Farsorbid

Farsorbid^®
Isosorbide Dinitrate

COMPOSITION
Farsorbid^® 5
Each sublingual tablet contains :
Isosorbide Dinitrate 5 mg

Farsorbid^® 10
Each tablet contains :
Isosorbide Dinitrate 10 mg

Farsorbid^® Injection
Each mL injection contains :
Isosorbide Dinitrate 1 mg in sterile isotonic saline

PHARMACOLOGY
Isosorbide Dinitrate is a direct acting vasodilator. It reduce myocardial oxygen requirements through its effects on the systemic circulation. Its major systemic action is a reduction in venous tone, which leads to pooling of blood in peripheral veins decreased venous return, and reduced ventricular volume and myocardial tension (preload). It dilates the large epicardial (conductance) arteries but has little effect on intramyocardial (resistance) vessels. In the normal non-ischemic myocardium, coronary blood flow may increase temporarily and then decrease because of the fall in central aortic pressure.
Isosorbide Dinitrate is believed to improve angina of effort through its effects on the peripheral circulation however, its haemodynamic action are not always closely correlated with antianginal activity, and increase in regional myocardial blood flow may contribute to the therapeutic response. It relieves variant angina primarily through effect on the coronary circulation.

INDICATIONS
Farsorbid^® sublingual tablet
Is indicated for the treatment and prophylaxis of angina pectoris.
Farsorbid^® injection
Is indicated in the treatment of unresponsive left ventricular failure secondary to acute myocardial infarction, unresponsive left ventricular failure of various aetiology and severe or unstable angina pectoris.

DOSAGE AND ADMINISTRATION
Farsorbid^® 5
Usual Adult dose :
1 to 2 sublingual tablet every two to three hours as needed.
Usual pediatric dose : dosage has not been established.

Farsorbid^® 10
Usual Adult dose :
Oral, 10 mg four times a day, the dosage being adjusted as needed and-tolerated.
Before sleeping, 10 mg use for the prophylaxis of angina pectoris.

Farsorbid^® Injection
Dosage:
The dose employed must be adjusted according to the patient's response. In general a dose of between 2 and 7 mg per hour is suitable although doses as high as 10 mg per hour may be necessary.
Children:
The safety and efficacy of Farsorbid^® injection has not been yet established in children.

Administration:
Farsorbid^® injection is supplied as a concentrated solution and should never be injected directly. It should always be administered as an intravenous admixture with a suitable vehicle such as Sodium Chloride Injection B.P. or Dextrose Injection B.P. Prepared Farsorbid^® injection admixtures are always given by intravenous infusion or with the aid of a syringe pump. During administration, there should be close monitoring of the patient's blood pressure and pulse. Admixtures are prepared by exchanging the required volume of Farsorbid^® injection with an equal volume of the infusion vehicle.

WARNINGS AND PRECAUTIONS
Farsorbid^® sublingual tablet

• Should be given with caution in patient at pregnancy or nursing mother, because problems in humans have not been documented however, risk benefit must be considered. Isosorbide Dinitrate may develop tolerance and cross tolerance to other nitrates and nitrites.
• Use of this medication should be carefully considered when the following medical problem exist anemia, hyperthyroidism, intracranial pressure (increased), myocardial infarction (recent).

Farsorbid^® injection
Close attention to pulse and blood pressure is necessary during the administration of Farsorbid^® injection.
Farsorbid^® injection should be used with caution in patients who are predisposed to closed angle glaucoma.
This product should not be used during pregnancy or lactation unless considered essential by the physicians.
Farsorbid^® injection should be used with caution in patients suffering from hypothyroidism, malnutrition, sever liver or renal disease or hypothermia.

SIDE EFFECTS

• Incidence more frequent: orthostatic hypotension, flushing of face and neck, headache, nausea or vomiting, rapid pulse.
• Incidence rare: skin rash.
• Whilst sharp falls in systemic arterial pressure can give rise to symptoms of cerebral flow deficiency and decreased coronary perfusion, clinical experience with Farsorbid^® injection has shown that this is not normally a problem. This is consistent with the known vasodilatory effects of Isosorbide Dinitrate which occur predominantly on the venous rather than on the arterial side of the circulation. In common with other nitrates, headaches and nausea may occur during administration.

CONTRAINDICATIONS

• Farsorbid^® sublingual tablet, is contraindicated in patients who have hypersensitivity reactions to nitrates, and glaucoma.
• Farsorbid^® injection, should not be used in the treatment of cardiogenic shock unless some means of maintaining an adequate diastolic pressure is undertaken, for example, by concurrent administration of an inotrope. Farsorbid^® injection is contraindicated in circulatory collapse and severe hypotension. Farsorbid^® injection, should not be given to patients with known sensitivity to nitrates. Farsorbid^® injection should not be used in patients with marked anemia, head trauma, cerebral haemorrhage, severe hypotension or hypovolaemia.

DRUG INTERACTIONS

• Alcohol (moderate or excessive amounts) or antihypertensives or vasodilators (other) concurrent use may intensify the orthostatic hypotensive effects of Isosorbide Dinitrate. 
• Sympathomimetics (such as phenylephrine, ephedrine, or epinephrine) concurrent use may reduce the antianginal effect of Isosorbide Dinitrate.

STORAGE
Store between 25° - 30°C. Protect from light

PRESENTATION
Farsorbid^® 5
Box, 10 strips @ 10 sublingual tablets, Reg. No. DKL8831500474A1

Farsorbid^® 10
Box, 10 strips @ 10 tablets, Reg. No. DKL9031527710A1

Farsorbid^® injection
Box, 2 vials @ 10 mL, Reg. No. DKL0631526443A1

ON MEDICAL PRESCRIPTION ONLY

Manufactured by :
PT. PRATAPA NIRMALA
Tangerang - Indonesia

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