Antibacterial agents / Internal Use

Sumamed ® 125 mg (6 tablets)

Brands: Pliva (Croatia)

$21.40

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Sumamed ® 125 mg (6 tablets) quantity

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348365ac71f6

Brands:: Pliva (Croatia)

Description

The instruction for medical use

of Sumamed Torgovoye medicine a name
Sumamed

Mezhdunarodnoye the unlicensed

name Azithromycin Dosage Form
of the Tablet film coated

Structure
active agent – azithromycin (in the form of dihydrate azithromycin)-125 mg,
excipients: calcium hydrophosphate anhydrous, gipromelloza (methylhydroxypropyl cellulose 15 mPas), starch corn, starch prezhelatinizirovanny, cellulose microcrystalline, sodium lauryl sulfate, magnesium stearate.
structure of a cover: gipromelloza (methylhydroxypropyl cellulose 3 mPas), dye varnish indigotinovy (E132), titan dioxide (E171), polysorbate 80, talc.

The description
of the Tablet, film coated light blue color, round, biconvex with marking of PLIVA on one party and 125 on other party.

Pharmacotherapeutic group
Antibacterial drugs for system use. Macroleads, linkozamida and streptogramina. Macroleads. Azithromycin.
The ATX J01FA10 code

the Pharmacological

Pharmacokinetics Azithromycin properties is quickly soaked up at oral administration that is caused by its stability in acidic environment and lipophilicity. After single dose 37% of azithromycin are inside soaked up, and the peak of concentration in plasma (0.41 µg/мл) is registered in 2-3 hours. Vd makes about 31 l/kg. Azithromycin well gets into airways, bodies and fabrics of an urogenital path, a prostate, into skin and soft tissues, reaching from 1 to 9 µg/мл depending on a type of fabric. High concentration in fabrics (is 50 times higher, than concentration in plasma) and the long half-life period is caused by low linking of azithromycin with proteins of blood plasma and also its ability to get into eukaryotic cells and to concentrate in the environment with a low rn, a surrounding lysosome. The ability of azithromycin to collect in lysosomes is especially important for elimination of intracellular activators. Phagocytes deliver azithromycin to places of localization of an infection where it is released in the course of phagocytosis. But despite high concentration in phagocytes, azithromycin does not affect their function. Therapeutic concentration remains 5-7 days after intake of the last dose. At intake of azithromycin perhaps tranzitorny increase in activity of liver enzymes. Removal of a half of a dose from plasma affects reduction of a half of a dose in fabrics within 2-4 days. After administration of drug in the range from 8 till 24 o’clock the half-life period is 14-20 hours, and after administration of drug in the range from 24 till 72 o’clock – 41 hour that Sumamed of 1 times a day allows to accept. The main way of removal – with bile. About 50% are removed in not changed look, other 50% – in the form of 10 inactive metabolites. About 6% of the accepted dose are removed by kidneys.
The pharmacodynamics
Sumamed is an antibiotic of a broad spectrum of activity, the first representative of new subgroup of makrolidny antibiotics – azaleads. Possesses bacteriostatic action, but during creation in the center of inflammation of high concentrations causes bactericidal effect. Connecting 50S a ribosome subunit, Sumamed suppresses synthesis of protein in sensitive microorganisms, showing activity concerning the majority of strains of gram-positive, gram-negative, anaerobic, intracellular and other microorganisms.
MIC90 ≤ 0.01 µg/мл

Mycoplasma pneumoniae Haemophilus ducreyi MIC90 0.01 – 0.1 µg/мл

Moraxella catarrhalis Propionibacterium acnes Gardnerella vaginalis Actinomyces species Bordetella pertussis Borrelia burgdorferi Mobiluncus species MIC900.1 – 2.0 µg/мл

Haemophilus influenzae Streptococcus pyogenes Haemophilus parainfluenzae Streptococcus pneumoniae Legionella pneumophila Streptococcus agalactiae Neisseria meningitidis Streptococcus viridans Neisseria gonorrhoeae Streptococcus group C, F,

G Helicobacter pylori Peptococcus species Campylobacter jejuni Peptostreptococcus Pasteurella multocida Fusobacterium necrophorum Pasteurella haemolytica Clostridium perfringens Brucella melitensis Bacteroides bivius Bordetella parapertussis Chlamydia trachomatis Vibrio cholerae Chlamydia pneumoniae Vibrio parahaemolyticus Ureaplasma urealyticum Plesiomonas shigelloides Listeria monocytogenes Staphylococcus epidermidis Staphylococcus aureus *
(*эритромицин – a sensitive strain)
MIC902.0 – 8.0 µg/мл

Escherichia coli Bacteroides fragilis Salmonella enteritidis Bacteroides oralis Salmonella typhi Clostridium difficile Shigella sonnei Eubacterium lentum Yersinia enterocolitica Fusobacterium nucleatum Acinetobacter calcoaceticus Aeromonas hydrophilia

Indications
– respiratory infections, including pharyngitis/tonsillitis, sinusitis, average otitis
– lower respiratory tract infections, including acute exacerbation of chronic bronchitis, not hospital pneumonia
– infections of skin and soft tissues: the migrating erythema (initial stage of a disease of Lyme), erysipelatous inflammation, impetigo, secondary pyodermatoses
–

without chewing the infections of a stomach and a duodenum caused by Helicobacter pylori the Route of administration and doses Inside, at least in 1 hour prior to or in 2 hours after a meal, 1 times a day. The tablets Sumamed of 125 mg are intended for children with the corresponding body weight who are capable to swallow a tablet. For all other children syrup Sumamed is recommended. At children with body weight more than 45 kg the recommended dose makes a dose for adults.
To children dose proceeding from value of body weight:

Body weight

Amount of azithromycin
(in tablets of 125 mg)

16-30 kg

2 tablets (250 mg)

of 31-44 kg

3 tablets (375 mg)

≥ 45 kg

Appoint the doses recommended for adults
In infections of upper and lower airways, ENT organs, skin and Sumamed soft tissues (125 mg) accept from calculation 10mg/kg body weights within 3 days (course dose of 30 mg/kg) once a day. For convenience of dosing it is recommended to use the above-stated table.
Azithromycin is effective at treatment of streptococcal pharyngitis at children in the form of a single dose of 10 mg/kg or 20 mg/kg for 3 days.

Side effect
Is frequent
– a headache
– nausea, vomiting, diarrhea, an abdominal pain
– reduction of quantity of leukocytes, increase in quantity of eosinophils, decrease in bicarbonate of blood, increase in quantity of basophiles, increase in quantity of monocytes, increase in quantity of neutrophils
Infrequently
– a constipation, a meteorism, dyspepsia, gastritis, a dysphagy, an abdominal distension,
dryness in a mouth, an eructation, ulcers in a mouth, hypersecretion of sialadens
– dizziness, drowsiness, a food faddism, paresthesias
– hearing disorder, dizziness
– a cardiopalmus
– short wind, nasal bleeding
– a disorder of vision
– anorexia
– an osteoarthritis, myalgia, a dorsodynia, neck pain
– nervousness, insomnia
– a leukopenia, a neutropenia, an eosinophilia
– candidiasis, vaginal infections, pneumonia, fungal infections, a bacterial infection, pharyngitis, a gastroenteritis, respiratory disorders, rhinitis, candidiasis
– inflows
– rash, an itching, urticaria, dermatitis, xeroderma, a hyperhidrosis
– a Quincke’s disease, hypersensitivity
– a dysuria, renal pain
– a metrorrhagia, defeat of testicles
– hypostasis, an asthenia, an indisposition, fatigue, a face edema, a stethalgia, fever, pain, peripheral hypostases
– increase in level of aspartate aminotransferase, increase in level
aminotransferase alanine, increase in bilirubin in blood, increase in urea in
blood, increase in creatinine of blood, abnormal level of potassium in blood, increase in level of alkaline phosphatase in blood, increase in level of chloride, increase in level of glucose, increase in level of thrombocytes, reduction of a hematocrit, increase in bicarbonate, the abnormal level of sodium
Seldom
– agitation
– abnormal hepatic function, cholestatic jaundice
– reaction of photosensitivity
Does not know
– pseudomembranous colitis
– thrombocytopenia, hemolytic anemia
– anaphylactic reaction
– aggression, alarm, nonsense, hallucinations
– faints, spasms, paresthesias, psychomotor hyperactivity, an anosmia, an ageusia, a parosomiya, a myasthenia
– a hearing disorder, up to deafness and/or sonitus
– bidirectional tachycardia and arrhythmia including ventricular tachycardia, lengthening of an interval of QT on the ECG
– hypotension
– pancreatitis, decolouration of language
– a liver failure (in rare instances with a lethal outcome) lightning hepatitis, liver necrosis
– Stephens-Johnson’s syndrome, a toxic epidermal necrolysis, a multiformny erythema
– an arthralgia
– an acute renal failure, interstitsialna y nephrite
the Side reactions connected with prevention and treatment of the infections caused by the Mycobacterium Avium complex are possible or probable, based on clinical trials and experience of post-marketing observation. These side reactions differ on type or frequency from the reactions reported for dosage forms with immediate release or the prolonged action:

A system and organ
class

Very often Often Infrequently

Disturbances from a metabolism and food

Disturbance anorexia from
nervous system

dizziness,
a headache,
paresthesias, disturbances
of taste

the Disturbance hypesthesia from an organ of sight

the Disturbance disorder of vision from
an organ of hearing and balance

deafness

a hearing disorder, sonitus

of Disturbance from
body of heart

the Disturbance cardiopalmus from

digestive tract

diarrhea, an abdominal pain,
nausea, a constipation,
discomfort in a stomach,
a soft chair

of Disturbance from
a liver and
biliary
tract

Disturbance hepatitis from
skin and hypodermic
fabrics

rash,

naggers Sindrom of Stephens – Johnson, reaction
of photosensitivity

of Disturbance from
skeletal and muscular and
connective tissue
an arthralgia

an arthralgia

the General disturbances and
reactions in
the injection site

fatigue

an asthenia,

the Contraindication indisposition
– hypersensitivity to makrolidny antibiotics
– heavy abnormal liver functions and kidneys

Medicinal interactions
Antacids: When studying influence of simultaneous use of antacids on pharmacokinetics of azithromycin did not note changes of bioavailability though the maximum concentration of azithromycin in blood plasma decreased by 25%. Patients should not accept azithromycin and antacids at the same time.
Tsetirizin: At healthy volunteers, did not lead joint reception of a 5-day rate of azithromycin from tsetiriziny 20 mg in an equilibrium state to pharmacokinetic interaction and significant change in QT interval.
Didanozin (didezoksiinozin): Joint reception of 1200 mg/days of azithromycin of 400 mg/days of a didanozin at 6 HIV-positive patients, does not influence an equilibrium condition of pharmacokinetics of a didanozin in comparison with placebo.
Digoxin (P-gp substrates): Simultaneous use of makrolidny antibiotics, including azithromycin, with P-glycoprotein substrates, such as digoxin leads to increase in serumal levels of substrates of a P-glycoprotein. Therefore at simultaneous use
of azithromycin and substrates of a P-glycoprotein, such as digoxin, it is necessary to remember a possibility of increase in concentration of substrates of a P-glycoprotein in serum.
Zidovudine: At single use of 1000 mg and repeated use of 1200 mg or 600 mg of azithromycin the insignificant influence on plasma pharmacokinetics or removal with urine of a zidovudine or its glyukuronidny metabolites is revealed. However intake of azithromycin increased concentration of a fosforilirovanny zidovudine (clinically active metabolite) in mononukleara of peripheral blood. There is uncertain a clinical importance of these indicators, but perhaps they can be useful to patients.
Azithromycin does not interact with the system of P450 cytochrome of a liver. He does not participate in pharmacokinetic medicinal interaction as erythromycin and other macroleads.
Azithromycin does not induce or inactivates P450 cytochrome by means of a complex cytochrome metabolite.
Ergotamine derivatives: Because of a theoretical possibility of development of an ergotism, simultaneous use of azithromycin with derivatives of an ergot is not recommended.
Pharmacokinetic researches were conducted with azithromycin and the following drugs with known R450-cytochrome mediated metabolizy.
Atorvastatin: Joint introduction of an atorvastatin (10 mg daily) and azithromycin (500 mg daily) did not change concentration of an atorvastatin in blood plasma (on the basis of the analysis of HMG CoA-reductases). Nevertheless, post-marketing cases of a rhabdomyolysis at the patients receiving azithromycin with statines are registered.
Carbamazepine: In a research of pharmacokinetic interaction of azithromycin on healthy volunteers, drug had no considerable impact on carbamazepine level in blood plasma or on its active metabolites.
Cimetidinum: Change of pharmacokinetics of azithromycin was not noted in the pharmacokinetic research studying action of the single dose of Cimetidinum accepted in 2 hours prior to azithromycin on azithromycin pharmacokinetics.
Oral coumarinic anticoagulants: In pharmacokinetic researches of interaction, azithromycin does not change anticoagulating effect of the single dose of 15 mg of warfarin entered to healthy volunteers. During the post-marketing period messages about strengthening of anti-coagulation after joint intake of azithromycin and oral coumarinic anticoagulants are received. Though relationship of cause and effect is not established, it is necessary to consider the frequency of monitoring of a prothrombin time, when prescribing azithromycin the patient receiving oral anticoagulants like coumarin.
Cyclosporine: In a pharmacokinetic research at healthy volunteers who within 3 days orally received 500 mg/day of azithromycin and then once orally of 10 mg/kg of cyclosporine, Cmax and AUC0-5 of cyclosporine were much raised. Therefore, it is necessary to show care before considering simultaneous administration of these drugs. If joint administration of these drugs is necessary, it is necessary to control levels of cyclosporine and as appropriate to correct a dose.
Efavirents: Joint reception of a single dose of azithromycin of 600 mg and 400 mg of an efavirenz a day within 7 days does not lead to clinically significant pharmacokinetic interactions.
Flukonazol: Joint reception of a single dose of 1200 mg of azithromycin does not change pharmacokinetics of a single dose of 800 mg of a flukonazol. The general influence and elimination half-life of azithromycin did not change at joint introduction with flukonazoly, however, clinically insignificant decrease in Cmax (18%) of azithromycin was observed.
Indinavir: Joint reception of a single dose of 1200 mg of azithromycin did not make significant impact on pharmacokinetics of the indinavir entered in a dosage of 800 mg three times a day within 5 days.
Methylprednisolonum: In a research of pharmacokinetic interaction at healthy volunteers azithromycin did not show considerable influence on Methylprednisolonum pharmacokinetics.
Midazolam: At healthy volunteers, joint introduction with azithromycin of 500 mg/days within 3 days does not cause clinically significant changes in pharmacokinetics and a pharmacodynamics of a single dose of 15 mg of midazolam.
Nelfinavir: Joint administration of azithromycin (1200 mg) and nelfinaviry in an equilibrium state (750 mg three times a day) led to increase in concentration of azithromycin. Clinically significant side effects were not observed and dose adjustment is not required.
Rifabutin: Simultaneous use of azithromycin and a rifabutin did not affect concentration of these drugs in blood plasma.
The neutropenia was revealed at simultaneous use of azithromycin and a rifabutin. Though the neutropenia was connected with use of a rifabutin, the causal relationship was not established with a concomitant use of azithromycin.
Sildenafil: At normal healthy male volunteers, the evidence of influence of azithromycin (500 mg daily within 3 days) on AUC and Cmax of a sildenafil or its main circulating metabolite is not obtained.
Terfenadin: In pharmacokinetic researches it was not reported about interaction between azithromycin and terfenadiny. In certain cases it is not possible to exclude interaction probability completely. Nevertheless, the specific evidence that such interaction took place was not obtained.
Theophylline: The evidence of clinically significant pharmacokinetic interaction between azithromycin and theophylline at their simultaneous use by healthy volunteers is not obtained.
To triazoles: 14 healthy volunteers, joint administration of azithromycin have 500 mg for 1 day and 250 mg for 2 day from 0.125 mg of a triazolam for the 2nd day had no significant effect on any of pharmacokinetic variables for a triazolam in comparison with joint introduction
of a triazolam and placebo.
Trimethoprimum/sulfamethoxazole: Joint administration of DS Trimethoprimum / sulfamethoxazole (160 mg / 800 mg) within 7 days with azithromycin of 1200 mg for the 7th day had no significant effect on the maximum concentration, the general influence or removal of Trimethoprimum or
sulfamethoxazole. Concentration of azithromycin in serum resembled that, observed in other researches.

Special instructions
As well as in a case with erythromycin and other macroleads, it was reported about rare serious allergic reactions, including a Quincke’s edema and anaphylaxis (in rare instances from the death).
Some of these reactions to azithromycin lead to development of recurrent symptoms and demand longer period of observation and treatment. The liver is the main body for azithromycin removal therefore patients should appoint azithromycin with care with the profound disease of a liver. Cases of the lightning hepatitis which is potentially leading to a life-threatening liver failure
At some patients, perhaps were reported there were existing diseases
of a liver or they accepted other hepatotoxic medicines.
In case of signs and symptoms of dysfunction of a liver, such as quickly developing asthenia connected with jaundice, dark urine, tendency to bleedings or hepatic encephalopathy to immediately carry out functional trials livers/analyses. At development of dysfunction of a liver to stop intake of azithromycin.
At the patients receiving ergotamine derivatives, emergence of an ergotism is provoked by a concomitant use of some makrolidny antibiotics. There are no data on a possibility of interaction between an ergot and azithromycin. Nevertheless, because of a theoretical possibility of development of an ergotism, azithromycin and derivatives of an ergot are accepted separately.
As well as at reception of any antibiotics, the observation of signs of superinfection caused by resistant microorganisms including mushrooms is recommended.
The diarrhea caused by Clostridium difficile was reported in all cases of use of antibacterial agents, including azithromycin, and can vary on severity from slight diarrhea to fatal colitis. Treatment by antibacterial agents changes normal flora of intestines that conducts to the overgrowth
of C. difficile. C. difficile produces A and B toxins which contribute to the development of CDAD. The strain producing C. difficile hyper toxin results in the increased incidence and mortality as these infections can be resistant to antimicrobic therapy and can demand performing colectomy. CDAD has to be considered at all patients who complain of diarrhea after use of antibiotics. The careful anamnesis is necessary as CDAD can develop in two months after introduction of antibacterial agents.
At patients with a heavy renal failure (SKF & lt, 10 ml/min.) observed 33% increase in system influence of azithromycin.
The prolonged warm repolarization and lengthening of an interval of QT leading to risk of developing cardiac arrhythmia and bidirectional tachycardia were noted at treatment with other macroleads, including azithromycin. The following states increase risk of developing
ventricular arrhythmias (including bidirectional tachycardia) which can lead to cardiac arrest therefore azithromycin should be applied with care at patients with the current proaritmogenny states (especially women and elderly patients), for example:
• with the congenital or documentary confirmed lengthening of an interval of QT
• which undergo now treatment with other active agents known as QT extending an interval, for example antiarrhytmic means of the class IA (quinidine and procaineamide) and class III (dofetilid, Amiodaronum and sotalol), tsizaprid and terfenadin, antipsychotic means, such as Pimozidum, antidepressants, such as to tsitalopra, and ftorkhinolona, such as moxifloxacin and levofloxacin
• with disturbance of electrolytic balance, especially in cases of a hypopotassemia and a hypomagnesiemia bradycardia, cardiac arrhythmia or heavy heart
failure.
Aggravation of symptoms of a myasthenia and the new beginning of a syndrome of a myasthenia were registered at the patients receiving azithromycin.
Penicillin, as a rule, is choice drug at treatment of laryngitis/tonsillitis, the caused Streptococcus pyogenes and is used as prevention in sharp rheumatic fever.
Azithromycin, as a rule, is effective against streptococcal pharyngitis, but there is no information, concerning its efficiency for prevention of acute rheumatic fever.
Safety and efficiency of the Mycobacterium Avium complex for prevention or treatment at children are not established.
For children up to 6 years, Sumamed or Sumamed forte in the form of oral suspension is recommended to appoint.
Duration of use of drug should not exceed the terms specified in the instruction.

There is no feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms of Data on Sumamed’s influence on ability to run the vehicle or potentially dangerous mechanisms.

Overdose
Symptoms: side effect strengthening
Treatment: symptomatic

the Form of release and packing
On 6 tablets place in planimetric, strip packagings from aluminum PVC/foil.
On 1 packing together with the instruction for use in the state and Russian languages place in a pack from cardboard.

To develop

Additional information