D-Norpseudoephedrine

Registered South African indications:

• An aid to mass reduction when used in combination with a reduced kilojoule intake

Registered South African contraindications

• Hypersensitivity to d-norpseudoephedrine hydrochloride or to any of the excipients
• Pregnancy
• Coronary thrombosis
• Hyperthyroidism
• Closed-angle glaucoma
• Severe hypertension
• Phaeochromocytoma
• Patients undergoing anaesthesia with cyclopropane, halothane, or other volatile anaesthetics
• Patients treated with monoamine oxidase inhibitors or within two weeks of stopping such treatment
• D-norpseudoephedrine should be avoided in young children

South African recommendations

Caution in the following patient groups

• Breastfeeding
• Renal impairment
• Hepatic impairment
• Elderly

Late afternoon administration

• D-norpseudoephedrine has a stimulant effect on the central nervous system, therefore, it should not be taken in the late afternoon

History of drug or alcohol abuse

• D-norpseudoephedrine tablets are liable to be abused
• Use with extreme caution in patients with a history of drug or alcohol abuse and in patients with personality disorders

Dependence

• Tolerance with dependence has been reported with the use of d-norpseudoephedrine

Long-term efficacy

• There is a lack of evidence for the efficacy of d-norpseudoephedrine in the long-term management of obesity

Diabetes mellitus

• D-norpseudoephedrine should be used with caution in patients with diabetes mellitus, as there is a high incidence of atherosclerotic disease, and they may be at a higher risk of cardiac effects. The effect of the medicine on blood glucose levels should also be considered

Cardiovascular disorders

• D-norpseudoephedrine should be used with caution in patients with cardiovascular disorders, including coronary insufficiency, ischemic heart disease, cardiac dysrhythmias, obstructive cardiomyopathy, cardiac decompensation, or anginal pain

Hypertension

• D-norpseudoephedrine should be used with caution in patients with hypertension, as systolic and diastolic blood pressure may be increased, especially with high doses

Occlusive vascular disease

• Patients with occlusive vascular disease are at an increased risk of peripheral ischemia and should use D-norpseudoephedrine with caution

Prostate disorders

• D-norpseudoephedrine should be used with caution in patients with prostate disorders, as they may be at an increased risk of urinary disorders, such as urinary retention or difficulty with micturition

Porphyria

• D-norpseudoephedrine should be used with caution in patients with porphyria and only when no safer alternative is available
• Precautions should be considered in vulnerable patients

Psychiatric illness

• D-norpseudoephedrine should be used with caution in patients with a history of psychiatric illness

Lactose monohydrate

• D-norpseudoephedrine contains lactose monohydrate and should not be taken by patients with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption

Effects on the ability to drive and use machines

• Patients are advised to take special care before performing tasks requiring their attention, until they know how d-norpseudoephedrine will affect them

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

South African registered indications and dosages

An aid to mass reduction when used in combination with a reduced kilojoule intake

• Oral (tab): 20-40mg at breakfast; Followed by: 20mg at lunchtime taken with a little water; Treatment duration: Not longer than 4 weeks at a time

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Do not exceed the recommended dosage

• Contraindicated (see Contraindications)

Pregnancy 

South African recommendations

• Contraindicated
• Safety and efficacy have not been established during pregnancy. Do not use d-norpseudoephedrine during pregnancy, as placental perfusion may be reduced

Breastfeeding

South African recommendations

• Caution; not recommended
• Safety and efficacy have not been established during breastfeeding. Do not use d-norpseudoephedrine during breastfeeding, as irritability and disturbed sleep have been reported in breastfed infants

Fertility

South African recommendations

• No information available

South African recommendations

• Caution; no dose adjustment recommended

South African recommendations

• Caution; no information available

South African recommendations

• Caution; no dose adjustment recommended
  Elderly patients may have a high incidence of atherosclerotic disease and may be at higher risk of cardiac effects

Psychiatric Disorders

Frequent

• Anxiety
• Fear
• Confusion
• Irritability
• Psychotic reactions

Frequency unknown

• Agitation
• Excitability

Nervous System Disorders

Frequent

• Restlessness
• Insomnia
• Headache

Less frequent

• Tremors

Frequency unknown

• Giddiness

Cardiac Disorders

Frequent

• Tachycardia

Less frequent

• Cardiac dysrhythmias

Frequency unknown

• Precordial pain
• Palpitations
• Increased cardiac contractility (resulting in angina and cardiac arrest)

Vascular Disorders

Less frequent

• Impaired circulation to the extremities
• Hypertension

Respiratory, Thoracic and Mediastinal Disorders

Frequent

• Dyspnoea

Gastrointestinal Disorders

Frequent

• Nausea
• Vomiting

Less frequent

• Dry mouth

Skin and Subcutaneous Tissue Disorders

Frequency unknown

• Sweating

Musculoskeletal, Connective Tissue and Bone Disorders

Frequency unknown

• Muscular weakness

Renal and Urinary Disorders

Frequency unknown

• Difficulty in micturition
• Urinary retention

General Disorders and Administration Site Conditions

Frequent

• Weakness

• Monoamine oxidase inhibitors
• Reversible inhibitors of monoamine oxidase (RIMAs)
• Sympathomimetics
• Dexamfetamine
• Dopamine
• Dopexamine
• Ephedrine
• Isometheptene
• Mephentermine
• Metaraminol
• Methylphenidate
• Phenylephrine
• Phenylpropanolamine
• Pseudoephedrine
• Volatile anaesthetics
• Chloroform
• Cyclopropane
• Halothane
• Digoxin
• Antidysrhythmics
• Quinidine
• Tricyclic antidepressants
• Central nervous system (CNS) stimulants
• Ergot alkaloids
• Oxytocin
• Thyroid hormones
• Antihypertensive medicine or medicine that cause hypotension
• Guanethidine
• Alpha blockers
• Beta blockers (non-selective)
• Antiparkinsonian medicines
• Levodopa
• Bromocriptine
• Medicines used for psychiatric or emotional conditions

Other interactions

• Caffeine

None routine

D-norpseudoephedrine is a sympathomimetic and has anorexigenic properties. The product promotes weight loss by suppressing appetite.

Tablet 20mg

• Relislim (Loock) originator

Capsule 50mg

• Dietene (Adcock Ingram)
• Eetless (Adcock Ingram)
• Thinz (Pharmacare)
• Nobese No 1 (Adcock Ingram)

Drops (per 15 drops) 20mg

• Eetless (Adcock Ingram) 
• Leanor (Pharmacare)