for medical use
of NOVOKAIN-DARNITSA medicine
the Trade name
the International unlicensed
name Procainum Dosage Form Solution for injections of 0.5% 5 ml
of 1 ml of drug contains
active agent – novocaine (Procainum a hydrochloride) 5 mg,
excipients: acid of chlorohydrogen 0.1 M, water for injections.
Transparent colourless liquid.
Anesthetics. Local anesthetics. Aminobenzoic acid ethers. Procainum.
The ATX N01BA02 code
Pharmacokinetics Degree properties of absorption depends on the place and a way of introduction (especially on vascularization and the speed of a blood-groove in the injection site) and a total dose (quantity and concentration). It is quickly hydrolyzed by esterases and cholinesterases of plasma and fabrics with education of two main pharmacological active metabolites: diethylaminoethanol (has moderate vasodilating effect) and paraaminobenzoic acid (is a competitive antagonist of sulfanamide chemotherapeutic medicines and can weaken their antimicrobial action). Elimination half-life makes 30-50 with, in the neonatal period – 54-114 pages. It is allocated mainly with kidneys in the form of metabolites (80%), in not changed look no more than 2% are removed.
It is badly absorbed by mucous membranes.
Mestnoanesteziruyushchy means with moderate activity and big therapeutic width. The mechanism of anesthetic effect is connected with blockade of natrium channels, braking of potassium current, the competition to calcium, decrease in surface intention of a phospholipidic layer of membranes, oppression of oxidation-reduction processes and generation of impulses. At receipt in blood reduces formation of acetylcholine, reduces excitability of peripheral holinoreaktivny systems, has the blocking effect on vegetative a ganglion, reduces spasms of smooth muscles, reduces excitability of a cardiac muscle and motor zones of a cerebral cortex.
– infiltration anesthesia
– medical blockade
the Route of administration and doses
For infiltration anesthesia enter 350-600 mg (70-120 ml). The highest doses for infiltration anesthesia for adults: the first single dose at the beginning of operation – is not higher than 0.75 g (150 ml), further for each hour of operation – it is not higher than 2 g (400 ml) of solution.
At perinephric blockade (according to A.V. Vishnevsky) enter 50-80 ml of 0.5% of solution of Novokain-Darnits into pararenal cellulose.
At circulator or juxtaspinal blockade vnutrikozhno enter 5-10 ml.
At vagosympathetic blockade enter 30-40 ml.
For reduction of absorption and lengthening of action at local anesthesia, in addition enter 0.1% solution of epinephrine of a hydrochloride (Adrenalinum hydrochloricum) – on 1 drop on 2-5-10 ml of solution of Procainum.
Novokain-Darnitsa is usually well had, however the following side reactions are sometimes possible:
– a headache, dizziness, drowsiness, weakness, motive concern, a loss of consciousness, spasms, a tremor, visual and acoustical disturbances, a nystagmus, a syndrome of a horse tail (paralysis of legs, paresthesias), paralysis of respiratory muscles, the block motor and sensitive
– in stomatology: insensitivity, paresthesias of lips and language, a lockjaw
– increase or a lowering of arterial pressure, a peripheral vazodilatation, collapse, bradycardia, arrhythmias, thorax pain
– involuntary urination
– nausea, vomiting, involuntary defecation
– a methemoglobinemia
– a skin itching, skin rashes, dermatitis, peeling of skin, other anaphylactic reactions (including. the Quincke’s disease, acute anaphylaxis), a small tortoiseshell (on skin and mucous membranes)
the Contraindication hypothermia
– hypersensitivity to drug (including to paraaminobenzoic acid and other local Anesthetics Ether)
– a myasthenia
– arterial hypotension
– purulent process in the injection site
– the urgent surgical interventions which are followed by sharp blood loss
– the significant fibrous changes in fabrics (for anesthesia by method of creeping infiltrate)
– age up to 18 years
Prolongs the muscular blockade caused by succinylcholine (as both drugs are hydrolyzed by plasma cholinesterase). Atropini sulfas enhances anesthetic effect of drug.
Novocaine weakens diuretic effect of diuretics.
Use along with MAO inhibitors (furasolidone, Procarbazinum, selegelin) increases risk of developing arterial hypotension. The toxicity of Procainum is increased by the antikholinesterazny drugs (suppressing its hydrolysis). Procainum metabolite (paraaminobenzoic acid) is a competitive antagonist of sulfanamide drugs and can weaken their antimicrobial action. Drug should not be used at treatment by streptocides.
When processing the place of an injection of local anesthetic disinfection the solutions containing heavy metals risk of development of local reaction in the form of morbidity and hypostasis increases.
Exponentiates effect of direct anticoagulants.
Drug reduces influence of antikholinesterazny funds for neuromuscular transmission.
The cross sensitization is possible.
For reduction of absorption and extension of effect of solution of Novokain-Darnits at local anesthesia usually add Adrenalinum hydrochloricum solution (0.1%) to them – on 1 drop on 2, 5 or 10 ml of solution of Novokain-Darnits.
For prevention of side reactions at first carry out test on shipping which hypostasis and reddening of the place of an injection demonstrates. At positive reaction Procainum is not applied.
At use of drug the control of function cardiovascular, respiratory and central nervous systems is necessary. With care appoint in a serious illness of heart, liver and kidneys.
When carrying out local anesthesia at use of the same general dose the toxicity of Procainum of subjects is higher, than the applied solution is more concentrated. In this regard with increase in concentration of solution drug solution to smaller concentration (sterile isotonic solution of sodium of chloride) is recommended to reduce or dilute the general dose.
Drug is used with care at the states which are followed by decrease in a hepatic blood-groove, progressing of cardiovascular insufficiency (usually owing ment of heart blocks and shock), inflammatory diseases, deficiency of pseudo-cholinesterase, a renal failure, at patients of advanced age (65 years are more senior), the seriously ill patients weakened patients at pregnancy, during childbirth and feeding by a breast.
Pregnancy and the period of a lactation
Use during pregnancy is possible on condition of good tolerance and only if the expected advantage for mother exceeds potential risk for a fruit.
During feeding by a breast drug use perhaps after preliminary careful estimate of the expected advantage of therapy for mother and potential risk for the baby.
At use the development of bradycardia, apnoea, spasms in the newborn is during childbirth possible.
The feature of influence of medicine on ability to run the vehicle and potentially dangerous mechanisms
during treatment needs to refrain from driving by vehicles and occupations potentially dangerous types of activity demanding the increased concentration of attention and speed of psychomotor reactions.
Is possible only at Novokain-Darnits’s use in high doses.
Symptoms: pallor of integuments and mucous membranes, dizziness, nausea, vomiting, the increased nervous irritability, cold sweat, tachycardia, a lowering of arterial pressure honor before collapse, a tremor,
spasms, an apnoea, a methemoglobinemia, respiratory depression, sudden cardiovascular collapse.
Action, on the central nervous system is shown by feeling of fear, hallucinations, spasms, motive excitement. In overdose cases the administration of drug should be stopped immediately. When carrying out local anesthesia the injection site can be cut away adrenaline.
Treatment: the general resuscitation actions which include oxygen inhalation, if necessary – carrying out artificial ventilation of the lungs. If spasms proceed more than 15-20 sec., stop them intravenous administration of thiopental (100-150 mg) or diazepam (5-20 mg). In arterial hypotension and/or a depression of a myocardium intravenously enter ephedrine (15-30 mg), in hard cases – disintoxication and symptomatic therapy.
In case of development of intoxication after Novokain-Darnits’s injection in muscles of a leg or a hand the urgent applying a tourniquet for decrease in the subsequent intake of drug in the general blood stream is recommended.
A form of release and packing
On 5 ml of drug in ampoules glass.
On 10 ampoules together with the instruction for medical use in the state and Russian languages and a knife for opening of ampoules put in a box with a corrugated insert. When packing ampoules with a color ring of a break or with a color point of a break, laying of knives for opening of ampoules is excluded.
On 5 ampoules together with a knife for opening of ampoules place in blister strip packaging (cartridge). On the 2nd blister strip packagings with the instruction for medical use in the state and Russian languages place in a pack. When packing ampoules with a color ring of a break or with a color point of a break, laying of knives for opening of ampoules is excluded.
To Store storage conditions in original packing, at a temperature not above 25 °C.
Not to freeze.
To store out of children’s reach!
not to use a period of storage after expiry date.
According to the prescription
CIAO Producer Pharmaceutical Darnitsa
Ukraine, 02093, Kiev, Borispolskaya St., 13.
The owner of the registration certificate
CIAO The pharmaceutical
Darnitsa Address of the Organization, the claim accepting in the territory of the Republic of Kazakhstan from consumers on quality of products (goods):
phone number / fax: (+ 380 44) 207 73 27