Triprolidine/ Pseudoephedrine/ Ascorbic Acid

Registered South African indications: 

• Colds and influenza

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

Contraindications

• Hypersensitivity to the active ingredient or any of the excipients in this combination product
• Pregnancy
• Breastfeeding
• Triprolidine/pseudoephedrine/ascorbic acid syrup is contra-indicated in patients who are taking or have taken monoamine oxidase inhibitors within the preceding two weeks
• Should not be administered to infants under the age of 2 years

Cautions

Caution in the following patient groups

• Severe renal impairment (pseudoephedrine hydrochloride)
• Severe hepatic impairment (pseudoephedrine hydrochloride)
• Elderly

Drowsiness

• The use of triprolidine/pseudoephedrine/ascorbic acid syrup may lead to drowsiness which is aggravated by the simultaneous intake of alcohol or other central nervous system depressants. Patients should be warned not to drive or operate dangerous machinery

Cardiovascular disease

• Great care is needed in patients with cardiovascular disease such as ischaemic heart disease, arrhythmia or tachycardia, occlusive vascular disorders, including arteriosclerosis, hypertension or aneurysms

Sorbitol content

• Contains sorbitol and may have a laxative effect. Patients with the rare hereditary condition of sorbitol intolerance should not take triprolidine/pseudoephedrine/ascorbic acid syrup

Pseudoephedrine hydrochloride

Caution in the following patient groups

• Care is required when pseudoephedrine is given to patients with hyperthyroidism, diabetes mellitus, closed-angle glaucoma or prostatic enlargement
• Caution should be exercised in the presence of severe renal or hepatic impairment

Cardiovascular risk

• An increased risk of arrhythmias may occur when given to patients receiving cardiac glycosides, quinidine or tricyclic antidepressants
• Pseudoephedrine should be avoided or used with caution in patients undergoing anaesthesia with cyclopropane, halothane, or other halogenated anaesthetics, as they may induce ventricular fibrillation

Triprolidine

Coadministration cautions

• Care should be observed when tricyclic antidepressants, guanethidine, reserpine, methyldopa or atropine are taken concomitantly, as the anti-muscarinic effect may be enhanced

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

Symptomatic relief of colds and influenza
- Nasal congestion

Triprolidine/ Pseudoephedrine/ Ascorbic acid
1.25/25/75 (mg)

• Oral (syr): 10ml, 8hrly

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

Symptomatic relief of colds and influenza
- Nasal congestion

Triprolidine/ Pseudoephedrine/ Ascorbic acid
1.25/25/75 (mg)

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

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

Pregnancy

• Contraindicated

Breastfeeding

• Contraindicated

Renal Impairment

• Severe: Caution, no dose adjustment recommended (pseudoephedrine hydrochloride)

Hepatic Impairment

• Severe: Caution; no dose adjustment recommended (pseudoephedrine hydrochloride)

Elderly

• Caution; no information available

Drugs in Sport

• Prohibited - In competition

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

Tripolidine
Central Nervous System Disorders

• Sedation
• Lassitude
• Dizziness
• Incoordination
• Headache
• Euphoria
• Insomnia
• Nervousness
• Tremor
• Seizures

Cardiovascular Disorders

• Tachycardia
• Hypotension

Respiratory Disorders

• Tight chest

Gastrointestinal Disorders

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

Genitourinary Disorders

• Dysuria

Musculoskeletal Disorders

• Muscular weakness

Immune, Blood and Lymphatic System Disorders

• Hypersensitivity reactions
• Agranulocytosis
• Leukopenia
• Thrombocytopenia
• Haemolytic anaemia

Sensory Disorders

• Blurred vision
• Tinnitus

Psuedoephedrine
Central Nervous System Disorders

• Hallucinations
• Insomnia
• Anxiety
• Restlessness
• Irritability
• Psychosis
• Headache
• Seizures
• Vertigo
• Ataxia
• Fatigue 
• Tremor

Cardiovascular Disorders

• Tachycardia
• Palpitations
• Arrhythmias
• Hypertension
• Impaired circulation to the extremities

Respiratory Disorders

• Dry throat
• Dry nose
• Dyspnoea
• Nasal congestion
• Pharyngeal oedema
• Thickening of bronchial secretions
• Wheezing

Gastrointestinal Disorders

• Dry mouth
• Nausea and vomiting
• Anorexia
• Constipation
• Diarrhoea
• Ischemic colitis

Genitourinary Disorders

• Urinary retention
• Dysuria

Skin and Subcutaneous Tissue Disorders

• Diaphoresis
• Skin photosensitivity
• Skin rash
• Urticaria

Immune, Blood and Lymphatic System Disorders

• Anaphylaxis
• Agranulocytosis
• Haemolytic anaemia
• Thrombocytopaenia

Sensory Disorders

• Angle closure glaucoma
• Blurred vision
• Diplopia
• Tinnitus

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

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

Triprolidine

• Central nervous system depressants
• Anticholinergic agents
• Azelastine 
• Secretin 

Pseudoephedrine

• Sympathomimetic agents
• Antihypertensive agents
• Monoamine oxidase inhibitors
• Volatile anaesthetics
• Cardiac glycosides
• Anticholinergic agents
• Antidepressants
• Antipsychotics 
• Doxapram 
• Oxytocin
• Alluminium oxide 

Ascorbic Acid

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

None routine

Triprolidine
Triprolidine provides symptomatic relief in conditions believed to depend wholly or partly upon the triggered release of histamine.  It is a potent competitive histamine H1-receptor antagonist of the pyrrolidine class with mild central nervous system depressant properties.

Pseudoephedrine
Pseudoephedrine acts mainly on alpha and also on beta adrenergic receptors. It produces vasoconstriction by acting on the alpha adrenergic receptors in the mucosa of the respiratory tract. This results in the decongestant properties of pseudoephedrine.

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.

COMBINATION PREPARATIONS

Triprolidine/ Pseudoephedrine/ Ascorbic acid

Syrup (per 5ml) 1,25mg/25mg/75mg

• Coryx Paediatric (Cipla Medpro)