Liver Injury
Patients with abnormal liver function are at an increased risk when using this medicine. These patients may have a fatal liver damage. Monitoring should be required for the development of more severe liver injuries. This medicine should be discontinued if the signs and symptoms consistently develop with the use of Azocan-P.
Severe Allergic Reaction (Anaphylaxis)
The patients with
anaphylaxis are at an increased risk when using this medicine. This medicine should be discontinued if the patient experiences a severe allergic reaction.
Skin Disorder
Patients with serious disorders such as
AIDS and
cancer are at an increased risk. These patients may develop serious skin
rashes when using this medicine. Closely monitor the patients who develop rashes and the medicine should be discontinued in case of symptoms further progress.
Women in their first Trimester of Pregnancy
The use of this medicine in a high dose in women who are in their first trimester are at an increased risk of having birth defects in their baby. The children from these women may have short head (brachycephaly), abnormal facies, abnormal skull development, splits in the upper lip and the roof of the mouth (cleft palate), bent leg bone (femoral bowing), thin ribs and long bones, curving of joints (arthrogryposis), and heart disease related to birth. The pregnant women should be informed of the potential hazard to the child.
Abnormal Functioning of Kidney Glands
Patients on treatment with Azocan-P may experience adrenal insufficiency.
Heart Problems
Patients with low
potassium level and heart failure are at an increased risk when using this medicine. Such patients are at risk of life-threatening heart disorders causing rhythm problems of the heart. Azocan-P should be taken with caution in patients of heart rhythm disorders.
Kidney Dysfunction
Patients with a disturbance in the functioning of the kidney are at an increased risk. Azocan-P should be given with caution to patients who have kidney problems.
Use of Halofantrine
Patients taking Azocan-P with halofantrine are at an increased risk. Such patients may experience prolonged and irregular heartbeat. Azocan-P and halofantrine should not be used together.
Use of Terfenadine
Patients taking Azocan-P with terfenadine are at an increased risk. Such patients may experience abnormal heart rhythm disorder (QT prolongation). The use of Azocan-P at a dose lower than 400 mg per day with terfenadine should be monitored carefully.
Use of Cytochrome P450 Enzymes
Patients taking Azocan-P with other compounds metabolized by CYP2C9 and CYP3A4 enzymes are at an increased risk. Patients should be carefully monitored and caution should be
exercised when using these combinations.
Intolerance to Sugars
Patients with a family history of galactose intolerance and defect in glucose-galactose absorption are at an increased risk. Such patients should not be advised to take Azocan-P capsules containing lactose.