The peach, round pill with the imprint 54 375 has been identified as Buprenorphine Hydrochloride and Naloxone Hydrochloride (Sublingual) 8 mg (base) / 2 mg (base) supplied by Hikma Pharmaceuticals PLC. Buprenorphine is an opioid medication, sometimes called a narcotic. Naloxone blocks the effects of opioid medication, including pain relief or feelings of well-being that can lead to opioid abuse.
54 375 pill is used to treat narcotic (opiate) addiction. Buprenorphine and naloxone is not for use as a pain medication. 54 375 pill may also be used for purposes not listed in this medication guide. Risk cannot be ruled out during pregnancy. Buprenorphine/naloxone 8 mg (base) / 2 mg (base) is classified as a Schedule 3 controlled substance under the Controlled Substance Act (CSA).
What should I discuss with my healthcare provider before taking 54 375 pill?
You should not use this medicine if you are allergic to buprenorphine or naloxone (Narcan).
Tell your doctor if you have ever had:
• breathing problems, sleep apnea;
• enlarged prostate, urination problems;
• liver or kidney disease;
• abnormal curvature of the spine that affects breathing;
• problems with your gallbladder, adrenal gland, or thyroid;
• a head injury, brain tumor, or seizures; or
• alcoholism, drug addiction, mental illness.
Some medicines can interact with 54 375 pill and cause a serious condition called serotonin syndrome. Be sure your doctor knows if you also take stimulant medicine, herbal products, or medicine for depression, mental illness, Parkinson’s disease, migraine headaches, serious infections, or prevention of nausea and vomiting. Ask your doctor before making any changes in how or when you take your medications.
If you use this medicine while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on habit-forming medicine may need medical treatment for several weeks. Tell your doctor if you are pregnant.
54 375 pill can pass into breast milk and may cause drowsiness or breathing problems in the nursing baby. Tell your doctor if you are breast-feeding.
How should I take 54 375 pill?
Follow all directions on your prescription label and read all medication guides. Your doctor may occasionally change your dose. Never use 54 375 pill in larger amounts, or for longer than prescribed.
This medicine may be habit-forming. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. MISUSE OF NARCOTIC MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription. Selling or giving away 54 375 pill is against the law.
Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.
Use dry hands when handling this medicine. Place the sublingual tablet or film under your tongue. Place the buccal film against the inside of your cheek. Allow the medicine to dissolve slowly. Do not chew or swallow it whole.
If you switch between medicines containing buprenorphine, you may not use the same dose for each one. Follow all directions carefully.
Do not stop using 54 375 pill suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using this medicine.
You will need frequent blood tests to check your liver function.
All your medical care providers should know that you are being treated for opioid addiction, and that you take 54 375 pill. Make sure your family members know how to provide this information in case they need to speak for you during an emergency.
Never crush or break a 54 375 pill to inhale the powder (snort) or mix it into a liquid to inject the drug into your vein. This practice has resulted in death.
Store this medicine in the foil pouch at room temperature, away from moisture and heat. Discard an empty pouch in a place children and pets cannot get to.
Keep track of your medicine. This medicine is a drug of abuse and you should be aware if anyone is using it improperly.
Do not keep leftover opioid medication. Just one dose can cause death in someone using this medicine accidentally or improperly. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, remove any unused films from the foil pack and flush the films down the toilet. Throw the empty foil pack into the trash.
What happens if I miss a dose?
Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose can be fatal, especially in a child or other person using this medicine without a prescription.
Overdose symptoms may include extreme drowsiness, cold or clammy skin, pinpoint pupils, fainting, slow heart rate, very slow breathing, or coma.
What should I avoid while taking 54 375 pill?
Do not drink alcohol. Dangerous side effects or death could occur.
Avoid driving or operating machinery until you know how this medicine will affect you. Dizziness or severe drowsiness can cause falls, accidents, or severe injuries.
What are the possible side effects of 54 375 pill?
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Like other narcotic medicines, 54 375 pill can slow your breathing. Death may occur if breathing becomes too weak. A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.
Call your doctor at once or seek emergency medical attention if you have:
• weak or shallow breathing, breathing that stops during sleep;
• a light-headed feeling, like you might pass out;
• confusion, loss of coordination, extreme weakness;
• blurred vision, slurred speech;
• liver problems –upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• low cortisol levels –nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness; or
• opioid withdrawal symptoms –shivering, goose bumps, increased sweating, feeling hot or cold, runny nose, watery eyes, diarrhea, muscle pain.
Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.
Long-term use of opioid medication may affect fertility (ability to have children) in men or women. It is not known whether opioid effects on fertility are permanent.
Common side effects may include:
• dizziness, drowsiness, blurred vision, feeling drunk, trouble concentrating;
• withdrawal symptoms;
• tongue pain, redness or numbness inside your mouth;
• nausea, vomiting, constipation;
• headache, back pain;
• fast or pounding heartbeats, increased sweating; or
• sleep problems (insomnia).
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect 54 375 pill?
Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.
Narcotic (opioid) medication can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:
• other narcotic medications –opioid pain medicine or prescription cough medicine;
• a sedative like Valium –diazepam, alprazolam, lorazepam, Ativan, Klonopin, Restoril, Tranxene, Versed, Xanax, and others; or
• drugs that make you sleepy or slow your breathing –a sleeping pill, muscle relaxer, tranquilizer, antidepressant, or antipsychotic medicine.
This list is not complete. Other drugs may affect 54 375 pill, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.
Where can I get more information?
Your pharmacist can provide more information about 54 375 pill.