Buprenorphine/naloxone

Medically reviewed by Drugs.com. Last updated on Jan 13, 2022.

Commonly used brand name(s)

In the U.S.

Cassipa
Suboxone
Zubsolv

Available Dosage Forms:

Tablet
Film

Therapeutic Class: Opioid Dependency

Pharmacologic Class: Opioid Agonist/Antagonist

Chemical Class: Opioid

Uses for buprenorphine/naloxone

Buprenorphine and naloxone sublingual tablet is used to treat opioid (narcotic) dependence or addiction. Buprenorphine and naloxone buccal film, sublingual film, or sublingual tablet is used for induction and maintenance treatment of opioid (narcotic) dependence. It should be used in patients who have already been treated with buprenorphine sublingual tablets.

When a narcotic medicine is used for a long time, it may become habit-forming, causing mental or physical dependence. Physical dependence may lead to withdrawal side effects if the narcotic is stopped suddenly. Severe withdrawal side effects can usually be prevented when a person is switched to buprenorphine and naloxone combination. It acts on the central nervous system (CNS) to help prevent the withdrawal side effects.

Buprenorphine/naloxone is available only with your doctor's prescription.

Before using buprenorphine/naloxone

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For buprenorphine/naloxone, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to buprenorphine/naloxone or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of buprenorphine and naloxone buccal film, sublingual film, or sublingual tablet in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of buprenorphine and naloxone combination in the elderly. However, elderly patients are more likely to have age-related kidney, liver, heart, or lung problems, which may require caution and an adjustment in the dose for patients receiving buprenorphine and naloxone combination.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking buprenorphine/naloxone, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using buprenorphine/naloxone with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Bepridil
Cisapride
Dronedarone
Fluconazole
Ketoconazole
Levoketoconazole
Mesoridazine
Nalmefene
Naltrexone
Pimozide
Piperaquine
Posaconazole
Safinamide
Samidorphan
Saquinavir
Sparfloxacin
Terfenadine

Using buprenorphine/naloxone with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acecainide
Acepromazine
Alfentanil
Alfuzosin
Almotriptan
Alprazolam
Amineptine
Amiodarone
Amisulpride
Amitriptyline
Amitriptylinoxide
Amobarbital
Amoxapine
Amphetamine
Amprenavir
Anagrelide
Anileridine
Apomorphine
Aprepitant
Aripiprazole
Aripiprazole Lauroxil
Armodafinil
Arsenic Trioxide
Asenapine
Astemizole
Atazanavir
Azithromycin
Baclofen
Bedaquiline
Benperidol
Benzhydrocodone
Benzphetamine
Boceprevir
Bosentan
Bromazepam
Bromopride
Brompheniramine
Bupropion
Buserelin
Buspirone
Butabarbital
Butorphanol
Calcium Oxybate
Cannabidiol
Carbamazepine
Carbinoxamine
Cariprazine
Carisoprodol
Carphenazine
Ceritinib
Cetirizine
Chloral Hydrate
Chlordiazepoxide
Chloroquine
Chlorpheniramine
Chlorpromazine
Chlorzoxazone
Ciprofloxacin
Citalopram
Clarithromycin
Clobazam
Clofazimine
Clomipramine
Clonazepam
Clopidogrel
Clorazepate
Clozapine
Cobicistat
Cocaine
Codeine
Conivaptan
Crizotinib
Cyclobenzaprine
Cyclosporine
Dabrafenib
Dantrolene
Daridorexant
Darunavir
Dasatinib
Degarelix
Delamanid
Delavirdine
Desipramine
Deslorelin
Desmopressin
Desvenlafaxine
Deutetrabenazine
Dexamethasone
Dexmedetomidine
Dextroamphetamine
Dextromethorphan
Dezocine
Diacetylmorphine
Diazepam
Dibenzepin
Dichloralphenazone
Difenoxin
Diltiazem
Diphenhydramine
Diphenoxylate
Disopyramide
Dofetilide
Dolasetron
Domperidone
Donepezil
Doxepin
Doxylamine
Droperidol
Duloxetine
Ebastine
Efavirenz
Eletriptan
Encorafenib
Enflurane
Entrectinib
Enzalutamide
Eribulin
Erythromycin
Escitalopram
Esketamine
Eslicarbazepine Acetate
Estazolam
Eszopiclone
Ethchlorvynol
Ethopropazine
Ethylmorphine
Etravirine
Famotidine
Felbamate
Fenfluramine
Fentanyl
Fexinidazole
Fingolimod
Flecainide
Flibanserin
Flunitrazepam
Fluoxetine
Fluphenazine
Flurazepam
Fluspirilene
Fluvoxamine
Formoterol
Fosamprenavir
Fosaprepitant
Foscarnet
Fosphenytoin
Fospropofol
Fostemsavir
Frovatriptan
Furazolidone
Gabapentin
Gabapentin Enacarbil
Galantamine
Gatifloxacin
Gemifloxacin
Glasdegib
Gonadorelin
Goserelin
Granisetron
Halazepam
Halofantrine
Haloperidol
Halothane
Hexobarbital
Histrelin
Hydrocodone
Hydromorphone
Hydroquinidine
Hydroxychloroquine
Hydroxytryptophan
Hydroxyzine
Ibutilide
Idelalisib
Iloperidone
Imatinib
Imipramine
Indinavir
Inotuzumab Ozogamicin
Iproniazid
Isocarboxazid
Isoflurane
Itraconazole
Ivabradine
Ivacaftor
Ivosidenib
Ketamine
Ketazolam
Ketobemidone
Lapatinib
Lasmiditan
Lefamulin
Lemborexant
Lenvatinib
Leuprolide
Levocetirizine
Levofloxacin
Levomilnacipran
Levorphanol
Linezolid
Lisdexamfetamine
Lithium
Lofepramine
Lofexidine
Lomitapide
Lopinavir
Lorazepam
Lorcaserin
Loxapine
Lumacaftor
Lumefantrine
Lurasidone
Macimorelin
Magnesium Oxybate
Meclizine
Mefloquine
Melitracen
Melperone
Meperidine
Mephobarbital
Meprobamate
Meptazinol
Metaxalone
Methadone
Methamphetamine
Methdilazine
Methocarbamol
Methohexital
Methotrimeprazine
Methylene Blue
Metoclopramide
Metronidazole
Mibefradil
Midazolam
Mifepristone
Milnacipran
Mirtazapine
Mitotane
Mizolastine
Mobocertinib
Moclobemide
Modafinil
Molindone
Moricizine
Morphine
Morphine Sulfate Liposome
Moxifloxacin
Nafarelin
Nafcillin
Nalbuphine
Naldemedine
Naloxegol
Naratriptan
Nefazodone
Nelfinavir
Nevirapine
Nialamide
Nicomorphine
Nilotinib
Nitrazepam
Nitrous Oxide
Norfloxacin
Nortriptyline
Octreotide
Ofloxacin
Olanzapine
Ondansetron
Opipramol
Opium
Opium Alkaloids
Orphenadrine
Osilodrostat
Osimertinib
Oxaliplatin
Oxazepam
Oxcarbazepine
Oxycodone
Oxymorphone
Ozanimod
Pacritinib
Palbociclib
Paliperidone
Palonosetron
Panobinostat
Papaveretum
Paregoric
Paroxetine
Pasireotide
Pazopanib
Pentamidine
Pentazocine
Pentobarbital
Perampanel
Perazine
Periciazine
Perphenazine
Phenelzine
Phenobarbital
Phenytoin
Pimavanserin
Pipamperone
Piperacetazine
Pipotiazine
Piritramide
Pitolisant
Ponesimod
Potassium Oxybate
Prazepam
Prednisone
Pregabalin
Primidone
Probucol
Procainamide
Procarbazine
Prochlorperazine
Promazine
Promethazine
Propafenone
Propofol
Protriptyline
Quazepam
Quetiapine
Quinidine
Quinine
Ramelteon
Ranitidine
Ranolazine
Rasagiline
Remifentanil
Remimazolam
Remoxipride
Ribociclib
Rifabutin
Rifampin
Rifapentine
Risperidone
Ritonavir
Rizatriptan
Ropeginterferon Alfa-2b-njft
Scopolamine
Secobarbital
Selegiline
Selpercatinib
Sertindole
Sertraline
Sevoflurane
Sibutramine
Siponimod
Sodium Oxybate
Sodium Phosphate
Sodium Phosphate, Dibasic
Sodium Phosphate, Monobasic
Solifenacin
Sorafenib
Sotalol
St John's Wort
Sufentanil
Sulpiride
Sultopride
Sumatriptan
Sunitinib
Suvorexant
Tacrolimus
Tamoxifen
Tapentadol
Telaprevir
Telavancin
Telithromycin
Temazepam
Tetrabenazine
Thiethylperazine
Thiopental
Thiopropazate
Thioridazine
Thiothixene
Tianeptine
Tilidine
Tizanidine
Tolonium Chloride
Tolterodine
Topiramate
Toremifene
Tramadol
Tranylcypromine
Trazodone
Triazolam
Triclabendazole
Trifluoperazine
Trifluperidol
Triflupromazine
Trimeprazine
Trimipramine
Triptorelin
Tryptophan
Vandetanib
Vardenafil
Vemurafenib
Venlafaxine
Verapamil
Vilanterol
Vilazodone
Vinflunine
Voclosporin
Voriconazole
Vorinostat
Vortioxetine
Zaleplon
Ziprasidone
Zolpidem
Zopiclone
Zotepine
Zuclopenthixol

Using buprenorphine/naloxone with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Clonidine
Yohimbine

Interactions with food/tobacco/alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using buprenorphine/naloxone with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use buprenorphine/naloxone, or give you special instructions about the use of food, alcohol, or tobacco.

Ethanol

Proper use of buprenorphine/naloxone

Take buprenorphine/naloxone exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

Buprenorphine/naloxone should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

If you are using the buccal film:

Use your tongue to wet the side of your cheek or rinse your mouth with water in the area where you will place the film.
Do not cut or tear the film. Hold the film on a clean, dry finger. If you are using Bunavail®, hold with the text (BN2, BN4, or BN6) facing up.
Place the side of the film against the inside of your cheek. If you are using Bunavail®, place with the text (BN2, BN4, or BN6) against the inside of your cheek.
Press the film and hold it there for 5 seconds.
Leave the film in place until it dissolves. Do not touch, move, chew, or swallow it.
If you must use more than one film, place the second film on the other side of your mouth. Do not place more than 2 buccal films to the inside of one cheek at a time.
Do not eat or drink anything until the film is completely dissolved.

If you are using the sublingual tablet:

Do not cut, crush, chew, or swallow it.
Place the tablet under the tongue until it is dissolved.
If you take 2 or more tablets at a time, place all of the tablets in different places under the tongue at the same time.
If this is uncomfortable, place 2 tablets at a time under the tongue and repeat the process until all the tablets have been taken.
Do not eat or drink anything until the tablets are completely dissolved.

If you are using the sublingual film:

Drink water before taking buprenorphine/naloxone to help moisten your mouth.
Place the film under the tongue until it is dissolved.
If you need to take an additional film, place the new film on the opposite side from the first film.
Do not eat or drink anything until the film is completely dissolved.
Do not cut, chew, swallow, or move the film after placing it under the tongue.

Check with your doctor first before changing dosage forms (eg, films, tablets) or dosage strengths. These forms are very different from each other.

Dosing

The dose of buprenorphine/naloxone will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of buprenorphine/naloxone. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For buccal dosage form (film):
- For induction treatment of opioid dependence:
  - Adults—On Day 1, your doctor may give you an induction dosage up to 4.2 milligrams (mg) of buprenorphine and 0.7 mg of naloxone in divided doses. On Day 2, your doctor may give you up to 8.4 mg of buprenorphine and 1.4 mg of naloxone taken as a single dose. If you have been taking methadone, heroin, short-acting, or long-acting opioid medicines, your doctor may recommend you to take buprenorphine alone.
  - Children—Use and dose must be determined by your doctor.
- For maintenance treatment of opioid dependence:
  - Adults—8.4 milligrams (mg) of buprenorphine and 1.4 mg of naloxone taken as a single dose once a day. Your doctor may adjust your dose as needed.
  - Children—Use and dose must be determined by your doctor.
For buccal or sublingual dosage form (film):
- For induction treatment of opioid dependence:
  - Adults—On Day 1, your doctor may give you an induction dosage up to 8 milligrams (mg) of buprenorphine and 2 mg of naloxone in divided doses. On Day 2, your doctor may give you up to 16 mg of buprenorphine and 4 mg of naloxone taken as a single dose. If you have been taking methadone, heroin, short-acting, or long-acting opioid medicines, your doctor may recommend you to take buprenorphine alone.
  - Children—Use and dose must be determined by your doctor.
- For maintenance treatment of opioid dependence:
  - Adults—16 milligrams (mg) of buprenorphine and 4 mg of naloxone taken as a single dose once a day. Your doctor may adjust your dose as needed.
  - Children—Use and dose must be determined by your doctor.
For sublingual dosage form (tablets):
- For induction treatment of opioid dependence:
  - Adults—On Day 1, your doctor may give you an induction dosage up to 5.7 milligrams (mg) of buprenorphine and 1.4 mg of naloxone in divided doses. On Day 2, your doctor may give you up to 11.4 mg of buprenorphine and 2.9 mg of naloxone taken as a single dose. If you have been taking methadone, heroin, short-acting or long-acting opioid medicines, your doctor may recommend you take buprenorphine alone.
  - Children—Use and dose must be determined by your doctor.
- For maintenance treatment of opioid dependence:
  - Suboxone®:
    - Adults—16 milligrams (mg) of buprenorphine and 4 mg of naloxone taken as a single dose once a day. Your doctor may adjust your dose as needed.
    - Children—Use and dose must be determined by your doctor.
  - Zubsolv®:
    - Adults—11.4 milligrams (mg) of buprenorphine and 2.9 mg of naloxone taken as a single dose once a day. Your doctor may adjust your dose as needed.
    - Children—Use and dose must be determined by your doctor.

Missed dose

If you miss a dose of buprenorphine/naloxone, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Drop off any unused narcotic medicine at a drug take-back location right away. If you do not have a drug take-back location near you, flush any unused narcotic medicine down the toilet. Check your local drug store and clinics for take-back locations. You can also check the DEA web site for locations. Here is the link to the FDA safe disposal of medicines website: www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/ensuringsafeuseofmedicine/safedisposalofmedicines/ucm186187.htm

Precautions while using buprenorphine/naloxone

It is very important that your doctor check your progress while you are using buprenorphine/naloxone. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood tests may be needed to check for unwanted effects.

Do not use buprenorphine/naloxone if you have used an MAO inhibitor (MAOI) (eg, isocarboxazid [Marplan®], linezolid [Zyvox®], phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®]) within the past 14 days.

It is against the law and dangerous for anyone else to use your medicine. Keep your unused films or tablets in a safe and secure place. People who are addicted to drugs might want to steal buprenorphine/naloxone.

Buprenorphine/naloxone may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.

Using too much of buprenorphine/naloxone may cause an overdose, which can be life-threatening. Symptoms of an overdose include: blurred vision, confusion, difficult or trouble breathing, dizziness, faintness, or lightheadedness when getting up suddenly from a lying position or sitting position, irregular, fast or slow, or shallow breathing, pale or blue lips, fingernails, or skin, pinpoint pupils, sleepiness, sweating, unusual tiredness or weakness. In case of an overdose, call your doctor right away. Your doctor may also give naloxone to treat an overdose.

Buprenorphine/naloxone may cause sleep-related breathing problems (eg, sleep apnea, sleep-related hypoxemia). Your doctor may decrease your dose if you have sleep apnea (stop breathing for short periods during sleep) while using buprenorphine/naloxone.

Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are using buprenorphine/naloxone. Serious unwanted effects can occur if certain medicines are given together with buprenorphine and naloxone combination.

Buprenorphine/naloxone will add to the effects of alcohol and other CNS depressants. CNS depressants are medicines that slow down the nervous system, which may cause drowsiness or make you less alert. Some examples of CNS depressants are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicine, other prescription pain medicine or narcotics, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. This effect may last for a few days after you stop using buprenorphine/naloxone. Check with your doctor before taking any of the medicines listed above while you are using buprenorphine/naloxone.

Dizziness, lightheadedness, or fainting may occur when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen this problem. Also, lying down for a while may relieve the dizziness or lightheadedness.

Buprenorphine/naloxone may make you dizzy, drowsy, or lightheaded. Do not drive or do anything else that could be dangerous until you know how buprenorphine/naloxone affects you.

Using buprenorphine/naloxone while you are pregnant may cause neonatal opioid withdrawal syndrome in your newborn baby. Tell your doctor right away if your baby has an abnormal sleep pattern, diarrhea, a high-pitched cry, irritability, shakiness or tremors, weight loss, vomiting, or fails to gain weight.

Buprenorphine/naloxone may cause adrenal insufficiency. Check with your doctor right away if you have darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or vomiting.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Buprenorphine/naloxone may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, hives, itching, hoarseness, trouble with breathing or swallowing, or any swelling of your hands, face, or mouth while you are using buprenorphine/naloxone.

Do not suddenly stop using it without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help reduce the possibility of withdrawal symptoms, including anxiety, fever, nausea, runny nose, stomach cramps, sweating, tremors, or trouble with sleeping.

Check with your doctor right away if you have anxiety, restlessness, a fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or see or hear things that are not there. These may be symptoms of a serious condition called serotonin syndrome. Your risk may be higher if you also take certain other medicines that affect serotonin levels in your body.

Using too much of buprenorphine/naloxone may cause infertility (unable to have children). Talk with your doctor before using buprenorphine/naloxone if you plan to have children.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Buprenorphine/naloxone side effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Chills
cough
feeling faint, dizzy, or lightheaded
feeling of warmth or heat
fever
flushing or redness of the skin, especially on the face and neck
headache
hoarseness
lower back or side pain
painful or difficult urination
sweating

Incidence not known

Agitation
bloating or swelling of the face, arms, hands, lower legs, or feet
chest tightness
darkening of the skin
diarrhea
difficulty swallowing
dizziness
fainting
fast heartbeat
hives, itching, skin rash
loss of appetite
mental depression
nausea
overactive reflexes
poor coordination
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
rapid weight gain
restlessness shivering talking or acting with excitement you cannot control
tingling of the hands or feet
trembling or shaking twitching
unusual weight gain or loss
vomiting

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Blurred vision
confusion
difficult or trouble breathing
dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
drowsiness
irregular, fast, slow, or shallow breathing
pale or blue lips, fingernails, or skin
pinpoint pupils
relaxed and calm feeling
sleepiness
unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Difficulty having a bowel movement
lack or loss of strength
stomach pain
trouble sleeping

Less common

Back pain
diarrhea
runny or stuffy nose
sneezing

Incidence not known

Burning or sore mouth
burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings inside the mouth
decline or loss of libido or sexual desire
irritability
mood swings
poor concentration
redness, swelling, or soreness of the tongue
reduced muscle strength
swelling, inflammation, or redness of the mouth

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Frequently asked questions

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More about buprenorphine / naloxone

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

Drug Status

Availability Prescription only Rx

Pregnancy & Lactation Risk data available

CSA Schedule* Moderate abuse potential 3

Approval History Drug history at FDA

WADA Class Anti-Doping Classification

User Reviews & Ratings

7.8 / 10

1048 Reviews

Images

Pill 54 375 is Buprenorphine Hydrochloride and Naloxone Hydrochloride (Sublingual) 8 mg (base) / 2 mg (base)

Buprenorphine / naloxone systemic 8 mg (base) / 2 mg (base) (54 375)