Sumamed forte suspension 200 mg/5 ml 37.5 ml (35.573 g) (Teva)

Sumamed

Antacids do not affect the bioavailability of azithromycin, but reduce Cmax in the blood by 30%, so Sumamed® should be taken at least 1 hour before or 2 hours after taking these drugs and food.

Concomitant use of azithromycin with cetirizine (20 mg) for 5 days in healthy volunteers did not lead to pharmacokinetic interaction or a significant change in the QT interval.

The simultaneous use of azithromycin (1200 mg/day) and didanosine (400 mg/day) in 6 HIV-infected patients did not reveal changes in the pharmacokinetic parameters of didanosine compared to the placebo group.

Simultaneous use of macrolide antibiotics, incl. azithromycin, with P-glycoprotein substrates such as digoxin, leads to increased concentrations of P-glycoprotein substrate in the blood serum. Thus, with the simultaneous use of azithromycin and digoxin, it is necessary to take into account the possibility of increasing the concentration of digoxin in the blood serum.

The simultaneous use of azithromycin (single dose of 1000 mg and multiple doses of 1200 mg or 600 mg) has a minor effect on pharmacokinetics, incl. renal excretion of zidovudine or its glucuronide metabolite. However, the use of azithromycin caused an increase in the concentration of phosphorylated zidovudine, a clinically active metabolite in peripheral blood mononuclear cells. The clinical significance of this fact is unclear.

Azithromycin interacts weakly with isoenzymes of the cytochrome P450 system. Azithromycin has not been shown to participate in pharmacokinetic interactions similar to erythromycin and other macrolides. Azithromycin is not an inhibitor or inducer of cytochrome P450 isoenzymes.

Given the theoretical possibility of ergotism, the simultaneous use of azithromycin with ergot alkaloid derivatives is not recommended.

Pharmacokinetic studies were conducted on the simultaneous use of azithromycin and drugs whose metabolism occurs with the participation of isoenzymes of the cytochrome P450 system.

Concomitant use of atorvastatin (10 mg daily) and azithromycin (500 mg daily) did not cause changes in atorvastatin plasma concentrations (based on an HMC-CoA reductase inhibition assay). However, in the post-marketing period, isolated case reports of rhabdomyolysis have been received in patients receiving concomitant azithromycin and statins.

Pharmacokinetic studies involving healthy volunteers did not reveal a significant effect on the plasma concentrations of carbamazepine and its active metabolite in patients receiving concomitant azithromycin.

In pharmacokinetic studies of the effect of cimetidine when taken in a single dose on the pharmacokinetics of azithromycin, no changes in the pharmacokinetics of azithromycin were detected, provided that cimetidine was used 2 hours before azithromycin.

In pharmacokinetic studies, azithromycin did not affect the anticoagulant effect of warfarin when taken in a single dose of 15 mg in healthy volunteers. Potentiation of the anticoagulant effect has been reported after simultaneous use of azithromycin and indirect anticoagulants (coumarin derivatives). Although a causal relationship has not been established, the need for frequent monitoring of prothrombin time should be considered when using azithromycin in patients receiving indirect oral anticoagulants (coumarin derivatives).

In a pharmacokinetic study involving healthy volunteers who took azithromycin (500 mg/day once) orally for 3 days, followed by cyclosporine (10 mg/kg/day once), a significant increase in plasma Cmax and AUC0-5 of cyclosporine was detected. . Caution is required with this combination. If concomitant use of these drugs is necessary, plasma concentrations of cyclosporine should be monitored and the dose adjusted accordingly.

Concomitant use of azithromycin (600 mg/day once) and efavirenz (400 mg/day) daily for 7 days did not cause any clinically significant pharmacokinetic interaction.

Concomitant use of azithromycin (1200 mg once) did not change the pharmacokinetics of fluconazole (800 mg once). The total exposure and T1/2 of azithromycin did not change with simultaneous use of fluconazole, however, a decrease in Cmax of azithromycin was observed (by 18%), which had no clinical significance.

The simultaneous use of azithromycin (1200 mg once) did not cause a statistically significant effect on the pharmacokinetics of indinavir (800 mg 3 times a day for 5 days).

Azithromycin does not have a significant effect on the pharmacokinetics of methylprednisolone.

The simultaneous use of azithromycin (1200 mg) and nelfinavir (750 mg 3 times / day) causes an increase in the Css of azithromycin in the blood plasma. No clinically significant side effects were observed and no dose adjustment of azithromycin was required when used concomitantly with nelfinavir.

The simultaneous use of azithromycin and rifabutin does not affect the concentration of each drug in the blood plasma. Neutropenia has sometimes been observed with simultaneous use of azithromycin and rifabutin. Although neutropenia has been associated with the use of rifabutin, a causal relationship between the use of the combination of azithromycin and rifabutin and neutropenia has not been established.

When used in healthy volunteers, there was no evidence of the effect of azithromycin (500 mg/day daily for 3 days) on the AUC and Cmax of sildenafil or its main circulating metabolite.

In pharmacokinetic studies, there was no evidence of interaction between azithromycin and terfenadine. There have been isolated cases reported where the possibility of such an interaction could not be completely excluded, but there was no concrete evidence that such an interaction occurred. It has been found that the simultaneous use of terfenadine and macrolides can cause arrhythmia and prolongation of the QT interval.

No interaction has been detected between azithromycin and theophylline.

No significant changes in pharmacokinetic parameters were detected with simultaneous use of azithromycin with triazolam or midazolam in therapeutic doses.

When trimethoprim/sulfamethoxazole was co-administered with azithromycin, there was no significant effect on Cmax, total exposure or renal excretion of trimethoprim or sulfamethoxazole. Azithromycin serum concentrations were consistent with those found in other studies.

Release form, composition and packaging

Blue film-coated tablets at the fracture - from white to almost white.

Excipients:

calcium hydrogen phosphate anhydrous, hypromellose, corn starch, pregelatinized starch, microcrystalline cellulose, sodium lauryl sulfate, magnesium stearate.

Shell composition:

hypromellose, indigo carmine dye (E132), titanium dioxide (E171), polysorbate 80, talc.

3 pcs. - blisters (1) - cardboard packs.

Indications for use of the drug

Infectious and inflammatory diseases caused by microorganisms sensitive to the drug:

- infections of the upper respiratory tract and ENT organs (pharyngitis/tonsillitis, sinusitis, otitis media);

— lower respiratory tract infections (acute bronchitis, exacerbation of chronic bronchitis, pneumonia, including those caused by atypical pathogens);

- diseases of the stomach and duodenum associated with Helicobacter pylori (for powder);

- infections of the skin and soft tissues (moderate acne, erysipelas, impetigo, secondary infected dermatoses);

- the initial stage of Lyme disease (borreliosis) - erythema migrans;

- urinary tract infections caused by Chlamydia trachomatis (urethritis, cervicitis).

Side effect

Determination of the frequency of adverse reactions: often (> 1/100 and < 1/10), sometimes (> 1/1000 and < 1/100), rarely (> 1/10,000 and < 1/1000), very rarely (< 1 /10 000).

From the hematopoietic system:

rarely - thrombocytopenia, neutropenia, eosinophilia.

From the central nervous system and peripheral nervous system:

sometimes - dizziness/vertigo, headache, drowsiness, convulsions; rarely - paresthesia, asthenia, insomnia, hyperactivity, aggressiveness, anxiety, nervousness.

From the senses:

rarely - tinnitus, reversible hearing loss up to deafness (when taken in high doses for a long time), impaired perception of taste and smell.

From the cardiovascular system:

rarely - palpitations, arrhythmia, including ventricular tachycardia, increased QT interval, bidirectional ventricular tachycardia.

From the digestive system:

often - nausea, vomiting, diarrhea, abdominal pain and cramps; sometimes - diarrhea, flatulence, digestive disorders, anorexia; rarely - constipation, discoloration of the tongue, pseudomembranous colitis, cholestatic jaundice, hepatitis, changes in laboratory parameters of liver function; very rarely - liver dysfunction and liver necrosis (possibly fatal).

Allergic reactions:

sometimes - itching, skin rashes; rarely - angioedema, urticaria, photosensitivity, anaphylactic reaction (in rare cases fatal), erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis.

From the musculoskeletal system:

sometimes - arthralgia.

From the urinary system:

rarely - interstitial nephritis, acute renal failure.

Other:

rarely - vaginitis, candidiasis.

Contraindications to the use of the drug

- severe dysfunction of the liver and kidneys;

- lactation period (breastfeeding);

- simultaneous use with ergotamine and dihydroergotamine;

- increased sensitivity to macrolide antibiotics;

- children under 12 years of age and body weight less than 45 kg (for capsules and tablets 500 mg);

- children under 3 years of age (for tablets 125 mg).

Carefully _

The drug should be prescribed for moderate impairment of liver and kidney function, for patients with disorders or predisposition to arrhythmias and prolongation of the QT interval, together with terfenadine, warfarin, digoxin.

pharmachologic effect

A broad-spectrum bacteriostatic antibiotic from the macrolide-azalide group. The mechanism of action of azithromycin is associated with the suppression of protein synthesis in microbial cells. By binding to the 50S ribosomal subunit, it inhibits peptide translocase at the translation stage and suppresses protein synthesis, slowing down the growth and reproduction of bacteria. In high concentrations it has a bactericidal effect.

Microorganisms may initially be resistant to the action of the antibiotic or may acquire resistance to it.

In most cases, Sumamed® is active against aerobic gram-positive bacteria:

Staphylococcus aureus (methicillin-sensitive strains), Streptococcus pneumoniae (penicillin-sensitive strains), Streptococcus pyogenes;
aerobic gram-negative bacteria:
Haemophilus influenzae, Haemophilus parainfluenzae, Legionella pneumophila, Moraxella catarrhalis, Pasteurella multocida, Neisseria gonorrhoeae;
anaerobic bacteria:
Clostridium perfringens, Fusobacterium spp., Prevotella spp., Porphyromonas spp;
other microorganisms
: Chlamydia trachomatis, Chlamydia pneumoniae, Chlamydia psittaci, Mycoplasma pneumoniae, Mycoplasma hominis, Borrelia burgdorferi.

Microorganisms that can develop resistance to azithromycin

:
gram-positive aerobes
- Streptococcus pneumoniae (penicillin-resistant strains).

Initially resistant microorganisms: gram-positive aerobes -

Enterococcus faecalis, Staphylococcus spp.
(methicillin-resistant strains of staphylococcus show a very high degree of resistance to macrolides), gram-positive bacteria resistant to erythromycin; anaerobes
- Bacteroides fragilis.

Pharmacokinetics

Suction

After oral administration, azithromycin is well absorbed and quickly distributed in the body. After a single dose of 500 mg, bioavailability is 37% due to the effect of the first pass through the liver. Cmax in blood plasma is reached after 2-3 hours and is 0.4 mg/l.

Distribution

Protein binding is inversely proportional to plasma concentration and ranges from 7-50%. The apparent Vd is 31.1 l/kg. Penetrates through cell membranes (effective against infections caused by intracellular pathogens). Transported by phagocytes to the site of infection, where it is released in the presence of bacteria. Easily penetrates histohematic barriers and enters tissues. The concentration in tissues and cells is 10-50 times higher than in plasma, and at the site of infection it is 24-34% higher than in healthy tissues.

Metabolism

In the liver it is demethylated, losing activity.

Removal

T1/2 long - 35-50 hours. T1/2 from tissues is much longer. The therapeutic concentration of azithromycin lasts up to 5-7 days after taking the last dose. Azithromycin is excreted mainly unchanged - 50% through the intestines, 6% by the kidneys.

special instructions

If you miss one dose of the drug, the missed dose should be taken as soon as possible, and subsequent doses should be taken at intervals of 24 hours.

Just like with any antibiotic therapy, when treating with azithromycin, superinfection (including fungal) may occur.

In the treatment of pharyngitis/tonsillitis caused by Streptococcus pyogenes, as well as for the prevention of acute rheumatic fever, penicillin is usually the drug of choice. Azithromycin is also active against streptococcal infection in these cases, but is ineffective in preventing the development of acute rheumatic fever.

The patient should be warned to notify the doctor if any side effect occurs.

Impact on the ability to drive vehicles and machinery

The drug does not affect the ability to drive vehicles and other activities that require high concentration and speed of psychomotor reactions.