A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Buprenex Side Effects, and Drug Interactions - Buprenorphine
Buprenex Side Effects, and Drug Interactions - Buprenorphine
SIDE EFFECTS
The most frequent side effect in clinical studies involving 1,133 patients
was sedation which occurred in approximately two-thirds of the patients. Although
sedated, these patients could easily be aroused to an alert state.
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Other less frequent adverse reactions occurring
in 5-10% of the patients were:
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Nausea
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Dizziness/Vertigo
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Occurring in 1-5% of the patients:
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Sweating
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Headache
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Hypotension
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Nausea/Vomiting
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Vomiting
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Hypoventilation
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Miosis
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The following adverse reactions were reported to have occurred in less than
1% of the patients:
CNS Effect: confusion, blurred vision, euphoria, weakness/
fatigue, dry mouth, nervousness, depression, slurred speech, paresthesia.
Cardiovascular: hypertension, tachycardia, bradycardia.
Gastrointestinal: constipation.
Respiratory: dyspnea, cyanosis.
Dermatological: pruritus.
Ophthalmological: diplopia, visual abnormalities.
Miscellaneous: injection site reaction, urinary retention,
dreaming, flushing/warmth, chills/cold, tinnitus, conjunctivitis, Wenckebach
block, and psychosis.
Other effects observed infrequently include malaise, hallucinations, depersonalization,
coma, dyspepsia, flatulence, apnea, rash, amblyopia, tremor, and pallor.
The following reactions have been reported to occur rarely: loss of appetite,
dysphoria/agitation, diarrhea, urticaria, and convulsions/lack of muscle coordination.
In the United Kingdom, buprenorphine hydrochloride was made available under
monitored release regulation during the first year of sale, and yielded data
from 1,736 physicians on 9,123 patients (17,120 administrations). Data on 240
children under the age of 18 years were included in this monitored release program.
No important new adverse effects attributable to buprenorphine hydrochloride
were observed.
DRUG ABUSE AND DEPENDENCE
Buprenorphine hydrochloride is a partial agonist of the morphine type: i.e.,
it has certain opioid properties which may lead to psychic dependence of
the morphine type due to an opiate-like euphoric component of the drug. Direct
dependence studies have shown little physical dependence upon withdrawal of
the drug. However, caution should be used in prescribing to individuals who
are known to be drug abusers or ex-narcotic addicts. The drug may not substitute
in acutely dependent narcotic addicts due to its antagonist component and may
induce withdrawal symptoms.
DRUG INTERACTIONS
Drug interactions common to other potent opioid analgesics also may occur with Buprenex. Particular care should be taken
when Buprenex is used in combination with central nervous system depressant
drugs (see WARNINGS). Although specific information is not presently available,
caution should be exercised when Buprenex is used in combination with MAO inhibitors.
There have been reports of respiratory and cardiovascular collapse in patients
who received therapeutic doses of diazepam and Buprenex. A suspected interaction
between Buprenex and phenprocoumon resulting in purpura has been reported.
CYP3A4 Inhibitors: Since the metabolism of buprenorphine is mediated by the CYP3A4
isozyme, coadministration of drugs that inhibit CYP3A4 activity may cause decreased clearance
of buprenorphine. Thus patients coadministered with inhibitors of CYP3A4 such as macrolide
antibiotics (e.g., erythromycin), azole antifungal agents (e.g., ketoconazole), and protease
inhibitors (e.g., ritanovir) while receiving Buprenex should be carefully monitored and
dosage adjustment made if warranted.
CYP3A4 Inducers: Cytochrome P450 inducers, such as rifampin, carbamazepine, and phenytoin,
induce metabolism and as such may cause increased clearance of buprenorphine. Caution is
advised when administering Buprenex to patients receiving these medications and if necessary
dose adjustments should be considered.
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