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  • Dolaren 100 tablets — Made in India — Free Delivery

Dolaren 100 tablets — Made in India — Free Delivery

(Dolaren)
Dolaren 100 tablets — Made in India — Free Delivery
Dolaren 100 tablets — Made in India — Free Delivery
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Nabros Pharma Brand: Nabros Pharma
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Description Dolaren 100 tablets — Made in India — Free Delivery

Pharmacological properties

Dolaren is a combined preparation with a pronounced anti-inflammatory, analgesic and antipyretic effect. the pharmacological activity of the preparation is due to the properties of diclofenac and paracetamol, which are part of Dolaren. diclofenac sodium has a pronounced anti-inflammatory and analgesic, as well as a moderate antipyretic effect. paracetamol has a pronounced analgesic, slight antipyretic and anti-inflammatory effect. the mechanism of action is associated with inhibition of prostaglandin synthesis.
When diclofenac sodium is taken inside, the active substance is rapidly absorbed into the blood, Cmax in blood plasma is reached after 1-2 hours. Food somewhat slows down the rate of absorption, but does not affect its level. The preparation is 99% bound to blood plasma proteins, penetrates well into tissues and synovial fluid, where its concentration can exceed that in blood plasma. T1 / 2 from blood plasma is 1–2 hours, from synovial fluid - 3–6 hours. Diclofenac sodium is metabolized in the liver, ≈35% of the preparation is excreted in the urine as metabolites and ≈1% - unchanged, ≈35% - with feces ... When taken orally, paracetamol is well absorbed. Cmax in the blood is reached 30 minutes after ingestion and lasts approximately 1 hour. About 25% of the preparation binds to plasma proteins, T1 / 2 - 1.5–2 hours. By hepatic metabolism, it is converted into glucuronides and sulfates. The concentration of the preparation in the urine is higher than in the blood plasma.

Indications

Headache, toothache, neuralgia, lumbago, sciatica, sciatica, osteoarthritis, rheumatoid arthritis, ankylosing spondylitis; diseases of the joints and spine, soft tissues, febrile condition, acute musculoskeletal pain, tendinitis, bursitis, postoperative pain, dysmenorrhea.

Application

The dose is determined by the doctor for each patient individually, depending on the patient's age, the nature and course of the disease, individual tolerance and therapeutic efficacy of the preparation. The preparation should be used in the most effective doses for a short period of time, taking into account the goals of treatment for each individual patient.
Adults and children over 14 years old - 1 tablet 2-3 times a day after meals.
The duration of treatment is no more than 5-7 days and depends on the course of the disease.
The maximum daily dose for adults and children over 14 years of age is no more than 3 tablets.

Contraindications

Hypersensitivity to active ingredients or to any other component of the preparation.
Acute stomach or intestinal ulcer; gastrointestinal bleeding or perforation.
During pregnancy and breastfeeding.
Severe hepatic, renal, or heart failure.
Patients who, in response to the use of acetylsalicylic acid or other NSAIDs, develop asthma attacks, urticaria or acute rhinitis.
Violation of hematopoiesis of unknown origin.
Leukopenia, significant anemia.
Congenital hyperbilirubinemia, deficiency of glucose-6-phosphate dehydrogenase.
Children up to age 14.

Side effects

On the part of the blood and lymphatic system: thrombocytopenia, neutropenia, leukopenia, aplastic anemia, agranulocytosis, pancytopenia, sulfhemoglobinemia and methemoglobinemia, hemolytic anemia (especially for patients with glucose-6-phosphate dehydrogenase deficiency).
From the immune system: hypersensitivity reactions, anaphylactic / anaphylactoid reactions, including hypotension and anaphylactic shock; angioedema (including facial edema).
Mental disorders: disorientation, depression, sleep disturbances, insomnia, nightmares, irritability, anxiety, fear, psychotic disorders, confusion, psychomotor agitation.
From the nervous system: often - headache, dizziness; drowsiness; paresthesia, memory impairment, convulsions, anxiety, tremor, aseptic meningitis, taste disorders, cerebrovascular accident.
From the side of the organ of vision: visual disturbances, blurred vision, diplopia.
On the part of the organ of hearing and the labyrinth of the ear: vertigo, ringing in the ears, tinnitus, hearing disorders.
From the heart: palpitations, tachycardia, shortness of breath, heart pain, heart failure, myocardial infarction.
Vascular disorders: hypertension, vasculitis.
From the respiratory system, chest and mediastinal organs: BA (including shortness of breath), bronchospasm; chest pain, pneumonitis.
From the gastrointestinal tract: nausea, vomiting, diarrhea, dyspepsia, abdominal pain, flatulence, anorexia; gastritis, gastrointestinal bleeding, vomiting of blood, hemorrhagic diarrhea, melena, stomach or intestinal ulcer (with / without bleeding or perforation); colitis (including hemorrhagic colitis and exacerbation of ulcerative colitis or Crohn's disease), constipation, stomatitis, glossitis, esophageal disorders, diaphragmatic intestinal strictures, pancreatitis.
From the hepatobiliary system: increased level of transaminases; hepatitis, hepatonecrosis (when taken in high doses), jaundice, liver disorders; fulminant hepatitis.
On the part of the skin and subcutaneous tissue: skin rash; hives; bullous rashes; eczema, erythema, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), exfoliative dermatitis, allergic dermatitis, exudative erythema multiforme, hair loss, photosensitivity, purpura, allergic purpura, pruritus.
From the urinary system: acute renal failure, hematuria, proteinuria, nephrotic syndrome, interstitial nephritis, renal papillary necrosis.
General disorders: edema, general weakness, increased sweating, hypoglycemia.

Special instructions

When using dolaren, it is necessary to monitor the state of health of a patient with complaints of gastrointestinal diseases or a history of ulcerative lesions of the stomach or intestines; a patient with ulcerative colitis or Crohn's disease.
In the above patients and patients requiring the concomitant use of preparations containing low doses of acetylsalicylic acid or other preparations that may increase the risk of developing adverse reactions from the gastrointestinal tract, the advisability of combination therapy in combination with protective preparations (for example, proton pump inhibitors or misoprostol) should be considered ).
NSAIDs can increase the risk of serious cardiovascular thrombotic events, myocardial infarction and stroke, which can be fatal, and therefore Dolaren is not recommended for the relief of postoperative pain in coronary artery bypass grafting.
In connection with the use of NSAIDs, including Dolaren, severe, lethal, skin reactions have been reported, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis. There is a high risk of these reactions at the beginning of therapy, treatment should be canceled at the first manifestations of skin rash, mucosal ulcers or any other manifestations of hypersensitivity.
In patients who have not previously taken Dolaren, during treatment, as during therapy with other NSAIDs, in rare cases, allergic reactions may develop, including anaphylactic and anaphylactoid reactions.
Due to its pharmacodynamic properties, Dolaren can mask symptoms characteristic of infectious and inflammatory diseases.
The preparation should be used with caution in the elderly, especially the weakened. For such patients and persons with insufficient body weight, it is recommended to use the preparation in the lowest effective dose.
Particular care is required in patients with asthma, seasonal allergic rhinitis, nasal mucosa edema, COPD, or chronic respiratory tract infections.
Allergic reactions to NSAIDs are more common in these patients. In the case of Dolaren's appointment to patients with impaired liver function, careful monitoring of their condition is necessary, since its deterioration is possible. When Dolaren is used, the level of one or more liver enzymes may increase. Therefore, regular monitoring of liver function indicators is indicated. If violations of the functional parameters of the liver persist or worsen, develop complaints or symptoms indicating liver disease, as well as other side effects (eg eosinophilia, rash, etc.), Dolaren should be canceled. It should be borne in mind that hepatitis while taking Dolaren can occur without prodromal phenomena.
Care must be taken when using Dolaren in patients with hepatic porphyria, as it can provoke an attack.
Since prostaglandins play an important role in maintaining renal blood flow, special care is needed in the treatment of patients with impaired cardiac or renal function (including functional renal failure associated with hypovolemia, nephrotic syndrome, lupus nephropathy and decompensated liver cirrhosis), patients with a history of hypertension, elderly people, patients receiving diuretics, as well as patients in whom there is a significant decrease in the volume of circulating blood plasma of any etiology, for example, before / after major surgical interventions. In these cases, during the use of Dolaren, it is recommended to carry out regular monitoring of renal function. Discontinuation of the preparation usually results in the restoration of renal function to its original level. With prolonged use of Dolaren, like other NSAIDs, systematic monitoring of the composition of peripheral blood is shown.
Dolaren, like other NSAIDs, can temporarily inhibit platelet aggregation. Therefore, patients with impaired hemostasis need careful monitoring of appropriate laboratory parameters.
Special security measures. With all NSAIDs, gastrointestinal bleeding, ulcers and perforations are possible, which can be fatal and may occur during treatment, with or without gastrointestinal symptoms, or in patients with a history of serious gastrointestinal disease. In general, such phenomena are most dangerous for the elderly. If patients using Dolaren develop such complications, the preparation should be discontinued.
To reduce the risk of toxic effects on the gastrointestinal tract in patients with a history of ulcers, in particular those complicated by bleeding and perforation, as well as in the elderly, treatment should be started with the lowest effective dose and adhered to in the future.
The ability to influence the reaction rate when driving or working with other mechanisms. Patients who, during the use of Dolaren, experience visual impairment, dizziness or other disorders of the central nervous system, should not drive vehicles or operate other mechanisms.
Application during pregnancy or lactation. Do not use during pregnancy or lactation.
Children. Do not use in children under 14 years of age.

Interactions

Lithium, digoxin. Dolaren can increase the concentration of lithium and digoxin in the blood plasma. monitoring of lithium and digoxin in blood plasma is recommended.
Diuretics and antihypertensive preparations. Dolaren, like other NSAIDs, when combined with diuretics or antihypertensive preparations (eg calcium channel blockers, ACE inhibitors) can reduce their antihypertensive effect. Therefore, a combination of such preparations should be prescribed with caution, and patients (especially the elderly) should be periodically monitored blood pressure. Patients should drink enough water, and after the start and after the end of concomitant therapy, it is necessary to periodically monitor renal function, in particular when using diuretics and ACE inhibitors due to the increased risk of nephrotoxicity.
The simultaneous use of potassium-sparing diuretics can lead to an increase in the level of potassium in the blood plasma, therefore, patients who are simultaneously using such preparations should control the level of potassium in the blood plasma.
Other NSAIDs and GCS. The combined use of Dolaren and other NSAIDs or corticosteroids can increase the incidence of adverse events from the gastrointestinal tract. The simultaneous use of the preparation Dolaren with other NSAIDs, including selective COX-2 inhibitors, should be avoided, in the absence of any evidence of a possible benefit from a synergistic action.
Anticoagulants and antiplatelet preparations. There may be an increase in the risk of bleeding in patients taking simultaneously Dolaren and anticoagulants and antiplatelet preparations. Therefore, in the case of such a combination of preparations, careful and regular monitoring of the patient's health is recommended.
Selective serotonin reuptake inhibitors (SSRIs). The simultaneous use of systemic NSAIDs and SSRIs may increase the risk of gastrointestinal bleeding.
Antidiabetic preparations. With the simultaneous use of the preparation Dolaren and antidiabetic preparations, the effectiveness of the latter does not change. However, there are isolated reports of the development in such cases of both hypoglycemia and hyperglycemia, which necessitated a change in the dose of hypoglycemic preparations during the use of Dolaren. For this reason, it is recommended to monitor blood glucose levels during therapy.
Methotrexate. Caution should be exercised when using NSAIDs less than 24 hours before or after taking methotrexate, since in such cases the concentration of methotrexate in the blood may increase and its toxic effect may increase.
Colestipol and colestyramine. The simultaneous use of diclofenac and colestipol or colestyramine reduces the absorption of diclofenac by ≈30 and ≈60%, respectively. The preparations should be taken at intervals of several hours.
Preparations that stimulate enzymes that metabolize preparations. Preparations that stimulate enzymes, such as rifampicin, carbamazepine, phenytoin, St. John's wort (Hypericum perforatum), and others, are theoretically capable of reducing the concentration of diclofenac in blood plasma.
Cyclosporine. The effect of NSAIDs on the synthesis of prostaglandins in the kidneys may increase the nephrotoxicity of cyclosporine. Therefore, the preparation should be prescribed in lower doses than when prescribing cyclosporine to patients.
Antibacterial agents are quinolone derivatives. There are isolated reports of the development of seizures in patients who received both quinolone derivatives and NSAIDs.
The absorption rate of paracetamol can be increased by metoclopramide and domperidone.

Overdose

Symptoms: arterial hypotension, respiratory depression, convulsions, renal failure, gastrointestinal disorders, vomiting, gastrointestinal bleeding, diarrhea, dizziness, ringing in the ears. in case of severe poisoning, the development of opn and liver damage is possible.
Treatment. Urgent measures of supportive and symptomatic therapy.
Supportive and symptomatic treatment is indicated for complications such as arterial hypotension, renal failure, convulsions, gastrointestinal disorders and respiratory depression. It is unlikely that forced diuresis, hemodialysis or hemoperfusion are effective for removing NSAIDs, since the active substances of the preparation are largely bound to blood plasma proteins and are extensively metabolized.

Storage conditions

In a dry, dark place at temperatures up to 25 ° C.

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