What is Procaine Serra and what is it used for?
Procaine is a drug that belongs to the group of ester local anesthetics and is indicated for local infiltration anesthesia (pain associated with wounds, minor surgical procedures, burns, abrasions) and for peripheral nerve block anesthesia (consists of injecting the anesthetic over the nerves to anesthetize a larger area).
What you need to know before you are given Procaine Serra
Do not use Procaine Serra
If you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).
If you are allergic to p-aminobenzoic acid (PABA), parabens or ester-type local anaesthetics (tetracaine, etc.) due to the risk of cross-allergy.
If in doubt, consult your doctor.
Warnings and precautions
Talk to your doctor or pharmacist before you are given Procaina Serra:
If your liver is not working well, your doctor will need to adjust your dose.
if your kidneys are not working well as this may increase the risk of toxicity.
in epilepsy: may cause tremors and/or convulsions.
in heart failure, since it can produce intense myocardial depression (decrease in the activity of the heart muscles) as well as prolonged arrhythmias (prolonged disturbances of the normal heart rhythm).
Anesthetic drugs may contribute to the development of malignant hyperthermia (a syndrome of rapidly rising body temperature and muscle rigidity that can lead to death) if additional general anesthesia is required.
There is a risk of severe shock, decreased heart rate or heart block if, due to the application site or the use of high doses, high blood levels are reached.
It is not advisable to apply this medicine on inflamed or infected areas as the effect of the anesthetic may be altered.
Children
This drug is not indicated for use in children because it is more likely to produce systemic toxicity (generalized toxicity of the blood circulatory system) and there is insufficient information on the relationship between age and the effects of procaine.
Elderly patients
This drug should be administered with caution in elderly patients due to the increased likelihood of systemic toxicity and potential accumulation with repeated doses. It is recommended to use reduced doses depending on your physical condition.
Other drugs and Procaine Serra
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Some drugs, if administered at the same time as Procaine Serra, can influence the mechanism of action of procaine:
Sulfonamides (group of antibiotic drugs).
Anticholinesterases and, above all, echothiophate in ophthalmology (medicines used for the treatment of glaucoma or to produce contraction of the pupils).
Muscle relaxants.
Hypercalcemia (increased concentration of calcium in the blood) decreases the action of local anesthetics.
Acetazolamide (diuretic drug): Simultaneous administration increases the residence time of procaine in the blood, potentially increasing its effect and toxicity.
Using Procaine Serra with Food, Drinks and Alcohol
There are no known interactions with foods or drinks.
Pregnancy, breastfeeding and fertility
Pregnancy
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. Your doctor should weigh the benefits against the risks of this type of medicine.
Local anesthetics readily cross the placenta. The safety of use in pregnant women, except during childbirth, has not been established. As a precaution, it is preferable to avoid the use of Procaina Serra during pregnancy.
Breastfeeding
Consult your doctor or pharmacist before using any medicine.
It is not known whether procaine or its metabolites are excreted in human milk and whether this may affect the infant; however, no problems have been described in humans. A risk to newborns/infants cannot be excluded.
Driving and using machinery
Procaine Serra may temporarily impair locomotor function and coordination depending on the area anesthetized, therefore activities that may require special attention should not be performed until instructed by your doctor.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Adverse effects of procaine are, in general, infrequent although moderately important. In most cases, adverse effects are dose-related and may result from administration of a high dose, rapid absorption or intravascular injection, or they may result from an allergic reaction, idiosyncrasy or reduced tolerance of the patient.
Common side effects: may affect up to 1 in 10 people
Excitement, agitation, dizziness, ringing in the ears (buzzing), blurred vision, tremors and convulsions, numbness or decreased sense of touch in and around the mouth.
Nausea and vomiting.
Rare side effects: may affect up to 1 in 1,000 people
Hives due to allergic reaction.
Anaphylactoid reaction (generalized allergic reaction).
Adverse effects of unknown frequency: cannot be estimated from the available data
Depression with drowsiness and coma
Respiratory depression (slow or insufficient breathing).
Methemoglobinemia (iron deficiency in hemoglobin (the red blood pigment) which causes it to not carry oxygen effectively to the tissues).
Myocardial depression (decreased activity of the heart muscles), hypotension (low blood pressure), bradycardia (slow and abnormal heart rhythm), arrhythmia (alteration of the normal heart rhythm) and cardiac arrest.
If you notice any side effects not mentioned in this leaflet, or if you get any of the side effects listed seriously, please tell your doctor or pharmacist.
Package contents and additional information
Composition of Procaína Serra 20 mg/ml solution for injection:
The active ingredient is procaine hydrochloride.
Each milliliter of solution contains 20 milligrams of procaine hydrochloride.
The other ingredients (excipients) are hydrochloric acid (for pH adjustment) and water for injections.