disorders

• Somnolence
• Psychomotor hyperactivity
• Dizziness
• Seizure
• Confusional state
• Insomnia

Respiratory Disorders

• Respiratory depression

Gastrointestinal Disorders

• Nausea and vomiting
• Diarrhoea
• Abdominal pain

Skin and Subcutaneous Tissue Disorders

• Angioedema
• Pruritus
• Rash
• Urticaria

Ascorbic acid 
Central Nervous System Disorders

• Dizziness
• Fatigue
• Headache

Cardiovascular Disorders

• Flushing

Gastrointestinal Disorders

• Diarrhoea
• Nausea and vomiting
• Flank pain
• Heartburn

Endocrine and Metabolic Disorders

• Hyperoxaluria

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

Chlorpheniramine

• Phenytoin 
• Monoamine oxidase inhibitors 
• Anticholinergic agents
• Antihistamines 
• Central nervous system depressants

Pseudoephedrine

• Sympathomimetic agents
• Antihypertensive agents
• Monoamine oxidase inhibitors
• Volatile anaesthetics
• Cardiac glycosides
• Anticholinergic agents
• Antidepressants
• Antipsychotics 
• Doxapram 
• Oxytocin
• Aluminium oxide 

Dextromethorphan

• Monoamine oxidase inhibitors
• Selective serotonin reuptake inhibitors
• Central nervous system depressants
• CYP2D6 inhibitors

Ascorbic acid

• Bortezomib
• Fluphenazine
• Desferoxamine
• Copper
• Aluminium
• Aspirin
• Nicotine
• Alcohol
• Appetite suppressants 
• Anticonvulsants
• Iron
• Oral contraceptives 
• Tetracycline 
• Oral anticoagulants 
• Citrate

None routine 

Chlorpheniramine 
Chlorpheniramine acts as a competitive antagonist at H1-receptors. These histamine receptors are present in the respiratory tract, gastrointestinal tract and blood vessels thus allowing chlorpheniramine to perform its role in modulating the immune response and as a decongestant.

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. 

Dextromethorphan
Dextromethorphan is a non-opioid antitussive drug. It exerts its antitussive activity by acting on the cough centre in the medulla oblongata, raising the threshold for the cough reflex. 

Ascorbic acid 
Ascorbic acid, a water-soluble vitamin, is essential for formation of collagen and intercellular material, and therefore necessary for the development of cartilage, bone, teeth and for the healing of wounds. It is also essential for the conversion from folic acid to folinic acid, facilitates iron absorption from the gastro-intestinal tract, influences haemoglobin formation and erythrocyte maturation and assists in providing resistance to infections.

COMBINATION PREPARATIONS

Chlorpheniramine/ Pseudoephedrine/ Dextromethorphan/ Ascorbic acid

Syrup (per 5ml) 2mg/25mg/7.5mg/50mg

• Flusin DM (Pharmacare)