Trinicalm Forte

Uses

Chlorpromazine is used for Psychoses, Nausea and vomiting, Psychoses, Intractable hiccup, Psychoses.

Anxiety states: It controls excessive anxiety, tension, and agitation seen in neuroses or associated with somatic conditions. The treatment or prevention of nausea and vomiting of various causes. The management of psychotic disorders, such as acute or chronic catatonic, hebephrenic and paranoid schizophrenia; psychosis due to organic brain damage, toxic psychosis, and the manic phase of manic-depressive illness.

Trinicalm Forte is also used to associated treatment for these conditions: Acute Intermittent Porphyria (AIP), Apprehension, Mania, Nausea and vomiting, Oppositional Defiant Disorder, Restlessness, Schizophrenia, Tetanus, Intractable singultus, Severe behavioural problems, Short term HyperactivityAgitation, Psychosis, Schizophrenia, Acute non-psychotic Anxiety

How Trinicalm Forte works

Chlorpromazine acts as an antagonist (blocking agent) on different postsysnaptic receptors -on dopaminergic-receptors (subtypes D1, D2, D3 and D4 - different antipsychotic properties on productive and unproductive symptoms), on serotonergic-receptors (5-HT1 and 5-HT2, with anxiolytic, antidepressive and antiaggressive properties as well as an attenuation of extrapypramidal side-effects, but also leading to weight gain, fall in blood pressure, sedation and ejaculation difficulties), on histaminergic-receptors (H1-receptors, sedation, antiemesis, vertigo, fall in blood pressure and weight gain), alpha1/alpha2-receptors (antisympathomimetic properties, lowering of blood pressure, reflex tachycardia, vertigo, sedation, hypersalivation and incontinence as well as sexual dysfunction, but may also attenuate pseudoparkinsonism - controversial) and finally on muscarinic (cholinergic) M1/M2-receptors (causing anticholinergic symptoms like dry mouth, blurred vision, obstipation, difficulty/inability to urinate, sinus tachycardia, ECG-changes and loss of memory, but the anticholinergic action may attenuate extrapyramidal side-effects). Additionally, Chlorpromazine is a weak presynaptic inhibitor of Dopamine reuptake, which may lead to (mild) antidepressive and antiparkinsonian effects. This action could also account for psychomotor agitation and amplification of psychosis (very rarely noted in clinical use).

Trifluoperazine blocks postsynaptic mesolimbic dopaminergic D1 and D2 receptors in the brain; depresses the release of hypothalamic and hypophyseal hormones and is believed to depress the reticular activating system thus affecting basal metabolism, body temperature, wakefulness, vasomotor tone, and emesis.

Dosage

Trinicalm Forte dosage

Oral: Psychoses:

• Adult: 25 mg tid; may be given as a single 75 mg dose at night. Maintenance: 25-100 mg tid increased to ≥1 g daily as required in psychotic patients.
• Child: 1-12 yr: 500 mcg/kg every 4-6 hr. Max: >5 yr: 75 mg daily; 1-5 yr: 40 mg daily.
• Elderly: Initially, ⅓-½ the normal adult dose.

Oral: Intractable hiccup:

• Adult: Initially, 25-50 mg 3-4 times daily for 2-3 days; if unresponsive, may admin 25-50 mg via IM inj. If still necessary, 25-50 mg in 500-1000 ml of normal saline may be given via slow IV infusion.
• Child: 1-12 yr: 500 mcg/kg every 4-6 hr. Max: >5 yr: 75 mg daily; 1-5 yr: 40 mg daily.
• Elderly: Initially, ⅓-½ the normal adult dose.

Intramuscular: Psychoses:

• Adult: 25-50 mg repeated every 6-8 hr. Substitute with oral therapy as soon as possible.
• Child: 1-12 yr: 500 mcg/kg every 4-6 hr. Max: >5 yr: 75 mg daily; 1-5 yr: 40 mg daily.
• Elderly: Initially, ⅓-½ the normal adult dose.

Intramuscular: Nausea and vomiting:

• Adult: Initially, 25 mg via IM inj, followed by 25-50 mg every 3-4 hr until vomiting stops.
• Child: 1-12 yr: 500 mcg/kg every 4-6 hr. Max: >5 yr: 75 mg daily; 1-5 yr: 40 mg daily.
• Elderly: Initially, ⅓-½ the normal adult dose.

Schizophrenia and other psychoses:

• Adults and child over 12 years: Recommended starting dose is 2-5 mg b.i.d, increased by 5 mg daily after 1 week then at interval of 3 days, according to response.
• Children (6-12 years): Dosage should be adjusted to the weight of the child and severity of the symptoms. The starting dosage is 1 mg b.i.d. Dosage may be increased gradually until symptoms are controlled or until side effects become troublesome. While it is usually not necessary to exceed dosages of 15 mg daily.
• Elderly: Reduce initial dose by at least half

Short-term management of severe anxiety:

• Adult and child over 12 years: 1-2 mg b.i.d, increased if necessary to 6 mg daily.
• Child (3-5 years): 1 mg daily
• Child (6-12 years): Up to 4 mg daily in divided dose.
• Elderly: Reduce initial dose by at least half

Antiemetic:

• Adult: 2-4 mg daily in divided doses; max. 6 mg daily;
• Child 3-5 years: up to 1 mg daily, 6-12 years up to 4 mg daily.

May be taken with or without food. May be taken with meals to reduce GI discomfort.

Side Effects

Tardive dyskinesia (on long-term therapy). Involuntary movements of extremities may also occur. Dry mouth, constipation, urinary retention, mydriasis, agitation, insomnia, depression and convulsions; postural hypotension, ECG changes. Allergic skin reaction, amenorrhoea, gynaecomastia, weight gain. Hyperglycaemia and raised serum cholesterol.

Common side effects are transient restlessness, dystonias or may resemble parkinsonism. Other CNS Reactions are drowsiness, dizziness, fatigue, blurred vision, seizures. Without these Peripheral oedema, blood dyscrasias, jaundice may occasionally occur. Tachycardia, constipation, urinary hesitancy and retention and hyperpyrexia have been reported very rarely.

Toxicity

Agitation, coma, convulsions, difficulty breathing, difficulty swallowing, dry mouth, extreme sleepiness, fever, intestinal blockage, irregular heart rate, low blood pressure, restlessness

Symptoms of overdose include agitation, coma, convulsions, difficulty breathing, difficulty swallowing, dry mouth, extreme sleepiness, fever, intestinal blockage, irregular heart rate, low blood pressure, and restlessness.

Precaution

Parkinson's disease; CV disease; renal or hepatic impairment; cerebrovascular and respiratoty disease; jaundice; DM; hypothyroidism; paralytic ileus; prostatic hyperplasia or urinary retention; epilepsy or history of seizures; myasthenia gravis; pregnancy; elderly (especially with dementia), and debilitated patients. Avoid direct sunlight.

Care should be taken when treating elderly patients, and initial dosage should be reduced. Such patients can be specially sensitive, particularly to extra pyramidal and hypotensive effects. Patients with cardiovascular disease including arrhythmias should also be treated with caution. Care should be taken in patients with angina pectoris.

Interaction

Potentiation of anticholinergic effects of antiparkinson agents and TCAs may lead to an anticholinergic crisis. Additive orthostatic hypotensive effect in combination with MAOIs. Reverses antihypertensive effect of guanethidine, methyldopa and clonidine.

Trifluoperazine may diminish the effect of oral anticoagulants. Concomitant administration of propranolol with trifluoperazine results in increased plasma levels of both drugs. Antihypertensive effects of guanethidine and related compounds may be counteracted when phenothiazines are used concurrently. Potentiation may occur if antipsychotic drugs are combined with CNS depressants such as alcohol. hypnotics and anticonvulsant.

Volume of Distribution

• 20 L/kg

Elimination Route

Readily absorbed from the GI tract. Bioavailability varies due to first-pass metabolism by the liver.

Half Life

~ 30 hours

10-20 hours

Elimination Route

Kidneys, ~ 37% excreted in urine

Pregnancy & Breastfeeding use

Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.

Pregnancy: Safety for the use of trifluoperazine during pregnancy has not been established. Therefore, it is not recommended that the drug be given to pregnant patients except when, in the judgement of the physician, it is essential. The potential benefits should clearly outweigh possible hazards. There are reported instances of prolonged jaundices, extrapyramidal signs, hyperreflexia or hypoflexia in newborn infants whose mother received phenothiazines.

Lactation: Adequate human data are not available in case of lactation.

Contraindication

Hypersensitivity; preexisting CNS depression, coma, bone-marrow supression; phaeochromocytoma; lactation

Do not use Trifluoperazine in comatose patients, or in those with existing blood dyscrasias or known liver damage, or in those hypersensitive to the active ingredient or related compounds.

Acute Overdose

Symptoms include somnolence, coma, hypotension and extrapyramidal symptoms. Other possible manifestations include agitation and restlessness, convulsions, fever, autonomic reactions such as dry mouth and ileus, EKG changes and cardiac arrhythmias.

Treatment is symptomatic and supportive. Early gastric lavage may be helpful. Observe patient and maintain an open airway.

Signs and symptoms will be predominantly extrapyramidal; hypotension may occur. Treatment consists of gastric lavage together with supportive and symptomatic measures. Do not induce vomiting. Extra pyramidal symptoms may be treated with an anticholinergic, antiparkinsonism drug. Treat hypotension with fluid replacement; if severe or persistent. nor adrenaline may be considered. Adrenaline is contraindicated.

Storage Condition

Store at 15-30°C.

It should be store at room temperature between 15-30° C away from light and moisture.

Innovators Monograph

You find simplified version here Trinicalm Forte