Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/2299
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ENDURONYL (Tablet)
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Dosage should be determined by individual titration
of ingredients (see BOXED WARNING). Dosage of both components should be carefully adjusted to
the needs of the individual patient. Since at least 10 days to 2 weeks may
elapse before the full effects of the drugs become manifest, the dosage of
the drugs should not be adjusted more frequently. Two
tablet strengths, ENDURONYL (methyclothiazide 5 mg, deserpidine 0.25 mg) and
ENDURONYL FORTE (methyclothiazide 5 mg, deserpidine 0.5 mg), each grooved,
are provided to permit considerable latitude in meeting the dosage requirements
of individual patients. The following table will
help in determining which dose of ENDURONYL or ENDURONYL FORTE tablets best
represents the equivalent of the titrated dose. The appropriate dose of ENDURONYL tablets is administered
orally, once daily. The usual adult dosage is one lower-strength ENDURONYL
tablet daily. Debilitated and elderly patients may require lower doses. There is no contraindication to combining ENDURONYL tablets
with other antihypertensive agents. When other antihypertensive agents are
to be added to the regimen, this should be accomplished gradually. Ganglionic
blocking agents should be given at only half the usual dose since their effect
is potentiated by pretreatment with ENDURONYL tablets.
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ENDURONYL tablets are an orally administered combination
of Enduron (methyclothiazide) and deserpidine. ENDURONYL
tablets are available in two dosage strengths. ENDURONYL tablets contain
methyclothiazide 5 mg and deserpidine 0.25 mg. ENDURONYL FORTE tablets
contain methyclothiazide 5 mg and deserpidine 0.5 mg.<br/>Inactive Ingredients:<br/>ENDURONYL Tablets: Corn starch, D&C Yellow No. 10, FD&C Yellow
No. 6, lactose, magnesium stearate and talc.<br/>ENDURONYL FORTE Tablets: Corn starch, iron oxide, lactose, magnesium stearate
and talc. Methyclothiazide is an oral diuretic-antihypertensive
of the benzothiadiazine (thiazide) class of drugs. It occurs as a white to
practically white crystalline powder which is basically odorless and has a
molecular weight of 360.25. Methyclothiazide is very slightly soluble in
water and chloroform, and slightly soluble in alcohol. Chemically, methyclothiazide
is represented as 6-chloro-3-(chloromethyl)-3,4-dihydro-2-methyl-2H-1,2,4-benzothiadiazine-7-sulfonamide
1,1-dioxide. Deserpidine is a purified rauwolfia
alkaloid. It occurs as a white to light yellow crystalline powder and has
a molecular weight of 578.64. Deserpidine is insoluble in water and very
slightly soluble in alcohol. Chemically, deserpidine is identified as 17��-methoxy-18��-[(3,4,5-trimethoxybenzoyl)oxy]-3��,20��-yohimban-16��-carboxylic
acid methyl ester. The structural formulas are:
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Methyclothiazide is contraindicated in patients with
anuria and in patients with a history of hypersensitivity to this or other
sulfonamide-derived drugs. Deserpidine is contraindicated
in patients with known hypersensitivity, history of mental depression especially
with suicidal tendencies, active peptic ulcer, and ulcerative colitis. It
is also contraindicated in patients receiving electroconvulsive therapy.
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ENDURONYL (methyclothiazide and deserpidine) is supplied
as monogrammed, grooved, square-shaped tablets in the following dosage sizes
and quantities: ENDURONYL (5 mg of methyclothiazide
and 0.25 mg of deserpidine) yellow tablets bearing the Abbott���A���logo and Abbo-Code LS for product identification
in bottles of 100 (NDC 0074-6838-01). ENDURONYL FORTE (5 mg of methyclothiazide and 0.5 mg of deserpidine)
gray-colored tablets bearing the Abbott���A���logo and Abbo-Code LT for product identification in bottles of 100
(NDC 0074-6854-01).<br/>Recommended Storage: Store below 86��F (30��C). Abbott Laboratories North Chicago,
IL 60064, U.S.A. Printed in U.S.A.
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WARNING:This
fixed combination drug is not indicated for initial therapy of hypertension.
Hypertension requires therapy titrated to the individual patient. If the
fixed combination represents the dosage so determined, its use may be more
convenient in patient management. The treatment of hypertension is not static,
but must be reevaluated as conditions in each patient warrant.
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Symptoms of thiazide overdosage include electrolyte
imbalance and signs of potassium deficiency such as confusion, dizziness,
muscular weakness, and gastrointestinal disturbances. General supportive
measures including replacement of fluids and electrolytes may be indicated
in treatment of overdosage. An overdosage of
deserpidine is characterized by flushing of the skin, conjunctival injection,
and pupillary constriction. Sedation ranging from drowsiness to coma may
occur. Hypotension, hypothermia, central respiratory depression, and bradycardia
may develop in cases of severe overdosage. Treatment consists of the careful
evacuation of stomach contents followed by the usual procedures for the symptomatic
management of CNS depressant overdosage. If severe hypotension occurs, it
should be treated with a direct-acting vasopressor (e.g., norepinephrine).
If bradycardia becomes marked, especially with cardiac arrhythmia, consider
use of atropine or other anticholinergic drug. Because of prolonged effects
of deserpidine, the patient should be closely observed for at least 72 hours.
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METHYCLOTHIAZIDE AND DESERPIDINE
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ENDURONYL (Tablet)
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Adverse reactions are usually reversible upon reduction
of dosage or discontinuation of ENDURONYL tablets. Whenever adverse reactions
are moderate or severe, it may be necessary to discontinue the drug. The following adverse reactions have been observed, but there
has not been enough systematic collection of data to support an estimate of
their frequency. Consequently, the reactions are categorized by organ system
and are listed in decreasing order of severity and not frequency.<br/>Methyclothiazide:<br/>Body as a Whole: Headache, cramping, weakness.<br/>Cardiovascular System: Orthostatic hypotension (may be potentiated by
alcohol, barbiturates, or narcotics).<br/>Digestive System: Pancreatitis, jaundice (intrahepatic cholestatic),
sialadenitis, vomiting, diarrhea, nausea, gastric irritation, constipation,
anorexia.<br/>Hemic and Lymphatic System: Aplastic anemia, hemolytic anemia, agranulocytosis,
leukopenia, thrombocytopenia.<br/>Hypersensitivity Reactions: Anaphylactic reactions, necrotizing angiitis (vasculitis,
cutaneous vasculitis), Stevens-Johnson syndrome, respiratory distress (including
pneumonitis and pulmonary edema), fever, purpura, urticaria, rash, photosensitivity.<br/>Metabolic and Nutritional Disorders: Hyperglycemia, hyperuricemia, electrolyte imbalance
(see PRECAUTIONS), hypercalcemia.<br/>Nervous System: Vertigo, dizziness, paresthesias, muscle spasm,
restlessness.<br/>Special Senses: Transient blurred vision, xanthopsia.<br/>Urogenital System: Glycosuria.<br/>Deserpidine:<br/>Body as a Whole: Headache.<br/>Cardiovascular System: Arrhythmias (particularly when used concurrently
with digitalis or quinidine), syncope, angina-like symptoms, bradycardia,
fluid retention.<br/>Digestive System: Vomiting, diarrhea, nausea, anorexia, dryness
of mouth, hypersecretion, increased motility, increased salivation.<br/>Hemic and Lymphatic System: Thrombocytopenic purpura.<br/>Metabolic and Nutritional Disorders: Weight gain.<br/>Musculoskeletal System: Muscular aches.<br/>Nervous System: Rare parkinsonian syndrome and other extrapyramidal
tract symptoms, dizziness, paradoxical anxiety, depression, nervousness, nightmares,
dull sensorium, drowsiness, decreased libido.<br/>Respiratory System: Asthma in asthmatic patients, dyspnea, epistaxis,
nasal congestion.<br/>Skin and Appendages: Rash, pruritus, flushing of skin.<br/>Special Senses: Deafness, optic atrophy, glaucoma, uveitis, conjunctival
injection.<br/>Urogenital System: Nonpuerperal lactation, impotence, dysuria, gynecomastia,
breast engorgement.
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Methyclothiazide: Methyclothiazide shares with other thiazides the
propensity to deplete potassium reserves to an unpredictable degree. There have been isolated reports that certain nonedematous
individuals developed severe fluid and electrolyte derangements after only
brief exposure to normal doses of thiazide and nonthiazide diuretics. Thiazides should be used with caution in patients with renal
disease or significant impairment of renal function, since azotemia may be
precipitated and cumulative drug effects may occur. Thiazides
should 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. 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. Hyperuricemia
may occur or frank gout may be precipitated in certain patients receiving
thiazide therapy.<br/>Deserpidine: Deserpidine differs slightly in chemical structure
from reserpine; however, its actions, indications, cautions, and adverse reactions
are common to the class of rauwolfia alkaloids. Reserpine may cause mental
depression. Recognition of depression may be difficult because this condition
may often be disguised by somatic complaints (Masked Depression). The drug
should be discontinued at first signs of depression such as despondency, early
morning insomnia, loss of appetite, impotence, or self-deprecation. Drug-induced
depression may persist for several months after drug withdrawal and may be
severe enough to result in suicide.
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ENDURONYL
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