Source: Health Products Regulatory Authority (ZA) Revision Year: 2024 Publisher: Macleods Pharmaceuticals SA (Pty) Ltd, Office Block 1, Bassonia Estate Office Park (East), 1 Cussonia Drive, Bassonia Rock, Ext. 12, Alberton, South Africa
Treatment of pulmonary arterial hypertension. MAKLITIO has been shown to improve exercise ability and to reduce mean pulmonary arterial pressure.
The recommended dose is 20 mg three times a day.
Efficacy of MAKLITIO at a dose of 20 mg three times a day has not been established in a sufficient number of patients beyond 12 weeks of treatment.
Dosage adjustments are not required in elderly patients.
Dose adjustments are not required in patients with mild to moderate renal impairment (see Section 4.3).
Dose adjustments are not required in patients with mild to moderate hepatic impairment (Child-Pugh class A and B). Patients with severe hepatic impairment (Child-Pugh class C) have not been studied (see Section 4.3).
Safety and effectiveness of MAKLITIO have not yet been demonstrated in children.
Co-administration of erythromycin or saquinavir and more potent CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, ritonavir) with MAKLITIO is contraindicated (see Section 4.5).
Dose adjustments of MAKLITIO may be required when co-administered with bosentan or other CYP3A4 inducers (see Section 4.5).
For oral use.
MAKLITIO should be taken approximately 6 to 8 hours apart with or without food.
In studies with healthy volunteers, of single doses up to 800 mg, adverse events were similar to those seen at lower doses, but incidence rates were increased. In cases of overdose, supportive measures should be adopted as required. Renal dialysis is not expected to accelerate clearance as sildenafil is highly bound to plasma proteins and not eliminated in the urine.
60 months for container pack and 48 months for blister pack from the date of manufacture.
Store at or below 25°C.
Keep the blisters in the carton until required for use.
Keep HDPE containers tightly closed.
Store in the original package in order to protect from light and moisture.
HDPE container:
Round, white, HDPE container (30 ml) with 28 mm neck finish, containing 90 tablets, closed with white a polypropylene child resistant with pulp and heat seal liner and packed in a pre-printed unit carton.
Blister pack:
Clear 250 μ PVC/60 gsmPVdC as the forming material and silver coloured plain 25μ aluminium foil/6-8 gsm HSL as the lidding material, packed in a pre-printed unit carton.
Pack sizes 10s, 28’s, 30’s and 90’s.
Not all pack sizes will be marketed.
No special requirements.
Any unused product or waste material should be disposed of in accordance with local requirements.
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