OXYCODONE HYDROCHLORIDE 50 MG / ML SOLUTION FOR INJECTION/INFUSION - patient leaflet, side effects, dosage

Oxycodone hydrochloride 50 mg/ml Solution for Injection/Infusion

Oxycodone hydrochloride

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

• 1. What Oxycodone hydrochloride is and what it is used for

• 2. What you need to know before you use Oxycodone hydrochloride

• 3. How to use Oxycodone hydrochloride

• 4. Possible side effects

• 5. How to store Oxycodone hydrochloride

• 6. Contents of the pack and other information

1. what oxycodone hydrochloride is and what it is used for

2. what you need to know before you use oxycodone hydrochloride

Information for Health Professionals

Oxycodone hydrochloride 50 mg/ml Solution for Injection/Infusion Oxycodone hydrochloride

This leaflet provides technical information for the healthcare professional about Oxycodone hydrochloride 50 mg/ml Solution for Injection/Infusion.

Please refer to the Summary of Product Characteristics for further information.

Posology and method of administration

The dose should be adjusted according to the severity of pain, the total condition of the patient and previous or concurrent medication.

Adults over 18 years:

The following starting doses are recommended. A gradual increase in dose may be required if analgesia is inadequate or if pain severity increases.

i.v, (Bolus) : Dilute in 0.9% saline, 5% dextrose or water for injections.

Administer a bolus dose of 1 to 10 mg slowly over 1–2 minutes in opioid naive patients. Doses should not be administered more frequently than every 4 hours.

i.v. (Infusion) : Dilute in 0.9% saline, 5% dextrose or water for injections. A starting dose of 2 mg/hour is recommended for opioid naive patients.

i.v. (PCA) : Dilute in 0.9% saline, 5% dextrose or water for injections. Bolus doses of 0.03 mg/kg should be administered with a minimum lock-out time of 5 minutes for opioid naive patients.

S.C. (Bolus): Use the 10 mg/ml or the 50 mg/ml and dilute in 0.9 % saline, 5% dextrose or water for injections if required. A starting dose of 5 mg is recommended, repeated at 4-hourly intervals as required for opioid naive patients.

S.C. (infusion): Dilute in 0.9% saline, 5% dextrose or water for injections if required.

A starting dose of 7.5 mg/day is recommended in opioid naive patients, titrating gradually according to symptom control.

Cancer patients transferring from oral oxycodone may require much higher doses (see below).

Transferring patients between oral and parenteral oxycodone:

The dose should be based on the following ratio: 2 mg of oral oxycodone is equivalent to 1 mg of parenteral oxycodone. It must be emphasised that this is a guide to the dose required. Inter- patient variability requires that each patient is carefully titrated to the appropriate dose.

Elderly patients:

Elderly patients should be treated with caution.

The lowest dose should be administered with careful titration to pain control.

DRxxxxxx

SAP No

3. how to use oxycodone hydrochloride

A doctor or nurse will usually prepare and administer the injection for you. The injection should be used immediately after opening. The dose and how often the injection is given may be adjusted according to the severity of your pain (see Information for Health Professionals).

Adults (over 18 years of age)

The usual starting dose is dependent upon how the injection is administered. The usual starting doses are as follows:

• as a single injection into a vein, the usual dose is 1 to 10 mg given slowly over 1 to 2 minutes. This can be repeated every 4 hours
• as an infusion into a vein, the usual starting dose is 2 mg/hour.
• as a single injection through a fine needle into the tissue under the skin, the usual starting dose is 5 mg repeated at 4-hourly intervals if needed.
• as an infusion through a fine needle into the tissue under the skin, the usual starting dose is 7.5 mg/day.
• if given by patient controlled analgesia (PCA), the dose is worked out according to your weight (0.03 mg per kg of body weight). Your doctor or nurse will set a suitable frequency.

Children

Children and adolescents under 18 years of age should not be given this injection.

Patients with kidney or liver problems

Please tell your doctor if you suffer from kidney or liver problems as they may prescribe a lower dose depending on your condition. The dose recommended by the doctor should not be exceeded. Check with the doctor or pharmacist if you are unsure.

If you find that you are still in pain whilst being given this injection, discuss this with your doctor.

If you use more Oxycodone hydrochloride than you should, or if someone else uses your injection Call your doctor or hospital straight away. People who have been given an overdose may feel very sleepy, sick or dizzy. They may also have breathing difficulties leading to unconsciousness or even death and may need emergency treatment in hospital. When seeking medical attention make sure that you take this leaflet and any remaining injection with you to show to the doctor.

If you stop using Oxycodone hydrochloride

You should not suddenly stop using this injection unless your doctor tells you to. If you want to stop using your injection, discuss this with your doctor first. They will tell you how to do this, usually by reducing the dose gradually so you do not experience unpleasant effects. Withdrawal symptoms such as agitation, anxiety, palpitations, shaking or sweating may occur if you suddenly stop using this injection. If you have any further questions on the use of this injection, ask your doctor or pharmacist.

4. possible side effects

Like all medicines, this injection can cause side effects, although not everybody gets them.

All medicines can cause allergic reactions, although serious allergic reactions are rare. Tell your doctor immediately if you get any sudden wheeziness, difficulties in breathing, swelling of the eyelids, face or lips, rash or itching especially those covering your whole body.

The most serious side effect is a condition where you breathe more slowly or weakly than expected (respiratory depression). Tell your doctor immediately if this happens to you.

As with all strong painkillers, there is a risk that you may become addicted or reliant on this injection.

Very common side effects (may affect more than 1 in 10 people)

• constipation (your doctor can prescribe a laxative to overcome this problem)
• feeling or being sick (this should normally wear off after a few days however your doctor can prescribe an anti-sickness medicine if it continues to be a problem)
• drowsiness (this is most likely when you start taking your medicine or when your dose is increased, but it should wear off after a few days)
• dizziness
• headache
• itchy skin

Common side effects (may affect up to 1 in 10 people)

• dry mouth, loss of appetite, indigestion, abdominal pain or discomfort, diarrhoea
• confusion, depression, a feeling of unusual weakness, shaking, lack of energy, tiredness, anxiety, nervousness, difficulty in sleeping, abnormal thoughts or dreams
• difficulty in breathing or wheezing, shortness of breath, decreased cough reflex
• rash
• sweating

Uncommon side effects (May affect up to

1 in 100 people)

• difficulty in swallowing, belching, hiccups, wind, a condition where the bowel does not work properly (ileus), inflammation of the stomach, changes in taste
• a feeling of dizziness or ‘spinning’ (vertigo), hallucinations, mood changes, unpleasant or uncomfortable mood, a feeling of extreme happiness, restlessness, agitation, generally feeling unwell, loss of memory, difficulty in speaking, reduced sensitivity to pain or touch, tingling or numbness in the hands or feet, seizures, fits or convulsions, blurred vision, fainting, unusual muscle stiffness or slackness, involuntary muscle contractions
• difficulty passing urine, impotence, decreased sexual drive, low levels of sex hormones in the blood (‘hypogonadism’, seen in a blood test)
• fast, irregular heart beat, flushing of the skin
• dehydration, thirst, chills, swelling of the hands, ankles or feet
• dry skin, severe flaking or peeling of the skin
• redness of the face, reduction in size of the pupils in the eye, muscle spasm, high temperature
• a need to take increasingly higher doses of this medicine to obtain the same level of pain relief (tolerance)
• colicky abdominal pain or discomfort
• a worsening in liver function tests (seen in a blood test)

Rare side effects (May affect up to 1 in 1,000 people)

• low blood pressure
• a feeling of ‘faintness’ especially on standing up
• hives (nettle rash)

Frequency not known (Frequency cannot be estimated from the available data)

• an increase in sensitivity to pain aggression tooth decay
• absence of menstrual periods
• a blockage in the flow of bile from the liver. This can cause itchy skin, yellow skin, very dark urine and very pale stools.
• Long term use of Oxycodone hydrochloride during pregnancy may cause life-threatening withdrawal symptoms in the newborn. Symptoms to look for in the baby include irritability, hyperactivity and abnormal sleep pattern, high pitched cry, shaking, being sick, diarrhoea and not putting on weight.

5. how to store oxycodone hydrochloride

Keep this medicine out of the sight and reach of children. Accidental overdose by a child is dangerous and may be fatal.

Do not use this injection after the expiry date which is stated on the ampoule label and carton. EXP 08 2020 means that you should not use the injection after the last day of that month i.e. August 2020.

Keep the ampoules in the outer carton in order to protect from light. Once the ampoule is opened the injection should be used immediately. Any unused portion should be discarded immediately.

The medicine should be examined visually and should not be used if particulate matter or discolouration are present.

If the solutions becomes discoloured or shows any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.

Oxycodone hydrochloride, undiluted or diluted to 1 mg/ml with 0.9% w/v saline, 5% w/v dextrose or water for injections, is physically and chemically stable when in contact with representative brands of polypropylene or polycarbonate syringes, polyethylene or PVC tubing and PVC or EVA infusion bags, over a 24 hour period at room temperature.

The injection, whether undiluted or diluted to 1 mg/ml in the infusion fluids used in these studies and contained in the various assemblies, does not need to be protected from light.

Inappropriate handling of the undiluted solution after opening of the original ampoule, or of the diluted solutions may compromise the sterility of the product.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. contents of the pack and other information

What Oxycodone hydrochloride Injection contains

The active ingredient is oxycodone hydrochloride. Each 1 ml of the solution for injection or infusion contains 50 mg oxycodone hydrochloride, equivalent to 45 mg oxycodone.

The other ingredients are citric acid monohydrate, sodium citrate, sodium chloride, hydrochloric acid, dilute (for pH adjustment), sodium hydroxide (for pH adjustment), water for injections. For excipients with known effect, see section 2.

What Oxycodone hydrochloride Injection looks like and contents of the pack

This injection is a clear, colourless solution supplied in clear glass ampoules. The 50 mg/ml strength is available as 1 ml of solution (containing 50 mg of oxycodone hydrochloride).

Marketing Authorisation Holder

Dr. Reddy’s Labora­tories (UK) Ltd., 6 Riverview Road, Beverley, East Yorkshire, HU17 0LD, United Kingdom

Manufacturer

HBM Pharma s.r.o.

Sklabinska 30 036 80 Martin Slovak Republic

This leaflet was last revised in December 2019

Patients with renal or hepatic impairment:

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 naive patients), and each patient should be titrated to adequate pain control according to their clinical situation.

Paediatric population:

There are no data on the use of Oxycodone hydrochloride in patients under 18 years of age.

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.

Endocrine system

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 be manifest from these hormonal changes.

Concomitant therapy

There can be an enhanced CNS depressant effect which can result in profound sedation, respiratory depression, coma and death during concomitant therapy with benzodiazepines or other drugs which affect the CNS such as tranquillisers, anaesthetics, hypnotics, anti-depressants, non-benzodiazepine sedatives, phenothiazines, neuroleptic drugs, alcohol, other opioids, muscle relaxants and antihypertensives.

Route of administration:

Subcutaneous injection or infusion.

Intravenous injection or infusion.

Duration of treatment

Oxycodone should not be used for longer than necessary.

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.

Instructions for use/handling

Each ampoule is for single use in a single patient.

The injection should be given immediately after opening the ampoule. Once opened any unused portion should be discarded. Chemical and physical in-use stability has been demonstrated for 24 hours at room temperature.

From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless reconstitution / dilution (etc) has taken place in controlled and validated aseptic conditions.