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HEWEDOLOR Procaine 2% ampoules

Hevert Arzneimittel GmbH & Co. KG

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HEWEDOLOR Procaine 2% ampoules

Dosage form: ampoules

Solution for injection Active

ingredient: Procaine hydrochloride 40 mg
Local anesthetic for neural therapy
Drugs for local anesthetic (ester-type local anesthetic)

Areas of application
For use as part of neural therapy application principles.

Local anesthetic for neural therapy.

Active ingredients

  • 40 mg procaine hydrochloride

ingredients

  • Water for injections
  • Hydrochloric acid for pH adjustment
  • Sodium chloride
Indication :
  • The preparation is a medicine for local anesthesia (local ester-type anesthetic)
  • It is used within the framework 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 used by a doctor. Please ask your doctor if you are unsure about how to use it.
  • The basic rule is that only the smallest dose that achieves the desired sufficient nerve block may be administered. The dosage must be determined individually according to the specifics of the individual case.
  • Unless prescribed otherwise by the doctor:
    • Adults and young people aged 15 and over with an average height:
  • Skin hives:
    • per wheal up to 10 mg corresponding to 0.5 ml injection solution.
  • The recommended maximum dose for a single dose in tissues from which drugs are rapidly absorbed is 500 mg procaine (corresponding to 25 ml injection solution). When used in the head, neck and genital area, the recommended single-time maximum dose is 200 mg procaine (within 2 hours).
  • In patients with certain previous illnesses (vascular occlusions, hardening and narrowing of the vessels (arteriosclerosis) or nerve damage due to diabetes), the dose should also be reduced by a third. If liver or kidney function is impaired, increased plasma levels may occur, especially with repeated use. In these cases, a lower dose range is also recommended.
  • Please talk to your doctor if you think the effect is too strong or too weak.

 

  • Duration of application:
    • The duration of application is in principle not limited, but please note the information under areas of application.

 

  • If you use more than you should,
    • The treating doctor must be informed immediately.
      • a. Symptoms of overdose
        • The drug acts as a stimulant on the central nervous system in low, damaging doses and has the opposite effect in high, damaging dosage ranges. Procaine hydrochloride poisoning occurs in 2 phases:
          • You become restless, complain of dizziness, acoustic and visual disturbances and tingling, especially in the tongue and lip area. Speech is slurred, chills and muscle twitching are harbingers of an impending seizure affecting the entire body. As the poisoning of the central nervous system progresses, there is increasing dysfunction of the brainstem with the symptoms of respiratory restriction and coma and even death.
      • b. Emergency measures and antidotes will be taken accordingly by the attending physician
        • of the symptoms of the disease should be initiated immediately.

 

  • If you forget to use:
    • Do not use a double dose if you forget the previous dose.

 

  • If you cancel the application:
    • The treatment can be stopped at any time.
Way :
  • The medicine is injected into the skin (intracutaneously).
  • It should only be injected by people with the appropriate knowledge to carry out the respective application successfully.
  • As a general rule, only low-concentration solutions of procaine should be used for continuous use.
  • Repeated use of this medicine can lead to reversible loss of effect due to tachyphylaxis (rapid development of tolerance to the medicine).
  • The injection solution is only intended for one-time use. The application must take place immediately after opening the container. Any unused leftovers must be discarded.
Side effects :
  • Like all medicines, this can cause side effects, although not everyone gets them.
  • The frequency information on 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.
  • Undesirable effects of procaine that affect the whole body primarily affect the central nervous and cardiovascular systems.
  • At plasma concentrations such as those generally achieved with regular use, blood pressure is usually only slightly influenced by the effect that promotes heart strength and beat speed.
  • Procaine can cause changes in the propagation of excitation in the heart, which show up on 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 with a damaging effect on the heart. Central nervous system disorders can include sensations around the mouth, restlessness, impaired consciousness or a seizure.
  • Allergic reactions in the form of hives, swelling of the tissue due to water retention, cramping of the airways or shortness of breath as well as circulatory reactions have been described.
  • Local allergies and allergy-like reactions in the form of skin inflammation with redness of the skin, itching and even blistering can occur upon contact with ester local anesthetics such as this one.
  • In addition, local reactions can include swelling, redness and bruising when used under the skin (subcutaneously) and in the muscle (intramuscularly).
  • If you notice any side effects, contact your doctor or pharmacist. This also applies to side effects that are not specified.
Interactions :
  • Use together with other medicines:
    • Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even if they are non-prescription medicines.
    • The following interactions of procaine with other medicines are known:
      • Prolongation of the effect of certain agents for relaxing skeletal muscles (non-depolarizing muscle relaxants)
      • Enhancement of the effect by physostigmine (agent for stimulating part of the autonomic nervous system)
      • Reduction in the effectiveness of certain antibiotics (sulfonamides). Procaine should not be used together with certain agents that stimulate part of the autonomic nervous system (cholinesterase inhibitors). Among other things, the influence on the breakdown of procaine leads to an increase in the toxicity of procaine.
    • By adding small amounts of atropine, it is possible to prolong the pain-relieving effect.
    • In low doses, physostigmine can have a preventive effect against toxic effects of procaine.
    • Most important chemical intolerances:
      • Procaine should not be mixed with other drugs as a change in pH or electrolyte concentration can lead to precipitation of the active ingredient.
  • Use with food and drinks:
    • No mutual interference is expected since it is an injection solution, meaning it is used bypassing the gastrointestinal tract.
Contraindications :
  • The medicine must not be used:
    • if you are hypersensitive (allergic) to procaine, other ester-type local anesthetics or any of the other ingredients
    • if there is a known deficiency of a certain endogenous substance (pseudocholinesterase), which results in a significantly slower breakdown of procaine
    • for injection into arteries, into the area surrounding the outer covering of the central nervous system (epidural) or into the spinal canal (spinal).
Pregnancy and breastfeeding :
  • Pregnancy:
    • Only use this medicine during pregnancy if your doctor thinks it is absolutely necessary.
  • Breastfeeding:
    • Procaine hydrochloride passes into breast milk. However, for short-term use, interruption of breastfeeding will not be necessary. If repeated treatment or treatment with higher doses is necessary, you should stop breast-feeding.
Patient information :
  • Warnings and Precautions:
    • if you are at one
      • certain form of muscle weakness (myasthenia gravis)
      • Disturbance of the cardiac conduction system
      • Suffer from heart muscle weakness or
      • the injection is to be made into an inflamed area.
    • Before use, the treating doctor will always ensure that the circulatory system is well filled, carry out careful circulatory monitoring and have all measures available for ventilation, treatment of seizures and resuscitation.
    • 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 an allergic reaction to procaine can then also occur (paragroup allergy). This can e.g. B. Sulfonamides (certain group of antibiotics), oral antidiabetics (medicines for diabetes), certain dyes, X-ray film developers or other local anesthetics.
    • If procaine can only be broken down 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 noted:
      • In certain cases, apply an additional drip before use.
      • Choose the dosage as low as possible.
      • As a rule, do not use a vasoconstrictor additive.
      • Before injection, aspirate carefully in two planes (rotate the cannula).
      • Be careful 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 during treatment with anticoagulants (anticoagulants, such as heparin), non-steroidal anti-inflammatory drugs or plasma substitutes, not only can accidental vascular injury as part of pain treatment lead to serious bleeding, but that in general an increased tendency to bleed must be expected . Therefore, have appropriate laboratory tests carried out before use. If necessary, the anticoagulant treatment should be discontinued as soon as possible.
    • Use with simultaneous preventive therapy to avoid thrombosis with low molecular weight heparin should only be carried out with particular caution.
    • Children:
      • There is no experience with use in children and adolescents under 15 years of age from which general dosage recommendations can be derived.
    • Older people:
      • In older people, a dosage adjustment is recommended according to the respective general condition.

 

  • Ability to drive and use machines:
    • Let your doctor decide on a case-by-case basis whether you can actively participate in traffic, operate machines or carry out work without secure support.