Antigrippin-ORVI neo (Tablets) Instructions for Use

ATC Code

N02BE51 (Paracetamol in combination with other drugs, excluding psycholeptics)

Active Substances

Ascorbic acid (Rec.INN registered by WHO)

Paracetamol (Rec.INN registered by WHO)

Phenylephrine (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Drug for symptomatic therapy of acute respiratory diseases

Pharmacotherapeutic Group

ARI and “common cold” symptoms relieving agent

Pharmacological Action

Combined medicinal product.

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

Phenylephrine is an alpha₁-adrenomimetic, causes vasoconstriction, and eliminates swelling and hyperemia of the nasal mucosa.

Ascorbic acid is involved in the regulation of redox processes, carbohydrate metabolism, blood clotting, tissue regeneration, and the synthesis of steroid hormones; increases the body’s resistance to infections, reduces vascular permeability, and reduces the need for vitamins B₁, B₂, A, E, folic acid, and pantothenic acid. It improves the tolerability of paracetamol and prolongs its action (associated with the prolongation of T_1/2).

Pharmacokinetics

Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract. C_max in plasma is reached within 10-60 minutes after oral administration. It is distributed in most body tissues. It crosses the placental barrier and is excreted in breast milk. In therapeutic concentrations, binding to plasma proteins is insignificant but increases with increasing concentration. It undergoes primary metabolism in the liver. It is excreted mainly in the urine as glucuronides and sulfates. T_1/2 ranges from 1 to 3 hours.

Phenylephrine is absorbed from the gastrointestinal tract. It is metabolized during the “first pass” through the intestinal wall and in the liver, so when taken orally, Phenylephrine Hydrochloride is characterized by limited bioavailability. C_max in plasma is reached within the interval from 45 minutes to 2 hours. It is excreted by the kidneys almost completely in the form of sulfate compounds. T_1/2 is 2-3 hours.

Ascorbic acid is rapidly and completely absorbed from the gastrointestinal tract. Binding to plasma proteins is 25%. It is excreted in the urine as metabolites. Ascorbic acid, taken in excessive amounts, is rapidly excreted unchanged in the urine.

Indications

Symptomatic treatment of colds and influenza accompanied by fever, headache, chills, nasal congestion, sore throat, and sinus pain.

ICD codes

Dosage Regimen

Administer orally with water.

Adhere strictly to a 4 to 6 hour interval between doses.

Do not exceed three doses within a 24-hour period.

Limit the total duration of treatment to 5 days for pain and 3 days for fever.

Discontinue use and consult a physician if symptoms persist beyond this period.

Avoid concomitant use with other products containing paracetamol.

Do not use in children under 12 years of age.

Consult a physician for use in patients with hepatic or renal impairment.

Adverse Reactions

From the hematopoietic system very rarely – thrombocytopenia.

Allergic reactions rarely – skin rash, urticaria, allergic dermatitis; very rarely – anaphylaxis, hypersensitivity reactions, including angioedema, Stevens-Johnson syndrome.

From the respiratory system very rarely – bronchospasm in patients sensitive to acetylsalicylic acid and other NSAIDs.

From the digestive system very rarely – nausea, vomiting, impaired liver function.

From the CNS very rarely – dizziness, headache, insomnia.

From the sensory organs: rarely – mydriasis, acute attack of glaucoma in most cases in patients with angle-closure glaucoma.

From the cardiovascular system: rarely – tachycardia, palpitations, increased blood pressure.

From the urinary system very rarely – dysuria, urinary retention in patients with bladder outlet obstruction due to prostatic hyperplasia.

With long-term use exceeding the recommended dose, hepatotoxic and nephrotoxic effects may be observed.

Contraindications

Severe liver dysfunction; severe renal dysfunction; hyperthyroidism (including thyrotoxicosis); cardiovascular diseases (severe aortic stenosis, acute myocardial infarction, tachyarrhythmia); arterial hypertension; prostatic hyperplasia; angle-closure glaucoma; simultaneous use of tricyclic antidepressants, beta-blockers, MAO inhibitors (including within 14 days after their discontinuation), other paracetamol-containing drugs; children under 12 years of age (for dosage forms intended for adults); hypersensitivity to the components of the combination.

With caution

Benign hyperbilirubinemia, glucose-6-phosphate dehydrogenase deficiency, pregnancy, lactation (breastfeeding), obliterating vascular diseases (Raynaud’s syndrome), glaucoma (excluding angle-closure glaucoma).

Use in Pregnancy and Lactation

Should be used with caution during pregnancy and breastfeeding.

Use in Hepatic Impairment

Contraindication — severe hepatic insufficiency.

Use in Renal Impairment

Contraindication — severe renal insufficiency.

Pediatric Use

Contraindication – children under 12 years of age (for dosage forms intended for adults).

Special Precautions

If the symptoms of the disease persist after 5 days of using this remedy, you should stop taking it and consult a doctor.

Should not be taken simultaneously with other drugs containing Paracetamol, as well as with other non-narcotic analgesics (metamizole sodium), NSAIDs (acetylsalicylic acid, ibuprofen), barbiturates, anticonvulsants, rifampicin and chloramphenicol, sympathomimetics (such as decongestants, appetite suppressants, amphetamine-like psychostimulants), with other remedies for relieving cold and flu symptoms.

Effect on the ability to drive vehicles and operate machinery

If dizziness occurs while using drugs containing this combination, it is not recommended to drive vehicles or operate machinery.

Drug Interactions

Inducers of microsomal oxidation in the liver (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants) increase the production of hydroxylated active metabolites of paracetamol, which may lead to the development of severe intoxication with small overdoses.

Paracetamol enhances the effects of MAO inhibitors, sedatives, ethanol .

Antidepressants, antiparkinsonian, antipsychotic drugs, phenothiazine derivatives – risk of urinary retention, dry mouth, constipation.

Corticosteroids – risk of developing glaucoma.

Phenylephrine reduces the hypotensive effect of guanethidine .

Guanethidine enhances the alpha-adrenostimulating effect, and tricyclic antidepressants – the sympathomimetic effects of phenylephrine.

With simultaneous use of oral contraceptives, the concentration of ascorbic acid in the blood plasma decreases. An increase in the concentration of ethinyl estradiol in the blood plasma is possible with its simultaneous use as part of oral contraceptives.

With simultaneous use with iron preparations, Ascorbic acid, due to its reducing properties, converts ferric iron to ferrous iron, which contributes to improved absorption.

With simultaneous use with warfarin, a decrease in the effects of warfarin is possible.

With simultaneous use, Ascorbic acid increases the excretion of iron in patients receiving deferoxamine .

With simultaneous use with tetracycline, the excretion of ascorbic acid in the urine increases.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.