Akupan-Biocodex (Acupan®-Biocodex)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
Read on
Active substanceNefopamNefopam
Similar drugsTo uncover
  • Akupan-Biocodex
    solution w / m d / infusion 
    BIOCODEX     France
    • Dosage form: & nbspsolution for infusion and intramuscular injection
    Composition:

    1 ampoule (2 ml) contains:

    Name of component

    amount

    Active ingredient:

    Nefopama hydrochloride

    20.0 mg

    Excipients:

    Sodium dihydrogen phosphate dihydrate

    32.215 mg

    Sodium hydrophosphate dodecahydrate

    3.440 mg

    Water for injections

    up to 2.0 ml


    Description:A clear, colorless, odorless solution.
    Pharmacotherapeutic group:Analgesic for central action.
    ATX: & nbsp

    N.02.B.G.   Other analgesics and antipyretics

    N.02.B.G.06   Nefopam

    Pharmacodynamics:

    An analgesic of central action, structurally different from other analgesics. Experimental studies indicate a central effect, which is based on inhibiting the reuptake of dopamine, norepinephrine and serotonin at the level of synapses.

    In animals nefopam showed antinociceptive activity, by possibly reducing the release of glutamate at the presynaptic level and activating N-methyl-D-aspartate receptors at the postsynaptic level. Nefopam in clinical studies showed a positive effect in postoperative tremors. Nefopam does not have an anti-inflammatory or antipyretic effect, does not depress respiration and does not affect intestinal peristalsis. Nefopam has a slight m-cholin-blocking effect.

    Pharmacokinetics:

    After the administration of a single dose of 20 mg intramuscularly, the maximum serum concentration is observed after 30-60 minutes, and is 25 ng / ml. The half-life is an average of 5 hours. After an intravenous dose of 20 mg, the half-life (T1 / 2) is 4 hours. Binding to plasma proteins is 71-76%. Biotransformation is significant, three metabolites have been identified: desmethylnepopam; nefopam N-oxide; N-glucuronide nefopam. Desmethylnepopham and nefopam NThe oxide is not glucuronized in the liver, does not exhibit analgesic activity in animal studies. 87 % of the administered dose is excreted by the kidneys, less than 5% of the administered dose is output unchanged.

    Metabolites found in urine are 6%, 3% and 36%, respectively, of the dose administered intravenously.

    Indications:

    Pain syndrome of different etiology and intensity:

    - pain syndrome with trauma,

    - pain syndrome after surgery,

    - anesthesia of childbirth,

    - toothache,

    - myalgia,

    - renal and hepatic colic, Premedication before painful medical procedures.

    Contraindications:

    - Hypersensitivity to nefopam or other components of the drug,

    - Age under 12 years,

    - Convulsions or their presence in the anamnesis, epilepsy,

    - The risk of urinary retention caused by damage to the urethra and prostate gland,

    - The risk of developing acute glaucoma,

    - Pregnancy, the period of breastfeeding.

    Carefully:

    Caution should be exercised in appointing patients with hepatic, renal insufficiency, elderly patients.

    Caution should be exercised in appointing patients with tachycardia.

    Pregnancy and lactation:contraindicated
    Dosing and Administration:

    The dose should correspond to the intensity of the pain syndrome and the patient's reaction.

    Intramuscular injection: ACUPAN®-BIOKODEX should be administered intramuscularly deep. The recommended dose per administration is 20 mg. If necessary, the administration is repeated every 6 hours. The maximum daily dose is 120 mg.

    Intravenous administration: ACUPAN®-BIOKODEX should be administered as an intravenous infusion lasting at least 15 minutes,the patient should be lying down. The recommended dose per administration is 20 mg. If necessary, the administration is repeated every 4 hours. The maximum daily dose is 120 mg.

    Method of administration: ACUPAN®-BIOKODEX can be administered in a usual solution for infusions (0.9% solution of sodium chloride or 5% solution of dextrose). The optimum ratio at dilution is the contents of the 1st ampoule of the drug in 50 ml of the infusion solution.

    The course of treatment is no more than 8-10 days.

    Side effects:

    Sweating, drowsiness, nausea, vomiting, atropin-like reactions (dry mouth, fainting, urinary retention, irritability, agitation), tachycardia and increased blood pressure, hypersensitivity, urticaria, Quincke's edema, anaphylactic shock, convulsions, hallucinations, drug dependence.

    Overdose:

    Symptoms: tachycardia, convulsions, hallucinations.

    Treatment: symptomatic, cardiac and respiratory monitoring in a hospital.

    Interaction:

    Contraindicated with the sympathomimetics and m-holinoblokiruyuschimi drugs that increase the side effects of the drug ACUPAN®-BIOKODEX, especially in the case of simultaneous

    introduction: atropine-like antispasmodics, m-cholinoblocking

    antiparkinsonian drugs, imipramine antidepressants and phenothiazine neuroleptics, H1-histamine receptor blockers, disopyramide.

    Special instructions:

    ACUPAN®-BIOKODEX does not apply to narcotic analgesics and antagonists opioids. Thus, discontinuation of treatment

    narcotic analgesics of dependent patients who are already receiving therapy with the drug ACUPAN®-BIOKODEX, increases the risk

    development of withdrawal syndrome. Moreover, ACUPAN®-BIOKODEX does not increase detoxification of the patient.

    The benefit / risk ratio for drug treatment is subject to constant reassessment.

    ACUPAN®-BIOKODEX should not be prescribed for the treatment of chronic pain syndromes, such as headache.

    Possible risk of drug dependence in patients with depression or in patients with any drug dependence in history.

    Effect on the ability to drive transp. cf. and fur:During treatment, it is not recommended to drive vehicles and engage in other potentially hazardous activities requiring increased concentration of attention and speed of psychomotor reactions.
    Form release / dosage:

    Solution for infusion and intramuscular injection 10 mg / ml.

    Packaging:2 ml per ampoules of colorless transparent glass (type I) with a break point and a coding stripe in blue. 5 ampoules on a plastic pallet, together with the instruction, are placed in a cardboard pack.
    Storage conditions:

    Store at a temperature of no higher than 25 ° C, in a place protected from light. Keep out of the reach of children.

    Shelf life:

    3 years.

    Do not use after expiry date.

    Terms of leave from pharmacies:On prescription
    Registration number:LP-000181
    Date of registration:20.01.2011
    The owner of the registration certificate:BIOCODEX BIOCODEX France
    Manufacturer: & nbsp
    BIOCODEX France
    Representation: & nbspBIOCODEX BIOCODEX France
    Information update date: & nbsp08.08.2015
    Illustrated instructions
      Instructions
      Up