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
Nizoral Side Effects, and Drug Interactions - Ketoconazole
Nizoral Side Effects, and Drug Interactions - Ketoconazole
SIDE EFFECTS
Tablets
In rare cases anaphylaxis
has been reported after the first dose. Several cases of hypersensitivity
reactions including urticaria have also been reported. However,
the most frequent adverse reactions were nausea
and/or vomiting in
approximately 3%, abdominal
pain in 1.2%, pruritus
in 1.5%, and the following in less than 1% of the patients: headache,
dizziness, somnolence,
fever and chills, photophobia,
diarrhea, gynecomastia,
impotence, thrombocytopenia,
leukopenia, hemolytic
anemia, and bulging fontanelles.
Oligospermia has been reported in investigational studies with the
drug at dosages above those
currently approved. Oligospermia has not been reported at dosages
up to 400 mg daily, however,
sperm counts have been
obtained infrequently in patients treated with these dosages. Most
of these reactions were mild and transient
and rarely required discontinuation of ketoconazole tablets. In
contrast, the rare occurrences of hepatic
dysfunction require special attention
(see WARNINGS.)
Neuropsychiatric disturbances, including suicidal tendencies and
severe depression, have occurred rarely in patients using ketoconazole
Tablets.
Ventricular dysrhythmias (prolonged QT intervals) have occurred
with the concomitant
use of terfenadine with ketoconazole tablets. (See BOXED
WARNING, CONTRAINDICATIONS,
and WARNINGS.)
Shampoo
In 11 double-blind trials
in 264 patients using ketoconazole 2% shampoo, an increase in normal
hair loss
and irritation occurred
in less than 1% of patients. In
three open-label safety trials in which 41 patients shampooed 4-10
times weekly for six months, the following adverse experiences each
occurred once: abnormal
hair texture, scalp
pustules, mild dryness of the skin,
and itching. As with other
shampoos, oiliness and dryness of hair
and scalp have been reported.
Cream
During clinical trials
45 (5.0%) of 905 patients treated with ketoconazole 2% Cream and
5 (2.4%) of 208 patients treated with placebo reported side
effects consisting mainly of severe irritation, pruritus and stinging.
One of the patients treated with ketoconazole Cream developed a
painful allergic reaction.
DRUG INTERACTIONS
Tablets
When taken orally, imidazole
compounds like ketoconazole may enhance the anticoagulant
effect of coumarin-like
drugs. In simultaneous treatment
with imidazole drugs
and coumarin drugs, the anticoagulant
effect should be carefully titrated and monitored.
Concomitant administration
of rifampin with ketoconazole
reduces the blood levels of the latter. INH
(isoniazid) is also reported to affect ketoconazole concentrations
adversely. These drugs should not be given concomitantly.
Ketoconazole tablets may alter the metabolism
of cyclosporine
and methylprednisolone, resulting in elevated plasma
concentrations of the latter drugs. Dosage adjustment may be required
if cyclosporine
or methylprednisolone
are given concomitantly with ketoconazole tablets.
Concomitant administration
of ketoconazole with phenytoin
may alter the metabolism
of one or both of the drugs. It is suggested to monitor both ketoconazole
and phenytoin.
Because severe hypoglycemia
has been reported in patients concomitantly receiving oral
miconazole (an imidazole) and oral
hypoglycemic agents, such a potential
interaction involving the latter agents when used concomitantly
with ketoconazole (an imidazole) can not be ruled out.
Ketoconazole tablets inhibit the metabolism
of terfenadine, resulting in an increased plasma
concentration
of terfenadine ad a delay
in the elimination of its acid
metabolite. Increased plasma
concentration
of terfenadine or its acid
metabolite may result
in prolonged QT intervals. (See BOXED
WARNING, CONTRAINDICATIONS,
and WARNINGS.)
Pharmacokinetic data indicate that oral
ketoconazole inhibits the metabolism of astemizole, resulting in
elevated plasma levels
of astemizole and its active metabolite
desmethylastemizole which may prolong QT intervals. Coadministration
of astemizole with ketoconazole tablets is therefore contraindicated.
(See BOXED WARNING, CONTRAINDICATIONS,
and WARNINGS.)
After the coadministration
of 200 mg oral
ketoconazole twice daily and one 20 mg
dose of loratadine
to 11 subjects, the AUC
and Cmax of loratadine
averaged 302% (± 142 S.D.) and 251% (± 68 S.D.), respectively,
of those obtained after co-treatment with placebo. The AUC and Cmax
of descarboethoxyloratadine, an active metabolite, averaged 155%
(± 27 S.D.) and 141% (± 35 S.D.), respectively. However,
no related changes were noted
in the QT0 on ECG
taken at 2, 6, and 24 hours after the coadministration. Also, there
were no clinically significant
differences in adverse events when loratadine
was administered with or without ketoconazole.
Rare cases of a disulfiram-like reaction
to alcohol have been
reported. These experiences have been characterized by flushing,
rash, peripheral edema,
nausea, and headache.
Symptoms resolved within a few hours.
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