INTRODUCTION

RITEBEAT 150 INJECTION contains Amiodarone which belongs to the group of medicines called Antiarrhythmics. It is used to treat uneven or fast heartbeats (like atrial flutter or atrial fibrillation), fast heartbeats which may happen suddenly and may be uneven only when other medicines either have not worked or cannot be used.

It also treats Wolff-Parkinson-White Syndrome (unusually fast heartbeats). It is normally only given in a hospital when a quick response is needed or when tablets cannot be given.

Your doctor might want you to keep out of direct sunlight while receiving RITEBEAT 150 INJECTION and for a few months after you have finished receiving it. Avoid consumption of alcohol and grapefruit juice during treatment with RITEBEAT 150 INJECTION.

RITEBEAT 150 INJECTION is not recommended for use if you have severe breathing and blood circulation problems, slower than usual heartbeat (called ‘sinus bradycardia’) or an illness called sino-atrial heart block.

It is also not recommended if you have other problems with your heartbeat without a pacemaker fitted, are going to have a heart transplantation, have ever had thyroid problems or low blood pressure.

Before receiving RITEBEAT 150 INJECTION, inform your doctor if you have heart failure or weak heart (cardiomyopathy), liver, kidney, thyroid, lung problems or asthma, require oxygen treatment, are to undergo a general anesthetic, or have eyesight problems (optic neuritis).

Also inform your doctor if you are about to have any surgery, blistering or peeling of the skin around the lips, eyes, mouth, nose and genitals, flu-like symptoms and fever (Stevens-Johnson syndrome), layers of the skin skin peeling off to leave large areas of raw exposed skin over the body (Toxic Epidermal Necrolysis).

RITEBEAT 150 INJECTION is not recommended for pregnant or breastfeeding women. RITEBEAT 150 INJECTION is contraindicated in premature babies or neonates and should be used with caution in infants and children up to 3 years old. Safety data has not been established in children and adolescents above 3 years of age.

RITEBEAT 150 INJECTION should be used with caution in elderly patients above 60 years of age. The most common side effects of receiving RITEBEAT 150 INJECTION are blurred eyesight, rashes, muscle weakness, difficulty sleeping, nightmares. Consult your doctor if any of the symptoms worsen.

USES OF RITEBEAT 150 INJECTION

It is usually used in hospitals when tablets cannot be given and a quick response is needed to treat:

• sudden fast or uneven heartbeats (atrial flutter or atrial fibrillation) when other medicines either have not worked or cannot be used
• Wolff-Parkinson-White Syndrome

HOW RITEBEAT 150 INJECTION WORKS

RITEBEAT 150 INJECTION works by blocking certain electrical signals and reducing the excitability of cardiac tissues which prevents the initiation and conduction of any new impulses in the heart that cause irregular heartbeats, thus making your heartbeat return to normal.

DIRECTIONS FOR USE

RITEBEAT 150 INJECTION must be given by a doctor or nurse into the vein as an intravenous injection or infusion. Your doctor will decide the correct dose and duration of RITEBEAT 150 INJECTION for you depending upon your age, body weight and disease condition.

SIDE EFFECTS OF RITEBEAT 150 INJECTION

HOW TO MANAGE SIDE EFFECTS

Dizziness, Fainting:

When you start receiving RITEBEAT 150 INJECTION, you may feel faint or dizzy. This is caused by your blood pressure dropping. If this happens, resting or lying down for some time can help. Consult your doctor if symptoms don't improve.

Rash:

Applying a cold compress, cool showers or damp cloth, cold water can bring immediate relief to swelling and reduce itching. Consult your doctor if symptoms don't improve.

Muscle pain:

Hot compress helps to increase blood flow, which relaxes sore muscles and joints and reduces pain. Cold compress can reduce inflammation around the aching muscle or joint. Consult your doctor if symptoms don't improve.

WARNING & PRECAUTIONS

INTERACTIONS

A. Drug - Drug interactions:

Before receiving RITEBEAT 150 INJECTION, inform your doctor if you are taking any of the following medicine:

• other medicines used to treat uneven heartbeats (Ex. sotalol, quinidine, procainamide, disopyramide, flecainide, bretylium or amiodarone tablets)
• medicines used to improve blood supply to the brain (Ex. vincamine).
• medicines used to treat other mental illnesses like depression (Ex. sultopride, sulpiride, pimozide, lithium, doxepin, maprotiline, amitriptyline, clomipramine, dosulepin, imipramine, lofepramine, nortriptyline or trimipramine)
• medicines used to treat infections (Ex. intra-venous erythromycin, co-trimoxazole, moxifloxacin, pentamidine, clarithromycin, ciprofloxacin, ofloxacin, levofloxacin or injections of pentamide)
• medicines used to treat schizophrenia (Ex. chlorpromazine, fluphenazine, thioridazine, haloperidol, sertindole or amisulpride)
• medicines used to treat hay fever, rashes or other allergies (Ex. terfenadine, astemizole or mizolastine)
• medicines used to treat malaria (Ex. quinine, mefloquine, chloroquine or halofantrine)
• medicines used to treat hepatitis C (Ex. sofosbuvir, daclatasvir, simeprevir or ledispasvir)
• medicine used to treat heart problems (such as high blood pressure, chest pain or high cholesterol) (Ex. propranolol, flecainide, diltiazem, verapamil, furosemide, simvastatin, atorvastatin or digitalis)
• medicines used to treat digestive problems like constipation (Ex. cisapride, droperidol, bisacodyl or senna)
• medicines used to treat fungal infection (Ex. amphotericin IV)
• medicines used to treat inflammation (Ex. hydrocortisone, betamethasone or prednisolone)
• medicines which may change the levels of potassium or magnesium in your blood Ex. diuretics (water tablets), steroid tablets
• medicines for high cholesterol called statins (e.g. simvastatin or atorvastatin).
• medicines used to treat fits (Ex. phenytoin)
• medicines used during surgery (Ex. lidocaine, midazolam, triazolam or high dose oxygen)
• medicines used to test some hormone problems (Ex. tetracosactide)
• medicines used to prevent rejection of transplants (Ex. ciclosporin, tacrolimus and sirolimus)
• medicines used to treat erection problems (Ex. sildenafil, tadalafil or vardenafil)
• medicines used to treat pain or migraines (Ex. fentanyl or ergotamine)
• medicines used to stop your blood from clotting (Ex. warfarin, dabigatran)
• medicine used in some blood tests or in treatment of Crohn’s disease (Ex. tetracosactrin)

B. Drug - Food interaction:

Avoid drinking grapefruit juice while receiving RITEBEAT 150 INJECTION as it may increase the risk of side effects.

Overdosage:

RITEBEAT 150 INJECTION will be given to you only by a doctor or nurse in a hospital and so it is unlikely to receive an overdose. However, if you experience any unusual symptoms like feeling dizzy, faint, sick, tired, confused or abnormally slow or fast heartbeats, contact your doctor immediately.

SYNOPSIS

MORE INFORMATION

• Keep RITEBEAT 150 INJECTION out of reach of children
• Do not store above 25°C

FAQs ABOUT RITEBEAT 150 INJECTION

What is RITEBEAT 150 INJECTION used for?

RITEBEAT 150 INJECTION is used to treat uneven or fast heartbeats (like atrial flutter or atrial fibrillation), fast heartbeats which may happen suddenly and may be uneven only when other medicines either have not worked or cannot be used. It also treats Wolff-Parkinson-White Syndrome (unusually fast heartbeats).

 How does RITEBEAT 150 INJECTION work?

RITEBEAT 150 INJECTION works by blocking certain electrical signals and reducing the excitability of cardiac tissues which prevents the initiation and conduction of any new impulses in the heart that cause irregular heartbeats, thus making your heartbeat return to normal.

Can RITEBEAT 150 INJECTION make my skin sensitive to the sun?

Yes. your skin will become much more sensitive to the sun after receiving RITEBEAT 150 INJECTION and may burn, tingle or severely blister. Do not expose yourself to direct sunlight while receiving this medicine and for a few months after you have finished receiving it. Use high factor sun cream without fail. Always wear a hat and clothes which cover your whole body.

What should I avoid while receiving RITEBEAT 150 INJECTION?

Avoid drinking grapefruit juice while receiving RITEBEAT 150 INJECTION as it may increase the risk of side effects. Avoid consumption of alcohol during treatment with RITEBEAT 150 INJECTION, as it may increase the chances of liver problems.

Will RITEBEAT 150 INJECTION cause any reaction at the site of injection?

RITEBEAT 150 INJECTION may cause swelling, pain, redness, infection and blue or grey marks on parts of your skin exposed to sunlight, especially the face. You can apply cold compress for relief. Consult your doctor before using any product for the reaction, other than RITEBEAT 150 INJECTION.

REFERENCES

1. Barbara G. Wells, Joseph T. DiPiro, Terry L. Shwinghammer, Cecily V. DiPiro. Arrhythmias. Pharmacotherapy handbook. Ninth edition. Page- 48, 49.

2. KD. Tripathi. Antiarrhythmic Drugs. Essentials of Medical Pharmacology. Seventh edition. 2013. Page – 533.

3. HBM Pharma. Electronic Medicines Compendium (EMC). [Revised in May 2022] [Accessed on 20th April 2022] https://www.medicines.org.uk/emc/files/pil.3940.pdf, https://www.medicines.org.uk/emc/product/3940/smpc

4. Bioindustria Laboratorio Medicinali S.p.A. Electronic Medicines Compendium (EMC). [Revised in December 2021] [Accessed on 20th April 2022] https://www.medicines.org.uk/emc/files/pil.8739.pdf

USEFUL DIAGNOSTIC TESTS

• Liver Function Test (LFT)
• Thyroid Function Test (TFT)
• Complete Blood Count (CBC)
• Chest X-Ray
• Electrocardiogram (ECG)