Trigan-D, pills, 20pcs

Composition

One tablet contains:

Active ingredients:

paracetamol-500 mg

dicycloverine hydrochloride-20 mg

Auxiliary substances:

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

Pharmacological action

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

ATX code [N02BE51]

Pharmacodynamics .

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

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, which results in inhibition of prostaglandin biosynthesis-modulators of pain sensitivity, thermoregulation, and inflammation.

The second component, dicycloverine hydrochloride, is a tertiary amine that has a relatively weak non-selective m-holinoblocking 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 side effects characteristic of atropine.

The combined action of two components of Trigan-D provides relaxation of spasmodic smooth muscles of internal organs and easing of pain.

Pharmacokinetics. The drug is well absorbed in the gastrointestinal tract. The maximum concentration in blood plasma is reached in 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-benzoquinonimine-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 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.

Use during pregnancy and lactation

Contraindicated. Nursing mothers should stop breastfeeding.

Contraindications

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

It should be used with caution in patients with severe liver or kidney dysfunction, with a genetic absence of glucose-6-phosphate dehydrogenase, blood disease, glaucoma, benign hyperbilirubinemia (including Gilbert’s syndrome), viral hepatitis, alcoholic liver damage, alcoholism, and in the elderly.

Side effects

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

Allergic reactions: skin rash, pruritus, urticaria, angioedema, 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.

Hematopoietic disorders: 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 side of the visual organs: mydriasis, blurred visual perception, paralysis of accommodation, increased intraocular pressure.

Reduced 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 slowing gastric emptying).

Stimulators of microsomal oxidation in the liver (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants) increase the production of hydroxylated active metabolites, which causes the possibility of severe intoxication with small overdoses of paracetamol.

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

Reduces the effectiveness of uricosuric drugs.

Paracetamol increases the effectiveness of indirect anticoagulants.

How to take, course of use and dosage

It is used orally for adults and children over 15 years of age,1 tablet 2-3 times a day. The maximum single dose for adults is 2 tablets, the daily dose is 4 tablets.

The duration of admission without consulting a doctor is no more than 5 days when prescribed as an analgesic and 3 days as an antipyretic.

With prolonged use of the drug, it is necessary to monitor the picture of peripheral blood and the functional state of the liver.

Do not exceed the daily dose; an increase or longer treatment is only possible under the supervision of a doctor, as an overdose of the drug can cause liver failure.

Overdose

Symptoms: tachycardia, tachypnea, fever, agitation, convulsions, epigastric pain, decreased 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 inside).

Special instructions

With caution and under the supervision of a doctor, the drug should be used 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 colestyramine, you should also consult your doctor.

Paracetamol distorts laboratory tests when quantifying the content of uric acid and glucose in plasma.

In order to avoid toxic liver damage, paracetamol should not be combined with the intake of alcoholic beverages, as well as taken by people who are 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 dangerous activities that require increased concentration and speed of psychomotor reactions (driving vehicles, etc. ).

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

Form of production

Tablets

Storage conditions

In a dark place at a temperature not exceeding 25 °C. Keep out of reach of children!

Shelf life

3 years

Active ingredient

Dicycloverine, Paracetamol

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Description

For adults as prescribed by a doctor, Children over 15 years of age, Pregnant women in the first and second trimester as prescribed by a doctor, Children as prescribed by a doctor

Indications

Migraine, Gastro-intestinal Spasm