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
D H E 45 Side Effects, and Drug Interactions - Dihydroergotamine
D H E 45 Side Effects, and Drug Interactions - Dihydroergotamine
SIDE EFFECTS
Serious cardiac events,
including some that have been fatal,
have occurred following use of D.H.E. 45® (dihydroergotamine
mesylate) Injection, USP, but are extremely rare. Events reported
have included coronary
artery vasospasm, transient
myocardial ischemia,
myocardial infarction,
ventricular tachycardia, and ventricular
fibrillation. ( See CONTRAINDICATIONS,
WARNINGS, and PRECAUTIONS)
Post-Introduction Reports
The following events derive from postmarketing experience
have been occasionally reported in patients receiving D.H.E. 45®
(dihydroergotamine mesylate) Injection, USP vasospasm,
paraesthesia, hypertension,
dizziness, anxiety, dyspnea,
headache, flushing,
diarrhea, rash,
increased sweating, and pleural
and retroperitoneal
fibrosis after long-term
use of dihydroergotamine. Extremely rare cases of myocardial
infarction and stroke
have been reported. A causal relationship has not been established.
D.H.E. 45® (dihydroergotamine mesylate) Injection, USP is not
recommended for prolonged daily use. (See DOSAGE
AND ADMINISTRATION)
DRUG ABUSE AND DEPENDENCE
Currently available data have not demonstrated drug
abuse or psychological
dependence with dihydroergotamine. However, cases of drug
abuse and psychological
dependence in patients on other forms of ergot
therapy have been reported.
That, due to the chronicity
of vascular headaches,
it is imperative
that patients be advised not to exceed recommended dosages.
DRUG INTERACTIONS
Vasoconstrictors: D.H.E. 45® (dihydroergotamine
mesylate) Injection, USP should not be used with peripheral
vasoconstrictors because the combination may cause
synergistic elevation
of blood pressure.
Sumatriptan: Sumatriptan has been reported to cause
coronary artery vasospasm,
and its effect could
be additive with D.H.E.
45® (dihydroergotamine mesylate) Injection, USP. Sumatriptan
and D.H.E. 45® (dihydroergotamine mesylate) Injection, USP should
not be taken within 24 hours of each other. (See CONTRAINDICATIONS).
Beta Blockers: Although the results of a clinical
study did not indicate a safe problem associated with the administration
of D.H.E. 45® (dihydroergotamine mesylate) Injection, USP to
subjects already receiving propranolol, there have been reports
that propranolol may potentiate the vasoconstrictive
action of ergotamine
by blocking the vasodilating
property of epinephrine.
Nicotine: Nicotine may provoke vasoconstriction
in some patients, predisposing
to a greater ischemic response
to ergot therapy.
Macrolide Antibiotics (e. g. erythromycin
and troleandomycin): Agents of the ergot
alkaloid class, of
which D.H.E. 45® (dihydroergotamine mesylate) Injection, USP
is a member, have been shown to interact with antibiotics of the
macrolide class, resulting
in increased plasma levels
of unchanged alkaloids and peripheral
vasoconstriction. Vasospastic reactions have been reported with
therapeutic doses
of ergotamine-containing drugs when co-administered with these antibiotics.
SSRI's: Weakness hyperreflexia,
and incoordination
have been reported rarely when 5-HT1 agonists have been
co-administered with SSRI's (e. g. fluoxetine, fluvoxamine, paroxetine,
sertraline). There have been no
reported cases from spontaneous
reports of drug interaction
between SSRI's and D.H.E. 45® (dihydroergotamine mesylate) Injection,
USP.
Oral Contraceptives: The effect
of oral contraceptives
on the pharmacokinetics
of D.H.E. 45® (dihydroergotamine mesylate) Injection, USP has
not been studied.
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