Elderly patients suffering from a mental disorder associated learning abnormality (dementia
) are at an increased risk when using Zedan. These patients may experience an increased incidence of stroke
, heart failure or lung infection, lack of energy, drowsiness, involuntary passage of urine, excessive salivation, or lightheadedness, which can be possibly fatal. Zedan should not be used in such patients.
Suicidal Thoughts and Behaviors
Children and young adults (age 18 to 24 years) or patients with depression/psychotics disorders are at an increased risk when using Zedan. These patients may experience worsening of the depression
and suicide-related/unusual changes in behaviors. Symptoms occurring in the patients during Zedan therapy are agitation, anxiety
, panic attacks, irritability etc. Patients should be monitored closely for suicide-related/unusual changes in behaviors in the starting of therapy or during dose adjustment. Discontinuation of Zedan, the lowest effective dose or changes in the therapy should be considered in such patients. Caregivers/family should be informed about the need to monitor the patients daily for the symptoms occurring during Zedan therapy.
Schizophrenia and Major Depressive Episode
Patients with schizophrenia
and major depressive
episode are at an increased risk when using Zedan. Treating such patients with Zedan alone may increase the occurrence of a mixed/manic episode and also increased suicide
attempt and weight gain. Weight gain usually occurs in patients with risk factors such as a history of thyroid disorders/non-cancerous growth in the pituitary gland. Before starting Zedan therapy, patients should be examined for the risk of bipolar disorder. The lowest effective dose should be used in these patients. Also, monitoring of the weight gain/dose reduction should be considered in children with bipolar disorder.
Neuroleptic Malignant Syndrome
Patients taking Zedan are at an increased risk. Drug-induced life-threatening reaction (neuroleptic malignant syndrome
) may occur in these patients. They may experience symptoms of a neuroleptic malignant syndrome such as high fever
, abnormal mental status, muscle rigidity, increased or abnormal heart rhythm, sweating, increased creatinine
phosphokinase, kidney failure, and myoglobin in the urine. Monitoring and treatment of neuroleptic malignant syndrome, discontinuation of Zedan or other drugs not required for the combined therapy should be considered. Antipsychotic drug therapy should be reintroduced after recovery from the neuroleptic malignant syndrome.
Patients taking Zedan, elderly patients especially elderly women are at an increased risk. These patients may experience irreversible and involuntary body movements (tardive dyskinesia
). This risk increases as the treatment duration increases. Long-term antipsychotic treatment should be given in patients with serious illness. The smallest dose for the shortest duration should be used in such patients. Zedan should be discontinued or dose reduction should be considered in patients developing symptoms of involuntary body movements.
Obese patients or patients with high blood sugar, or taking Zedan are at an increased risk. These patients may experience an increased level of glucose and acids in the blood, abnormally increased fats in the body, a complication of high blood sugar (diabetic hyperosmolar coma
) or fatality. These patients should be observed for symptoms and signs of high blood sugar such as weakness, increased thirst or urine passage and excessive eating (polyphagia
). Patients with high blood sugar should be monitored regularly for worsening of sugar level. Fasting blood sugar test should be performed in the starting and during the treatment with Zedan.
Low Blood Pressure on Quickly Standing
Patients taking Zedan are at an increased risk. Zedan may cause a blood clot in the leg, arms, or groin (venous thromboembolism) or low blood pressure on quickly standing up in these patients. Precaution should be taken in patients with low blood volume, low body fluid, high blood pressure or taking antihypertensive drugs. Also, caution is required in patients with blood vessel related heart and brain diseases. When the use of benzodiazepines injection with Zedan injection is necessary, sedation and low blood pressure on quickly standing up should be monitored. Patients should be examined for the risk of blood clot (venous thromboembolism) in the starting or during Zedan therapy.
Low Levels of White Blood Cells
Patients with history or already low levels of white blood cells count/absolute neutrophil count, or taking Zedan are at an increased risk. Zedan may decrease the number of leukocytes (leukopenia), granulocytes, or neutrophils in these patients. Complete blood count test should be performed in such patients in the initial period of drug therapy. On the occurrence of low white blood cell or neutrophil count, Zedan should be discontinued. Patients should be monitored and treated for symptoms of infection such as fever
Elderly patients, patients with a history of seizures
or condition associated with seizures, or taking Zedan are at an increased risk. Zedan may cause seizures in these patients. Precaution should be taken in such patients.
Memory and Movement Problems
Patients taking Zedan are at an increased risk. Zedan may cause drowsiness, sedation, and abnormality in thinking, judgment or movements. Patients should take necessary precaution while operating
heavy machines such as automobiles.
Regulation of Body Temperature
Patients taking Zedan are at an increased risk. Zedan may affect the body's capacity to decrease the body temperature. Care should be taken in the patients who get exposed to excess heat or are taking medicines having reduced muscle spasm (anticholinergic) activity. This should also be considered in dehydrated patients or in patients doing hard exercise
Difficulty in Swallowing (Dysphagia)
Patients taking Zedan or elderly patients especially those with learning abnormality are at an increased risk. Zedan may cause decreased muscles activity in the digestive tract and complication due to inhalation of food, acid or saliva (aspiration pneumonia
). This may occur in elderly patients and in patients having memory
problems. Precaution should be taken in such patients.
Abnormal Heart Rhythm
Patients with a family history of abnormal heart rhythm (QT prolongation) or taking Zedan are at an increased risk. Precaution should be taken in such patients.
Drug-Induced Movement Disorders
Patients taking Zedan or children are at an increased risk. These patients may experience a sensation restlessness and movement disorder. Dose reduction along with clinical monitoring should be considered in such patients.
Patients taking Zedan are at an increased risk. These patients may experience allergic reactions such as swelling of the lower layer of the skin, severe itching
, life-threatening reactions, muscular contraction
of the vocal cord and throat or swelling of the tongue.