CONIPAN 7.5
-
Chemical Name:
Ivabradine -
Therapeutic Category:
Cardiovascular drugs -
Pharmacologic Category:
Heart rate lowering agent -
Pharmaceutical Form:
Tablets -
Composition:
Ivabradine 7.5mg
CONIPAN
Film Coated Tablets
Ivabradine (Hydrochloride)
1-MECHANISM OF ACTION:
Ivabradine is a heart rate lowering agent. It acts by selective and specific inhibition of the cardiac pacemaker if current, an importantionic current that usually controls spontaneous diastolic depolarization in the sinus node and thereby regulates heart rate.
The cardiac effects of Ivabradine are specific to the sinus nodeand Ivabradine has no effect on intra-atrial, atrioventricular orintraventricular conduction times, myocardial contractility orventricular depolarization.
An elevated heart rate increases myocardial oxygen demandand limits tissue perfusion, the latter by reducing the duration ofdiastole, during which most myocardial perfusion occurs. Therefore, a pure reduction in heart rate can reduce myocardial ischemia and prevent angina pectoris.
2-INDICATIONS:
CONIPAN is indicated for the symptomatic treatment of chronic stableangina pectoris in patients with normal sinus rhythm who are intolerantto beta-blockers or in whom these agents are contraindicated.
3-CONTRAINDICATIONS:
CONIPAN is contraindicated in patients with cardiac dysrhythmias,unstable angina pectoris, acute coronary syndrome, class lll to lVheart failure, 3rd degree AV block, cardiogenic shock, those with apacemaker, a resting heart rate below 60 bpm or severe hypotension(< 90/50 mm Hg).
Ivabradine is not recommended for use in patients with liverdysfunction and is contraindicated in patients with severe liverdysfunction.
4-PRECAUTIONS:
- Heart failure should be controlled before Ivabradine is started.
- If unexpected deterioration in visual function occurs, stopping treatment may be considered.
- Should be used with caution in patients with retinitis pigmentosa.
- Should be used with caution in patients with renal impairment.
5-PREGNANCY & LACTATION:
CONIPANis contraindicated for use during pregnancy and lactation.
6-ADVERSE EFFECTS:
Luminous phenomena (phosphenes) i.e. enhanced brightness in thevisual field, have been reported in 14.5% of patients. These effectsusually resolve spontaneously during treatment.
Other common side effects include bradycardia, AV 1st degreeheart block, ventricular extrasystoles, headache and dizziness.
7-DRUG INTERACTIONS:
The concurrent use of Ivabradine with strong cytochrome P450 inhibitors, the concomitant use of medicines that prolong the QT intervals should be avoided since QT prolongation may be exacerbated by heart rate reduction. The concomitant use of Ivabradine with heart rate reducing calcium channel blockers such as verapamil or diltiazem is not recommended.
The following medicines should not be taken at all withCONIPAN:
-Grapefruit and grapefruit juice
- Antibiotics of the macrolide class including azithromycin, clarithromycin,erythromycin, roxithromycin
- Ketoconazole
- Medicines to treat HIV infections
- Cyclosporin, used to prevent rejection following transplants
- Gestodene
- Rifampicin (an antibiotic)
- Barbiturates (for difficulty sleeping or epilepsy)
- Phenytoin (for epilepsy)
- Quinidine, disopyramide, ibutilide, sotalol (to treat heart rhythm disorders)
- Certain types of medicines to treat depression (such as imipramine)
- Certain types of medicines to treat anxiety, schizophrenia or other psychoses (such as phenothiazines and thioridazine)
- Amiodarone (for heart rhythm disorders)
- Some herbal remedies such as St John’s Wort
8-DOSAGE& ADMINISTRATION:
The usual recommended dose is 5 mg twice daily. The dose may be increased after 2 to 4 weeks to 7.5 mg twice daily, if necessary.
If the heart rate decreases below 50 bpm at rest or if the patient experiences symptoms related to bradycardia, the dose should be reduced to 2.5 mg twice daily. Treatment should be stopped if the heart rate remains below 50 bpm or if symptoms of bradycardia persist.
Adults over the age of 75 years should start treatment with alower dose i.e. 2.5 mg twice daily.
9-PACKAGING AND COMPOSITION:
CONIPAN 5 –F.C.Tablets: A pack of10 or 30 f.c.tablets. Each f.c.tablet contains Ivabradine (Hydrochloride) 5mg.
CONIPAN7.5 –F.C.Tablets: A pack of10 or 30 f.c.tablets. Each f.c.tablet contains Ivabradine (Hydrochloride) 7.5mg.
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