Promtil5 mg

Promtil is a phenothiazine antipsychotic/antiemetic agent approved and commonly used for the following indications, listed by strength of evidence:

Established / FDA-approved uses

• Control of severe nausea and vomiting – including nausea and vomiting associated with surgery, radiotherapy, chemotherapy, and other causes of severe emesis.
• Management of psychotic disorders, including schizophrenia, at higher doses under close medical supervision.
• Short-term treatment of non-psychotic (generalized) anxiety – Promtil is not a first-line agent for anxiety and is generally limited to a maximum dose of 20 mg/day for no longer than 12 weeks because of the risk of tardive dyskinesia.

Additional guideline-supported / commonly reported use

• Vertigo associated with Meniere's disease and other vestibular disorders (reported in regional labeling; use per treating physician's judgement).

Promtil is not approved for the treatment of dementia-related psychosis in elderly patients (see Warnings).

Each tablet/film-coated tablet of Prochlorperazine (as maleate) is available in strengths such as 5 mg and 10 mg. Injectable formulations (as edisylate) are available in strengths such as 12.5 mg/mL for intramuscular or slow intravenous use. Actual strengths and formulations available depend on the specific manufactured product; always check the product label/pack insert for the exact composition and excipients.

Promtil is a piperazine-derivative phenothiazine used both as an antiemetic and as an antipsychotic agent, depending on the dose used. It is available as tablets and as injection for intramuscular or intravenous administration.

As an antiemetic, Promtil acts primarily at the chemoreceptor trigger zone in the brain to prevent nausea and vomiting. At higher doses, it exerts central dopamine-receptor blocking effects that underlie its antipsychotic action.

Promtil belongs to the phenothiazine derivative class of drugs, specifically a piperazine-type phenothiazine. It is classified as a first-generation (typical) antipsychotic and antiemetic agent.

Prochlorperazine is a dopamine D2-receptor and histamine H1-receptor antagonist. Its antiemetic effect results primarily from blockade of dopamine D2 receptors in the chemoreceptor trigger zone of the medulla, which suppresses the vomiting reflex. It also has weak central antihistaminic and anticholinergic activity.

As an antipsychotic, Prochlorperazine blocks post-synaptic mesolimbic dopaminergic D2 receptors in the brain, which is believed to underlie its efficacy against the positive symptoms of psychosis. It also has alpha-adrenergic blocking activity, which contributes to its hypotensive and sedative effects.

Prochlorperazine is well absorbed after oral administration, undergoes extensive hepatic metabolism, and is excreted mainly in urine and feces as metabolites. It is not significantly removed by dialysis.

Promtil tablets are taken orally, with or without food, at evenly spaced intervals as directed by the physician. Injectable Promtil is administered by deep intramuscular injection or, in a monitored clinical setting, by slow intravenous administration. Do not administer subcutaneously, as it may cause local tissue irritation. Injection sites should be rotated. Do not self-administer the injectable form; it should be given by a qualified healthcare professional.

Promtil has the following clinically significant drug interactions:

• CNS depressants (alcohol, barbiturates, opioids, general anesthetics, sedative-hypnotics): additive sedation and respiratory/CNS depression; avoid concurrent use or use with caution and reduced doses.
• Anticholinergic drugs: additive anticholinergic effects (dry mouth, constipation, urinary retention, confusion), particularly in elderly patients.
• QT-prolonging drugs (certain antiarrhythmics, macrolides, other antipsychotics): additive risk of QT prolongation and arrhythmia; avoid combination where possible and monitor ECG if co-administration is necessary.
• Antihypertensive agents: additive hypotensive effect, including risk of orthostatic hypotension.
• Drugs that lower seizure threshold (e.g., tramadol, bupropion): increased risk of seizures when combined with Promtil.
• Lithium: rare reports of an encephalopathic syndrome resembling neuroleptic malignant syndrome; use with caution and monitor closely.
• Propranolol: may increase plasma concentrations of both drugs.
• Phenytoin: Promtil may interfere with its metabolism, potentially leading to phenytoin toxicity.
• Oral anticoagulants: phenothiazines, including Promtil, may reduce anticoagulant effect.

Side effects of Promtil range from common and mild to rare but serious.

Common

• Drowsiness and sedation
• Dizziness
• Dry mouth, blurred vision, constipation (anticholinergic effects)
• Orthostatic hypotension
• Skin reactions, photosensitivity

Extrapyramidal Symptoms (more common in younger patients and at higher doses)

• Acute dystonia (muscle spasms of face, neck, back, tongue protrusion)
• Akathisia (restlessness, inability to sit still)
• Drug-induced parkinsonism (tremor, rigidity, shuffling gait)
• Tardive dyskinesia – potentially irreversible involuntary movements of the face, tongue, and body that can develop with long-term use; risk increases with cumulative dose and duration of treatment.

Rare but Serious

• Neuroleptic malignant syndrome (NMS) – a rare, potentially fatal reaction with fever, muscle rigidity, altered consciousness, and autonomic instability; requires immediate discontinuation and emergency medical care.
• Blood dyscrasias (leukopenia, agranulocytosis, thrombocytopenia)
• Cholestatic jaundice
• Cardiac arrhythmias and QT prolongation
• Seizures

Patients should seek prompt medical attention for fever, unexplained muscle stiffness, sore throat, unusual bruising/bleeding, or yellowing of the skin/eyes while taking Promtil.

Pregnancy: Promtil should be used during pregnancy only if clearly needed and if the potential benefit justifies the potential risk to the fetus; consult a physician before use. Use in the third trimester has been associated with extrapyramidal symptoms and withdrawal effects in the newborn, including agitation, abnormal muscle tone, tremor, feeding difficulties, and respiratory distress, which may require extended hospital monitoring of the newborn.

Lactation: Promtil and other phenothiazines are excreted in breast milk. Breastfeeding is not generally recommended during treatment unless the physician determines the benefit outweighs the potential risk to the infant; if used, monitor the infant for sedation and feeding difficulties.

Increased Mortality in Elderly Patients with Dementia-Related Psychosis

Elderly patients with dementia-related psychosis treated with antipsychotic drugs, including Promtil, are at an increased risk of death compared with placebo, primarily from cardiovascular or infectious causes. Promtil is not approved for the treatment of dementia-related psychosis.

Tardive Dyskinesia

Long-term use of Promtil can cause tardive dyskinesia, a syndrome of potentially irreversible, involuntary movements. The risk increases with duration of treatment and total cumulative dose; the lowest effective dose for the shortest duration necessary should be used.

Neuroleptic Malignant Syndrome

A rare but potentially fatal syndrome that can occur with Promtil; requires immediate discontinuation of the drug and intensive medical management.

Extrapyramidal Symptoms

Promtil can mask signs of other conditions (e.g., intestinal obstruction, brain tumor, Reye's syndrome) or cause extrapyramidal reactions, particularly in children and young adults; use the lowest effective dose.

Other Precautions

• Use with caution in patients with cardiovascular disease, glaucoma, seizure disorders, and hepatic impairment.
• May impair mental/physical abilities; caution when driving or operating machinery.
• May reduce the ability of the body to regulate temperature; avoid extreme heat exposure and dehydration.
• Avoid alcohol during treatment.
• Periodic monitoring of blood counts and liver function is advisable with prolonged therapy.
• Not for use in comatose or severely CNS-depressed patients (see Contraindications).

Take Promtil exactly as prescribed by your physician; do not stop, extend, skip doses, or share this medicine with others without medical advice.

Overdose of Promtil may cause extrapyramidal/dystonic reactions, drowsiness progressing to coma, agitation, restlessness, seizures, abnormal heart rhythms, low blood pressure, dry mouth, and reduced bowel motility.

Overdose is a medical emergency. Seek immediate medical attention or contact emergency services/poison control if an overdose is suspected. Treatment is supportive and symptomatic and should only be provided in a hospital or emergency care setting; do not attempt home treatment or induce vomiting.

Store Promtil at room temperature (below 30°C), protected from light and moisture. Keep out of reach of children.

Pediatric Use

Promtil may be used in children 2 years of age and older for severe nausea/vomiting and, in some regions, for schizophrenia, using weight-based dosing (see Dosage and Administration). Children are more susceptible to extrapyramidal reactions, particularly with acute illness or dehydration. Safety and efficacy in children under 2 years of age or under approximately 9 kg have not been established, and use is contraindicated in this group and in pediatric surgery.

Geriatric Use

Elderly patients are more sensitive to the hypotensive, anticholinergic, and extrapyramidal effects of Promtil, and are at increased risk of falls. Elderly patients with dementia-related psychosis have an increased risk of death with antipsychotic use (see Precautions and Warnings); Promtil is not approved for this use. Use the lowest effective dose with close monitoring.

Renal/Hepatic Impairment

There is no well-established dose adjustment guideline for renal impairment; use with caution. In hepatic impairment, use with caution and at reduced doses given extensive hepatic metabolism of Promtil.

Duration of Promtil therapy depends on the indication: short courses (single dose to a few days) are typical for acute nausea/vomiting, while treatment for non-psychotic anxiety should not exceed 12 weeks. For psychotic disorders, duration is determined by the treating physician based on response and risk of tardive dyskinesia with prolonged use; the lowest effective dose for the shortest necessary duration should always be used.

Prochlorperazine is classified as a phenothiazine derivative (piperazine-type), functioning as a first-generation antipsychotic and antiemetic agent.

Prochlorperazine works primarily by blocking dopamine D2 receptors in the chemoreceptor trigger zone (for its antiemetic effect) and in mesolimbic pathways of the brain (for its antipsychotic effect). It also has histamine H1-receptor and alpha-adrenergic blocking activity, along with weak anticholinergic activity, contributing to its overall pharmacologic profile.

Promtil may be used in children 2 years of age and older (and generally at least 9 kg body weight) for control of severe nausea and vomiting, using weight-based dosing. It may also be used in some settings for schizophrenia in children aged 2–12 years under specialist supervision. Children are more prone to extrapyramidal reactions than adults, especially during acute illness or dehydration, so the lowest effective dose should be used. Promtil is contraindicated in children under 2 years of age or under approximately 9 kg, and must not be used for pediatric surgery.