PCaution when used during lactation : Caution when used during pregnancy

LCaution when used during lactation : Caution when used during lactation

Molecule Info

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Indication(s) & Dosage

Oral route
Supraventricular and ventricular arrhythmias
Adult: Initially, 80 mg daily as a single or in 2 divided doses, increased gradually every 2-3 days. Usual dose: 160-320 mg daily in 2 divided doses. Max: 640 mg daily.
Child: Neonates: Initially, 1 mg/kg bid, increased every 3-4 days, if necessary. Max: 4 mg/kg bid. 1 mth-12 yr: Initially, 1 mg/kg bid, increased as necessary every 2-3 days. Max: 4 mg/kg bid, not exceeding 80 mg bid. For refractorysupraventricular tachycardia, sotalol may be given with flecainide; <1 yr: 100-250 mg/m2 daily of sotalol and 40-150 mg/m2 daily of flecainide.

Life-threatening ventricular arrhythmias
Adult: 480-640 mg daily.

Intravenous
Acute arrhythmias
Adult: 20-120 mg (0.5-1.5 mg/kg) given by inj over 10 min, may repeat every 6 hr if needed. To substitute for oral treatment, 0.2-0.5 mg/kg/hr infusion may be used.


Programmed electrical stimulation (to test antiarrhythmic efficacy)
Adult: Initially, 1.5 mg/kg inj over 10-20 minutes, followed by of 0.2-0.5 mg/kg/hr infusion.


Special Populations: Renal impairment: CrCl 30-60 mL/min: ½ of the dose for both oral and IV route; 10-30 mL/min: ¼ of the dose for both oral and IV route.

Administration May be taken with or without food. Take w/ a full glass of water & remain upright for at least ½ hr. Take w/ food or milk if GI irritation occurs.
Overdosage Rarely results in death.
Contraindications Bronchospasm, asthma, history of obstructive airways disease, sinus bradycardia, cardiogenic shock. 2nd and 3rd degree AV block, uncontrolled cardiac failure, metabolic acidosis, hypotension, severe peripheral arterial disease.
Special Precautions Pregnancy and lactation. Renal insufficiency; preexisting sick sinus syndrome; compensated heart failure; gradual withdrawal is recommended. DM, 1st degree AV block. May mask the symptoms of hyperthyroidism and of hypoglycaemia. May unmask myasthenia gravis. May worsen psoriasis.
Adverse Drug Reactions Nausea, sleep disorders, lassitude, diarrhoea, palpitations, bradycardia, weakness, dyspnoea, decreased sexual activity, impotence, extremity pain, back pain, asthma, visual disturbances, cardiac arrhythmias. Rebound angina, arrhythmias and MI if withdrawn abruptly.
Potentially Fatal: Polymorphic ventricular tachycardia (very rare). Rebound hypertension.
Drug Interactions Decreased effect with antacids, calcium salts, NSAIDs, ampicillin, rifampicin. May reduce response to insulin and oral hypoglycaemics. May lead to enhanced hypotension when used with aldesleukin and general anaesthetics. Increased risk of bradycardia and heart block when used with calcium channel blockers and other cardiac depressants. May develop elevated BP when used with adrenaline. Reduced absorption when used with aluminium salts and bile-acid binding resins. Decreased metabolism when used with cimetidine, hydralazine, erythromycin and fluvoxamine.
Potentially Fatal: Rebound hypertension with clonidine and abrupt withdrawal of either drug. Polymorphic ventricular tachycardia with antidepressants andquinidine.
Food Interaction Absorption may be reduced by food especially by milk.
Pregnancy Category (US FDA)

Category B: Either animal-reproduction studies have not demonstrated a foetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the 1sttrimester (and there is no evidence of a risk in later trimesters).

Category D: in 2nd & 3rd trimesters. There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).

Storage Intravenous: Store at 20-25°C. Oral: Store at 20-25°C.
Mechanism of Action Sotalol is a non-cardioselective β-blocker. It increases sinus cycle length, slows heart rate, decreases AV nodal conduction and increases AV nodal refractoriness. It also prolongs AV monophasic action potentials. However, it lacks intrinsic sympathomimetic and membrane-stabilising properties. It is used in the treatment of ventricular arrhythmias.
Absorption: Almost completely absorbed from the GI tract (oral); peak plasma concentrations after 2-4 hr.
Distribution: Crosses the placenta and enters breast milk; crosses the blood-brain barrier and enters CSF (small amounts). Protein-binding: Low.
Metabolism: Minimal metabolism.
Excretion: Via urine (as unchanged). Elimination half-life: 10-20 hr.
ATC Classification C07AA07 - sotalol, belongs to the class of non-selective beta-blocking agents. Used in the treatment of cardiovascular diseases.

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Gen. MedInfo

Why do I need Sotalol?

Sotalol is used to treat arrhythmia - a heart disease where the heartbeat is not regular or is too fast. When the heart is not pumping regularly or is pumping too fast, blood cannot be efficiently pumped out of the heart to other parts of the body.

Sotalol slows down the heart rate and helps to make the heartbeat more regular.

How do I take Sotalol?

Take Sotalol exactly as directed by your doctor. Do not take more or less than instructed by your doctor. 

Continue taking Sotalol even when you feel better. Do not stop taking it unless instructed by your doctor. Your condition may worsen rapidly if Sotalol is stopped suddenly.

Take Sotalol on an empty stomach 1-2 hours before meals, with a glass of plain water. Try to take it at the same time each day.

What to do if I have forgotten to take Sotalol?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and return to your normal schedule.

DO NOT double a dose under any circumstances.

Remember to take your medicine regularly. Sotalol must be taken exactly as directed for it to be effective. If you often forget to take your medicine, let your doctor know.

When to not use Sotalol?

Inform your doctor if you have asthma or other lung conditions.

Sotalol may not be suitable for certain heart conditions. Inform your doctor to any heart conditions that you have.

What to take note of while taking Sotalol?

Inform your doctor if you have kidney or thyroid disease, diabetes, any disease that affects your blood vessels or blood circulation as well as other illnesses such as myasthenia gravis and phaeochromocytoma. You should also inform your doctor if you are seeing a psychiatrist.

If you also have diabetes, monitor your blood sugar more closely.

Inform your doctor if you are pregnant or breastfeeding. Do not breastfeed while you are being treated with Sotalol.

You may feel dizzy when getting up from a sitting or lying position, especially if you are taking Sotalol for the very first time. This is common and tomprove gradually as you get used to the medicine. It will help if you get up slowly from a sitting or lying position. If you feel dizzy, do not drive or take part in any activity in which you need to be Inform.

If you are going for an operation, including minor operations and dental work, always inform your doctor, surgeon or dentist that you are taking Sotalol.

Why is it important to keep my appointments with the doctor?

Your doctor needs to check your response to the medication regularly. He may also need to do routine blood tests to monitor your condition. Be sure to keep all appointments with your doctor.

What side effects could I experience?

Sotalol may cause dizziness. If you feel dizzy, do not drive or take part in any activity in which you need to be Inform.

Sotalol may also cause tiredness, weakness, headache, stomach upset, difficulty sleeping, numbness or tingling of the fingers and toes. Inform your doctor if these side effects are severe or refuse to go away.

Other side effects are less common but may need medical attention. Inform your doctor if you develop wheezing, difficulty breathing, chest pain, abnormally slow or fast heart rate, blurred vision or rashes.

Can I take this with other medicines?

Do not take Sotalol with a stomach medicine called cisapride, or antihistamines such as terfenadine, astemizole or mizolastine.

Inform your doctor if you are taking any other medicines, especially those listed here:

- other medicines for heart disease or high blood pressure, especially digoxin, amiodarone, frusemide, clonidine, prazosin
- migraine medicines such as ergotamine
- mood medicines such as haloperidol or antidepressants
- antibiotics such as erythromycin, ciprofloxacin and related medicines

Do not take antacids together with Sotalol. Antacids may affect the effectiveness of Sotalol. If you must take antacids, take it at least 1 hour before or 2 hours after you take Sotalol.

Always inform your doctor if you are taking any other medicines, including herbal tonics, supplements and medicines that you buy without a prescription.

Are there any restrictions on the type of food I can take?

Avoid alcohol.

How to store Sotalol?

Store in a cool, dry place away from the reach of children.
Medicines must be used within the expiry date.