SUMAMED

Active material: Azithromycin
When ATH: J01FA10
CCF: Macrolide antibiotics – azalid
ICD-10 codes (testimony): A31.0, A38, A46, A48.1, A56.0, A56.1, A56.4, A69.2, B96.0, H66, J01, J03, J15, J15.7, J16.0, J20, J32, J35.0, J42, K25, K26, L01, L30.3, N34, N72
Manufacturer: PLIVA HRVATSKA d.o.o. (Croatia)

Pharmaceutical form, composition and packaging

Pills, Film-coated blue, round, lenticular, Engraved “SWIM” on one side and “125” – another; of presentations – from white to almost white.

Excipients: calcium phosphate dibasic anhydrous, gipromelloza, corn starch, pre-gelatinized starch, microcrystalline cellulose, sodium lauryl, magnesium stearate.

The composition of the shell: gipromelloza, dye indigo carmine (E132), Titanium dioxide (E171), polysorbate 80, talc.

6 PC. – blisters (1) – packs cardboard.

Capsules hard gelatin, №1, with blue shell and blue Cap; contents of capsules – powder or compacted mass from white to light yellow in colour, raspadaûŝaâsâ when clicked.

Excipients: microcrystalline cellulose, sodium lauryl, magnesium stearate.

The composition of solid gelatinous capsules No. 1: gelatin, Titanium dioxide (E171), indigokarmin.

6 PC. – blisters (1) – packs cardboard.

Pills, Film-coated blue, oblong, lenticular, Engraved “SWIM” on one side and “500” – another; of presentations – from white to almost white.

Excipients: calcium hydrogen phosphate, anhydrous, gipromelloza, corn starch, pre-gelatinized starch, microcrystalline cellulose, sodium lauryl, magnesium stearate.

The composition of the shell: gipromelloza, dye indigo carmine (E132), Titanium dioxide (E171), polysorbate 80, talc.

3 PC. – blisters (1) – packs cardboard.

Powder for oral suspension granular, white or light-yellow, with a characteristic smell of strawberries; cooked aqueous suspension of white or light yellow in colour, uniform, with a characteristic smell of strawberries.

Excipients: sucrose, anhydrous sodium carbonate,, Sodium benzoate, tragacanth, Titanium dioxide, glycine, colloidal silicon dioxide, aroma Strawberry, the aroma of Apple, the fragrance of peppermint.

17 g – vials of dark glass volume 50 ml (1) complete with measuring spoon (on 2.5 and 5 ml) and/or dosing syringe (on 5 ml) – packs cardboard.

Pharmacological action

Bacteriostatic antibiotic broad-spectrum from the macrolides-azalidov. The mechanism of action of azithromycin is associated with suppression of protein synthesis microbial cells. Communicating with the 50S subjedinica ribosoma-, oppressing peptidtranslokazu being broadcast and suppresses protein synthesis, slowing the growth and reproduction of bacteria. In high concentrations it has a bactericidal effect.

Micro-organisms may initially be resilient to the effects of the antibiotic, or can acquire resistance to it.

Scale the sensitivity of microorganisms to azithromycin (MIK, mg / l)

In most cases, the product Sumamed^® 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.

Organisms, able to develop resistance to azithromycin: Gram-positive aerobes – Streptococcus pneumoniae (Penicillin-resistant strains).

Initially resistant organisms: Gram-positive aerobes – Enterococcus faecalis, Staphylococcus spp. (Methicillin-resistant staph strains have shown a very high degree of resistance to macrolides); Gram-positive bacteria, resistant to erythromycin; anaerobes – Bacteroides fragilis.

Pharmacokinetics

Absorption

After intake of azithromycin is absorbed and rapidly distributed in the body. After a single dose 500 mg bioavailability is 37% due to the effect of the first passage through the liver. C_max plasma levels achieved after 2-3 h and is 0.4 mg / l.

Distribution

Linking protein is inversely proportional to the concentration in the blood plasma and is 7-50%. In Кажущийся_d is 31.1 l / kg. Penetrates the cell membrane (effective in infections, caused by intracellular pathogens). Transported by phagocytes to the site of infection, where is released in the presence of bacteria. Easily permeates through gistogematicalkie barriers and enters the fabric. The concentration in the tissues and cells in 10-50 times higher, than in plasma, and the source of infection – on 24-34% better, than in healthy tissues.

Metabolism

Demetiliruetsa in the liver, losing activity.

Deduction

T_1/2 long – 35-50 no. T_1/2 from the tissues much more. Therapeutic concentrations of azithromycin is saved to 5-7 days after the last dose. Azithromycin appears, primarily, in unchanged form – 50% through the intestine, 6% kidney.

Testimony

Infectious-inflammatory diseases, caused by susceptible to malaria infections:

-infections of the upper respiratory tract and Lor-organov (Pharyngitis/Tonsillitis, sinusitis, otitis media);

-infections of the lower respiratory tract: acute bronchitis, exacerbation of chronic bronchitis, pneumonia, incl. caused by atypical pathogens;

- Infections of the skin and soft tissues (moderate acne, mug, impetigo, secondarily infected dermatitis);

is the initial stage of Lyme disease (ʙorrelioz) – erythema migrans (Erythema migrans);

-urinary tract infection, caused by Chlamydia trachomatis (uretrit, cervicitis).

Dosage regimen

The drug is prescribed inside 1 time / day, at least, for 1 hours before or after 2 hours after meals. The tablets are not liquid.

Adults (including the elderly) and children over 12 years old with a body weight more 45 kg the drug is prescribed in form of tablets and capsules.

For children 6 months and older the agent should be appointed in the form of suspension for admission into, for children 3 and older the drug can also prescribe in pill form 125 mg. Drug in tablet form 125 mg dose, taking into account the body weight of the child, as shown in Table.

At Lor-organov infections, upper and lower divisions of the respiratory tract, skin and soft tissue (with the exception of chronic erythema migrans) adults and children over 12 years old with a body weight more 45 kg the drug is prescribed in a dose 500 mg 1 times / day for 3 days, kursovaya dose – 1.5 g. For children 6 months and older appoint at 10 mg / kg body weight 1 times / day for 3 days, kursovaya dose – 30 mg / kg.

At Erythema Migrans drug prescribed 1 times / day for 5 days. Adults and children over 12 years old with a body weight more 45 kg is prescribed 1 day – 1 g, then with 2 by 5 days – by 500 mg; kursovaya dose – 3 g. For children 6 months and older assign 1-St day dose 20 mg/kg of body weight and then with 2 by 5 days – daily dose 10 mg / kg body weight, kursovaya dose – 60 mg / kg.

At Acne moderately toursovaâ dose 6.0 g. Adults and children over 12 years old with a body weight more 45 kg Appointed dose 500 mg 1 times / day for 3 days, then 500 mg 1 once a week for 9 weeks. The first weekly dose should be taken through 7 days after taking the first daily dose (8-day from the treatment beginning), subsequent 8 weekly doses should be taken with an interval of 7 days.

At infections, sexually transmitted, treatment uncomplicated urethritis/cervicitis, caused by Chlamydia trachomatis, the drug is prescribed in a dose 1 g once; treatment complicated long-flowing urethritis/cervicitis, caused by Chlamydia trachomatis, appoint 1 g 3 times at intervals 7 days (1, 7, 14 days), kursovaya dose – 3 g.

To patients with moderate kidney dysfunction (CC > 40 ml / min) dose adjustment is not required.

Cooking and receive suspensions

In vial, comprising 17 grams, contribute 12 ml distilled water or boiled. Amount received suspensions – 23 ml. Shelf life of prepared 5 days. Before taking the content of the vial thoroughly shake until a homogeneous suspension. Directly after receiving the suspension give the child drink several sips of tea in order, to wash down and swallow the remaining amount of oral suspension.

After using syringe assort and washed with running water, dry and store in a dry place with drug.

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), rarely (< 1/10 000).

From the hematopoietic system: rarely – thrombocytopenia, neutropenia, eozinofilija.

From the central and peripheral nervous system: sometimes – dizziness/vertigo, headache, drowsiness, convulsions; rarely – paresthesia, asthenia, insomnia, hyperactivity, aggressiveness, anxiety, nervousness.

From the senses: rarely – noise in ears, reversible hearing loss until deafness (When taken in high doses for a long time), the perception of taste and smell.

Cardio-vascular system: rarely – heartbeat, arrhythmia, including ventricular tachycardia, QT prolongation, bidirectional ventricular tachycardia.

From the digestive system: often – nausea, vomiting, diarrhea, abdominal pain and cramping; sometimes – diarrhea, flatulence, digestive disorders, anorexia; rarely – constipation, color change language, psevdomembranoznыy colitis, cholestatic jaundice, hepatitis, changing the values of laboratory indicators of liver function; rarely – violations of the liver and liver necrosis (possibly fatal).

Allergic reactions: sometimes – itch, skin rashes; rarely – angioedema, hives, photosensitivity, anaphylactic reaction (in rare cases, fatal), erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis.

On the part of the musculoskeletal system: sometimes – arthralgia.

From the urinary system: rarely – interstitial nephritis, acute renal failure.

Other: rarely – vaginitis, candidiasis.

Contraindications

— severe violations of the liver and kidney;

- Lactation (breast-feeding);

-simultaneous reception with ergotaminom and digidroergotaminom;

-hypersensitivity to azithromycin and other components of the drug;

- Hypersensitivity to macrolide antibiotics;

- Children up to age 12 years and weight less than 45 kg (for capsules and tablets 500 mg);

- Children up to age 3 years (Pill 125 mg).

FROM caution should designate product under moderate human liver and kidneys, patients who are blind or have a predisposition to arrhythmias and elongation QT interval, together with terfenadine, varfarinom, digoksinom.

Pregnancy and lactation

Drug use during pregnancy is possible only in case, If the potential benefits of therapy for a mother than the potential risk to the fetus.

If necessary, use during lactation should stop breastfeeding.

Cautions

In case of taking one dose is missed dose should be taken as soon as possible, and subsequent-intermittent 24 no.

As well as any antibiotic therapy, When azithromycin, possible accession of superinfection (incl. fungal).

In the treatment of pharyngitis/tonsillitis, caused by Streptococcus pyogenes , as well as to prevent acute rheumatic fever, usually the treatment of choice is penicillin. Azithromycin is also active against streptococcal infection in these cases, However, it is ineffective to prevent the development of acute rheumatic fever.

The patient should be warned of the need to inform your doctor about any side effect.

Impact on the ability to drive vehicles and mechanisms

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

Overdose

Symptoms: nausea, temporary hearing loss, vomiting, diarrhea.

Treatment: simptomaticheskaya therapy.

Drug Interactions

Antacids means do not affect the bioavailability of azithromycin, but reduce the C_max the blood on the 30%, product Sumamed^® should be taken, at least, for 1 hours before or after 2 hours after taking these drugs and food.

Together with the use of azithromycin does not affect the concentration of carbamazepine, didanozina, rifabutin and methylprednisolone in the blood.

When injecting azithromycin does not affect the concentration in the blood plasma zimetidina, èfavirenza, flukonazola, indinavir, midazolama, teofillina, triazolama, trimethoprim/sulfamethoxazole combination therapy, However, one should not exclude the possibility of such interaction with Sumamed appoint^® inside.

Azithromycin does not affect the farmakokinetiku theophylline, However, when coupled with other macrolides theofillina concentration in plasma may increase.

If necessary, the joint use of ziklosporinom, We recommend that you control the content of Cyclosporine in the blood. Despite, that data about the effects of azithromycin on changing the concentration of Cyclosporine in the blood no, other members of the class of macrolides are capable of altering its concentration in blood plasma.

When digoxin should control the azithromycin and concentration of Digoxin in the blood, tk. many macrolides increase digoxin absorption from the intestines, thereby increasing its concentration in the blood plasma.

If necessary, a joint reception with warfarin is recommended careful monitoring of prothrombin time.

It was found, that simultaneous terfenadina and antibiotic macrolides class causes arrhythmia and elongation QT interval. Proceeding from this, You cannot exclude data development complications when terfenadina and azithromycin.

Since there is a possibility of inhibition of azithromycin in parenteral form izofermenta CYP3A4, with a joint appointment with ziklosporinom, terfenadine, ergot alkaloids, cizapridom, pimozidom, xinidinom, astemizolom and other drugs, metabolism which takes place with the participation of izofermenta the, consider such interactions when prescribing of azithromycin for oral administration.

When azithromycin and zidovudine, Azithromycin doesn't affect the pharmacokinetic parameters of zidovudine in plasma or excretion kidneys it and its metabolite glucuronide. Nonetheless, increases the concentration of the active metabolite – fosforilirovannogo zidovudine in mononuclear cells of peripheral blood vessels. The clinical significance of this fact is not clear.

While admission macrolides with ergotaminom and digidroergotaminom possible manifestation of their toxicity.

Conditions of supply of pharmacies

The drug is released under the prescription.

Conditions and terms

List B. The drug should be stored out of reach of children at temperature from 15 ° to 25 ° C. Shelf life in the form of capsules and tablets, coated tablets- 3 year, powder for suspension for the reception inside- 2 year, cooked suspension – 5 days.