Fluphenazine Decanoate

Registered South African indications:

• Psychotic disorders

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Cross sensitivity to phenothiazine derivatives
• Suspected or established Parkinsonism
• Phenothiazine compounds should not be used in patient receiving large doses of hypnotics
• Comatose or severely depressed states
• Presence of blood dyscrasia
• Liver damage precludes the use of phenothiazines
• Pregnancy
• Lactation
• Safety and efficacy in children has not been established
• Patient exposed to organophosphates

Cautions 

• Hypersensitivity to other phenothiazines
• Mild to moderate renal impairment
• Elderly 
• Cardiac arrhythmias
• Cardiac disease 
• Thyrotoxicosis 
• Severe respiratory disease 
• Epilepsy
• Conditions predisposing to epilepsy
• Parkinson's disease
• Personal or family history of narrow angle glaucoma
• High ambient temperatue
• Hypothermia risk
• Hypothyroidism
• Myasthenia gravis
• Prostatic hypertrophy
• Family history of cardiovascular disease 
• Risk factors for venous thromboembolism 
• Patients undergoing surgery 
• Exposure to organophosphorus insecticides
• Dementia 
• Prolonged duration of treatment
• Pregnancy
• May affect ability to drive and operate machinery

Forms avail. in SA and covered in this monograph: inj

Psychotic disorders
- Management of manifestations of psychotic disorders

• IM: Usual dose: 25mg, every 3-4 weeks; Adjust amount and dosage interval in accordance with patient's response if necessary; Optimal dose is 25mg, every 3-4 weeks, with a range of 12.5-100mg; Dose interval ranges from 2-5 weeks in most instances, however some patients have required doses as often as every 3 days for the first few injections, while the response to a single dose can last 6 weeks or longer in a few patients on maintenance therapy

It is of particular value in the treatment of chronic schizophrenia. It is not only useful in the hospital milieu but is useful because of its long duration of action in the long-term maintenance therapy of chronically psychotic patients who are amenable to out-patient therapy. The optimal amount of the drug and the frequency of administration must be determined for each patient, since dosage requirements have been found to vary with clinical circumstances as well as with individual response to the drug

For patients who have had no previous therapy, it is advisable to initiate treatment with an oral antipsychotic agent or a quick-acting parenteral antipsychotic. When optimal response has been established, fluphenazine decanoate should be admin. every 3-4 weeks

In switching over to fluphenazine decanoate, the quick-acting antipsychotic agent should be admin. concurrently for 3 days and then discontinued. Fluphenazine decanoate may be administered intramuscularly or subcutaneously. A dry needle and syringe should be used. Use of a wet needle or syringe may cause the solution to become cloudy 

• Not established for use (See contraindications)

Pregnancy 

• Contraindicated

Breastfeeding 

• Contraindicated

Renal Impairment 

Hepatic Impairment 

• Contraindicated 

Elderly

• Caution; dose adjustment recommended 

Porphyria Information

• Not porphyrinogenic (NP)

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Dystonia
• Tardive dyskinesia
• Drowsiness
• Impairment of judgement and mental skills
• Seizures
• Headache
• Agitation 
• Excitement 
• Insomnia 
• Pseudo-parkinsonism
• Akathisia
• Oculogyric crises
• Opisthotonus
• Hyperreflexia
• Neuroleptic Malignant Syndrome (NMS)
• Abnormal dreams
• Neonatal drug withdrawal syndrome

Cardiovascular Disorders

• Hypotension 
• ECG changes 
• Venous thromboembolism
• Oedema
• Hypertension

Respiratory Disorders

• Nasal congestion

Gastrointestinal Disorders

• Constipation 
• Vomiting 

Hepatobiliary Disorders

• Jaundice
• Abnormalities in hepatic function test 

Genitourinary Disorders

• Urinary hesitancy
• Incontinence
• Polyuria
• Puerperium and perinatal conditions

Endocrine and Metabolic Disorders

• Hyponatraemia
• Increased serum cholesterol levels
• Hypoprolactinaemia
• Galactorrhoea
• Gynaecomastia 
• Weight change
• Peripheral oedema
• Syndrome of inappropriate antidiuretic hormone secretion
• Menstrual irregularities
• False results on pregnancy tests
• Impotency in men
• Increased libido in women  
• Loss of appetite
• Body temperature irregulation
• Hyperthermia

Skin and Subcutaneous Tissue Disorders

• Skin pigmentation 
• Photosensitivity reactions
• Rashes 
• Perspiration
• Itching
• Erythema
• Urticaria
• Seborrhoea

Immune, Blood and Lymphatic System Disorders

• Blood dyscrasias
• Transient leucopenia 
• Transient thrombocytopenia
• Systemic lupus erythymatosus-like syndrome
• Hypersensitivity 
• Anaphylactic reactions

Sensory Disorders

• Blurred vision 
• Dryness of mouth 
• Lens opacities

• Central nervous system depressants
• Analgesics
• Sympathomimetics  
• Levodopa
• Anticonvulsants
• Tricylic antidepressants
• Lithium
• Anticholinergic agents
• Corticosteroids
• Digoxin
• Neuromuscular blocking agents 
• CYP2D6 substrates
• Antiarrhythmics
• Selective serotonin reuptake inhibitors
• Antipsychotics
• Betablockers
• Protease inhibitors
• Opiates
• Cimetidine
• Barbiturates 
• QT prolonging agents 
• Agents causing electrolyte imbalances 
• Monoamine oxidase inhibitors 
• Adrenergic vasoconstrictors 
• Phenylpropanolamine 
• Angiotensin-converting enzyme inhibitors
• Angiotensin II antagonists 
• Thiazide diuretics
• Clonidine 
• Methyldopa
• Calcium channel blockers 
• Amphetamine/anorectic agents
• Cocaine
• Antidiabetic agents

• Full blood count

Specific cases may require

• ECG 
• Ophthalmic examination

Fluphenazine decanoate is an esterified trifluoromethyl phenothiazine derivative. It is an antipsychotic agent with an extended duration of action. The mechanism of action is unknown, but may be due to competitive antagonism of dopamine, and to blockade of alpha adrenergic receptors or muscarinic receptors.

Injection (per 1ml)  25mg

• Modecate (Bristol-Myers Squibb) originator