Patient information on Suboxone (buprenorphine and naloxone)

 

 Here the word Drug would be referred to a narcotic substance.

Manufacturing company: Indivior Inc.

Uses of Suboxone: it is used for treating the patients who are addicted to opioids (morphine, heroin) or abuse such drugs. This medicine is a part of the treatment of opioid dependence along with behavioral and psychological education and counseling. If you have an addiction problem it does not mean that you are a wrong or a bad person but it is important to understand that it is okay to talk about it to your family, and seek proper clinical help as there are now various treatments available in this respect.   

You should be aware of the adverse effects of a drug addiction. It leads to the development of violent behavior, theft, physical, psychological problems, illegal activities, various health problems, transmission of diseases due to the use of contaminated syringes and needles, family and work-related complications, accidents, overdosing and death. Suboxone is indicated for people who have become addicted to heroin, morphine, codeine, oxycodone, and fentanyl.

Factors or conditions that usually play role in a person becoming addicted to illegitimate drugs involve;

Stress which could be either family or work related, community where drugs are sold and abused, joblessness, people who have a rough childhood and have an abusive child life, whose parents or siblings or spouse abuses drugs, self-diagnosis and self-medication with drugs that can have effects on mental health, people with an underlying mental or a psychological illness, deficit in neurotransmitters in brain e.g. endorphin.

Dosing of Suboxone: it should be taken into account that this medicine can only be prescribed by those doctors who are registered under DATA (drug addiction treatment act) and Suboxone will be prescribed to you by taking into account various clinical and behavioral factors. You should only take Suboxone in quantities as guided by your doctor and should never taper the dose by yourself.

 

The regimen is usually altered and adjusted by monitoring;

  • the event that the patient has been securely and proficiently taking care of the medicinal use
  • Has not experienced any sort of adverse effects concerning physical and mental health
  • Has not been overdosing or abusing the medicine
  • Has undergone improvements.
  • Has been following the treatment properly and regularly as instructed.

Correct administration:

  • Always put the whole intact in the mouth. Do not chew or swallow it.
  • Do not eat anything while you have placed Suboxone in the mouth, for the prevention of an accidental swallow.
  • Buccal administration: place the tablet inside the cheek on either side. If more than one tablet is to be placed, place one tablet in the right cheek and another tablet in the left cheek. Do not move the tablets from their place after placing them inside. Let them stay until completely dissolved.
  • Sub-lingual administration: place one film on either right or left side under the tongue until dissolved. If you need to place another film along with it for adequate dosing (prescribed by the doctor) put it on the opposite side under the tongue, ensuring that they do not touch or join each other.
  • If you are supposed to place a 3rd tablet or film, administer it after one side has dissolved.
  • You can easily switch from sub-lingual to the buccal site of administration without risking the fluctuation in the dosage levels.
  • But do not switch strengths and potency of the product without consulting your respective doctor as the concentrations of the agents can vary and lead to unwanted effects.

Suboxone in special populations:

  • In pregnancy: it falls under the category C. It should only be used under the supervision and recommendations of the specified doctor.
  • During lactation: buprenorphine gets excreted in human milk and so should be used if the benefits of taking the medicine are more than its risks. Monitor your baby for increased lethargy, or any breathing problems.
  • In children: it should not be used by young kids due to the danger of respiratory failure.
  • In older people: although considered safe should be started at lowest doses possible.
  • In liver failure: Suboxone can cause hepatitis, jaundice, damage to the liver cells (necrosis), which leads to lesser clearance and enhanced exposure of Naloxone. As it is a combination dosage form and the dose of a single agent can’t be adjusted alone, hence, Suboxone should be avoided in patients having a moderate-severe liver failure.
  • In unstable patients: people who do not respond to the medication or start abusing it are transferred to the rehabilitation centers.

Contra-indications to Suboxone use:

  • Promptly contact restorative help if on taking Suboxone you face breathing challenges, swelling, rash, blushed skin, hives as it is the indications of a hypersensitive response to the medication.
  • Do not give Suboxone to children as it is could produce fatal breathing issues in them. Always make sure the medicine is placed in a secure place away from the child’s reach.
  • Suboxone is not for pain relieving use specifically in people who are opioid naïve i.e. have not used any kind of opioid preparation in the past.

Precautions and Warnings related to Suboxone:

  • You should always take Suboxone as described by your doctor. Taking it in increased amounts can lead to addiction as well. You will be kept under supervision during the initiation of the treatment. You should talk to your doctor if you start experiencing addictive behavior towards Suboxone which may include joyousness and euphoria, the presence of many multiple Suboxone packages in the house, decreased desire for other opiates (heroin, morphine etc.), need for regular refills of Suboxone, distracted and unusual behavior.
  • You should not self-inject CNS depressants such as benzodiazepines, anesthetics, or consume alcohol, tranquilizers with Suboxone as it could result in severe respiratory collapse, nervous system shut down, coma and even death.
  • You should never discontinue Suboxone on your own as an abrupt stoppage of the medication can cause severe withdrawal symptoms such as nausea, vomiting, weariness, aggression, muscle pain, sleeplessness, restlessness, nervousness, and headache.
  • It should be given with extreme care if the patient has stomach issues and disorders, if alcoholic, has bile malfunction, cranial injuries, breathing problems.
  • Do not drive after taking Suboxone. Prevent doing heavy machine work as well.
  • Neonatal opioid withdrawal syndrome (NOWS): babies who are born to women who abuse opioids suffer from NOWS which includes severe diarrhea, non-stop crying, convulsions, sleep disturbances, tremors, sneezing, fever, and increased tone of muscle.

Adverse effects:

Suboxone can cause the following side effects;

Withdrawal symptoms, weakness, diarrhea, chills, vomiting, nausea, edema, swelling, respiration problems, pain, insomnia, constipation, excessive sweating, cough, headache, infections, abdominal aches, inflammation of the tongue, oral cavities.

Drug interactions:

  • With benzodiazepines: use of Suboxone with such agents leads to shut down of the respiratory systems.
  • With anti-retroviral: decreased dose of buprenorphine is used with Protease inhibitors like ritonavir and atazanavir. No adjustments are required with Nucleoside reverse transcriptase inhibitors. Non‐nucleoside reverse transcriptase inhibitors such as delavirdine, nevirapine, efavirenz, etravirine can increase or decrease the Suboxone levels in plasma.
  • With CYP3A4 affecting agents: Suboxone should be used carefully with medicines that can induce or inhibit these enzymes as the inhibition could lead to increased levels of Suboxone and increased sedation whereas the induction can lead to low levels and sub-therapeutic effects. You can contact your pharmacist to know which drugs come under this category.

Mode of action:

Naloxone: it is a strong antagonist at mu opioid receptors

Buprenorphine: it is a partial agonist and partial antagonist of mu, delta receptors and kappa opioid receptors respectively.

Mu receptors when activated can cause relief in pain, low blood pressure, itching, euphoria, sedation, nausea, constipation, reduced respiration, and constricted pupils.

Delta receptors cause physical dependence, intense happiness, and convulsions.

Kappa produces depression, dysphoria (extreme sadness), lethargy, stress, constriction of the pupils.

Absorption: Suboxone undergoes full absorption after 0.77-0.81 hours for naloxone and 1.53-1.72 hours for buprenorphine.

Distribution: naloxone binds to the albumin whereas buprenorphine binds to alpha and beta globulin proteins of the plasma.

Metabolism: naloxone undergoes metabolism through glucuronidation whereas buprenorphine is subjected to CYP3A4 enzymes.

Excretion: it gets removed from the body through feces and urine.

Storage: store it at room temperature at a place where children can’t reach the product.

Ingredients: buprenorphine and naloxone, sodium citrate, lime flavor, Sunset Yellow FCF and a white printing ink, hypromellose, acesulfame potassium, citric acid, polyethylene oxide, and maltitol solution.

Toxicity:

  • It did not produce any changes in the genetic makeup of the animals during pre-clinical studies.
  • Suboxone decreased the rate of pregnancy in female rats.
  • It also up the levels and rates of adenomas in rats.

 Inform your doctor:

Before starting treatment with Suboxone, inform your doctor of the following;

  • Time length of your addiction
  • How and when you got addicted
  • If you abuse any other drugs apart from opioids
  • If you suffer from psychological disorders
  • About respiratory problems if any
  • If has a liver disease
  • If pregnant or
  • Breast-feeding

 

 

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