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

Megamox 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 “penicillin” that can sometimes be stopped from working (made inactive). The other active component (clavulanic acid) stops this from happening.

 Megamox is used in adults and children to treat the following infections:

  • sinus infections
  • urinary tract infections
  • skin infections
  • dental infections

 


Do not take Megamox:

  • If you are allergic to amoxicillin, clavulanic acid, penicillin or any of the other ingredients of Megamox (listed in section 6)
  • If you 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 you have ever had liver problems or jaundice (yellowing of the skin) when taking an antibiotic.

Do not take Megamox if any of the above apply to you. If you are not sure, talk to their doctor or pharmacist before taking Megamox.

Warnings and Precautions

Talk to your doctor or pharmacist before taking Megamox

if you:

  • 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 apply to you, talk to your doctor or pharmacist before taking Megamox.

In some cases, your doctor may investigate the type of bacteria that is causing your infection. Depending on the results, you may be given a different strength of Megamox or a different medicine.

Conditions you need to look out for

Megamox 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 you are taking Megamox, to reduce the risk of any problems. See ‘Conditions you need to look out for’ in Section 4.

Blood or urine tests

If you are having blood tests (such as red blood cell status tests or liver function tests) or urine tests (for glucose), let the doctor or nurse know that you are taking Megamox. This is because Megamox can affect the results of these types of tests.

 Other medicines and Megamox

Tell your doctor or pharmacist if you are using, have recently used any other medicines.

  • If you are taking allopurinol (used for gout) with Megamox, it may be more likely that you’ll have an allergic skin reaction.
  • If you are taking probenecid (used for gout), your doctor may decide to adjust your dose of Megamox.
  • If medicines to help stop blood clots (such as warfarin) are taken with Megamox then extra blood tests may be needed.
  • Megamox can affect how methotrexate (a medicine used to treat cancer or rheumatic diseases) works..
  • Megamox can affect how mycophenolate mofetil (a medicine used to prevent the rejection of transplanted organs) works.

Pregnancy, breast‐feeding and fertility

If you are pregnant or breast‐feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Megamox can have side effects and the symptoms may make you unfit to drive.

Do not drive or operate machinery unless you are feeling well.


Always take Megamox exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Since both the 375 mg and 625 mg tablets of Megamox contain the same amount of clavulanic acid (125 mg, as the potassium salt), two 375 mg tablets of Megamox are not equivalent to one 625 mg tablet of Megamox; therefore, two 375 mg tablets of Megamox should not be substituted for one 625 mg tablet of Megamox.

Adults and children weighing 40 kg and over

The usual dose is one 625 mg tablet of Megamox every 12 hours or one 375 mg tablet of Megamox every 8 hours. For more severe infections and infections of the respiratory tract, the dose should be one 1 g tablet of Megamox every 12 hours or one 625 mg tablet of Megamox every 8 hours. Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of <30 ml/min. should not receive the 1 g tablet. Patients with a glomerular filtration rate of 10 to 30 ml/min. should receive 625 mg or 375 mg every 12 hours, depending on the severity of the infection. Patients with a less than 10 ml/min. glomerular filtration rate should receive 625 mg or 375 mg every 24 hours, depending on severity of the infection. Hemodialysis patients should receive 625 mg or 375 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis. Hepatically impaired patients should be dosed with caution and hepatic function monitored at regular intervals.

Children weighing less than 40 kg

Children aged 6 years or less should preferably be treated with Megamox oral suspension or sachets.

Megamox tablets are not recommended

Patients with kidney and liver problems

  • If you have kidney problems the dose might be changed. A different strength or a different medicine may be chosen by your doctor.
  • If you have liver problems, you may have more frequent blood tests to see how their liver is working.

How to take Megamox

  • Take with a meal
  • Swallow the tablets whole with a glass of water
  • Space the doses evenly during the day, at least 4 hours apart. Do not take 2 doses in 1 hour.
  • Do not take Megamox for more than 2 weeks. If you still feel unwell you should go back to see the doctor.

If you take more Megamox than you should

If you take too much Megamox, signs might include an upset stomach (feeling sick, being sick or diarrhoea) or convulsions. Talk to your doctor as soon as possible. Take the medicine carton or bottle to show the doctor.

If you forget to take Megamox

If you forget to take a dose, take it as soon as you remember. You should not take the next dose too soon, but wait about 4 hours before taking the next dose. Do not take a double dose to make up for a forgotten dose.

If you stop taking Megamox

Keep taking Megamox until the treatment is finished, even if you feel better. You need 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 medicine, ask your doctor or pharmacist.


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 throat (angioedema), causing difficulty in breathing.
  • Collapse.

Contact a doctor immediately if you gets any of these symptoms. Stop taking Megamox.

Inflammation of large intestine

Inflammation of the large intestine, causing watery diarrhea usually with blood and mucus, stomach pain and/or fever.

Contact your doctor as soon as possible for advice if you 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 Megamox 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.

Other side effects

Other side effects have occurred in a very small number of people but their exact frequency is unknown:

  • 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 puscontaining blisters (bullous exfoliative dermatitis).

‐ A red, scaly rash with bumps under the skin and blisters (exanthemous pustulosis).

Contact a doctor immediately if you 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 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 Megamox 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, healthcare provider or pharmacist.

 


Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date (EXP) which is stated on the carton. The expiry date refers to the last day of that month.

Store below 30°C.

Store in the original package to protect from moisture.

Do not use if the tablets are chipped or damaged.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment


Megamox 375 mg tablets contain

The active substances are 250 mg amoxicillin and 125 mg clavulanic acid (present as potassium clavulanate) in each tablet.

What Megamox 625 mg tablets contain

The active substances are 500 mg amoxicillin and 125 mg clavulanic acid (present as potassium clavulanate) in each tablet.

What Megamox 1000 mg tablets contain

The active substances are 875 mg amoxicillin and 125 mg clavulanic acid (present as potassium clavulanate) in each tablet.

The other ingredients for tablets are: Colloidal Anhydrous Silica; Sodium Starch Glycolate; Microcrystalline Cellulose; Magnesium Stearate; Opadry

OY‐S‐7191 White; Methylene Chloride; Methanol.

 


Megamox 375 mg tablets are: White to off‐white scored, capsule shape film coated tablet embossed 'JI' on the left side and '77' on the right side. The score line is only to facilitate breaking and ease of swallowing and not to divide into equal doses. Pack size: 20 tablets. Megamox 625 mg tablets are: White to off‐white oblong film coated tablet embossed with "Jl". Pack size: 14 or 20 tablets. Megamox 1000 mg tablets are: film‐coated tablets are White to off‐white oblong scored tablet. Embossed "JI "on the left side and "112" on the Right side. The score line is only to facilitate breaking and ease of swallowing and not to divide into equal doses. Pack size: 14 tablets

Jazeera Pharmaceutical Industries

Al‐Kharj Road P.O. BOX 106229

Riyadh, 11666, Saudi Arabia

Tel: +966 11 2078172

Fax: +966 11 2078097

E‐mail: medical@jpi.com.sa

 


This leaflet was last revised in 09/2018 ; version .number 2.3
  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 ميجاموكس هو مضاد حيوي ويعمل على قتل البكتيريا التي تسبب الالتهابات. أنه يحتوي على نوعين مختلفين من الأدوية التي تسمى أموكسيسيلين وحامض الكلافولانيك. ينتمي أموكسيسيلين إلى مجموعة من الأدوية تسمى "البنسيلينات" التي يمكن في بعض الأحيان أن تتوقف عن العمل (جعلها غير نشطة). ويوقف العنصر النشط الآخر (حامض الكلافولانيك) هذا من الحدوث.
يستخدم ميجاموكس لدى الكبار والأطفال في علاج الالتهابات التالية:

  • التهابات الجيوب الأنفية.
  •  التهابات المسالك البولية.
  • التهابات الجلد .
  • التهابات الأسنان 

موانع استخدام ميجاموكس:
لا تستخدم ميجاموكس:

  • إذا كنت تعاني من حساسية لأموكسيسيلين، حامض الكلافولانيك، البنسلين أو لأي من مكونات ميجاموكس الأخرى (المدرجة في القسم 6) 
  • إذا كان لديك في أي وقت مضى حساسية شديدة رد فعل إلى أي مضاد حيوي آخر. يمكن أن يتضمن هذا طفح جلدي أو تورم في الوجه أو في الحلق.
  • إذا كان لديك في أي وقت مضى مشاكل في الكبد أو اليرقان (اصفرار الجلد) حين تتناول المضادات الحيوية

لا تاخذ ميجاموكس إذا كان ينطبق عليك أي من المذكور أعلاه. إذا كنت غير متأكد، تحدث إلى طبيبك أو الصيدلي قبل اخذ ميجاموكس.
الإحتياطات و التحذيرات
تحدث مع طبيبك أو الصيدلي قبل استخدام ميجاموكس إذا كنت:

  • تعاني من الحمى الغدية.
  • تعالج من مشاكل في الكبد أو في الكلى.
  • لا تتبول بانتظام.

إذا لم تكن متأكدا مما إذا كان ينطبق عليك أي من المذكور أعلاه، تحدث إلى طبيبك أو الصيدلي قبل استخدام ميجاموكس.
في بعض الحالات، قد يحقق طبيبك في نوع البكتيريا التي تسبب الالتهاب الذي أصابك. اعتمادا على هذه النتائج، قد يعطيك تركيز مختلف من ميجاموكس أو دواء مختلف.
الحالات الصحية التي تحتاج إلى الانتباه إليها 
يمكن أن يجعل ميجاموكس بعض الظروف القائمة أسوأ، أو أن يسبب آثار جانبية خطيرة. وتشمل هذه الحساسية، التشنجات (النوبات) والتهاب الأمعاء الغليظة. يجب أن تنتبه إلى بعض الأعراض أثناء تناولك ميجاموكس، للحد من خطر أي مشاكل. انظر " الظروف التي تحتاج إلى الانتباه إليها " في القسم 4
اختبارات الدم أو البول
إذا كان لديك اختبارات الدم (مثل اختبارات حالة خلايا الدم الحمراء أو اختبارات وظائف الكبد) أو اختبارات البول (من أجل الجلوكوز)، يجب اخبار الطبيب أو الممرضة انك تتناول ميجاموكس. وذلك لأن ميجاموكس يمكن أن يؤثر على نتائج هذه  الأنواع من الاختبارات.

  • الأدوية الأخرى و ميجاموكس

أخبر طبيبك أو الصيدلي إذا كنت تأخذ ، أخذت مؤخرا أية أدوية أخرى.

  • إذا كنت تاخذ الوبيورينول (الذي يستخدم لمعالجة النقرس) مع ميجاموكس، فقد يكون من المرجح أنك سوف تعاني من رد فعل تحسسي للجلد.
  • إذا كنت تاخذ البروبينسيد (الذي يستخدم لمعالجة النقرس) فقد يقرر طبيبك تعديل جرعتك من ميجاموكس.
  • إذا تم أخذ أدوية للمساعدة في وقف تجلط الدم (مثل الوارفارين) مع ميجاموكس فقد تكون هناك حاجة إلى فحوصات دم إضافية.
  • قد يؤثر ميجاموكس على كيفية عمل مايكوفينوليت موفيتيل ( دواء يستخدم في منع رفض الاعضاء المزروعة )
  • قد يؤثر ميجاموكس على كيفية عمل ميثوتركسات (دواء يستخدم في علاج السرطان أو الأمراض الروماتيزمية).

الحمل،الرضاعة والخصوبة
إذا كنت حاملا أو مرضع أو تعتقدين بأنك حاملا أو تخططين لذلك، اسألي طبيبك أو الصيدلي للحصول على المشورة الطبية قبل تناول هذا الدواء.
القيادة واستخدام الآلات
يمكن أن يكون لميجاموكس آثار جانبية وأعراض قد تجعلك غير مؤهل للقيادة.
لا تقد ولا تشغل الآلات إلا إذا كنت على ما يرام.

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دائما تناول ميجاموكس تماما كما قد أخبرك طبيبك. ويجب عليك التحقق مع طبيبك أو الصيدلي إذا كنت غير متأكد.
حيت ان اقراص ميجاموكس 375 ملغ و 625 ملغ تحتوي نفس الكمية من حامض الكلافيونك 125 (ملغم كملح بوتاسيوم),فان قرصين ميجاموكس 375 ملغم لا يعادلان قرص ميجاموكس 625 ملغم,لذلك لا يجب اخذ قرصين 375 ملغ بدلا من قرص واحد ميجاموكس 625 ملغ .
الكبار والأطفال الذين وزنهم 40 كغم وأكثر:
الجرعة المعتادة هي قرص واحد من ميجاموكس 625 ملغ كل 12 ساعة او قرص واحد من ميجاموكس كل 8 ساعات.للالتهابات الاشد و التهابات المجاري التنفسية,يجب ان تكون الجرعة قرص واحد من ميجاموكس 1000 ملغ كل 12 ساعة ,او قرص واحد من ميجاموكس 625 ملغ كل 8 ساعات.
لا يحتاج مرضى القصور الكلوي الى تقليص الجرعة الا اذا كان القصور حادا.المرضى الذين يعانون من قصور كلوي شديد (تصفية الكرياتين < 30 ملليتر/دقيقة) يجب ان لا يتناولوا اقراص 1000 ملغم.اما المرضى الذين يبلغ عندهم تصفية الكرياتنين (10 - 30 )ملليتر/دقيقة ,فيجب ان يتناولوا اقراص ميجاموكس 625 ملغم او 375 ماغم كل 12 ساعة وذلك حسب شدة  الالتهاب.
و المرضى الذين تقل عندهم تصفية الكرياتنين عن 10 ملليتر/دقيقة,فيجب ان يتناولوا اقراص ميجاموكس 625 ملغم او 375 ملغم كل 24 ساعة وذلك حسب شدة الالتهاب,كما يجب ان يتناولوا جرعة اضافية خلال و في عملية غسيل الكلى.
بالنسبة للمرضى الذين لديهم قصور في الكبد,يجب توخي الحذر في جرعاتهم و مراقبة وظائف الكبد لديهم يشكل منتظم.
الأطفال الذين وزنهم أقل من 40 كغم
للاطفال بعمر اقل من 6 سنوات,يفضل استخدام ميجاموكس المعلق.
لا ينصح باستخدام أقراص ميجاموكس .
المرضى الذين يعانون من مشاكل في الكلى والكبد

  • إذا كنت تعاني من مشاكل في الكلى قد تتغير الجرعة. ويمكن أن يختار طبيبك تركيز مختلف أو دواء آخر.
  • إذا كنت تعاني من مشاكل في الكبد فيجب عمل فحوصات متكررة للدم من أجل معرفة كيف تعمل كبده. 

كيف تتناول اقراص ميجاموكس

  • خذ الحبة مع الوجبة 
  • إبلع الاقراص كاملة مع كوب من الماء 
  • باعد بين الجرعات بالتساوي خلال اليوم,على الاقل 4 ساعات عن بعضها البعض.لاتاخذ جرعتين في ساعة واحده. 
  • لا تاخذ ميجاموكس لاكثر من اسبوعين,اذا كنت تشعر بانك مريض يجب ان تعود لرؤية الطبيب. 

الجرعة الزائدة من ميجاموكس
إذا كنت تناولت الكثير من ميجاموكس، قد تشمل علامات اضطراب في المعدة (الشعور بالغثيان، أو الإسهال) أو التشنجات. تحدث إلى طبيبك في أقرب وقت ممكن. خذ علبة الدواء لعرضها إلى الطبيب.
نسيان تناول جرعة ميجاموكس
إذا كنت قد نسيت أن تاخذ جرعة، خذها حالما تتذكر. يجب أن لا تاخذ الجرعة التالية في وقت قريب جدا، ولكن انتظر حوالي 4 ساعات قبل تناول الجرعة التالية. لا تقم بأخذ جرعة مضاعفة لتعويض الجرعة المفقودة.
التوقف عن تناول ميجاموكس
يجب المحافظة على اخذ ميجاموكس حتى يتم الانتهاء من العلاج، حتى لو كنت تشعر بالتحسن. إنك تحتاج إلى كل جرعة للمساعدة في مكافحة الالتهاب. إذا بقيت بعض أنواع البكتيريا على قيد الحياة يمكن أن تتسبب في إعادة الالتهاب.
إذا كان لديك أي أسئلة إضافية حول إستخدام هذا الدواء، اسأل طبيبك أو الصيدلي

مثل جميع الأدوية، قد يسبب هذا الدواء آثارا جانبية، إلا أنه ليس بالضرورة أن تحدث لدى جميع مستخدمي هذا الدواء. يمكن أن تحدث الآثار الجانبية أدناه مع هذا الدواء.
الظروف التي تحتاج إلى الانتباه إليها 
ردود الفعل التحسسية:

  • الطفح الجلدي. 
  • التهاب الأوعية الدموية (التهاب الأوعية) والتي قد تكون مرئية على شكل بقع حمراء أو أرجوانية تطفوا على سطح 
  • الجلد، ولكن يمكن أن تؤثر على أجزاء أخرى من الجسم.
  • الحمى، آلام المفاصل، وتورم الغدد في الرقبة، الإبط أو أعلى الفخذ. 
  • تورم، أحيانا في الوجه أو الحلق (وذمة وعائية)، مما تسبب صعوبة في التنفس.
  • انخماص. 

اتصل بالطبيب فورا إذا حصل لديك أي من هذه الأعراض. توقف عن أخذ ميجاموكس.
التهاب الأمعاء الغليظة
التهاب الأمعاء الغليظة، يسبب الإسهال المائي عادة مع الدم والمخاط ، آلام في المعدة و / أو الحمى.
اتصل بطبيبك في أقرب وقت ممكن للحصول على المشورة الطبية إذا حصلت لديك هذه الأعراض.
الآثار الجانبية الشائعة جدا
قد تؤثر هذه أكثر من 1 في 10 أشخاص:

  • الإسهال (لدى البالغين). 

الآثار الجانبية الشائعة
قد تؤثر هذه فيما يصل إلى 1 في 10 أشخاص:

  • مرض القلاع (الفطريات المبيضة - عدوى الخميرة في المهبل، الفم أو طيات الجلد) 
  • الشعور بالغثيان (غثيان)، وخصوصا عند تناول جرعات عالية. إذا تأثر به خذ ميجاموكس قبل الطعام. 
  • التقيؤ 
  • الإسهال (لدى الأطفال) 

الآثار الجانبية الغير شائعة
قد تؤثر هذه فيما يصل إلى 1 في 100 شخص:

  • الطفح الجلدي والحكة 
  • طفح حاك مثار (شرى) 
  • عسر الهضم 
  • الدوخة 
  • الصداع 

الآثار الجانبية الغير شائعة التي قد تظهر في فحوصات الدم:

  • الزيادة في بعض المواد (الإنزيمات) التي ينتجها الكبد. 

الآثار الجانبية النادرة
قد تؤثر هذه فيما يصل إلى 1 في 1000 شخص:

  • الطفح الجلدي الذي قد يبدو, وكأنه نفطة ويشبه البقع الصغيرة (بقع داكنة مركزية تحيط بها منطقة أكثر شحوبا، مع حلقة  داكنة حول الحافة من الحمامى متعددة الأشكال). إذا لاحظت أي من هذه الأعراض اتصل بطبيب على وجه السرعة.

الآثار الجانبية النادرة التي قد تظهر في فحوصات الدم:

  • انخفاض عدد الخلايا المشاركة في تخثر الدم 
  • انخفاض عدد خلايا الدم البيضاء. 

الآثار الجانبية الأخرى
تم حدوث آثار جانبية أخرى لدى عدد قليل جدا من الناس ولكن ترددھا لم يكن معروفا بالضبط:

  • ردود الفعل التحسسية (انظر أعلاه) 
  • التهاب الأمعاء الغليظة (انظر أعلاه) 
  • تفاعلات جلدية خطيرة: 

-  الطفح الجلدي على نطاق واسع مع ظهور بثور وقشور على الجلد، وبخاصة حول الفم والأنف والعينين والأعضاء التناسلية (متلازمة ستيفنز جونسون)، وشكل أكثر خطورة، يتسبب في تقشير واسع للجلد (أكثر من 30 ٪ من سطح الجسم - انحلال البشرة السمي)
-  الطفح الجلدي الأحمر واسع النطاق مع ظهور بثور صغيرة تحتوي على صديد (التهاب الجلد التقشري الفقاعي).
-  طفح أحمر متقشر مع تحاديب تحت الجلد وظهور بثور (البثور الطفحية).
اتصل بطبيب على الفور إذا حصل لديك أي من هذه الأعراض.

  • التهاب الكبد 
  • اليرقان الناجم عن زيادات البيليروبين في الدم (مادة تنتج في الكبد) والتي قد تجعل جلد طفلك وبياض عينيه يظهر أصفر 
  • التهاب الأنابيب في الكلى 
  • يأخذ الدم وقتا أطول للتجلط 
  • فرط النشاط
  • التشنجات (في الأشخاص الذين يتناولون جرعات عالية من ميجاموكس أو الذين لديهم مشاكل في الكلى) 
  • اللسان الأسود الذي يبدو مشعر 
  • الأسنان الملطخة (عند الأطفال)، تتم إزالتها عادة عن طريق فرشاه الأسنان. 

الآثار الجانبية التي قد تظهر في اختبارات الدم أو البول:

  • انخفاض شديد في عدد خلايا الدم البيضاء 
  • انخفاض عدد خلايا الدم الحمراء (فقر الدم الانحلالي) 
  • البلورات في البول. 

في حال اصبحت أي من الاثار الجانبية أكثر سوءا, أو في حال ظهور أية آثار جانبية جديدة لم تذكر في هذه النشرة, يرجى الاتصال بالطبيب, مقدم الرعاية الصحية أو الصيدلي.


احفظ هذا الدواء بعيدا عن مرأى و متناول الأطفال.
لا تستخدم هذا الدواء بعد تاريخ انتهاء الصلاحية المذكور على العلبة. يشير تاريخ الانتهاء إلى اليوم الأخير من ذلك الشهر 
احفظ الدواء عند درجة حرارة أقل من 30 درجة مئوية.
احفظ الدواء داخل عبوته الخارجية للحماية من الرطوبة.
لا تستخدم الدواء إذا كانت الاقراص متكسرة او لاحظت علامات تلف واضحة عليه.
لا تتخلص من الأدوية عن طريق مياه الصرف الصحي أو النفايات المنزلية. اسأل الصيدلي عن كيفية التخلص من الأدوية التي لم تعد بحاجة إليها . اتبع هذه الاجراءات للحفاظ على سلامة البيئة

ماهي محتويات ميجاموكس
محتويات ميجاموكس 375 ملغم اقراص
المواد الفعالة في كل قرص هي 250 ملغم اموكسيسيلين و 125 ملغم حامض الكلافولانيك (موجود على شكل كلافولانات البوتاسيوم).
ما هي محتويات ميجاموكس 625 ملغم اقراص
المواد الفعالة في كل قرص هي 500 ملغم اموكسيسيلين و 125 ملغم حامض الكلافولانيك (موجود على شكل كلافولانات البوتاسيوم)
ما هي محتويات ميجاموكس 1000 ملغم اقراص
المواد الفعالة في كل قرص هي 875 ملغم اموكسيسيلين و 125 ملغم حامض الكلافولانيك (موجود على شكل كلافولانات البوتاسيوم).
المكونات الاخرى للاقراص هي :ستيرات المغنيسيوم,غليكولات نشا الصوديوم,ثاني اكسيد السيليكون الغروي,هيدروكسي بروبيل ميثيل سيلليلوز,ثاني اكسيد التيتانيوم,البروبيلين غليكول,ايثيل سيلليلوز و السيلليوز البلوري الدقيق

ماهو الشكل الصيدلاني لميجاموكس ووصفه وحجم عبوته.
 ميجاموكس 375 ملغم اقراص هي: اقراص بيضاء مائلة الى اللون الاصفر مغلفة بفيلم,على شكل كبسولة محفور عليها  "JI" و على الجانب الاخر " 77 ",الخط الفاصل المحدد على القرص لتسهيل بلع القرص وليس لتقسيم القرص الى جرعتين متساويتين.تحتوي العبوة على: 20 قرص
ميجاموكس 625 ملغم اقراص هي: اقراص بيضاء مائلة الى اللون الاصفر مغلفة بفيلم,على شكل كبسولة محفور عليها "JI" تحتوي العبوة على: 14 او 20 قرص .
ميجاموكس 1000 ملغم اقراص هي: اقراص بيضاء مائلة الى اللون الاصفر مغلفة بفيلم,على شكل كبسولة محفور عليها  "JI" و على الجانب الاخر " 112 ",الخط الفاصل المحدد على القرص لتسهيل بلع القرص وليس لتقسيم القرص الى جرعتين متساويتين.تحتوي العبوة على: 14 قرص

( JPI)   الجزيرة للصناعات الدوائية
الرياض، المملكة العربية السعودية، الرياض 11666 ، صندوق البريد 106229
+966-11-207- رقم الهاتف: 8172
+966-11-207- فاكس: 8097
medical@jpi.com.sa : البريد الإلكتروني

تمت مراجعة هذه النشرة بتاريخ 09/2018 ؛ الإصدار رقم 2.3
 Read this leaflet carefully before you start using this product as it contains important information for you

Megamox® 625 mg Tablet

Megamox 625 mg Tablets: Each tablet contains co-amoxiclav 500/125. The amoxicillin is present as amoxicillin trihydrate and the clavulanic acid is present as potassium clavulanate. For a full list of excipients, see section 6.1

White to off-white oblong film coated tablet embossed with "Jl"

Megamox 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 agents

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 Megamox 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 Megamox (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 Megamox provides a total daily dose of 750 mg amoxicillin/375 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 Megamox is selected in order to avoid administration of unnecessarily high daily doses of clavulanic acid (see sections 4.4 and 5.1).

Treatment should not be extended beyond 14 days without review.

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 Megamox tablets, suspensions or paediatric sachets.

As the tablets cannot be divided, children weighing less than 25 kg must not be treated with Megamox tablets.

The table below presents the received dose (mg/kg body weight) in children weighing 25 kg to 40 kg upon administering a single 500/125 mg tablet.

Body weight [kg]

40

35

30

25

Single dose recommended [mg/kg body weight] (see above)

Amoxicillin [mg/kg body weight] per single dose (1 film-coated tablet)

12.5

14.3

16.7

20.0

6.67 – 20

Clavulanic acid [mg/kg body weight] per single dose (1 film-coated tablet)

3.1

3.6

4.2

5.0

1.67 - 5

Children aged 6 years and below or weighing less than 25 kg should preferably be treated with Megamox suspension.

No clinical data are available on doses of Megamox 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

Megamox is for oral use.

Administer at the start of a meal to minimise potential gastrointestinal intolerance and optimise absorption of amoxicillin/clavulanic acid.


Hypersensitivity to the active substances, to any of the penicillins or to any of the excipients. History of a severe immediate hypersensitivity reaction (e.g. anaphylaxis) to another beta-lactam agent (e.g. a cephalosporin, carbapenem or monobactam). History of jaundice/hepatic impairment due to amoxicillin/clavulanic acid (see section 4.8).

Before initiating therapy with amoxicillin/clavulanic acid, careful enquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins or other beta-lactam agents.

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.

This presentation of Megamox is not suitable for use when there is a high risk that the presumptive pathogens have reduced susceptibility or resistance to beta-lactam agents that is not mediated by beta-lactamases susceptible to inhibition by clavulanic acid (e.g. penicillin-insusceptible S. pneumoniae).

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 Megamox 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 sections 4.2, 4.3 and 4.8).

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 Megamox 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.


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 section 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. The possibility of sensitisation should be taken into account. 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 Megamox, 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

Reversible agranulocytosis

Not known

Haemolytic anaemia

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

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

Reporting of suspected adverse events:

Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting systems applied at their countries.

  • Saudi Arabia:

− The National Pharmacovigilance and Drug Safety Centre (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

  • Other GCC States: Please contact the relevant competent authority.

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

staphylococci2

≤ 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

Staphylococcus aureus ( methicillin-susceptible)£

Streptococcus agalactiae

Streptococcus pneumoniae1

Streptococcus pyogenes and other beta-hemolytic 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.

Morganella morganii

Providencia spp.

Pseudomonas sp.

Serratia sp.

Stenotrophomonas maltophilia

$ Natural intermediate susceptibility in the absence of acquired mechanism of resistance.

£All methicillin-resistant staphylococci are resistant to amoxicillin/clavulanic acid

1Streptococcus pneumoniae that is fully susceptible to penicillin may be treated with this presentation of amoxicillin/clavulanic acid. Organisms that show any degree of reduced susceptibility to penicillin should not be treated with this presentation (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 mg/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 Megamox 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 Megamox or its components


 

  • Colloidal anhydrous silica
  • Microcrystalline Cellulose
  • Sodium Starch Glycolate
  • Magnesium Stearate
  • Opadry YS-1-7191 White
  • Methylene Chloride
  • Methanol

None


3 years

Store below 250C


Form pack Aluminum foil 161 mm, Aluminum Foil Megamox 625 mg Tabs. Containing 20 and 14 Tablets.


None.
 


Jazeera Pharmaceutical Industries (JPI) Riyadh, Saudi Arabia 11666 Riyadh, P.O.Box 106229

18-may-2017
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