Naltrexone Hydrochloride

Registered South African indications:

• Opioid dependence

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Patients receiving opioid analgesics
• Patients currently dependent on opioids
• Patients in acute opioid withdrawal
• Individuals who have a positive urine screen for opioids or who failed the naloxone challenge test
• Patients with acute hepatitis or liver failure
• Pregnancy
• Lactation

Cautions

• Renal impairment
• Hepatic dysfunction
• Elderly
• Obesity
• Galactose intolerance
• Lactase deficiency 
• Glucose-galactose malabsorption 

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

Opioid dependence
- Adjunctive therapy in the maintenance of abstinence of opioids in opioid-dependent patients, who have ceased the use of opioids

• Oral (tab): Initial: 25mg, dly; Titrate by 25mg, dly if no withdrawal symptoms occur; Maintenance: 50mg, dly; Treatment duration: 3 months

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Prolonged administration may be necessary as full recovery from opioid dependence is variable

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Treatment should be considered only in patients who have remained opioid-free for a minimum of 7-10 days

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Administration of naltrexone must not be started before a naloxone challenge test is performed and a negative result obtained

Not established for use in children below 18 years

Pregnancy

• Contraindicated

Breastfeeding

• Contraindicated

Renal Impairment

• Caution; no dose adjustment recommended

Hepatic Impairment

• Hepatic dysfunction: Caution; no dose adjustment recommended
• Acute hepatitis or liver failure: Contraindicated

Elderly

• Caution; no dose adjustment recommended

Porphyria Information

• Not yet classified (NC)

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Headache
• Restlessness
• Dizziness
• Tremor
• Somnolence
• Asthenia
• Nervousness
• Anxiety
• Insomnia
• Irritability
• Affective disorders
• Hallucination
• Confusional state
• Depression
• Paranoia
• Disorientation
• Nightmares
• Agitation
• Disordered libido disorders
• Abnormal dreams
• Suicidal ideation
• Attempted suicide

Cardiovascular Disorders

• Tachycardia
• Palpitations
• ECG changes
• Blood pressure fluctuations
• Flushing

Respiratory Disorders

• Chest pain
• Nasal congestion
• Nasal discomfort
• Rhinorrhea
• Sneezing
• Oropharyngeal pain
• Increased sputum
• Sinus disorder
• Dyspnoea
• Dysphonia
• Cough
• Yawning

Gastrointestinal Disorders

• Abdominal pain
• Nausea and vomiting
• Diarrhoea
• Constipation
• Flatulence
• Haemorrhoids
• Ulcer
• Dry mouth
• Thirst

Hepatobiliary Disorders

• Abnormal hepatic function
• Increased bilirubin
• Hepatitis 
• Increased transaminases

Genitourinary Disorders

• Delayed ejaculation
• Erectile dysfunction
• Pollakiuria
• Dysuria

Endocrine and Metabolic Disorders

• Decreased appetite
• Increased appetite
• Decreased weight
• Increased weight

Musculoskeletal Disorders

• Arthralgia
• Myalgia
• Groin pain
• Rhabdomyolysis

Skin and Subcutaneous Tissue Disorders

• Rash
• Seborrhoea
• Pruritus
• Acne
• Alopecia
• Oral herpes
• Tinea pedis
• Hyperhidrosis

Immune, Blood and Lymphatic System Disorders

• Lymphadenopathy
• Idiopathic thrombocytopenic purpura
• Fever

Sensory Disorders

• Increased lacrimation
• Blurred vision
• Eye irritation
• Photophobia
• Eye swelling
• Eye pain
• Asthenopia
• Ear discomfort
• Tinnitus
• Vertigo

• Methadone
• Opioid-containing agents or derivatives
• Centrally acting antihypertensives
• Barbiturates
• Benzodiazepines
• Anxiolytics 
• Hypnotics
• Sedative antidepressants
• Sedative antihistamines
• Neuroleptics
• Acamprosate
• Thioridazine

Hepatic function

Naltrexone likely acts as a competitive antagonist at melanocortin, kappa, and delta opioid receptors in the central nervous system. This blocks the effects of opiates, including euphoria and drug craving.

Tablet 50mg

• Naltima (Accord)