Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/3899
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Inderide (Tablet)
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Inderide Tablets for oral administration combine
two antihypertensive agents: Inderal (propranolol hydrochloride),
a beta-adrenergic blocking agent, and hydrochlorothiazide, a thiazide
diuretic-antihypertensive. Inderide 40/25 Tablets contain 40 mg
propranolol hydrochloride and 25 mg hydrochlorothiazide; Inderide
80/25 Tablets contain 80 mg propranolol hydrochloride and 25 mg
hydrochlorothiazide. Inderal (propranolol hydrochloride)
is a synthetic beta-adrenergic receptor-blocking agent chemically
described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-,
hydrochloride,(��)-. Its structural formula is: Propranolol hydrochloride is a stable, white, crystalline solid which
is readily soluble in water and ethanol. Its molecular weight is 295.80. Hydrochlorothiazide is a white, or practically white,
practically odorless, crystalline powder. It is slightly soluble in
water; freely soluble in sodium hydroxide solution; sparingly soluble
in methanol; insoluble in ether, chloroform, benzene, and dilute mineral
acids. Its chemical name is: 6-Chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide
1,1-dioxide. Its structural formula is: The inactive ingredients contained in Inderide Tablets are lactose,
magnesium stearate, microcrystalline cellulose, stearic acid, and
yellow ferric oxide.
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Angina Pectoris: There have been reports of exacerbation of angina and, in some cases,
myocardial infarction following abrupt discontinuation of propranolol therapy. Therefore, when discontinuance
of propranolol is planned, the dosage should be gradually reduced
and the patient should be carefully monitored. In addition, when propranolol
is prescribed for angina pectoris, the patient should be cautioned
against interruption or cessation of therapy without the physician's
advice. If propranolol therapy is interrupted and exacerbation of
angina occurs, it usually is advisable to reinstitute propranolol
therapy and take other measures appropriate for the management of
unstable angina pectoris. Since coronary artery disease may be unrecognized,
it may be prudent to follow the above advice in patients considered
at risk of having occult atherosclerotic heart disease, who are given
propranolol for other indications.
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Propranolol Hydrochloride and Hydrochlorothiazide
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Inderide (Tablet)
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The following adverse reactions have been observed,
but there is not enough systematic collection of data to support an
estimate of their frequency. Within each category, adverse reactions
are listed in decreasing order of severity. Although many side effects
are mild and transient, some require discontinuation of therapy.<br/>Propranolol hydrochloride (Inderal): Cardiovascular: Congestive heart failure; hypotension; intensification of AV block;
bradycardia; thrombocytopenic purpura; arterial insufficiency, usually
of the Raynaud type; paresthesia of hands. Central Nervous System: Reversible
mental depression progressing to catatonia; mental depression manifested
by insomnia, lassitude, weakness, fatigue; an acute reversible syndrome
characterized by disorientation for time and place, short-term memory
loss, emotional lability, slightly clouded sensorium, decreased performance
on neuropsychometrics; hallucinations; visual disturbances; vivid
dreams; light-headedness. Total daily doses above 160 mg (when
administered as divided doses of greater than 80 mg each) may
be associated with an increased incidence of fatigue, lethargy, and
vivid dreams. Gastrointestinal: Mesenteric arterial thrombosis; ischemic
colitis; nausea, vomiting, epigastric distress, abdominal cramping,
diarrhea, constipation. Allergic: Hypersensitivity reactions,
including anaphylactic/anaphylactoid reactions; laryngospasm and respiratory
distress; pharyngitis and agranulocytosis; fever combined with aching
and sore throat; erythematous rash. Respiratory: Bronchospasm. Hematologic: Agranulocytosis;
nonthrombocytopenic purpura; thrombocytopenic purpura. Autoimmune: In
extremely rare instances, systemic lupus erythematosus has been reported. Miscellaneous: Male impotence. Alopecia, LE-like reactions, psoriasiform rashes,
dry eyes, and Peyronie's disease have been reported rarely. Oculomucocutaneous
reactions involving the skin, serous membranes, and conjunctivae reported
for a beta blocker (practolol) have not been associated with propranolol. Skin: Stevens-Johnson
Syndrome; toxic epidermal necrolysis; exfoliative dermatitis; erythema
multiforme; urticaria.<br/>Hydrochlorothiazide: Cardiovascular: Orthostatic hypotension (may be aggravated by alcohol, barbiturates
or narcotics). Central Nervous System: Dizziness, vertigo, headache, xanthopsia,
paresthesias. Gastrointestinal: Pancreatitis; jaundice (intrahepatic
cholestatic jaundice); sialadenitis; anorexia, nausea, vomiting, gastric
irritation, cramping, diarrhea, constipation. Hypersensitivity: Anaphylactic
reactions; necrotizing angiitis (vasculitis, cutaneous vasculitis);
respiratory distress including pneumonitis; fever; urticaria, rash,
purpura, photosensitivity. Hematologic: Aplastic anemia, agranulocytosis,
leukopenia, thrombocytopenia. Miscellaneous: Hyperglycemia, glycosuria;
hyperuricemia; muscle spasm; weakness; restlessness; transient blurred
vision. Whenever adverse reactions are moderate
or severe, thiazide dosage should be reduced or therapy withdrawn.
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Propranolol hydrochloride (Inderal): Hypersensitivity reactions, including anaphylactic/anaphylactoid
reactions, have been associated with the administration of propranolol
(see���ADVERSE
REACTIONS���). Cardiac Failure: Sympathetic stimulation is a vital component supporting circulatory
function in congestive heart failure, and inhibition with beta blockade
always carries the potential hazard of further depressing myocardial
contractility and precipitating cardiac failure. Propranolol acts
selectively without abolishing the inotropic action of digitalis on
the heart muscle (i.e., that of supporting the strength of myocardial
contractions). In patients already receiving digitalis, the positive
inotropic action of digitalis may be reduced by propranolol's
negative inotropic effect. Patients Without a History
of Heart Failure: Continued depression of the myocardium
over a period of time can, in some cases, lead to cardiac failure.
In rare instances, this has been observed during propranolol therapy.
Therefore, at the first sign or symptom of impending cardiac failure,
patients should be fully digitalized and/or given additional diuretic,
and the response observed closely: a) if cardiac failure continues,
despite adequate digitalization and diuretic therapy, propranolol
therapy should be withdrawn (gradually, if possible); b) if tachyarrhythmia
is being controlled, patients should be maintained on combined therapy
and the patient closely followed until threat of cardiac failure is
over. Angina Pectoris: There have been reports of exacerbation of angina and, in some cases,
myocardial infarction following abrupt discontinuation of propranolol therapy. Therefore, when discontinuance
of propranolol is planned, the dosage should be gradually reduced
and the patient should be carefully monitored. In addition, when propranolol
is prescribed for angina pectoris, the patient should be cautioned
against interruption or cessation of therapy without the physician's
advice. If propranolol therapy is interrupted and exacerbation of
angina occurs, it usually is advisable to reinstitute propranolol
therapy and take other measures appropriate for the management of
unstable angina pectoris. Since coronary artery disease may be unrecognized,
it may be prudent to follow the above advice in patients considered
at risk of having occult atherosclerotic heart disease, who are given
propranolol for other indications. Nonallergic Bronchospasm (e.g., chronic bronchitis, emphysema): PATIENTS WITH BRONCHOSPASTIC
DISEASES SHOULD, IN GENERAL, NOT RECEIVE BETA BLOCKERS. Propranolol
should be administered with caution since it may block bronchodilation
produced by endogenous and exogenous catecholamine stimulation of
beta receptors. Major Surgery: The necessity or desirability of withdrawal of beta-blocking therapy
prior to major surgery is controversial. It should be noted, however,
that the impaired ability of the heart to respond to reflex adrenergic
stimuli may augment the risks of general anesthesia and surgical procedures. Propranolol, like other beta blockers, is a competitive
inhibitor of beta-receptor agonists, and its effects can be reversed
by administration of such agents, e.g., dobutamine or isoproterenol.
However, such patients may be subject to protracted severe hypotension.
Difficulty in starting and maintaining the heartbeat has also been
reported with beta blockers. Diabetes and Hypoglycemia: Beta-adrenergic blockade may prevent the appearance of certain premonitory
signs and symptoms (pulse rate and pressure changes) of acute hypoglycemia
in labile insulin-dependent diabetes. In these patients, it may be
more difficult to adjust the dosage of insulin. Hypoglycemic attack
may be accompanied by a precipitous elevation of blood pressure in
patients on propranolol. Propranolol therapy,
particularly in infants and children, diabetic or not, has been associated
with hypoglycemia especially during fasting as in preparation for
surgery. Hypoglycemia also has been found after this type of drug
therapy and prolonged physical exertion and has occurred in renal
insufficiency, both during dialysis and sporadically, in patients
on propranolol. Acute increases in blood pressure
have occurred after insulin-induced hypoglycemia in patients on propranolol. Thyrotoxicosis: Beta blockade may mask certain clinical signs of hyperthyroidism.
Therefore, abrupt withdrawal of propranolol may be followed by an
exacerbation of symptoms of hyperthyroidism, including thyroid storm.
Propranolol may change thyroid-function tests, increasing Tand reverse T, and decreasing T. Wolff-Parkinson-White Syndrome: Several cases have been reported in which, after propranolol, the
tachycardia was replaced by a severe bradycardia requiring a demand
pacemaker. In one case this resulted after an initial dose of 5 mg
propranolol. Skin Reactions: Cutaneous reactions, including Stevens-Johnson Syndrome, toxic epidermal
necrolysis, exfoliative dermatitis, erythema multiforme, and urticaria,
have been reported with use of propranolol .<br/>Hydrochlorothiazide: Thiazides should be used with caution in severe renal
disease. In patients with renal disease, thiazides may precipitate
azotemia. In patients with impaired renal function, cumulative effects
of the drug may develop. Thiazides should also
be used with caution in patients with impaired hepatic function or
progressive liver disease, since minor alterations of fluid and electrolyte
balance may precipitate hepatic coma. Thiazides
may add to or potentiate the action of other antihypertensive drugs.
Potentiation occurs with ganglionic or peripheral adrenergic-blocking
drugs. Sensitivity reactions may occur in patients
with a history of allergy or bronchial asthma. The possibility of
exacerbation or activation of systemic lupus erythematosus has been
reported.
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Inderide
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