Ammonium Chloride/ Diphenhydramine

Registered South African indications:

• Cough

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

Ammonium chloride
Contraindications

• Hypersensitivity to the active ingredient 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

Diphenhydramine
Contraindications

• Hypersensitivity to the active ingredient or any of the excipients in this combination product
• Asthma
• Narrow 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

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

Relief of cough

Ammonium Chloride/ Diphenhydramine
125/12.5 (mg/5ml)

• Oral (syr): 5-10ml, 3-4 hrly; Max: 40ml/24hrs

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

Relief of cough

Ammonium Chloride/ Diphenhydramine
125/12.5 (mg/5ml)

• Younger than 6: Not established for use
• Between 6-12 years: Oral (syr): 2.5-5ml, 4hrly; Max: 20ml/24hrs
• Older than 12 years: See adult dosage

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

Pregnancy

• Caution (Ammonium chloride, Diphenhydramine)
• The safety of ammonium chloride during pregnancy has not been established, although there is no good evidence of an association between first-trimester exposure to ammonium chloride  and foetal abnormalities
• Diphenhydramine crosses the placenta. Because animal reproduction studies are not always predictive of human response and since there is inadequate experience with the use of diphenhydramine in pregnant women, the potential risk for humans is unknown. Use of sedating antihistamines during the third trimester may result in reactions in the newborn or premature neonates. This agent is not recommended during pregnancy

Breastfeeding

• Caution; not recommended (Diphenhydramine)
• Diphenhydramine has been detected in breast milk, but the effect of this on breastfed infants is unknown. Diphenhydramine is not recommended for use during lactation in nursing mothers
• The safety of ammonium chloride during lactation has not been established, although use during this period would not be considered to constitute a hazard

Renal Impairment

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

Hepatic Impairment

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

Elderly

• No dose adjustment recommended (Ammonium chloride, Diphenhydramine)

Porphyria Information

• Not yet classified (NC) (Ammonium chloride, Diphenhydramine)

Drugs in Sport

• Permitted - No warnings

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

Ammonium chloride
Central Nervous System Disorders

• Coma
• Confusion
• Seizures
• Fever

Gastrointestinal Disorders

• Gastrointestinal discomfort
• Nausea and vomiting

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

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

Ammonium chloride

• Potassium-sparing diuretics

Diphenhydramine

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

None routine

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.

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.

COMBINATION PREPARATIONS

Ammonium Chloride/ Diphenhydramine

Syrup (per 5ml) 125mg/12.5mg

• Benylin Original (Johnson & Johnson) originator
• Diphal Expectorant (MDI Healthcare)
• Expectalin (Johnson & Johnson) originator