CLARITHROMYCIN 500 MG POWDER FOR SOLUTION FOR INFUSION - patient leaflet, side effects, dosage

Clarithromycin

Read all 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 your pharmacist.

• – This medicine has been prescribed for you. Do not pass it on to others. It may harm them even if their symptoms are the same as yours.

• – If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or your pharmacist. See section 4.

What is in this leaflet:

• 1. What Clarithromycin is and what it is used for

• 2. What you need to know before you use Clarithromycin

• 3. How to use Clarithromycin

• 4. Possible side effects

• 5. How to store Clarithromycin

• 6. Contents of the pack and other information

1. What Clarithromycin is and what it is used for

Clarithromycin contains the active substance clarithromycin and is an antibiotic that belongs to a group of substances called “macrolide antibiotics”. Antibiotics inhibit the growth of bacteria (germs) that cause infections.

Clarithromycin is indicated whenever an intravenous (injection into the vein) antibiotic is required to treat severe infections or, alternatively, if a patient cannot swallow tablets.

It is used to treat infections such as:

• 1. Chest infections such as bronchitis and pneumonia

• 2. Throat and sinus infections

• 3. Skin and tissue infections

Clarithromycin is indicated in adults and children 12 years and older.

2. what you need to know before you use clarithromycin

Do not use Clarithromycin:

• - if you are allergic to clarithromycin

• – if you are taking tricagrelor or ranolazine

• – if you are taking any of the following medicinal products:

Astemizole (for allergic rhinitis and allergies), cisapride (for stomach problems), pimozide (for psychiatric disorders), terfenadine (for allergic rhinitis and allergies) as this may cause specific heart problems (e.g. QT prolongation and cardiac arrhythmias, including ventricular tachycardia, ventricular fibrillation, and torsade de pointes) and midazolam – if you suffer from hypokalaemia (low potassium concentration in the blood)

• – if you suffer from severe hepatic failure in combination with renal impairment

• – if you suffer from QT prolongation (congenital or documented acquired) or ventricular cardiac arrhythmia, including torsades de pointes, in the past

• – if you are taking statins (e.g. HMG-CoA reductase inhibitors as lovastatin or simvastatin), to lower your blood cholesterol-level), as concomitant use may cause severe muscle problems.

• – if you are taking ergotamine or dihydroergotamine (medicines for migraine headaches)

• – if you are taking colchicine (for treatment of gout)

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using Clarithromycin

• - if you suffer severe or prolonged diarrhea during or after the treatment with this medicine, ask your doctor immediately.

• – if you suffer from coronary artery disease, severe cardiac insufficiency or bradycardia

• – if you taking other medicinal products with a QT-prolongation effect.

• – if you have hepatic insufficiency

• – if you have moderate to severe kidney disease

• – if you are taking other macrolides, such as lincomycin and clindamycin

• – if you are an elderly patient.

Use in children and adolescents

Children and adolescents (aged under 18 years) should not be given this medicine. Your doctor will prescribe another medicine for your child.

Other medicines and Clarithromycin

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

• – Rifampicin (antibiotic)

• – Carbamazepine, valproate,phenytoin or phenobarbital (medicinal products for epilepsy).

• – St John’s wort (treatment for depression)

• – Efavirenz (antiretroviral agent)

• – Nevirapine (anti-viral medicine (anti-HIV))

• – Rifabutin (for the treatment of some infections).

• – Rifapentine (antibiotic)

• – Etravirine (antiretroviral agent)

• – Fluconazole (treatment for fungal infections)

• – Ritonavir (anti-viral medicine (anti-HIV))

• – Digoxine, quinidine or disopyramide (medicines for the heart)

• – Sildenafil, Tadalafil, Vardenafil(for erectile dysfunction).

• – Theophylline (it makes breathing easier)

• – Tolterodine (used for symptomatic treatment of urinary incontinence)

• – Aminoglycosides (antibacterial agents)

• – Triazolam, alprazolam or midazolam (sedative medicinal products)

• – Oral hypoglycemic agents (antidiabetic medicinal products)

• – Insulin (antidiabetic medicinal product)

• – Omeprazole (for stomach problems)

• – CYP3 A-based interactions (medicinal product interaction in oncology)

• – Cilostazol (for circulation problems)

• – Cyclosporine (immunosuppressant)

• – Methylprednisolone (a corticosteroid)

• – Warfarin or other anticoagulant medicinal products

• – Tacrolimus (for organ transplants).

• – Vinblastine (for treatment of cancer)

• – Antiarrhythmics (treatment for cardiac arrhythmias

• – Ataznavir (antiretroviral medicinal product)

• – Calcium channel blockers (e.g. Verapamil, Amlodipine,Dil­tiazem)

• – Itraconazol (antifungal agent)

• – Saquinavir (antiretroviral medicinal product)

• – Zidovudine (anti-viral agent)

Clarithromycin does not interact with oral contraceptives.

Pregnancy and breast-feeding

The safety of clarithromycin during pregnancy and breast-feeding has not been established. Do not use this medicine if you are breast-feeding.

Ask your doctor or pharmacist before you take any medicine.

Driving and using machines

Do not drive or use machines because, there are no data on the effect of clarithromycin to undertake these tasks. If you wish to do so, please ask your doctor.

3. how to use clarithromycin

Clarithromycin is administered intravenously by your doctor or nurse.

The recommended daily dose of intravenous clarithromycin for adults 18 years of age and older is 1000 mg/day, divided into two equal doses of 500 mg and perfused over a period of 60 minutes after appropriate dilution.

Adults : The recommended dosage is 1 gram daily, divided into two 500 mg doses, appropriately diluted as described below.

Children older than 12 years : As for adults.

Children under 12 years : Use of Clarithromycin 500 mg powder for solution for infusion is not recommended for children younger than 12 years

Elderly: As for adults.

Renal impairment : In patients with renal impairment who have creatinine clearance less than 30 ml/min, the dosage of clarithromycin should be reduced to one half of the normal recommended dose.

Hepatic impairment : Clarithromycin should not be used in patients who suffer from severe hepatic failure in combination with renal impairment.

Method of administration

Clarithromycin should be administered into one of the larger proximal veins as an intravenous infusion over 60 minutes, using a solution concentration of about 2 mg/ml.

If you use more Clarithromycin than you should

As Clarithromycin is given to you by a doctor, an overdose is unlikely but symptoms may include vomiting and stomach pains.

If you forgot to use Clarithromycin

Do not take a double dose to make up for a forgotten dose.

If you have any further question about the use of this product, ask your doctor or pharmacist.

4. possible side effects

Like all medicines, Clarithromycin can cause side effects, although not everyone gets them.

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

• Infusion site phlebitis (vein inflammation)

Common side effects (may effect up to 1 in 10 people):

• Insomnia
• Dysgeusia (distortion of the sense of taste),
• Headache
• Taste perversion
• Vasodilation
• Diarrhea
• Vomiting
• Dyspepsia (indigestion)
• Nausea
• Abdominal pain
• Liver function test abnormal
• Rash
• Hyperhidrosis (excessive sweating)
• Infusion site pain
• Infusion site inflammation

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

• Cellulitis
• Candidiasis
• Gastroenteritis
• Infection
• Vaginal infection
• Leukopenia
• Neutropenia
• Thrombocythemia,
• Eosinophilia
• Anaphylactoid reaction
• Hypersensitivity
• Anorexia
• Decreased appetite
• Anxiety
• Nervousness
• Screaming
• Loss of consciousness
• Dyskinesia (movement disorders)
• Dizziness
• Somnolence
• Tremor
• Vertigo
• Hearing impaired
• Tinnitus
• Cardiac arrest
• Atrial fibrillation
• Electrocardiogram QT prolonged
• Extrasystoles
• Palpitations
• Asthma
• Epistaxis
• Pulmonary embolism
• Esophagitis
• Gastrooesophageal reflux disease
• Gastritis
• Proctalgia
• Stomatitis
• Glossitis
• Abdominal distension
• Constipation
• Dry mouth
• Eructation
• Flatulence
• Cholestasis
• Hepatitis
• Alanine aminotransferase increased
• Aspartate aminotransferase increased
• Gamma-glutamyltransferase increased
• Dermatitis bullous
• Pruritus (severe itching of the skin)
• Urticaria
• Rash maculo-papular
• Muscle spasms
• Musculoskeletal stiffness
• Myalgia
• Blood creatinine increased
• Blood urea increased
• Malaise
• Pyrexia
• Asthenia,
• Chest pain
• Chills
• Fatigue
• Albumin globulin ratio abnormal
• Blood alkaline phosphatase increased
• Blood lactate dehydrogenase increased.

Not Known (cannot be estimated from the available data):

• Pseudomembranous colitis
• Erysipelas bacterial skin infection
• Agranulocytosis
• Thrombocytopenia
• Anaphylactic reaction
• Angioedema
• Hypoglycaemia
• Psychotic disorder
• Confusional state
• Depersonalisation
• Depression
• Disorientation
• Hallucination
• Abnormal dreams
• Convulsion
• Ageusia
• Parosmia (distortion of sense of smell)
• Anosmia
• Paraesthesia
• Deafness
• Torsade de pointes
• Ventricular tachycardia
• Hemorrhage
• Pancreatitis acute
• Tongue discolouration
• Tooth discolouration
• Hepatic failure
• Jaundice hepatocellular
• Stevens-Johnson syndrome
• Toxic epidermal necrolysis
• Drug rash with eosinophilia and systemic symptoms (DRESS)
• Acne
• Rhabdomyolysis
• Myopathy
• Renal failure
• Nephritis interstitial
• International normalised ratio increased
• Prothrombin time prolonged
• Urine color abnormal.

Contact a doctor immediately if you experience a serious skin reaction: a red, scaly rash with bumps under the skin and blisters (exanthematous pustulosis). The frequency of this side effect is not know (cannot be estimated from the available data).

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 via the national reporting system listed in the Yellow Card Scheme, Website: or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store clarithromycin

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 or label. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

For Reconstituted solution (500 mg in 10 ml of water for infusion): it can be stored up to 24 hours at room temperature and up to 48 hours refrigerated (2 °C – 8 °C). The final reconstituted solution (reconstituted solution for infusion added to 250 ml of diluent, respectively to each mentioned diluent) can be stored up to 24 hours at room temperature (25 °C) or up to 48 hours refrigerated (2 °C – 8° C). The reconstitution of the drug product can take up to 3 minutes.

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

6. contents of the pack and other information

What Clarithromycin contains

The active substance is clarithromycin as clarithromycin lactobionate. Each vial contains 500 mg clarithromycin (equivalent to 739.5 mg clarithromycin lactobionate).

1 ml contains 25 mg clarithromycin (equivalent to 36.98 mg clarithromycin lactobionate).

Excipients: lactobionic acid, sodium hydroxide and water for injection.

What Clarithromycin looks like and contents of the pack

Clarithromycin is a white or almost white powder for concentrate for solution or infusion.

Pack sizes: 1 vial.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Altan Pharma Ltd.

The Lennox Building

50 South Richmond Street

Dublin 2, D02 FK02, Ireland

Manufacturer

Altan Pharmaceuticals, S.A.

Avda. de la Constitucion, 198–199,

Potfgono Industrial Monte Boyal, Casarrubios del Monte 45950 (Toledo) Spain

This leaflet was last revised in 11/2019

INFORMATION FOR THE HEALTHCARE PROFESSIONAL

The recommended daily dose of intravenous clarithromycin is 1000 mg/day, divided into two equal doses of 500 mg and perfused over a period of 60 minutes after appropriate dilution. Intravenous therapy may be given for 2 to 5 days and should be changed to oral clarithromycin therapy when appropriate.

Reconstitute each vial with 10 ml sterile water for injections. The reconstitution of the drug product can be taken up to 3 minutes.

The reconstituted solution can be diluted in 250 ml of the following diluents:

• sodium chloride 9 mg/ml (0.9%) solution for infusion
• dextrose 5 mg/ml (5%) solution
• dextrose 0.05 mg/ml (5%) in sodium chloride (0.003 mg/ml (0.3%) or 0.0045 mg/ml (0.45%)) solution for infusion
• dextrose 0.05 mg/ml (5%) in Ringers solution
• dextrose 0.05 mg/ml (5%) in Ringers Lactate solution