CLINDAMYCIN 150 MG/ML SOLUTION FOR INJECTION OR INFUSION

Active substance: CLINDAMYCIN PHOSPHATE

View full screen / Print PDF » Download PDF ⇩

Transcript
PACKAGE LEAFLET: INFORMATION FOR THE USER
Clindamycin 150 mg/ml Solution for Injection or Infusion
Clindamycin phosphate
Read all of this leaflet carefully before you start taking this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or 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 pharmacist.
In this leaflet:
1. What Clindamycin 150 mg/ml Solution for Injection or Infusion is and what it is used for
2. Before you take Clindamycin 150 mg/ml Solution for Injection or Infusion
3. How to take Clindamycin 150 mg/ml Solution for Injection or Infusion
4. Possible side effects
5. How to store Clindamycin 150 mg/ml Solution for Injection or Infusion
6. Further information

1. What Clindamycin 150 mg/ml Solution for Injection or Infusion is and what it
is used for
This medicine contains clindamycin phosphate, which is an antibiotic. It is used to cause infections.
Clindamycin is usually reserved for the treatment of serious infections, especially when other
antibiotics have been unable to clear the infection and when the infection is caused by bacteria that are
sensitive to clindamycin.
Therapeutic indications
Clindamycin is indicated for the treatment of:
-

Intra-abdominal infections
Skin and soft tissue infections
Respiratory tract infections
Pelvic inflammatory disease

2. Before you take Clindamycin 150 mg/ml Solution for Injection or Infusion
Do not take Clindamycin 150 mg/ml Solution for Injection or Infusion
- if you are allergic (hypersensitive) to the active substance (clindamycin) or to one of the
ingredients of Clindamycin 150 mg/ml Solution for Injection or Infusion.
Take special care with Clindamycin 150 mg/ml Solution for Injection or Infusion
- if you have impaired hepatic (liver) and renal (kidney) function
- if you have disturbances in neuromuscular transmission (myasthenia gravis(muscle weakness),
Parkinson’s disease, etc)
- if you have a history of gastrointestinal disorders (e.g. earlier inflammations of the colon)
- if you have atopic (allergic) disease
- if diarrhoea is developed; it can be a symptom of colitis

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines,

In particular tell or doctor or pharmacist if you are taking:


Erythromycin an antibiotic used to treat infection: Clindamycin Injection and erythromycin may
not work as well when they are used together.



Contraceptive pill: the pill may not work and may not prevent pregnancy. Use additional
contraception, such as a condom, while receiving Clindamycin Injection and for 7 days after your
last dose of Clindamycin Injection.

If you are in hospital to have an operation or a hospital procedure tell your doctor you are taking
Clindamycin Injection. Clindamycin Injection may increase the effect of certain medicines (such as
those given to help your muscles relax).

Pregnancy and breast-feeding
If you are pregnant, thinking of getting pregnant, or are breast-feeding, ask your doctor or nurse for
advice before they give you Clindamycin Injection.

Driving and using machines
Side effects like dizziness, sleepiness and headaches can constrict the ability to drive and use
machines.
Important information about some of the ingredients of Clindamycin 150mg/ml Solution for
Injection or Infusion
This medicinal product contains less than 1mmol sodium (23mg) per dose, i.e essentialy “sodium
free”..

3. How to take Clindamycin 150 mg/ml Solution for Injection or Infusion
You will usually be in hospital when you are given Clindamycin Injection.
You will be given Clindamycin Injection by a doctor or nurse as an injection into your muscle, or
infusion into a vein (using a drip). The injection or infusion will take 10-60 minutes.
Adults


The usual dose is 600-1200mg clindamycin per day. This will be given in 2, 3 or 4 equal doses
over a 24-hour period.
• If you have a very severe infection your doctor may increase your dose to a maximum of 2700mg
per day. This will be given in 2, 3 or 4 equal doses over a 24-hour period.
Doses up to 4800mg per day have been given in life-threatening cases.
Children
Children (over 1 month of age up to 12 years):


The dose for children is based on your child’s body weight.





The doctor will decide how much to give your child.
The usual dose is 15 to 25mg per kg of body weight. This will be given in 3 or 4 equal doses over
a 24-hour period.
If your child has a very severe infection your doctor may increase the dose to at least 300mg. The
dose is not related to the weight of your child. This will be given in 3 or 4 equal doses over a 24hour period.

Your doctor will check that your liver and kidneys are working properly if:



you are given Clindamycin Injection for a long time;
your baby is given Clindamycin Injection.

If you have problems with your liver and kidneys your dose may be reduced.
If you forget to use Clindamycin Injection
Clindamycin Injection will be given to you by a doctor or nurse. If you think you have missed a dose
tell your doctor or nurse.
If you have too much Clindamycin Injection
If you think you have been given too much Clindamycin Injection tell a doctor or a nurse.
If you have any further questions on the use of this product, ask your doctor or nurse.

4. Possible side effects
Like all medicines, Clindamycin 150mg/mg Solution for Injection or Infusion can cause side effects,
although not everybody gets them.

Very common: affecting more than 1 user in 10
- gastrointestinal disturbances occur in the form of nausea, vomiting, stomach pains or diarrhoea.
Common: affecting 1 to 10 users in 100
- mild, transient increase of the serum transaminases (in liver enzymes).
- intramuscular injection may be followed by local irritations, pain, indurations and sterile abscess at
the injection site.
Uncommon: affecting 1 to 10 users in 1.000
-Symptoms of colitis such as severe diarrhoea, severe stomach and abdominal cramps, blood in the
faeces.
Rare: affecting 1 to 10 users in 10.000
- instances of cardiopulmonary arrest and low blood pressure (hypotension) have been reported
following too rapid intravenous administration.
- cutaneous inflammations.
- swellings, drug fever as well as skin redness (erythema exudativum multiforme) and toxic
epidermal necrolysis.
Very rare: affecting less than 1 user in 10.000
-

transient hepatitis with cholestatic jaundice
polyarthritis

-

severe acute allergic reactions such as anaphylactic shock.

Unknown: the frequency cannot be estimated from the available data
Taste and smell perversion, headaches, sleepiness, dizziness.
If any of the side effects gets serious or if you notice any side effects not listed in this leaflet tell your
doctor or pharmacist.

5. How to store Clindamycin 150 mg/ml Solution for Injection or Infusion
Keep out of the reach and sight of children
Store below 25°C
Store in the original package in order to protect from light.
Do not refrigerate or freeze
Do not use Clindamycin 150mg/ml Solution for Injection or Infusion after the expiry date which is
stated on the label and carton after EXP. The expiry date refers to the last day of that month.
Do not use Clindamycin 150mg/ml Solution for injection or Infusion if the solution is not clear.
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 Clindamycin 150 mg/ml Solution for Injection or Infusion contains
The active substance of Clindamycin 150 mg/ml Solution for Injection or Infusion is clindamycin
phosphate.
Each ml of solution contains clindamycin phosphate equivalent to 150mg of clindamycin.
The other ingredients are edetate disodium, sodium hydroxide (for pH adjustment) and sterilised water
for injections.
What Clindamycin 150 mg/ml Solution for Injection or Infusion looks like and contents of the
pack
Clindamycin 150 mg/ml Solution for injection or Infusion is a clear colourless solution in a clear
ampoule.
Type I, clear glass ampoules
Pack sizes
2ml: carton box with 5 ampoules
4ml: carton box with 5 ampoules
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Fannin UK Ltd.
42-46 Booth Drive
Park Farm South
Wellingborough

Northamptonshire NN8 6GT
U.K.
Hikma Farmacêutica (Portugal), S.A.
Estrada do Rio da Mó, nº 8, 8A – 8B
Fervença
2705 – 906 Terrugem SNT
Portugal
Tel: +351 21 960 84 10
Fax: +351 21 961 51 02
e-mail: geral@hikma.pt

This medicinal product is authorised in the Member States of the EEA under the following
names:
Ireland: Clindamycin 150mg/ml Solution for injection or Infusion
UK: Clindamycin 150mg/ml Solution for injection or Infusion
Portugal: Clindamicina 150mg/ ml Solução Injectável
The Netherlands: Clindamycine Fannin 150 mg/ml oplossing voor infusie

This leaflet was last approved in {07/2011}

--------------------------------------------------------------------------------------------------------------------------The following information is intended for medical or healthcare professionals only:
Clindamycin 150 mg/ml Solution for Injection or Infusion
Clindamycin phosphate
Under certain circumstances, clindamycin therapy may be an alternative form of treatment in patients
with penicillin allergy (penicillin hypersensitivity). There have been no reports of a cross-allergy
between clindamycin and penicillin and, based on the structural differences between the substances,
this is not to be expected. However, in individual cases, information does not exist on anaphylaxis
(hypersensitivity) towards clindamycin in persons with an already existing penicillin allergy. This
should be taken into consideration in a course of clindamycin treatment in patients with a penicillin
allergy.
Clindamycin should not be used in case of acute infections of the respiratory tract, if these are caused
by viruses.
Clindamycin is not suitable for the treatment of meningitis, for the concentration of antibiotic obtained
in the liquor cerebrospinalis is too little.
Instructions for use and handling
Dilution and infusion:
Clindamycin must be diluted prior to IV administration (not exceeding 12 mg clindamycin per ml)
and should be infused over at least 10 – 40 minutes (nor exceeding 30mg/min). It can never be
injected as an IV bolus.
Dose
300 mg
600 mg
900 mg
1200 mg

Diluent
50 ml
50 ml
100 ml
100 ml

Minimum infusion-time
10 minutes
20 minutes
30 minutes
40 minutes

Clindamycin may be diluted with 0.9% sodium chloride solution, 5% glucose solution or Ringer’s
lactate. Intramuscular administration is indicated when intravenous infusion is not possible for any
reasons.
Dosage in presence of liver diseases
In patients with liver disease of moderate to severe degree, elimination half-life of clindamycin is
prolonged. A reduction in dosage is generally not necessary if clindamycin is administered every 8
hours. However, the plasma concentration of clindamycin should be monitored in patients with severe
hepatic insufficiency. Depending on the results, this measure can make a reduction in dosage or an
increase in the dose intervals necessary.
Dosage in presence of kidney diseases
In the presence of kidney diseases, elimination half-life is prolonged; however, a dosage reduction is
not necessary in the event of mild to moderate impairment of renal function. Nevertheless, the plasma
concentration should be monitored in patients with severe renal insufficiency or anuria. Depending on
the results, this measure can make a reduction in dosage or an increase in the dose interval of 8 or even
12 hours necessary.
Compatibility and stability:
Clindamycin should not be combined with erythromycin as, with regard to the antibacterial action, an
antagonist effect has been observed in vitro.
There is cross-resistance between clindamycin and lincomycin.
Due to its neuromuscular-blocking properties, clindamycin can potentiate the effect of muscle
relaxants.
The reliability of the contraceptive effect of oral contraceptives applied concomitantly with
clindamycin is subject to question. Hence, during clindamycin therapy, other, non hormonal
contraceptive measures should be taken in addition.
The following drugs are physically incompatible with clindamycin: ampicillin, phenytoin sodium,
barbiturates, aminophylline, calcium gluconate, ciprofloxacin, magnesium sulphate, ceftriaxone
sodium, diphenylhydantoin, idarubicin hydrochloride. Solutions of clindamycin salts have a low pH
and incompatibility may reasonably be expected with alkaline preparations or with drugs unstable at
low pH.
After dilution:
Chemical and physical in-use stability has been demonstrated for 48 hours at 25ºC with 0.9% sodium
chloride solution, 5% glucose solution or Ringer’s lactate solutions.

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web2)