Etofylline/ Diphenhydramine/ Ammonium Chloride

Registered South African indications:

• Cough 

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

Etofylline
Contraindications

• Hypersensitivity to the active ingredient or any of the excipients in this combination product
• Seizure disorders

Cautions

• Pregnancy
• Breastfeeding
• Renal impairment
• Hepatic impairment
• Elderly
• Peptic ulcer disease
• Cardiac disease
• Benign prostatic hypertrophy 
• Glaucoma 

Diphenhydramine
Contraindications

• Hypersensitivity to the active ingredient 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 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

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

For the relief of coughing and to facilitate bronchodilation and expectoration

Etofylline/ Diphenhydramine/ Ammonium Chloride
105.5/42.2/410.5 (mg/15ml)

• Oral (syr): 15ml, 6-8hrly

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

For the relief of coughing and to facilitate bronchodilation and expectoration

Etofylline/ Diphenhydramine/ Ammonium Chloride
105.5/42.2/410.5 (mg/15ml)

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

Breastfeeding

• Caution; not recommended (Diphenhydramine) 

Renal Impairment

• Mild to moderate: Caution; no information available (Etofylline) 
• Severe: Contraindicated (Ammonium chloride)

Hepatic Impairment

• Mild to moderate: Caution; no information available (Etofylline) 
• Severe: Contraindicated (Ammonium chloride)

Elderly

• Caution; no information available (Etofylline)

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

Etofylline
Central Nervous System Disorders

• Insomnia
• Irritability

Cardiovascular Disorders

• Tachycardia
• Palpitations

Gastrointestinal Disorders

• Abdominal pain
• Diarrhoea
• 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

Ammonium Chloride
Central Nervous System Disorders

• Coma
• Confusion
• Seizures
• Fever  

Gastrointestinal Disorders

• Gastrointestinal discomfort
• Nausea and vomiting

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

Etofylline

• Central nervous system depressants 
• Warfarin
• Sulphonylureas

Diphenhydramine

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

Ammonium Chloride

• Potassium sparing diuretics

None routine 

Etofylline
Etofylline is N-7 substituted theophylline derivative which acts similar to other xanthines. The bronchodilating action of xanthines is thought to result from the competitive inhibition of phosphodiesterase, which is the enzyme responsible for the breakdown cyclic AMP in smooth muscle cells.

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. 

COMBINATION PREPARATIONS

Ammonium Chloride/ Etofylline/ Diphenhydramine

Syrup (per 15ml) 410.5mg/105.5mg/42.2mg

• Dilinct ( Adcock)