Drugs List

Therapeutic Indications

Uses

Maintenance treatment of paranoid psychoses
Maintenance treatment of schizophrenia

Contraindications

Children under 18 years
Impaired consciousness
Circulatory failure
Coma
Long QT syndrome
Torsade de pointes

Precautions and Warnings

Elderly
Family history of long QT syndrome
Females of childbearing potential
Photosensitivity
Predisposition to epileptic disorder
Predisposition to venous thromboembolism
Risk of cerebrovascular accident
Acute porphyria
Alcoholism
Benign prostatic hyperplasia
Breastfeeding
Cardiac arrhythmias
Cardiac disorder
Cardiovascular disorder
Diabetes mellitus
Electrolyte imbalance
Epileptic disorder
Hepatic impairment
History of cerebrovascular disorder
History of jaundice
History of opioid abuse
History of torsade de pointes
Hyperthyroidism
Hypothyroidism
Myasthenia gravis
Narrow angle glaucoma
Organic brain syndrome
Parkinson's disease
Phaeochromocytoma
Pregnancy
Recent myocardial infarction
Renal impairment
Severe bradycardia
Severe respiratory disease

Correct electrolyte disorders before treatment
If renal function impaired, reduce dose to lowest to maintain control
Reduce dose in patients with hepatic impairment
Advise ability to drive/operate machinery may be affected by side effects
Evaluate patients for cardiovascular disease prior to treatment
Reduce initial dose in the elderly
Diabetic control may need adjustment
Monitor ECG in patients at risk of QT prolongation
Monitor patients with a history of alcoholism and drug abuse
Monitor serum electrolytes
Perform blood counts if signs of persistent infection exist
Risk of cerebrovascular events
Consider discontinuation if signs of tardive dyskinesia occur
Increased risk for venous thromboembolism - take preventive measures
May aggravate/provoke arrhythmias
Potential for withdrawal symptoms
Avoid abrupt withdrawal
To discontinue, reduce dose gradually
Discontinue if patient develops neuroleptic malignant syndrome
Maintain treatment at the lowest effective dose
Female: Ensure adequate contraception during treatment
Avoid direct exposure to sunlight

Avoid use in elderly people with dementia as studies have shown an increased risk of death in those treated with antipsychotics.

Monitor patients for up to 2 years after discontinuing treatment.

Pregnancy and Lactation

Pregnancy

Use zuclopenthixol decanoate with caution in pregnancy.

Animal studies using zuclopenthixol decanoate in pregnancy have shown reproductive toxicity. Schaefer (2015) states that a recent study using a depot preparation of zuclopenthixol during pregnancy showed no toxic effects on infants after birth. Both infants studied have developed at a normal rate and other studies using zuclopenthixol have shown no increased rate of malformations (Schaefer et al, 2015). Using zuclopenthixol decanoate during the third trimester of pregnancy increases the risk of adverse reactions in neonates including withdrawal symptoms and extrapyramidal, therefore it is recommended if zuclopenthixol is used in pregnancy, carefully monitor newborns. The manufacturer suggests to avoid the use of zuclopenthixol during pregnancy unless the potential benefit to the mother outweighs the potential risk to the foetus.

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

Use zuclopenthixol decanoate with caution in breastfeeding.

Zuclopenthixol is excreted in breast milk in low concentrations, less than 1% of the maternal weight related dose. Hale (2014) states although studies have shown plasma levels of zuclopenthixol in infants to be low, caution should be exercised when exposing infants to this drug. Schaefer (2015) states zuclopenthixol can be administered during breastfeeding under careful monitoring of the infant. Although no adverse effects have been reported, long term effects have not yet been established, therefore Briggs (2011) advises to use zuclopenthixol with caution, especially in long term therapy.
The manufacturer states zuclopenthixol decanoate can be administered during breastfeeding if the treatment is necessary and the infant is carefully monitored, particularly within the first 4 weeks of birth.

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

Abdominal pain
Abnormal vision
Agitation
Agranulocytosis
Akathisia
Altered liver function tests
Amenorrhoea
Amnesia
Anaphylactic reaction
Anxiety
Apathy
Asthenia
Ataxia
Attention disturbances
Cholestatic hepatitis
Confusion
Constipation
Convulsions
Decreased glucose tolerance
Depression
Dermatitis
Diarrhoea
Disturbances in accommodation
Disturbances of appetite
Dizziness
Dream abnormalities
Dry mouth
Dyskinesia
Dyspepsia
Dyspnoea
Dystonia
Erectile dysfunction
Failure of ejaculation
Fatigue
Flatulence
Gait abnormality
Galactorrhoea
Gynaecomastia
Headache
Hot flushes
Hyperacusis
Hyperglycaemia
Hyperhidrosis
Hyperkinesia
Hyperlipidaemia
Hyperprolactinaemia
Hyperreflexia
Hypersalivation
Hypertonia
Hypokinesia
Hypotension
Hypothermia
Increased libido
Insomnia
Jaundice
Leukopenia
Malaise
Micturition disorders
Migraine
Muscle rigidity
Myalgia
Mydriasis
Nasal congestion
Nausea
Nervousness
Neuroleptic malignant syndrome
Neutropenia
Nightmares
Oculogyric crisis
Orgasmic dysfunction
Pain
Palpitations
Paraesthesia
Parkinsonism
Photosensitivity
Polyuria
Priapism
Prolongation of QT interval
Pruritus
Purpura
Rash
Reduced libido
Seborrhoea
Somnolence
Speech disturbances
Sudden unexplained death
Syncope
Tachycardia
Tardive dyskinesia
Thirst
Thrombocytopenia
Tinnitus
Torticollis
Tremor
Trismus
Urinary retention
Vertigo
Vomiting
Vulvovaginal disorders
Weight changes

Presentation

Parenteral formulations of zuclopenthixol decanoate

Drugs List

Therapeutic Indications

Uses

Maintenance treatment of paranoid psychoses
Maintenance treatment of schizophrenia

Dosage

Adults

Elderly

Additional Dosage Information

Contraindications

Children under 18 years
Impaired consciousness
Circulatory failure
Coma
Long QT syndrome
Torsade de pointes

Precautions and Warnings

Elderly
Family history of long QT syndrome
Females of childbearing potential
Photosensitivity
Predisposition to epileptic disorder
Predisposition to venous thromboembolism
Risk of cerebrovascular accident
Acute porphyria
Alcoholism
Benign prostatic hyperplasia
Breastfeeding
Cardiac arrhythmias
Cardiac disorder
Cardiovascular disorder
Diabetes mellitus
Electrolyte imbalance
Epileptic disorder
Hepatic impairment
History of cerebrovascular disorder
History of jaundice
History of opioid abuse
History of torsade de pointes
Hyperthyroidism
Hypothyroidism
Myasthenia gravis
Narrow angle glaucoma
Organic brain syndrome
Parkinson's disease
Phaeochromocytoma
Pregnancy
Recent myocardial infarction
Renal impairment
Severe bradycardia
Severe respiratory disease

Correct electrolyte disorders before treatment
If renal function impaired, reduce dose to lowest to maintain control
Reduce dose in patients with hepatic impairment
Advise ability to drive/operate machinery may be affected by side effects
Evaluate patients for cardiovascular disease prior to treatment
Reduce initial dose in the elderly
Diabetic control may need adjustment
Monitor ECG in patients at risk of QT prolongation
Monitor patients with a history of alcoholism and drug abuse
Monitor serum electrolytes
Perform blood counts if signs of persistent infection exist
Risk of cerebrovascular events
Consider discontinuation if signs of tardive dyskinesia occur
Increased risk for venous thromboembolism - take preventive measures
May aggravate/provoke arrhythmias
Potential for withdrawal symptoms
Avoid abrupt withdrawal
To discontinue, reduce dose gradually
Discontinue if patient develops neuroleptic malignant syndrome
Maintain treatment at the lowest effective dose
Female: Ensure adequate contraception during treatment
Avoid direct exposure to sunlight

Avoid use in elderly people with dementia as studies have shown an increased risk of death in those treated with antipsychotics.

Monitor patients for up to 2 years after discontinuing treatment.

Pregnancy and Lactation

Pregnancy

Use zuclopenthixol decanoate with caution in pregnancy.

Animal studies using zuclopenthixol decanoate in pregnancy have shown reproductive toxicity. Schaefer (2015) states that a recent study using a depot preparation of zuclopenthixol during pregnancy showed no toxic effects on infants after birth. Both infants studied have developed at a normal rate and other studies using zuclopenthixol have shown no increased rate of malformations (Schaefer et al, 2015). Using zuclopenthixol decanoate during the third trimester of pregnancy increases the risk of adverse reactions in neonates including withdrawal symptoms and extrapyramidal, therefore it is recommended if zuclopenthixol is used in pregnancy, carefully monitor newborns. The manufacturer suggests to avoid the use of zuclopenthixol during pregnancy unless the potential benefit to the mother outweighs the potential risk to the foetus.

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

Use zuclopenthixol decanoate with caution in breastfeeding.

Zuclopenthixol is excreted in breast milk in low concentrations, less than 1% of the maternal weight related dose. Hale (2014) states although studies have shown plasma levels of zuclopenthixol in infants to be low, caution should be exercised when exposing infants to this drug. Schaefer (2015) states zuclopenthixol can be administered during breastfeeding under careful monitoring of the infant. Although no adverse effects have been reported, long term effects have not yet been established, therefore Briggs (2011) advises to use zuclopenthixol with caution, especially in long term therapy.
The manufacturer states zuclopenthixol decanoate can be administered during breastfeeding if the treatment is necessary and the infant is carefully monitored, particularly within the first 4 weeks of birth.

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

Abdominal pain
Abnormal vision
Agitation
Agranulocytosis
Akathisia
Altered liver function tests
Amenorrhoea
Amnesia
Anaphylactic reaction
Anxiety
Apathy
Asthenia
Ataxia
Attention disturbances
Cholestatic hepatitis
Confusion
Constipation
Convulsions
Decreased glucose tolerance
Depression
Dermatitis
Diarrhoea
Disturbances in accommodation
Disturbances of appetite
Dizziness
Dream abnormalities
Dry mouth
Dyskinesia
Dyspepsia
Dyspnoea
Dystonia
Erectile dysfunction
Failure of ejaculation
Fatigue
Flatulence
Gait abnormality
Galactorrhoea
Gynaecomastia
Headache
Hot flushes
Hyperacusis
Hyperglycaemia
Hyperhidrosis
Hyperkinesia
Hyperlipidaemia
Hyperprolactinaemia
Hyperreflexia
Hypersalivation
Hypertonia
Hypokinesia
Hypotension
Hypothermia
Increased libido
Insomnia
Jaundice
Leukopenia
Malaise
Micturition disorders
Migraine
Muscle rigidity
Myalgia
Mydriasis
Nasal congestion
Nausea
Nervousness
Neuroleptic malignant syndrome
Neutropenia
Nightmares
Oculogyric crisis
Orgasmic dysfunction
Pain
Palpitations
Paraesthesia
Parkinsonism
Photosensitivity
Polyuria
Priapism
Prolongation of QT interval
Pruritus
Purpura
Rash
Reduced libido
Seborrhoea
Somnolence
Speech disturbances
Sudden unexplained death
Syncope
Tachycardia
Tardive dyskinesia
Thirst
Thrombocytopenia
Tinnitus
Torticollis
Tremor
Trismus
Urinary retention
Vertigo
Vomiting
Vulvovaginal disorders
Weight changes

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: February 2017

Reference Sources

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) 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. Wolters Kluwer Health, Philadelphia.

Joint Formulary Committee. British National Formulary. 72nd ed. London: BMJ Group and Pharmaceutical Press; 2016.

Medications and Mothers' Milk, Sixteenth Edition (2014) Hale, T and Rowe, H, Hale Publishing, Plano, Texas.

Summary of Product Characteristics: Clopixol Injection and Conc Injection. Lundbeck Limited. Revised October 2015.