Description of the drug AZITHROMYCIN for systemic use

Description of the drug AZITHROMYCIN for systemic use

Carbamazepine

In pharmacokinetic studies conducted in healthy volunteers, azithromycin did not have a significant effect on plasma levels of carbamazepine or its active metabolite.

Oral coumarin anticoagulants

In a pharmacokinetic interaction study, azithromycin never altered the anticoagulant effect of warfarin when administered as a single 15 mg dose in healthy patients. In the post-marketing period, an increase in the anticoagulant effect of coumarin derivatives was observed when used in combination with azithromycin. Although a cause-and-effect relationship has not been established, more frequent monitoring of prothrombin time should be considered when azithromycin is used in patients taking coumarin anticoagulants.

While taking cimetidine

two hours before taking azithromycin, no changes in the pharmacokinetics of azithromycin were observed.

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Cyclosporine

In a pharmacokinetic study in healthy volunteers who received a daily dose of azithromycin 500 mg orally for 3 days and who subsequently took a single dose of 10 mg/kg cyclosporine orally, the Cmax and AUC0-5 values ​​of cyclosporine were significantly increased. Therefore, these drugs should be used simultaneously with caution. If concomitant use of these drugs is necessary, monitor cyclosporine levels and adjust the dose accordingly.

Efavirenz

Co-administration of a single dose of azithromycin 600 mg and efavirenz 400 mg per day for 7 days did not result in a clinically significant pharmacokinetic interaction.

Fluconazole

The simultaneous use of a single dose of 1200 mg of azithromycin does not change the pharmacokinetics of a single dose of 800 mg of fluconazole. The total concentration and half-life of azithromycin did not change with concomitant use of fluconazole. However, a clinically insignificant decrease in Cmax (18%) of azithromycin was noted.

Indinavir

Concomitant use of a single dose of 1200 mg of azithromycin does not have a significant effect on the pharmacokinetics of indinavir when administered at a dose of 800 mg three times daily for 5 days.

Methylprednisolone

In a pharmacokinetic study of drug interactions in healthy patients, azithromycin did not have a significant effect on the pharmacokinetics of methylprednisolone.

Midazolam

In healthy patients, simultaneous administration of azithromycin 500 mg daily for 3 days does not cause clinically significant changes in the pharmacokinetics and pharmacodynamics of midazolam when administered once 15 mg.

Nelfinavir

The simultaneous use of azithromycin (1200 mg) and nelfinavir (750 mg three times a day) leads to an increase in the concentration of azithromycin at steady state. No clinically significant side effects were identified. There is no need to adjust the dose.

Rifabutin

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Concomitant use of azithromycin and rifabutin did not affect the serum concentrations of either drug. With simultaneous use of azithromycin and rifabutin, neutropenia was observed in patients. Neutropenia is associated with the use of rifabutin; a causal relationship when taken in combination with azithromycin has not been established.

Sildenafil

There was no evidence of an effect of azithromycin (500 mg daily for 3 days) on the blood AUC and Cmax values ​​of sildenafil or its major metabolites.

Theophylline

Azithromycin did not affect the pharmacokinetics of theophylline in healthy volunteers. Concomitant use of theophylline and other macrolide antibiotics has sometimes resulted in increased serum theophylline concentrations.

Triazolam

Co-administration of azithromycin 500 mg on day 1 and 250 mg on day 2 and triazolam 0.125 mg on day 2 in 14 healthy patients did not have a significant effect on the pharmacokinetic parameters of triazolam compared with co-administration of triazolam and placebo.

Trimethoprim/sulfamethoxazole

Co-administration of trimethoprim/sulfamethoxazole DS (160 mg/800 mg) for 7 days and 1200 mg azithromycin on day 7 had no significant effect on peak concentrations and urinary excretion of trimethoprim/sulfamethoxazole. Azithromycin serum concentrations were similar to those in other studies.

Cisapride

metabolized in the liver by the enzyme CYP3A4.
Because macrolides inhibit this enzyme, concomitant administration of cisapride may result in QT prolongation, ventricular arrhythmias, and torsades de pointes
.

Data on interactions with astemizole

and
alfentanil
are absent. Caution should be exercised when these drugs are used concomitantly with azithromycin, given the potential effects described with concomitant use of the macrolide antibiotic erythromycin.

Azithromycin should not be used concomitantly with other active substances that prolong the QT interval

.

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AZITHROMYCIN (Azithromycin)

Antacids

Antacids do not affect the bioavailability of azithromycin, but reduce the maximum blood concentration by 30%, so the drug should be taken at least one hour before or two hours after taking these drugs and eating.

Cetirizine

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

Didanosine (dideoxyinosine)

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 indications of didanosine compared to the placebo group.

Digoxin and colchicine (P-glycoprotein substrates)

Concomitant use of macrolide antibiotics, including azithromycin, with P-glycoprotein substrates, such as digoxin and colchicine, 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.

Zidovudine

Concomitant use of azithromycin (single dose of 1000 mg and multiple doses of 1200 mg or 600 mg) has a minor effect on the pharmacokinetics, including 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.

Ergot alkaloids

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.

Atorvastatin

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.

Carbamazepine

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.

Cimetidine

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

Indirect anticoagulants (coumarin derivatives)

In pharmacokinetic studies, azithromycin did not affect the anticoagulant effect of a single 15 mg dose of warfarin administered to 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).

Cicposporin

In a pharmacokinetic study involving healthy volunteers who took azithromycin (500 mg/day once) orally for 3 days and then cyclosporine (10 mg/kg/day once), a significant increase in maximum plasma concentration (Cmax) and area under the concentration-time curve (AUC0-5) of cyclosporine. Caution is advised when using these drugs together. If simultaneous use of these drugs is necessary, it is necessary to monitor the concentration of cyclosporine in the blood plasma and adjust the dose accordingly.

Efavirenz

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.

Fluconazole

Concomitant use of azithromycin (1200 mg once) did not change the pharmacokinetics of fluconazole (800 mg once). The total exposure and half-life 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.

Indinavir

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).

Methylprednisolone

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

Nelfinavir

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

Rifabutin

The simultaneous use of azithromycin and rifabutin does not affect the concentration of each drug in the blood serum. 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.

Sildenafil

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 and its main circulating metabolite.

Terfenadine

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.

Theophylline

There was no interaction between azithromycin and theophylline.

Triazolam/midazolam

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

Trimethoprim/sulfamethoxazole
Concomitant use of trimethoprim/sulfamethoxazole with azithromycin did not show a significant effect on Cmax, total exposure or renal excretion of trimethoprim or sulfamethoxazole. Azithromycin plasma concentrations were consistent with those found in other studies.

Azithromycin Pharmland tablets p/o 500 mg No. 3x2

Name

Azithromycin Pharmland tablet p/o 500 mg in container pack No. 3x2

Description

Tablets 500 mg: pink, oblong, biconvex, film-coated, scored on one side.

Main active ingredient

Azithromycin

Release form

Film-coated tablets

Dosage

500mg

Indications for use

Treatment of infectious diseases caused by microorganisms sensitive to Azithromycin:

• Upper respiratory tract infections (acute and chronic bacterial pharyngitis/tonsillitis, sinusitis, acute otitis media);
• Lower respiratory tract infections (acute bacterial bronchitis, exacerbation of chronic bronchitis, community-acquired bacterial pneumonia, including those caused by atypical pathogens);
• infections of the skin and soft tissues (uncomplicated forms of achne vulgaris, chronic migratory erythema (initial stage of Lyme disease), erysipelas, impetigo, secondary pyodermatoses);
• Sexually transmitted infections (urethritis, cervicitis);
• Diseases of the stomach and duodenum associated with Helicobacter pylori.

Directions for use and doses

Take Azithromycin strictly as prescribed by your doctor. If you are not sure about something, ask again. Azithromycin is taken orally, without chewing, 1 time per day, one hour before meals or two hours after meals, since food affects the absorption of Azithromycin. Usual dose for adults and children weighing ? 45 kg: 500 mg 1 time per day for 3 days. For various diseases, the doctor may prescribe doses and treatment regimens that differ from the above. If you are not sure about something, ask again. Carefully read the dosage instructions on the package, this will help you take the required number of tablets. Continue treatment as prescribed by your doctor, even if you feel better. If there is no improvement after completing the prescribed course of treatment, consult a doctor.

Use during pregnancy and lactation

If you are pregnant (or think you may be pregnant), or breastfeeding, be sure to consult a physician before use. Effect on the ability to drive a car and use machinery. Does not affect the ability to drive a car or use machinery.

Precautionary measures

If you have any liver, kidney or heart problems; If you are taking ergot alkaloid derivatives: ergotamine, dihydroergotamine; If you are pregnant or breastfeeding.

Interaction with other drugs

• Ergot alkaloid derivatives: ergotamine, dihydroergotamine;
• warfarin or other medicines to reduce blood clotting;
• Cyclosporine (for immunosuppression);
• Antacids (to reduce stomach acidity);
• Digoxin (to treat heart failure);
• Terfenadine (to treat allergic reactions).

Tell your doctor if you are taking any other medicines not listed on this list.

Contraindications

• you are allergic to Azithromycin, other macrolide antibiotics (erythromycin, clarithromycin) or to any other component of the drug;
• If you take ergot alkaloid derivatives: ergotamine, dihydroergotamine (ergotoxicity may develop).

Compound

Each Azithromycin tablet contains 250 mg or 500 mg of the active substance azithromycin and excipients: sodium starch glycolate, microcrystalline cellulose, talc, sodium lauryl sulfate, magnesium stearate, corn starch; shell – Opadry II pink (polyvinyl alcohol, macrogol, titanium dioxide, talc, red charm (E 129), tartrazine (E 102)). This medicine belongs to the group of macrolide antibiotics. Antibiotics inhibit the growth of microorganisms that cause infections.

Overdose

If the number of tablets per day you take is more than the number recommended by your doctor, or your child swallows the tablets, contact your doctor or call an ambulance.

Side effect

If any of the following symptoms occur during treatment with Azithromycin, stop taking the medication immediately and contact your doctor:

• Loose stools for a long time, possibly with blood or mucus in it. Loose stools may appear even two months after taking Azithromycin;
• Sudden wheezing, difficulty breathing, swelling of the face or difficulty swallowing, rash, itching, especially all over the body. These symptoms may indicate an allergic reaction;
• Severe skin disorders with blistering on the skin, mouth, lips, eyes or genitals. These are symptoms of a rare allergic reaction called toxic epidermal necrolysis;
• fast or irregular heart rhythm;
• Low blood pressure.

The most common side effects when taking Azithromycin (affect 1 in 10 people):

• Stomach cramps;
• Weakness;
• Stool disorder.

Common side effects when taking Azithromycin (occur less than 1 in 10 people):

• Dizziness, headache;
• Numbness, tingling;
• Weakness, indigestion;
• Loss of appetite, taste disturbance;
• Visual and hearing impairment;
• rash or peeling skin;
• Joint pain;
• Low number of lymphocytes, high number of eosinophils in the blood;
• Fatigue, weakness.

Other rarer side effects of Azithromycin (occurring in less than one in 100 people):

• Fungal diseases of the mouth or genitals;
• Low number of leukocytes, neutrophils in the blood;
• Allergic reactions of varying severity;
• blisters on the skin, mouth, lips, eyes, or genitals;
• Skin sensitivity to sunlight;
• Nervousness;
• Decreased sensitivity;
• Deterioration of hearing, circles before the eyes;
• Palpitations, chest pain;
• Constipation or stomach pain, accompanied by loose stools and fever;
• Inflammation of the liver and changes in liver tests;
• General weakness;
• Swelling;
• General discomfort;
• Changes in blood tests.

Be sure to consult your doctor if any of these symptoms appear, if they persist and bother you, or if you experience any other symptoms that are unusual and not described in this leaflet!

Storage conditions

Store in a place protected from moisture and light at a temperature not exceeding 25°C. Keep out of the reach of children.

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