Dimethindene/ Phenylephrine

Registered South African indications:

• Nasal and sinus congestion

Contraindications

• Hypersensitivity to the active ingredient or any of the excipients in this combination product
• Simple atrophic rhinitis
• Atrophic rhinitis with fetid discharges (ozena)
• Coadministration with monoamine oxidase inhibitors or within 14 days of their use

Cautions

• Pregnancy
• Breastfeeding
• Renal impairment
• Hepatic impairment
• Elderly
• Infants and children <6 years
• Prolonged or excessive use
• Hypertension or other cardiovascular diseases
  - Coronary artery disease
  - Heart disease (including angina)
  - Ischaemic heart disease
  - Arrhythmia or tachycardia
  - Occlusive vascular disorders (including arteriosclerosis)
  - Aneurysms
• Diabetes mellitus
• Hyperthyroidism
• Thyrotoxicosis
• Closed-angle glaucoma
• Psychiatric or emotional conditions
• Undergoing anaesthesia (with cyclopropane, halothane, or other halogenated anaesthetics)
• Coadministration with medicines for depression

Forms avail. in SA and covered in this monograph: gel, nas

Relief of nasal and sinus congestion due to colds

Dimethindene/ Phenylephrine
25/250 (mg/100g or 100ml)

• Nasal (gel): Apply to nose, 6hrly
• Nasal (nas): 1 spray in each nostril, 6-8hrly

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See additional prescribing points for administration directions

Paed. forms avail. in SA and covered in this monograph: gel, nas

Relief of nasal and sinus congestion due to colds

Dimethindene/ Phenylephrine
25/250 (mg/100g or 100ml)

• Younger than 6 years: Not established for use
• Older than 6 years: See adult dosage

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See additional prescribing points for administration directions

Pregnancy

• Caution; not recommended
• Safety in pregnancy has not been established

Breastfeeding

• Caution; not recommended
• Safety in breastfeeding has not been established 

Renal Impairment

• Caution; no information available

Hepatic Impairment

• Caution; no information available

Elderly

• Caution; no dose adjustment recommended 

Drugs in Sport

• Permitted - No warnings 

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

Dimethindene
Central Nervous System Disorders

• Excitement 
• Vertigo
• Drowsiness
• Headache
• Nervousness

Cardiovascular Disorders

• Palpitations 

Respiratory Disorders

• Dyspnoea 
• Dry nose

Gastrointestinal Disorders

• Nausea
• Diarrhoea
• Dry mouth
• Gastralgia 

Skin and Subcutaneous Tissue Disorders

• Rash
• Facial oedema
• Itching
• Morbilliform eruption 

Immune, Blood and Lymphatic System Disorders

• Anaphylaxis

Sensory Disorders

• Blurred vision

Phenylephrine
Central Nervous System Disorders

• Headache 
• Anxiety 
• Restlessness 
• Tremor 
• Insomnia 
• Confusion 
• Irritability 
• Weakness 
• Psychotic states 
• Cerebral haemorrhage 

Cardiovascular Disorders

• Hypertension 
• Palpitations 
• Reflex bradycardia 
• Cardiac arrest 
• Angina 
• Hypotension 

Respiratory Disorders

• Rhinitis medicamentosa 
• Pulmonary oedema 
• Dyspnoea

Gastrointestinal Disorders

• Vomiting 
• Reduced appetite 

Genitourinary Disorders

• Difficulty with micturition 
• Urinary retention 

Endocrine and Metabolic Disorders

• Altered glucose metabolism 

Skin and Subcutaneous Tissue Disorders

• Nasal irritation 

Others

• Sweating 
• Hypersalivation 

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

Dimethindene

• Donepezil
• Sedatives 

Phenylephrine

• Monoamine oxidase inhibitors 
• Tricyclic antidepressant 
• Adrenergic neurone-blocking agents 
• Centrally acting antiadrenergic agents 

None routine

Administration directions for microdoser (sol):

• Blow nose carefully
• Remove protective cap
• Before using microdoser for the first time, operate microdoser several times to prime it
• Insert microdoser into one nostril and press while breathing in at the same time
• Repeat operation in other nostril
• Replace protective cap

Dimethindene
Dimethindene is a competitive inhibitor of histamine at H1 receptors. In low concentrations it stimulates histamine methyletransferase resulting in histamine deactivation. Dimethindene is a strong mast cell stabiliser, has local anaesthetic effects, and also acts as antagonist to bradykinin, serotonin, and acetylcholine

Phenylephrine
Phenylephrine  is a sympathomimetic amine that acts agonistically at alpha-1 adrenoreceptors. Binding at these receptors causes vasoconstriction and decreases nasal blood flow which results in alleviation of nasal congestion

COMBINATION PREPARATIONS

Phenylephrine/ Dimethindene

Nasal gel (per 100g) 250mg/25mg

• Vibrocil-S (GSK) originator

Nasal solution (per 100ml) 250mg/25mg

• Vibrocil-S (GSK) originator