Zaldiar (Zaldiar)

Indications for use:
• the need for analgesia of painful medical or diagnostic manipulations;
• inflammatory, post-traumatic, vascular pain syndrome (moderate and severe).

Pharmacological action:
Zaldiar is a combined pain reliever containing tramadol and paracetamol.

Tramadol is an analgesic of the synthetic opioid group (opioid receptor agonist). It acts on μ-, κ-, δ-opioid receptors of the nociceptive system of the brain and gastrointestinal tract through their activation at the level of pre- and postsynaptic membranes of afferent fibers. It acts on the polarization of membranes, opening potassium and calcium channels, which causes hyperpolarization and inhibits the conduction of pain impulses. Potentiates the effect of sedative products.

Paracetamol is an analgesic with antipyretic properties. It affects the pain and temperature centers of the brain by deactivating cyclooxygenase. It does not affect the prostaglandin-synthetic function of peripheral tissues, therefore it does not have an irritating effect on the gastrointestinal mucosa and does not affect water-electrolyte metabolism.

Tramadol prolongs the rapid analgesic effect caused by paracetamol. The two components act synergistically, which is associated with a decrease in the likelihood of side effects.

Zaldiar (Zaldiar) method of administration and doses:
Dosage and regimen of application is prescribed individually by a doctor. The drug can not be used over the prescribed period. Tablets are taken orally, without chewing, with a small amount of liquid. There is no dependence on food intake. Do not double the next dose if the patient forgot to take the next pill. Starting single dose – 1-2 tablets, the largest dose per day – 300 mg of tramadol, 2600 mg of paracetamol (8 tablets). The interval between doses is at least 6 hours.

In gerontological patients (over 75 years old), the interval between taking the product is increased, the single dose remains the same.
In case of impaired renal function (creatinine clearance 10-30 ml / min), the interval between taking zaldiar tablets should be at least 12 hours.

If the patient is on chronic dialysis, after the dialysis procedure, an additional intake is not required (tramadol is almost not excreted through dialysis and hemofiltration).

In case of liver failure, the interval for taking zaldiar is increased; in case of severe hepatic disorders, the product is not prescribed.

Zaldiar (Zaldiar) contraindications:
• Combination with monoamine oxidase inhibitors (zaldiar can be taken if 14 days or more have passed since the last MAO intake);
• acute intoxication with psychotropic drugs, opioid analgesics, sleeping pills, alcohol;
• creatinine clearance less than 10 ml/min;
• age up to 14 years;
• drug withdrawal syndrome;
• hypersensitivity to the components of the product.

Zaldiar (Zaldiar) side effects:
Central and peripheral nervous system: headache, general weakness, dizziness, increased fatigue, paradoxical hyperexcitability (tremor, spastic disorders, anxiety, agitation, nervousness, labile mood, hallucinogenic phenomena, euphoria). There may also be insomnia, confusion, drowsiness, convulsive syndrome of central origin, discoordinated motor activity, depression, memory loss, memory loss, taste and vision disturbances, and unsteady gait.

Allergic manifestations: rash, itching of the skin, Quincke’s edema.

Gastrointestinal tract:nausea, vomiting, abdominal pain, excessive gas formation, dry mouth, difficulty swallowing, diarrhea, increased transaminase activity (without jaundice).

Endocrine system: hypoglycemic state up to the development of hypoglycemic coma.

Cardiovascular system: orthostatic collapse, tachycardia, syncopal arrhythmia.
Urinary system: dysuric phenomena, difficulty urinating, urinary retention. When the dose is exceeded and unreasonably long use – nephrotoxic effects (papillary necrosis and interstitial nephritis).

Skin reactions: erythema, exanthema, Steven-Johnson syndrome, Lyell’s syndrome (toxic epidermal necrosis), bullous rash.

Respiratory system:violation of the rhythm of breathing.

Hematopoietic function: sulfhemoglobinemia, aplastic anemia, agranulocytosis, pancytopenia – if the recommended dosage is exceeded and used for a long time.

Other effects: menstrual irregularities, excessive sweating.

Zaldiar is contraindicated in pregnant women and women who are breastfeeding.

Symptoms of an overdose of zaldiar include signs of overdose of both tramadol and paracetamol, or the prevalence of symptoms of one of the components.

Acute overdose of paracetamol (symptoms appear after 6-14 hours): decreased appetite, diarrhea. Rarely – fulminant development of liver failure, renal tubular nephrosis (renal failure).
Chronic overdose of paracetamol (in case of exceeding the dose develops after 2-4 days): hypocoagulation, DIC, cerebral edema, arrhythmia, hypoglycemia, collapse.

Tramadol: vomiting, miosis, collapse, convulsions, coma, dyspnea, apnea, depression of the respiratory center.

Therapeutic measures include gastric lavage, the appointment of enterosorbents, ensuring the patency of the upper respiratory tract, symptomatic treatment of symptoms from the cardiovascular system.
Convulsive syndrome is stopped by the appointment of diazepam.
Hemodialysis and hemofiltration are ineffective. When the respiratory center is depressed, an antagonist, naloxone, is administered.
При превалировании симптомов передозировки парацетамола вводят предшественники синтеза глутатиона и средства–донаторы сульфгидрильных групп, причем если прошло 8–9 часов – показано введение метионина, а через 12 часов вводят N–ацетилцистеин. В зависимости от содержания парацетамола в сыворотке крови и времени от в последствииднего употребления решается вопрос о целесообразности дальнейшего назначения метионина и N–ацетилцистеина.

Использование с другими лекарственными препаратами:
Не рекомендуется комбинация залдиара с бупренорфином, пентазоцином, налбуфином (агонистами–антагонистами опиоидных рецепторов). Эффект залдиара в этом случае будет уменьшен за счет конкурентных взаимодействий с рецепторами, может развиться синдром отмены.

Drugs that depress the functions of the central nervous system (tranquilizers, psychotropic drugs), as well as ethanol, increase the side effects of tramadol.
The analgesic effect of zaldiar is completely eliminated when using naloxone (an opioid receptor antagonist).

The combined use of microsomal oxidation inducers (phenytoin, tricyclic antidepressants, ethanol, barbiturates, carbamazepine, phenylbutazone, rifampicin) reduces the analgesic effect and duration of analgesia of zaldiar.

Long-term use of barbiturates reduces the severity of the action of paracetamol. Joint reception in the aftermath with non-steroidal anti-inflammatory drugs increase the likelihood of developing renal papillary necrosis and nephropathy, and also accelerate the development of end-stage renal failure. The combination of paracetamol-salicylates with long-term use increases the risk of bladder or kidney cancer.

Cimetidine and other inhibitors of microsomal oxidation, when taken with zaldiar, reduce the hepatotoxic effects of zaldiar.
Drugs that reduce convulsive readiness (selective serotonin reuptake inhibitors, antipsychotics, tricyclic antidepressants) in combination with zaldiar can provoke the development of convulsive syndrome.

The risk of bleeding increases when Zaldiar is taken for a long time with indirect anticoagulants (coumarins: warfarin, etc.) due to increased anticoagulant effect in the aftermath.
The metabolism of tramadol is reduced when ketoconazole or erythromycin is used concomitantly.

The concentration in the blood of tramadol increases with the simultaneous administration of diflunisal, quinidine, while the hepatotoxic effects of zaldiar are enhanced.
Paracetamol alters the absorption rate when combined with domperidone or metoclopramide (increased rate) and cholestyramine (decreased).

Release form:
Tablets, coated with a yellow shell, with the symbol “T5” on one side and the logo of the pharmaceutical company “Grunenthal” on the other. There are 10 tablets in a blister.

Storage conditions:
Zaldiar is stored in a dark place, out of the reach of children. Temperature conditions – no more than 25 ° С. The storage period is no more than 3 years. Vacation from the pharmacy – only by prescription from a doctor.

Zaldiar (Zaldiar) composition:
Active ingredients: tramadol – 37.5 mg; paracetamol – 325 mg.

Inactive Ingredients: Microcrystalline cellulose, sodium starch glycolate, corn starch, magnesium stearate, pregelatinized starch, purified water.

Sheath: dye YS-1-6382-G Opadry light yellow (titanium dioxide, hypromellose, macrogol, iron oxide yellow, polysorbate), carnauba wax.

For traumatic brain injury, shock, intracranial hypertension, confused consciousness of unknown origin, respiratory dysfunction, biliary tract pathology, viral hepatitis, benign hyperbilirubinemia, toxic (alcoholic hepatitis), drug addiction, alcoholism, glucose-6-phosphate dehydrogenase deficiency, use with caution.

Use with caution a combination of zaldiar with: psychotropic drugs, centrally acting analgesics, local anesthetics.
With symptoms of an “acute” abdomen, do not use (masks the full clinical picture).
Carefully used in gerontology (in patients over 75 years).
Zaldiar is prescribed for health reasons in case of increased convulsive readiness (epilepsy controlled by drug therapy).

When taking Zaldiar, patients should strictly observe the regimen of taking the product and not use other drugs containing tramadol and paracetamol without a doctor’s recommendation.
If zaldiar is used for a long time and uncontrolled, addiction (drug dependence, withdrawal syndrome) may develop. Signs of drug dependence are the appearance of phobias, irritability, insomnia, nervousness, tremors, psychomotor activity, and dyspepsia.

For patients who are prone to abuse or develop a dependence syndrome, the use of tramadol should be supervised by a physician.
While taking zaldiar, ethanol (alcohol and alcoholic beverages) is contraindicated. If a patient has alcoholic hepatosis, while taking Zaldiar, the likelihood of developing hepatic dysfunction increases dramatically.
While taking Zaldiar, it is recommended to monitor the clinical blood count and laboratory tests for liver function.
When taking the product, it is recommended not to drive vehicles; work that requires concentration of attention and control of complex mechanisms is contraindicated.

Before using the medication“Zaldiar (Zaldiar)” you need to consult a doctor.
The instructions are provided solely for familiarization with “Zaldiar (Zaldiar) “.

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