Oxycodone/Naloxone Stada
Oxycodone/Naloxone Stada treats severe pain and severe restless legs syndrome when other treatments have not been effective, and it also helps prevent constipation.
How to Use
Dosage
Your doctor will tell you the exact dose. Typically, for pain, the starting dose is one 10 mg/5 mg tablet every 12 hours. For restless legs syndrome, the starting dose is one 5 mg/2.5 mg tablet every 12 hours.
Method
Swallow the tablet whole or divided (if your dose allows), with about half a glass of water, with or without food. Do not crush, chew, or break the tablet if it's not meant to be divided.
For pain, the maximum is 160 mg oxycodone hydrochloride and 80 mg naloxone hydrochloride per day. For restless legs syndrome, the maximum is 60 mg oxycodone hydrochloride and 30 mg naloxone hydrochloride per day. Your doctor will set your specific maximum dose.
Possible Side Effects
- •Headache
- •Dizziness
- •Sleepiness
- •Constipation
- •Nausea
- •Sweating
- •Tiredness or fatigue
- •Abdominal pain
- •Diarrhea
- •Dry mouth
- •Indigestion
- •Vomiting
- •Flatulence (gas)
- •Decreased or loss of appetite
- •Hot flushes
- •Unusual weakness
- •Itching
- •Skin reactions or rash
- •Vertigo (spinning sensation)
- •Difficulty sleeping
- •Depression
- •Tremor
- •Tingling in hands or feet
- •Blurred vision or decreased vision
- •Low blood pressure
- •High blood pressure
- •Increased liver enzyme values
- •Chest pain
- •Chills
- •General pain
- •Thirst
- •Difficulty concentrating
- •Increased heart rate
- •Drug dependence
- •Dental changes
- •Weight gain
- •Yawning
- •Decreased sexual desire
- •Sudden sleep episodes
- •Changes in taste
- •Breathing difficulties
- •Erectile dysfunction
- •Withdrawal symptoms (e.g., agitation)
- •Swelling in hands, ankles, or feet
- •Accidental injury
Important Warnings
- Do not take if you are allergic to oxycodone, naloxone, or any other ingredients in this medicine.
- Do not take if you have severe breathing problems (like very slow and shallow breathing), severe lung disease (such as COPD or severe asthma), or heart problems due to lung disease.
- Do not take if you have moderate to severe liver problems.
- Do not take if you have a history of opioid misuse. This medicine can cause addiction. Never inject the tablets as this can be fatal.
- Do not drink alcohol or grapefruit juice while taking this medicine. Alcohol increases the risk of serious side effects like very slow breathing and loss of consciousness.
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- Do not use if you are pregnant or breastfeeding. It can harm the baby.
- This medicine can make you sleepy and affect your ability to drive or operate machines. Do not drive or operate machinery if you feel drowsy.
- Tell your doctor about all other medicines you take, especially antidepressants, sedatives, strong painkillers (opioids), and MAO inhibitors, as they can cause serious side effects.
- Taking too much can cause very slow breathing, extreme drowsiness or unconsciousness, small pupils, slow heart rate, low blood pressure, and can be fatal. Seek immediate medical help if you take too much.
- Do not stop taking this medicine suddenly without talking to your doctor, as it can cause withdrawal symptoms.
- If you have severe diarrhea at the start of treatment, tell your doctor. This might mean your bowels are returning to normal.
- Contact your doctor if you have severe stomach pain, nausea, vomiting, or fever, as these could be signs of pancreatitis or gallstone problems.
Use in Elderly Patients
Suitable for older adults, with specific precautions. Sedative. Reduce the dose already in mild renal impairment. Increases the risk of confusion and falling. Need for laxative is often necessary. Consider potential interactions. Avoid grapefruit. (updated 24.3.2025)