Gerard Laboratories

Sotoger 80mg Tablets

Sotoger 160mg Tablets

80mg: Each tablets contains Sotalol Hydrochloride 80mg

160mg: Each tablets contains Sotalol Hydrochloride 160mg

For a full list of excipients, see section 6.1

Tablets

80mg: White flat bevel-edged tablet with “SL” breakline “80” on one side and blank on the reverse, approximately 7mm in diameter.

160mg: White flat bevel-edged tablet with “SL” breakline “160” on one side and blank on the reverse, approximately 9.5mm in diameter.

The breakline allows the tablet to be divided into two equal halves.

Prophylaxis of and rate control in cases of atrial flutter and fibrillation.

Suppression of life threatening ventricular tachycardia and the prevention of inducible ventricular tachycardia.

For oral administration only.

Arrhythmia:

Dosage titration should be performed slowly under close medical supervision and ECG

control.

Impaired renal function:

Liver insufficiency:

No dose adaption

• cardiogenic shock;

• uncontrolled heart failure;

• hypersensitivity to Sotalol or excipients;

• sick sinus syndrome or sinu-atrial block;

• chronic obstructive pulmonary disease;

• pulmonary hypotension;

• second and third degree heart block;

• Prinzmetal's angina;

• severe bradycardia;

• hypotension;

• severe peripheral circulatory disturbances;

• metabolic acidosis,

• diabetic ketoacidosis;

• untreated phaeochromocytoma;

• history of bronchospasm, bronchial asthma;

• allergy, including seasonal rhinitis;

• severe renal insufficiency or renal failure;

• congenital or acquired prolonged QT-syndromes.

During treatment blood pressure and heart rate should be monitored, ECGs should be carried out. The safety and effectiveness in children have not been established.

During treatment with sotalol proarrythmic effects have been shown either by worsening of existing arrhythmias or provocation of new ones. Incidence varies with dose and underlying cardiac disease. Patients with sustained VT and sinus node dysfunction, congestive heart failure or following recent myocardial infarction should receive dose titration in the hospital. The most likely risk is the occurrence of torsade do pointe, which especially occurs in combination with other agents which prolong the QT-interval such as diuretics, antidepressants, phenothiazines and class-I-antiarrhythmics. In the above mentioned patient categories, ECG monitoring during initiation of treatment is mandatory with measurment of the QT(c)-interval. When the QT(c)-interval is more than 550 mSec., dose should be lowered or treatment discontinued. Bradycardia increases risk of torsade de points. Females may be at increased risk of developing torsades de pointes.

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

Diabetes mellitus which is not well controlled.

Patients with anamestically known psoriasis should take beta-blockers only after careful consideration.

Beta-blockers may increase both the sensitivity towards allergens and the seriousness of anaphylactic reactions.

In patients with ischemic heart disease, discontinuation of therapy should take place over one to two weeks, if necessary at the same time initiating replacement therapy to prevent exacerbation of angina pectoris. When it has been decided to interrupt a beta-blockade in preparation for surgery, therapy should be discontinued for at least 24 hours.

Beta -blockers should not be used in patients with untreated congestive heart failure.

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.

Due to its negative effect on conduction time, Sotoger should only be given with caution to patients with first degree heart block. Patients with liver or kidney insufficiency may need a lower dosage.

A lower dosage is recommended in the elderly and they should be treated with caution although tolerance is usually good.

Not recommended association

Increases the negative inotropic effect of other antiarrhythmics, especially verapamil.

Beta-blockers increase the risk of “rebound hypertension”. When Clonidine is used in conjunction with Sotoger, treatment with Clonidine should be continued for some time after treatment when Sotoger has been discontinued.

Precautions for use

Simultaneous treatment with Class I-antiarrhythmics (e.g., such as quinidine), Class III antiarrhythmics or other drugs known to be associated with torsade de pointe (e.g., antidepressant agents) should be observed closely. Class I and Class III agents should not be given together with Sotoger.

Additive synergism occurs with other antihypertensives.

Sotoger may intensify the blood sugar lowering effect of insulin and oral antidiabetic drugs, and the beta-adrenergic blockade may prevent signs of hypoglycaemia (tachycardia) and, hence, symptoms of hypoglycaemia in diabetes mellitus patients may be masked and prolonged.

There is an increased risk of vasospasm by ergotamine.

The presence of Sotoger in the urine may lead to a false elevation of urinary metanephrine when measured by photometric methods. A HPLC assay with solid phase extraction should be used to screen urine of patients suspected of having phaeochromocytoma.

Pregnancy: Should not be used in the third trimester due to the risk to the new-born baby at birth. Beta-blockers reduce placental perfusion, which may result in intrauterine foetal death, immature and premature deliveries. In addition, adverse effects (especially hypoglycaemia and bradycardia) may occur in foetus and neonate. There is an increased risk of cardiac and pulmonary complications in the neonate in the postnatal period.

Lactation: Some Sotoger is excreted in breast milk, and breastfeeding is therefore not recommended during administration of these compounds. Because of the potential for adverse reactions in nursing infants a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

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.

May cause increased QT interval with risk of torsade-de-pointe (polymorphic ventricular tachycardia), ventricular tachycardia and ventricular fibrillation.

Hypersensitivity to Sotoger or excipients.

Bradycardia, hypotension, dyspnea.

Rare cases of retroperitoneal fibrosis have been reported.

May demask latent heart insufficiency.

Tiredness; Headache; Dizziness; Sleep disturbances; Depression; Muscle tiredness; Nausea; Diarrhoea; Psoriasis

Peripheral circulatory disorders.

Symptoms of overdosage are:

bradycardia, hypotension, bronchospasm, hypoglycaemia, cardiac arrhythmias and in extreme cases the patient may go into shock.

Treatment:

After ingestion of an overdose or in a case of hypersensitivity, the patient should be kept under close supervision and treated in an intensive-care ward. Absorbtion of any drug material still present in the gastro-intestinal tract can be prevented by gastric lavage, administration of activated charcoal and a laxative. 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 5µg/minute until required effect has been obtained. Alternatively, glucogon may be used as a cardiac stimulant, 8-10mg as an intravenous injection. If required the injection should be repeated within one hour, to be followed - if required - by an i.v. infusion of glucagon at an administration rate of 1-3 mg/hour. Administration of calcium ions, or the use of a cardiac pacemaker may also be considered.

Therapeutic classification

C 07 AA 07. Group of Beta blocking agents, non-selective.

Sotoger belongs to the group of non-selective beta receptor blocking agents. It counteracts the sympathetic neurotransmitters by competitive dislocation around the sympathetic nerve endings. This causes a decrease in the contractile strength of the heart muscle and the heart rate. Sotoger does not have any Intrinsic Sympathomimetic Activity (ISA) or local anaesthetic effect but it does have Class III anti-arrhythmic activity.

Sotoger is totally absorbed by the gastrointestinal tract. After oral administration the bioavailability is close to 100%, which indicates an insignificant first pass metabolism in the liver. Sotoger is absorbed relatively slowly compared with other beta blockers. Maximum plasma concentrations are achieved two to four hours after dosage. The absorption may be influenced by food, milk and milk products.

Sotoger is not bound to plasma proteins. The main part is excreted unchanged through the kidneys. The plasma half life is approximately 13 hours. Investigations have demonstrated that Sotoger can pass the placenta and has been found in breast milk.

Sotoger passes the blood-brain barrier only slightly.

Animal studies with sotalol hydrochloride have shown no evidence of teratogenicity or other harmful effects on the foetus.

Calcium Hydrogen Phosphate Anhydrous

Maize Starch

Povidone K29/32

Sodium Starch Glycollate (Type A)

Talc

Magnesium Stearate

Not applicable

Securitainer: 5 years

Blister: 4 years

Polypropylene Containers

Store in the original container in order to protect from light.

Blister Packs

Keep the container in the outer carton in order to protect from light.

Securitainer: (Polypropylene container with a polyethylene push-on, tamper evident closure and a low-density polyethylene Jayfilla)

Blister Packs: Opaque PVC bonded to Aluminium foil by heat seal lacquer.

Registered pack sizes: 20, 28, 30, 40, 50, 60, 100 & 300 – Not all pack sizes may be marketed.

No special requirements.

McDermott Laboratories Ltd t/a Gerard Laboratories

35/36 Baldoyle Industrial Estate

Grange Road

Dublin 13

Ireland

80mg: PA 577/21/1

160mg: PA 577/21/2

Date of first authorisation: 24 June 1996

Date of last renewal: 02 February 2010

April 2011