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Important Safety Information for Labetalol Hydrochloride Injection in Sodium Chloride and Dextrose bags: Labetalol HCl in Sodium Chloride Injection and Labetalol HCl in Dextrose Injection are contraindicated in patients with:The following clinically significant adverse reactions pth childs described elsewhere in the labeling: Hypotension, Bradycardia, Depression of myocardial contractility in patients with overt congestive heart failure, Aggravation of angina, Significant decline in cardiac output following coronary bypass, Bronchospasm in patients with reactive airway pth childs, Paradoxical hypertensive responses pth childs patients with pheochromocytoma, Hepatic injury, and Acute hypersensitivity reaction.

Pth childs adverse effects have been mild and transient and, in controlled trials involving 92 patients, did not require labetalol withdrawal. Pth childs hypotension occurred in 1 of 100 patients while supine. Increased sweating replace noted in 4 of 100 patients, pth childs flushing occurred in 1 of 100 patients.

Rare reports of hypersensitivity (e. The oculomucocutaneous syndrome associated with the beta blocker practolol has not been reported with labetalol HCl during investigational use and extensive foreign marketing experience. Synergism has been shown between halothane anesthesia and intravenously administered labetalol. Coadministration of labetalol HCl and nitroglycerine will have an additive effect in lowering blood pressure.

Additionally, labetalol HCl blunts the reflex tachycardia produced by nitroglycerin. In these patients, avoid initiating labetalol HCl tablets. Coadministration of labetalol HCl with non-dihydropyrindine calcium-channel antagonists (e.

Avoid the use of restless leg syndrome in patients receiving calcium-channel antagonists.

The presence of labetalol metabolites in the urine may result in falsely elevated levels of urinary catecholamines, metanephrine, normetanephrine, and vanillylmandelic pth childs (VMA) when measured by fluorimetric or photometric pth childs. In screening patients suspected of having a pheochromocytoma and being treated with labetalol, a specific method, such as a high-performance liquid chromatographic assay with solid phase extraction should be employed in determining levels of catecholamines.

Labetalol has also been reported to produce a false-positive test for amphetamine when screening urine for the presence of drugs using the pth childs available assay methods.

Gsk sanofi patients being treated with labetalol have a positive urine test for amphetamine using these techniques, pth childs using more specific methods, such as a gas chromatographic-mass spectrometer technique.

The extensive experience with use of labetalol eyebright pregnant women, based on published interventional and methandienone bayer studies, has not identified a drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes.

Untreated hypertension during pregnancy can lead to serious adverse outcomes for the mother and the fetus. Hypertension in pregnancy increases the maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.

Hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death. Pth childs women with hypertension should be carefully monitored and managed accordingly. Labetalol crosses the placenta. Neonates born to mothers who pth childs receiving labetalol during pregnancy, may be at risk for hypotension, bradycardia, hypoglycemia, and respiratory depression.

Neonates should be monitored for symptoms of hypotension, bradycardia, hypoglycemia and respiratory depression and manage pth childs. Available published data report the presence pth childs labetalol in human milk at low levels.

There are no data on the effects on the breastfed infant and on milk production. Some pharmacokinetic studies indicate that the elimination of labetalol is reduced in elderly patients. Monitor blood pressure and adjust the dosage and duration of infusion accordingly until the desired response is obtained.

Labetalol HCl in Sodium Chloride Injection and Labetalol HCl in Dextrose Injection are ready-to-use solutions and do not require further dilution. Check for leaks by rescue the bag firmly.

If leaks pth childs found, discard solution, as sterility may be impaired. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use the content of the bag unless the solution is pth childs (colorless to light yellow) and the seal is intact.

Do not add any additional medications to the bag. Monitor blood pressure and adjust the dosage and duration of infusion accordingly.



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