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
Visken Side Effects, and Drug Interactions - Pindolol
Visken Side Effects, and Drug Interactions - Pindolol
SIDE EFFECTS
Most adverse reactions have been mild. The incidences listed in the following
table are derived from 12-week comparative double-blind, parallel design
trials in hypertensive patients given pindolol as monotherapy, given various
active control drugs as monotherapy, or given placebo. Data for pindolol
and the positive controls were pooled from several trials because no striking
differences were seen in the individual studies, with 1 exception. When
considering all adverse reactions reported, the frequency of edema was
noticeably higher in positive control trials (16% pindolol vs. 9% positive
control) than in placebo controlled trials (6% pindolol vs. 3% placebo).
The table includes adverse reactions either volunteered or elicited,
and at least possibly drug related, which were reported in greater than
2% of pindolol patients and other selected important reactions.
Adverse Reactions Which Were Volunteered or Elicited
(and at least possibly drug related)
|
Body System/
Adverse REACTIONS
|
Pindolol
(N = 322)
|
Active
Controls*
(N = 188)
|
Placebo
(N = 78)
|
| Central Nervous System |
| Bizarre or Many Dreams |
5
|
0 |
6 |
| Dizziness |
9
|
11 |
1 |
| Fatigue |
8
|
4 |
4 |
| Hallucinations |
<1 |
0 |
0 |
| Insomnia |
10 |
3 |
10 |
| Nervousness |
7 |
3 |
5 |
| Weakness |
4 |
2 |
1 |
| Autonomic Nervous System |
| Paresthesia |
3
|
1
|
6
|
| Cardiovascular |
| Dyspnea |
5 |
4 |
6 |
| Edema |
6 |
3 |
1 |
| Heart Failure |
<1 |
<1 |
0 |
| Palpitations |
<1 |
1 |
0 |
| Musculoskeletal |
| Chest Pain |
3 |
1 |
3 |
| Joint Pain |
7 |
4 |
4 |
| Muscle Cramps |
3 |
1 |
0 |
| Muscle Pain |
10 |
9 |
8 |
| Gastrointestinal |
| Abdominal Discomfort |
4 |
4
|
5
|
| Nausea |
5 |
2
|
1
|
| Skin |
| Pruritus |
<1 |
<1 |
0
|
| Rash |
<1 |
<1 |
1
|
*Active Controls: Patients received either propranolol, µ-methyldopa
or a diuretic (hydrochlorothiazide or chlorthalidone).
The following selected (potentially important) adverse reactions were
seen in 2% or fewer patients and their relationship to pindolol is uncertain.
Central Nervous System: anxiety, lethargy;
Autonomic Nervous System: visual disturbances, hyperhidrosis;
Caroiovascular: bradycardia, claudication, cold extremities,
heart block, hypotension, syncope, tachycardia, weight gain;
Gastrointestinal: diarrhea, vomiting;
Respiratory: wheezing;
Urogenital: impotence, pollakiuria;
Miscellaneous: eye discomfort or burning eyes.
Potential Adverse Effects
In addition, other adverse effects not afore-mentioned have been reported
with other beta-adrenergic blocking agents and should be considered potential
adverse effects of pindolol.
Central Nervous System: Reversible mental depression progressing
to catatonia; an acute reversible syndrome characterized by disorientation
for time and place, short-term memory loss, emotional lability, slightly
clouded sensorium, and decreased performance on neuropsychometrics.
Cardiovascular: Intensification of AV block. (See CONTRAINDICATIONS.)
Allergic: Erythematous rash; fever combined with aching and sore
throat; laryngospasm; respiratory distress.
Hematologic: Agranulocytosis; thrombocytopenic and nonthrombocytopenic
purpura.
Gastrointestinal: Mesenteric arterial thrombosis; ischemic colitis.
Miscellaneous: Reversible alopecia; Peyronie’s disease.
The oculomucocutaneous syndrome associated with the beta-blocker practolol
has not been reported with pindolol during investigational use and extensive
foreign experience amounting to over 4 million patient-years.
DRUG INTERACTIONS
Catecholamine-depleting drugs (e.g., reserpine) may have an additive
effect when given with beta-blocking agents. Patients receiving pindolol
plus a catecholamine-depleting agent should, therefore, be closely observed
for evidence of hypotension and/or marked bradycardia which may produce
vertigo, syncope, or postural hypotension.
Pindolol has been used with a variety of antihypertensive agents, including
hydrochlorothiazide, hydralazine, and guanethidine without unexpected
adverse interactions.
Pindolol has been shown to increase serum thioridazine levels when both
drugs are co-administered. Pindolol levels may also be increased with
this combination.
Risk of anaphylactic reaction: While taking beta blockers,
patients with a history of severe anaphylactic reaction to a variety of
allergens may be more reactive to repeated challenge, either accidental,
diagnostic, or therapeutic. Such patients may be unresponsive to the usual
doses of epinephrine used to treat allergic reactions.
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