Viloxidon® For Healthcare Professionals

Viloxidon® contains as its active substance oxycodone, which belongs to the class of natural opium alkaloids. It is a semi-synthetic opium alkaloid that acts as a potent agonist of the μ opioid receptors in the brain, while it also interacts with the δ and κ opioid receptors in the brain, as well as with peripheral opioid receptors. Its action is analgesic, anxiolytic and sedative.

For the treatment of moderate to severe pain in patients with cancer or postoperative pain. For the treatment of severe pain requiring the administration of a strong opioid.

Adults over 18 years of age:

Viloxidon® oral solution should be administered every 4-6 hours. The dose is individualised according to the severity of pain, the patient’s general condition and previous or concurrent analgesic treatment

Increasing pain intensity is managed with an increased dose of Viloxidon® oral solution. The correct dose for each patient is the one that ensures adequate analgesia and is well tolerated. Patients should be titrated to adequate analgesia unless uncontrolled adverse effects of the medicine prevent this.

The usual starting dose for patients who have not previously received opioids or patients with severe pain that is not managed by mild opioids is 5 ml (5 mg), every 4 – 6 hours. The dose should be adjusted daily if necessary, in order to achieve analgesia. For the majority of patients a daily dose greater than 400 ml (400 mg) is not required. However, some may need a higher dose.

Conversion from oral morphine:

Patients who were receiving oral morphine before oxycodone treatment should adjust their daily dose according to the ratio: 10 ml (10mg) of oral oxycodone is equivalent to 20 ml (20mg) of oral morphine. We point out that this is a guide for determining the dose of Viloxidon® oral solution. Because of the variability that occurs between patients, careful titration must be carried out for each patient in order to achieve the appropriate dose.

Elderly patients:

Dose adjustment is usually not required in elderly patients. Controlled pharmacokinetic studies in elderly patients (over 65 years of age) have shown that, compared with younger adults, the clearance of oxycodone is minimally reduced. No adverse reaction attributable to age has been observed, which is why the dosage and dosing intervals stated for adults are considered appropriate for elderly patients as well.

Patients with renal or hepatic impairment:

Plasma concentration in this group of patients may be increased. The starting dose should follow a conservative approach. The recommended starting dose for adults must be reduced by 50% [for example a total daily dose of 10 ml (10 mg), orally for patients receiving opioids for the first time], and each patient must be titrated to adequate analgesia according to their clinical condition.

Paediatric population:

Viloxidon® oral solution should not be given to patients under 18 years of age.

Use for pain caused by benign lesions

Opioids are not first-line treatment for chronic benign pain, nor are they recommended as the sole treatment. Various types of chronic pain that have been shown to respond to strong opioids include chronic osteoarthritic pain and intervertebral disc disease. The need for continued treatment in these cases must be assessed at regular intervals.

 Method of Administration

 

Viloxidon® oral solution is administered orally.

Duration of Treatment

Oxycodone should not be used for longer than necessary. As with other strong opioids, the need for continued administration should be assessed at regular intervals.

Discontinuation of treatment

When a patient no longer requires treatment with oxycodone, it is recommended that the dose be reduced gradually in order to avoid withdrawal symptoms.

The undesirable effects of the medicine are those typical of pure opioid agonists. Symptoms of tolerance and dependence may be observed (see section 4.4). Constipation can be prevented with an appropriate laxative. If nausea and vomiting are troublesome, oxycodone may be combined with an antiemetic.

Adverse reactions are classified by frequency:

 

Term	Frequency
Very common Common Uncommon Rare Very rare Not known	≥ 1/10 ≥ 1/100 to <1/10 ≥ 1/1,000 to <1/100 ≥ 1/10,000 to <1/1,000 < 1/10,000 Frequency cannot be estimated from the available data

 

Immune system disorders:

Uncommon: hypersensitivity.

Not known: anaphylactoid reaction, anaphylactic reaction.

Metabolism and nutrition disorders:

Common: decreased appetite. Uncommon: dehydration.

Psychiatric disorders:

Common: anxiety, confusional state, depression, insomnia, nervousness, abnormal thinking, abnormal dreams.

Uncommon: agitation, feeling unsteady, euphoria, hallucinations, decreased libido, drug dependence (see section 4.4), disorientation, mood swings, restlessness, dysphoria.

Not known: aggression.

Nervous system disorders:

Very common: somnolence, dizziness, headache. Common: tremor, lethargy, narcosis.

Uncommon: amnesia, convulsions, hypertension, hypoaesthesia, involuntary muscle contractions, speech disorder, syncope, paraesthesia, dysgeusia, hypotonia.

Not known: hyperalgesia.

Eye disorders:

Uncommon: visual impairment, miosis.

Ear and labyrinth disorders:

Uncommon: vertigo.

Cardiac disorders:

Uncommon: palpitations (in the context of withdrawal syndrome), supraventricular tachycardia.

Vascular disorders:

Uncommon: vasodilatation, facial rashes. Rare: hypotension, orthostatic hypotension.

Respiratory, thoracic and mediastinal disorders:

Common: dyspnoea, bronchospasm

Uncommon: respiratory depression, hiccups.

Gastrointestinal disorders:

Very common: constipation, nausea, vomiting.

Common: abdominal pain, diarrhoea, dry mouth, dyspepsia.

Uncommon: dysphagia, flatulence, eructation, ileus, gastritis. Not known: dental caries.

Hepatobiliary disorders:

Uncommon: increased liver enzymes, cholestasis, biliary colic.

Not known: Sphincter of Oddi dysfunction

Skin and subcutaneous tissue disorders:

Very common: pruritus.

Common: rash, hyperhidrosis.

Uncommon: dry skin, exfoliative dermatitis. Rare: urticaria.

Renal and urinary disorders:

Uncommon: urinary retention, urethral spasm.

Reproductive system and breast disorders:

Uncommon: erectile dysfunction, hypogonadism. Not known: amenorrhoea.

General disorders and administration site conditions:

Common: asthenic conditions, fatigue.

Uncommon: withdrawal syndrome, malaise, oedema, peripheral oedema, drug tolerance, thirst, pyrexia, chills.

Not known: neonatal withdrawal syndrome.

Find the full SmPC of  Viloxidon® here

Guidelines of the Hellenic Society for Pain Therapy and Palliative Care – PARI.SY.A  

WHO Guidelines for the pharmacological and radiotherapeutic management of cancer pain in adults and adolescents 

Management of Cancer Pain in Adult Patients: ESMO Clinical Practice Guidelines 

Use of Opioids for Adults With Pain From Cancer or Cancer Treatment: ASCO Guideline