Sodium citrate/ Dextromethorphan/ Doxylamine/ Cetylpyridinium

Registered South African indications:

• Cough
• Bronchitis
• Laryngitis 

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

Sodium citrate
Contraindications

• Hypersensitivity to the active ingredient or any of the excipients in this combination product 
• Severe renal impairment
• Dehydration
• Sodium controlled diet
• Untreated Addison's disease
• Hyperkalaemia
• Severe myocardial damage

Cautions

• Breastfeeding
• Hepatic impairment
• Cardiac failure
• Hypertension
• Peripheral oedema
• Pulmonary oedema
• Shock
• Debilitated patients

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

Doxylamine
Contraindications

• Hypersensitivity to the active ingredient or any of the excipients in this combination product  
• Pregnancy
• Breastfeeding
• Epileptics
• Severe cardiac disease
• Acute asthma attack

Cautions

• Hepatic impairment
• Elderly
• Closed angle glaucoma
• Urinary retention
• Prostatic hypertrophy
• Pyloroduodenal obstruction
• Cardiac failure
• Hypertension
• Oedema
• Cardiovascular disease
• May impair ability to drive and operate machinery

Cetylpyridinium
Contraindications

• Hypersensitivity to the active substance or any of the excipients in this combination product

Cautions

• Pregnancy
• Breastfeeding
• Prolonged use

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

Bronchitis
- Acute bronchial attacks
- Tracheobronchitis
- Allergic bronchitis
Laryngitis
Cough
- Viral
- Associated with chronic obstructive pulmonary disease
- Allergic

Sodium citrate/ Dextromethorphan/ Doxylamine/ Cetylpyridinium
500/30/6/2.5 (mg/10ml)

• Oral (syr): 10ml, 6-8hrly and before bedtime

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

Bronchitis
- Acute bronchial attacks
- Tracheobronchitis
- Allergic bronchitis
Laryngitis
Cough
- Viral
- Associated with chronic obstructive pulmonary disease
- Allergic

Sodium citrate/ Dextromethorphan/ Doxylamine/ Cetylpyridinium
500/30/6/2.5 (mg/10ml)

• Younger than 6 years: Not established for use
• Between 6-12 years: Oral (syr): 5ml, 6-8hrly and before bedtime
• 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) (Sodium citrate, Doxylamine, Cetylpyridinium)

Breastfeeding

• Contraindicated (Doxylamine)

Renal Impairment

• Severe: Contraindicated (Sodium citrate)

Hepatic Impairment

• Caution; no information available (Dextromethorphan)

Elderly

• Caution; no dose adjustment recommended (Doxylamine)

Drugs in Sport

• Permitted - No warning

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

Sodium citrate
Central Nervous System Disorders

• Tetany

Gastrointestinal Disorders

• Diarrhoea
• Nausea and vomiting

Endocrine and Metabolic Disorders

• Metabolic acidosis

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

Doxylamine
Central Nervous System Disorders

• Sedation
• Lassitude
• Dizziness 
• Incoordination
• Euphoria 
• Depression
• Headache
• Irritability 
• Nightmares
• Insomnia
• Nervousness
• Tachycardia
• Tremors
• Convulsions
• Epileptiform seizures

Cardiovascular Disorders

• Hypotension

Gastrointestinal Disorders

• Nausea and vomiting
• Diarrhoea 
• Constipation
• Anorexia 
• Increased appetite 
• Epigastric pain

Genitourinary Disorders

• Difficulty in micturition
• Dysuria

Musculoskeletal Disorders

• Muscular weakness

Immune, Blood and Lymphatic System Disorders

• Allergic reactions 
• Agranulocytosis
• Leucopenia 
• Haemolytic anemia 

Sensory Disorders

• Blurred vision
• Tinnitus

Others

• Dryness of the mouth
• Tightness of the chest

Cetylpyridinium
Gastrointestinal Disorders

• Nausea and vomiting
• Tongue discolouration
• Mouth irritation

Skin and Subcutaneous Tissue Disorders

• Irritant
• Burning

Immune, Blood and Lymphatic System Disorders

• Hypersensitivity reaction

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

Sodium citrate

• Aluminium hydroxide

Dextromethorphan

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

Doxylamine

• Central nervous system depressants
• Monoamine oxidase inhibitors
• Antimuscarinic agents
• Ototoxic agents

Cetylpyridinium

• No information available

None routine

Sodium citrate
Sodium citrate is metabolized to sodium bicarbonate and acts as a systemic alkalizer. 

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.

Doxylamine
Doxylamine is a competitive histamine H1-receptor antagonist. It has sedative and anticholinergic properties. 

Cetylpyridinium
Cetylpyridinium chloride is a cationic antiseptic with activity against both gram positive and gram negative organisms.

COMBINATION PREPARATIONS

Sodium citrate/ Dextromethorphan/ Doxylamine/ Cetylpyridium

Syrup (per 10ml) 500mg/30mg/6mg/2.5mg

• Cepacol cough linctus (Adcock)