Paracetamol/ Ascorbic Acid/ Diphenhydramine/ Phenylephrine

Registered South African indications:

• Colds and flu

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

Paracetamol
Contraindications

• Hypersensitivity to the active ingredient or any of the excipients in this combination product
• Severe hepatic impairment

Cautions

• Pregnancy
• Renal impairment
• Mild to moderate hepatic impairment

Ascorbic acid
Contraindications

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

Cautions

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

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

Phenylephrine
Contraindications 

• Hypersensitivity to the active ingredient or any of the excipients in this combination product
• Cardiovascular disease
• Hypertension
• Diabetes mellitus
• Closed angle glaucoma
• Hyperthyroidism
• Prostatic hypertrophy
• Phaeochromocytoma
• Coadministration with monoamine oxidase inhibitors or within 14 days of use

Cautions 

• Pregnancy
• Breastfeeding
• Occlusive vascular disease
• Prolonged use

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

Symptomatic relief of colds and influenza

Paracetamol/ Ascorbic acid/ Diphenhydramine/ Phenylephrine
400/50/10/5 (mg)

• Oral (cap): 1-2 cap, 4-6hrly; Max: 8 cap/24hrs

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

Symptomatic relief of colds and influenza

Paracetamol/ Ascorbic acid/ Diphenhydramine/ Phenylephrine
400/50/10/5 (mg)

Younger than 12 years

• Not established for use

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 C (Paracetamol, Phenylephrine)

Breastfeeding

• Caution; not recommended (Diphenhydramine)

Renal Impairment

• Caution; no dose adjustment recommended (Paracetamol, Ascorbic acid, Diphenhydramine)

Hepatic Impairment

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

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

Paracetamol
Respiratory Disorders

• Bronchospasm

Hepatobiliary Disorders

• Hepatic dysfunction

Immune, Blood and Lymphatic System Disorders

• Anaphylaxis
• Cutaneous hypersensitivity reactions 
• Angioedema
• Stevens Johnson syndrome
• Thrombocytopenia 
• Agranulocytosis
• Methaemoglobinaemia

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

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

Phenylepherine
Central Nervous System Disorders

• Headache

Cardiovascular Disorders

• Tachycardia
• Cardiac arrhythmia
• Palpitations
• Hypertension

Gastrointestinal Disorders

• Nausea and vomiting

Genitourinary Disorders

• Urinary retention

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

Paracetamol

• Metoclopramide 
• Domperidone
• Cholestyramine
• Oral anticoagulants
• Chloramphenicol

Ascorbic acid

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

Diphenhydramine

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

Phenylephrine

• Monoamine oxidase inhibitors
• Anticholinergic agents
• Digoxin
• Sympathomimetic agents
• Tricyclic antidepressants
• Vasodilating agents
• Beta blockers
• CYP450 inducers
• Linezolid
• Alcohol

None routine

Paracetamol
Paracetamol increases the pain threshold by inhibiting both isoforms of cyclooxygenase, COX-1, COX-2, and COX-3 enzymes involved in prostaglandin synthesis. It does not inhibit cyclooxygenase in peripheral tissues and, thus, has no peripheral anti-inflammatory affects.

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.

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.

Phenylephrine
Phenylephrine is a sympathomimetic agent which acts directly on adrenoreceptors. It has predominantly alpha adrenergic activity and does not cause stimulation of the central nervous system. It produces vasoconstriction which relieves nasal congestion. 

COMBINATION PREPARATIONS

Paracetamol/ Ascorbic acid/ Diphenhydramine/ Phenylephrine

Capsule 400mg/50mg/10mg/5mg

• Fluend (Akacia)