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)
Oral nifedipine or intravenous labetalol for hypertensive emergency in pregnancy:
a randomized controlled trial. [2013]
hypertensive emergency of pregnancy... CONCLUSION: As administered in this trial, oral nifedipine lowered blood pressure
Changes in fetal and maternal Doppler parameters observed during acute severe hypertension treatment with hydralazine or labetalol: a randomized controlled trial. [2011.01]
We evaluated 16 pregnant women with gestational age between 20 and 32 weeks in acute severe hypertension which were randomly allocated to receive either hydralazine or labetalol. Blood pressure and Doppler ultrasound parameters from maternal uterine and fetal middle cerebral and umbilical arteries were assessed during acute severe hypertension and after treatment...
CLUE: a randomized comparative effectiveness trial of IV nicardipine versus labetalol use in the emergency department. [2011]
INTRODUCTION: Our purpose was to compare the safety and efficacy of food and drug administration (FDA) recommended dosing of IV nicardipine versus IV labetalol for the management of acute hypertension... CONCLUSIONS: Patients treated with nicardipine are more likely to reach the physician-specified SBP target range within 30 minutes than those treated with 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.
Clinical Trials Related to Trandate (Labetalol)
Labetalol and Esmolol: Vital Signs and Post Operative Pain Management [Recruiting]
This study proposes to investigate the effects of labetalol or esmolol on managing the vital
signs (like blood pressure and heart rate) during surgery, on pain management, and on the
later recovery after surgery.
It will also assess the cost-effectiveness of Labetalol and esmolol for outpatient surgery.
Oral Nifedipine Versus Oral Labetalol [Recruiting]
This study's aim is to determine whether oral extended release nifedipine is superior to
oral labetolol for the management of postpartum severe hypertension, specifically time to
achieve goal blood pressure, and shortening hospital stay. Our hypothesis is that oral
extended release nifedipine is superior to oral labetolol for achieving goal blood pressure
in the postpartum period.
Hydralazine Versus Labetalol for the Management of Hypertensive Disorders of Pregnancy [Completed]
Hypertensive crisis (defined as a systolic pressure > 160mmHg or a diastolic pressure >
110mmHg) in patients with a hypertensive disorder of pregnancy is a serious complication
with severe and even deadly consequences. The management in this population had been
studied, but no consensus has been reached with regards to which treatment is better. Our
study will compare two drugs: Hydralazine and Labetalol for the management of hypertensive
crisis.
Evaluation of Intravenous Cardene(Nicardipine)and Labetalol Use in the Emergency Department [Completed]
Labetalol Versus Magnesium Sulfate (MgSO4) for the Prevention of Eclampsia Trial [Suspended]
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.
Reports of Suspected Trandate (Labetalol) Side Effects
Foetal Growth Restriction (7),
Leukocytoclastic Vasculitis (5),
Maternal Exposure Timing Unspecified (3),
Foetal Exposure During Pregnancy (2),
Vascular Purpura (2),
Premature Baby (2),
Renal Impairment (2),
Renal Injury (1),
Creatinine Renal Clearance Decreased (1),
Hypoglycaemia (1), more >>
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Page last updated: 2014-11-30
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