Cleocin 300 mg Capsules

Brand name

The drug is presented in the pharmaceutical market under the trade name Cleocin. This designation is assigned to the drug in medical practice and is used for its identification in pharmacies, hospitals and among health care professionals. The name reflects its belonging to a certain group of antibiotics and has become recognizable due to its effectiveness in the fight against bacterial infections. The manufacturers chose this name to emphasize the unique properties of the medicine, which distinguish it from other drugs with similar action.

International Nonproprietary Name (INN)

The international nonproprietary name of this medication is clindamycin. This term is adopted by the international community to designate the active substance that underlies the therapeutic effect. Clindamycin belongs to the class of lincosamides, characterized by a specific mechanism of suppression of bacterial activity, which makes it an important tool in the treatment of infections resistant to other antibiotics. The name is standardized by the World Health Organization and is used worldwide regardless of brand names.

Pharmaceutical formulation

The drug is available in several dosage forms, allowing it to be used in a variety of clinical situations and to tailor treatment to individual patient needs. The main options include:

• Capsules for oral administration with dosages of 75 mg, 150 mg and 300 mg of the active substance. This form is convenient for outpatient use.
• Solution for intramuscular or intravenous injection (150 mg/mL), supplied in 2 mL, 4 mL, or 6 mL ampoules. It is intended for inpatient treatment of severe conditions.
• Granules for preparing an oral suspension (75 mg/5 mL after dilution), often used in pediatrics.
• Gel, cream or solution for external use (1% concentration) for the treatment of skin infections.

Each form is designed with specific application in mind: capsules and suspension are suitable for home treatment, injections for emergency treatment, and topical agents for topical application to affected skin areas.

Composition

The main active ingredient is clindamycin, an antibiotic from the group of lincosamides, which has a pronounced antibacterial effect. Auxiliary components depend on the form of release. In capsules, the following are used:

• Lactose monohydrate - a filler that provides volume and consistency.
• Corn starch - a binder for the formation of the mass.
• Talc - prevents particles from sticking.
• Magnesium stearate - lubricating agent that facilitates the production process.
• Gelatin - the basis of the capsule shell.

The solution for injection contains sodium phosphate as a buffer, benzyl alcohol as a preservative, and water for injection. The suspension includes sucrose for taste, flavorings (e.g., cherry), and xanthan gum to create a uniform texture. The external forms contain propylene glycol, isopropanol, and purified water as a base.

Pharmacologic Properties

Pharmacodynamics

The drug exhibits bacteriostatic action by inhibiting protein synthesis in bacterial cells by binding to the 50S-subunit of ribosomes. This process disrupts the formation of peptide bonds necessary for the growth and multiplication of microorganisms. In high concentrations or against particularly sensitive strains, the drug may act bactericidally, causing bacterial death. Activity covers mainly Gram-positive cocci such as Staphylococcus aureus (including some penicillin-resistant strains), Streptococcus pneumoniae and Streptococcus pyogenes, as well as anaerobic bacteria including Bacteroides fragilis, Clostridium perfringens and Peptostreptococcus spp.

The ability to penetrate tissues with a high density of anaerobic pathogens, such as abscesses or necrotic foci, is a special feature, making it indispensable in infections caused by mixed flora. The drug is also effective against some protozoa, such as Toxoplasma gondii, in combination with other agents. The action begins soon after reaching the therapeutic concentration, providing rapid control of the infectious process.

Pharmacokinetics

Absorption

After oral administration, the active substance is rapidly absorbed in the gastrointestinal tract, mainly in the small intestine. Maximum concentration in plasma is reached in 45-60 minutes when taken on an empty stomach. Bioavailability is about 90%, which makes the oral form highly effective. Food slows absorption but does not reduce total absorption, allowing the drug to be taken independently of meals.

Distribution

The compound is well distributed in the body, penetrating bone, lung, skin, soft tissue, bile, and pleural fluid. Binding to plasma proteins is about 90%, which provides a stable presence in the blood. The drug is able to accumulate in foci of infection, especially in anaerobic processes, due to high lipophilicity. Penetration through the blood-brain barrier is limited, but increases with inflammation of the cerebral membranes.

Metabolism

Metabolism occurs in the liver with the formation of active and inactive metabolites such as N-desmethylclindamycin and clindamycin sulfoxide. About 10-20% of the administered dose undergoes metabolic transformations, which ensures the prolonged presence of the active substance in the body.

Excretion

It is excreted through the kidneys (10-20% unchanged) and with bile (about 60-70% in the form of metabolites). The elimination half-life is 2-3 hours in patients with normal renal and hepatic function, but may increase in case of disorders of excretory systems. A small proportion is excreted through the lungs and skin.

Indications for Use

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

• Infections of the respiratory tract: pneumonia, lung abscess, empyema.
• Infections of the skin and soft tissues: cellulitis, abscesses, infected wounds.
• Bone and joint infections: osteomyelitis, septic arthritis.
• Gynecologic infections: endometritis, salpingitis, pelvic abscesses.
• Intraabdominal infections: peritonitis, abdominal abscesses.
• Sepsis and bacteremia caused by anaerobes or gram-positive cocci.
• Prevention of infections during oral or intestinal surgery.

External forms are used for acne or bacterial infections of the skin. The drug is often used in cases where penicillins are contraindicated due to allergy.

Contraindications

The use is prohibited in:

• Hypersensitivity to lincosamides or components of the formulation.
• Pseudomembranous colitis or pseudomembranous colitis in the anamnesis.
• Severe hepatic impairment without dose adjustment.
• Miasthenia gravis due to the risk of increased muscle weakness.

Cautiously administered in bronchial asthma, allergic history or renal dysfunction.

Method of Administration and Dosage

How to take

Capsules are taken orally, drinking plenty of water (200 ml), regardless of meals, although taking with food may reduce gastric irritation. The suspension is prepared by adding water to the mark, shaken before use. Solution for injection is administered by intramuscular or intravenous drip (diluted in 0.9% NaCl) over 30-60 minutes. External agents are applied in a thin layer to the affected areas of the skin.

Dosages for adults and children

Dosage depends on the severity of the infection:

• Adults (oral): 150-450 mg every 6-8 hours, course 7-14 days.
• Adults (injections): 600-2700 mg/day, divided into 2-4 injections.
• Children older than 1 month: 10-25 mg/kg/day (orally) or 15-40 mg/kg/day (parenterally), divided into 3-4 administrations.
• Externally: 1-2 times a day with a thin layer.

Dose adjustment for certain conditions

No correction is required in renal failure if liver function is normal. In hepatic insufficiency:

• Moderate: dose reduction by 25-50%.
• Severe: the interval between doses is increased up to 12 hours.

Side Effects

Unwanted reactions include:

• Gastrointestinal: nausea, diarrhea, abdominal pain, pseudomembranous colitis
• Skin: rash, pruritus, rare: toxic epidermal necrolysis.
• Hematologic: neutropenia, eosinophilia.
• hepatic: increase in transaminases, jaundice.
• Local (injection): pain, phlebitis.

When symptoms are severe, discontinue use and consult a physician.

Overdose

Symptoms of overdose

Exceeding the dose causes nausea, vomiting, diarrhea, seizures, arrhythmias.

First aid measures

For overdose:

• Stop taking it.
• Rinse the stomach (within 1-2 hours).
• Provide symptomatic treatment.
• Seek medical attention.

Drug Interactions

Influence on the effects of other drugs

The medication affects:

• Neuromuscular blockers: enhancement of their action.
• Erythromycin: antagonism, reduction in the effectiveness of both.
• Barfarin: enhancement of anticoagulant effect.

Compatibility with alcohol and food

Alcohol increases the risk of hepatic side effects and is avoided. Food does not affect absorption, but fatty foods may slow down the process.

Special Precautions

Use in pregnancy and breastfeeding

Use in pregnancy is possible only for vital indications (category B). Penetrates into milk, lactation is suspended.

Effects on driving and operating machinery

Dizziness or weakness may make driving difficult.

Particularities of use in the elderly and children

In the elderly more often occur intestinal disorders, control is required. In children, the drug is safe from 1 month of age with accurate dosage.