Medicinal Products

ATENOLOL ZENTIVA 50 mg

Generic drug of Tenormine
Therapeutic class: Cardiology and angiology
active ingredients: Atenolol
laboratory: Sanofi-Aventis France

Tablet breackable
Box of 90
All forms

Indication

· Hypertension
This dosage is particularly suitable in patients with renal insufficiency, in which the dosage should be adjusted to the degree of renal insufficiency.

· Supraventricular arrhythmias

o paroxysmal supraventricular tachycardias (as preventive or curative treatment)

o atrial fibrillation or flutter in case of insufficient response to digitalis at maximum doses and in cases where digitalis are contraindicated or have an adverse benefit / risk ratio.

· Ventricular arrhythmias

o Ventricular extrasystoles (preventive or curative treatment) in case of extrasystoles resulting from an increase in sympathetic activity;

ventricular tachycardias and ventricular fibrillations (preventive treatment), especially when the ventricular anomaly results from significant sympathetic activity.

Dosage ATENOLOL ZENTIVA 50 mg scored tablet Box of 90

Hypertension

The recommended dose is 100 mg once daily (two 50 mg tablets).

However, in cases of severe hypertension, a higher dosage may be necessary.

The combination with other antihypertensive therapies, for example with diuretics, is possible.

Rhythm disorders

After controlling for rhythm disturbances with intravenous atenolol (if indicated), atenolol will be administered orally and the recommended maintenance dose is 50 to 100 mg / day.

In case of renal insufficiency, the dosage is adjusted to the values ​​of serum creatinine or creatinine clearance according to the table below:

Serum creatinine

Creatinine clearance (Cl CR ) (ml / min / 1.73 m 2 )

Dosage

mg / l

mmol / l

<25

<0.3

≥ 35

unchanged (2 x 50 mg / d) in 1 intake

25 - 50

0.3 - 0.6

15 ≤ Cl CR <35

1 x 50 mg / d

> 50

> 0.6

<15

1 x 25 mg / day, ½ tablet daily 50 mg or 1 x 50 mg every 2 days

Chronic hemodialysis: treatment initiated in hospital

50 mg after each session

Against indications

This medicine MUST NEVER be used in the following cases:

· Asthma and chronic obstructive pulmonary disease in their severe forms,

· Heart failure not controlled by treatment,

· Cardiogenic shock,

· Non-paired second and third degree atrioventricular blocks,

· Prinzmetal's angina (in pure forms and monotherapy),

· Sinus disease (including sinoatrial block),

· Bradycardia (<45-50 beats per minute),

· Raynaud's phenomenon and peripheral arterial disorders in their severe forms,

· Untreated pheochromocytoma,

· Hypotension,

Hypersensitivity to atenolol,

· History of anaphylactic reaction,

· Breastfeeding,

· Combination with floctafenine, sultopride (see section 4.5).

Side effects Atenolol Zentiva

Clinically

The most frequently reported:

· Asthenia,

· Cooling of the ends,

· Bradycardia, severe if any,

· Digestive disorders (gastralgia, nausea, vomiting),

· incapacity.

Much less often:

· Slowing of atrioventricular conduction or intensification of an existing atrioventricular block,

· heart failure,

· Blood pressure drop,
bronchospasm,

· Hypoglycemia,

· Raynaud's syndrome,

· Aggravation of an existing intermittent claudication,

· Various skin manifestations including psoriasiform eruptions.

Biologically

In rare cases, it has been possible to observe the appearance of antinuclear antibodies which only exceptionally accompany clinical manifestations such as lupus syndrome and cede at the end of treatment.

Exceptional elevations of hepatic transaminases (as well as some cases of intrahepatic cholestasis).

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