Data from FDA (Food and Drug Administration, USA) - Curated by EPG Health - Last updated 25 January 2017
CONTRAINDICATIONS TRANDATE Tablets are contraindicated in bronchial asthma, overt cardiac
Beta-blockers, even those with apparent cardioselectivity, should not be used in patients with a history of obstructive airway disease, including asthma.
Intraoperative Floppy Iris Syndrome (IFIS) has been observed during cataract surgery in some patients treated with alpha-1 blockers (labetalol is an alpha/beta blocker).
This variant of
The patient 's ophthalmologist should be prepared for possible modifications to the surgical technique, such as the utilization of iris hooks, iris dilator rings, or viscoelastic substances.
There does not appear to be a
Information for Patients: As with all drugs with beta-blocking activity, certain advice to patients being treated with labetalol HCl is warranted.
It is not
Patients being treated with TRANDATE Tablets should consult a physician at any signs or symptoms of
Also, transient scalp tingling may occur, usually when treatment with TRANDATE Tablets is initiated (see
Laboratory Tests: As with any new drug given over
Drug Interactions: In one survey, 2.3 % of patients taking
The contribution of each of the treatments to this
Cimetidine has been shown to increase the bioavailability of labetalol HCl.
Since this could be explained either by
Synergism has been shown between halothane anesthesia and intravenously administered labetalol HCl.
The anesthesiologist should be informed when a patient is receiving labetalol HCl.
If labetalol HCl is used with nitroglycerin in patients with angina pectoris, additional antihypertensive effects may occur.
Both digitalis glycosides and beta-blockers
Concomitant use can increase the risk of bradycardia.
Risk of Anaphylactic Reaction: While taking beta-blockers, patients with a history of
Drug/Laboratory Test Interactions: The presence of labetalol metabolites in the
In screening patients suspected of having a pheochromocytoma and being treated with labetalol HCl, a specific method, such as
Labetalol HCl has also been reported to produce a false-positive test for amphetamine when screening
When patients being treated with
Studies with labetalol HCl using dominant
Pregnancy: Teratogenic Effects: Pregnancy Category C: Teratogenic studies were performed with labetalol in
A teratology study performed with labetalol in rabbits at IV doses up to 1.7 times the MRHD revealed
Labetalol should be used during pregnancy only if the potential
Nonteratogenic Effects: Hypotension, bradycardia, hypoglycemia, and respiratory
Oral administration of labetalol to
Labor and Delivery: Labetalol HCl given to pregnant women with hypertension did not appear to affect the usual course of labor and delivery.
Elderly Patients: As in the general population, some elderly patients (60 years of age and older) have experienced orthostatic hypotension, dizziness, or lightheadedness during treatment with labetalol.
Because elderly patients are generally more likely than younger patients to experience orthostatic symptoms,
In these same trials, other agents with solely beta-blocking activity used in the control groups led to discontinuation in 8 % to 10 % of patients, and a
The incidence rates of
Where the frequency of
The rates are based on
If all reports are considered,
Labetalol HCI Placebo Propranolol Metoprolol (n = 227) (n = 98) (n = 84) (n = 49)
Body as a whole
a group excluding patients with bronchospastic disease,
Clinical trials also included studies utilizing daily doses up to 2,400 mg in
Labetalol HCl Daily Dose (mg) 200 300 400 600 800 900 1,200 1,600 2,400 Number of patients 522 181 606 608 503 117 411 242 175 Dizziness (%) 2 3 3 3 5 1 9 13 16
Cardiovascular: Hypotension, and rarely, syncope, bradycardia, heart block.
In most cases,
Eyes: Dry eyes.
Immunological System: Antimitochondrial antibodies.
Liver and Biliary System: Hepatic necrosis, hepatitis, cholestatic jaundice,
Musculoskeletal System: Muscle cramps,
Respiratory System: Bronchospasm.
Skin and Appendages: Rashes of various types, such as generalized maculopapular, lichenoid, urticarial, bullous lichen planus, psoriaform, and facial erythema; Peyronie 's disease; reversible alopecia.
Results of this survey indicate that the type,
Cardiovascular: Intensification of A-V block (see CONTRAINDICATIONS).
Hematologic: Agranulocytosis, thrombocytopenic or nonthrombocytopenic purpura.
Gastrointestinal: Mesenteric artery thrombosis, ischemic colitis.
The oculomucocutaneous syndrome associated with the beta-blocker practolol has not been reported with labetalol HCl.
Clinical Laboratory Tests: There have been reversible
DOSAGE AND ADMINISTRATION DOSAGE MUST BE INDIVIDUALIZED.
After 2 or 3 days, using standing
The usual maintenance dosage of labetalol HCl is between 200 and 400 mg twice daily.
Since the full antihypertensive effect of labetalol HCl is usually seen within the first
The antihypertensive effects of continued dosing can be measured at subsequent visits, approximately 12 hours after a dose, to determine whether further titration is necessary.
Should side effects (principally
When a diuretic is added, an additive antihypertensive effect can be expected.
In some cases this may necessitate a labetalol HCl dosage adjustment.
As with most antihypertensive drugs,
When transferring patients from other antihypertensive drugs, TRANDATE Tablets should be introduced as
Elderly Patients: As in the general patient population, labetalol therapy may be initiated at 100 mg twice daily and titrated upwards in increments of 100 mg b.i.d. as
Since some elderly patients eliminate
|Agency product number||R5H8897N95|
|Date Last Revised||14-12-2009|
|Type||HUMAN PRESCRIPTION DRUG|
|Marketing authorisation holder||Prometheus Laboratories Inc.|