Adrenal Insufficiency
Patients who suddenly stop the treatment with Defnalone after prolonged therapy are at an increased risk. Such patients may suffer from adrenal insufficiency and other fatal conditions. Patients should carry
'Steroid treatment'
cards which provides them information regarding necessary precautions need to be taken to minimize risk and which provide the detailed information of prescriber, drug, dosage and the duration of treatment with Defnalone.
High Cortisol Levels (Cushing’s Syndrome)
Patients with prolonged treatment with
corticosteroids including Defnalone are at an increased risk. Such patients may develop increased levels of cortisol
hormone in the body. Patients taking Defnalone should be monitored for high cortisol levels after withdrawal of Defnalone.
High Blood Sugar Levels (Hyperglycemia)
Patients who are on long-term therapy to
diabetes mellitus are at an increased risk while using this medicine. Use of
corticosteroids including Defnalone may lead to increased blood glucose levels, worsening of the condition of the diabetes and may reduce the effect of anti-diabetic drugs. Proper monitoring of blood glucose levels is required at regular intervals. In patients with high blood glucose levels, an anti-diabetic treatment should be initiated or adjusted accordingly.
Altered Thyroid Function
Patients with altered functioning of the thyroid gland are at an increased risk. Patients with decreased thyroid function may have reduced body clearance of
corticosteroids and enhanced clearance in patients with increased thyroid function. The use of corticosteroids with levothyroxine may cause an adrenal insufficiency. The dose of corticosteroids should be adjusted in patients with altered thyroid function. If the use of corticosteroids with levothyroxine is necessary, use corticosteroid before starting levothyroxine treatment to reduce the risk of adrenal insufficiency.
Unstable Condition of Cancer of Adrenal Gland
Patients taking
corticosteroids are at increased risk. Patients using corticosteroids (Defnalone) may suffer from the critical situation of
cancer of adrenal gland which may lead to a fatal condition. Examine the risk of manifestation of adrenal gland cancer before starting corticosteroid treatment in patients who have or are suspected of adrenal gland cancer.
Suppression of Immune System
The patients having an infection or with a history of infection are at an increased risk while using
corticosteroids. Use of corticosteroids including Defnalone, may suppress the immune system and increase the risk of infection with pathogenic agents including viral, bacterial, fungal, protozoan, or helminthic. Corticosteroids reduce the resistance to new infections, worsen the condition of existing infections and further mask some signs of infection. Carefully monitor for the development of infection and consider withdrawal of corticosteroids or reduce the dose of corticosteroids as needed.
Viral Infections
Patients with the weak immune system and those who are on
corticosteroids therapy are at an increased risk. Such patients may suffer from the fatal conditions of viral infections (chicken pox and
measles). Patients with a condition of
chickenpox should be advised to avoid close personal contact with others. Passive
immunization should be followed with
varicella zoster immunoglobulin (VZIG). If a diagnosis of chickenpox is confirmed, urgent treatment is required in such a case. Use of corticosteroids including Defnalone should not be discontinued, and the dose may need to be increased in such cases.
Altered Kidney or Heart Function
Defnalone can cause increased excretion of
calcium and
potassium, and an increase in blood pressure, water, and
salt retention. Carefully monitor the potassium levels in the blood. Dietary salt restriction and potassium supplementation may be necessary in this case. Take the precautions while using Defnalone in patients with heart failure, high blood pressure, and kidney insufficiency.
Ruptured Bowel
Patients with certain stomach and intestinal disorders such as stomach
ulcers, and inflammation of the wall of the intestine (diverticulitis) are at an increased risk while using this medicine. There is an increased risk of ruptured bowel during
corticosteroid use in patients with stomach or intestinal disorders such as stomach ulcers, and inflammation of the wall of the intestine (diverticulitis). Avoid use of corticosteroids including Defnalone if there is a possibility of severe condition of the stomach or intestinal disorders.
Bipolar Disorder
Use of
corticosteroids, including Defnalone may lead to severe symptoms of psychiatric effects such as
insomnia, intense feeling of excitement or pleasure and mood swings. Patients should immediately seek medical attention especially in severe cases of
depression or suicidal ideation. To overcome these reactions, either reduce or withdraw the use of Defnalone.
Decreased Bone Mineral Density
Corticosteroids, including Defnalone, decrease the process of bone formation and increase bone resorption. Consider a patient’s risk of
osteoporosis before starting treatment with Defnalone. Carefully monitor bone
mineral density in patients who are on long-term therapy with Defnalone.
Effects on Eyes
Use of
corticosteroids, including Defnalone, may lead to a cloudy appearance on the back surface of the lens. Defnalone may also cause the condition of increased intraocular pressure with possible damage to the optic nerves. Use of corticosteroids including Defnalone are not recommended for use in patients with active ocular herpes simplex viral infections. If treatment with Defnalone is continued for more than six weeks, carefully monitor the intraocular pressure.
Vaccination
Corticosteroids may increase organisms that present in live vaccines. Patients taking Defnalone may show less response to inactivated toxins and live or inactive vaccines because of blockage of antibody response. Patients using corticosteroids should not take live or inactive live vaccines. Inactive or killed vaccines may be used while on corticosteroid therapy.
Serious Condition of Skin Rashes
The use of Defnalone may cause a drug-induced severe allergic reaction which shows symptoms within 8 weeks of initiating the treatment. Stop the treatment if any sign of drug-related rash occurs.
Effects on Growth and Development
Long-term use of
corticosteroids, including Defnalone, may lead to negative effects on growth and development in children.