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IVABLES
Composition Ivabradine 5mg and 7.5mg Tablets
Indication Chronic Stable Angina and Chronic Heart Failure
Mechanism of Action

Ivabradine is a heart rate lowering agent that works through selective and specific inhibition of the cardiac pacemaker If current that controls the spontaneous diastolic depolarisation in the sinus node and regulates heart rate.

Pharmacokinetic's

Absorption: Almost completely absorbed from GI tract. Food delays absorption by approx 1 hr and increases exposure by 20-30%. Absolute bioavailability: Approx 40%. Time to peak plasma concentration: Approx 1 hr.

Distribution: Volume of distribution: Approx 100 L. Plasma protein binding: Approx 70%.

Metabolism: Extensively metabolised in the liver and gut via oxidation by CYP3A4 isoenzyme to form major active metabolite N-desmethyl-ivabradine (S-18982).

Excretion: Approx 4% as unchanged drug via urine; metabolites are excreted to a similar extent via urine and faeces. Plasma elimination half-life: 2 hr.

Side effects

Chronic stable angina pectoris in coronary artery disease patients with normal sinus rhythm Adult: Initially, should not exceed 5 mg twice a day. Increase if necessary to 7.5 mg twice a day after 3-4 wk. Titrate downward to as low as 2.5 mg twice a day, if patient develops bradycardia symptoms (e.g. dizziness, fatigue) or resting heart rate is persistently <50 beats/min.

Elderly: ≥75 yr Initiate treatment at 2.5 mg twice a day. Titrate up if necessary.

Renal impairment:

CrCl (ml/min)

Dosage Recommendation

<15

Use w/ caution.

Hepatic impairment: Severe: Contraindicated.

Oral

Chronic heart failure

Adult: Initially, 5 mg twice a day. After 2 wk, increase to 7.5 mg twice a day if resting heart rate is persistently >60 beats/min or decrease to 2.5 mg twice a day if resting heart rate is persistently 50 beats/min. If heart rate is between 50-60 beats/min, maintain 5 mg twice a day. Max: 7.5 mg twice a day.

Elderly: ≥75 yr Initiate treatment at 2.5 mg twice a day. Titrate up if necessary.

Renal impairment:

CrCl (ml/min)

Dosage Recommendation

<15

Use w/ caution.

Hepatic impairment: Severe: Contraindicated.

Precaution

Patient with G6PD deficiency, autonomic neuropathy, thyroid or adrenocortical insufficiency. Patient exposed to stress (e.g. fever, trauma, infection, surgery). Mild to moderate hepatic or renal impairment. Elderly, debilitated and malnourished patients.

Pregnancy and lactation: Patient Counselling Adhere to diet and exercise regimen.

Monitoring Parameters: Monitor blood glucose, glycosylated Hb level, signs and symptoms of hypoglycaemia.

Dosage

Type 2 diabetes mellitus

Adult: Initially, 1-2 mg daily. May be increased in increments of 1-2 mg at intervals of 1-2 wk. Maintenance: 4 mg daily. Max: 6 mg daily.

Elderly: Initially, 1 mg once daily.

Renal impairment: Severe: Contraindicated.

Hepatic impairment: Severe: Contraindicated.