Sufentanil

Registered South African indications:

• Pain
• Anaesthesia

Contraindications

• Hypersensitivity to the active ingredient or to any of its excipients
• Intravenous (IV) use in labour 
• IV use in caesarian section prior to clamping of the cord
• Haemorrhage
• Shock
• Septicaemia
• Coagulopathy
• Blood dyscrasias

Cautions

• Pregnancy
• Breastfeeding
• Renal impairment
• Hepatic impairment
• Elderly
• Cardiac arrhythmias
• Hypovolaemia
• Compromised intracerebral compliance
• Decreased respiratory reserve
• Alcoholism
• Impaired consciousness
• Coma
• Biliary tract obstruction
• Acute abdominal conditions
• Delirium tremens
• Head injury
• Raised intracranial pressure
• Morbidly obese
• Prostatic hyperplasia
• Urinary stricture
• Toxic psychosis
• Chronic pulmonary disease
• Respiratory depression
• History of seizure disorders
• History of thyroid dysfunction
• May affect ability to drive or operate machinery

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

Analgesic adjunct to nitrous oxide/oxygen

• IV: Initial: 1-8μg/kg; Maintenance: 0.1-0.5μg/kg

Anaesthetic agent

• IV: Initial: 8-30μg/kg; Maintenance: 0.5-0.75μg/kg 

Consider use of antiemetic

Postoperative analgesia

• Epidural (SC): 30-50μg; Titrate by 25μg at 1hrly intervals

Analgesic adjunct during labour and vaginal deliveries

• Epidural (SC): 10-50μg, with 10ml bupivacaine 0.125%; Additional doses may be repeated twice at intervals of 1 hr

Paed. forms avail. in SA and covered in this monograph: inj

Anaesthetic agent

Younger than 12 years

• Not established for use

Older than 12 years

• IV: Initial: 10-25μg/kg; Maintenance: 0.5-0.75μg/kg

Pregnancy

• Caution
• There is insufficient data on the use of sufentanil during human pregnancy to evaluate its potential harmful effects. There are no indications to date that the use of sufentanil during pregnancy increases the risk of congenital abnormalities. Sufentanil crosses the placenta
• Reproductive toxicity has been shown in animal studies. Sufentanil is not recommended during pregnancy and in women of childbearing potential not using contraception

Breastfeeding

• Caution; not recommended
• Sufentanil is excreted in human milk when administered intravenously; therefore caution is advised when sufentanil is administered to breastfeeding women. Breastfeeding is not recommended when sufentanil is administered, due to the risk of opioid effects or toxicity in the breastfed newborns/infants

Renal Impairment

• Caution; no dose adjustment recommended
  Titrate gradually; Reduce dose if necessary

Hepatic Impairment

• Caution; no dose adjustment recommended
  Titrate gradually; Reduce dose if necessary

Elderly

• Caution; no dose adjustment recommended 
  Titrate gradually; Reduce dose if necessary

Porphyria Information

• Probably not porphyrinogenic (PNP)

Drugs in Sport

• Prohibited - In competition

Central Nervous System Disorders

• Sedation
• Tremor
• Dizziness
• Headache
• Apathy
• Nervousness
• Ataxia
• Dyskinesia
• Dystonia
• Hyperreflexia
• Hypertonia
• Hypokinesia
• Somnolence
• Coma
• Seizures
• Muscle contractions

Cardiovascular Disorders

• Tachycardia
• Hypertension
• Hypotension
• Pallor
• Arrhythmia
• Abnormal ECG
• Atrioventricular block
• Bradycardia
• Cyanosis
• Cardiac arrest
• Shock

Respiratory Disorders

• Cyanosis
• Bronchospasm
• Cough
• Dysphonia
• Hiccups
• Rhinitis
• Hypoventilation
• Respiratory arrest
• Apnoea
• Respiratory depression
• Pulmonary oedema
• Laryngospasm

Gastrointestinal Disorders

• Nausea and vomiting

Genitourinary Disorders

• Urinary retention
• Urinary incontinence

Endocrine and Metabolic Disorders

• Hypothermia 

Musculoskeletal Disorders

• Muscle twitching
• Back pain
• Hypotonia
• Muscle rigidity
• Muscle spasms

Skin and Subcutaneous Tissue Disorders

• Pruritus
• Skin discolouration
• Allergic dermatitis
• Dry skin
• Hyperhidrosis
• Rash
• Erythema

Immune, Blood and Lymphatic System Disorders

• Anaphylaxis

Sensory Disorders

• Visual disturbance
• Miosis

• Central nervous system depressants
• CYP3A4 inhibitors
• Monoamine oxidase inhibitors

None routine

Sufentanil exerts its analgesic activity by conversion to morphine. Opioids open calcium-dependent potassium channels. This results in hyperpolarization and decreased neuronal excitability.

Injection (per ml) 5μg

• Mylan sufentanil (Mylan)
• Sufenta (Piramal Critical) originator

Injection (per 2ml) 10μg

• Pharma-Q Sufentanil (Pharma-Q)

Injection (per ml) 50μg 

• Sufenta forte (Piramal Critical) originator

Injection (per 10ml) 50μg 

• Pharma-Q Sufentanil (Pharma-Q)

Injection (per 5ml) 250μg 

•  Pharma-Q Sufentanil Forte (Pharma-Q)