Chlorphenamine Maleate/ Phenylpropanolamine Hydrochloride/ Phenylephrine Hydrochloride

Registered South African indications:

• Symptomatic relief of nasal congestion due to the common cold and flu, hay fever, allergic rhinitis, other upper respiratory allergies, or associated with sinusitis
• Relief of eustachian tube congestion as an adjunct to treatment of middle ear infection

Registered South African contraindications

• Hypersensitivity to the active ingredient or any of the excipients in this combination product
• During acute attacks of asthma
• Patients on a monoamine oxidase inhibitor for depression (e.g. tranylcypromine) or within two weeks of stopping treatment
• Pregnancy
• Lactation
• Hypertension
• Hyperthyroidism
• Cardiovascular disease such as ischaemic heart disease
• Syrup: Not to be used in children under 6 years of age
• Capsule: Not to be used in children under 12 years of age

South African recommendations

Caution in the following patient groups

• Renal impairment
• Hepatic impairment
• Elderly

Use cautiously in patients with

• Occlusive vascular disease (arteriosclerosis, aneurysms)
• Closed-angle glaucoma
• Phaeochromocytoma
• Narrow-angle glaucoma
• Urinary retention
• Prostatic hypertrophy

Duration of use

• Not to be taken for more than seven days. After 5 to 7 days tachyphylaxis may occur and the product loses effect. Consult a doctor if symptoms persist or are accompanied by fever

Overdosage risks

• Exceeding recommended dosage can cause nervousness, dizziness, sleeplessness, tremulousness, or cardiac dysrhythmia, even at small doses in sensitive individuals

Hypertensive episodes

• Risk of severe hypertensive episodes and intracranial haemorrhage following phenylpropanolamine ingestion. Increased risk of hypertensive crisis and haemorrhagic stroke

Aggravation of conditions

• May aggravate diabetes, glaucoma, prostatic enlargement

Impact on skin tests

• May suppress positive skin results; discontinue several days before testing

Susceptibility to sympathomimetics

• Sympathomimetics should be used with caution in patients who may be hyper susceptible to the effects of sympathomimetics, particularly those with hyperthyroidism. Great care is also needed in patients with cardiovascular disease such as ischaemic heart disease; dysrhythmias or tachycardia; occlusive vascular disorders, including arteriosclerosis, hypertension, or aneurysms

Interaction with antihypertensives

• May reverse the action of antihypertensive agents

Effects on ability to drive and use machines

• Caution advised as the combination product may cause drowsiness and impaired concentration, heightened by alcohol or CNS depressants
• Advise patients affected to not drive or operate machinery

Excipient cautions

• The capsules contains sucrose and lactose monohydrate, affecting glycaemic control in diabetes. Not suitable for patients with hereditary conditions like galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption, fructose intolerance, sucrase-isomaltase insufficiency
• The syrup contains sorbitol which may have a laxative effect. Not for patients with sorbitol intolerance

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

South African registered indications and dosages

Symptomatic relief of nasal congestion due to the common cold and flu, hay fever, allergic rhinitis, other upper respiratory allergies, or associated with sinusitis
Relief of eustachian tube congestion as an adjunct to treatment of middle ear infection

Chlorphenamine Maleate/ Phenylpropanolamine Hydrochloride/ Phenylephrine Hydrochloride
12/30/20 (mg)

• Oral (cap): 1 cap, 8-12hrly; Max duration: 7 days

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Do not chew the capsule or the content

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4/5/5 (mg/5ml)

• Oral (syr): 5ml, 3 to 4 times daily; Max duration: 7 days

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Do not exceed recommended dose

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

South African registered indications and dosages

Symptomatic relief of nasal congestion due to the common cold and flu, hay fever, allergic rhinitis, other upper respiratory allergies, or associated with sinusitis
Relief of eustachian tube congestion as an adjunct to treatment of middle ear infection

Chlorphenamine Maleate/ Phenylpropanolamine Hydrochloride/ Phenylephrine Hydrochloride
12/30/20 (mg)

• Younger than 12 years: Contraindicated
• Older than 12 years: See adult dosage

4/5/5 (mg/5ml)

• Younger than 6 years: Contraindicated
• Between 6-12 years: Oral (syr): 2.5ml, 3 to 4 times daily; Max duration: 7 days
• Older than 12 years: See adult dosage

2/2.5/2.5 (mg/5ml)

• Younger than 6 years: Contraindicated
• Between 6-12 years: 5ml, 3 to 4 times daily; Max duration: 7 days
• Older than 12 years: Not indicated for use

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Do not exceed recommended dose

Pregnancy

South African recommendations

• Contraindicated
• Safety in pregnancy has not been established
• Phenylephrine hydrochloride is best avoided in pregnancy, because of the potential promotion of uterine contractility and peripheral vasoconstriction, with the possibility of foetal hypoxia

Breastfeeding

South African recommendations

• Contraindicated
• Safety in lactation has not been established

Fertility

South African recommendations

• No information available

South African recommendations

• Caution; no information available

South African recommendations

• Caution; no information available

South African recommendations

• Caution; no dose adjustment recommended
  Elderly patients are more susceptible to these central nervous system depressant and hypotensive effects even at therapeutic doses

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

Chlorphenamine Maleate

Blood and Lymphatic System Disorders

Less frequent

• Agranulocytosis
• Leucopenia
• Haemolytic anaemia

Psychiatric Disorders

Less frequent

• Depression
• Nightmares
• Irritability

Frequency unknown

• Euphoria

Nervous System Disorders

Frequent

• Sedation (ranging from slight drowsiness to deep sleep)
• Lassitude
• Dizziness

Less frequent

• Incoordination
• Headache
• Impaired concentration

Eye Disorders

Less frequent

• Blurred vision

Ear and Labyrinth Disorders

Less frequent

• Tinnitus

Cardiac Disorders

Less frequent

• Palpitation
• Tachycardia
• Dysrhythmia

Vascular Disorders

Less frequent

• Hypotension

Respiratory, Thoracic and Mediastinal Disorders

Less frequent

• Increased viscosity of bronchial secretions

Gastrointestinal Disorders

Less frequent

• Nausea and vomiting
• Diarrhoea or constipation
• Anorexia or increased appetite
• Abdominal pain
• Dyspepsia
• Dryness of the mouth
• Epigastric pain

Hepato-biliary Disorders

Less frequent

• Hepatitis
• Jaundice

Skin and Subcutaneous Tissue Disorders

Less frequent

• Allergic reactions including exfoliative dermatitis
• Cross-sensitivity to related medicines
• Photosensitivity
• Urticaria

Musculoskeletal, Connective Tissue and Bone Disorders

Less frequent

• Muscular weakness
• Twitching

Renal and Urinary Disorders

Less frequent

• Urinary retention

Frequency unknown

• Difficulty in micturition
• Dysuria

General Disorders and Administration Site Conditions

Less frequent

• Tightness of the chest

Frequency unknown

• Paradoxical CNS stimulation
  • Insomnia
  • Nervousness
  • Tachycardia
  • Tremors
  • Convulsions

Phenylpropanolamine Hydrochloride

Psychiatric Disorders

Frequency unknown

• Fear
• Anxiety
• Restlessness
• Tremor
• Insomnia
• Confusion
• Irritability
• Weakness
• Psychotic states

Gastrointestinal Disorders

Frequency unknown

• Nausea and vomiting
• Reduced appetite
• Hypersalivation

Metabolism and Nutritional Disorders

Frequency unknown

• Altered metabolism including disturbances of glucose metabolism

Phenylephrine Hydrochloride

Psychiatric Disorders

Frequent

• Nervousness
• Irritability
• Restlessness
• Excitability

Frequency unknown

• Fear
• Anxiety
• Tremor
• Insomnia
• Confusion
• Weakness
• Psychotic states

Nervous System Disorders

Frequent

• Headache
• Dizziness
• Insomnia

Eye Disorders

Frequency unknown

• Mydriasis
• Acute angle closure glaucoma

Cardiac Disorders

Frequency unknown

• Tachycardia or bradycardia
• Cardiac dysrhythmias
• Angina pain
• Palpitations
• Cardiac arrest

Vascular Disorders

Frequent

• Increased blood pressure

Frequency unknown

• Hypotension with dizziness, fainting, and flushing
• Haemorrhagic stroke
• Flushing
• Sweating
• Vasoconstriction

Respiratory, Thoracic and Mediastinal Disorders

Frequency unknown

• Dyspnoea

Gastrointestinal Disorders

Frequent

• Nausea
• Vomiting
• Diarrhoea

Frequency unknown

• Reduced appetite
• Hypersalivation

Metabolism and Nutritional Disorders

Frequency unknown

• Altered metabolism including disturbances of glucose metabolism

Skin and Subcutaneous Tissue Disorders

Frequency unknown

• Allergic reactions
  • Rash
  • Urticaria
  • Allergic dermatitis
• Hypersensitivity reactions
• Cross-sensitivity with other sympathomimetics

Renal and Urinary Disorders

Frequency unknown

• Difficulty in micturition
• Urinary retention
• Dysuria

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

• Monoamine oxidase inhibitors
• Antihypertensive agents
• Alpha- and beta-blockers
• Cardiac glycosides
• Quinidine
• Tricyclic antidepressants
• Halothane
• Other halogenated anaesthetics
• Hypnotics
• Anxiolytics
• Atropine
• Central nervous system depressants
• Barbiturates
• Narcotic analgesics
• Sedatives
• Tranquilisers
• Reserpine
• Alpha-methyldopa
• Digoxin

Other interactions

• Alcohol

Chlorphenamine Maleate

• Phenytoin

None routine

The combination has antihistaminic and sympathomimetic properties.

Chlorphenamine Maleate
Chlorphenamine is an antihistamine with sedative properties.

Phenylephrine Hydrochloride
Phenylephrine is a sympathomimetic amine which acts directly on alpha-adrenergic receptors. It is without significant stimulating effects on the central nervous system at usual doses. The sympathomimetic amines have alpha-adrenergic receptor stimulating properties on the mucosa of the respiratory tract producing vasoconstriction.

Phenylpropanolamine Hydrochloride
Phenylpropanolamine is a sympathomimetic amine which acts directly by displacing noradrenaline from pre-synaptic stores. It has some direct effects on both alpha- and beta-adrenergic receptors with predominantly alpha-adrenergic activity. The sympathomimetic amines have alpha-adrenergic receptor stimulating properties on the mucosa of the respiratory tract producing vasoconstriction.

COMBINATION PREPARATIONS

Chlorpheniramine Maleate/ Phenylpropanolamine Hydrochloride/ Phenylephrine Hydrochloride

Syrup (per 5ml) 2mg/2.5mg/2.5mg

• Betalix Decongestant (Ranbaxy Pharmaceuticals)
• Rinex Paed (Pharmacare)

Syrup (per 5ml) 4mg/5mg/5mg

• Rinex (Pharmacare)

Capsule 12mg/30mg/20mg

• Rinex Diffucaps (Pharmacare)