Ampicillin Sodium&Cloxacillin Sodium for Injection
AMCLO FORTE Contents :
Each vial of AMCLO FORTE contains ampicillin 250 mg and cloxacillin 250 mg without other ingredients.
AMCLO FORTE Character:
AMCLO FORTE is supplied as a clear glass vial of sterile powder .
AMCLO FORTE Pack:
1 vial plus 1 ampoule.
1. What AMCLO FORTE is and what it is used for What AMCLO FORTE is
AMCLO FORTE is an antibiotic and works by killing bacteria that cause infections. It contains two diﬀerent medicines called ampicillin and cloxacillin. They both belong to a group of antibiotics called 'penicillins'. This sterile powder is made up into a solution for injection.
What AMCLO FORTE is used for
AMCLO FORTE is used in adults and children to treat the following infections:
•infected wounds or lung infections following surgery
•respiratory tract infections
•fever associated with childbirth
2. What you need to know before you take AMCLO FORTE Do not use AMCLO FORTE if you:
•are allergic (hypersensitive) to the active ingredients of ampicillin or cloxacillin.
•have ever had an allergic (hypersensitive) reaction to any antibiotic. This can include a skin rash or swelling of the face or neck.
Do not have AMCLO FORTE if any of the above apply. If you are not sure, talk to your doctor, pharmacist or nurse before having AMCLO FORTE.
Take special care with AMCLO FORTE:
Check with your doctor, pharmacist or nurse before having this medicine if you:
•have ever had any reactions to antibiotics, including a skin rash or swelling of the face or neck when taking any antibiotic
•are being treated for kidney or liver problems
•have glandular fever and/or leukaemia as you may develop a rash if you have these conditions and take ampicillin
•are on a diet that restricts the amount of sodium you can eat.
If this medicine is being given to your baby, tell your doctor:
•if you (mother) are allergic to penicillin
•if your baby has jaundice (yellowing of the skin and/or eyes).
If you are not sure if any of the above apply to you, talk to your doctor, pharmacist or nurse before you have AMCLO FORTE.
Other medicines and AMCLO FORTE
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
•If you are taking allopurinol (used for gout) with AMCLO FORTE, it may be more likely that you’ll have an allergic skin reaction.
•If you are taking probenecid (used for gout), your doctor may decide to adjust your dose of AMCLO FORTE.
•If you are taking methotrexate for conditions such as rheumatoid arthritis, psoriasis or cancer, your doctor may decide to adjust your dose of AMCLO FORTE
AMCLO FORTE may stop the contraceptive pill working. You will need to use extra contraceptive precautions, such as using a condom. If you need any advice, talk to your doctor, pharmacist or nurse.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
1.How to take AMCLO FORTE
You will never give yourself this medicine. A qualified person, like a doctor or a nurse, will give you this medicine.
• AMCLO FORTE will be given as an injection or an infusion into a vein (intravenously) or muscle (intramuscularly).
• Your doctor will decide how much you need each day and how often the injections should be given.
• Make sure you drink plenty of fluids while having AMCLO FORTE. The usual doses are as follows.
Adults, elderly patients and children over 10 years of age
One to two vials every four to six hours
Children 2 – 10 years
Half adult dose. Dosage may be further increased where necessary.
Children up to 2 years
Quarter adult dose.
Kidney and liver problems
If you have kidney or liver problems the dose might be lower than the usual dose.
If more AMCLO FORTE is given to you than recommended
It is unlikely you will be given too much, but if you think you have been given too much AMCLO FORTE, tell your doctor, pharmacist or nurse immediately. Signs might be an upset stomach (feeling sick, being sick or diarrhoea) or neurotoxic symptoms (limb weakness or numbness, loss of memory, loss of vision, headache) in very high doses. You may also experience these signs if you have kidney problems.
If you think you have missed an injection of AMCLO FORTE
Speak to your doctor, pharmacist or nurse.
How long will you need to take AMCLO FORTE for?
Your doctor will tell you how long you will need to be given your medication.
If you have any further questions on the use of this medication, ask your doctor, pharmacist or nurse.
2.Possible side effects
Like all medicines, this medicine can cause side eﬀects, although not everybody gets them. The following side eﬀects may happen with this medicine.
Tell your doctor or nurse straight away if you notice any of the following serious side effects – you may need urgent medical treatment:
The following are very rare (aﬀects less than 1 in 10,000 people)
•allergic reactions, the signs may include: skin itching or rash, swelling of the face, lips, tongue, body or breathing diﬃculties.
•rash or pinpoint flat red round spots under the skin surface or bruising of the skin. This is due to inflammation of blood vessel walls due to an allergic reaction. It can be associated with joint pain (arthritis) and kidney problems
•a delayed allergic reaction can occur usually 7 to 12 days after having AMCLO FORTE, some signs include: rashes, fever, joint pains and enlargement of the lymph nodes especially under the arms
•a skin reaction known as ‘erythema multiforme’ where you may develop: itchy reddish purple patches on the skin especially on the palms of the hands or soles of the feet, ‘hive-like’ raised swollen areas on the skin, tender areas on the surfaces of the mouth, eyes and private parts. You may have a fever and be very tired
•other severe skin reactions can include: changes in skin colour, bumps under the skin, blistering, pustules, peeling, redness, pain, itching, scaling. These may be associated with fever, headaches and body aches
•high temperature (fever), chills, a sore throat or other signs of an infection, or if you bruise easily. These may be signs of a problem with your blood cells
•inflammation of the large bowel (colon) with diarrhoea sometimes containing blood, pain and fever
•serious liver side eﬀects may occur which are often reversible. You must tell your doctor or nurse urgently if you get:
-severe diarrhoea with bleeding
-blisters, redness or bruising of the skin
-darker urine or paler stools
-yellowing of the skin or the whites of the eyes (jaundice). See also anaemia below which might result in jaundice.
These can happen when having the medicine or for up to several weeks after.
If any of the above happen to you talk to your doctor or nurse straight away as your medicine should be stopped. Sometimes you may get less severe skin reactions such as:
• a mildly itchy rash (round, pink-red patches), ‘hive-like’ swollen areas on forearms, legs, palms, hands or feet. This is uncommon (aﬀects less than 1 in 100 people).
If you have any of these talk to your doctor or nurse as AMCLO FORTE will need to be stopped.
The other possible side eﬀects are: Common (may aﬀect up to 1 in 10 people)
•feeling sick (nausea)
Uncommon (may aﬀect up to 1 in 100 people)
• being sick (vomiting).
Very rare (may aﬀect up to 1 in 10,000 people)
•fits (convulsions), seen in patients on high doses or with kidney problems
•sudden, involuntary jerking or a muscle or group of muscles
•an excessive breakdown of red blood cells causing a form of anaemia. Signs include: tiredness, headaches, shortness of breath, dizziness, looking pale and yellowing of the skin and the whites of the eyes
Contents of the pack and other information
What AMCLO FORTE contains
• Each vial of AMCLO FORTE contains ampicillin 250 mg and cloxacillin 250 mg. There are no other ingredients.
• The doctor, nurse or pharmacist will make up the injection before use using an appropriate fluid.
What AMCLO FORTE looks like and contents of the pack
AMCLO FORTE is supplied as a clear glass vial of sterile powder for making up as an injection.
The pack contains a vial containing ampicillin 250 mg and cloxacillin 250 mg, also contains 1 ampoule containing 5 ml sterile water for injections.
How to store AMCLO FORTE
AMCLO FORTE is for use in hospital only and the expiry date and storage instructions stated on the vial label and carton are for the doctor, nurse or pharmacist’s information. The doctor, pharmacist or nurse will make up your medicine.
AMCLO FORTE should be stored below 25℃ until given to you.
There is an expiry date on the label, the doctor or nurse will check that this date has not passed.