Zithromax (azithromycin 500 mg) vial ….. Broad spectrum Antibiotic

Zithromax vial (azithromycin 500 mg/ vial) belongs to a group of medicines called macrolide antibiotics, Antibiotics are used to treat infections caused by micro-organisms like bacteria, Azithromycin is used for the treatment of certain infections caused by bacteria.

Azithromycin is an azalide, a sub-class of the macrolide antibiotics. By binding to the 50-S ribosomal sub-unit, azithromycin avoids the translocation of peptide chains from one side of the ribosome to the other. As a consequence of this, RNA-dependent protein synthesis in sensitive organisms is prevented.

Zithromax 500 mg Vial

 What Zithromax is used for? 

Zithromax vial is used for the treatment of certain infections caused by bacteria that are sensitive to it, such as:

  • Acute bacterial sinusitis (adequately diagnosed).
  • Acute bacterial otitis media (adequately diagnosed).
  • Pharyngitis, tonsillitis.
  • Acute exacerbation of chronic bronchitis (adequately diagnosed).
  • Mild to moderately severe community acquired pneumonia.
  • Infections of the skin and soft tissues of mild to moderate severity e.g. folliculitis, cellulitis, erysipelas.
  • Uncomplicated Chlamydia trachomatis urethritis and cervicitis.

You must talk to a doctor if you do not feel better or if you feel worse.

What you need to know before you take Zithromax?

Do not take Zithromax if:

  • you are allergic to azithromycin dihydrate, erythromycin or any macrolide or ketolide antibiotic
  • you are allergic to any of the other ingredients of this medicine.
  • you has history of cholecystitis jaundice/ hepatic dysfunction associated with preior use of Zithromax.

Warnings and precautions

Talk to your doctor or pharmacist before taking Zithromax if:

  • you have severe liver or kidney problems.
  • you have severe heart problems or problems with your heart beat such as long QT syndrome (shown on an electro-cardiogram or ECG machine).
  • your blood levels of potassium or magnesium are too low.
  • you develop signs of another infection.
  • you are taking any ergot derivatives such as ergotamine (to treat migraine).
  • you have a certain type of muscle weakness called myasthenia gravis.
  • you have nervous (neurological) or mental (psychiatric) problems.

Tell your doctor immediately:

  • if you feel your heart beating in your chest or have an abnormal heartbeat, get dizzy or faint, or suffer from muscle weakness when taking Zithromax.
  • if you develop diarrhoea or loose stools during or after treatment, tell your doctor at once. Do not take any medicine to treat your diarrhoea without first checking with your doctor. If your diarrhoea continues, please inform your doctor.
  • if you feel you are having an allergic reaction (e.g. difficulty in breathing, dizziness, swelling of the face or throat, rash, wheals, blistering). Stop taking this medicine and seek urgent medical advice.
  • if you develop signs of liver problems (e.g. dark urine, profound loss of appetite or yellowing of the skin or whites of the eyes). Stop taking this medicine and seek urgent medical advice.
  • if you are giving this medicine to an infant (less than 6 weeks of age) and they vomit or become irritable when fed.

Other medicines and Zithromax

Tell your doctor if you are taking, have recently taken or might take any other medicines.

Tell your doctor or pharmacist if you are taking any of the following medicines:

  • antacids – used for heartburn and indigestion. Zithromax should be taken at least 1 hour before or 2 hours after the antacid.
  • ergotamine – (used for migraine) should not be taken at the same time as serious side effects may develop (with numbness or tingling sensations in the limbs, muscle cramps, headaches, convulsions, abdominal or chest pain).
  • cholesterol lowering medicines (statins).
  • warfarin or similar medicines – used to thin the blood. Zithromax can thin the blood even more.
  • cisapride – (used to treat stomach problems) should not be taken at the same time as this may cause severe heart problems (shown on an electrocardiogram or ECG machine).
  • terfenadine – (used to treat hay fever) should not be taken at the same time as this may cause severe heart problems (shown on an electro-cardiogram or ECG machine).
  • zidovudine or nelfinavir – used to treat HIV infections. Taking nelfinavir with Azithromycin (Zithromax) may mean that you get more of the side effects.
  • rifabutin – used to treat tuberculosis (TB).
  • quinidine – used to treat heart rhythm problems.
  • cyclosporine – used to stop your body rejecting an organ transplant. Your doctor will regularly check your blood levels of cyclosporine and may change your dose.

Tell your doctor or pharmacist if you are taking any of the following medicines. Zithromax can make the effects of these other medicines stronger. Your doctor may change your dose:

  • alfentanil – a painkiller used e.g. during operations.
  • theophylline – used for breathing problems such as asthma and chronic obstructive pulmonary disease (COPD).
  • digoxin – used to treat heart problems.
  • astemizol – used to treat hay fever.
  • pimozide – used to treat mental health problems.

Pregnancy, breast-feeding and fertility

  • If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
  • There is insufficient information available about the use of Azithromycin (Zithromax ) during pregnancy. Therefore you should not use Zithromax during pregnancy, unless explicitly advised by your doctor.
  • Azithromycin (Zithromax) is partially passed through the mother’s milk. It is not known whether azithromycin may have adverse effects on the breast-fed infant. Breastfeeding should therefore be discontinued during treatment with Azithromycin.
  • It is recommended to discard the milk during treatment and up until 2 days after discontinuation of treatment. Breast-feeding may be resumed thereafter.

Driving and using machines

There are no data available about the influence of Azithromycin (Zithromax) on the ability to drive or operate machines. However Zithromax vial may cause dizziness and seizures so make sure you are not affected before driving or operating machinery.

 what is the recommended dose of  Zithromax?

Always take this medicine exactly as your doctor or pharmacist has told you, Check with your doctor or pharmacist if you are not sure.

The recommended dose:

  • For adults, children and adolescents with a body weight of 45 kg or over: 500 mg ( one vial intravenous -IV infusion) once daily during three days with a total dose of 1500 mg. Your doctor may decide to prescribe the total dose of 1500 mg during a period of 5 days, with 500 mg the first day and one vial of 250 mg on days 2 to 5. 
  • For infections of the neck of the womb and urethra caused by Chlamydia trachomatis: One dose of 1000 mg(2 vial intravenous -IV infusion), to be taken one time.
  • Children and adolescents under 45 kg: 5 – 10 mg/ kg once daily (intravenous -IV infusion)
  • Patients with kidney or liver problems: You should tell your doctor if you have kidney or liver problems as your doctor may need to alter the normal dose.
  • Dosage for elderly: For elderly the same dosage as for adults applies.

Method of administration

  • Zithromax  vial taken only by intravenous (IV) infusion and not suitable for intramuscular injection..
  • Add the solvent solution to the dry powder in the vial.
  • Doctors sometimes prescribe different doses to the recommended dose. The label on the pack will tell you which dose you should take. If you are still not sure, ask your doctor or pharmacist.
  • Always continue with the course even if you 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 take more Zithromax than you should (Over dose)

  • If you have taken too much Zithromax, contact your doctor, pharmacist or go to your nearest hospital at once.
  • Symptoms of overdose are loss of hearing, feeling sick or being sick and diarrhoea. In case of overdosage admission into hospital may be necessary.

If you forget to take Zithromax

  • If you forget to take Zithromax, take your dose as soon as possible. If it is almost time for the next dose, just skip that dose and take the next one when it is due. If in doubt, please contact your doctor or pharmacist. If you have to skip a dose, still take all of your vial. This means that you will finish your course a day later.
  • Do not take a double dose to make up for a forgotten dose.

If you stop taking Zithromax

  • Never stop the treatment with Zithromax on your own, but first discuss this with your doctor. If the prescribed treatment is not completely finished, the infection may come back again.
  • If you have any further questions on the use of this medicine, ask your doctor or pharmacist

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you have any of the below symptoms of a severe allergic reaction stop taking this medicine and tell your doctor immediately or go to the casualty department at your nearest hospital. The frequency of these reactions is not known (frequency cannot be estimated from the available data):

  • Sudden difficulty in breathing, speaking and swallowing.
  • Swelling of the lips, tongue, eyelids, face and neck.
  • Extreme dizziness or collapse.
  • Severe or itchy skin rash, especially if this shows blistering and there is soreness of the eyes, mouth or genital organs.
  • Skin rash, fever, swollen glands, increase in a type of white blood cell (eosinophilia) and inflammation of internal organs (liver, lungs, heart, kidneys and large intestine) as they may be signs of a hypersensitivity reaction (Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)).

 If you experience any of the following side effects contact your doctor as soon as possible:

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

  • Increased or reduced urine output, or traces of blood in your urine
  • Skin eruption that is characterised by the rapid appearance of red skin studded with small pustules (small blisters filled with white/yellow fluid).
  • Vomiting and diarrhoea can rarely cause dehydration. It is important to drink plenty of fluid if you experience sickness and/or diarrhoea.
  • Diarrhoea that is serious, lasts a long time or has blood in it, with stomach pain or fever. This can be a sign of a serious bowel inflammation. This is something that can occasionally happen after taking antibiotics.
  • Yellowing of the skin or whites of the eyes caused by liver problems.
  • Inflammation of the pancreas, which causes severe pain in the abdomen and back.
  • Skin rash caused by sensitivity to sunlight.
  • Unusual bruising or bleeding.
  • Rapid or irregular heartbeat.
  • Low blood pressure.

These are all serious side effects. You may need urgent medical attention.

Other side effects include:

Very common (may affect more than 1 in 10 people):

  • diarrhoea
  • abdominal pain.
  • feeling sick (nausea).
  • loose wind (flatulence).

Common (may affect up to 1 in 10 people):

  • lack of appetite (anorexia).
  • feeling dizzy.
  • headache.
  • sensation of pins and needles or numbness (paraesthesia).
  • changes in your sense of taste.
  • visual impairment.
  • deafness.
  • being sick (vomiting), stomach pain or cramps, loss of appetite, problems digesting your food.
  • skin rashes and itching.
  • joint pain (arthralgia).
  • fatigue.
  • change in the quantity of the white blood cells and the concentration of bicarbonate in the blood.

Uncommon (may affect up to 1 in 100 people):

  • thrush (candidiasis) – a fungal infection.
  • bacterial infection.
  • inflammation of the throat (pharyngitis).
  • breathlessness, chest pain, wheeze and cough (respiratory disorder).
  • inflammation of the mucous membrane inside the nose (rhinitis).
  • stomach flu (gastroenteritis).
  • inflammation inside your vagina (vaginitis).
  • pneumonia.
  • reduction in the number of white blood cells.
  • angioedema.
  • hypersensitivity.
  • nervousness.
  • reduced sense of touch (hypoaesthesia).
  • feeling drowsy (somnolence).
  • having difficulty sleeping (insomnia).
  • ear disorder.
  • spinning sensation (vertigo).
  • hearing loss or ringing in your ears.
  • palpitations, chest pain.
  • hot flushes.
  • general loss of strength.
  • shortness of breath.
  • nosebleed.
  • inflammation of the lining of the stomach (gastritis).
  • constipation.
  • difficulty swallowing.
  • swollen abdomen.
  • dry mouth.
  • belching.
  • indigestion.
  • mouth ulcer.
  • increased salivary flow.
  • liver problems such as hepatitis.
  • allergic skin reactions such as being sensitive to sunlight, red, flaking and swollen skin.
  • severe form of skin flushing.
  • inflammation of the skin (dermatitis).
  • dry skin.
  • increased sweating.
  • pain, swelling and reduced motion in your joints (osteoarthritis).
  • muscle pain.
  • back pain.
  • neck pain.
  • increase in blood urea levels.
  • painful or difficult urination.
  • pain in the upper back (renal pain).
  • spotting.
  • testicular disorder.
  • urticaria.
  • chest pain.
  • face swelling.
  • fever.
  • pain, numbness, muscle weakness, burning or tingling sensation (peripheral pain).
  • swelling (oedema).
  • general feeling of being unwell (malaise).
  • weakness (asthenia).
  • change in liver enzyme levels and blood levels.
  • post procedural complications.

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

  • feeling agitated, feeling of unreality to the self and own feeling.
  • abnormal hepatic function.
  • allergic skin reactions.
  • swelling of the hands, feet, lips, genitals or throat (angioneurotic oedema)
  • kidney problems.
  • a delayed allergic reaction (up to several weeks after exposure) with rash and other possible symptoms such as swelling of the face, swollen glands and abnormal test results (e.g. liver tests and raised level of some white blood cells).
  • gut (colon) infection (pseudomembranous colitis).
  • reduced number of red blood cells due to destruction (haemolytic anaemia); reduction in number of platelets (thrombocytopenia).
  • anaphylactic reaction.
  • feeling angry, aggressive.
  • anxiety.
  • confusion.
  • hallucinations.
  • fainting (syncope).
  • fits (convulsions).
  • feeling hyperactive.
  • severe or prolonged diarrhoea, which may have blood or mucus in it, during or after treatment with Zithromax as this may be a sign of serious bowel inflammation.
  • change in your sense of smell (anosmia, parosmia).
  • change in your sense of taste (ageusia).
  • exacerbation or aggravation of muscle weakness (myasthenia gravis).
  • rapid (ventricular tachycardia) or irregular heart beat, sometimes being life threatening, changes of the heart rhythm found by an electro-cardiogram (QT prolongation and torsade de pointes).
  • low blood pressure.
  • inflammation of the pancreas (pancreatitis).
  • inflammation of the kidney or kidney failure.
  • your tongue and teeth changes colour.
  • liver failure.
  • allergic skin reactions.
  • blistering of the skin, severe skin reaction.

How to store Zithromax?

  • Keep this medicine out of the sight and reach of children.
  • Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
  •  Store below 25°C. Store in the original packaging to protect from moisture.
  • This medicinal product does not require any special storage conditions.
  • 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.

For Arabic Information

 زيثروماكس فيال- معلومات باللغة العربية

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