What happens if I overdose Uresix?
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include fainting; severe or persistent dizziness; symptoms of dehydration or electrolyte problems (eg, very dry mouth; unusual thirst; decreased urination; mental or mood changes, such as confusion; fast or irregular heartbeat; muscle aches, cramps, pain, spasms, or weakness; drowsiness; seizures; sluggishness; unusual restlessness, loss of appetite, or weakness; nausea and vomiting).
Proper storage of Uresix tablets:
Store Uresix tablets at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store in a tight, light-resistant container. Exposure to light may cause a slight discoloration. Do not take discolored tablets. Store away from heat and moisture. Do not store in the bathroom. Keep Uresix tablets out of the reach of children and away from pets.
Overdose of Uresix in details
The principal signs and symptoms of overdosage with Uresix are dehydration, blood volume reduction, hypotension, electrolyte imbalance, hypokalemia and hypochloremic alkalosis, and are extensions of its diuretic action.
The acute toxicity of Uresix has been determined in mice, rats and dogs. In all three, the oral LD50 exceeded 1000 mg/kg body weight, while the intravenous LD50 ranged from 300 to 680 mg/kg. The acute intragastric toxicity in neonatal rats is 7 to 10 times that of adult rats.
The concentration of Uresix in biological fluids associated with toxicity or death is not known.
Treatment of overdosage is supportive and consists of replacement of excessive fluid and electrolyte losses. Serum electrolytes, carbon dioxide level and blood pressure should be determined frequently. Adequate drainage must be assured in patients with urinary bladder outlet obstruction (such as prostatic hypertrophy).
Hemodialysis does not accelerate Uresix elimination.
What should I avoid while taking Uresix?
If you also take sucralfate, take it at least 2 hours before or after you take Uresix.
Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.
Avoid becoming dehydrated. Follow your doctor's instructions about the type and amount of liquids you should drink while you are taking Uresix.
Drinking alcohol with this medicine can cause side effects.
Uresix warnings
In patients with hepatic cirrhosis and ascites, Uresix therapy is best initiated in the hospital. In hepatic coma and in states of electrolyte depletion, therapy should not be instituted until the basic condition is improved. Sudden alterations of fluid and electrolyte balance in patients with cirrhosis may precipitate hepatic coma; therefore, strict observation is necessary during the period of diuresis. Supplemental potassium chloride and, if required, an aldosterone antagonist are helpful in preventing hypokalemia and metabolic alkalosis.
If increasing azotemia and oliguria occur during treatment of severe progressive renal disease, Uresix should be discontinued.
Cases of tinnitus and reversible or irreversible hearing impairment and deafness have been reported. Reports usually indicate that Uresix ototoxicity is associated with rapid injection, severe renal impairment, the use of higher than recommended doses, hypoproteinemia, or concomitant therapy with aminoglycoside antibiotics, ethacrynic acid, or other ototoxic drugs. If the physician elects to use high dose parenteral therapy, controlled intravenous infusion is advisable (for adults, an infusion rate not exceeding 4 mg Uresix per minute has been used)
Pediatric Use: In premature neonates with respiratory distress syndrome, diuretic treatment with Uresix in the first few weeks of life may increase the risk of persistent patent ductus arteriosus (PDA), possibly through a prostaglandin-E-mediated process.
Literature reports indicate that premature infants with post conceptual age (gestational plus postnatal) less than 31 weeks receiving doses exceeding 1 mg/kg/24 hours may develop plasma levels which could be associated with potential toxic effects including ototoxicity.
Hearing loss in neonates has been associated with the use of Uresix Injection.
What should I discuss with my healthcare provider before taking Uresix?
You should not use Uresix if you are allergic to Uresix, or:
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if you are unable to urinate.
To make sure Uresix is safe for you, tell your doctor if you have:
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kidney disease;
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enlarged prostate, bladder obstruction or other urination problems;
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cirrhosiss or other liver disease;
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an electrolyte imbalance (such as low levels of potassium or magnesium in your blood);
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high cholesterol or triglycerides (a type of fat in the blood);
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gout;
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lupus;
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diabetes; or
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sulfa drug allergy.
Tell your doctor if you have an MRI (magnetic resonance imaging) or any type of scan using a radioactive dye that is injected into your veins. Both contrast dyes and Uresix can harm your kidneys.
It is not known whether Uresix will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.
Uresix can pass into breast milk and may harm a nursing baby. This medicine may also slow breast milk production. Tell your doctor if you are breast-feeding a baby.
Uresix precautions
General
Excessive diuresis may cause dehydration and blood volume reduction with circulatory collapse and possibly vascular thrombosis and embolism, particularly in elderly patients. As with any effective diuretic, electrolyte depletion may occur during Uresix therapy, especially in patients receiving higher doses and a restricted salt intake. Hypokalemia may develop with Uresix, especially with brisk diuresis, inadequate oral electrolyte intake, when cirrhosis is present, or during concomitant use of corticosteroids, ACTH, licorice in large amounts, or prolonged use of laxatives. Digitalis therapy may exaggerate metabolic effects of hypokalemia, especially myocardial effects.
All patients receiving Uresix therapy should be observed for these signs or symptoms of fluid or electrolyte imbalance (hyponatremia, hypochloremic alkalosis, hypokalemia, hypomagnesemia or hypocalcemia): dryness of mouth, thirst, weakness, lethargy, drowsiness, restlessness, muscle pains or cramps, muscular fatigue, hypotension, oliguria, tachycardia, arrhythmia, or gastrointestinal disturbances such as nausea and vomiting. Increases in blood glucose and alterations in glucose tolerance tests (with abnormalities of the fasting and 2-hour postprandial sugar) have been observed, and rarely, precipitation of diabetes mellitus has been reported.
In patients with severe symptoms of urinary retention (because of bladder emptying disorders, prostatic hyperplasia, urethral narrowing), the administration of Uresix can cause acute urinary retention related to increased production and retention of urine. Thus, these patients require careful monitoring, especially during the initial stages of treatment.
In patients at high risk for radiocontrast nephropathy, Uresix can lead to a higher incidence of deterioration in renal function after receiving radiocontrast compared to high-risk patients who received only intravenous hydration prior to receiving radiocontrast.
In patients with hypoproteinemia (e.g., associated with nephrotic syndrome), the effect of Uresix may be weakened and its ototoxicity potentiated.
Asymptomatic hyperuricemia can occur and gout may rarely be precipitated.
Patients allergic to sulfonamides may also be allergic to Uresix. The possibility exists of exacerbation or activation of systemic lupus erythematosus.
As with many other drugs, patients should be observed regularly for the possible occurrence of blood dyscrasias, liver or kidney damage, or other idiosyncratic reactions.
Information for Patients
Patients receiving Uresix should be advised that they may experience symptoms from excessive fluid and/or electrolyte losses. The postural hypotension that sometimes occurs can usually be managed by getting up slowly. Potassium supplements and/or dietary measures may be needed to control or avoid hypokalemia.
Patients with diabetes mellitus should be told that Uresix may increase blood glucose levels and thereby affect urine glucose tests. The skin of some patients may be more sensitive to the effects of sunlight while taking Uresix.
Hypertensive patients should avoid medications that may increase blood pressure, including over-the-counter products for appetite suppression and cold symptoms.
Laboratory Tests
Serum electrolytes (particularly potassium), CO2, creatinine and BUN should be determined frequently during the first few months of Uresix therapy and periodically thereafter. Serum and urine electrolyte determinations are particularly important when the patient is vomiting profusely or receiving parenteral fluids. Abnormalities should be corrected or the drug temporarily withdrawn. Other medications may also influence serum electrolytes.
Reversible elevations of BUN may occur and are associated with dehydration, which should be avoided, particularly in patients with renal insufficiency.
Urine and blood glucose should be checked periodically in diabetics receiving Uresix, even in those suspected of latent diabetes.
Uresix may lower serum levels of calcium (rarely cases of tetany have been reported) and magnesium. Accordingly, serum levels of these electrolytes should be determined periodically.
In premature infants Uresix may precipitate nephrocalcinosis/nephrolithiasis, therefore renal function must be monitored and renal ultrasonography performed.
Drug Interactions
Uresix may increase the ototoxic potential of aminoglycoside antibiotics, especially in the presence of impaired renal function. Except in life-threatening situations, avoid this combination.
Uresix should not be used concomitantly with ethacrynic acid because of the possibility of ototoxicity. Patients receiving high doses of salicylates concomitantly with Uresix, as in rheumatic disease, may experience salicylate toxicity at lower doses because of competitive renal excretory sites.
There is a risk of ototoxic effects if cisplatin and Uresix are given concomitantly. In addition, nephrotoxicity of nephrotoxic drugs such as cisplatin may be enhanced if Uresix is not given in lower doses and with positive fluid balance when used to achieve forced diuresis during cisplatin treatment.
Uresix has a tendency to antagonize the skeletal muscle relaxing effect of tubocurarine and may potentiate the action of succinylcholine.
Lithium generally should not be given with diuretics because they reduce lithium’s renal clearance and add a high risk of lithium toxicity.
Uresix combined with angiotensin converting enzyme inhibitors or angiotensin II receptor blockers may lead to severe hypotension and deterioration in renal function, including renal failure. An interruption or reduction in the dosage of Uresix, angiotensin-converting enzyme inhibitors, or angiotensin receptor blockers may be necessary.
Potentiation occurs with ganglionic or peripheral adrenergic blocking drugs.
Uresix may decrease arterial responsiveness to norepinephrine. However, norepinephrine may still be used effectively.
Simultaneous administration of sucralfate and Uresix tablets may reduce the natriuretic and antihypertensive effects of Uresix. Patients receiving both drugs should be observed closely to determine if the desired diuretic and/or antihypertensive effect of Uresix is achieved. The intake of Uresix and sucralfate should be separated by at least two hours.
In isolated cases, intravenous administration of Uresix within 24 hours of taking chloral hydrate may lead to flushing, sweating attacks, restlessness, nausea, increase in blood pressure, and tachycardia. Use of Uresix concomitantly with chloral hydrate is therefore not recommended.
Phenytoin interferes directly with renal action of Uresix. There is evidence that treatment with phenytoin leads to decreased intestinal absorption of Uresix, and consequently to lower peak serum Uresix concentrations.
Methotrexate and other drugs that, like Uresix, undergo significant renal tubular secretion may reduce the effect of Uresix. Conversely, Uresix may decrease renal elimination of other drugs that undergo tubular secretion. High-dose treatment of both Uresix and these other drugs may result in elevated serum levels of these drugs and may potentiate their toxicity as well as the toxicity of Uresix.
Uresix can increase the risk of cephalosporin-induced nephrotoxicity even in the setting of minor or transient renal impairment.
Concomitant use of cyclosporine and Uresix is associated with increased risk of gouty arthritis secondary to Uresix-induced hyperurecemia and cyclosporine impairment of renal urate excretion.
High doses (>80 mg) of Uresix may inhibit the binding of thyroid hormones to carrier proteins and result in transient increase in free thyroid hormones, followed by an overall decrease in total thyroid hormone levels.
One study in six subjects demonstrated that the combination of Uresix and acetylsalicylic acid temporarily reduced creatinine clearance in patients with chronic renal insufficiency. There are case reports of patients who developed increased BUN, serum creatinine and serum potassium levels, and weight gain when Uresix was used in conjunction with NSAIDs.
Literature reports indicate that coadministration of indomethacin may reduce the natriuretic and antihypertensive effects of Uresix (Uresix) in some patients by inhibiting prostaglandin synthesis. Indomethacin may also affect plasma renin levels, aldosterone excretion, and renin profile evaluation. Patients receiving both indomethacin and Uresix should be observed closely to determine if the desired diuretic and/or antihypertensive effect of Uresix is achieved.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Uresix was tested for carcinogenicity by oral administration in one strain of mice and one strain of rats. A small but significantly increased incidence of mammary gland carcinomas occurred in female mice at a dose 17.5 times the maximum human dose of 600 mg. There were marginal increases in uncommon tumors in male rats at a dose of 15 mg/kg (slightly greater than the maximum human dose) but not at 30 mg/kg.
Uresix was devoid of mutagenic activity in various strains of Salmonella typhimurium when tested in the presence or absence of an in vitro metabolic activation system, and questionably positive for gene mutation in mouse lymphoma cells in the presence of rat liver S9 at the highest dose tested. Uresix did not induce sister chromatid exchange in human cells in vitro, but other studies on chromosomal aberrations in human cells in vitro gave conflicting results. In Chinese hamster cells it induced chromosomal damage but was questionably positive for sister chromatid exchange. Studies on the induction by Uresix of chromosomal aberrations in mice were inconclusive. The urine of rats treated with this drug did not induce gene conversion in Saccharomyces cerevisiae.
Uresix (Uresix) produced no impairment of fertility in male or female rats, at 100 mg/kg/day (the maximum effective diuretic dose in the rat and 8 times the maximal human dose of 600 mg/day).
Pregnancy
PREGNANCY CATEGORY C - Uresix has been shown to cause unexplained maternal deaths and abortions in rabbits at 2, 4 and 8 times the maximal recommended human dose. There are no adequate and well-controlled studies in pregnant women. Uresix should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Treatment during pregnancy requires monitoring of fetal growth because of the potential for higher birth weights.
The effects of Uresix on embryonic and fetal development and on pregnant dams were studied in mice, rats and rabbits.
Uresix caused unexplained maternal deaths and abortions in the rabbit at the lowest dose of 25 mg/kg (2 times the maximal recommended human dose of 600 mg/day). In another study, a dose of 50 mg/kg (4 times the maximal recommended human dose of 600 mg/day) also caused maternal deaths and abortions when administered to rabbits between Days 12 and 17 of gestation. In a third study, none of the pregnant rabbits survived a dose of 100 mg/kg. Data from the above studies indicate fetal lethality that can precede maternal deaths.
The results of the mouse study and one of the three rabbit studies also showed an increased incidence and severity of hydronephrosis (distention of the renal pelvis and, in some cases, of the ureters) in fetuses derived from the treated dams as compared with the incidence in fetuses from the control group.
Nursing Mothers
Because it appears in breast milk, caution should be exercised when Uresix is administered to a nursing mother.
Uresix may inhibit lactation.
Pediatric Use
In premature infants Uresix may precipitate nephrocalcinosis/nephrolithiasis. Nephrocalcinosis/nephrolithiasis has also been observed in children under 4 years of age with no history of prematurity who have been treated chronically with Uresix. Monitor renal function, and renal ultrasonography should be considered, in pediatric patients receiving Uresix.
If Uresix is administered to premature infants during the first weeks of life, it may increase the risk of persistence of patent ductus arteriosus
Geriatric Use
Controlled clinical studies of Uresix did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for the elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection and it may be useful to monitor renal function.
What happens if I miss a dose of Uresix?
Uresix is sometimes used only once, so you may not be on a dosing schedule. If you are using the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
References
- DailyMed. "FUROSEMIDE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- DrugBank. "furosemide". http://www.drugbank.ca/drugs/DB00695 (accessed September 17, 2018).
- MeSH. "Sodium Potassium Chloride Symporter Inhibitors". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
