Subutex or Buprenorphine

Subutex(Buprenorphine) is an opioid used to treat opioid use disorder, acute pain, and chronic pain. It can be used under the tongue, in the cheek, by injection, as a skin patch, or as an implant.

Uses

Subutex is used as part of a medical, social and psychological treatment program for patients dependent on opioids like heroin, morphine, oxycodone or codeine also, is used to help patients overcome this medical condition.

The tablets contain the active ingredient buprenorphine hydrochloride. It acts as a substitute for opioids like heroin, morphine, oxycodone or codeine and it helps withdrawal from opioids over some time however, this should be used exactly as prescribed by your doctor and also consult your doctor if you have any questions about why it was been prescribed for you.

Before you take Subutex

When you must not take Subutex

• If you are under the age of 16 years.
• If you are allergic to buprenorphine or any of the other ingredients in this medicine (see Product Description below).
• If you have serious breathing problems.
• If you have serious problems with your liver, or if your doctor detects the development of such a problem during treatment.
• If you are intoxicated due to CNS depressant medicines (eg. sedative/hypnotics, narcotic pain killers, anti-anxiety or antipsychotic medicines), alcohol or have delirium treatment (the ‘shakes’ and hallucinations).

Do not take Subutex if the package is torn, shows signs of tampering or if the tablets do not look quite right.

Before you start to use Subutex

Tell your doctor if you have any of the following before treatment, or develop them during treatment, as your doctor may need to adjust your dose of Subutex:

• if you are pregnant
• if you are breastfeeding
• asthma or other breathing problems;
• thyroid problems;
• prostate problems;
• problems with excess alcohol use;
• problems with drowsiness;
• Addison’s disease;
• Kyphoscoliosis (hunchback disease);
• low blood pressure;
• urination problems;
• kidney problems;
• liver problems;
• if you have head injuries or have a condition where you have increased pressure within your head,
• if you have problems related to the biliary tract
• if you have a history of seizures.
• if you have severe mental problems or hallucinations (seeing or hearing things that are not there)

Important note

Some people have died from respiratory failure (inability to breathe) when using benzodiazepines (medicines used to treat anxiety or sleeping problems), or other depressants such as alcohol or other opioids at the same time as Subutex. For further information please discuss it with your doctor.

Subutex may cause fatal respiratory failure in children who accidentally ingest it.

Keep this medicine out of reach and sight of children.

Subutex can cause withdrawal symptoms if you take it less than six hours after you use heroin or morphine.

Also, if treatment is stopped abruptly, withdrawal symptoms may occur, which may be delayed in some cases if you are drowsy, do not drive or operate machinery.

Subutex may cause your blood pressure to drop suddenly, causing you to feel dizzy if you get up too quickly from sitting or lying down.

Athletes should be aware that this medicine may cause a positive reaction to “anti-doping” tests.

The safety and effectiveness in patients over 65 years of age have not been established.

Your doctor may ask you to have additional blood tests to see if this medication is right for you.

Taking Other Medicines with Subutex

Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop before you begin treatment with Subutex.

Several medicines may alter the effects of Subutex. These include:

• certain medicines for treating HIV/AIDS;
• certain medicines for treating fungal and bacterial infections;
• strong pain killers;
• cough medicines containing opioid-related substances;
• certain antidepressants including mono-amine oxidase inhibitors;
• certain medicines used to treat fits or epilepsy (anti-convulsion);
• sedating antihistamines;
• sedatives, alcohol;
• anti-anxiety medicines;
• certain medicines for high blood pressure, and
• antipsychotic medicines
• naltrexone.

Warning

Alcohol and certain other medicines (as listed above) may increase the sedative effects of buprenorphine, which can make driving and operating machinery hazardous.

Some people have died when using sedatives (benzodiazepines) or other depressants, alcohol or other opioids at the same time as Subutex.

How much Subutex to take

Subutex is only for adults and children over the age of 16 years. Your doctor will tell you how much Subutex to take and you should always follow medical advice.

On the first day, the recommended starting dose is 4-8 mg Subutex with an additional 4 mg depending on your needs as determined by your treating doctor.

• For patients receiving methadone: before beginning treatment with Subutex , your doctor will probably reduce your dose of methadone to the minimum methadone daily dose that you can tolerate.

Subutex may cause withdrawal symptoms if taken while still under the influence of another opioid.

During your treatment, your doctor may increase your dose of Subutex to a maximum of 32mg, depending upon your response to treatment.

After a period of successful treatment, your doctor may gradually reduce your dose.

Do not suddenly stop taking the tablets, as this may cause withdrawal symptoms.

If you take too much Subutex (overdose)

If you think that you or anyone else may have taken too much Subutex , immediately telephone your doctor or National Poison Centre (in Australia telephone 13 11 26 or in New Zealand telephone 0800 POISON or 0800 764 766), or go to the accident and emergency at your nearest hospital. Do this even if there are no signs of discomfort or poisoning.

You may need urgent medical attention.

Keep telephone numbers for these places handy.

Subutex Side effects

Like all medicines, Subutex may have unwanted side effects which may need medical treatment.

Ask your doctor or pharmacist to answer any questions you may have.

Do not be alarmed by the following lists of side effects. You may not experience any of them.

Many of the common side effects reported with the use of Subutex were related to opioid withdrawal symptoms, such as:

• difficulty sleeping, anxiety, nervousness,
• malaise, fatigue,
• pain in the abdomen, back, joints and muscles, leg cramps, muscle weakness,
• flu-like symptoms such as chills, fever, sore throat, coughing, runny nose, watery eyes and sweating,
• upset stomach and diarrhea.

other side effects which have occurred are

• dry mouth, tooth disorders
• headache, migraine
• sleepiness, dizziness, fainting, vertigo
• abnormal vision
• depression, abnormal thinking, hostility, agitation, paranoid reactions, tremor
• difficulty sleeping
• chest pain, neck pain
• pain in joints, muscles, back, stomach, cramps
• palpitations, flushing
• difficulty in breathing
• yawning, cough, respiratory infection
• nausea, vomiting, constipation, diarrhea, flatulence or wind, poor appetite, decreased weight
• swelling of the legs and arms, numbness
• fatigue, weakness
• lymph node problems
• hives, rash and itching
• painful periods
• sweating
• difficulty in bladder control

If you think you are suffering from any of the above side effects, or any other side effects, you should tell your doctor immediately.

If any of the following happen, tell your doctor immediately or go to Accident and Emergency at your nearest hospital. You may need urgent medical attention.

• There have been rare cases of life-threatening severe hypersensitive reactions with symptoms of severe difficulty in breathing, and swelling of the face, lips, mouth or throat.
• Some cases of severe liver problems have occurred during treatment. If you develop severe fatigue, have no appetite or if your skin or eyes look yellow, you have light-colored bowel motions or dark colored urine, tell your doctor immediately.

Other side-effects not listed above may occur in some patients. Tell your doctor if you notice anything else that is making you feel unwell.

After Using Subutex

If you stop taking Subutex and start using opioids again, you are at risk of being more sensitive to opioids, which could be dangerous. You should talk to your doctor if you start using opioids again.