Trandate (Labetalol Hydrochloride) - Summary

TRANDATE SUMMARY

TRANDATE^®
(labetalol hydrochloride)
Tablets

TRANDATE Tablets are adrenergic receptor blocking agents that have both selective alpha₁-adrenergic and nonselective beta-adrenergic receptor blocking actions in a single substance.

TRANDATE Tablets are indicated in the management of hypertension. TRANDATE Tablets may be used alone or in combination with other antihypertensive agents, especially thiazide and loop diuretics.

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NEWS HIGHLIGHTS

Published Studies Related to Trandate (Labetalol)

Benzodiazepine and opioid sedation attenuate the sympathetic response to fiberoptic bronchoscopy. Prophylactic labetalol gave no additional benefit. Results of a randomized double-blind placebo-controlled study. [2008.07]
BACKGROUND: Hypertension and tachycardia are common during fiber-optic bronchoscopy (FOB), and this may lead to cardiac ischemia. The prophylactic addition of a beta-adrenergic anatagonist might mask this response and prevent the deleterious cardiovascular effects of FOB... CONCLUSIONS: Patients undergoing FOB under adequate midazolam-alfentanil sedation do not develop excessive sympathetic drive that may lead to cardiac stress. The addition of labetalol did not confer additional benefit or risk to the patients. (ClinicalTrials.gov number, NCT00394537).

Management of severe hypertension in the postpartum period with intravenous hydralazine or labetalol: a randomized clinical trial. [2007]
OBJECTIVE: To compare the safety and efficacy of intravenous labetalol and intravenous hydralazine for acutely lowering blood pressure in the puerperium. DESIGN: Randomized clinical trial. SETTING: Critical care unit of gynecology and obstetrics department in the Complejo hospitalario "Dr. AAM" de la Caja de Seguro Social in Panama. POPULATION: Eighty-two women with severe hypertension during the postpartum period... CONCLUSIONS: This randomized clinical trial shows that intravenous hydralazine and intravenous labetalol are effective and safe in the management of severe hypertension in the postpartum period.

Severe hypertension in pregnancy: hydralazine or labetalol. A randomized clinical trial. [2006.09]
OBJECTIVE: The objective was to compare the safety and efficacy of intravenous labetalol and intravenous hydralazine for acutely lowering blood pressure in pregnancy... CONCLUSIONS: This randomized clinical trial shows that labetalol and hydralazine fulfill the criteria required for an antihypertensive drug to treat severe hypertension in pregnancy.

Pharmacokinetic interaction studies of atosiban with labetalol or betamethasone in healthy female volunteers. [2005.11]
OBJECTIVES: In two separate trials, we studied the concomitant administration of atosiban with labetalol and betamethasone to determine any possibility of a clinically relevant pharmacokinetic interaction. DESIGN: Study 1 was an open-label, single dose atosiban, multiple dose labetalol, interaction study. Study 2 was an open-label, randomised, three-period crossover pharmacokinetic study. SETTING: The studies were carried out at the Clinical Pharmacology Unit of AAI Deutschland GmbH & Co KG, Neu-Ulm, Germany. POPULATION: The study population consisted of healthy female volunteers... CONCLUSION: The co-administration of atosiban with betamethasone or labetalol had no clinically relevant influence on their bioavailability or tolerability.

Labetalol treatment enhances the attenuation of tobacco withdrawal symptoms by nicotine in abstinent smokers. [2003.12]
The noradrenergic system may mediate some of the acute physiological effects of nicotine and nicotine withdrawal symptoms. This study examined the effects of labetalol, an alpha- and beta-adrenergic receptor blocker, on acute physiological and subjective effects of intravenous nicotine and on tobacco withdrawal symptoms...

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Clinical Trials Related to Trandate (Labetalol)

Evaluation of IV Cardene(Nicardipine)and Labetalol Use in the Emergency Department [Recruiting]

Labetalol Versus Magnesium Sulfate (MgSO4) for the Prevention of Eclampsia Trial [Recruiting]
Eclampsia is a major cause of perinatal morbidity and mortality. The pathophysiology is not known but magnetic resonance imaging (MRI) and Doppler data suggest that overperfusion of the cerebral tissues is a major etiologic factor. Hypertensive encephalopathy from overperfusion, and vascular damage from excessive arterial pressure (cerebral barotrauma) are believed to lead to vasogenic and cytotoxic cerebral edema, with resultant neuronal anomalies, seizure activity and cerebral bleeding if left unchecked. Doppler data have shown that cerebral perfusion pressure (CPP) is abnormally increased in severe preeclampsia and that autoregulation of the middle cerebral artery is affected by this condition leading to increased CPP. Magnesium sulfate (MgSO4) is the most widely accepted eclampsia treatment and prophylactic agent, and it has been used in the USA since the 1950's. Despite widespread use, its mechanism of action is unknown. MgSO4 is given intravenously or intramuscularly and requires specialized nursing training and monitoring to minimize toxicity from respiratory and cardiac depression. Labetalol, a combined alpha and beta blocker, has been used for many years to safely treat hypertension in preeclamptic women, and is now known to reduce CPP in women with preeclampsia. In the United Kingdom labetalol was for many years used as the sole agent in treating preeclampsia, and the rate of seizure was no different to that reported in the USA with MgSO4. Since labetalol can be administered orally, is economical, has low toxicity potential, does not require specialized training to administer or monitor, and decreases CPP, it may be an ideal agent for controlling blood pressure (BP) and decreasing the incidence of eclampsia in women with preeclampsia. The current study is a multicenter, randomized, controlled trial to compare the anti-seizure effect of parenteral MgSO4 versus oral labetalol in hypertensive pregnant women who are eligible for MgSO4 therapy. The primary outcome measure is eclampsia, and the secondary outcome measures include blood pressure control, and relevant antenatal, intrapartum, and postnatal maternal and fetal/neonatal parameters including adverse effects and complications. Inclusion criteria are deliberately broad in order to make the study clinically relevant. Hypertensive pregnant women, in whom the decision for delivery has been made, will be enrolled after written, informed consent. Patients will be randomized to receive MgSO4 therapy as given in their institution, versus oral labetalol (200mg/q6 hours), from enrollment in the study until 24 hours post delivery. There will be 4000 patients in each arm of the study and analysis will be by intention-to-treat. The study is powered to show both therapeutic superiority as well as clinical equivalence. This study has the potential to change the way preeclampsia is managed, and will represent a major advance in terms of the availability and safety of prophylactic therapy, especially in developing nations where MgSO4 is underutilized due to cost constraints.

Effects of Labetalol on Human Cocaine Use - 8 [Completed]

Effects of Labetalol on Nicotine Administration in Humans - 14 [Completed]

Labetalol to Prevent Hypertension and Tachycardia During Fiberoptic Bronchoscopy [Completed]
Passing a bronchoscope through the airways frequently causes a stress response even though patients are sedated. This stress response is usually an increase in pulse and blood pressure, which may have undesirable effects on the heart and circulation.

We plan to give patients labetalol (a beta blocker which reduces pulse and blood pressure) in addition to normal sedation, to patients undergoing bronchoscopy in our department.

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