Labetalol Hydrochloride for injection 20mg/4ml in Pre-filled Syringe Taj Pharma

  1. Name of the medicinal product

Labetalol Hydrochloride for injection 20mg/4ml in Pre-filled Syringe Taj Pharma

Labetalol Hydrochloride 5mg/ml Solution for Injection in Pre-filled Syringe

  1. Qualitative and quantitative composition

Labetalol hydrochloride 5mg/ml

  1. Pharmaceutical form

Prefilled Syringe

  1. Clinical particulars

4.1 Therapeutic indications

Labetalol Hydrochloride Injection/Labetalol Injection is indicated for the treatment of:-

  1. Severe hypertension, including severe hypertension of pregnancy, when rapid control of blood pressure is essential.
  2. Anaesthesia when a hypotensive technique is indicated.
  3. Hypertensive episodes following acute myocardial infarction.

4.2 Posology and method of administration

Adults:

Labetalol Hydrochloride Injection/Labetalol Injection is intended for intravenous use in hospitalised patients. The plasma concentrations achieved after intravenous dose of labetalol in severe hypertension are substantially greater than those following oral administration of the drug and provide a greater degree of blockade of alpha-adrenoceptors necessary to control the more severe disease. Patients should, therefore, always receive the drug whilst in the supine or left lateral position. Raising the patient into the upright position, within three hours of intravenous labetalol administration, should be avoided since excessive postural hypotension may occur.

Bolus injection

If it is essential to reduce blood pressure quickly, as for example, in hypertensive encephalopathy, a dose of 50mg of labetalol hydrochloride should be given by intravenous injection over a period of at least one minute. If necessary, doses of 50mg may be repeated at five minute intervals until a satisfactory response occurs. The total dose should not exceed 200mg. After bolus injection, the maximum effect usually occurs within five minutes and the effective duration of action is usually about six hours but may be as long as eighteen hours.

Intravenous infusion

An alternative method of administering labetalol is intravenous infusion of a solution made by diluting the contents of two Prefilled Syringe (200mg) to 200ml with Sodium Chloride and Dextrose Injection BP or 5% Dextrose Intravenous Infusion BP. The resultant infusion solution contains 1mg/ml of labetalol hydrochloride. It should be administered using a paediatric giving set fitted with a 50ml graduated burette to facilitate dosage.

In the hypertension of pregnancy: The infusion can be started at the rate of 20mg per hour and this dose may be doubled every thirty minutes until a satisfactory reduction in blood pressure has been obtained or a dosage of 160mg per hour is reached. Occasionally, higher doses may be necessary.

In hypertensive episodes following acute myocardial infarction: The infusion should be commenced at 15mg per hour and gradually increased to a maximum of 120mg per hour depending on the control of blood pressure.

In hypertension due to other causes: The rate of infusion of labetalol hydrochloride should be about 2mg (2ml of infusion solution) per minute, until a satisfactory response is obtained; the infusion should then be stopped. The effective dose is usually in the range of 50-200mg depending on the severity of the hypertension. For most patients it is unnecessary to administer more than 200mg but larger doses may be required especially in patients with phaeochromocytoma. The rate of infusion may be adjusted according to the response, at the discretion of the physician. The blood pressure and pulse rate should be monitored throughout the infusion.

It is desirable to monitor the heart rate after injection and during infusion. In most patients, there is a small decrease in the heart rate; severe bradycardia is unusual but may be controlled by injecting atropine 1-2 mg intravenously. Respiratory function should be observed particularly in patients with any known impairment.

Once the blood pressure has been adequately reduced, maintenance therapy with labetalol tablets should be instituted with a starting dose of one 100 mg tablet twice daily (see labetalol tablet SmPC for further details). Labetalol Hydrochloride Injection/Labetalol Injection has been administered to patients with uncontrolled hypertension already receiving other hypotensive agents, including beta-blocking drugs, without adverse effects.

In hypotensive anaesthesia: Induction should be with standard agents (e.g. sodium thiopentone) and anaesthesia maintained with nitrous oxide and oxygen with or without halothane. The recommended starting dose of Labetalol Hydrochloride Injection/Labetalol Injection is 10-20 mg intravenously depending on the age and condition of the patient. Patients for whom halothane is contra-indicated usually require a higher initial dose of labetalol hydrochloride (25-30 mg). If satisfactory hypotension is not achieved after five minutes, increments of 5-10 mg should be given until the desired level of blood pressure is attained.

Halothane and labetalol act synergistically therefore the halothane concentration should not exceed 1-1.5% as profound falls in blood pressure may be precipitated.

Following Labetalol Hydrochloride Injection/Labetalol Injection the blood pressure can be quickly and easily adjusted by altering the halothane concentration and/or adjusting table tilt. The mean duration of hypotension following 20-25 mg of labetalol hydrochloride is fifty minutes.

Hypotension induced by Labetalol Hydrochloride Injection/Labetalol Injection is readily reversed by atropine 0.6 mg and discontinuation of halothane.

Tubocurarine and pancuronium may be used when assisted or controlled ventilation is required. Intermittent Positive Pressure Ventilation (IPPV) may further increase the hypotension resulting from Labetalol Hydrochloride Injection/Labetalol Injection and/or halothane.

Children:

Safety and efficacy have not been established.

4.3 Contraindications

  • Cardiogenic shock.
  • Uncontrolled, incipient or digitalis refractory heart failure.
  • Sick sinus syndrome (including sino-atrial block).
  • Second- or third-degree heart block.
  • Prinzmetal’s angina.
  • History of wheezing or asthma.
  • Untreated phaeochromocytoma.
  • Metabolic acidosis.
  • Bradycardia (<45-50 bpm).
  • Hypotension.
  • Hypersensitivity to labetalol.
  • Severe peripheral circulatory disturbances.
  • Where peripheral vasoconstriction suggests low cardiac output, the use of Labetalol Hydrochloride Injection/Labetalol Injection to control hypertensive episodes following acute myocardial infarction is contra-indicated.

4.4 Special warnings and precautions for use

There have been reports of skin rashes and/or dry eyes associated with the use of beta-adrenoceptor blocking drugs. The reported incidence is small and in most cases the symptoms have cleared when the treatment was withdrawn. Gradual discontinuance of the drug should be considered if any such reaction is not otherwise explicable.

The occurrence of intraoperative floppy iris syndrome (IFIS, a variation of Horner’s syndrome) has been observed during cataract surgeries in some patients who were being treated with tamsulosine, or have been treated with tamsulosine in the past. IFIS has also been reported when other alpha-1-blockers were being used, and the possibility of a class effect cannot be excluded. Since IFIS can lead to a higher chance of complications during cataract surgeries, the ophthalmologist needs to be informed if alpha-1-blockers are currently being used, or have been used in the past.

There have been rare reports of severe hepatocellular injury with labetalol therapy. The hepatic injury is usually reversible and has occurred after both short- and long-term treatment. Appropriate laboratory testing should be done at the first sign or symptom of liver dysfunction. If there is laboratory evidence of liver injury or the patient is jaundiced, labetalol therapy should be stopped and not re-started.

Due to negative inotropic effects, special care should be taken with patients whose cardiac reserve is poor and heart failure should be controlled before starting labetalol therapy.

Patients, particularly those with ischemic heart disease, should not interrupt/discontinue abruptly labetalol therapy. The dosage should gradually be reduced, i.e. over 1-2 weeks, if necessary, at the same time initiating replacement therapy, to prevent exacerbation of angina pectoris. In addition, hypertension and arrhythmias may develop.

It is not necessary to discontinue labetalol therapy in patients requiring anesthesia, but the anesthetist must be informed and the patient should be given intravenous atropine prior to induction. During anesthesia labetalol may mask the compensatory physiological responses to sudden hemorrhage (tachycardia and vasoconstriction). Close attention must therefore be paid to blood loss and the blood volume maintained. If beta-blockade is interrupted in preparation for surgery, therapy should be discontinued for at least 24 hours. Anaesthetic agents causing myocardial depression (e.g. cyclopropane, trichloroethylene) should be avoided. Labetalol may enhance the hypotensive effects of halothane.

In patients with peripheral circulatory disorders (Raynaud’s disease or syndrome, intermittent claudication), beta-blockers should be used with great caution as aggravation of these disorders may occur.

Beta-blockers may induce bradycardia. If the pulse rate decreases to less than 50-55 beats per minute at rest and the patient experiences symptoms related to the bradycardia, the dosage should be reduced.

Beta-blockers, even those with apparent cardioselectivity, should not be used in patients with asthma or a history of obstructive airways disease unless no alternative treatment is available. In such cases the risk of inducing bronchospasm should be appreciated and appropriate precautions taken. If bronchospasm should occur after the use of labetalol it can be treated with a beta2-agonist by inhalation, e.g. salbutamol (the dose of which may need to be greater than the usual in asthma) and, if necessary, intravenous atropine 1mg.

Due to a negative effect on conduction time, beta-blockers should only be given with caution to patients with first degree heart block. Patients with liver or kidney insufficiency may need a lower dosage, depending on the pharmacokinetic profile of the compound. The elderly should be treated with caution, starting with a lower dosage but tolerance is usually good in the elderly.

Patients with a history of psoriasis should take beta-blockers only after careful consideration.

Risk of anaphylactic reaction: While taking beta-blockers, patients with a history of severe anaphylactic reaction to a variety of allergens may be more reactive to repeated challenge, either accidental, diagnostic or therapeutic. Such patients may be unresponsive to the usual doses of epinephrine use to treat allergic reaction.

The label will state “Do not take Labetalol Hydrochloride  Injection/Labetalol Injection if you have a history of wheezing or asthma as it can make your breathing worse.”

4.5 Interaction with other medicinal products and other forms of interaction

Concomitant use not recommended:

  • Calcium antagonists such as verapamil and to a lesser extent diltiazem have a negative influence on contractility and atrio-ventricular conduction.
  • Digitalis glycosides used in association with beta-blockers may increase atrio-ventricular conduction time.
  • Clonidine: Beta-blockers increase the risk of rebound hypertension. When clonidine is used in conjunction with non-selective beta-blockers, such as propranolol, treatment with clonidine should be continued for some time after treatment with the beta-blocker has been discontinued.
  • Monoamineoxidase inhibitors (except MOA-B inhibitors).

Use with caution:

  • Class I antiarrhythmic agents (e.g. disopyramide, quinidine) and amiodarone may have potentiating effects on atrial conduction time and induce negative inotropic effect.
  • Insulin and oral antidiabetic drugs may intensify the blood sugar lowering effect, especially of non-selective beta-blockers. Beta- blockade may prevent the appearance of signs of hypoglycaemia (tachycardia).
  • Anaesthetic drugs may cause attenuation of reflex tachycardia and increase the risk of hypotension. Continuation of beta-blockade reduces the risk of arrhythmia during induction and intubation. The anaesthesiologist should be informed when the patient is receiving a beta-blocking agent. Anaesthetic agents causing myocardial depression, such as cyclopropane and trichlorethylene, are best avoided.
  • Cimetidine, hydralazine and alcohol may increase the bioavailability of labetalol.
  • Several different drugs or drug classes may enhance the hypotensive effects of labetalol: ACE inhibitors; angiotensin-II antagonists; aldesleukin, alprostadil; anxiolytics; hypnotics; moxisylyte; diuretics; alpha-blockers.
  • Several different drugs or drug classes may antagonise the hypotensive effects of labetalol: NSAIDs, corticosteroids; oestrogens; progesterones.

Take into account:

  • Calcium antagonists: dihydropyridine derivates such as nifedipine. The risk of hypotension may be increased. In patients with latent cardiac insufficiency, treatment with beta-blockers may lead to cardiac failure.
  • Prostaglandin synthetase inhibiting drugs may decrease the hypotensive effect of beta-blockers.
  • Sympathicomimetic agents may counteract the effect of beta-adrenergic blocking agents.
  • Concomitant use of tricyclic antidepressants, barbiturates, phenothiazines or other antihypertensive agents may increase the blood pressure lowering effect of labetalol. Concomitant use of tricyclic antidepressants may increase the incidence of tremor.
  • Labetalol has been shown to reduce the uptake of radioisotopes of metaiodobenzylguanidine (MIBG), and may increase the likelihood of a false negative study. Care should therefore be taken in interpreting results from MIBG scintigraphy. Consideration should be given to withdrawing labetalol for several days at least before MIBG scintigraphy, and substituting other beta or alpha-blocking drugs.
  • Antimalarials such as mefloquine or quinine may increase the risk of bradycardia.
  • Ergot derivatives may increase the risk of peripheral vasoconstriction.
  • Tropisetron may increase the risk of ventricular arrhythmia.
  • Labetalol interferes with laboratory tests for catecholamines.

4.6 Fertility, pregnancy and lactation

Although no teratogenic effects have been demonstrated in animals, labetalol should only be used during the first trimester of pregnancy if the potential benefit outweighs the potential risk.

Labetalol crosses the placental barrier and the possibility of the consequences of alpha- and beta-adrenoceptor blockade in the foetus and neonate should be borne in mind. Perinatal and neonatal distress (bradycardia, hypotension, respiratory depression, hypoglycaemia, hypothermia) has been rarely reported. Sometimes these symptoms have developed a day or two after birth. Response to supportive measures (e.g. intravenous fluids and glucose) is usually prompt but with severe pre-eclampsia, particularly after prolonged intravenous labetalol, recovery may be slower. This may be related to diminished liver metabolism in premature babies.

Beta-blockers reduce placental perfusion, which may result in intrauterine foetal death, immature and premature deliveries. There is an increased risk of cardiac and pulmonary complications in the neonate in the post-natal period. Intra-uterine and neonatal deaths have been reported with labetalol but other drugs (e.g. vasodilators, respiratory depressants) and the effects of pre-eclampsia, intra-uterine growth retardation and prematurity were implicated. Such clinical experience warns against unduly prolonging high dose labetalol and delaying delivery and against co-administration of hydralazine.

Labetalol is excreted in breast milk. Breast-feeding is therefore not recommended.

4.7 Effects on ability to drive and use machines

There are no studies on the effect of this medicine on the ability to drive. When driving vehicles or operating machines it should be taken into account that occasionally dizziness or fatigue may occur.

4.8 Undesirable effects

Labetalol Hydrochloride Injection/Labetalol Injection is usually well tolerated. Excessive postural hypotension may occur if patients are allowed to assume an upright position within three hours of receiving Labetalol Hydrochloride Injection/Labetalol Injection.

Most side-effects are transient and occur during the first few weeks of treatment with labetalol. They include:

Blood and the lymphatic system disorders

Rare reports of positive antinuclear antibodies unassociated with disease, hyperkalaemia, particularly in patients who may have impaired renal excretion of potassium, thrombocytopenia.

Psychiatric disorders

Depressed mood and lethargy, hallucinations, psychoses, confusion, sleep disturbances, nightmares.

Nervous system disorders

Headache, tiredness, dizziness, tremor has been reported in the treatment of hypertension of pregnancy.

Eye disorders

Impaired vision, dry eyes.

Cardiac disorders

Bradycardia, heart block, heart failure, hypotension.

Vascular disorders

Ankle oedema, increase of an existing intermittent claudication, postural hypotension, cold or cyanotic extremities, Raynaud’s phenomenon, paraesthesia of the extremities.

Respiratory, thoracic and mediastinal disorders

Bronchospasm (in patients with asthma or a history of asthma), nasal congestion, interstitial lung disease.

Gastrointestinal disorders

Epigastric pain, nausea, vomiting, diarrhoea.

Hepato-biliary disorders

Raised liver function tests, jaundice (both hepatocellular and cholestatic), hepatitis and hepatic necrosis.

Skin and subcutaneous tissue disorders

Sweating, tingling sensation in the scalp, usually transient, may occur in a few patients early in treatment, reversible lichenoid rash, systemic lupus erythematosus, exacerbation of psoriasis.

Musculoskeletal, connective tissue and bone disorders:

Cramps, toxic myopathy.

Renal and urinary disorders

Acute retention of urine, difficulty in micturition.

Reproductive system and breast disorders

Ejaculatory failure.

General disorders and administration site conditions

Hypersensitivity (rash, pruritus, angioedema and dyspnoea), drug fever, masking of the symptoms of thyrotoxicosis or hypoglycaemia, reversible alopecia.

4.9 Overdose

Symptoms of overdosage are bradycardia, hypotension, bronchospasm and acute cardiac insufficiency.

After an overdose or in case of hypersensitivity, the patient should be kept under close supervision and be treated in an intensive-care ward. Artificial respiration may be required. Bradycardia or extensive vagal reactions should be treated by administering atropine or methylatropine. Hypotension and shock should be treated with plasma/plasma substitutes and, if necessary, catecholamines. The beta-blocking effect can be counteracted by slow intravenous administration of isoprenaline hydrochloride, starting with a dose of approximately 5mcg/min, or dobutamine, starting with a dose of approximately 2.5mcg/min, until the required effect has been obtained. If this does not produce the desired effect, intravenous administration of 8-10 mg glucagon may be considered. If required the injection should be repeated within one hour, to be followed, if necessary, by an iv infusion of glucagon at 1-3 mg/hour. Administration of calcium ions, or the use of a cardiac pacemaker, may also be considered.

Oliguric renal failure has been reported after massive overdosage of labetalol orally. In one case, the use of dopamine to increase the blood pressure may have aggravated the renal failure.

Labetalol does have membrane stabilising activity which may have clinical significance in overdosage.

Haemodialysis removes less than 1% labetalol hydrochloride from the circulation.

  1. Pharmacological properties

5.1 Pharmacodynamic properties

Labetalol lowers the blood pressure primarily by blocking peripheral arteriolar alpha-adrenoceptors thus reducing peripheral resistance and, by Concurrent beta-blockade protects the heart from reflex sympathetic drive that would otherwise occur. Cardiac output is not significantly reduced at rest or after moderate exercise. Increases in systolic blood pressure during exercise are reduced but corresponding changes in diastolic pressure are essentially normal.

In patients with angina pectoris co-existing with hypertension, the reduced peripheral resistance decreases myocardial afterload and oxygen demand. All these effects would be expected to benefit hypertensive patients and those with coexisting angina.

5.2 Pharmacokinetic properties

The plasma half-life of labetalol is about 4 hours. About 50% of labetalol in the blood is protein bound. Labetalol is metabolised mainly through conjugation to inactive glucuronide metabolites. These are excreted both in urine and via the bile into the faeces.

Only negligible amounts of the drug cross the blood brain barrier in animal studies.

5.3 Preclinical safety data

Not applicable since Labetalol Hydrochloride Injection/Labetalol Injection has been used in clinical practice for many years and its effects in man are well known.

  1. Pharmaceutical particulars

6.1 List of excipients

Hydrochloric acid dilute, Sodium hydroxide, Water for Injection

 

6.2 Incompatibilities

Labetalol Hydrochloride Injection/Labetalol Injection has been shown to be incompatible with sodium bicarbonate injection BP 4.2% w/v

6.3 Shelf life

24 months.

6.4 Special precautions for storage

Protect from light. Store below 30°C

6.5 Nature and contents of container

Prefilled Syringe: 5 Prefilled Syringe of 20ml (per pack).

6.6 Special precautions for disposal and other handling

None

  1. Manufactured in India by:
    TAJ PHARMACEUTICALS LTD.
    Mumbai, India
    Unit No. 214.Old Bake House,
    Maharashtra chambers of  Commerce Lane,
    Fort, Mumbai – 400001
    at: Gujarat, INDIA.
    Customer Service and Product Inquiries:
    1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
    Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
    E-mail: tajgroup@tajpharma.com

Labetalol Hydrochloride for injection 20mg/4ml in Pre-filled Syringe Taj Pharma

Read all of this leaflet carefully before you start taking this medicine.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
  • In this leaflet Labetalol Hydrochloride 5mg/ml Solution for Injection will be called Labetalol Injection.

In this leaflet:

  1. What Labetalol Injection is for
    2. Before you are given Labetalol Injection
    3. How you will be given Labetalol Injection
    4. Possible side effects
    5. How to store Labetalol Injection
    6. Further information

1.What Labetalol Injection is for

Labetalol Injection belongs to a group of medicines called beta blockers.

Labetalol Injection works by causing the heart to beat more slowly and with less force. It also widens the arteries in the body. This helps to lower the pressure of the blood as it travels around the body. The result is a rapid lowering of a person’s blood pressure.

Labetalol Injection is given in hospital and can be used to:

  • lower very high blood pressure, especially in pregnant women;
  • keep your blood pressure down during an operation;
  • lower high blood pressure after a heart attack.

It is very important that the doctor treats your high blood pressure, because left untreated it can cause damage to your blood vessels in the long-term. This could lead to heart attacks, kidney failure, stroke or blindness.

  1. Before you are given Labetalol Injection

Do not use Labetalol Injection if:

  • you are allergic to labetalol hydrochloride;
  • you are allergic to any of the other ingredients of Labetalol Injection (see section 6);
  • your heart cannot maintain adequate circulation of blood (cardiogenic shock);
  • you have heart failure that is out of control or not responding to treatment with digitalis;
  • you have a heart defect that leads to a decreased function of the heart (heart block);
  • your heart has difficulty pumping the proper amount of blood to the body’s tissues;
  • you have a problem that is common in the elderly, related to poor control of the working of your heart (sick sinus syndrome);
  • you suffer from angina (chest pains) when at rest;
  • you suffer from wheezing, obstructive airways disease or asthma – taking labetalol can make your breathing worse;
  • you have a tumour near your kidneys (phaeochromocytoma);
  • you have increased acid levels in the blood (metabolic acidosis);
  • you have a weak heart or a very slow heartbeat (less than 45 or 50 beats per minute);
  • you have low blood pressure (hypotension);
  • you have liver disease or your liver was affected when taking labetalol in the past;
  • you have very bad circulation, especially in your hands and feet.

This medicine is not suitable for children.

If any of the above applies to you, talk to your doctor.

Check with your doctor before you are given Labetalol Injection if:

  • you are about to receive an anaesthetic: as labetalol may mask the effects of a sudden loss of blood;
  • you suffer or have suffered from any serious allergic reactions in the past;
  • you have ever suffered from a skin condition called psoriasis;
  • you have kidney or liver problems;
  • you are receiving a procedure called MIBG scintigraphy (often used to detect certain tumours);
  • you are elderly (65 years and over).
  • you are scheduled for cataract surgery as Labetalol may affect your pupils during this procedure. Please tell your eye surgeon before your surgery about your treatment with this medicine. You do not need to stop treatment with this medicine unless your surgeon advises otherwise.

Tell your doctor if you are taking any of the following medicines:

  • Medicines used to treat your heart or blood pressure (such as digitalis, clonidine, hydralazine, disopyramide, quinidine, amiodarone, calcium antagonists such as verapamil, alpha blockers such as doxazosin, diltiazem, nifedipine, ACE inhibitors, angiotensin-II antagonists, xamoterol and diuretics (water tablets).
  • Medicines to treat depression (such as monoamine oxidase inhibitors or tricyclic antidepressants).
  • Anxiolytic and hypnotic medicines for anxiety and sedation.
  • NSAIDs, corticosteroids or other medicines to treat pain or inflammatory conditions.
  • Cimetidine used to treat stomach ulcers.
  • Insulin or oral anti-diabetic drugs.
  • Anaesthetic drugs (such as cyclopropane, trichloroethylene, alcohol, barbiturates).
  • Phenothiazines such as chlorpromazine.
  • Antimalarial medicines such as halofantrine, mefloquine or quinine.
  • Medicines for stimulating the heart e.g. adrenaline.
  • Ergot derivatives used to treat Parkinson’s disease.
  • Tropisetron used to treat nausea.
  • Alprostadil and moxisylyte to treat impotence.
  • Aldesleukin for the treatment of secondary cancer of the kidney.
  • Hormones such as oestrogen and progesterone used as contraceptives or for hormone replacement therapy.
  • Any other medicine, including medicines obtained without a prescription.

Taking Labetalol Injection, at the same time as the drugs mentioned for treating your heart or blood pressure, can lead to a severe drop in blood pressure, reduced heart rate, heart failure or heart block. It is important to tell your doctor if you are taking these or any of the other drugs listed above.

The results of blood or urine tests may be affected by taking labetalol. If you need to have a blood or urine test, tell your doctor that you have been given Labetalol Injection.

Pregnancy and breast-feeding

Labetalol Injection should only be used during the first three months of pregnancy if it is absolutely necessary. Therefore, tell your doctor if you are pregnant or trying to become pregnant.

Labetalol Injection is not recommended whilst breast-feeding.

Driving and using machines

You may feel dizzy or tired when taking Labetalol Injection. If this happens to you, do not drive or operate machinery.

Important information about some of the other ingredients in Labetalol Injection

This medicinal product contains less than 1mmol (23mg) of sodium (salt) per 20ml vial, i.e. essentially sodium (salt) free.

  1. How you will be given Labetalol Injection

Labetalol Injection is usually only given to patients in hospital by a doctor or anaesthetist. It may be given as an injection into a vein, or by a slow drip, depending on how quickly your blood pressure needs to be reduced.

IMPORTANT: Your doctor will decide how the Labetalol Injection will be given to you and the correct dose for you.

Remember: You should only be given this drug if you are lying down.

You should avoid sitting upright for three hours after being given Labetalol Injection as you may feel very dizzy and lightheaded.

While you are having Labetalol Injection your doctor may check your heart rate, blood pressure and breathing, to check your medicine is working properly.

Adults:

Injection into a vein (to reduce blood pressure very quickly)

  • A dose of 50mg of Labetalol Injection will be given into your vein over a period of one minute.
  • If necessary this dose can be repeated every five minutes up to three times until your blood pressure has been lowered.
  • The total dose should not exceed 200mg.

Slow drip into a vein (to reduce blood pressure more slowly)

  • A solution containing 1mg/ml Labetalol Injection will be made up by the doctor or nurse.
  • The solution will then be given to you via a drip into your vein.
  • The amount of the solution you will be given will depend on why your blood pressure needs to be lowered:
  1. To lower high blood pressure in pregnancy
  • 20mg of Labetalol Injection will be given over one hour.
  • The dose may then be doubled every 30 minutes until your blood pressure has been reduced or the dose has reached 160mg per hour.
  • Your doctor may occasionally need to use a higher dose.
  1. To lower high blood pressure after a heart attack
  • 15mg of Labetalol Injection will be given over one hour.
  • The dose may then be gradually increased up to a maximum of 120mg per hour if needed.
  1. To lower high blood pressure for other reasons
  • 2mg of Labetalol Injection will be given per minute.
  • When your blood pressure is low enough, the doctor will stop your drip.
  • Your doctor may change the rate at which the drip goes in depending on how well you are responding to the medicine.
  • The total dose given is usually between 50mg and 200mg, but occasionally higher doses may be needed.

To lower blood pressure during an operation

  • Whilst you are under anaesthetic, 10-20mg Labetalol Injection (depending on your age and health) will be injected into your vein.
  • If after five minutes your blood pressure has not been reduced, a dose of 5-10mg can be given every five minutes until your blood pressure is low enough.

Maintaining your blood pressure

  • After you have had Labetalol Injection your doctor may suggest you take labetalol tablets to keep your blood pressure low.
  • If this applies to you, your doctor or pharmacist will tell you exactly how many tablets to take and when to take them.

People with liver or kidney problems:

If you have problems with your liver or kidneys, your doctor may give you a lower dose of Labetalol Injection.

The elderly (65 years and over):

Your doctor may start you on a lower dose than the usual adult dose to make sure that the medicine is working properly.

Children:

Labetalol Injection is not recommended for use in children.

If you are given more Labetalol Injection than you should

If you think you may have been given too much Labetalol Injection, tell your doctor immediately.

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

  1. Possible side effects

Like all medicines Labetalol Injection can cause side effects, although not everybody gets them.

Remember:

You should avoid sitting upright for three hours after being given Labetalol Injection as you may feel very dizzy and lightheaded.

Stop using Labetalol Injection and seek immediate medical help if you have an allergic reaction. This includes any of the following symptoms:

  • Difficulty in breathing
  • Swelling of your eyelids, face or lips
  • Rash or itching

Most of the side effects related to Labetalol Injection will wear off after the first few weeks. These include:

  • headaches, tiredness or dizziness
  • depression or exhaustion (lethargy)
  • tingling of the scalp, or a blocked nose
  • swollen ankles or sweating
  • difficulty passing urine or not being able to pass urine
  • not being able to ejaculate
  • stomach pain, feeling sick or being sick
  • the shakes after taking labetalol when pregnant
  • dizziness when standing up
  • low blood pressure (hypotension)
  • poor circulation in the hands, cold or blue extremities, numbness or tingling of the extremities
  • increase of existing leg pain on walking
  • mental disturbances such as delusions and altered thought patterns, hallucinations or confusion
  • sleep disturbances including nightmares
  • diarrhoea
  • wheezing or shortness of breath (in patients with asthma)
  • the symptoms of an overactive thyroid (increased heart rate) or low blood sugar (as seen in blood test results) may be hidden
  • high blood potassium levels (hyperkalaemia) especially if you have reduced kidney function
  • hair loss; this may grow back after stopping treatment
  • worsening of psoriasis
  • heart failure causing shortness of breath with swelling of the feet and ankles
  • poor blood circulation leading to nipple pain, cold or blue extremities with numbness or tingling in your fingers and toes

If any of these side effects occur, speak to your doctor immediately:

  • problems with the immune system (e.g. systemic lupus erythematosus) causing shortness of breath, joint pain, or a rash on the cheeks and arms that worsen with sun exposure
  • thrombocytopenia causing nosebleeds or bleeding in the mouth or bruising because your blood does not clot as it should
  • drug fever making you feel hot and flu-like
  • muscle disease (toxic myopathy) causing weakness and wasting of the muscles in the arms and legs
  • flat topped bumps on your skin that join up into scaly patches (lichenoid rash)
  • blurred vision or dry eyes
  • cramps
  • liver problems or jaundice causing discomfort and tenderness in the upper abdomen, yellowing of the skin and whites of the eyes
  • slowing of the heart and heart block (where the heart signals are delayed causing your heartbeat to slow to 20-40 beats per minute)
  • cough or breathing problems that may indicate inflammation of the lungs (interstitial lung disease)

Rare side effects on your baby

If you are being treated for high blood pressure during pregnancy, your baby may suffer the following effects for a few days after birth:

  • low blood pressure
  • slow heartbeat
  • shallow or slow breathing
  • low blood sugar
  • feeling cold

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. You can also report side effects directly. By reporting side effects you can help provide more information on the safety of this medicine.

  1. How to store Labetalol Injection

Keep out of the sight and reach of children.

Do not use Labetalol Injection after the expiry date which is stated on the carton and the ampoule label. The expiry date refers to the last day of that month.

Store below 30°C.

Keep the Prefilled Syringe in the original packaging in order to protect from light.

For single use only. Once opened use immediately. Discard any unused material.

Medicines should not be disposed of via wastewater or household waste.

Return any medicine you no longer need to your pharmacist.

Your doctor or nurse will make sure your medicine is correctly stored and disposed of.

  1. Further information

What Labetalol Injection contains

  • The active ingredient is labetalol hydrochloride . Each 1ml of liquid contains 5mg of the active ingredient.
  • The other ingredients are dilute hydrochloric acid, sodium hydroxide, for pH adjustment, and water for injections.

What Labetalol Injection looks like

Labetalol Hydrochloride 5mg/ml Solution for Injection is a clear colourless solution.

Labetalol Injection comes in 20ml glass Prefilled Syringe, with five Prefilled Syringe in each pack.

  1. Manufactured in India by:
    TAJ PHARMACEUTICALS LTD.
    Mumbai, India
    Unit No. 214.Old Bake House,
    Maharashtra chambers of  Commerce Lane,
    Fort, Mumbai – 400001
    at: Gujarat, INDIA.
    Customer Service and Product Inquiries:
    1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
    Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
    E-mail: tajgroup@tajpharma.com