Rotate the site of injection to avoid irritation or sterile abscess formation with repeat administration. Intramuscular Depot injection (fluphenazine decanoate or . PACKAGE LEAFLET: INFORMATION FOR THE USER. Modecate® 25mg/ml Injection fluphenazine decanoate. Is this leaflet hard to see or read? Phone . ADMINISTRATION). Fluphenazine decanoate is not indicated for the management of severely agitated psychotic patients or psychoneurotic.

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Neonates exhibiting signs or symptoms of extrapyramidal effects or withdrawal should be carefully monitored. Slight yellow to amber color does not alter potency.

fluphenazine decanoate

In addition, fluoxetine is a potent inhibitor of CYP2D6 and may result in increases fluphenazune serum phenothiazine concentrations, leading to side effects. Monitor patients during anagrelide therapy for cardiovascular effects and evaluate as necessary. A fall risk assessment should be completed when initiating an antipsychotic in patients with conditions, diseases, or concurrent medication use that could exacerbate orthostasis.

Additive drowsiness may also occur.

Educate patients about the risks and symptoms of excessive CNS depression. Oedema has been reported with phenothiazine medication. Moderate Dry mouth and drowsiness may occur in patients receiving cetirizine or levocetirizine; caution may be necessary during concomitant use of cetirizine or levocetirizine with phenothiazines. Phenothiazines may lower the seizure threshold. Additionally, sleep-related behaviors, such as sleep-driving, are more likely to occur during concurrent use of other CNS depressants than with the use of sedatives alone.

Droperidol administration is associated with an established risk for QT prolongation and torsades de pointes TdP.

Fluphenazine is thought to exert antipsychotic effects by postsynaptic blockade of CNS dopamine receptors, thereby inhibiting dopamine-mediated effects. For doses greater than 50 mg, increase cautiously in increments of Liver disease Renal impairment Cardiac arrhythmias, cardiac disease Thyrotoxicosis Severe respiratory disease Epilepsy, conditions predisposing to epilepsy eg.

Modecate Injection 25mg/ml – Summary of Product Characteristics (SmPC) – (eMC)

Although QT interval prolongation has not been reported with gemtuzumab, it has been devanoate with other drugs that contain calicheamicin. Keep patient in a recumbent position for at least 30 minutes following injection to minimize hypotensive effects.


Blood dyscrasias have rarely been reported with phenothiazine derivatives. There were no significant differences regarding habituation between the medication exposure groups. Plasma level profiles of fluphenazine following intramuscular injection have shown half-lives of plasma clearance ranging from 2. Therefore, gradual withdrawal is advisable.

Modecate Injection 25mg/ml

Overdosage should be treated symptomatically and supportively, extrapyramidal reactions will respond to oral or parenteral anti-parkinsonian drugs such as procyclidine or benzatropine.

Fluphenazine, perphenazine, prochlorperazine, and trifluoperazine are associated with a possible risk for QT prolongation. Aluminum- and magnesium-containing antacids and antidiarrheals: Cases of QT prolongation and TdP have been reported during postmarketing use of fluvoxamine.

Minor Due to the potential for QT prolongation and torsade de pointes TdPcaution is advised when administering bedaquiline with fluphenazine. The need for continued treatment should be reassessed periodically. A dose reduction of one or both drugs may be warranted. Anticholinergics, including antidepressants, antihistamines, antiparkinsonians, atropine, MAO inhibitors, meperidine, phenothiazines: Phenothiazines may also induce hyperprolactinemia and galactorrhea, and thus may interfere with proper lactation.

Use fluphenazine with caution in patients with cardiac disease or other conditions that may increase the risk of QT prolongation including cardiac arrhythmias, congenital long QT syndrome, heart failure, bradycardia, myocardial infarction, hypertension, coronary artery disease, hypomagnesemia, hypokalemia, hypocalcemia, or in patients receiving medications known to prolong the QT interval or cause electrolyte imbalances. Chronic antipsychotic treatment should generally be reserved for patients who suffer from a chronic illness that is known to respond to antipsychotics, and for whom alternative, equally effective, but potentially less harmful treatments are not available or appropriate.

Fluphenazine is not licensed for the treatment of dementia-related behavioural disturbances. Monitor for signs and symptoms of neuroleptic malignant syndrome NMSrestlessness, and agitation. Minor Administer fluphenazine and donepezil with caution. Thiazide diuretics may potentiate the orthostatic hypotension that can be seen with the use of the phenothiazine antipsychotics.


Moderate Timolol interacts with phenothiazines by adding to the overall hypotensive effect. Recurrence of NMS has been reported with resumption of drug therapy. Clinical monitoring for adverse effects is recommended during coadministration.

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Minor Chloroquine administration is associated with an increased risk of QT prolongation and torsades de pointes TdP. Additionally, fluphenazine is associated with a possible risk for QT prolongation. Drug inhibits cough reflex, and aspiration may occur. Therefore, appropriate monitoring and dose adjustment may be necessary. In many reported cases, confounding factors have been present e. In addition, in vitro data suggest that fluphenazine is a weak CYP2D6 inhibitor and has the potential to decrease the metabolism of CYP2D6 substrates such as tramadol.

Concurrent use of phenothiazines and ACE inhibitors or angiotensin II antagonists may result in severe postural hypotension. Metabolized extensively by the liver, but no active metabolites are formed; duration of action is about 6 to 8 hours after oral administration; 1 to 6 weeks average, 2 weeks after I. Patients with a history of jaundice secondary to phenothiazine use should not, if possible, be re-exposed to phenothiazine treatment.

Moderate Indapamide may cause electrolyte disturbances, which may increase the potential for proarrhythmic effects of selected phenothiazines.

Administer these agents and drugs that can prolong the QT interval with caution.

Fluphenazine, also a phenothiazine, is associated with a possible risk for QT prolongation. Elderly patients may be particularly susceptible to extrapyramidal reactions, sedative and hypotensive effects. Regardless of the antipsychotic used, the nursing infant should be closely monitored for excessive drowsiness, decanoare, and developmental delays.

The syndrome is characterised by hyperthermia, together with some or all of the following: