FORTZAAR Tablet Ref.[50605] Active ingredients: Hydrochlorothiazide Losartan

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2021  Publisher: MSD (Pty) Ltd, 117 16th Road, Halfway House, South Africa, 1685

4.1. Therapeutic indications

FORTZAAR is indicated for the treatment of hypertension in patients established on identical doses of the individual agents.

4.2. Posology and method of administration

The maximum dose is one tablet of FORTZAAR (100 mg losartan potassium and 25 mg hydrochlorothiazide) once daily (see section 4.1). The maximum antihypertensive effect is usually attained within three weeks after initiation of therapy.

Special populations

FORTZAAR should not be initiated in patients who are intravascularly volume-depleted (e.g. those treated with high-dose diuretics).

FORTZAAR is not recommended for patients with severe renal impairment or for patients with hepatic impairment (see section 4.3 and section 4.4).

FORTZAAR should not be used as initial therapy in elderly patients.

Paediatric population: N/A

Method of administration

FORTZAAR may be administered with other antihypertensive agents, such as calcium channel blockers and beta-blockers.

FORTZAAR may be administered with or without food.

4.9. Overdose

LOSARTAN POTASSIUM

The most likely manifestation of overdosage would be hypotension and tachycardia; bradycardia could occur from parasympathetic (vagal) stimulation. If symptomatic hypotension should occur, supportive treatment should be instituted.

Neither losartan nor the active metabolite can be removed by haemodialysis.

HYDROCHLOROTHIAZIDE

The most common signs and symptoms observed are those caused by electrolyte depletion (hypokalaemia, hypochloraemia, hyponatraemia) and dehydration resulting from excessive diuresis. If digoxin has also been administered, hypokalaemia may accentuate cardiac dysrhythmias. The degree to which hydrochlorothiazide is removed by haemodialysis has not been established.

6.3. Shelf life

36 months.

6.4. Special precautions for storage

Store at or below 30°C. Keep well closed.

This medicine does not require any special storage conditions.

6.5. Nature and contents of container

FORTZAAR tablets are supplied in blister packs of 30.

6.6. Special precautions for disposal and other handling

No special requirements.

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