Principen
Principen is a beta-lactam antibiotic from the penicillin group.
It is recommended for treating bacterial infections that are sensitive to medication.
What Does Principen Contain?
The active substance is:
Ampicillin sodium quantity corresponding to 1g of Ampicillin.
For 1 vial.
The other component is:
Solvent
Water for injection.
This medicinal product comes in the form of a vial of powder + ampoule of solvent.
Box of 1 or 25 vial(s) +.ampoule(s) or box of 25 powder vials.
How To Take
Always follow the dosage instructions given by your doctor. If in doubt, consult your doctor or pharmacist.
The usual dose is:
Adults
- I.M.: 2 g per day
- I.V.: 2 to 12 g per day
Infants and children
- I.M.: 50 mg / kg per day
- I.V.: 100 to 300 mg / kg per day
- In neonates: I.V.: 100 to 300 mg / kg per day
Dosage must be adjusted in cases of renal impairment.
Duration of treatment
The absence of fever or other symptoms does not necessarily indicate a complete recovery. Fatigue is often caused by the infection itself, not by the antibiotics. Reducing or stopping your treatment prematurely won't alleviate this tiredness and could prolong your recovery time.
If you have used more Principen than you should have
The symptoms of overdosage are largely consistent with the side effect profile.
As with all antibiotics in this therapeutic class, administration of this medicinal product, particularly in the event of overdosage, may lead to a risk of encephalopathy, which may result in confusion, disturbances of consciousness, convulsive seizures or abnormal movements. If you experience any of these symptoms, consult your doctor or pharmacist immediately.
Do not take a double dose to make up for the one you have forgotten to take.
Side Effects
Like all medicines, this drug may cause undesirable effects, but they do not occur systematically in everyone.
Reactions requiring special attention
If you experience any of the serious side effects listed below, you should seek medical advice immediately as you may require emergency medical treatment.
Allergic reactions and serious skin reactions:
- Allergies: angioedema (sudden swelling of the face and neck), difficulty breathing, allergic shock with sudden malaise and fall in blood pressure;
- Redness spreading to the whole body with pustules and accompanied by fever (acute generalised exanthematous pustulosis). Skin detachment that can rapidly spread to the whole body in a very serious way (Stevens-Johnson/Lyell syndrome).
If you experience any of the following symptoms, ask your doctor for advice as soon as possible.
Inflammation of the large intestine, leading to watery diarrhoea with blood and mucus, abdominal pain.
The occurrence of diarrhoea during antibiotic treatment should not be treated without medical advice.
In addition:
- Nausea, vomiting, diarrhoea, candidiasis (infection due to a fungus;
- Urticaria, rash, itching;
- Eosinophilia (increase in certain white blood cells), anaemia (decrease in red blood cells), leucopenia (more or less significant decrease in the number of white blood cells), thrombocytopenia (decrease in the number of platelets), these changes being reversible;
- Moderate and transient increase in liver enzymes (transaminases) in the blood;
- Impairment of renal function.
Serious neurological disorders called encephalopathies, such as confusion, consciousness disorders, convulsive seizures or abnormal movements, particularly in the case of high doses or kidney dysfunction.
Precautions
Never use Principen:
- If you are allergic (hypersensitive) to ampicillin, penicillins or any of the other components contained in this medicine;
- If you have ever had an allergic reaction to an antibiotic. This may include a skin rash or swelling of the face or throat.
If you are in any doubt, ask your doctor, pharmacist or nurse for advice before using this medicine.
Talk to your doctor, pharmacist or nurse before using Principen if you:
- have kidney problems,
- have infectious mononucleosis (sore throat, swollen glands and extreme tiredness),
- do not urinate regularly.
In the event of any allergic reaction, treatment should be stopped and appropriate medication instituted.
Regular monitoring of the functioning of your liver, kidneys and blood count may be necessary in the event of prolonged treatment.
Children and adolescents
Not applicable.
Other medicinal products and Principen
Tell your pharmacist or nurse if you are taking, have recently taken or may take any other medicines.
- If you are taking methotrexate (used in the treatment of cancer and severe psoriasis), ampicillin may cause an increase in undesirable effects. Principen should not generally be used in combination with methotrexate;
- If you are taking allopurinol (used in the treatment of gout) with ampicillin, the risk of an allergic skin reaction is increased;
- Allopurinol (used to treat gout): the concomitant administration of Principen and Allopurinol is not recommended (increased risk of skin lesions);
- If you are taking mycophenolate mofetil (used to prevent rejection by your body of an organ that has been transplanted into you), there may be a risk of reduced efficacy.
Principen and alcohol
Not applicable.
Driving vehicles and using machines
This medicine may have a significant influence on the ability to drive vehicles and use machines, particularly due to the possible occurrence of encephalopathy.
Pregnancy and Breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Principen may be prescribed by your doctor during pregnancy if necessary.
Ampicillin is excreted in breast milk. Breast-feeding is only possible with this medicine after assessment by the attending physician. If your newborn baby develops problems such as diarrhoea, skin rashes or candidiasis (an infection caused by certain microscopic fungi), tell your doctor immediately, who will advise you on what to do, as these effects on your child may be due to this medicine.