Bol-Ran 100 tablets — Made in India — Free Delivery

Pharmacological properties

Diclofenac sodium - npvp. Shows anti-inflammatory, analgesic and antipyretic activity. The mechanism of action is inhibition of prostaglandin synthesis by inhibiting the enzyme prostaglandin synthetase. By blocking the synthesis of prostaglandins, diclofenac eliminates or significantly reduces the severity of symptoms of inflammation. reduces the hypersensitivity of nerve endings to mechanical stimuli and biologically active substances caused by prostaglandins; also reduces the increased body temperature due to the impossibility of the influence of prostaglandins on the structures of the hypothalamus, which are involved in the process of thermoregulation; diclofenac reduces the concentration of prostaglandins in the menstrual blood and the intensity of pain in primary dysmenorrhea.

Paracetamol has analgesic, antipyretic and mild anti-inflammatory properties. The mechanism of action is associated with inhibition of prostaglandin synthesis and a predominant effect on the center of thermoregulation in the hypothalamus.

After oral administration, the active ingredients of the preparation are rapidly and almost completely absorbed in the gastrointestinal tract.

After absorption, about 99.7% of diclofenac binds to serum proteins. The volume of distribution is 0.12–0.17 l / kg. Diclofenac is able to penetrate into the synovial fluid, where its maximum concentration is reached 2-4 hours later than in the blood plasma. Paracetamol is well distributed in tissues, with the exception of adipose tissue and cerebrospinal fluid. The binding of paracetamol to blood plasma proteins is approximately 10% and slightly increases with overdose.

Diclofenac sodium is metabolized in part by glucuronidation of the unchanged molecule, but mainly by methoxylation, which leads to the formation of several phenolic metabolites, most of which are conjugated to glucuronic acid. Paracetamol is metabolized mainly in the liver by conjugation with glucuronide, conjugation with sulfate and oxidation with the participation of mixed liver oxidases and cytochrome P450.

The half-life of diclofenac from blood plasma is 1-2 hours, the half-life of metabolites is 1-3 hours. Approximately 60% of the used diclofenac is excreted in the urine in the form of glucurone conjugates and metabolites, most of which are also converted to glucurone conjugates. In an unchanged state, less than 1% of diclofenac is excreted. Part of the administered dose is excreted in the form of metabolites with bile and feces. There are no significant changes in the pharmacokinetics of diclofenac in the elderly, patients with kidney disease, chronic hepatitis or compensated liver cirrhosis.

The half-life of paracetamol is 1-3 hours. In patients with liver cirrhosis, the half-life is increased. The renal clearance of paracetamol is 5%. It is excreted in the urine mainly in the form of glucuronide and sulfate conjugates. Less than 5% is excreted as unchanged paracetamol.

Indications

Rheumatism, rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, gout, juvenile chronic arthritis, lumbago, neuralgia, myalgia, primary dysmenorrhea, mild to moderate pain, including headache, migraine, toothache, algomenorrhea; pain with injuries, burns; fever in infectious and inflammatory diseases.

Application

Adults and children over 14 years of age are taken orally 1 tablet 2-3 times a day. for maintenance therapy, the daily dose is 1 tablet 2 times a day.

The duration of the course of treatment is set individually.

The maximum daily dose of the preparation in terms of sodium diclofenac is 100 mg or 4 tablets.

For the treatment of dysmenorrhea, the preparation is used 2-3 times a day.

The preparation is recommended to be used without chewing during or immediately after a meal, with 1/2 glass of water.

Contraindications

Hypersensitivity to the components of the preparation; erosive and ulcerative damage to the gastrointestinal tract in the acute phase; history - attacks of bronchospasm, urticaria, acute rhinitis, which are associated with the use of acetylsalicylic acid or other NSAIDs; the period of pregnancy and lactation, children's age.

Side effects

From the side of the central nervous system: irritability, convulsions, impaired sensitivity or vision (diplopia), tinnitus, fatigue, dizziness, headache, rarely - drowsiness, loss of consciousness.

From the gastrointestinal tract and liver: epigastric pain, heartburn, nausea, vomiting, flatulence; rarely - erosive and ulcerative lesions of the gastrointestinal tract, sometimes complicated by bleeding, increased activity of hepatic transaminases, exacerbation of ulcerative colitis, intestinal perforation.

Allergic reactions: asthma attacks, urticaria.

Dermatological reactions: skin rash, itching; rarely - photosensitivity.

From the side of the blood system: in some cases, anemia, leukopenia, thrombocytopenia, agranulocytosis, methemoglobinemia.

From the urinary system: interstitial nephritis, nephrotic syndrome, very rarely - acute renal failure. Nephropathy occurs with prolonged use of the preparation.

Others: peripheral edema, hypertensive crisis.

Special instructions

During pregnancy and breastfeeding. during pregnancy, the use of the preparation is possible only if there are absolute indications, if the likely benefit to the mother outweighs the potential risk to the fetus. if it is necessary to use the preparation during breastfeeding, it is necessary to resolve the issue of stopping feeding.

Caution should be exercised when using the preparation in patients with severe impaired renal and liver function, including alcoholic liver disease, biliary tract diseases, and chronic heart failure.

Throughout the course of treatment, it is necessary to monitor the function of the kidneys and liver. With prolonged use of Bol-Ran, one must refrain from driving vehicles and performing potentially hazardous work that require increased attention and speed of reactions.

Interactions

GCs potentiate the toxic effects of diclofenac. for patients receiving methotrexate, diclofenac is prescribed 24 hours before or after the administration of methotrexate, since the concentration and toxic effect of the latter may increase.

With the simultaneous use of diclofenac with saluretics, the diuretic effect of loop diuretics may decrease. Diclofenac reduces the effectiveness of antihypertensive preparations .

With the simultaneous use of diclofenac with acetylsalicylic acid and other NSAIDs, the risk of side effects increases and the effectiveness of one of the preparations decreases.

With the simultaneous use of diclofenac with lithium preparations and digoxin, the concentration of the latter in the blood plasma increases.

When using diclofenac in combination with potassium-sparing diuretics, an increase in the concentration of potassium in the blood is possible.

When used in combination with anticoagulants, the risk of developing hemorrhagic complications significantly increases.

With the simultaneous use of the preparation with barbiturates, anticonvulsants, rifampicin, alcohol, the risk of hepatotoxic action of paracetamol significantly increases.

Overdose

Symptoms: sharp headache, motor agitation, dizziness, convulsions.

Perhaps the hepatotoxic effect of paracetamol, which is manifested by pallor of the skin, anorexia, nausea, vomiting, with a significant overdose - hepatonecrosis. The toxic effect of paracetamol develops when the preparation is taken at a dose of more than 10-15 g. The clinical picture of liver damage is manifested after 1-6 days, in some patients renal failure (tubular necrosis) may develop against the background of liver dysfunction.

Treatment is symptomatic; with the development of hepatotoxic action, donors of SH-groups, precursors of the synthesis of glutathione (methionine), acetylcysteine ​​are administered. In acute poisoning with Bol-Ran, the stomach is washed through a tube and activated charcoal is prescribed.

Storage conditions

In a dry place at a temperature not exceeding 25 ° C.