Active substanceParacetamol + TramadolParacetamol + Tramadol
Similar drugsTo uncover
  • Zaldiar
    pills inwards 
    Grünenthal GmbH     Germany
  • Rutram®
    pills inwards 
    BALTIMOR FK, LLC     Russia
  • TRAMACETTE
    capsules inwards 
  • Dosage form: & nbspcoated tablets
    Composition:

    Active substances: one tablet, coated with a shell, contains tramadol hydrochloride 37.5 mg and paracetamol 325 mg.

    Excipients: cellulose microcrystalline, starch pregelatinized, sodium starch glycolate, corn starch, purified water, magnesium stearate.

    Shell composition: ODADRAY® light yellow (YS-1-6382-G), carnauba wax.

    The composition of OUADRAY® light yellow (YS-1-6382-G): hypromelose, titanium dioxide, polyethylene glycol 400 (Macrogol), iron oxide, yellow oxide, polysorbate.

    Description:

    Light yellow tablets of oblong form, biconvex, covered with a film membrane, on a fracture of almost white color. On the tablet, engraving: on one side of the "T5", on the other logo of the company "Grünental".

    Pharmacotherapeutic group:Analgesic opioid + analgesic non-narcotic remedy
    ATX: & nbsp

    N.02.A.X   Other opioids

    N.02.A.X.52   Tramadol in combination with other drugs

    Pharmacodynamics:

    Zaldiar is a combination drug containing tramadol and paracetamol.

    Tramadol - opioid synthetic analgesic, has analgesic effect, is an agonist of opiate receptors. Has a central action and action on the spinal cord (contributes to the discovery of K+ and Ca2+ channels, causes hyperpolarization of membranes and inhibits pain impulses), enhances the effect of sedatives. Activates opiate receptors (mu, delta, kappa) on the pre- and postsynaptic membranes of the afferent fibers of the nociceptive system in the brain and gastrointestinal tract.

    Paracetamol - has an analgesic and antipyretic effect. It blocks cyclooxygenase in the central nervous system, affecting the centers of pain and thermoregulation. Does not cause irritation of the gastric mucosa and intestine, does not affect the water-salt metabolism, since it does not affect the synthesis of prostaglandins in peripheral tissues. Thanks to paracetamol, rapid anesthesia occurs, while tramadol provides a prolonged effect.

    Synergism of analgesic action of two active substances reduces the risk of side effects.

    Pharmacokinetics:

    When ingested, the drug is quickly and almost completely absorbed from the digestive tract.

    The absorption of tramadol is slower than paracetamol. Tramadol metabolized in the liver by N- and O-demethylation followed by conjugation with glucuronic acid. Identified 11 metabolites, of which mono-O-desmethyltramadol (M1) has pharmacological activity. The average elimination half-life for the tramadol metabolite is 4.7 - 5.1 hours, for paracetamol 2-3 hours. The maximum concentration in the blood plasma of paracetamol is reached within 1 hour, and does not change when combined with tramadol. The bioavailability of tramadol is approximately 75%, with repeated application increases to 90%. Binding to plasma proteins is about 20%, the volume of distribution is about 0.9 l / kg. A relatively small part (up to 20%) of paracetamol binds to plasma proteins. Tramadol (about 30%) and its metabolites (about 60%) are excreted mainly through the kidneys. Paracetamol mainly metabolized in the liver. Paracetamol and its conjugates are excreted by the kidneys.

    Indications:Pain syndrome (medium and strong intensity of various etiologies, including inflammatory, traumatic, vascular origin).Anesthesia in the conduct of painful diagnostic or therapeutic measures.
    Contraindications:

    - hypersensitivity to the active components or excipients of the drug;

    - acute intoxication with alcohol or drugs that depress the central nervous system (CNS), hypnotics, narcotic analgesics and psychotropic preparations;

    - simultaneous use of MAO inhibitors (and 2 weeks after their cancellation);

    - severe hepatic and / or renal failure (creatinine clearance less than 10 ml / min);

    - epilepsy, uncontrolled by treatment;

    - syndrome of "withdrawal" of drugs;

    - Children's age (up to 14 years).

    Carefully:

    In patients with shock, craniocerebral trauma, intracranial hypertension, propensity to convulsive syndrome (in patients with epilepsy, controlled therapeutically, the drug can be used only for vital reasons), confusion of unknown etiology, respiratory function disorder, simultaneous use of psychotropic and other painkillers of the central action, means of local anesthesia,diseases of the biliary tract; benign hyperbilirubinemia, viral hepatitis, glucose-6-phosphate dehydrogenase deficiency, alcoholic liver damage, alcoholism, drug addiction, abdominal pain of unclear genesis ("acute" abdomen), elderly age (over 75 years).

    Pregnancy and lactation:

    Do not use during pregnancy and during lactation.

    Dosing and Administration:

    Zal'diar is used under the supervision of a doctor, the dosing regimen and the duration of treatment are selected individually, depending on the severity of the pain syndrome and the sensitivity of the patient. Do not prescribe the drug beyond the term justified from a therapeutic point of view.

    For adults and children over 14 years the recommended initial single dose is 1-2 tablets, the interval between doses is at least 6 hours. Applied regardless of the meal, swallowed whole (can not be broken or chewed), squeezed with liquid. The maximum daily dose - 8 tablets (300 mg of tramadol and 2.6 g of paracetamol).

    If the patient forgot to take the next pill, then the next one is taken, as recommended by the doctor.Do not take a double dose to make up the missed dose!

    In elderly patients (at the age of 75 and over) the usual doses can be used. However, in connection with the possibility of delayed excretion, the interval between doses of the drug can be increased.

    Have patients with renal insufficiency (clearance of creatinine from 10 to 30 ml / min). The drug should be taken with 12-hour intervals between doses. As tramadol very slow withdrawal in hemodialysis or haemofiltration, postdialysis to maintain analgesic effect is usually not required.

    Have patients with severe impairment of liver function the drug is not used. With a moderate violation of liver function, the interval between doses of the drug should be increased. The risk associated with paracetamol overdose is higher in patients with liver disease of alcoholic etiology.

    Side effects:

    Allergic reactions: urticaria, itching, Quincke's edema, exanthema, bullous rash.

    From the nervous system: sweating, dizziness, headache, weakness, increased fatigue, retardation,paradoxical stimulation of the central nervous system (nervousness, agitation, anxiety, tremor, muscle spasms, euphoria, emotional lability, hallucinations), drowsiness, sleep disturbance, confusion, impaired coordination of motion, convulsions of the central genesis (with concomitant administration of antipsychotics), depression, amnesia, violation of cognitive function, paresthesia, unsteadiness of gait.

    From the digestive system: dry mouth, nausea, vomiting, flatulence, abdominal pain, constipation, diarrhea, difficulty in swallowing; an increase in the activity of "hepatic" enzymes, usually without the development of jaundice.

    From the cardiovascular system: tachycardia, orthostatic hypotension, syncope, collapse.

    From the endocrine system: hypoglycemia, up to hypoglycemic coma.

    From the urinary system: difficulty urinating, dysuria, urinary retention. With prolonged admission in doses significantly exceeding the recommended - nephrotoxicity (interstitial nephritis, papillary necrosis).

    From the sense organs: impaired vision, taste.

    From the respiratory system: dyspnoea.

    From the skin: multiforme exudative erythema (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome).

    On the part of the organs of hematopoiesis: sulfgemoglobinemia. With prolonged admission in doses much higher than recommended - aplastic anemia, pancytopenia, agranulocytosis.

    Other: violation of the menstrual cycle.

    With prolonged use - the development of drug dependence. With a sharp cancellation, the "cancellation" syndrome.

    Overdose:

    In the case of an acute overdose of Zaldiar, the symptoms may include signs and symptoms of an overdose of tramadol and / or paracetamol.

    Symptoms of an overdose of tramadol: miosis, vomiting, collapse, coma, convulsions, depression respiratory center, apnea.

    Symptoms of paracetamol overdose: (acute overdose develops 6-14 hours after paracetamol administration, chronic overdose after 2-4 days if dose is exceeded).

    Symptoms of acute overdose: diarrhea, decreased appetite. Symptoms of chronic overdose: cerebral edema, hypocoagulation, development of DIC syndrome, hypoglycemia, metabolic acidosis, arrhythmia,collapse; rarely a violation of liver function develops lightning fast and can be complicated by renal failure (renal tubular necrosis).

    Treatment. The usual emergency measures are applied. Recommended gastric lavage and intake of enterosorbents (Activated carbon, polyphepan), to support the functions of the cardiovascular system, to ensure the patency of the respiratory tract. For the reversibility of respiratory depression, like the tramadol overdose syndrome, naloxone. Seizures that occur with toxic doses can be eliminated by diazepam. Tramadol is minimally excreted from blood serum by hemodialysis or hemofiltration, therefore, only carrying out these measures for overdose therapy is ineffective.

    When there are symptoms of paracetamol overdose: the introduction of donators SH-groups and precursors of glutathione-methionine synthesis 8-9 hours after an overdose and N-acetylcysteine ​​- after 12 hours The need for additional measures (further introduction of methionine, iv administration N-acetylcysteine) is determined depending on the concentration of paracetamol in the blood, as well as on the time elapsed after its administration.

    Interaction:

    Joint use with opioid agonists-antagonists (buprenorphine, nalbuphine, pentazocine) is not recommended, t. The analgesic effect is reduced as a result of a competing effect on the receptors and there is a risk of withdrawal syndrome. When the drug is administered together with other drugs that have a depressing effect on the central nervous system (for example, hypnotics or tranquilizers), and also with the simultaneous intake of alcohol, the side effects characteristic of tramadol may be more pronounced.

    Inductors of microsomal oxidation (incl. carbamazepine, phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants) reduce the analgesic effect and its duration. Naloxone activates breathing, eliminating analgesia.

    Long-term use of barbiturates reduces the effectiveness of paracetamol. Ethanol promotes the development of acute pancreatitis.

    Prolonged sharing of paracetamol and other non-steroidal anti-inflammatory drugs increases the risk of developing "analgesic" nephropathy and renal papillary necrosis, the onset of the terminal stage of renal failure.Simultaneous long-term administration of paracetamol in high doses and salicylates increases the risk of developing kidney or bladder cancer. Diflunisal increases the concentration in the blood plasma of paracetamol by 50% - the risk of developing hepatotoxicity.

    Concomitant use with funds that lower the epileptic threshold, for example selective inhibitors of serotonin uptake, tricyclic antidepressants, neuroleptics, may increase the risk of seizures. Preparations that inhibit CYP3A4, such as ketoconazole and erythromycin, can slow the metabolism of tramadol (N-demethylation) and an active O-demethylated metabolite.

    HeeMr.anddin increases the concentration in the blood plasma of tramadol and reduces the concentration M1 metabolite by competitive inhibition of isoenzyme CYP2D6.

    Inhibitors of microsomal oxidation (cimetidine) reduce the risk of hepatotoxic effects.

    The rate of absorption of paracetamol can be increased by taking metoclopramide or domperidone and lowered with cholestyramine.

    The drug, when taken for a long time, enhances the effect of indirect anticoagulants (warfarin and other coumarins), which increases the risk of bleeding.
    Special instructions:

    Patients should be informed of the need to follow the dosing regimen and should not use other medications containing tramadol or paracetamol.

    With prolonged uncontrolled use, symptoms of dependence may appear: irritability, phobias, nervousness, sleep disorders, psychotomotor activity, tremor, discomfort in the stomach or intestine. Patients who are addicted to abuse or addiction should be treated under close medical supervision for a short period.

    During the treatment with the drug is forbidden to take alcohol. The risk of liver damage increases in patients with alcoholic hepatosis.

    During long-term treatment, monitoring of the peripheral blood pattern and the functional state of the liver is necessary.

    Effect on the ability to drive transp. cf. and fur:During treatment Zaldiar should refrain from driving motor vehicles and activities potentially hazardous activities that require high concentration and psychomotor speed reactions.
    Form release / dosage:

    The coated tablets are 325 mg + 37.5 mg.

    Packaging:For 10 tablets, coated in a blister of polypropylene / polypropylene or polypropylene / aluminum foil, PVC / aluminum foil. 1, 2, 3 or 5 contour packs (blisters) together with the instruction for use are placed in a cardboard pack.
    Storage conditions:At temperatures not higher than 25 ° C, in places inaccessible to children.
    Shelf life:

    3 years. Do not use the drug after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:P N 015588/01
    Date of registration:25.03.2009
    The owner of the registration certificate:Grünenthal GmbHGrünenthal GmbH Germany
    Manufacturer: & nbsp
    Representation: & nbspGRUNENTAL GmbH GRUNENTAL GmbH Germany
    Information update date: & nbsp12.08.2015
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