Check with your doctor if you notice any symptom that worries you while you are taking this medication. Are there any other precautions or warnings for this medication? Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health.
These factors may affect how you should use this medication. The combination of alcohol use while taking lovastatin can increase the risk of harm to the liver. People who drink large quantities of alcohol should be closely monitored by their doctor while they are taking this medication. Lovastatin may cause an increase in blood sugar levels may cause a loss of blood glucose control and glucose tolerance may change.
People with diabetes may find it necessary to monitor their blood sugar more frequently while using this medication. If you have diabetes or are at risk for developing diabetes, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of thismedication, and whether any special monitoring is needed.
People with severely reduced kidney function should be closely monitored by their doctors if they take this medication Liver effects: Laboratory test results show that signs of harmful liver effects occur in about 1.
When the medication is stopped, the laboratory tests usually slowly return to normal. If you take lovastatin, your doctor will likely monitor your liver function with blood tests. If you have liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
The glandular mucosa was not affected. The human stomach contains only glandular mucosa. An increased incidence of thyroid neoplasms in rats appears to be a response that has been seen with other HMG-CoA reductase inhibitors.
Liver carcinomas were significantly increased in high dose females and mid- and high dose males, with a maximum incidence of 90 percent in males. The incidence of adenomas of the liver was significantly increased in mid- and high dose females. Drug treatment also significantly increased the incidence of lung adenomas in mid- and high dose males and females. Adenomas of the Harderian gland a gland of the eye of rodents were significantly higher in high dose mice than in controls. No evidence of mutagenicity was observed in a microbial mutagen test using mutant strains of Salmonella typhimurium with or without rat or mouse liver metabolic activation.
In addition, no evidence of damage to genetic material was noted in an in vitro alkaline elution assay using rat or mouse hepatocytes, a V mammalian cell forward mutation study, an in vitro chromosome aberration study in CHO cells, or an in vivo chromosomal aberration assay in mouse bone marrow.
Similar findings were seen with another drug in this class. No drug-related effects on fertility were found in studies with lovastatin in rats. No microscopic changes were observed in the testes from rats of either study.
The clinical significance of these findings is unclear. Safety in pregnant women has not been established. No effect was seen in male rats. Rare clinical reports of congenital anomalies following intrauterine exposure to HMG-CoA reductase inhibitors have been received. However, in an analysis3 of greater than prospectively followed pregnancies exposed during the first trimester to lovastatin or another closely related HMG-CoA reductase inhibitor, the incidence of congenital anomalies was comparable to that seen in the general population.
This number of pregnancies was sufficient to exclude a 3-fold or greater increase in congenital anomalies over the background incidence. Maternal treatment with lovastatin may reduce the fetal levels of mevalonate, which is a precursor of cholesterol biosynthesis. Atherosclerosis is a chronic process, and ordinarily discontinuation of lipid-lowering drugs during pregnancy should have little impact on the long-term risk associated with primary hypercholesterolemia.
Lovastatin should be administered to women of child-bearing potential only when such patients are highly unlikely to conceive and have been informed of the potential hazards.
Treatment should be immediately discontinued as soon as pregnancy is recognized. Nursing Mothers It is not known whether lovastatin is excreted in human milk. Pediatric Use Safety and effectiveness in patients 10 to 17 years of age with heFH have been evaluated in controlled clinical trials of 48 weeks duration in adolescent boys and controlled clinical trials of 24 weeks duration in girls who were at least 1 year post-menarche.
Patients treated with lovastatin had an adverse experience profile generally similar to that of patients treated with placebo. Doses greater than 40 mg have not been studied in this population.
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