Labetalol hcl 200 mg

Labetalol hydrochloride for hypertension

This leaflet is about the use of labetalol for high blood pressure (which is also called hypertension).

This leaflet has been written specifically for parents and carers about the use of this medicine in children. The information may differ from that provided by the manufacturer. Please read this leaflet carefully. Keep it somewhere safe so that you can read it again.

Name of drug

Labetalol hydrochloride; also referred to as labetalol
Brand name: Trandate®

Why is it important for my child to take this medicine?

High blood pressure can lead to damage to internal organs. Labetalol is in a group of medicines called beta blockers, which help to lower blood pressure. It opens up blood vessels and slows the heart down so that it pumps less forcefully.

What is labetalol available as?

  • Tablets: 50 mg, 100 mg, 200 mg and 400 mg
  • Liquid medicine can be ordered specially from your pharmacist

When should I give labetalol?

Labetalol is usually given three or four times each day. Your doctor will tell you how often to give it.

  • Three times each day: this should be once in the morning, once in the early afternoon, and once in the evening. Ideally, these times are at least 6 hours apart, for example 8 am, 2 pm and 8 pm.
  • Four times each day: this should be first thing in the morning, at about midday, late in the afternoon and at bedtime. Ideally, these times should be at least 4 hours apart, for example 8 am, midday, 4 pm and 8 pm.

Give the medicine at about the same time(s) each day so that this becomes part of your child’s daily routine, which will help you to remember.

How much should I give?

Your doctor will work out the amount of labetalol (the dose) that is right for your child. The dose will be shown on the medicine label.

Your doctor will start the medicine at a low dose then gradually increase it until your child’s blood pressure is at the right level.

It is important that you follow your doctor’s instructions about how much to give.

How should I give it?

Tablets should be swallowed with a glass of water, milk or juice. Your child should not chew the tablet.
You can crush the tablet and mix it with a small amount of water or soft food such as yogurt, honey or jam. Make sure your child swallows it straight away, without chewing.

Liquid medicine: Measure out the right amount using an oral syringe or medicine spoon. You can get these from your pharmacist. Do not use a kitchen teaspoon as it will not give the right amount.

When should the medicine start working?

Your child’s blood pressure will start to come down after a few days, although you will not see any difference in your child.

What if my child is sick (vomits)?

  • If your child is sick less than 30 minutes after having a dose of labetalol, give them the same dose again.
  • If your child is sick more than 30 minutes after having a dose of labetalol, you do not need to give them another dose. Wait until the next normal dose.

What if I forget to give it?

Do not give the missed dose. Just give the next dose as usual.

Never give a double dose of labetalol.

What if I give too much?

It can be dangerous to give too much labetalol because it may make your child’s blood pressure too low.

If you think you may have given your child too much labetalol, contact your doctor or NHS Direct (0845 4647 in England and Wales; 08454 24 24 24 in Scotland) or take your child to hospital.

Take the medicine container or packaging with you, even if it is empty. This will be useful to the doctor. Have the medicine or packaging with you if you telephone for advice.

Are there any possible side-effects?

We use medicines to make our children better, but sometimes they have other effects that we don’t want (side-effects).

Side-effects you must do something about

If your child is short of breath or wheezy after taking labetalol, take them to hospital or call an ambulance straight away as it may have triggered an asthma attack.

If your child starts being sick every few hours, has stomach pains, is very sleepy or has jaundice (the skin or eyes look yellow), contact your doctor or take your child to hospital straight away, as there may be a problem with your child’s liver.

Other side-effects you need to know about
  • Your child may feel dizzy or light-headed when they stand up or may faint. Encourage them to take their time standing up, for at least 30 minutes after taking labetalol, and to sit or lie down if they feel dizzy or light-headed. If this happens too often, contact your doctor to check your child’s blood pressure, as it may be too low.
  • They may feel physically tired or weak and may have difficulty getting to sleep or nightmares.

Your child may also get some of the following side-effects when they first start taking labetalol. If they are still a problem after one week or you are worried, contact your doctor but continue to give labetalol.

  • They may have a headache or a tingling sensation on their scalp.
  • They may say their heart is beating slowly.
  • Their hands and feet may feel cold. If their hands or feet hurt contact your doctor for advice.
  • They may feel sick (nausea) or be sick (vomit). Giving the medicine with some food or milk may help.
  • They may have difficulty in urinating (doing a wee).

There may, sometimes, be other side-effects that are not listed above. If you notice anything unusual and are concerned, contact your doctor.

Can other medicines be given at the same time as labetalol?

  • You can give your child medicines that contain paracetamol or ibuprofen, unless your doctor has told you not to.
  • Labetalol should not be taken with some common drugs that you get on prescription. Tell your doctor and pharmacist about any other medicines your child is taking before giving labetalol.
  • Check with your doctor or pharmacist before giving any other medicines to your child. This includes herbal or complementary medicines.

Is there anything else I need to know about this medicine?

Labetalol can trigger an asthma attack. You must tell your doctor if your child has ever had asthma or wheezy chest episodes.

Your doctor will check your child’s blood pressure and pulse rate regularly while they are taking labetalol. They will also test their blood to make sure labetalol has not affected their liver.

General advice about medicines

  • Try to give medicines at about the same times each day, to help you remember.
  • If you are not sure a medicine is working, contact your doctor but continue to give the medicine as usual in the meantime. Do not give extra doses, as you may do harm.
  • Only give this medicine to your child. Never give it to anyone else, even if their condition appears to be the same as this could do harm.

If you think someone else may have taken the medicine by accident, contact your doctor straight away.

  • Make sure that you always have enough medicine. Order a new prescription at least 2 weeks before you will run out.
  • Make sure that the medicine you have at home has not reached the ‘best before’ or ‘use by’ date on the packaging. Give old medicines to your pharmacist to dispose of.

Where I should keep this medicine?

  • Keep the medicine in a cupboard, away from heat and direct sunlight. It does not need to be kept in the fridge.
  • You may need to keep liquid medicine in the fridge – check the instructions on the bottle. Make sure the medicine doesn’t freeze.
  • Make sure that children cannot see or reach the medicine.
  • Keep the medicine in the container it came in.

Who to contact for more information

Your child’s doctor, pharmacist or nurse will be able to give you more information about labetalol and about other medicines used to treat hypertension.

Labetalol

Generic Name: labetalol (oral/injection) (la BAY ta lol)
Brand Name: Trandate, Normodyne

Medically reviewed by Drugs.com on Dec 4, 2019 – Written by Cerner Multum

  • Overview
  • Side Effects
  • Dosage
  • Professional
  • Tips
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What is labetalol?

Labetalol is a beta-blocker that affects the heart and circulation (blood flow through arteries and veins).

Labetalol is used to treat hypertension (high blood pressure). Labetalol oral is sometimes given with other blood pressure medications.

Labetalol injection is used when hypertension is severe.

Labetalol may also be used for purposes not listed in this medication guide.

Important Information

You should not use labetalol if you have asthma, very low blood pressure, or a serious heart condition such as 2nd or 3rd degree “AV block,” uncontrolled heart failure, or very slow heartbeats.

Before taking this medicine

You should not use labetalol if you are allergic to it, or if you have:

  • asthma;

  • “AV block” (2nd or 3rd degree);

  • uncontrolled heart failure;

  • very low blood pressure;

  • slow heartbeats that have caused you to faint; or

  • if your heart cannot pump blood properly.

Tell your doctor if you have ever had:

  • congestive heart failure;

  • angina (chest pain);

  • liver disease;

  • emphysema, chronic bronchitis, or other breathing problems;

  • pheochromocytoma (tumor of the adrenal gland);

  • diabetes;

  • coronary artery bypass surgery (sometimes called “CABG”);

  • kidney disease; or

  • allergies.

Labetalol can affect your pupils during cataract surgery. Tell your eye surgeon ahead of time that you use labetalol.

It is not known whether labetalol will harm an unborn baby. Labetalol may cause low blood pressure, low blood sugar, slow heartbeats, or breathing problems in a newborn if the mother uses labetalol during pregnancy. Tell your doctor if you are pregnant or plan to become pregnant.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

Labetalol is not approved for use by anyone younger than 18 years old.

How should I use labetalol?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Labetalol oral is taken by mouth.

Labetalol injection is given as an infusion into a vein when hypertension is severe. A healthcare provider will give you this injection.

After receiving a labetalol injection, you may need to remain lying down for up to 3 hours. You may feel light-headed when you first stand up.

Your blood pressure will need to be checked often, and you may need other medical tests.

Keep using this medicine as directed, even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medicine for the rest of your life.

Using labetalol can make it harder for you to tell when your blood sugar is low. If you have diabetes, check your blood sugar regularly.

Labetalol can cause false results with certain lab tests of the urine. This medicine also may affect a drug-screening urine test and you may have false results. Tell the laboratory staff that you use labetalol.

If you need surgery, tell the surgeon ahead of time that you are using labetalol.

You should not stop using labetalol suddenly. Stopping suddenly may make your condition worse.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Labetalol oral: Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Because you will receive labetalol injection in a clinical setting, you are not likely to miss a dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include slow heart rate, wheezing, chest tightness, trouble breathing, extreme dizziness, seizure, or fainting.

What should I avoid while using labetalol?

Avoid driving or hazardous activity until you know how labetalol will affect you. Your reactions could be impaired.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

Drinking alcohol can further lower your blood pressure and may increase certain side effects of labetalol.

Labetalol side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • a light-headed feeling, like you might pass out;

  • slow heart rate, weak pulse, fainting, slow breathing (breathing may stop);

  • shortness of breath (even with mild exertion), swelling, rapid weight gain;

  • severe headache, blurred vision, pounding in your neck or ears; or

  • liver problems–loss of appetite, stomach pain (upper right side), flu-like symptoms, itching, dark urine, jaundice (yellowing of the skin or eyes).

Severe dizziness or fainting may be more likely in older adults.

Common side effects may include:

  • dizziness, drowsiness, tiredness;

  • nausea, vomiting;

  • sudden warmth, skin redness, sweating;

  • numbness; or

  • tingly feeling in your scalp.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect labetalol?

Tell your doctor about all your other medicines, especially:

  • any other blood pressure medicine;

  • aminophylline, theophylline;

  • cimetidine;

  • heart medication;

  • insulin or oral diabetes medicine;

  • an antidepressant–amitriptyline, doxepin, desipramine, imipramine, nortriptyline, and others; or

  • a bronchodilator–albuterol, formoterol, levalbuterol, metaproterenol, olodaterol, salmeterol, and others.

This list is not complete. Other drugs may affect labetalol, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Copyright 1996-2018 Cerner Multum, Inc. Version: 11.01.

Medical Disclaimer

More about labetalol

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  • Drug class: non-cardioselective beta blockers
  • FDA Alerts (2)

Consumer resources

  • Labetalol Tablets
  • Labetalol Injection
  • Labetalol (Advanced Reading)
  • Labetalol Intravenous (Advanced Reading)

Other brands: Trandate, Normodyne

Professional resources

  • Labetalol Hydrochloride (AHFS Monograph)
  • … +3 more

Related treatment guides

  • High Blood Pressure
  • Mitral Valve Prolapse
  • Hypertensive Emergency
  • Pheochromocytoma
  • Postural Orthostatic Tachycardia Syndrome

Identification

Are you a new drug developer? Contact us to learn more about our customized products and solutions. Stay in the know! As part of our commitment to providing the most up-to-date drug information, we will be releasing #DrugBankUpdates with our newly added curated drug pages. #DrugBankUpdates Name Labetalol Accession Number DB00598 (APRD01062) Type Small Molecule Groups Approved Description

Labetalol is a racemic mixture of 2 diastereoisomers where dilevalol, the R,R’ stereoisomer, makes up 25% of the mixture.8 Labetalol is formulated as an injection or tablets to treat hypertension.7,8

Labetalol was granted FDA approval on 1 August 1984.6

Structure 3D Download Similar Structures

Structure for Labetalol (DB00598)

× Close Synonyms Product Ingredients

Ingredient UNII CAS InChI Key
Labetalol hydrochloride 1GEV3BAW9J 32780-64-6 WQVZLXWQESQGIF-UHFFFAOYSA-N

Product Images Prescription Products

Name Dosage Strength Route Labeller Marketing Start Marketing End
Unlock Additional Data
Labetalol HCl Injection, solution 5 mg/1mL Intravenous Cantrell Drug Company 2012-05-18 2015-01-14 US
Labetalol Hydrochloride Tablet, film coated 100 mg/1 Oral A-S Medication Solutions 2018-03-01 Not applicable US
Labetalol Hydrochloride Tablet 100 mg/1 Oral St. Mary’s Medical Park Pharmacy 2014-12-01 Not applicable US
Labetalol Hydrochloride Tablet 100 mg/1 Oral Nucare Pharmaceuticals, Inc. 2014-12-01 Not applicable US
Labetalol Hydrochloride Tablet, film coated 300 mg/1 Oral Alvogen Inc. 2018-03-01 Not applicable US
Labetalol Hydrochloride Tablet 100 mg/1 Oral REMEDYREPACK INC. 2016-11-30 Not applicable US
Labetalol Hydrochloride Tablet 200 mg/1 Oral A-S Medication Solutions 2014-12-01 Not applicable US
Labetalol Hydrochloride Tablet, film coated 200 mg/1 Oral Alvogen Inc. 2018-03-01 Not applicable US
Labetalol Hydrochloride Tablet 300 mg/1 Oral County Line Pharmaceuticals LLC 2014-12-01 2020-11-01 US
Labetalol Hydrochloride Tablet 300 mg/1 Oral WellSpring Pharma Services Inc. 2014-12-01 2017-11-29 US

Additional Data Available

  • Application Number Application Number

    A unique ID assigned by the FDA when a product is submitted for approval by the labeller.

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  • Product Code Product Code

    A governmentally-recognized ID which uniquely identifies the product within its regulatory market.

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Generic Prescription Products

Name Dosage Strength Route Labeller Marketing Start Marketing End
Unlock Additional Data
Apo-labetalol Tablets Tablet Oral Apotex Corporation 2001-06-01 Not applicable Canada
Apo-labetalol Tablets Tablet Oral Apotex Corporation 2001-03-16 Not applicable Canada
Labetalol Tablet, film coated 200 mg/1 Oral Sun Pharmaceutical Industries Limited 1999-07-29 2018-04-23 US
Labetalol Tablet, film coated 300 mg/1 Oral Marlex Pharmaceuticals Inc 2018-04-01 Not applicable US
Labetalol Tablet, film coated 100 mg/1 Oral Sun Pharmaceutical Industries Limited 1999-07-29 2018-04-23 US
Labetalol Injection, solution 5 mg/1mL Intravenous Sagent Pharmaceuticals 2010-02-17 2015-09-30 US
Labetalol Tablet, film coated 200 mg/1 Oral Marlex Pharmaceuticals Inc 2018-04-01 Not applicable US
Labetalol Tablet, film coated 100 mg/1 Oral Marlex Pharmaceuticals Inc 2018-04-01 Not applicable US
Labetalol Tablet, film coated 300 mg/1 Oral Sun Pharmaceutical Industries Limited 1999-07-29 2018-04-23 US
Labetalol HCL Tablet, film coated 100 mg/1 Oral Ncs Health Care Of Ky, Inc Dba Vangard Labs 2018-07-02 Not applicable US

Additional Data Available

  • Application Number Application Number

    A unique ID assigned by the FDA when a product is submitted for approval by the labeller.

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  • Product Code Product Code

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Unapproved/Other Products

Name Ingredients Dosage Route Labeller Marketing Start Marketing End
Labetalol HCl Labetalol hydrochloride (5 mg/1mL) Injection, solution Intravenous Cantrell Drug Company 2012-05-18 2015-01-14 US

International/Other Brands Albetol (Leiras) / Latol (Standard) / Normadate (GlaxoSmithKline) / Normodyne (Schering) Categories UNII R5H8897N95 CAS number 36894-69-6 Weight Average: 328.4055
Monoisotopic: 328.178692644 Chemical Formula C19H24N2O3 InChI Key SGUAFYQXFOLMHL-UHFFFAOYSA-N InChI InChI=1S/C19H24N2O3/c1-13(7-8-14-5-3-2-4-6-14)21-12-18(23)15-9-10-17(22)16(11-15)19(20)24/h2-6,9-11,13,18,21-23H,7-8,12H2,1H3,(H2,20,24) IUPAC Name 2-hydroxy-5-{1-hydroxy-2-ethyl}benzamide SMILES CC(CCC1=CC=CC=C1)NCC(O)C1=CC(C(N)=O)=C(O)C=C1

Pharmacology

Indication

Labetalol injections are indicated to control blood pressure in severe hypertension.7 Labetalol tablets are indicated alone or in combination with antihypertensives like thiazides and loop diuretics to manage hypertension.8

Associated Conditions

  • Chronic Stable Angina Pectoris
  • High Blood Pressure (Hypertension)
  • Hypertensive Emergency
  • Hypertensive crisis
  • Pheochromocytomas
  • Subarachnoid Hemorrhage

Pharmacodynamics

Labetalol antagonizes various adrenergic receptors to decrease blood pressure.5,3,4,7 The duration of action is long as it is generally given twice daily, and the therapeutic window is wide as patients usually take 200-400mg twice daily.8 Patients susceptible to bronchospasms should not use labetalol unless they are unresponsive to or intolerant of other antihypertensives.8

Mechanism of action

Labetalol non-selectively antagonizes beta-adrenergic receptors, and selectively antagonizes alpha-1-adrenergic receptors.5 Following oral administration, labetalol has 3 times the beta-blocking ability than alpha-blocking ability.5 This increases to 6.9 times following intravenous administration.5 Antagonism of alpha-1-adrenergic receptors leads to vasodilation and decreased vascular resistance.3 This leads to a decrease in blood pressure that is most pronounced while standing.4 Antagonism of beta-1-adrenergic receptors leads to a slight decrease in heart rate.7 Antagonism of beta-2-adrenergic receptors leads to some of the side effects of labetalol such as bronchospasms, however this may be slightly attenuated by alpha-1-adrenergic antagonism.4 Labetalol leads to sustained vasodilation over the long term without a significant decrease in cardiac output or stroke volume, and a minimal decrease in heart rate.3,4

Target Actions Organism
ABeta-1 adrenergic receptor antagonist Humans
ABeta-2 adrenergic receptor antagonist Humans
AAlpha-1 adrenergic receptors antagonist Humans

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Learn more Absorption

100mg and 200mg oral doses of labetalol have a Tmax of 20 minutes to 2 hours.2 Bioavailability may be as low as 11% or as high as 86% and may increase in older patients or when taken with food.2

Volume of distribution

In normotensive patients, the volume of distribution is 805L.2 In hypertensive patients, the volume of distribution is between 188-747L with an average of 392L.2

Protein binding

Labetalol is approximately 50% protein bound in serum.2,7,8

Metabolism

The metabolism of labetalol has not been fully described in the literature but studies in sheep show an N-dealkylation to 3-amino-1-phenyl butane.1 This metabolite may be further metabolized to benzylacetone and 3-amino-(4-hydroxyphenyl)butane.1 Labetalol in humans is mainly metabolized to glucuronide metabolites such as the O-phenyl-glucuronide and the N-glucuronide.2,7,8

  • Labetalol Labetalol Benzyl Glucuronide Metabolite (II)
  • Labetalol Labetalol Phenolic Glucuronide Metabolite (III)
  • Labetalol Labetalol Hydroxylated Metabolite (IV)
    • Labetalol Hydroxylated Metabolite (IV) Labetalol Phenolic Glucuronide Metabolite (V)
  • Labetalol Labetalol 3-hydroxylated Metabolite (VI)
    • Labetalol 3-hydroxylated Metabolite (VI) Labetalol C1′ Glucuronidated Metabolite (VII) and Labetalol C3 Glucuronidated Metabolite (VIII)
    • Labetalol 3-hydroxylated Metabolite (VI) Labetalol Theoretical Metabolite (IX)
      • Labetalol Theoretical Metabolite (IX) Labetalol Glucuronide Metabolite (X) and Labetalol Glucuronide Metabolite (XI)

Route of elimination

Radiolabelled doses of labetalol are 55-60% recovered in the urine and 12-27% recovered in the feces.2

Half life

Labetalol has a half life of 1.7-6.1 hours.2

Clearance

Labetalol has a plasma clearance of approximately 1500mL/min and a whole blood clearance of 1100mL/min.2

Toxicity

The oral LD50 in mice is 600mg/kg and in rats is >2g/kg.7,8 The intravenous LD50 in mice and rats is 50-60mg/kg.7,8

Patients experiencing an overdose may present with excessive hypotension and bradycardia.7,8 Patients should be placed on their back with their legs raised to maintain perfusion of the brain.7,8 Oral overdoses may be treated with gastric lavage or emesis, bradycardia may be treated with atropine or epinephrine, cardiac failure may be treated with digitalis and a diuretic, hypotension may be treated with vasopressors, bronchospasms may be treated with epinephrine or a beta2 agonist, and seizures may be treated with diazepam.7,8

Affected organisms

  • Humans and other mammals

Pathways

Pathway Category
Labetalol Action Pathway Drug action

Pharmacogenomic Effects/ADRs Not Available

Interactions

Drug Interactions This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.

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Drug Interaction
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(R)-warfarin The metabolism of (R)-warfarin can be decreased when combined with Labetalol.
(S)-Warfarin The metabolism of (S)-Warfarin can be decreased when combined with Labetalol.
1-(2-Phenylethyl)-4-phenyl-4-acetoxypiperidine The metabolism of Labetalol can be decreased when combined with 1-(2-Phenylethyl)-4-phenyl-4-acetoxypiperidine.
1-(3-Mercapto-2-Methyl-Propionyl)-Pyrrolidine-2-Carboxylic Acid 1-(3-Mercapto-2-Methyl-Propionyl)-Pyrrolidine-2-Carboxylic Acid may decrease the antihypertensive activities of Labetalol.
1-benzylimidazole 1-benzylimidazole may decrease the antihypertensive activities of Labetalol.
1,10-Phenanthroline 1,10-Phenanthroline may increase the bradycardic activities of Labetalol.
2,4-thiazolidinedione The therapeutic efficacy of 2,4-thiazolidinedione can be increased when used in combination with Labetalol.
2,5-Dimethoxy-4-ethylamphetamine The therapeutic efficacy of Labetalol can be decreased when used in combination with 2,5-Dimethoxy-4-ethylamphetamine.
2,5-Dimethoxy-4-ethylthioamphetamine The therapeutic efficacy of Labetalol can be decreased when used in combination with 2,5-Dimethoxy-4-ethylthioamphetamine.
25-desacetylrifapentine The metabolism of Labetalol can be increased when combined with 25-desacetylrifapentine.

Additional Data Available

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  • Severity Severity

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  • Evidence Level Evidence Level

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  • Action Action

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Food Interactions

  • Take without regard to meals.

Synthesis Reference

U.S. Patent 4,012,444.

General References External Links Human Metabolome Database HMDB0014736 KEGG Drug D08106 KEGG Compound C07063 PubChem Compound 3869 PubChem Substance 46505511 ChemSpider 3734 BindingDB 25758 ChEBI 6343 ChEMBL CHEMBL429 Therapeutic Targets Database DAP000038 PharmGKB PA164743150 RxList RxList Drug Page Drugs.com Drugs.com Drug Page PDRhealth PDRhealth Drug Page Wikipedia Labetalol ATC Codes C07BG01 — Labetalol and thiazides

  • C07BG — Alpha and beta blocking agents and thiazides
  • C07B — BETA BLOCKING AGENTS AND THIAZIDES
  • C07 — BETA BLOCKING AGENTS
  • C — CARDIOVASCULAR SYSTEM

C07CG01 — Labetalol and other diuretics

  • C07CG — Alpha and beta blocking agents and other diuretics
  • C07C — BETA BLOCKING AGENTS AND OTHER DIURETICS
  • C07 — BETA BLOCKING AGENTS
  • C — CARDIOVASCULAR SYSTEM

C07AG01 — Labetalol

  • C07AG — Alpha and beta blocking agents
  • C07A — BETA BLOCKING AGENTS
  • C07 — BETA BLOCKING AGENTS
  • C — CARDIOVASCULAR SYSTEM

AHFS Codes

  • 24:24.00 — Beta-adrenergic Blocking Agents

FDA label (401 KB) MSDS (53.7 KB)

Clinical Trials

Clinical Trials

Phase Status Purpose Conditions Count
0 Completed Supportive Care Controlled Hypotension for Nasal Surgeries 1
0 Recruiting Prevention Chronic Hypertension Complicating Pregnancy (Diagnosis) / Preeclampsia 1
0 Recruiting Prevention Obesity, Morbid / Preeclampsia 1
1, 2 Completed Treatment Craniotomy / High Blood Pressure (Hypertension) 1
1, 2 Withdrawn Treatment High Blood Pressure (Hypertension) / Pregnancy Toxemias / Proteinuria 1
2 Completed Treatment Cerebral Hemorrhage 1
2 Completed Treatment Chronic Rhinosinusitis 1
2 Completed Treatment Cocaine-Related Disorders 1
2 Completed Treatment Hydralazine Adverse Reaction / Pre-eclampsia Superimposed Pre-existing Hypertension / Pregnancy associated hypertension / Prophylaxis of preeclampsia 1
2 Completed Treatment Stroke, Acute 1
2 Completed Treatment Tobacco Use Disorders 1
2 Recruiting Treatment Bloodpressure / Heart Rate 1
2 Recruiting Treatment Cerebral Hemorrhage 1
2 Recruiting Treatment Endovascular Thrombectomy / Stroke, Acute 1
2, 3 Recruiting Treatment Severe Pre-Eclampsia, Antepartum 1
2, 3 Withdrawn Prevention Chronic Hypertension / Gestational Hypertension / Preeclampsia / Pregnancy associated hypertension / Superimposed Preeclampsia 1
3 Completed Treatment Pregnancy associated hypertension 1
3 Not Yet Recruiting Treatment Postnatal Hypertension 1
4 Completed Prevention Surgery, Laparoscopic 1
4 Completed Treatment Bronchoscopy 1
4 Completed Treatment Hypertension in Pregnancy / Preeclampsia 2
4 Completed Treatment Hypertensive Urgency 1
4 Not Yet Recruiting Treatment Stroke, Ischemic 1
4 Recruiting Prevention Hypertension, Pregnancy-Induced / Prophylaxis of preeclampsia 1
4 Recruiting Supportive Care Deliberate Hypotension / Sinus Endoscopic Surgery / Tissue Perfusion 1
4 Recruiting Treatment Chronic Hypertension in Obstetric Context / Preeclampsia With Severe Features 1
4 Recruiting Treatment High Blood Pressure (Hypertension) 1
4 Recruiting Treatment Preeclampsia With Severe Features 1
Not Available Completed Not Available Acute Bacterial Exacerbation of Chronic Bronchitis (ABECB) / Acute Bacterial Sinusitis (ABS) / Acute Decompensated Heart Failure (ADHF) / Acute Pyelonephritis / Adenovirus / Adjunct to general anesthesia therapy / Adrenal Insufficiency / Airway Swelling / Anaesthesia therapy / Anxiety / Anxiolysis / Autism, Early Infantile / Autistic Disorder / Bartonellosis / Benzodiazepine Withdrawal / Benzodiazepines / Bipolar Disorder (BD) / Bloodstream Infections / Bone and Joint Infections / Bradycardia / Brain Swelling / Bronchospasm / Brucellosis / Cardiac Arrest / Cardiac Dysrhythmia / Central Nervous System Infections / Cholera / Chronic Bacterial Prostatitis / Chronic Kidney Disease (CKD) / Community Acquired Pneumonia (CAP) / Complicated Urinary Tract Infection / Convulsions / Cytomegalovirus Retinitis / Drug hypersensitivity reaction / Early-onset Schizophrenia Spectrum Disorders / Edema / Endocarditis / Epilepsies / Fibrinolytic Bleeding / Flu caused by Influenza / Gastroparesis / Gram-negative Infection / Gynaecological infection / Headache / Heart Failure / Heavy Menstrual Bleeding / Hemophilia / Herpes Simplex Virus / High Blood Pressure (Hypertension) / High Cholesterol / Hospital-acquired bacterial pneumonia / Hyperaldosteronism / Hyperlipidemias / Hypokalemia / Hypotension / Infantile Hemangiomas / Infection / Infection caused by staphylococci / Inflammatory Conditions / Inflammatory Reaction / Influenza Treatment or Prophylaxis / Inhalational Anthrax (Post-Exposure) / Insomnia / Intra-Abdominal Infections / Life-threatening Fungal Infections / Lower Respiratory Tract Infection (LRTI) / Meningitis, Bacterial / Methicillin Resistant Staphylococcus Aureus (MRSA) / Migraine / Muscle Spasms / Nausea / Neuromuscular Blockade / Neutropenia / Opioid Addiction / Pain / Plague / Pneumonia / Prophylaxis / Psittacosis / Pulmonary Arterial Hypertension (PAH) / Q Fever / Reflux / Relapsing Fever / Rocky Mountain Spotted Fever / Schizophrenia / Sedation / Seizures / Sepsis / Skeletal Muscle Spasms / Skin and Subcutaneous Tissue Bacterial Infections / Skin Structures and Soft Tissue Infections / Stable Angina (SA) / Thromboprophylaxis / Thrombotic events / Toxic effect of hydrocyanic acid and cyanides / Trachoma / Treatment-resistant Schizophrenia / Tularemia / Typhus Fever / Uncomplicated Skin and Skin Structure Infections / Uncomplicated Urinary Tract Infections / Urinary Tract Infection / Vomiting / Withdrawal 1
Not Available Completed Treatment Cerebral Hemorrhage / Cerebrovascular Accident / Intracranial Hemorrhages 1
Not Available Completed Treatment Severe Postpartum Hypertension 1
Not Available Recruiting Treatment Acute Coronary Syndromes (ACS) 1
Not Available Unknown Status Prevention Intubation, Endotracheal / Patients Who Are Intubated for General Anesthesia 1
Not Available Withdrawn Treatment High Blood Pressure (Hypertension) 1

Pharmacoeconomics

Manufacturers

  • Apothecon inc div bristol myers squibb
  • Bedford laboratories div ben venue laboratories inc
  • Claris lifesciences ltd
  • Hospira inc
  • Taylor pharmaceuticals
  • Sagent strides llc
  • Schering corp sub schering plough corp
  • Prometheus laboratories inc
  • Ivax pharmaceuticals inc sub teva pharmaceuticals usa
  • Mutual pharmaceutical co inc
  • Sandoz inc
  • Teva pharmaceuticals usa inc
  • Watson laboratories inc

Packagers

  • Akorn Inc.
  • Amerisource Health Services Corp.
  • Apotex Inc.
  • Baxter International Inc.
  • Bedford Labs
  • Ben Venue Laboratories Inc.
  • Cardinal Health
  • Comprehensive Consultant Services Inc.
  • Diversified Healthcare Services Inc.
  • Eon Labs
  • Goldline Laboratories Inc.
  • Heartland Repack Services LLC
  • Hospira Inc.
  • Ivax Pharmaceuticals
  • Kaiser Foundation Hospital
  • Major Pharmaceuticals
  • Mckesson Corp.
  • Murfreesboro Pharmaceutical Nursing Supply
  • Neuman Distributors Inc.
  • Novex Pharma
  • Nucare Pharmaceuticals Inc.
  • Pharmaceutical Utilization Management Program VA Inc.
  • Physicians Total Care Inc.
  • Prometheus Laboratories Inc.
  • Rebel Distributors Corp.
  • Sagent Pharmaceuticals
  • Sandhills Packaging Inc.
  • Southwood Pharmaceuticals
  • Teva Pharmaceutical Industries Ltd.
  • UDL Laboratories
  • United Research Laboratories Inc.
  • Vangard Labs Inc.
  • Watson Pharmaceuticals
  • Wellspring Pharmaceutical

Dosage forms

Form Route Strength
Powder Not applicable 1 kg/1kg
Injection Intravenous 5 mg/1mL
Tablet, coated Oral 100 mg/1
Tablet, coated Oral 200 mg/1
Tablet, coated Oral 300 mg/1
Tablet, film coated Oral 100 mg/1
Tablet, film coated Oral 200 mg/1
Tablet, film coated Oral 300 mg/1
Liquid Intravenous
Solution Intravenous
Injection, solution Intravenous 5 mg/1mL
Tablet Oral 100 mg
Tablet Oral 100 mg/1
Tablet Oral 200 mg
Tablet Oral 200 mg/1
Tablet Oral 300 mg/1
Tablet Oral

Prices

Unit description Cost Unit
Labetalol Hydrochloride 5 mg/ml 1.36USD ml
Trandate 300 mg tablet 1.28USD tablet
Trandate 5 mg/ml vial 1.25USD ml
Trandate 200 mg tablet 1.08USD tablet
Labetalol hcl 300 mg tablet 1.02USD tablet
Normodyne 200 mg tablet 1.0USD tablet
Labetalol hcl 200 mg tablet 0.76USD tablet
Trandate 100 mg tablet 0.68USD tablet
Labetalol hcl 100 mg tablet 0.53USD tablet
Trandate 200 mg Tablet 0.47USD tablet
Trandate 100 mg Tablet 0.27USD tablet
Labetalol hcl 5 mg/ml vial 0.1USD ml

DrugBank does not sell nor buy drugs. Pricing information is supplied for informational purposes only. Patents Not Available

Properties

State Solid Experimental Properties Predicted Properties

Property Value Source
Water Solubility 0.00578 mg/mL ALOGPS
logP 1.73 ALOGPS
logP 1.89 ChemAxon
logS -4.8 ALOGPS
pKa (Strongest Acidic) 8.05 ChemAxon
pKa (Strongest Basic) 9.8 ChemAxon
Physiological Charge 1 ChemAxon
Hydrogen Acceptor Count 4 ChemAxon
Hydrogen Donor Count 4 ChemAxon
Polar Surface Area 95.58 Å2 ChemAxon
Rotatable Bond Count 8 ChemAxon
Refractivity 94.72 m3·mol-1 ChemAxon
Polarizability 36.83 Å3 ChemAxon
Number of Rings 2 ChemAxon
Bioavailability 1 ChemAxon
Rule of Five Yes ChemAxon
Ghose Filter Yes ChemAxon
Veber’s Rule No ChemAxon
MDDR-like Rule No ChemAxon

Predicted ADMET features

Property Value Probability
Human Intestinal Absorption + 0.9943
Blood Brain Barrier 0.8313
Caco-2 permeable + 0.8867
P-glycoprotein substrate Substrate 0.7073
P-glycoprotein inhibitor I Non-inhibitor 0.8908
P-glycoprotein inhibitor II Non-inhibitor 0.9269
Renal organic cation transporter Non-inhibitor 0.8457
CYP450 2C9 substrate Non-substrate 0.7448
CYP450 2D6 substrate Substrate 0.8918
CYP450 3A4 substrate Non-substrate 0.6202
CYP450 1A2 substrate Non-inhibitor 0.9046
CYP450 2C9 inhibitor Non-inhibitor 0.9071
CYP450 2D6 inhibitor Inhibitor 0.8932
CYP450 2C19 inhibitor Inhibitor 0.8995
CYP450 3A4 inhibitor Non-inhibitor 0.8256
CYP450 inhibitory promiscuity Low CYP Inhibitory Promiscuity 0.8383
Ames test Non AMES toxic 0.9133
Carcinogenicity Non-carcinogens 0.9189
Biodegradation Not ready biodegradable 0.945
Rat acute toxicity 2.1174 LD50, mol/kg Not applicable
hERG inhibition (predictor I) Weak inhibitor 0.9501
hERG inhibition (predictor II) Non-inhibitor 0.7398

ADMET data is predicted using admetSAR, a free tool for evaluating chemical ADMET properties. (23092397)

Spectra

Mass Spec (NIST) Not Available Spectra

Taxonomy

Description This compound belongs to the class of organic compounds known as salicylamides. These are carboxamide derivatives of salicylic acid. Salicylic acid is the ortho-hydroxylated derivative of benzoic acid. Kingdom Organic compounds Super Class Benzenoids Class Benzene and substituted derivatives Sub Class Benzoic acids and derivatives Direct Parent Salicylamides Alternative Parents Benzamides / Benzoyl derivatives / Aralkylamines / 1-hydroxy-2-unsubstituted benzenoids / Vinylogous acids / Secondary alcohols / Primary carboxylic acid amides / Amino acids and derivatives / 1,2-aminoalcohols / DialkylaminesOrganopnictogen compounds / Organic oxides / Hydrocarbon derivatives / Aromatic alcohols show 4 more Substituents Salicylamide / Benzamide / Benzoyl / 1-hydroxy-2-unsubstituted benzenoid / Phenol / Aralkylamine / Vinylogous acid / Amino acid or derivatives / 1,2-aminoalcohol / Secondary alcoholCarboxamide group / Primary carboxylic acid amide / Secondary amine / Carboxylic acid derivative / Secondary aliphatic amine / Organopnictogen compound / Organonitrogen compound / Organooxygen compound / Alcohol / Organic oxygen compound / Aromatic alcohol / Organic nitrogen compound / Amine / Hydrocarbon derivative / Organic oxide / Aromatic homomonocyclic compound show 16 more Molecular Framework Aromatic homomonocyclic compounds External Descriptors benzamides, secondary amino compound (CHEBI:6343)

Targets

Binding Properties

×

Property Measurement pH Temperature (°C)
Kd (nM) 23.5 7.4 37 15655528
Kd (nM) 31.62 N/A N/A 3012084

Details Binding Properties1. Beta-1 adrenergic receptor Kind Protein Organism Humans Pharmacological action Yes Actions Antagonist General Function Receptor signaling protein activity Specific Function Beta-adrenergic receptors mediate the catecholamine-induced activation of adenylate cyclase through the action of G proteins. This receptor binds epinephrine and norepinephrine with approximately e… Gene Name ADRB1 Uniprot ID P08588 Uniprot Name Beta-1 adrenergic receptor Molecular Weight 51322.1 Da Kind Protein Organism Humans Pharmacological action Yes Actions Antagonist General Function Protein homodimerization activity Specific Function Beta-adrenergic receptors mediate the catecholamine-induced activation of adenylate cyclase through the action of G proteins. The beta-2-adrenergic receptor binds epinephrine with an approximately … Gene Name ADRB2 Uniprot ID P07550 Uniprot Name Beta-2 adrenergic receptor Molecular Weight 46458.32 Da Kind Protein group Organism Humans Pharmacological action Yes Actions Antagonist General Function Protein heterodimerization activity Specific Function This alpha-adrenergic receptor mediates its action by association with G proteins that activate a phosphatidylinositol-calcium second messenger system. Its effect is mediated by G(q) and G(11) prot…

Components:

Enzymes

Kind Protein Organism Humans Pharmacological action Unknown Actions Substrate Inhibitor General Function Steroid hydroxylase activity Specific Function Responsible for the metabolism of many drugs and environmental chemicals that it oxidizes. It is involved in the metabolism of drugs such as antiarrhythmics, adrenoceptor antagonists, and tricyclic… Gene Name CYP2D6 Uniprot ID P10635 Uniprot Name Cytochrome P450 2D6 Molecular Weight 55768.94 Da Kind Protein Organism Humans Pharmacological action Unknown Actions Substrate General Function Steroid hydroxylase activity Specific Function Responsible for the metabolism of a number of therapeutic agents such as the anticonvulsant drug S-mephenytoin, omeprazole, proguanil, certain barbiturates, diazepam, propranolol, citalopram and im… Gene Name CYP2C19 Uniprot ID P33261 Uniprot Name Cytochrome P450 2C19 Molecular Weight 55930.545 Da

  1. Flockhart Table of Drug Interactions

Kind Protein Organism Humans Pharmacological action Unknown Actions Substrate General Function Steroid binding Specific Function UDPGT is of major importance in the conjugation and subsequent elimination of potentially toxic xenobiotics and endogenous compounds. This isoform glucuronidates bilirubin IX-alpha to form both the… Gene Name UGT1A1 Uniprot ID P22309 Uniprot Name UDP-glucuronosyltransferase 1-1 Molecular Weight 59590.91 Da Kind Protein Organism Humans Pharmacological action Unknown Actions Substrate General Function Glucuronosyltransferase activity Specific Function UDPGT is of major importance in the conjugation and subsequent elimination of potentially toxic xenobiotics and endogenous compounds.Its unique specificity for 3,4-catechol estrogens and estriol su… Gene Name UGT2B7 Uniprot ID P16662 Uniprot Name UDP-glucuronosyltransferase 2B7 Molecular Weight 60694.12 Da Kind Protein Organism Humans Pharmacological action Unknown Actions Substrate General Function Retinoic acid binding Specific Function UDPGT is of major importance in the conjugation and subsequent elimination of potentially toxic xenobiotics and endogenous compounds. This isoform has specificity for phenols. Isoform 2 lacks trans… Gene Name UGT1A9 Uniprot ID O60656 Uniprot Name UDP-glucuronosyltransferase 1-9 Molecular Weight 59940.495 Da

Carriers

Details1. Serum albumin Kind Protein Organism Humans Pharmacological action Unknown Actions Substrate General Function Toxic substance binding Specific Function Serum albumin, the main protein of plasma, has a good binding capacity for water, Ca(2+), Na(+), K(+), fatty acids, hormones, bilirubin and drugs. Its main function is the regulation of the colloid… Gene Name ALB Uniprot ID P02768 Uniprot Name Serum albumin Molecular Weight 69365.94 Da Kind Protein group Organism Humans Pharmacological action Unknown Actions Substrate General Function Not Available Specific Function Functions as transport protein in the blood stream. Binds various ligands in the interior of its beta-barrel domain. Also binds synthetic drugs and influences their distribution and availability in…

Name UniProt ID
Alpha-1-acid glycoprotein 1 P02763
Alpha-1-acid glycoprotein 2 P19652

Transporters

Kind Protein Organism Humans Pharmacological action Unknown General Function Efflux transmembrane transporter activity Specific Function Drug efflux transporter present in a number of stem cells that acts as a regulator of cellular differentiation. Able to mediate efflux from cells of the rhodamine dye and of the therapeutic drug do… Gene Name ABCB5 Uniprot ID Q2M3G0 Uniprot Name ATP-binding cassette sub-family B member 5 Molecular Weight 138639.48 Da ×Unlock Data

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Drug created on June 13, 2005 07:24 / Updated on February 02, 2020 04:06

About labetalol

Type of medicine A beta-adrenoceptor blocking drug (often referred to as a beta-blocker)
Used for High blood pressure
Also called Trandate®
Available as Tablets and injection

Labetalol is a medicine which works on your heart and blood vessels. It does this by blocking tiny areas (called receptors) where messages are received by your heart and blood vessels. As a result, the pressure of blood within your blood vessels is reduced, and your heart beats more slowly and with less force. When it is given by injection, it reduces blood pressure quickly, and for this reason it is used to keep blood pressure down during surgery, and in people who have had a heart attack.

Tablets of labetalol are prescribed for the treatment of high blood pressure (hypertension). Most people with high blood pressure do not feel unwell, but it is important that your high blood pressure is treated even if you feel fine. This is because high blood pressure can be damaging to your blood vessels and can put a strain on your heart. In particular, labetalol is one of the medicines of choice for treating high blood pressure during pregnancy.

Before taking labetalol

Some medicines are not suitable for people with certain conditions, and sometimes a medicine can only be used if extra care is taken. For these reasons, before you start taking labetalol it is important that your doctor knows:

  • If you are pregnant or breastfeeding.
  • If you have asthma or any other breathing disorder.
  • If you have any problems with the way your liver works.
  • If you have poor circulation.
  • If you have sugar diabetes (diabetes mellitus).
  • If you have a skin problem called psoriasis.
  • If you have a condition causing muscle weakness, called myasthenia gravis.
  • If you have been told you have a slow heartbeat, heart failure, or heart block (a slow and irregular heartbeat).
  • If you have been told you have chest pain caused by spasms of your heart’s blood vessels, called Prinzmetal’s angina.
  • If you are taking any other medicines. This includes any medicines you are taking which are available to buy without a prescription, as well as herbal and complementary medicines.
  • If you have ever had an allergic reaction to a medicine, or if you have ever had any other serious allergic reaction.

How to take labetalol

  • Before you start the treatment, read the manufacturer’s printed information leaflet from inside the pack. It will give you more information about labetalol and will provide you with a full list of the side-effects which you may experience from taking it.
  • Take labetalol exactly as your doctor tells you to. It is usual to take two doses a day. The directions will be printed on the label of the pack of tablets to remind you about what the doctor said to you.
  • Swallow the tablet with a drink of water. Take labetalol at a mealtime, or with something to eat.
  • If you forget to take a dose, take it as soon as you remember (unless it is nearly time for your next dose, in which case leave out the missed dose). Do not take two doses together to make up for a forgotten dose.

Getting the most from your treatment

  • Try to keep your regular appointments with your doctor. This is so your doctor can check on your progress.
  • Treatment with labetalol is often long-term. Continue to take the tablets unless your doctor tells you to stop. Stopping treatment suddenly can cause problems in some people, so your doctor may want you to reduce your dose gradually if this becomes necessary.
  • If you are due to have an operation or dental treatment, it is important to tell the person carrying out the treatment that you are taking a beta-blocker. This is particularly important if you are likely to be given an anaesthetic.
  • Drinking alcohol while you are on labetalol is not recommended. Alcohol will add to the blood pressure-lowering effect of labetalol which will increase the chances of you experiencing side-effects such as feeling sleepy and dizzy.
  • If you buy any medicines, check with a pharmacist that they are suitable for you to take with labetalol. Some medicines may not be (including some anti-inflammatory painkillers, and cold or flu remedies).
  • Your doctor may give you dietary and lifestyle advice about eating a healthy diet, not smoking, and taking regular exercise. If so, it is important that you follow the advice you are given.
  • If you have diabetes, labetalol can block the symptoms of low blood sugar. Your doctor will advise you about this.

Can labetalol cause problems?

Along with their useful effects, most medicines can cause unwanted side-effects although not everyone experiences them. The table below contains some of the ones associated with labetalol. You will find a full list in the manufacturer’s information leaflet supplied with your medicine. The unwanted effects often improve as your body adjusts to the new medicine, but speak with your doctor or pharmacist if any of the following continue or become troublesome.

Labetalol side-effects What can I do if I experience this?
Feeling dizzy, sleepy, tired or light-headed If this happens, do not drive and do not use tools or machines while affected
Feeling sick (nausea) or being sick (vomiting), stomach ache Stick to simple meals – avoid rich and spicy foods
Headache Drink plenty of water and ask your pharmacist to recommend a suitable painkiller. If the headaches continue let your doctor know
Cold fingers or toes, disturbed sleep, slow heartbeat, blocked nose, swollen ankles, tingling feelings, feeling depressed, difficulties passing urine, and difficulties getting an erection If any of these become troublesome, speak with your doctor

Important: labetalol can occasionally cause liver problems. If you notice any yellowing of your skin or the whites of your eyes (jaundice), let your doctor know about this straightaway.

If you experience any other symptoms which you think may be due to the medicine, speak with your doctor or pharmacist for further advice.

How to store labetalol

  • Keep all medicines out of the reach and sight of children.
  • Store in a cool, dry place, away from direct heat and light.

Important information about all medicines

Never take more than the prescribed dose. If you suspect that you or someone else might have taken an overdose of this medicine, go to the accident and emergency department of your local hospital. Take the container with you, even if it is empty.

This medicine is for you. Never give it to other people even if their condition appears to be the same as yours.

Do not keep out-of-date or unwanted medicines. Take them to your local pharmacy which will dispose of them for you.

If you have any questions about this medicine ask your pharmacist.

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