Swelling of the lower layer of skin
Patients with the previous episode of swelling of the lower layer of skin, using Neugaba 75, or drugs associated with swelling are at an increased risk. The use of Neugaba 75 may cause swelling of the face, neck (larynx and throat), and mouth (tongue, gums, and lips) and abnormality in respiratory function (respiratory compromise) in these patients. Take necessary precautions while using Neugaba 75 in patients with previous history of swelling of the lower layer of the skin.
Allergic reactions
Patients using Neugaba 75 are at an increased risk of emergence of allergic symptoms. These patients may experience allergic reactions shortly after starting Neugaba 75 therapy, which includes
hives,
wheezing, rash, difficulty in breathing (
dyspnea), skin redness, and
blisters. Neugaba 75 should be discontinued immediately on the occurrence of the allergic reaction.
Suicidal behavior and ideation
Patients with
epilepsy, other psychotic disorders or taking Neugaba 75 are at increased risk. The use of Neugaba 75 may increase the risk of suicidal behavior or thoughts, worsening of the
depression, and unusual changes in behavior or mood changes in these patients. Carefully monitor the patients for the emergence or worsening of depression, suicidal thoughts and mood or behavioral changes.
Dizziness and drowsiness
Patients using Neugaba 75 alone or with other central nervous system drugs are at increased risk. The use of Neugaba 75 may cause
dizziness and drowsiness in these patients. The effects may worsen on combined usage of Neugaba 75 with other central nervous system drugs. Patients should be informed about their weakened ability to perform tasks such as
operating machinery or driving due to Neugaba 75 related drowsiness and dizziness.
Weight gain
Patients using Neugaba 75 are at an increased risk. The use of Neugaba 75 may cause weight gain.
Abrupt or rapid discontinuation of treatment with Neugaba 75
Patients with
seizure disorders or who suddenly discontinue using this medicine are at increased risk. These patients may develop symptoms including
diarrhea,
headache,
nausea,
anxiety, seizures, and
insomnia. Neugaba 75 should not be discontinued suddenly rather it should be tapered slowly over a minimum of 1 week.
Eye-related effects (ophthalmological effects)
Patients using Neugaba 75 are at increased risk. The use of Neugaba 75 may cause vision-related events such as blurred vision in these patients. If this happens, contact your doctor right away. Frequent assessment should be considered in patients with persisting visual disturbance and in patients who are already examined for eye conditions.
Increased level of creatine kinase in the blood (creatine kinase elevations)
Patients using Neugaba 75 are at increased risk. The use of Neugaba 75 may cause muscle injury (
rhabdomyolysis) and increased levels of creatine kinase in the body. Tell your doctor immediately on the occurrence of tenderness, weakness, muscle
pain,
fever, and feeling of discomfort. Neugaba 75 should be discontinued if (abnormality in muscle fiber)
myopathy or increased level of creatine kinase in the blood occurs.
Low levels of thrombocytes and heart block (PR Interval prolongation)
Patients using Neugaba 75 are at increased risk. The use of Neugaba 75 causes low levels of thrombocytes and heart blockage in such patients.
Swelling of the lower legs or hands
Patients using Neugaba 75 alone or with thiazolidinedione antidiabetic agent are at an increased risk. These patients may experience higher frequencies of weight gain and swelling of the lower legs or hands, which may lead to heart failure. Such patients should be monitored for the occurrence of swelling of the skin when using Neugaba 75 with thiazolidinedione antidiabetic agent. There are no sufficient studies of heart failure patients, these patients should be monitored for the worsening of heart failure.