Patient leaflet - Clindamycin 150 mg / ml solution for injection or infusion
1. What Clindamycin Solution for Injection or Infusion is and what it is used for
Clindamycin Injection contains clindamycin phosphate which is an antibiotic used in the treatment of serious bacterial infections. Clindamycin Injection is a sterile solution for injection into a vein (intravenously) or into a muscle (intramuscularly).
2. What you need to know before you use Clindamycin Solution for Injection or Infusion
Do not use Clindamycin Solution for Injection or Infusion
- If you are allergic to clindamycin, lincomycin or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor before taking Clindamycin Injection if you:
- have diarrhoea or usually get diarrhoea when you take antibiotics or have ever suffered from problems with your stomach or intestines (bowel disease). If you develop severe or prolonged or bloody diarrhoea during or after using Clindamycin Injection tell your doctor immediately since it may be necessary to interrupt the treatment. This may be a sign of bowel inflammation (pseudomembranous colitis) which can occur even after 2 to 3 weeks following treatment with antibiotics.
- suffer from problems with your kidneys or liver.
- suffer from asthma, eczema or hayfever.
Acute kidney disorders may occur. Please inform your doctor about any medication you currently take and if you have any existing problems with your kidneys. If you experience decreased urine output, fluid retention causing swelling in your legs, ankles or feet, shortness of breath, or nausea you should contact your doctor immediately.
Clindamycin Injection does not get into the brain and is therefore not suitable for treating serious infections in and around the brain. Your doctor may need to give you another antibiotic if you have these infections.
Other medicines and Clindamycin Solution for Injection or Infusion
Tell your doctor if you are taking, have recently taken or might take any other medicines. Some medicines can affect the way Clindamycin Injection works, or Clindamycin Injection itself can reduce the effectiveness of other medicines taken at the same time. These include:
- muscle relaxants used during operations.
- oral contraceptive pills. You should use extra contraception such as condoms whilst receiving Clindamycin Injection and for seven days after receiving Clindamycin Injection.
- warfarin or similar medicines – used to thin the blood. You may be more likely to have a bleed. Your doctor may need to take regular blood tests to check how well your blood can clot.
- CYP3A4 or CYP3A5 inducers like Rifampicin may impact effectiveness of the medicine.
Pregnancy and breast-feeding
Pregnancy
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Breast-feeding
Tell your doctor if you will be breast-feeding while taking Clindamycin Injection as clindamycin may be passed into breast milk. Your doctor will decide if Clindamycin Injection is appropriate for you. Although it is not likely that a nursing infant will take in very much of the active substance from the milk it drinks, if your baby gets bloodstained diarrhoea or shows any signs of illness, tell your doctor at once. You should stop breast-feeding if this happens.
Driving and using machines
No effects on the ability to drive or use machines have been seen with Clindamycin Injection.
Clindamycin Solution for Injection or Infusion contains sodium
Clindamycin Injection contains less than 1 mmol (23 mg) of sodium per ml (essentially ‘sodium-free’).
3. How to use Clindamycin Solution for Injection or Infusion
Your doctor will give you your medicine as an injection into your vein (intravenous) or your muscle (intramuscular). If it is given into a vein, it is always mixed with a sugar or saline (salt) solution before use and given using a drip.
When giving you Clindamycin Injection, your doctor will ensure that the concentration of clindamycin does not exceed 18 mg per ml and the rate it is given to you does not exceed 30 mg per minute. If Clindamycin Injection is given too fast it could rarely cause a heart attack.
Adults and elderly
The recommended dose of Clindamycin Injection is 600 to 2700 mg clindamycin per day in two to four equal doses, depending on the severity of your infection. Higher doses than this (up to 4800 mg daily) may be given by your doctor for very severe infections. Use in children
The recommended dosage for children (over 1 month of age) is 15 to 40 mg of clindamycin per kg bodyweight each day in three or four equal doses. Clindamycin should be dosed based on total body weight regardless of obesity. Higher doses of up to 300 mg per day (regardless of body weight) may be given by your doctor for very severe infections until a full response to treatment is observed.
Normally Clindamycin Injection is only given to patients in hospital. The medical staff will be keeping a close eye on you during your treatment. If you need to have more than one course of treatment with clindamycin, your doctor may want to check that the clindamycin is not having any effect on the way your kidneys and liver are working.
Long term use can also make you more likely to get other infections that do not respond to Clindamycin Injection treatment. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor immediately if you develop:
- severe, persistent or bloody diarrhoea (which may be associated with stomach pain or fever). This is a common side effect which may occur during or after completing treatment with antibiotics and can be a sign of serious bowel inflammation.
- signs of a severe allergic reaction such as sudden wheeziness, difficulty in breathing, dizziness, swelling of the eyelids or face or lips or throat or tongue, rash or itching (especially if affecting the whole body).
potentially life-threatening skin rashes:
- blistering and peeling of large areas of skin, fever, cough, feeling unwell and swelling of the gums, tongue or lips.
- a widespread rash with blistering and peeling of large areas of skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome), and a more severe form, causing extensive peeling of the skin (more than 30% of the body surface - toxic epidermal necrolysis).
- widespread red skin rash with small pus-containing blisters (exfoliative dermatitis bullous).
- skin rash, which may blister, and looks like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge, known as erythema multiforme.
- fever, swollen lymph nodes or skin rash, these may be symptoms of a condition known as DRESS (Drug reaction with eosinophilia and systemic symptoms) can be severe and life- threatening. The symptoms of DRESS usually begins several weeks after exposure to clindamycin.
- a rare skin eruption that is characterised by the rapid appearance of areas of red skin studded with small pustules (small blisters filled with white/yellow fluid) (Acute Generalised Exanthematous Pustulosis (AGEP)).
- yellowing of the skin and whites of the eyes (jaundice).
- a marked decrease in the number of blood cells which may cause bruising or bleeding or weaken the immune system (agranulocytosis), a slight decrease in the number of white blood cells (leukopenia), reduced blood platelet (thrombocytopenia).
- fluid retention causing swelling in your legs, ankles or feet, shortness of breath or nausea.
Other possible side effects may include:
Common: may affect up to 1 in 10 people
- blood clot (vein inflammation)
- abnormalities in liver function tests
- rash characterised by a flat, red area on the skin that is covered with small bumps.
Uncommon: may affect up to 1 in 100 people
- change of sense of taste
- low blood pressure (feeling lightheaded, dizzy or faint), heart and lungs stop functioning (when the heart suddenly stops pumping blood around the body)
- feeling sick, diarrhoea
- itchy skin
- hives
- pain, abscess (boil).
Not known: frequency cannot be estimated from available data
- reduced numbers of blood cells which may cause bruising or bleeding or weaken the immune system
- an increase in the number of white blood cells (eosinophilia)
- stomach pain, being sick (throwing up)
- inflammation of the lining of the oesophagus (gullet) open sores or lesions in the lining of the oesophagus (gullet)
- infection inside and around the vagina
- irritation at the site of the injection.
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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard 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 Clindamycin Solution for Injection or Infusion
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.
Do not store above 25°C. Do not refrigerate or freeze. If only part used, discard the remaining solution.
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 Clindamycin Solution for Injection or Infusion contains
The active substance is clindamycin phosphate. Each ml of solution contains clindamycin phosphate equivalent to 150 mg of clindamycin. The other ingredients disodium edetate, sodium hydroxide and water for injections.
What Clindamycin Solution for Injection or Infusion looks like and contents of the pack
Clindamycin Injection is a clear, colourless solution. It is supplied in glass ampoules containing either 2 ml or 4 ml of solution. Each ampoule is packed in a cardboard carton with a leaflet containing packs of 1 x 2ml, 5 x 2ml, 10 x 2ml, 20 x 2ml, 50 x 2ml, 1 x 4ml, 5 x 4ml, 10 x 4ml, 20 x 4ml and 50 x 4ml ampoules. Not all pack sizes may be marketed.
Marketing Authorisation Holder Morningside Healthcare Ltd. Unit C, Harcourt Way, Leicester, LE19 1WP, UK Manufacturer Morningside Pharmaceuticals Ltd. 5 Pavilion Way Loughborough, LE11 5GW, UK This leaflet was last revised in January 2024. PHYSICIAN LEAFLET The following information is intended for healthcare professionals only: Clindamycin 150 mg/ml Solution for Injection or Infusion FOR FURTHER INFORMATION PLEASE REFER TO THE SUMMARY OF PRODUCT CHARACTERISTICS (SPC). Posology and method of administration Posology Parenteral (IM or IV administration). Clindamycin 150 mg/ml Injection must be diluted prior to IV administration and should be infused over at least 10-60 minutes (see ‘Dilution for IV use and IV infusion rates’ below). Clindamycin 150 mg/ml Injection should be used undiluted for IM administration. Method of administration Dilution for IV use and IV infusion rates: The concentration of clindamycin in diluent for infusion should not exceed 18 mg per ml and INFUSION RATES SHOULD NOT EXCEED 30 MG PER MINUTE. The usual infusion rates are as follows: | ||
| Dose | Diluent | Time |
| 300 mg | 50 ml | 10 min |
| 600 mg | 50 ml | 20 min |
| 900 mg | 50-100 ml | 30 min |
| 1200 mg | 100 ml | 40 min |
Special precautions for disposal and other handling Clindamycin 150 mg/ml Injection has been shown to be physically and chemically compatible for at least 24 hours in dextrose 5% wat | ||
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| and sodium chloride injection solutions containing the following antibiotics in usually administered concentrations: amikacin sulfate, aztreonam, cefamandole nafate, cephazolin sodium, cefotaxime sodium, cefoxitin sodium, ceftazidime sodium, ceftizoxime sodium, gentamicin sulfate, netilmicin sulfate, piperacillin and tobramycin. The compatibility and duration of stability of drug admixtures will va |
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depending upon concentration and other conditions. Clindamycin 150 mg/ml Injection is a single dose use only and any unused contents should be discarded. Any unused medicinal product or waste material should be dispose |
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of in accordance with local requirements. Incompatibilities Solutions of clindamycin salts have a low pH and incompatibilities may reasonably be expected with alkaline preparations or drugs unstable at low pH. Incompatibility has been reported with: ampicill |
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sodium, aminophylline, barbiturates, calcium gluconate, ceftriaxone sodium, ciprofloxacin, diphenylhydantoin, idarubicin hydrochloride, magnesium sulfate, phenytoin sodium and ranitidine hydrochloride. Handling and Storage requirements Do not store above 25°C. Do not refrigerate or freeze. M0405LAMUKNA-P1-0 |