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Zimax is one of a group of antibiotics called macrolides. It is used to treat infections caused by certain bacteria and other micro-organisms, which include:
• Chest, throat or nasal infections (such as bronchitis, pneumonia, tonsillitis, sore throat (pharyngitis) and sinusitis).
• Ear infections.
• Skin and soft tissue infections (such as an abscess or boil).
• Sexually transmitted diseases caused by an organism called Chlamydia.
Do not take Zimax if you or your child:
• Are allergic to Zimax or any other macrolide antibiotic such as erythromycin or clarithromycin or any of the ingredients listed in section 6. An allergic reaction may cause skin rash or wheezing.
• Are taking any ergot derivatives such as ergotamine (used to treat migraine) as these medicines should not be taken together with Zimax.
• Are patient with a history of cholestatic jaundice/hepatic dysfunction associated with prior use of azithromycin.
• patients with known prolongation of the QT interval, patients with ongoing proarrhythmic conditions such as uncorrected hypokalemia or hypomagnesemia, clinically significant bradycardia, and in patients receiving Class IA (quinidine,procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents.
Take special care with Zimax
Your doctor needs to know before you take Zimax if you/your child have or have had any of the following conditions:
• Kidney problems.
• Heart conditions.
•Diabetes.
• If you are taking any ergot derivatives such as ergotamine (used to treat migraine) as these medicines should not be taken together with Zimax.
• Abnormal liver function, hepatitis, cholestatic jaundice, hepatic necrosis and hepatic failure.
Tell your doctor immediately if you feel your heart beating in your chest or have an abnormal heartbeat, or get dizzy or faint or suffer from any muscle weakness when taking Zimax.
If you/your child develop diarrhea or loose stools during or after treatment, tell your doctor at once. Do not take any medicine to treat your diarrhea without first checking with your doctor. If your diarrhea continues, please inform your doctor.
Hypersensitivity
· Fatalities have been reported. Cases of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) have also been reported. Despite initially successful symptomatic treatment of the allergic symptoms, when symptomatic therapy was discontinued, the allergic symptoms recurred soon thereafter in some patients without further azithromycin exposure.Serious allergic reactions, including angioedema, anaphylaxis, and dermatologic reactions including Stevens-Johnson Syndrome, and toxic epidermal necrolysis, have been reported rarely in patients on azithromycin therapy.
Taking other medicines
Tell your doctor before taking Zimax, if you/your child are taking any of the medicines listed below:
• Ergot or ergotamine – see ‘Do not take Zimax’ section.
• Warfarin or any similar medicine to prevent blood clots.
• Ciclosporin (used to suppress the immune system to prevent and treat rejection of a transplanted organ or bone marrow).
• Antacids (for indigestion).
• Nelfinavir (Antiviral)
• Digoxin (used to treat heart failure).
• Phenytoin (Antiepileptic)
• Terfenadine (for hay fever or a skin allergy).
• Class IA (quinidine,procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents – see ‘Do not take Zimax’ section.
You should always tell your doctor if you/your child are taking or have recently taken any other medicines including those obtained without a prescription.
Taking Zimax with food and drink
You should take Zimax capsules or tablets either 1 hour before a meal or 2 hours after a meal.
Zimax Powder for Oral Suspension is not affected by food or drink.
Pregnancy and breast-feeding
If you are pregnant, trying to get pregnant or are breast-feeding you should not take Zimax without discussing it with your doctor first.
Driving and using machines
Zimax is not expected to affect your ability to drive or use machines.
Important information about some of the ingredients of Zimax
Zimax 250 mg capsules contains a small amount of lactose (milk sugar), if you have been told by your doctor that you have intolerance to some sugars, please contact your doctor before taking this medicine.
Zimax powder for oral suspension contains sucrose, if you have been told by your doctor that you have intolerance to some sugars, please contact your doctor before taking this medicine.
Caution in diabetic patients: 5 ml of reconstituted suspension contains 3.965 g of sucrose.
Always take Zimax exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Zimax capsules and tablets:
The usual dose in adults and children over (45 kg) is 500mg taken together, once a day, for 3 days.
For some diseases such as Chlamydia the dose is 1g taken all together on one day only.
Zimax tablet or capsules should not be taken by children weighing less than 45kg.
Zimax Powder for Oral Suspension:
Zimax Powder for Oral Suspension is generally used for children under (45kg). It may also be used in adults and older children who have difficulty swallowing capsules and tablets.
Children under 45kg
The usual dose in children is 10 mg for each kg of bodyweight, given as a single daily dose for 3 days.
If your child is under three years of age or weighs up to 15kg in bodyweight, you should measure the dose as clearly as possible using the 10ml oral dosing syringe provided. The syringe is graduated in 0.25ml divisions, providing 10mg of azithromycin (the active ingredient) in every graduation.
How to give Zimax Powder for Oral Suspension in children between 3 and 14 years of age
Bodyweight and age | Dose and duration |
15-25kg bodyweight (3-7 years): | 5ml (200mg), once daily for 3 days. |
26-35kg bodyweight (8-11 years): | 7.5ml (300mg), once daily for 3 days. |
36-45kg bodyweight (12-14 years): | 10ml (400mg), once daily for 3 days. |
You should tell your doctor if you/your child have kidney or liver problems as your doctor may need to alter the normal dose.
Doctors sometimes prescribe different doses to these. If you are still not sure, ask your doctor or pharmacist.
Always continue with the course even if you/your child feel better. If your infection gets worse or you do not start to feel better within a few days or a new infection develops, go back and see your doctor.
If you/your child take more Zimax than you should
If you take too much Zimax you may feel unwell. Tell your doctor or contact your nearest hospital casualty department immediately.
If you forget to take or give Zimax
If you forget to take Zimax take it as soon as you can. Take your next dose at the right time. Do not take a double dose to make up for a forgotten dose.
If you stop taking Zimax
If you/your child stop taking Zimax too soon, the infection may return. Take Zimax for the full time of treatment, even when you begin to feel better.
If you have any further questions about the use of this product, ask your doctor or pharmacist for advice.
Like all medicines Zimax can cause side effects although not everybody gets them.
Tell your doctor immediately if you experience any of the following symptoms after taking this medicine as the symptoms can be severe.
· Sudden wheeziness, difficulty in breathing, swelling of eyelids, face or lips, rash or itching (especially affecting the whole body).
· Severe or prolonged diarrhea, which may have blood or mucus in it, during or after treatment with Zimax as this may be a sign of serious bowel inflammation.
· Severe skin rash causing redness and flaking rapid or irregular heartbeat.
· Low blood pressure.
The most common side effects that occur when taking Zimax are listed below. These may go away during treatment as your body adjusts to the medicine. Tell your doctor if any of these side effects continue to bother you.
Very common side effects (occurring in at least 1 in 10 people taking Zimax):
• Stomach cramps, feeling sick, diarrhea, wind.
Common side effects (likely to occur in less than 1 in 10 people):
• Dizziness, headache.
• Numbness or pins and needles.
• Being sick, indigestion.
• Loss of appetite, taste disturbance.
• Visual disturbances, deafness.
• Skin rash and /or itching.
• Joint pain.
• Low numbers of lymphocytes (type of white blood cells), higher number of eosinophils (type of white blood cells).
• Low blood bicarbonate.
• Tiredness or weakness.
Uncommon side effects that occur in less than 1 in 100 people taking Zimax are:
• Yeast infections of the mouth and vagina (thrush).
• Low numbers of leukocytes (type of white blood cells), low number of neutrophils (type of white blood cells).
• Allergic reactions of various severities.
• blistering of the skin, mouth, eyes and genitals.
• Skin more sensitive to sunlight than normal.
• Feeling nervous.
• Reduced sense of touch or sensation (hypoesthesia).
• Sleepiness or sleeplessness (insomnia).
• Poor hearing or ringing in the ears.
• Heart palpitations, chest pain.
• Constipation, stomach pain associated with diarrhea and fever.
• Inflammation of the liver (hepatitis), changes in liver enzymes.
• General loss of strength.
• Swelling.
• General discomfort.
• Abnormal laboratory test values (e.g. blood or liver tests).
Rare side effects that occur in less than 1 in 1,000 people taking Zimax are:
• Agitation.
• Vertigo.
• Changes in liver function.
Other side effects that have been reported, but it is not known how frequently they occur:
• Fits or fainting.
• Aggression or anxiety.
• Feeling hyperactive.
• localized muscle weakness.
• Loss of smell or altered sense of smell, loss of taste.
• Tongue discoloration.
• Inflammation of the pancreas (pancreatitis).
• Inflammation of the kidney or kidney failure.
• Yellowing of the skin or eyes (jaundice) or liver failure (rarely life-threatening).
• Bruising or prolonged bleeding after injury.
• Blistering of the skin, severe skin reaction.
• Abnormal electrocardiogram (EEG). Prolongation of the QT interval: Cases of torsades de points have been spontaneously reported during postmarketing surveillance in patients receiving azithromycin. Although the absolute risk is unknown, it appears to be low with azithromycin likely due to the lack of appreciable drug interactions, and the observation that it is rarely reported as a postmarketing adverse event. However, it would be prudent to avoid use in patients with known prolongation of the QT interval, patients with ongoing proarrhythmic conditions such as uncorrected hypokalemia or hypomagnesemia, clinically significant bradycardia, and in patients receiving Class IA (quinidine,procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents. Elderly patients may be more susceptible to drug-associated effects on the QT interval.
• Reduction in red blood cells which can make the skin pale and cause weakness or breathlessness.
Laboratory Abnormalities
In subjects with normal baseline values, the following clinically significant laboratory abnormalities (irrespective of drug relationship) were reported in Zimax clinical trials in adults and pediatric patients:
Adults:
Laboratory abnormalities with an incidence of greater than or equal to 1%: reduced lymphocytes and increased eosinophils; reduced bicarbonate. Laboratory abnormalities with an incidence of less than 1%: leukopenia, neutropenia, elevated bilirubin, AST, ALT, BUN, creatinine, alterations in potassium. Where follow-up was provided, changes in laboratory tests appeared to be reversible.
Pediatric Patients:
Laboratory abnormalities with an incidence of greater than or equal to 1%: elevated eosinophils, BUN, and potassium; decreased lymphocytes; and alterations in neutrophils; with an incidence of less than 1%: elevated SGOT, SGPT and creatinine; decreased potassium; and alterations in sodium and glucose.
Postmarketing Experience
- Gastrointestinal: Anorexia, constipation, dyspepsia, flatulence, vomiting/diarrhea rarely resulting in dehydration, pseudomembranous colitis, pancreatitis, oral candidiasis, pyloric stenosis, and rare reports of tongue discoloration.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Do not store above 30°C.
Keep all medicines out of the sight and reach of children.
For Zimax Suspension: Keep the reconstituted suspension in a refrigerator and use within 5 Days".
Discard when full dosing is completed.
Active ingredient:
Each capsule of Zimax 250 mg Capsules contains 262.03 mg of azithromycin dihydrate equivalent to 250 mg azithromycin.
Each tablet of Zimax 250 mg tablets contains 262.03 mg of azithromycin dihydrate equivalent to 250 mg azithromycin.
Each tablet of Zimax 500 mg tablets contains 524.05 mg of azithromycin dihydrate equivalent to 500 mg azithromycin.
Each 5 ml of Zimax Powder for Oral Suspension after reconstitution contains 210 mg of azithromycin dihydrate equivalent to 200 mg azithromycin.
The other ingredients are:
Zimax 250 mg Capsules contain: Maize starch, gelatin caps, colloidal silicon dioxide, sodium lauryl sulphate, magnesium stearate, lactose.
Zimax 250 mg and 500 mg tablets contain:
Tablet core: Sodium lauryl sulphate, dicalcium phosphate anhydrous, crospovidone, klucel, colloidal silicon dioxide, stearic acid, magnesium stearate, pre-gelatinized starch dry.
Tablet coating: purified water, iron oxide red, hydroxypropyl methylcellulose, polyethylene glycol, purified talc, titanium dioxide, Polysorbate.
Zimax Powder for Oral Suspension contains: Banana flavor, vanilla flavor, strawberry flavor, keltrol (xantham gum), klucel, sodium phosphate tribasic, sucrose.
SPIMACO
Al-Qassim pharmaceutical plant
Saudi Pharmaceutical Industries &
Medical Appliance Corporation
Saudi Arabia
ينتمي زيماكس إلى مجموعة من المضادات الحيوية تسمى الماكروليدات. وتستخدم لعلاج العدوى التي تتسبب بها أنواع معينة من البكتيريا والكائنات الدقيقة الأخرى، وتشتمل على:
· التهابات الصدر، الحنجرة والأنف (مثل التهاب القصبات، الالتهاب الرئوي، التهاب اللوزتين، التهاب الحلق (التهاب البلعوم) و التهاب الجيوب الأنفية).
· التهاب الأذن.
· التهاب الجلد و التهاب الأنسجة الرخوة (مثل الخراج أو الدمل).
· الأمراض التي تنتقل جنسيا والتي تسببها كائنات دقيقة تدعى كلاميديا.
امتنع عن تناول أو إعطاء زيماكس لطفلك فى الحالات الآتية:
- إذا كنت تعاني من التحسس لزيماكس أو لأي من المضادات الحيوية التي تنتمي لعائلة الماكروليد مثل إريثرومايسين أو كلاريثرومايسين أو لأي من المكونات الأخرى المذكورة في نقطة 6. إن تفاعل التحسس قد يسبب طفح الجلد أو صفير الصدر.
- إذا كنت تتناول أيا من مشتقات الإيرجوتامين ( يستخدم لعلاج الصداع النصفي) حيث أنه يجب عدم تناول هذه الأدوية بالتزامن مع تناول زيماكس.
- إذا حدث عند المريض سابقا اصفرار مراري / فشل كبدي عقب تناول الآزيثرومايسين.
- في حالة المرضى الذين يعانون من عدم انتظام نظم القلب زيادة الفترة QT، أو المرضى الذين يعانون من عدم انتظام نظم القلب الناتج عن نقص بوتاسيوم الدم غير المصحح أونقص مغنيسيوم الدم غير المصحح. أو في حالة المرضى الذين يعانون من بطء نظم القلب، كما يتوجب عدم تناوله مع المرضى الذين يتناولون أدوية علاج اضطراب نظم القلب من النوع IA (كوانيدين، بروكايناميد) أو النوع III (دوفيتيلايد، أميودارون، سوتالول).
ينبغى توخى الحذر عند تناول زيماكس:
يتوجب عليك إخبار طبيبك المعالج قبل البدء بتناول زيماكس إذا كنت أو كان طفلك يعاني من المشاكل التالية:
· مشاكل في الكلى.
· مشاكل في القلب.
· مرض السكري.
· عدم انتظام وظائف الكبد، الالتهاب الكبدي، الاصفرار المراري، النخر الكبدي والفشل الكبدي.
- إذا كنت تتناول أيا من مشتقات الإيرجوت مثل إيرجوتامين ( يستخدم لعلاج الصداع النصفي) حيث أنه يجب عدم تناول هذه الأدوية بالتزامن مع تناول زيماكس.
يجب عليك إخبار طبيبك على الفور إذا شعرت بضربات قلبك في صدرك أو بعدم انتظام ضربات القلب لديك، أو شعرت بالدوار أو الدوخة او عانيت من ضعف في العضلات عند تناولك لزيماكس.
إذا حدث عندك/عند طفلك اسهال أو براز رخو أثناء أو بعد العلاج، فضلا أخبر طبيبك على الفور. لاتتناول أي دواء لعلاج الاسهال بدون مراجعة طبيبك. وإذا استمر الاسهال أخبره بذلك.
فرط الحساسية
• تم الإبلاغ عن حالات وفاة. كما تم الإبلاغ عن حالات ردود فعل دوائية مع فرط الحمضات والأعراض الجهازية (دريس). على الرغم من علاج أعراض الحساسية بنجاح في البداية، ولكن عندما تم وقف العلاج ب آزيثرومايسين تكرر ظهور أعراض الحساسية بعد ذلك بوقت قصير في بعض المرضى. وقد تم تسجيل حالات نادرة مع آزيثرومايسين مثل ردود فعل تحسسية خطيرة، بما في ذلك وذمة وعائية، الحساسية المفرطة، والتفاعلات الجلدية بما في ذلك متلازمة ستيفنز جونسون ، نخر البشرة.
تناول أدوية أخرى أو أعشاب أو مكملات غذائية
قبل القيام بتناول زيماكس، أخبر طبيبك المعالج إذا كنت/ كان طفلك يتناول أيا من الأدوية التالية:
- إيرجوت او إيرجوتامين –انظر الفقرة "امتنع عن تناول زيماكس".
- وارفارين أو أية أدوية مشابهة لمنع تخثر الدم.
- سايكلوسبورين (يستخدم لتقليل المناعة لمعالجة رفض الأعضاء المزروعة أو زراعة نخاع العظم).
- أدوية معادلة حموضة المعدة (المستخدمة لعلاج عسر الهضم).
- نيلفينافير (مضاد للفيروسات)
- ديجوكسين (يستخدم لعلاج فشل القلب).
- فينيتوين (مضاد للتشنجات)
- تيرفينادين (يستخدم لعلاج حمى القش وتحسس الجلد).
- أدوية علاج اضطراب نظم القلب من النوع IA (كوانيدين، بروكايناميد) أو النوع III (دوفيتيلايد ، أميودارون، سوتالول) – انظر امتنع عن تناول زيماكس.
أخبر طبيبك بالأدوية التى تتناولها/ يتناولها طفلك بما فى ذلك الأدوية التى وصفها لك طبيب آخر أو حتى الأدوية التى حصلت عليها بدون وصفة طبية.
تناول زيماكس مع الطعام والشراب
يتوجب عليك تناول زيماكس على هيئة كبسولات أو أقراص قبل وجبة الطعام بساعة أو بعدها بساعتين.
إن زيماكس على هيئة مسحوق يتم تحضيره لمعلق فموي يمكن تناوله مع الأكل أوبدونه.
الحمل والارضاع
يتوجب عليك عدم تناول زيماكس إذا كنت حاملا، أو تحاولين الحصول على حمل أو كنت ترضعين طفلك طبيعيا بدون استشارة طبيبك المعالج أولا.
القيادة واستخدام الآلات:
لا يؤثر تناول زيماكس على القدرة على القيادة أو استخدام الالآت.
معلومات هامة حول بعض مكونات زيماكس
تحتوي زيماكس على هيئة كبسولات 250 ملجم على كمية قليلة من اللاكتوز (سكر اللبن)، إذا تم إخبارك من قبل الطبيب المعالج بأنك لا تستطيع تحمل بعض أنواع السكريات، فضلا تواصل مع طبيبك المعالج قبل تناول هذا الدواء.
يحتوي زيماكس على هيئة مسحوق لعمل معلق فموى على سكروز، إذا تم إخبارك من قبل الطبيب المعالج بأنك لا تستطيع تحمل بعض أنواع السكريات، فضلا تواصل مع طبيبك المعالج قبل تناول هذا الدواء.
تنبيه لمرضى السكري: كل 5 مل من معلق زيماكس بعد التحضير تحتوي على 3.965 جم من السكروز.
يتوجب عليك تناول زيماكس تماما كما أخبرك الطبيب. في حالة عدم تأكدك، تأكد من الجرعة من طبيبك أو الصيدلي.
زيماكس على هيئة أقراص أو كبسولات:
الجرعة الاعتيادية للبالغين و الأطفال الذين يزنون أكثر من 45 كجم هي 500 ملجم مرة واحدة يوميا لمدة 3 أيام.
في حالة بعض الأمراض مثل كلاميديا تكون الجرعة 1 جم مرة واحدة فقط.
لا يجب تناول زيماكس على هيئة أقراص أو كبسولات في حالة الأطفال الذين تقل أوزانهم عن 45 كجم.
زيماكس على هيئة مسحوق لعمل معلق فموى
يستخدم زيماكس على هيئة مسحوق لعمل معلق فموى في حالة الأطفال الذين تقل أوزانهم عن 45 كجم. كما أنه يمكن استخدامه في حالة البالغين و الأطفال الأكبر سنا ممن يعانون صعوبة في البلع لا تمكنهم من ابتلاع الكبسولة أو القرص.
الأطفال أقل من 45 كجم
الجرعة الاعتيادية في حالة الأطفال هي 10 ملجم لكل كيلوجرام من وزن الطفل. تؤخذ كجرعة واحدة يوميا ولمدة 3 أيام.
في حالة الأطفال الذين تقل أعمارهم عن 3 سنوات أو 15 كجم يجب أخذ الجرعة باستخدام المحقنة المرفقة للدواء. إن المحقنة تم تدريجها حتى 10 مل ومقسمة إلى أقسام كل قسم حجمه 0.25 مل وتركيز الدواء فيه يساوى 10ملجم.
كيفية تناول زيماكس على هيئة مسحوق لعمل معلق فموى في حالة الأطفال الذين تتراوح أعمارهم بين 3 سنوات و 14 سنة
الجرعة والمدة الزمنية | الوزن و العمر |
5 مل (200ملجم)، مرة واحدة يوميا لمدة 3 أيام. | 15-25 كجم (3-7 سنوات): |
.7.5 مل (300 ملجم)، مرة واحدة يوميا لمدة 3 أيام | 26-35 كجم (8-11 سنة): |
10 مل (400 ملجم)، مرة واحدة يويما لمدة 3 أيام. | 36-45 كجم (12-14 سنة): |
أخبر طبيبك المعالج إذا كنت أو كان طفلك يعاني من مشاكل في الكبد أو الكلى، إذ قد يقوم الطبيب بتعديل الجرعات.
قد يقوم الطبيب بوصف جرعة مختلفة. إذا كنت غير متأكد من الجرعة فضلا اسأل الطبيب أو الصيدلي.
كما يتوجب عليك متابعة تناول هذا الدواء حتى لو شعرت/طفلك بالتحسن. إذا ازدادت حدة العدوى أو لم تشعر بالتحسن خلال أيام أو أصبت بعدوى جديدة، ارجع إلى طبيبك.
الجرعة الزائدة من زيماكس
في حالة تناولك جرعة زائدة من زيماكس سوف تشعر بأنك غير جيد. أخبر طبيبك أو راجع أقرب مستشفى أو وحدة رعاية على الفور.
نسيان تناول جرعة من زيماكس
في حالة نسيان تناول جرعة من زيماكس تناول الجرعة فور تذكرها. إلا إذا كان وقت الجرعة الثانية قد جاء تناول التالية في وقتها. لا تتناول جرعة مضاعفة لتعويض الجرعة الفائتة.
التوقف عن تناول زيماكس
إذا توقفت أو طفلك عن تناول زيماكس بسرعة فقد تعود العدوى من جديد. تناول زيماكس على طول فترة العلاج حتى و إن شعرت بتحسن.
إذا كان لديك أية أسئلة اضافية حول كيفية استخدام هذا الدواء، استشر طبيبك أو الصيدلي.
كما هو الحال في جميع الأدوية إن تناول زيماكس قد يصاحبه ظهور بعض الأعراض الجانبية هذه الأعراض ليس بالضرورة أن تظهر في حالة كل المرضى الذين يتناولون زيماكس.
أخبر طبيبك على الفور إذا ظهرت عليك أي من الأعراض التالية عند تناول زيماكس، إذ قد تكون هذه الأعراض خطيرة.
· صوت صفير مفاجئ في الصدر، صعوبة في التنفس، تورم الأجفان أو الوجه أو الشفاه، طفح أو حكة (خصوصا إذا كانت تصيب كل الجسم).
· إسهال شديد أو مستمر لفترة طويلة، وقد يحتوي على دم أو مخاط، خلال أو بعد تناول زيماكس إذ قد يكون ذلك علامة خطيرة لحدوث التهاب في الأمعاء.
· طفح شديد في الجلد يسبب احمرارا و قشورا و سرعة أو عدم انتظام في نظم القلب.
· انخفاض ضغط الدم.
إن معظم الأعراض الجانبية الشائعة التي تم رصدها عند تناول زيماكس المذكورة أدناه قد تزول بمجرد اعتياد جسمك على الدواء أثناء فترة العلاج. أخبر طبيبك المعالج إذا استمر أي من الأعراض الجانبية التالية في الظهور عليك.
أعراض جانبية شائعة جدا (قد تظهر على الأقل في 1 من كل 10 أشخاص يتناولون زيماكس):
· تقلصات في المعدة، شعور بالغثيان، اسهال، ريح.
أعراض جانيبة شائعة ( قد تظهر عند أقل من 1 من كل 10 أشخاص):
· دوخة، صداع.
· تنميل، الشعور بوخز إبر أو دبابيس.
· الشعور بالمرض، عسر الهضم.
· فقدان الشهية، اضطراب حاسة التذوق.
· الاضطرابات البصرية، الصمم.
· طفح الجلد و/ أو الحكة.
· ألم المفاصل.
· انخفاض عدد الخلايا الليمفاوية (نوع من خلايا الدم البيضاء)، ارتفاع عدد الحمضات (نوع من خلايا الدم البيضاء).
· انخفاض مستوى البيكربونات في الدم.
· الإرهاق أوالضعف.
أعراض جانيبة غير شائعة ( قد تظهر عند أقل من 1 من كل 100 شخص يتناولون زيماكس):
· عدوى الخميرة في الفم و المهبل (القلاع).
· انخفاض عدد كريات الدم البيضاء (نوع من خلايا الدم البيضاء)، انخفاض عدد العدلات (نوع من خلايا الدم البيضاء).
· تفاعلات التحسس على اختلاف شدتها.
· ظهور تقرحات على الجلد، الفم، العينين والأعضاء التناسلية.
· تحسس الجلد تجاه الضوء بشكل أكثر من الطبيعي.
· الشعور بالعصبية.
· ضعف حاسة اللمس والإحساس (نقص الحس).
· النعاس أو عدم القدرة على النوم (الأرق).
· ضعف السمع أو طنين الأذن.
· خفقان القلب، ألم في الصدر.
· الإمساك، ألم المعدة المصحوب بالاسهال والحمى.
· التهاب الكبد، تغيرات في مستويات انزيمات الكبد.
· ضعف عام.
· تورم.
· عدم الارتياح بشكل عام.
· قيم غير طبيعية للفحوصات المخبرية (سواء اختبارات الدم أو الكبد).
أعراض جانيبة نادرة (قد تظهر عند أقل من 1 من كل 1000 شخص يتناولون زيماكس):
· الإنفعالات.
· الدوار.
· اضطرابات في وظائف الكبد.
أعراض جانبية أخرى قد تم تسجيلها و لا يعلم حتى الآن مدى تكرار حدوثها:
· النوبات والإغماء.
· العدوانية أوالقلق.
· الشعور بفرط النشاط.
· ضعف موضعي بالعضلات.
· ضعف الشم أو اضطراب الشم، فقدان حاسة التذوق.
· تغير لون اللسان.
· التهاب البنكرياس.
· التهاب الكلى أو الفشل الكلوي.
· اصفرار الجلد والعينين (اليرقان) و الفشل الكبدي (نادرا ما يكون مهددا للحياة).
· الكدمات أو نزيف لفترة طويلة بعد الجروح.
· تقرحات الجلد، تفاعلات جلدية شديدة.
- تخطيط القلب الكهربائي الغير طبيعي، قد تم تسجيل حدوث حالات من زيادة الفترة QT : حالات تعرف بتورسيديس دي بوينتز في حالة المرضى الذين تناولوا آزيثرومايسين. و بالرغم من أن مدى خطورة ذلك غير معروفة إلا أن معدل ظهورها يبدو منخفضا نتيجة لقلة التفاعلات الدوائية بين آزيثرومايسيين و الأدوية الأخرى. بالرغم من ذلك فإنه يفضل عدم تناول الدواء في في حالة المرضى الذين يعانون من عدم انتظام نظم القلب زيادة الفترة QT، أو المرضى الذين يعانون من عدم انتظام نظم القلب الناتج عن نقص بوتاسيوم الدم غير المصحح أو نقص مغنيسيوم الدم غير المصحح. أو في حالة المرضى الذين يعانون من بطء نظم القلب، كما يتوجب عدم تناوله مع المرضى الذين يتناولون أدوية علاج اضطراب نظم القلب من النوع IA (كوانيدين، بروكايناميد) أو النوع III (دوفيتيلايد، أميودارون، سوتالول).
· قلة عد كريات الدم الحمراء الذي يتسبب بشحوب الجلد والضعف أوصعوبة التنفس.
شذوذ في نتائج التحاليل المخبرية
ورد في تجارب سريرية أجريت علي زيماكس في المرضى البالغين والأطفال حدوث شذوذ في نتائج التحاليل المخبرية الهامة سريريا (بغض النظر عن العلاقة بالدواء) في افراد ذوي القيم الأساسية الطبيعية:
البالغين:
شذوذ في نتائج التحاليل المخبرية ذات حدوث أكبر من أو يساوي 1٪: انخفاض الخلايا الليمفاوية وزيادة إيوسنوفيل. انخفاض البيكربونات.
شذوذ في نتائج التحاليل المخبرية ذات حدوث أقل من 1٪: نقص الكريات البيض، نقص العدلات، ارتفاع البيليروبين ، AST، ALT، اليوريا والكرياتينين، وتعديلات في البوتاسيوم. إذا تم توفير المتابعة، سوف تعود التغييرات فى نتائج التحاليل المخبرية إلى طبيعتها.
المرضى الأطفال:
شذوذ في نتائج التحاليل المخبرية ذات حدوث أكبر من أو يساوي 1٪: ارتفاع إيوسنوفيل، واليوريا، والبوتاسيوم و انخفاض الخلايا الليمفاوية وتعديلات في العدلات.
شذوذ في نتائج التحاليل المخبرية ذات حدوث أقل من 1٪: ارتفاع ناقلة الأمين الأسبارتية، و ناقلة الأمين الألانينية والكرياتينين و انخفاض البوتاسيوم وتعديلات في الصوديوم والجلوكوز.
أعراض ظهرت بعد التسويق
• الجهاز الهضمي: فقدان الشهية، والإمساك، وعسر الهضم، وانتفاخ البطن، والتقيؤ / الإسهال نادرا ما يؤدي إلى الجفاف، التهاب القولون الكاذب، التهاب البنكرياس، داء المبيضات الفموي، تضيق البواب، وتقارير النادرة من تلون اللسان.
إذا لاحظت أن أياً من الأعراض الجانبية لهذا الدواء أصبحت جسيمة، أو لاحظت ظهور أعراض جانبية لم ترد فى هذه النشرة، فضلاً أخبر طبيبك المعالج أو الصيدلى الذى تتعامل معه.
لا يحفظ في درجة حرارة أعلى من 30 درجة مئوية.
يحفظ بعيدا عن متناول ونظر الأطفال.
بالنسبة لمسحوق زيماكس لتحضير معلق للشرب: بعد تحضير المعلق يحفظ بالثلاجة ويستخدم خلال 5 أيام.
يتم التخلص من الكمية المتبقية بعد إتمام الجرعة الخاصة بدورة العلاج بالكامل.
المكونات الفعالة:
كل كبسولة من زيماكس 250 ملجم تحتوي على 262.03 ملجم آزيثرومايسين دايهيدرات مكافئ ل 250 ملجم آزيثرومايسين.
كل قرص من زيماكس 250 ملجم تحتوي على 262.03 ملجم آزيثرومايسين دايهيدرات مكافئ ل 250 ملجم آزيثرومايسين.
كل قرص من زيماكس 500 ملجم تحتوي على 524.05 ملجم آزيثرومايسين دايهيدرات مكافئ ل 500 ملجم آزيثرومايسين.
كل 5 مل زيماكس على هيئة مسحوق لعمل معلق فموى بعد التحضير تحتوي على 210 ملجم آزيثرومايسين دايهيدرات مكافئ ل 200 ملجم آزيثرومايسين.
المكونات الأخرى
زيماكس على هيئة كبسولات 250 ملجم تحتوي على: نشاء مايز، كبسولات جيلاتينية، ثنائي أكسيد السيلكون الغرواني، سلفات لوريل الصويوم، ستيارت المغنيسيوم، لاكتوز.
زيماكس على هيئة أقراص 250ملجم و 500 ملجم
حشوة القرص تحتوي على: سلفات لوريل الصويوم، فوسفات ثنائي الكالسيوم اللامائي، كروسبوفيدون، كلوسيل، ثنائي أكسيد السيلكون الغرواني، حمض الستايريك، ستيارت المغنيسيوم، نشأ مجفف.
قشرة القرص تحتوي على: ماء نقي، أكسيد الحديد الأحمر،هيدروكس بروبيل ميثل سيليلوز، بوي إيثيلين جلايكول، تالك نقي، ثنائي أكسيد التيتانيوم، بولي سوربات.
زيماكس على هيئة مسحوق لعمل معلق فموى يحتوي على نكهة الموز، نكهة الفانيلا، نكهة الفراولة، كاليترول (صمغ زانثان)، فوسفات الصوديوم ثلاثي القاعدة، سكروز.
زيماكس على هيئة كبسولات 250 ملجم: مقاس رقم صفر، كبسولات ثنائية التماثل من الجيلاتين الصلب تحتوي على مسحوق أبيض، جسم الكبسولة ذو لون أبيض وغطاؤها أزرق اللون. الكبسولة مطبوع عليها كلمة “Zimax 250’ من كلا الجانبين.
زيماكس على هيئة أقراص 250 ملجم: ذات لون بني محمر، مستطيلة محدبة الجانبين مغلفة بطبقة رقيقة محفور علي أحد جانبيها "206" والجانب الآخر لا يحوي أي طباعة.
زيماكس على هيئة أقراص 500 ملجم: ذات لون أبيض الي أبيض مطفي، ، مستطيلة محدبة الجانبين مغلفة بطبقة رقيقة محفور على أحد جانبيها " 216" والجانب الآخر لايحوي أي طباعة.
زيماكس على هيئة مسحوق لعمل معلق فموى:
قبل التحضير: حبيبات بيضاء اللون مع حبيبات ذات لون بني فاتح. برائحة مميزة.
بعد التحضير: ملعق ذو لون أبيض كريمي ذو طعم حلو و بنكهة الموز.
محتويات العبوة
زيماكس على هيئة كبسولات 250 ملجم: تحتوي العبوة على 4 كبسولات أو 6 كبسولات.
زيماكس على هيئة أقراص 250 ملجم: تحتوي العبوة على 6 أقراص.
زيماكس على هيئة أقراص 500 ملجم: تحتوي العبوة على 3 أقراص.
زيماكس 200 ملجم/5 مل على هيئة مسحوق لعمل معلق فموى: عند التحضير يصبح حجمه 15 مل.
زيماكس 300 ملجم/7.5 مل على هيئة مسحوق لعمل معلق فموى: عند التحضير يصبح حجمه 22.5 مل.
زيماكس 400 ملجم/10 مل على هيئة مسحوق لعمل معلق فموى: عند التحضير يصبح حجمه 30 مل.
يتوفر مسحوق زيماكس لعمل معلق فموي في زجاجة 60 مل من العنبر مع غطاء أبيض مقاوم لعبث الأطفال.
الدوائية
مصنع الأدوية بالقصيم
الشركة السعودية للصناعات الدوائية والمستلزمات الطبية
المملكة العربية السعودية
Azithromycin is indicated for the treatment of the following infections when known or likely to be due to one or more susceptible microorganisms (see Section 5.1 Pharmacodynamic properties):
- Bronchitis.
- Community-acquired pneumonia.
- Sinusitis.
- Pharyngitis/tonsillitis (see 4.4 regarding streptococcal infections).
- Otitis media.
- Skin and soft tissue infections.
- Uncomplicated genital infections due to Chlamydia trachomatis.
Considerations should be given to official guidance regarding the appropriate use of antibacterial agents.
Method of administration:
Zimax should be given as a single daily dose. In common with many other antibiotics Zimax Capsules should be taken at least 1 hour before or 2 hours after food. Zimax Suspension can be taken with food.
Children over 45 kg body weight and adults, including elderly patients:
The total dose of azithromycin is 1500 mg which should be given over three days (500 mg once daily).
In uncomplicated genital infections due to Chlamydia trachomatis, the dose is 1000 mg as a single oral dose.
In children under 45 kg body weight:
Zimax Capsules are not suitable for children under 45 kg. Zimax Suspension should be used for children under 45 kg. There is no information on children less than 6 months of age. The dose in children is 10mg/kg as a single daily dose for 3 days:
Up to 15 kg (less than 3 years): Measure the dose as closely as possible using the 10 ml oral dosing syringe provided. The syringe is graduated in 0.25 ml divisions, providing 10 mg of azithromycin in every graduation.
For children weighing more than 15 kg, Zimax Suspension should be administered using the spoon provided according to the following guidance:
15-25 kg (3-7 years): 5 ml (200 mg) given as 1 x 5 ml spoonful, once daily for 3 days.
26-35 kg (8-11 years): 7.5 ml (300 mg) given as 1 x 7.5 ml spoonful, once daily for 3 days.
36-45 kg (12-14 years): 10 ml (400 mg) given as 1 x 10 ml spoonful, once daily for 3 days.
Over 45 kg: Dose as per adults.
See 'Nature and contents of container', Section 6.5, for appropriate pack size to use depending on age/body weight of child.
The specially supplied measure should be used to administer Zimax suspension to children.
Renal failure:
No dose adjustment is necessary in patients with mild to moderate renal impairment (GFR 10 - 80 ml/min). Caution should be exercised when azithromycin is administered to patients with severe renal impairment (GFR < 10 ml/min) (see Section 4.4 - Special warnings and precautions for use and Section 5.2 Pharmacokinetic properties).
Hepatic failure:
Since azithromycin is metabolised in the liver and excreted in the bile, the drug should not be given to patients suffering from severe liver disease. No studies have been conducted regarding treatment of such patients with azithromycin (see Section 4.4 Special warnings and precautions for use).
Zimax Capsules & Tablets are for oral administration only.
Zimax Suspension is for oral administration only.
As with erythromycin and other macrolides, rare serious allergic reactions including angioneurotic oedema and anaphylaxis (rarely fatal), have been reported. Some of these reactions with azithromycin have resulted in recurrent symptoms and required a longer period of observation and treatment.
Since the liver is the principal route of elimination for azithromycin, the use of azithromycin should be undertaken with caution in patients with significant hepatic disease. Cases of fulminant hepatitis potentially leading to life-threatening liver failure have been reported with azithromycin (see Section 4.8 Undesirable effects). Some patients may have had pre-existing hepatic disease or may have been taking other hepatotoxic medicinal products.
In case of signs and symptoms of liver dysfunction, such as rapid developing asthenia associated with jaundice, dark urine, bleeding tendency or hepatic encephalopathy, liver function tests/ investigations should be performed immediately. Azithromycin administration should be stopped if liver dysfunction has emerged.
In patients receiving ergot derivatives, ergotism has been precipitated by co-administration of some macrolide antibiotics. There are no data concerning the possibility of an interaction between ergot and azithromycin. However, because of the theoretical possibility of ergotism, azithromycin and ergot derivatives should not be co-administrated.
Prolonged cardiac repolarisation and QT interval, imparting a risk of developing cardiac arrhythmia and torsades de pointes, have been seen in treatment with other macrolides. A similar effect with azithromycin cannot be completely ruled out in patients at increased risk for prolonged cardiac repolarisation (see Section 4.8 Undesirable effects); therefore caution is required when treating patients:
• With congenital or documented QT prolongation
• Currently receiving treatment with other active substance known to prolong QT interval such as antiarrhytmics of classes Ia and III, cisapride and terfenadine
• With electrolyte disturbance, particularly in case of hypokalaemia and hypomagnesemia
• With clinically relevant bradycardia, cardiac arrhythmia or severe cardiac insufficiency.
As with any antibiotic preparation, observation for signs of superinfection with non-susceptible organisms including fungi is recommended.
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including azithromycin, and may range in severity from mild diarrhea to fatal colitis. Strains of C. difficile producing hypertoxin A and B contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. Therefore, CDAD must be considered in patients who present with diarrhea during or subsequent to the administration of any antibiotics. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. Discontinuation of therapy with azithromycin and the administration of specific treatment for C. difficile should be considered.
Streptococcal infections: Penicillin is usually the first choice for treatment of pharyngitis/tonsillitis due to Streptococcus pyogenes and also for prophylaxis of acute rheumatic fever. Azithromycin is in general effective against streptococcus in the oropharynx, but no data are available that demonstrate the efficacy of azithromycin in preventing acute rheumatic fever.
Use in renal impairment: In patients with severe renal impairment (GFR <10 ml/min) a 33% increase in systemic exposure to azithromycin was observed (see Section 5.2 Pharmacokinetic properties).
Exacerbations of the symptoms of myasthenia gravis and new onset of myasthenia syndrome have been reported in patients receiving azithromycin therapy (See Section 4.8).
Safety and efficacy for prevention or treatment of MAC in children have not been established.
Caution in diabetic patients: 5 ml of reconstituted suspension contains 3.965 g of sucrose.
Due to the sucrose content (3.965 g/ 5 ml of reconstituted suspension), this medicinal product is not indicated for persons with fructose intolerance (hereditary fructose intolerance), glucose-galactose malabsorption or saccharase-isomaltase deficiency.
Zimax 250 mg Capsules contain lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Hypersensitivity
· Fatalities have been reported. Cases of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) have also been reported. Despite initially successful symptomatic treatment of the allergic symptoms, when symptomatic therapy was discontinued, the allergic symptoms recurred soon thereafter in some patients without further azithromycin exposure.Serious allergic reactions, including angioedema, anaphylaxis, and dermatologic reactions including Stevens-Johnson Syndrome, and toxic epidermal necrolysis, have been reported rarely in patients on azithromycin therapy.
Zimax Capsules, Tablets and Suspension are for oral administration only.
Antacids: In a pharmacokinetic study investigating the effects of simultaneous administration of antacid with azithromycin, no effect on overall bioavailability was seen, although peak serum concentrations were reduced by approximately 25%. In patients receiving both azithromycin and antacids, the drugs should not be taken simultaneously. Cetirizine: In healthy volunteers, co-administration of a 5-day regimen of azithromycin with cetirizine 20 mg at steady-state resulted in no pharmacokinetic interaction and no significant changes in the QT interval. Didanosine (Dideoxyinosine): Co-administration of 1200 mg/day azithromycin with 400 mg/day didanosine in 6 HIV-positive subjects did not appear to affect the steady-state pharmacokinetics of didanosine as compared with placebo. Digoxin: Some of the macrolide antibiotics have been reported to impair the microbial metabolism of digoxin in the gut in some patients. In patients receiving concomitant azithromycin, a related azalide antibiotic, and digoxin the possibility of raised digoxin levels should be borne in mind. Zidovudine: Single 1000 mg doses and multiple 1200 mg or 600 mg doses of azithromycin had little effect on the plasma pharmacokinetics or urinary excretion of zidovudine or its glucuronide metabolite. However, administration of azithromycin increased the concentrations of phosphorylated zidovudine, the clinically active metabolite, in peripheral blood mononuclear cells. The clinical significance of this finding is unclear, but it may be of benefit to patients. Azithromycin does not interact significantly with the hepatic cytochrome P450 system. It is not believed to undergo the pharmacokinetic drug interactions as seen with erythromycin and other macrolides. Hepatic cytochrome P450 induction or inactivation via cytochrome-metabolite complex does not occur with azithromycin. Ergot derivatives: Due to the theoretical possibility of ergotism, the concurrent use of azithromycin with ergot derivatives is not recommended. (See Section 4.4 Special warnings and precautions for use). Pharmacokinetic studies have been conducted between azithromycin and the following drugs known to undergo significant cytochrome P450 mediated metabolism. Atorvastatin: Co-administration of atorvastatin (10 mg daily) and azithromycin (500 mg daily) did not alter the plasma concentrations of atorvastatin (based on a HMG CoA-reductase inhibition assay). Carbamazepine: In a pharmacokinetic interaction study in healthy volunteers, no significant effect was observed on the plasma levels of carbamazepine or its active metabolite in patients receiving concomitant azithromycin. Cimetidine: In a pharmacokinetic study investigating the effects of a single dose of cimetidine, given 2 hours before azithromycin, on the pharmacokinetics of azithromycin, no alteration of azithromycin pharmacokinetics was seen. Coumarin-Type Oral Anticoagulants: In a pharmacokinetic interaction study, azithromycin did not alter the anticoagulant effect of a single 15 mg dose of warfarin administered to healthy volunteers. There have been reports received in the post-marketing period of potentiated anticoagulation subsequent to co-administration of azithromycin and coumarin-type oral anticoagulants. Although a causal relationship has not been established, consideration should be given to the frequency of monitoring prothrombin time when azithromycin is used in patients receiving coumarin-type oral anticoagulants. Ciclosporin: In a pharmacokinetic study with healthy volunteers that were administered a 500 mg/day oral dose of azithromycin for 3 days and were then administered a single 10 mg/kg oral dose of ciclosporin, the resulting ciclosporin Cmax and AUC0-5 were found to be significantly elevated (by 24% and 21% respectively), however no significant changes were seen in AUC0- Efavirenz: Co-administration of a 600 mg single dose of azithromycin and 400 mg efavirenz daily for 7 days did not result in any clinically significant pharmacokinetic interactions. Fluconazole: Co-administration of a single dose of 1200 mg azithromycin did not alter the pharmacokinetics of a single dose of 800 mg fluconazole. Total exposure and half-life of azithromycin were unchanged by the co-administration of fluconazole, however, a clinically insignificant decrease in Cmax (18%) of azithromycin was observed. Indinavir: Co-administration of a single dose of 1200 mg azithromycin had no statistically significant effect on the pharmacokinetics of indinavir administered as 800 mg three times daily for 5 days. Methylprednisolone: In a pharmacokinetic interaction study in healthy volunteers, azithromycin had no significant effect on the pharmacokinetics of methylprednisolone. Midazolam: In healthy volunteers, co-administration of azithromycin 500 mg/day for 3 days did not cause clinically significant changes in the pharmacokinetics and pharmacodynamics of a single 15 mg dose of midazolam. Nelfinavir Co-administration of nelfinavir at steady-state with a single oral dose of azithromycin resulted in increased azithromycin serum concentrations. Although a dose adjustment of azithromycin is not recommended when administered in combination with nelfinavir, close monitoring for known adverse reactions of azithromycin, such as liver enzyme abnormalities and hearing impairment, is warranted. Rifabutin: Co-administration of azithromycin and rifabutin did not affect the serum concentrations of either drug. Neutropenia was observed in subjects receiving concomitant treatment of azithromycin and rifabutin. Although neutropenia has been associated with the use of rifabutin, a causal relationship to combination with azithromycin has not been established (see Section 4.8. Undesirable effects). Sildenafil: In normal healthy male volunteers, there was no evidence of an effect of azithromycin (500 mg daily for 3 days) on the AUC and Cmax, of sildenafil or its major circulating metabolite. Terfenadine: Pharmacokinetic studies have reported no evidence of an interaction between azithromycin and terfenadine. There have been rare cases reported where the possibility of such an interaction could not be entirely excluded; however there was no specific evidence that such an interaction had occurred. Theophylline: There is no evidence of a clinically significant pharmacokinetic interaction when azithromycin and theophylline are co-administered to healthy volunteers. Triazolam: In 14 healthy volunteers, co-administration of azithromycin 500 mg on Day 1 and 250 mg on Day 2 with 0.125 mg triazolam on Day 2 had no significant effect on any of the pharmacokinetic variables for triazolam compared to triazolam and placebo. Trimethoprim/sulfamethoxazole: Co-administration of trimethoprim/sulfamethoxazole DS (160 mg/800 mg) for 7 days with azithromycin 1200 mg on Day 7 had no significant effect on peak concentrations, total exposure or urinary excretion of either trimethoprim or sulfamethoxazole. Azithromycin serum concentrations were similar to those seen in other studies. Warfarin Spontaneous post-marketing reports suggest that concomitant administration of azithromycin may potentiate the effects of oral anticoagulants such as warfarin, although the prothrombin time was not affected in the dedicated drug interaction study with azithromycin and warfarin. Prothrombin times should be carefully monitored while patients are receiving azithromycin and oral anticoagulants concomitantly. Potential Drug-Drug Interactions with Macrolides Interactions with digoxin or phenytoin have not been reported in clinical trials with azithromycin; however, no specific drug interaction studies have been performed to evaluate potential drug-drug interactions. However, drug interactions have been observed with other macrolide products. Until further data are developed regarding drug interactions when digoxin or phenytoin are used concomitantly with azithromycin careful monitoring of patients is advised. |
. Consequently, caution should be exercised before considering concurrent administration of these drugs. If co-administration of these drugs is necessary, ciclosporin levels should be monitored and the dose adjusted accordingly.Animal reproduction studies have been performed at doses up to moderately maternally toxic dose concentrations. In these studies, no evidence of harm to the fetus due to azithromycin was found. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, azithromycin should be used during pregnancy only if clearly needed. There are no data on secretion in breast milk. As many drugs are excreted in human milk, azithromycin should not be used in the treatment of a lactating woman unless the physician feels that the potential benefits justify the potential risks to the infant. |
There is no evidence to suggest that Zimax may have an effect on a patient's ability to drive or operate machinery. |
Zimax is well tolerated with a low incidence of side effects. The section below lists the adverse reactions identified through clinical trial experience and postmarketing surveillance by system organ class and frequency. Adverse reactions identified from post-marketing experience are included in italics. The frequency grouping is defined using the following convention: 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); and Not known (cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. Adverse reactions possibly or probably related to azithromycin based on clinical trial experience and post-marketing surveillance: Infections and Infestations Uncommon (≥1/1,000 to <1/100) Candidiasis, oral candidiasis, vaginal infection. Not known (cannot be estimated from available data) Pseudomembranous colitis (See Section 4.4). Blood and Lymphatic System Disorders Uncommon (≥ 1/1,000 to < 1/100) Leukopenia, neutropenia. Not known (cannot be estimated from available data) Thrombocytopenia, haemolytic anaemia. Immune System Disorders Uncommon (≥1/1,000 to <1/100) Angioedema, hypersensitivity. Not known (cannot be estimated from available data) Anaphylactic reaction (See Section 4.4). Metabolism and Nutrition Disorders Common (> 1/100 < 1/10) Anorexia. Psychiatric Disorders Uncommon (≥1/1,000 to <1/100) Nervousness. Rare (> 1/10,000 < 1/1,000) Agitation. Not known (cannot be estimated from available data) Aggression, anxiety. Nervous System Disorders Common (> 1/100 < 1/10) Dizziness, headache, paraesthesia, dysgeusia. Uncommon (≥1/1,000 to <1/100) Hypoaesethesia, somnolence, insomnia. Not known (cannot be estimated from available data) Syncope, convulsion, psychomotor hyperactivity, anosmia, ageusia, parosmia, Myasthenia gravis (See Section 4.4). Eye Disorders Common (> 1/100 < 1/10) Visual impairment. Ear and Labyrinth Disorders Common (> 1/100 < 1/10) Deafness. Uncommon (≥1/1,000 to <1/100) Hearing impaired, tinnitus. Rare (> 1/10,000 < 1/1,000) Vertigo. Cardiac Disorders Uncommon (≥1/1,000 to <1/100) Palpitations. Not known (cannot be estimated from available data) Torsades de pointes (See Section 4.4), arrhythmia (See Section 4.4) including ventricular tachycardia. Vascular Disorders Not known (cannot be estimated from available data) Hypotension. Gastrointestinal Disorders Very common (≥1/10) Diarrhoea, abdominal pain, nausea, flatulence Common (> 1/100 < 1/10) Vomiting, dyspepsia. Uncommon (> 1/1,000 < 1/100) Gastritis, constipation. Not known (cannot be estimated from available data) Pancreatitis, tongue discolouration. Hepatobiliary Disorders Uncommon (> 1/1,000 < 1/100) Hepatitis Rare (> 1/10,000 < 1/1,000) Hepatic function abnormal Not known (cannot be estimated from available data) Hepatic failure (See Section 4.4), which has rarely resulted in death, hepatitis fulminant, hepatic necrosis, jaundice cholestatic. Skin and Subcutaneous Tissue Disorders Common (> 1/100 < 1/10) Pruritus and rash. Uncommon (> 1/1,000 < 1/100) Stevens-Johnson syndrome, photosensitivity reaction, urticaria Not known (cannot be estimated from available data) Toxic epidermal necrolysis, erythema multiforme Musculoskeletal, Connective Tissue Disorders Common (> 1/100 < 1/10) Arthralgia. Renal and Urinary Disorders Not known (cannot be estimated from available data) Renal failure acute, nephritis interstitial. General disorders and Administration Site Conditions Common (> 1/100 < 1/10) Fatigue. Uncommon (> 1/1,000 < 1/100) Chest pain, oedema, malaise, asthenia. Investigations Common (> 1/100 < 1/10) Lymphocyte count decreased, eosinophil count increased, blood bicarbonate decreased. Uncommon (> 1/1,000 < 1/100) Aspartate aminotransferase increased, alanine aminotransferase increased, blood bilirubin increased, blood urea increased, blood creatinine increased, blood potassium abnormal. Not known (cannot be estimated from available data) Electrocardiogram QT prolonged (See Section 4.4). Laboratory Abnormalities In subjects with normal baseline values, the following clinically significant laboratory abnormalities (irrespective of drug relationship) were reported in Zimax clinical trials in adults and pediatric patients: Adults: Laboratory abnormalities with an incidence of greater than or equal to 1%: reduced lymphocytes and increased eosinophils; reduced bicarbonate. Laboratory abnormalities with an incidence of less than 1%: leukopenia, neutropenia, elevated bilirubin, AST, ALT, BUN, creatinine, alterations in potassium. Where follow-up was provided, changes in laboratory tests appeared to be reversible. Pediatric Patients: Laboratory abnormalities with an incidence of greater than or equal to 1%: elevated eosinophils, BUN, and potassium; decreased lymphocytes; and alterations in neutrophils; with an incidence of less than 1%: elevated SGOT, SGPT and creatinine; decreased potassium; and alterations in sodium and glucose.
Postmarketing Experience
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Adverse events experienced in higher than recommended doses were similar to those seen at normal doses. The typical symptoms of an overdose with macrolide antibiotics include reversible loss of hearing, severe nausea, vomiting and diarrhea. In the event of overdose, the administration of medicinal charcoal and general symptomatic treatment and supportive measures are indicated as required. |
General properties
Antibacterials for systemic use. ATC code: J01FA10
Mode of action:
Zimax is a macrolide antibiotic belonging to the azalide group. The molecule is constructed by adding a nitrogen atom to the lactone ring of erythromycin A. The chemical name of azithromycin is 9-deoxy-9a-aza-9a-methyl-9a-homoerythromycin A. The molecular weight is 749.0. The mechanism of action of azithromycin is based upon the suppression of bacterial protein synthesis by means of binding to the ribosomal 50s sub-unit and inhibition of peptide translocation.
Mechanism of resistance:
Resistance to azithromycin may be inherent or acquired. There are three main mechanisms of resistance in bacteria: target site alteration, alteration in antibiotic transport and modification of the antibiotic.
Complete cross resistance exists among Streptococcus pneumoniae, betahaemolytic streptococcus of group A, Enterococcus faecalis and Staphylococcus aureus, including methicillin resistant S. aureus (MRSA) to erythromycin, azithromycin, other macrolides and lincosamides.
Breakpoints
Azithromycin susceptibility breakpoints for typical bacterial pathogens are:
NCCLS:
• Susceptible ≤2mg/l; resistant ≥8mg/l
• Haemophilus spp.: susceptible ≤4mg/l
• Streptococcus pneumoniae and Streptococcus pyogenes:
Susceptible ≤0.5 mg/l; resistant ≥2 mg/l
Susceptibility
The prevalence of acquired resistance may vary geographically and with time for selected species and local information on resistance is desirable, particularly when treating severe infections. As necessary, expert advice should be sought when the local prevalence of resistance is such that the utility of the agent in at least some types of infections is questionable.
Table: Antibacterial spectrum of Azithromycin
Commonly susceptible species |
Aerobic Gram-positive microorganisms |
Staphylococcus aureus Methycillin-susceptible |
Streptococcus pneumoniae Penicillin-susceptible |
Streptococcus pyogenes (Group A) |
Aerobic Gram-negative microorganisms |
Haemophilus influenzae Haemophilus parainfluenzae |
Legionella pneumophila |
Moraxella catarrhalis |
Pasteurella multocida |
Anaerobic microorganisms |
Clostridium perfringens |
Fusobacterium spp. |
Prevotella spp. |
Porphyromonas spp. |
Other microorganisms |
Chlamydia trachomatis |
Species for which acquired resistance may be a problem |
Aerobic Gram-positive microorganisms |
Streptococcus pneumoniae Penicillin-intermediate Penicillin-resistant |
Inherently resistant organisms |
Aerobic Gram-positive microorganisms |
Enterococcus faecalis |
Staphylococci MRSA, MRSE* |
Anaerobic microorganisms |
Bacteroides fragilis group |
* Methycillin-resistant staphylococci have a very high prevalence of acquired resistance to macrolides and have been placed here because they are rarely susceptible to azithromycin.
Absorption
Bioavailability after oral administration is approximately 37%. Peak plasma concentrations are attained 2-3 hours after taking the medicinal product.
Distribution
Orally administered azithromycin is widely distributed throughout the body. In pharmacokinetic studies it has been demonstrated that the concentrations of azithromycin measured in tissues are noticeably higher (as much as 50 times) than those measured in plasma, which indicates that the agent strongly binds to tissues.
Binding to serum proteins varies according to plasma concentration and ranges from 12% at 0.5 microgram/ml up to 52% at 0.05 microgram azithromycin/ml serum. The mean volume of distribution at steady state (VVss) has been calculated to be 31.1 l/kg.
Elimination
The terminal plasma elimination half-life closely reflects the elimination half-life from tissues of 2-4 days.
Approximately 12% of an intravenously administered dose of azithromycin is excreted unchanged in urine within the following three days. Particularly high concentrations of unchanged azithromycin have been found in human bile. Also in bile, ten metabolites were detected, which were formed through N- and O- demethylation, hydroxylation of desosamine – and aglycone rings and cleavage of cladinose conjugate. Comparison of the results of liquid chromatography and microbiological analyses has shown that the metabolites of azithromycin are not microbiologically active.
In animal tests, high concentrations of azithromycin have been found in phagocytes. It has also been established that during active phagocytosis higher concentrations of azithromycin are released from inactive phagocytes. In animal models this results in high concentrations of azithromycin being delivered to the site of infection.
Phospholipidosis (intracellular phospholipid accumulation) has been observed in several tissues (e.g. eye, dorsal root ganglia, liver, gallbladder, kidney, spleen, and/or pancreas) of mice, rats, and dogs given multiple doses of azithromycin. Phospholipidosis has been observed to a similar extent in the tissues of neonatal rats and dogs. The effect has been shown to be reversible after cessation of azithromycin treatment. The significance of the finding for animals and for humans is unknown.
Carcinogenic potential:
Long-term studies in animals have not been performed to evaluate carcinogenic potential as the drug is indicated for short-term treatment only and there were no signs indicative of carcinogenic activity.
Mutagenic potential:
There was no evidence of a potential for genetic and chromosome mutations in in-vivo and in-vitro test models.
Reproductive toxicity:
In animal studies for embryotoxic effects of the substance, no teratogenic effect was observed in mice and rats. In rats, azithromycin doses of 100 and 200 mg/kg bodyweight/day led to mild retardation of fetal ossification and in maternal weight gain. In peri- and postnatal studies in rats, mild retardation following treatment with 50 mg/kg/day azithromycin and above was observed.
Zimax 250 mg Capsules contain: Maize Starch, Gelatin Caps-Zimax 250, Colloidal Silicon Dioxide, Sodium Lauryl Sulphate, Magnesium Stearate, Lactose Anhydrous N.F DC. Zimax 250 mg and 500 mg tablets contain: Sodium Lauryl Sulphate, Dicalcium Phosphate Anhydrous, Crospovidone NF, Klucel EF, Colloidal Silicon Dioxide, Stearic Acid BPC, Magnesium Stearate, Pre-gelatinized Starch Dry as excipients, and Purified Water, Iron Oxide Red, Hydroxypropyl Methylcellulose, Polyethylene Glycol MW 6000, Purified Talc, Titanium Dioxide, Polysorbate 80 as coating material. Zimax Suspension contains: Banana Durarome 860701 TD0590, Vanilla Durarome 860705 TD1092, Strawberry Dura 860000 TD0590, Keltrol (Xantham Gum), Klucel EF, Sodium Phosphate Tribasic Anhy, Sucrose (Powder). |
Not Applicable |
Do not store above 30°C.
For Zimax suspension: Once reconstituted with water, Zimax Suspension has a shelf-life of 5 days.
Zimax 250 mg Capsules are available as: White Opaque PVC/PVDC 250 micron and Aluminum Foil 250 micron. 4 Capsules /pack and 6 Capsules /pack Zimax 500 mg and 250 mg Tablets are available as: White Opaque PVC/PVDC Blister Strip and Aluminium Foil. 3 tablets /pack for 500mg and 6 tablets /pack for 250mg Zimax Powder for Oral Suspension is available as: 30ml (400mg/10ml), 22.5 (300mg/7.5ml) and 15ml (200mg/5ml) in 60ml Amber glass bottle with white child-resistant cap and tamper evident ring.
Each pack contains a patient information/ instruction leaflet. |
When dispensing the 15 ml pack, advice should be given as to whether the dose should be measured using the oral dosing syringe or the spoon provided and on correct usage. If the dose is to be given using the oral dosing syringe, before dispensing the syringe adaptor should be detached from the syringe and inserted into the bottle neck and the cap replaced.
When dispensing 22.5 ml and 30 ml packs, advice should be given as to the correct usage of the multi-dosing spoon.
Zimax Capsules should be swallowed whole.
