Sumycin 250 mg Tablets

Brand name

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

International Nonproprietary Name (INN)

The international nonproprietary name of this medicine is tetracycline. This term is adopted by the international community to designate the active substance that provides the therapeutic effect. Tetracycline belongs to the class of tetracycline antibiotics, known for their ability to inhibit the growth of a wide range 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.

Form of release

The drug is available in several forms, which makes it convenient for use depending on the age of the patient and the peculiarities of treatment. The main options include:

• Tablets with dosages of 250 mg and 500 mg of the active substance, intended for oral administration by adults and older children.
• Capsules with dosages of 250 mg and 500 mg, providing an alternative for convenient use.
• Powder for preparation of suspension for oral administration with a concentration of 125 mg/5 ml after dilution, often used in pediatrics.

Each form is designed to meet the needs of therapy: tablets and capsules are suitable for adults, while the suspension is convenient for children or patients with 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 ingredient is tetracycline, an antibiotic from the group of tetracyclines. Auxiliary components depend on the form of release. In tablets, the following are used:

• Microcrystalline cellulose - filler for even distribution of the active substance.
• Lactose monohydrate - an auxiliary substance to create mass.
• Magnesium stearate - lubricating agent to facilitate production.
• Corn starch - a binder to form the structure.
• Hypromellose and titanium dioxide film shell - for protection and ease of administration.

The capsules add gelatin for the shell and povidone as a solvent. The suspension contains sucrose to improve taste, flavorings (e.g., orange) and xanthan gum as a thickener. The composition is balanced to ensure stability and bioavailability.

Pharmacologic Properties

Pharmacodynamics

Sumycin has bacteriostatic action, inhibiting protein synthesis in bacterial cells. It binds to 30S-subunit of ribosomes, preventing the process of translation and formation of peptide chains, which stops the growth and multiplication of microorganisms. The drug is effective against Gram-positive bacteria (Staphylococcus aureus, Streptococcus pneumoniae), Gram-negative pathogens (Escherichia coli, Haemophilus influenzae) and atypical pathogens (Chlamydia spp., Mycoplasma pneumoniae, Rickettsia spp.).

The mechanism of action makes the drug useful in infections requiring a broad spectrum of antibacterial action. Sumycin is particularly valuable when therapy against intracellular pathogens or bacteria resistant to other antibiotics is needed.

Pharmacokinetics

Absorption

After oral administration, the active substance is absorbed in the gastrointestinal tract, predominantly in the small intestine, reaching maximum plasma concentrations after 2-4 hours. Bioavailability is about 60-80%, but decreases when taken with food, especially rich in calcium or iron, due to the formation of chelate complexes. For optimal absorption it is recommended to take the drug on an empty stomach.

Distribution

The component is well distributed in the body, penetrating into the lungs, liver, kidneys, bones, skin and soft tissues. Binding to plasma proteins is about 20-65%, which provides sufficient distribution to the foci of infection. Concentrations in tissues often exceed plasma concentrations, which enhances the effect in systemic infections.

Metabolism

Metabolism is minimal: more than 90% of the dose taken remains unchanged. A minor part undergoes metabolic transformations in the liver to form inactive derivatives.

Excretion

Extracted mainly through the kidneys (60-70% unchanged) by tubular filtration, as well as with bile and feces (20-30%). The elimination half-life is 6-11 hours, but increases in case of renal dysfunction.

Indications for Use

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

• Infections of the respiratory tract: bronchitis, pneumonia, sinusitis.
• Infections of the genitourinary system: cystitis, urethritis, pyelonephritis.
• Infections of the skin and soft tissues: acne, furunculosis, abscesses.
• Sexually transmitted infections: chlamydia, gonorrhea, syphilis (if allergic to penicillin).
• Rickettsioses: Q fever, typhoid fever.
• Brucellosis and infections caused by Pasteurella spp.

The drug is also used for chronic inflammatory processes such as moderate to severe acne. Prescribing requires confirmation of the sensitivity of the pathogen.

Contraindications

The use of Sumycin is prohibited in:

• Hypersensitivity to tetracyclines.
• Pregnancy and lactation due to risk to fetus and child.
• Childhood under 8 years of age (risk of tooth staining).
• Severe hepatic or renal insufficiency without correction.

Prescribe with caution in cases of peptic ulcer and photosensitivity.

Method of Administration and Dosage

How to take

Tablets and capsules are taken orally, drinking plenty of water (200-250 ml), 1 hour before a meal or 2 hours after to avoid interaction with food. The suspension is prepared by adding water up to the mark, shake before use. Patients are advised to avoid lying down after administration to prevent esophageal irritation.

Dosages for adults and children

Dosage depends on the infection:

• Adults: 250-500 mg every 6 hours or 500 mg every 12 hours, course 7-14 days.
• Children over 8 years of age: 25-50 mg/kg/day divided into 4 doses, maximum 2 g/day.

Dose adjustment for certain conditions

In renal insufficiency:

• Clearance 10-50 mL/min: 250 mg every 12 hours.
• Clearance less than 10 mL/min: 250 mg every 24 hours.

In hepatic insufficiency the dose is reduced to 250 mg/day.

Side Effects

Unwanted reactions include:

• Gastrointestinal: nausea, diarrhea, esophagitis
• Skin: photosensitivity, rash.
• Hematologic: anemia, thrombocytopenia.
• Nervous: dizziness, headache.
• hepatic: increase in transaminases.

Treatment should be discontinued if symptoms are severe.

Overdose

Symptoms of overdose

Exceeding the dose of Sumycin causes nausea, vomiting, diarrhea, convulsions.

First aid measures

In overdose:

• Stop taking it.
• Rinse stomach (within 1-2 hours).
• Provide hydration and symptomatic therapy.
• Seek medical attention.

Drug Interactions

Influence on the effects of other drugs

The medication affects:

• Antacids (calcium, magnesium): decrease in absorption.
• Barfarin: increased anticoagulant effect.
• Penicillins: decrease in their effectiveness.

Compatibility with alcohol and food

Alcohol reduces efficacy and increases toxicity and is avoided. Dairy products slow absorption.

Special Precautions

Use in pregnancy and breastfeeding

Sumycin is contraindicated in pregnancy (category D) and lactation due to the risk to the fetus and child.

Effects on driving and mechanisms

Dizziness may make driving difficult.

Particulars of Use in the Elderly and Children

The elderly require monitoring of renal function. Do not use in children under 8 years of age due to dental risk.