Drugs List

Therapeutic Indications

Uses

Schizophrenia and other psychoses

Administration

For intramuscular administration.

Fluphenazine decanoate should be administered by deep intramuscular injection into the upper outer buttock. Correct injection technique, such as the z-track technique, and rotation of injection site are essential.

As with all oil based injections it is important to ensure, by aspiration before injection, that inadvertent intravascular entry does not occur.

When a small volume of injection is desired, the 100 mg/ml strength should be used.

Contraindications

Children under 18 years
Breastfeeding
Central nervous system depression
Coma
Haematological disorder
Marked cerebral atherosclerosis
Myelosuppression
Phaeochromocytoma
Severe cardiac dysfunction
Severe depression
Severe hepatic impairment
Severe renal impairment

Precautions and Warnings

Elderly
Hot climates
Predisposition to epileptic disorder
Predisposition to long QT syndrome
Predisposition to narrow angle glaucoma
Predisposition to venous thromboembolism
Alcohol withdrawal syndrome
Brain damage
Cardiac arrhythmias
Cardiac disorder
Dementia
Depression
Epileptic disorder
Hepatic impairment
History of cardiovascular disorder
History of narrow angle glaucoma
History of torsade de pointes
Hypocalcaemia
Hypokalaemia
Hypomagnesaemia
Hypothyroidism
Myasthenia gravis
Narrow angle glaucoma
Parkinson's disease
Pregnancy
Prostate disorder
Renal impairment
Severe respiratory disease
Thyrotoxicosis

Correct electrolyte disorders before treatment
Use with caution in patients exposed to organophosphorous insecticides
Advise ability to drive/operate machinery may be affected by side effects
Treatment should be initiated by a psychiatrist
Use correct injection technique e.g. z-track technique
Consider ECG before treatment
Consider possibility of silent pneumonia on long term treatment
Elderly more susceptible to sedation, hypotensive & temp regulatory effects
Hypothermia may develop in the elderly
Monitor ECG prior to and during treatment in existing cardiac abnormalities
Monitor patients at risk for signs & symptoms of venous thromboembolism
Perform blood counts if unexplained infection or fever develops
Consider discontinuation if signs of tardive dyskinesia occur
Potential for withdrawal symptoms
Discontinue if patient develops neuroleptic malignant syndrome
Reduce dose in elderly
Advise that effects are potentiated by CNS depressants (including alcohol)
Avoid direct exposure to sunlight

There is a possibility of increased risk of cerebrovascular adverse events in the dementia population. Fluphenazine is not licensed of the treatment of dementia related behavioural disturbance.

Response to treatment may be delayed. If treatment is withdrawn recurrence of symptoms may not become apparent for several weeks or months.

Pregnancy and Lactation

Pregnancy

Use fluphenazine with caution in pregnancy.

Data on pregnancy outcomes are conflicting. Safety has not been established for the use of fluphenazine during pregnancy, therefore the potential hazards should be weighed against the benefits when administering this product to pregnant patients. Fluphenazine is a phenothiazine. Phenothiazines are known to cross the placenta. Schaefer (2007) considers that treatment with phenothiazines, such as fluphenazine, is not an indication for termination of pregnancy. Regular psychiatric and obstetric care will be required (Schaefer, 2007). NICE (2007) states that depot antipsychotics should not routinely be prescribed to pregnant women because there is relatively little information on their safety and their infants may show extra-pyramidal symptoms (usually self limiting) several months after administration of the depot (NICE, 2007). When neuroleptics have been used up to delivery, observation of the neonate for at least 2 days is recommended. In order to prevent neonatal adaptation disorders, prescribers may consider reduction of the dose or even interruption to treatment in the days immediately preceding delivery.

NICE advises that anticholinergic dugs should not be prescribed routinely for the extra-pyramidal side effects of antipsychotic drugs except for acute short term use. Instead the dose and timing of the antipsychotic drug should be adjusted, or the drug changed (NICE, 2007).

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Fluphenazine is contraindicated in breastfeeding.

Breastfeeding is not recommended during treatment with depot fluphenazine due to the possibility that it may be excreted in breast milk.

Infants of mothers who are breastfeeding while taking psychotropic medication, or following earlier depot therapy, should be monitored for adverse reactions.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Abnormal liver function
Abnormal liver function tests
Acute dystonias
Acute renal failure
Agitation
Akathisia
Akinesia
Altered consciousness
Amenorrhoea
Anaphylactic reaction
Apathy
Autonomic instability
Blood dyscrasias
Blurred vision
Cardiac arrhythmias
Coma
Confusion
Constipation
Corneal opacities
Creatine phosphokinase increased
Deep vein thrombosis (DVT)
Diaphoresis
Drowsiness
Dry mouth
Dyskinesia
Dystonia
ECG changes
Epileptiform attacks
Excitement
False pregnancy test results
Galactorrhoea
Glaucoma (closed angle)
Gynaecomastia
Headache
Hyperprolactinaemia
Hypersensitivity reactions
Hyperthermia
Hyponatraemia
Hypotension
Hypothermia
Impaired consciousness
Impairment of judgement
Impairment of mental skills
Impotence
Inappropriate secretion of antidiuretic hormone
Increase in antinuclear antibodies (ANA)
Increase in serum cholesterol (transient)
Insomnia
Interference with temperature regulation
Jaundice
Lens opacities
Lethargy
Menstrual disturbances
Nasal stuffiness
Neuroleptic malignant syndrome
Oculogyric crisis
Oedema
Oligomenorrhoea
Opisthotonos
Pallor
Parkinsonism
Photosensitivity
Pneumonia
Prolongation of QT interval
Pulmonary embolism
Purplish pigmentation of cornea, conjunctiva, retina
Purplish pigmentation of skin
Rash
Rhythmic protrusion of tongue
Rigidity
Sexual dysfunction
Stupor
T-wave changes
Tachycardia
Tardive dyskinesia
Tremor
Urinary hesitancy
Urinary incontinence
Venous thrombosis
Ventricular fibrillation
Ventricular tachycardia
Vomiting

Presentation

Solution for injection formulations of fluphenazine decanoate

Drugs List

Therapeutic Indications

Uses

Schizophrenia and other psychoses

Dosage

It is recommended that patients be stabilised on the injection in hospital.

Dosage should be individually determined. Maintain as much flexibility in the dose as possible to achieve the best therapeutic response with the least side effects.

Effective in acute states but particularly useful in chronic patients who are unreliable at taking oral medication or who do not absorb oral phenothiazines adequately.

Adults

Elderly

Patients with Renal Impairment

Additional Dosage Information

Administration

For intramuscular administration.

Fluphenazine decanoate should be administered by deep intramuscular injection into the upper outer buttock. Correct injection technique, such as the z-track technique, and rotation of injection site are essential.

As with all oil based injections it is important to ensure, by aspiration before injection, that inadvertent intravascular entry does not occur.

When a small volume of injection is desired, the 100 mg/ml strength should be used.

Contraindications

Children under 18 years
Breastfeeding
Central nervous system depression
Coma
Haematological disorder
Marked cerebral atherosclerosis
Myelosuppression
Phaeochromocytoma
Severe cardiac dysfunction
Severe depression
Severe hepatic impairment
Severe renal impairment

Precautions and Warnings

Elderly
Hot climates
Predisposition to epileptic disorder
Predisposition to long QT syndrome
Predisposition to narrow angle glaucoma
Predisposition to venous thromboembolism
Alcohol withdrawal syndrome
Brain damage
Cardiac arrhythmias
Cardiac disorder
Dementia
Depression
Epileptic disorder
Hepatic impairment
History of cardiovascular disorder
History of narrow angle glaucoma
History of torsade de pointes
Hypocalcaemia
Hypokalaemia
Hypomagnesaemia
Hypothyroidism
Myasthenia gravis
Narrow angle glaucoma
Parkinson's disease
Pregnancy
Prostate disorder
Renal impairment
Severe respiratory disease
Thyrotoxicosis

Correct electrolyte disorders before treatment
Use with caution in patients exposed to organophosphorous insecticides
Advise ability to drive/operate machinery may be affected by side effects
Treatment should be initiated by a psychiatrist
Use correct injection technique e.g. z-track technique
Consider ECG before treatment
Consider possibility of silent pneumonia on long term treatment
Elderly more susceptible to sedation, hypotensive & temp regulatory effects
Hypothermia may develop in the elderly
Monitor ECG prior to and during treatment in existing cardiac abnormalities
Monitor patients at risk for signs & symptoms of venous thromboembolism
Perform blood counts if unexplained infection or fever develops
Consider discontinuation if signs of tardive dyskinesia occur
Potential for withdrawal symptoms
Discontinue if patient develops neuroleptic malignant syndrome
Reduce dose in elderly
Advise that effects are potentiated by CNS depressants (including alcohol)
Avoid direct exposure to sunlight

There is a possibility of increased risk of cerebrovascular adverse events in the dementia population. Fluphenazine is not licensed of the treatment of dementia related behavioural disturbance.

Response to treatment may be delayed. If treatment is withdrawn recurrence of symptoms may not become apparent for several weeks or months.

Pregnancy and Lactation

Pregnancy

Use fluphenazine with caution in pregnancy.

Data on pregnancy outcomes are conflicting. Safety has not been established for the use of fluphenazine during pregnancy, therefore the potential hazards should be weighed against the benefits when administering this product to pregnant patients. Fluphenazine is a phenothiazine. Phenothiazines are known to cross the placenta. Schaefer (2007) considers that treatment with phenothiazines, such as fluphenazine, is not an indication for termination of pregnancy. Regular psychiatric and obstetric care will be required (Schaefer, 2007). NICE (2007) states that depot antipsychotics should not routinely be prescribed to pregnant women because there is relatively little information on their safety and their infants may show extra-pyramidal symptoms (usually self limiting) several months after administration of the depot (NICE, 2007). When neuroleptics have been used up to delivery, observation of the neonate for at least 2 days is recommended. In order to prevent neonatal adaptation disorders, prescribers may consider reduction of the dose or even interruption to treatment in the days immediately preceding delivery.

NICE advises that anticholinergic dugs should not be prescribed routinely for the extra-pyramidal side effects of antipsychotic drugs except for acute short term use. Instead the dose and timing of the antipsychotic drug should be adjusted, or the drug changed (NICE, 2007).

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Fluphenazine is contraindicated in breastfeeding.

Breastfeeding is not recommended during treatment with depot fluphenazine due to the possibility that it may be excreted in breast milk.

Infants of mothers who are breastfeeding while taking psychotropic medication, or following earlier depot therapy, should be monitored for adverse reactions.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Abnormal liver function
Abnormal liver function tests
Acute dystonias
Acute renal failure
Agitation
Akathisia
Akinesia
Altered consciousness
Amenorrhoea
Anaphylactic reaction
Apathy
Autonomic instability
Blood dyscrasias
Blurred vision
Cardiac arrhythmias
Coma
Confusion
Constipation
Corneal opacities
Creatine phosphokinase increased
Deep vein thrombosis (DVT)
Diaphoresis
Drowsiness
Dry mouth
Dyskinesia
Dystonia
ECG changes
Epileptiform attacks
Excitement
False pregnancy test results
Galactorrhoea
Glaucoma (closed angle)
Gynaecomastia
Headache
Hyperprolactinaemia
Hypersensitivity reactions
Hyperthermia
Hyponatraemia
Hypotension
Hypothermia
Impaired consciousness
Impairment of judgement
Impairment of mental skills
Impotence
Inappropriate secretion of antidiuretic hormone
Increase in antinuclear antibodies (ANA)
Increase in serum cholesterol (transient)
Insomnia
Interference with temperature regulation
Jaundice
Lens opacities
Lethargy
Menstrual disturbances
Nasal stuffiness
Neuroleptic malignant syndrome
Oculogyric crisis
Oedema
Oligomenorrhoea
Opisthotonos
Pallor
Parkinsonism
Photosensitivity
Pneumonia
Prolongation of QT interval
Pulmonary embolism
Purplish pigmentation of cornea, conjunctiva, retina
Purplish pigmentation of skin
Rash
Rhythmic protrusion of tongue
Rigidity
Sexual dysfunction
Stupor
T-wave changes
Tachycardia
Tardive dyskinesia
Tremor
Urinary hesitancy
Urinary incontinence
Venous thrombosis
Ventricular fibrillation
Ventricular tachycardia
Vomiting

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Further Information

Last Full Review Date: September 2013

Reference Sources

British National Formulary, 65th Edition (March - September 2013) Pharmaceutical Press, London.

BNF for Children (2013-2014) Pharmaceutical Press, London.

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

Martindale: The Complete Drug Reference, 37th edition (2011) ed. Sweetman, S. Pharmaceutical Press, London.

Psychotropic Drug Directory (2009) Bazire, S. HealthComm UK Ltd, Aberdeen.

Summary of Product Characteristics: Modecate Injection 25mg/ml. Sanofi. Revised February 2013.

Summary of Product Characteristics: Modecate Concentrate Injection 100mg/ml. Sanofi. Revised January 2013.

Summary of Product Characteristics: Fluphenazine Decanoate Injection BP 25mg/ml, 0.5ml, 1ml and 2ml. Mercury Pharma international Ltd. Revised August 2013.

Summary of Product Characteristics: Fluphenazine Decanoate Injection BP 100mg/ml, 0.5ml and 1ml. Mercury Pharma international Ltd. Revised August 2012.

The Renal Drug Handbook. 3rd edition. (2009) ed. Ashley, C and Currie, Radcliffe Publishing Ltd, Abingdon.

Antenatal and postnatal mental health
National Institute for Health and Care Excellence (NICE) 4th February 2008
Available at: https://www.mhra.gov.uk/NewsCentre/Pressreleases/CON2033960
Last accessed: September 5, 2013

US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Fluphenazine Last revised: November 1, 2010
Last accessed: September 5, 2013