Drugplain

Labetalol HCl in Sodium Chloride 1 mg/mL

LABETALOL HYDROCHLORIDE · INJECTION · Hikma Pharmaceuticals USA Inc.

No Recall History
Plain English

Labetalol HCl in Sodium Chloride is a injection containing labetalol hydrochloride at 1 mg/mL, taken intravenous. Manufactured by Hikma Pharmaceuticals USA Inc..

Key Facts

Brand Name
Labetalol HCl in Sodium Chloride
Generic Name
LABETALOL HYDROCHLORIDE
NDC Code (Product)
0143-9363
Manufacturer
Hikma Pharmaceuticals USA Inc.
Strength
1 mg/mL
Dosage Form
INJECTION
Route
INTRAVENOUS
Marketing Status
Application #
NDA213330
Marketing Start
11/09/2020

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective174 reports
maternal exposure during pregnancy169 reports
premature baby138 reports
foetal exposure during pregnancy135 reports
fatigue121 reports
hypertension108 reports
nausea103 reports
off label use96 reports
diarrhoea93 reports
low birth weight baby83 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND 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

2 DOSAGE AND 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 so…

Contraindications

4 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 )

Drug Interactions

7 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 pressur…

Adverse Reactions

6 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 …

Frequently Asked Questions

What is Labetalol HCl in Sodium Chloride used for?

Labetalol HCl in Sodium Chloride contains LABETALOL HYDROCHLORIDE. It is a injection taken intravenous. Consult your doctor for specific uses.

Is Labetalol HCl in Sodium Chloride a controlled substance?

Labetalol HCl in Sodium Chloride is not classified as a controlled substance by the DEA.

What is the generic name for Labetalol HCl in Sodium Chloride?

The generic name for Labetalol HCl in Sodium Chloride is LABETALOL HYDROCHLORIDE. There are 10 other brand versions of LABETALOL HYDROCHLORIDE.

What is the NDC code for Labetalol HCl in Sodium Chloride 1 mg/mL?

The NDC (National Drug Code) for Labetalol HCl in Sodium Chloride 1 mg/mL is 0143-9363, listed by Hikma Pharmaceuticals USA Inc..

Product NDC

0143-9363

Package NDC

0143-9363-10

Other Labetalol HCl in Sodium Chloride Dosages

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)