LABETALOL HYDROCHLORIDE
(+2 other brands)
Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Labetalol HCl in Sodium Chloride Injection and Labetalol HCl in Dextrose Injection are preservative-free, clear, colorless to pale yellow sterile solutions that are available in a single-dose single-port bag with an aluminum overwrap. The container closure is not made with natural rubber latex. It is available in the following presentations: Product Strength Package NDC Number Labetalol HCl in Sodium Chloride Injection 100 mg/100 mL (1 mg/mL) preservative-free 1 single-dose bag 0143-9363-01 Box of 10 bags 0143-9363-10 Labetalol HCl in Sodium Chloride Injection 200 mg/200 mL (1 mg/mL) preservative-free 1 single-dose bag 0143-9364-01 Box of 10 bags 0143-9364-10 Labetalol HCl in Sodium Chloride Injection 300 mg/300 mL (1 mg/mL) preservative-free 1 single-dose bag 0143-9365-01 Box of 10 bags 0143-9365-10 Labetalol HCl in Dextrose Injection 200 mg/200 mL (1 mg/mL) preservative-free 1 single-dose bag 0143-9366-01 Box of 10 bags 0143-9366-10 Labetalol Hydrochloride Injection, USP is a preservative-free, clear, colorless to pale yellow sterile solution that is available in a single-dose prefilled syringe or vial. It is available in the following presentations: Product Strength Package NDC Number Labetalol Hydrochloride Injection, USP 10 mg/2 mL (5 mg/mL) preservative-free 1 single-dose prefilled syringe 0641-6252-01 Carton of 10 prefilled syringes 0641-6252-10 Labetalol Hydrochloride Injection, USP 20 mg/4 mL (5 mg/mL) preservative-free 1 single-dose vial 0143-9183-01 Carton of 10 vials 0143-9183-10 16.2 Storage Store at 20°C to 25°C (68°F to 77°F) with excursions permitted between 15°C to 30° C (59°F to 86° F) [see USP Controlled Room Temperature]. DO NOT FREEZE. PROTECT FROM LIGHT. Labetalol HCl in Sodium Chloride Injection and Labetalol HCl in Dextrose Injection: Do not remove from overwrap until ready to use. Labetalol Hydrochloride Injection, USP, prefilled syringe and vial: Retain in carton until time of use.; 16.1 How Supplied Labetalol HCl in Sodium Chloride Injection and Labetalol HCl in Dextrose Injection are preservative-free, clear, colorless to pale yellow sterile solutions that are available in a single-dose single-port bag with an aluminum overwrap. The container closure is not made with natural rubber latex. It is available in the following presentations: Product Strength Package NDC Number Labetalol HCl in Sodium Chloride Injection 100 mg/100 mL (1 mg/mL) preservative-free 1 single-dose bag 0143-9363-01 Box of 10 bags 0143-9363-10 Labetalol HCl in Sodium Chloride Injection 200 mg/200 mL (1 mg/mL) preservative-free 1 single-dose bag 0143-9364-01 Box of 10 bags 0143-9364-10 Labetalol HCl in Sodium Chloride Injection 300 mg/300 mL (1 mg/mL) preservative-free 1 single-dose bag 0143-9365-01 Box of 10 bags 0143-9365-10 Labetalol HCl in Dextrose Injection 200 mg/200 mL (1 mg/mL) preservative-free 1 single-dose bag 0143-9366-01 Box of 10 bags 0143-9366-10 Labetalol Hydrochloride Injection, USP is a preservative-free, clear, colorless to pale yellow sterile solution that is available in a single-dose prefilled syringe or vial. It is available in the following presentations: Product Strength Package NDC Number Labetalol Hydrochloride Injection, USP 10 mg/2 mL (5 mg/mL) preservative-free 1 single-dose prefilled syringe 0641-6252-01 Carton of 10 prefilled syringes 0641-6252-10 Labetalol Hydrochloride Injection, USP 20 mg/4 mL (5 mg/mL) preservative-free 1 single-dose vial 0143-9183-01 Carton of 10 vials 0143-9183-10; PRINCIPAL DI SPLAY PANEL NDC 0143-9363-01 Rx only 100 mL Labetalol Hydrochloride in 0.72% Sodium Chloride Injection 100 mg per 100 mL (1 mg/mL) For Intravenous Infusion Ready to Use Sterile, nonpyrogenic Single-Dose Flexible Container NDC 0143-9363-01 Rx only 100 mL Labetalol Hydrochloride in 0.72% Sodium Chloride Injection 100 mg per 100 mL (1 mg/mL) For Intravenous Infusion Ready to Use Sterile, nonpyrogenic Single-Dose Flexible Container bag 9363 100 mg overwrap; PRINCIPAL DI SPLAY PANEL NDC 0143-9364-01 Rx only 200 mL Labetalol Hydrochloride in 0.72% Sodium Chloride Injection 200 mg per 200 mL (1 mg/mL) For Intravenous Infusion Ready to Use Sterile, nonpyrogenic Single-Dose Flexible Container NDC 0143-9364-01 Rx only 200 mL Labetalol Hydrochloride in 0.72% Sodium Chloride Injection 200 mg per 200 mL (1 mg/mL) For Intravenous Infusion Ready to Use Sterile, nonpyrogenic Single-Dose Flexible Container bag 9364 200 mg overwrap; PRINCIPAL DI SPLAY PANEL NDC 0143-9365-01 Rx only 300 mL Labetalol Hydrochloride in 0.72% Sodium Chloride Injection 300 mg per 300 mL (1 mg/mL) For Intravenous Infusion Ready to Use Sterile, nonpyrogenic Single-Dose Flexible Container NDC 0143-9365-01 Rx only 300 mL Labetalol Hydrochloride in 0.72% Sodium Chloride Injection 300 mg per 300 mL (1 mg/mL) For Intravenous Infusion Ready to Use Sterile, nonpyrogenic Single-Dose Flexible Container bag 9365 300 mg overwrap; PRINCIPAL DI SPLAY PANEL NDC 0143-9366-01 Rx only 200 mL Labetalol Hydrochloride in 5% Dextrose Injection 200 mg per 200 mL (1 mg/mL) For Intravenous Infusion Ready to Use Sterile, nonpyrogenic Single-Dose Flexible Container NDC 0143-9366-01 Rx only 200 mL Labetalol Hydrochloride in 5% Dextrose Injection 200 mg per 200 mL (1 mg/mL) For Intravenous Infusion Ready to Use Sterile, nonpyrogenic Single-Dose Flexible Container bag 9366 200 mg overwrap; PRINCIPAL DISPLAY PANEL NDC 0143- 9183 -01Rx only Labetalol HCI Injection, USP 20 mg per 4 mL (5 mg/mL) For Intravenous Use ONLY Preservative-Free 4 mL Single-Dose Vial Discard unused portion NDC 0143- 9183 -10 Rx only Labetalol HCI Injection, USP 20 mg per 4 mL (5 mg/mL) For Intravenous Use ONLY Preservative-Free 10 X 4 mL Single-Dose Vials Discard unused portion Labetalol 4 mL Vial Label Labetalol 4 mL Carton Label
- 16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Labetalol HCl in Sodium Chloride Injection and Labetalol HCl in Dextrose Injection are preservative-free, clear, colorless to pale yellow sterile solutions that are available in a single-dose single-port bag with an aluminum overwrap. The container closure is not made with natural rubber latex. It is available in the following presentations: Product Strength Package NDC Number Labetalol HCl in Sodium Chloride Injection 100 mg/100 mL (1 mg/mL) preservative-free 1 single-dose bag 0143-9363-01 Box of 10 bags 0143-9363-10 Labetalol HCl in Sodium Chloride Injection 200 mg/200 mL (1 mg/mL) preservative-free 1 single-dose bag 0143-9364-01 Box of 10 bags 0143-9364-10 Labetalol HCl in Sodium Chloride Injection 300 mg/300 mL (1 mg/mL) preservative-free 1 single-dose bag 0143-9365-01 Box of 10 bags 0143-9365-10 Labetalol HCl in Dextrose Injection 200 mg/200 mL (1 mg/mL) preservative-free 1 single-dose bag 0143-9366-01 Box of 10 bags 0143-9366-10 Labetalol Hydrochloride Injection, USP is a preservative-free, clear, colorless to pale yellow sterile solution that is available in a single-dose prefilled syringe or vial. It is available in the following presentations: Product Strength Package NDC Number Labetalol Hydrochloride Injection, USP 10 mg/2 mL (5 mg/mL) preservative-free 1 single-dose prefilled syringe 0641-6252-01 Carton of 10 prefilled syringes 0641-6252-10 Labetalol Hydrochloride Injection, USP 20 mg/4 mL (5 mg/mL) preservative-free 1 single-dose vial 0143-9183-01 Carton of 10 vials 0143-9183-10 16.2 Storage Store at 20°C to 25°C (68°F to 77°F) with excursions permitted between 15°C to 30° C (59°F to 86° F) [see USP Controlled Room Temperature]. DO NOT FREEZE. PROTECT FROM LIGHT. Labetalol HCl in Sodium Chloride Injection and Labetalol HCl in Dextrose Injection: Do not remove from overwrap until ready to use. Labetalol Hydrochloride Injection, USP, prefilled syringe and vial: Retain in carton until time of use.
- 16.1 How Supplied Labetalol HCl in Sodium Chloride Injection and Labetalol HCl in Dextrose Injection are preservative-free, clear, colorless to pale yellow sterile solutions that are available in a single-dose single-port bag with an aluminum overwrap. The container closure is not made with natural rubber latex. It is available in the following presentations: Product Strength Package NDC Number Labetalol HCl in Sodium Chloride Injection 100 mg/100 mL (1 mg/mL) preservative-free 1 single-dose bag 0143-9363-01 Box of 10 bags 0143-9363-10 Labetalol HCl in Sodium Chloride Injection 200 mg/200 mL (1 mg/mL) preservative-free 1 single-dose bag 0143-9364-01 Box of 10 bags 0143-9364-10 Labetalol HCl in Sodium Chloride Injection 300 mg/300 mL (1 mg/mL) preservative-free 1 single-dose bag 0143-9365-01 Box of 10 bags 0143-9365-10 Labetalol HCl in Dextrose Injection 200 mg/200 mL (1 mg/mL) preservative-free 1 single-dose bag 0143-9366-01 Box of 10 bags 0143-9366-10 Labetalol Hydrochloride Injection, USP is a preservative-free, clear, colorless to pale yellow sterile solution that is available in a single-dose prefilled syringe or vial. It is available in the following presentations: Product Strength Package NDC Number Labetalol Hydrochloride Injection, USP 10 mg/2 mL (5 mg/mL) preservative-free 1 single-dose prefilled syringe 0641-6252-01 Carton of 10 prefilled syringes 0641-6252-10 Labetalol Hydrochloride Injection, USP 20 mg/4 mL (5 mg/mL) preservative-free 1 single-dose vial 0143-9183-01 Carton of 10 vials 0143-9183-10
- PRINCIPAL DI SPLAY PANEL NDC 0143-9363-01 Rx only 100 mL Labetalol Hydrochloride in 0.72% Sodium Chloride Injection 100 mg per 100 mL (1 mg/mL) For Intravenous Infusion Ready to Use Sterile, nonpyrogenic Single-Dose Flexible Container NDC 0143-9363-01 Rx only 100 mL Labetalol Hydrochloride in 0.72% Sodium Chloride Injection 100 mg per 100 mL (1 mg/mL) For Intravenous Infusion Ready to Use Sterile, nonpyrogenic Single-Dose Flexible Container bag 9363 100 mg overwrap
- PRINCIPAL DI SPLAY PANEL NDC 0143-9364-01 Rx only 200 mL Labetalol Hydrochloride in 0.72% Sodium Chloride Injection 200 mg per 200 mL (1 mg/mL) For Intravenous Infusion Ready to Use Sterile, nonpyrogenic Single-Dose Flexible Container NDC 0143-9364-01 Rx only 200 mL Labetalol Hydrochloride in 0.72% Sodium Chloride Injection 200 mg per 200 mL (1 mg/mL) For Intravenous Infusion Ready to Use Sterile, nonpyrogenic Single-Dose Flexible Container bag 9364 200 mg overwrap
- PRINCIPAL DI SPLAY PANEL NDC 0143-9365-01 Rx only 300 mL Labetalol Hydrochloride in 0.72% Sodium Chloride Injection 300 mg per 300 mL (1 mg/mL) For Intravenous Infusion Ready to Use Sterile, nonpyrogenic Single-Dose Flexible Container NDC 0143-9365-01 Rx only 300 mL Labetalol Hydrochloride in 0.72% Sodium Chloride Injection 300 mg per 300 mL (1 mg/mL) For Intravenous Infusion Ready to Use Sterile, nonpyrogenic Single-Dose Flexible Container bag 9365 300 mg overwrap
- PRINCIPAL DI SPLAY PANEL NDC 0143-9366-01 Rx only 200 mL Labetalol Hydrochloride in 5% Dextrose Injection 200 mg per 200 mL (1 mg/mL) For Intravenous Infusion Ready to Use Sterile, nonpyrogenic Single-Dose Flexible Container NDC 0143-9366-01 Rx only 200 mL Labetalol Hydrochloride in 5% Dextrose Injection 200 mg per 200 mL (1 mg/mL) For Intravenous Infusion Ready to Use Sterile, nonpyrogenic Single-Dose Flexible Container bag 9366 200 mg overwrap
- PRINCIPAL DISPLAY PANEL NDC 0143- 9183 -01Rx only Labetalol HCI Injection, USP 20 mg per 4 mL (5 mg/mL) For Intravenous Use ONLY Preservative-Free 4 mL Single-Dose Vial Discard unused portion NDC 0143- 9183 -10 Rx only Labetalol HCI Injection, USP 20 mg per 4 mL (5 mg/mL) For Intravenous Use ONLY Preservative-Free 10 X 4 mL Single-Dose Vials Discard unused portion Labetalol 4 mL Vial Label Labetalol 4 mL Carton Label
Overview
Labetalol HCl in Sodium Chloride Injection, Labetalol HCl in Dextrose Injection and Labetalol Hydrochloride Injection, USP contain labetalol HCl an adrenergic receptor blocking agent that has both selective alpha1-adrenergic and nonselective beta-adrenergic receptor blocking actions. Labetalol hydrochloride (HCl) is a racemate chemically designated as 5-[1-Hydroxy-2-[(1-methyl-3-phenylpropyl)amino]ethyl]-salicylamide monohydrochloride and it has the following structural formula: Labetalol HCl is a white or off-white crystalline powder, soluble in water. Labetalol HCl has the molecular formula C19H24N2O3•HCl and a molecular weight of 364.87. It has two asymmetric centers and therefore exists as a molecular complex of two diastereoisomeric pairs. Labetalol HCl in Sodium Chloride Injection and Labetalol HCl in Dextrose Injection are two preservative-free, ready- to use formulations of labetalol. Labetalol HCl in Sodium Chloride Injection and Labetalol HCl in Dextrose Injection are clear, colorless to pale yellow, aqueous, sterile, isotonic solution for intravenous injection. Each milliliter of Labetalol HCl in Sodium Chloride Injection contains 1 mg of labetalol HCl, 7.2 mg sodium chloride, 9 mg of anhydrous dextrose, 0.02 mg of edetate disodium; and citric acid monohydrate and sodium hydroxide, as necessary, to bring the solution into the pH range of 3.5 to 4.5. Each milliliter of Labetalol HCl in Dextrose Injection contains 1 mg of labetalol HCl, 45 mg of anhydrous dextrose, 0.02 mg of edetate disodium; and citric acid monohydrate and sodium hydroxide, as necessary, to bring the solution into the pH range of 3.5 to 4.5. Labetalol Hydrochloride Injection prefilled syringe and vial are two preservative-free, ready-to use formulations of labetalol. Labetalol Hydrochloride Injection is a clear, colorless to pale yellow, aqueous, sterile, isotonic solution for intravenous injection. Each milliliter of Labetalol Hydrochloride Injection, USP, contains 5 mg of labetalol HCI, 45 mg of anhydrous dextrose, 0.1 mg of edetate disodium, and citric acid monohydrate and sodium hydroxide, as necessary, to bring the solution into the pH range of 3.0 to 4.5. structural formula
Indications & Usage
Labetalol HCl Injection is indicated in severe hypertension, to lower blood pressure. Labetalol Hydrochloride (HCl) is a beta-adrenergic blocker. Labetalol HCl injection is indicated in severe hypertension, to lower blood pressure. ( 1 )
Dosage & Administration
Administer Labetalol Hydrochloride in Sodium Chloride Injection or Dextrose Injection as a slow continuous intravenous infusion at a rate of 2 mL/min (2 mg/min). ( 2.2 ) Alternatively, administer Labetalol Hydrochloride Injection in a prefilled syringe or vial at 0.25 mg/kg (up to a maximum of 20 mg) intravenously over 2 minutes. Additional injections of 40 mg or 80 mg can be given at 10-minute intervals. ( 2.2 ) 2.1 General Information Inspect parenteral drug products for particulate matter and discoloration prior to administration, whenever solution and container permit. Labetalol HCl in Sodium Chloride Injection and Labetalol HCl in Dextrose Injection: 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 squeezing the bag firmly. If leaks are found, discard solution, as sterility may be impaired. Do not add any additional medications to the bag. Once infusion has started, discard any remaining at 24 hours. Labetalol HCl Injection in a prefilled syringe or vial: Labetalol HCl Injection, USP, in a prefilled syringe or vial are ready-to-use solutions that do not require further dilution. The prefilled syringe and vial are intended for single dose. Discard any unused portion. 2.2 Recommended Dosage Labetalol HCI can be administered by slow continuous intravenous infusion or repeated intravenous injection. Once supine diastolic blood pressure has begun to rise, transition to oral labetalol HCl. Slow Continuous Intravenous Infusion: Initiate at 2 mg/minute. Monitor blood pressure and adjust the dosage and duration of infusion accordingly. Repeated Intravenous Injection: Administer 0.25 mg/kg up to 20 mg over 2 minutes. Administer 20 mg to 80 mg over 2 minutes at 10-minute intervals until a desired supine blood pressure is achieved. The maximum effect usually occurs within 5 minutes of each injection. The safety of doses above 300 mg has not been established. 2.3 Instructions for Use of Labetalol HCl Injection Prefilled Syringe CAUTION: Glass syringes may malfunction, break or clog when connected to some Needleless Luer Access Devices (NLADs) and needles. The external collar must remain attached to the syringe (See Figure 1) . Spontaneous disconnection of this glass syringe from needles and NLADs with leakage of drug product may occur. Assure that the needle or NLAD is securely attached before beginning the injection. Inspect the glass syringe-needle or glass syringe –NLAD connection before and during drug administration. Figure 1 1. Push plunger rod slightly to break the stopper loose while tip cap is still on. 2. Remove tip cap by twisting it off. (See Figure 2) Figure 2 3. Connect the syringe to an appropriate injection connection. 4. Depress plunger rod to deliver the required dose. Figure 1 figure 2
Warnings & Precautions
Exacerbation of heart failure: Avoid use. ( 5.3 ) Acute exacerbation of coronary artery disease upon cessation of therapy: Do not abruptly discontinue. ( 5.4 ) Non-allergic bronchospasm (e.g., chronic bronchitis and emphysema): Avoid since it has not been studied. ( 5.5 ) Diabetes: May mask symptoms of hypoglycemia and alter glucose levels; monitor ( 5.6 ) Exacerbation of pheochromocytoma: Paradoxical increases in blood pressure may occur. ( 5.7 ) Severe hepatocellular injury: Discontinue permanently for liver injury or jaundice ( 5.8 ) 5.1 Hypotension Symptomatic postural hypotension (incidence, 58%) is likely to occur if patients are tilted or allowed to assume the upright position within 3 hours of receiving labetalol HCl injection. Before permitting any ambulation, establish patient’s ability to tolerate an upright position and observe the patient at the time of first ambulation. 5.2 Bradycardia Bradycardia, including sinus pause, heart block, severe bradycardia, and cardiac arrest have occurred with the use of beta blockers. Monitor heart rate and rhythm in patients receiving labetalol hydrochloride injection. 5.3 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 precipitating more severe failure. Avoid labetalol HCl injection in patients with overt congestive heart failure. If patients develop signs or symptoms of heart failure during administration, discontinue labetalol and treat appropriately. 5.4 Ischemic Heart Disease Abrupt cessation of therapy with beta blocking agents in patients with coronary artery disease, can cause exacerbations of angina pectoris and, in some cases, myocardial infarction has been reported. Therefore, even in the absence of overt angina pectoris, after the discontinuation of labetalol HCl injection observe patients for development or worsening of angina. If patient experiences angina or angina markedly worsens or if acute coronary insufficiency develops, promptly reinstitute labetalol HCl injection and manage as unstable angina. 5.5 Reactive Airway Disease and Nonallergic Bronchospasm Patients with reactive airways disease should, in general, not receive beta blockers. Labetalol HCl at the usual intravenous therapeutic doses has not been studied in patients with nonallergic bronchospastic disease. In the event of bronchospasm, stop the infusion immediately, and treat as appropriate. 5.6 Hypoglycemia Beta-blockers may prevent early warning signs of hypoglycemia, such as tachycardia, and increase the risk for severe or prolonged hypoglycemia at any time during treatment, especially in patients with diabetes mellitus or children and patients who are fasting (i.e., surgery, not eating regularly, or are vomiting). If severe hypoglycemia occurs, patients should be instructed to see medical treatment. 5.7 Use in Patients with Pheochromocytoma Intravenous labetalol has been shown to lower blood pressure and relieve symptoms in patients with pheochromocytoma; higher than usual doses may be required. However, paradoxical hypertensive responses have been reported in a few patients with this tumor; therefore, monitor blood pressure when administering intravenous labetalol HCl to patients with pheochromocytoma. 5.8 Hepatic Injury Severe hepatocellular injury occurs rarely with labetalol therapy. The hepatic injury is usually reversible, but hepatic necrosis and death have been reported. If the patient develops signs or symptoms of liver injury, institute appropriate treatment and investigate the probable cause. Do not restart labetalol in patients without another explanation for the observed liver injury. 5.9 Use in Patients at Risk of Severe Acute Hypersensitivity Reactions Patients at risk of anaphylactic reactions may be more reactive to allergen exposure (accidental, diagnostic, or therapeutic). Patients using beta-blockers may be unresponsive to the usual doses of epinephrine used to treat anaphylactic or anaphylactoid reactions. Avoid labetalol HCl injection in patients at high risk of anaphylactic reactions. 5.10 Intraoperative Floppy Iris Syndrome (IFIS) IFIS has been observed during cataract surgery in some patients treated with alpha-1 blockers (labetalol is an alpha/beta blocker). This variant of small pupil syndrome is characterized by the combination of flaccid iris that billows in response to intraoperative irrigation currents, progressive intraoperative miosis despite preoperative dilation with standard mydriatic drugs, and potential prolapse of the iris toward the phacoemulsification incisions. Inform the patient’s ophthalmologist to be prepared for possible modifications to the surgical technique, such as the utilization of iris hooks, iris dilator rings, or viscoelastic substances.
Contraindications
Labetalol Hydrochloride Injection is contraindicated in patients with: Bronchial asthma or obstructive airway disease. Severe sinus bradycardia: Heart block greater than first degree. Cardiogenic shock. IV administration of non-dihydropyridine calcium-channel antagonists (e.g., verapamil) Hypersensitivity reactions, including anaphylaxis, to labetalol Bronchial asthma ( 4 ) Overt cardiac failure ( 4 ) Greater-than-first-degree heart block ( 4 ) Cardiogenic shock ( 4 ) Severe bradycardia ( 4 )
Adverse Reactions
The following clinically significant adverse reactions are described elsewhere in the labeling: Hypotension [see Warnings and Precautions (5.1) ] Bradycardia [see Warnings and Precautions (5.2) ] Depression of myocardial contractility in patients with overt congestive heart failure [see Warnings and Precautions (5.3) ] Aggravation of angina [see Warnings and Precautions (5.4) ] Significant decline in cardiac output following coronary bypass [see Warnings and Precautions (5.3) ] Bronchospasm in patients with reactive airway disease [see Warnings and Precautions (5.5) ] Paradoxical hypertensive responses in patients with pheochromocytoma [see Warnings and Precautions (5.7) ] Hepatic injury [see Warnings and Precautions (5.8) ] Acute hypersensitivity reaction [see Warnings and Precautions (5.9) ] Most common adverse events: Symptomatic postural hypotension. ( 6 ) Nausea13%, dizziness 9% ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-877-845-0689, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. For product Inquiry call 1-877-845-0689. 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Most adverse effects have been mild and transient and, in controlled trials involving 92 patients, did not require labetalol withdrawal. Symptomatic postural hypotension (incidence, 58%) is likely to occur if patients are tilted or allowed to assume the upright position within 3 hours of receiving labetalol HCl. Moderate hypotension occurred in 1 of 100 patients while supine. Increased sweating was noted in 4 of 100 patients, and flushing occurred in 1 of 100 patients. The following also were reported with labetalol HCl with the incidence as noted: Central and Peripheral Nervous Systems Dizziness in 9% Paresthesia, most frequently described as tingling of the scalp/skin in 7% Gastrointestinal System Nausea in 13% Vomiting in 4% Metabolic Disorders Transient increases in blood urea nitrogen and serum creatinine levels occurred in 8%; these were associated with drops in blood pressure, generally in patients with prior renal insufficiency. Respiratory System Bronchospasm In addition, a number of other less common adverse events have been reported: Cardiovascular: Hypotension, and rarely, syncope, bradycardia, heart block. Liver and Biliary System Hepatic necrosis, hepatitis, cholestatic jaundice, elevated liver function tests. Hypersensitivity Rare reports of hypersensitivity (e.g., rash, urticaria, pruritus, angioedema, dyspnea) and anaphylactoid reactions. The oculomucocutaneous syndrome associated with the beta blocker practolol has not been reported with labetalol HCl during investigational use and extensive foreign marketing experience. Clinical Laboratory Tests Among patients dosed with labetalol tablets, there have been reversible increases of serum transaminases in 4% of patients tested and, more rarely, reversible increases in blood urea.
Drug Interactions
Beta blockers antagonize the bronchodilator effect of beta-receptor agonists. ( 7.1 ) Increase hypotension may occur with halothane anesthesia. ( 7.2 ) Nitroglycerin may result in additional hypotensive effects. ( 7.3 ) 7.1 Bronchodilators Labetalol HCl antagonizes the bronchodilatory effect of beta-receptor agonist drugs; therefore, labetalol HCl is contraindicated in patients with bronchial asthma [see Contraindications (4) ] . 7.2 Anesthesia Synergism has been shown between halothane anesthesia and intravenously administered labetalol. During controlled hypotensive anesthesia using labetalol in association with halothane, high concentrations (3% or above) of halothane should not be used because the degree of hypotension will be increased and because of the possibility of a large reduction in cardiac output and an increase in central venous pressure. 7.3 Nitroglycerin Coadministration of labetalol HCl and nitroglycerin will have an additive effect in lowering blood pressure. Additionally, labetalol HCl blunts the reflex tachycardia produced by nitroglycerin. If labetalol is used in patients with angina pectoris on nitroglycerin, monitor patients’ blood pressure and adjust labetalol HCl injection dose as needed. In these patients, avoid initiating labetalol HCl tablets. 7.4 Calcium Channel Blockers Coadministration of labetalol HCl with non-dihydropyrindine calcium-channel antagonists (e.g., verapamil) is contraindicated [see Contraindications (4) ]. Avoid the use of labetalol in patients receiving calcium-channel antagonists. 7.5 Drug/Laboratory Test Interactions The presence of labetalol metabolites in the urine may result in falsely elevated levels of urinary catecholamines, metanephrine, normetanephrine, and vanillylmandelic acid (VMA) when measured by fluorimetric or photometric methods. 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 commercially available assay methods. When patients being treated with labetalol have a positive urine test for amphetamine using these techniques, confirm using more specific methods, such as a gas chromatographic-mass spectrometer technique.
Storage & Handling
16.2 Storage Store at 20°C to 25°C (68°F to 77°F) with excursions permitted between 15°C to 30° C (59°F to 86° F) [see USP Controlled Room Temperature]. DO NOT FREEZE. PROTECT FROM LIGHT. Labetalol HCl in Sodium Chloride Injection and Labetalol HCl in Dextrose Injection: Do not remove from overwrap until ready to use. Labetalol Hydrochloride Injection, USP, prefilled syringe and vial: Retain in carton until time of use.
Similar Drugs
Related medications based on brand, generic name, substance, active ingredients.