Stemetil

Stemetil

Prochlorperazine

• Tablets:

• 5 mg – Used for mild nausea, vomiting, and as part of combination therapy for anxiety disorders.

• 10 mg – Used for more pronounced symptoms, including vestibular disorders.

• Injection Solution:

• 12.5 mg/ml – Intended for intramuscular or intravenous administration. Used in emergency cases requiring rapid symptom relief (e.g., severe vomiting, inability to take tablets, psychomotor agitation).

• Suppositories (Rectal):

• 5 mg – Suitable for patients with sensitive gastrointestinal tracts or difficulty taking tablets.

• 25 mg – Used for severe nausea and vomiting, as well as in combination therapy for psychotic disorders.

Each dosage form is selected by a physician based on the patient's age, diagnosis, and symptom severity.

• Nausea and vomiting (including postoperative, drug-induced, and migraine-related).

• Dizziness associated with vestibular disorders.

• Anxiety disorders and psychotic conditions (as part of combination therapy).

• Tablets:

• Initial dosage for adults: 5–10 mg 2–3 times daily, depending on symptom severity.

• Dosage may be increased based on the patient's condition and physician's recommendation.

• Tablets should be swallowed with water without chewing. Food intake does not significantly affect efficacy, but if gastrointestinal discomfort occurs, it is better to take after meals.

• Treatment duration: 2–3 months, followed by a reduction to a maintenance dose.

• Maximum daily dose: 40 mg.

• Injections:

• Used when tablet intake is impossible or a faster effect is required.

• Intramuscular: 12.5 mg 2–3 times daily.

• Intravenous: Administered in a hospital setting under medical supervision.

• Suppositories:

• Suitable for patients with difficulty taking tablets or with increased gastrointestinal sensitivity.

• Dosage: 5–25 mg 1–2 times daily, depending on the patient's condition.

• Suppositories should be administered after natural bowel movements for maximum absorption.

Dosage adjustments may be required for elderly patients and those with liver or kidney diseases, with treatment plans tailored individually by a physician.

• Hypersensitivity to prochlorperazine or phenothiazines.

• Severe liver diseases.

• Cardiovascular diseases.

• Parkinson's disease.

• Children under 2 years of age.

• Coma or CNS depression.

• Brain injuries.

• Use with caution in patients with cardiovascular diseases, epilepsy, or glaucoma.

• Risk of extrapyramidal symptoms with prolonged use.

• Abrupt discontinuation is not recommended.

• Enhances the effects of sedatives, antihypertensives, and anticholinergic drugs.

• May increase the risk of serotonin syndrome when taken with antidepressants (SSRIs, tricyclics).

• Avoid alcohol (risk of CNS depression).

• Use cautiously with drugs that prolong the QT interval (increased risk of arrhythmias).

• Category C (FDA) – Not recommended but may be prescribed if benefits outweigh risks.

• During breastfeeding: Only under strict indications, as it passes into breast milk.

• May cause drowsiness, dizziness, and reduced concentration. Avoid driving and operating hazardous machinery.

• CNS and Peripheral Nervous System: Drowsiness, dizziness, insomnia, extrapyramidal disorders (parkinsonism, tardive dyskinesia). Paradoxical reactions: hallucinations, psychomotor agitation.

• Digestive System: Dry mouth, appetite changes, nausea, vomiting, cholestatic jaundice.

• Reproductive System: Amenorrhea, hyperprolactinemia, decreased libido, dysmenorrhea, galactorrhea, ejaculation disorders, gynecomastia, false-positive pregnancy tests.

• Hematopoietic System: Bone marrow suppression (thrombocytopenia, leukopenia, anemia, pancytopenia, eosinophilia).

• Allergic Reactions: Skin rash, urticaria, angioedema.

• Others: Weight gain, fatigue.

• Cardiovascular System: Cases of sudden death (possibly cardiological causes) reported with phenothiazine neuroleptics; may prolong QT interval, increasing the risk of ventricular arrhythmias (especially with baseline bradycardia, hypokalemia, or prolonged QT).

• Symptoms: CNS depression, seizures, hypotension, coma.

• Treatment: Symptomatic therapy, maintenance of vital functions.

• Blocks dopamine receptors in the chemoreceptor trigger zone and vomiting center, providing antiemetic effects.

• Also has sedative and antipsychotic effects.

• Absorption: Well absorbed with oral and rectal administration.

• Distribution: Crosses the blood-brain barrier.

• Excretion: Metabolized in the liver, excreted by the kidneys, with a half-life of approximately 7 hours.

Antiemetics, neuroleptics (phenothiazine derivatives).

• Auxiliary components depend on the dosage form (e.g., lactose, starch, magnesium stearate in tablets).

• Enhances the effects of sedatives and antihypertensive drugs.

• Avoid alcohol and CNS depressants.

3–5 years (depending on the dosage form).

Store at temperatures up to 25°C, protected from light and moisture.

• Tablets: 20–50 pieces in blisters or plastic bottles.

• Injection Solution: Ampoules of 1–2 ml, 5–10 pieces per pack.

• Suppositories: 5–10 pieces in blister packs.

Do not dispose of in wastewater or household waste. Dispose of in accordance with local regulations.

Aventis Pharma Limited also trading as

Aventis Pharma

One Onslow Street

Guildford

Surrey

GU1 4YS

UK

Or trading as

Sanofi-aventis or Sanofi

One Onslow Street

Guildford

Surrey

GU1 4YS

UK

PL 04425/0593

Date of first authorisation: 2 October 2006

10 February 2016

• Officially registered in the following countries: USA, Canada, UK, France, Germany, Spain, Italy, Australia, New Zealand, South Africa, India, Brazil, Russia, China, Japan.

• Sanofi (France)

• GlaxoSmithKline (GSK) (UK)

• Novartis (Switzerland)

• Pfizer (USA)

• Teva Pharmaceuticals (Israel)

• Mylan (USA)

• Aspen Pharmacare (South Africa)

• Sandoz (Generics, subsidiary of Novartis)

• Sun Pharmaceutical (India)

• Actavis (USA, subsidiary of Teva Pharmaceuticals)

• Prescription-only. In the UK, low doses may be available over the counter.

• Do not use after the expiration date.

• Dose adjustment is required for patients with liver and kidney diseases.

Code: N05AB04 (Prochlorperazine).

• F20 Schizophrenia

• F28 Other nonorganic psychotic disorders

• R11 Nausea and vomiting