Clacid granules for suspension preparation 125mg/5ml 70.70g vials, 100ml

Composition

5 ml of ready-made suspension. : Active ingredients: clarithromycin 250 mg

Auxiliary substances:

karbomer (carbopol 974P) – 150 mg,

povidone K 90 – 35 mg,

these phthalate – 304.2 mg

castor oil – 32.1 mg,

silicon dioxide 10 mg,

maltodextrin – 238.7 mg,

sucrose 2276.2 mg,

titanium dioxide – 35.7 mg,

gum xanthan – 3.8 mg,

flavoring fruit – 35.7 mg,

potassium sorbate,20 mg,

citric acid 4.24 mg.

Pharmacological action

Klacid is an antibiotic of the macrolide group. Clarithromycin inhibits protein synthesis in the microbial cell by interacting with the 50S ribosomal subunit of bacteria. Highly active against a wide range of aerobic, anaerobic, gram-positive and gram-negative bacteria. Clarithromycin showed high activity in vitro against standard and isolated bacterial cultures. Highly effective against many aerobic and anaerobic gram-positive and gram-negative microorganisms. In vitro studies confirm the high efficacy of clarithromycin against Legionella pneumophila and Mycoplasma pneumoniae. The drug is also active against aerobic gram-positive microorganisms:  Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus pyogenes, Listeria monocytogenes; aerobic gram-negative microorganisms: Haemophilus influenzae, Haemophilus parainftuenzae, Moraxella catarrhalis, Neisseria gonorrhoeae; other microorganisms: Mycoplasma pneumoniae, Chlamydia pneumoniae (TWAR), Chlamydia trachomatis, Mycobacterium leprae, Mycobacterium kansasii, Mycobacterium chelonae, Mycobacterium fortuitum, Mycobacterium avium complex (MAC): Mycobacterium avium, Mycobacferium intracellulare. They are insensitive to clarithromycin Enterobacteriaceae, Pseudomonas spp., as well as other gram-negative bacteria that do not decompose lactose. The production of b-lactamase does not affect the activity of clarithromycin. Most strains of staphylococci that are resistant to methicillin and oxacillin are also resistant to clarithromycin. Clarithromycin has an in vitro effect on most strains of the following microorganisms (however, the safety and efficacy of clarithromycin in clinical practice has not been confirmed by clinical studies, and the practical significance remains unclear): aerobic gram-positive microorganisms: Streptococcus agalactiae, streptococci (groups C, F, G), streptococci of the Viridans group; aerobic gram-negative microorganisms: Bordeteila pertussis, Pasteurella multocida; anaerobic gram-positive microorganisms: Clostridium perfringens, Peptococcus niger, Propionibacterium acnes; anaerobic gram-negative microorganisms: Bacteroides melaninogenicus; Borrelia burgdorferi, Treponema pallidum, Campylobacter jejuni. The microbiological activity of the metabolite is the same as that of the parent substance, or 1-2 times weaker against most microorganisms. The exception is Hemophilus influenzae, for which the effectiveness of the metabolite is 2 times higher. The parent substance and its main metabolite have either an additive or synergistic effect against Haemophilus influenzae in vitro and in vivo, depending on the bacterial culture. Tablets of prolonged action are a homogeneous crystalline base, during the passage of which through the gastrointestinal tract, a long-term release of the Active ingredient is ensured.

Indications

Infectious and inflammatory diseases caused by microorganisms sensitive to the drug: – upper respiratory tract infections (pharyngitis, tonsillitis and sinusitis);– lower respiratory tract infections (bronchitis, pneumonia);– otitis media;– skin and soft tissue infections (impetigo, folliculitis, cellulitis, abscesses); – disseminated or localized mycobacterial infections caused by Mycobacterium avium or Mycobacterium intracellulare; – localized infections caused by Mycobacterium fortuitum, Mycobacterium kansasii, Mycobacterium chelonae.

Contraindications

-severe renal dysfunction (with creatinine clearance less than 30 ml / min); such patients are prescribed clarithromycin rapid release; – concomitant use of astemizole, cisapride, pimozide, terfenadine– – porphyria; – pregnancy; – lactation (breastfeeding)– – hypersensitivity to macrolide antibiotics.

Side effects

• Oral suspension Klacid can very rarely accompanied by symptoms characteristic of clarithromycin: distortion of taste sensations, functional disorders of the gastrointestinal tract (dyspepsia, nausea, vomiting, diarrhea), increased levels of liver enzymes;

• headache, vertigo, anxiety, insomnia, nightmares, ringing in the ears;

• in rare cases, disorientation, hallucinations, psychosis, depersonalization, confusion, thrombocytopenia;

• in rare cases, hearing loss, going after drug withdrawal.

Interaction

Concomitant use of Clacid with cisapride, pimozide and terfenadine is prohibited. It is possible to develop cross-resistance between Clacid and lincomycin and clindamycin. Caution should be exercised when prescribing Klacid concomitantly with lovastatin, simvastatin, and other HMG-CoA reductase inhibitors. Concomitant use of Klacid with drugs that metabolize cytochrome P450 (warfarin, ergot alkaloids, disopyramide, lovastatin, midazolam, rifabutin, triazolam, phenytoin, cyclosporine), there is an increase in the concentration of the latter in the blood serum. Concomitant use of Klacid with digoxin, theophylline, and carbamazepine resulted in an increase in serum levels of the latter.

How to take, course of use and dosage

The finished suspension should be taken orally regardless of food intake (you can use milk).

To prepare the suspension, water is gradually added to the bottle with granules up to the mark, then the bottle is shaken. The finished suspension can be stored for 14 days at room temperature.

The recommended daily dose of clarithromycin suspension for non-mycobacterial infections in children is 7.5 mg / kg 2 times / day. The maximum dose is 500 mg 2 times / day.

The usual duration of treatment is 5-7 days, depending on the pathogen and the severity of the patient’s condition. Before each use, you should shake the bottle with the drug well.

Overdose

Symptoms:  nausea, vomiting, diarrhea. Treatment:  gastric lavage, symptomatic therapy.

Description

Powder for preparing a suspension for oral use is white or almost white, granular, with a fruity aroma; when shaken with water, an opaque suspension of white or almost white color is formed, with a fruity aroma.

Special instructions

Caution should be exercised when prescribing the drug to patients with impaired liver function. It is possible to develop cross-resistance between Clacid and lincomycin and clindamycin.

Storage conditions

The drug should be stored at room temperature (no higher than 30°C).

Active ingredient

Clarithromycin

Conditions of release from pharmacies

By prescription

Dosage form

suspension for oral use

Description

Children as prescribed by a doctor

Indications

From sore throats, Colds, Stomach and duodenal ulcers, Sinusitis, tonsillitis, Respiratory tract infections, Skin infections, boils, Bronchitis, Gastrointestinal infections caused by Helicobacter Pylori, Pharyngitis, Otitis