SHORTEC LIQUID

Adults over 18 years:

Shortec concentrate should be taken at 4-6 hourly intervals. The dosage is dependent on the severity of the pain, and the patient’s previous history of analgesic requirements. Increasing severity of pain will require an increased dosage of Shortec concentrate.

The correct dosage for any individual patient is that which controls the pain and is well tolerated throughout the dosing period. Patients should be titrated to pain relief unless unmanageable adverse drug reactions prevent this. The usual starting dose for opioid naive patients or patients presenting with severe pain uncontrolled by weaker opioids is 5 mg, 4-6 hourly.

The dose should then be carefully titrated, as frequently as once a day if necessary, to achieve pain relief. The majority of patients will not require a daily dose greater than 400 mg. However, a few patients may require higher doses.

Conversion from oral morphine:

Patients receiving oral morphine before oxycodone therapy should have their daily dose based on the following ratio: 10 mg of oral oxycodone is equivalent to 20 mg of oral morphine. It must be emphasised that this is a guide to the dose of Shortec concentrate required.

Inter-patient variability requires that each patient is carefully titrated to the appropriate dose.

Elderly patients:

A dose adjustment is not usually necessary in elderly patients. Controlled pharmacokinetic studies in elderly patients (aged over 65 years) have shown that, compared with younger adults, the clearance of oxycodone is only slightly reduced.

No untoward adverse drug reactions were seen based on age, therefore adult doses and dosage intervals are appropriate.

Patients with renal or hepatic impairment:

The plasma concentration in this patient population may be increased. The dose initiation should follow a conservative approach in these patients. The recommended adult starting dose should be reduced by 50% (for example a total daily dose of 10 mg orally in opioid naïve patients), and each patient should be titrated to adequate pain control according to their clinical situation.

Paediatric population:

Shortec concentrate should not be used in patients under 18 years.

Use in non-malignant pain:

Opioids are not first-line therapy for chronic non-malignant pain, nor are they recommended as the only treatment. Types of chronic pain which have been shown to be alleviated by strong opioids include chronic osteoarthritic pain and intervertebral disc disease.

The need for continued treatment in non-malignant pain should be assessed at regular intervals. Method of administration Shortec concentrate is for oral use Duration of treatment Oxycodone should not be used for longer than necessary.

In common with other strong opioids, the need for continued treatment should be assessed at regular intervals. Discontinuation of treatment When a patient no longer requires therapy with oxycodone, it may be advisable to taper the dose gradually to prevent symptoms of withdrawal.

Adverse drug reactions are typical of full opioid agonists. 4). Constipation may be prevented with an appropriate laxative. If nausea and vomiting are troublesome, oxycodone may be combined with an anti-emetic. The following frequency categories form the basis for classification of the undesirable effects: Term Frequency Very common ≥ 1/10 Common ≥ 1/100 to <1/10 Uncommon ≥ 1/1,000 to <1/100 Rare ≥1/10,000 to <1/1,000 Very rare <1/10,000 Frequency not known Cannot be estimated from the available data Immune system disorders: Uncommon: hypersensitivity, anaphylactic responses Frequency not known: anaphylactic reaction, anaphylactoid reaction Metabolism and nutrition disorders: Common: decreased appetite.

Uncommon: dehydration. 4), disorientation, mood altered, restlessness, dysphoria Frequency not known: aggression.

Nervous system disorders:

Very common: somnolence, dizziness, headache. Common: tremor, lethargy, sedation. Uncommon: amnesia, convulsion, hypertonia, hypoesthesia, involuntary muscle contractions, speech disorder, syncope, paraesthesia, dysgeusia, hypotonia.

Frequency 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 flushing, Rare: hypotension, orthostatic hypotension Respiratory, thoracic and mediastinal disorders: Common: dyspnoea, bronchospasm, cough decreased. Uncommon: respiratory depression, hiccups.

Gastrointestinal disorders:

Very common: constipation, nausea, vomiting. Common: abdominal pain, diarrhoea, dry mouth, dyspepsia. Uncommon: dysphagia, flatulence, eructation, ileus, gastritis. Frequency not known: dental caries.

Hepato-biliary disorders:

Uncommon: increased hepatic enzymes, biliary colic. Frequency not known: cholestasis.

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, ureteral spasm.

Reproductive system and breast disorders:

Uncommon: erectile dysfunction, hypogonadism. Frequency not known: amenorrhoea.

General disorders and administration site conditions:

Common: asthenia fatigue. Uncommon: drug withdrawal syndrome, malaise, oedema, peripheral oedema, drug tolerance, thirst, pyrexia, chills. Frequency not known: drug withdrawal syndrome neonatal. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

The major risk of opioid excess is respiratory depression. Caution must be exercised when administering oxycodone to the debilitated elderly; opioid-dependent patients; patients with severely impaired pulmonary function, patients with impaired hepatic or renal function; patients with myxedema, hypothyroidism, Addison’s disease, toxic psychosis, prostate hypertrophy, adrenocortical insufficiency, alcoholism, delirium tremens, diseases of the biliary tract, pancreatitis, inflammatory bowel disorders, hypotension, hypovolaemia, raised intracranial pressure, head injury (due to risk of increased intracranial pressure or patients taking benzodiazepines, other CNS depressants (including alcohol) or MAO inhibitors.

Concomitant use of benzodiazepines and opioids may result in sedation, respiratory depression, coma and death. Because of these risks, concomitant prescribing of sedative medicines such as benzodiazepines or related drugs with opioids should be reserved for patients for whom alternative treatment options are not possible.

2). The patients should be followed closely for signs and symptoms of respiratory depression and sedation. 5). Shortec liquid should not be used where there is a possibility of paralytic ileus occurring. Should paralytic ileus be suspected or occur during use, Shortec liquid should be discontinued immediately.

Shortec liquid should be used with caution pre-operatively and within the first 12-24 hours post-operatively. As with all opioid preparations, oxycodone products should be used with caution following abdominal surgery as opioids are known to impair intestinal motility and should not be used until the physician is assured of normal bowel function.

g. surgery, plexus blockade) should not receive Shortec liquid for 6 hours prior to the intervention. If further treatment with oxycodone is indicated then the dosage should be adjusted to the new post-operative requirement. For appropriate patients who suffer with chronic non-malignant pain, opioids should be used as part of a comprehensive treatment programme involving other medications and treatment modalities.

A crucial part of the assessment of a patient with chronic non-malignant pain is the patient’s addiction and substance abuse history. If opioid treatment is considered appropriate for the patient, then the main aim of treatment is not to minimise the dose of opioid but rather to achieve a dose which provides adequate pain relief with a minimum of side effects.

There must be frequent contact between physician and patient so that dosage adjustments can be made. It is strongly recommended that the physician defines treatment outcomes in accordance with pain management guidelines. The physician and patient can then agree to discontinue treatment if these objectives are not met.

The patient may develop tolerance to the drug with chronic use and require progressively higher doses to maintain pain control. Prolonged use of this product may lead to physical dependence and a withdrawal syndrome may occur upon abrupt cessation of therapy.

When a patient no longer requires therapy with oxycodone, it may be advisable to taper the dose gradually to prevent symptoms of withdrawal. The opioid abstinence or withdrawal syndrome is characterised by some or all of the following: restlessness, lacrimation, rhinorrhoea, yawning, perspiration, chills, myalgia, mydriasis and palpitations.

Other symptoms also may develop, including: irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhoea, or increased blood pressure, respiratory rate or heart rate. Hyperalgesia that will not respond to a further dose increase of oxycodone may occur, particularly in high doses.

An oxycodone dose reduction or change to an alternative opioid may be required. Oxycodone has an abuse profile similar to other strong opioids. Oxycodone may be sought and abused by people with latent or manifest addiction disorders.

There is potential for development of psychological dependence [addiction] to opioid analgesics, including oxycodone. Shortec should be used with particular care in patients with a history of alcohol and drug abuse. As with other opioids, infants who are born to dependent mothers may exhibit withdrawal symptoms and may have respiratory depression at birth.

Abuse of oral dosage forms by parenteral administration can be expected to result in serious adverse events, which may be fatal. Concomitant use of alcohol and Shortec liquid may increase the undesirable effects of Shortec liquid; concomitant use should be avoided.

Opioids, such as oxycodone hydrochloride, may influence the hypothalamic-pituitary- adrenal or – gonadal axes. Some changes that can be seen include an increase in serum prolactin, and decreases in plasma cortisol and testosterone. Clinical symptoms may manifest from these hormonal changes.

1. Oxycodone must not be used in any situation where opioids are contraindicated: severe respiratory depression with hypoxia, paralytic ileus, acute abdomen, delayed gastric emptying, severe chronic obstructive lung disease, cor pulmonale, severe bronchial asthma, elevated carbon dioxide levels in the blood, moderate to severe hepatic impairment, chronic constipation,.