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Julmentin is an antibiotic and works by killing bacteria that cause infections. It contains two different medicines called amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medicines called “penicillins” that can sometimes be stopped from working (made inactive). The other active component (clavulanic acid) stops this from happening.
Julmentin is used in babies and children to treat the following infections:
• Middle ear and sinus infections
• Respiratory tract infections
• Urinary tract infections
• Skin and soft tissue infections including dental infections
• Bone and joint infections.
Do not give your child Julmentin:
• If they are allergic to amoxicillin, clavulanic acid, penicillin or any of the other ingredients of this medicine (listed in section 6)
• If they have ever had a severe allergic reaction to any other antibiotic. This can include a skin rash or swelling of the face or throat.
• If they have ever had liver problems or jaundice (yellowing of the skin) when taking an antibiotic.
Do not give Julmentin to your child if any of the above applies to your child. If you are not sure, talk to their doctor or pharmacist before giving Julmentin.
Warning and Precautions
Check with their doctor, pharmacist or nurse before giving your child Julmentin if they:
• Have glandular fever
• Are being treated for liver or kidney problems
• Are not passing water regularly.
If you are not sure if any of the above applies to your child, talk to their doctor or pharmacist before giving Julmentin.
In some cases, your doctor may investigate the type of bacteria that is causing your child’s infection. Depending on the results, your child may be given a different strength of Julmentin or a different medicine.
Conditions you need to look out for
Julmentin can make some existing conditions worse, or cause serious side effects. These include allergic reactions, convulsions (fits) and inflammation of the large intestine. You must look out for certain symptoms while your child is taking Julmentin, to reduce the risk of any problems. See ‘Conditions you need to look out for’ in section 4.
Blood or urine tests
If your child is having blood tests (such as red blood cell status tests or liver function tests) or urine tests, let the doctor or nurse know that they are taking Julmentin. This is because Julmentin can affect the results of these types of tests.
Other medicines and Julmentin
Tell your doctor or pharmacist if your child is taking, has recently taken or might take any other medicines.
• If your child is taking allopurinol (used for gout) with Julmentin, it may be more likely that they will have an allergic skin reaction.
• If your child is taking probenecid (used for gout), your doctor may decide to adjust the dose of Julmentin.
• If medicines to help stop blood clots (such as warfarin) are taken with Julmentin then extra blood tests may be needed.
Julmentin can affect how methotrexate (a medicine used to treat cancer or rheumatic diseases) works.
Julmentin may affect how mycophenolate mofetil (a medicine used to prevent the rejection of transplanted organs) works.
Important information of some ingredients of Julmentin
Julmentin contains saccharin. If you have been told by your doctor that your child have intolerance to some sugars, talk to your doctor before giving this medicine to your child.
Always give this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
How to give Julmentin
• Always shake the bottle well before each dose
• Give at the start of a meal or slightly before
• Space the doses evenly during the day, at least 4 hours apart. Do not take 2 doses in 1 hour.
• Do not give your child Julmentin for more than 2 weeks. If your child still feels unwell they should go back to see the doctor.
Adults and children weighing 40 kg or over
• This suspension is not usually recommended for adults and children weighing 40 kg and over. Ask your doctor or pharmacist for advice.
Children weighing less than 40 kg
All doses are worked out depending on the child’s bodyweight in kilograms.
• Your doctor will advise you how much Julmentin you should give to your baby or child.
• You will provide with a measuring device. You should use this to give the correct dose to your baby or child.
• Recommended dose - 20 mg/5 mg to 60 mg/15 mg for each kilogram of body weight a day, given in three divided doses.
Patients with kidney and liver problems
• If your child has kidney problems the dose might be lowered. A different strength or a different medicine may be chosen by your doctor.
• If your child has liver problems they may have more frequent blood tests to see how their liver is working.
If you give more Julmentin than you should
If you give your child too much Julmentin, signs might include an upset stomach (feeling sick, being sick or diarrhoea) or convulsions. Talk to their doctor as soon as possible. Take the medicine bottle to show the doctor.
If you forget to give Julmentin
If you forget to give your child a dose, give it as soon as you remember. You should not give your child the next dose too soon, but wait about 4 hours before giving the next dose. Do not take a double dose to make up for a forgotten dose.
If your child stops taking Julmentin
Keep giving your child Julmentin until the treatment is finished, even if they feel better. Your child needs every dose to help fight the infection. If some bacteria survive they can cause the infection to come back.
If you have any further questions on the use of this product, ask your doctor, pharmacist or nurse.
Like all medicines, this medicine can cause side effects, although not everybody gets them. The side effects below may happen with this medicine..
Conditions you need to look out for
Allergic reactions:
• Skin rash
• Inflammation of blood vessels (vasculitis) which may be visible as red or purple raised spots on the skin, but can affect other parts of the body
• Fever, joint pain, swollen glands in the neck, armpit or groin
• Swelling, sometimes of the face or mouth (angioedema), causing difficulty in breathing
• Collapse.
Contact a doctor immediately if your child gets any of these symptoms. Stop taking Julmentin.
Inflammation of large intestine
Inflammation of the large intestine, causing watery diarrhoea usually with blood and mucus, stomach pain and/or fever.
Contact your doctor as soon as possible for advice if your child gets these symptoms.
Very common side effects
These may affect more than 1 in 10 people
• Diarrhoea (in adults).
Common side effects
These may affect up to 1 in 10 people
• Thrush (candida - a yeast infection of the vagina, mouth or skin folds)
• Feeling sick (nausea), especially when taking high doses
§ If affected take Julmentin before food
• Vomiting
• Diarrhoea (in children).
Uncommon side effects
These may affect up to 1 in 100 people
• Skin rash, itching
• Raised itchy rash (hives)
• Indigestion
• Dizziness
• Headache.
Uncommon side effects that may show up in blood tests:
• Increase in some substances (enzymes) produced by the liver
Rare side effects
These may affect up to 1 in 1000 people
• Skin rash, which may blister, and looks like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge - erythema multiforme)
§ If you notice any of these symptoms contact a doctor urgently.
Rare side effects that may show up in blood tests:
• Low number of cells involved in blood clotting.
• Low number of white blood cells.
Frequency not known
Frequency cannot be estimated from available data.
• Allergic reactions (see above)
• Inflammation of the large intestine (see above)
• Inflammation of the protective membrane surrounding the brain (aseptic meningitis)
• Serious skin reactions:
§ a widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome), and a more severe form, causing extensive peeling of the skin (more than 30% of the body surface - toxic epidermal necrolysis)
§ widespread red skin rash with small pus-containing blisters (bullous exfoliative dermatitis)
§ a red, scaly rash with bumps under the skin and blisters (exanthemous pustulosis).
Contact a doctor immediately if your child gets any of these symptoms.
• Inflammation of the liver (hepatitis)
• Jaundice, caused by increases in the blood of bilirubin (a substance produced in the liver) which may make your child’s skin and whites of the eyes appear yellow
• Inflammation of tubes in the kidney
• Blood takes longer to clot
• Hyperactivity
• Convulsions (in people taking high doses of Julmentin or who have kidney problems)
• Black tongue which looks hairy
• Stained teeth (in children), usually removed by brushing.
Side effects that may show up in blood or urine tests:
• Severe reduction in the number of white blood cells
• Low number of red blood cells (haemolytic anaemia)
• Crystals in urine.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
To report any side effect(s):
The National Pharmacovigilance and Drug Safety Center (NPC)
Fax: +966-11-205-7662
Call NPC at +966-11-2038222
Exts: 2317-2356-2353-2354-2334-2340
Toll free phone: 8002490000
E-mail: npc.drug@sfda.gov.sa
Website: www.sfda.gov.sa/npc
• Keep out of the reach and sight of children.
• Do not give Julmentin after the expiry date which is stated on the carton and the inner label.
• Before reconstitution, store below 30°C, in a dry place, protected from light.
• After reconstitution, store in a refrigerator (2-8°C) and use within 7 days. Shake well before use.
• Do not give Julmentin if you notice any visible sign of deterioration.
• 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.
Julmentin Suspension 156mg:
Each teaspoonful (5mL) of the reconstituted suspension contains:
Active ingredients: Amoxicillin trihydrate equivalent to 125mg amoxicillin and potassium clavulanate equivalent to 31.25mg clavulanic acid.
The other ingredients: Citric acid anhydrous, sodium citrate, sodium benzoate, microcrystalline cellulose, xanthan gum, colloidal silicon dioxide, saccharin sodium, strawberry flavour, and mannitol.
Julmentin Forte Suspension 312mg:
Each teaspoonful (5mL) of the reconstituted suspension contains:
Active ingredients: Amoxicillin trihydrate equivalent to 250mg amoxicillin and potassium clavulanate equivalent to 62.5mg clavulanic acid.
The other ingredients: Citric acid anhydrous, sodium citrate, sodium benzoate, microcrystalline cellulose, xanthan gum, colloidal silicon dioxide, saccharin sodium, cherry flavour and mannitol.
Gulf Pharmaceutical Industries " Julphar".
جلمنتين مضاد حيوي يعمل عن طريق القضاء على البكتيريا المسببة للعدوى. ويحتوي على نوعين مختلفين من المواد الدوائية وهما أموكسيسيلين وحمض كلافيولانيك. ينتمي أموكسيسيلين إلى مجموعة من الأدوية التي تعرف باسم "البنسيلينات" والذي من الممكن في بعض الأحيان أن تتوقف آلية عمله (يصبح غير نشط). بينما تعمل المادة الأخرى في هذا الدواء (حمض كلافيولانيك) على منع حدوث ذلك الأمر.
يستخدم جلمنتين من قبل الرضع والأطفال لعلاج حالات العدوى التالية:
• عدوى الأذن الوسطى والجيوب الأنفية
• عدوى الجهاز التنفسي
• عدوى المسالك البولية
• عدوى الجلد والأنسجة الرخوة بما في ذلك عدوى الأسنان
• عدوى العظام والمفاصل
يجب عليك عدم إعطاء جلمنتين لطفلك في الحالات التالية:
• إذا كان يعاني من الحساسية تجاه أموكسيسيلين، حمض الكلافيولانيك، البنسيلين أو أياً من المكونات الأخرى في هذا الدواء (المذكورة في قسم 6)
• إذا عانى مسبقاً من تفاعل تحسسي شديد تجاه أياً من المضادات الحيوية الأخرى. من الممكن أن يتضمن ذلك على حدوث طفح جلدي أو تورم في الوجه أو الحلق
• إذا عانى مسبقاً من مشاكل في الكبد أو يرقان (اصفرار الجلد) عند تناول المضادات الحيوية.
يجب عدم إعطاء جلمنتين لطفلك إذا كان أياً من المذكور أعلاه ينطبق عليه. يرجى منك إخبار الطبيب المعالج أو الصيدلي الذي تتعامل معه قبل إعطاء جلمنتين مالم تكن متأكداً من ذلك.
تحذيرات واحتياطات
يرجى منك استشارة الطبيب المعالج، أو الصيدلي الذي تتعامل معه أو الممرض قبل إعطاء جلمنتين لطفلك إذا كان :
• يعاني من الحمى الناجمة عن اضطرابات في الغدد
• يتلقى علاجاً لمشاكل في الكبد أو الكلى
• يعاني من عدم التبول بصورة منتظمة
يرجى منك التحدث إلى الطبيب المعالج أو الصيدلي الذي تتعامل معه قبل إعطاء جلمنتين، مالم تكن متأكداً ما إذا كان أياً من المذكور أعلاه ينطبق على طفلك.
في بعض الحالات، قد يحتاج الطبيب المعالج بإجراء فحص مختبري لمعرفة نوع البكتيريا المسببة للعدوى لدى الطفل. وبناءً على هذه النتائج، قد يتم إعطاء جلمنتين لطفلك بتركيز مختلف أو إعطائه أدوية أخرى.
الحالات التي تتطلب منك الانتباه
من الممكن أن يؤدي جلمنتين إلى تدهور بعض الحالات المرضية الذي يعاني منها طفلك في الوقت الحالي، أو يؤدي إلى حدوث تأثيرات جانبية خطيرة. بما في ذلك تفاعلات تحسسية، اختلاجات (نوبات تشنجية) والتهاب الأمعاء الغليظة. يجب عليك الانتباه من ظهور أعراض معينة أثناء تناول طفلك جلمنتين، وذلك لتقليل من خطر حدوث أية مشاكل. انظر، "الحالات التي تتطلب منك الانتباه" المذكورة في قسم 4.
فحوصات الدم أو البول
إذا كان طفلك سوف يخضع لفحوصات الدم (على سبيل المثال فحوصات خلايا الدم الحمراء أو فحوصات وظائف الكبد) أو فحوصات البول، فيرجى منك إخبار الطبيب المعالج أو الممرض بأن طفلك يتناول جلمنتين. وذلك لأن من الممكن أن يؤثر جلمنتين على نتائج هذه الفحوصات.
تناول جلمنتين بالتزامن مع الأدوية الأخرى:
يرجى منك إخبار طبيبك المعالج أو الصيدلي الذي تتعامل معه إذا كان طفلك يتناول، تناول مؤخراً أو قد يتناول أية أدوية أخرى.
• إذا كان طفلك يتناول ألوبيورينول (دواء يستخدم لعلاج النقرس) بالتزامن مع جلمنتين، قد يكون أكثر عرضة لحدوث تفاعل تحسسي جلدي.
• إذا كان طفلك يتناول بروبنسيد (دواء يستخدم لعلاج النقرس)، فقد يقرر طبيبك المعالج تعديل مقدار الجرعة من جلمنتين.
• إذا كان طفلك يتناول الأدوية التي تعمل على منع تخثر الدم (على سبيل المثال وارفارين) بالتزامن مع جلمنتين، فسوف يتطلب ذلك إجراء فحوصات دم إضافية.
من الممكن أن يؤثر جلمنتين على آلية عمل ميثوتركسات (دواء يستخدم لعلاج السرطان أو الأمراض الروماتيزمية).
من الممكن أن يؤثر جلمنتين على آلية عمل مايكوفينولات موفيتل (دواء يستخدم لمنع رفض الجسم للأعضاء المزروعة).
معلومات هامة حول بعض مكونات جلمنتين
يحتوي جلمنتين على السكارين. يرجى منك استشارة الطبيب المعالج قبل إعطاء هذا الدواء إذا كان قد أخبرك مسبقاً بأن طفلك يعاني من مشكلة تتمثل في عدم القدرة على تحمل بعض أنواع السكر.
يرجى منك دائماً إعطاء هذا الدواء لطفلك بدقة كما أخبرك الطبيب المعالج أو الصيدلي الذي تتعامل معه. يرجى منك استشارة طبيبك المعالج أو الصيدلي الذي تتعامل معه مالم تكن متأكداً من كيفية إعطاء هذا الدواء لطفلك.
كيفية إعطاء جلمنتين
• رج الزجاجة دائماً قبل استخدام كل جرعة
• يتم إعطاء الدواء عند البدء في تناول وجبة الطعام أو قبلها بقليل.
• يجب ترك فترة زمنية فاصلة بين الجرعات على مدار اليوم، ما لا يقل عن 4 ساعات بين الجرعات. يجب عدم استخدام جرعتين خلال ساعة واحدة.
• يجب عليك عدم إعطاء جلمنتين لطفلك لمدة تزيد عن أسبوعين. يجب عليك مراجعة الطبيب المعالج إذا لم تتحسن الحالة الصحية لطفلك.
البالغون والأطفال الذين تبلغ أوزانهم 40 كيلوغرام فما فوق
• لا يوصى عادةً بتناول المعلق من قبل البالغين والأطفال الذين تبلغ أوزانهم 40 كغم فما فوق. يرجى منك استشارة الطبيب المعالج أو الصيدلي الذي تتعامل معه لطلب النصيحة الطبية.
الأطفال الذين تقل أوزانهم عن 40 كيلوغرام
يتم وصف جميع الجرعات اعتماداً على وزن جسم الطفل بالكيلوغرامات.
• سوف يقدم لك طبيبك المعالج النصيحة حول مقدار الجرعة الواجب عليك إعطائها للرضيع أو للطفل من جلمنتين.
• سوف يكون الدواء مزوداً بأداة للقياس. يجب عليك استخدامها لإعطاء الطفل أو الرضيع المقدار الصحيح من الجرعة.
• الجرعة الموصى بها هي 20ملغم/ 5ملغم لتصل إلى 60ملغم/15ملغم لكل كليوغرام من وزن جسم الطفل يومياً، ويتم إعطاؤها على جرعات مقسمة إلى 3 جرعات منفصلة.
المرضى الذين يعانون من مشاكل في الكلى والكبد
• إذا كان الطفل يعاني من مشاكل في الكلى فقد يتم تقليل مقدار الجرعة المعطاة. قد يختار الطبيب المعالج تركيزاً مختلفاً من الجرعات أو دواءً مختلفاً.
• إذا كان الطفل يعاني من مشاكل في الكبد، فقد يكون بحاجة إلى إجراء فحوصات الدم بشكل دوري لمعرفة مدى كفاءة عمل الكبد.
إذا تم إعطاء جلمنتين بجرعة أكبر مما يجب
إذا تم إعطاء جلمنتين بجرعة أكبر مما يجب للطفل، قد يؤدي ذلك إلى ظهور علامات بما في ذلك اضطراب في المعدة (الشعور بالإعياء، التوعك أو إسهال) أو اختلاجات. يرجى منك إخبار الطبيب المعالج بهذا الأمر في أسرع وقت ممكن. خذ زجاجة الدواء معك لإظهارها للطبيب المعالج.
إذا سهوت عن إعطاء جلمنتين لطفلك
إذا سهوت عن إعطاء الجرعة لطفلك، قم بإعطائه الجرعة في أقرب وقت حال تذكرها. ويجب عليك الانتظار 4 ساعات قبل إعطاء طفلك الجرعة التالية. يجب عليك عدم مضاعفة الجرعة للتعويض عن الجرعة التي سهوت عن إعطائها لطفلك.
إذا توقفت عن إعطاء جلمنتين لطفلك
يرجى منك إعطاء جلمنتين لطفلك إلى أن تنتهي مدة العلاج المقررة حتى لو تحسنت حالة الطفل الصحية. حيث يحتاج طفلك إلى كل جرعة من الدواء الموصوف له للمساعدة على القضاءعلى العدوى. في حال لم يتم القضاء على جميع البكتيريا المسببة للعدوى فقد يتسبب ذلك في معاودة حدوث العدوى مرة أخرى.
يرجى منك استشارة الطبيب المعالج أو الصيدلي الذي تتعامل معه، إذا كان لديك أية أسئلة إضافية حول استخدام هذا الدواء.
شأنه شأن جميع الأدوية، من الممكن أن يؤدي هذا الدواء إلى حدوث تأثيرات جانبية، ولكنها قد لا تحدث لكل شخص. قد تحدث التأثيرات الجانبية المذكورة أثناء فترة تناول هذا الدواء
الحالات التي تتطلب منك الإنتباه
تفاعلات تحسسية:
• طفح جلدي.
• التهاب الأوعية الدموية الذي يظهر على شكل بقع حمراء أو بنفسجية مرتفعة عن سطح الجلد، ولكن من الممكن أن يؤثر على أجزاء أخرى من الجسم.
• حمى، ألم في المفاصل، تورم الغدد في منطقة الرقبة، الفخذين أو الإبطين.
• تورم، والذي يشمل في بعض الأحيان الوجه أو الفم (وذمة وعائية)، مسببة بذلك صعوبة في التنفس.
• تدهورعام في الصحة.
يرجى منك التواصل مع الطبيب المعالج على الفور إذا تعرض الطفل لأياً من تلك الأعراض. كما يجب عليك التوقف عن إعطاء جلمنتين.
التهاب الأمعاء الغليظة
قد يؤدي التهاب الأمعاء الغليظة إلى حدوث إسهال مائي مصحوب عادةً بخروج دم و مخاط، ألم في المعدة و/أو حمى.
يرجى منك التواصل مع الطبيب المعالج في أقرب وقت ممكن لطلب المشورة الطبية في حال تعرض الطفل لأياً من هذه الأعراض.
التأثيرات الجانبية الشائعة جداً
قد تؤثر على أكثر من شخص واحد من كل 10 أشخاص.
• إسهال (لدى البالغين).
التأثيرات الجانبية الشائعة
قد تؤثر على ما يصل إلى شخص واحد من كل 10 أشخاص
• داء القلاع (الكانديدا – عدوى الخميرة في المهبل، الفم أوثنايا الجلد).
• الشعور بالإعياء (غثيان)، وبصفة خاصة عند تناول الجرعات العالية.
§ في حال الإصابة بذلك، ينصح بتناول جلمنتين قبل وجبات الطعام.
• تقيؤ.
• إسهال (لدى الأطفال).
التأثيرات الجانبية الغير شائعة
قد تؤثر على ما يصل إلى شخص واحد من كل 100 شخص
• طفح جلدي، حكة.
• طفح جلدي مرتفع عن سطح الجلد مصحوب بحكة (طفح جلدي على شكل خلايا النحل).
• عسر هضم.
• دوخة.
• صداع.
التأثيرات الجانبية الغير شائعة التي قد تظهرعند إجراء فحوصات الدم:
• زيادة في إفراز بعض المواد (الإنزيمات) التي تفرز عن طريق الكبد.
التأثيرات الجانبية النادرة
قد تؤثر على ما يصل إلى شخص واحد من كل 1000 شخصاً
• طفح جلدي، الذي قد يكون بصورة تقرحات، ويظهر على هيئة أقراص دائرية صغيرة (بقع داكنة في المركز محاطة بمنطقة شاحبة اللون مع وجود حلقة داكنة اللون حول الأطراف – حمامي متعددة الأشكال).
§ إذا لاحظت أياً من هذه الأعراض، يرجى منك التواصل مع الطبيب المعالج على الفور.
التأثيرات الجانبية النادرة التي قد تظهر عند إجراء فحوصات الدم:
• نقص تعداد الخلايا المساهمة في عملية التجلط الدم.
• نقص تعداد خلايا الدم البيضاء.
التأثيرات الجانبية الغير معروفة
لا يمكن تقدير معدل تكرار حدوثها من البيانات المتاحة.
• تفاعلات تحسسية (انظر أعلاه).
• التهاب الأمعاء الغليظة (انظر أعلاه).
• التهاب الغشاء الواقي المحيط بالدماغ (التهاب السحايا العقيم).
• تفاعلات جلدية خطيرة بما في ذلك:
§ طفح جلدي منتشر على مساحة واسعة من الجلد مصحوباً بظهور تقرحات وتقشر الجلد، وبصفة خاصة حول الفم، الأنف، العينين والأعضاء التناسلية (متلازمة ستيفن- جونسن)، وقد يؤدي النوع الأكثر خطورة من هذا المرض إلى حدوث تقشر في مساحات واسعة من الجلد (أكثر من 30٪ من سطح الجسم- انحلال البشرة السمي التنخري).
§ طفح جلدي منتشر على مساحات واسعة من جلد أحمراللون مصحوباً بظهور بثورصغيرة متقيحة (التهاب الجلد التقشري الفقاعي).
§ طفح جلدي أحمر اللون متقشر مصحوباً بظهور نتوءات تحت الجلد وتقرحات (الطفح البثري).
يرجى منك التواصل مع الطبيب المعالج على الفور إذا تعرض الطفل لأياً من هذه الأعراض.
• التهاب الكبد (الالتهاب الكبدي).
• يرقان، والناجم عن زيادة نسبة البليروبين في الدم (مادة تفرز في الكبد) والذي قد يؤدي إلى اصفرار لون الجلد وبياض العينين.
• التهاب الأنابيب الكلوية.
• زيادة الفترة الزمنية اللازمة لتجلط الدم.
• فرط النشاط.
• اختلاجات (لدى المرضى الذين يتناولون جرعات عالية من جلمنتين أو الذين يعانون من مشاكل في الكلى).
• لسان مشعر أسود اللون.
• تلون الأسنان (لدى الأطفال)، عادةً يختفي بعد غسل الأسنان بالفرشاة.
التأثيرات الجانبية التي قد تظهر عند إجراء فحوصات الدم أو البول:
• نقص شديد في تعداد خلايا الدم البيضاء.
• نقص تعداد خلايا الدم الحمراء (فقر الدم الإنحلالي).
• ظهور بلورات في البول.
يرجى منك استشارة الطبيب المعالج أو الصيدلي الذي تتعامل معه. إذا زادت حدة أيا من هذه التأثيرات الجانبية، أو لاحظت أعراض جانبية لم يتم ذكرها في هذه النشرة.
للإبلاغ عن حدوث أية تأثيرات جانبية:
المركز الوطني للتيقظ والسلامة الدوائية
رقم الفاكس: 7662-205-11-966+
يرجى الاتصال بالمركز الوطني للتيقظ والسلامة الدوائية على: 2038222-11-966+
وصلة هاتف:2340-2334-2354-2353-2356-2317
الهاتف المجاني: 8002490000
البريد الإلكتروني: npc.drug@sfda.gov.sa
الموقع الإلكتروني: www.sfda.gov.sa/npc
• يحفظ بعيداً عن متناول ومرأى الأطفال.
• يجب عدم إعطاء جلمنتين بعد تاريخ انتهاء الصلاحية المذكورعلى العبوة والملصق الداخلي للزجاجة.
• قبل التحضير، يحفظ في درجة حرارة أقل من 30ºم، في مكان جاف، بعيداً عن الضوء.
• بعد التحضير، يحفظ في الثلاجة (2-8ºم) ويستخدم خلال 7 أيام. رج الزجاجة جيداً قبل الاستعمال.
• يجب عدم إعطاء جلمنتين إذا لاحظت وجود أي علامات تلف واضحة.
• يجب عدم التخلص من الأدوية عبر المياه المبتذلة (مياه الصرف الصحي) أو النفايات المنزلية. اسأل الصيدلي الذي تتعامل معه عن كيفية التخلص من الأدوية التي لم تعد بحاجة إليها. ستساعد هذه الإجراءات على حماية البيئة.
معلق جلمنتين 156 ملغم
تحتوي كل ملعقة صغيرة (5 ملليلتر) من المعلق بعد التحضير على:
المواد الفعالة: أموكسيسيلين ثلاثي الهيدرات بما يعادل 125 ملغم من أموكسيسيلين وكلافيولانات البوتاسيوم بما يعادل 31,25 ملغم من حمض كلافيولانيك.
المواد غير الفعالة: حمض الستريك اللامائي، سترات الصوديوم، بنزوات الصوديوم، سليلوز دقيق البلورات، صمغ الزانثان، ثنائي أكسيد السيليكون الغروي، سكارين الصوديوم، نكهة الفراولة ومانيتول.
معلق جلمنتين فورت 312 ملغم
تحتوي كل ملعقة صغيرة (5 ملليلتر) من المعلق بعد التحضير على:
المواد الفعالة: أموكسيسيلين ثلاثي الهيدرات بما يعادل 250 ملغم من أموكسيسيلين وكلافيولانات البوتاسيوم بما يعادل 62,5 ملغم من حمض كلافيولانيك.
المواد غير الفعالة: حمض الستريك اللامائي، سترات الصوديوم، بنزوات الصوديوم، سليلوز دقيق البلورات، صمغ الزانثان، ثنائي أكسيد السيليكون الغروي، سكارين الصوديوم، نكهة الكرز البري ومانيتول.
"الخليج للصناعات الدوائية " جلفار
Julmentin Forte is indicated for the treatment of the following infections in adults and children (see sections 4.2, 4.4 and 5.1):
§ Acute bacterial sinusitis (adequately diagnosed)
§ Acute otitis media
§ Acute exacerbations of chronic bronchitis (adequately diagnosed)
§ Community acquired pneumonia
§ Cystitis
§ Pyelonephritis
§ Skin and soft tissue infections in particular cellulitis, animal bites, severe dental abscess with spreading cellulitis
§ Bone and joint infections, in particular osteomyelitis.
Consideration should be given to official guidance on the appropriate use of antibacterial
Doses are expressed throughout in terms of amoxicillin/clavulanic acid content except when doses are stated in terms of an individual component.
The dose of Julmentin Forte that is selected to treat an individual infection should take into account:
§ The expected pathogens and their likely susceptibility to antibacterial agents (see section 4.4)
§ The severity and the site of the infection
§ The age, weight and renal function of the patient as shown below.
The use of alternative presentations of Julmentin Forte (e.g. those that provide higher doses of amoxicillin and/or different ratios of amoxicillin to clavulanic acid) should be considered as necessary (see sections 4.4 and 5.1).
For adults and children ≥ 40 kg, this formulation of Julmentin Forte provides a total daily dose of 1500 mg amoxicillin/375 mg clavulanic acid, when administered as recommended below. For children < 40 kg, this formulation of Julmentin Forte provides a maximum daily dose of 2400 mg amoxicillin/600 mg clavulanic acid, when administered as recommended below. If it is considered that a higher daily dose of amoxicillin is required, it is recommended that another preparation of Julmentin Forte is selected in order to avoid administration of unnecessarily high daily doses of clavulanic acid (see sections 4.4 and 5.1).
The duration of therapy should be determined by the response of the patient. Some infections (e.g. osteomyelitis) require longer periods of treatment. Treatment should not be extended beyond 14 days without review (see section 4.4 regarding prolonged therapy).
Adults and children ≥ 40 kg
One 500 mg/125 mg dose taken three times a day.
Children < 40 kg
20 mg/5 mg/kg/day to 60 mg/15 mg/kg/day given in three divided doses.
Children may be treated with Julmentin Forte tablets or suspensions.
No clinical data are available on doses of Julmentin Forte 4:1 formulations higher than 40 mg/10 mg/kg per day in children under 2 years.
Elderly
No dose adjustment is considered necessary.
Renal impairment
Dose adjustments are based on the maximum recommended level of amoxicillin.
No adjustment in dose is required in patients with creatinine clearance (CrCl) greater than
30 ml/min.
Adults and children ≥ 40 kg
CrCl: 10-30 ml/min | 500 mg/125 mg twice daily |
CrCl < 10 ml /min | 500 mg/125 mg once daily |
Haemodialysis | 500 mg/125 mg every 24 hours, plus 500 mg/125 mg during dialysis, to be repeated at the end of dialysis (as serum concentrations of both amoxicillin and clavulanic acid are decreased) |
Children < 40 kg
CrCl: 10-30 ml/min | 15 mg/3.75 mg/kg twice daily (maximum 500 mg/125 mg twice daily). |
CrCl < 10 ml /min | 15 mg/3.75 mg/kg as a single daily dose (maximum 500 mg/125 mg). |
Haemodialysis | 15 mg/3.75 mg/kg per day once daily. Prior to haemodialysis 15 mg/3.75 mg/kg. In order to restore circulating drug levels, 15 mg/3.75 mg per kg should be administered after haemodialysis. |
Hepatic impairment
Dose with caution and monitor hepatic function at regular intervals (see sections 4.3 and 4.4).
Method of administration
Julmentin Forte is for oral use.
Administer at the start of a meal to minimise potential gastrointestinal intolerance and optimise absorption of amoxicillin/clavulanic acid.
Therapy can be started parenterally according to the SmPC of the IV-formulation and continued with an oral preparation.
Shake to loosen powder, add water as directed, invert and shake.
Shake the bottle before each dose (see section 6.6).
For instructions on reconstitution of the medicinal product before administration, see section 6.6.
Before initiating therapy with amoxicillin/clavulanic acid, careful enquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins or other beta-lactam agents (see sections 4.3 and 4.8).
Serious and occasionally fatal hypersensitivity (anaphylactoid) reactions have been reported in patients on penicillin therapy. These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity and in atopic individuals. If an allergic reaction occurs, amoxicillin/clavulanic acid therapy must be discontinued and appropriate alternative therapy instituted.
In the case that an infection is proven to be due to an amoxicillin-susceptible organisms(s) then consideration should be given to switching from amoxicillin/clavulanic acid to amoxicillin in accordance with official guidance.
Convulsions may occur in patients with impaired renal function or in those receiving high doses (see section 4.8).
Amoxicillin/clavulanic acid should be avoided if infectious mononucleosis is suspected since the occurrence of a morbilliform rash has been associated with this condition following the use of amoxicillin.
Concomitant use of allopurinol during treatment with amoxicillin can increase the likelihood of allergic skin reactions.
Prolonged use may occasionally result in overgrowth of non-susceptible organisms.
The occurrence at the treatment initiation of a feverish generalised erythema associated with pustula may be a symptom of acute generalised exanthemous pustulosis (AGEP) (see Section 4.8). This reaction requires Amoxicillin/clavulanic acid discontinuation and contra-indicates any subsequent administration of amoxicillin.
Amoxicillin/clavulanic acid should be used with caution in patients with evidence of hepatic impairment (see section 4.2).
Hepatic events have been reported predominantly in males and elderly patients and may be associated with prolonged treatment. These events have been very rarely reported in children. In all populations, signs and symptoms usually occur during or shortly after treatment but in some cases may not become apparent until several weeks after treatment has ceased. These are usually reversible. Hepatic events may be severe and, in extremely rare circumstances, deaths have been reported. These have almost always occurred in patients with serious underlying disease or taking concomitant medications known to have the potential for hepatic effects (see section 4.8).
Antibiotic-associated colitis has been reported with nearly all antibacterial agents and may range in severity from mild to life threatening (see section 4.8). Therefore, it is important to consider this diagnosis in patients who present with diarrhoea during or subsequent to the administration of any antibiotics. Should antibiotic-associated colitis occur, amoxicillin/clavulanic acid should immediately be discontinued, a physician be consulted and an appropriate therapy initiated. Anti-peristaltic medicinal products are contra-indicated in this situation.
Periodic assessment of organ system functions; including renal, hepatic and haematopoietic function is advisable during prolonged therapy.
Prolongation of prothrombin time has been reported rarely in patients receiving amoxicillin/clavulanic acid. Appropriate monitoring should be undertaken when anticoagulants are prescribed concomitantly. Adjustments in the dose of oral anticoagulants may be necessary to maintain the desired level of anticoagulation (see section 4.5 and 4.8).
In patients with renal impairment, the dose should be adjusted according to the degree of impairment (see section 4.2).
In patients with reduced urine output, crystalluria has been observed very rarely, predominantly with parenteral therapy. During the administration of high doses of amoxicillin, it is advisable to maintain adequate fluid intake and urinary output in order to reduce the possibility of amoxicillin crystalluria. In patients with bladder catheters, a regular check of patency should be maintained (see section 4.9).
During treatment with amoxicillin, enzymatic glucose oxidase methods should be used whenever testing for the presence of glucose in urine because false positive results may occur with non-enzymatic methods.
The presence of Clavulanic acid in Julmentin Forte may cause a non-specific binding of IgG and albumin by red cell membranes leading to a false positive Coombs test.
There have been reports of positive test results using the Bio-Rad Laboratories Platelia Aspergillus EIA test in patients receiving amoxicillin/clavulanic acid who were subsequently found to be free of Aspergillus infection. Cross-reactions with non-Aspergillus polysaccharides and polyfuranoses with Bio-Rad Laboratories Platelia Aspergillus EIA test have been reported. Therefore, positive test results in patients receiving amoxicillin/clavulanic acid should be interpreted cautiously and confirmed by other diagnostic methods.
This medicinal product contains saccharin. Patients with rare glucose-galactose malabsorption should not take this medicine.
Oral anticoagulants
Oral anticoagulants and penicillin antibiotics have been widely used in practice without reports of interaction. However, in the literature there are cases of increased international normalised ratio in patients maintained on acenocoumarol or warfarin and prescribed a course of amoxicillin. If co-administration is necessary, the prothrombin time or international normalised ratio should be carefully monitored with the addition or withdrawal of amoxicillin. Moreover, adjustments in the dose of oral anticoagulants may be necessary (see sections 4.4 and 4.8).
Methotrexate
Penicillins may reduce the excretion of methotrexate causing a potential increase in toxicity.
Probenecid
Concomitant use of probenecid is not recommended. Probenecid decreases the renal tubular secretion of amoxicillin. Concomitant use of probenecid may result in increased and prolonged blood levels of amoxicillin but not of clavulanic acid.
Mycophenolate mofetil
In patients receiving mycophenolate mofetil, reduction in pre-dose concentration of the active metabolite mycophenolic acid (MPA) of approximately 50% has been reported following commencement of oral amoxicillin plus clavulanic acid. The change in pre-dose level may not accurately represent changes in overall MPA exposure. Therefore, a change in the dose of mycophenolate mofetil should not normally be necessary in the absence of clinical evidence of graft dysfunction. However, close clinical monitoring should be performed during the combination and shortly after antibiotic treatment.
Pregnancy
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3). Limited data on the use of amoxicillin/clavulanic acid during pregnancy in humans do not indicate an increased risk of congenital malformations. In a single study in women with preterm, premature rupture of the foetal membrane it was reported that prophylactic treatment with amoxicillin/clavulanic acid may be associated with an increased risk of necrotising enterocolitis in neonates. Use should be avoided during pregnancy, unless considered essential by the physician.
Lactation
Both substances are excreted into breast milk (nothing is known of the effects of clavulanic acid on the breast-fed infant). Consequently, diarrhoea and fungus infection of the mucous membranes are possible in the breast-fed infant, so that breast-feeding might have to be discontinued. Amoxicillin/clavulanic acid should only be used during breast-feeding after benefit/risk assessment by the physician in charge.
No studies on the effects on the ability to drive and use machines have been performed. However, undesirable effects may occur (e.g. allergic reactions, dizziness, convulsions), which may influence the ability to drive and use machines (see section 4.8).
The most commonly reported adverse drug reactions (ADRs) are diarrhoea, nausea and vomiting.
The ADRs derived from clinical studies and post-marketing surveillance with
co-amoxiclav sorted by MedDRA System Organ Class are listed below.
The following terminologies have been used in order to classify the occurrence of undesirable effects.
Very common (≥1/10)
Common (≥1/100 to <1/10)
Uncommon (≥1/1,000 to <1/100)
Rare (≥1/10,000 to <1/1,000)
Very rare (<1/10,000)
Not known (cannot be estimated from the available data)
Infections and infestations | |
Mucocutaneous candidosis | Common |
Overgrowth of non-susceptible organisms | Not known |
Blood and lymphatic system disorders | |
Reversible leucopenia (including neutropenia) | Rare |
Thrombocytopenia | Rare |
Reversible agranulocytosis | Not known |
Haemolytic anaemia | Not known |
Prolongation of bleeding time and prothrombin time1 | Not known |
Immune system disorders10 | |
Angioneurotic oedema | Not known |
Anaphylaxis | Not known |
Serum sickness-like syndrome | Not known |
Hypersensitivity vasculitis | Not known |
Nervous system disorders | |
Dizziness | Uncommon |
Headache | Uncommon |
Reversible hyperactivity | Not known |
Convulsions2 | Not known |
Aseptic meningitis | Not known |
Gastrointestinal disorders | |
Diarrhoea | Very common |
Nausea3 | Common |
Vomiting | Common |
Indigestion | Uncommon |
Antibiotic-associated colitis4 | Not known |
Black hairy tongue | Not known |
Tooth discolouration11 | Not known |
Hepatobiliary disorders | |
Rises in AST and/or ALT5 | Uncommon |
Hepatitis6 | Not known |
Cholestatic jaundice6 | Not known |
Skin and subcutaneous tissue disorders 7 | |
Skin rash | Uncommon |
Pruritus | Uncommon |
Urticaria | Uncommon |
Erythema multiforme | Rare |
Stevens-Johnson syndrome | Not known |
Toxic epidermal necrolysis | Not known |
Bullous exfoliative-dermatitis | Not known |
Acute generalised exanthemous pustulosis (AGEP)9 | Not known |
Renal and urinary disorders | |
Interstitial nephritis | Not known |
Crystalluria8 | Not known |
1 See section 4.4 2 See section 4.4 3 Nausea is more often associated with higher oral doses. If gastrointestinal reactions are evident, they may be reduced by taking Amoxicillin/clavulanic acid at the start of a meal. 4 Including pseudomembranous colitis and haemorrhagic colitis (see section 4.4) 5 A moderate rise in AST and/or ALT has been noted in patients treated with beta-lactam class antibiotics, but the significance of these findings is unknown. 6 These events have been noted with other penicillins and cephalosporins (see section 4.4). 7 If any hypersensitivity dermatitis reaction occurs, treatment should be discontinued (see section 4.4). 8 See section 4.9 9 See section 4.4 10 See sections 4.3 and 4.4 11 Superficial tooth discolouration has been reported very rarely in children. Good oral hygiene may help to prevent tooth discolouration as it can usually be removed by brushing. | |
To report any side effect(s): The National Pharmacovigilance and Drug Safety Center (NPC) Fax: +966-11-205-7662 Call NPC at +966-11-2038222, Exts: 2317-2356-2353-2354-2334-2340. Toll free phone: 8002490000 E-mail: npc.drug@sfda.gov.sa Website: www.sfda.gov.sa/npc |
Symptoms and signs of overdose
Gastrointestinal symptoms and disturbance of the fluid and electrolyte balances may be evident. Amoxicillin crystalluria, in some cases leading to renal failure, has been observed (see section 4.4).
Convulsions may occur in patients with impaired renal function or in those receiving high doses.
Amoxicillin has been reported to precipitate in bladder catheters, predominantly after intravenous administration of large doses. A regular check of patency should be maintained (see section 4.4).
Treatment of intoxication
Gastrointestinal symptoms may be treated symptomatically, with attention to the water/electrolyte balance.
Amoxicillin/clavulanic acid can be removed from the circulation by haemodialysis.
Pharmacotherapeutic group: Combinations of penicillins, incl. beta-lactamase inhibitors; ATC code: J01CR02.
Mode of action
Amoxicillin is a semisynthetic penicillin (beta-lactam antibiotic) that inhibits one or more enzymes (often referred to as penicillin-binding proteins, PBPs) in the biosynthetic pathway of bacterial peptidoglycan, which is an integral structural component of the bacterial cell wall. Inhibition of peptidoglycan synthesis leads to weakening of the cell wall, which is usually followed by cell lysis and death.
Amoxicillin is susceptible to degradation by beta-lactamases produced by resistant bacteria and therefore the spectrum of activity of amoxicillin alone does not include organisms which produce these enzymes.
Clavulanic acid is a beta-lactam structurally related to penicillins. It inactivates some beta-lactamase enzymes thereby preventing inactivation of amoxicillin. Clavulanic acid alone does not exert a clinically useful antibacterial effect.
PK/PD relationship
The time above the minimum inhibitory concentration (T>MIC) is considered to be the major determinant of efficacy for amoxicillin.
Mechanisms of resistance
The two main mechanisms of resistance to amoxicillin/clavulanic acid are:
§ Inactivation by those bacterial beta-lactamases that are not themselves inhibited by clavulanic acid, including class B, C and D.
§ Alteration of PBPs, which reduce the affinity of the antibacterial agent for the target.
§ Impermeability of bacteria or efflux pump mechanisms may cause or contribute to bacterial resistance, particularly in Gram-negative bacteria.
Breakpoints
MIC breakpoints for amoxicillin/clavulanic acid are those of the European Committee on Antimicrobial Susceptibility Testing (EUCAST)
Organism | Susceptibility Breakpoints (μg/ml) | ||
| Susceptible | Intermediate | Resistant |
Haemophilus influenzae1 | ≤ 1 | - | > 1 |
Moraxella catarrhalis1 | ≤ 1 | - | > 1 |
Staphylococcus aureus 2 | ≤ 2 | - | > 2 |
Coagulase-negative staphylococci 2 | ≤ 0.25 |
| > 0.25 |
Enterococcus1 | ≤ 4 | 8 | > 8 |
Streptococcus A, B, C, G5 | ≤ 0.25 | - | > 0.25 |
Streptococcus pneumoniae3 | ≤ 0.5 | 1-2 | > 2 |
Enterobacteriaceae1,4 | - | - | > 8 |
Gram-negative Anaerobes1 | ≤ 4 | 8 | > 8 |
Gram-positive Anaerobes1 | ≤ 4 | 8 | > 8 |
Non-species related breakpoints1 | ≤ 2 | 4-8 | > 8 |
1 The reported values are for Amoxicillin concentrations. For susceptibility testing purposes, the concentration of Clavulanic acid is fixed at 2 mg/l. 2 The reported values are Oxacillin concentrations. 3 Breakpoint values in the table are based on Ampicillin breakpoints. 4 The resistant breakpoint of R>8 mg/l ensures that all isolates with resistance mechanisms are reported resistant. 5 Breakpoint values in the table are based on Benzylpenicillin breakpoints. | |||
The prevalence of 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 the agent in at least some types of infections is questionable.
Commonly susceptible species |
Aerobic Gram-positive micro-organisms Enterococcus faecalis Gardnerella vaginalis Staphylococcus aureus ( methicillin-susceptible)£ Coagulase-negative staphylococci (methicillin-susceptible) Streptococcus agalactiae Streptococcus pneumoniae1 Streptococcus pyogenes and other beta-haemolytic streptococci Streptococcus viridans group Aerobic Gram-negative micro-organisms Capnocytophaga spp. Eikenella corrodens Haemophilus influenzae2 Moraxella catarrhalis Pasteurella multocida Anaerobic micro-organisms Bacteroides fragilis Fusobacterium nucleatum Prevotella spp. |
Species for which acquired resistance may be a problem |
Aerobic Gram-positive micro-organisms Enterococcus faecium $ Aerobic Gram-negative micro-organisms Escherichia coli Klebsiella oxytoca Klebsiella pneumoniae Proteus mirabilis Proteus vulgaris |
Inherently resistant organisms |
Aerobic Gram-negative micro-organisms Acinetobacter sp. Citrobacter freundii Enterobacter sp. Legionella pneumophila Morganella morganii Providencia spp. Pseudomonas sp. Serratia sp. Stenotrophomonas maltophilia Other micro-organisms Chlamydophila pneumoniae Chlamydophila psittaci Coxiella burnetti Mycoplasma pneumoniae |
$ Natural intermediate susceptibility in the absence of acquired mechanism of resistance. £All methicillin-resistant staphylococci are resistant to amoxicillin/clavulanic acid 1Streptococcus pneumoniae that are resistant to penicillin should not be treated with this presentation of amoxicillin/clavulanic acid (see sections 4.2 and 4.4). 2 Strains with decreased susceptibility have been reported in some countries in the EU with a frequency higher than 10%. |
Absorption
Amoxicillin and clavulanic acid, are fully dissociated in aqueous solution at physiological pH. Both components are rapidly and well absorbed by the oral route of administration. Absorption of amoxicillin/clavulanic acid is optimised when taken at the start of a meal. Following oral administration, amoxicillin and clavulanic acid are approximately 70% bioavailable. The plasma profiles of both components are similar and the time to peak plasma concentration (Tmax) in each case is approximately one hour.
The pharmacokinetic results for a study, in which amoxicillin/clavulanic acid (500 mg/125 mg tablets three times daily) was administered in the fasting state to groups of healthy volunteers are presented below.
Mean (± SD) pharmacokinetic parameters | |||||
Active substance(s) administered | Dose | Cmax | Tmax * | AUC (0-24h) | T 1/2 |
(mg) | (μg/ml) | (h) | ((μg.h/ml) | (h) | |
Amoxicillin | |||||
AMX/CA 500/125 mg | 500 | 7.19 ± 2.26 | 1.5 (1.0-2.5) | 53.5 ± 8.87 | 1.15 ± 0.20 |
Clavulanic acid | |||||
AMX/CA 500 mg/125 mg | 125 | 2.40 ± 0.83 | 1.5 (1.0-2.0) | 15.72 ± 3.86 | 0.98 ± 0.12 |
AMX – amoxicillin, CA – clavulanic acid * Median (range) | |||||
Amoxicillin and clavulanic acid serum concentrations achieved with amoxicillin/clavulanic acid are similar to those produced by the oral administration of equivalent doses of amoxicillin or clavulanic acid alone.
Distribution
About 25% of total plasma clavulanic acid and 18% of total plasma amoxicillin is bound to protein. The apparent volume of distribution is around 0.3-0.4 l/kg for amoxicillin and around 0.2 l/kg for clavulanic acid.
Following intravenous administration, both amoxicillin and clavulanic acid have been found in gall bladder, abdominal tissue, skin, fat, muscle tissues, synovial and peritoneal fluids, bile and pus. Amoxicillin does not adequately distribute into the cerebrospinal fluid.
From animal studies there is no evidence for significant tissue retention of drug-derived material for either component. Amoxicillin, like most penicillins, can be detected in breast milk. Trace quantities of clavulanic acid can also be detected in breast milk (see section 4.6).
Both amoxicillin and clavulanic acid have been shown to cross the placental barrier (see section 4.6).
Biotransformation
Amoxicillin is partly excreted in the urine as the inactive penicilloic acid in quantities equivalent to up to 10 to 25% of the initial dose. Clavulanic acid is extensively metabolized in man and eliminated in urine and faeces and as carbon dioxide in expired air.
Elimination
The major route of elimination for amoxicillin is via the kidney, whereas for clavulanic acid it is by both renal and non-renal mechanisms.
Amoxicillin/clavulanic acid has a mean elimination half-life of approximately one hour and a mean total clearance of approximately 25 l/h in healthy subjects. Approximately 60 to 70% of the amoxicillin and approximately 40 to 65% of the clavulanic acid are excreted unchanged in urine during the first 6 h after administration of single amoxicillin and clavulanic acid 250 mg/125 mg or 500 mg/125 mg tablets. Various studies have found the urinary excretion to be 50-85% for amoxicillin and between 27-60% for clavulanic acid over a 24 hour period. In the case of clavulanic acid, the largest amount of drug is excreted during the first 2 hours after administration.
Concomitant use of probenecid delays amoxicillin excretion but does not delay renal excretion of clavulanic acid (see section 4.5).
Age
The elimination half-life of amoxicillin is similar for children aged around 3 months to 2 years and older children and adults. For very young children (including preterm newborns) in the first week of life the interval of administration should not exceed twice daily administration due to immaturity of the renal pathway of elimination. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
Gender
Following oral administration of amoxicillin/clavulanic acid to healthy males and female subjects, gender has no significant impact on the pharmacokinetics of either amoxicillin or clavulanic acid.
Renal impairment
The total serum clearance of amoxicillin/clavulanic acid decreases proportionately with decreasing renal function. The reduction in drug clearance is more pronounced for amoxicillin than for clavulanic acid, as a higher proportion of amoxicillin is excreted via the renal route. Doses in renal impairment must therefore prevent undue accumulation of amoxicillin while maintaining adequate levels of clavulanic acid (see section 4.2).
Hepatic impairment
Hepatically impaired patients should be dosed with caution and hepatic function monitored at regular intervals.
Nonclinical data reveal no special hazard for humans based on studies of safety pharmacology, genotoxicity and toxicity to reproduction.
Repeat dose toxicity studies performed in dogs with amoxicillin/clavulanic acid demonstrate gastric irritancy and vomiting, and discoloured tongue.
Carcinogenicity studies have not been conducted with amoxicillin/clavulanic acid or its components.
Inactive Ingredients: |
1. Citric acid, anhydrous |
2. Sodium citrate |
3. Sodium benzoate |
4. Microcrystalline cellulose |
5. Xanthan gum |
6. Colloidal silicon dioxide |
7. Cherry flavour permaseal |
8. Saccharin sodium |
9. Mannitol |
Not applicable.
Before reconstitution, store below 30oC, in a dry place, protected from light.
After reconstitution, store in a refrigerator (2-8oC) and use within 7 days. Shake well before use.
Pack of 100mL (when reconstituted) in a sealed labelled glass bottle, type III, USP in a printed carton along with a leaflet and measuring spoon
Directions for reconstitution:
Loosen powder, add 85mL of water in two portions and shake well after each addition, or add water to 2/3 of the mark on the bottle. Shake well and make up to the mark. Shake well.
