DEXAMETHASONE 4 MG AND 8 MG TABLET

NAME OF THE MEDICINAL PRODUCT

Dexamethasone Tablet IP 0.5 mg,

Dexamethasone Tablet IP 8 mg,

Dexamethasone BP  Tablet 0.5 mg,

Dexamethasone BP  Tablet  4 mg,

Dexamethasone Tablet USP 0.5 mg,

Dexamethasone Tablet USP 0.75 mg,

Dexamethasone Tablet USP 2 mg,

Dexamethasone Tablet USP 4 mg,

Dexamethasone Tablet USP 8 mg

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 4 mg dexamethasone.
Each tablet contains 8mg dexamethasone.
Excipient with known effect:
Each tablet contains 77.9 mg lactose (as lactose monohydrate).

PHARMACEUTICAL FORM
Tablet
White or almost white, round tablets with bevelled edges and scored on one side (Thickness: 2.5-3.5 mm; Diameter: 5.7-6.3 mm). The tablet can be divided into equal doses.

CLINICAL PARTICULARS

Therapeutic indications


Neurology
Cerebral oedema (only with symptoms of intracranial pressure evidenced by computerised tomography) caused by a brain tumour, neuro-surgical intervention, cerebral abscess.

Pulmonary and respiratory diseases
Acute asthma exacerbations when use of an oral corticosteroid (OCS) is appropriate, croup.

Dermatology
Initial treatment of extensive, severe, acute, skin diseases responding to glucocorticoids, e.g. erythroderma, pemphigus vulgaris.

Autoimmune disorders/rheumatology Initial treatment of autoimmune disorders like systemic lupus erythematodes.
Active phases of systemic vasculitides like panarteritis nodosa (treatment duration should be limited to two weeks in cases of concomitant positive hepatitis B serology).
Severe progressive course of active rheumatoid arthritis, e.g. fast proceeding destructive forms and/or extraarticular manifestations.
Severe systemic course of juvenile idiopathic arthritis (Still’s disease).

Haematological disorder
Idiopathic thrombocytopenic purpura in adults.

Infectology
Tuberculous meningitis only in conjunction with anti-infective therapy.

Oncology
Palliative treatment of neoplastic diseases.
Prophylaxis and treatment of emesis induced by cytostatics, emetogenic chemotherapy within antiemetic treatment.
Treatment of symptomatic multiple myeloma, acute lymphoblastic leukemia, Hodgkin’s disease and non-Hodgkin’s lymphoma in combination with other medicinal products.

Various
Prevention and treatment of postoperative vomiting, within antiemetic treatment.

 Posology and method of administration


Posology

Dexamethasone is given in usual doses of 0.5 to 10 mg daily, depending on the disease being treated. In more severe disease conditions doses above 10 mg per day may be required. The dose should be titrated to the individual patient response and disease severity. In order to minimize side effects, the lowest effective possible dose should be used.

Unless otherwise prescribed, the following dosage recommendations apply:
The below mentioned dosing recommendations are given for guidance only. The initial and daily doses should always be determined based on individual patient response and disease severity.
Cerebral oedema: Initial dose and duration of treatment depending on the cause and severity, 6-16 mg (up to 24 mg) / day orally, divided into 3-4 individual doses.
Acute asthma: Adults: 16 mg / day for two days. Children: 0.6 mg / kg body weight for one or two days.
Croup: Children: 0.15mg/kg-0.6 mg/kg in a single dose.
Acute skin diseases: Depending on the nature and extent of the disease daily doses of 8-40 mg, in some cases up to 100 mg, which should be followed by down titration according to clinical need.
Active phase of rheumatic system disorders: Systemic lupus erythematosus 6-16 mg / day.
– Active rheumatoid arthritis with severe progressive course form: running at fast destructive forms 12-16 mg / day, with extra-articular manifestations 6-12 mg / day.
Idiopathic thrombocytopenic purpura: 40 mg for 4 days in cycles.
Tuberculous meningitis: Patients with grade II or III disease received intravenous treatment for four weeks (0.4 mg per kilogram per day for week 1, 0.3 mg per kilogram per day for week 2, 0.2 mg per kilogram per day for week 3, and 0.1 mg per kilogram per day for week 4) and then oral treatment for four weeks, starting at a total of 4 mg per day and decreasing by 1 mg each week. Patients with grade I disease received two weeks of intravenous therapy (0.3 mg per kilogram per day for week 1 and 0.2 mg per kilogram per day for week 2) and then four weeks of oral therapy (0.1 mg per kilogram per day for week 3, then a total of 3 mg per day, decreasing by 1 mg each week).
Palliative treatment of neoplastic diseases: Initial dose and duration of treatment depending on the cause and severity, 3-20 mg / day. Very high doses up to 96 mg may also be used for palliative treatment. For optimal dosing and reduction of the number or tablets the combination of lower dose strengths (4 and 8 mg) and higher dose strengths (20 mg or 40 mg) can be used.
Prophylaxis and treatment of emesis induced by cytostatics, emetogenic chemotherapy within antiemetic treatment: 8-20 mg dexamethasone prior to chemotherapy treatment, then 4-16 mg/day on day 2 and 3.
Prevention and treatment of postoperative vomiting, within antiemetic treatment: single dose of 8 mg before the surgery.
Treatment of symptomatic multiple myeloma, acute lymphoblastic leukemia, Hodgkin’s disease and non-Hodgkin’s lymphoma in combination with other medicinal products: the usual posology is 40 mg or 20 mg once per day.
The dose and administration frequency varies with the therapeutic protocol and the associated treatment(s). Dexamethasone administration should follow instructions for dexamethasone administration when described in the Summary of Product Characteristics of the associated treatment(s). If this is not the case, local or international treatment protocols and guidelines should be followed. Prescribing physicians should carefully evaluate which dose of dexamethasone to use, taking into account the condition and disease status of the patient.


Renal impairment
Patients undergoing active hemodialysis may show an increased clearance of drug via the dialysate and thus require an adjustment of steroid dose.


Hepatic impairment
In patients with severe liver disease dose adjustment may be necessary. In patients with a severe liver impairment, the biological effects of dexamethasone may be potentiated due to its slower metabolism (prolonged plasma half-life) and hypoalbuminaemia (increased plasma levels of free drug), which may also cause more side effects.

Elderly
Treatment of elderly patients, particularly if long term, should be planned bearing in mind the more serious consequences of the common side effects of corticosteroids in old age (osteoporosis, diabetes mellitus, hypertension, reduced immunity, psychological changes). In such patients, the plasma concentrations of dexamethasone may be higher and its excretion slower than in younger patients, therefore its dose should be reduced accordingly.


Paediatric population
The excretion of dexamethasone is approximately equal in children and adults if dosage is adjusted to their body area. Dosage should be planned bearing in mind possible effects upon growth and development and for signs of adrenal suppression.


Long term treatment
For the long-term treatment of several conditions, after initial therapy, glucocorticoid treatment should be switched from dexamethasone to prednisone/prednisolone to reduce suppression on the function of the adrenal cortex.


Discontinuation of treatment
Acute adrenocortical failure may occur after abrupt discontinuation of long-term treatment with large doses of glucocorticoids. Therefore, glucocorticoid doses should be gradually reduced in such cases and treatment should be discontinued gradually

Method of administration

Dexamethasone should be taken with or after food to minimise irritation to the gastrointestinal tract. Drinks containing alcohol or caffeine should be avoided.
Dexamethasone is in the form of tablets 4 mg, 8 mg, 20 mg and 40 mg. The tablets can be divided into equal halves and can provide additional 2 mg and 10 mg strengths and make it easier for the patient to swallow the tablet.
When alternate-day therapy is not possible, the entire daily dose of glucocorticoid can usually be administered as a single morning dose; however, some patients will require divided daily doses of glucocorticoids.

CONTRAINDICATION


Hypersensitivity to the active substance or to any of the excipients.
Systemic infection unless specific anti-infective therapy is employed.
Stomach ulcer or duodenal ulcer.
Vaccination with live vaccines during treatment with large therapeutic doses of dexamethasone (and other corticosteroids) is contraindicated due to the possibility of viral infection.

SPECIAL PRECAUTIONS & WARNINGS


Adrenocortical insufficiency
An adrenocortical insufficiency, which is caused by glucocorticoid treatment, can, depending on the dose and length of treatment, remain for many months, and in some cases more than a year, after discontinuation of treatment. During treatment with dexamethasone for specific physical stress conditions (trauma, surgery, childbirth, etc.), a temporary increase in dose may be required. Because of the possible risk in stressful conditions, a corticosteroid ID should be made for patients undergoing long-term treatment. Even in cases of prolonged adrenocortical insufficiency after discontinuation of treatment, the administration of glucocorticoids can be necessary in physically stressful situations. An acute therapy-induced adrenocortical insufficiency can be minimized by slow dose reduction until a planned discontinuation time.
Treatment with dexamethasone should only be implemented in the event of the strongest indications and, if necessary, additional targeted anti-infective treatment administered for the following illnesses:
– Acute viral infections (Herpes zoster, Herpes simplex, Varicella, herpetic keratitis)
– HBsAG-positive chronic active hepatitis
– Approx. 8 weeks prior through 2 weeks after vaccinations with live vaccines
– Systemic mycoses and parasitosis (e.g. Nematodes)
– Poliomyelitis
– Lymphadenitis after BCG vaccination
– Acute and chronic bacterial infections
– With a history of tuberculosis (reactivation risk) use only under tuberculostatic protection
– Known or suspected Strongyloidiasis (threadworm infestation). Treatment with glucocorticoids may lead to lead to Strongyloides hyperinfection and dissemination with widespread larval migration.
In addition, treatment with dexamethasone should only be implemented under strong indications and, if necessary, additional specific treatment must be implemented for:
– Gastrointestinal ulcers
– Severe osteoporosis (as corticosteroids have a negative effect on the calcium balance)
– Difficult to regulate high blood pressure
– Difficult to regulate diabetes mellitus
– Psychiatric disorders (including history)
– Angle closure glaucoma and wide-angle glaucoma
– Corneal ulcerations and corneal injuries
– Severe heart failure

Anaphylactic reaction
Serious anaphylactic reactions may occur.
Tendinitis
The risk of tendinitis and tendon rupture is increased in patients treated concomitantly with glucocorticoids and fluoroquinolones.
Myasthenia gravis
Pre-existing myasthenia gravis may initiallydeteriorate in the beginning of dexamethasone treatment.
Ocular disorders
Systemic treatment with glucocorticoids can induce chorioretinopathy which may result in impaired vision including loss of vision.
Prolonged use of corticosteroids may cause posterior subcapsular cataracts, glaucoma with possible damage to the optic nerve and can increase the risk of secondary ocular infections due to fungi or viruses.
Corticosteroids should be used cautiously in patients with ocular herpes simplex because of possible corneal perforation.
Intestinal perforation
Because of the risk of an intestinal perforation, dexamethasone must only be used under urgent indication and under appropriate monitoring for:
– Severe ulcerative colitis with threatened perforation
– Diverticulitis
– Entero-anastomosis (immediately postoperative)
Signs of peritoneal irritation after gastrointestinal perforation may be absent in patients receiving high doses of glucocorticoids.
Diabetes
A higher need for insulin, or oral antidiabetics, must be taken into consideration when administering dexamethasone to diabetics.
Cardiovascular disorders
Regular blood pressure monitoring is necessary during treatment with dexamethasone, particularly during administration of higher doses and with patients with difficult to regulate high blood pressure. Because of the risk of deterioration, patients with severe cardiac insufficiency should be carefully monitored.
Bradycardia may occur in patients treated with high doses of dexamethasone.
Caution should be exercised when using corticosteroids in patients who have recently suffered myocardial infarction as myocardial rupture has been reported.
Infections
Treatment with dexamethasone can conceal the symptoms of an existing, or developing infection thereby making a diagnosis more difficult. The prolonged use of even small amounts of dexamethasone leads to an increased risk of infection, even by microorganisms which otherwise rarely cause infections (so-called opportunistic infections).
Vaccination
Vaccinations with inactivated vaccine are always possible. However, it should be noted that the immune reaction and thereby the success of inoculation, can be affected by higher doses of corticoids.
Regular checkups with doctors (including vision checkups in three-month intervals) are advised during long-term treatment with dexamethasone.
Metabolic disorders
At high doses, sufficient calcium intake and sodium restriction, as well as serum potassium levels should be monitored. Depending on the length and dosage of the treatment, a negative influence on calcium metabolism can be expected, so that an osteoporosis prophylaxis is recommended. This applies, above all, to co-existing risk factors like familial disposition, increased age, after menopause, insufficient protein and calcium intake, heavy smoking, excessive alcohol intake, as well as insufficient exercise. Prevention consists of sufficient calcium and vitamin D intake and physical activity. Additional medical treatment should be considered in the event of pre-existing osteoporosis.
Corticosteroids should be used cautiously in patients with migraine, as corticosteroids may cause fluid retention.

Psychological changes
Psychological changes are manifested in various forms, the most common being euphoria. Depression, psychotic reactions and suicidal tendencies may also appear.
These illnesses can be serious. Usually they start within a few days or weeks of starting the medicine. They are more likely to happen at high doses. Most of these problems go away if the dose is lowered or the medicine is stopped. However, if problems do happen, they might need treatment. In a few cases, mental health problems have happened when doses are being lowered or stopped.
Cerebral oedema or increased intracranial pressure
Corticosteroids should not be used in conjunction with a head injury since they will probably not be of benefit or may even do harm.
Discontinuation of treatment
Glucocorticoid doses should be gradually reduced.
The following risks should be considered upon interruption or discontinuation of long-term glucocorticoid administration:
– Exacerbation or recurrence of the underlying disease, acute adrenal insufficiency, corticosteroid withdrawal syndrome (A ‘withdrawal syndrome’ may include fever, muscle and joint pain, inflammation of the nose lining (rhinitis), weight loss, itchy skin and inflammation of the eye (conjunctivitis).
– Certain viral diseases (chickenpox, measles) in patients treated with glucocorticoids, may be very severe.
– Children and immunocompromised persons without previous chickenpox or measles infection are particularly at risk. If these people have contact with people infected with measles or chickenpox while undergoing treatment with dexamethasone, a preventative treatment should be introduced if necessary.
Other
Pheochromocytoma crisis, which can be fatal, has been reported after administration of systemic corticosteroids. Corticosteroids should only be administered to patients with suspected or identified pheochromocytoma after an appropriate risk/benefit evaluation.

Paediatric population
Corticosteroids cause a dose-dependent inhibition of growth in infancy, childhood, and adolescence since corticosteroids may give rise to early closing of the epiphyses, which may be irreversible. Therefore, during long-term treatment with dexamethasone, the indication should be very strongly presented in children and their growth rate should be checked regularly.
Available evidence suggests long-term neurodevelopmental adverse events after early treatment (< 96 hours) of premature infants with chronic lung disease at starting doses of 0.25mg/hg twice daily.

Elderly
The adverse effects of systemic corticosteroids can have serious consequences especially in old age, mainly osteoporosis, hypertension, hypokalemia, diabetes, susceptibility to infection and skin atrophy. Close clinical monitoring is required to prevent life-threatening reactions.

Influence of diagnostic tests
Glucocorticoids can suppress skin reaction to allergy testing. They can also affect the nitroblue tetrazolium test for bacterial infections and cause false-negative results.

Note on doping
The use of doping tests when taking dexamethasone can lead to positive results.
Dexamethasone contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.

Interaction with other medicinal products and other forms of interaction
Prior to the use of Dexamethasone in combination with any other medicinal product, reference should be made to the Summary of Product Characteristics of that product.

Pharmacodynamic interactions

Patients taking NSAIDs should be monitored, as NSAIDs may increase the incidence and/or severity of gastric ulcers. Acetylsalicylic acid should be used carefully in combination with corticosteroids in hypoprothrombinaemia.
The renal clearance of salicylates is increased by corticosteroids. Therefore, the dosage of salicylates may be reduced once the steroids are discontinued. Steroid withdrawal may result in salicylate intoxication due to the increase of salicylate concentration in the serum.
Corticosteroids reduce the effect of antidiabetic agents such as insulin, sulfonylurea, and metformin. Hyperglycaemia and diabetic ketoacidosis may occur occasionally.
Therefore, at the beginning of treatment, diabetics should have more frequent blood and urine tests.
The hypokalemic effect of acetazolamide, loop diuretics, thiazide diuretics, kaliuretics, amphotericin B injections (glucomineral)-corticosteroids, tetracosactide and laxatives will increase. Hypokalemia promotes cardiac arrhythmias, especially torsade de pointes, and increases the toxicity of cardiac glycosides. Before the start of corticosteroid treatment, hypokalemia should be corrected and patients should be monitored clinically, for electrolytes and by electrocardiography. Furthermore, there are case reports in which the simultaneous use of amphotericin B and hydrocortisone led to an enlarged heart and heart failure.
Antiulcer drugs: Carbenoxolone increases the risk of hypokalemia.

Chloroquine, hydroxychloroquine and mefloquine: Increased risk of myopathies and cardiomyopathies.
Concomitant administration of ACE inhibitors creates an increased risk of blood disorders.
The blood pressure-lowering effects of antihypertensive drugs may be affected by corticosteroids. The dose of the anti-hypertensive treatment may have to be adjusted during the treatment with dexamethasone.
Thalidomide: Great care should be taken during co-administration with thalidomide, a there have been reported cases of toxic epidermal necrolysis.
The effect of vaccinations may be reduced during treatment with dexamethasone.
Vaccination with live vaccines during treatment with large therapeutic doses of dexamethasone (and other corticosteroids) is contraindicated due to the possibility of viral infection. In this case, vaccination should be postponed for at least 3 months after the completion of treatment with corticosteroids. Other types of immunisation during treatment with large therapeutic doses of corticosteroids are dangerous due to the risk of neurological complications and decreased or absent increase in the antibody titers (in comparison with expected values) and therefore a smaller protective effect. However, patients who have received corticosteroids locally (parenteral) or for a short period of time (less than 2 weeks), in smaller doses may be immunised.
Cholinesterase inhibitors: Concomitant use of cholinesterase inhibitors and corticosteroids may cause serious muscle weakness in patients with myasthenia gravis. If possible, cholinesterase inhibitors should be discontinued at least 24 hours before the start of corticosteroid therapy.

The risk of tendinitis and tendon rupture is increased in patients treated concomitantly with glucocorticoids and fluoroquinolones.
Co-treatment with CYP3A inhibitors, including cobicistat-containing products, is expected to increase the risk of systemic side-effects. The combination should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid side-effects, in which case patients should be monitored for systemic corticosteroid side-effects.

Pharmacokinetic interactions

Effects of other medicinal products on dexamethasone:

Dexamethasone is metabolized via the cytochrome P450 3A4 (CYP3A4).
The administration of dexamethasone with inducers of CYP3A4, such as ephedrine, barbiturates, rifabutin, rifampicin, phenytoin, and carbamazepine can lead to reduced plasma concentrations of dexamethasone, so the dose must be increased.
Aminoglutethimide can accelerate the reduction of dexamethasone and reduce its efficacy. If necessary, the dexamethasone dosage should be adjusted.
Bile acid resins, such as cholestyramine, may decrease the absorption of dexamethasone.
Topically applied gastrointestinal drugs, antacids, activated charcoal: Decreased glucocorticoid resorption has been described during co-administration of prednisolone and dexamethasone. Therefore, the administration of glucocorticoids and topically applied gastrointestinal drugs, antacids, activated charcoal should be postponed (with an interval of at least two hours).
The administration of dexamethasone with inhibitors of CYP3A4, such as azoleantifungals (e.g. ketoconazole, itraconazole), HIV protease inhibitors (e.g. ritonavir) and macrolide antibiotics (e.g. erythromycin) may lead to increased plasma concentrations and reduced clearance of dexamethasone. If required, the dexamethasone dose should be reduced.
Ketoconazole may not only increase the plasma concentration of dexamethasone by inhibition of CYP3A4, but also suppress adrenal corticosteroid synthesis and cause adrenal insufficiency upon discontinuation of corticosteroid treatment.
Estrogens, including oral contraceptives, may inhibit the metabolism of certain corticosteroids and thus enhance their effect.

Effects of dexamethasone on other medicinal products

Dexamethasone is a moderate inducer of CYP3A4. The administration of dexamethasone with substances metabolized by CYP3A4 can lead to increased clearance and decreased plasma concentrations of these substances.
Tuberculostatics: A reduction of isoniazid plasma concentrations was observed during concurrent use of prednisolone. Patients taking isoniazid should be monitored closely.
Cyclosporine: Concomitant administration of cyclosporine and corticosteroids may lead to an increased effect of both substances. There is an increased risk of cerebral seizures.
Praziquantel: Reduced praziquantel plasma concentrations create a risk of treatment failure due to the increased hepatic metabolism of dexamethasone.
Oral anticoagulants (coumarin): Concomitant corticosteroid therapy may either potentiate or lead to a weakening of the effect of oral anticoagulants. In case of high doses or of treatment lasting over 10 days there is a risk of bleeding specific to corticosteroid therapies (gastrointestinal mucosa, vascular fragility). Patients who use corticosteroids combined with oral anticoagulants should be closely monitored (controls on day 8, then every two weeks during and after treatment).
Atropine and other anticholinergics: Intraocular pressure increases may be noted during co-administration with dexamethasone.
Non-depolarizing muscle relaxants: the muscle relaxing effect may last longer.
Somatotropin: the effect of the growth hormone can be reduced.
Protirelin: Reduced increase in TSH may be noted during administration of protirelin.

Fertility, pregnancy and lactation


Pregnancy
Dexamethasone crosses the placenta. Administration of corticosteroids to pregnant animals can cause abnormalities in foetal development, including cleft palate, intrauterine growth retardation and effects on brain growth and development. There is no evidence that corticosteroids result in an increased incidence of congenital abnormalities, such as cleft palate/lip in man. Long-term or repeated corticosteroid therapy in pregnancy increases the risk of intrauterine growth retardation. In newborns exposed to corticosteroids in the prenatal period, there is an increased risk of adrenal insufficiency, which under normal circumstances undergoes spontaneous postnatal regression, and is rarely of clinical significance. Dexamethasone should be prescribed during pregnancy, and particularly in the first trimester, only if the benefit outweighs the risks for the mother and child.

Breast-feeding
Glucocorticoids are excreted in breast milk. There is insufficient information on the excretion of dexamethasone in human milk. A risk to the newborns/infants cannot be excluded. Infants of mothers taking high doses of systemic corticosteroids for prolonged periods may have a degree of adrenal suppression.
A decision on whether to continue/discontinue breast feeding or to continue/discontinue therapy with dexamethasone should be made taking into account the benefit of breast feeding to the child and the benefit of dexamethasone therapy to the woman.

Fertility
Dexamethasone decreases testosterone biosynthesis and endogenous ACTH secretion which has an effect on the spermatogenesis and the ovarian cycle.

Effects on ability to drive and use machines
There have been no studies on the effects on the ability to drive and use machines.
Dexamethasone may cause confusional state, hallucinations, dizziness, somnolence, fatigue, syncope and blurred vision. If affected, patients should be instructed not to drive, use machines or perform hazardous tasks while being treated with dexamethasone.

UNDESIRABLE EFFECTS


Summary of the safety profile

The incidence of anticipated adverse effects correlates with the relative potency of the substance, dose, time of day of administration and duration of treatment. During a short-term therapy, in compliance with the dosage recommendations and close monitoring of patients, the risk of side effects is low.
The usual side effects of short-term dexamethasone treatment (days/weeks) include weight gain, psychological disorders, glucose intolerance and transitory adrenocortical insufficiency. Long-term dexamethasone treatment (months/years) usually causes central obesity, skin fragility,muscle atrophy, osteoporosis,growthretardation and long term suprarenal Insufficiency

Description of selected adverse reactions Adrenocortical insufficiency

An adrenocortical insufficiency, which is caused by glucocorticoid treatment, can, depending on the dose and length of treatment, remain for many months and in some cases more than a year, after discontinuation of treatment.

Psychological changes
Psychological changes are manifested in various forms, the most common being euphoria. Depression, psychotic reactions and suicidal tendencies may also appear. These illnesses can be serious. Usually they start within a few days or weeks of starting the medicine. They are more likely to happen at high doses. Most of these problems go away if the dose is lowered or the medicine is stopped.

Infections
Treatment with dexamethasone can conceal the symptoms of an existing, or developing infection thereby making a diagnosis more difficult and can lead to an increased risk of infection

Intestinal perforation
Corticosteroids can be associated with an increased risk of colonic perforation in severe ulcerative colitis with threatened perforation, diverticulitis and entero-anastomosis (immediately postoperative).
Signs of peritoneal irritation after gastrointestinal perforation may be absent in patients receiving high doses of glucocorticoids.

Cardiovascular disorders
Bradycardia, deterioration of severe cardiac insufficiency and difficult to regulate high blood pressure may occur. Caution should be exercised when using corticosteroids in patients who have recently suffered myocardial infarction as myocardial rupture has been reported.
Paediatric population

Corticosteroids cause a dose-dependent inhibition of growth in infancy, childhood, and adolescence since corticosteroids may give rise to early closing of the epiphyses, which may be irreversible.

Elderly

The adverse effects of systemic corticosteroids can have serious consequences especially in old age, mainly osteoporosis, hypertension, hypokalemia, diabetes, susceptibility to infection and skin atrophy.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via theYellow Card Scheme at: www.mhra.gov.uk/yellowcard.

Not known
Infections and infestations Increased susceptibility to, or exacerbation of, (latent) infections* (including septicaemia, tuberculosis, eye infections, chickenpox, measles, fungal and viral infections) with masking of clinical symptoms, opportunistic infections
Blood and lymphatic system disorders Leukocytosis, lymphopenia, eosinopenia, polycythemia, abnormal coagulation
Immune system disorders Hypersensitivity reactions including anaphylaxis, immunosuppression (see also under “Infections and parasitic diseases”)
Endocrine disorders Suppression of the hypothalamic-pituitary-adrenal axis and induction of Cushing’s syndrome (typical symptoms: full-moon face, plethora, truncal obesity), secondary adrenal and pituitary insufficiency* (especially in stress such as trauma or surgery), growth suppression in infancy, childhood and adolescence, menstrual irregularity and amenorrhoea, hirsutism
Metabolism and nutrition disorders Weight gain, negative protein and calcium balance*, increased appetite, sodium and water retention*, potassium loss* (caution: rhythm disorders), hypokalemic alkalosis, manifestation of latent diabetes mellitus, impaired carbohydrate tolerance with increased dose requirements of antidiabetic therapy*, hypercholesterolemia, hypertriglyceridaemia
Psychiatric disorders* Psychological dependence, depression, insomnia, aggravated schizophrenia, mental illness, from euphoria to manifest psychosis
Nervous system disorders Increased intracranial pressure with papilloedema in children (pseudotumor cerebri) usually following discontinuation of treatment; manifestation of latent epilepsy, increased seizures in overt epilepsy, vertigo, headache
Eye disorders Elevated intraocular pressure, glaucoma*, papilloedema, cataract*, mainly with posterior subcapsular opacity, corneal and scleral atrophy, increased ophthalmic viral, fungal and bacterial infections, worsening of symptoms associated with corneal ulcers*
Cardiac disorders Cardiac muscle rupture after recent history of myocardial infarction, congestive heart failure in predisposed patients, cardiac decompensation*
Vascular disorders Hypertension, vasculitis, increased atherosclerosis and risk of thrombosis/thromboembolism (increase in coagulability of blood may lead to thromboembolic complications)
Respiratory, thoracic and mediastinal disorders Hiccough
Gastrointestinal disorders Dyspepsia, abdominal distension*, gastric ulcers with perforation and bleeding, acute pancreatitis, ulcerative esophagitis, oesophageal candidiasis, flatulence, nausea, vomiting
Skin and subcutaneous tissue disorders Hypertrichosis, skin atrophy, telangiectasia, striae, erythema, steroid acne, petechiae, ecchymosis, allergic dermatitis, urticaria, angioneurotic oedema, thinning hair, pigment disorders, increased capillary fragility, perioral dermatitis, hyperhidrosis, tendency to bruise
Musculoskeletal and connective tissue disorders Premature epiphyseal closure, osteoporosis, fractures of the spine and long bones, aseptic necrosis of the femoral and the humeral bones, tendon tears*, proximal myopathy, muscle weakness, loss of muscle mass
Reproductive system and breast disorders Impotence

Overdose


Symptoms
Reports of acute toxicity and/or deaths following overdose with glucocorticoids are rare.
Overdose or prolonged use may exaggerate glucocorticoid adverse effects.

Management
No antidote is available. Treatment should be symptomatic and supportive with the dosage of dexamenthasone being reduced or slowly withdrawn where possible. Treatment is probably not indicated for reactions due to chronic poisoning unless the patient has a condition that would render him unusually susceptible to ill effects from corticosteroids. In this case, the stomach should be emptied and symptomatic treatment should be instituted as necessary. Anaphylactic and hypersensitivity reactions may be treated with epinephrine (adrenaline), positive-pressure artificial respiration and aminophylline. The patient should be kept warm and quiet. The biological half-life of dexamethasone in plasma is about 190 minutes.

Pharmacological particulars


Pharmacodynamic properties
Pharmacotherapeutic group: corticosteroids for systemic use, glucocorticoids, ATC code: H02AB02.
Mechanism of action
Dexamethasone is a highly potent and long-acting glucocorticoid with negligible sodium retaining properties and is therefore, particularly suitable for the use in patients with cardiac failure and hypertension.
Its anti-inflammatory potency is 7 times greater than prednisolone and, like other glucocorticoids, dexamethasone also has anti-allergic, antipyretic and immunosuppressive properties.
Dexamethasone has a biological half life of 36 – 54 hours and therefore is suitable in conditions where continuous glucocorticoid action is required.

Pharmacokinetic properties


Absorption and distribution

Dexamethasone is well absorbed when given by mouth; peak plasma levels are reached between 1 and 2 hours after ingestion and show wide interindividual variations. The mean plasma half-life is 3.6 ± 0.9 h. Dexamethasone is bound (to about 77%) to plasma proteins, mainly albumins. Percentage protein binding of dexamethasone, unlike that of cortisol, remains practically unchanged with increasing steroid concentrations. Corticosteroids are rapidly distributed to all body tissues. They cross the placenta and may be excreted in small amounts in breast milk.

Biotransformation
Dexamethasone is metabolised mainly in the liver but also in the kidney.

Elimination

Dexamethasone and its metabolites are excreted in the urine.

Preclinical safety data
Studies in animals have shown that glucocorticoids increase the incidence of cleft palate, spontaneous abortions and intrauterine growth retardation. In some cases these divergences were combined with defects of the central nervous system and of the heart. In non-human primates, minor cranial skeletal abnormalities were observed. These effects were observed after use of high doses of dexamethasone.

Pharmaceutical particulars

List of excipients
Lactose monohydrate
Starch, pregelatinised, maize
Colloidal anhydrous silica
Magnesium stearate (E572)

Incompatibilities
Not applicable.

Shelf life
2 years

Special precautions for storage
This medicine does not require any special temperature storage conditions.
Store in the original package in order to protect from light and moisture.

Nature and contents of container
Blister (OPA/Alu/PVC//Alu): 10, 20, 28, 30, 50, 56, 60, 100, 10 x 1, 20 x 1, 28 x 1, 30 x 1, 50 x 1, 56 x 1, 60 x 1 and 100 x 1 tablets, in a box.
Not all pack sizes may be marketed.

Special precautions for disposal and other handling

No special requirements.

MARKETING AUTHORISATION HOLDER

TAJ PHARMA CIS LTD.
Marksistsky lane 6, office 221, Moscow, 109147, Russia

MANUFACTURER:

Manufactured in India by:
TAJ PHARMACEUTICALS LTD,
220, Mahagujarat Ind. Estate,  Moraiya,

Tal. Sanand , Dist. Ahmedabad,

Gujarat, INDIA.

Package leaflet:

Information for the patient

DEXAMETHASONE 4mg and 8mg  tablets

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
– Keep this leaflet. You may need to read it again.
 – If you have any further questions, ask your doctor or pharmacist.
– This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
– If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

What is in this leaflet

Your medicine is called either DEXAMETHASONE 4mg and 8mg  tablets depending on what your doctor has prescribed. It will be known as DEXAMETHASONE Tablets for ease hereafter.

What is in this leaflet
1. What DEXAMETHASONE Tablets are and what they are used for
2. What you need to know before you take DEXAMETHASONE Tablets
3. How to take DEXAMETHASONE Tablets
4. Possible side effects
5. How to store DEXAMETHASONE Tablets
6. Contents of the pack and other information

WHAT DEXAMETHASONE TABLETS ARE AND WHAT THEY ARE USED FOR

Dexamethasone is a synthetic glucocorticoid. Glucocorticoids are hormones produced by the cortex of adrenal glands. The medicine has anti-inflammatory, analgesic and anti-allergic effects, and suppresses the immune system. Dexamethasone is recommended for the treatment of rheumatic and autoimmune diseases (e.g. systemic lupus erythematosus, rheumatoid arthritis, juvenile idiopathic arthritis, polyarthritis nodosa), diseases of respiratory tract (e.g. bronchial asthma, croup), skin (e.g. erythroderma, pemphigus vulgaris), tuberculous meningitis only in conjunction with anti-infective therapy, diseases of blood (e.g. idiopathic thrombocytopenic purpura in adults), cerebral oedema, treatment of symptomatic multiple myeloma, acute lymphoblastic leukemia, Hodgkin’s disease and nonHodgkin’s lymphoma in combination with other medicinal products, palliative treatment of neoplastic diseases, prophylaxis and treatment of nausea and vomiting caused by chemotherapy and prevention and treatment of vomiting after operation, within antiemetic treatment.

WHAT YOU NEED TO KNOW BEFORE YOU TAKE DEXAMETHASONE TABLETS

Do not take Dexamethasone:
• if you are allergic to dexamethasone or any of the other ingredients of this medicine
• if you have an infection that affects the whole body (unless you are receiving treatment).
• if you have a stomach or duodenal ulcer.
• if you are going to have a vaccination by live vaccines.

Warnings and precautions
Talk to your doctor or pharmacist before taking Dexamethasone:
• if you have ever had severe depression or manic depression (bipolar disorder). This includes having had depression before or while taking steroid medicines like dexamethasone.
• if any of your close family has had these illnesses. Mental health problems can happen while taking steroids like Dexamethasone.
• These illnesses can be serious.
• Usually they start within a few days or weeks of starting the medicine.
• They are more likely to happen at high doses.
• Most of these problems go away if the dose is lowered or the medicine is stopped. However, if problems do happen, they might need treatment. Talk to a doctor if you (or someone taking this medicine), show any signs of mental health problems. This is particularly important if you are depressed, or might be thinking about suicide. In a few cases, mental health problems have happened when doses are being lowered or stopped.
Talk to your doctor before taking this medicine if:
• you have kidney or liver problems (liver cirrhosis or chronic liver failure),
• you have a tumour of the adrenal gland (pheochromocytoma),
• you have high blood pressure, heart disease or you have recently had a heart attack (myocardial rupture has been reported),
• you have diabetes or there is a family history of diabetes,
• you have osteoporosis (thinning of the bones), particularly if you are a female who has been through the menopause,
• you have suffered from muscle weakness with this or other steroids in the past,
• you have glaucoma (raised eye pressure) or there is a family history of glaucoma, cataract (clouding of the lens in the eye leading to a decrease in vision),

  • you have myasthenia gravis (a condition causing weak muscles),
    • you have a bowel disorder or a stomach (peptic) ulcer,
    • you have psychiatric problems or you have had a psychiatric illness which was made worse by this type of medicine,
    • you have epilepsy (condition where you have repeated fits or convulsions),
    • you have migraine,
    • you have an underactive thyroid gland,
    • you have a parasitic infection,
    • you have tuberculosis, septicaemia or a fungal infection in the eye,
    • you have cerebral malaria,
    • you have herpes (cold sores or genital herpes and ocular herpes simplex because of possible corneal perforation),
    • you have asthma,
    • you are treated for a blockage of blood vessels by blood clots (thromboembolism),
    • you have corneal ulcerations and corneal injuries.
    Treatment with corticosteroid may reduce your body’s ability to fight infection. This can sometimes lead to infections caused by germs that rarely cause infection under normal circumstances (called opportunistic infections). If you get an infection of any kind during treatment with this medicine, contact your doctor immediately. This is particularly important if you notice signs of pneumonia: cough, fever, shortness of breath and chest pain. You may also feel confused, particularly if you are elderly. You should also tell your doctor if you have had tuberculosis or if you have stayed in regions where roundworm infections are common. It is important that whilst you are taking this medicine you avoid contact with anybody who has chickenpox, shingles or measles. If you think you may have had exposure to any of these diseases, you should consult your doctor immediately. You should also inform your doctor if you have ever had infectious diseases such as measles or chickenpox and of any vaccinations.
    Treatment with this medicine may cause central serous chorioretinopathy, an eye disease that leads to blurred or distorted vision. This happens usually in one of the eyes. If you notice blurring or distorted vision that lasts for several days, please contact your doctor. Treatment with this medicine may cause tendon inflammation. In extremely rare cases, a tendon may rupture. This risk is increased by treatment with certain antibiotics and by kidney problems. Contact your doctor if you notice painful, stiff or swollen joints or tendons.
    Treatment with Dexamethasone can cause a condition called adrenocortical insufficiency. This can cause change in effectiveness of the medicine following stress and trauma, surgery, childbirth or illness and your body may not be able to respond in the usual way to severe stress such as accidents, surgery, childbirth or illness. If you have an accident, are ill, have other specific physical stress conditions, or require any surgery (even at the dentists) or you require a vaccination (particularly with ‘live virus’ vaccines) whilst taking or when you have finished taking Dexamethasone, you should inform the person treating you that you are taking or have taken steroids.
    If you have suppression tests (test for the amount of hormone in the body), skin test for allergy or test for bacterial infection you should inform the person performing the test that you are taking dexamethasone as it may interfere with the results. You may also find that your doctor will reduce the amount of salt in your diet and give you a potassium supplement whilst you are taking this medicine.
    If you are elderly, some of the side effects of this medicine may be more serious, especially thinning of the bones (osteoporosis), high blood pressure, low potassium levels, diabetes, susceptibility to infection and thinning of the skin. Your doctor will monitor you more closely.

Children
If a child is taking this medicine, it is important that the doctor monitors their growth and development at frequent intervals. Dexamethasone should not be used routinely in preterm neonates with respiratory problems.

Other medicines and Dexamethasone
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines:
• Anticoagulant medicines which thin the blood (e.g. warfarin)
• Acetylsalicylic acid or similar (Non-Steroidal AntiInflammatory drugs) e.g. indomethacin
• Medicines used to treat diabetes
• Medicines used to treat high blood pressure
• Medicines used to treat cardiac diseases
• Diuretics (water tablets)
• Amphotericin B injection
• Phenytoin, carbamazepine, primidone (epilepsy medication)
• Rifabutin, rifampicin, isoniazid (antibiotics used to treat tuberculosis)
• Antacids – particularly those containing magnesium trisilicate
• Barbiturates (medication used to aid sleep and relieve anxiety)
• Aminoglutethimide (anti-cancer treatment)
• Carbenoxolone (used in the treatment of stomach ulcers)
• Ephedrine (nasal decongestant)
• Acetazolamide (used for glaucoma and epilepsy)
• Hydrocortisone, cortisone and other corticosteroids
• Ketoconazole, itraconazole (for fungal infections)
• Ritonavir (for HIV)
• Antibiotics including erythromycin, fluoroquinolones
• Medicines that help muscle movement in myasthenia gravis (e.g. neostigmine)

  • Colestyramine (for high cholesterol levels)
    • Estrogen hormones including the contraceptive pill
    • Tetracosactide used in the test for adrenocortical function
    • Sultopride used to calm emotions
    • Ciclosporin used to prevent rejection after transplants
    • Thalidomide used for e.g. multiple myeloma
    • Praziquantel given for certain worm infections • Vaccination with live vaccines
    • Chloroquine, hydroxychloroquine and mefloquine (for malaria)
    • Somatotropin
    • Protirelin

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. You may be at an increased risk of serious side effects if you take dexamethasone together with these medicines:
• Some medicines may increase the effects of Dexamethasone and your doctor may wish to monitor you carefully if you are taking these medicines (including some medicines for HIV: ritonavir, cobicistat).
• Acetylsalicylic acid or similar (Non-Steroidal AntiInflammatory drugs) e.g. indometacin
• Medicines used to treat diabetes
• Medicines used to treat cardiac diseases
• Diuretics (water tablets)
• Amphotericin B injection
• Acetazolamide (used for glaucoma and epilepsy)
• Tetracosactide used in the test for adrenocortical function
• Carbenoxolone (used in the treatment of stomach ulcers)
• Chloroquine, hydroxychloroquine and mefloquine (for malaria)
• Medicines used to treat high blood pressure
• Thalidomide used for e.g. multiple myeloma

 

  • Vaccination with live vaccines
    • Medicines that help muscle movement in myasthenia gravis (e.g. neostigmine)
    • Antibiotics including fluoroquinolones
    You must read the package leaflets of all medicinal products to be taken in combination with Dexamethasone for information related to these medicines before starting treatment with Dexamethasone. When thalidomide, lenalidomide or pomalidomide is used, particular attention to pregnancy testing and prevention requirements is needed.
    Dexamethasone with food, drink and alcohol
    Dexamethasone should be taken with or after food to minimise irritation to the gastrointestinal tract. Drinks containing alcohol or caffeine should be avoided. Eating small, frequent meals is recommended, and possibly taking of antacids, if recommended by your doctor.

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Dexamethasone should be prescribed during pregnancy and particularly in the first trimester only if the benefit outweighs the risks for the mother and child. If you become pregnant during the use of the product, do not stop using Dexamethasone, but tell your doctor immediately that you are pregnant. Corticosteroids may pass into breast milk. A risk to the newborns/infants cannot be excluded. A decision on whether to continue/discontinue breast feeding or to continue/ discontinue therapy with dexamethasone should be made taking into account the benefit of breast feeding to the child and the benefit of dexamethasone therapy to the woman.

Driving and using machines
Do not drive, use any tools or machines or carry out any hazardous tasks if you experience side effects, such as confusion, hallucinations, dizziness, tiredness, sleepiness, fainting or blurred vision.

Dexamethasone contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

HOW TO TAKE DEXAMETHASONE TABLETS

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Dexamethasone is in the form of tablets 4 mg, 8 mg, 20 mg and 40 mg. The tablet can be divided into equal halves to provide additional 2 mg and 10 mg strengths or to help swallowing. Dexamethasone is given in usual doses of 0.5 to 10 mg daily, depending on the disease being treated. In more severe disease conditions doses above 10 mg per day may be required. The dose should be titrated to the individual patient response and disease severity. In order to minimize side effects, the lowest effective possible dose should be used.

Unless otherwise prescribed, the following dosage recommendations apply:
The below mentioned dosing recommendations are given for guidance only. The initial and daily doses should always be determined based on individual patient response and disease severity
Cerebral oedema:
Initial dose and duration of treatment depending on the cause and severity, 6-16 mg (up to 24 mg)/day orally, divided into 3-4 individual doses.

Acute asthma: Adults: 16 mg/day for two days. Children: 0.6 mg/kg body weight for one or two days.
Croup: Children: 0.15mg/kg-0.6 mg/kg in a single dose.
• Acute skin diseases: Depending on the nature and extent of the disease daily doses of 8-40 mg, in some cases up to 100 mg, which should be followed by down titration according to clinical need.

  • Active phase of rheumatic system disorders: Systemic lupus erythematosus 6-16 mg/day.
    • Active rheumatoid arthritis with severe progressive course form: running at fast destructive forms 12-16 mg/ day, with extra-articular manifestations 6-12 mg/day.
    Idiopathic thrombocytopenic purpura: 40 mg for 4 days in cycles.
    Tuberculous meningitis: Patients with grade II or III disease received intravenous treatment for four weeks (0.4 mg per kilogram per day for week 1, 0.3 mg per kilogram per day for week 2, 0.2 mg per kilogram per day for week 3, and 0.1 mg per kilogram per day for week 4) and then oral treatment for four weeks, starting at a total of 4 mg per day and decreasing by 1 mg each week. Patients with grade I disease received two weeks of intravenous therapy (0.3 mg per kilogram per day for week 1 and 0.2 mg per kilogram per day for week 2) and then four weeks of oral therapy (0.1 mg per kilogram per day for week 3, then a total of 3 mg per day, decreasing by 1 mg each week).
    Palliative treatment of neoplastic diseases: Initial dose and duration of treatment depending on the cause and severity, 3-20 mg/day. Very high doses up to 96 mg may also be used for palliative treatment. For optimal dosing and reduction of the number or tablets the combination of lower dose strengths (4 and 8 mg) and higher dose strengths (20 mg or 40 mg) can be used.
    • Prophylaxis and treatment of emesis induced by cytostatics, emetogenic chemotherapy within antiemetic treatment: 8-20 mg dexamethasone prior to chemotherapy treatment, then 4-16 mg/day on day 2 and 3.
    • Prevention and treatment of postoperative vomiting, within antiemetic treatment: single dose of 8 mg before the surgery.
    • Treatment of symptomatic multiple myeloma, acute lymphoblastic leukemia, Hodgkin’s disease and non-Hodgkin’s lymphoma in combination with other medicinal products: the usual posology is 40 mg or 20 mg once per day. The dose and administration frequency varies with the therapeutic protocol and the associated treatment(s). Dexamethasone administration should follow instructions for dexamethasone administration when described in the Summary of Product Characteristics of the associated treatment(s). If this is not the case, local or international treatment protocols and guidelines should be followed. Prescribing physicians should carefully evaluate which dose of dexamethasone to use, taking into account the condition and disease status of the patient.

Long term treatment
For the long-term treatment of several conditions, after initial therapy, glucocorticoid treatment should be switched from dexamethasone to prednisone/prednisolone to reduce suppression on the function of the adrenal cortex.

Use in children
If a child is taking this medicine, it is important that the doctor monitors their growth and development at frequent intervals.

If you take more Dexamethasone than you should
If you take too much medicine contact a doctor or hospital immediately.


If you forget to take Dexamethasone

If you forget to take a dose, take it as soon as you remember unless it is almost time for the next dose. Do not take a double dose to make up for a forgotten tablet.


If you stop taking Dexamethasone

If your treatment is to be stopped follow your doctor’s advice. He may tell you to reduce the amount of medicine you are taking gradually until you stop taking it altogether. The symptoms that have been reported when treatment has been stopped too quickly have included low blood pressure and in some cases, relapse of the disease for which the treatment was given. A ‘withdrawal syndrome’ may also occur which includes fever, muscle and joint pain, inflammation of the nose lining (rhinitis), weight loss, itchy skin and inflammation of the eye (conjunctivitis). If you stop treatment too soon and some of the mentioned symptoms occur, you must talk to your doctor as soon as possible. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell a doctor straight away if you experience serious mental health problems. They can affect about 5 in every 100 people taking medicines like dexamethasone. These problems include:
• feeling depressed, including thinking about suicide,
• feeling high (mania) or moods that go up and down,
• feeling anxious, having problems sleeping, difficulty in thinking or being confused and losing your memory,
• feeling, seeing or hearing things that do not exist. Having strange and frightening thoughts, changing how you act or having feelings of being alone. Tell a doctor straight away if you experience:
• severe abdominal pains, nausea, vomiting, diarrhoea, profound muscle weakness and fatigue, extremely low blood pressure, weight loss and fever as these may be signs of adrenocortical insufficiency;
• sudden abdominal pain, tenderness, nausea, vomiting, fever and blood in stool as these may be signs of tearing of the bowel particularly if you have or have had a bowel disease.
This medicine may worsen your existing heart problem. If you experience shortness of breath or ankle swelling, consult your doctor straight away.

Other side effects may be: (frequency not known):
• Greater chance of picking up infections, including viral and fungal infections e.g. thrush; recurrence of tuberculosis or some other infections, e.g. eye infections if you have already had it
• Reduction in the number of white blood cells or increased number of white blood cells, abnormal coagulation
• An allergic reaction to the medicine, including serious, potentially life-threatening allergic reaction (which may show as a rash and swelling of the throat or tongue and in severe cases difficulty in breathing or dizziness)
• Impairment of the body’s regulation of hormones, swelling and weight gain of the body, full-moon face (Cushingoid state), change in effectiveness of endocrines following stress and trauma, surgery, childbirth or illness, your body may not be able to respond in the usual way to severe stress such as accidents, surgery, childbirth or illness, stunted growth in children and teenagers, irregular and absence of menstrual cycles (periods) development of excess body hair (particularly in women)
• Weight gain, loss of protein and calcium balance, increased appetite, salt imbalances, water retention in the body, potassium loss which can cause rhythm disorder, increased requirement for diabetic medication, unknown diabetes becomes evident, high levels of cholesterol and triglycerides in the blood (hypercholesterolemia and hypertriglyceridaemia)
• Extreme mood swings, schizophrenia (mental disorder) may become worse, depression, inability to sleep
• Severe unusual headache with visual disturbances linked with the withdrawal of treatment, fits and worsening of epilepsy, dizziness
• Increased pressure in the eye, papilloedema, thinning of the eye membranes, increased eye viral, fungal and bacterial infections, worsening of symptoms associated with corneal ulcers, worsening of existing eye infections, protrusion of the eyeballs, cataracts
• Congestive heart failure in susceptible people, cardiac muscle rupture after a recent heart attack, cardiac decompensation
• High blood pressure, blood clots: formation of blood clots that may clog blood vessels for example in legs or lungs (thromboembolic complications)
• Hiccups
• Nausea, vomiting, stomach discomfort and swollen abdomen, inflammation and ulcers in the oesophagus, peptic ulcers that may split and bleed, inflamed pancreas (which may show as pain in the back and abdomen), flatulence, oesophageal candidiasis
• Thinned delicate skin, unusual marks on the skin, bruising, redness and inflammation of the skin, stretch marks, visible swollen, capillaries, acne, increased sweating, skin rash, swelling, thinning of the hair, unusual fat deposits, excessive hair growth, water retaining in the body, pigment disorders, weakened capillaries that rupture easily, observed as bleeding under the skin (increased capillary fragility), skin irritation around the mouth (perioral dermatitis) • Thinning of the bone with an increased risk of fractures (osteoporosis), bone necrosis, tendinitis, ruptured tendons, muscle wasting, myopathy, muscle weakness, early stoppage of bone growth (premature epiphyseal closure)
• Changes to the number and movement of sperm, impotence
• Impaired reaction to vaccination and skin tests, slow wound healing, discomfort, malaise.
• A ‘withdrawal syndrome’ may also occur which includes fever, muscle and joint pain, inflammation of the nose lining (rhinitis), weight loss, painful itchy skin nodules and inflammation of the eye (conjunctivitis).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine.

HOW TO STORE DEXAMETHASONE TABLETS

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special temperature storage conditions. Store in the original package in order to protect from light and moisture.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

Further Information

What Dexamethasone contains
• The active substance is dexamethasone. Dexamethasone 4 mg and 8mg tablets Each tablet contains 4 mg and 8mg dexamethasone.
• The other ingredients are lactose monohydrate, pregelatinised maize starch, colloidal anhydrous silica, and magnesium stearate (E572). “Dexamethasone contains lactose”.

What Dexamethasone looks like and contents of the pack
White or almost white, round tablets with bevelled edges and scored on one side (Thickness: 2.5 – 3.5 mm; Diameter: 5.7 – 6.3 mm). The tablet can be divided into equal doses. Dexamethasone tablets are available in boxes containing 10, 20, 28, 30, 50, 56, 60, 100, 10 x 1, 20 x 1, 28 x 1, 30 x 1, 50 x 1, 56 x 1, 60 x 1 and 100 x 1 tablets in blisters. Not all pack sizes may be marketed

Manufactured by:
Taj Pharmaceuticals Limited
220, Mahagujarat Ind. Estate, Moraiya, Tal. Sanand, Dist. Ahmedabad, Gujarat, INDIA

Marketing Authorization Holder:
Regal sun co., Ltd.Myanmar

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