Diphenhydramine/ Ammonium Chloride/ Sodium Citrate

Registered South African indications:

• Cough 

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

Diphenhydramine
Contraindications

• Hypersensitivity to the active ingredients or any of the excipients in this combination product
• Asthma
• Closed angle glaucoma
• Prostatic hypertrophy
• Stenosing peptic ulcer
• Pyloroduodenal obstruction
• Bladder neck obstruction
• Porphyria

Cautions

• Breastfeeding
• Moderate to severe renal impairment
• Hepatic impairment 
• Elderly
• Glaucoma
• Urinary retention
• Myasthenia gravis
• Epilepsy
• Bronchitis
• Chronic obstructive pulmonary disease
• Tinnitus
• Prolonged use

Ammonium Chloride
Contraindications

• Hypersensitivity to the active ingredients or any of the excipients in this combination product
• Severe renal impairment
• Severe hepatic impairment
• Metabolic alkalosis 

Cautions

• Pregnancy
• Breastfeeding
• Mild to moderate renal impairment
• Mild to moderate hepatic impairment
• Respiratory insufficiency

Citric Acid 
Contraindications

• Hypersensitivity to the active ingredients 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
• Heart failure
• Hypertension
• Peripheral oedema
• Pulmonary oedema
• Shock
• Debilitated patients

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

Alleviation of cough

Diphenhydramine/ Ammonium chloride/ Citric acid
14.1/135/55 (mg/5ml)
14/136/56 (mg/5ml)
14.1/137/57 (mg/5ml)

• Oral (syr): 5-10ml, 3-4hrly; Max: 4 doses/24hrs 

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

Alleviation of cough

Diphenhydramine/ Ammonium chloride/ Citric acid
14.07/137/57 (mg/5ml) 

• Younger than 1 year: Not established for use 
• Between 1-5 years: Oral (syr): 2.5ml, 3-4hrly
• Between 6-12 years: Oral (syr): 5ml, 3-4hrly

14.1/135/55 (mg/5ml)
14/136/56 (mg/5ml)
14.1/137/57 (mg/5ml)

• Younger than 6 years: Not established for use 
• Between 6-12 years: Oral (syr): 2.5-5ml, 3-4hrly; Max: 4 doses/24hrs
• 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) (Citric acid)

Breastfeeding

• Caution; not recommended (Diphenhydramine)

Renal impairment

• Mild to moderate: Caution; no dose adjustment recommended (Diphenhydramine, Ammonium chloride) 
• Severe: Contraindicated (Ammonium chloride, Citric acid)

Hepatic impairment

• Mild to moderate: Caution; no dose adjustment recommended (Diphenhydramine, Ammonium chloride, Citric acid)
• Severe: Contraindicated (Ammonium chloride)

Elderly

• Caution; no dose adjustment recommended (Diphenhydramine)

Drugs in Sport

• Permitted - No warning

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

Diphenhydramine
Central Nervous System Disorders

• Sedation
• Disturbances in attention
• Unsteadiness
• Dizziness
• Seizures
• Headache
• Paraesthesia
• Dyskinesias
• Fatigue
• Confusion
• Paradoxical excitement

Cardiovascular Disorders

• Tachycardia
• Palpitations

Respiratory Disorders

• Dyspnoea
• Thickening of bronchial secretions

Gastrointestinal Disorders

• Dry mouth
• Nausea and vomiting

Genitourinary Disorders

• Urinary difficulty
• Urinary retention

Musculoskeletal Disorders

• Muscle twitching

Immune, Blood and Lymphatic System Disorders

• Hypersensitivity reactions
• Urticaria
• Angioedema

Sensory Disorders

• Blurred vision
• Tinnitus

Ammonium Chloride
Central Nervous System Disorders

• Coma
• Confusion
• Seizures
• Fever  

Gastrointestinal Disorders

• Gastrointestinal discomfort
• Nausea and vomiting

Citric Acid
Central Nervous System Disorders

• Tetany

Gastrointestinal Disorders

• Diarrhoea
• Nausea and vomiting

Endocrine and Metabolic Disorders

• Metabolic acidosis

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

Diphenhydramine

• Central nervous system depressants
• Monoamine oxidase inhibitors
• Anticholinergic agents
• CYP2D6 substrates

Ammonium Chloride

• Potassium sparing diuretics

Citric Acid

• Aluminium hydroxide

None routine. Specific cases may require

• Renal function
• Hepatic function
• Electrolytes

Diphenhydramine
Diphenhydramine is a histamine H1 receptor antagonist that competes with free histamine for binding at histamine receptors. In addition to its usual anti-allergy actions, it also has significant sedative and antimuscarinic properties. 

Ammonium chloride
Ammonium chloride is used as an expectorant. It causes irritation of the bronchial mucosa, which results in the production of excess respiratory tract fluid. This allows for easier mucus expulsion due to its decreased viscosity.  

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

COMBINATION PREPARATIONS

Ammonium/ Citric acid/ Diphenhydramine

Syrup (per 5ml) 137mg/57mg/14.07mg

• Broncleer children (Adcock)

Syrup (per 5ml) 135mg/55mg/14.1mg

• Clear cough syrup (Be-Tabs)

Syrup (per 5ml) 136mg/56mg/14mg

• Amcough (Innovata)
• Betalin (Ranbaxy Pharmaceuticals)
• Medilyn (Cipla Medpro)

Syrup (per 5ml) 137mg/57mg/14.1mg

• DPH (Adcock)