Trigan-D, tablets 100 pcs

Pharmacotherapeutic group: analgesic (analgesic non-narcotic agent + antispasmodic agent).

ATC code [N02BE51]

Pharmacodynamics.

The paracetamol contained in the drug has analgesic, antipyretic and mild anti-inflammatory effects.

The mechanism of action is related to moderate inhibition of cyclooxygenase-1 and, to a lesser degree, of cyclooxygenase-2 in peripheral tissues and central nervous system, which results in inhibition of prostaglandin biosynthesis – modulators of pain sensitivity, thermoregulation and inflammation.

The second component is dicycloverine hydrochloride, a tertiary amine which has relatively weak non-selective m-cholinoblocking and direct myotropic spasmolytic effect on the smooth muscles of internal organs.

In therapeutic doses, it causes effective relaxation of smooth muscles, which is not accompanied by the side effects typical of atropine.

The combined action of the two components of Trigan-D provides relaxation of the spasmed smooth muscle of the internal organs and reduction of pain sensations.

Pharmacokinetics. The drug is well absorbed in the gastrointestinal tract. Maximal concentration in blood plasma is reached after 60-90 min. The volume of distribution is 3.65 l/kg.

Paracetamol is metabolized in the liver to form several metabolites, one of which – N-acetyl-benzoquinonimine – under certain conditions (drug overdose, lack of glutathione in the liver) may have a damaging effect on the liver and kidneys.

About 80% of the drug is excreted with urine and in small amounts with feces.

Indications

Spasm of smooth muscles of internal organs – intestinal, hepatic and renal colic, algodismenorrhea;

Headache, toothache, migraine pain, neuralgia, myalgia;

Infectious and inflammatory diseases accompanied by fever.

Pharmacological effect

Pharmacotherapeutic group: analgesic (non-narcotic analgesic + antispasmodic).

ATX code [N02BE51]

Pharmacodynamics.

Paracetamol, which is part of the drug, has an analgesic, antipyretic and slight anti-inflammatory effect.

The mechanism of action is associated with moderate inhibition of cyclooxygenase-1 and, to a lesser extent, cyclooxygenase-2 in peripheral tissues and the central nervous system, resulting in inhibition of the biosynthesis of prostaglandins – modulators of pain sensitivity, thermoregulation and inflammation.

The second component is dicycloverine hydrochloride, a tertiary amine that has a relatively weak, non-selective m-anticholinergic and direct myotropic antispasmodic effect on the smooth muscles of internal organs.

In therapeutic doses, it causes effective relaxation of smooth muscles, which is not accompanied by the side effects characteristic of atropine.

The combined action of the two components of Trigana-D ensures relaxation of the spasmodic smooth muscles of the internal organs and alleviation of pain.

Pharmacokinetics. The drug is well absorbed from the gastrointestinal tract. The maximum concentration in blood plasma is achieved after 60-90 minutes. The volume of distribution is 3.65 l/kg.

Paracetamol is metabolized in the liver with the formation of several metabolites, one of which – N-acetyl-benzoquinoneimine – under certain conditions (overdose of the drug, lack of glutathione in the liver) can have a damaging effect on the liver and kidneys.

About 80% of the drug is excreted in the urine and in small quantities in feces.

Special instructions

The drug should be used with caution and under the supervision of a physician in patients with impaired liver or kidney function, simultaneously with other anti-inflammatory and analgesic drugs, as well as with anticoagulants and drugs that affect the central nervous system.

If you are taking metoclopramide, domperidone or cholestyramine, you should also consult your doctor.

Paracetamol distorts laboratory results in the quantitative determination of uric acid and glucose in plasma.

To avoid toxic liver damage, paracetamol should not be combined with alcoholic beverages, or taken by persons prone to chronic alcohol consumption. The risk of developing liver damage increases in patients with alcoholic hepatosis.

When using the drug, you should refrain from potentially hazardous activities that require increased concentration and speed of psychomotor reactions (driving vehicles, etc.).

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

Active ingredient

Dicycloverine, Paracetamol

Composition

One tablet contains:

Active ingredients:

paracetamol – 500 mg

dicycloverine hydrochloride – 20 mg

Excipients:

Sodium carboxymethyl starch – 25.0 mg

Corn starch – 15.0 mg

Microcrystalline cellulose – 17.5 mg

Povidone K-30 – 4.5 mg

Colloidal silicon dioxide (Aerosil) – 3.0 mg

Magnesium stearate – 5.0 mg

Contraindications

Hypersensitivity to paracetamol and dicycloverine, obstructive diseases of the intestines, biliary and urinary tracts, gastric and duodenal ulcers (acute phase), reflux esophagitis, hypovolemic shock, myasthenia gravis, pregnancy, lactation. Children’s age (up to 15 years).

Caution should be used in patients with severe impairment of liver or kidney function, in the genetic absence of glucose-6-phosphate dehydrogenase, blood disease, glaucoma, benign hyperbilirubinemia (including Gilbert’s syndrome), viral hepatitis, alcoholic liver damage, alcoholism, and in old age.

Side Effects

From the gastrointestinal tract: dry mouth, loss of taste, decreased appetite, epigastric pain, constipation, increased activity of liver enzymes, usually without the development of jaundice, hepatonecrosis (dose-dependent effect).

Allergic reactions: skin rash, itching, urticaria, Quincke’s edema, exudative erythema multiforme (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell’s syndrome).

From the central nervous system (usually develops when taking high doses): drowsiness, dizziness, psychomotor agitation and disorientation, hallucinations (frequency unknown).

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

From the hematopoietic organs: anemia, methemoglobinemia (cyanosis, shortness of breath, heart pain), hemolytic anemia (especially for patients with gluco-6-phosphate dehydrogenase deficiency).

From the genitourinary system: pyuria, urinary retention, interstitial nephritis, papillary necrosis.

From the organs of vision: mydriasis, blurred vision, paralysis
accommodation, increased intraocular pressure.

Decreased potency.

Interaction

The effect of dicycloverine is enhanced by amantadine, class I antiarrhythmic drugs, antipsychotics, benzodiazepines, MAO inhibitors, narcotic analgesics, nitrates and nitrites, sympathomimetic drugs, tricyclic antidepressants.

Dicycloverine increases the concentration of digoxin in the blood (due to slower gastric emptying).

Stimulators of microsomal oxidation in the liver (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants) increase the production of hydroxylated active metabolites, which makes it possible to develop severe intoxications with small overdoses of paracetamol.

Adrenergic stimulants, as well as other drugs with anticholinergic effects, increase the risk of side effects. Microsomal oxidation inhibitors (cimetidine) reduce the risk of hepatotoxicity.

Reduces the effectiveness of uricosuric drugs.

Paracetamol increases the effectiveness of indirect anticoagulants.

Overdose

Symptoms: tachycardia, tachypnea, fever, agitation, convulsions, epigastric pain, loss of appetite, anemia, thrombocytopenia, hemolytic anemia, aplastic anemia, methemoglobinemia, pancytopenia, nephrotoxicity (papillary necrosis), hepatonecrosis.

Treatment: stop taking the drug, perform gastric lavage, prescribe adsorbents, introduce agents that increase the formation of glutathione (acetylcysteine ​​intravenously) and enhance conjugation reactions (methionine orally).

Storage conditions

In a place protected from light at a temperature no higher
25 °C. Keep out of the reach of children!

Shelf life

3 years

Manufacturer

Cadila Pharmaceuticals Ltd, India