CLINDAMYCIN 150 MG / ML SOLUTION FOR INJECTION, DALACIN C 600 MG / 4ML STERILE SOLUTION, DALACIN C 300 MG / 2ML STERILE SOLUTION - patient leaflet, side effects, dosage

Dalacin

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or your pharmacist.
• If you get any of the side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Your medicine is available using the above names but will be referred to as Dalacin C Solution throughout this leaflet.

What is in this leaflet:

• 1. What Dalacin C Solution is and what it is used for

• 2. What you need to know before you use Dalacin C Solution

• 3. How to use Dalacin C Solution

• 4. Possible side effects

• 5. How to store Dalacin C Solution

• 6. Contents of the pack and other information

1. what dalacin c solution is and what it is used for

Dalacin C Solution contains clindamycin phosphate which is an antibiotic used in the treatment of serious bacterial infections. Dalacin C Solution is a sterile solution for injection into a vein (intravenously) or into a muscle (intramuscularly).

2. what you need to know before you use dalacin c solution do not use dalacin c solution

• if you are allergic to clindamycin, lincomycin or any of the other ingredients in this medicine (listed in section 6).
• In premature babies or neonates.

Warnings and precautions

Talk to your doctor before taking Dalacin C Solution 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 Dalacin C Solution 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.

Dalacin C Solution 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 Dalacin C Solution

Tell your doctor if you are taking, have recently taken or might take any other medicines. Some medicines can affect the way Dalacin C Solution works, or Dalacin C Solution 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 Dalacin C Solution and for seven days after receiving Dalacin C Solution.
• 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 or think you might 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 Dalacin C Solution as clindamcycin may be passed into breast milk.

Your doctor will decide if Dalacin 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 breastfeeding if this happens.

Driving and using machines

No effects on the ability to drive or use machines have been seen with Dalacin C Solution.

Dalacin C Solution contains benzyl alcohol

Dalacin C Solution contains benzyl alcohol (9.45 mg/ml as preservative) and must not be given to premature babies or babies less than one month old. It may cause allergy and toxic reactions and has caused serious side effects in the brain, heart, blood, and breathing rate in children, which have been fatal in some cases.

3. how to use dalacin c solution

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 Dalacin C Solution, 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 Dalacin C Solution is given too fast it could rarely cause a heart attack.

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. 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 Dalacin C Solution 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 Dalacin C Solution treatment.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. possible side effects

Dalacin

150 mg/ml

Your medicine is available using the above names but will be referred to as Dalacin C Solution throughout this leaflet.

For further information consult the Summary of Product Characteristic­s (SPC).

Qualitative and quantitative composition

Each ml of solution contains clindamycin phosphate equivalent to 150 mg clindamycin, benzyl alcohol 9.45 mg/ml, disodium edetate and sterilised water for injections.

Directions for use

Parenteral (IM or IV administration).

Dalacin C Solution should be used undiluted for IM administration.

Dalacin C Solution 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

Adults including the elderly:

Serious infections: 600–1200 mg/day in 2, 3 or 4 equal doses.

More severe infections: 1200–2700 mg/day in 2, 3 or 4 equal doses.

Single IM injections of greater than 600 mg are not recommended nor is administration of more than 1200 mg in a single one-hour infusion.

Children (over 1 month of age):

Serious infections: 15–25 mg/kg/day in 3 or 4 equal doses.

More severe infections: 25–40 mg/kg/day in 3 or 4 equal doses.

In severe infections it is recommended that children be given no less than 300 mg/day regardless of body weight.

Dilution of 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:

Indications

The management of serious infections due to organisms susceptible to this anti-infective.

Contra-indication

Dalacin C Solution is contra-indicated in patients previously found to be sensitive to clindamycin, lincomycin, any component of the formulation, or to any excipients listed in section 6.1 of the SPC.

Dalacin C Solution must not be given to premature babies or neonates because of the benzyl alcohol content (see Warnings ).

Warnings

The clindamycin phosphate injectable formulation contains benzyl alcohol (9.45 mg/ml). Intravenous administration of the preservative benzyl alcohol has been associated with serious adverse events, and death in paediatric patients including neonates characterized by central nervous system depression, metabolic acidosis, gasping respirations, cardiovascular failure and haematological anomalies (“gasping syndrome”). Although normal therapeutic doses of this product ordinarily deliver amounts of benzyl alcohol that are substantially lower than those reported in association with the “gasping syndrome”, the minimum amount of benzyl alcohol at which toxicity may occur is not known. Use only if it is necessary and if there are no alternatives possible. If given in high volumes, should be used with caution and preferably for short term treatment in subjects with liver or kidney impairment because of the risk of accumulation and toxicity (metabolic acidosis) due to benzoic acid (a metabolite of benzyl alcohol).

Premature and low-birth weight infants may be more likely to develop toxicity.

Benzyl alcohol containing products should not be used in pre-term or full-term neonates unless strictly necessary.

Benzyl alcohol can cross the placenta and clindamycin should only be used during pregnancy if clearly needed.

Severe hypersensitivity reactions, including severe skin reactions such as drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP) have been reported in patients receiving clindamycin therapy. If a hypersensitivity or severe skin reaction occurs, clindamycin should be discontinued and appropriate therapy should be initiated (see SPC sections 4.3 and 4.8).

Dalacin C Solution should only be used in the treatment of serious infections. In considering the use of the product, the practitioner should bear in mind the type of infection and the potential hazard of the diarrhoea which may develop, since cases of colitis have been reported during, or even two or three weeks following, the administration of clindamycin.

Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of Clostridium difficile. This has been reported with use of nearly all antibacterial agents, including clindamycin. Clostridium difficile produces toxins A and B which contribute to the development of Clostridium difficile associated diarrhoea (CDAD) and is a primary cause of ‘antibiotic-associated colitis’.

The disease is likely to follow a more severe course in older patients, or patients who are debilitated. Diagnosis is usually made by the recognition of the clinical symptoms, but can be substantiated by endoscopic demonstration of pseudomembranous colitis. Colitis is a disease, which has a clinical spectrum from mild, watery diarrhoea to severe, persistent diarrhoea, leucocytosis, fever, severe abdominal cramps, which may be associated with the passage of blood and mucus. If allowed to progress, it may produce peritonitis, shock and toxic megacolon. This may be fatal. The presence of the disease may be further confirmed by culture of the stool for C. difficile on selective media and assay of the stool specimen for the toxin(s) of C. difficile.

It is important to consider the diagnosis of CDAD in patients who present with diarrhoea subsequent to the administration of antibacterial agents. This may progress to colitis, including pseudomembranous colitis, which may range from mild to fatal colitis. If antibiotic-associated diarrhoea or antibiotic-associated colitis is suspected or confirmed, ongoing treatment with antibacterial agents, including clindamycin, should be discontinued and adequate therapeutic measures should be initiated immediately. When 125 mg to 500 mg of vancomycin are administered orally four times a day for 7–10 days, there is a rapid observed disappearance of the toxin from faecal samples and a coincident clinical recovery from the diarrhoea. Drugs inhibiting peristalsis are contraindicated in this situation.

Precautions

History of gastro-intestinal disease; use in atopic individuals; superinfection with resistant organisms. Since clindamycin does not diffuse adequately into cerebrospinal fluid, the drug should not be used in the treatment of meningitis.

If therapy is prolonged, liver and kidney function tests should be performed. Such monitoring is also recommended in neonates and infants. Safety and appropriate dosage in infants less than one month old have not been established. The use of clindamycin phosphate may result in overgrowth of non-susceptible organisms, particularly yeasts.

The dosage of Dalacin C Solution may require reduction in patients with renal or hepatic impairment due to prolongation of the serum half-life. Clindamycin phosphate should not be injected intravenously undiluted as a bolus, but should be infused over at least 10–60 minutes as directed in section “directions for use ”.

Interactions

Use with caution in patients receiving neuromuscular blocking agents.

Vitamin K antagonists

Increased coagulation tests (PT/INR) and/or bleeding, have been reported in patients treated with clindamycin in combination with a vitamin K antagonist (e.g. warfarin, acenocoumarol and fluindione). Coagulation tests, therefore, should be frequently monitored in patients treated with vitamin K antagonists.

Co-administration of clindamycin with inhibitors of CYP3A4 and CYP3A5 Clindamycin is metabolized predominantly by CYP3A4, and to a lesser extent by CYP3A5, to the major metabolite clindamycin sulfoxide and minor metabolite N desmethylclin­damycin. Therefore inhibitors of CYP3A4 and CYP3A5 may reduce clindamycin clearance and inducers of these isoenzymes may increase clindamycin clearance. In the presence of strong CYP3A4 inducers such as rifampicin, monitor for loss of effectiveness.

In vitro studies indicate that clindamycin does not inhibit CYP1A2, CYP2C9, CYP2C19, CYP2E1 or CYP2D6 and only moderately inhibits CYP3A4. Therefore, clinically important interactions between clindamycin and co-administered drugs metabolized by these CYP enzymes are unlikely.

Pregnancy and lactation

Pregnancy

Oral and subcutaneous reproductive toxicity studies in rats and rabbits revealed no evidence of impaired fertility or harm to the fetus due to clindamycin, except at doses that caused maternal toxicity. Animal reproduction studies are not always predictive of human response. Clindamycin crosses the placenta in humans. After multiple doses, amniotic fluid concentrations were approximately 30% of maternal blood concentrations. Benzyl alcohol can cross the placenta (see Warnings). In clinical trials with pregnant women, the systemic administration of clindamycin during the second and third trimesters has not been associated with an increased frequency of congenital abnormalities. There are no adequate and well-controlled studies in pregnant women during the first trimester of pregnancy. Clindamycin should be used in pregnancy only if clearly needed.

Lactation

Orally and parenterally administered clindamycin has been reported to appear in human breast milk in ranges from <0.5 to 3.8 pg/ml. Clindamycin has the potential to cause adverse effects on the breastfed infant’s gastro­intestinal flora such as diarrhoea or blood in the stool, or rash. If oral or intravenous clindamycin is required by a nursing mother, it is not a reason to discontinue breastfeeding, but an alternate drug may be preferred. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for clindamycin and any potential adverse effects on the breastfed child from clindamycin or from the underlying maternal condition.

• – 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)

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 light headed, 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 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 dalacin c solution

• – Keep out of the sight and reach of children.

• – Dalacin C Solution will not be used after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

• – Do not store above 25°C.

• – Do not refrigerate or freeze.

• – If the solution shows any signs of deterioration or discolouration, you should seek the advice of your pharmacist who will tell you what to do.

• – 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. contents of the pack and other informationwhat dalacin c solution containsthe active substance is clindamycin phosphate.

Each ml contains 150mg clindamycin (as phosphate).

The other ingredients are benzyl alcohol, disodium edetate, sodium hydroxide and water for injection.

What Dalacin C Solution looks like and contents of the pack

Dalacin

Dalacin

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or your pharmacist.
• If you get any of the side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Your medicine is available using the above names but will be referred to as Dalacin C Solution throughout this leaflet.

What is in this leaflet:

• 1. What Dalacin C Solution is and what it is used for

• 2. What you need to know before you use Dalacin C Solution

• 3. How to use Dalacin C Solution

• 4. Possible side effects

• 5. How to store Dalacin C Solution

• 6. Contents of the pack and other information

1. what dalacin c solution is and what it is used for

Dalacin C Solution contains clindamycin phosphate which is an antibiotic used in the treatment of serious bacterial infections. Dalacin C Solution is a sterile solution for injection into a vein (intravenously) or into a muscle (intramuscularly).

2. what you need to know before you use dalacin c solution do not use dalacin c solution

• if you are allergic to clindamycin, lincomycin or any of the other ingredients in this medicine (listed in section 6).
• In premature babies or neonates.

Warnings and precautions

Talk to your doctor before taking Dalacin C Solution 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 Dalacin C Solution 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.

Dalacin C Solution 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 Dalacin C Solution

Tell your doctor if you are taking, have recently taken or might take any other medicines. Some medicines can affect the way Dalacin C Solution works, or Dalacin C Solution 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 Dalacin C Solution and for seven days after receiving Dalacin C Solution.
• 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 or think you might 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 Dalacin C Solution as clindamcycin may be passed into breast milk.

Your doctor will decide if Dalacin 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 breastfeeding if this happens.

Driving and using machines

No effects on the ability to drive or use machines have been seen with Dalacin C Solution.

Dalacin C Solution contains benzyl alcohol

Dalacin C Solution contains benzyl alcohol (9.45 mg/ml as preservative) and must not be given to premature babies or babies less than one month old. It may cause allergy and toxic reactions and has caused serious side effects in the brain, heart, blood, and breathing rate in children, which have been fatal in some cases.

3. how to use dalacin c solution

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 Dalacin C Solution, 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 Dalacin C Solution is given too fast it could rarely cause a heart attack.

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. 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 Dalacin C Solution 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 Dalacin C Solution treatment.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. possible side effects

Dalacin

150 mg/ml

Your medicine is available using the above names but will be referred to as Dalacin C Solution throughout this leaflet.

For further information consult the Summary of Product Characteristic­s (SPC).

Qualitative and quantitative composition

Each ml of solution contains clindamycin phosphate equivalent to 150 mg clindamycin, benzyl alcohol 9.45 mg/ml, disodium edetate and sterilised water for injections.

Directions for use

Parenteral (IM or IV administration).

Dalacin C Solution should be used undiluted for IM administration.

Dalacin C Solution 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

Adults including the elderly:

Serious infections: 600–1200 mg/day in 2, 3 or 4 equal doses.

More severe infections: 1200–2700 mg/day in 2, 3 or 4 equal doses.

Single IM injections of greater than 600 mg are not recommended nor is administration of more than 1200 mg in a single one-hour infusion.

Children (over 1 month of age):

Serious infections: 15–25 mg/kg/day in 3 or 4 equal doses.

More severe infections: 25–40 mg/kg/day in 3 or 4 equal doses.

In severe infections it is recommended that children be given no less than 300 mg/day regardless of body weight.

Dilution of 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:

Indications

The management of serious infections due to organisms susceptible to this anti-infective.

Contra-indication

Dalacin C Solution is contra-indicated in patients previously found to be sensitive to clindamycin, lincomycin, any component of the formulation, or to any excipients listed in section 6.1 of the SPC.

Dalacin C Solution must not be given to premature babies or neonates because of the benzyl alcohol content (see Warnings ).

Warnings

The clindamycin phosphate injectable formulation contains benzyl alcohol (9.45 mg/ml). Intravenous administration of the preservative benzyl alcohol has been associated with serious adverse events, and death in paediatric patients including neonates characterized by central nervous system depression, metabolic acidosis, gasping respirations, cardiovascular failure and haematological anomalies (“gasping syndrome”). Although normal therapeutic doses of this product ordinarily deliver amounts of benzyl alcohol that are substantially lower than those reported in association with the “gasping syndrome”, the minimum amount of benzyl alcohol at which toxicity may occur is not known. Use only if it is necessary and if there are no alternatives possible. If given in high volumes, should be used with caution and preferably for short term treatment in subjects with liver or kidney impairment because of the risk of accumulation and toxicity (metabolic acidosis) due to benzoic acid (a metabolite of benzyl alcohol).

Premature and low-birth weight infants may be more likely to develop toxicity.

Benzyl alcohol containing products should not be used in pre-term or full-term neonates unless strictly necessary.

Benzyl alcohol can cross the placenta and clindamycin should only be used during pregnancy if clearly needed.

Severe hypersensitivity reactions, including severe skin reactions such as drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP) have been reported in patients receiving clindamycin therapy. If a hypersensitivity or severe skin reaction occurs, clindamycin should be discontinued and appropriate therapy should be initiated (see SPC sections 4.3 and 4.8).

Dalacin C Solution should only be used in the treatment of serious infections. In considering the use of the product, the practitioner should bear in mind the type of infection and the potential hazard of the diarrhoea which may develop, since cases of colitis have been reported during, or even two or three weeks following, the administration of clindamycin.

Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of Clostridium difficile. This has been reported with use of nearly all antibacterial agents, including clindamycin. Clostridium difficile produces toxins A and B which contribute to the development of Clostridium difficile associated diarrhoea (CDAD) and is a primary cause of ‘antibiotic-associated colitis’.

The disease is likely to follow a more severe course in older patients, or patients who are debilitated. Diagnosis is usually made by the recognition of the clinical symptoms, but can be substantiated by endoscopic demonstration of pseudomembranous colitis. Colitis is a disease, which has a clinical spectrum from mild, watery diarrhoea to severe, persistent diarrhoea, leucocytosis, fever, severe abdominal cramps, which may be associated with the passage of blood and mucus. If allowed to progress, it may produce peritonitis, shock and toxic megacolon. This may be fatal. The presence of the disease may be further confirmed by culture of the stool for C. difficile on selective media and assay of the stool specimen for the toxin(s) of C. difficile.

It is important to consider the diagnosis of CDAD in patients who present with diarrhoea subsequent to the administration of antibacterial agents. This may progress to colitis, including pseudomembranous colitis, which may range from mild to fatal colitis. If antibiotic-associated diarrhoea or antibiotic-associated colitis is suspected or confirmed, ongoing treatment with antibacterial agents, including clindamycin, should be discontinued and adequate therapeutic measures should be initiated immediately. When 125 mg to 500 mg of vancomycin are administered orally four times a day for 7–10 days, there is a rapid observed disappearance of the toxin from faecal samples and a coincident clinical recovery from the diarrhoea. Drugs inhibiting peristalsis are contraindicated in this situation.

Precautions

History of gastro-intestinal disease; use in atopic individuals; superinfection with resistant organisms. Since clindamycin does not diffuse adequately into cerebrospinal fluid, the drug should not be used in the treatment of meningitis.

If therapy is prolonged, liver and kidney function tests should be performed. Such monitoring is also recommended in neonates and infants. Safety and appropriate dosage in infants less than one month old have not been established. The use of clindamycin phosphate may result in overgrowth of non-susceptible organisms, particularly yeasts.

The dosage of Dalacin C Solution may require reduction in patients with renal or hepatic impairment due to prolongation of the serum half-life. Clindamycin phosphate should not be injected intravenously undiluted as a bolus, but should be infused over at least 10–60 minutes as directed in section “directions for use ”.

Interactions

Use with caution in patients receiving neuromuscular blocking agents.

Vitamin K antagonists

Increased coagulation tests (PT/INR) and/or bleeding, have been reported in patients treated with clindamycin in combination with a vitamin K antagonist (e.g. warfarin, acenocoumarol and fluindione). Coagulation tests, therefore, should be frequently monitored in patients treated with vitamin K antagonists.

Co-administration of clindamycin with inhibitors of CYP3A4 and CYP3A5 Clindamycin is metabolized predominantly by CYP3A4, and to a lesser extent by CYP3A5, to the major metabolite clindamycin sulfoxide and minor metabolite N desmethylclin­damycin. Therefore inhibitors of CYP3A4 and CYP3A5 may reduce clindamycin clearance and inducers of these isoenzymes may increase clindamycin clearance. In the presence of strong CYP3A4 inducers such as rifampicin, monitor for loss of effectiveness.

In vitro studies indicate that clindamycin does not inhibit CYP1A2, CYP2C9, CYP2C19, CYP2E1 or CYP2D6 and only moderately inhibits CYP3A4. Therefore, clinically important interactions between clindamycin and co-administered drugs metabolized by these CYP enzymes are unlikely.

Pregnancy and lactation

Pregnancy

Oral and subcutaneous reproductive toxicity studies in rats and rabbits revealed no evidence of impaired fertility or harm to the fetus due to clindamycin, except at doses that caused maternal toxicity. Animal reproduction studies are not always predictive of human response. Clindamycin crosses the placenta in humans. After multiple doses, amniotic fluid concentrations were approximately 30% of maternal blood concentrations. Benzyl alcohol can cross the placenta (see Warnings). In clinical trials with pregnant women, the systemic administration of clindamycin during the second and third trimesters has not been associated with an increased frequency of congenital abnormalities. There are no adequate and well-controlled studies in pregnant women during the first trimester of pregnancy. Clindamycin should be used in pregnancy only if clearly needed.

Lactation

Orally and parenterally administered clindamycin has been reported to appear in human breast milk in ranges from <0.5 to 3.8 pg/ml. Clindamycin has the potential to cause adverse effects on the breastfed infant’s gastro­intestinal flora such as diarrhoea or blood in the stool, or rash. If oral or intravenous clindamycin is required by a nursing mother, it is not a reason to discontinue breastfeeding, but an alternate drug may be preferred. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for clindamycin and any potential adverse effects on the breastfed child from clindamycin or from the underlying maternal condition.

• – 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)

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 light headed, 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 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 dalacin c solution

• – Keep out of the sight and reach of children.

• – Dalacin C Solution will not be used after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

• – Do not store above 25°C.

• – Do not refrigerate or freeze.

• – If the solution shows any signs of deterioration or discolouration, you should seek the advice of your pharmacist who will tell you what to do.

• – 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. contents of the pack and other informationwhat dalacin c solution containsthe active substance is clindamycin phosphate.

Each ml contains 150mg clindamycin (as phosphate).

The other ingredients are benzyl alcohol, disodium edetate, sodium hydroxide and water for injection.

What Dalacin C Solution looks like and contents of the pack

Dalacin

150 mg/ml

Your medicine is available using the above names but will be referred to as Dalacin C Solution throughout this leaflet.

Undesirable effects

The table below lists the adverse reactions identified through clinical trial experience and post-marketing surveillance by system organ class and frequency.

Reporting of side-effects

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 the Yellow Card Scheme at: or search for MHRA Yellow Card in the Google Play or Apple App Store.

Overdose

In cases of overdosage no specific treatment is indicated.

The serum biological half-life of lincomycin is 2.4 hours. Haemodialysis and peritoneal dialysis are not effective in removing clindamycin from the serum.

Handling and storage requirements

Do not store this product above 25°C.

Do not refrigerate or freeze.

This product is for single dose only.

Any unused solution should be discarded.

Dilution and compatibility

In-vitro compatibility studies monitored for 24 hours at room temperature using a concentration no greater than 6 mg/ml have demonstrated no inactivation or physical incompatibility with the use of Dalacin C Solution in IV solutions containing sodium chloride, glucose or potassium usually used clinically.

Dalacin C Solution has been shown to be physically and chemically compatible for at least 24 hours in dextrose 5% water and sodium chloride injection solutions containing the following antibiotics in usually administered concentrations: amikacin sulfate, aztreonam, cefamondole 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 vary depending upon concentration and other conditions.

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: ampicillin sodium, aminophylline, barbiturates, calcium gluconate, ceftriaxone sodium, ciprofloxacin, diphenylhydantoin, idarubicin hydrochloride, magnesium sulfate, phenytoin sodium and ranitidine hydrochloride.

Manufacturer and product licence holder

Manufactured by Pfizer Manufacturing Belgium NV, Rijksweg 12, 2870 Puurs, Belgium.

Procured from within the EU by product licence holder Star Pharmaceuticals Ltd, 5 Sandridge Close, Harrow, Middlesex, HA1 1XD. Repackaged by Servipharm Ltd.

Leaflet revision and issue date (Ref.) 15.04.21[10]

Clindamycin 150 mg/ml Sterile Solution

(clindamycin phosphate)

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or your pharmacist.
• If you get any of the side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Your medicine is available using the above names but will be referred to as Clindamycin Solution throughout this leaflet.

What is in this leaflet:

• 1. What Clindamycin Solution is and what it is used for

• 2. What you need to know before you use Clindamycin Solution

• 3. How to use Clindamycin Solution

• 4. Possible side effects

• 5. How to store Clindamycin Solution

• 6. Contents of the pack and other information

1. what clindamycin solution is and what it is used for

Clindamycin Solution contains clindamycin phosphate which is an antibiotic used in the treatment of serious bacterial infections.

Clindamycin Solution 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 do not use clindamycin solution

• if you are allergic to clindamycin, lincomycin or any of the other ingredients in this medicine (listed in section 6).
• In premature babies or neonates.

Warnings and precautions

Talk to your doctor before taking Clindamycin Solution 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 Solution 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.

Clindamycin Solution 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

Tell your doctor if you are taking, have recently taken or might take any other medicines. Some medicines can affect the way Clindamycin Solution works, or Clindamycin Solution 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 Solution and for seven days after receiving Clindamycin Solution.
• 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 or think you might 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 Solution as clindamcycin may be passed into breast milk.

Your doctor will decide if Dalacin 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 breastfeeding if this happens.

Driving and using machines

No effects on the ability to drive or use machines have been seen with Clindamycin Solution.

Clindamycin Solution contains benzyl alcohol

Clindamycin Solution contains benzyl alcohol (9.45 mg/ml as preservative) and must not be given to premature babies or babies less than one month old. It may cause allergy and toxic reactions and has caused serious side effects in the brain, heart, blood, and breathing rate in children, which have been fatal in some cases.

3. how to use clindamycin solution

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 Solution, 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 Solution is given too fast it could rarely cause a heart attack.

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. 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 Solution 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 Solution 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, 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

THE FOLLOWING IS INTENDED FOR HEALTHCARE PROFESSIONAL ONLY:

Clindamycin 150 mg/ml Sterile Solution

(clindamycin phosphate)

150 mg/ml

Your medicine is available using the above names but will be referred to as Clindamycin Solution throughout this leaflet.

For further information consult the Summary of Product Characteristic­s (SPC).

Qualitative and quantitative composition

Each ml of solution contains clindamycin phosphate equivalent to 150 mg clindamycin, benzyl alcohol 9.45 mg/ml, disodium edetate and sterilised water for injections.

Directions for use

Parenteral (IM or IV administration).

Clindamycin Solution should be used undiluted for IM administration.

Clindamycin Solution 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

Adults including the elderly:

Serious infections: 600–1200 mg/day in 2, 3 or 4 equal doses.

More severe infections: 1200–2700 mg/day in 2, 3 or 4 equal doses.

Single IM injections of greater than 600 mg are not recommended nor is administration of more than 1200 mg in a single one-hour infusion.

Children (over 1 month of age):

Serious infections: 15–25 mg/kg/day in 3 or 4 equal doses.

More severe infections: 25–40 mg/kg/day in 3 or 4 equal doses.

In severe infections it is recommended that children be given no less than 300 mg/day regardless of body weight.

Dilution of 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:

Indications

The management of serious infections due to organisms susceptible to this anti-infective.

Contra-indication

Clindamycin Solution is contra-indicated in patients previously found to be sensitive to clindamycin, lincomycin, any component of the formulation, or to any excipients listed in section 6.1 of the SPC.

Clindamycin Solution must not be given to premature babies or neonates because of the benzyl alcohol content (see Warnings ).

Warnings

The clindamycin phosphate injectable formulation contains benzyl alcohol (9.45 mg/ml). Intravenous administration of the preservative benzyl alcohol has been associated with serious adverse events, and death in paediatric patients including neonates characterized by central nervous system depression, metabolic acidosis, gasping respirations, cardiovascular failure and haematological anomalies (“gasping syndrome”). Although normal therapeutic doses of this product ordinarily deliver amounts of benzyl alcohol that are substantially lower than those reported in association with the “gasping syndrome”, the minimum amount of benzyl alcohol at which toxicity may occur is not known. Use only if it is necessary and if there are no alternatives possible. If given in high volumes, should be used with caution and preferably for short term treatment in subjects with liver or kidney impairment because of the risk of accumulation and toxicity (metabolic acidosis) due to benzoic acid (a metabolite of benzyl alcohol).

Premature and low-birth weight infants may be more likely to develop toxicity.

Benzyl alcohol containing products should not be used in pre-term or full-term neonates unless strictly necessary.

Benzyl alcohol can cross the placenta and clindamycin should only be used during pregnancy if clearly needed.

Severe hypersensitivity reactions, including severe skin reactions such as drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP) have been reported in patients receiving clindamycin therapy. If a hypersensitivity or severe skin reaction occurs, clindamycin should be discontinued and appropriate therapy should be initiated (see SPC sections 4.3 and 4.8).

Clindamycin Solution should only be used in the treatment of serious infections. In considering the use of the product, the practitioner should bear in mind the type of infection and the potential hazard of the diarrhoea which may develop, since cases of colitis have been reported during, or even two or three weeks following, the administration of clindamycin.

Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of Clostridium difficile. This has been reported with use of nearly all antibacterial agents, including clindamycin. Clostridium difficile produces toxins A and B which contribute to the development of Clostridium difficile associated diarrhoea (CDAD) and is a primary cause of ‘antibiotic-associated colitis’.

The disease is likely to follow a more severe course in older patients, or patients who are debilitated. Diagnosis is usually made by the recognition of the clinical symptoms, but can be substantiated by endoscopic demonstration of pseudomembranous colitis. Colitis is a disease, which has a clinical spectrum from mild, watery diarrhoea to severe, persistent diarrhoea, leucocytosis, fever, severe abdominal cramps, which may be associated with the passage of blood and mucus. If allowed to progress, it may produce peritonitis, shock and toxic megacolon. This may be fatal. The presence of the disease may be further confirmed by culture of the stool for C. difficile on selective media and assay of the stool specimen for the toxin(s) of C. difficile.

It is important to consider the diagnosis of CDAD in patients who present with diarrhoea subsequent to the administration of antibacterial agents. This may progress to colitis, including pseudomembranous colitis, which may range from mild to fatal colitis. If antibiotic-associated diarrhoea or antibiotic-associated colitis is suspected or confirmed, ongoing treatment with antibacterial agents, including clindamycin, should be discontinued and adequate therapeutic measures should be initiated immediately. When 125 mg to 500 mg of vancomycin are administered orally four times a day for 7–10 days, there is a rapid observed disappearance of the toxin from faecal samples and a coincident clinical recovery from the diarrhoea. Drugs inhibiting peristalsis are contraindicated in this situation.

Precautions

History of gastro-intestinal disease; use in atopic individuals; superinfection with resistant organisms. Since clindamycin does not diffuse adequately into cerebrospinal fluid, the drug should not be used in the treatment of meningitis.

If therapy is prolonged, liver and kidney function tests should be performed. Such monitoring is also recommended in neonates and infants. Safety and appropriate dosage in infants less than one month old have not been established. The use of clindamycin phosphate may result in overgrowth of non-susceptible organisms, particularly yeasts.

The dosage of Clindamycin Solution may require reduction in patients with renal or hepatic impairment due to prolongation of the serum half-life.

Clindamycin phosphate should not be injected intravenously undiluted as a bolus, but should be infused over at least 10–60 minutes as directed in section “directions for use ”.

Interactions

Use with caution in patients receiving neuromuscular blocking agents.

Vitamin K antagonists

Increased coagulation tests (PT/INR) and/or bleeding, have been reported in patients treated with clindamycin in combination with a vitamin K antagonist (e.g. warfarin, acenocoumarol and fluindione). Coagulation tests, therefore, should be frequently monitored in patients treated with vitamin K antagonists.

Co-administration of clindamycin with inhibitors of CYP3A4 and CYP3A5 Clindamycin is metabolized predominantly by CYP3A4, and to a lesser extent by CYP3A5, to the major metabolite clindamycin sulfoxide and minor metabolite N desmethylclin­damycin. Therefore inhibitors of CYP3A4 and CYP3A5 may reduce clindamycin clearance and inducers of these isoenzymes may increase clindamycin clearance. In the presence of strong CYP3A4 inducers such as rifampicin, monitor for loss of effectiveness.

In vitro studies indicate that clindamycin does not inhibit CYP1A2, CYP2C9, CYP2C19, CYP2E1 or CYP2D6 and only moderately inhibits CYP3A4. Therefore, clinically important interactions between clindamycin and co-administered drugs metabolized by these CYP enzymes are unlikely.

Pregnancy and lactation

Pregnancy

Oral and subcutaneous reproductive toxicity studies in rats and rabbits revealed no evidence of impaired fertility or harm to the fetus due to clindamycin, except at doses that caused maternal toxicity. Animal reproduction studies are not always predictive of human response. Clindamycin crosses the placenta in humans. After multiple doses, amniotic fluid concentrations were approximately 30% of maternal blood concentrations. Benzyl alcohol can cross the placenta (see Warnings). In clinical trials with pregnant women, the systemic administration of clindamycin during the second and third trimesters has not been associated with an increased frequency of congenital abnormalities. There are no adequate and well-controlled studies in pregnant women during the first trimester of pregnancy. Clindamycin should be used in pregnancy only if clearly needed.

Lactation

Orally and parenterally administered clindamycin has been reported to appear in human breast milk in ranges from <0.5 to 3.8 pg/ml. Clindamycin has the potential to cause adverse effects on the breastfed infant’s gastro­intestinal flora such as diarrhoea or blood in the stool, or rash. If oral or intravenous clindamycin is required by a nursing mother, it is not a reason to discontinue breastfeeding, but an alternate drug may be preferred. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for clindamycin and any potential adverse effects on the breastfed child from clindamycin or from the underlying maternal condition.

– 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)

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 light headed, 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 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 clindamycin solution

• – Keep out of the sight and reach of children.

• – Clindamycin Solution will not be used after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

• – Do not store above 25°C.

• – Do not refrigerate or freeze.

• – If the solution shows any signs of deterioration or discolouration, you should seek the advice of your pharmacist who will tell you what to do.

• – 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. contents of the pack and other informationwhat clindamycin solution containsthe active substance is clindamycin phosphate.

Each ml contains 150mg clindamycin (as phosphate).

The other ingredients are benzyl alcohol, disodium edetate, sodium hydroxide and water for injection.

What Clindamycin Solution looks like and contents of the pack

Clindamycin Solution is available in pack sizes of 1 × 2ml, 5 × 2ml, 1 × 4ml and 5 × 4ml glass ampoules.

Manufacturer and product licence holder

Manufactured by Pfizer Manufacturing Belgium NV, Rijksweg 12, 2870 Puurs, Belgium.

Procured from within the EU by product licence holder Star Pharmaceuticals Ltd, 5 Sandridge Close, Harrow, Middlesex, HA1 1XD. Repackaged by Servipharm Ltd.

POM PL 20636/2895

Leaflet revision and issue date (Ref.) 15.04.21[10]

Blind or partially sighted?

Is this leaflet hard to see or read? Call 020 8423 2111 to obtain the leaflet in a format suitable for you.

THE FOLLOWING INFORMATION IS INTENDED FOR HEALTHCARE PROFESSIONAL

Clindamycin 150 mg/ ml Sterile Solution

(clindamycin phosphate)

150 mg/ml

Your medicine is available using the above names but will be referred to as Clindamycin Solution throughout this leaflet.

Undesirable effects

The table below lists the adverse reactions identified through clinical trial experience and post-marketing surveillance by system organ class and frequency.

Reporting of side-effects

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 the Yellow Card Scheme at: or search for MHRA Yellow Card in the Google Play or Apple App Store.

Overdose

In cases of overdosage no specific treatment is indicated.

The serum biological half-life of lincomycin is 2.4 hours. Haemodialysis and peritoneal dialysis are not effective in removing clindamycin from the serum.

Handling and storage requirements

Do not store this product above 25°C.

Do not refrigerate or freeze.

This product is for single dose only.

Any unused solution should be discarded.

Dilution and compatibility

In-vitro compatibility studies monitored for 24 hours at room temperature using a concentration no greater than 6 mg/ml have demonstrated no inactivation or physical incompatibility with the use of Clindamycin Solution in IV solutions containing sodium chloride, glucose or potassium usually used clinically.

Clindamycin Solution has been shown to be physically and chemically compatible for at least 24 hours in dextrose 5% water and sodium chloride injection solutions containing the following antibiotics in usually administered concentrations: amikacin sulfate, aztreonam, cefamondole 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 vary depending upon concentration and other conditions.

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: ampicillin sodium, aminophylline, barbiturates, calcium gluconate, ceftriaxone sodium, ciprofloxacin, diphenylhydantoin, idarubicin hydrochloride, magnesium sulfate, phenytoin sodium and ranitidine hydrochloride.

Manufacturer and product licence holder

Manufactured by Pfizer Manufacturing Belgium NV, Rijksweg 12, 2870 Puurs, Belgium.

Procured from within the EU by product licence holder Star Pharmaceuticals Ltd, 5 Sandridge Close, Harrow, Middlesex, HA1 1XD. Repackaged by Servipharm Ltd.

Leaflet revision and issue date (Ref.) 15.04.21[10]

ADR identified post-marketing.

t ADRs apply only to injectable formulations.

# See Warnings

Rare instances have been reported following two rapid intravenous administration (see SmPC section 4.2)

ADR identified post-marketing.

t ADRs apply only to injectable formulations.

# See Warnings

Rare instances have been reported following two rapid intravenous administration (see SmPC section 4.2)

ADR identified post-marketing.

t ADRs apply only to injectable formulations.

# See Warnings

Rare instances have been reported following two rapid intravenous administration (see SmPC section 4.2)