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نشرة الممارس الصحي نشرة معلومات المريض بالعربية نشرة معلومات المريض بالانجليزية صور الدواء بيانات الدواء
  SFDA PIL (Patient Information Leaflet (PIL) are under review by Saudi Food and Drug Authority)

Dexamethasone Sodium Phosphate belongs to a group of medicines called steroids.Their full name is corticosteroids.

Corticosteroids occur naturally in the body that help to maintain health and well-being. Boosting your body with extra corticosteroid,such as Dexamethasone, is an effective way to treat various illnesses involving inflammation in the body. Dexamethasone reduces inflammation, which could otherwise go on making your condition worse. You must take this medicine regularly to get maximum benefit from it.

Dexamethasone Sodium Phosphate is a steroid which is used to:

- Treat acute adrenocortical insufficiency and other conditions that respond to steroid therapy

- Treat shock caused by excessive bleeding, serious injury, before and after surgery

- Treat allergic conditions which occur suddenly, such as swelling of the face, neck and throat and acute deterioration of long term conditions such as bronchial asthma or serum sickness

- Treat inflammation of the joints e.g. rheumatoid arthritis


Do not use this product:

- You are allergic to dexamethasone or any other ingredients in this medicine Tof this medicine, (listed in section 6).

- infection affecting the whole body (unless you are taking appropriate antibiotics)

- infection at the injection site, particularly in the joint where Dexamethasone Sodium Phosphate will be injected (unless you are taking the appropriate antibiotic).

- unstable joints (this is a condition where joints, such as knee, can suddenly give way), where Dexamethasone Sodium Phosphate Solution for Injection will be injected.

-stomach ulcer.

- Active tuberculosis

- Acute psychosis (a form of mental condition)

- You have a severe allergy to sulfites

Contact your doctor if you experience blurred vision or other visual disturbances.

Check with your doctor first:

- If you have ever had severe depression or manic depression (bipolar disorder). This includes having had depression before while taking steroid medicines like Dexamethasone Sodium Phosphate.

- If any of your close family has had these illnesses.

If either of these applies to you, talk to a doctor before taking Dexamethasone Sodium Phosphate.

Warnings and precautions:

Talk to your doctor before using Dexamethasone Sodium Phosphate:

- if you have symptoms of tumour lysis syndrome such as muscle cramping, muscle weakness, confusion, visual loss or disturbances and shortness of breath, in case you suffer from haematological malignancy.

- if you suffer from or have suffered from head injury or stroke.

- if you suffer from or have suffered from heart problems, kidney problems, liver problems, high blood pressure, epilepsy or migraine.

- if you have a stomach ulcer.

- if you suffer from osteoporosis (post-menopausal women are at particular risk).

- if you have low output from the thyroid (hypothyroid).

- if you have had tuberculosis in the past.

- if you suffer from a specific infection called amoebiasis.

- if you have a herpes infection of the eye.

- if you suffer or have suffered from, or have a family history of schizophrenia or psychiatric disorders (especially previous steroid psychosis), affective disorders; depressive, manic-depressive or psychotic illness.

- if you have diabetes or a family history of diabetes.

- if you suffer from glaucoma or have a family history of glaucoma (increased pressure in the eye).

- if you suffer from muscle weakness caused by steroids.

- if you have measles.

- in premature babies.

- in children.

- if you are elderly.

- if you take a repeat course, or have taken a recent or current course of corticosteroids, or take repeat evening doses.

- if you have adrenocortical insufficiency.

- if you are taking high doses of corticosteroids (more than 6 mg per day).

- if you have had exposure to chicken pox, varicella virus or measles.

- if you have an illness, suffered trauma or have had surgery whilst taking this product as you might have false negative lab test results for bacterial infection when taking this product as severe infections may be masked.

- if you suffer from Cushing’s syndrome.

- if you have stunted growth.

- if you have an inflammation of a tendon or of the fluid-filled sheath that surrounds the tendon.

- if you have been diagnosed with Acute Respiratory.

Mental problems while having Dexamethasone Sodium Phosphate:

Mental health problems can happen while having steroids like Dexamethasone (see also section 4 Possible Side Effects). 

- These illnesses can be serious

- Usually they start within a few days or weeks of starting the medicine

- They are more likely to happen at high doses

- Most of these problems go away if the dose is lowered or the medicine is stopped. However, if problems do happen, they might need treatment

Talk to a doctor if you (or someone taking this medicine), show any signs of mental problems. This is particularly important if you are depressed, or might be thinking about suicide. In a few cases, mental problems have happened when doses are being lowered or stopped.

Children:

Special care should be taken if Dexamethasone Sodium Phosphate Solution for Injection is to be given to babies or children.

Dexamethasone should not be used routinely in preterm neonates with respiratory problems.

The lowest effective dose of corticosteroid should be used to control the condition under treatment for the minimum period.

Other medicines and Dexamethasone Sodium Phosphate for Injection:

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

In particular the following may affect the use of dexamethasone phosphate:

- barbiturates (medicines for treating sleep disorders and epilepsy).

- ephedrine (a medicine that is used as a nasal decongestant or for respiratory conditions).

- rifampicin and rifabutin ( antibiotics used in the treatment of TB).

- carbamazepine, phenytoin or primidone(drugs used in the treatment of epilepsy).

- aminoglutethimide (anti-cancer medicine).

- drugs used to thin the blood (anti-coagulants) – your prothrombin time may need to be monitored more frequently.

- drugs used to treat diabetes (hypoglycaemic agents and insulin).

- salicylates, including aspirin.

- phenylbutazone, non-steroidal anti-inflammatory drugs (pain-killers).

- some water tablets (diuretics).

- carbenoxolone (medicine for treating stomach ulcers).

- specific heart drugs such as cardiac glycosides (e.g. digoxin).

- medicines used to treat high blood pressure (antihypertensives).

- vaccinations – some vaccines (live vaccines) should not be used and the response to other vaccines may be altered.

- acetazolamide (medicine used to treat glaucoma).

- anticholinesterases (medicines used in the treatment of myasthenia gravis).

- Some medicines may increase the effects of Dexamthasone Phosphate Solution and your doctor may wish to monitor you carefully if you are taking these medicines (including some medicines for HIV: ritonavir, cobicistat).

Pregnancy, breast-feeding and fertility:

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. You should only be given Dexamethasone Sodium Phosphate if your doctor thinks it is essential, as it may cause birth or growth defects and hormonal problems in the baby, especially if given in high doses for a long time.

Driving and using machines:

Do not drive or use machines if you experience any side effects which may lessen your ability to do so.

Dexamethasone Sodium Phosphate for Injection contains sodium and sulfites.

Sodium metabisulphite may rarely cause severe hypersensitivity reactions and  bronchospasm.


Dexamethasone Sodium Phosphate may be given into a vein (iv), a muscle (im), or into an affected joint or soft tissue (tendon sheath or ganglion).

The usual iv or im dose is between 0.5 and 24 mg daily but the dose used will usually depend on how serious your condition is, your body weight and your response to the treatment.

If the injection is being given into a joint or soft tissue, the dose will vary between 0.4 and 6 mg and may be repeated every 3 to 5 days for soft tissues or every 2 to 3 weeks for joints.

As this medicine will be given to you by a healthcare professional, it is unlikely that you will be given too little or too much; however, tell your doctor or pharmacist if you have any concerns.

Your doctor will monitor the dose frequently to make sure you are getting the correct dose for your condition. The treatment should not be stopped suddenly without your doctor telling you to do so.

If you receive Dexamethasone Sodium Phosphate injection into a joint or soft tissue, your doctor will advise you to not overuse the joint. The inflammation in the joint may still be present even though the pain in the joint may be reduced.

If you have any further questions on the use of this product, ask your doctor.


Like all medicines, this medicine can cause side effects, although not everybody gets them. The severity and significance of the side effects vary with the dose and the length of time the drug was used.

If any of the following happen, tell the doctor immediately:

- severe allergic reaction (hypersensitivity) - you may experience a sudden itchy rash (hives), swelling of the hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty in swallowing or breathing), and you may feel you are going to faint

- glaucoma. If you have any severe eye pain, especially if it occurs with vomiting, or seeing haloes around lights, obtain medical attention at once.

Serious effects: tell a doctor straight away:

Steroids including Dexamethasone Sodium Phosphate can cause serious mental health problems. These are common in both adults and children. They can affect about 5 in every 100 people taking medicines like dexamethasone.

- Feeling depressed, including thinking about suicide.

- Feeling high (mania) or moods that go up and down.

- Feeling anxious, having problems sleeping, difficulty in thinking or being confused and losing your memory.

- Feeling, seeing or hearing things which do not exist. Having strange and frightening thoughts, changing how you act or having feelings of being alone.

If you notice any of these problems talk to a doctor straight away.

High doses of Dexamethasone Sodium Phosphate are intended for short term therapy and therefore adverse reactions are uncommon.

Visual disturbance, blurred vision and loss of vision may occur, but the frequency is not known

However, stomach ulceration (abdominal pain) and severe breathlessness may occur even with use over a short time.

Joint problems such as pain, inflammation and infection may occur where the dexamethasone phosphate injection has been made into a joint.

Be careful not to overuse your joints if you have been given dexamethasone phosphate to relieve symptoms in them, as the inflammatory process that causes the pain may still be there.

Prolonged use of this product may cause:

- Influence on hormones (hypothalamic-pituitary-adrenal axis) may cause:

- lowered response to stress (such as surgery or trauma) showing as weakness, fatigue, muscle pain, light-headedness.

- sodium and water retention.

- increased blood pressure.

- increased loss of potassium, calcium and protein.

- muscle cramps which may be due to low potassium and changed blood acidity

- increased sweating.

- increased appetite and weight gain.

- high blood sugar with increased need for anti-diabetic drugs.

- changes in facial appearance (moon face due to Cushing-like condition).

- excessive body hair growth.

- irregularity in the menstrual cycle (periods) or complete absence of periods

- Eye problems including cataracts, eye infections and glaucoma

- Blindness associated with injecting the product directly into lesions around the face and neck.

- Muscular weakness, wasting and pain, brittleness of bones (osteoporosis and osteonecrosis) which may increase likelihood of breaks or fractures.

- Tendon rupture.

- Increased chance of picking up infections and mild infections may be more severe with the symptoms being less obvious.

- Recurrence of previous tuberculosis (TB).

- The long bones in children may not grow fully if the drug is used for a long time so that growth in infants, children and adolescents may be reduced.

- Stomach ulcers which may perforate or bleed - tell your doctor if you begin to notice heartburn or stomach pains.

- Ulcers of the food-pipe (oesophageal ulcerations).

- Sudden or gradual pain in the upper middle or upper left part of the abdomen (pancreatitis).

- Pain in the upper abdomen, bloating and feeling full (dyspepsia).

- White spots (yeast infections) in the mouth or throat.

- Thinning of the skin and increased bruising.

- The skin may appear lighter or darker.

- Wounds may heal more slowly and red marks may appear on the skin.

- Burning, tingling, itching, acne and yeast infections (candidiasis or thrush) of the skin may occur.

- Burning or tingling sensation around the genitals and anus.

- Allergic dermatitis.

- Reduced reaction to skin tests and vaccinations.

- Increased pressure in the brain with specific eye signs (papilledema) in children.

- Abscesses that are not due to infection.

- Charcot-like arthropathy (breakdown of weight-bearing joints).

- Blood clots that may be local or spread.

- Swelling caused by fluid under the skin (oedema).

- Mental disturbances, schizophrenia may get worse, psychological dependence, euphoria, depression, insomnia, headache, convulsions (epilepsy may get worse) and vertigo may happen after stopping treatment.

Tests may also show increased white blood cell counts.

If you or your carer notices any worrying psychological symptoms develop such as feeling depressed or suicidal, please tell your doctor immediately.

Withdrawal:

Suddenly stopping treatment (withdrawal) after prolonged treatment (greater than three weeks) or large doses can have very serious consequences. The symptoms that you may get with ‘withdrawal syndrome’ are fever, muscle aches, joint pains, runny nose, red eyes, painful itchy skin lumps, and weight loss. Stopping too quickly may lead to insufficient adrenal hormones, low blood pressure and death.

Psychiatric reactions may occur on withdrawal of corticosteroids, including affective disorders (such as being irritable, euphoric, depressed, having severe mood swings or suicidal thoughts), psychotic reactions (including being manic, having delusions or hallucinations and aggravation of schizophrenia), changes in behaviour, feeling irritable or anxious, having disturbed sleep, feeling confused or having amnesia.

If you or your carer notices any psychiatric reactions that may occur either during or immediately after reducing the amount, or stopping treatment of steroids, please tell your doctor.


- Keep out of the reach and sight of children.

- Store at temperature not exceeding 30°C.

- Do not use after the expiry date which is stated on the pack.

- Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.


-  The active ingredient: is dexamethasone sodium phosphate.

Each ampoule contains 8 mg dexamethasone phosphate (as disodium salt).

- Inactive ingredients: Creatinine, sodium citrate, sodium metabisulphite, methyl paraben, propyl paraben, sodium hydroxide, water for injection


Package: Carton box containing 5, 100 ampoules.

Egyptian International Pharmaceutical Industries Company, E.I.P.I.CO.


November 2020
  نشرة الدواء تحت مراجعة الهيئة العامة للغذاء والدواء (اقرأ هذه النشرة بعناية قبل البدء في استخدام هذا المنتج لأنه يحتوي على معلومات مهمة لك)

ينتمي ديكساميثازون صوديوم فوسفات إلى مجموعة من الأدوية تسمى ستيرويدات و تسمي كاملاً بالكورتيكوستيرويدات. الكورتيكوستيرويدات توجد بشكل طبيعي في الجسم و تساعد على إبقاء الجسم سليما معافى.إن إعطاء جسمك كورتيكوستيرويدات إضافية، مثل ديكساميثازون، تعتبر وسيلة فعالة لعلاج الأمراض المختلفة بما في ذلك الإلتهابات. إن ديكساميثازون يقلل من الإلتهاب، والذي يمكن أن أن يجعل حالتك أسوأ. يجب أن تأخذ هذا الدواء بانتظام للحصول على الفائدة القصوى منه.

ديكساميثازون صوديوم فوسفات هو ستيرويد يستخدم في:

- علاج قصور قشرة الكظرية الحاد والحالات الأخرى التي تستجيب للعلاج بالستيرويدات.

- علاج الصدمة الناتجة عن النزيف الشديد والإصابة الخطيرة قبل الجراحة وبعدها.

- علاج حالات الحساسية التي تحدث فجأة، مثل تورم الوجه، العنق والحلق والتدهور الحاد للحالات طويلة الأمد مثل الربو القصبي أو داء المصل.

-علاج التهاب المفاصل مثل التهاب المفصل الروماتويدي.

لا تأخذ هذا الدواء:

إذا كنت تعاني من أي من الحالات التاليه:

- إذا كان لديك حساسية من ديكساميثازون أو من أي من المكونات الأخرى بهذا الدواء (المدرجة في القسم ٦).

- العدوى التي تصيب الجسم كله (إلا إذا كنت تتناول المضادات الحيوية المناسبة).

- عدوى في موقع الحقن، وخاصة في المفصل حيث سيتم حقن ديكساميثازون صوديوم فوسفات (إلا إذا كنت تتناول المضاد الحيوي المناسب)

- المفاصل غير المستقرة (في هذه الحالة يمكن للمفاصل مثل الركبة  أن تتهاوي)، حيث يتم حقن محلول ديكساميثازون صوديوم فوسفات .

- قرحة المعدة.

- مرض السل النشط.

- الذهان الحاد (شكل من أشكال الحالة العقلية).

- لديك حساسية شديدة من سالفيت.

تحقق مع طبيبك أولا:

- إذا كان سبق لك أن عانيت من الإكتئاب الشديد أو الهوس الإكتئابي، ويشمل هذا الإصابة بالإكتئاب أثناء أو قبل العلاج بالستيرويدات مثل ديكساميثازون صوديوم فوسفات .

- إذا كان أي من أفراد عائلتك سبق له الإصابة بأي من الأمراض السابقة.

إذا كان أي من الحالات السابقة ينطبق عليك، تحدث إلى الطبيب قبل اخذ الدواء.

التحذيرات و الاحتياطات

تحدث إلى طبيبك قبل أخذ الدواء:

- إذا كنت تعاني من أعراض متلازمة انحلال الورم مثل تقلصات العضلات، ضعف العضلات، الارتباك، فقدان البصر أو اضطرابات وضيق في التنفس، في حال كنت تعاني من أمراض الدم الخبيثه.

- إذا كنت تعاني أو عانيت من إصابة في الرأس أو سكتة دماغية.

- إذا كنت تعاني أو عانيت من مشاكل في القلب، الكلى، الكبد، ارتفاع في ضغط الدم، صرع أو صداع نصفي

- إذا كنت تعاني من قرحة في المعدة.

- إذا كنت تعاني من هشاشة العظام (النساء بعد انقطاع الطمث معرضات لخطر خاص).

- إذا كان تعاني من إنخفاض إنتاج الغدة الدرقية (قصور الغدة الدرقية).

- إذا كنت سبق لك أن أصبت بمرض السل.

- إذا كنت تعاني من عدوى معينة تسمى داء الأميبات.

- إذا كنت تعاني من عدوى الهربس في العين.

- إذا كنت تعاني أو عانيت أو لديك تاريخ عائلي من الفصام أو الاضطرابات النفسية (خاصة الذهان الستيرويدي السابق) ، الاضطرابات العاطفية؛ الاكتئاب، الهوس الاكتئابي أو مرض ذهاني.

- إذا كنت تعاني من مرض السكري أو لديك تاريخ عائلي من الإصابة بمرض السكري.

- إذا كنت تعاني من الجلوكوما أو لديك تاريخ عائلي من الإصابة بالجلوكوما (زيادة الضغط في العين).

- إذا كنت تعاني من ضعف بالعضلات ناجم عن الستيرويدات.

- إذا كنت مصابًا بالحصبة.

- في الأطفال الخدج.

- في الأطفال.

- إذا كنت مسناً.

- إذا قمت بتكرار، أو أخذت العلاج مؤخراً أو تأخذ حالياً كورتيكوستيرويدات، أو تأخذ جرعات متكرره  مساء.

- إذا كنت تعاني من قصور في قشرة الكظرية.

- إذا كنت تأخذ جرعات عالية من الكورتيكوستيرويدات (أكثر من ٦ مجم في اليوم).

- إذا كنت قد تعرضت لجدري الماء أو فيروس فيرسيلا أو الحصبة.

- إذا كنت تعاني من مرض، أو تعرضت لصدمة أو خضعت لعملية جراحية أثناء أخذ هذا الدواء، فقد تكون لديك نتائج اختبار مخبرية سلبية خاطئة للعدوى البكتيرية عند أخذ هذا الدواء حيث قد يتم إخفاء العدوى الشديدة.

- إذا كنت تعاني من متلازمة كوشينغ.

- إذا كانت تعاني من من توقف في النمو.

- إذا كانت تعاني من التهاب في الوتر أو في الغمد المملوء بالسوائل الذي يحيط بالوتر.

- إذا تم تشخيص إصابتك بمتلازمة الضيق التنفسي الحاد(ARDS ، مرض رئوي خطير) لأكثر من أسبوعين.

المشاكل العقليه أثناء العلاج بديكساميثازون :

يمكن أن تواجه مشاكل في الصحة العقلية أثناء العلاج بالستيرويدات مثل ديكساميثازون (أنظر فقره٤: ما هي الأعراض الجانبية المتوقعة).

- يمكن لهذه الأمراض أن تكون خطيرة.

- عادة ما تبدأ في غضون بضعة أيام أو أسابيع من بدء العلاج.

-  تحدث غالباً عند اخذ جرعات عالية.

- تختفي معظم هذه المشاكل إذا تم خفض الجرعة أو إيقاف الدواء. مع ذلك، إذا حدثت هذه المشاكل، فإنها قد تحتاج إلى علاج.

تحدث إلى الطبيب إذا كنت أنت (أو أي شخص أخر) قام بأخذ هذا الدواء، وقد ظهرت عليك أي علامات على حدوث مشاكل عقلية.  هذا يعتبر شيء ضروري خاصة إذا كنت مكتئب، أو قد تفكر في الانتحار. في عدد قليل من الحالات، يمكن أن تحدث مشاكل عقلية عند خفض الجرعات أو إيقاف العلاج.

الأطفال

يجب توخي الحذر بشكل خاص إذا كان سيتم إعطاء محلول ديكساميثازون صوديوم فوسفات للرضع أو الأطفال.

لا ينبغي استخدام ديكساميثازون صوديوم فوسفات بشكل روتيني عند الخدج المصابين بمشاكل في الجهاز التنفسي.

يجب استخدام أقل جرعة فعالة من الكورتيكوستيرويد للتحكم في الحالة تحت العلاج لأدنى فترة.

الأدوية الأخرى ديكساميثازون صوديوم فوسفات : 

يرجى إخبار طبيبك إذا كنت تأخذ أو أخذت مؤخرًا أي أدوية أخرى، بما في ذلك الأدوية التي تم الحصول عليها بدون وصفة طبية.

على وجه الخصوص، قد يؤثر ما يلي على استخدام ديكساميثازون صوديوم فوسفات:

- الباربيتورات (أدوية لعلاج اضطرابات النوم والصرع).

- الايفيدرين (دواء يستخدم كمزيل لاحتقان الأنف أو لأمراض الجهاز التنفسي).

- ريفامبيسين وريفابوتين (مضادات حيوية تستخدم في علاج السل).

- كاربامازيبين، فينيتوين أو بريميدون (الأدوية المستخدمة في علاج الصرع).

- أمينوجلوتيثيميد (دواء مضاد للسرطان).

- الأدوية المستخدمة لترقيق الدم (مضادات التجلط) - قد تحتاج إلى مراقبة وقت البروثرومبين بشكل متكرر.

- الأدوية المستخدمة في علاج مرض السكري (الادويه المستخدمه لخفض سكر الدم والأنسولين).

- الساليسيلات بما في ذلك الأسبرين.

- فينيل بوتازون، الأدوية غير الستيرويدية المضادة للالتهاب (مسكنات الآلام).

- بعض مدرات البول.

- كاربينوكسولون (دواء لعلاج قرحة المعدة).

- أدوية للقلب محددة مثل الجليكوسيدات القلبية (مثل الديجوكسين).

- الأدوية المستخدمة في علاج ارتفاع ضغط الدم (الأدوية الخافضة للضغط).

- التطعيمات - يجب عدم استخدام بعض اللقاحات (لقاحات حية) وقد تتغير الاستجابة للقاحات الأخرى.

- أسيتازولاميد (دواء يستخدم لعلاج الجلوكوما).

- مضادات الكولينستراز (الأدوية المستخدمة في علاج الوهن العضلي الشديد).

- قد تزيد بعض الأدوية من تأثير محلول ديكساميثازون صوديوم فوسفات وقد يرغب طبيبك في مراقبتك بعناية إذا كنت تتناول هذه الأدوية (بما في ذلك بعض أدوية فيروس نقص المناعة البشرية: ريتونافير، كوبيسيستات).

الحمل، الرضاعة الطبيعية والخصوبة

إذا كنت حاملاً أو تقومين بالرضاعه الطبيعيه، تعتقدين أنك حاملا أو تخططين للإنجاب، استشيري طبيبك قبل اخذ هذا الدواء. يجب أن تأخذ ديكساميثازون صوديوم فوسفات فقط إذا كان طبيبك يعتقد أنه ضروري، لأنه قد يسبب عيوب خلقية أو عيوب في النمو ومشاكل هرمونية عند الطفل، خاصة إذا تم إعطاؤه بجرعات عالية لفترة طويلة.

القيادة و العمل أمام الآلات:

لا تقوم بقياده السيارة أو تستخدم الآلات إذا واجهت أي أعراض جانبية قد تقلل من قدرتك على القيام بذلك.

يحتوي ديكساميثازون صوديوم فوسفات على صوديوم وسالفيت.

نادرا ما يسبب صوديوم ميتا باي سالفيت رد فعل تحسسي شديد وتشنج قصبي.

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يمكن إعطاء ديكساميثازون صوديوم فوسفات في الوريد (حقن وريدي) أو العضل (حقن عضلي) أو في المفصل المصاب أو الأنسجة الرخوة (غمد الوتر أو العقد العصبيه).

تتراوح الجرعة المعتادة في الحقن الوريدي أو العضلي بين ٠٫٥ و ٢٤ مجم يوميًا ولكن الجرعة المستخدمة ستعتمد عادةً على مدى خطورة حالتك و وزن جسمك واستجابتك للعلاج.

إذا تم إعطاء الحقن في مفصل أو أنسجة رخوة، فستتراوح الجرعة بين ٠٫٤ و ٦ مجم ويمكن تكرارها كل ٣ إلى ٥ أيام للأنسجة الرخوة أو كل أسبوعين إلى ثلاثة أسابيع للمفاصل.

نظرًا لأن هذا الدواء سيتم إعطاؤه لك من قبل أخصائي رعاية صحية، فمن غير المرجح أن تحصل على جرعة قليلة جدًا أو أكثر من اللازم؛ ومع ذلك، أخبر طبيبك أو الصيدلي إذا كان لديك أي مخاوف.

سيراقب طبيبك الجرعة بشكل متكرر للتأكد من حصولك على الجرعة الصحيحة لحالتك. لا ينبغي إيقاف العلاج فجأة دون أن يطلب منك طبيبك القيام بذلك.

إذا أخذت ديكساميثازون صوديوم فوسفات في مفصل أو نسيج رخو، فسوف ينصحك طبيبك بعدم الإفراط في استخدام المفصل. قد يظل الالتهاب في المفصل موجودًا على الرغم من قلة الألم في المفصل.

إذا كان لديك أي أسئلة أخرى حول كيفية استخدام هذا الدواء، اسأل طبيبك.

مثل جميع الأدوية ، يمكن أن يسبب هذا الدواء أعرض جانبية، على الرغم من عدم حدوثها لدى الجميع. تختلف شدة الأعراض الجانبية وأهميتها باختلاف الجرعة وطول مدة استخدام الدواء.

في حالة حدوث أي مما يلي، أخبر الطبيب على الفور:

- رد فعل تحسسي شديد (فرط الحساسية) - قد تعاني من طفح جلدي مفاجئ وحكة (ارتيكاريا)، تورم في اليدين، القدمين، الكاحلين، الوجه، الشفتين، الفم أو الحلق (مما قد يسبب صعوبة في البلع أو التنفس)، وقد تشعر انك سوف تفقد الوعي

- جلوكوما. إذا كنت تعاني من ألم شديد في العين، خاصة إذا حدث مع القيء، أو رؤية هالات حول الأضواء، احصل على رعاية طبية في الحال.

اعراض خطيرة: اخبر الطبيب علي الفور:

يمكن أن تسبب الستيرويدات بما في ذلك الديكساميثازون مشاكل صحية عقلية خطيرة. هذه شائعة في كل من البالغين والأطفال. يمكن أن تؤثر على حوالي ٥ أشخاص من كل ١٠٠ شخص يتناولون أدوية مثل ديكساميثازون صوديوم فوسفات.

- الشعور بالاكتئاب، بما في ذلك التفكير في الانتحار.

- الشعور بالإنتشاء(الهوس) أو الحالة المزاجية التي ترتفع وتنخفض.

- الشعور بالقلق، صعوبة في النوم، صعوبة في التفكير أو تشوش وفقدان الذاكرة.

- الشعور أو رؤية أو سماع أشياء غير موجودة. وجود أفكار غريبة ومخيفة أو تغيير طريقة تصرفك أو الشعور بالوحدة.

إذا لاحظت أيًا من هذه المشاكل التاليه، تحدث إلى الطبيب على الفور.

الجرعات العالية من الديكساميثازون مخصصة للعلاج قصير الأمد، وبالتالي فإن ردود الفعل السلبيه غير شائعة.

قد يحدث اضطراب بصري وتشوش الرؤية وفقدان الرؤية، لكن التردد غير معروف.

مع ذلك، قد تحدث تقرحات في المعدة (ألم في البطن) وضيق شديد في التنفس حتى مع الاستخدام لفترة قصيرة.

قد تحدث مشاكل في المفاصل مثل الألم والالتهاب والعدوى حين يتم حقن ديكساميثازون صوديوم فوسفات في المفصل.

احرص على عدم الإفراط في استخدام مفاصلك إذا تم إعطاؤك ديكساميثازون صوديوم فوسفات لتخفيف الأعراض فيها، حيث قد تظل الالتهابات التي تسبب الألم موجودة.

قد يؤدي الاستخدام المطول لهذا المنتج إلى:

- قد يؤثر علي الهرمونات (الغدة النخامية- محور الغدة الكظرية ) إلى:

- انخفاض الاستجابة للتوتر (مثل الجراحة أو الصدمة) التي تظهر على شكل ضعف، تعب، آلام في العضلات، دوار خفيف.

- احتباس الماء والصوديوم.

- إرتفاع ضغط الدم.

- زيادة فقدان البوتاسيوم والكالسيوم والبروتين.

- تقلصات عضلية قد تكون ناجمة عن انخفاض البوتاسيوم وتغير حموضة الدم.

- زيادة التعرق.

- زيادة الشهية وزيادة الوزن.

- ارتفاع نسبة السكر في الدم مع زيادة الحاجة إلى الأدوية المضادة للسكري.

- تغيرات في مظهر الوجه (وجه القمر بسبب حالة تشبه حالة كوشينغ).

- نمو شعر الجسم بشكل مفرط.

- عدم انتظام الدورة الشهرية (فترات) أو الغياب التام للدورة.

- مشاكل بالعين بما في ذلك إعتام عدسة العين والتهابات العين و الجلوكوما.

- العمى المصاحب لحقن الدواء مباشرة في الجروح حول الوجه والرقبة.

- ضعف العضلات، هزال وألم، وهشاشة العظام(هشاشة العظام ونخر العظام)مما قد يزيد من احتمالية حدوث شروخ أو كسور

- تمزق الاوتار.

- زيادة فرصة الإصابة بالعدوى وقد تكون العدوى الخفيفة أكثر حدة وتكون الأعراض أقل وضوحًا.

- تكرار الإصابة بمرض السل السابق (TB).

- قد لا تنمو العظام الطويلة عند الأطفال بشكل كامل إذا تم استخدام الدواء لفترة طويلة بحيث يمكن تقليل النمو عند الرضع والأطفال والمراهقين.

- قرح في المعدة قد تكون مثقوبة أو تنزف - أخبر طبيبك إذا بدأت في ملاحظة حرقان أو آلام في المعدة.

- قرح بالأنبوب الغذائي (تقرحات المريء).

- ألم مفاجئ أو تدريجي في الجزء العلوي الأوسط أو الأيسر العلوي من البطن (التهاب البنكرياس).

- ألم في الجزء العلوي من البطن، انتفاخ وشعور بالشبع (عسر الهضم).

- بقع بيضاء (عدوى فطريه) في الفم أو الحلق.

- ترقق الجلد وزيادة الكدمات.

- قد يبدو الجلد أفتح أو أغمق.

- قد تلتئم الجروح بشكل أبطأ وقد تظهر علامات حمراء على الجلد.

- قد يحدث حرقان، وخز، حكة، حب الشباب، وعدوى فطريه(داء المبيضات أو القلاع) في الجلد.

- إحساس بالحرقان أو وخز حول الأعضاء التناسلية والشرج.

- التهاب الجلد التحسسي.

- انخفاض رد الفعل على اختبارات الجلد واللقاحات.

- زيادة الضغط في المخ مع وجود علامات محددة للعين (أوديمابحليمة العصب البصري) عند الأطفال.

- خراج ليس بسبب عدوى.

- اعتلال مفصلي يشبه شاركو (انهيار المفاصل الحاملة للوزن).

- جلطات دموية التي قد تكون موضعية أو منتشرة.

- التورم الناجم عن وجود سائل تحت الجلد (أوديما).

- اضطرابات عقلية، قد يزداد الفصام سوءًا، اعتماد نفسي، نشوة، اكتئاب، أرق، صداع وتشنجات (قد يزداد الصرع سوءًا) وقد يحدث دوار بعد التوقف عن العلاج.

قد تُظهر الاختبارات أيضًا زيادة في عدد خلايا الدم البيضاء.

إذا لاحظت أنت أو مقدم الرعاية ظهور أي أعراض نفسية مقلقة مثل الشعور بالاكتئاب أو الرغبة في الانتحار ، فيرجى إخبار طبيبك على الفور.

الانسحاب:

قد يؤدي التوقف المفاجئ عن العلاج (الانسحاب) بعد العلاج المطول (أكثر من ثلاثة أسابيع) أو الجرعات الكبيرة إلى عواقب وخيمة للغاية. الأعراض التي قد تصاب بها مع "متلازمة الانسحاب" هي حمى، آلام بالعضلات، آلام بالمفاصل، سيلان الأنف، احمرار العينين، كتل جلدية مؤلمة مثيرة للحكة، فقدان الوزن. قد يؤدي التوقف بسرعة كبيرة إلى عدم كفاية هرمونات الغدة الكظرية وانخفاض ضغط الدم والوفاة.

قد تحدث ردود فعل نفسية عند الانسحاب من الكورتيكوستيرويدات، بما في ذلك الاضطرابات العاطفية (مثل الانفعال، النشوة، الاكتئاب، تقلب المزاج الحاد أو الأفكار الانتحارية)، ردود فعل نفسية (بما في ذلك الهوس، الأوهام أو الهلوسة وتفاقم الفصام)، تغيرات في السلوك، الشعور بالضيق أو القلق، النوم المضطرب، الشعور بالارتباك أو فقدان الذاكرة.

إذا لاحظت أنت أو مقدم الرعاية الخاصه بأي ردود فعل نفسية قد تحدث إما أثناء أو مباشرة بعد تقليل الكمية، أو التوقف عن العلاج بالستوريدات، فيرجى إخبار طبيبك.

يحفظ الدواء بعيدا عن متناول الأطفال.

يجب عدم تعاطي ديكساميثازون صوديوم فوسفات بعد إنتهاء تاريخ الصلاحية المكتوبة علي العلبة، و يشير تاريخ إنتهاء الصلاحية إلي آخر يوم في الشهر المذكور.

يحفظ الدواء في درجة حرارة لا تزيد عن ٣٠˚م.

يجب عدم التخلص من الدواء عن طريق مياة المجاري أو عن طريق القمامة. و يجب إستشارة الصيدلي عن كيفية التخلص من الدواء الغير مستخدم، و الهدف من ذلك المحافظة علي البيئة نظيفة.

المادة الفعالة: ديكساميثازون فوسفات.

كل أمبول يحتوي علي ٨ مجم ديكساميثازون فوسفات (علي هيئة ملح ثنائي الصوديوم).

المواد غير الفعالة: كرياتينين، سيترات الصوديوم، صوديوم ميتا باي سالفيت، ميثيل بارابين، بروبيل بارابين، هيدروكسيد الصوديوم، ماء معد للحقن.

العبوة:

علب بكل منها ٥  أو ١٠٠ أمبولة.

الشركة المصرية الدولية للصناعات الدوائية (إيبيكو)

نوفمبر ٢٠٢٠
 Read this leaflet carefully before you start using this product as it contains important information for you

Dexamethasone Sodium Phosphate 8mg-2ml Ampoule.

Each 1 ml contains: Dexamethasone sodium phosphate (as disodium salt) 4 mg/ml For a full list of excipients see Section 6.1

Clear colourless solution.

In the management of acute adrenocortical insufficiency, pre and post operative support, shock and in the active management of corticosteroid responsive conditions.

In the management of inflammatory diseases of joints and soft tissue such as rheumatoid arthritis.

In the short term management of acute self-limited allergic conditions such as angioneurotic oedema or acute exacerbations of chronic allergic disorders such as bronchial asthma or serum sickness.


Route of Administration:

Intravenous

Intramuscular

Intra-articular and intralesional

Recommended Dosage:

N.B. All doses are expressed as mg dexamethasone ampoule.

The usual dosage is 0.5-24 mgdaily depending on the individual patient’s condition and response.

In Shock:

Usually a dose of 2 to 6 mg/kg bodyweightis given intravenously as a single dose. This may be repeated if required, in 2 to 6 hours, or followed by the same dose as an intravenous infusion.

High-dose therapy should be continued only until the patient's condition has stabilised and usually for no longer than 48-72 hours. This bolus injection can then be followed by continuous IV infusion of 3 mg/kg bodyweight per 24 hours. Dexamethasone Injection can be diluted with Sodium Chloride Injection B.P . or Glucose Injection B.P.

In Cerebral Oedema:

Initially 10 mg is given intravenously followed by 4 mg intramuscularly every 6 hours. When response occurs dosage may be gradually reduced and stopped over 5-7 days. If required, maintenance therapy may be effective at doses of 2 mg IM or IV 2-3 times daily.

Life-Threatening Cerebral Oedema:

High Dose Schedule:

 

Adults

Children > 35 kg

Children < 35 kg

Initial dose

50 mg IV

25mg IV

20mg IV

1stday

8mg IV every 2 hrs

4mg IV every 2 hrs

4mg IV every 3 hrs

2ndday

8mg IV every 2 hrs

4mg IV every 2 hrs

4mg IV every 3 hrs

3rdday

8mg IV every 2 hrs

4mg IV every 2 hrs

4mg IV every 3 hrs

4thday

4mg IV every 2 hrs

4mg IV every 4 hrs

4mg IV every 6 hrs

5th–8thday

4mg IV every 4 hrs

4mg IV every 6 hrs

2mg IV every 6 hrs

After 8 days

Decrease by daily reduction of 4mg

Decrease by daily reduction of 2mg

Decrease by daily reduction of 1mg

Note: The intravenous and intramuscular routes of administration of dexamethasone (as sodium phosphate) should only be used where acute illness or life-threatening situations exist. Oral therapy should be substituted as soon as possible.

Intra-Articular and Soft Tissue Injections:

Dosage varies with the degree of inflammation and the size and location of the affected area. Injections may be repeated from once every 3-5 days (e.g. for bursae) to once every 2- 3 weeks (for joints).

Site of Injection                      Dosage

1. Large Joint                          2 mg to 4 mg

2. Small Joints                         800 microgram to 1 mg

3. Bursae                                 2 mg to 3 mg

4. Tendon Sheaths                  400 microgram to 1 mg

5. Soft Tissue Infiltration        2 mg to 6 mg

6. Ganglia                                1 mg to 2 mg

Children

Dosage requirements are variable and may have to be changed according to individual need. Usually 200 micrograms/kg to 400 micrograms/kg of body weight daily.

Corticosteroids cause growth retardation in infancy, childhood and adolescence. Treatment should be limited to the minimum dosage for the shortest possible time. In order to minimise suppression of the hypothalamic-pituitary-adrenal axis and growth retardation, treatment should be limited, where possible, to a single dose on alternate days.

Growth and development of infants and children on prolonged corticosteroid therapy should be carefully monitored.

Elderly:

Treatment of elderly patients, particularly long-term, should be planned bearing in mind the more serious consequences in old age. Such effects include osteoporosis, hypertension, hypokalaemia, diabetes, susceptibility to infection, thinning and fragility of the skin.


Hypersensitivity to the active substance, sulphites or to any of the excipients listed in section 6.1. Use in patients with peptic ulcer, active tuberculosis, acute psychosis, acute bacterial or viral infection. Systemic infection unless specific anti-infective therapy is employed. Local injection in: • bacteraemia • systemic fungal infections • unstable joints • infection at the injection site e.g. septic arthritis resulting from gonorrhoea or tuberculosis.

In post marketing experience tumour lysis syndrome (TLS) has been reported in patients with haematological malignancies following the use of dexamethasone alone or in combination with other therapeutic agents. Patients at high risk of TLS, such as patients with high proliferative rate, high tumour burden and high sensitivity to cytotoxic agents, should be monitored closely and appropriate precaution taken.

The lowest effective dose of corticosteroid should be used to control the condition under treatment for the minimum period. Frequent patient review is required to appropriately titrate the dose against disease activity.

Patients currently on corticosteroid therapy or those who have been on such treatment within the previous year may require special control measures if involved in anaesthesia, surgical procedures and other stress.

Withdrawal of corticosteroids should always be gradual and related to the duration of use. Too rapid a reduction of dexamethasone dosage following prolonged treatment can lead to acute adrenal insufficiency, hypotension and death.

A withdrawal syndrome may occur. Withdrawal may result in acute rebound exacerbation of disease, acute adrenocortical insufficiency, polyarteritis. Symptoms of this may include fever, myalgia, arthralgia, rhinitis, conjunctivitis, painful itchy skin nodules and loss of weight.

In patients who have received more than physiological doses of systemic corticosteroids (approximately 1 mg dexamethasone (equivalent to 1.2 mg dexamethasone) for greater than 3 weeks, withdrawal should not be abrupt. How dose reduction should be carried out depends largely on whether the disease is likely to relapse as the dose of systemic corticosteroids is reduced. Clinical assessment of disease activity may be needed during withdrawal. If the disease is unlikely to relapse on withdrawal of systemic corticosteroids but there is uncertainty about HPA suppression, the dose of systemic corticosteroid may be reduced rapidly to physiological doses. Once a daily dose of 1 mg dexamethasone is reached, dose reduction should be slower to allow the HPA-axis to recover.

Abrupt withdrawal of systemic corticosteroid treatment, which has continued up to 3 weeks is appropriate if it is considered that the disease is unlikely to relapse. Abrupt withdrawal of doses up to 6 mg of dexamethasone (equivalent to 7.3 mg dexamethasone phosphate) for 3 weeks is unlikely to lead to clinically relevant HPA-axis suppression, in the majority of patients. In the following patient groups, gradual withdrawal of systemic corticosteroid therapy should be considered even after courses lasting 3 weeks or less:

• Patients who have had repeated courses of systemic corticosteroids, particularly if taken for greater than 3 weeks,

• When a short course has been prescribed within one year of cessation of long-term therapy (months or years),

• Patients who may have reasons for adrenocortical insufficiency other than exogenous corticosteroid therapy,

• Patients receiving doses of systemic corticosteroid greater than 6 mg daily of dexamethasone,

• Patients repeatedly taking doses in the evening.

Adrenal suppression: adrenal cortical atrophy develops during prolonged therapy and may persist for years after stopping treatment. Withdrawal of corticosteroids after prolonged therapy must, therefore, be gradual to avoid acute adrenal insufficiency, being tapered off over weeks or months according to the dose and duration of treatment. During prolonged therapy any intercurrent illness, trauma or surgical procedure will require a temporary increase in dosage; if corticosteroids have been stopped following prolonged treatment they may need to be temporarily re-introduced.

Patients should carry 'Steroid treatment' cards which give clear guidance on the precautions to be taken to minimise risk and which provide details of prescriber, drug, dosage and the duration of treatment.

There is a lack of evidence to support the prolonged use of corticosteroids in septic shock. Although they may be of value in the early treatment, the overall survival may not be influenced.

Severe anaphylactoid reactions have occurred after administration of parenteral corticosteroids, such as glottis oedema, urticaria and bronchospasm, particularly in patients with a history of allergy. Appropriate precautions should be taken prior to administration. If such an anaphylactoid reaction occurs, the following measures are recommended: immediate slow intravenous injection of adrenaline, intravenous administration of aminophylline, and artificial respiration if necessary.

The slower rate of absorption after intramuscular injection should be noted.

Intra-articular corticosteroids are associated with a substantially increased risk of an inflammatory response in the joint, particularly a bacterial infection introduced with the injection. Great care is required and all intra-articular corticosteroid injections should be undertaken in an aseptic environment. Charcot-like arthropathies have been reported particularly after repeated injections.

Prior to intra-articular injection the joint fluid should be examined to exclude a septic process. A marked increase in pain, accompanied by local swelling, further restriction of joint motion, fever and malaise are suggestive of septic arthritis. If this complication occurs and sepsis is confirmed, appropriate antimicrobial therapy should be commenced.

Patients should be impressed strongly with the importance of not overusing joints in which symptomatic benefit has been obtained, but the inflammatory process remains active.

Corticosteroids may mask some signs of infection, decrease resistance and inhibit localisation of infection. Suppression of the inflammatory response and the immune function increases the susceptibility to infections and their severity. The clinical presentation may be atypical and serious infections, such as septicaemia and tuberculosis, may be masked and may reach an advanced stage before being recognised.

Live vaccines should not be given to individuals with impaired immune responsiveness. The antibody response to other vaccines may be diminished.

Chickenpox is of particular concern since this normally minor illness may be fatal in immunosuppressed patients. Patients (or parents of children) without a definite history of chicken pox should be advised to avoid close personal contact with chickenpox or herpes zoster and if exposed they should seek urgent medical attention. Passive immunisation with varicella zoster immunoglobin (VZIG) is needed by exposed non-immune patients who are receiving systemic dexamethasone or who have received it during the previous 3 months; this should be given within 10 days of exposure to chickenpox. If a diagnosis of chickenpox is confirmed, the illness warrants specialist care and urgent treatment. Dexamethasone should not be stopped and the dose may need to be increased.

Measles can have a more serious or even fatal course in immunosuppressed patients. In such children or adults, particular care should be taken to avoid exposure to measles. If exposed, prophylaxis with pooled immunoglobin may be indicated. Exposed patients should be advised to seek medical advice without delay. Prolonged use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerve and may enhance the establishment of secondary ocular infections due to fungi or viruses.

False negative results may occur with the nitroblue tetrazolium test for bacterial infection.

Extreme caution should be exercised in the treatment of patients with the following conditions and frequent patient monitoring is necessary:

• Liver failure, chronic renal failure, renal insufficiency, gastro-intestinal ulceration, congestive heart failure, hypertension, epilepsy, migraine and patients with Cushing's syndrome

• Osteoporosis, since coticosteroids increase calcium excretion. Post-menopausal women are at particular risk.

• Latent tuberculosis, as corticosteroids can cause reactivation.

• Hypothyroidism or cirrhosis, because such patients often show an exaggerated response to corticosteroids.

• Certain parasitic infestations, in particular amoebiasis. Latent amoebiasis, as corticosteroids may cause reactivation. Prior to treatment, amoebiasis should be ruled out in any patient with unexplained diarrhoea or who has recently spent time in the tropics.

• Ocular herpes simplex, because corticosteroids may cause corneal perforation.

• Incomplete statural growth since glucocorticoids on prolonged administration may accelerate epiphyseal closure.

• In the treatment of conditions such as tendinitis or tenosynovitis care should be taken to inject into the space between the tendon sheath and the tendon as cases of ruptured tendon have been reported.

Corticosteroids should also be used with caution in patients with diabetes mellitus (or a family history of diabetes), affective disorders, glaucoma (or a family history of glaucoma), or previous corticosteroid-induced myopathy.

Visual disturbance

Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.

The use of corticosteroids in the presence of other disorders or of drugs with specific actions (e.g hypoglycaemics), impinging on the effects of corticosteroids will result in imbalance of control.

Dexamethasone has been used ‘off–label’ to treat and prevent chronic lung disease in preterm infants. Clinical trials have shown a short term benefit in reducing ventilator dependence but no long term benefit in reducing time to discharge, the incidence of chronic lung disease or mortality. Recent trials have suggested an association between the use of dexamethasone in preterm infants and the development of cerebral palsy. In view of this possible safety concern, an assessment of the risk:benefit should be made on an individual patient basis.

In view of multiple adverse effects noted in premature infants who received dexamethasone, the risks in many cases outweigh the benefits. Very serious consideration should therefore be given before dexamethasone is administered to such patients.

Available evidence suggests long-term neurodevelopmental adverse events after early treatment (< 96 hours) of premature infants with chronic lung disease at starting doses of 0.25 mg/hg twice daily.

Prolonged use in children may lead to growth retardation. Some recovery may occur on discontinuing therapy.

The common adverse effects of systemic corticosteroids may be associated with more serious consequences in old age, especially osteoporosis, hypertension, hypokalaemia, diabetes, susceptibility to infection and thinning of the skin. Close clinical supervision is required to avoid life-threatening reaction.

Corticosteroids should not be used for the management of head injury or stroke because it is unlikely to be of any benefit and may even be harmful.

Patients and/or carers should be warned that potentially severe psychiatric adverse reactions may occur with systemic steroids (see section 4.8). Symptoms typically emerge within a few days or weeks of starting the treatment. Risks may be higher with high doses/systemic exposure (see also section 4.5 pharmacokinetic interactions that can increase the risk of side effects), although dose levels do not allow prediction of the onset, type, severity or duration of reactions. Most reactions recover after either dose reduction or withdrawal, although specific treatment may be necessary.

Patient/carers should be encouraged to seek medical advice if worrying psychological symptoms develop, especially if depressed mood or suicidal ideation is suspected. Patients/carers should also be alert to possible psychiatric disturbances that may occur either during or immediately after dose tapering/withdrawal of systemic steroids, although such reactions have been reported infrequently.

Particular care is required when considering the use of systemic corticosteroids in patients with existing or previous history of severe affective disorders in themselves or in their first degree relatives. These would include depressive or manic-depressive illness and previous steroid psychosis.

The results of a randomized, placebo-controlled study suggest an increase in mortality if methylprednisolone therapy starts more than two weeks after the onset of Acute Respiratory Distress Syndrome (ARDS). Therefore, treatment of ARDS with corticosteroids should be initiated within the first two weeks of onset of ARDS.

This medicinal product contains less than 1 mmol sodium (23 mg) per 2ml, i.e. essentially ‘sodium-free’.

The excipient, sodium sulphite may rarely cause severe hypersensitivity reactions and bronchospasm.

The vial stopper contains dry natural rubber (a derivative of latex), which may cause allergic reactions.


Concurrent administration of barbiturates, phenylbutazone, phenytoin may increase the metabolism of corticosteroids, while if anticoagulants are given with the corticosteroid, adjustment of dosage of the former is usually necessary.

Liver enzyme inducing drugs such as barbiturates, phenytoin, ephedrine, rifampicin, rifabutin, carbamazepine, aminoglutethimide and primidone may enhance the metabolism of corticosteroids, resulting in a decrease in pharmacological action, and a need for dosage adjustment.

The prothrombin time of patients undergoing concomitant treatment with corticosteroids and coumarin anti-coagulants should be checked frequently.

Corticosteroids may affect glucose tolerance and increase the need for anti-diabetic drugs.

The incidence of gastro-intestinal ulceration is increased in patients receiving concomitant non-steroidal anti-inflammatory drugs and corticosteroids.

Salicylate intoxication has been reported to occur when adjustment is made to corticosteroid dosage, in patients concomitantly receiving aspirin. The renal clearance of salicylates is increased by corticosteroids and steroid withdrawal may result in salicylate intoxication. There may be interaction with salicylates in patients with hypoprothrombinaemia.

The desired effects of hypoglycaemic agents (including insulin), anti-hypertensives, cardiac glycosides and diuretics are antagonized by corticosteroids, and the hypokalaemic effects of acetazolamide, loop diuretics, thiazide diuretics and carbenoxolone are enhanced. Patients receiving corticosteroids and potassium depleting diuretics, and/or cardiac glycosides, should be monitored for hypokalaemia. This is of particular importance in patients receiving cardiac glycosides, since hypokalaemia increases the toxicity of these drugs.

Live virus vaccines should not be administered to patients on immunosuppressant doses of corticosteroids. If inactivated vaccines are administered to such individuals, the expected serum antibody response may not be obtained.

The effects of anticholinesterases are antagonised by corticosteroids in myasthenia gravis.

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


Pregnancy:

Corticosteroids should only be used during pregnancy or lactation if considered essential by the physician. Corticosteroids have been shown to be teratogenic in animals. To date there is no confirmed report of a similar effect in human beings.

The ability of corticosteroids to cross the placenta varies between individual drugs, however, dexamethasone readily crosses the placenta.

Administration of corticosteroids to pregnant animals can cause abnormalities of fetal development including cleft palate, intra-uterine growth retardation and effects on brain growth and development. There is no evidence that corticosteroids result in an increased incidence of congenital abnormalities, such as cleft palate/lip in man. See also section 5.3 of the SmPC. However, when administered for prolonged periods or repeatedly during pregnancy, corticosteroids may increase the risk of intra-uterine growth retardation. Hypoadrenalism may, in theory, occur in the neonate following prenatal exposure to corticosteroids but usually resolves spontaneously following birth and is rarely clinically important. As with all drugs, corticosteroids should only be prescribed when the benefits to the mother and child outweigh the risks. When corticosteroids are essential however, patients with normal pregnancies may be treated as though they were in the non-gravid state.

Breastfeeding:

Corticosteroids may pass into breast milk, although no data are available for dexamethasone. Infants of mothers taking high doses of systemic corticosteroids for prolonged periods may have a degree of adrenal suppression.


Not relevant.


Corticosteroid administration will result in certain effects, the severity, significance and extent of which vary with the dosage and duration of treatment and the particular corticosteroid used.

High doses of Dexamethasone are intended for short term therapy and therefore adverse reactions are uncommon. However, peptic ulceration and bronchospasm may occur.

Except for hypersensitivity, the following adverse effects have been associated with prolonged systemic corticosteroid therapy.

Endocrine disorders:

Suppression of the hypothalamic-pituitary adrenal axis; Cushing-like syndrome.

Metabolism and nutrition disorders:

Weight gain; suppression of growth in infants, children and adolescents; secondary adrenocortical unresponsiveness, particularly in times of stress, as in surgery or trauma; impaired glucose tolerance with increased requirement for anti-diabetic therapy; hyperglycaemia; negative protein/nitrogen and calcium balance; increased appetite.

Electrolyte imbalance (retention of sodium and water with oedema and hypertension); nitrogen depletion; hyperglycaemia; hypokalaemic alkalosis; increased calcium and potassium excretion.

Reproductive system and breast disorders:

Menstrual irregularities and amenorrhoea; a transient burning or tingling sensation mainly in the perineal area following intravenous injection of large doses of corticosteroid phosphates.

Infections and Infestations:

Increased susceptibility to and severity of infection with suppression of clinical symptoms and signs; opportunistic infections; recurrence of dormant tuberculosis, exacerbation of ophthalmic viral or fungal diseases, candidiasis.

Musculoskeletal and joint disorders:

Charcot-like arthropathy, muscular atrophy, proximal myopathy, premature epiphyseal closure, osteoporosis, avascular osteonecrosis, muscle weakness.

Gastro-intestinal disorders:

Dyspepsia, peptic ulceration with perforation and haemorrhage, oesophageal ulcerations, acute pancreatitis and candidiasis.

Skin and subcutaneous disorders:

Impaired wound healing; skin atrophy; bruising; telangiectasia and striae; petechiae and ecchymoses; erythema; increased sweating; possible suppression of skin tests; burning or tingling; allergic dermatitis; urticaria, candidiasis, acne, hyperpigmentation; hypopigmentation; subcutaneous and cutaneous atrophy; sterile abscess, hirsuitism.

Psychiatric disorders:

Mental disturbances, psychological dependence, affective disorders (such as euphoria, depression, irritable labile mood and suicidal thoughts), psychotic reactions (including mania, delusions, hallucinations, and aggravation of schizophrenia), behavioral disturbances, irritability, anxiety, insomnia, confusion.

Nervous System disorders:

Aggravation of epilepsy. Increased intra-cranial pressure with papilloedema in children (pseudotumour cerebri), usually after treatment withdrawal, headache, convulsions, vertigo, cognitive dysfunction and amnesia.

Eye disorders:

Posterior sub-capsular cataracts or increased intraocular pressure may result in glaucoma or occasionally damage to the optic nerve; exophthalmos papilloedema; corneal or scleral thinning; exacerbation of ophthalmic viral or fungal diseases, blindness associated with intralesional therapy around the face and neck. Chorioretinopathy, blurred vision though the frequency is unknown (see also section 4.4).

Immune system disorders:

Diminished immune response, decreased responsiveness to vaccination and skin tests, hypersensitivity including anaphylaxis has been reported.

General disorders and administration site conditions:

Post injection flare (following intra-articular injection), impaired healing.

Blood and lymphatic disorders:

Diminished lymphoid tissue, leucocytosis.

Vascular disorders:

Hypertension, thromboembolism.

Injury, poisoning, and procedural complications:

Vertebral and long bone fractures, tendon rupture, bruising.

Withdrawal

Withdrawal symptoms and signs: Too rapid a reduction of corticosteroid dosage following prolonged treatment can lead to acute adrenal insufficiency, hypotension and death (see section 4.4, Special warnings and precautions for use).

A ‘withdrawal syndrome’ may also occur including fever, myalgia, arthralgia, rhinitis, conjunctivitis, painful itchy skin nodules and loss of weight.

A wide range of psychiatric reactions including affective disorders (such as irritable, euphoric, depressed and labile mood, and suicidal thoughts), psychotic reactions (including mania, delusions, hallucinations, and aggravation of confusion and amnesia have been reported. Reactions are common and may occur in both adults and children. In adults, the frequency of severe reactions has been estimated to be 5-6%. Psychological effects have been reported on withdrawal of corticosteroids; the frequency is unknown.

Reporting of suspected adverse reactions

The National Pharmacovigilance Center (NPC)

SFDA Call Center: 19999

Email: NPC.drug@sfda.gov.sa

Website: https://ade.sfda.gov.sa/


It is difficult to define an excessive dose of a corticosteroid as the therapeutic dose will vary according to the indication and patient requirements. High-dose corticosteroids given as recommended for pulse therapy are relatively free from hazardous effects.

Exaggeration of corticosteroid related adverse effects may occur. Treatment should be asymptomatic and supportive as necessary.

Treat anaphylaxis with adrenaline and positive pressure ventilation. Other supportive measures aimed to maintain the patient unstressed.


Pharmacology of the corticosteroids is complex and the drugs affect almost all body systems. Maximum pharmacological activity lags behind peak blood concentrations, suggesting that most effects of the drugs result from modification of enzyme activity rather than from direct actions by the drugs.


Intramuscular injections of dexamethasone gives maximum plasma concentrations of dexamethasone at 1 hour. Dexamethasone is readily absorbed from the gastro-intestinal tract. Its biological half-life in plasma is about 190 minutes. Binding of dexamethasone to plasma proteins is less than for most other corticosteroids. Dexamethasone penetrates into tissue fluids and cerebrospinal fluids. Metabolism of the drug takes place in the kidneys and liver and excretion is via the urine.


None known.


Creatinine, sodium citrate, sodium metabisulphite, sodium hydroxide, methyl paraben, propyl paraben, water for injection.


None known.


3 years.

Store at temperature not exceeding 30˚C.


Dexamethasone Sodium Phosphate 1 ml, 2ml Ampoules: Boxes of 5 or 100 ampoules, each.


Dexamethasone solution for injection may be diluted with the following solutions for injection or infusion:

Sodium Chloride 0.9% infusion

Glucose 5% Infusion

Compound Sodium Lactate Infusion

Hartmann's Solution for Injection

Ringer-Lactate Solution for Injection

Ringer's Solution for injection

Sorbitol 5% Injection

Invert Sugar 10% Injection

Rheomacrodex

Using these infusion fluids, Dexamethasone solution for injection can also be injected into the infusion line without causing precipitation of the ingredients.

For single use only.

Discard any unused solution after use.

Any unused product or waste material should be disposed of in accordance with local requirements.

The product should only be used when the solution is clear and particle free.


Egyptian International Pharmaceutical Industries Company, E.I.P.I.CO., Egypt

November 2020
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