It is a South African Schedule 5 medicine that contains sulpiride, available as capsules and as an oral elixir.It is used mainly for schizophrenia, certain depressive conditions, acute confusional states, specific behavioural disorders, and as an adjunct in duodenal ulceration of psychosomatic origin. It is also used to treat vertigo, and has anti-emetic (anti-nausea) effects.
What it is and what it is used for
What it is
- ESPIRIDE contains sulpiride, described as a substituted benzamide listed under tranquillisers (miscellaneous). It exerts antipsychotic and anti-emetic actions and influences gastrin secretion .
What it is used for
- Reactive depression and depression associated with psychoses of other origins; prophylaxis and treatment of depressive psychoses.
- Schizophrenia, particularly where hallucinations, autism, aggressiveness, or withdrawn–inhibited features are present.
- Acute delirium, acute hallucinatory states, and confused states.
- Behaviour disorders in all age groups where abnormal aggressive symptoms are prominent.
- As a useful adjunct in the medical treatment of duodenal ulceration of psychosomatic origin.
- Vertigo treatment.
- Anti-emetic action.
How it works
The source states that sulpiride has antipsychotic and anti-emetic actions and affects gastrin secretion. In everyday terms, it helps steady disordered thinking and perception, reduces nausea, and influences a stomach hormone (gastrin). It is absorbed when taken by mouth, and its effects are related to a half-life of about 7–9 hours, which guides dosing frequency.
Who should NOT use this medicine
Do not use ESPIRIDE if any of the following apply
- You are hypersensitive/allergic to sulpiride or phenothiazines.
- You have a phaeochromocytoma.
- You have bone-marrow depression.
- You are hypomanic, in the manic or pre-manic phase of manic-depressive psychosis, or you have acute mania (ESPIRIDE may exacerbate symptoms).
- You have acute porphyria (ESPIRIDE is considered unsafe).
Special excipient-related exclusions :
- Capsules: contain lactose monohydrate. Patients with rare hereditary conditions of galactose intolerance (e.g., galactosaemia, Lapp lactase deficiency, glucose-galactose malabsorption) or fructose intolerance should not take ESPIRIDE.
- Elixir: patients with sorbitol intolerance should not take ESPIRIDE ELIXIR.
Pregnancy
- The safety in pregnancy has not been established (see section on pregnancy for details).
Warnings and precautions (Read before use)
General cautions
- Tapering: Slowly decrease the dosage before total withdrawal.
- Cardiovascular/respiratory disease: Use with caution, particularly where a sudden drop in blood pressure would be risky. Dose adjustments may be needed if you are taking other medicines that cause postural hypotension (drop in blood pressure when standing).
- Heart conditions: Use with care in existing tachycardia or cardiac insufficiency.
- Liver: Use with care in liver dysfunction or a history of jaundice.
- Parkinsonism: Use with care (see Interactions).
- Seizure risk: Care is required if you are on anticonvulsant therapy; ESPIRIDE may lower the convulsive threshold (see Interactions).
- Elderly/debilitated: Use with care; reduced doses are recommended in the elderly.
- Eye/skin monitoring: During long-term therapy, have regular examinations for abnormal pigmentation or ocular changes.
- Diabetes: The capsules contain lactose, which may affect glycaemic control in patients with diabetes mellitus.
- Gastrointestinal warning: The anti-emetic action may mask symptoms of conditions such as gastrointestinal obstruction.
Driving and using machines
- ESPIRIDE may cause drowsiness and impaired concentration. These effects can be aggravated by alcohol or other central nervous system depressants. Do not drive, operate hazardous machinery, or perform dangerous tasks if affected.
Blood disorders
- The source reports various haematological disorders, including haemolytic anaemia, aplastic anaemia, thrombocytopenic purpura, and a potentially fatal agranulocytosis.
- Important: Many cases of agranulocytosis occurred within 4–10 weeks of starting treatment. If you develop sore throat or fever, seek medical advice urgently; white cell counts should be checked if these symptoms appear.
Temperature regulation
- ESPIRIDE can impair body temperature regulation, leading to hypothermia or hyperthermia depending on the environment.
Endocrine/metabolic
- The source notes hyperglycaemia, altered glucose tolerance, and increased serum-cholesterol concentrations in some patients.
Alcohol content and sweeteners (Elixir)
- Elixir contains alcohol (5,0% v/v) as well as sorbitol and sweeteners (sodium cyclamate and saccharin sodium). See Interactions and excipient cautions.
Pregnancy, planning pregnancy, and breastfeeding
- Not specified in the source beyond: “The safety in pregnancy has not been established.”
- Advice: Speak to your doctor or pharmacist before use if you are pregnant, planning a pregnancy, or breastfeeding.
Interactions
- Levodopa (and other anti-Parkinson medicines): The anti-Parkinsonian actions (e.g., of levodopa) may be diminished by ESPIRIDE.
- Sucralfate/antacids (aluminium/magnesium hydroxides): These reduce ESPIRIDE bioavailability. If needed together, take ESPIRIDE before (rather than with or after) sucralfate/antacids.
- Atropine and tricyclic antidepressants: ESPIRIDE may enhance anticholinergic properties.
- Medicines that may cause leucopenia: Do not combine with agents such as phenylbutazone and thiouracils.
- Adrenergic neuron blockers (e.g., guanethidine): ESPIRIDE may reduce antihypertensive action.
- Central nervous system depressants: ESPIRIDE enhances the activity of alcohol, anaesthetics, hypnotics, and narcotic analgesics; dose reductions of those agents may be required.
- Anticonvulsants (e.g., diazepam, phenobarbitone, phenytoin): ESPIRIDE does not enhance their anticonvulsant effects and may lower the convulsive threshold.
- Clinical masking: Its anti-emetic action may mask signs of disorders like gastrointestinal obstruction.
Practical tip
- If you must use ESPIRIDE with sucralfate or antacids, take ESPIRIDE first.
How to take (Step-by-step)
Important: The following is copied in meaning (not wording) from the professional information. Do not change your dose without medical advice.
For schizophrenia (Adults):
- Initial dose: 200–400 mg twice daily.
- If needed: May be increased to a maximum of 1,2 g twice daily.
- Maintenance: 600–800 mg per day in divided doses, continued as long as necessary.
For common, milder psychiatric conditions of shorter duration and behavioural disorders (Adults):
- 100–200 mg daily, up to 300 mg per day in divided doses.
- For maintenance, reduce or increase as necessary (as per clinical response).
Children (6–12 years) with behavioural disorders (from the source group):
- 3–5 mg/kg body mass per day in divided doses.
For gastro-enterology (Adults):
- 150–300 mg daily in divided doses.
- Maintenance and duration according to patient’s requirements.
For vertigo (Adults):
- 150–300 mg daily in divided doses, depending on intensity of vertigo.
Elderly:
- Use reduced doses (no specific amounts provided in the source).
Tapering/Stopping:
- Slowly decrease the dosage before totally withdrawing ESPIRIDE.
With or without food:
- Not specified in the source.
Missed dose:
- Not specified in the source.
Overdose :
- Symptoms: See Side effects section.
- Treatment: In severe overdosage, the stomach should be emptied by aspiration and lavage. Emetics should not be used. Ongoing management is symptomatic and supportive.
Dosing table
| Indication / Setting | Population | Dose | Frequency | Notes / Maximum |
|---|---|---|---|---|
| Schizophrenia (initial) | Adults | 200–400 mg | Twice daily | May increase if needed |
| Schizophrenia (maximum during titration) | Adults | Up to 1,2 g | Twice daily | As per source “maximum of 1,2 g twice daily” |
| Schizophrenia (maintenance) | Adults | 600–800 mg/day | Divided doses | Continue as long as necessary |
| Milder psychiatric conditions / behavioural disorders | Adults | 100–200 mg/day (up to 300 mg/day) | Divided doses | Adjust for maintenance as necessary |
| Behavioural disorders | Children 6–12 years | 3–5 mg/kg/day | Divided doses | – |
| Gastro-enterology | Adults | 150–300 mg/day | Divided doses | Maintenance & duration as required |
| Vertigo | Adults | 150–300 mg/day | Divided doses | Depending on intensity |
| Elderly | Older adults | Reduced doses | – | Exact amounts not specified |
Possible side effects
The professional information lists the following unwanted effects.
Side effects reported
- Neurological/extrapyramidal: Mild sedation; extrapyramidal disorders including acute dystonia, Parkinsonism-like syndrome, akathisia, and neuroleptic malignant syndrome; tardive dyskinesia; perioral tremor; sleep disturbances; overstimulation; agitation; insomnia; depression; convulsions.
- Cardiovascular: Hypertension, tachycardia, cardiac arrhythmias, electrocardiographic changes, postural hypotension.
- Endocrine/metabolic: Impotence, amenorrhoea, galactorrhoea, gynaecomastia, mass gain; hyperglycaemia, altered glucose tolerance, increased serum-cholesterol.
- Gastrointestinal/antimuscarinic-type: Dry mouth, constipation, urinary retention, mydriasis (pupil dilation).
- Respiratory/ENT: Nasal congestion; blurred vision (listed under antimuscarinic effects).
- Hepatic: Minor abnormalities in liver function tests; jaundice (reported, probably allergic in origin).
- Allergic/skin & eyes: Urticaria, exfoliative dermatitis, erythema multiforme, contact sensitivity; photosensitivity reactions; pigment deposition in skin and more often eyes with corneal and lens opacities (with prolonged therapy).
- Haematological: Haemolytic anaemia, aplastic anaemia, thrombocytopenic purpura, agranulocytosis (potentially fatal; many cases within 4–10 weeks of starting).
- Thermoregulation: Hypo- or hyperthermia depending on environment.
- Withdrawal after high doses: Nausea, vomiting, gastritis, tremors on abrupt discontinuation.
Serious—seek urgent help
- Neuroleptic malignant syndrome.
- Agranulocytosis (especially if you develop fever or sore throat within 4–10 weeks of starting).
- Cardiac arrhythmias or significant postural hypotension.
- Jaundice (yellowing of the skin/eyes).
- Severe allergic skin reactions (e.g., exfoliative dermatitis, erythema multiforme).
- Corneal or lens opacities and abnormal ocular pigmentation noted on examinations.
What to do: If you notice any severe reaction or worrying symptoms mentioned above, stop taking ESPIRIDE and seek urgent medical care. For fever or sore throat, arrange white cell counts as directed in the source.
Storage and disposal
- Store at or below 25 °C.
- Protect from light and moisture.
- Keep in the original packaging until needed.
- Keep out of the reach of children.
What the medicine contains
Capsules (ESPIRIDE capsules):
- Active: Sulpiride 50 mg per capsule.
- Excipients (from source): Colloidal silicon dioxide, gelatin, lactose monohydrate (contains sugar; 112 mg lactose per capsule), magnesium stearate, purified talc, maize starch, titanium dioxide (C.I. 77891).
Elixir (ESPIRIDE ELIXIR):
- Active: Sulpiride 25 mg per 5 ml.
- Excipients (from source): Alcohol (5,0% v/v), disodium edetate, dye Lennon yellow (C.I. 47005), flavour lemon essence No.1, glycerol, saccharin sodium, sodium cyclamate, sorbitol (70%) solution, methyl hydroxybenzoate, propyl hydroxybenzoate, purified water.
- Preservatives (from source): Methyl hydroxybenzoate 0,08% m/v, propyl hydroxybenzoate 0,02% m/v.
- Contains sugar/sweeteners: Sorbitol 26,058 mg (per 5 ml), sodium cyclamate 55 mg, saccharin sodium 2,5 mg.
Excipient cautions: See “Who should NOT use this medicine” for lactose, sorbitol, sweetener, and alcohol warnings that are specified in the source.
Pack information and appearance
Identification
- ESPIRIDE capsules: White powder in a No. 3 off-white, opaque capsule, printed with a mortar and pestle and “Lennon” in blue ink.
- ESPIRIDE ELIXIR: Clear, bright, yellowish-green solution.
Presentation
- Capsules: Packs of 100 capsules in various securitainers; 28 or 56 capsules in Ziploc metallised lay-flat bags (grouped into polyethylene bags).
- Elixir: 100 ml bottles (various materials and caps) supplied in an outer cardboard carton.
- Note: Not all packs and pack sizes are necessarily marketed.
FAQs
1) What scheduling status does ESPIRIDE have in South Africa?
It is listed as S5 in the professional information.
2) What strengths and forms are available?
Capsules with 50 mg sulpiride each; elixir containing 25 mg per 5 ml.
3) Can I drive or operate machinery while taking ESPIRIDE?
Use caution. It may cause drowsiness and impaired concentration, which are worse with alcohol or other CNS depressants. Do not drive or operate hazardous machinery if affected.
4) Does the elixir contain alcohol or sweeteners?
Yes. The elixir contains alcohol (5,0% v/v), sorbitol, sodium cyclamate, and saccharin sodium (amounts are listed in the source).
5) I take antacids or sucralfate—how should I time ESPIRIDE?
ESPIRIDE bioavailability is reduced with sucralfate/antacids. If used together, take ESPIRIDE before (rather than with or after) these agents.
6) Can I take ESPIRIDE with levodopa for Parkinson’s disease?
The source states that the anti-Parkinsonian actions of agents like levodopa may be diminished by ESPIRIDE. Discuss with your doctor.
7) Do I need to taper off ESPIRIDE?
Yes. The source advises a slow decrease in dose before total withdrawal.
8) Is ESPIRIDE safe in pregnancy or breastfeeding?
The safety in pregnancy has not been established. Speak to your doctor or pharmacist before use.
9) Are there people who must not take ESPIRIDE because of the excipients?
Yes. Capsules should not be used by patients with galactose intolerance conditions (e.g., galactosaemia, Lapp lactase deficiency, glucose-galactose malabsorption) or fructose intolerance (per source wording). The elixir should not be used in sorbitol intolerance.
10) Is ESPIRIDE used for vertigo and duodenal ulcers?
Yes. The source lists use in vertigo (adults 150–300 mg/day in divided doses) and as a useful adjunct in the medical treatment of duodenal ulceration of psychosomatic origin.
