Document: 08.08.2007 Specialist information (German)change
Information for professionals (SPC)
OxyNorm® capsules5 mg/10mg/20 mg
1. NAME OF THE MEDICINAL PRODUCT
2.QUALITATIVE AND QUANTITATIVE COMPOSITION
1Kapsel OxyNorm®Capsules 5 mg contains 5 mg oxycodone hydrochloride.
1Kapsel OxyNorm®Capsules 10 mg contains 10 mg oxycodone hydrochloride.
1Kapsel OxyNorm®Capsules 20 mg contains 20 mg oxycodone hydrochloride.
OxyNorm®Capsules 5 mg contain Yellow Orange S (E 110).
For a full list of excipients, see section 6.1.
OxyNorm®Capsules 5 mg are orange/beige capsules, labeled “ONR 5”.
OxyNorm®Capsules 10 mg are white/beige capsules, marked “ONR 10”.
OxyNorm®Capsules 20 mg are pink/beige capsules, labeled “ONR 20”.
4.1Areas of application
Severe to very severe pain.
4.2 Dosage, method and duration of use
The dosage should be adjusted to the pain intensity and the individual sensitivity of the patient.
For dose adjustment and treatment of breakthrough pain OxyNorm®Capsules 5 mg, 10 mg and 20 mg available.
The following general dosage recommendations apply:
The starting dose for non-opioid addicted patients is generally 5 mg oxycodone hydrochloride every 6 hours.
Some patients receiving prolonged-release oxycodone on a fixed time schedule require rescue medication for immediate-release analgesics to manage breakthrough pain.OxyNorm® Capsules are intended for the treatment of these breakthrough pains. The single dose of the required medication is to be determined individually. For the level of required medication, 1/6 of the daily dose of slow-release oxycodone can be assumed as a guide.
The dose should then be carefully titrated daily until adequate pain relief is achieved. The dosing interval can vary from OxyNorm®Capsules can be reduced to a 4 hour interval if necessary. However, the capsules should not be taken more than 6 times a day.
If rescue medication is required more than twice a day, this is an indication that an increase in the dose of prolonged-release oxycodone is required. The goal is a patient-specific dosage that allows adequate analgesia with tolerable side effects and as little rescue medication as possible with twice daily administration of slow-release oxycodone for as long as pain therapy is necessary.
Type of application
OxyNorm®In the dosage determined, capsules are taken daily no more frequently than every 4-6 hours. When using OxyNorm®Dose adjustment capsules should be taken on a fixed schedule (every 6 hours).
OxyNorm®Capsules can either be taken with meals or taken independently with sufficient liquid.
Duration of intake
OxyNorm®Capsules should not be taken longer than absolutely necessary. After or during dose adjustment, twice daily administration of delayed-release oxycodone should take place as soon as possible. If long-term treatment is necessary depending on the type and severity of the disease, careful and regular monitoring should ensure whether and to what extent further treatment is necessary. If opioid therapy is no longer indicated, it may be advisable to gradually reduce the daily dose to avoid the onset of withdrawal syndrome symptoms.
Children under 12 years old
OxyNorm®Capsules are not recommended for use in children under the age of 12 due to a lack of data on safety and efficacy.
In elderly patients without clinically manifest hepatic and/or renal dysfunction, dose adjustment is not usually necessary.
In high-risk patients, e.g. Patients with renal or hepatic dysfunction, low body weight or slow metabolisers of drugs, should be given initially - if not opoid addicted - half the normally recommended dose for adults. The lowest dosage of 5 mg oxycodone hydrochloride every 6 hours as the starting dose recommended elsewhere in this product information is not suitable for such high-risk patients.
Hypersensitivity to oxycodone hydrochloride,Yellow orange S (E110) (only at the potency 5 mg) or one of the other ingredients,
Severe respiratory depression with hypoxia and/or hypercapnia,See AlsoOxynorm Caps 5 mg 30 pcs
severe chronic obstructive pulmonary disease,
severe bronchial asthma,
pregnancy (see section 4.6),
Lactation (see section 4.6).
4.4 Special warnings and precautions for use
OxyNorm®Capsules have not been studied in children under 12 years of age. Safety and effectiveness have therefore not been verified, so use in children under the age of 12 is not recommended.
Caution is advised in elderly or debilitated patients with severe impairment of lung, liver or kidney function, myxedema, hypothyroidism, Addison's disease (adrenal insufficiency), prostatic hypertrophy, intoxication psychosis (e.g. alcohol), alcoholism, delirium tremens, known opioid dependence,Pancreatitis, cholelithiasis, obstructive and inflammatory bowel disease, conditions with increased intracranial pressure, circulatory disorders, epilepsy or predisposition to seizures, use of MAO inhibitors. If paralytic ileus occurs or is suspectedOxyNorm®capsules are discontinued immediately.
Respiratory depression is the most significant hazard of opioid overdose and is most likely to occur in elderly or debilitated patients, so special monitoring may be required. The respiratory depressant effect of oxycodone can lead to an increase in the carbon dioxide concentration in the blood and secondarily in the cerebrospinal fluid. In susceptible patients, opioids can cause severe falls in blood pressure.
With long-term use of OxyNorm®Capsules may develop tolerance, requiring higher doses to achieve the desired analgesic effect. There is cross tolerance to other opioids. The chronic use ofOxyNorm®Encapsulation can lead to physical dependence. Withdrawal syndrome may occur if therapy is stopped abruptly. When oxycodone therapy is no longer required, it may be advisable to gradually reduce the daily dose to avoid the onset of symptoms of a withdrawal syndrome.
OxyNorm®Capsules possess a primary addiction potential. However, when used as directed in chronic pain patients, the risk of physical and psychological dependence is significantly reduced or assessed in a differentiated manner. However, data on the actual incidence of psychological dependence in chronic pain patients are lacking.In the case of a history of alcohol or drug abuse, the product should only be prescribed with particular caution.
Abusive parenteral administration of the capsule components can result in serious, potentially fatal, adverse events.
4.5 Drug Interactions and Other Interactions
Central depressant drugs (e.g. sedatives, hypnotics, phenothiazines, neuroleptics, antidepressants, antihistamines, antiemetics) and other opioids or alcohol can increase the side effects of oxycodone, especially respiratory depression.
Medicines with an anticholinergic effect (e.g. psychotropics, antihistamines, antiemetics, medicines for Parkinson's disease) can increase the anticholinergic side effects of oxycodone (such as constipation, dry mouth or urinary disorders).
In individual cases, a clinically relevant decrease or increase in the International Normalized Ratio (INR) was observed when oxycodone and coumarin anticoagulants were taken at the same time.
Cimetidine can inhibit the breakdown of oxycodone.
Inhibition of cytochrome P450 2D6 and 3A4 has no clinical relevance. The influence of other relevant isoenzyme inhibitors of the cytochrome system on the metabolism of oxycodone is not known. Possible interactions should be considered.
OxyNorm®Capsules should not be taken during pregnancy and lactation.
There is insufficient experience of oxycodone use in humans during pregnancy. Oxycodone crosses the placenta. Prolonged use of oxycodone during pregnancy may cause withdrawal symptoms in the newborn. Administered during labor may cause respiratory depression in the fetus.
Oxycodone passes into breast milk. A milk-to-plasma concentration ratio of 3.4:1 was measured.
4.7 Effects on ability to drive and use machines
Oxycodone can change alertness and the ability to react to such an extent that the ability to drive or use machines is impaired or no longer given. This is particularly to be expected at the start of oxycodone therapy, after increasing the dose or changing preparations, and when oxycodone interacts with alcohol or other CNS-depressant substances.
With a stable therapy, a general driving ban is not absolutely necessary. The assessment of the individual situation must be carried out by the attending physician.
4.8 Side Effects
Oxycodone can cause respiratory depression, miosis, bronchial and spasm smooth muscle spasms, and cough reflex vapors.
The most frequently reported side effects are nausea (especially at the beginning of therapy) and constipation.
Respiratory depression is the most significant hazard of opioid overdose and is most likely to occur in elderly or debilitated patients. In susceptible patients, opioids can cause severe falls in blood pressure.
The assessment of side effects is based on the following frequencies:
Very often(>10 %)
Frequently(>1 % - <10 %)
Occasionally(>0,1 % - <1 %)
Rarely(>0,01 % - <0,1 %)
Very rare (< 0.01% or unknown)
Within each frequency grouping, adverse reactions are presented in order of seriousness (decreasing).
Infections and parasitic diseases
Rare: herpes simplex
Immune System Diseases
Uncommon: Hypersensitivity reactions
Very rare: Anaphylactic reactions
Metabolic and nutritional disorders
Common: Decreased appetite up to loss of appetite
Rare: dehydration, increased appetite
Frequently:Mood and personality changes (e.g. anxiety, depression, euphoric mood), decreased activity, restlessness, psychomotor hyperactivity, agitation, nervousness, Insomnia, thought disorders, confusional states
Occasionally: Perceptual disturbances (e.g. hallucinations, derealisation), decreased libido
Dependence can develop.
Diseases of the nervous system
Very often: sedation (somnolence to a clouded state of consciousness), dizziness, headache
Uncommon: trouble concentrating, Migraine,taste disorders,increased muscle tone, tremor, involuntary muscle contractions,hypoesthesia, incoordination
Rarely:convulsions (especially in people with epilepsy and predisposition to seizures),amnesia
Very rare: speech disorders
Uncommon: visual disturbances
Diseases of the ear and labyrinth
Uncommon: hearing impairment
Respiratory, thoracic and mediastinal diseases
Uncommon: dysphonia, cough
Very common: constipation, vomiting, nausea
Common: abdominal pain, diarrhea, dry mouth, hiccups, dyspepsia
Uncommon: mouth ulcerations, stomatitis, flatulence
Rare: melaena, dental disease, bleeding gums, dysphagia
Very rare: ileus
Liver and bile diseases
Uncommon: Biliary colic
Very rare: increase in liver-specific enzymes
Skin and subcutaneous tissue disorders
Very common: pruritus
Common: skin reactions/rash
Rare: Dry skin
Very rare: urticaria
Diseases of the kidneys and urinary tract
Common: urinary retention, dysuria, urinary urgency
Diseases of the genital organs and the mammary gland
Uncommon: Erectile dysfunction
General disorders and administration site conditions
Common: hyperhidrosis leading to chills, asthenia
Uncommon: Physical dependence with drug withdrawal syndrome, pain (e.g. chest pain), malaise, oedema
Rare: weight gain or loss, thirst
Tolerance can develop.
Injury, poisoning and procedural complications
Uncommon: Accidental injuries
Only with the potency 5mg:
Sunset yellow (E 110) can cause allergic reactions.
Symptoms of intoxication:
Miosis, respiratory depression, somnolence up to stupor, decreased tension of the skeletal muscles, bradycardia and drop in blood pressure. In more severe cases, coma, noncardiogenic pulmonary edema, and circulatory failure can occur, which can be fatal.
Therapy of intoxications:
In the event of an overdose, intravenous administration of an opiate antagonist (e.g. 0.4-2 mg naloxone intravenously) may be indicated. This single dose must be repeated at two to three minute intervals as clinically required. Also administration by infusion of 2 mg naloxone in 500 mlIsotonic saline or 5% dextrose solution (equivalent to 0.004 mg naloxone/ml) is possible. The rate of infusion should be tailored to the previously administered bolus dosages and the patient's response.
Gastric lavage may be considered.
Supportive measures (artificial ventilation, oxygenation, administration of vasopressors and infusion therapy) should be used, if necessary, in the management of concomitant circulatory shock. Cardiac arrest or arrhythmias may indicate chest compressions or defibrillation. If necessary, assisted ventilation and maintenance of water and electrolyte balance.
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: natural opium alkaloids
Oxycodone has affinity for kappa, mu, and delta opiate receptors in the brain, spinal cord, and peripheral organs. Oxycodone acts as an opioid agonist at these receptors without any antagonistic effect. The therapeutic effect is predominantly analgesic and sedating.
Opioids may affect the hypothalamic-pituitary-adrenal or gonadal axes. Changes that may be observed include an increase in serum prolactin and a decrease in plasma cortisol and testosterone. A manifestation of clinical symptoms due to these hormonal changes may be possible.
Other pharmacological effects
Preclinical studies show different effects of natural opioids on components of the immune system. The clinical significance of these findings is unknown. It is not known whether oxycodone, a semisynthetic opioid, has immune system effects similar to natural opioids.
5.2 Pharmacokinetic properties
After ingestion of the capsules, maximum plasma concentrations occur after about 1 to 1.5 hours. In a bioavailability study of another immediate-release oxycodone preparation (solution), the extent of absorption (AUC) after ingestion of a high-fat meal was approximately 20% increased, while the rate of absorption (Cmax) was decreased by about 20% compared to fasting. Clinical consequences are not assumed and specific recommendations are made for taking the OxyNorm®Capsules not necessary in relation to the timing of meals.
distribution and elimination
The absolute bioavailability of oxycodone is approximately two-thirds relative to parenteral administration. Oxycodone has a volume of distribution of 2.6 L/kg at steady state; a plasma protein binding of 38-45%, an elimination half-life of 4 to 6 hours and a plasma clearance of 0.8 l/min.
Oxycodone is metabolized in the gut and liver via the P450 cytochrome system to noroxycodone and oxymorphone, as well as to several glucuronide conjugates. Invitro- Studies indicate that therapeutic doses of cimetidine are unlikely to significantly affect the formation of noroxycodone. Quinidine reduces the production of oxymorphone in humans, but the pharmacodynamics of oxycodone remain essentially unaffected. The contribution of the metabolites to the overall pharmacodynamic effect is negligible. Oxycodone and its metabolites are excreted in both urine and stool. Oxycodone crosses the placenta and can be detected in breast milk.
5.3 Preclinical safety data
Oxycodone has not been adequately tested for reproductive toxicological properties. There are no studies on fertility and on the postnatal effects of intrauterine exposure. Oxycodone did not induce any malformations in the rat at doses of up to 8 mg/kg body weight/day and in the rabbit at doses of up to 5 mg/kg body weight/day.
Oxycodonzeigte in in vitro-Investigations of a clastogenic potential. Underlive-conditions, however, such findings were not observed even at toxic doses.
Long-term carcinogenicity studies have not been performed.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Microcrystalline cellulose (E 460i), magnesium stearate, sodium dodecyl sulfate, gelatine, titanium dioxide (E171), iron oxide hydrate (E172), indigo carmine (E132), only with a potency of 5 mg additionally: sunset yellow FCF (E110).
6.3 Shelf Life
6.4 Special Storage Precautions
Do not store above 30°C.
6.5 Nature and content of the container
Child-resistant polyvinyl chloride foil blister packs, Pack sizes: 20, 50 and 100 capsules
6.6 Special precautions for disposal
No special requirements.
7. Marketing Authorization Holder
65549 Limburg (Lahn)
9. Date of Granting of Authorization
10. Stand derInformation
11. Sales accrual
OxyNorm capsules 5mg/10 mg/20 mgSPC 0707.docPage 14 von15 20.12.2016 12:04:31
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 ...How long does 5mg OxyNorm last? ›
Take OxyNorm capsules every 4 to 6 hours or as directed by your doctor. If you begin to experience pain and you are taking your OxyNorm capsules as prescribed, contact your doctor as your dosage may have to be reviewed. Continue taking your medicine for as long as your doctor tells you.What are the contraindications for OxyNorm? ›
OxyNorm injection is contraindicated in patients with known hypersensitivity to oxycodone or any of the other constituents; respiratory depression; head injury; paralytic ileus; acute abdomen; chronic obstructive airways disease; cor pulmonale; chronic bronchial asthma; hypercarbia; moderate to severe hepatic ...What are the side effects of OxyNorm 5? ›
- 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;
Oxycodone is stronger at relieving pain but also more likely than tramadol to lead to addiction and dependence. Tramadol has mood-boosting properties but a lower risk of respiratory depression than oxycodone. Tramadol also carries the risk of seizure.What is the duration of action for OxyNorm? ›
Mechanism of Action
Duration range is from 3 to 6 hours for immediate-release or 12 hours in controlled-release formulations. The plasma half-life is 3 to 5 hours, and stable plasma levels are reached within 24 to 36 hours.
Peak plasma concentrations of oxycodone are reached approximately one hour after administration of OxyNorm capsules, and less than one hour (approximately 45 minutes) after administration of OxyNorm liquid.Which is stronger oxycodone or hydrocodone? ›
Oxycodone is stronger than hydrocodone, with 5 mg of oxycodone being equivalent to 7.5 mg of hydrocodone. Oxycodone is often combined with acetaminophen. The brand name for this combination is Percocet. However, it is also available in generic formulations.How long does 5mg of oxycodone affect you? ›
How long does it take oxycodone to work, and how long does it last? The immediate-release (IR) forms of oxycodone (Oxaydo, Roxicodone, generic oxycodone) generally start to work within 10 to 30 minutes. But the pain-relieving effects might wear off after about 3 to 6 hours.Is OxyNorm hard on the stomach? ›
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 dreams, abnormal thoughts.
Mixing Gabapentin and Oxycodone can be dangerous and potentially life-threatening. The combination of these medications can have additive effects, increasing the risk of respiratory depression, overdose, and death.How many 5mg OxyNorm can you take a day? ›
capsules containing 5mg, 10mg or 20mg of oxycodone – usually taken 4 to 6 times a day. standard tablets containing 5mg, 10mg or 20mg of oxycodone – usually taken 4 to 6 times a day. slow-release tablets containing 5mg, 10mg, 15mg, 20mg, 30mg, 40mg, 60mg, 80mg or 120mg of oxycodone – usually taken 1 to 2 times a day.Is OxyNorm bad for liver? ›
However, oxycodone and other opioid-acetaminophen combinations have become a common cause of acute liver injury, which is usually the result of excessive use of the medication for the opioid effect, which leads secondarily and unintentionally to an overdose of acetaminophen.What is the strongest pain relief? ›
Morphine is a stronger opioid drug. Other examples of strong opioids include diamorphine, oxycodone, fentanyl, methadone and buprenorphine. Opioid medicines come in many forms including tablets, capsules, liquids, skin patches and injections.What is OxyNorm also known as? ›
It comes as a tablet that is used to prevent certain side effects, such as constipation. Oxycodone with naloxone is known by the brand names Myloxifin, Oxyargin or Targinact.What is the same as OxyNorm? ›
Endone is the brand name of a medicine containing the active ingredient oxycodone hydrochloride. Other brands of oxycodone include OxyContin and OxyNorm.What happens if you take too much OxyNorm? ›
If you take more OxyNorm oral solution than you should or if someone accidentally swallows your medicine. Call your doctor or hospital immediately. People who have taken an overdose may feel very sleepy, sick or dizzy, or have hallucinations.Can OxyNorm lower BP? ›
Low blood pressure: Oxycodone can make low blood pressure worse or cause low blood pressure, which may be severe. If you experience severe dizziness, especially when standing from a lying or sitting position, contact your doctor.How much OxyNorm should I take? ›
The usual starting dose is 5 mg every 4 to 6 hours. However, your doctor will prescribe the dose required to treat your pain. If you find that you are still in pain whilst taking this medicine discuss this with your doctor. Children and adolescents under 18 years of age should not take the medicine.What is stronger 5 mg oxycodone or 10 mg hydrocodone? ›
One of the most important differences between the two drugs is their potency. Even though they are both Schedule II drugs, oxycodone is about 50% stronger than hydrocodone. In addition, long-acting forms of hydrocodone can last longer than long-acting forms of oxycodone.
Fentanyl is far more potent than oxycodone, and it is involved in more overdose deaths in the US.Can you drive on 5mg of oxycodone? ›
This medicine may make you dizzy, drowsy, or lightheaded. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.Does OxyNorm affect the breathing? ›
Sleep-related breathing disorders OxyNorm capsules can cause sleep-related breathing disorders such as sleep apnoea (breathing pauses during sleep) and sleep related hypoxemia (low oxygen level in the blood).Can you drive with OxyNorm? ›
Strong painkillers commonly prescribed by doctors include: Oramorph, MST, Oxynorm, Fentanyl, Oxycontin and Sevredol. You should not drive for at least five days when you first start taking strong painkillers, or if you are changing the dose of strong painkillers.What painkillers can I take with OxyNorm? ›
It's safe to take oxycodone with paracetamol, ibuprofen or aspirin (do not give aspirin to children under 16 years of age). Do not take oxycodone with painkillers that contain codeine. You'll be more likely to get side effects.Is oxycodone the same as Percocet? ›
What's the difference between Percocet and oxycodone-CR products? Both Percocet and oxycodone-CR products relieve pain, but while Percocet gives relief for about five hours, the effects of oxycodone-CR last for about 12 hours, when taken as prescribed.Why take gabapentin with oxycodone? ›
Gabapentin is a drug often used together with opioids to treat chronic pain, and both of these drugs have been shown to suppress breathing, which can be fatal. Concomitant opioid use can also increase the amount of gabapentin absorbed by the body, potentially leading to higher risks when these drugs are used together.What happens if you take gabapentin and opiates together? ›
Although gabapentin is generally considered safe and is infrequently associated with overdose on its own, when used with other central nervous system depressants such as opioids, there is risk for respiratory depression, potentially resulting in death (2).Which pain reliever is least harmful? ›
Acetaminophen is generally considered safer than other pain relievers. It doesn't cause side effects such as stomach pain and bleeding.What is oxycodone contraindicated with? ›
OXYCONTIN is contraindicated in patients with: Significant respiratory depression. Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment. Known or suspected gastrointestinal obstruction, including paralytic ileus.
A worsening in liver function tests (seen in a blood test). Withdrawal symptoms (see section 3 'If you stop taking OxyNorm'). Rare side effects: may affect up to 1 in 1,000 people • A feeling of 'faintness' especially on standing up. Low blood pressure.What are contraindications for oxycodone Apap? ›
Oxycodone is contraindicated in any situation where opioids are contraindicated including patients with significant respiratory depression (in unmonitored settings or the absence of resuscitative equipment) and patients with acute or severe bronchial asthma or hypercarbia.Does oxycodone interfere with blood pressure? ›
Low blood pressure: Oxycodone can make low blood pressure worse or cause low blood pressure, which may be severe.Which is stronger hydrocodone or oxycodone? ›
Both drugs can provide effective pain relief, but generally, oxycodone is thought to be more potent than hydrocodone.What is the strongest pain killer? ›
The most powerful pain relievers are opioids. They are very effective, but they can sometimes have serious side effects. There is also a risk of addiction. Because of the risks, you must use them only under a doctor's supervision.What is the schedule for OxyNorm? ›
Elderly and adults over 18 years: OxyNorm® Capsules 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.Can OxyNorm cause insomnia? ›
People who abuse this drug may think it relaxes them enough to encourage sleep, and it does generally cause excessive drowsiness; however, it can also cause other sleep disturbances, like insomnia.Is Percocet the same as oxycodone? ›
What's the difference between Percocet and oxycodone-CR products? Both Percocet and oxycodone-CR products relieve pain, but while Percocet gives relief for about five hours, the effects of oxycodone-CR last for about 12 hours, when taken as prescribed.What's the difference between OxyContin and oxycodone? ›
OxyContin and oxycodone are the same drug; the main difference is that OxyContin is a long-acting version of oxycodone. As such, they have a lot in common: Both drugs are opioids that people take to relieve and manage severe pain.What does 325 mean on a pill? ›
The first number is the dose of narcotic. The second number is the dose of the other medicine, usually Tylenol. For example, if you are taking Percocet 10/325, every single pill has 10 mg of oxycodone and 325 mg of Tylenol. If you are taking Norco 5/325, every single pill has 5 mg of hydrocodone and 325 mg of Tylenol.