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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)

Diusemide 20 mg/2 ml Injection contains the active ingredient furosemide. Furosemide is one of a group of medicines called diuretics. Furosemide works by helping to produce more urine. This helps to relieve symptoms caused when your body contains too much fluid.

Your doctor has prescribed Diusemide for one of the following reasons:

  • When quick and effective removal of excess fluid is needed.
  • You are not able to take this kind of medicine by mouth or in an emergency.
  • You have too much fluid around your heart, lungs, liver or kidneys.
  • In periods with extremely high blood pressure that may lead to life-threatening conditions (hypertensive crisis)

Diusemide injection must only be used under medical supervision.


Do not use Diusemide if:

  • You are allergic (hypersensitive) to furosemide or any of the other ingredients of this medicine (see section 6)
  • You are allergic to sulphonamide antibiotics
  • You are severely dehydrated (you have lost lots of body fluid for example by suffering from severe diarrhoea or being sick)
  • You have kidney failure and are not producing urine, despite treatment with furosemide
  • You have kidney failure as a consequence of poisoning with kidney or liver toxic substances
  • You have very low levels of potassium or sodium in your blood. The patient is in a coma caused by liver failure
  • You are breast-feeding.

If you are uncertain whether you can use this medicine or not, ask your doctor or pharmacist.

Take special care with Diusemide if:

  • You normally have problems passing water due to an obstruction (such as an enlarged prostate)
  • You have diabetes
  • You have low blood pressure or sometimes have sudden falls in blood pressure (your blood vessels in your heart or brain are too narrow)
  • You have liver disease (such as cirrhosis)
  • You have kidney problems (such as nephrotic syndrome)
  • You are dehydrated (you have lost body fluids by suffering from severe diarrhoea or being sick), this might lead to a collapse or blood clotting
  • You have gout (painful or inflamed joints) due to high levels of uric acid (a by-product of metabolism) in your blood
  • You have an inflammatory disease called “systemic lupus erythematosus (SLE)”
  • You have hearing problems
  • You are using sorbitol (sugar substitute for people with diabetes)
  • You have porphyria (disease where the production of the oxygen binding molecule of the red blood cells is disrupted and urine is purple-coloured)
  • Your skin has an increased sensitivity to sunlight (photosensitivity)
  • If you are elderly, if you are on other medications which can cause the drop the blood pressure and if you have other medical conditions that are risks for the drop of blood pressure.

If given to premature babies Diusemide can cause kidney stones or calcification.
If any of these apply to you, your doctor may want to change your treatment or give you special advice.
Your doctor may recommend regular blood tests of your blood sugar levels or your blood uric acid levels. They will also check your blood levels for important body salts such as potassium and sodium, which are particularly important if you are sick or have diarrhea

Other medicines and Diusemide
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines you have obtained without a prescription. This is important because some medicines should not be taken together with Diusemide.
In particular tell your doctor or pharmacist if you are taking:

  • Lithium – for mood disorders, as its effect and side effects may be increased by Diusemide. Your doctor will prescribe this medicine to you only if absolutely necessary and he will then check your lithium levels and may change your dose
  • Heart medicines, such as digoxin; your doctor may need to change your dose
  • Any medicines for high blood pressure, including thiazide diuretics (such as bendroflumethiazide or hydrochlorothiazide), ACE inhibitors (such as lisinopril), angiotensin II antagonists (such as losartan), as Diusemide may cause your blood pressure to fall too low. Your doctor may need to change your dose of Diusemide
  • Cholesterol or lipid-lowering medicines such as colestyramine, colestipol and fibrates, such as clofibrate, as the effect of Diusemide may be reduced
  • Diabetes medicines, such as metformin and insulin, as your sugar levels may be increased
  • Anti-inflammatory medicines, including NSAIDS (such as aspirin or celecoxib), as they can reduce the effects of Diusemide; high doses of pain killers (salicylates) may increase the side effects of furosemide
  • Anti-inflammatory or anti-allergic medicines such as corticosteroids, medicines used to treat stomach ulcers such as carbenoxolone, or laxatives, as in combination with furosemide they will affect your sodium and potassium levels. Your doctor will check your potassium levels
  • Injections given during operations, including tubocurarine, curarine derivates and succinylcholine
  • Chloral hydrate – for sleeping problems (in isolated cases, the intravenous administration [injection into a vein] of furosemide in a 24 hour period prior to chloral hydrate administration may lead to flushing, increased sweating, anxiety, nausea, increase in blood pressure and faster heart beat). Therefore, the simultaneous administration of Diusemide and chloral hydrate is not recommended
  • Phenytoin or Phenobarbital – for epilepsy, as the effect of Diusemide may be decreased
  • Theophylline – for asthma, as its effect may be increased by Diusemide
  • Antibiotics such as cephalosporins, polymyxins, aminoglycosides or quinolones or other drugs which may affect your kidneys such as immunosuppressants, iodinated contrast media, foscarnet or pentamidine as furosemide can make this worse
  • Probenecid – used with some other medicines to protect the kidney, as it may reduce the effects of Diusemide
  • Organoplatins – used in some cancers, as furosemide may increase the side effects of this drug
  • Methotrexate – used in some cancers and for severe arthritis, as it may reduce the effects of Diusemide
  • Drugs to raise your blood pressure (pressor amines), as they may not work as well when you take them with Diusemide
  • Aminoglutethimide – used to suppress corticosteroid production (Cushing´s syndrome), as it may increase the side effects of furosemide
  • Carbamazepine – used to treat epilepsy or schizophrenia, as it may increase the side effects of furosemide.
  • Sucralfate – used to treat stomach ulcers. Do not take Diusemide within two hours of taking sucralfate as the effect of Diusemide will be decreased
  • Ciclosporin – used to prevent rejection of transplants, as you are at risk of gouty arthritis (painful joints)
  • Drugs that alter your heart beat such as amiodarone, sotalol, dofetilide and ibutilide as their effects may be increased by Diusemide.
  • Risperidone – used for the treatment of mental disorders.

Diusemide with food, drink and alcohol
Food is not expected to influence this medicine when it is given into a vein. Chronic moderate to heavy drinking raises blood pressure and reduces the effectiveness of antihypertensive drugs. Patients may experience dizziness and fainting shortly after drinking alcohol whilst on treatment.

Pregnancy and breast feeding
Diusemide should not be used during pregnancy unless there are very good medical reasons for using it. Furosemide gets into breast milk, and you must not breastfeed while taking it.
If you are pregnant or if you are breastfeeding, ask your doctor or pharmacist for further advice before taking Diusemide or any other medicine.

Driving and using machines
Do not drive or operate machinery as furosemide may reduce mental alertness.

Diusemide contains sodium
Diusemide contains sodium. Each 2 ml of Diusemide 20 mg/2 ml Solution for Injection/Infusion contains 5.819 mg sodium. This medicine contains less than 1 mmol sodium (23 mg) per 2 ml, that is to say essentially ‘sodium-free’


Diusemide Injection is given:

  • As a slow injection into a vein (intravenous) or
  • In exceptions, into a muscle (intramuscular)

Your doctor will decide how much you need, when it is to be given to you and the duration of treatment. This will depend on your age, weight, medical history, any other medicines that you are taking and type and severity of your disease.

General:

  • The parenteral administration of Diusemide is indicated in cases where oral administration is not feasible is not efficient (for example in case of reduced intestinal absorption) or when a quick effect is required.
  • In cases where parenteral administration is used, the switch to oral administration is recommended, as soon as possible.
  • To achieve optimum efficacy and suppress counter-regulation, a continuous Diusemide infusion is generally to be preferred to repeated bolus injections.
  • Where continuous Diusemide infusion in not feasible for follow-up treatment after one or several acute bolus doses, a follow-up regimen with low doses given at short intervals (approx. 4 hours) is to be preferred to a regimen with higher bolus doses at longer intervals.
  • Intravenous Diusemide must be injected or infused slowly; a rate of 4 mg per minute must not be exceeded and should never be given in association with other medicinal products in the same syringe.

Dosage regimen:
Adults:

  • In the absence of conditions requiring a reduced dose (see below) the initial dose recommended for adults and adolescents over 15 years, is of 20 mg to 40 mg Diusemide (1 or 2 ampules) by intravenous (or in exceptional cases intramuscular) administration; the maximum dose varying according to individual response.
  • If larger doses are required, they should be given increasing by 20 mg increments and not given more often than every two hours.
  • In adults, the recommended maximum daily dose of Diusemide administration is 1500 mg.
  • Larger initial or maintenance doses may be needed in certain circumstances, depending on your medical condition. This will be determined by your doctor. If such doses are needed, they may be given by continuous infusion.

Children and adolescents (up to 18 years of age):

  • The experience in children and adolescents are limited. The intravenous administration of Diusemide to children and adolescents below 15 years is only recommended in exceptional cases.
  • The dosage will be adapted to the body weight, and the recommended dose ranges from 0.5 to 1 mg/kg body weight daily up to a maximum total daily dose of 20 mg. There should be a switch to oral therapy as soon as possible.

Renal impairment:

  • In patients with severe impairment of renal function (serum creatinine > 5 mg/dl) it is recommended that an infusion rate of 2.5 mg Diusemide per minute is not exceed.

Elderly:

  • The recommended initial dose is 20 mg/day, increasing gradually until the required response is achieved.

If you receive more Diusemide than you should
If you are concerned that you may have been given too much Diusemide, talk to your doctor or other medicinal staff immediately. Signs which may occur if you have been given too much of this medicine are dryness of the mouth, increased thirst, irregular heartbeat, mood changes, muscle cramps or pain, feeling or being sick, unusual tiredness or weakness, a weak pulse or loss of appetite.

If you miss a dose of Diusemide
If you are concerned that you may have missed a dose, talk to your doctor or other medicinal staff immediately.

While you are receiving Diusemide
If you develop severe allergic reactions, like swelling of your face and/or throat or fever tell your doctor or other medicinal staff immediately.

If you stop using Diusemide
If you stop treatment early before your doctor’s recommendation, your heart, lungs or kidneys may be seriously affected by too much fluid.
If you have any further questions on the use of this product, ask your doctor or other medicinal staff


Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you notice any of the following, tell the doctor or nurse immediately:
Uncommon (may affect up to 1 in 100 people)

  • Skin rashes (including itching, redness, peeling), a bruising tendency or your skin being sensitive to sunlight.
  • Blood cell changes can lead to failure of blood clotting (with increased risk of bleeding).
  • Deafness (sometimes irreversible).

Rare (may affect up to 1 in 1,000 people)

  • Feeling or being sick, diarrhoea, constipation, loss of appetite, discomfort in the mouth and stomach.
  • Hearing problems (more common in kidney failure) and tinnitus (ringing in the ears).
  • Anaphylaxis, a severe allergic reaction which can cause skin rashes, swelling, breathing difficulties, and loss of consciousness. Seek medical help immediately.
  • Kidney damage (interstitial nephritis).
  • Very low white blood cell levels in the blood (which can lead to life threatening infections). Get medical help immediately.
  • Muscle problems, including leg cramps or muscle weakness.
  • Pain or discomfort where the injection is given (particularly after injection into muscle).
  • The inflammatory disease lupus erythematosus may occur or get worse.
  • Changes in blood test results (fat-like substances in your blood).
  • A numb feeling, tingling or feeling dizzy.
  • High temperature.
  • Blurred eyesight, confusion, sleepiness.
  • Dry mouth.   

Very rare (may affect up to 1 in 10,000 people)

  • Severe muscle problems including twitching, spasms, cramps (also called “tetanus”).
  • Blood cell changes that can lead to anaemia, inability to fight infection.
  • Pancreatitis (severe tummy pain) due to inflammation of the pancreas.

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

  • Acute generalized exanthematous pustulosis (AGEP) (acute febrile drug eruption).
  • Dizziness, fainting and loss of consciousness (caused by symptomatic hypotension).     

The following may also occur:

  • Low blood pressure making you feel faint or dizzy. It may also cause the feeling of pressure in the head, joint pain, blood clot formation, or collapse of your circulation (shock).
  • Low potassium levels in the blood. This can cause muscle weakness, tingling and numbness, slight inability to move a body part, being sick, constipation, increased gas in your gut, increased urine production, increased urge to drink, or slow or irregular heart rhythm. These problems are more likely if you have other diseases like liver or heart problems or too little potassium in your diet or if you take other medicines (see “Other medicines and Diusemide”).
  • Low sodium, calcium and magnesium levels in the blood. This may occur due to increased loss of sodium, calcium and magnesium with your urine. Low sodium levels typically cause a lack of interest, cramp in the calf, reduced appetite, weakness, sleepiness, being sick and confusion. Cramps can also be associated with low calcium levels or low magnesium levels in your body.
  • Gout may occur or get worse.
  • Existing problems passing water may be made worse.
  • Diabetes may occur or get worse.
  • Liver problems or changes in the blood may cause jaundice (yellow skin, dark urine, tiredness).
  • Reduced volume of body fluid especially in elderly patients. Sever fluid loss may lead to increased concentration of the blood with a tendency for the development of blood clots.
  • Premature babies may get kidney stones or calcification in premature babies the channel between the lung artery and the aorta which is open in the unborn baby might stay open.

Keep this medicine out of the sight and reach of children.
Store below 25°C.
Store in the original package in order to protect from light.
After dilution: Chemical and physical in-use stability has been demonstrated for 24 hours at 25°C, protected from light.
For single use only. Use immediately after first opening.
Do not use this medicine after the expiry date which is stated on the package after “EXP”.  The expiry date refers to the last day of that month.
Do not use this medicine if you notice any visible signs of deterioration.
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.


The active substance is furosemide.

Each 2 ml of Diusemide 20 mg/2 ml Solution for Injection/Infusion contains 20 mg furosemide.

The other ingredients are sodium chloride, sodium hydroxide, hydrochloric acid and water for injection.

 


Diusemide 20 mg/2 ml Solution for Injection/Infusion is a clear, colorless or almost colorless solution in type I amber glass ampoules. Pack size: 5 ampoules (2 ml).

Marketing Authorization Holder
Jazeera Pharmaceutical Industries
Al-Kharj Road
P.O. Box 106229
Riyadh 11666, Saudi Arabia
Tel: + (966-11) 8107023, + (966-11) 2142472
Fax: + (966-11) 2078170
e-mail: SAPV@hikma.com

Manufacturer
Hikma Italia S.P.A.
Viale Certosa, 10
27100 Pavia, Italy
Tel: + (39-0382) 1751844/+ (39-0382) 1751801
Fax: + (39-0382) 422745

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects, you can also help provide more information on the safety of this medicine.

  • Saudi Arabia

The National Pharmacovigilance Centre (NPC)

SFDA Call Center: 19999

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

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

  • Other GCC States

Please contact the relevant competent authority.


This leaflet was last revised in 07/2023; version number SA2.0.
  نشرة الدواء تحت مراجعة الهيئة العامة للغذاء والدواء (اقرأ هذه النشرة بعناية قبل البدء في استخدام هذا المنتج لأنه يحتوي على معلومات مهمة لك)

يحتوي دايوسيمايد 20 ملغم/2 مللتر للحقن على المادة الفعالة فيوروسيمايد. يُعتبر فيوروسيمايد دواءً من مجموعة أدوية تُسمى مدرات البول. يعمل فيوروسيمايد عن طريق المساعدة في در المزيد من البول. يساعد هذا في تخفيف الأعراض التي تحدث عندما يحتوي جسمك على الكثير من السوائل.

وصف لك طبيبك دايوسيمايد لأحد الأسباب التالية:

  • الحاجة إلى التخلص السريع والفعّال من السوائل الزائدة.
  • عدم تمكنك من تناول هذا النوع من الأدوية عن طريق الفم أو في حالات الطوارئ.
  • لديك الكثير من السوائل حول القلب، الرئتين، الكبد أو الكليتين.
  • في فترات الارتفاع الشديد في ضغط الدم الذي قد يؤدي إلى حالات مهددة للحياة (نوبة فرط الضغط)

يجب استخدام دايوسيمايد للحقن تحت إشراف طبي فقط.

لا تستخدم دايوسيمايد إذا:

  • كنت تعاني من حساسية (حساسية مفرطة) لفيوروسيمايد أو لأي من المواد الأخرى المستخدمة في تركيبة هذا الدواء (انظر القسم 6)
  • كنت تعاني من حساسية لمضادات السلفوناميد الحيوية
  • كنت تعاني من الجفاف الشديد (فقدت الكثير من سوائل الجسم على سبيل المثال لأنك تعاني من اسهال شديد أو غثيان)
  • كنت تعاني من فشل كلوي ولا تخرج البول رغم العلاج بفيوروسيمايد
  • كنت تعاني من فشل كلوي نتيجة التسمم بمواد سامة في الكلى أو الكبد
  • كنت تعاني من انخفاض شديد في البوتاسيوم أو الصوديوم في دمك، أو دخول المريض في غيبوبة ناجمة عن فشل الكبد
  • كنتِ ترضعين طبيعياً

اسأل طبيبك أو الصيدلي، إن لم تكن متأكداً إذا ما كان يمكنك استخدام هذا الدواء أم لا.

اتبع عناية خاصة مع دايوسيمايد إذا:

  • كنت تعاني عادة من مشاكل في التبول بسبب انسداد (مثل تضخم البروستاتا)
  • كنت تعاني من مرض السكري
  • كنت تعاني من انخفاض ضغط الدم أو انخفاض ضغط دم مفاجئ في بعض الأحيان (أوعيتك الدموية في القلب أو الدماغ ضيقة جداً)
  • كنت تعاني من مرض في الكبد (مثل تليُّف الكبد)
  • كنت تعاني من مشاكل في الكلى (مثل متلازمة كُلائية)
  • كنت تعاني من الجفاف (فقدت سوائل الجسم لأنك تعاني من إسهال شديد أو غثيان)، وقد يؤدي ذلك إلى الانهيار أو تجلط الدم
  • كنت تعاني من النقرس (ألم أو التهاب بالمفاصل) بسبب ارتفاع مستويات حمض اليوريك (منتج مشتق لعملية الأيض) في دمك
  • كنت تعاني من مرض التهابي يسمى "الذئبة الحمامية المجموعية"
  • كنت تعاني من مشكلات في السمع
  • كنت تستخدم سوربيتول (بديل السكر لمرضى السكري)
  • كنت تعاني من البُرفيرية (مرض يحدث فيه خلل في إنتاج الجزيء الرابط للأكسجين بخلايا الدم الحمراء ويكون فيه لون البول أرجوانياً)
  • كان جلدك يعاني من حساسية متزايدة لأشعة الشمس (الحساسية للضوء)
  • كنت من كبار السن، وتخضع للعلاج بأدوية أخرى يمكن أن تسبب انخفاض ضغط الدم، وإذا كنت تعاني من حالات طبية أخرى قد تؤدي إلى انخفاض ضغط الدم

يمكن أن يسبب دايوسيمايد حصوات الكلى أو التكلس إذا تم إعطاؤه للأطفال الخدج.
إذا كان ينطبق عليك أي من هذه الحالات، فقد يرغب طبيبك في تغيير علاجك أو يسدي إليك نصيحة خاصة.
قد يوصي طبيبك بإجراء اختبارات دم بشكل منتظم لمستويات السكر في الدم أو مستويات حمض اليوريك في الدم. سيفحص أيضاً مستويات الدم لديك لمعرفة أملاح الجسم المهمة مثل البوتاسيوم والصوديوم، والتي تعتبر مهمة بشكل خاص إذا كنت تعاني من الغثيان أو الإسهال

الأدوية الأخرى ودايوسيمايد
يرجى إخبار طبيبك أو الممرض إذا كنت تتناول، أو تناولت مؤخراً أية أدوية أخرى. ويشمل ذلك الأدوية التي تحصل عليها بدون وصفة طبية.
يعتبر هذا مهماً لأنه ينبغي ألا يتم تناول بعض الأدوية مع دايوسيمايد.
على وجه الخصوص أبلغ طبيبك أو الصيدلي إذا كنت تتناول:

  • الليثيوم - لاضطرابات المزاج، حيث قد يزداد تأثيره وآثاره الجانبية بسبب دايوسيمايد. سيصف لك طبيبك هذا الدواء فقط عند الضرورة القصوى، وسيقوم بعد ذلك بفحص مستويات الليثيوم لديك وقد يغير جرعتك
  • أدوية القلب، مثل الديجوكسين، قد يحتاج طبيبك إلى تغيير جرعتك
  • أي أدوية لارتفاع ضغط الدم، بما في ذلك مدرات البول الثيازيدية (مثل بِندروفلوميثيازيد أو هيدروكلوروثَيازيد)، مثبطات الإنزيم المحول للأنجيوتنسين (مثل ليزينوبريل)، وحاصرات مستقبلات الأنجيوتنسين 2 (مثل لوزارتان)، حيث قد يتسبب دايوسيمايد في انخفاض شديد في ضغط الدم لديك. قد يحتاج طبيبك إلى تغيير جرعتك من دايوسيمايد
  • الأدوية الخافضة للكوليستيرول أو الدهون مثل كوليستيرامين وكوليستيبول والفايبرات، مثل كلوفايبرات حيث يمكنها تقليل تأثير دايوسيمايد
  • أدوية السكري، مثل ميتفورمين والأنسولين، حيث يمكن زيادة مستويات السكر لديك
  • الأدوية المضادة للالتهابات، بما في ذلك مضادات الالتهابات غير الستيرويدية (مثل الأسبرين أو سيليكوكسيب)، لأنها يمكن أن تقلل من تأثيرات دايوسيمايد؛ حيث إن الجرعات العالية من مسكنات الألم (الساليسيلات) قد تزيد من آثار فيوروسيمايد الجانبية
  • الأدوية المضادة للالتهابات أو المضادة للحساسية مثل الكورتيكوستيرويدات، أو الأدوية المستخدمة لعلاج قرح المعدة مثل كاربينوكسولون، أو المُلَيِّنات، نظراً لأن استخدامها مع فيوروسيمايد سيؤثر على مستويات الصوديوم والبوتاسيوم لديك. سيفحص طبيبك مستويات البوتاسيوم لديك
  • الحقن التي تُعطى أثناء العمليات، بما في ذلك توبوكورارين، ومشتقات الكورارين، وسكسينيل كولين
  • هيدرات الكلورال - لمشكلات النوم (في حالات منفردة، قد يؤدي إعطاء فيوروسيمايد في الوريد [الحقن في الوريد] في فترة 24 ساعة قبل إعطاء هيدرات الكلورال إلى بَيغ، وزيادة في التعرق، وقلق، وغثيان، وزيادة في ضغط الدم، وسرعة ضربات القلب). لذلك، لا يُنصح بإعطاء دايوسيمايد وهيدرات الكلورال بالتزامن
  • فنيتوين أو فينوباربيتال - لعلاج الصرع؛ حيث قد ينخفض تأثير دايوسيمايد
  • ثيوفيلين - لعلاج الربو، حيث قد يزداد تأثيره بواسطة دايوسيمايد
  • المضادات الحيوية مثل السيفالوسبورينات، أو البوليميكسينات، الأمينوغليكوزيدات، أو الكينولونات، أو الأدوية الأخرى التي قد تؤثر على كليتيك مثل الأدوية المثبطة للمناعة، أو وسائط التباين باليود، أو الفوسكارنيت، أو البنتاميدين حيث يمكن أن يزيد فيوروسيمايد ضررها سوءاً
  • بروبينسيد - يستخدم مع بعض الأدوية الأخرى لحماية الكلى، لأنه قد يقلل من آثار دايوسيمايد
  • البلاتينات العضوية - تُستخدم في علاج بعض السرطانات؛ حيث قد يتسبب فيوروسيمايد في زيادة الآثار الجانبية لهذا الدواء
  • ميثوتريكسات - يستخدم في علاج بعض السرطانات والتهاب المفاصل الحاد؛ لأنه قد يقلل من تأثيرات دايوسيمايد
  • أدوية رفع ضغط الدم (الأمينات الضاغطة)؛ نظراً لأن مفعولها قد لا يكون فعالاً عند تناولها مع دايوسيمايد
  • أمينوغلوتيثيميد - يستخدم لقمع إنتاج الكورتيكوستيرويد (متلازمة كوشينغ)؛ لأنه قد يزيد من آثار فيوروسيمايد الجانبية
  • كاربامازيبين - يستخدم لعلاج الصرع أو الفصام؛ لأنه قد يزيد من آثار فيوروسيمايد الجانبية.
  • سوكرالفات - يستخدم لعلاج قرح المعدة. لا تأخذ دايوسيمايد في غضون ساعتين من تناول سوكرالفات لأن تأثير دايوسيمايد سينخفض
  • سيكلوسبورين - يستخدم لمنع رفض الجسم للعضو المزروع؛ لأنك قد تكون عرضة للإصابة بالتهاب المفاصل النقرسي (ألم المفاصل)
  • الأدوية التي تغير نبض القلب لديك مثل أميودارون، وسوتالول، ودوفيتيليد، وإيبوتيليد حيث يمكن زيادة تأثيرها بواسطة دايوسيمايد
  • ريسبيريدون - يستخدم لعلاج الإضطرابات العقلية.

دايوسيمايد مع الطعام، الشراب والكحول
ليس من المتوقع أن يؤثر الطعام على هذا الدواء عند إعطائه في الوريد. شرب السوائل المتواصل المعتدل إلى الكثيف يرفع ضغط الدم ويقلل من فاعلية الأدوية الخافضة للضغط. قد يعاني المرضى من الدوخة والإغماء بعد فترة وجيزة من شرب الكحول أثناء فترة العلاج.

الحمل والرضاعة
يجب ألا يتم استخدام دايوسيمايد أثناء الحمل ما لم تكن هناك أسباب طبية كافية لاستخدامه. يدخل فيوروسيمايد في حليب الثدي ويجب ألا تُرضعي أثناء تناوله.
اطلبي مزيداً من النصيحة من طبيبك أو الصيدلي قبل تناول دايوسيمايد أو أي دواء آخر إذا كنت حاملاً أو مرضعاً.

القيادة واستخدام الآلات
تجنب قيادة السيارة أو تشغيل الآلات لأن فيوروسيمايد قد يقلل من الانتباه الذهني.

يحتوي دايوسيمايد على الصوديوم
يحتوي دايوسيمايد على الصوديوم. يحتوي كل 2 مللتر من دايوسيمايد 20 ملغم/2 مللتر محلول للحقن/للتسريب على 5.819 ملغم صوديوم. يحتوي هذا الدواء على أقل من 1 ملمول صوديوم (23 ملغم) لكل 2 مللتر، وبذلك يمكن اعتباره ’خالٍ من الصوديوم‘ بشكل أساسي.

https://localhost:44358/Dashboard

يتم إعطاء حقن دايوسيمايد:

  • بالحقن البطيء في الوريد (داخل الوريد) أو
  • في العضلة (داخل العضل)، وذلك في بعض الاستثناءات

سيقرر طبيبك مقدار الجرعة التي تحتاج إليها، وموعدها، ومدة العلاج. يعتمد هذا على عمرك ووزنك وتاريخك الطبي وأي أدوية أخرى تتناولها ونوع مرضك وحدته.

بشكل عام:

  • يتم وصف إعطاء دايوسيمايد عن طريق الحقن في الحالات التي يكون فيها الإعطاء عن طريق الفم غير مجدٍ وغير فعّال (على سبيل المثال في حالة انخفاض الامتصاص المعوي)، أو عندما يكون التأثير السريع مطلوباً.
  • في الحالات التي يتم إعطاء الدواء فيها حقناً، يوصى بالتحول إلى الإعطاء عن طريق الفم في أقرب وقت ممكن.
  • لتحقيق الفعالية المثلى وقمع التنظيم المضاد، يفضل بشكل عام التسريب المستمر لدايوسيمايد على حقن البلعة المتكررة.
  • عندما لا يكون التسريب المستمر لدايوسيمايد مجدياً لمتابعة العلاج بعد جرعة واحدة أو جرعات بلعة كبيرة عديدة، يُفضل اتباع نظام متابعة بجرعات منخفضة تُعطى على فترات قصيرة (4 ساعات تقريباً) بدلاً من نظام بجرعات بلعة أعلى على فترات أطول.
  • يجب حقن دايوسيمايد داخل الوريد أو تسريبه ببطء؛ ويجب ألا يتجاوز معدل تسريب أو حقن 4 ملغم في الدقيقة، ويجب عدم إعطائه مع مستحضرات طبية أخرى في المحقنة نفسها.

نظام الجرعات:
البالغون:

  • في حالة غياب الحالات التي تستدعي تناول جرعة مخفضة (انظر أدناه)، تكون الجرعة الأولية الموصى بها للبالغين والمراهقين الذي تتجاوز أعمارهم 15 عاماً هي 20 ملغم إلى 40 ملغم دايوسيمايد (1 أو 2 أمبولات) داخل الوريد (أو في العضل في بعض الحالات الاستثنائية)؛ وتختلف الجرعة القصوى حسب الاستجابة الفردية.
  • إذا استدعى الأمر جرعات أكبر، فيجب إعطاؤها بزيادات قدرها 20 ملغم، ولا تُعطى بمعدل أكبر من كل ساعتين.
  • تعتبر الجرعة اليومية القصوى الموصى بها للبالغين من دايوسيمايد هي 1500 ملغم.
  • قد تكون هناك حاجة لتناول جرعات أولية أو جرعات مستمرة أكبر في حالات معينة، ويتوقف ذلك على حالتك الطبية. سيحدد طبيبك ذلك. إذا استدعت الحاجة إعطاء هذه الجرعات، فيمكن إعطاؤها بالتسريب المستمر.

الأطفال والمراهقون (حتى سن 18 عاماً):

  • الخبرة في الأطفال والمراهقين محدودة. يوصى بإعطاء دايوسيمايد داخل الوريد للأطفال والمراهقين الذين تقل أعمارهم عن 15 عاماً في حالات استثنائية فقط.
  • يتم توفيق الجرعة مع وزن الجسم، وتتراوح الجرعة الموصى بها من 0.5 إلى 1 ملغم/ كيلوغرام من وزن الجسم يومياً إلى أقصى جرعة يومية إجمالية بمقدار 20 ملغم. يجب أن يكون هناك تحول إلى العلاج عن طريق الفم في أسرع وقت ممكن.

القصور الكُلوي:

  • بالنسبة إلى المرضى الذين يعانون من قصور شديد في وظائف الكلى (كرياتينين الدم > 5 ملغم/ديسيلتر)، يوصى بعدم تجاوز معدل التسريب 2.5 ملغم دايوسيمايد في الدقيقة.

كبار السن:

  • تكون الجرعة الأولية الموصى بها 20 ملغم/يومياً، وتزداد تدريجياً حتى تتحقق الاستجابة المطلوبة.

إذا تم إعطاؤك دايوسيمايد أكثر من اللازم
إذا ساورك القلق بأنه قد تم إعطاؤك جرعة زائدة من دايوسيمايد، فأخبر طبيبك أو أحد أفراد الطاقم الطبي على الفور. تتمثل العلامات التي قد تحدث إذا تم إعطاؤك جرعة زائدة من هذا الدواء في جفاف الفم، أو زيادة الشعور بالعطش، أو عدم انتظام نبضات القلب، أو تغيرات المزاج، أو تشنج العضلات، أو الألم، أو الشعور بالغثيان أو القئ، أو التعب أو الضعف غير العاديين، أو النبض الضعيف، أو فقدان شهية.

إذا فاتتك جرعة من دايوسيمايد
إذا ساورك القلق بأنك قد نسيت جرعة من الجرعات، فأخبر طبيبك أو أحد أفراد الطاقم الطبي على الفور.

أثناء تلقي العلاج بدايوسيمايد
إذا عانيت من ردود فعل تحسسية حادة، مثل تورم وجهك وحلقك أو أحدهما، أو الحمى، فأخبر طبيبك أو أحد أفراد الطاقم الطبي على الفور.

إذا توقفت عن استخدام دايوسيمايد
إذا توقفت عن العلاج مبكراً قبل توصية طبيبك، فقد يتأثر قلبك أو رئتيك أو كليتيك بشكل كبير بسبب كثرة السوائل.
إذا كان لديك أية أسئلة إضافية حول استخدام هذا الدواء، اسأل الطبيب أو أحد أفراد الطاقم الطبي

مثل جميع الأدوية، قد يسبب هذا الدواء آثاراً جانبيةً، إلا أنه ليس بالضرورة أن تحدث لدى جميع مستخدمي هذا الدواء.
إذا لاحظت أياً مما يلي، أخبر الطبيب أو الممرض على الفور:

غير شائعة (قد تؤثر فيما يصل إلى شخص من بين كل 100 شخص)

  • طفح جلدي (بما في ذلك الحكة والاحمرار والتقشير)، الميل للإصابة بالكدمات، أو أن تصبح بشرتك حساسة لأشعة الشمس.
  • يمكن أن تؤدي تغيرات خلايا الدم إلى فشل تخثر الدم (مع زيادة خطر النزيف).
  • صمم (لا يمكن التعافي منه في بعض الأحيان).

نادرة (قد تؤثر فيما يصل إلى شخص من كل 1000 شخص)

  • الشعور بالغثيان، القئ، الإسهال، الإمساك، فقدان الشهية، أو عدم الراحة في الفم والمعدة.
  • مشكلات في السمع (أكثر شيوعاً في مرضى الفشل الكلوي) وطنين الأذن (رنين في الأذنين).
  • التأق، رد فعل تحسسي شديد يمكن أن يسبب طفحاً جلدياً، تورماً، وصعوبات في التنفس وفقداناً للوعي. اطلب المساعدة الطبية على الفور.
  • تلف الكلى (التهاب الكُلية الخِلالي).
  • انخفاض شديد في مستويات كريات الدم البيضاء في الدم (مما قد يؤدي إلى حالات عدوى مهددة للحياة). احصل على المساعدة الطبية على الفور.
  • مشكلات في العضلات، تشمل تشنجات الساق أو ضعف العضلات.
  • الشعور بألم أو عدم راحة في مكان الحقن (خاصة بعد الحقن في العضلات).
  • قد تصاب بداء الذئبة الحمامية الالتهابي أو قد يتفاقم إذا كنت مصاباً به.
  • تغيرات في نتائج اختبار الدم (وجود مواد شبيهة بالدهون في دمك).
  • الشعور بالتخدير، أو التنميل، أو الشعور بالدوار.
  • ارتفاع درجة الحرارة.
  • عدم وضوح الرؤية والارتباك والشعور بالنعاس.
  • جفاف الفم.   

نادرة جداً (قد تؤثر فيما يصل إلى شخص من بين كل 10000 شخص)

  • مشكلات عضلية حادة تشمل النَفَضان، والتقلصات، والتشنجات (ويطلق عليها أيضاً "الكُزاز").
  • تغيرات في خلايا الدم التي يمكن أن تؤدي إلى فقر الدم، وعدم القدرة على مقاومة العدوى.
  • التهاب البنكرياس (أو ألم شديد في البطن) بسبب التهاب البنكرياس.

غير معروف (لا يمكن تقدير التكرار من البيانات المتاحة)

  • البثار الطفحي الحاد المعمم (طفح دوائي حموي حاد).
  • دوخة وإغماء وفقدان الوعي (بسبب انخفاض ضغط الدم المصحوب بأعراض).     

قد يحدث أيضاً ما يلي:

  • انخفاض في ضغط الدم يجعلك تشعر بالإغماء أو الدوار. قد يتسبب أيضاً في الشعور بالضغط في الرأس، أو ألم المفاصل، أو تشكل جلطة دموية، أو انهيار الدورة الدموية (الصدمة).
  • انخفاض مستويات البوتاسيوم في الدم. يمكن أن يتسبب ذلك في ضعف وتنميل واخدِرار في العضلات، أو عجز طفيف في تحريك أحد أجزاء الجسم، أو شعور بالغثيان، أو الإمساك، أو زيادة الغازات في الأمعاء، أو زيادة إنتاج البول، أو زيادة الرغبة في الشرب، أو بطء نبضات القلب أو عدم انتظامها. تزداد احتمالية حدوث هذه المشكلات إذا كنت تعاني من أمراض أخرى مثل مشكلات في الكبد أو القلب، أو تتبع حمية غذائية منخفضة البوتاسيوم للغاية، أو إذا كنت تتناول أدوية أخرى (انظر " الأدوية الأخرى ودايوسيمايد").
  • انخفاض مستويات الصوديوم، الكالسيوم والمغنسيوم في الدم. قد يحدث هذا بسبب زيادة فقدان الصوديوم والكالسيوم والمغنسيوم في البول. عادةً ما يسفر انخفاض مستويات الصوديوم عن الخمول، وتشنج ربلة الساق، وانخفاض الشهية، والشعور بالضعف، والنعاس الغثيان والارتباك. يمكن أن يصاحب التشنجات أيضاً انخفاض في مستويات الكالسيوم أو المغنسيوم في جسمك.
  • قد تصاب بالنقرس أو يتفاقم إذا كنت مصاباً به.
  • قد تتفاقم مشكلات التبول الحالية.
  • قد تصاب بداء السكري أو يتفاقم إذا كنت مصاباً به.
  • قد تسبب مشكلات الكبد أو التغيرات في الدم اليرقان (اصفرار الجلد والبول الداكن والتعب).
  • انخفاض كمية السوائل بالجسم خاصة لدى المرضى المسنين. قد يسفر فقدان السوائل الحاد عن زيادة تركيز الدم مع الميل إلى تشكل جلطات الدم.
  • قد يصاب الأطفال الخدج بحصوات الكلى أو التكلس، وقد تظل القناة بين الشريان الرئوي والشريان الأبهر المفتوحة عند الجنين كما هي لدى الأطفال الخدج.

احفظ هذا الدواء بعيداً عن مرأى ومتناول الأطفال.

يحفظ عند درجة حرارة أقل من 25° مئوية.

يحفظ داخل العبوة الأصلية للحماية من الضوء.

بعد الحل: تم إثبات الاستقرار الكيميائي والفيزيائي خلال فترة الاستخدام وذلك لمدة 24 ساعة عند درجة حرارة 25° مئوية، محمياً من الضوء.

للاستخدام لمرة واحدة فقط. استخدمه فوراً بعد الفتح لأول مرة.

لا تستخدم هذا الدواء بعد تاريخ انتهاء الصلاحية المذكور على العبوة الخارجية بعد "EXP". يشير تاريخ انتهاء الصلاحية إلى اليوم الأخير من ذلك الشهر.

لا تستخدم هذا الدواء إذا لاحظت أي علامات تلف واضحة عليه.

لا تتخلص من أي أدوية عن طريق مياه الصرف الصحي أو النفايات المنزلية. اسأل الصيدلي عن كيفية التخلص من الأدوية التي لم تعد بحاجة إليها. هذه الإجراءات ستساعد في الحفاظ على سلامة البيئة.

المادة الفعالة هي فيوروسيمايد.

 

يحتوي كل 2 مللتر من دايوسيمايد 20 ملغم/2 مللتر محلول للحقن/للتسريب على 20 ملغم فيوروسيمايد.

 

المواد الأخرى المستخدمة في التركيبة التصنيعية هي كلوريد الصوديوم، هيدروكسيد الصوديوم، حمض الهيدروكلوريك وماء معد للحقن.

 

دايوسيمايد 20 ملغم/2 مللتر محلول للحقن/للتسريب هو محلول صافٍ، عديم اللون أو بدون لون تقريباً في أمبولات زجاجية كهرمانية من النوع رقم واحد.

 

حجم العبوة: 5 أمبولات (2 مللتر).

مالك رخصة التسويق
شركة الجزيرة للصناعات الدوائية
طريق الخرج
صندوق بريد 106229
الرياض 11666، المملكة العربية السعودية
هاتف: 8107023 (11-966) +، 2142472 (11-966) +
فاكس: 2078170 (11-966) +
البريد الإلكتروني: SAPV@hikma.com

الشركة المصنعة
شركة الحكمة إيطاليا المساهمة العامة المحدودة
طريق سيرتوزا، 10
27100 بافيا، إيطاليا
هاتف: 1751844 (0382-39) +/ 1751801 (0382-39) +
فاكس: 422745 (0382-39) +

للإبلاغ عن الآثار الجانبية
تحدث إلى الطبيب، الصيدلي، أو الممرض إذا عانيت من أية آثار جانبية. وذلك يشمل أي آثار جانبية لم يتم ذكرها في هذه النشرة. كما أنه يمكنك الإبلاغ عن هذه الآثار مباشرةً (انظر التفاصيل المذكورة أدناه). من خلال الإبلاغ عن الآثار الجانبية، يمكنك المساعدة بتوفير معلومات مهمة عن سلامة الدواء.

  • المملكة العربية السعودية

المركز الوطني للتيقظ والسلامة الدوائية

مركز الاتصال الموحد: 19999

البريد الإلكتروني: npc.drug@sfda.gov.sa

الموقع الإلكتروني: https://ade.sfda.gov.sa

  • دول الخليج العربي الأخرى

الرجاء الاتصال بالجهات الوطنية في كل دولة.

تمت مراجعة هذه النشرة بتاريخ 07/2023؛ رقم النسخة SA2.0.
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Diusemide 20 mg/2 ml Solution for Injection/Infusion

Each 2 ml of Diusemide 20 mg/2 ml Solution for Injection/Infusion contains 20 mg furosemide. Excipients with known effects: sodium. Each 2 ml contains 5.819 mg sodium. For a full list of excipients, see section 6.1.

Solution for Injection/Infusion Diusemide 20 mg/2 ml Solution for Injection/Infusion is a clear, colorless or almost colorless solution

When a prompt diuresis is required. Use in emergencies or when oral therapy is precluded. Indications include:

  • Oedema and/or ascites caused by cardiac or hepatic diseases
  • Oedema caused by renal diseases (in case of nephrotic syndrome, treatment of the underlying disease is essential)
  • Pulmonary oedema (e.g. in case of acute heart failure)
  • Hypertensive crisis (in addition to other therapeutic measures)

Route of administration: intravenous or (in exceptional cases) intramuscular

General:
The parenteral administration of Diusemide is indicated in cases where oral administration is not feasible or not efficient (for example in case of reduced intestinal absorption) or when a quick effect is required. To achieve optimum efficacy and suppress counter-regulation, a continuous Diusemide infusion is generally to be preferred to repeated bolus injections.

Consideration should be given to current clinical guidelines where available.

Where continuous Diusemide infusion is not feasible for follow-up treatment after one or several acute bolus doses, a follow-up regimen with low doses given at short intervals (approx. 4 hours) is to be preferred to a regimen with higher bolus doses at longer intervals.

Therapy should be individualized according to patient response to gain maximal therapeutic response and to determine the minimal dose needed to maintain that response.

Intravenous Diusemide must be injected or infused slowly; a rate of 4 mg per minute must not be exceeded and should never be given in association with other medicinal products in the same syringe.

Generally, Diusemide should be administered intravenously. Intramuscular administration must be restricted to exceptional cases where neither oral nor intravenous administration is feasible. It must be noted that intramuscular injection is not suitable for the treatment of acute conditions such as pulmonary oedema.

Adults:
In the absence of conditions requiring a reduced dose (see below) the initial dose recommended for adults and adolescents over 15 years, is of 20 mg to 40 mg Diusemide by intravenous (or in exceptional cases intramuscular) administration; the maximum dose varying according to individual response.

If larger doses are required, they should be given increasing by 20 mg increments and not given more often than every two hours.

In adults, the recommended maximum daily dose of Diusemide administration is 1500 mg.

When administered as an infusion, Diusemide may be administered undiluted using a constant-rate infusion pump, or the solution may be further diluted with a compatible carrier fluid, such as Sodium Chloride Injection B.P. or Lactated Ringer’s solution for Injection. In either case, the rate of infusion should not exceed 4mg/minute.

The parenteral administration of Diusemide is indicated in cases where oral administration is not feasible or not efficient (for example in case of reduced intestinal absorption) or when a quick effect is required. In cases where parenteral administration is used, the switch to oral administration is recommended, as soon as possible.

Children and adolescents (up to 18 years of age):
The experience in children and adolescents are limited. The intravenous administration of Diusemide to children and adolescents below 15 years is only recommended in exceptional cases.

The dosage will be adapted to the body weight, and the recommended dose ranges from 0.5 to 1 mg/kg body weight daily up to a maximum total daily dose of 20 mg.

There should be a switch to oral therapy as soon as possible.

Renal impairment:
In patients with severe impairment of renal function (serum creatinine > 5 mg/dl) it is recommended that an infusion rate of 2.5 mg Diusemide per minute is not exceeded.

Elderly:
The recommended initial dose is 20 mg/day, increasing gradually until the required response is achieved.

Special dosage recommendations:
For adults, the dose is based on the following conditions:
- Oedema associated to chronic and acute congestive heart failure
The recommended initial dose is 20 to 40 mg daily. This dose can be adapted to the patient´s response, as necessary. The dose should be given in two or three individual doses per day for chronic congestive heart failure and as a bolus for acute congestive heart failure.
- Oedema associated with renal disease
The recommended initial dose is 20 to 40 mg daily. This dose can be adapted to the response as necessary. The total daily dose can be administered as a single dose or as several doses throughout the day.

If this does not lead to an optimal fluid excretion increase, Diusemide must be administered in continuous intravenous infusion, with an initial rate of 50 mg to 100 mg per hour.
Before beginning the administration of Diusemide, hypovolaemia, hypotension and acid-base and electrolytic imbalances must be corrected.

In dialyzed patients, the usual maintenance dose ranges from 250 mg to 1,500 mg daily.
In patients with nephrotic syndrome the dosage must be determined with caution, because of the risk of a higher incidence of adverse events.
- Oedema associated with hepatic disease

When intravenous treatment is absolutely needed, the initial dose should range from 20 mg to 40 mg. This dose can be adapted to the response as necessary. The total daily dose can be administered as a single dose or in several doses.

Diusemide can be used in combination with aldosterone antagonists in cases in which these agents in monotherapy are not sufficient. In order to avoid complications such as orthostatic intolerance or acid-base and electrolytic imbalances or hepatic encephalopathy, the dose must be carefully adjusted to achieve a gradual fluid loss. The dose may produce in adults a daily body weight loss of approximately 0.5 kg.

In cases of ascites with oedema, weight loss induced by enhanced diuresis should not exceed 1 kg / day.
- Pulmonary oedema (in acute heart failure)
The initial dose to be administered is 40 mg Diusemide by intravenous application. If required by the condition of the patient, another injection of 20 to 40 mg Diusemide is given after 30 – 60 minutes.

Diusemide should be used in addition to other therapeutic measures.
- Hypertensive crisis (in addition to other therapeutic measures)
The recommended initial dose in hypertensive crisis is 20 mg to 40 mg administrated in bolus by intravenous injection. This dose can be adapted to the response as necessary.


• Hypersensitivity to the active substance or to any of the excipients. • Patients with anuria or renal failure with oligoanuria not responding to furosemide • Renal failure as a result of poisoning by nephrotoxic or hepatotoxic agents • Renal failure associated with hepatic coma • Patients with severe hypokalaemia or severe hyponatraemia • Patients with hypovolaemia (with or without hypotension) or dehydration • Patients in pre-comatose and comatose state associated with hepatic encephalopathy • Patients with hypersensitivity to sulphonamides (e.g. Sulfonyureas or antibiotics of sulphonamides group) may show cross-sensitivity to furosemide • Lactation (see section 4.6)

Careful monitoring is required in case of:

  • Patients with partial obstruction of urinary outflow (e.g. prostatic hypertrophy, hydronephrosis, ureterostenosis). Urinary output must be secured
  • Patients with hypotension or at increased risk from pronounced fall in blood pressure (patients with coronary artery stenosis or cerebral artery stenosis)
  • Patients with manifest or latent diabetes mellitus or variation of glycaemia (regular monitoring of blood glucose levels necessary)
  • Patients with gout and hyperuricaemia (regular monitoring of uric acid levels in serum necessary)
  • Patients with hepatic disease or hepatorenal syndrome (renal impairment associated to severe hepatic disease)
  • Hypoproteinaemia (associated to nephrotic syndrome, furosemide´s effect may be reduced and its ototoxicity increased)
  • Co-administration with lithium salts (monitoring of lithium levels is required, see section 4.5)
  • Acute porphyria (the use of diuretics is considered to be unsafe in acute porphyria and caution should be exercised)
  • In cases of ascites with oedema, weight loss induced by enhanced diuresis should not exceed 1 kg / day
  • Too vigorous diuresis may cause orthostatic hypotension or acute hypotensive episodes.
  • NSAIDs may antagonise the diuretic effect of furosemide and other diuretics. Use of NSAIDs with diuretics may increase the risk of nephrotoxicity.
  • Where indicated, steps should be taken to correct hypotension or hypovolaemia before commencing therapy.

Cautious dose titration is required:

  • Electrolyte variations (e.g. hypokalaemia, hyponatraemia). Potassium supplements and/or dietary measures may be needed to control or avoid hypokalemia
  • Fluid variations, dehydration, blood volume reduction with circulatory collapse and possibility of thrombosis and embolism, particular in elderly, with excessive use
  • Ototoxicity (if administered faster than 4 mg/min - other ototoxic compounds administered concomitantly can increase this risk, see section 4.5
  • Administration of high dosages
  • Administration in progressive and severe renal disease
  • Administration with sorbitol. Concomitant administration of both substances may lead to increased dehydratation (sorbitol might cause additional fluid loss by inducing diarrhoea)
  • Administration in Lupus Erythematosus
  • Medication that prolong the QT interval

Symptomatic hypotension leading to dizziness, fainting or loss of consciousness can occur in patients treated with furosemide, particularly in the elderly, patients on other medications which can cause hypotension and patients with other medical conditions that are risks for hypotension.

Premature infants (possible development of nephrocalcinosis /nephrolithiasis; renal function must be monitored and renal ultrasonography performed). In premature infants with respiratory distress syndrome, diuretic treatment with furosemide during the first weeks of life can increase the risk of persistent ductus arteriosus Botalli.

Caution should be observed in patients liable to electrolyte deficiency.

Regular monitoring of serum sodium, potassium and creatinine is generally recommended during Diusemide therapy; particularly close monitoring is required in patients at high risk of developing electrolyte imbalances or in case of significant additional fluid loss. (e.g. due to vomiting or diarrhoea).

Hypovolaemia or dehydration as well as any significant electrolyte and acid-base disturbances must be corrected. This may require temporary discontinuation of Diusemide.

In patients who are at high risk for radiocontrast nephropathy, furosemide is not recommended to be used for diuresis as part of the preventative measures against radiocontrast-induced nephropathy.

Concomitant use with risperidone
In risperidone placebo-controlled trials in elderly patients with dementia, a higher incidence of mortality was observed in patients treated with furosemide plus risperidone (7.3%; mean age 89 years, range 75-97 years) when compared to patients treated with risperidone alone (3.1%; mean age 84 years, range 70-96 years) or furosemide alone (4.1%; mean age 80 years, range 67-90 years). Concomitant use of risperidone with other diuretics (mainly thiazide diuretics used in low dose) was not associated with similar findings.

No pathophysiological mechanism has been identified to explain this finding, and no consistent pattern for cause of death observed. Nevertheless, caution should be exercised and the risks and benefits of this combination or co-treatment with other potent diuretics should be considered prior to the decision to use. There was no increased incidence of mortality among patients taking other diuretics as concomitant treatment with risperidone. Irrespective of treatment, dehydration was an overall risk factor for mortality and should therefore be avoided in elderly patients with dementia (see section 4.3 Contraindications).

Photosensitivity: Cases of photosensitivity reactions have been reported. If photosensitivity reaction occurs during treatment, it is recommended to stop the treatment. If a re-administration is deemed necessary, it is recommended to protect exposed areas to the sun or to artificial UVA.

Diusemide contains sodium
Diusemide contains sodium. Each 2 ml of Diusemide 20 mg/2 ml Solution for Injection/Infusion contains 5.819 mg sodium. This medicine contains less than 1 mmol sodium (23 mg) per 2 ml, that is to say essentially ‘sodium-free’ 


Not recommended combinations

Lithium:
Lithium excretion levels may be reduced by furosemide, resulting in increased cardiotoxic effect and lithium toxicity. Therefore, this combination is not recommended (see section 4.4). If this combination is deemed necessary lithium levels should be carefully monitored and lithium dosage should be adjusted.

Risperidone:
Caution should be exercised and the risks and benefits of the combination or co-treatment with Diusemide or with other potent diuretics should be considered prior to the decision to use. See section 4.4 Special warnings and precautions for use regarding increased mortality in elderly patients with dementia concomitantly receiving risperidone.

Combinations requiring a caution for use

Ototoxic drugs (e.g. aminoglycosides, cisplatin):
Furosemide may intensify the ototoxicity of certain drugs, for example cisplatin or aminoglycoside antibiotics such as kanamycin, gentamicin and tobramycin, in particular in patients with renal impairment. Since this may lead to irreversible damage, these drugs must only be used with furosemide if there are compelling medical reasons.

Chloral Hydrate:
In isolated cases, the intravenous administration of furosemide in a 24 hour period prior to chloral hydrate administration may lead to flush, hyperhidrosis, anxiety, nausea, increase in blood pressure and tachycardia. Therefore, the simultaneous administration of furosemide and chloral hydrate is not recommended.

Carbamazepine and aminoglutethimide:
Concomitant administration of carbamazepine or aminoglutethimide may increase the risk of hyponatraemia.

Other anti-hypertensive agents:
The effect of other certain anti-hypertensive agents (diuretics and other drugs that low blood pressure) may be potentiated by concurrent administration of furosemide.

Inhibitors of the angiotensin converting enzyme (ACE) and Angiotensin II receptor antagonists:
The effects of other antihypertensives can be potentiated by concomitant administration of furosemide. Severe fall in blood pressure with shock in extreme cases and deterioration of renal function (acute renal failure in isolated cases) have been observed in combination with ACE inhibitors, when the ACE inhibitor was administered for the first time, or for the first time at high dosage (first dose hypotension). If possible, Diusemide therapy should be temporarily discontinued (or at least the dose reduced) for three days before therapy with an ACE inhibitor or an Angiotensin II receptor antagonists is initiated or the dose of an ACE inhibitor or Angiotensin II receptor antagonists is increased.

Patients taking diuretics may suffer accentuated hypotension and deterioration of renal function; renal impairment may also occur during the first concurrent administration, or with the first administration of high doses of ACE or of an antagonist of the angiotensin II receptor.

Thiazides:
A synergetic effect of diuresis occurs as result of interaction of furosemide and thiazides.

Anti-diabetic agents:
A decrease in glucose tolerance may occur, since furosemide may reduce these drugs action.

Metformin:
The blood levels of metformin may be increased by furosemide. Inversely, metformin may reduce furosemide concentration. The risk is linked to an increased occurrence of lactic acidosis in case of functional renal insufficiency.

Cardiac glycosides (e.g. digoxin) and other medicinal products that may cause prolongation of the QT-interval:
A decrease of potassium levels may increase digitalis toxicity; for this reason, potassium levels should be monitored.

Some electrolyte disturbances may increase the toxicity of certain concomitantly administered drugs that may cause prolongation of the QT interval. e.g. (class Ia antiarrhythmics and class III antiarrhythmics like amiodarone, sotalol, dofetilide, ibutilide and quinolones). Monitoring of potassium plasma levels and ECG are recommended.

Fibrates:
Blood levels of furosemide and of fibric acid derivates (for example clofibrate and fenofibrate) may be increased during concurrent administration (particularly in case of hypoalbuminaemia). The increase of its effect/toxicity should be monitored.

Non-steroidal anti-inflammatory agents and high doses of salicylates:
Non-steroidal anti-inflammatory agents (including coxibs) may induce acute renal failure in cases of pre-existing hypovolaemia and reduce its diuretic, natriuretic and antihypertensive effect. When co-administered with high doses of salicylates, the predisposition for salicylic toxicity may be increased due to a reduced renal excretion or to a modified renal function.

Nephrotoxic drugs (e.g. polymyxins, aminoglycosides, cephalosporins organoplatins, immunosuppressants, iodinated contrast media, foscarnet, pentamidine):

Furosemide may intensify the nephrotoxic effects of nephrotoxic drugs.

Antibiotics like cephalosporins-impairment of renal function may develop in patients receiving treatment with furosemide and high doses of certain cephalosporins.

There is a risk of cytotoxic effects if cisplatin and furosemide are given concomitantly.

In addition, Nephrotoxicity of cisplatin may be enhanced if furosemide in not given in low doses (e.g. 40 mg in patients with normal renal function) and with positive fluid balance, when used to achieve forced diuresis during cisplatin treatment.

Drugs that undergo significant renal tubular secretion:
Probenecid, methotrexate and other drugs which, like furosemide, undergo significant renal tubular secretion may reduce the effect of furosemide. Conversely, furosemide may decrease renal elimination of these products. In case of high-dose treatment (in particular, of both furosemide and the other medicinal products), this may lead to increased serum levels and an increased risk of adverse effects due to furosemide or the concomitant medication.

Peripheral adrenergic inhibitors:
These agents´ effects may be enhanced by the simultaneous administration of furosemide.

Phenobarbital and phenytoin:
Attenuation of the effect of furosemide may occur following concurrent administration of these drugs.

Tubocurarine, curarine derivatives and succinyl choline:
The muscle relaxing effect of these agents may be enhanced or prolonged by Diusemide.

Glucocorticoids, carbenoxolone, Amphotericin B, Penicillin G, ACTH, laxatives and liquorice:
Co-administration of Diusemide with glucocorticoids, carbenoxolone,large amount of liquorice or prolonge use of laxatives may increase potassium loss. In the association with glucocorticoids, hypokalaemia should be considered and its aggravation with the overuse of laxatives. Since, this may lead to irreversible hearing damages, this combination should only be used if there are compelling medical reasons.

Potassium levels should be monitored.

Sucralfate:
Simultaneous administration of sucralfate and Diusemide may reduce the natriuretic and antihypertensive effects of Diusemide. Patients receiving both drugs should be observed closely to determine if the desired diuretic and/or antihypertensive effect of furosemide is achieved. The intake of furosemide and sucralfate should be separated by at least two hours.

Oral anticoagulants:
Furosemid increases the effects of oral anticoagulants.

Theophylline:
The effects of theophylline and of curare-type muscle relaxants may be potentiated.

Pressor amines (e.g. adrenaline (epinephrine), noradrenaline (norepinephrine)):

Concomitant use of Diusemide may attenuate the effects of pressor amines.

Other interactions:
Concomitant use of ciclosporin and furosemide is associated with increased risk of gouty arthritis.


Use during pregnancy
Furosemide should not be given during pregnancy unless there are compelling medical reasons. Furosemide crosses the placental barrier, and can therefore cause a diuresis of the fetus. Treatment during pregnancy requires monitoring of fetal growth.


Treatment of pregnancy hypertension and oedema is in general not recommended, as physiological hypovolemia can be induced which causes reduction of placental perfusion.


If use of furosemide is essential for the treatment of cardiac or renal insufficiency during pregnancy, careful monitoring of electrolytes, haematocrit and fetal growth is essential. Possible displacement of bilirubin from albumin binding and thus elevated risk of nuclear icterus in hyperbilirubinaemia is discussed for furosemide. Furosemide can predispose the fetus to hypercalciuria, nephrocalcinosis, and secondary hyperparathyroidism.


Furosemide reaches 100% of the maternal serum concentration in cord blood. No malformations in humans which might be associated with exposure to furosemide have been reported to date. However, there is limited experience to allow a conclusive evaluation of a potential damaging effect in the embryo/fetus.

Use during lactation
Furosemide passes into breast milk and may inhibit lactation. Women must not breast-feed if they are treated with furosemide (see section 4.3).


Furosemide has negligible influence on the ability to drive and use machines.

Patients respond individually to Furosemide.

The ability to drive or operate machines can incidentally be reduced because of treatment with furosemide, especially at the start of therapy, change of medication or in combination with alcohol.


The evaluation of adverse reactions is based on the following definition of frequency:
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).

Blood and lymphatic system disorders

Uncommon: thrombocytopenia; thrombocytopenia may become manifest, especially with an increase of haemorrhage tendency.

Rare: eosinophilia, leukopenia, bone marrow depression; occurrence of this symptom necessitates withdrawal of treatment.

Very rare: haemolytic anaemia, aplastic anaemia, agranulocytosis.

Severe fluid depletion may lead to haemoconcentration with a tendency for thromboses to develop especially in elder patients.

Immune system disorders

Rare: severe anaphylactic and anaphylactoid reactions such as anaphylactic shock (for treatment see section 4.9).

Endocrine disorders

Glucose tolerance may decrease with Diusemide. In patients with diabetes mellitus this may lead to a deterioration of the metabolic control; latent diabetes mellitus may become manifest.

Metabolism and nutrition disorders

Hypokalaemia, hyponatraemia and metabolic alkalosismay occur, especially after prolonged therapy or when high doses are administered. Regular monitoring of serum electrolytes (especially potassium, sodium and calcium) is therefore indicated.

Potassium depletion may occur, especially due to poor potassium diet. Particulary when the supply of potassium is concomitantly reduced and/or extrarenal potassium losses are increased (e.g. in vomiting or chronic diarrhoea) hypokalaemia may occur as a result of increased renal potassium losses.

Underlying disorders (e.g. cirrhotic disease or heart failure), concomitant medication (see section 4.5) and nutrition may cause predisposition to potassium deficiency. In such cases, adequate monitoring is necessary as well as therapy substitution.

As a result of increased renal sodium losses, hyponatraemia with corresponding symptoms may occur, particularly if the supply of sodium chloride is restricted.

Increased renal calcium losses can lead to hypocalcaemia, which may induce tetania in rare cases.

In patients with increased renal magnesium losses, tetania or cardiac arrhythmias were observed in rare cases as a consequence of hypomagnesaemia.

Uric acid levels may increase and gout attacks may occur.

Metabolic alkalosis may develop, or pre-existing metabolic alkalosis (for e.g. decompensated hepatic cirrhosis) may become more severe with Diusemide.

Nervous system disorders

Rare: paraesthesia, vertigo, dizziness, sleepiness, confusion, sensations of pressure in the head.

Not known: Dizziness, fainting and loss of consciousness (caused by symptomatic hypotension)

Eye disorders

Rare: aggravation of myopia, blurred vision; disturbances of vision with hypovolaemia symptoms.

Ear and labyrinth disorders

Rare: dysacusis and/or syrigmus (tinnitus aurium) due to furosemide are rare and usually transitory; incidence is higher in rapid intravenous administration, particularly in patients with renal failure or hypoproteinaemia (e.g. in nephrotic syndrome).

Uncommon: deafness (sometimes irreversible)

Cardiac disorders

In particular, at the initial state of treatment and in elderly, a very intense diuresis may cause a reduction in blood pressure which, if pronounced may cause signs and symptoms such as orthostatic hypotension, acute hypotension, sensations of pressure in the head, dizziness, circulatory collapse, thrombophlebitis or sudden death (with i.m. or i.v. administration).

Gastrointestinal disorders

Rare: nausea, vomiting, diarrhoea, anorexia, gastric distress, constipation, dry mouth.

Hepato-biliary disorders

Very rare: acute pancreatitis, intrahepatic cholestasis, cholestasis jaundice, hepatic ischaemia, increases in hepatic transaminases.

Skin and subcutaneous tissue disorders

Uncommon: pruritus, dermal and mucosal reactions (e.g. bullous exanthema, rash, urticaria, purpura, erythema multiforme, exfoliative dermatitis, photosensitivity)

Rare: vasculitis, lupus erythematosus exacerbation or activation.

Not known: acute generalised exanthematous pustulosis (AGEP)

Musculoskeletal and connective tissue disorders

Rare: leg muscle cramps, asthenia. chronic arthritis.

Renal and urinary disorders

Diuretics may exacerbate or reveal acute retention of urine symptoms (bladder-emptying disorders, prostatic hyperplasia or narrowing of the urethra), vasculitis, glycosuria, transitorily increase of blood creatinine and urea levels.

Rare: interstitial nephritis.

Pregnancy, puerperium and perinatal conditions

Premature infants treated with furosemide may develop nephrocalcinosis and/or nephrolithiasis; due to calcium deposit in renal tissue.

In premature infants with respiratory distress syndrome, diuretic treatment in the first weeks of life with furosemide can increase the risk of persistent ductus arteriosus Botalli.

General disorders and administration site conditions

Rare: febrile conditions; following i.m. injection local reactions such as pain may appear.

Investigations

Rare: serum cholesterol and triglyceride levels may rise during furosemide treatment.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via:

  • Saudi Arabia

The National Pharmacovigilance Centre (NPC)

SFDA Call Center: 19999

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

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

  • Other GCC States

Please contact the relevant competent authority.


The clinical picture in acute or chronic overdose depends primarily on the extent and consequences of electrolyte and fluid loss, e.g. hypovolaemia, dehydration, haemoconcentration, cardiac arrhythmias - including AV blockage and ventricular fibrillation) due to excessive diuresis.

Symptoms:
Symptoms of these disturbances include severe hypotension (progressing to shock), acute renal failure, thrombosis, delirious states, flaccid paralysis, apathy and confusion.

Treatment:
At the first signs of shock (hypotension, sudoresis, nausea, cyanosis) the injection should be immediately interrupted, place the patient head down and allow free breathing.

Fluid replacement and correction of the electrolyte imbalance; monitoring of metabolic functions, and maintenance of urinary flux.

Medicinal treatment in case of anaphylactic shock: dilute 1 ml of 1:1000 adrenaline solution in 10 ml and inject slowly 1 ml of the solution (corresponding to 0.1 mg of adrenaline), control pulse and tension and monitor eventual arrhythmias. Adrenaline administration may be repeated, if necessary. Subsequently, inject intravenously a glucocorticoid (for example 250 mg of methylprednisolone), repeating if necessary.

Adapt the above-mentioned dosages for children, according body weight.

Correct hypovolaemia with available means and complement with artificial ventilation, oxygen and in case of anaphylactic shock with anti-histamines.

No specific antidote to furosemide is known. If overdose during parenteral treatment has taken place, in principle the treatment consists on follow up and supportive therapy. Haemodialysis does not accelerate furosemide elimination.

 


Pharmacotherapeutic group: Diuretics; Sulfonamides, plain,

ATC code: C03CA01

Furosemide is a strong diuretic agent of fast action. From a pharmacological point of view, furosemide inhibits the co-transport system (reabsorption) of the following electrolytes Na+, K+ and 2CL-, located on the luminal cell membrane on the ascending limb of the loop of Henle. Consequently, furosemide´s efficiency depends on the drug reaching the tubular lumen through an anionic transport mechanism. The diuretic effect results on the inhibition of sodium chloride reabsorption in this segment of the loop of Henle. As a result, the fraction of excreted sodium may ascend to 35% of sodium glomerular filtration. The secondary effects of increased elimination of sodium are: increase of urinary excretion and increase of potassium distal secretion at the distal tube. Excretion of calcium and magnesium salts is also increased.

Furosemide inhibits the feedback mechanism in the dense macula and induces dose-dependent stimulation of the renin-angiotensin-aldosterone system.

In case of heart failure, furosemide induces an acute reduction of cardiac pre-load (through the enlargement of the blood vessels capacity). This early vascular effect seems to be mediated by prostaglandins and assumes an adequate renal function with activation of the renin-angiotensin system and an intact synthesis of prostaglandins. Due to its natriuretic effect, furosemide reduces the vascular reactivity to catecholamine that is increased in hypertensive patients

The diuretic effect of furosemide is established within 15 minutes of an intravenous administration.
A dose-dependent increase in diuresis and natriuresis was found in healthy individuals to whom furosemide was administerd (doses between 10 and 100 mg). The duration of action in healthy individuals after the administration of an intravenous 20 mg dose of furosemide is approximately 3 hours and 3 to 6 hours, when an oral 40 mg dose is given.
In ill patients, the relation between tubular concentration of free furosemide and bound furosemide (determined through the urine excretion rate) andits natriuretic effect is translated in a sigmoid graphic, with a minimum effective excretion rate of approximately 10 micrograms per minute. Consequently, a continuous infusion of furosemide is more effective than repeated bolus injections. Above a certain bolus administration dose, the drugs effects do not significantly increase. The efficacy of furosemide is decreased in cases of reduced tubular secretion or in cases of intra-tubular binding of the drug to albumin.


Distribution
Furosemide distribution volume is 0.1 to 1.2 litres per kg of body weight. The distribution volume may be increased depending on the concomitant illness.
Protein binding (mostly to albumin) is higher than 98%.

Elimination
Furosemide is mostly eliminated as the non-conjugated form, mainly through secretion at the proximal tube. After intravenous administration, 60% to 70% of furosemide is eliminated by this manner. The glucuronic metabolite of furosemide represents 10% to 20% of the recovered substances in the urine. The remaining dose is eliminated in the faeces, probably after biliary secretion. After intravenous administration, the plasma half-life of furosemide ranges from 1 to 1.5 hours.
Furosemide is excreted in breast milk. It crosses the placental barrier transferring itself slowly to the foetus. Furosemide achieves similar concentrations in the mother, foetus and newborn.

Renal impairment
In case of renal impairment, furosemide´s elimination is slower and its half-life is increased. In patients with end-stage renal disease the average half-life is 9.7 hours. In several multi-organ failure the half life may range from 20-24 hours.
In case of nephrotic syndrome, the lower concentration of plasma proteins leads to higher concentrations of unbound furosemide . On the other hand, the efficiency of furosemide is reduced in these patients, due to intratubular albumin binding and to reduced tubular secretion.
Furosemide exhibits low dialysis in patients undergoing haemodialysis, peritoneal dialysis or CAPD (Chronic Ambulatory Peritoneal Dialysis).

Hepatic impairment
In case of hepatic impairment, furosemide´s half-life increases 30% to 90%, mainly due to the higher distribution volume. Biliary elimination might be reduced (up to 50%). In this group of patients, there is a wider variability of the pharmacokinetic parameters.

Congestive heart failure, severe hypertension, elderly
Furosemide elimination is slower due to reduced renal function in patients with congestive heart failure, severe hypertension or in elderly.

Premature infants and new-born
Depending on the maturity of the kidney, elimination of furosemide may be slow. In case of children with insufficient capacity of glucuronidation, the metabolism of the drug is also reduced. In term neonates the half-life is generally less than 12 hours.


Chronic toxicity studies in the rat and dog led to renal alterations (among others fibrous degeneration and renal calcification). Furosemide did not show genotoxic or carcinogenic potential.

In reproductive toxicology studies, a reduced number of differentiated glomeruli, skeletal anomalies of the scapulae, humerus and ribs (induced by hypokalaemia) were seen in fetal rats, as well as hydronephrosis that occurred in fetal mice and rabbits after administration of high doses. The results of a mouse study and one of the three rabbit studies showed an increased incidence and severity of hydronephrosis (distention of the renal pelvis and, in some cases, of the ureters) in fetuses derived from the treated dams as compared with those from the control group.

Preterm rabbits given furosemide had a higher incidence of intraventricular haemorrhage than saline-treated littermates, possibly due to furosemide-induced intracranial hypotension.

 


-        Sodium chloride

-        Sodium hydroxide 

-        Hydrochloric acid

-        Water for injection


Furosemide may precipitate out of solution in fluids of low pH This medicinal product should not be mixed with other medicinal products except those mentioned in section 6.6.


60 months. After first opening: Once opened the product should be used immediately. After dilution: Chemical and physical in-use stability has been demonstrated for 24 hours at 25°C, protected from light. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.

Store below 25°C.

Store in the original package in order to protect from light.

After dilution: Chemical and physical in-use stability has been demonstrated for 24 hours at 25°C, protected from light.


Type I amber glass ampoules.

Pack size: 5 ampoules (2 ml).


Diusemide Injection diluted to 1 mg/ml is compatible with Sodium Chloride Injection or Lactated Ringer’s solution for Injection for 24 hours at room temperature, protected from light. The dilution of the solution for injection is to be made under aseptic conditions.

The solution is to be inspected visually for particulate matter and discoloration prior to administration. The solution should only be used if the solution is clear and free from particles. Any unused product or waste material should be disposed of in accordance with local requirements. For single use only, discard any remaining contents after use.

Furosemide should not be mixed with any other drugs in the injection bottle.


Jazeera Pharmaceutical Industries Al-Kharj Road P.O. Box 106229 Riyadh 11666, Saudi Arabia Tel: + (966-11) 8107023, + (966-11) 2142472 Fax: + (966-11) 2078170 e-mail: SAPV@hikma.com

09 July 2023
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