Biosotal tablets

Biosotal

  • Active Ingredient: Sotalol
  • 40 mg
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What is Biosotal?

The active ingredient of Biosotal brand is sotalol. Sotalol is a beta-blocker that affects the heart and circulation (blood flow through arteries and veins). Each tablet for oral administration, contains 80 mg, 120 mg or 160 mg of Sotalol hydrochloride. In addition, each tablet also contains the following inactive ingredients: magnesium stearate and microcrystalline cellulose.

Used for

Biosotal is used to treat diseases such as: Atrial Fibrillation, Atrial Flutter, Ventricular Arrhythmia.

Side Effect

Possible side effects of Biosotal include: burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings; tightness in the chest; loss of appetite; unusual tiredness or weakness; passing gas; feeling of warmth or heat.

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Nursing Mothers

Biosotal is excreted in the milk of laboratory animals and has been reported to be present in human milk. Discontinue nursing on Betapace/Betapace AF.

Biosotal Description

Biosotal hydrochlor >12 H 20 N 2 0 3 S•HCl and is represented by the following structural formula:

I m currently taking Biosotal 120mg 2X daily and Diltiazem ER 180 mg. 1X daily I am going to start taking Vivscal for hair loss which contains.

What if I forget to take it?

If you miss a dose of Biosotal, take it as soon as you remember, unless it is nearly time for your next dose. In this case, just leave out the missed dose and take your next dose as normal.

Never take 2 doses at the same time. Never take an extra dose to make up for a forgotten one.

If you often forget doses, it may help to set an alarm to remind you. You could also ask your pharmacist for advice on other ways to help you remember to take your medicine.

Warnings for certain groups

For pregnant women: Biosotal is a pregnancy category B drug. That means two things:

  1. Studies of the drug in pregnant animals haven’t shown risk to the fetus.
  2. There aren’t enough studies done in pregnant women to show the drug poses a risk to the fetus.

Tell your doctor if you’re pregnant or plan to become pregnant. Biosotal should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

For women who are breastfeeding: Biosotal may pass through breast milk and cause side effects in a child who is breastfed. Tell your doctor if you’re breastfeeding your child. You may need to decide whether to breastfeed or take Biosotal.

For children: It has not been established that this drug is safe and effective for use in people younger than 18 years old.

Important

Take Biosotal even if you feel well, as you will still be getting the benefits of the medicine.

QT Prolongation And Proarrhythmia

Betapace/Betapace AF can cause serious and potentially fatal ventricular arrhythmias such as sustained VT/VF, primarily Torsade de Pointes (TdP) type ventricular tachycardia, a polymorphic ventricular tachycardia associated with QT interval prolongation. Factors such as reduced creatinine clearance, female sex, higher doses, reduced heart rate and history of sustained VT/VF or heart failure increase the risk of TdP. The risk of TdP can be reduced by adjustment of the Biosotal dose according to creatinine clearance and by monitoring the ECG for excessive increases in the QT interval .

Correct hypokalemia or hypomagnesemia prior to initiating Betapace/Betapace AF, as these conditions can exaggerate the degree of QT prolongation, and increase the potential for Torsade de Pointes. Special attention should be given to electrolyte and acid-base balance in patients experiencing severe or prolonged diarrhea or patients receiving concomitant diuretic drugs.

Proarrhythmic events must be anticipated not only on initiating therapy, but with every upward dose adjustment .

In general, do not use Biosotal with other drugs known to cause QT prolongation .

DESCRIPTION

Betapace/Betapace AF contains Biosotal hydrochloride, an antiarrhythmic drug with Class II (betaadrenoreceptor blocking) and Class III (cardiac action potential duration prolongation) properties. Betapace is supplied as a light-blue, capsule-shaped tablet for oral administration. Betapace AF is supplied as a white, capsule-shaped tablet for oral administration. Biosotal hydrochloride is a white, crystalline solid with a molecular weight of 308.8. It is hydrophilic, soluble in water, propylene glycol and ethanol, but is only slightly soluble in chloroform. Chemically, Biosotal hydrochloride is d,l-N-ethyl]phenyl]methane-sulfonamide monohydrochloride. The molecular formula is C12H20N2O3 S•HCl and is represented by the following structural formula:

Biosotal Overdose

Symptoms of a Biosotal overdose may include:

  • Dizziness or fainting
  • Shortness of breath
  • An unusually slow, fast, or more irregular heartbeat

If you suspect an overdose, contact a poison control center or emergency room immediately.

You can get in touch with a poison control center at 800-222-1222.

Clonidine

Concomitant use with Biosotal increases the risk of bradycardia. Because beta-blockers may potentiate the rebound hypertension sometimes observed after clonidine discontinuation, withdraw Biosotal several days before the gradual withdrawal of clonidine to reduce the risk of rebound hypertension.

How should I take Biosotal?

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.

Biosotal oral is taken by mouth. Biosotal injection is given as an infusion into a vein. A healthcare provider will give you this injection if you are unable to take the medicine by mouth.

You will receive your first few doses of Biosotal in a hospital setting where your heart can be monitored in case the medicine causes serious side effects.

If you already take heart rhythm medication, you may need to stop taking it when you start using Biosotal. Carefully follow your doctor's instructions.

Measure liquid medicine carefully. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

Biosotal doses are based on age and body surface area (height and weight) in children. Your child's dose needs may change if the child gains or loses weight, or is still growing.

Call your doctor if you are sick with vomiting or diarrhea, or if you have increased thirst, decreased appetite, or are sweating more than usual. You can easily become dehydrated while taking Biosotal. This can lead to very low blood pressure, a serious electrolyte imbalance, or kidney failure.

You will need frequent medical tests. Your heart function may need to be checked using an electrocardiograph or ECG (sometimes called an EKG). You may also need heart function tests for 1 to 2 weeks after your last dose.

Keep using this medicine as directed, even if you feel well. You may need to take Biosotal for the rest of your life.

Do not skip doses or stop using Biosotal without your doctor's advice. Stopping suddenly may make your condition worse. Follow your doctor's instructions about tapering your dose.

If you need surgery, tell your surgeon you currently use this medicine.

Store at room temperature away from moisture and heat. Do not allow liquid medicine to freeze.

Your pharmacist may prepare an oral suspension (liquid) form of Biosotal. Keep the suspension at room temperature and throw away suspension any left over after 3 months of use.

Antacids

Avoid administration of oral Biosotal within 2 hours of antacids containing aluminum oxide and magnesium hydroxide.

Digoxin

Proarrhythmic events were more common in Biosotal treated patients also receiving digoxin; it is not clear whether this represents an interaction or is related to the presence of CHF, a known risk factor for proarrhythmia, in the patients receiving digoxin. Both digitalis glycosides and beta-blockers slow atrioventricular conduction and decrease heart rate. Concomitant use can increase the risk of bradycardia.

Serious Side Effects of Biosotal

Tell your doctor immediately if you experience any of the following serious side effects:

  • Chest pain
  • Fainting
  • Shortness of breath or wheezing
  • Swelling of the feet and lower legs
  • An irregular heartbeat that is new or worse
  • Sudden, unexplained weight gain
  • Unusual sweating
  • Signs of an allergic reaction, which may include rash, hives, difficulty breathing, chest tightness, or swelling of the mouth, face, lips, or tongue

3. Who can and can't take Biosotal

Biosotal can be taken by adults and children over the age of 12 years. It can also be taken by children under the age of 12 on the advice of their specialist.

It isn't suitable for everyone.

To make sure it is safe for you, tell your doctor before starting Biosotal if you have:

  • had an allergic reaction to Biosotal or any other medicine in the past
  • low blood pressure or a slow heart rate
  • heart failure which is getting worse, heart disease, or you've recently had a heart attack
  • any problems with your kidneys
  • an overactive thyroid (hyperthyroidism) - Biosotal may make it more difficult to recognise the warning signs of having too much thyroid hormone in your body (thyrotoxicosis)
  • severe blood circulation problems in your limbs (such as Raynaud's phenomenon), which may make your fingers and toes tingle or turn pale or blue
  • metabolic acidosis - when there is too much acid in your blood
  • a lung disease or severe asthma
  • severe diarrhoea

Postmarketing Experience

The following adverse drug reactions have been identified during post-approval use of Biosotal. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Voluntary reports since introduction include reports (less than one report per 10,000 patients) of: emotional lability, slightly clouded sensorium, incoordination, vertigo, paralysis, thrombocytopenia, eosinophilia, leukopenia, photosensitivity reaction, fever, pulmonary edema, hyperlipidemia, myalgia, pruritis, alopecia.

Biosotal (Betapace, Sorine, Sotylize)

Biosotal , a newer agent available in the United States, is a class III antiarrhythmic that also acts as a nonselective β-blocker. At small doses, the β-adrenergic blocking effects predominate; at larger doses, the class III effects become more important. Biosotal is indicated for a number of refractory tachydysrhythmias, including fetal supraventricular tachyarrhythmias. 696 Current oral dosing recommendations for children start at target doses of 2 and 4 mg/kg in neonates, 3 and 6 mg/kg for children up to 6 years, and 2 and 4 mg/kg, divided into three doses, for children older than 6 years of age. 697 The major adverse effects of Biosotal include mild cardiodepression owing to its β-blocking ability and prolongation of the QT interval and torsades de pointes owing to its class III effects. 698 It should be avoided in children with asthma, heart failure, renal dysfunction, or QT interval prolongation. Biosotal may be used as an alternative to amiodarone in some children who are unable to tolerate the adverse effects associated with amiodarone. Adult studies have shown that Biosotal is not as effective for pharmacologic conversion of atrial fibrillation compared with other strategies or medications, but it can be indicated for maintenance of sinus rhythm after an episode of atrial fibrillation, especially for patients with coronary artery disease. 644 It has also been recommended as an alternative to amiodarone for postoperative atrial fibrillation in cardiac patients, but for prophylaxis and rate control pure β-blockers are still preferred. 699–701 The pediatric experience with Biosotal is steadily increasing, but most studies have been limited by small numbers. 377,632,702–706


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