Patient Information Leaflet

Decadron 0.5 mg tablets, 0.75 mg tablets

dexamethasone
Please read all of this leaflet carefully before you take this medicine, because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Decadron is and what it is used for
What you need to know before taking Decadron
How to take Decadron
Possible side effects
How to store Decadron
Contents of the pack and other information

1. What Decadron is and what it is used for

The active substance in Decadron is dexamethasone, a potent anti-inflammatory medicine.
Decadron is used in the treatment of the following conditions:
➢ Allergies and disabling conditions following allergies that do not respond to conventional anti-allergy medicines. These allergic conditions may include:

seasonal (pollen allergies) or perennial allergic rhinitis;
bronchial asthma, including status asthmaticus (spasm of the airways);
contact dermatitis (caused by allergenic or irritating substances coming into contact with the skin);
atopic dermatitis (localized, itchy skin irritation);
serum sickness (allergic reaction triggered by intravenous administration of blood derivatives);
angioneurotic edema (swelling due to fluid accumulation);
urticaria (skin irritation).

➢ Temporary supplement to other medicines during acute rheumatic pain or flare-ups of rheumatic conditions such as:

psoriatic arthritis (skin scaling followed by joint pain);
rheumatoid arthritis (joint pain and stiffness), including juvenile rheumatoid arthritis (in selected cases, low-dose maintenance therapy may be required);
ankylosing spondylitis (chronic inflammatory disease primarily affecting the spine and pelvic joints);
acute and subacute bursitis (painful inflammation of the elbow or knee);
acute nonspecific tenosynovitis (painful tendon inflammation);
acute gouty arthritis (joint pain associated with elevated uric acid levels).

➢ Skin diseases such as:

pemphigus (blisters of the skin and mucous membranes);
dermatitis herpetiformis (widespread red blisters and vesicles);
Stevens-Johnson syndrome (severe, potentially fatal allergic reaction);
exfoliative dermatitis (widespread skin peeling reaction);
mycosis fungoides (fungal infection of the skin);
severe psoriasis (severe redness and scaly patches on the skin).

➢ Allergies and inflammations of the eyes and surrounding areas, either short- or long-term, such as:

allergic conjunctivitis (eye infection and redness);
keratitis (infection of the transparent part of the eye);
allergic marginal corneal ulcer (wound on the transparent part of the eye);
ophthalmic herpes zoster (viral eye infection);
iritis and iridocyclitis (inflammation of the iris and ciliary body);
chorioretinitis (retinal inflammation causing blurred vision);
anterior segment inflammation (inflammation of the front part of the eye);
diffuse posterior uveitis and choroiditis (inflammation of the deep eye structures associated with pain);
ophthalmic neuritis (inflammation of the optic nerve);
retrobulbar neuritis (inflammation of the optic nerve);
sympathetic ophthalmia (traumatic inflammation potentially leading to vision loss).

➢ Endocrine (hormonal) diseases:

primary or secondary adrenal insufficiency (insufficiency of the gland producing hormones derived from the adrenal glands). In these cases, hydrocortisone or cortisone are the drugs of first choice; other chemically derived medicines may be used in combination with mineralocorticoids (a type of hormone normally present in the body). In children, mineralocorticoid hormone supplementation is particularly important.
congenital adrenal hyperplasia (hereditary disease characterized by abnormally large adrenal glands);
non-suppurative thyroiditis (thyroid inflammation not caused by bacteria).

➢ Respiratory diseases such as:

sarcoidosis (disease characterized by the growth of small inflammatory nodules in the lungs or other organs);
Loeffler's syndrome not treatable by other means (a disease causing heart damage);
berylliosis (disease caused by exposure to beryllium);
fulminant or disseminated pulmonary tuberculosis (severe bacterial lung infection), in combination with other anti-tuberculosis medicines;
pulmonary emphysema (rupture of microscopic lung structures), in cases where bronchial narrowing (bronchospasm) or pulmonary fluid swelling (bronchial edema) play a significant role;
diffuse interstitial pulmonary fibrosis or Hamman-Rich syndrome (fibrous tissue growth in the lungs).

➢ Blood disorders such as:

idiopathic and secondary thrombocytopenia in adults (reduction in certain blood-clotting components without an obvious cause);
acquired autoimmune hemolytic anemia (immune system disorder causing destruction of red blood cells);
erythroblastopenia (deficiency of red blood cells);
congenital erythroid hypoplastic anemia (hereditary disease characterized by insufficient red blood cell production by the bone marrow).

➢ Tumors:

symptomatic treatment (without removing the underlying cause) of leukemias and lymphomas (blood and lymphatic system tumors) in adults;
acute leukemia (active blood tumors) in children.

➢ Edematous states (fluid swelling):

to increase urine elimination or to treat protein loss through urine in patients with kidney diseases of uncertain cause or due to systemic lupus erythematosus (an immune system disease causing self-destruction of body tissues). Decadron is used in combination with medicines that increase urine output (diuretics).
liver cirrhosis (severe liver disease) with fluid accumulation in the abdomen;
refractory congestive heart failure (heart insufficiency);
cerebral edema (fluid accumulation in the skull) of various origins. In patients with cerebral edema due to brain tumors, oral administration of Decadron may be beneficial.

This medicine may also be used:

for preoperative preparation in patients with increased intracranial pressure caused by tumors;
to relieve symptoms in patients with inoperable or recurrent (relapsed) brain tumors;
in the treatment of cerebral edema (fluid accumulation in the skull) following neurosurgical procedures. Some patients with excess fluid volume in the skull due to head injuries or pseudotumors (excess fluid in the skull due to high pressure or excessive body weight) may benefit from oral therapy with this medicine. The use of this medicine in cerebral edema does not exclude the need for careful neurosurgical evaluation and radical treatments such as neurosurgical interventions or other specific therapies.

➢ Gastrointestinal disorders: this medicine may be used as an adjunct in:

ulcerative colitis (inflammation of the colon with mucosal ulceration);
regional enteritis (intestinal inflammation);
refractory sprue (intestinal disease unresponsive to dietary treatment).

➢ Miscellaneous conditions such as:

tuberculous meningitis (brain inflammation due to tuberculosis) with subarachnoid block or obstruction (this medicine may be used with various anesthesia methods) in combination with appropriate antituberculosis therapy;
inflammatory reactions following dental surgery;
flare-ups or maintenance therapy in selected cases of systemic lupus erythematosus (an immune system disease characterized by self-destruction of body tissues);
inflammation of the heart muscle and valves due to infection (acute rheumatic endocarditis).

➢ For the diagnosis of various possible causes of adrenal gland diseases.

2. What you should know before taking Decadron

Do not take Decadron

if you are allergic to dexamethasone or any of the other ingredients of this medicine (listed in section 6),
if you have systemic fungal infections;
if you have tuberculosis;
if you have a gastric ulcer;
if you suffer from psychiatric disorders (psychosis);
if you have herpes simplex ophthalmic infection;
if you are receiving live viral vaccines;
if you are breastfeeding.

Warnings and precautions
Talk to your doctor or pharmacist before taking Decadron.
Take the lowest effective dose necessary to control your condition, and reduce the dose gradually as soon as possible.
Be especially careful with Decadron if:

If you are taking moderate or high doses of hydrocortisone or cortisone (hormonal medicines similar to Decadron), because these may cause increased blood pressure, fluid and salt retention, or excessive potassium loss. These effects are less likely with synthetic derivatives (such as this medicine), provided they are administered at low doses. You may need to reduce salt intake and increase potassium in your diet.

If you suffer from bone fragility due to calcium deficiency, because Decadron increases calcium excretion from the body.

If you are exposed to significant stress, because in such cases an increase in fast-acting corticosteroids (such as hydrocortisone or cortisone) is recommended before, during, and after the stressful event. Gradually reduce the dose of this medicine to minimize the risk of adverse effects such as secondary adrenal insufficiency (adrenal gland failure to produce hormones). This relative insufficiency may, however, persist for several months after stopping treatment.

If you have adrenal insufficiency (hormone deficiency) during stressful situations occurring while on treatment, resume hormonal therapy. If you are already undergoing steroid (hormonal) treatment, a dose increase may be necessary. Since mineralocorticoid secretion (your body's normal hormonal secretion) might be inadequate, concomitant administration of salts and/or a mineralocorticoid may be appropriate.

If you have low prothrombin levels (a blood clotting factor); use caution when taking aspirin (acetylsalicylic acid) during Decadron therapy.

If you have reduced thyroid function or suffer from hepatic cirrhosis (a severe inflammatory liver disease), because your body's response to this medicine may be enhanced.

If you have active tuberculosis; this medicine should only be prescribed in cases of fulminant or disseminated tuberculosis and must always be taken in combination with appropriate antituberculosis medicines. If you have latent tuberculosis (not active) or a positive tuberculin test (tuberculosis test), you must undergo strict monitoring, as reactivation of the disease may occur.

If you suffer from herpes simplex ophthalmic infection (viral infection of the eye area), due to the possible risk of corneal ulceration and perforation.

Symptoms of tumor lysis syndrome such as muscle cramps, muscle weakness, confusion, vision loss or disturbances, and shortness of breath, if you suffer from hematological neoplasms.

If you suffer from psychiatric disorders; indeed, psychiatric disturbances may occur during treatment with this medicine, ranging from euphoria, insomnia, mood swings, personality changes, severe depression, to frank psychotic manifestations. When present, emotional instability and psychotic tendencies may be worsened by this medicine.

If you need to take this medicine for prolonged periods, because it may cause cataracts (clouding of vision), glaucoma (increased pressure inside the eye) with possible optic nerve damage, and may promote eye infections caused by fungi or viruses. Contact your doctor if you experience blurred vision or other visual disturbances.

Also be cautious if you suffer from:

non-specific ulcerative colitis (intestinal inflammation) with risk of perforation,
abscesses (swellings with fluid) or other pyogenic infections (with pus),
diverticulitis (intestinal inflammation),
recent intestinal anastomoses (intestinal surgery involving removal of part of the intestine),
active or latent gastric ulcer (lesion or wound in the stomach),
renal insufficiency (reduced kidney function),
hypertension (high blood pressure),
osteoporosis (poor bone calcification),
myasthenia gravis (a serious disease characterized by muscle weakness), or a tumor of the adrenal gland (pheochromocytoma).

During treatment with Decadron, you must not be vaccinated against smallpox. Furthermore, you should not undergo any other immunization procedures, especially if you are receiving high doses of Decadron, due to the risk of nervous system complications and vaccine or immunization procedure inefficacy.
This medicine may mask symptoms of infection, and during its use, other infections (such as latent amebiasis) may emerge. During Decadron therapy, a reduced resistance to infections and a tendency for infectious processes not to localize may be observed.
Literature reports suggest an association between corticosteroid use and rupture of the left ventricular wall following a recent myocardial infarction; therefore, corticosteroids should be used with extreme caution in these patients.
For athletes: using this medicine without therapeutic need constitutes doping and may lead to a positive anti-doping test.
Children and adolescents
Decadron must not be used in premature infants with respiratory problems.
Children and adolescents undergoing prolonged Decadron therapy should be carefully monitored for growth and development.
Other medicines and Decadron
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor if you are taking:
Phenytoin, phenobarbital (used for epilepsy), ephedrine (used in asthma and to relieve nasal congestion), or rifampicin (an antibiotic), and other medicines belonging to the inducers of cytochrome P450 3A4 enzymes, because these medicines may increase the elimination of Decadron, reducing its blood levels and effectiveness. A dose adjustment of Decadron may be necessary.
Interactions with the above-mentioned medicines may interfere with dexamethasone suppression tests (tests to assess adrenal gland function), which should be interpreted cautiously during administration of these medicines.
Anticoagulant medicines (used to thin the blood). If you frequently receive Decadron together with anticoagulants, your doctor should regularly monitor your blood clotting speed, as similar medicines have in some cases altered the response to these anticoagulants.
Potassium-depleting diuretics (used to increase urine and potassium excretion); in this case, you should be closely monitored for the development of hypokalemia (low potassium levels in the blood).
Some medicines may increase the effects of Decadron, and your doctor may wish to monitor you closely if you are taking these medicines (including some HIV treatments: ritonavir, cobicistat).
Erythromycin and certain anti-HIV drugs (indinavir, ritonavir, lopinavir, saquinavir): may reduce the effect of Decadron.
Phenytoin (used for epilepsy): both increases and decreases in blood levels of this medicine may occur when administered with Decadron, leading to changes in seizure control.
The effects of certain medicines that lower blood glucose, including insulin, may be counteracted.
Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you are pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
If you are pregnant, planning a pregnancy, or breastfeeding, take this medicine only if clearly indicated by your doctor.
Infants born to mothers who received substantial doses of Decadron during pregnancy should be carefully monitored for signs of adrenal insufficiency.
Breastfeeding
Do not use Decadron if you are breastfeeding, as it passes into breast milk.
In some patients, steroids may increase or decrease sperm motility and count.
Driving and using machines
This medicine does not affect the ability to drive or operate machinery.
Decadron contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.

3. How to take Decadron

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Treatment should follow these general principles:

The dose must be adjusted to the individual case, depending on the severity of the disease and the individual response. For children, the recommended doses should generally be reduced; however, the choice of the appropriate dose should be guided more by the severity of the condition than by age or body weight.
Hormone therapy is an adjunct and not a substitute for conventional therapy, which must be implemented when indicated.
When Decadron is administered for longer than a few days, the dose should be reduced or treatment discontinued gradually.
After stopping treatment with this medicine, you should remain under medical supervision, as a sudden recurrence of severe symptoms of the disease for which you were treated may occur.

In acute conditions requiring immediate effect, high doses may be administered, which for a short period may be essential.
In chronic conditions requiring long-term therapy, it is advisable to use the lowest effective dose sufficient to provide adequate, but not necessarily complete, relief.
If your doctor considers it essential to administer this medicine at high doses for prolonged periods, you must be closely monitored for any symptoms that may require dose reduction or discontinuation of hormone therapy.
Chronic (long-lasting) diseases may undergo periods of temporary spontaneous remission. During such periods, administration of Decadron should be gradually discontinued. During prolonged therapy, you should undergo regular routine laboratory tests such as urine analysis, blood sugar levels (glycemia) measured two hours after a meal, blood pressure and body weight monitoring, and chest X-ray examination. If you are receiving high doses of Decadron, your doctor may recommend periodic monitoring of blood potassium levels.
If you have a past or current history of peptic ulcer (wounds or tears in the stomach lining) or gastrointestinal disorders and are receiving this medicine for long periods, you should undergo radiological examinations of the upper gastrointestinal tract.
With appropriate dose adjustment, it is possible to switch from any other glucocorticoid (a hormone medicine similar to this one) to Decadron.

Recommended doses are:
Chronic diseases normally not life-threatening, such as:

endocrine (hormonal) disorders and chronic rheumatic conditions
edematous states (fluid retention and swelling)
respiratory and gastrointestinal diseases
skin and blood disorders

You will be advised to start with low doses (0.5 to 1 mg daily), gradually increasing the dose until reaching the lowest effective dose sufficient to achieve the desired degree of symptom relief. The dose may be divided into two, three, or four daily doses. Once adequate symptom control is achieved, the maintenance dose should consist of the lowest dose necessary to provide sufficient relief without excessive hormonal effects. Once the optimal maintenance dose is established, regardless of the initial daily dose, a regimen of two daily administrations is generally sufficient.

Congenital adrenal hyperplasia (a hereditary condition characterized by excessive adrenal gland size)
The recommended daily dose is 0.5–1.5 mg daily.

Non-life-threatening acute diseases, such as:

allergic conditions
eye diseases
acute and subacute rheumatic diseases

The recommended dose ranges from 2 to 3 mg daily. However, higher doses may be required in some patients. Generally, prolonged maintenance therapy is not needed, as these conditions have a well-defined course and resolve within a specific time period.

Combination therapy for:
Acute self-limiting allergies and exacerbations of chronic allergic diseases, such as:

acute allergic rhinitis (hay fever)
acute attacks of seasonal allergic bronchial asthma (airway obstruction of allergic origin)
drug-induced urticaria (hives)
angioneurotic edema (fluid swelling) and contact dermatitis (caused by allergens or irritants in contact with the skin)

The following parenteral (injection) and oral (by mouth) combination dosing schedule is recommended:
Day 1: A single intramuscular injection of 1 ml (4 mg) of Decadron 4 mg injectable solution (dexamethasone 21-phosphate disodium)
Day 2: 2 tablets of Decadron (0.5 mg) twice daily
Day 3: 2 tablets of Decadron (0.5 mg) twice daily
Day 4: 1 tablet of Decadron (0.5 mg) twice daily
Day 5: 1 tablet of Decadron (0.5 mg) twice daily
Day 6: 1 tablet of Decadron (0.5 mg) once daily
Day 7: 1 tablet of Decadron (0.5 mg) once daily
Day 8: Follow-up visit

Alternatively, the following alternative dosing schedule may be used:
Day 1: 1 or 2 ml (4 mg/ml) intramuscular injection of Decadron 4 mg injectable solution
Day 2: 2 tablets of Decadron (0.75 mg) twice daily
Day 3: 2 tablets of Decadron (0.75 mg) twice daily
Day 4: 1 tablet of Decadron (0.75 mg) twice daily
Day 5: 1 tablet of Decadron (0.75 mg) once daily
Day 6: 1 tablet of Decadron (0.75 mg) once daily
Day 7: No treatment
Day 8: Follow-up visit

The aim of this regimen is to provide adequate therapy during acute episodes while minimizing the risk of overdosage in chronic conditions. In some patients, additional treatment may be necessary, for example with topical steroids, antihistamines, bronchodilators, or other systemic steroids.

Potentially life-threatening chronic diseases, such as:

systemic lupus erythematosus (an autoimmune disease)
pemphigus (blisters of the skin and mucous membranes)
symptomatic sarcoidosis (a disease characterized by the growth of small inflammatory nodules in the lungs or other organs)

The recommended initial dose is 2–4.5 mg daily. Higher doses may be required in some patients. As soon as adequate relief is achieved, the dose should be gradually reduced to the lowest dose sufficient to maintain the desired therapeutic effect.

Life-threatening acute diseases, such as:

acute rheumatic endocarditis (inflammation of the heart valve lining)
acute attacks of systemic lupus erythematosus (a severe autoimmune disease)
severe allergic reactions
pemphigus (blisters of the skin and mucous membranes)
neoplasms (tumors)

The recommended initial dose ranges from 4 to 10 mg daily, divided into at least four doses. To achieve consistent control, the dose may need to be increased in some patients. As soon as control is achieved, your dose should be gradually reduced to the lowest dose sufficient to maintain the relief obtained. If an extremely rapid onset of action is required, the first two or three doses of Decadron injectable solution may be administered intravenously. In severe allergic reactions, adrenaline is the first-line treatment. Decadron tablets are useful as an adjunctive or supportive therapy.

Cerebral edema (fluid accumulation in the skull)
Decadron injectable solution is generally administered initially at a dose of 10 mg intravenously (direct injection into a vein), followed by 4 mg intramuscularly every 6 hours until symptoms of cerebral edema resolve. A response is usually observed within 12–24 hours, and treatment may be reduced after 2–4 days and gradually discontinued over 5–7 days.
In the treatment of symptoms of inoperable or recurrent brain tumors, the maintenance dose should be individually adjusted using Decadron injectable solution or Decadron tablets. A dose of 2 mg two or three times daily may be adequate. The lowest effective dose necessary to control cerebral edema should be used, and standard precautions associated with corticosteroid therapy should be followed. Your doctor should consider the possible need to prescribe medications to prevent stomach acidity (antacids), anticholinergics (medications for respiratory spasms), and dietary measures to prevent gastrointestinal ulcers or bleeding.

Adrenogenital syndrome (hormonal imbalance)
The recommended dose is 0.5–1.5 mg daily. This dose may be sufficient to control the disease and prevent recurrence of abnormal hormonal function.

High-dose therapy for certain conditions, such as:

acute leukemia (blood cancer)
nephrotic syndrome (kidney disease)
pemphigus (blisters of the skin and mucous membranes)

The recommended dose ranges from 10 to 15 mg daily. If you receive such high doses, you must be closely monitored to detect the early onset of serious adverse reactions.

Dexamethasone suppression test and diagnostic test for Cushing's syndrome
The recommended dose is 1 tablet of 0.5 mg of Decadron every 6 hours for 48 hours. 17-hydroxycorticosteroids should be measured in a 24-hour urine sample. For greater accuracy, your doctor may administer 1.0 mg of Decadron orally at 11 p.m. A blood sample will then be taken the following morning at 8 a.m. to measure plasma cortisol (a hormone).

Diagnostic test to differentiate adrenal tumors from adrenal hyperplasia
The recommended dose is 2 mg of Decadron orally every 6 hours for 48 hours. Your urine will be collected to determine 17-hydroxycorticosteroid excretion (a test of hormonal system and adrenal gland function).

Use in children and adolescents
For children, recommended doses should generally be reduced; however, the choice of appropriate dose should be guided more by the severity of the condition than by age or body weight.

If you take more Decadron than you should
In case of accidental overdose or ingestion of too much Decadron, contact your doctor immediately or go to the nearest hospital.

If you forget to take Decadron
Do not take a double dose to make up for the missed dose.

If you stop taking Decadron
Do not abruptly stop taking this medicine unless clearly instructed by your doctor.
When Decadron has been administered for longer than a few days, the dose should be reduced or treatment discontinued gradually.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects may occur with Decadron: sodium retention
water retention
loss of potassium from the body
decreased blood acidity due to low potassium levels (hypokalemic alkalosis)
protein loss (protein catabolism) with negative nitrogen balance (therefore, in prolonged treatments, dietary protein intake should be adequately increased)
increased appetite
loss of calcium
congestive heart failure (heart insufficiency) in predisposed individuals
high blood pressure
circulatory problems (thromboembolism)
loss of muscle tone (weakness)
muscle disease caused by hormonal therapy (steroid myopathy)
reduction in muscle mass
bone decalcification (osteoporosis)
vertebral compression fractures
loss of bone tissue in the femur (aseptic necrosis of the femoral and humeral head)
spontaneous fractures of long bones
tendon ruptures
stomach mucosa tears (peptic ulcer), possibly leading to perforation and bleeding (haemorrhage)
perforation of the small and large intestine
severe disease characterised by inflammation of the pancreas (pancreatitis)
abdominal swelling
inflammation of the oesophagus with mucosal tearing (ulcerative oesophagitis)
nausea
hiccups
indigestion
fungal infection (candida)
delayed wound healing
thin and fragile skin
minor bleeding and bruising (petechiae and ecchymoses)
irritation and redness of the face (facial erythema)
acne
increased sweating
suppression of responses to skin tests (distortion of skin test results)
other skin reactions such as irritation (allergic dermatitis, urticaria), angioneurotic oedema (fluid-induced swelling)
seizures
increased intracranial pressure with papilledema (cerebral oedema)
dizziness
headache
various psychological disturbances such as: euphoria, depression, mood changes, suicidal thoughts, psychotic symptoms (including mania, delusions, hallucinations and worsening of schizophrenia), irritability, anxiety, sleep disorders, confusion and memory disturbances. These reactions are common and may occur in both adults and children.
widespread swelling of the face and limbs (development of Cushingoid state)
secondary adrenal and pituitary insufficiency (hormonal production deficiency of the adrenal glands and pituitary gland), especially during periods of stress due to trauma, surgery or serious illness
manifestation of latent diabetes mellitus (sugar intolerance not evident in blood tests)
increased need for insulin or oral hypoglycaemic agents (medicines that reduce blood sugar levels) in diabetic patients
excess glucose in the blood
menstrual irregularities
cataract (progressive clouding of vision)
increased intraocular pressure
glaucoma (disease of the optic nerve)
exophthalmos (increased protrusion of the eyeball)
choroidoretinopathy, worsening of viral eye diseases, papilledema, thinning of the cornea or sclera
blurred vision (frequency not known)
hypersensitivity
malaise

Withdrawal syndrome: too rapid reduction of the Decadron dosage after prolonged treatment may lead to acute liver failure, hypotension and death.
Diagnostic tests: reduced carbohydrate tolerance, increased weight.
In some cases, withdrawal symptoms may mimic a clinical relapse of the disease for which the patient was being treated.

Additional side effects in children and adolescents

growth retardation in children.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Decadron

Keep this medicine out of the sight and reach of children.
Store below 25 °C.
Do not use this medicine after the expiry date stated on the carton after "Exp". The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Decadron contains
Decadron 0.5 mg tablets

The active substance is dexamethasone. Each tablet contains 0.5 mg of dexamethasone.
The other components are: maize starch, calcium hydrogen phosphate dihydrate, lactose monohydrate, magnesium stearate.

Decadron 0.75 mg tablets

The active substance is dexamethasone. Each tablet contains 0.75 mg of dexamethasone.
The other components are: maize starch, calcium hydrogen phosphate dihydrate, lactose monohydrate, magnesium stearate, E142 Brilliant Acid Green BS.

Description of the appearance of Decadron and contents of the pack
Decadron is available as tablets.
Decadron 0.5 mg tablets contain 10, 20 or 30 tablets of 0.5 mg.
Decadron 0.75 mg tablets contain 10, 20 or 30 tablets of 0.75 mg.

Marketing Authorization Holder
I.B.N. Savio srl – Via del Mare, 36 – 00071 Pomezia (RM)

Manufacturer:
SPECIAL PRODUCT’S LINE S.p.A. – Via Fratta Rotonda Vado Largo, 1 Anagni (FR)

The following information is intended exclusively for healthcare professionals:

Read carefully the information contained in sections 1-6.
By appropriately adjusting the dosage, it is possible to switch from the administration of any other
glucocorticoid to Decadron. The following equivalences (milligram for milligram) facilitate the transition from other glucocorticoids to Decadron:
Table 1: Equivalence

Dexamethasone	0.75 mg
Methylprednisolone and triamcinolone	4 mg
Prednisolone and prednisone	5 mg
Hydrocortisone	20 mg
Cortisone	25 mg

Milligram for milligram, dexamethasone is practically equivalent to betamethasone, four to six times more potent than methylprednisolone and triamcinolone, six to eight times more potent than prednisone and prednisolone, 25 to 30 times more potent than hydrocortisone, and approximately 35 times more potent than cortisone. At equivalent anti-inflammatory doses, dexamethasone is almost completely free from the sodium-retaining effects of hydrocortisone and is very similar, in this regard, to hydrocortisone-derived corticosteroids.

Patient Information Leaflet

Decadron 4 mg/1 ml vials, 8 mg/2 ml vials

dexamethasone 21-phosphate disodium
Please read this leaflet carefully before this medicine is administered to you, because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or nurse.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

What Decadron is and what it is used for
What you need to know before being given Decadron
How Decadron is administered
Possible side effects
How to store Decadron
Contents of the pack and other information

1. What Decadron is and what it is used for

The active substance in Decadron ampoules is dexamethasone 21-phosphate disodium, a
medicinal product with anti-inflammatory properties.
Decadron ampoules are administered intravenously (direct injection into a vein) or intramuscularly
(deep injection into muscle) when oral administration is not feasible, in the following conditions:

Adrenal insufficiency
Decadron injectable solution has predominantly anti-inflammatory (glucocorticoid) activity and minimal mineralocorticoid (hormonal metabolism) activity. Therefore, its use should be supplemented with mineral salts or desoxycorticosterone (a hormonal medicinal product), or both. When supplemented in this way, this medicinal product is indicated for all types of adrenal gland insufficiency, such as Addison's disease or following surgical removal of the adrenal glands, which requires supportive therapy with medicinal products.

Partial adrenocortical insufficiency
Partial adrenocortical insufficiency may occur following discontinuation of prolonged treatment with suppressive doses of hormones. When an immediate effect is required, Decadron injectable solution may be life-saving, as its efficacy may become evident within a few minutes after administration.

Pre-operative and post-operative supportive treatment in patients undergoing surgical removal of both adrenal glands or of the pituitary gland (which regulates body development):

Surgical situations where inadequate adrenal hormonal reserve is suspected;
Cases of post-operative shock unresponsive to conventional therapy.

Thyroid infection (non-suppurative thyroiditis), when treatment with orally administered medicinal products is not possible.

Shock

Adjunctive treatment of shock when high doses of corticosteroids are required, such as in severe haemorrhagic, traumatic, or surgical shock. Treatment with Decadron injectable solution is complementary and does not replace specific or supportive measures that may be necessary, for example, restoration of circulating blood volume, correction of water and electrolyte balance, oxygen administration, surgical interventions, or antibiotic therapy.

➢ Rheumatic diseases such as:

Bone and joint pain following trauma (post-traumatic osteoarthritis);
Inflammation of joint spaces (osteoarthritic synovitis);
Psoriatic arthritis (skin desquamation followed by joint pain);
Rheumatoid arthritis (joint pain and stiffness), including juvenile rheumatoid arthritis (in selected cases, low-dose maintenance therapy may be required);
Ankylosing spondylitis (chronic inflammatory disease primarily affecting the spine and pelvic joints);
Epicondylitis;
Acute and subacute bursitis (painful inflammation of the elbow or knee);
Nonspecific acute tenosynovitis (painful tendon inflammation);
Acute gouty arthritis (joint pain associated with elevated uric acid levels);
Joint pain and stiffness in young patients (juvenile rheumatoid arthritis).

➢ Collagen diseases (basic substance of human tissues such as skin, bones, and tendons)

During exacerbations or for maintenance therapy in selected cases of systemic lupus erythematosus (a severe autoimmune disease) and acute rheumatic carditis (inflammation of the heart).

➢ Skin diseases such as:

Pemphigus (blisters of the skin and mucous membranes);
Stevens-Johnson syndrome (severe, potentially fatal allergic reaction);
Exfoliative dermatitis (desquamative skin reaction);
Herpetiform bullous dermatitis (skin reaction with blisters and vesicles);
Severe seborrheic dermatitis (eczema of the skin associated with sebum);
Mycosis fungoides (fungal skin infection);
Severe psoriasis (severe redness and scaly patches on the skin).

➢ Allergic conditions
Initial treatment of severe allergic conditions such as:

Bronchial asthma, including status asthmaticus (spasm of the airways);
Contact dermatitis (caused by allergenic or irritating substances in contact with the skin);
Atopic dermatitis (localized, itchy skin irritation);
Hypersensitivity reactions to medicinal products;
Allergic sinusitis, seasonal or perennial;
Allergic reactions to blood transfusions;
Non-infectious swelling of the throat (adrenaline is the first-choice treatment);
Facial, neck, or limb swelling, in combination with adrenaline (a nervous system stimulant), in severe hypersensitivity reactions.

➢ Allergic and inflammatory eye and surrounding tissue conditions, acute or chronic, such as:

Allergic conjunctivitis (eye infection and redness);
Keratitis (infection of the transparent part of the eye);
Allergic marginal corneal ulcer;
Ophthalmic herpes zoster (viral eye infection);
Iritis and iridocyclitis (inflammation of the iris and ciliary body);
Chorioretinitis (retinal inflammation with blurred vision);
Anterior segment inflammation (inflammation of the front part of the eye);
Diffuse posterior uveitis and choroiditis (deep eye inflammation associated with pain);
Optic neuritis (inflammation of the optic nerve);
Retrobulbar neuritis (inflammation of the optic nerve);
Sympathetic ophthalmia (traumatic inflammation with potential vision loss).

➢ Respiratory diseases such as:

Sarcoidosis (disease characterized by growth of small inflammatory nodules in the lungs or other areas);
Loeffler's syndrome not treatable by other means (a disease causing cardiac damage);
Berylliosis (disease caused by beryllium exposure);
Fulminant or disseminated pulmonary tuberculosis (severe bacterial lung infection), in combination with other anti-tuberculosis medicinal products;
Pulmonary emphysema (rupture of lung microstructures), in cases where bronchial constriction (bronchospasm) or fluid in the lungs (bronchial edema) play a significant role;
Diffuse interstitial pulmonary fibrosis or Hamman-Rich syndrome (fibrous tissue growth in the lungs);
Aspiration pneumonia.

➢ Blood disorders such as:

Idiopathic and secondary thrombocytopenia in adults (reduction in blood clotting elements without obvious cause);
Acquired autoimmune haemolytic anaemia (autoimmune disease causing self-destruction of red blood cells);
Erythroblastopenia (deficiency of red blood cells);
Congenital erythroid hypoplastic anaemia (inherited disease characterized by insufficient red blood cell production by the bone marrow).

➢ Tumours:

Palliative treatment of symptoms in leukaemias and lymphomas (blood and lymphatic system tumours) in adults;
Acute leukaemia (active blood tumours) in children.

➢ Oedematous states (fluid swelling):

To increase urine excretion or to treat protein loss through urine in patients with kidney diseases of uncertain cause or due to systemic lupus erythematosus (an autoimmune disease causing self-destruction of body tissues). Decadron is used in combination with medicinal products that increase urine excretion (diuretics);
Hepatic cirrhosis (severe liver disease) with fluid accumulation in the abdomen;
Refractory congestive heart failure (heart insufficiency);
Cerebral oedema (fluid accumulation in the skull) of various origins. When fluid accumulation is due to brain tumours, oral (by mouth) administration of Decadron may be beneficial.

This medicinal product may also be used:

Pre-surgical preparation in patients with increased intracranial pressure due to tumours;
To relieve symptoms in patients with inoperable or recurrent (relapsed) brain tumours;
In the treatment of cerebral oedema (fluid accumulation in the skull) following neurosurgical procedures.

➢ Gastrointestinal disorders: this medicinal product may be used as an adjunct in:

Ulcerative colitis (inflammation of the colon with intestinal mucosa ulceration);
Regional enteritis (intestinal inflammation).

➢ For injection into natural joint cavities or soft tissues; short-term supplementary treatment in the following conditions:

Joint space inflammation (synovitis) due to osteoarthritis;
Joint pain and stiffness (rheumatoid arthritis);
Inflammation of tendons in elbows, knees, or shoulders (acute and subacute bursitis);
Gout-related joint inflammation (acute gouty arthritis);
Inflammation of the arm tendon (epicondylitis);
Inflammation of the tendon sheath (nonspecific acute tenosynovitis);
Joint disease following trauma (post-traumatic osteoarthritis);
Joint pain following trauma (traumatic arthritis);
Dupuytren's disease (a condition causing hand deformity);
Muscle inflammation (fibromyositis);
Nerve inflammation and intercostal neuralgia (inflammation of nerves between the ribs);
Tendon inflammation (tendinitis);
Inflammation around tendons (peritendinitis);
Wrist tendon inflammation (De Quervain's disease);
Trigger finger.

➢ Various diseases such as:

Tuberculous meningitis (brain inflammation due to tuberculosis) with nerve conduction block, in combination with appropriate anti-tuberculosis therapy.

➢ Croup

Episodes of laryngospasm (spasm of the larynx, the soft part of the throat);
Swelling causing airway narrowing, cough, or stridor. This medicinal product generally results in sustained improvement within 12 hours after the first dose. Concurrently, conventional antidiphtheritic therapy, including antibiotics, must be administered.

➢ Decadron may be used by hospital personnel to differentiate between various possible causes of adrenal gland disorders.

2. What you should know before being administered Decadron

Do not be administered Decadron if:

you are allergic to dexamethasone or to any of the other ingredients of this medicine (listed in section 6);
you have systemic fungal infections;
you have tuberculosis;
you have a gastric ulcer;
you suffer from psychiatric disorders (psychosis);
you have herpes simplex ophthalmic infection;
you are currently receiving live viral vaccines;
you are breastfeeding.

Warnings and precautions
Talk to your doctor or nurse before being administered Decadron.
Take the lowest effective dose necessary to control the disease, and gradually reduce the dose as soon as possible.
If dexamethasone is administered to premature infants, cardiac function and structure must be monitored.

Exercise particular caution with Decadron if:

you are taking moderate or high doses of hydrocortisone or cortisone (hormonal medicines similar to Decadron), as these may cause increased blood pressure, fluid and salt retention, or excessive potassium loss. It may be necessary to reduce salt intake and increase potassium in your diet.
you suffer from calcium-deficiency osteoporosis, as Decadron increases calcium excretion from the body.
you are to receive this medicine for prolonged periods; in this case, your doctor may prescribe stomach acid-reducing medicines as a precaution.
you are exposed to significant stress, as in such cases an increase in the dose of fast-acting corticosteroids (such as hydrocortisone or cortisone) may be required before, during, and after the stressful event. Gradually reduce the dose of this medicine to minimize the risk of adverse effects such as secondary adrenal insufficiency (adrenal gland failure to produce hormones).
you are to receive this medicine via deep intramuscular injection, as absorption into the body will be slower and the effect longer-lasting. If you develop adrenal insufficiency (hormone deficiency) during stress episodes while under treatment, resume hormone therapy. If you are already on steroid (hormonal) treatment, a dose increase may be necessary. Since your body's normal hormone secretion may be inadequate, concomitant administration of salts and/or a hormonal medicine may be advisable.
you have previously experienced allergic reactions to medicines; in such cases, your doctor must take important precautions before administering this medicine, as severe allergic reactions have been reported rarely in patients who received steroid (hormonal) treatment by injection.
you have low prothrombin levels (a blood clotting factor); in this case, use caution when taking aspirin (acetylsalicylic acid) during Decadron therapy.
you have reduced thyroid function or suffer from hepatic cirrhosis (severe inflammatory liver disease), as your body's response to this medicine may be enhanced.
during a severe systemic infection (septic shock), for which you may receive this medicine, you have elevated creatinine levels (a liver waste product) or develop an additional infection; in such cases, you may be at higher risk of death.
you have active tuberculosis; this medicine should only be prescribed in cases of fulminant or disseminated tuberculosis and must always be taken in combination with appropriate anti-tuberculosis medicines. If you have latent (non-active) tuberculosis or a positive tuberculin skin test, careful monitoring is required, as reactivation of the disease may occur.
you suffer from herpes simplex ophthalmicus (viral eye infection), due to the possible risk of corneal ulceration and perforation.
you experience symptoms of tumor lysis syndrome such as muscle cramps, muscle weakness, confusion, visual disturbances or loss, and shortness of breath, particularly if you have hematological neoplasms.
you suffer from psychiatric disorders; during treatment with this medicine, psychiatric disturbances may occur ranging from euphoria, insomnia, mood swings, personality changes, severe depression, to frank psychotic manifestations. When present, psychological instability and psychotic tendencies may be worsened by this medicine.
you are to take this medicine for prolonged periods, as it may cause cataract (progressive clouding of vision), glaucoma (increased intraocular pressure) with possible optic nerve damage, and fungal or viral eye infections.
Contact your doctor if you experience blurred vision or other visual disturbances.
you have inflammatory joint effusions, as you may require appropriate tests to rule out serious inflammation. If you experience a marked increase in pain accompanied by local swelling, further limitation of joint mobility, fever, and general malaise, you may have a serious infection. If medical staff confirm such a condition, appropriate anti-infective treatment should be administered. This medicine must not be injected into infected areas, unstable joints, or tendons. Avoid overusing joints in which symptoms have improved until inflammation has resolved.
Direct injection of Decadron into joints may cause both systemic and local effects.

Also be cautious if you suffer from:

non-specific ulcerative colitis (intestinal inflammation) with risk of perforation,
abscesses (fluid-filled swellings) or other pyogenic (pus-forming) infections,
diverticulitis (intestinal inflammation),
recent intestinal anastomoses (surgical removal of intestinal segments),
active or latent gastric ulcer (stomach erosion or wound),
renal insufficiency (reduced kidney function),
hypertension (high blood pressure),
osteoporosis (reduced bone calcification),
myasthenia gravis (a severe disease characterized by muscle weakness),
hepatic cirrhosis,
reduced thyroid function (hypothyroidism),
adrenal gland tumor (pheochromocytoma).

During treatment with Decadron, you must not be vaccinated against smallpox. Additionally, no other immunization procedures should be performed, especially if you are receiving high doses of Decadron, due to the risk of neurological complications and vaccine or immunization inefficacy.
This medicine may mask signs of infection, and other infections may develop during its use. During Decadron therapy, you may experience reduced resistance to infections.
Medical literature suggests an association between corticosteroid use and rupture of the left ventricular wall following recent myocardial infarction; therefore, corticosteroids should be used with extreme caution in such patients.
For athletes: using this medicine without therapeutic need constitutes doping and may lead to a positive anti-doping test.

Children and adolescents
Decadron must not be used in premature infants with respiratory problems.
Children and adolescents undergoing prolonged Decadron therapy should be closely monitored for growth and development.

Other medicines and Decadron
Inform your doctor or nurse if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor if you are taking:
Phenytoin, phenobarbital (used for epilepsy), ephedrine (used in asthma and for nasal congestion), or rifampicin (an antibiotic), and other medicines that are inducers of cytochrome P450 3A4 enzymes, as these may increase Decadron elimination and reduce its effectiveness. Dose adjustment of Decadron may be necessary.
Interactions with the above medicines may interfere with dexamethasone suppression tests (tests to assess adrenal gland function).
Anticoagulant medicines (used to thin the blood). If you frequently receive Decadron together with anticoagulants, your doctor should frequently monitor your blood clotting speed, as medicines similar to Decadron have in some cases altered the response to these anticoagulants.
Potassium-depleting diuretics (used to increase urine and potassium excretion); in this case, you should be carefully monitored for the development of hypokalemia (low blood potassium levels).
Some medicines may enhance the effects of Decadron, and your doctor may wish to monitor you closely if you are taking these (including certain HIV treatments: ritonavir, cobicistat).
Erythromycin and certain anti-HIV drugs (indinavir, ritonavir, lopinavir, saquinavir): may reduce the effect of Decadron.
Phenytoin (used for epilepsy): both increases and decreases in blood levels of this drug may occur when administered with Decadron, leading to altered seizure control.
The effects of certain medicines that lower blood glucose, including insulin, may be counteracted.

Decadron contains parahydroxybenzoates that may cause allergic reactions (including delayed reactions) and, exceptionally, bronchospasm.
This medicine contains less than 1 mmol (23 mg) of sodium per vial, i.e., essentially "sodium-free".

Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or nurse before receiving this medicine.
If you are pregnant, planning a pregnancy, or breastfeeding, take this medicine only if clearly indicated by your doctor.
Infants born to mothers who received substantial doses of Decadron during pregnancy should be carefully monitored for signs of impaired adrenal gland function.
Premature infants born to mothers who received Decadron near the end of pregnancy may have low blood sugar levels after birth.
Do not breastfeed while receiving this medicine. Corticosteroids (medicines of the same type as Decadron) have been found in breast milk and may suppress growth, interfere with hormone production, or cause other adverse effects in the infant.
In some patients, steroids may increase or decrease sperm motility and sperm count.

Driving and using machines
This medicine does not impair the ability to drive or operate machinery.

Decadron contains parahydroxybenzoates (parabens) and sodium bisulfite
This medicine contains methyl parahydroxybenzoate and propyl parahydroxybenzoate, which may cause allergic reactions (including delayed reactions) and, exceptionally, bronchospasm.
This medicine contains sodium bisulfite, which rarely may cause severe hypersensitivity reactions and bronchospasm.
If you have celiac disease, you can take DECADRON without risk.

3. How to take Decadron

Decadron will be administered into your vein or deeply into your muscle by a doctor or nurse. If you have any doubts, consult your doctor or nurse.
The doctor will decide the amount you need, when the medicine should be administered, and how long the treatment should last. This will depend on your age, weight, medical history, other medicines you are taking, and the type and severity of your illness.
However, in certain emergency situations in which your life may be at risk, you may be given a dose higher than usual. The initial dose may be repeated unchanged or adjusted according to the specific needs of the case. If, after a reasonable period of time, the medical staff do not observe a satisfactory clinical response, your treatment should be discontinued and you should switch to another appropriate therapy.
Each dose must be tailored to your individual case based on your body's response.
Once a favourable response has been achieved, your doctor will determine the appropriate maintenance dose by gradually reducing the initial dose in small increments and at suitable intervals until reaching the lowest effective dose. You should be monitored regularly to ensure correct determination of the most suitable dose for you. Changes in your condition (improvement or worsening of your illness, your body's response to the medicine, and other situations not directly related to the illness) may require adjustment of the dose.
If you suffer from other conditions not directly related to your illness, it may be necessary to increase the dose of this medicine for a period of time depending on your condition. When the medicine has been administered for longer than a few days, discontinuation of treatment must be done gradually and not abruptly.
Intravenous (into the vein) and intramuscular (into the muscle) administration
If you are in shock, hospital staff will administer Decadron by direct injection into the vein for both the initial dose and all subsequent doses (because in such cases any other route of administration, regardless of the medicine, results in irregular absorption into the body). If hospital staff observe a positive response (an increase in blood pressure) from your body, they will switch to deep intramuscular administration until oral (by mouth) administration becomes possible. To avoid discomfort, no more than 2 ml should be injected into each injection site.
Use in children and adolescents
For children, doses will be reduced compared to those given to adults and will be determined by the doctor based on the severity of the case and the child's age or body weight.
If you take more Decadron than you should
If you are accidentally given more Decadron than prescribed, contact your doctor or go to the nearest hospital immediately.
If you forget to take Decadron
If you miss an injection, you should receive it as soon as possible. However, if it is almost time for your next scheduled injection, skip the missed dose. Do not take a double dose (two injections together) to make up for a forgotten dose.
If you stop treatment with Decadron
Do not stop taking Decadron unless instructed by your doctor.
In some cases, when the medicine has been administered for longer than a few days, discontinuation of treatment must be done gradually and not abruptly.
If you have any doubts about using this medicine, consult your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur with Decadron:

sodium retention
water retention
loss of potassium from the body
decreased blood acidity due to low potassium levels (hypokalemic alkalosis)
protein breakdown (protein catabolism) with negative nitrogen balance (in prolonged treatments, dietary protein intake should be adequately increased)
increased appetite
loss of calcium
congestive heart failure (heart failure) in predisposed individuals
high blood pressure
formation of blood clots in veins (thromboembolism)
loss of muscle tone (weakness)
muscle disease caused by hormonal therapy (steroid myopathy)
reduction in muscle mass
bone decalcification (osteoporosis)
vertebral compression fractures
loss of bone tissue in the femur (aseptic necrosis of the femoral and humeral head)
spontaneous fractures of long bones
tearing of the stomach lining (peptic ulcer), possibly leading to perforation and bleeding
perforation of the small and large intestine
severe disease characterized by inflammation of the pancreas (pancreatitis)
abdominal swelling
inflammation of the esophagus with mucosal tearing (ulcerative esophagitis)
nausea
hiccups
indigestion
fungal infection (candida)
delayed wound healing
thin and fragile skin
minor bleeding and bruising (petechiae and ecchymoses)
irritation and redness of the face (facial erythema)
acne
increased sweating
suppression of responses to skin tests (distortion of skin test results)
other skin reactions such as irritation (allergic dermatitis, urticaria), angioneurotic edema (fluid-related swelling)
seizures
increased intracranial pressure with papilledema (cerebral edema)
dizziness
headache
various types of psychiatric disturbances such as: euphoria, depression, mood changes, suicidal thoughts, psychotic symptoms (including mania, delusions, hallucinations and worsening of schizophrenia), irritability, anxiety, sleep disorders, confusion and memory disturbances. These reactions are common and may occur in both adults and children.
generalized swelling of the face and limbs (development of Cushingoid state)
secondary adrenal and pituitary insufficiency (hormone production deficiency by the adrenal glands and pituitary), especially during periods of stress due to trauma, surgery or severe illness
manifestation of latent diabetes mellitus (sugar intolerance not evident in blood tests)
increased need for insulin or oral hypoglycemic agents (medicines that reduce blood sugar levels) in diabetic patients
excess glucose in the blood
menstrual irregularities
cataract (progressive clouding of vision)
increased pressure inside the eye
glaucoma (disease of the optic nerve)
exophthalmos (increased protrusion of the eyeball)
chorioretinopathy, worsening of viral eye diseases, papilledema, thinning of the cornea or sclera
blurred vision (frequency not known: may affect up to 1 in 1,000 people)
hypersensitivity
malaise
thickening of the heart muscle (hypertrophic cardiomyopathy) in premature infants, which usually returns to normal after discontinuation of treatment (frequency not known)

Withdrawal syndrome: too rapid reduction of the Decadron dosage after prolonged treatment may lead to acute liver failure, hypotension and death.
In some cases, withdrawal symptoms may mimic a clinical relapse of the disease for which the patient was being treated.

Additional side effects in children and adolescents

growth retardation in children.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Decadron

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
This product, like other steroid preparations, is heat-sensitive. Therefore, it should not be placed in an autoclave when sterilizing the outer surface of the vials. Protect the medicine from freezing.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Decadron contains

The active substance is dexamethasone-21-phosphate. Each ml of injectable solution contains 4 mg of dexamethasone-21-phosphate.
The other components are: creatinine, sodium bisulfite, sodium citrate, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, water for injections.

Description of the appearance of Decadron and package contents

Decadron 4 mg/1 ml vials contain 1 vial of 1 ml or 3 vials of 1 ml or 6 vials of 1 ml.
Decadron 8 mg/2 ml vials contain 1 vial of 2 ml or 3 vials of 2 ml or 6 vials of 2 ml.

Marketing Authorization Holder
I.B.N. Savio S.r.l. – Via del Mare, 36 – Pomezia (RM)

Manufacturer:
Savio Industrial S.r.l.
Via E. Bazzano, 14 - Ronco Scrivia (GE)
Esseti Farmaceutici Srl
Via Campobello 15 – Pomezia (Rm)
Biomedica Foscama Industria Chimico-Farmaceutica S.p.A.
Via Morolense 87 - Ferentino (FR)

The following information is intended exclusively for healthcare professionals:

Read carefully the information contained in sections 1-6.
How to administer Decadron
The preparation may be injected directly from the vial without mixing or dilution. If preferred, it
may be added, without loss of efficacy, to injectable sodium chloride, injectable dextrose, or suitable
blood for transfusion, and administered by intravenous drip infusion. When Decadron injectable solution
is added to an infusion solution, the mixture must be used within 24 hours, as the solutions do not contain
preservatives. Standard aseptic techniques for injections should be observed.

Intravenous and intramuscular injection: whenever possible, the intravenous route should be used both for the initial dose and for all subsequent doses administered while the patient is in shock (this is because in such patients, any other route of administration, regardless of the drug, results in irregular absorption rates). If a pressor response is observed, the intramuscular route may be used until oral therapy can be initiated. To avoid patient discomfort, no more than 2 ml should be injected intramuscularly at any single injection site. In emergency situations, the usual dose of Decadron injectable solution for intravenous or intramuscular injection is 1–5 ml (4–20 mg), depending on the severity of the disease (see also "Shock"). This dose may be repeated until an adequate response is observed. Once initial improvement is achieved, single doses of 0.5–1 ml (2–4 mg) may be sufficient and may be repeated as necessary. The total daily dosage should generally not exceed 20 ml (80 mg), even in severe cases. When a constant maximum effect is desired, administration should be repeated every 3–4 hours or carried out via continuous intravenous drip infusion. Intravenous and intramuscular injections are indicated in acute conditions. After the acute phase has passed, switch as soon as possible to oral steroid therapy.
Shock: the usual dose is 2–6 mg/kg body weight administered as a single intravenous injection. When shock persists, this dose may be repeated within 2–6 hours. Alternatively, Decadron injectable solution may be administered at a dose of 2–6 mg/kg body weight as a single intravenous injection, immediately followed by an intravenous infusion of an equal dose. Therapy with Decadron injectable solution constitutes a complement, not a substitute, for conventional therapy (see "Precautions for use"). These recommendations reflect the current medical practice trend of using high (pharmacological) doses of corticosteroids in the treatment of shock. The following dosage guidelines for Decadron injectable solution have been suggested by various authors:
Cavanagh: 3 mg/kg body weight for continuous intravenous infusion over 24 hours, following an initial intravenous injection of 20 mg.
Dietzman: 2–6 mg/kg body weight as a single intravenous injection.
Frank: initially 40 mg, followed by repeated intravenous injections every 4–6 hours if shock persists.
Oaks: initially 40 mg, followed by repeated intravenous injections every 2–6 hours if shock persists.
Schumer: 1 mg/kg body weight as a single intravenous injection. These doses are higher than the doses usually recommended for Decadron injectable solution; however, they are intended for use in emergency situations and acute conditions requiring high pharmacological doses. Administration of corticosteroids at high doses should be continued only until stabilization of the patient's condition is achieved, and generally for no longer than 48–72 hours. Prolonged therapy with these high doses should be avoided to prevent potential complications such as adrenal insufficiency or gastrointestinal ulceration.

Cerebral edema associated with acute apoplexy: initially 10 mg (2.5 ml) of Decadron
injectable solution administered intravenously, followed by 4 mg (1 ml) intramuscularly every 6
hours for 10 days. The dose should be tapered to zero within the following 7 days.
Cerebral edema associated with treatment of primary or metastatic brain tumors, neurosurgical procedures, head trauma, pseudotumors of the brain, or preoperative preparation of patients with increased intracranial pressure due to brain tumor:
initially 10 mg (2.5 ml) of Decadron injectable solution administered intravenously, followed by 4 mg (1 ml) intramuscularly every 6 hours until symptoms of cerebral edema subside. A response is generally observed within 12–24 hours: dosage may be reduced after 2–4 days and gradually discontinued over 5–7 days. For palliative treatment of patients with recurrent or inoperable tumors: maintenance dosage should be individualized using Decadron injectable solution or Decadron tablets. A dosage of 2 mg two or three times daily may be adequate. The lowest effective dose necessary to control cerebral edema should be used. Standard precautions associated with corticosteroid therapy should be followed. Consideration should be given to prescribing antacids, anticholinergics, and dietary measures to prevent gastrointestinal ulcers or bleeding.

Croup: the usual dosage generally involves a single dose ranging from 0.5 to 1.25 ml (2 to 5 mg), depending on the child's age and body weight. Conventional antitoxoid therapy, including adequate doses of antibiotics, should be administered concurrently. In particularly severe cases, steroid therapy may be continued at low doses for 2 or 3 days as a precautionary measure to prevent further acute attacks.

Combination of parenteral and oral therapy: in acute self-limiting allergies or exacerbations of chronic allergic diseases (acute allergic rhinitis, acute attacks of seasonal allergic asthma, drug-induced urticaria, angioneurotic edema, contact dermatitis, etc.), the following dosage regimen is recommended, combining parenteral and oral therapy:

DOSAGE (total daily dose)
Day 1: one single intramuscular injection of 1 ml (4 mg) of Decadron 4 mg injectable solution
Day 2: 2 tablets of Decadron 0.5 mg twice daily → 4 tablets
Day 3: 2 tablets of Decadron 0.5 mg twice daily → 4 tablets
Day 4: 1 tablet of Decadron 0.5 mg twice daily → 2 tablets
Day 5: 1 tablet of Decadron 0.5 mg twice daily → 2 tablets
Day 6: 1 tablet of Decadron 0.5 mg once daily → 1 tablet
Day 7: 1 tablet of Decadron 0.5 mg once daily → 1 tablet
Day 8: Follow-up visit

ALTERNATIVE DOSAGE SCHEDULE
Day 1: 1 or 2 ml (4 mg) of Decadron injectable solution (4 mg/ml) → 4 or 8 mg intramuscularly
Day 2: 2 tablets of Decadron 0.75 mg twice daily → 4 tablets
Day 3: 2 tablets of Decadron 0.75 mg twice daily → 4 tablets
Day 4: 1 tablet of Decadron 0.75 mg twice daily → 2 tablets
Day 5: 1 tablet of Decadron 0.75 mg once daily → 1 tablet
Day 6: 1 tablet of Decadron 0.75 mg once daily → 1 tablet
Day 7: No treatment
Day 8: Follow-up visit

The aim of this regimen is to provide adequate therapy during acute episodes while minimizing the risk of overdosage in chronic cases. In some patients, this regimen alone may be sufficient to control the disease. Other patients may require additional treatment, for example topical steroids, antihistamines, or bronchodilators. In a limited number of patients, systemic steroid therapy may also be necessary. Based on the dosage used the day before symptom recurrence in this latter group of patients, the physician can more easily determine whether further treatment should be prescribed. In asthma exacerbations accompanied by signs of infection, concomitant administration of antibiotics is recommended.

Intra-articular and soft tissue injections: intra-articular and soft tissue injections are generally used when no more than one or two joints or affected sites are involved. They do not eliminate the need for conventional measures usually adopted. While they provide symptomatic relief, they do not constitute a cure, as the hormone has no effect on the underlying cause of inflammation.

The following are some examples of commonly used single doses:

Injection site | Injection volume (ml) | Amount of dexamethasone phosphate (mg)
---|---|---
Large joints (e.g., knee) | 0.5–1 | 2–4
Small joints (e.g., interphalangeal, temporomandibular) | 0.2–0.25 | 0.8–1
Bursae (including calcified bursae) | 0.5–0.75 | 2–3
Tendon sheaths | 0.1–0.25 | 0.4–1
Calluses and corns | 0.05–0.25 | 0.2–1
Plantar | 0.1–0.25 | 0.4–1
Digital | 0.05–0.2 | 0.2–0.8
Soft tissue infiltration | 0.5–1.5 | 2–6
Ganglia | 0.25–0.5 | 1–2

The frequency of injections varies from once every 3–5 days to once every 2–3 weeks, depending on the response to treatment.

Incompatibilities
No incompatibilities with other medicinal products are known.

Shelf life
24 months when packaging is intact.

Special precautions for storage
Like other steroid preparations, this product is sensitive to heat. Therefore, it should not be placed in an autoclave if sterilization of the external surface of the vials is required. Protect from freezing.

Patient Information Leaflet

Decadron 2 mg/ml oral drops, solution

Dexamethasone sodium phosphate
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

What Decadron is and what it is used for
What you need to know before taking Decadron
How to take Decadron
Possible side effects
How to store Decadron
Contents of the pack and other information

1. What Decadron is and what it is used for

Decadron contains the active substance dexamethasone, which belongs to a group of medicines called corticosteroids.
This medicine suppresses inflammatory symptoms and is used to treat the following conditions:
inflammatory joint disorders caused by: degenerative and post-traumatic osteoarthritis, progressive chronic polyarthritis (diseases causing joint pain and stiffness), ankylosing spondylarthritis (inflammation and stiffness of the spinal joints)
asthmatic conditions
allergic dermatitis and dermatoses
in all cases where treatment with a corticosteroid medicine is required.

2. What you should know before taking Decadron

Do not take Decadron

if you are allergic to dexamethasone or to any of the other ingredients of this medicine (listed in section 6);
if you have a fungal infection (mycotic);
if you have tuberculosis;
if you have peptic ulcer (a lesion of the mucosa of the stomach or duodenum);
if you suffer from psychiatric disorders (psychosis);
if you have an eye infection caused by the Herpes simplex virus;
if you are pregnant, unless otherwise prescribed by your doctor (see "Pregnancy and breastfeeding");
if you are breastfeeding (see "Pregnancy and breastfeeding");
if you are currently receiving live viral vaccines.

Warnings and precautions
Talk to your doctor or pharmacist before taking Decadron.
Before administering Decadron, your doctor will ask you about any previous allergic reactions, as anaphylactoid reactions have rarely been reported in patients receiving parenteral (injection) corticosteroid therapy.
Contact your doctor if you experience blurred vision or other visual disturbances.
Take special care with Decadron:
If you have active tuberculosis; in this case, use of the medicine should be limited to fulminant or disseminated disease, and Decadron must be used in conjunction with appropriate antitubercular therapy. If you have latent tuberculosis or a positive tuberculin test (a test to diagnose tuberculosis), especially if you are to take Decadron for a prolonged period, your doctor will monitor you closely and prescribe suitable preventive therapy to avoid reactivation of the disease.
If you have inflammation of the colon (non-specific ulcerative colitis) with risk of perforation, or inflammation of the diverticula—small outpouchings on the colon wall (diverticulitis)—or if you have collections of pus (abscesses) or general purulent infections;
If you have recently undergone intestinal surgery (intestinal anastomoses);
If you have reduced kidney function (renal insufficiency);
If you have high blood pressure (hypertension);
If you suffer from a disease characterized by muscle weakness and fatigue called "myasthenia gravis";
If you have diabetes;
If you have osteoporosis (porous bones);
If you have acute or chronic infections.
If your thyroid gland does not produce enough hormones (hypothyroidism) or if you have hepatic cirrhosis (progressive destruction of liver cells), as in these cases your response to the medicine may be increased.
If you need to take high doses for a prolonged period, as this may lead to an imbalance in the body's mineral levels. It may be necessary to adjust your intake of sodium, potassium, and/or calcium.
If you experience symptoms of tumor lysis syndrome such as muscle cramps, muscle weakness, confusion, vision loss or disturbances, and shortness of breath, particularly if you suffer from hematological neoplasms.
If you have a tumor of the adrenal gland (pheochromocytoma).
This type of medicine may mask certain signs of infection, and other infections may occur during treatment. In such cases, consult your doctor for appropriate antibiotic therapy.
If you are under significant stress and are taking corticosteroid medicines (such as Decadron), your doctor will adjust the dose according to the severity of the stress condition. Secondary adrenal insufficiency (inadequate production of adrenal hormones) induced by corticosteroids can be minimized by gradually reducing the dose. This relative insufficiency may persist for months after stopping treatment. Therefore, in any stressful situation occurring during this time, consult your doctor about resuming hormonal therapy.
Medical literature suggests an association between corticosteroid use and rupture of the left ventricular wall following a recent myocardial infarction; therefore, corticosteroids should be used with extreme caution in these patients.
For athletes: using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.

Children and adolescents
Decadron must not be used in premature infants with breathing problems.
In very early infancy, Decadron should be administered only when strictly necessary and under direct medical supervision.
Children undergoing prolonged treatment with corticosteroid medicines (such as Decadron) must be closely monitored for growth and development.

Other medicines and Decadron
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor if you are taking:
Phenytoin, phenobarbital (used for epilepsy), ephedrine (used in asthma and to relieve nasal congestion), or rifampicin (an antibiotic), and other medicines that are inducers of cytochrome P450 3A4 enzymes: these medicines may increase the elimination of Decadron and reduce its activity.
The interaction with these medicines may interfere with the dexamethasone suppression test (a test to assess adrenal gland function).
Coumarin anticoagulants (used to thin the blood): your doctor will monitor your blood clotting speed (prothrombin time).
Potassium-depleting diuretics (used to increase urine and potassium excretion), as this may lead to low potassium levels in the blood.
Some medicines may increase the effects of Decadron, and your doctor may wish to monitor you closely if you are taking these medicines (including certain HIV treatments: ritonavir, cobicistat).
Erythromycin and certain anti-HIV drugs (indinavir, ritonavir, lopinavir, saquinavir): may reduce the effect of Decadron.
Phenytoin (used for epilepsy): both increases and decreases in blood levels of this medicine may occur when taken with Decadron, leading to changes in seizure control.
The effects of certain medicines that lower blood glucose, including insulin, may be counteracted.

Decadron contains 34.5 mg of propylene glycol per drop, equivalent to 1036 mg/ml.
If the child is less than 4 weeks old, speak with your doctor or pharmacist before administering this medicine, especially if the child is taking other medicines containing propylene glycol or alcohol.
This medicine contains less than 1 mmol (23 mg) of sodium per drop, i.e., essentially 'sodium-free'.

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
During pregnancy, take Decadron only if clearly indicated by your doctor, when strictly necessary, and under direct medical supervision.
Infants born to mothers who were treated with corticosteroids (such as Decadron) during pregnancy should be carefully monitored for signs of impaired adrenal function (adrenal insufficiency).
Decadron passes into breast milk and may interfere with the infant's growth, with endogenous corticosteroid production, or cause other adverse effects. Therefore, do not take Decadron during breastfeeding.

Driving and use of machinery
Decadron does not impair the ability to drive vehicles or operate machinery.

3. How to take Decadron

Take this medicine exactly as instructed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
The recommended dose is:
The dosage should be adjusted according to your condition and response to treatment.
As a general guide, treatment may be started with a dose of 2 mg to 5 mg administered in three
daily doses (2 mg/day in three divided doses corresponds to 10 drops three times a day; 5 mg/day
corresponds to 25 drops three times a day).
As soon as improvement occurs, the dose should be gradually reduced to the lowest therapeutic
dose capable of controlling symptoms, which may range from 0.2 mg (equivalent to 3 drops) to 2 mg
per day (equivalent to 30 drops).
1 ml of solution (= 2 mg) corresponds to 30 drops.
Dilute the drops in a small amount of water and shake the resulting solution before administration.

If you take more Decadron than you should
In case of overdose, the following symptoms may occur: obesity, reduction in muscle mass (muscle atrophy), porous bones (osteoporosis), excessive hair growth (hypertrichosis), purpura, acne, excitement, agitation, glycosuria, excess sugar in the blood (hyperglycemia), reduced potassium levels in the blood (hypokalemia), excessive production of cortisol hormone by the adrenal gland (Cushing's syndrome), growth suppression in children.
If excessive doses of the medicine have been taken, the dosage should be gradually reduced.
In case of accidental ingestion/overdose of Decadron, contact your doctor immediately or go to the nearest hospital.

If you forget to take Decadron
Do not take a double dose to make up for a forgotten dose.

If you stop taking Decadron
Do not stop taking this medicine abruptly unless clearly instructed by your doctor.
Dose reduction or discontinuation of treatment should be carried out gradually.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

Instructions for using the dropper pump
Packages containing 30 ml bottles include a dropper pump with a protective cap.
The dropper pump is graduated at 0.5 ml and 1 ml.

Open the bottle by unscrewing the cap (Figure A).
Unscrew the plastic protective cap of the dropper (Figure B).
Insert the dropper into the bottle to draw up the solution.
Dilute the drops in a small amount of water and shake the resulting solution before administration.
Close the bottle by screwing the cap back on (Figure C).
Screw the protective cap back onto the dropper.
Store the bottle and dropper in the original packaging.

Figure A – Unscrew the bottle cap
Figure B – Unscrew the dropper protective cap
Figure C – Screw the bottle cap back on

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur with Decadron:

sodium retention
water retention
loss of potassium from the body
decreased blood acidity due to low potassium levels (hypokalemic alkalosis)
protein loss (protein catabolism) with negative nitrogen balance (in prolonged treatments, dietary protein intake should be adequately increased)
increased appetite
loss of calcium
congestive heart failure (heart failure) in predisposed individuals
high blood pressure
circulatory problems (thromboembolism)
loss of muscle tone (weakness)
muscle disease caused by hormonal therapy (steroid myopathy)
reduction in muscle mass
bone decalcification (osteoporosis)
vertebral compression fractures
loss of bone tissue in the femur (aseptic necrosis of the femoral and humeral head)
spontaneous fractures of long bones
tendon ruptures
stomach lining tears (peptic ulcer), possibly leading to perforation and bleeding
perforation of the small and large intestine
severe disease characterized by inflammation of the pancreas (pancreatitis)
abdominal swelling
inflammation of the esophagus with mucosal tearing (ulcerative esophagitis)
nausea
hiccups
indigestion
fungal infection (candida)
delayed wound healing
thin and fragile skin
minor bleeding and bruising (petechiae and ecchymoses)
irritation and redness of the face (facial erythema)
acne
increased sweating
suppression of responses to skin tests (distortion of skin test results)
other skin reactions such as irritation (allergic dermatitis, urticaria), angioneurotic edema (fluid-induced swelling)
seizures
increased intracranial pressure with papilledema (brain edema)
dizziness
headache
various types of psychiatric disturbances such as: euphoria, depression, mood changes, suicidal thoughts, psychotic symptoms (including mania, delusions, hallucinations, and worsening of schizophrenia), irritability, anxiety, sleep disorders, confusion, and memory disturbances. These reactions are common and may occur in both adults and children.
generalized swelling of the face and limbs (development of Cushingoid state)
secondary adrenal and pituitary insufficiency (reduced hormone production by the adrenal glands and pituitary), especially during periods of stress due to trauma, surgery, or serious illness
manifestation of latent diabetes mellitus (sugar intolerance not evident from blood tests)
increased need for insulin or oral hypoglycemic agents (medicines that reduce blood sugar levels) in diabetic patients
excess glucose in the blood
menstrual irregularities
cataract (progressive clouding of vision)
increased pressure inside the eye
glaucoma (disease of the optic nerve)
exophthalmos (increased protrusion of the eyeball)
chorioretinopathy, worsening of viral eye diseases, papilledema, thinning of the cornea or sclera
blurred vision (frequency not known)
hypersensitivity
malaise

Withdrawal syndrome: too rapid reduction of the Decadron dosage after prolonged treatment may lead to acute liver failure, hypotension, and death.
Diagnostic tests: reduced carbohydrate tolerance, increased body weight.
In some cases, withdrawal symptoms may mimic a clinical relapse of the disease for which the patient was being treated.

Additional side effects in children and adolescents

growth disturbances.

Following the instructions contained in this leaflet reduces the risk of side effects.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Decadron

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after “Exp.”.
The expiry date refers to the last day of that month. The expiry date refers to the product in its original, unopened packaging, correctly stored.
Store below 25°C.
Use the medicine within 80 days after the first opening of the bottle. After this period, dispose of any remaining medicine.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Decadron contains
1 ml of solution contains:

The active substance is sodium phosphate dexamethasone. 1 ml of solution contains 2 mg of sodium phosphate dexamethasone.
The other component is: propylene glycol.

Description of the appearance of Decadron and contents of the pack
Decadron is available as an oral drops solution.
Box containing 1 bottle of 10 ml with dropper
Box containing 1 bottle of 30 ml with pump dropper
Box containing 2 bottles of 30 ml each with pump dropper

Marketing Authorization Holder
I.B.N. Savio S.r.l. – Via del Mare, 36 – Pomezia (RM)

Manufacturer
Genetic S.p.A. – Contrada Canfora – Fisciano (SA)
Savio Industrial S.r.l., Via Emilia, 21 - Pavia