برجاء الإنتظار ...

Search Results



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)

TREXON is an antibiotic given to adults and children (including newborn babies).
It works by killing bacteria that cause infections. It belongs to a group of medicines called cephalosporins.
TREXON is used to treat infections of
• The brain (meningitis).
• The lungs.
• The middle ear.
• The abdomen and abdominal wall (peritonitis).
• The urinary tract and kidneys.
• Bones and joints.
• The skin or soft tissues.
• The blood.
• The heart.
It can be given:
• To treat specific sexually transmitted infections (gonorrhoea and syphilis).
• To treat patients with low white blood cell counts (neutropenia) who have fever due to bacterial infection.
• To treat infections of the chest in adults with chronic bronchitis.
• To treat Lyme disease (caused by tick bites) in adults and children including newborn babies from 15 days of age.
• To prevent infections during surgery.


You must not be given TREXON if:
• You are allergic to ceftriaxone or any of the other ingredients of this medicine (listed in section 6).
• You have had a sudden or severe allergic reaction to penicillin or similar antibiotics (such as cephalosporins, carbapenems or monobactams). The signs include sudden swelling of the throat or face which might make it difficult to breath or swallow, sudden swelling of the hands, feet and ankles, and a severe rash that develops quickly.
• You are allergic to lidocaine and you are to be given TREXON as an injection into a muscle.
TREXON must not be given to babies if:
• The baby is premature.
• The baby is newborn (up to 28 days of age) and has certain blood problems or jaundice (yellowing of the skin or the whites of the eyes) or is to be given a
product that contains calcium into their vein.
Warnings and precautions:
Talk to your doctor or pharmacist or nurse before you are given TREXONif:
• You have recently received or are about to receive products that contain calcium.
• You have recently had diarrhoea after having an antibiotic medicine. You have ever had problems with your gut, in particular colitis (inflammation of the bowel).
• You have liver or kidney problems.
• You have gall stones or kidney stones
• You have other illnesses, such as haemolytic anaemia (a reduction in your red blood cells that may make your skin pale yellow and cause weakness or breathlessness).
• You are on a low sodium diet.
If you need a blood or urine test
If you are given TREXON for a long time, you may need to have regular blood tests. TREXON can affect the results of urine tests for sugar and a blood test
known as the Coombs test. If you are having tests:
Tell the person taking the sample that you have been given TREXON.
Children
Talk to your doctor or pharmacist or nurse before your child is administered TREXON if:
• He/She has recently been given or is to be given a product that contains calcium into their vein.
Other medicines and TREXON:
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:
• A type of antibiotic called an aminoglycoside.
• An antibiotic called chloramphenicol (used to treat infections, particularly of the eyes).
Pregnancy and 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.
The doctor will consider the benefit of treating you with TREXON against the risk to your baby.
Driving and using machines:
TREXON can cause dizziness. If you feel dizzy, do not drive or use any tools or machines. Talk to your doctor if you experience these symptoms.


TREXON is usually given by a doctor or nurse. It can be given as a drip (intravenous infusion) or as an injection directly into a vein or into a muscle.
TREXON is made up by the doctor, pharmacist or nurse and will not be mixed with or given to you at the same time as calcium-containing injections.
The usual dose
Your doctor will decide the correct dose of TREXON for you. The dose will depend on the severity and type of infection; whether you are on any other antibiotics; your weight and age; how well your kidneys and liver are working.
The number of days or weeks that you are given TREXON depends on what sort of infection you have.
Adults, older people and children aged 12 years and over with a body weight greater than or equal to 50 kilograms (kg):
• 1 to 2 g once a day depending on the severity and type of infection. If you have a severe infection, your doctor will give you a higher dose (up to 4 g once a day).
If your daily dose is higher than 2 g, you may receive it as a single dose once a day or as two separate doses.
Newborn babies, infants and children aged 15 days to 12 years with a body weight of less than 50 kg:
• 50-80 mg TREXON for each kg of the child’s body weight once a day depending on the severity and type of infection. If you have a severe infection, your doctor will give you a higher dose up to 100 mg for each kg of body weight to a maximum of 4 g once a day. If your daily dose is higher than 2 g, you may receive it as a single dose once a day or as two separate doses.
• Children with a body weight of 50 kg or more should be given the usual adult dose.
Newborn babies (0-14 days):
• 20 – 50 mg TREXON for each kg of the child’s body weight once a day depending on the severity and type of infection.
• The maximum daily dose is not to be more than 50 mg for each kg of the baby’s weight.
People with liver and kidney problems:
You may be given a different dose to the usual dose. Your doctor will decide how much TREXON you will need and will check you closely depending on the
severity of the liver and kidney disease.
If you are given more TREXON than you should:
If you accidentally receive more than your prescribed dose, contact your doctor or nearest hospital straight away.
If you forget to use TREXON:
If you miss an injection, you should have it as soon as possible. However, if it is almost time for your next injection, skip the missed injection. Do not take a double dose (two injections at the same time) to make up for a missed dose.
If you stop using TREXON:
Do not stop taking TREXON unless your doctor tells you to. If you have any further questions on the use of this medicine, ask your doctor or nurse.


Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may happen with this medicine:
Severe allergic reactions (not known, frequency cannot be estimated from the available data)
If you have a severe allergic reaction, tell a doctor straight away.
The signs may include:
• Sudden swelling of the face, throat, lips or mouth. This can make it difficult to breathe or swallow.
• Sudden swelling of the hands, feet and ankles.
Severe skin rashes (not known, frequency cannot be estimated from the available data)
If you get a severe skin rash, tell a doctor straight away.
• The signs may include a severe rash that develops quickly, with blisters or peeling of the skin and possibly blisters in the mouth.
Other possible side effects:
Common (may affect up to 1 in 10 people)
• Abnormalities with your white blood cells (such as a decrease of leucocytes and an increase of eosinophils) and platelets (decrease of thrombocytes).
• Loose stools or diarrhoea.
• Changes in the results of blood tests for liver functions.
• Rash.
Uncommon (may affect up to 1 in 100 people)
• Fungal infections (for example, thrush).
• A decrease in the number of white blood cells (granulocytopenia).
• Reduction in number of red blood cells (anaemia).
• Problems with the way your blood clots. The signs may include bruising easily and pain and swelling of your joints.
• Headache.
• Dizziness.
• Feeling sick or being sick.
• Pruritis (itching).
• Pain or a burning feeling along the vein where TREXON has been given. Pain where the injection was given.
• A high temperature (fever).
• Abnormal kidney function test (blood creatinine increased).
Rare (may affect up to 1 in 1,000 people)
• Inflammation of the large bowel (colon). The signs include diarrhoea, usually with blood and mucus, stomach pain and fever.
• Difficulty in breathing (bronchospasm).
• A lumpy rash (hives) that may cover a lot of your body, feeling itchy and swelling.
• Blood or sugar in your urine.
• Oedema (fluid build-up).
• Shivering.
Not known (Frequency cannot be estimated from the available data)
• A secondary infection that may not respond to the antibiotic previously prescribed.
• Form of anaemia where red blood cells are destroyed (haemolytic anaemia).
• Severe decrease in white blood cells (agranulocytosis).
• Convulsions.
• Vertigo (spinning sensation).
• Inflammation of the pancreas (pancreatitis). The signs include severe pain in the stomach which spreads to your back.
• Inflammation of the mucus lining of the mouth (stomatitis).
• Inflammation of the tongue (glossitis). The signs include swelling, redness and soreness of the tongue.
• Problems with your gallbladder, which may cause pain, feeling sick and being sick.
• A neurological condition that may occur in neonates with severe jaundice (kernicterus).
• Kidney problems caused by deposits of calcium ceftriaxone. There may be pain when passing water (urine) or low output of urine.
• A false positive result in a Coombs’ test (a test for some blood problems).
• A false positive result for galactosaemia (an abnormal build up of the sugar galactose).
• TREXON may interfere with some types of blood glucose tests - please check with your doctor.


- Keep out of the reach and sight of children.
- Do not use TREXON after the expiry date (marked ‘Exp’) on the bottle and the carton. The expiry date refers to the last day of that month.
- Medicines should not be disposed of via waste water or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures
will help to protect the environment.
Do not store above 30°C, keep vial or bottle in the outer carton in order to protect from light.
Chemical and physical in-use stability of the reconstituted product has been demonstrated for at least 6 hours at or below 25°C or 24 hours at 2-8°C.
From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the
responsibility of the user and would not be longer than the times stated above for the chemical and physical in-use stability.
Do not throw away any medicines via wastewater. Ask your pharmacist to throw away medicines you no longer use. These measures will help protect the environment.


What TREXON contains
Active ingredient: ceftriaxone (as the disodium salt)..... 500 mg,1 gm.


Package: Packs for IM injection: TREXON 250 mg Vials:1 vial + 1 ampoule (2 ml) of 1% lidocaine solution. TREXON 500 gm vial: 1 vial + 1 ampoule (2 ml) of 1% lidocaine solution. TREXON 1 gm vial: 1 vial + 1 ampoule (3.5 ml) of 1% lidocaine solution. Packs for IV injection: TREXON 250 mg Vials: 1 vial + 1 ampoule (5 ml) of sterile water for injection. TREXON 500 mg vial: 1 vial + 1 ampoule (5 ml) of sterile water for injection. TREXON 1 gm vial: 1 vial + 1 ampoule (10ml) of sterile water for injection. Packs for I.V. Infusion: TREXON 2 gm Vials: 1 vial + 1 ampoule (10 ml) of (Sterile Water for Injection) solvent and insert leaflet.

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


JANUARY 2021
  نشرة الدواء تحت مراجعة الهيئة العامة للغذاء والدواء (اقرأ هذه النشرة بعناية قبل البدء في استخدام هذا المنتج لأنه يحتوي على معلومات مهمة لك)

إن تريكسون مضاد حيوي يعطى للبالغين والأطفال (بما في ذلك الأطفال حديثي الولادة)، وهو يعمل عن طريق قتل البكتيريا المسببة للعدوي، وهو ينتمي إلى مجموعة من الأدوية تسمى السيفالوسبورين.

يستخدم تريكسون لعلاج عدوي:

- المخ (السحايا).

- الرئتين.

- الأذن الوسطى.

- البطن وجدار البطن (إلتهاب الصفاق).

- المسالك البولية والكلى.

- العظام والمفاصل.

- الجلد أو الأنسجة الرخوة.

- الدم.

- القلب.

ويمكن أن يعطى:

- لعلاج أمراض محددة تنتقل عن طريق الإتصال الجنسي (السيلان والزهري).

- لعلاج المرضى الذين يعانون من إنخفاض عدد خلايا الدم البيضاء (المتعادلات) الذين لديهم حمى بسبب عدوى بكتيرية.

- لعلاج عدوي الصدر في البالغين الذين يعانون من إلتهاب الشعب الهوائية المزمن.

- لعلاج مرض لايم (الناجم عن لدغات القراد) في البالغين والأطفال بما في ذلك الأطفال حديثي الولادة من 15 يوما من العمر.

- لمنع العدوى أثناء الجراحة.

لا تأخذ تريكسون إذا كنت:

- لديك حساسية من سيفترياكسون أو أي من المكونات الأخرى لهذا الدواء (المدرجة في القسم 6).

- سبق إصابتك بتفاعلات حساسية مفاجئة أو شديدة من البنيسللين أو المضادات الحيوية المماثلة (مثل السيفالوسبورين، كاربابنيم أو مونوباكتام)،  وتشمل العلامات إنتفاخ مفاجئ في الحلق أو الوجه مما قد يجعل هناك صعوبة في التنفس أو البلع، إنتفاخ مفاجئ في اليدين، القدمين والكاحلين، وطفح جلدي شديد يتطور بسرعة.

- لديك حساسية من ليدوكايين وسوف تعطى تريكسون حقن في العضل.

يجب عدم إعطاء تريكسون للرضع فى حالة:

- كان الطفل خديج.

- كان الطفل حديث الولادة (يصل إلى 28 يوما) ويعاني من مشاكل معينة في الدم أو اليرقان (اصفرار الجلد أو بياض العينين)، أو على وشك أن يعطى حقن أخري تحتوي على كالسيوم.

التحذيرات و الإحتياطات:

يجب إستشارة الطبيب أو الصيدلي قبل إستخدام تريكسون إذا كنت:

- تلقيت مؤخرا أو على وشك ان تأخذ مستحضرات تحتوي علي الكالسيوم.

- سبق لك الإصابة بالإسهال بعد أخذ مضاد حيوي. لديك في أي وقت مضى مشاكل في الأمعاء، خاصة في القولون (إلتهاب الأمعاء).

- لديك مشاكل الكبد أو الكلى.

- لديك حصوات في المرارة أو في الكلي.

- مصاب بأمراض أخرى، مثل مشاكل في الدم (إنخفاض في خلايا الدم الحمراء التي قد يجعل لون جلدك أصفر باهت ويسبب ضعف وضيق في التنفس).

- على نظام غذائي منخفض الصوديوم.

إذا كنت بحاجة إلي إختبارات الدم أو البول:

إذا كنت تأخذ تريكسون لفترة طويلة، قد تحتاج إلى إجراء إختبارات دورية علي الدم. يمكن أن يؤثر تريكسون على نتائج إختبارات السكر في البول وإختبارات الدم المعروفة باسم إختبار كومبس.

إذا كنت ستجري إختبارات أخبر الشخص الذي يأخذ العينة أنك تأخذ تريكسون.

الأطفال:

تحدث إلى طبيبك أو الصيدلي أو الممرضة قبل إعطاء تريكسون لطفلك إذا كان أعطي مؤخرا أو سيعطي أي من المستحضرات التي تحتوي على الكالسيوم في الوريد.

أدوية أخري و تريكسون:

يجب عليك إخبار الطبيب أو الصيدلي إذا كنت تأخذ أدوية أو أخذت مؤخرا بعض الأدوية.

يجب عليك إخبار الطبيب أو الصيدلي إذا كنت تأخذ أي من الأدوية التالية:

- نوع من المضادات الحيوية يسمي أمينوجليكوسيد.

- مضاد حيوي يسمي كلورامفينيكول (الذي يستخدم لعلاج العدوي، وخصوصا التي تصيب العين).

الحمل و الرضاعة:

اسأل الطبيب أو الصيدلي قبل أخذ الدواء إذا كنت حاملا أو هناك نية للحمل أو أثناء الرضاعة،

وسوف يحدد الطبيب مقدار الإستفادة من أخذ تريكسون مقارنة بالمخاطر التي قد يتعرض لها طفلك.

القيادة والعمل أمام الماكينات:

إن تريكسون يمكن أن يسبب دوخة، لذلك في حالة حدوث ذلك، يجب عدم القيادة أو العمل أمام الماكينات. يجب مخاطبة الطبيب في حالة التعرض لهذه الأعراض.

https://localhost:44358/Dashboard

عادة ما يتم إعطاء تريكسون بواسطة الطبيب أو الممرضة. يمكن إعطاؤه على شكل تنقيط (تسريب في الوريد) أو كحقن مباشرة في الوريد أو العضل. يتم تحضير تريكسون من قبل الطبيب أو الصيدلي أو الممرضة ولن يتم خلطه أو إعطاؤه لك في نفس وقت الحقن التي تحتوي على الكالسيوم.

الجرعة المعتادة:

سوف يقرر الطبيب الجرعة الصحيحة من تريكسون بالنسبة لك. تعتمد الجرعة على شدة ونوع العدوى؛ إذا كنت تأخذ أي مضادات حيوية أخرى؛ وزنك وعمرك؛ مدى كفاءة عمل الكلى والكبد لديك.

تعتمد فترة العلاج بالتريكسون على نوع العدوى لديك.

البالغين، كبار السن والأطفال الذين تتراوح أعمارهم بين 12 سنة و ما فوق و وزنهم أكثر من أو يساوي 50 كجم:

- 1-2 جم مرة واحدة يومياً تبعاً لشدة ونوع العدوى. إذا كان لديك عدوى حادة، طبيبك سوف يعطيك جرعة أعلى (تصل إلى 4 جم مرة واحدة يوميا). إذا كانت الجرعة اليومية أعلى من 2 جم، فإنك يمكن أن تأخذها كجرعة واحدة مرة واحدة في اليوم أو مقسمة علي جرعتين منفصلتين.

الأطفال حديثي الولادة و الرضع و الأطفال الذين تتراوح أعمارهم بين 15 يوم إلى 12 سنة و وزنهم أقل من 50 كجم:

- 50-80 مجم من تريكسون  لكل كجم من وزن الطفل مرة واحدة يومياً تبعاً لشدة ونوع العدوى. إذا كان لديك عدوى حادة، طبيبك سوف يعطيك جرعة أعلى تصل إلى 100 مجم لكل كجم من وزن الجسم بحد أقصي 4 جم مرة واحدة يوميا. إذا كانت الجرعة اليومية أعلى من 2 جم، فإنك يمكن أن تأخذها كجرعة واحدة مرة واحدة في اليوم أو مقسمة علي جرعتين منفصلتين.

- الأطفال الذين وزنهم 50 كجم أو أكثر: يجب أن يأخذوا جرعة الكبار المعتادة.

الأطفال حديثي الولادة (0-14 يوم):

20-50 مجم من تريكسون لكل كجم من وزن الطفل مرة واحدة يوميا تبعا لشدة ونوع العدوى.

الجرعة اليومية القصوى يجب أن لا تتعدي 50 مجم لكل كجم من وزن الطفل.

الأشخاص الذين يعانون من مشاكل فى الكبد والكلى:

قد تعطى جرعة مختلفة عن الجرعة المعتادة. طبيبك سوف يقرر مقدار الجرعة التي تحتاج إليها وسوف يراقبك عن كثب طبقا لشدة المرض بالكبد والكلى.

عند أخذ جرعة أكبر من التي تم وصفها لك:

إذا أخذت عن طريق الخطأ جرعة أكبر من التي تم وصفها لك، إتصل بطبيبك أو إذهب إلي أقرب مستشفى على الفور.

عند نسيان أخذ إحدي الجرعات:

إذا نسيت أن تأخذ إحدي الجرعات، خذها في أقرب وقت ممكن، إلا إذا كان موعد الجرعة التالية قد إقترب، في هذه الحالة لا تأخذ الجرعة المنسية وخذ الجرعة التالية في موعدها. لا تأخذ جرعة مضاعفة (حقنتين في نفس الوقت) لتعويض الجرعة المنسية.

عند التوقف عن أخذ الدواء:

لا تتوقف عن أخذ الدواء ما لم يخبرك طبيبك بذلك.

إذا كان لديك أي أسئلة أخرى عن كيفية إستخدام هذا الدواء، إسأل طبيبك أو الممرضة.

مثل جميع الأدوية، يمكن أن يسبب تريكسون بعض الأعراض الجانبية، بالرغم من أنه ليس علي جميع المرضي الإصابة بهذه الأعراض.

تفاعلات حساسية شديدة (غير معروفة، ومعدل حدوثها لا يمكن تقديره من البيانات المتاحة):

إذا كان لديك تفاعلات حساسية شديدة، أخبر الطبيب على الفور.

قد تتضمن الأعراض:

- إنتفاخ مفاجئ في الوجه، الحلق، الشفتين أو الفم، وهذا يمكن أن يجعل هناك صعوبة في التنفس أو البلع.

- إنتفاخ مفاجئ في القدمين، اليدين والكاحلين.

طفح جلدي شديد (غير معروف، لا يمكن تقدير معدل حدوثه من البيانات المتاحة):

قد تتضمن الأعراض طفح جلدي شديد يتطور بسرعة، مع ظهور بثور أو تقشير بالجلد وربما بثور في الفم.

من الأعراض الجانبية المحتملة الأخري:

الشائعة (تؤثر على ما يصل إلى شخص فى كل 10 أشخاص):

- شذوذ في خلايا الدم البيضاء (مثل إنخفاض كريات الدم البيضاء وزيادة الحمضات) والصفائح الدموية (نقصان الصفائح الدموية).

- براز رخو أو إسهال.

- تغيرات في نتائج إختبارات الدم لوظائف الكبد.

- طفح جلدي.

غير شائعة (تؤثر على ما يصل إلى شخص فى كل 100 شخص):

- عدوي فطرية (مثل القلاع).

- إنخفاض في عدد خلايا الدم البيضاء (المحببات).

- إنخفاض في عدد خلايا الدم الحمراء (فقر الدم).

- مشاكل في طريقة تجلط الدم. ويمكن أن تشمل العلامات سهولة الإصابة بكدمات وألم وتورم المفاصل.

- صداع.

- دوخة.

- شعور بالغثيان أو قيء.

- حكة.

- ألم أو شعور بحرقان في الوريد حيث تم حقن تريكسون. ألم عند موضع الحقن.

- إرتفاع في درجة الحرارة (حمى).

- نتائج إختبارات وظائف الكلى غير طبيعية (زيادة الكرياتينين في الدم).

نادرة (تؤثر على ما يصل إلى شخص فى كل 1000 شخص):

- إلتهاب الأمعاء الغليظة (القولون). وتشمل العلامات: إسهال، وعادة مع دم ومخاط، آلام في المعدة وحمى.

- صعوبة في التنفس (تشنج شعبي).

- طفح جلدي عقدي (أرتيكاريا) والتي قد تغطي الكثير من جسمك، شعور بحكة وتورم.

- دم أو سكر في البول.

- أوديما (تراكم السوائل).

- رعشة.

غير معروفة (لا يمكن تقدير معدل حدوثها من البيانات المتاحة):

- عدوى ثانوية قد لا تستجيب للمضادات الحيوية الموصوفة سابقا.

- شكل من أشكال فقر الدم حيث يتم تدمير خلايا الدم الحمراء (فقر الدم الإنحلالي).

- إنخفاض حاد في خلايا الدم البيضاء (ندرة المحببات).

- تشنجات.

- دوار.

- إلتهاب البنكرياس. وتشمل العلامات: آلام حادة في المعدة والتي تنتشر على ظهرك.

- إلتهاب بطانة المخاط بالفم (إلتهاب الفم).

- إلتهاب اللسان. تشمل العلامات: تورم، إحمرار وألم حاد في اللسان.

- مشاكل في المرارة، والتي قد تسبب ألم، الشعور بالغثيان وقيء.

- حالة عصبية قد تحدث في الأطفال حديثي الولادة مع يرقان شديد.

- مشاكل في الكلى ناتجة عن ترسب الكالسيوم من سيفترياكسون. قد يكون هناك ألم عند التبول (البول) أو إنخفاض في كمية البول المخرجة.

- نتائج إيجابية كاذبة في إختبار كومبس (إختبار لبعض المشاكل في الدم).

- نتائج إيجابية كاذبة لجلاكتوسيميا (بناء غير طبيعي لسكر الجالاكتوز).

- قد يتداخل تريكسون مع بعض أنواع إختبارات السكر في الدم - يرجى مراجعة طبيبك.

- يحفظ الدواء بعيداً عن متناول الأطفال.

- يجب عدم اخذ تريكسون بعد إنتهاء تاريخ الصلاحية المكتوب علي العلبة و الزجاجة، و يشير تاريخ إنتهاء الصلاحية إلي آخر يوم في الشهر المذكور.

يحفظ الدواء في درجة حرارة لا تزيد عن 30˚م.  صالح الاستخدام بعد الحل لمدة 6 ساعات على الأكثر عند أو أقل من25°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.

مما يتكون تريكسـون؟

المادة الفعالة: سيفترياكسون (على هيئة ملح صوديوم).

تحتوي كل ڤيال على:

سيفترياكسون (على هيئة ملح صوديوم)    250 مجم, 500 مجم، 1جم, 2 جم .

العبوة :

عبوات الحقن بالعضل:

تريكسـون 250 مجم ڤيال: 1 ڤيال + أمبول (2 مل) محلول معقم 1% ليدوكايين.

تريكسـون 500 مجم ڤيال: 1 ڤيال + أمبول (2 مل) محلول معقم 1% ليدوكايين.

تريكسـون 1 جم ڤيال: 1 ڤيال + 1 أمبول (3.5 مل) محلول معقم 1% ليدوكايين.

عبوات الحقن فى الوريد:

تريكسـون 250 مجم ڤيال: 1 ڤيال + 1 أمبول (5 مل) ماء معقم للحقن.

تريكسـون 500 مجم ڤيال: 1 ڤيال + 1 أمبول (5 مل) ماء معقم للحقن.

تريكسـون 1 جم ڤيال: 1 ڤيال + 1 أمبول (10 مل) ماء معقم للحقن.

عبوات للحقن للتسريب الوريدى:

تريكسون 2 جم ڤيال: 1 ڤيال + 1 أمبول (10 مل)  به ماء للحقن معقم .

الشركة المصرية الدولية للصناعات الدوائية (إيبيكو)

يناير ٢٠٢١
 Read this leaflet carefully before you start using this product as it contains important information for you

Trexon 500 mg Powder and solvent for solution for injection

Each vial contains: Ceftriaxone Disodium hemiheptahydrate 596.5 mg Equivalent to Ceftriaxone 500.0 mg

500 mg Powder and solvent for solution for injection. Powder and solvent for solution for injection.

Trexon is indicated for the treatment of the following infections in adults and children including term neonates (from birth):

Bacterial Meningitis

Community acquired pneumonia

Hospital acquired pneumonia

Acute otitis media

Intra-abdominal infections

Complicated urinary tract infections (including pyelonephritis)

Infections of bones and joints

Complicated skin and soft tissue infections

Gonorrhoea

Syphilis

Bacterial endocarditis

Trexon may be used:

For treatment of acute exacerbations of chronic obstructive pulmonary disease in adults

For treatment of disseminated Lyme borreliosis (early (stage II) and late (stage III)) in adults and children including neonates from 15 days of age

For Pre-operative prophylaxis of surgical site infections

In the management of neutropenic patients with fever that is suspected to be due to a bacterial infection

In the treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above.

Trexon should be co-administered with other antibacterial agents whenever the possible range of causative bacteria would not fall within its spectrum (see section 4.4).

Consideration should be given to official guidelines on the appropriate use of antibacterial agents.


Posology

The dose depends on the severity, susceptibility, site and type of infection and on the age and hepato-renal function of the patient.

The doses recommended in the tables below are the generally recommended doses in these indications. In particularly severe cases, doses at the higher end of the recommended range should be considered.

Adults and children over 12 years of age (≥ 50 kg)

Ceftriaxone Dosage*

Treatment frequency**

Indications

1-2 g

 

Once daily

 

Community acquired pneumonia

Acute exacerbations of chronic obstructive pulmonary disease

Intra-abdominal infections

Complicated urinary tract infections (including pyelonephritis)

2 g

Once daily

Hospital acquired pneumonia

Complicated skin and soft tissue infections

Infections of bones and joints

2-4 g

Once daily

 

Management of neutropenic patients with fever that is suspected to be due to a bacterial infection

Bacterial endocarditis

Bacterial meningitis

* In documented bacteraemia, the higher end of the recommended dose range should be considered.

** Twice daily (12 hourly) administration may be considered where doses greater than 2 g daily are administered.

Indications for adults and children over 12 years of age (≥ 50 kg) that require specific dosage schedules:

Acute otitis media

A single intramuscular dose of Trexon 1-2 g can be given.

Limited data suggest that in cases where the patient is severely ill or previous therapy has failed, Trexon may be effective when given as an intramuscular dose of 1-2 g daily for 3 days.

Pre-operative prophylaxis of surgical site infections

2 g as a single pre-operative dose.

Gonorrhoea

500 mg as a single intramuscular dose.

Syphilis

The generally recommended doses are 500 mg-1 g once daily increased to 2 g once daily for neurosyphilis for 10-14 days. The dose recommendations in syphilis, including neurosyphilis, are based on limited data.

National or local guidance should be taken into consideration.

Disseminated Lyme borreliosis (early [Stage II] and late [Stage III])

2 g once daily for 14-21 days. The recommended treatment durations vary and national or local guidelines should be taken into consideration.

Paediatric population

Neonates, infants and children 15 days to 12 years of age (< 50 kg)

For children with bodyweight of 50 kg or more, the usual adult dosage should be given.

Ceftriaxone Dosage*

Treatment frequency**

Indications

50-80 mg/kg

 

Once daily

 

Intra-abdominal infections

Complicated urinary tract infections (including pyelonephritis)

Community acquired pneumonia

Hospital acquired pneumonia

50-100 mg/kg (Max 4 g)

 

Once daily

Complicated skin and soft tissue infections

Infections of bones and joints

Management of neutropenic patients with fever that is suspected to be due to a bacterial infection

80-100 mg/kg (max 4 g)

Once daily

Bacterial meningitis

100 mg/kg (max 4 g)

Once daily

Bacterial endocarditis

* In documented bacteraemia, the higher end of the recommended dose range should be considered.

** Twice daily (12 hourly) administration may be considered where doses greater than 2 g daily are administered.

Indications for neonates, infants and children 15 days to 12 years (< 50 kg) that require specific dosage schedules:

Acute otitis media

For initial treatment of acute otitis media, a single intramuscular dose of Trexon 50 mg/kg can be given.

Limited data suggest that in cases where the child is severely ill or initial therapy has failed, Trexon may be effective when given as an intramuscular dose of 50 mg/kg daily for 3 days.

Pre-operative prophylaxis of surgical site infections

50-80 mg/kg as a single pre-operative dose.

Syphilis

The generally recommended doses are 75-100 mg/kg (max 4 g) once daily for 10-14 days. The dose recommendations in syphilis, including neurosyphilis, are based on very limited data. National or local guidance should be taken into consideration.

Disseminated Lyme borreliosis (early [Stage II] and late [Stage III])

50–80 mg/kg once daily for 14-21 days. The recommended treatment durations vary and national or local guidelines should be taken into consideration.

Neonates 0-14 days

Trexon is contraindicated in premature neonates up to a postmenstrual age of 41 weeks (gestational age + chronological age).

Ceftriaxone Dosage*

Treatment frequency**

Indications

20-50 mg/kg

 

Once daily

 

Intra-abdominal infections

Complicated skin and soft tissue infections

Complicated urinary tract infections (including pyelonephritis)

Community acquired pneumonia

Hospital acquired pneumonia

Infections of bones and joints

Management of neutropenic patients with fever that is suspected to be due to a bacterial infection

50 mg/kg

Once daily

Bacterial meningitis

Bacterial endocarditis

* In documented bacteraemia, the higher end of the recommended dose range should be considered.

A maximum daily dose of 50 mg/kg should not be exceeded.

Indications for neonates 0-14 days that require specific dosage schedules:

Acute otitis media

For initial treatment of acute otitis media, a single intramuscular dose of Trexon 50 mg/kg can be given.

Pre-operative prophylaxis of surgical site infections

20-50 mg/kg as a single pre-operative dose.

Syphilis

The generally recommended dose is 50 mg/kg once daily for 10-14 days. The dose recommendations in syphilis, including neurosyphilis, are based on very limited data. National or local guidance should be taken into consideration.

Duration of therapy

The duration of therapy varies according to the course of the disease. As with antibiotic therapy in general, administration of ceftriaxone should be continued for 48 - 72 hours after the patient has become afebrile or evidence of bacterial eradication has been achieved.

Older people

The dosages recommended for adults require no modification in older people provided that renal and hepatic function is satisfactory.

Patients with hepatic impairment

Available data do not indicate the need for dose adjustment in mild or moderate liver function impairment provided renal function is not impaired.

There are no study data in patients with severe hepatic impairment (see section 5.2).

Patients with renal impairment

In patients with impaired renal function, there is no need to reduce the dosage of ceftriaxone provided hepatic function is not impaired. Only in cases of preterminal renal failure (creatinine clearance < 10 ml/min) should the ceftriaxone dosage not exceed 2 g daily.

In patients undergoing dialysis no additional supplementary dosing is required following the dialysis. Ceftriaxone is not removed by peritoneal- or haemodialysis. Close clinical monitoring for safety and efficacy is advised.

Patients with severe hepatic and renal impairment

In patients with both severe renal and hepatic dysfunction, close clinical monitoring for safety and efficacy is advised.

Method of administration

Trexon can be administered by intravenous infusion over at least 30 minutes (preferred route) or by slow intravenous injection over 5 minutes, or by deep intramuscular injection. Intravenous intermittent injection should be given over 5 minutes preferably in larger veins. Intravenous doses of 50 mg/kg or more in infants and children up to 12 years of age should be given by infusion. In neonates, intravenous doses should be given over 60 minutes to reduce the potential risk of bilirubin encephalopathy (see section 4.3 and 4.4). Intramuscular injections should be injected well within the bulk of a relatively large muscle and not more than 1 g should be injected at one site. Intramuscular administration should be considered when the intravenous route is not possible or less appropriate for the patient. For doses greater than 2 g intravenous administration should be used.

If lidocaine is used as a solvent, the resulting solution should never be administered intravenously (see section 4.3). The information in the Summary of Product Characteristics of lidocaine should be considered.

Ceftriaxone is contraindicated in neonates (≤ 28 days) if they require (or are expected to require) treatment with calcium-containing intravenous solutions, including continuous calcium-containing infusions such as parenteral nutrition, because of the risk of precipitation of ceftriaxone-calcium (see section 4.3).

Diluents containing calcium, (e.g. Ringer’s solution or Hartmann’s solution), should not be used to reconstitute ceftriaxone vials or to further dilute a reconstituted vial for intravenous administration because a precipitate can form. Precipitation of ceftriaxone-calcium can also occur when ceftriaxone is mixed with calcium-containing solutions in the same intravenous administration line. Therefore, ceftriaxone and calcium-containing solutions must not be mixed or administered simultaneously (see sections 4.3, 4.4 and 6.2).

For pre-operative prophylaxis of surgical site infections, ceftriaxone should be administered 30-90 minutes prior to surgery.

For instructions on reconstitution of the medicinal product before administration, see section 6.6.


Hypersensitivity to ceftriaxone, to any other cephalosporin or to any of the excipients listed in section 6.1. History of severe hypersensitivity (e.g. anaphylactic reaction) to any other type of beta-lactam antibacterial agent (penicillins, monobactams and carbapenems). Ceftriaxone is contraindicated in: Premature neonates up to a postmenstrual age of 41 weeks (gestational age + chronological age)* Full-term neonates (up to 28 days of age): - with hyperbilirubinaemia, jaundice, or who are hypoalbuminaemic or acidotic because these are conditions in which bilirubin binding is likely to be impaired* - if they require (or are expected to require) intravenous calcium treatment, or calcium-containing infusions due to the risk of precipitation of a ceftriaxone-calcium salt (see sections 4.4, 4.8 and 6.2). * In vitro studies have shown that ceftriaxone can displace bilirubin from its serum albumin binding sites leading to a possible risk of bilirubin encephalopathy in these patients. Contraindications to lidocaine must be excluded before intramuscular injection of ceftriaxone when lidocaine solution is used as a solvent (see section 4.4). See information in the Summary of Product Characteristics of lidocaine, especially contraindications. Ceftriaxone solutions containing lidocaine should never be administered intravenously.

Hypersensitivity reactions

As with all beta-lactam antibacterial agents, serious and occasionally fatal hypersensitivity reactions have been reported (see section 4.8). In case of severe hypersensitivity reactions, treatment with ceftriaxone must be discontinued immediately and adequate emergency measures must be initiated. Before beginning treatment, it should be established whether the patient has a history of severe hypersensitivity reactions to ceftriaxone, to other cephalosporins or to any other type of beta-lactam agent. Caution should be used if ceftriaxone is given to patients with a history of non-severe hypersensitivity to other beta-lactam agents.

Severe cutaneous adverse reactions (Stevens Johnson syndrome or Lyell's syndrome/toxic epidermal necrolysis) have been reported; however, the frequency of these events is not known (see section 4.8).

Interaction with calcium containing products

Cases of fatal reactions with calcium-ceftriaxone precipitates in lungs and kidneys in premature and full-term neonates aged less than 1 month have been described. At least one of them had received ceftriaxone and calcium at different times and through different intravenous lines. In the available scientific data, there are no reports of confirmed intravascular precipitations in patients, other than neonates, treated with ceftriaxone and calcium-containing solutions or any other calcium-containing products. In vitro studies demonstrated that neonates have an increased risk of precipitation of ceftriaxone-calcium compared to other age groups.

In patients of any age ceftriaxone must not be mixed or administered simultaneously with any calcium-containing intravenous solutions, even via different infusion lines or at different infusion sites. However, in patients older than 28 days of age ceftriaxone and calcium-containing solutions may be administered sequentially one after another if infusion lines at different sites are used or if the infusion lines are replaced or thoroughly flushed between infusions with physiological salt-solution to avoid precipitation. In patients requiring continuous infusion with calcium-containing total parenteral nutrition (TPN) solutions, healthcare professionals may wish to consider the use of alternative antibacterial treatments which do not carry a similar risk of precipitation. If the use of ceftriaxone is considered necessary in patients requiring continuous nutrition, TPN solutions and ceftriaxone can be administered simultaneously, albeit via different infusion lines at different sites. Alternatively, infusion of TPN solution could be stopped for the period of ceftriaxone infusion and the infusion lines flushed between solutions (see sections 4.3, 4.8, 5.2 and 6.2).

Paediatric population

Safety and effectiveness of Trexon in neonates, infants and children have been established for the dosages described under Posology and Method of Administration (see section 4.2). Studies have shown that ceftriaxone, like some other cephalosporins, can displace bilirubin from serum albumin.

Trexon is contraindicated in premature and full-term neonates at risk of developing bilirubin encephalopathy (see section 4.3).

Immune mediated haemolytic anaemia

An immune mediated haemolytic anaemia has been observed in patients receiving cephalosporin class antibacterials including Trexon (see section 4.8). Severe cases of haemolytic anaemia, including fatalities, have been reported during Trexon treatment in both adults and children.

If a patient develops anaemia while on ceftriaxone, the diagnosis of a cephalosporin-associated anaemia should be considered and ceftriaxone discontinued until the aetiology is determined.

Long term treatment

During prolonged treatment complete blood count should be performed at regular intervals.

Colitis/Overgrowth of non-susceptible microorganisms

Antibacterial agent-associated colitis and pseudo-membranous colitis have been reported with nearly all antibacterial agents, including ceftriaxone, and may range in severity from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhoea during or subsequent to the administration of ceftriaxone (see section 4.8). Discontinuation of therapy with ceftriaxone and the administration of specific treatment for Clostridium difficile should be considered. Medicinal products that inhibit peristalsis should not be given.

Superinfections with non-susceptible micro-organisms may occur as with other antibacterial agents.

Severe renal and hepatic insufficiency

In severe renal and hepatic insufficiency, close clinical monitoring for safety and efficacy is advised (see section 4.2).

Interference with serological testing

Interference with Coombs tests may occur, as Trexon may lead to false-positive test results. Trexon can also lead to false-positive test results for galactosaemia (see section 4.8).

Non-enzymatic methods for the glucose determination in urine may give false-positive results. Urine glucose determination during therapy with Trexon should be done enzymatically (see section 4.8).

Sodium

Each gram of Trexon contains 3.6 mmol sodium. This should be taken into consideration in patients on a controlled sodium diet.

Antibacterial spectrum

Ceftriaxone has a limited spectrum of antibacterial activity and may not be suitable for use as a single agent for the treatment of some types of infections unless the pathogen has already been confirmed (see section 4.2). In polymicrobial infections, where suspected pathogens include organisms resistant to ceftriaxone, administration of an additional antibiotic should be considered.

Use of lidocaine

In case a lidocaine solution is used as a solvent, ceftriaxone solutions must only be used for intramuscular injection. Contraindications to lidocaine, warnings and other relevant information as detailed in the Summary of Product Characteristics of lidocaine must be considered before use (see section 4.3). The lidocaine solution should never be administered intravenously.

Biliary lithiasis

When shadows are observed on sonograms, consideration should be given to the possibility of precipitates of calcium ceftriaxone. Shadows, which have been mistaken for gallstones, have been detected on sonograms of the gallbladder and have been observed more frequently at ceftriaxone doses of 1 g per day and above. Caution should be particularly considered in the paediatric population. Such precipitates disappear after discontinuation of ceftriaxone therapy. Rarely precipitates of calcium ceftriaxone have been associated with symptoms. In symptomatic cases, conservative nonsurgical management is recommended and discontinuation of ceftriaxone treatment should be considered by the physician based on specific benefit risk assessment (see section 4.8).

Biliary stasis

Cases of pancreatitis, possibly of biliary obstruction aetiology, have been reported in patients treated with Trexon (see section 4.8). Most patients presented with risk factors for biliary stasis and biliary sludge e.g. preceding major therapy, severe illness and total parenteral nutrition. A trigger or cofactor of Trexon-related biliary precipitation cannot be ruled out.

Renal lithiasis

Cases of renal lithiasis have been reported, which is reversible upon discontinuation of ceftriaxone (see section 4.8). In symptomatic cases, sonography should be performed. Use in patients with history of renal lithiasis or with hypercalciuria should be considered by the physician based on specific benefit risk assessment.


Calcium-containing diluents, such as Ringer's solution or Hartmann's solution, should not be used to reconstitute Trexon vials or to further dilute a reconstituted vial for intravenous administration because a precipitate can form. Precipitation of ceftriaxone-calcium can also occur when ceftriaxone is mixed with calcium-containing solutions in the same intravenous administration line. Ceftriaxone must not be administered simultaneously with calcium-containing intravenous solutions, including continuous calcium-containing infusions such as parenteral nutrition via a Y-site. However, in patients other than neonates, ceftriaxone and calcium-containing solutions may be administered sequentially of one another if the infusion lines are thoroughly flushed between infusions with a compatible fluid. In vitro studies using adult and neonatal plasma from umbilical cord blood demonstrated that neonates have an increased risk of precipitation of ceftriaxone-calcium (see sections 4.2, 4.3, 4.4, 4.8 and 6.2).

Concomitant use with oral anticoagulants may increase the anti-vitamin K effect and the risk of bleeding. It is recommended that the International Normalised Ratio (INR) is monitored frequently and the posology of the anti-vitamin K drug adjusted accordingly, both during and after treatment with ceftriaxone (see section 4.8).

There is conflicting evidence regarding a potential increase in renal toxicity of aminoglycosides when used with cephalosporins. The recommended monitoring of aminoglycoside levels (and renal function) in clinical practice should be closely adhered to in such cases.

In an in-vitro study antagonistic effects have been observed with the combination of chloramphenicol and ceftriaxone. The clinical relevance of this finding is unknown.

There have been no reports of an interaction between ceftriaxone and oral calcium-containing products or interaction between intramuscular ceftriaxone and calcium-containing products (intravenous or oral).

In patients treated with ceftriaxone, the Coombs' test may lead to false-positive test results.

Ceftriaxone, like other antibiotics, may result in false-positive tests for galactosaemia.

Likewise, non-enzymatic methods for glucose determination in urine may yield false-positive results. For this reason, glucose level determination in urine during therapy with ceftriaxone should be carried out enzymatically.

No impairment of renal function has been observed after concurrent administration of large doses of ceftriaxone and potent diuretics (e.g. furosemide).

Simultaneous administration of probenecid does not reduce the elimination of ceftriaxone.


Pregnancy

Ceftriaxone crosses the placental barrier. There are limited amounts of data from the use of ceftriaxone in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to embryonal/foetal, perinatal and postnatal development (see section 5.3). Ceftriaxone should only be administered during pregnancy and in particular in the first trimester of pregnancy if the benefit outweighs the risk.

Breastfeeding

Ceftriaxone is excreted into human milk in low concentrations but at therapeutic doses of ceftriaxone no effects on the breastfed infants are anticipated. However, a risk of diarrhoea and fungal infection of the mucous membranes cannot be excluded. The possibility of sensitisation should be taken into account. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from ceftriaxone therapy, taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.

Fertility

Reproductive studies have shown no evidence of adverse effects on male or female fertility.


During treatment with ceftriaxone, undesirable effects may occur (e.g. dizziness), which may influence the ability to drive and use machines (see section 4.8). Patients should be cautious when driving or operating machinery.


The most frequently reported adverse reactions for ceftriaxone are eosinophilia, leucopenia, thrombocytopenia, diarrhoea, rash, and hepatic enzymes increased.

Data to determine the frequency of ceftriaxone ADRs was derived from clinical trials.

The following convention has been used for the classification of frequency:

Very common (≥ 1/10)

Common (≥ 1/100 - < 1/10)

Uncommon (≥ 1/1000 - < 1/100)

Rare (≥ 1/10000 - < 1/1000)

Not known (cannot be estimated from the available data).

System Organ Class

Common

Uncommon

Rare

Not Known a

Infections and infestations

 

Genital fungal infection

Pseudo-membranous colitisb

Superinfectionb

Blood and lymphatic system disorders

Eosinophilia

Leucopenia

Thrombocytopenia

Granulocytopenia

Anaemia

Coagulopathy

 

Haemolytic anaemiab

Agranulocytosis

Immune system disorders

 

 

 

Anaphylactic shock

Anaphylactic reaction

Anaphylactoid reaction

Hypersensitivityb

Nervous system disorders

 

Headache

Dizziness

 

Convulsion

 

Ear and labyrinth disorders

 

 

 

Vertigo

Respiratory, thoracic and mediastinal disorders

 

 

Bronchospasm

 

Gastrointestinal disorders

Diarrhoeab

Loose stools

Nausea

Vomiting

 

Pancreatitisb

Stomatitis

Glossitis

Hepatobiliary disorders

Hepatic enzyme increased

 

 

Gall bladder precipitationb

Kernicterus

Skin and subcutaneous tissue disorders

Rash

 

Pruritus

 

Urticaria

 

Stevens Johnson Syndromeb

Toxic epidermal necrolysisb

Erythema multiforme

Acute generalised exanthematous pustulosis

Renal and urinary disorders

 

 

Haematuria

Glycosuria

Oliguria

Renal precipitation (reversible)

General disorders and administration site conditions

 

Phlebitis

Injection site pain

Pyrexia

Oedema

Chills

 

 

Investigations

 

 

Blood creatinine increased

 

Coombs test false positiveb

Galactosaemia test false positiveb

Non enzymatic methods for glucose determination false positiveb

a Based on post-marketing reports. Since these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency which is therefore categorised as not known.

b See section 4.4

Infections and infestations

Reports of diarrhoea following the use of ceftriaxone may be associated with Clostridium difficile. Appropriate fluid and electrolyte management should be instituted (see section 4.4).

Ceftriaxone-calcium salt precipitation

Rarely, severe, and in some cases, fatal, adverse reactions have been reported in pre-term and full-term neonates (aged < 28 days) who had been treated with intravenous ceftriaxone and calcium. Precipitations of ceftriaxone-calcium salt have been observed in lung and kidneys post-mortem. The high risk of precipitation in neonates is a result of their low blood volume and the longer half-life of ceftriaxone compared with adults (see sections 4.3, 4.4, and 5.2).

Cases of renal precipitation have been reported, primarily in children older than 3 years of age and who have been treated with either high daily doses (e.g. ≥ 80 mg/kg/day) or total doses exceeding 10 grams and who presented with other risk factors (e.g. fluid restrictions or confinement to bed). The risk of precipitate formation is increased in immobilized or dehydrated patients. This event may be symptomatic or asymptomatic, may lead to renal insufficiency and anuria, and is reversible upon discontinuation of ceftriaxone (see section 4.4).

Precipitation of ceftriaxone calcium salt in the gallbladder has been observed, primarily in patients treated with doses higher than the recommended standard dose. In children, prospective studies have shown a variable incidence of precipitation with intravenous application - above 30 % in some studies. The incidence appears to be lower with slow infusion (20 - 30 minutes). This effect is usually asymptomatic, but the precipitations have been accompanied by clinical symptoms such as pain, nausea and vomiting in rare cases. Symptomatic treatment is recommended in these cases. Precipitation is usually reversible upon discontinuation of ceftriaxone (see section 4.4).

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

To report any side effects﴿:

• Saudi Arabia: The National Pharmacovigilance Centre (NPC)

SFDA Call center: 19999

E-mail: npc.drug@sfda.gov.sa

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


In overdose, the symptoms of nausea, vomiting and diarrhoea can occur. Ceftriaxone concentrations cannot be reduced by haemodialysis or peritoneal dialysis. There is no specific antidote. Treatment of overdose should be symptomatic.


Pharmacotherapeutic group: Antibacterials for systemic use, Third-generation cephalosporins, ATC code: J01DD04.

Mode of action

Ceftriaxone inhibits bacterial cell wall synthesis following attachment to penicillin binding proteins (PBPs). This results in the interruption of cell wall (peptidoglycan) biosynthesis, which leads to bacterial cell lysis and death.

Resistance

Bacterial resistance to ceftriaxone may be due to one or more of the following mechanisms:

• hydrolysis by beta-lactamases, including extended-spectrum beta-lactamases (ESBLs), carbapenemases and Amp C enzymes that may be induced or stably derepressed in certain aerobic Gram-negative bacterial species.

• reduced affinity of penicillin-binding proteins for ceftriaxone.

• outer membrane impermeability in Gram-negative organisms.

• bacterial efflux pumps.

Susceptibility testing breakpoints

Minimum inhibitory concentration (MIC) breakpoints established by the European Committee on Antimicrobial Susceptibility Testing (EUCAST) are as follows:

 

 

Pathogen

Dilution Test

(MIC, mg/L)

Susceptible

Resistant

Enterobacteriaceae

≤ 1

> 2

Staphylococcus spp.

a.

a.

Streptococcus spp.

(Groups A, B, C and G)

b.

 

b.

 

Streptococcus pneumoniae

≤ 0.5c.

> 2

Viridans group Streptococci

≤0.5

>0.5

Haemophilus influenzae

≤ 0.12c.

> 0.12

Moraxella catarrhalis

≤ 1

> 2

Neisseria gonorrhoeae

≤ 0.12

> 0.12

Neisseria meningitidis

≤ 0.12 c.

> 0.12                                 

Non-species related

≤ 1d.

> 2

a. Susceptibility inferred from cefoxitin susceptibility.

b. Susceptibility inferred from penicillin susceptibility.

c. Isolates with a ceftriaxone MIC above the susceptible breakpoint are rare and, if found, should be re-tested and, if confirmed, should be sent to a reference laboratory.

d. Breakpoints apply to a daily intravenous dose of 1 g x 1 and a high dose of at least 2 g x 1.

Clinical efficacy against specific pathogens

The prevalence of acquired resistance may vary geographically and with time for selected species and local information on resistance is desirable, particularly when treating severe infections. As necessary, expert advice should be sought when the local prevalence of resistance is such that the utility of ceftriaxone in at least some types of infections is questionable.

Commonly susceptible species

Gram-positive aerobes

Staphylococcus aureus (methicillin-susceptible)£

Staphylococci coagulase-negative (methicillin-susceptible)£

Streptococcus pyogenes (Group A)

Streptococcus agalactiae (Group B)

Streptococcus pneumoniae

Viridans Group Streptococci

Gram-negative aerobes

Borrelia burgdorferi

Haemophilus influenzae

Haemophilus parainfluenzae

Moraxella catarrhalis

Neisseria gonorrhoea

Neisseria meningitidis

Proteus mirabilis

Providencia spp

Treponema pallidum

Species for which acquired resistance may be a problem

Gram-positive aerobes

Staphylococcus epidermidis+

Staphylococcus haemolyticus+

Staphylococcus hominis+

Gram-negative aerobes

Citrobacter freundii

Enterobacter aerogenes

Enterobacter cloacae

Escherichia coli%

Klebsiella pneumoniae%

Klebsiella oxytoca%

Morganella morganii

Proteus vulgaris

Serratia marcescens

Anaerobes

Bacteroides spp.

Fusobacterium spp.

Peptostreptococcus spp.

Clostridium perfringens

Inherently resistant organisms

Gram-positive aerobes

Enterococcus spp.

Listeria monocytogenes

Gram-negative aerobes

Acinetobacter baumannii

Pseudomonas aeruginosa

Stenotrophomonas maltophilia

Anaerobes

Clostridium difficile

Others:

Chlamydia spp.

Chlamydophila spp.

Mycoplasma spp.

Legionella spp.

Ureaplasma urealyticum

£ All methicillin-resistant staphylococci are resistant to ceftriaxone.

+ Resistance rates >50% in at least one region.

% ESBL producing strains are always resistant.


Absorption

After intravenous bolus administration of ceftriaxone 500 mg and 1 g, mean peak plasma ceftriaxone levels are approximately 120 and 200 mg/l respectively. After intravenous infusion of ceftriaxone 500 mg, 1 g and 2 g, the plasma ceftriaxone levels are approximately 80, 150 and 250 mg/l respectively. Following intramuscular injection, mean peak plasma ceftriaxone levels are approximately half those observed after intravenous administration of an equivalent dose. The maximum plasma concentration after a single intramuscular dose of 1 g is about 81 mg/l and is reached in 2 - 3 hours after administration.

The area under the plasma concentration-time curve after intramuscular administration is equivalent to that after intravenous administration of an equivalent dose.

Distribution

The volume of distribution of ceftriaxone is 7 – 12 l. Concentrations well above the minimal inhibitory concentrations of most relevant pathogens are detectable in tissue including lung, heart, biliary tract/liver, tonsil, middle ear and nasal mucosa, bone, and in cerebrospinal, pleural, prostatic and synovial fluids. An 8 - 15 % increase in mean peak plasma concentration (Cmax) is seen on repeated administration; steady state is reached in most cases within 48 - 72 hours depending on the route of administration.

Penetration into particular tissues

Ceftriaxone penetrates the meninges. Penetration is greatest when the meninges are inflamed. Mean peak ceftriaxone concentrations in CSF in patients with bacterial meningitis are reported to be up to 25 % of plasma levels compared to 2 % of plasma levels in patients with uninflamed meninges. Peak ceftriaxone concentrations in CSF are reached approximately 4-6 hours after intravenous injection. Ceftriaxone crosses the placental barrier and is excreted in the breast milk at low concentrations (see section 4.6).

Protein binding

Ceftriaxone is reversibly bound to albumin. Plasma protein binding is about 95 % at plasma concentrations below 100 mg/l. Binding is saturable and the bound portion decreases with rising concentration (up to 85 % at a plasma concentration of 300 mg/l).

Biotransformation

Ceftriaxone is not metabolised systemically; but is converted to inactive metabolites by the gut flora.

Elimination

Plasma clearance of total ceftriaxone (bound and unbound) is 10 - 22 ml/min. Renal clearance is 5 - 12 ml/min. 50 - 60 % of ceftriaxone is excreted unchanged in the urine, primarily by glomerular filtration, while 40 - 50 % is excreted unchanged in the bile. The elimination half-life of total ceftriaxone in adults is about 8 hours.

Patients with renal or hepatic impairment

In patients with renal or hepatic dysfunction, the pharmacokinetics of ceftriaxone are only minimally altered with the half-life slightly increased (less than two fold), even in patients with severely impaired renal function.

The relatively modest increase in half-life in renal impairment is explained by a compensatory increase in non-renal clearance, resulting from a decrease in protein binding and corresponding increase in non-renal clearance of total ceftriaxone.

In patients with hepatic impairment, the elimination half-life of ceftriaxone is not increased, due to a compensatory increase in renal clearance. This is also due to an increase in plasma free fraction of ceftriaxone contributing to the observed paradoxical increase in total drug clearance, with an increase in volume of distribution paralleling that of total clearance.

Older people

In older people aged over 75 years the average elimination half-life is usually two to three times that of young adults.

Paediatric population

The half-life of ceftriaxone is prolonged in neonates. From birth to 14 days of age, the levels of free ceftriaxone may be further increased by factors such as reduced glomerular filtration and altered protein binding. During childhood, the half-life is lower than in neonates or adults.

The plasma clearance and volume of distribution of total ceftriaxone are greater in neonates, infants and children than in adults.

Linearity/non-linearity

The pharmacokinetics of ceftriaxone are non-linear and all basic pharmacokinetic parameters, except the elimination half-life, are dose dependent if based on total drug concentrations, increasing less than proportionally with dose. Non-linearity is due to saturation of plasma protein binding and is therefore observed for total plasma ceftriaxone but not for free (unbound) ceftriaxone.

Pharmacokinetic/pharmacodynamic relationship

As with other beta-lactams, the pharmacokinetic-pharmacodynamic index demonstrating the best correlation with in vivo efficacy is the percentage of the dosing interval that the unbound concentration remains above the minimum inhibitory concentration (MIC) of ceftriaxone for individual target species (i.e. %T > MIC).


There is evidence from animal studies that high doses of ceftriaxone calcium salt led to formation of concrements and precipitates in the gallbladder of dogs and monkeys, which proved to be reversible. Animal studies produced no evidence of toxicity to reproduction and genotoxicity. Carcinogenicity studies on ceftriaxone were not conducted. 


None.


Based on literature reports, ceftriaxone is not compatible with amsacrine, vancomycin, fluconazole and aminoglycosides.

Solutions containing ceftriaxone should not be mixed with or added to other agents except those mentioned in section 6.6. In particular diluents containing calcium, (e.g. Ringer's solution, Hartmann's solution) should not be used to reconstitute ceftriaxone vials or to further dilute a reconstituted vial for intravenous administration because a precipitate can form. Ceftriaxone must not be mixed or administered simultaneously with calcium containing solutions including total parenteral nutrition (see section 4.2, 4.3, 4.4 and 4.8).


Unopened vial: 3 years. Chemical and physical in-use stability of the reconstituted product has been demonstrated for at least 6 hours at or below 25°C or 24 hours at 2-8°C. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would not be longer than the times stated above for the chemical and physical in-use stability.

Do not store above 30°C, keep vial in the outer carton in order to protect from light.

For storage conditions of the reconstituted medicinal product, see section 6.3.


Packs for Intramuscular injection:

Trexon 500 mg vial: 1 vial + 1 ampoule (2 ml) of 1% lidocaine solution.

Trexon 1 g vial: 1 vial + 1 ampoule (3.5 ml) of 1% lidocaine solution.

Packs for intravenous injection:

Trexon 500 mg vial: 1 vial + 1 ampoule (5 ml) of sterile water for injection.

Trexon 1 g vial: 1 vial + 1 ampoule (10 ml) of sterile water for injection.

Packs for intravenous infusion:

Trexon 2 g vial: 1 vial + 1 ampoule (10 ml) of sterile water for injection.


Concentrations for the intravenous injection: 100 mg/ml,

Concentrations for the intravenous infusion: 50 mg/ml

(Please refer to section 4.2 for further information).

Preparation of solutions for injection and infusion

The use of freshly prepared solutions is recommended. For storage conditions of the reconstituted medicinal product, see section 6.3.

Trexon should not be mixed in the same syringe with any drug other than 1% Lidocaine Hydrochloride solution (for intramuscular injection only).

The infusion line should be flushed after each administration.

Trexon 2 g powder for solution for injection or infusion

For IV infusion 2 g Trexon is dissolved in 40 ml of one of the following calcium-free infusion fluids: sodium chloride 0.9%, sodium chloride 0.45% + dextrose 2.5%, dextrose 5%, dextrose 10%, dextran 6% in dextrose 5%, hydroxyethly-starch 6 – 10%, water for injections. The infusion should be administered over at least 30 minutes. See also the information in section 6.2.

Trexon 1 g powder for solution for injection or infusion

For IV injection 1 g Trexon is dissolved in 10 ml of water for injections. The injection should be administered over 5 minutes, directly into the vein or via the tubing of an intravenous infusion.

For IM injection 1 g Trexon is dissolved in 3.5 ml of 1% Lidocaine Hydrochloride solution. The solution should be administered by deep intramuscular injection. Dosages greater than 1 g should be divided and injected at more than one site.

Trexon 500 mg powder for solution for injection

For IV injection 500 mg Trexon is dissolved in 5 ml of water for injections. The injection should be administered over 5 minutes, directly into the vein or via the tubing of an intravenous infusion.

For IM injection 500 mg Trexon is dissolved in 2 ml of 1% Lidocaine Hydrochloride solution. The solution should be administered by deep intramuscular injection. Dosages greater than 1 g should be divided and injected at more than one site.

Trexon 250 mg powder for solution for injection

For IV injection 250 mg Trexon is dissolved in 2.5 ml of water for injections. The injection should be administered over 5 minutes, directly into the vein or via the tubing of an intravenous infusion.

For IM injection 250 mg Trexon is dissolved in 2 ml of 1% lidocaine hydrochloride solution. The solution should be administered by deep intramuscular injection. Dosages greater than 1 g should be divided and injected at more than one site.

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


Egyptian International Pharmaceutical Industries Company, E.I.P.I.CO. 10th of Ramadan City – Industrial Area B1 – P.O. Box: 149 Tenth – Egypt. Tel: 0554/499199 0554/499277 Fax: 0554/499306 E-mail: eipico@eipico.com.eg

January 2021
}

صورة المنتج على الرف

الصورة الاساسية