Suboxone strips : Ingredients, uses, side effects and drug test

Suboxone Strips

What are Suboxone strips?

Dependence and addiction are essential components which are to be considered in substance use. A person can show either physical dependence or psychological dependence. Suboxone is a combination medication that is used to treat and maintain opioid dependence. This formulation contains buprenorphine and naloxone. Buprenorphine is an opioid drug which is also classified as a narcotic. Naloxone is an opioid antagonist which inhibits the effects of the opioid drug.

One of the common routes for the administration of Suboxone is via strips. This is sometimes called as Suboxone film. This strip is administered to the patient sublingually in which it is positioned under the tongue and allow it to dissolve. The time for dissolving of the drug is within 1 minute. Special care is needed while administrating the strip that it should not be cut, chewed or even swallowed.  At times, the Suboxone strip can be positioned on the inside of the left or right cheek. If placed in such a place, it will dissolve in the same manner as that when it is placed under the tongue.

What are the ingredients of Suboxone strips?

Active ingredients of suboxone strips include buprenorphine and naloxone.

Excipients used are polyethylene oxide, hydroxypropyl methylcellulose, maltitol, acesulfame potassium, lime flavor, citric acid, sodium citrate, FD&C yellow #6, and white ink.

Suboxone strips’ active ingredients molecular structure, weight, IUPAC name, and drug class

Buprenorphine:

Buprenorphine is a derivative of the opioid alkaloid thebaine that is a more potent (25 – 40 times) and longer lasting analgesic than morphine. It works as a partial agonist at mu and kappa opioid receptors and as an antagonist at delta receptors. The lack of delta-agonist activity has been suggested to account for the observation that buprenorphine tolerance may not develop with chronic use.

IUPAC name: (1S,2R,6S,14R,15R,16R)-3-(cyclopropylmethyl)-16-[(2S)-2-hydroxy-3,3-dimethylbutan-2-yl]-15-methoxy-13-oxa-3-azahexacyclo[13.2.2.1²,⁸.0¹,⁶.0⁶,¹⁴.0⁷,¹²]icosa-7,9,11-trien-11-ol

Molecular formula: C29H41NO4

Molecular weight: 467.64 g/mol

Molecular structure:

Suboxone strips' active ingredients molecular structure, weight, IUPAC name, and drug class

Drug class: Buprenorphine belongs to the class of organic compounds called phenanthrenes and derivatives which are polycyclic compounds containing a phenanthrene moiety, that is a tricyclic aromatic compound with three non-linearly fused benzene.

Naloxone: Naloxone is an opioid antagonist medication used to block or reverse the effects of opioid drugs in the setting of drug overdoses which are rapidly becoming a leading cause of death worldwide. More specifically, naloxone has a high affinity for μ-opioid receptors, where it acts as an inverse agonist, causing the rapid removal of any other drugs bound to these receptors. When taken in large quantities, opioid medications such as morphine, hydromorphone, methadone, heroin, or fentanyl are capable of causing life-threatening symptoms such as respiratory depression, reduced heart rate, slurred speech, drowsiness, and constricted pupils. If untreated, this can progress to vomiting, absent pulse and breathing, loss of consciousness, and even death. Naloxone is indicated for the rapid reversal of these symptoms of central nervous system depression in opioid overdose. It’s important to note that naloxone only works on opioid receptors within the body, and is therefore not capable of reversing the effects of non-opioid medications such as stimulants like methamphetamine or cocaine, or benzodiazepines like lorazepam or diazepam.

IUPAC name: (1S,5R,13R,17S)-10,17-dihydroxy-4-(prop-2-en-1-yl)-12-oxa-4-azapentacyclo[9.6.1.0^{1,13}.0^{5,17}.0^{7,18}]octadeca-7(18),8,10-trien-14-one

Molecular formula: C19H21NO4

Molecular weight: 327.37 g/mol

Molecular structure:

How long does the blocker last in Suboxone?

Drug class: Naloxone belongs to the class of organic compounds named phenanthrenes and derivatives which are polycyclic compounds with a phenanthrene moiety, which is a tricyclic aromatic compound with three non-linearly fused benzene.

How do Suboxone strips work?

Recently, FDA has approved a new method of drug delivery system which is termed as “buccal delivery system”. This is a type of mucoadhesive system in which the drug is absorbed directly into the mucosa of the cheek. The product is made by using an adhesive that shows rapid absorption through the cheek mucosa. This delivery system of drug has demonstrated twice the bioavailability of the suboxone film in comparison to the conventional dosage form.

How do you take a Suboxone strip?
How do you take a Suboxone strip?

How do Suboxone strips exert their actions?

Buprenorphine is a drug which is a partial agonist at the mu-opioid receptor and acts as an antagonist at the kappa opioid receptor at the same time. Whereas, naloxone is a potent antagonist acting on the mu opioid receptors and generates opioid withdrawal signs and symptoms in patients who have developed physical dependence on opioids especially when they are administered parenterally. Here the primary rationale of combining naloxone with buprenorphine is to act as a deterrent to injection.

What does Suboxone strips do to you?

What is the need for Suboxone strips?

Buprenorphine has a poor absorption in the gastrointestinal region and ultimately a low bioavailability. When given in oral dosage form, less than 10% of the drug would be absorbed in the bloodstream. When prepared in sublingual form, the percentage of drug availability increases from 10% to 30%. Sometimes this can increase up to 50%. In the gastric and intestinal environment, certain other factors including pH, motility and micro flora can also decrease the bioavailability of the drug. One another reason to poorer bioavailability of drug is first pass effect. All these problems are resolved when preparing the buccal drug delivery system.

In such a formulation which has a higher bioavailability, only a small quantity of drug is used in manufacture. When small quantity of drug is needed the unit price will eventually be less.

Suboxone strips dosage

Suboxone film/ strip is administered to the patient either sublingually or buccally in a single daily dose. However, while prescribing this product, number of revisits of patients should be kept in consideration as multiple refills are not recommended in the treatment especially during the early phase. If in a case, refills are advised, appropriate patient follow up shall be done.

For every individual, the dose of the medicine is different. Any change required in dosing should not be done without the consultation of the doctor. The amount of the medicine a patient is prescribed is solely dependent on the strength of the drug. Also, the number of doses given in a single day, the time in between two doses and the duration of the therapy recommended to the patient is dependent on the severity of the problem a patient is suffering.

The following dosage information comprises only the average doses of Suboxone.

FOR BUCCAL DOSAGE FORM (FILM)

  • For induction treatment of opioid treatment
  • Adults: For patients who are dependent on heroin or any other short acting opioid may be inducted either Suboxone sublingual film or even with sublingual buprenorphine monotherapy. On the initiation of treatment, the first dose of Suboxone is administered when signs and symptoms of opioid withdrawal appears in a time period of not less than six hours after the patient last used opioid intake.

Day 1: an induction dosage of up to 8mg/2mg of Suboxone film is advised. Clinicians should start the therapy with a starting dose of 2mg/ 0.5mg or 4mg/ 1mg of buprenorphine/ naloxone. This ratio can be titrated up to 2 or 4mg escalation of buprenorphine, at an approximate time interval of 2 hours. In special cases, this can raise upto 8mg/ 2mg of buprenorphine/naloxone depending on the control of acute withdrawal symptoms.

Day 2: a single dose containing 16mg/ 4mg of Suboxone is advised.

The patients who are dependent on long acting opioid such as methadone are at a higher risk of precipated and prolonged withdrawal symptoms. In such individuals, combination products such as Suboxone, have not yet established well controlled studies. Naloxone in such a combination, even present in small quantity could further deteriorate the condition. For this rationale, buprenorphine alone is recommended.

  • Children: Use and dose must be directed by the doctor.
  • For maintaince treatment of opioid treatment
  • From Day 3, the dosage should be adjusted whether increasing or decreasing the quantities of buprenorphine/ naloxone to a level that stabilizes the patient condition and continue to lessen the withdrawal signs and symptoms. One the patient is stabilized, the maintenance dose is given within a range of 4mg/ 1mg to 24mg/ 6mg of buprenorphine/ naloxone per day. No maximum duration of maintenance therapy is suggested till now.
  • Children: Use and dose must be directed by the doctor.

What if a dose of Suboxone strips is missed?

In case when a dose is missed, the patient is advised to take as soon as he remembers it. However, if it is time for next dose, the patent should skip the missed dose and continue with the regular prescribed dosing schedule. Doubling of the dose at a single time is not recommended.

Suboxone strips dosage form and available strengths

Suboxone strip is manufactured as an orange rectangular film engraved with a white printed logo. It is available is four different dosage strengths.

  • Buprenorphine 2 mg/naloxone 0.5 mg,
  • Buprenorphine 4 mg/naloxone 1 mg,
  • Buprenorphine 8 mg/naloxone 2 mg
  • Buprenorphine 12 mg/naloxone 3 mg

Proper use of Suboxone strips

For using the buccal film, the following steps should be followed.

  • Use your tongue to wet the sides of cheeks or rinse the mouth with water.
  • Do not cut or tear the film. By using a dry hand/ finger hold the film facing upwards.
  • Carefully place the film inside the mouth on the cheek.
  • Slightly press the film against the mucosa for 5 seconds.
  • Leave the film allowing the drug to dissolve.
  • Avoid touching or moving of the film by the action of the tongue. The film should not be chewed or swallowed by the patient.
  • In cases where more than one film is advised, place the second film on the other side of mouth.
  • Until the film is completely dissolved, the patient should avoid eating or drinking anything.

For using the sublingual film, the following steps should be followed.

  • Make sure the mouth is moist. For this purpose, intake of water in sufficient quantities is recommended.
  • By using clean dry finger, carefully place the strip under the tongue and allow it to dissolve completely.
  • When 2 strips are prescribed for a single time, place the second strip on the opposite side from the first strip.
  • Do not cut, chew, swallow or move the film.

Side effects of Suboxone strips

Suboxone, even though has the ability to undo the effects of narcotics but itself can cause addiction.  Following are some of the serious side effects that are observed on the use of Suboxone sublingual film.

  • Sleepiness, dizziness and other coordination problems
  • Dependency or abuse
  • Respiratory problems: trouble breathing
  • Low blood pressure
  • Allergic reaction: rash, hives, swelling of face and peripheries and wheezing.
  • Liver problems: jaundice, dark colored urine, pale stools, decreased appetite, abdominal pain & nausea.
  • Signs of opiod withdrawal: sweating, shaking, goose bumps, diarrhea, confusion, seizures, feeling hot and cold more than normal, muscle aches.
  • Raised cerebrospinal fluid pressure
  • Raised intracholedochal pressure
  • Adrenal insufficiency

Common side effects of Suboxone strip include:

  • Headache
  • Sweating
  • Numb mouth
  • Painful tongue
  • The inside of mouth is redder than normal
  • Intoxication (drunk)
  • Lack of attention
  • Insomnia
  • Irregular heartbeats (palpitations)
  • Blurred vision
  • Backpain
  • Fainting

Contraindications for using Suboxone strips

Suboxone strip is contraindicated in patients who have a history of hypersensitivity to any of the two ingredients. Before prescribing of Suboxone strip, the healthcare provider should check for

  • Liver and kidney problems
  • Breathing or any other lung problems
  • Having enlarged prostate gland (in men)
  • Head injury or any brain problem
  • Having difficulty in urinating
  • Having a curve in spine which affects breathing
  • Any gallbladder problems
  • Any adrenal gland problems
  • Addison’s disease
  • Hypothyroidism

Suboxone strips use during pregnancy and breastfeeding

Those women who are pregnant or planning to start a family soon should discuss it with their healthcare provider. Studies haven’t yet established the effect of Suboxone on the unborn baby but chances are that the baby may develop symptoms of withdrawal at the time of birth as this drug belongs to Pregnancy Category C.

In case of breast feeding mothers who are using sSuboxone it should be bought in their knowledge that the drug can pass through mother’s milk to the baby and cause harm. It is suggested to avoid breast feeding while Suboxone therapy is in process. In cases where this is not possible, it should be discussed with the doctor for finding out the best alternate way to breast feed the baby.

Suboxone strips use in geriatrics

Dose selection in geriatric patients should be done vigilantly. The treatment is usually started at the lowest effect dose of the medicine. This imitates the greater frequency of diminished hepatic, renal or cardiac function and also of concomitant disease or other drug therapy.

Pharmacokinetics of Suboxone strips

  • Absorption: A combination of one 8mg/ 2mg and two 2mg/ 0.5mg Suboxone strips sublingually administered shows comparable relative bioavailability to the same total dose of Suboxone sublingual tablets while buccally administered strips have demonstrated higher relative bioavailability.
  • Distribution: Buprenorphine is 96% protein bound whereas Naloxone is more or less 45% protein bound.
  • Elimination: when the strip is given sublingually or buccally, elimination half life of buprenorphine ranges between 24 to 42 hours and naloxone’s half life is between 2 to 12 hours.
  • Metabolism: Buprenorphine undergoes N-dealkylation and glucuronidation. Norbuprenorphine is the major metabolite obtained in glucuronidation pathway. Naloxone undergoes glucuronidation to form naloxone-3-glucoronide.

What drugs can interact with Suboxone strips?

Although Suboxone have established safety and efficacy profiles over time but certain drugs when used together with Suboxone have caused clinically significant interactions. Some of the most major drug interaction that have occurred with the concomitant use of Suboxone are as below.

Benzodiazepines and other CNS depressants

  • Clinical Effect: due to additive effect, the simultaneous use of BZD or other CNS depressants have lead to an increased risk of respiratory depression, sedation and in severe cases coma and eventually death.
  • Intervention: stopping of BZD or any other anti depressants. However, in some cases, observing in a higher level of care for taper may be correct. While in other patients, gradually decreasing the dose of prescribed BZD or any other anti-depressant to the lowest effective dose may be appropriate.
  • Examples: Alcohol, barbiturates, anxiolytics, tranquilizers, general anesthestics and muscle relaxants.

Inhibitiors of CYP3A4

  • Clinical Effect: due to the concomitant use of suboxone and inhibitors of CY3A4, the plasma concentration of buprenorphine increases as a result of which drug stays in blood for longer time prolonging the effects of buprenorphine. This happens particularly when an inhibitor is added to a dose on which the patient stabilized. However, when the administration of the inhibitor of CYP3A4 is ceased, the plasma concentration of of buprenorphine also decreases. This results in decreased opioid efficacy or can even result in the development of withdrawal symptoms in patients who have become physically dependent on the drug.
  • Intervention: If both the drugs are important to use at the same time then consideration should be given to reducing the dose of Suboxone strip until stable drug effects are observed. Constant monitoring of such patients should be done in order to check for respiratory depression and sedation at frequent intervals.
  • Examples: Macrolide Antibiotics, protease inhibitors, azole-antifungal agents.

Diuretics

  • Clinical Effect: The simultaneous use of these drugs can diminish the efficacy of diuretics by inducing the release of antidiuretic hormone.
  • Interventions: Regular monitoring of patients for signs of diminished diuresis and also changes occurring in blood pressure.

Serotogenic agents

  • Clinical Effect: The concomitant use of these drugs has resulted in serotonin syndrome.
  • Interventions: careful observation of the patient is required especially during the initiation phase of therapy. Impede Suboxone if serotonin syndrome is suspected.
  • Examples: SSRIs, SNRIs, TCAs

Suboxone strips overdosage

Clinical Presentation:

the patient is presented with pinpoint pupils, sedation, hypotension, respiratory depression and in most severe cases death occurs.

Treatment:

When overdosage occurs, respiratory and cardiac status of the patient should be examined cautiously. In such a condition, primary consideration shall be given to the re-establishment of adequate and sufficient respiratory exchange by providing a clear airway and introducing an assisted or controlled ventilation. Oxygen, IV fluids, vasopressors and other supportive actions shall be taken immediately. Naloxone acts as an antagonist to buprenorphine. Higher than normal doses and repeated administration may be required to overcome the overdosage.

Suboxone strips abuse and dependence

  • Controlled Substance

Buprenorphine is a drug mentioned in Schedule III narcotic under the Controlled Substance Act. Under another Drug Addiction Treatment Act, the prescription use of this product is only limited to physicians and no other healthcare providers who meet certain qualifying requirements.

  • Abuse

Buprenorphine like other opioids have the potential for being abused and is subject to criminal pastime. Abuse of the product increases the risk of overdosage which will ultimately cause death of the user.

  • Dependence

Prolong use of Suboxone strip has produced physical dependence which is distinguished by moderate withdrawal symptoms occurring on sudden discontinuation or rapidly decreasing the dose of the drug from a high strength to a lower strength.

What precautionary measure should be taken during Suboxone strips use?

Before going under any kind of surgery (even dental surgery) or procedure required in emergency treatment, the patient should inform the doctor or any healthcare provider in charge that he is using Suboxone strips.

After the initiation of the therapy with Suboxone strips the patient might feel dizziness, lightheadedness, or even faint when he suddenly gets up from lying or sitting position. It is better to get up slowly and while standing up hold on to something as a support.

Excessive use of Suboxone strips has demonstrated infertility in both men and women. It is thus necessary to take the prescribed amount for prescribed duration of time. At the same time, sudden discontinuation of Suboxone will cause the patient to suffer from opioid withdrawal symptoms.

Suboxone strips storage conditions

Suboxone strip should be stored in a safe place, away from the reach of children.

It should be stored at a room temperature at 25°C.

Disposal of unused strips

When the Suboxone strips are no longer needed, disposal of all unopened film/ strips is necessary. This can be done by:

  • Remove the strip from its foil pouch.
  • Drop only the strip into the toilet.
  • Repeat these 2 steps for each strip.
  • Flush the toilet after all the strips have been put into the toilet.

It is to keep in mind, that only the strips are flushed and not the foil pouches or cartons.

How long do Suboxone strips stay in your system?

To find out how long the drug is likely to stay in the system after the last dose is taken, it is necessary to consider Suboxone’s elimination half-life, or more specifically, the half-lives of its active ingredients buprenorphine and naloxone.  The elimiantion half-life of buprenorphine is an calculate to be 37 hours, which is considered extremely long compared to naloxone which is eportedly between 30 minutes and 1 hour 21 minutes. Thus it will take your body nearly 2 full days to excrete just half of the buprenorphine within a Suboxone dose.  Considering the 37 hour half-life of buprenorphine, it could be estimated to be fully cleared from your system in about 9 days.

This means that the naloxone component of Suboxone strips is cleared from the body well before buprenorphine.  Most people will excrete naloxone within 8 hours post-ingestion as a result of its extremely short elimination half-life.  It is important to note that although the elimination half-life of buprenorphine is around 37 hours, it is metabolized into “norbuprenorphine” which has a half-life that exceeds 37 hours.

Though the specific half-life of the metabolite “norbuprenorphine” hasn’t been scientifically elucidated, it is likely to remain in the body for longer than 9 days.  This means that Suboxone metabolites may remain in your system for potentially up to 2 weeks after your last dose.

Suboxone strips and patient counseling information

Following instructions shall be made available to every patient each time Suboxone strip is dispensed.

  • The strip must be administered as whole. It should not be cut, torn apart or even chewed or swallowed by the patient.
  • Advise patients that Suboxone contains opioid that can be a target for people who abuse prescription medication or street drugs. It is important to protect such drugs from theft.
  • It is important to keep Suboxone strips away from children as it may cause respiratory depression that can result in death.
  • Advise the patient to not to handover the Suboxone film to anyone even if that person is suffering same signs and symptoms. It may cause harm and death of that person.
  • Warn the patient that selling of the film is against the law.
  • Inform the patient to take the Suboxone strip once daily.
  • Advise the patient that the Suboxone strip may produce orthostatic hypotension in ambulatory patients.
  • Inform the patient that prolonged use of Suboxone had decreased fertility and it is still unknown whether the effects are reversible or not.
  • Suggest the patient to avoid taking any other drug whether its over the counter drug or prescription drug or even any herbal supplements.
  • Direct the patient to inform their closest family member or friend that in case of any emergency they should inform the healthcare provider that the patient is physically dependent on an opioid and is currently using Suboxone strip.

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About Miljan Krcobic 355 Articles
Miljan Krčobić. has bachelor degree in Pharmacy.