Labetalol HCL 100 mg/1
Labetalol Hydrochloride · TABLET, FILM COATED · Bryant Ranch Prepack
Labetalol HCL is a tablet, film coated containing labetalol hydrochloride at 100 mg/1, taken oral. Manufactured by Bryant Ranch Prepack.
Key Facts
- Brand Name
- Labetalol HCL
- Generic Name
- Labetalol Hydrochloride
- NDC Code (Product)
71335-2145- Manufacturer
- Bryant Ranch Prepack
- Strength
- 100 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- Application #
- ANDA200908
- Marketing Start
- 07/24/2012
Recall History
SCA Pharmaceuticals, LLC
Lack of Assurance of Sterility
Pharmedium Services, LLC
Lack of sterility assurance.
KRS Global Biotechnology, Inc
Lack of Assurance of Sterility
Pharmedium Services, LLC
Lack of sterility assurance.
Nephron Sterile Compounding Center LLC
Lack of Assurance of Sterility
Nephron Sterile Compounding Center LLC
CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
Pharmedium Services, LLC
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Nephron Sterile Compounding Center LLC
CGMP Deviations: Potential for cross contamination due to product carry over.
Nephron Sterile Compounding Center LLC
Lack of Assurance of Sterility
Advanced Pharma Inc.
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Labetalol hydrochloride tablets, USP are indicated in the management of hypertension. Labetalol hydrochloride tablets, USP may be used alone or in combination with other antihypertensive agents, especially thiazide and loop diuretics.
Dosage & Administration
DOSAGE AND ADMINISTRATION DOSAGE MUST BE INDIVIDUALIZED. The recommended initial dosage is 100 mg twice daily whether used alone or added to a diuretic regimen. After 2 or 3 days, using standing blood pressure as an indicator, dosage may be titrated in increments of 100 mg b.i.d. every 2 or 3 days. 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 1 to 3 hours of the initial dose or dose increment, the assurance of a lack of an exaggerated hypotensive response can be clinically established in the office setting. 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. Patients with severe hypertension may require from 1,200 to 2,400 mg per day, with or without thiazide diuretics. Should side effects (principally nausea or dizziness) occur with these doses administered twice daily, the same total daily dose administered three times daily may improve tolerability and facilitate further titration. Titration increments should not exceed 200 mg tw…
Warnings
WARNINGS Hepatic Injury: Severe hepatocellular injury, confirmed by rechallenge in at least one case, occurs rarely with labetalol therapy.The hepatic injury is usually reversible, but hepatic necrosis and death have been reported. Injury has occurred after both short- and long-term treatment and may be slowly progressive despite minimal symptomatology. Similar hepatic events have been reported with a related research compound, dilevalol HCl, including two deaths. Dilevalol HCl is one of the four isomers of labetalol HCl. Thus, for patients taking labetalol, periodic determination of suitable hepatic laboratory tests would be appropriate. Appropriate laboratory testing should be done at the first symptom/sign of liver dysfunction (e.g., pruritus, dark urine, persistent anorexia, jaundice, right upper quadrant tenderness, or unexplained "flu-like" symptoms). If the patient has laboratory evidence of liver injury or jaundice, labetalol should be stopped and not restarted. Cardiac Failure: Sympathetic stimulation is a vital component supporting circulatory function in congestive heart failure. Beta-blockade carries a potential hazard of further depressing myocardial contractility and …
Contraindications
CONTRAINDICATIONS Labetalol hydrochloride tablets are contraindicated in bronchial asthma, overt cardiac failure, greater-than-first-degree heart block, cardiogenic shock, severe bradycardia, other conditions associated with severe and prolonged hypotension, and in patients with a history of hypersensitivity to any component of the product (see WARNINGS ). Beta-blockers, even those with apparent cardioselectivity, should not be used in patients with a history of obstructive airway disease, including asthma.
Drug Interactions
Drug Interactions In one survey, 2.3% of patients taking labetalol HCl in combination with tricyclic antidepressants experienced tremor, as compared to 0.7% reported to occur with labetalol HCl alone. The contribution of each of the treatments to this adverse reaction is unknown, but the possibility of a drug interaction cannot be excluded. Drugs possessing beta-blocking properties can blunt the bronchodilator effect of beta-receptor, agonist drugs in patients with bronchospasm; therefore, doses greater than the normal antiasthmatic dose of beta-agonist bronchodilator drugs may be required. Cimetidine has been shown to increase the bioavailability of labetalol HCl. Since this could be explained either by enhanced absorption or by an alteration of hepatic metabolism of labetalol HCl, special care should be used in establishing the dose required for blood pressure control in such patients. Synergism has been shown between halothane anesthesia and intravenously administered labetalol HCl. During controlled hypotensive anesthesia using labetalol HCl in association with halothane, high concentrations (3% or above) of halothane should not be used because the degree of hypotension will be…
Adverse Reactions
ADVERSE REACTIONS Most adverse effects are mild and transient and occur early in the course of treatment. In controlled clinical trials of 3 to 4 months' duration, discontinuation of labetalol hydrochloride tablets due to one or more adverse effects was required in 7% of all patients. 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 centrally acting alpha-agonist led to discontinuation in 30% of patients. The incidence rates of adverse reactions listed in the following table were derived from multicenter, controlled clinical trials comparing labetalol HCl, placebo, metoprolol, and propranolol over treatment periods of 3 and 4 months. Where the frequency of adverse effects for labetalol HCl and placebo is similar, causal relationship is uncertain. The rates are based on adverse reactions considered probably drug related by the investigator. If all reports are considered, the rates are somewhat higher (e.g., dizziness, 20%; nausea, 14%; fatigue, 11%), but the overall conclusions are unchanged. Labetalol HCI Placebo Propranolol Metoprolol (n = 227) (n = 98) (n = 84) (n = 49) % % % % …
Frequently Asked Questions
What is Labetalol HCL used for?
Labetalol HCL contains Labetalol Hydrochloride. It is a tablet, film coated taken oral. Consult your doctor for specific uses.
Is Labetalol HCL a controlled substance?
Labetalol HCL is not classified as a controlled substance by the DEA.
What is the generic name for Labetalol HCL?
The generic name for Labetalol HCL is Labetalol Hydrochloride. There are 12 other brand versions of Labetalol Hydrochloride.
What is the NDC code for Labetalol HCL 100 mg/1?
The NDC (National Drug Code) for Labetalol HCL 100 mg/1 is 71335-2145, listed by Bryant Ranch Prepack.
Other Labetalol Brands
See all →- Labetalol Hydrochloride100 mg/172162-1675
- Labetalol Hydrochloride300 mg/10904-7453
- labetalol hydrochloride5 mg/mL25021-317
- Labetalol HCl in Sodium Chloride1 mg/mL0143-9363
- Labetalol HCl in Sodium Chloride1 mg/mL0143-9364
- Labetalol Hydrochloride100 mg/150090-7458
- Labetalol Hydrochloride200 mg/155154-2143
- Labetalol Hydrochloride300 mg/158657-604
- Labetalol Hydrochloride300 mg/162135-800
- Labetalol Hydrochloride200 mg/163629-2053
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)