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
Vicoprofen Side Effects, and Drug Interactions - Hydrocodone and Ibuprofen
Vicoprofen Side Effects, and Drug Interactions - Hydrocodone and Ibuprofen
SIDE EFFECTS
VICOPROFEN was administered to approximately 300 pain patients in a safety
study that employed dosages and a duration of treatment sufficient to encompass
the recommended usage (see DOSAGE AND ADMINISTRATION ). Adverse event rates
generally increased with increasing daily dose. The event rates reported below
are from approximately 150 patients who were in a group that received one tablet
of VICOPROFEN an average of three to four times daily. The overall incidence
rates of adverse experiences in the trials were fairly similar for this patient
group and those who received the comparison treatment, acetaminophen 600 mg
with codeine 60 mg.
The following lists adverse events that occurred with an incidence of 1% or
greater in clinical trials of VICOPROFEN, without regard to the causal relationship
of the events to the drug. To distinguish different rates of occurrence in clinical
studies, the adverse events are listed as follows:
name of adverse event = less than 3%
adverse events marked with an asterisk * = 3% to 9%
adverse event rates over 9% are in parentheses.
Body as a Whole: Abdominal pain*; Asthenia*; Fever; Flu
syndrome; Headache (27%); Infection*; Pain.
Cardiovascular: Palpitations; Vasodilation.
Central Nervous System: Anxiety*; Confusion; Dizziness (14%);
Hypertonia; Insomnia*; Nervousness*; Paresthesia; Somnolence (22%); Thinking
abnormalities.
Digestive: Anorexia; Constipation (22%); Diarrhea*; Dry
mouth*; Dyspepsia (12%); Flatulence*; Gastritis; Melena; Mouth ulcers; Nausea
(21%); Thirst; Vomiting*.
Metabolic and Nutritional Disorders: Edema*.
Respiratory: Dyspnea; Hiccups; Pharyngitis; Rhinitis.
Skin and Appendages: Pruritus*; Sweating*.
Special Senses: Tinnitus.
Urogenital: Urinary frequency.
Incidence less than 1%
Body as a Whole: Allergic reaction.
Cardiovascular: Arrhythmia; Hypotension; Tachycardia.
Central Nervous System: Agitation; Abnormal dreams; Decreased
libido; Depression; Euphoria; Mood changes; Neuralgia; Slurred speech; Tremor,
Vertigo.
Digestive: Chalky stool; "Clenching teeth"; Dysphagia; Esophageal
spasm; Esophagitis; Gastroenteritis; Glossitis; Liver enzyme elevation.
Metabolic and Nutritional: Weight decrease.
Musculoskeletal: Arthralgia; Myalgia.
Respiratory: Asthma; Bronchitis; Hoarseness; Increased cough;
Pulmonary congestion; Pneumonia; Shallow breathing; Sinusitis.
Skin and Appendages: Rash; Urticaria.
Special Senses: Altered vision; Bad taste; Dry eyes.
Urogenital: Cystitis; Glycosuria; Impotence; Urinary incontinence;
Urinary retention.
DRUG ABUSE AND DEPENDENCE
Controlled Substance: VICOPROFEN Tablets are a Schedule
III controlled substance.
Abuse: Psychic dependence, physical dependence, and tolerance
may develop upon repeated administration of opioids; therefore, VICOPROFEN Tablets
should be prescribed and administered with the same degree of caution appropriate
to use of other oral narcotic medications.
Dependence: Physical dependence, the condition in which
continued administration of the drug is required to prevent the appearance of
a withdrawal syndrome, assumes clinically significant proportions only after
several weeks of continued opioid use, although a mild degree of physical dependence
may develop after a few days of opioid therapy. Tolerance, in which increasingly
large doses are required in order to produce the same degree of analgesia, is
manifested initially by a shortened duration of analgesic effect, and subsequently
by decreases in the intensity of analgesia. The rate of development of tolerance
varies among patients. However, psychic dependence is unlikely to develop when
VICOPROFEN Tablets are used for a short time for the treatment of acute pain.
DRUG INTERACTIONS
ACE-Inhibitors: Reports suggest that NSAIDs may
diminish the antihypertensive effect of ACE-inhibitors. This interaction should
be given consideration in patients taking VICOPROFEN concomitantly with ACE-inhibitors.
Anticholinergics: The concurrent use of anticholinergics
with hydrocodone preparations may produce paralytic ileus.
Antidepressants: The use of MAO inhibitors or tricyclic
antidepressants with VICOPROFEN may increase the effect of either the antidepressant
or hydrocodone.
Aspirin: As with other products containing NSAIDs,
concomitant administration of VICOPROFEN and aspirin is not generally recommended
because of the potential of increased adverse effects.
CNS Depressants: Patients receiving other opioids,
antihistamines, antipsychotics, antianxiety agents, or other CNS depressants
(including alcohol) concomitantly with VICOPROFEN may exhibit an additive CNS
depression. When combined therapy is contemplated, the dose of one or both agents
should be reduced.
Furosemide: Ibuprofen has been shown to reduce the
natriuretic effect of furosemide and thiazides in some patients. This response
has been attributed to inhibition of renal prostaglandin synthesis. During concomitant
therapy with VICOPROFEN the patient should be observed closely for signs of
renal failure (see PRECAUTIONS - Renal Effects ), as well as diuretic efficacy.
Lithium: Ibuprofen has been shown to elevate plasma
lithium concentration and reduce renal lithium clearance. This effect has been
attributed to inhibition of renal prostaglandin synthesis by ibuprofen. Thus,
when VICOPROFEN and lithium are administered concurrently, patients should be
observed for signs of lithium toxicity.
Methotrexate: Ibuprofen, as well as other NSAIDs,
has been reported to competitively inhibit methotrexate accumulation in rabbit
kidney slices. This may indicate that ibuprofen could enhance the toxicity of
methotrexate. Caution should be used when VICOPROFEN is administered concomitantly
with methotrexate.
Warfarin: The effects of warfarin and NSAIDs on
GI bleeding are synergistic, such that users of both drugs together have a risk
of serious GI bleeding higher than users of either drug alone.
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