• 40 mg procaine hydrochloride

• Sodium chloride
• Citric acid monohydrate
• Sodium hydroxide for pH adjustment
• Water for injections

Indication / for local anesthesia, procaine hydrochloride application

• The preparation is a medicine for local anesthesia (local anesthetic of the ester type)
• It is used in the context of neural therapeutic application principles.

dosage

• Always use the medicine exactly as directed. Please ask your doctor or pharmacist if you are not sure.
• The medicine is generally administered by a doctor. Please ask your doctor if you are not sure how to use it.
• The basic rule is that only the smallest dose may be administered with which the desired adequate nerve block is achieved. The dosage is to be carried out individually according to the particularities of the individual case.
• Unless otherwise used by the doctor:
  • Adults and adolescents from 15 years of age with an average height:
• Skin wheals:
  • Up to 10 mg per wheal, corresponding to 0.5 ml solution for injection.
• The recommended maximum dose for single use in tissues from which medicinal substances are rapidly absorbed is 500 mg procaine (corresponding to 25 ml injection solution). For use in the head, neck and genital area, the recommended maximum single dose is 200 mg procaine (within 2 hours).
• In patients with certain pre-existing conditions (vascular occlusions, hardening and narrowing of the vessels (arteriosclerosis) or nerve damage due to diabetes) the dose should also be reduced by a third. With impaired liver or kidney function, increased plasma levels can occur, especially with repeated use. In these cases, a lower dose range is also recommended.
• Please talk to your doctor if you have the impression that the effect is too strong or too weak.

• Duration of application:
  • In principle, there is no limit to the duration of use, but please note the information given under areas of application.

• If you use more than you should,
  • the attending physician must be informed immediately.
    • a. Symptoms of overdose
      • In low damaging doses, the drug acts as a stimulant on the central nervous system; in high damaging dose ranges, it works in the opposite direction. Procaine hydrochloride poisoning has two phases:
        • They become restless, complain of dizziness, acoustic and visual disturbances and tingling, especially in the tongue and lip area. The language is slurred, chills and muscle twitching are harbingers of an impending seizure affecting the whole body. As the poisoning of the central nervous system progresses, there is an increasing dysfunction of the brain stem with symptoms of impaired breathing and coma up to and including death.
    • b. Emergency measures and antidotes are set by the attending physician accordingly
      • the symptoms are initiated immediately.

• If you forget to use:
  • Do not use a double dose to make up for a forgotten dose.

• If you cancel the application:
  • The treatment can be canceled at any time.

way

• The medicine is injected into the skin (intracutaneously).
• It should only be sprayed by people with the appropriate knowledge to successfully carry out the respective application.
• As a general rule, only low-concentration solutions of procaine are used for continuous use.
• Repeated use of this drug can lead to reversible loss of effectiveness due to tachyphylaxis (rapid development of tolerance to the drug).
• The solution for injection is only intended for single withdrawal. The application must take place immediately after opening the container. Unused leftovers are to be discarded.

Side procaine hydrochloride effects

• Like all medicines, this can cause side effects, although not everybody gets them.
• The frequency of side effects is based on the following categories:
• Possible side effects:
  • If you experience any of the side effects listed below, stop using the medicine and contact your doctor as soon as possible.
• Adverse effects of procaine affecting the whole body primarily affect the central nervous and cardiovascular systems.
• At plasma concentrations, as they are generally achieved with regular use, the blood pressure is usually only slightly influenced by the effect that promotes the strength and rate of the heart.
• Procaine can trigger changes in the spread of excitation in the heart, which show up in the ECG (as a flattened T wave or shortened ST segment).
• A drop in blood pressure can be the first sign of a relative overdose in terms of heart-damaging effects. As central nervous disorders, abnormal sensations around the mouth area, restlessness, impaired consciousness or a seizure can be triggered.
• Allergic reactions in the form of hives, swelling of the tissue due to water retention, cramping of the airways or shortness of breath and circulatory reactions have been described.
• Local allergies and allergy-like reactions in the form of skin inflammation with reddening of the skin, itching and even blistering can occur on contact with ester local anesthetics like this one.
• In addition, local reactions when used under the skin (subcutaneous) and in the muscles (intramuscular) may include swelling, reddening of the skin and bruising.
• If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects that are not specified.

Interactions

• Use with other medicinal products:
  • Please inform your doctor or pharmacist if you are taking / using or have recently taken / used any other medicines, including medicines obtained without a prescription.
  • The following interactions of procaine with other drugs are known:
    • Prolongation of the effect of certain means to relax the skeletal muscles (non-depolarizing muscle relaxants)
    • Enhancement of the effect by physostigmine (agent for stimulating part of the autonomic nervous system)
    • Decrease in the effectiveness of certain antibiotics (sulfonamides). Procaine should not be used together with certain agents to stimulate part of the autonomic nervous system (cholinesterase inhibitors). Among other things, the influence on procaine breakdown leads to an increase in the toxicity of procaine.
  • By adding small amounts of atropine, the pain-eliminating effect can be prolonged.
  • Physostigmine in low doses can have a preventive effect against the toxic effects of procaine.
  • Most important chemical incompatibilities:
    • Procaine should not be mixed with other medicinal products, as a change in the pH value or the electrolyte concentration can lead to the precipitation of the active ingredient.
• Use with food and drink:
  • No mutual interference is to be expected, since it is an injection solution, ie it is used bypassing the gastrointestinal tract.

Contraindications

• The drug must not be used:
  • if you are allergic (hypersensitive) to procaine, other local anesthetics of the ester type or any of the other ingredients
  • in the case of a known deficiency of a certain endogenous substance (pseudocholinesterase) with the consequence of a considerably slower breakdown of procaine
  • For injection into arteries, in the vicinity of the outer covering of the central nervous system (epidural) or in the vertebral canal (spinal).

pregnancy for local anesthesia, procaine hydrochloride and breast feeding period

• Pregnancy:
  • Only use the medicine during pregnancy if your doctor thinks it is absolutely necessary.
• Breastfeeding:
  • Procaine hydrochloride passes into breast milk. However, with short-term use, it will not be necessary to interrupt breastfeeding. If repeated treatment or treatment with higher doses is necessary, breastfeeding should be discontinued.

Patient, local anesthesia, procaine hydrochloride information

• Warnings and Precautions:
  • if you are in a
    • certain form of muscle weakness (myasthenia gravis)
    • Disturbance of the cardiac conduction system
    • Suffer from heart failure or
    • the injection is to be made in an inflamed area.
  • Before use, the doctor who uses it will always ensure that the circulation is properly replenished, carefully monitor the circulation and have all ventilation, seizure therapy and resuscitation measures available.
  • The doctor must also find out from you whether you have had an allergic reaction to other drugs that are chemically related to procaine, as this can also lead to an allergic reaction to procaine (para group allergy). This can e.g. B. be sulfonamides (certain group of antibiotics), oral antidiabetic drugs (agents for diabetes), certain dyes, X-ray film developer or other means of local anesthesia.
  • If you can only break down procaine extremely slowly because a certain body substance is not as active (pseudocholinesterase deficiency), side effects from procaine are more likely to occur.
  • When used in the neck and head area, there is a higher degree of danger because the risk of symptoms of poisoning in the central nervous system is increased.
  • To avoid side effects, the following points should be observed:
    • In certain cases, put on a drip before use.
    • Choose the dosage as low as possible.
    • As a rule, do not use a vasoconstrictor additive.
    • Before the injection, carefully aspirate in two planes (turn the cannula).
    • Caution when injecting into infected areas (due to increased absorption with reduced effectiveness).
    • Inject slowly.
    • Check blood pressure, pulse and pupil size.
  • It should be noted that treatment with anti-coagulants (anticoagulants such as heparin), non-steroidal anti-inflammatory drugs or plasma substitutes can lead to serious bleeding not only inadvertent vascular injury as part of pain treatment, but also in general with an increased tendency to bleed . Therefore, have appropriate laboratory tests carried out before use. If necessary, the anticoagulant treatment should be discontinued early enough.
  • Use with simultaneous preventive therapy to avoid thrombosis with low molecular weight heparin should only be carried out with particular caution.
  • Children:
    • For use in children and adolescents under 15 years of age, there is no experience from which general dosage recommendations can be derived.
  • Elderly people:
    • In the elderly, it is recommended that the dose be adjusted according to their general condition.

• Driving and using machines:
  • Let your doctor decide on a case-by-case basis whether you can actively participate in road traffic, use machines or carry out work without a secure footing.