Clarithromycin 500 Mg Powder For Solution For Infusion
PACKAGE LEAFLET: INFORMATION FOR THE USER
Clarithromycin 500 mg Powder for Infusion
Read all of this leaflet carefully before you start using this medicine.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
If any of the side effects gets serious, or you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Clarithromycin Powder for Infusion is and what it is used for
2. Before you use Clarithromycin Powder for Infusion
3. How to use Clarithromycin Powder for Infusion
4. Possible side effects
5. How to store Clarithromycin Powder for Infusion
6. Further information
1. WHAT CLARITHROMYCIN POWDER FOR INFUSION IS AND WHAT IT IS USED FOR
Clarithromycin Powder for Infusion is an antibiotic medicine. The medicine is presented in the form of a powder for solution for infusion i.e. a powder, which is made into a solution, which can be given as a slow injection via a drip.
Clarithromycin Powder for Infusion is a type of antibiotic called macrolides. Antibiotics stop the growth of bacteria (bugs) which cause infections. It is used when an intravenous (injection into a vein) antibiotic is required to treat severe infections.
It is used to treat infections such as
• Chest infections e.g. bronchitis, pneumonia
• Throat and sinus infections
• Skin and tissue infections
2. BEFORE YOU USE CLARITHROMYCIN POWDER FOR INFUSION Do not use Clarithromycin Powder for Infusion if you;
• know that you are allergic (hypersensitive) to clarithromycin or other macrolide antibiotics (such as erythromycin or azithromycin) or any of the other ingredients in the product.
• are taking medicines called ergotamine or dihydroergotamine tablets, or use ergotamine inhalers for migraine. Consult your doctor for advice on alternative medicines.
• are taking medicines called terfenadine and astemizole (widely taken for hay fever and allergies) or cisapride (for stomach disorders) or pimozide (for mental problems) as combining these drugs can sometimes cause serious disturbances in heart rhythm. Consult your doctor for advice on alternative medicines.
• are taking other medicines which are known to cause serious disturbances in heart rhythm.
• are taking simvastatin (to reduce cholesterol levels)
• know that your blood potassium or magnesium is abnormally low (hypokalaemia or hypomagnesaemia)
• you have severe liver problems
• You or someone in your family has a history of heart rhythm disorders (ventricular cardiac arrhythmia including torsade de pointes) or abnormality or electrocardiogram (ECG, electrical recording of the heart) called “long QT syndrome”
Take special care with Clarithromycin Powder for Infusion if:
• you have liver or kidney problems
• you have H. pylori Infection
• you have or have had an allergic reaction to certain other antibiotics (lincomycin and clindamycin). There is a risk of an allergic reaction to Clarithromycin as well (crosshypersensitivity).
• you have heart problems (such as coronary vessel disease, slow or irregular heart beat or a weak heart) or if medicinal products are used at the same time which may affect the heart beat.
• you have low blood values or potassium and/or magnesium. The rhythm of heartbeat may become affected in such cases.
• you have myasthenia gravis (a disease affecting muscle functions) symptoms may become more severe if clarithromycin is used.
• you are taking colchicines (medicine used for the treatment of gout)
If you have any of the following conditions speak to your doctor before using Clarithromycin.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Do not take Clarithromycin if you are taking any one of the following medicines:
-terfenadine or astemizole (for hay fever or allergy),
-cisapride (for stomach disorders),
-pimozide (for certain severe mental disorders),
-ergotamine or dihydroergotamine (for hypotension and migraine),
-colchicine (usually taken for gout),
Combining Clarithromycin with these drugs may cause serious disturbances in heartbeat rhythm or serious side effects.
If taken with Clarithromycin, the levels and therefore the effects of the following listed medicines may be increased:
• Digoxin, quinidine or disopyramide (heart drugs)
• Warfarin (blood thinner )
• Ergotamine or dihydroergotamine (used for migraine)
• Carbamazepine, valproate or phenytoin (drugs for epilepsy)
• Colchicine (for gout)
• Theophylline (helps breathing)
• Terfenadine or astemizole (for hay fever or allergy)
• Triazolam, alprazolam or midazolam (sedatives, known as benzodiazepines)
• Lovastatin or simvastatin (drugs for high cholesterol)
• Cisapride or omeprazole (for stomach disorders) and
• Pimozide (an antipsychotic drug)
Clarithromycin may interact with the anti-viral (HIV) drugs in the following manner:
• Clarithromycin may lower the levels of zidovudine.
• Ritonavir may increase the levels of Clarithromycin.
• Atazanavir and Saquinavir: taking these drugs with Clarithromycin may increase both the levels of Atazanavir (or Saquinavir) and Clarithromycin.
• Nevirapine and Efavirenz may lower the levels of Clarithromycin.
Other interactions include:
• Rifabutin (an antibiotic effective against some infections) may lower the levels of Clarithromycin.
• Itraconazole (anti-fungal drug) taken together with Clarithromycin may increase the levels of both medicines.
• Fluconazole, another anti-fungal drug, may increase the level of Clarithromycin.
• Ketoconazole (anti-fungal drug)
• Sildenafil, tadalafil or vardenafil (for treating erectile dysfunction). Taking these drugs with Clarithromycin may increase both their levels.
• Tolterodine (to treat symptoms of overactive bladder syndrome). In certain patients, the levels of tolterodine may be increased when taken with Clarithromycin.
• Insulin (and other anti-diabetic products may lower blood sugar levels when taken with Clarithromycin.
• Glibenclamide (anti-diabetic drug)
• Vinblastine (a chemotherapy agent used to treat cancer).
• Ziprasidone (and antipsychotic drugs).
• Eletriptan (used for migraine).
• Halofantrine (used to treat malaria).
• Aprepitant (used to prevent vomiting during chemotherapy).
• Cilostazol (used to improve circulation in the legs).
• Rifampicin (to treat tuberculosis).
• Any beta-lactam antibiotics and
• Tacrolimus or cyclosporin (for organ transplants)
• St. John’s Wort (herbal product to treat depression).
• Phenobarbital (drug for epilepsy).
• Quetiapine (and atypical antipsychotics).
• Atorvastatin and cerivastatin (statins)Methylprednisolone (to treat inflammatory conditions)
• Sirolimus (for organ transplants)
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
Experience of treating pregnant women and nursing mothers is limited. Pregnant women and nursing mothers should be treated only if the expected benefits outweighs the possible risks.
Driving and using machines
Do not drive or use machines, if you suffer from one of the following side effects: dizziness, confusion or disorientation.
3. HOW TO USE CLARITHROMYCIN POWDER FOR INFUSION
Clarithromycin Powder for Infusion is prepared by dissolving the powder in the vial in sterile water. The solution is then added to a larger volume of a solution such as sodium chloride 0.9% before it is given to you. It will be given to you by a slow injection via a drip into a vein over 60 minutes.
This medicine will usually be given for two to five days, and should be changed to oral clarithromycin treatment (tablets) when appropriate.
Treatment for Adults and the Elderly:
The usual dose is 1.0 gram daily split into two 500 mg doses.
Children under 12 years old:
This medicine is not recommended for children.
Patients with kidney problems:
Your doctor will be especially careful when giving you this medicine if your kidneys are not working properly, and the dose will be reduced.
If you are concerned about how much medicine you have been given or how often you have been given it, please tell your doctor or nurse.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Clarithromycin Powder for Infusion can cause side effects, although not everybody gets them.
If any of the following happen, tell the doctor immediately:
• Liver failure leading to death might happen if you already have liver disease or are taking certain other medicines that can damage your liver.
• Allergic reactions ranging from mild itchy skin eruption to shock (drop of blood pressure, restlessness, weak rapid pulse, clammy skin, reduced consciousness). These allergic reactions may occur uncommonly.
• severe prolonged diarrhoea. This may indicate a very rare inflammation of the large intestine (pseudomembranous colitis).
• a severe hypersensitivity reaction involving mucous membranes, with (high) fever, red spotted skin, joint pain and or inflammation of the eyes (Steven-Johnson syndrome) or if you experience a severe sudden hypersensitivity reaction with fever and skin blisters/skin disintegration (toxic epidermal necrolysis). These serious side effects may occur very rarely.
Other possible side effects include:
Common side effects (seen in more than 1 in 100 patients, but less than 1 in 10) include:
• Redness, tenderness or pain around the injection site
• Stomach problems such as nausea, vomiting, indigestion, stomach pains_or diarrhoea.
• Change in sense of smell and taste
• Inflammation of the mouth or tongue, tongue discolouration, thrush in the mouth (causing soreness of the mouth sometimes accompanied by white spots)
• Teeth discolouration (this can usually be corrected by professional cleaning)
• Headache
• Changes in blood test levels
Uncommon side effects (seen in more than 1 in 1,000 patients, but less than 1 in 100) include:
• Depression
• Joint and muscle pain
• Decrease in the number of a type of blood cell (leucocytes), which makes infections more likely
• Allergic reactions which may range from skin rash, swollen itchy skin and skin eruptions to difficulty in breathing and dizziness
• Liver or gall bladder problems, yellowing of the skin or eyes (jaundice)
Rare side effects (seen in more than 1 in 10,000 patients but less than 1 in 1,000) include:
• Ringing in the ears (tinnitus)
Very rare side effects (seen in less than 1 person in 10,000) include:
• Difficulty sleeping, bad dreams, hallucinations, disorientation
• Confusion, depersonalisation, change in the sense of reality and feeling panicky
• Dizziness, vertigo, numbness or pins and needles, fits (convulsions)
• Changes in heart beat/rhythm
• Hearing loss (usually reversible on withdrawal of treatment)
• Low blood sugar levels or a “hypo” in diabetic patients
• Kidney problems
• Liver problems
• Nausea, vomiting, abdominal pain and back pain (pancreatitis)
• Reduction in blood cells (thrombocytopenia) with bruises and tendency to bleed
Not known: frequency cannot be estimated from the available data
• Life threatening irregular heartbeat
Clarithromycin may worsen the symptoms of myasthenia gravis (a condition in which the muscles become weak and tire easily) in patients who already suffer from this condition.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
5. HOW TO STORE CLARITHROMYCIN POWDER FOR INFUSION
For single use. Discard any unused contents.
Keep the vial in the outer container in order to protect from light.
Keep out of the reach and sight of children.
Do not use Clarithromycin Powder for Infusion after the expiry date which is stated on the label and carton. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION
What Clarithromycin Powder for Infusion contains
• The active substance is clarithromycin
• The other ingredient is lactobionic acid
What Clarithromycin Powder for Infusion looks like and contents of the pack
Clarithromycin Powder for Infusion is an antibiotic medicine. The medicine is presented in the form of a powder for solution for infusion i.e. a powder which is made into a solution which can be given as a slow injection via a drip.
Each vial of Clarithromycin Powder for Infusion contains 500 mg of clarithromycin. It is available in packs of 1, 4 and 6 vials. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Mylan, Potters Bar, Hertfordshire, EN6 1TL, UK
Manufacturer
Agila Specialties Polska Sp z o o, Poland This leaflet was last revised in 01/2016
The following information is intended for medical or healthcare professionals only:
Route of administration
For intravenous administration only. Must be reconstituted and diluted before use.
Incompatibilities
None known. However, clarithromycin should only be diluted with the diluents recommended in Preparation Instructions.
Preparation Instructions
Clarithromycin should be administered into one of the larger proximal veins as an IV infusion over 60 minutes, using a solution concentration of about 2 mg/ml. Clarithromycin should not be given as a bolus or an intramuscular injection.
Reconstitution of powder (Step 1)
Add 10 ml of sterile Water for Injections into the vial and shake.
Dilution (Step 2)
Add 10 ml of the reconstituted solution from Step 1 to 250 ml of a suitable diluent to provide a 2 mg/ml solution.
Recommended diluents
5% dextrose in Lactated Ringer's Solution
5% dextrose
Lactated Ringer's solution 5% dextrose in 0.3% sodium chloride 5% dextrose in 0.45% sodium chloride 0.9% sodium chloride
Dosage and Administration
Intravenous therapy may be given for 2 to 5 days and should be changed to oral clarithromycin therapy when appropriate.
Adults: The recommended dosage of clarithromycin is 1.0 gram daily, divided into two 500 mg doses, appropriately diluted as described above.
Children: At present, there are insufficient data to recommend a dosage regimen for routine use in children.
Elderly: As for adults.
Renal Impairment: In patients with renal impairment who have creatinine clearance less than 30ml/min, the dosage of clarithromycin should be reduced to one half of the normal recommended dose.
Recommended administration:
Clarithromycin should be administered into one of the larger proximal veins as an IV infusion over 60 minutes, using a solution concentration of about 2 mg/ml. Clarithromycin should not be given as a bolus or an intramuscular injection.
Special Precautions for Storage
As packaged for sale: Store the vial in the outer carton.
In use:
After reconstitution with 10 ml of Water for Injections, chemical and physical in-use stability has been demonstrated for 24 hours at 5°C - 25°C.
After dilution in 250 ml of a recommended diluent, chemical and physical stability has been demonstrated for 6 hours at 25°C or 24 hours at 5°C.
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 2-8°C, unless reconstitution/dilution has taken place in controlled and validated aseptic conditions.