Rulide 150 mg Tablets

Brand name

The drug is known under the trade name Rulide. This name is officially registered in pharmaceutical registries and is used to identify the drug in pharmacies, medical institutions and among health professionals. Rulide is recognized for its effectiveness in the treatment of bacterial infections requiring reliable antibacterial action. The name was chosen by the manufacturers to indicate its belonging to a certain group of antibiotics, emphasizing its importance and unique properties in clinical practice.

International Nonproprietary Name (INN)

The international nonproprietary name of this medicine is roxithromycin. This term is accepted by the international community to designate the active substance that provides the therapeutic effect. Roxithromycin belongs to the class of macrolide antibiotics, known for their ability to inhibit the growth of bacteria. The name is standardized by the World Health Organization, which ensures uniformity in the prescription and production of this drug in different countries and regions, regardless of brand names.

Form of release

The drug is presented in several forms, which makes it convenient for use depending on the age of the patient and the specifics of the infectious process. The main options include:

• Film-coated tablets with dosages of 50 mg, 100 mg, 150 mg and 300 mg of the active ingredient, intended for oral administration.
• Powder for preparation of suspension for oral administration with a concentration of 50 mg/5 ml after dilution, often used in pediatrics.

Each form is designed to meet the needs of treatment: tablets are suitable for adults and older children, while the suspension is convenient for young patients or those who have difficulty swallowing solid forms. The choice of form is determined by the physician based on the diagnosis and condition of the patient.

Composition

The main active substance is roxithromycin, an antibiotic from the group of macrolides. Auxiliary components depend on the form of release. In tablets, the following are used:

• Microcrystalline cellulose - filler for uniform distribution of the active substance.
• Corn starch - a binder for the formation of the mass.
• Magnesium stearate - lubricating agent for ease of manufacture.
• Povidone - solvent to improve structure.
• Hypromellose, titanium dioxide and polyethylene glycol film coating - for protection and ease of administration.

Saccharose is added to the suspensions to improve taste, flavorings (e.g., raspberry), xanthan gum as a thickener, and purified water. The composition is balanced to ensure the stability and bioavailability of the active ingredient.

Pharmacologic Properties

Pharmacodynamics

Rulide has bacteriostatic action, inhibiting protein synthesis in bacterial cells. It binds to 50S-subunit of ribosomes, preventing the process of translation and formation of peptide chains, which stops the growth and multiplication of microorganisms. The drug is active against Gram-positive bacteria (Streptococcus pneumoniae, Staphylococcus aureus, Streptococcus pyogenes), some Gram-negative pathogens (Haemophilus influenzae, Moraxella catarrhalis) and atypical pathogens (Mycoplasma pneumoniae, Chlamydia pneumoniae, Legionella pneumophila).

The mechanism of action makes the drug effective in infections requiring a mild but prolonged antibacterial effect. Rulide is especially valuable in the treatment of atypical infections due to its ability to penetrate into cells and affect intracellular pathogens.

Pharmacokinetics

Absorption

After oral administration, the active substance is absorbed in the gastrointestinal tract, mainly in the small intestine, reaching maximum plasma concentration in 1.5-2 hours. Bioavailability is about 50-60% due to the effect of first passage through the liver. Food intake slows absorption, so it is recommended to take the drug on an empty stomach for optimal absorption.

Distribution

The component is well distributed in the body, penetrating into the lungs, tonsils, skin, mucous membranes and tissues of the upper respiratory tract. Binding to plasma proteins is about 92-96%, which provides a stable presence in the blood. Concentrations in tissues often exceed plasma concentrations, which enhances the therapeutic effect in respiratory tract infections.

Metabolism

Metabolism occurs in the liver with the participation of cytochrome P450 (CYP3A4) enzymes, forming active and inactive metabolites such as dezclathithromycin. About 70% of the dose taken undergoes metabolic transformation, which reduces the renal burden.

Excretion

Excretion is predominantly with bile (50-60%) and partially through the kidneys (10-15% unchanged). The elimination half-life is 10-12 hours, which allows taking the drug 1-2 times a day. Prolonged excretion ensures stable concentration in tissues.

Indications for Use

Rulide is prescribed for the treatment of infections caused by sensitive microorganisms:

• Infections of the upper respiratory tract: pharyngitis, tonsillitis, sinusitis.
• Infections of the lower respiratory tract: bronchitis, out-of-hospital pneumonia.
• Infections of the skin and soft tissues: impetigo, rye.
• Infections caused by atypical bacteria: mycoplasma pneumonia, chlamydial infections.
• Middle otitis media in children and adults.

The drug is often used in cases of allergy to penicillins or in cases requiring treatment of atypical pathogens. Prescribing requires confirmation of pathogen sensitivity.

Contraindications

The use of Rulide is prohibited in:

• Hypersensitivity to macrolides or components of the composition.
• Severe hepatic insufficiency.
• Simultaneous administration with ergotamine or terfenadine (risk of arrhythmias).
• Prolongation of the QT interval in the anamnesis.

Caution is used in myasthenia gravis and electrolyte imbalance.

Method of Administration and Dosage

How to take

Tablets are taken orally, drinking water (150-200 ml), 15-30 minutes before meals to maximize absorption. Suspension is prepared by adding water to the mark on the bottle, shake before each use. Patients are advised to avoid concomitant administration with food so as not to reduce bioavailability.

Dosages for adults and children

Dosage depends on the severity of the infection:

• Adults: 150 mg every 12 hours or 300 mg once daily, course 5-10 days.
• Children over 4 years of age: 5-8 mg/kg/day (suspension) divided into 2 doses, course 5-10 days.

Dose adjustment for certain conditions

In hepatic insufficiency:

• Mild/moderate: 150 mg once daily.
• Severe: use is contraindicated.

In renal insufficiency correction is not required.

Side Effects

Unwanted reactions include:

• Gastrointestinal: nausea, diarrhea, abdominal pain, change in taste.
• Nervous: dizziness, headache, insomnia.
• Skin: rash, itching, rarely - angioedema.
• hepatic: increase in transaminases, hepatitis (rare).
• Cardiac: QT prolongation (rare).

Discontinue use if symptoms are severe.

Overdose

Symptoms of overdose

Exceeding the dose is manifested by nausea, vomiting, arrhythmias, confusion.

First aid measures

In overdose:

• Stop taking.
• Rinse the stomach (within 1-2 hours).
• Supply symptomatic therapy (ECG monitoring).
• Refer to a doctor.

Drug Interactions

Influence on the effects of other drugs

Rulide affects:

• Theophylline: increase in blood concentrations.
• Barfarin: increased anticoagulant effect.
• Cisapride: risk of arrhythmias.

Compatibility with alcohol and food

Alcohol increases liver side effects and is avoided. Food reduces absorption.

Special Precautions

Use in pregnancy and breastfeeding

Rulide is contraindicated in pregnancy (category C) and lactation due to insufficient data.

Effects on driving and mechanisms

Dizziness may make driving difficult.

Particulars of Use in the Elderly and Children

In the elderly, monitoring of liver function is required. In children under 4 years of age, the suspension should be used with caution.