Patient Information Leaflet

CRYSTAPEN INJECTION

Benzylpenicillin Sodium

600 mg and 1200 mg

This leaflet tells you about the medicine you are receiving. It does not contain all the information about your medicine. If you have any questions or are unsure about anything, ask your doctor or pharmacist.

What Does Your Medicine Contain?

Crystapen Injection is available in 600 mg and 1200 mg vials, which contain 600 mg and 1200 mg of benzylpenicillin sodium respectively, as the active ingredient in each vial. Benzylpenicillin sodium is also known as penicillin G.

The 600 mg vial is available in packs of 2 and 25 vials. The 1200 mg vial is available in packs of 25.

Benzylpenicillin sodium is one of a group of medicines known as penicillins, which are antibiotics. Antibiotics are used to kill the bacteria (‘germs’), which cause infection. Benzylpenicillin sodium is used to treat infections of the ear, nose, throat, chest, heart, bones and skin. It may also be used to treat some sexually transmitted infections (e.g. gonorrhoea and syphilis), meningitis, brain abscesses, gangrene, blood infections, anthrax, tetanus, diphtheria, listeria (a type of food poisoning), leptospirosis (an infection from animals), pasteurellosis (an infection following animal bites), severe Lyme disease (an infection from tick bites), actinomycosis (an infection caused by trauma/surgery) and some infections caused by rat bites. Benzylpenicillin sodium is also used for the prevention of infection in newborn babies (specifically group B streptococcal infection).

Before Your Medicine Is Used

IF THE ANSWER IS YES TO ANY OF THE FOLLOWING QUESTIONS, PLEASE TELL YOUR DOCTOR BEFORE YOUR MEDICINE IS USED:

• Are you pregnant, think you might be pregnant, or intending to become pregnant?
• Are you a breast-feeding mother?
• Have you ever had an allergic reaction to benzylpenicillin sodium or any other antibiotic (in particular other penicillins, cephalosporins or beta-lactams)?
• Do you suffer from other allergies, especially an allergy to medicines?
• Do you have kidney problems?
• Do you have liver problems?
• Do you have any heart problems?
• Are you diabetic?
• Are you currently taking any other medication, particularly oral contraceptives, probenecid or methotrexate?

How Your Medicine is Given

Crystapen Injection is a white powder. The doctor or nurse will mix the powder with an injection solution, which is usually Water for Injections or Sodium Chloride Injection, before injecting it. (Sodium Chloride Injection will not be used if you have kidney or heart problems). Your medicine will be injected either intramuscularly (into the muscle) or intravenously (into a vein). Repeated injections will be given at different sites. Infants and diabetics will normally receive Crystapen into a vein.

The dose for adults may be 600 mg to 3,600 mg daily. For severe infections such as meningitis and gangrene higher daily doses of up to 14,400 mg and 43,200 mg respectively may be used.

 

The dose for babies and children is based on their weight. The usual dose for newborn babies is 50 mg/kg body weight per day and for infants (1 to 4 weeks old) is 75 mg/kg body weight per day. The usual dose for children is 100 mg/kg body weight per day although higher doses of up to 4,000 mg per day, may be given.

The daily dose may be divided into between two and six separate injections.

Higher doses for severe infections, are usually given by slow intravenous infusion (drip).

Crystapen is sometimes given as a single dose in cases of suspected meningitis. The usual dose is 1,200 mg for adults and children over 10 years, 600 mg for children (1 - 9 years) and 300 mg for infants (under 1 year), by intramuscular or intravenous injection.

For the treatment of meningitis the dose is 2.4g every 4 hours for adults and children over 12 years, 180-300 mg/kg/day (up to 12 g/day) for children up to 12 years, 150 mg/kg/day for infants (1-4 weeks old) and 100 mg/kg/day for newborn babies.

If Crystapen is administered during labour for the prevention of infection (specifically group B streptococcal infection) in newborn babies, 3,000 mg of Crystapen should be given to the mother followed by 1,500 mg every 4 hours until the baby is delivered.

If you have kidney problems, your doctor will carry out some tests to check this. You may then be given a lower dose of Crystapen Injection. Lower doses may also be given to some elderly patients, premature babies and neonates.

Side Effects

All medicines may sometimes cause side effects in some people. Tell your doctor immediately if you think your medicine is making you feel unwell, or, if you get any of the following:

Allergy to benzylpenicillin sodium which may occur as:-

• Skin rash or itchy skin
• Difficulty in breathing or tightness of the chest
• Puffiness of the eyelids, face or lips
• Swelling or redness of the tongue
• Fever
• Joint pains
• Swollen lymph nodes

The following effects have also been reported after either long-term use or with high doses of your medicine:-

• Reduction in blood cell count and anaemias which might make you feel, tired or dizzy
• Low levels of potassium in the blood
• High levels of sodium in the blood
• Inflammation of the kidney
• Skin irritation, fever, headache, sore throat, sore muscles and fast heart beat particularly in patients being treated for syphilis.
• Diarrhoea, which may, rarely, have blood in it
• Thrush or infections with other germs
• Fits (convulsions)

Storage of Your Medicine

Crystapen Injection vials should be stored below 25°C.

Once the contents of the vial has been mixed with an injection solution it should be used immediately

Your medicine should always be used before the expiry date on the label.

Your doctor will know how to store your medicine.

All medicines should be stored away from children.

Do not throw this leaflet away as you may want to read it again.