Dexamethasone phosphate Pfizer

Package leaflet: Information for the user

DESAMETASONE FOSFATO PFIZER 8 mg/2 ml solution for injection, 4 mg/ml solution for injection

Dexamethasone
Generic medicine
Read this leaflet carefully before you use 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, pharmacist 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 may be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

1. What Desametasone Fosfato Pfizer is and what it is used for
2. What you need to know before using Desametasone Fosfato Pfizer
3. How to use Desametasone Fosfato Pfizer
4. Possible side effects
5. How to store Desametasone Fosfato Pfizer
6. Contents of the pack and other information

1. What Desametasone Fosfato Pfizer is and what it is used for

Desametasone Fosfato Pfizer contains the active substance desametasone, which belongs to a group of medicines called glucocorticoids. These medicines work by reducing inflammation (anti-inflammatory action), allergies, fever (antipyretic effect), and are used in cases of inadequate blood circulation (anti-shock effect).

Desametasone Fosfato Pfizer is administered into a muscle (intramuscularly) or into a vein (intravenously) when oral administration is not possible, for the following indications:

Adrenal insufficiency
Desametasone Fosfato Pfizer has mainly anti-inflammatory (glucocorticoid) activity and weak hormonal metabolism activity (mineralocorticoid). Therefore, its use should be combined with mineral salts or desoxycorticosterone (a hormonal medicine), or both. When used in combination, this medicine is indicated in all types of adrenal gland insufficiency, such as Addison's disease or following surgical removal of the adrenal glands requiring hormonal support therapy.

Relative insufficiency of the adrenal cortex
Partial adrenal gland insufficiency that may occur after discontinuation of prolonged treatment with suppressive doses of hormones. When an immediate effect is required, injectable Desametasone Fosfato Pfizer may be life-saving, as its efficacy may appear within minutes after administration.

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

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

Thyroid inflammation without pus formation (non-suppurative thyroiditis), when treatment with other oral medications is not feasible.

Shock

• Adjunctive treatment of shock when high doses of corticosteroids are required, such as severe hemorrhagic, traumatic, or surgical shock. Treatment with injectable Desametasone Fosfato Pfizer 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
Adjunctive short-term treatment in the following conditions:

• 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;
• 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).

Collagen diseases (connective tissue disorders affecting skin, bones, tendons):

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

Skin diseases such as:

• Pemphigus (skin and mucosal blisters);
• Stevens-Johnson syndrome (severe, potentially fatal allergic reaction);
• Exfoliative dermatitis (widespread skin peeling);
• 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 (airway spasms);
• Contact dermatitis (caused by allergenic or irritating substances contacting the skin);
• Atopic dermatitis (localized, itchy skin irritation);
• Drug hypersensitivity reactions;
• Allergic sinusitis (seasonal or perennial);
• Allergic reactions to blood transfusions;
• Non-infectious swelling of the throat (adrenaline is the first-line 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 disorders, acute or chronic, such as:

• Allergic conjunctivitis (eye infection and redness);
• Keratitis (inflammation 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 causing 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 behind the eye);
• Sympathetic ophthalmia (traumatic eye inflammation potentially leading to vision loss).

Respiratory diseases such as:

• Sarcoidosis (a disease characterized by small inflammatory nodules in the lungs or other organs);
• Loeffler's syndrome not responsive to other treatments (a condition causing heart damage);
• Berylliosis (disease caused by beryllium exposure);
• Fulminant or disseminated pulmonary tuberculosis (severe bacterial lung infection), in combination with other anti-tuberculosis drugs;
• Pulmonary emphysema (destruction of lung microstructures), in cases where bronchoconstriction or lung fluid (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, via intravenous administration (reduction in blood clotting elements without apparent cause);
• Acquired autoimmune hemolytic anemia (autoimmune disease causing destruction of red blood cells);
• Erythroblastopenia (deficiency of red blood cells);
• Congenital erythroid hypoplastic anemia (inherited disorder characterized by insufficient red blood cell production in the bone marrow).

Tumors:

• Palliative treatment of symptoms in leukemias and lymphomas (blood and lymphatic system cancers) in adults;
• Acute leukemia (aggressive blood cancers) in children.

Edematous states (fluid retention):

• To increase urine output 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).

Desametasone Fosfato Pfizer may be used in combination with diuretic medicines (drugs that increase urine output) in cases of:

• Hepatic cirrhosis (severe liver disease) with abdominal fluid accumulation;
• Refractory congestive heart failure (heart insufficiency);
• Cerebral edema (fluid accumulation in the skull) of various causes. When cerebral edema is due to brain tumors, oral administration of Desametasone Fosfato Pfizer may be beneficial.

This medicine may also be used:

• Pre-surgically in patients with increased intracranial pressure due to brain tumors;
• To relieve symptoms in patients with inoperable or recurrent (relapsed) brain tumors;
• In the treatment of cerebral edema following neurosurgical procedures.

Gastrointestinal disorders: This medicine 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 spaces or soft tissues:
Adjunctive short-term 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);
• Arm tendon inflammation (epicondylitis);
• Acute nonspecific tenosynovitis (inflammation of tendon sheaths);
• Trauma-related joint disease (post-traumatic osteoarthritis);
• Joint pain following trauma (traumatic arthritis);
• Dupuytren's disease (hand deformity);
• Muscle inflammation (fibromyositis);
• Nerve inflammation and intercostal neuralgia (nerve inflammation between ribs);
• Tendinitis;
• Peritendinitis (inflammation around tendons);
• Wrist tendon inflammation (De Quervain's disease);
• Trigger finger.

Various other conditions:

• Tuberculous meningitis (brain inflammation due to tuberculosis) with nerve transmission 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 medicine generally leads to sustained improvement within 12 hours after the first dose. Concomitantly, standard antitoxoid therapy, including antibiotics, must be administered.

Desametasone Fosfato Pfizer may be used by hospital staff to differentiate between various possible causes of adrenal gland disorders.

2. What you should know before using Desametasone Fosfato Pfizer

Do not use Desametasone Fosfato Pfizer

• if you are allergic to sodium phosphate dexamethasone or to any of the other ingredients of this medicine (listed in section 6);
• if you have a fungal and/or bacterial infection that is widespread throughout the body (systemic), unless you are already receiving specific treatment for the infection;
• for local injection if there is bacteria in the blood (bacteraemia), fungal infections that are widespread in the body (systemic mycotic infections), in unstable joints, or infections at the injection site due to other diseases such as septic arthritis secondary to gonorrhoea or tuberculosis;
• if you have a respiratory tract infection (tuberculosis);
• if you suffer from stomach and intestinal problems (peptic ulcer);
• if you suffer from mental disorders (psychosis);
• if you have an eye infection caused by a virus called Herpes simplex.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Desametasone Fosfato Pfizer.
Desametasone Fosfato Pfizer may worsen a fungal infection that is widespread throughout the body (systemic fungal infection), unless it is required to control an allergic reaction (drug reaction) due to amphotericin B. On the other hand, it has been reported that the concomitant use of amphotericin B and hydrocortisone may cause increased body weight and heart tissue volume (congestive cardiac hypertrophy).
The use of this medicine may:

• promote the onset of infections (latent amoebiasis), mask serious infections, and alter the results of certain tests, giving false negatives for bacterial infections (nitroblue tetrazolium test);
• cause allergic reactions, even severe ones (anaphylactic reactions), which may manifest as throat swelling (glottis oedema), skin irritation (urticaria), and breathing difficulties (bronchospasm), especially if you have previously experienced allergic reactions to other medicines. Inform your doctor immediately if you experience any of the symptoms listed above;
• cause a tumour of the adrenal gland (pheochromocytoma).

This medicine should be used at the lowest possible dose. A gradual dose reduction is recommended. During treatment with this medicine, your doctor may prescribe medications to prevent stomach damage (anti-acid medicines).
Desametasone Fosfato Pfizer, when taken at high doses, may cause:

• increased blood pressure;
• changes in the levels of salts and fluids in the body (fluid and salt retention), or increased potassium loss; in such cases, a low-sodium diet and potassium supplements may be necessary.

All medicines belonging to the class of Desametasone Fosfato Pfizer (corticosteroid medicines) increase calcium excretion.
Intra-articular injection of a corticosteroid may cause both systemic and local effects.
Inform your doctor if you experience increased pain, swelling, limited joint movement, fever, or general malaise – these are signs suggesting a joint infection.
Your doctor will advise you not to strain the treated joint even when pain has decreased. Indeed, the joint must be protected as long as the inflammatory process is still active.
Inform your doctor if you are being treated with other medicines, if you need to receive vaccinations, or undergo allergy tests (skin tests) during treatment with dexamethasone.
Use Desametasone Fosfato Pfizer with caution and inform your doctor if:

• you are under significant stress;
• you have adrenal problems due to this medicine (secondary adrenal insufficiency); in such cases, your doctor may gradually reduce your dose. These problems may persist for several months after stopping treatment. If during this period you experience stress or take other medicines (steroids), consult your doctor;
• you have a lung infection (tuberculosis) or viral or fungal eye infections; in such cases, your doctor will prescribe concomitant antimicrobial therapy;
• you have never had chickenpox or shingles (diseases caused by the Herpes zoster virus), as these diseases can be very dangerous if they occur during treatment with this medicine. If you or your child have never had these diseases, take special care to avoid contagion. If you or your child develop symptoms of these diseases (chickenpox, shingles) or measles during treatment with Desametasone Fosfato Pfizer, contact your doctor immediately;
• you have undergone treatment with high doses for more than 3 weeks; in this case, the dose must be reduced gradually, as you may experience sudden adrenal problems (acute adrenal insufficiency), low blood pressure (hypotension), and possibly death;
• you suffer from thyroid problems (hypothyroidism) or liver problems (hepatic cirrhosis);
• you have a lung disease (active tuberculosis). In this case, you may use this medicine only if it is a fulminant or disseminated disease. If you have latent tuberculosis or a positive tuberculin test, you must be closely monitored by your doctor;
• you suffer from malignant blood disorders. Your doctor will monitor you closely to prevent a condition caused by the death of tumour cells after treatment with dexamethasone, alone or in combination with other medicines called chemotherapeutic agents, which release substances that could cause kidney damage;
• you have persistent intestinal inflammation (unspecific ulcerative colitis);
• you have a pus-forming infection (abscess) or bacterial infections causing pus (pyogenic infections);
• you have an intestinal disorder (diverticulitis);
• you have recently undergone intestinal surgery (recent intestinal anastomoses);
• you suffer from stomach or intestinal disorders associated with lesions (active or latent peptic ulcer);
• you have kidney problems (renal failure);
• you suffer from high blood pressure (hypertension);
• you suffer from bone disorders (osteoporosis);
• you suffer from muscle disorders (myasthenia gravis);
• you have a viral eye infection caused by Herpes simplex, as serious eye damage (corneal perforation) may occur;
• you are male, as the use of this medicine may cause increased or decreased sperm motility and count;
• you have diarrhoea or have travelled to tropical areas, as the use of this medicine may trigger an infection (amoebiasis);
• you are elderly, as potentially dangerous side effects (including death) may occur, such as bone weakening (osteoporosis), increased blood pressure (hypertension), decreased potassium levels (hypokalaemia), diabetes, increased susceptibility to infections, and skin thinning. In such cases, consult your doctor, who will monitor you closely;
• you experience symptoms of tumour lysis syndrome such as muscle cramps, muscle weakness, confusion, vision loss or disturbances, and shortness of breath, especially if you suffer from haematological neoplasms (blood cell tumours). Contact your doctor if blurred vision or other visual disturbances occur.

Mental problems
The use of this medicine may cause psychiatric effects. These reactions cease after dose reduction or discontinuation of the medicine. If you experience depression, suicidal thoughts, or other psychological disturbances, consult your doctor. These disorders may occur both during and after dose reduction or discontinuation of treatment. Inform your doctor before taking this medicine if you or a family member have previously experienced mental disorders (depression, manic-depressive illness, steroid-induced psychosis).

Your doctor will closely monitor you during treatment if:

• you have bone problems (osteoporosis), especially if you are a postmenopausal woman;
• you have high blood pressure (hypertension);
• you suffer from heart disorders (congestive heart failure);
• you or a family member has diabetes mellitus;
• you have previously had a lung infection;
• you or a family member has an eye disorder (glaucoma);
• you have previously experienced muscle problems during corticosteroid therapy (previous myopathy);
• you suffer from liver disorders (hepatic insufficiency);
• you suffer from kidney disorders (renal failure);
• you suffer from epilepsy;
• you suffer from stomach and intestinal disorders due to lesions (gastrointestinal ulcerations);
• you suffer from headaches (migraine);
• you have intestinal infections (amoebiasis);
• you have impaired growth (incomplete structural growth);
• you suffer from a condition called Cushing's syndrome;
• you or a family member has previously suffered from severe affective disorders (such as depression, mania, manic-depressive illness, or steroid-induced psychosis). The use of this medicine may cause severe psychiatric effects, the symptoms of which appear within a few days or weeks of starting treatment, and the risk is higher if high doses are administered intravenously.
  Prolonged use of this medicine may cause eye problems (posterior subcapsular cataract).
  Always carry a medical card indicating the doctor who prescribed this medicine, the dose, and the duration of treatment.
  For athletes: the use of this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.

Children and adolescents
Desametasone Fosfato Pfizer must not be used in preterm newborns with respiratory problems.
If dexamethasone is administered to a prematurely born child, thickening of the heart muscle (hypertrophic cardiomyopathy) may develop; therefore, appropriate diagnostic evaluation and monitoring of heart function and structure are required.
Growth and development of children and adolescents undergoing prolonged treatment with this medicine must be monitored, as Desametasone Fosfato Pfizer may cause irreversible growth delay.

Other medicines and Desametasone Fosfato Pfizer
Inform your doctor if you are taking or have recently taken any other medicines, including those obtained without a prescription.
Some medicines may increase the effects of Desametasone Fosfato Pfizer, and your doctor may wish to monitor you closely if you are taking these medicines (including some HIV treatments: ritonavir, cobicistat).
Use Desametasone Fosfato Pfizer with caution and inform your doctor if you are taking the following medicines, as specific monitoring may be necessary:

• medicines used to treat epilepsy (phenytoin, phenobarbital, carbamazepine, primidone);
• ephedrine, a medicine used to reduce nasal congestion (nasal decongestant);
• aminoglutethimide, a medicine used to treat a hormonal disorder (Cushing's syndrome) or breast cancer;
• ketoconazole, amphotericin B, medicines used to treat fungal infections;
• macrolide antibiotics, erythromycin, used to treat bacterial infections;
• indinavir, a medicine used to treat AIDS;
• hydrocortisone, a medicine used to treat skin allergies;
• medicines used to treat bacterial infections (rifabutin, rifampicin);
• medicines called anticholinesterases, used to treat muscle disorders (myasthenia gravis);
• medicines used to thin the blood (coumarin anticoagulants);
• medicines that promote urine elimination (potassium-depleting diuretics and diuretics in general, such as acetazolamide, loop diuretics, thiazide diuretics);
• medicines used to lower blood sugar levels (hypoglycaemics), including insulin;
• medicines used to lower blood pressure (antihypertensives);
• medicines used to treat certain heart conditions (digitalis glycosides);
• a medicine for stomach lesions (carbenoxolone);
• non-steroidal anti-inflammatory medicines (salicylates, phenylbutazone). If you stop Desametasone Fosfato Pfizer, you may experience salicylate intoxication. Additionally, if you have low prothrombin levels (hypoprothrombinemia), you may experience an interaction with salicylates.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Pregnancy
If you are pregnant or of childbearing age, your doctor will assess whether starting treatment with this medicine is necessary only if the benefits to you outweigh the risks to your baby.
Newborns of mothers who received high doses of corticosteroids during pregnancy must be closely monitored, as they may develop adrenal problems (adrenal insufficiency).
Breastfeeding
Do not use Desametasone Fosfato Pfizer if you are breastfeeding, as it passes into breast milk.

Driving and using machines
This medicine does not affect the ability to drive or use machinery.

Desametasone Fosfato Pfizer contains parahydroxybenzoates (methyl parahydroxybenzoate, propyl parahydroxybenzoate) and sodium (sodium citrate)
This medicine contains parahydroxybenzoates, which may cause allergic reactions (including delayed reactions), including respiratory problems (bronchospasm).
This medicine contains less than 1 mmol (23 mg) of sodium per vial, i.e., it is practically "sodium-free".

3. How to use Desametasone Fosfato Pfizer

This medicine will be administered to you by a doctor or trained medical personnel. If you have any doubts, consult your doctor, pharmacist, or nurse.
This medicine can be given by injection into the muscle (intramuscular route) or by direct injection into a vein (intravenous route).
Your doctor will decide the dose you need, when the medicine should be administered, and how long the treatment should last. This will depend on your age, body weight, medical history, other medicines you are taking, and the type and severity of your illness.
This medicine may also be administered directly into the membrane lining the joints (intrasynovial route) or into soft tissues for:

• short-term treatment of sudden episodes (acute) or flare-ups (exacerbations) of joint inflammation (such as osteoarthritic synovitis, rheumatoid arthritis, acute and subacute bursitis, acute gouty arthritis).

If you use more Desametasone Fosfato Pfizer than you should
Overdose of this medicine causes an increase in undesirable effects (see section “Possible side effects”).
In case of accidental ingestion or administration of an excessive dose of this medicine, contact your doctor immediately or go to the nearest hospital.
If you forget to use Desametasone Fosfato Pfizer
Do not take a double dose to make up for the missed dose.
If you stop using Desametasone Fosfato Pfizer
Do not stop treatment with Desametasone Fosfato Pfizer injectable solution suddenly or without first discussing it with your doctor. The dose must be gradually reduced before treatment is discontinued.
Stopping after prolonged treatment may cause fever, joint and muscle pain (arthralgia, myalgia), allergic-type cold symptoms (rhinitis), eye inflammation (conjunctivitis), itchy and painful skin nodules, and weight loss.
If you have any questions about how to use 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:

Frequency not known (frequency cannot be estimated from the available data):

• altered sodium and fluid levels in the body (sodium and water retention), reduced heart function if predisposed to heart problems (congestive heart failure), reduced potassium levels and consequent alteration of blood acidity (potassium depletion, hypokalemic alkalosis), increased calcium excretion;
• increased blood sugar levels and possible diabetes (reduced carbohydrate tolerance and onset or unmasking of latent diabetes mellitus), this condition may increase the need for insulin or oral hypoglycemic agents in diabetic patients;
• increased protein excretion (negative nitrogen balance due to protein catabolism); in case of prolonged treatment, dietary protein intake should be increased;
• weight gain and increased appetite;
• fluid retention, which may rarely lead to increased blood pressure and heart problems (congestive heart failure), especially if predisposed to such conditions;
• heart rhythm disturbances (arrhythmias), circulatory collapse, if a high dose is administered rapidly by intravenous injection;
• increased white blood cell count (leukocytosis), lymphatic system disorders;
• increased or decreased blood pressure (hypertension, hypotension), inadequate blood flow to vital organs (shock), circulatory problems (thromboembolism), blood accumulation (hematomas);
• hiccups;
• muscle weakness (muscular asthenia), muscle disorders (steroid myopathy and proximal myopathy), loss of muscle mass, bone weakening (osteoporosis), vertebral fractures (compression fractures), bone problems (aseptic necrosis of the femoral and humeral head), severe joint problems (reminiscence of Charcot's arthropathy, particularly after repeated intra-articular injections), inhibition of long bone growth (premature epiphyseal closure), bone destruction (avascular osteonecrosis);
• growth suppression in children and adolescents;
• injury, poisoning, and procedural complications such as tendon rupture, long bone fractures, bone fragility, worsening (re-activation) after direct injection into joints. Compression fractures of the vertebrae;
• development of stomach lesions (gastric ulcer) with possible perforation and bleeding (hemorrhage), intestinal lesions especially if inflamed;
• pancreatitis, abdominal distension, esophagitis with ulcer formation (ulcerative esophagitis), nausea, malaise, digestive problems (dyspepsia);
• delayed wound healing, thinning and fragility of the skin (cutaneous and subcutaneous atrophy), altered results of allergy tests (skin tests), appearance of red spots (petechiae) and bruises (ecchymoses), facial redness (erythema), increased sweating, burning and itching, especially around the anus (after intravenous injection), other skin reactions such as irritation (allergic dermatitis, urticaria), swelling of the face, lips, mouth, tongue, or throat due to fluid accumulation (angioneurotic edema), increased or decreased skin pigmentation (hyperpigmentation or hypopigmentation), increased hair growth (hirsutism), appearance of stretch marks (striae), dilation of small blood vessels (telangiectasia), acne formation and irritation (acne);
• abscesses without infection (sterile abscesses);
• seizures, increased pressure in the head (intracranial pressure), which in children is associated with swelling (pseudotumor cerebri); these effects generally occur after discontinuation of treatment;
• dizziness, headache (cephalalgia), memory problems (cognitive dysfunction, amnesia), worsening of epilepsy;
• behavioral disorders (euphoria, mood and personality changes, suicidal thoughts, psychosis), severe depression, mania, delusions, mental disorders (psychotic reactions such as hallucinations and worsening of schizophrenia), irritability, anxiety, sleep disturbances, confusion, psychological dependence (psychological need to continue using this medicine). These effects may be more likely if you have previously suffered from mental disorders;
• suppression of production of certain hormones (hypothalamic-pituitary-adrenal axis suppression), fat deposition around the shoulders and back of the neck (buffalo hump), hormonal imbalances (Cushingoid state), growth suppression in children, altered regulation of hormone production (secondary pituitary-adrenal hyporeactivity), especially under stress (e.g., trauma, surgery, or serious illness);
• menstrual cycle irregularities, absence of menstruation (amenorrhea);
• increased levels of certain liver enzymes;
• eye problems (posterior subcapsular cataract, increased pressure inside the eye (intraocular pressure), optic nerve damage (glaucoma), marked protrusion of one or both eyes (exophthalmos), eye swelling (papilledema), corneal problems (corneal or scleral thinning);
• rare cases of vision loss after administration of dexamethasone directly into lesions of the face and head;
• visual disturbances, vision loss;
• blurred vision;
• increased susceptibility and severity of infections without symptoms or signs (including opportunistic infections), reactivation of tuberculosis (onset or unmasking of latent tuberculosis), worsening of eye diseases caused by viruses or fungi, fungal infections (e.g., candidiasis);
• severe allergic reactions (anaphylaxis) or milder reactions (hypersensitivity), reduced immune system function, reduced response to vaccinations and allergy tests (skin tests).

Additional side effects in children and adolescents
If dexamethasone is administered to prematurely born children, it may cause thickening of the heart muscle (hypertrophic cardiomyopathy) (see section 2).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. 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 Desametasone Fosfato Pfizer injectable solution

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, for the product in its original unopened packaging and
correctly stored.
Store the medicine at a temperature not exceeding 25°C. Do not freeze.
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 Desametasone Fosfato Pfizer 4 mg/ml injectable suspension contains

• The active substance is sodium dexamethasone phosphate. Each millilitre contains 4.37 mg of sodium dexamethasone phosphate (equivalent to 4 mg of dexamethasone 21-phosphate).
• The other components are: creatinine, ascorbic acid, sodium citrate, methyl parahydroxybenzoate, propyl parahydroxybenzoate, water for injections.

What Desametasone Fosfato Pfizer 8 mg/2 ml contains

• The active substance is sodium dexamethasone phosphate. Each millilitre contains 4.37 mg of sodium dexamethasone phosphate (equivalent to 4 mg of dexamethasone 21-phosphate).
• The other components are: creatinine, ascorbic acid, sodium citrate, methyl parahydroxybenzoate, propyl parahydroxybenzoate, water for injections.

Description of the appearance of Desametasone Fosfato Pfizer and contents of the pack
Desametasone Fosfato Pfizer 4 mg/ml
Pack size: 3 or 10 vials.
Desametasone Fosfato Pfizer 8 mg/2 ml
Pack size: 1 or 10 vials.
It is possible that not all pack sizes are marketed.

Marketing Authorization Holder
Pfizer Italia S.r.l. – Via Isonzo, 71 – 04100 Latina – Italy

Manufacturer
Biologici Italia Laboratories S.R.L. - Via Filippo Serpero 2 – Masate (MI) - Italy

The following information is intended exclusively for healthcare professionals:

Special Warnings and Precautions for Use
Live vaccines must not be administered to individuals with impaired immune response. Antibody response to other vaccines may be reduced.

In patients who have received systemic corticosteroid doses exceeding physiological levels (approximately 1 mg of dexamethasone) for more than 3 weeks, treatment must not be discontinued abruptly. Gradual dose reduction depends on the risk of disease flare-up, clinical assessment of disease activity during withdrawal, and the potential degree of HPA axis suppression. When the daily dose reaches 1 mg, dose tapering should proceed more slowly to allow full recovery of HPA axis function.

Abrupt discontinuation of doses up to 6 mg/day of dexamethasone after treatment courses lasting up to 3 weeks is unlikely to result in clinically significant HPA axis suppression; however, there are certain patient groups in whom gradual withdrawal is advisable even after treatment durations of 3 weeks or less. These include patients receiving repeated courses of systemic corticosteroids, patients treated with short-term therapy within one year of stopping chronic therapy, patients with other disorders causing adrenal insufficiency, patients receiving daily doses up to 6 mg of dexamethasone, and patients chronically treated with evening doses.

A rapid decrease in corticosteroid dosage after prolonged treatment may cause acute adrenal insufficiency, hypotension, and death. Discontinuation of corticosteroids after chronic therapy may lead to symptoms (corticosteroid withdrawal syndrome) such as fever, myalgia, arthralgia, rhinitis, conjunctivitis, pruritic and painful cutaneous nodules, and weight loss. These symptoms may occur even in patients without signs of adrenal insufficiency.

During chronic therapy, any intercurrent illness, trauma, or surgical procedure requires a temporary increase in dosage; if corticosteroid therapy has been discontinued after prolonged treatment, temporary reinstatement of therapy may be necessary.

Anaphylactic reactions have occasionally been reported in patients treated with systemic corticosteroids. In the event of such reactions, the following measures are recommended: immediate slow intravenous injection of adrenaline, intravenous administration of aminophylline, and, if necessary, artificial respiration.

Corticosteroids must not be used in the management of traumatic brain injury or stroke, as their clinical benefit is uncertain and they may even be hazardous to the patient.

When treating tendinitis or tenosynovitis, care must be taken during injection into the space between the sheath and the tendon itself, as cases of tendon rupture have been reported.

Interactions
Prothrombin time and INR must be monitored frequently to avoid spontaneous bleeding in patients receiving corticosteroids and coumarin anticoagulants concomitantly, as corticosteroids have in some cases altered the response to these anticoagulants. Some studies have shown that the usual effect of adding corticosteroids is inhibition of response to coumarin compounds, although conflicting reports have indicated enhancement.

Dosage, Method, and Timing of Administration
The preparation may be injected directly from the vial without mixing or dilution. Alternatively, it may be added, without loss of efficacy, to injectable sodium chloride, injectable dextrose, or compatible transfusion blood, and administered by slow intravenous infusion. When 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 must be observed. Parenteral dosage is typically one-third to one-half of the oral dose administered every 12 hours. However, in certain acute emergency situations where the patient's life is at risk, doses higher than the usual dosage may be justified, potentially reaching multiples of the oral doses. The initial dosage should be maintained unchanged or appropriately adjusted until a satisfactory response is achieved. If no satisfactory clinical response is observed after a reasonable period, treatment with Desametasone Fosfato Pfizer injectable solution should be discontinued and alternative appropriate therapy initiated. It is important to emphasize that dosage requirements are variable and must be individualized according to the disease and the patient's response. Once a favorable response is obtained, the appropriate maintenance dosage should be determined by gradually reducing the initial dosage in small increments at appropriate intervals until the minimum effective dose required to maintain the desired clinical response is reached. Dosage must be adjusted based on continuous clinical monitoring. Situations that may necessitate dosage adjustments include changes in clinical status due to remission or exacerbation of the disease, individual patient response, and the effect of patient exposure to stress situations not directly related to the disease; in the latter case, the dosage of Desametasone Fosfato Pfizer injectable solution may need to be maintained for a period varying according to the patient's condition. When the drug has been administered for more than a few days, treatment discontinuation must be gradual and not abrupt.

Intravenous and Intramuscular Injection: Whenever possible, the intravenous route should be used for both the initial dose and all subsequent doses while the patient is in shock (because in such patients, any other route of administration results in irregular absorption rates regardless of the drug). 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 cases, the usual dose for intravenous or intramuscular injection is 1–5 ml (4–20 mg), depending on disease severity (see also Shock). This dose may be repeated until an adequate response is observed. After initial improvement, single doses of 0.5–1 ml (2–4 mg) may be sufficient, repeated as needed. The total daily dosage should generally not exceed 20 ml (80 mg), even in severe cases. When a sustained maximum effect is desired, administration should be repeated every 3–4 hours or performed via continuous intravenous infusion. Intravenous and intramuscular injections are indicated in acute diseases. After the acute phase, transition to oral steroid therapy should be made as soon as possible.

Shock: The usual dose is 2–6 mg/kg body weight administered as a single intravenous injection. If shock persists, this dose may be repeated within 2–6 hours. Alternatively, Desametasone Fosfato Pfizer 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 Desametasone Fosfato Pfizer injectable solution is complementary and not a substitute for conventional therapy.

These recommendations reflect the current medical practice trend of using high (pharmacological) doses of corticosteroids in shock treatment. The following dosage regimens have been suggested by various authors:

• Cavanagh: 3 mg/kg body weight by continuous intravenous infusion for 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 those usually recommended for injectable dexamethasone phosphate; however, they are intended for emergency situations and acute conditions requiring high pharmacological doses. Administration of corticosteroids at high doses should be continued only until patient stabilization is achieved, generally for no longer than 48–72 hours. Prolonged therapy at these high doses should be avoided to prevent potential complications such as adrenal insufficiency or gastrointestinal ulceration.

Acute stroke-associated cerebral edema: initially 10 mg (2.5 ml) of Desametasone Fosfato Pfizer 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 subsequent 7 days.

Associated with treatment of primary or metastatic brain tumors, neurosurgical procedures, head trauma, pseudotumor cerebri, or preoperative preparation in patients with increased intracranial pressure due to brain tumor: initially 10 mg (2.5 ml) of Desametasone Fosfato Pfizer injectable solution administered intravenously, followed by 4 mg (1 ml) intramuscularly every 6 hours until symptoms of cerebral edema resolve. Response is typically 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 Desametasone Fosfato Pfizer injectable solution or dexamethasone phosphate tablets. A dosage of 2 mg 2–3 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 observed. Consideration should be given to prescribing antacids, anticholinergics, and dietary measures to prevent gastrointestinal ulcers or hemorrhage.

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 antibiotic doses, must 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, in which parenteral and oral therapy are administered in combination:

The aim of this regimen is to provide adequate therapy during acute episodes while at the same time
minimizing the risk of overdosage in chronic cases. In some patients, it is sufficient on its own to achieve
disease control. Other patients 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 the recurrence of symptoms in this latter group of patients, the physician can more easily decide on the appropriateness of prescribing further treatment. In exacerbations of asthma 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 routinely adopted. Although they have a favorable effect on symptoms, they absolutely do not constitute a cure, since the hormone has no effect on the underlying cause of inflammation. The following are some commonly used single doses:
The frequency of injection varies from once every 3–5 days to once every 2–3 weeks, depending on the response to treatment.
For further information, consult the Summary of Product Characteristics.