Labetalol Hydrochloride Injection USP 20mg/4ml

Labetalol Hydrochloride Injection USP 20mg/4ml
Labetalol Hydrochloride Injection USP 100mg/20ml
Labetalol Hydrochloride Injection USP 200mg/40ml

Read all of this leaflet carefully before you start taking this medicine. It contains important information for you.

Keep this leaflet; you may need to read it again.
If you have further questions, ask your doctor, pharmacist or nurse.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See Section 4.

WHAT IS IN THIS LEAFLET:

What Labetalol is and what it is used for
What you need to know before you are given Labetalol
How Labetalol is given
Possible side effects
How to store Labetalol
Contents of the pack and other information

1. WHAT LABETALOL IS AND WHAT IT IS USED FOR

Labetalol contains the active substance labetalol. It is used to treat severe hypertension (high blood pressure), including severe hypertension of pregnancy (pregnancy-induced high blood pressure) when rapid control of blood pressure is necessary. Labetalol may also be used to control blood pressure during anaesthesia.

Labetalol belongs to a group of medicines called alpha and beta-blocking agents. These medicines lower blood pressure by blocking the receptors in the cardiovascular (circulatory) system, causing a decrease in blood pressure in the blood vessels far from the heart.

2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN LABETALOL DO NOT TAKE LABETALOL

if you are allergic to labetalol or any of the other ingredients of this medicine (listed in section 6)
if you have certain heart diseases for example heart block or sick sinus syndrome (unless you have a pacemaker), cardiogenic shock or heart failure which is not under the control
if you have ongoing low blood pressure
If you have an extremely slow heart rate (severe bradycardia)
if you have a condition known as Prinzmetal angina

if you have asthma or similar lung disease (obstructive airway disease)

if you have a particular type of tumour of the adrenal gland (phaeochromocytoma), untreated with an adequate pharmacologic therapy (see section ?Warning and Precautions?)

Warnings and Precautions

Talk to your doctor or pharmacist before you take Labetalol:

if you have reduced liver function or liver damage
if you have reduced kidney function
if you have peripheral vascular disease, for example, Raynaud’s syndrome, intermittent claudication
if you have diabetes mellitus (type 1 or type 2)
if you have an overactive thyroid (thyrotoxicosis, hyperthyroidism)
if you have previously had a severe allergic reaction (anaphylaxis) to any substance
if you have heart failure or other problems with your heart (for example; poor left ventricular systolic function, first-degree atrioventricular block)
if you know you are scheduled to have an operation
if you have metabolic acidosis (when your body produces too much acid or when the kidneys are not removing enough acid from your body) and phaeochromocytoma
if you have a condition called ischaemic heart disease
if you have any lung or respiratory system problems

If you develop a low heart rate (bradycardia) as a result of being given Labetalol, your doctor may lower your dose.

If you develop skin rashes and/or dry eyes, or any kind of allergic reaction when you are being given Labetalol, tell your doctor as they may reduce or discontinue your treatment.

Surgery

If you are having surgery requiring general anaesthetic, you must tell your surgeon ahead of your surgery that you are using Labetalol as labetalol may mask the effects of a sudden loss of blood.

Labetalol can affect your pupils during cataract surgery. Tell your eye surgeon ahead of your surgery that you are using this medication. Do not stop using labetalol before surgery unless your surgeon tells you to.

Tests

This medicine may interfere with certain medical tests/laboratory tests and possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this medicine.

Children and adolescents

This medicine should not be given to children and adolescents under the age of 18.

Other medicines and Labetalol

Tell your doctor if you are taking, have recently taken or might take any other medicines before you are given Labetalol. This is especially important for the following medicines:

NSAIDs (non-steroidal anti-inflammatory drugs) for example sulindac or indomethacin, which are used to treat pain and inflammation
digoxin (heart medicine)
adrenaline which may be used to treat serious anaphylactic (allergic) reactions
medicines for heart disorders (Class I antiarrhythmic agents, for example, disopyramide and quinidine) and (Class II antiarrhythmic agents e.g. amiodarone)
other medicines that lower the blood pressure (calcium blockers such as verapamil)
general anaesthetics (used in surgery for narcosis)
tricyclic anti-depressants for example; imipramine (used for the treatment of depression)
oral antidiabetics, for example; biguanides (e.g. metformin), sulfonylureas (e.g. glimepiride), meglitinides (e.g. repaglinide), and ?-glucosidase inhibitors (e.g. acarbose) which are used to lower glucose levels in the blood
ergotamine derivates, for example; ergotamine or dihydroergotamine which are used to treat migraine
cholinesterase inhibitors, for example, donepezil, galantamine or rivastigmine which are used for the treatment of mild cognitive impairment, Alzheimer’s disease and Parkinson’s disease
nitrates, antipsychotics (eg. phenothiazine derivatives, chlorpromazine) and other antipsychotics, antidepressants
clonidine which is used to treat high blood pressure.

Pregnancy, breast-feeding and fertility

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before you are given Labetalol. It is possible that the foetus may be affected, but Labetalol can be used when rapid control of blood pressure is necessary during pregnancy.

Labetalol is excreted in breast milk in small amounts. If you are breast-feeding, ask your doctor for advice before you are given Labetalol.

Driving and using machines

Not applicable.

Labetalol contains Glucose monohydrate

1 ml contains 49.5 mg of Glucose monohydrate. To be considered in people with diabetes mellitus.

3. HOW LABETALOL IS GIVEN

Labetalol should always be used as instructed by your doctor. Labetalol is intended for intravenous treatment in hospitalised patients and should be administered by healthcare personnel.

It is important that you are lying down when the injection is being given to you. You will be asked to remain lying down for three hours after you have received Labetalol as you may get dizzy (from low blood pressure) if you move to an upright position sooner than this. Labetalol can either be given as a bolus injection (where the medicine is injected directly into a vein) or an intravenous infusion (where the medicine is injected directly into a vein over a longer period of time). Your doctor will decide how Labetalol should be administered and what dose of Labetalol that you should be given.

If you are given more Labetalol than you should

Symptoms of Labetalol overdose include extreme dizziness when you move to an upright position (sitting or standing) and sometimes low heart rate which you will feel like a slow pulse (bradycardia).

Contact a doctor or nurse if you think you have been given too much of this medicine.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Common: may affect up to 1 in 10 people

congestive heart failure
dizziness due to low blood pressure if you move too quickly from a lying to sitting position or from sitting to a standing position (postural hypotension). This may occur within three hours after Labetalol injection and is normally temporary and occurs in the first few weeks of treatment
congestion in your nose, which is normally temporary and occurs in the first few weeks of treatment
raised liver function tests. This is usually reversible on withdrawal of the medicinal product
erectile dysfunction (impotence)
allergic reactions (hypersensitivity) may also include rash (of varying severity), itching, shortness of breath and, very rarely, fever or rapid swelling of the skin.

Uncommon: may affect up to 1 in 100 people

tightening of the lower airways (bronchospasm).

Rare: may affect up to 1 in 1,000 people

low heart rate, which may be felt like a low pulse (bradycardia).

Very rare: may affect up to 1 in 10,000 people

disruption of the electrical pulses that control the heartbeat (heart block)
worsening of the symptoms of Raynaud’s Syndrome (cold fingers due to impaired blood circulation)
inflammation of the liver (hepatitis) which is usually reversible when the treatment with Labetalol is stopped
hepatocellular jaundice (the skin and the whites of the eyes turn yellow), cholestatic jaundice (symptoms include fatigue and nausea, followed by pruritus, dark urine and jaundice, and may include a rash or fever), and hepatic necrosis (damaged liver tissue). These symptoms are usually reversible when treatment with Labetalol is stopped.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

5. HOW TO STORE LABETALOL

Keep this medicine out of the sight and reach of children.

This medicinal product does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the ampoule and carton after EXP. The expiry date refers to the last day of that month.

Do not use this medicine if you notice signs of deterioration.

Chemical and physical in-use stability has been demonstrated for 24 hours at 25?C, 30?C and 40?C. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8 ?C.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Labetalol contains

Each ml of Injection contains:
Labetalol hydrochloride?????..20mg

The active substance is labetalol hydrochloride. One ml of the solution contains 20 mg of labetalol hydrochloride.

Other ingredients are glucose monohydrate, disodium edetate and water for injection; sodium hydroxide and hydrochloric acid (for pH adjustment).

What Labetalol looks like and contents of the pack

A clear, colourless solution in a clear glass ampoule. Each package contains 5 ampoules of 20 ml. Each ampoule contains 20 mg of labetalol hydrochloride.

7. MANUFACTURED IN INDIA BY:
TAJ LIFE SCIENCES PVT. LTD.
Unit No. 214, Old Bake House,
Bake House Lane, Fort,
Mumbai-400001
at: Ahmedabad- Gujarat, INDIA.
Ho.NO.+91 8448 444 095
Toll Free Phone: (1800-222-434 / 1800-222-825)