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Suboxone
Overview
What is Suboxone?
SUBOXONE sublingual tablets contain buprenorphine HCl and
naloxone HCl dihydrate at a ratio of 4:1 buprenorphine: naloxone (ratio of free
bases).
SUBUTEX sublingual tablets contain buprenorphine HCl.
Buprenorphine is a partial agonist at the mu-opioid receptor and an
antagonist at the kappa-opioid receptor. Naloxone is an antagonist at the
mu-opioid receptor.
Buprenorphine is a Schedule III narcotic under the Controlled Substances
Act.
Buprenorphine hydrochloride is a white powder, weakly acidic with limited
solubility in water (17mg/mL). Chemically, buprenorphine is
17-(cyclopropylmethyl)-α-(1,1-dimethylethyl)-4,5-epoxy-18,19-dihydro-3-hydroxy-6-methoxy-
α-methyl-6,14-ethenomorphinan-7-methanol, hydrochloride [5α, 7α(S)]-.
Buprenorphine hydrochloride has the molecular formula C
HN0 HCl and the molecular
weight is 504.10.
STRUCTURAL FORMULA OF BUPRENORPHINE
Naloxone hydrochloride is a white to slightly off-white powder and is soluble
in water, in dilute acids and in strong alkali. Chemically, naloxone is
17-Allyl-4,5 α -epoxy-3,14-dihydroxymorphinan-6-one hydrochloride. Naloxone
Hydrochloride has the molecular formula C H N0 HCl .2H 0
and the molecular weight is 399.87.
STRUCTURAL FORMULA OF NALOXONE
SUBOXONE is an uncoated
intended for sublingual administration. It is available in two dosage strengths,
2mg buprenorphine with 0.5mg naloxone, and 8mg buprenorphine with 2mg naloxone
free bases. Each tablet also contains lactose, mannitol, cornstarch, povidone
K30, citric acid, sodium citrate, FD&C Yellow No.6 color, magnesium
stearate, and the tablets also contain Acesulfame K sweetener and a lemon / lime
flavor.
SUBUTEX is an uncoated intended for
sublingual administration. It is available in two dosage strengths, 2mg
buprenorphine and 8mg buprenorphine free base. Each tablet also contains
lactose, mannitol, cornstarch, povidone K30, citric acid, sodium citrate and
magnesium stearate.
What does Suboxone look like?
What are the available doses of Suboxone?
Sorry No records found.
What should I talk to my health care provider before I take Suboxone?
Sorry No records found
How should I use Suboxone?
SUBOXONE and SUBUTEX are indicated for the treatment of opioid dependence.
SUBUTEX or SUBOXONE is administered sublingually as a single daily dose in the
range of 12 to 16mg/ day. When taken sublingually, SUBOXONE and SUBUTEX have
similar clinical effects and are interchangeable. There are no adequate and
well-controlled studies using SUBOXONE as initial medication. SUBUTEX contains
no naloxone and is preferred for use during induction. Following induction,
SUBOXONE, due to the presence of naloxone, is preferred when clinical use
includes unsupervised administration. The use of SUBUTEX for unsupervised
administration should be limited to those patients who cannot tolerate SUBOXONE,
for example those patients who have been shown to be hypersensitive to naloxone.
What interacts with Suboxone?
SUBOXONE and SUBUTEX should not be administered to patients who have been shown to be hypersensitive to buprenorphine, and SUBOXONE should not be administered to patients who have been shown to be hypersensitive to naloxone.
What are the warnings of Suboxone?
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Respiratory Depression:
Significant respiratory depression has been associated with
buprenorphine, particularly by the intravenous route. A number of deaths have
occurred when addicts have intravenously misused buprenorphine, usually with
benzodiazepines concomitantly. Deaths have also been reported in association
with concomitant administration of buprenorphine with other depressants such as
alcohol or other opioids. Patients should be warned of the potential danger of
the self-administration of benzodiazepines or other depressants while under
treatment with SUBUTEX or SUBOXONE.
IN THE CASE OF OVERDOSE, THE PRIMARY MANAGEMENT SHOULD BE THE
RE-ESTABLISHMENT OF ADEQUATE VENTILATION WITH MECHANICAL ASSISTANCE OF
RESPIRATION, IF REQUIRED. NALOXONE MAY NOT BE EFFECTIVE IN REVERSING ANY
RESPIRATORY DEPRESSION PRODUCED BY BUPRENORPHINE.
SUBOXONE and SUBUTEX should be used with caution in patients with compromised
respiratory function (e.g., chronic obstructive pulmonary disease, cor
pulmonale, decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing
respiratory depression).
CNS Depression:
Patients receiving buprenorphine in the presence of other narcotic analgesics,
general anesthetics, benzodiazepines, phenothiazines, other tranquilizers,
sedative/hypnotics or other CNS depressants (including alcohol) may exhibit
increased CNS depression. When such combined therapy is contemplated, reduction
of the dose of one or both agents should be considered.
Dependence:
Buprenorphine is a partial agonist at the mu-opiate receptor and chronic
administration produces dependence of the opioid type, characterized by
withdrawal upon abrupt discontinuation or rapid taper. The withdrawal syndrome
is milder than seen with full agonists, and may be delayed in onset.
Hepatitis, hepatic events:
Cases of cytolytic hepatitis and hepatitis with jaundice have been observed in
the addict population receiving buprenorphine both in clinical trials and in
post-marketing adverse event reports. The spectrum of abnormalities ranges from
transient asymptomatic elevations in hepatic transaminases to case reports of
hepatic failure, hepatic necrosis, hepatorenal syndrome, and hepatic
encephalopathy. In many cases, the presence of preexisting liver enzyme
abnormalities, infection with hepatitis B or hepatitis C virus, concomitant
usage of other potentially hepatotoxic drugs, and ongoing injecting drug use may
have played a causative or contributory role. In other cases, insufficient data
were available to determine the etiology of the abnormality. The possibility
exists that buprenorphine had a causative or contributory role in the
development of the hepatic abnormality in some cases. Measurements of liver
function tests prior to initiation of treatment is recommended to establish a
baseline. Periodic monitoring of liver function tests during treatment is also
recommended. A biological and etiological evaluation is recommended when a
hepatic event is suspected. Depending on the case, the drug should be carefully
discontinued to prevent withdrawal symptoms and a return to illicit drug use,
and strict monitoring of the patient should be initiated.
Allergic Reactions:
Cases of acute and chronic hypersensitivity to buprenorphine have been reported
both in clinical trials and in the post-marketing experience. The most common
signs and symptoms include rashes, hives, and pruritus. Cases of bronchospasm,
angioneurotic edema, and anaphylactic shock have been reported. A history of
hypersensitivity to buprenorphine is a contraindication to Subutex or Suboxone
use. A history of hypersensitivity to naloxone is a contraindication to Suboxone
use.
Use in Ambulatory Patients:
SUBOXONE and SUBUTEX may impair the mental or physical abilities required for
the performance of potentially dangerous tasks such as driving a car or
operating machinery, especially during drug induction and dose adjustment.
Patients should be cautioned about operating hazardous machinery, including
automobiles, until they are reasonably certain that buprenorphine therapy does
not adversely affect their ability to engage in such activities. Like other
opioids, SUBOXONE and SUBUTEX may produce orthostatic hypotension in ambulatory
patients.
Head Injury and Increased Intracranial Pressure:
SUBOXONE and SUBUTEX, like other potent opioids, may elevate cerebrospinal fluid
pressure and should be used with caution in patients with head injury,
intracranial lesions and other circumstances where cerebrospinal pressure may be
increased. SUBOXONE and SUBUTEX can produce miosis and changes in the level of
consciousness that may interfere with patient evaluation.
Opioid withdrawal effects:
Because it contains naloxone, SUBOXONE is highly likely to produce marked and
intense withdrawal symptoms if misused parenterally by individuals dependent on
opioid agonists such as heroin, morphine, or methadone. Sublingually, SUBOXONE
may cause opioid withdrawal symptoms in such persons if administered before the
agonist effects of the opioid have subsided.
What are the precautions of Suboxone?
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General:
SUBOXONE and SUBUTEX should be administered with caution in
elderly or debilitated patients and those with severe impairment of hepatic,
pulmonary, or renal function; myxedema or hypothyroidism, adrenal cortical
insufficiency (e.g., Addison's disease); CNS depression or coma; toxic
psychoses; prostatic hypertrophy or urethral stricture; acute alcoholism;
delirium tremens; or kyphoscoliosis.
The effect of hepatic impairment on the pharmacokinetics of buprenorphine and
naloxone is unknown. Since both drugs are extensively metabolized, the plasma
levels will be expected to be higher in patients with moderate and severe
hepatic impairment. However, it is not known whether both drugs are affected to
the same degree. Therefore, dosage should be adjusted and patients should be
watched for symptoms of precipitated opioid withdrawal.
Buprenorphine has been shown to increase intracholedochal pressure, as do
other opioids, and thus should be administered with caution to patients with
dysfunction of the biliary tract.
As with other mu-opioid receptor agonists, the administration of SUBOXONE or
SUBUTEX may obscure the diagnosis or clinical course of patients with acute
abdominal conditions.
Drug Interactions:
Buprenorphine is metabolized to norbuprenorphine by cytochrome
CYP 3A4. Because CYP 3A4 inhibitors may increase plasma concentrations of
buprenorphine, patients already on CYP 3A4 inhibitors such as azole antifungals
(e.g. ketoconazole), macrolide antibiotics (e.g. erythromycin), and HIV protease
inhibitors (e.g. ritonavir, indinavir and saquinavir) should have their dose of
SUBUTEX or SUBOXONE adjusted.
Based on anecdotal reports, there may be an interaction between buprenorphine
and benzodiazepines. There have been a number of reports in the post-marketing
experience of coma and death associated with the concomitant intravenous misuse
of buprenorphine and benzodiazepines by addicts. In many of these cases,
buprenorphine was misused by self-injection of crushed SUBUTEX tablets. SUBUTEX
and SUBOXONE should be prescribed with caution to patients on benzodiazepines or
other drugs that act on the central nervous system, regardless of whether these
drugs are taken on the advice of a physician or are taken as drugs of abuse.
Patients should be warned of the potential danger of the intravenous
self-administration of benzodiazepines while under treatment with SUBOXONE or
SUBUTEX.
Information for Patients:
Patients should inform their family members that, in the event of
emergency, the treating physician or emergency room staff should be informed
that the patient is physically dependent on narcotics and that the patient is
being treated with SUBOXONE or SUBUTEX.
Patients should be cautioned that a serious overdose and death may occur if
benzodiazepines, sedatives, tranquilizers, antidepressants, or alcohol are taken
at the same time as SUBOXONE or SUBUTEX.
SUBOXONE and SUBUTEX may impair the mental or physical abilities required for
the performance of potentially dangerous tasks such as driving a car or
operating machinery, especially during drug induction and dose adjustment.
Patients should be cautioned about operating hazardous machinery, including
automobiles, until they are reasonably certain that buprenorphine therapy does
not adversely affect their ability to engage in such activities. Like other
opioids, SUBOXONE and SUBUTEX may produce orthostatic hypotension in ambulatory
patients.
Patients should consult their physician if other prescription medications are
currently being used or are prescribed for future use.
Carcinogenesis, Mutagenesis and Impairment of Fertility:
Carcinogenicity:
SUBOXONE: The 4:1 combination of buprenorphine and naloxone was
not mutagenic in a bacterial mutation assay (Ames test) using four strains of
and two strains of The combination was not clastogenic in an cytogenetic assay in human lymphocytes, or in an
intravenous micronucleus test in the rat.
SUBUTEX: Buprenorphine was studied in a series of tests utilizing
gene, chromosome, and DNA interactions in both prokaryotic and eukaryotic
systems. Results were negative in yeast for recombinant, gene convertant, or forward mutations;
negative in assay, negative
for clastogenicity in CHO cells, Chinese hamster bone marrow and spermatogonia
cells, and negative in the mouse lymphoma L5178Y assay. Results were equivocal
in the Ames test: negative in studies in two laboratories, but positive for
frame shift mutation at a high dose (5mg/plate) in a third study. Results were
positive in the Green-Tweets survival test,
positive in a DNA synthesis inhibition (DSI) test with testicular tissue from
mice, for both and incorporation of [H]thymidine, and positive
in unscheduled DNA synthesis (UDS) test using testicular cells from mice.
SUBOXONE: Dietary administration of SUBOXONE in the rat at dose
levels of 500 ppm or greater (equivalent to approximately 4/mg/kg/day or
greater; estimated exposure was approximately 28 times the recommended human
daily sublingual dose of 16 mg on a mg/m basis) produced
a reduction in fertility demonstrated by reduced female conception rates. A
dietary dose of 100 ppm (equivalent to approximately 10 mg/kg/day; estimated
exposure was approximately 6 times the recommended human daily sublingual dose
of 16 mg on a mg/m basis) had no adverse effect on
fertility.
SUBUTEX: Reproduction studies of buprenorphine in rats
demonstrated no evidence of impaired fertility at daily oral doses up to
80mg/kg/day (estimated exposure was approximately 50 times the recommended human
daily sublingual dose of 16 mg on a mg/m basis) or up to
5mg/kg/day or
(estimated exposure was approximately 3 times the recommended human daily
sublingual dose of 16 mg on a mg/m basis).
Pregnancy:
SUBOXONE: Effects on embryo-fetal development were studied in
Sprague-Dawley rats and Russian white rabbits following oral (1:1) and
intramuscular (3:2) administration of mixtures of buprenorphine and naloxone.
Following oral administration to rats and rabbits, no teratogenic effects were
observed at doses up to 250 mg/kg/day and 40 mg/kg/day, respectively (estimated
exposure was approximately 150 times and 50 times, respectively, the recommended
human daily sublingual dose of 16 mg on a mg/m basis).
No definitive drug-related teratogenic effects were observed in rats and rabbits
at intramuscular doses up to 30 mg/kg/day (estimated exposure was approximately
20 times and 35 times, respectively, the recommended human daily dose of 16 mg
on a mg/m basis). Acephalus was observed in one rabbit
fetus from the low-dose group and omphacele was observed in two rabbit fetuses
from the same litter in the mid-dose group; no findings were observed in fetuses
from the high-dose group. Following oral administration to the rat, dose-related
post-implantation losses, evidenced by increases in the numbers of early
resorptions with consequent reductions in the numbers of fetuses, were observed
at doses of 10 mg/kg/day or greater (estimated exposure was approximately 6
times the recommended human daily sublingual dose of 16 mg on a mg/m basis). In the rabbit, increased post-implantation losses
occurred at an oral dose of 40 mg/kg/day. Following intramuscular administration
in the rat and the rabbit, post-implantation losses, as evidenced by decreases
in live fetuses and increases in resorptions, occurred at 30 mg/kg/day.
SUBUTEX: Buprenorphine was not teratogenic in rats or rabbits after or doses up to 5 mg/kg/day
(estimated exposure was approximately 3 and 6 times, respectively, the
recommended human daily sublingual dose of 16 mg on a mg/m basis), after doses up to 0.8
mg/kg/day (estimated exposure was approximately 0.5 times and equal to,
respectively, the recommended human daily sublingual dose of 16 mg on a
mg/m basis), or after oral doses up to 160 mg/kg/day in
rats (estimated exposure was approximately 95 times the recommended human daily
sublingual dose of 16 mg on a mg/m basis) and 25
mg/kg/day in rabbits (estimated exposure was approximately 30 times the
recommended human daily sublingual dose of 16 mg on a mg/m basis). Significant increases in skeletal abnormalities
(e.g., extra thoracic vertebra or thoraco-lumbar ribs) were noted in rats after
administration of 1 mg/kg/day and up (estimated
exposure was approximately 0.6 times the recommended human daily sublingual dose
of 16 mg on a mg/m basis), but were not observed at oral
doses up to 160 mg/kg/day. Increases in skeletal abnormalities in rabbits after
administration of 5 mg/kg/day (estimated exposure
was approximately 6 times the recommended human daily sublingual dose of 16 mg
on a mg/m basis) or oral administration of 1 mg/kg/day
or greater (estimated exposure was approximately equal to the recommended human
daily sublingual dose of 16 mg on a mg/m basis) were not
statistically significant.
In rabbits, buprenorphine produced statistically significant pre-implantation
losses at oral doses of 1 mg/kg/day or greater and post-implantation losses that
were statistically significant at doses of 0.2
mg/kg/day or greater (estimated exposure was approximately 0.3 times the
recommended human daily sublingual dose of 16 mg on a mg/m basis).
There are no adequate and well-controlled studies of SUBOXONE or SUBUTEX in
pregnant women. SUBOXONE or SUBUTEX should only be used during pregnancy if the
potential benefit justifies the potential risk to the fetus.
Dystocia was noted in pregnant rats treated with buprenorphine 5 mg/kg/day (approximately 3 times
the recommended human daily sublingual dose of 16 mg on a mg/m basis). Both fertility and peri- and postnatal development
studies with buprenorphine in rats indicated increases in neonatal mortality
after oral doses of 0.8 mg/kg/day and up (approximately 0.5 times the
recommended human daily sublingual dose of 16 mg on a mg/m basis), after doses of 0.5
mg/kg/day and up (approximately 0.3 times the recommended human daily sublingual
dose of 16 mg on a mg/m basis), and after doses of 0.1 mg/kg/day and up (approximately 0.06 times
the recommended human daily sublingual dose of 16 mg on a mg/m basis). Delays in the occurrence of righting reflex and
startle response were noted in rat pups at an oral dose of 80 mg/kg/day
(approximately 50 times the recommended human daily sublingual dose of 16 mg on
a mg/m basis).
Neonatal withdrawal has been reported in the infants of women
treated with SUBUTEX during pregnancy. From post-marketing reports, the time to
onset of neonatal withdrawal symptoms ranged from Day 1 to Day 8 of life with
most occurring on Day 1. Adverse events associated with neonatal withdrawal
syndrome included hypertonia, neonatal tremor, neonatal agitation, and
myoclonus. There have been rare reports of convulsions and in one case, apnea
and bradycardia were also reported.
Nursing Mothers:
An apparent lack of milk production during general reproduction studies with
buprenorphine in rats caused decreased viability and lactation indices. Use of
high doses of sublingual buprenorphine in pregnant women showed that
buprenorphine passes into the mother's milk. Breast-feeding is therefore not
advised in mothers treated with SUBUTEX or SUBOXONE.
Pediatric Use:
SUBOXONE and SUBUTEX are not recommended for use in pediatric patients. The
safety and effectiveness of SUBOXONE and SUBUTEX in patients below the age of 16
have not been established.
What are the side effects of Suboxone?
The safety of SUBOXONE has been evaluated in 497 opioid-dependent
subjects. The prospective evaluation of SUBOXONE was supported by clinical
trials using SUBUTEX (buprenorphine tablets without naloxone) and other trials
using buprenorphine sublingual solutions. In total, safety data are available
from 3214 opioid-dependent subjects exposed to buprenorphine at doses in the
range used in treatment of opioid addiction.
Few differences in adverse event profile were noted between SUBOXONE and
SUBUTEX or buprenorphine administered as a sublingual solution.
In a comparative study, adverse event profiles were similar for subjects
treated with 16 mg SUBOXONE or 16mg SUBUTEX. The following adverse events were
reported to occur by at least 5% of patients in a 4-week study ().
The adverse event profile of buprenorphine was also characterized in the
dose-controlled study of buprenorphine solution, over a range of doses in four
months of treatment. shows adverse events reported by
at least 5% of subjects in any dose group in the dose-controlled study.
| N(%) | N(%) | N(%) | |||
|---|---|---|---|---|---|
| Body System / Adverse Event (COSTART Terminology) | SUBUTEX 16mg/day N=103 | Placebo N=107 | |||
| Body as a Whole | |||||
| Asthenia | 7 (6.5%) | 5 (4.9%) | 7 (6.5%) | ||
| Chills | 8 (7.5%) | 8 (7.8%) | 8 (7.5%) | ||
| Headache | 39 (36.4%) | 30(29.1%) | 24 (22.4%) | ||
| Infection | 6 (5.6%) | 12(11.7%) | 7 (6.5%) | ||
| Pain | 24 (22.4%) | 19(18.4%) | 20(18.7%) | ||
| Pain Abdomen | 12(11.2%) | 12(11.7%) | 7 (6.5%) | ||
| Pain Back | 4 (3.7%) | 8 (7.8%) | 12(11.2%) | ||
| Withdrawal Syndrome | 27 (25.2%) | 19(18.4%) | 40 (37.4%) | ||
| Cardiovascular System | |||||
| Vasodilation | 10(9.3%) | 4 (3.9%) | 7 (6.5%) | ||
| Digestive System | |||||
| Constipation | 13(12.1%) | 8 (7.8%) | 3 (2.8%) | ||
| Diarrhea | 4 (3.7%) | 5 (4.9%) | 16(15.0%) | ||
| Nausea | 16(15.0%) | 14(13.6%) | 12(11.2%) | ||
| Vomiting | 8 (7.5%) | 8 (7.8%) | 5 (4.7%) | ||
| Nervous System | |||||
| Insomnia | 15(14.0%) | 22(21.4%) | 17(15.9%) | ||
| Respiratory System | |||||
| Rhinitis | 5 (4.7%) | 10(9.7%) | 14(13.1%) | ||
| Skin And Appendages | |||||
| Sweating | 15(14.0%) | 13(12.6%) | 11 (10.3%) | ||
| Body System /Adverse Event (COSTART Terminology) | Buprenorphine Dose* | ||||
| Very Low* (N=184) | Low* (N=180) | Moderate* (N=186) | High* (N=181) | Total* (N=731) | |
| N (%) | N (%) | N | N (%) | N (%) | |
| Body as a Whole | |||||
| Abscess | 9 (5%) | 2(1%) | 3 (2%) | 2(1%) | 16(2%) |
| Asthenia | 26(14%) | 28(16%) | 26(14%) | 24(13%) | 104(14%) |
| Chills | 11 (6%) | 12(7%) | 9 (5%) | 10(6%) | 42 (6%) |
| Fever | 7 (4%) | 2(1%) | 2(1%) | 10(6%) | 21 (3%) |
| Flu Syndrome. | 4 (2%) | 13(7%) | 19(10%) | 8 (4%) | 44 (6%) |
| Headache | 51 (28%) | 62 (34%) | 54 (29%) | 53 (29%) | 220 (30%) |
| Infection | 32(17%) | 39 (22%) | 38 (20%) | 40 (22%) | 149 (20%) |
| Injury Accidental | 5 (3%) | 10(6%) | 5 (3%) | 5 (3%) | 25 (3%) |
| Pain | 47 (26%) | 37(21%) | 49 (26%) | 44 (24%) | 177 (24%) |
| Pain Back | 18(10%) | 29(16%) | 28(15%) | 27 (15%) | 102(14%) |
| Withdrawal Syndrome | 45 (24%) | 40 (22%) | 41 (22%) | 36 (20%) | 162(22%) |
| Digestive System | |||||
| Constipation | 10(5%) | 23(13%) | 23(12%) | 26(14%) | 82(11%) |
| Diarrhea | 19(10%) | 8 (4%) | 9 (5%) | 4 (2%) | 40 (5%) |
| Dyspepsia | 6 (3%) | 10(6%) | 4 (2%) | 4 (2%) | 24 (3%) |
| Nausea | 12 (7%) | 22(12%) | 23(12%) | 18(10%) | 75(10%) |
| Vomiting | 8 (4%) | 6 (3%) | 10(5%) | 14 (8%) | 38 (5%) |
| Nervous System | |||||
| Anxiety | 22(12%) | 24(13%) | 20(11%) | 25(14%) | 91 (12%) |
| Depression | 24(13%) | 16(9%) | 25(13%) | 18(10%) | 83(11%) |
| Dizziness | 4 (2%) | 9 (5%) | 7 (4%) | 11 (6%) | 31 (4%) |
| Insomnia | 42 (23%) | 50 (28%) | 43 (23%) | 51 (28%) | 186(25%) |
| Nervousness | 12 (7%) | 11 (6%) | 10(5%) | 13 (7%) | 46 (6%) |
| Somnolence | 5 (3%) | 13(7%) | 9 (5%) | 11 (6%) | 38 (5%) |
| Respiratory System | |||||
| Cough Increase | 5 (3%) | 1 | 6 (3%) | 4 (2%) | 26 (4%) |
| Pharyngitis | 6 (3%) | 7 (4%) | 6 (3%) | 9 (5%) | 28 (4%) |
| Rhinitis | 27(15%) | 16(9%) | 1 5 (8%) | 21 (12%) | 79(11%) |
| Skin And Appendages | |||||
| Sweat | 23 (13%) | 21 (12%) | 20(11%) | 23(13%) | 87(12%) |
| Special Senses | |||||
| Runny Eyes | 13(7%) | 9 (5%) | 6 (3%) | 6 (3%) | 34 (5%) |
What should I look out for while using Suboxone?
SUBOXONE and SUBUTEX should not be administered to patients who have been shown
to be hypersensitive to buprenorphine, and SUBOXONE should not be administered
to patients who have been shown to be hypersensitive to naloxone.
Enter section text here
What might happen if I take too much Suboxone?
Enter section text here
How should I store and handle Suboxone?
Store at controlled room temperature, 20º to 25ºC (68º to 77ºF) [ USP]. The USP defines controlled room temperature as a temperature maintained thermostatically that encompasses the usual and customary working environment of 20º to 25ºC (68º to 77ºF); that results in a mean kinetic temperature calculated to be not more than 25ºC; and that allows for excursions between 15º and 30ºC (59º and 86ºF) that are experienced in pharmacies, hospitals, and warehouses.SUBOXONE is supplied as sublingual tablets in white HDPE bottles.Hexagonal orange tablets containing 2mg buprenorphine with 0.5mg naloxoneHexagonal orange tablets containing 8mg buprenorphine with 2mg naloxoneStore at 25°C (77°F), excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]SUBOXONE is supplied as sublingual tablets in white HDPE bottles.Hexagonal orange tablets containing 2mg buprenorphine with 0.5mg naloxoneHexagonal orange tablets containing 8mg buprenorphine with 2mg naloxoneStore at 25°C (77°F), excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]SUBOXONE is supplied as sublingual tablets in white HDPE bottles.Hexagonal orange tablets containing 2mg buprenorphine with 0.5mg naloxoneHexagonal orange tablets containing 8mg buprenorphine with 2mg naloxoneStore at 25°C (77°F), excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]SUBOXONE is supplied as sublingual tablets in white HDPE bottles.Hexagonal orange tablets containing 2mg buprenorphine with 0.5mg naloxoneHexagonal orange tablets containing 8mg buprenorphine with 2mg naloxoneStore at 25°C (77°F), excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Comparisons of buprenorphine with full agonists such as methadone
and hydromorphone suggest that sublingual buprenorphine produces typical opioid
agonist effects which are limited by a ceiling effect.
In non-dependent subjects, acute sublingual doses of SUBOXONE tablets
produced opioid agonist effects, which reached a maximum between doses of 8 mg
and 16mg of SUBUTEX. The effects of 16mg SUBOXONE were similar to those produced
by 16mg SUBUTEX (buprenorphine alone).
Opioid agonist ceiling effects were also observed in a double-blind, parallel
group, dose ranging comparison of single doses of buprenorphine sublingual
solution (1, 2, 4, 8, 16, or 32 mg), placebo, and a full agonist control at
various doses. The treatments were given in ascending dose order at intervals of
at least one week to 16 opioid-experienced, non-dependent subjects. Both drugs
produced typical opioid agonist effects. For all the measures for which the
drugs produced an effect, buprenorphine produced a dose-related response but, in
each case, there was a dose that produced no further effect. In contrast, the
highest dose of the full agonist control always produced the greatest effects.
Agonist objective rating scores remained elevated for the higher doses of
buprenorphine (8-32 mg) longer than for the lower doses and did not return to
baseline until 48 hours after drug administrations. The onset of effects
appeared more rapidly with buprenorphine than with the full agonist control,
with most doses nearing peak effect after 100 minutes for buprenorphine compared
to 150 minutes for the full agonist control.
Non-Clinical Toxicology
SUBOXONE and SUBUTEX should not be administered to patients who have been shown to be hypersensitive to buprenorphine, and SUBOXONE should not be administered to patients who have been shown to be hypersensitive to naloxone.Enter section text here
Buprenorphine is metabolized to norbuprenorphine by cytochrome CYP 3A4. Because CYP 3A4 inhibitors may increase plasma concentrations of buprenorphine, patients already on CYP 3A4 inhibitors such as azole antifungals (e.g. ketoconazole), macrolide antibiotics (e.g. erythromycin), and HIV protease inhibitors (e.g. ritonavir, indinavir and saquinavir) should have their dose of SUBUTEX or SUBOXONE adjusted.
Based on anecdotal reports, there may be an interaction between buprenorphine and benzodiazepines. There have been a number of reports in the post-marketing experience of coma and death associated with the concomitant intravenous misuse of buprenorphine and benzodiazepines by addicts. In many of these cases, buprenorphine was misused by self-injection of crushed SUBUTEX tablets. SUBUTEX and SUBOXONE should be prescribed with caution to patients on benzodiazepines or other drugs that act on the central nervous system, regardless of whether these drugs are taken on the advice of a physician or are taken as drugs of abuse. Patients should be warned of the potential danger of the intravenous self-administration of benzodiazepines while under treatment with SUBOXONE or SUBUTEX.
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The safety of SUBOXONE has been evaluated in 497 opioid-dependent subjects. The prospective evaluation of SUBOXONE was supported by clinical trials using SUBUTEX (buprenorphine tablets without naloxone) and other trials using buprenorphine sublingual solutions. In total, safety data are available from 3214 opioid-dependent subjects exposed to buprenorphine at doses in the range used in treatment of opioid addiction.
Few differences in adverse event profile were noted between SUBOXONE and SUBUTEX or buprenorphine administered as a sublingual solution.
In a comparative study, adverse event profiles were similar for subjects treated with 16 mg SUBOXONE or 16mg SUBUTEX. The following adverse events were reported to occur by at least 5% of patients in a 4-week study ().
The adverse event profile of buprenorphine was also characterized in the dose-controlled study of buprenorphine solution, over a range of doses in four months of treatment. shows adverse events reported by at least 5% of subjects in any dose group in the dose-controlled study.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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