NIKP-Pitavastatin Special Precautions

According to Announcement of Ministry of Public Health Thailand, HMG CoA-Reductase inhibitor should be treated with cautions as follows.
Do not use in pregnancy and lactation.
Do not use in patient with liver disease.
Do not use medicine when muscle pain at the area of, gastrocnemius, back or body. Stop medicine and consult with physicians immediately.
Hepatic function test should be performed pre-dose and post-dose 6 and 12 months respectively. Hepatic function test should be monitored every 6 months. Stop medicine and consult physician when serum transaminases level exceeds 3 times of the upper limit of normal [ULN].
Carefully use during co-administration with digoxin, warfarin due to the level of medicine may be high and contribute to dangerous.
Risk of myopathy or rhabdomyolysis will be increased when co-administration with following medicines namely Azole antifungals group such as Ketoconazole, Itraconazole etc., Macrolides group such as Erythromycin, Clarithromycin etc., HIV protease inhibitors such as Indinavir, Ritonavir, Saquinavir etc., Verapamil, Diltiazem, Gemfibrozil, Nicotinic acid, Cyclosporine, Amiodarone etc.
Risk of rhabdomyolysis will be increased in following conditions for instance high dose of Pitavastatin calcium in elderly, hepatic impairment or renal impairment or chronic alcoholic or hypothyroidism.
Carefully use when co-administration with Colchicine especially elderly or patients with renal impairment due to there are risk of myopathy and rhabdomyolysis.
This medicine may increase risk of elevation of blood sugar.
With regard to information on influence of concomitant use of Pitavastatin with Colchicine, Digoxin, Enalapril, Erythromycin, Ezetimibe, Fibric acid derivative, Cyclosporin, Niacin and Warfarin in the next topic (see Interactions).