Fastorik Plus (Tablets) Instructions for Use

Marketing Authorization Holder

Plethico Pharmaceuticals, Ltd. (India)

ATC Code

R01BA52 (Pseudoephedrine in combination with other drugs)

Active Substances

Paracetamol (Rec.INN WHO registered)

Pseudoephedrine (Rec.INN WHO registered)

Triprolidine (Rec.INN WHO registered)

Dosage Form

Fastorik Plus

Tablets 325 mg+30 mg+10 mg: 10 or 20 pcs.

Dosage Form, Packaging, and Composition

10 pcs. – blisters (1) – cardboard packs.

Clinical-Pharmacological Group

Drug for symptomatic therapy of acute respiratory diseases

Pharmacotherapeutic Group

Acute respiratory infections and “cold” symptom relief agent (non-narcotic analgesic agent + sympathomimetic agent + H1-histamine receptor blocker)

Pharmacological Action

Paracetamol has antipyretic and analgesic effects.

Triprolidine is a representative of histamine H₁-receptor antagonists. It does not have a pronounced anticholinergic effect, blocks the early phase of inflammatory and anaphylactic reactions during which histamine is released.

Pseudoephedrine is a vasoconstrictor. The doses used cause vasoconstriction but do not lead to an increase in blood pressure or stimulation of the central nervous system.

Pharmacokinetics

After oral administration, Paracetamol is rapidly absorbed from the gastrointestinal tract. After a single dose of 500 mg, C_max in blood plasma is reached within 10-60 minutes and is about 6 µg/ml, then gradually decreases and after 6 hours is 11-12 µg/ml. 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. T_1/2 is 1-3 hours. It is excreted in the urine mainly in the form of glucuronic and sulfate conjugates.

In the gastrointestinal tract, Triprolidine is rapidly absorbed, C_max in blood plasma is reached within 2 hours. T_1/2 from blood plasma is about 5 hours. Triprolidine is decomposed to inactive metabolites and only 1.5% of the administered dose can be found unchanged in the urine.

When used orally, Pseudoephedrine is well absorbed, C_max in blood plasma is reached within 2-3 hours. The rate of drug elimination depends on urine acidity. Normally, T_1/2 is 5-8 hours; a decrease in urine pH leads to a decrease in T_1/2 to 3-6 hours, while an alkaline urine reaction increases T_1/2 to 9-16 hours.

Indications

• Symptomatic treatment of colds and influenza.

ICD codes

Dosage Regimen

Administer orally with a sufficient amount of water.

For adults and children over 12 years, prescribe 1 tablet 3 times per day.

For children from 6 to 12 years, prescribe 1/2 tablet 3 times per day.

Maintain an interval of at least 4 hours between doses.

Do not exceed 3 tablets in 24 hours for adults and adolescents.

Do not exceed 1.5 tablets in 24 hours for children aged 6 to 12 years.

The total duration of self-treatment without medical consultation should not exceed 3 to 5 days for analgesia and antipyresis.

Discontinue use and consult a physician if symptoms persist or worsen.

Adjust dosing frequency in patients with renal or hepatic impairment; consider extending the dosing interval.

Avoid concomitant use with other paracetamol-containing products to prevent overdose.

Adverse Reactions

Most often, drowsiness and a feeling of dry mouth may occur. In rare cases, during the first 3 days of therapy, the appearance of insomnia, mild tachycardia, and increased blood pressure, allergic reactions (skin rash, itching, urticaria, angioedema) are possible.

The following are possible: agitation, dizziness, sleep disorders, nausea, epigastric pain, anemia, thrombocytopenia, agranulocytosis.

With long-term use in large doses – hepatotoxic effect, hemolytic anemia, aplastic anemia, methemoglobinemia, pancytopenia; nephrotoxicity (renal colic, aseptic pyuria, interstitial nephritis, papillary necrosis).

Contraindications

• Pregnancy;
• Lactation period;
• Children under 6 years of age;
• Hypersensitivity to the drug components.

Use with caution in renal failure, Gilbert’s syndrome, elderly age, glucose-6-phosphate dehydrogenase deficiency, blood diseases, hepatic failure, diabetes mellitus (for syrup).

Use in Pregnancy and Lactation

Contraindicated during pregnancy and lactation.

Use in Hepatic Impairment

Use with caution in Gilbert’s syndrome, hepatic failure.

Use in Renal Impairment

Use with caution in renal failure.

Pediatric Use

Contraindicated in children under 6 years of age. Children from 6 to 12 years are prescribed according to the dosage regimen.

Geriatric Use

Prescribe with caution to elderly patients.

Special Precautions

The drug is prescribed with caution to patients with increased intraocular pressure, stenosing peptic ulcer of the stomach, pyloroduodenal narrowing, prostatic hypertrophy, urinary disorders, arterial hypertension, angina pectoris, hyperthyroidism, and diabetes mellitus.

Effect on the ability to drive vehicles and machinery

The drug belongs to the group of medicinal products that can cause drowsiness and a sedative effect. Temporary reduction in the ability to drive a car and operate other machinery requiring increased attention is possible.

Overdose

Overdose, usually due to paracetamol (more than 10-15 g).

Symptoms: pale skin, anorexia, nausea, vomiting, hepatic necrosis, increased activity of liver transaminases, increased prothrombin time. The full clinical picture of liver damage appears after 1-6 days. Rarely, liver dysfunction develops rapidly and may be complicated by renal failure (tubular necrosis). In case of overdose symptoms, consult a doctor immediately.

Treatment: gastric lavage followed by administration of activated charcoal; symptomatic therapy, administration of methionine 8-9 hours after overdose and N-acetylcysteine – after 12 hours.

Drug Interactions

The drug may enhance the effects of MAO inhibitors, sedatives, ethanol, and ethanol-containing drugs.

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

Tricyclic antidepressants enhance the sympathomimetic effect.

Paracetamol reduces the effectiveness of diuretic drugs.

Microsomal oxidation inhibitors (including cimetidine) reduce the risk of hepatotoxic effects.

Storage Conditions

Store the drug in a dry, light-protected place at a temperature up to 25°C (77°F). Keep out of reach of children.

Shelf Life

Shelf life – 5 years. Do not use after the expiration date.

Dispensing Status

The drug is dispensed by prescription.

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.