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
Mykrox Side Effects, and Drug Interactions - Metolazone
Mykrox Side Effects, and Drug Interactions - Metolazone
SIDE EFFECTS
Adverse experience information is available from more than 14 years of accumulated
marketing experience with other formulations of metolazone for which reliable
quantitative information is lacking and from controlled clinical trials with
MYKROX from which incidences can be calculated.
In controlled clinical trials with MYKROX, adverse experiences resulted in
discontinuation of therapy in 6.7-6.8% of patients given 1 / 2
to 1 mg of MYKROX.
Adverse experiences occurring in controlled clinical trials with MYKROX with
an incidence of > 2%, whether or not considered drug-related, are summarized
in the following table.
Incidence of Adverse Experiences
Volunteered or Elicited
(by Patient in Percent) *
| |
MYKROX
n=226 **
|
|
Dizziness (lightheadedness)
|
10.2 |
|
Headaches
|
9.3 |
|
Muscle Cramps
|
5.8 |
|
Fatigue (malaise, lethargy, lassitude)
|
4.4 |
|
Joint Pain, swelling
|
3.1 |
|
Chest Pain (precordial discomfort)
|
2.7 |
|
* Percent of patients reporting an adverse experience
one or more times.
|
|
** All doses combined ( 1 / 2 ,
1 and 2 mg).
|
Some of the adverse effects reported in association with MYKROX also occur
frequently in untreated hypertensive patients, such as headache and dizziness,
which occurred in 14.8 and 7.4% of patients in a smaller parallel placebo group.
The following adverse effects were reported in less than 2% of the MYKROX treated
patients.
Cardiovascular: Cold extremities, edema, orthostatic hypotension,
palpitations.
Central and Peripheral Nervous System: Anxiety, depression,
dry mouth, impotence, nervousness, neuropathy, weakness, "weird" feeling.
Dermatological: Pruritus, rash, skin dryness.
Eyes, Ears, Nose, Throat: Cough, epistaxis, eye itching,
sinus congestion, sore throat, tinnitus.
Gastrointestinal: Abdominal discomfort (pain, bloating),
bitter taste, constipation, diarrhea, nausea, vomiting.
Genitourinary: Nocturia.
Musculoskeletal: Back pain.
Other Adverse Experiences:
Adverse experiences reported with other marketed metolazone formulations and
most thiazide diuretics, for which quantitative data are not available, are
listed in decreasing order of severity within body systems. Several are single
or rare occurrences.
Cardiovascular: excessive volume depletion, hemoconcentration,
venous thrombosis.
Central and Peripheral Nervous System: syncope, paresthesias,
drowsiness, restlessness (sometimes resulting in insomnia).
Dermatologic/Hypersensitivity: necrotizing angiitis (cutaneous
vasculitis), purpura, dermatitis, photosensitivity, urticaria.
Gastrointestinal: hepatitis, intrahepatic cholestatic
jaundice, pancreatitis, anorexia.
Hematologic: aplastic (hypoplastic) anemia, agranulocytosis,
leukopenia.
Metabolic: hypokalemia (see WARNINGS, Hypokalemia),
hyponatremia, hyperuricemia, hypochloremia, hypochloremic alkalosis, hyperglycemia,
glycosuria, increase in serum urea nitrogen (BUN) or creatinine, hypophosphatemia,
hypomagnesemia, hypercalcemia.
Musculoskeletal: acute gouty attacks.
Other: transient blurred vision, chills.
In addition, rare adverse experiences reported in association with similar
anti-hypertensive-diuretics but not reported to date for metolazone include:
sialadenitis, xanthopsia, respiratory distress (including pneumonitis), thrombocytopenia,
and anaphylactic reactions. These experiences could occur with clinical use
of metolazone.
DRUG INTERACTIONS
Diuretics
Furosemide and probably other loop diuretics given concomitantly with metolazone
can cause unusually large or prolonged losses of fluid and electrolytes (see
WARNINGS).
Other Antihypertensives
When MYKROX Tablets are used with other antihypertensive drugs, care must be
taken, especially during initial therapy. Dosage adjustments of other antihypertensives
may be necessary.
Alcohol, Barbiturates, and Narcotics
The hypotensive effects of these drugs may be potentiated by the volume contraction
that may be associated with metolazone therapy.
Digitalis Glycosides
Diuretic-induced hypokalemia can increase the sensitivity of the myocardium
to digitalis. Serious arrhythmias can result.
Corticosteroids or ACTH
May increase the risk of hypokalemia and increase salt and water retention.
Lithium
Serum lithium levels may increase (see WARNINGS).
Curariform Drugs
Diuretic-induced hypokalemia may enhance neuromuscular blocking effects of
curariform drugs (such as tubocurarine) the most serious effect would be respiratory
depression which could proceed to apnea. Accordingly, it may be advisable to
discontinue MYKROX Tablets three days before elective surgery.
Salicylates and Other Non-Steroidal Anti-Inflammatory Drugs
May decrease the antihypertensive effects of MYKROX Tablets.
Sympathomimetics
Metolazone may decrease arterial responsiveness to norepinephrine, but this
diminution is not sufficient to preclude effectiveness of the pressor agent
for therapeutic use.
Insulin and Oral Antidiabetic Agents
See Glucose Tolerance under PRECAUTIONS, GENERAL.
Methenamine
Efficacy may be decreased due to urinary alkalizing effect of metolazone.
Anticoagulants
Metolazone, as well as other thiazide-like diuretics, may affect the hypoprothrombinemic
response to anticoagulants; dosage adjustments may be necessary.
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