Romyk (Tablets) Instructions for Use

Marketing Authorization Holder

Lindopharm, GmbH (Germany)

ATC Code

J01FA06 (Roxithromycin)

Active Substance

Roxithromycin (Rec.INN registered by WHO)

Dosage Form

Romyk

Film-coated tablets, 150 mg: 10 or 20 pcs.

Dosage Form, Packaging, and Composition

10 pcs. – blister packs (1) – cardboard packs.
10 pcs. – blister packs (2) – cardboard packs.

Clinical-Pharmacological Group

Antibiotic of the macrolide group

Pharmacotherapeutic Group

Antibiotic-macrolide

Pharmacological Action

A semisynthetic antibiotic of the macrolide group. The mechanism of action is due to the disruption of intracellular protein synthesis in microorganisms. At low concentrations, it has a bacteriostatic effect, at high concentrations – a bactericidal effect.

It is active against gram-positive bacteria: Streptococcus pneumoniae, Streptococcus pyogenes, methicillin-sensitive strains of Staphylococcus aureus; against gram-negative bacteria: Moraxella catarrhalis.

Roxithromycin is also active against Mycoplasma pneumoniae, Ureaplasma urealyticum, Chlamydia spp.

The activity of roxithromycin against Haemophilus influenzae is less pronounced than that of erythromycin.

It has low activity against Mycoplasma hominis.

Pseudomonas spp., Enterobacter spp., Acinetobacter spp. are resistant to roxithromycin.

Pharmacokinetics

After oral administration, it is rapidly absorbed from the gastrointestinal tract. It is detected in the blood serum as early as 15 minutes later. It is more stable in the acidic environment of the stomach than other macrolides. Food intake does not affect absorption. The C_max in blood plasma is reached in 1.5-2 hours. The C_ss in blood plasma when taking 150 mg 2 times/day is reached after 2-4 days and is 9.3 mg/l, when taking 300 mg once a day – 10.9 mg/l.

Roxithromycin penetrates well into tissues, especially into the lungs, tonsils, and prostate, as well as into neutrophils and monocytes, stimulating their phagocytic activity. Plasma protein binding is 96%, decreasing with an increase in roxithromycin concentration above 4 mg/l. Less than 0.05% of the administered dose is excreted in breast milk.

It is partially metabolized in the liver, more than half of the active substance is excreted in the feces unchanged, about 12% is excreted by the kidneys and about 15% by the lungs. The T_1/2 in adults with normal renal function is 10.5 hours with a dosing frequency of 1-2 times/day.

Indications

Infectious and inflammatory diseases caused by microorganisms sensitive to roxithromycin, including infections of the upper and lower respiratory tract, skin and soft tissue infections, non-gonococcal urethritis.

ICD codes

Dosage Regimen

Orally for adults – 150 mg 2 times/day (every 12 hours) or 300 mg once a day 15 minutes before meals or on an empty stomach.

For patients with hepatic insufficiency, the dose is 150 mg every 24 hours.

For patients with severe renal insufficiency, the recommended dose is 150 mg every 24 hours.

For children, the daily dose is 5-8 mg/kg, depending on the type of pathogen and the severity of the infectious process, divided into 2 doses.

Adverse Reactions

From the digestive system: nausea, vomiting, epigastric pain, diarrhea, anorexia, flatulence, transient increase in the level of liver transaminases and alkaline phosphatase in the blood (more often in patients over 65 years old); rarely – impaired liver function, cholestatic hepatitis, pancreatitis.

Allergic reactions: urticaria, rash, itching, angioedema, bronchospasm, anaphylactoid reactions, tongue edema, general edema, erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome.

From the central and peripheral nervous system: headache, dizziness, paresthesia.

Effects due to chemotherapeutic action: rarely – candidiasis.

Other: rarely – general malaise, tinnitus, disturbances of taste and/or smell.

Contraindications

Severe liver dysfunction, simultaneous use of ergot alkaloids with vasoconstrictive effect, hypersensitivity to roxithromycin and other macrolides (including erythromycin).

Use in Pregnancy and Lactation

Adequate and strictly controlled studies on the safety of roxithromycin use during pregnancy and lactation have not been conducted.

Roxithromycin is excreted in small amounts in breast milk.

In experimental studies on animals, no mutagenic or embryotoxic effects, or negative effects on fertility were identified.

Use in Hepatic Impairment

Contraindicated in severe liver dysfunction. Use with caution in patients with mild and moderate liver dysfunction.

Use in Renal Impairment

Use with caution in patients with renal impairment.

Pediatric Use

Use is possible according to the dosing regimen.

Special Precautions

Use with caution in patients with impaired liver and kidney function.

If superinfection or pseudomembranous colitis develops, Roxithromycin should be discontinued immediately and appropriate therapy should be prescribed.

Use with caution simultaneously with terfenadine and astemizole.

In experimental studies, no carcinogenic effect was identified.

Drug Interactions

With simultaneous use with indirect anticoagulants, an enhancement of the anticoagulant effect is possible.

With simultaneous use with ergot preparations, ergotamine-like vasoconstrictive agents, the development of ergotism up to necrosis of limb tissues is possible.

With simultaneous use with digoxin, the absorption of digoxin increases.

With simultaneous use, a slight increase in the plasma concentrations of midazolam and triazolam is possible.

With simultaneous use with theophylline, an increase in the plasma concentration of theophylline is possible.

The possibility of an increase in the plasma concentrations of cisapride, astemizole, terfenadine when used simultaneously with roxithromycin cannot be excluded.

With simultaneous use with cyclosporine, some increase in the blood concentration and toxic effect of cyclosporine is possible.

With simultaneous use with ethambutol, synergism against Mycobacterium avium is noted.

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

Rx Only

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.