Description
Release form
Powder for oral suspension.
Packaging
100 ml high-density polyethylene bottles (1) complete with double-sided measuring spoon and dosing syringe.
Pharmacological action
Bacteriostatic antibiotic of the azalide macrolide group. It has a wide range of antimicrobial effects. The mechanism of action of azithromycin is associated with inhibition of protein synthesis of microbial cells. By binding to the 50S subunit of the ribosome, it inhibits the peptide translocase at the translation stage and inhibits protein synthesis, slowing the growth and reproduction of bacteria. In high concentrations it has a bactericidal effect.
Has activity against a number of gram-positive, gram-negative, anaerobes, intracellular and other microorganisms.
Sumamed forte is active against aerobic gram-positive microorganisms: Staphylococcus aureus (methicillin-sensitive strains), Streptococcus pneumoniae (methicillin-sensitive strains), Streptococcus pyogenes aerobic gram-negative bacteria: Haemophilus influenzae, Haemophilus parainfluenzae, Legionella pneumophila, Moraxella catarrhalis, Pasteurella multocida, Nefferia gonorrrhoeae perfermaerobesaerobesaerobesaerobesaerobesaerobesaerobesa other microorganisms: Chlamydia trachomatis, Chlamydia pneumoniae, Chlamydia psittaci, Mycoplasma pneumoniae, Mycoplasma hominis, Borrelia burgdorferi.
Microorganisms capable of developing resistance to azithromycin: gram-positive aerobes – Streptococcus pneumoniae (penicillin-resistant strains and strains with moderate sensitivity to penicillin).
Microorganisms with natural resistance: gram-positive aerobes – Enterococcus faecalis, Staphylococcus aureus. (methicillin-resistant strains), Staphylococcus epidermidis (methicillin-resistant strains) anaerobes – Bacteroides fragilis.
Cases of cross-resistance between Streptococcus pneumoniae, Streptococcus pyogenes (beta-hemolytic streptococcus of group A), Enterococcus faecalis and Staphylococcus aureus, including Staphylococcus aureus (methicillin-resistant macrilomycinum, other erythromycinum, other erythromycinum, are described.
Indications
Infectious and inflammatory diseases caused by drug-sensitive microorganisms:
– infections of the upper respiratory tract and ear, incl. pharyngitis, tonsillitis, sinusitis, otitis media
– infections of the lower respiratory tract, including acute bronchitis, exacerbation of chronic bronchitis, community-acquired pneumonia
– infections of the skin and soft tissues, including erysipelas, impetigo, secondary infected dermatoses
– Lyme disease (the initial stage of borreliosis) – erythema migrans (erythema migrans).
Contraindications
– severe liver dysfunction (no data on efficacy and safety)
– renal dysfunction (QC <40 ml / min) (no data on efficacy and safety)
– children under 6 months
– lactation (breastfeeding)
– sucrose / isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption
– increased sensitivity to the components of the drug
– increased sensitivity to other macrolide antibiotics.
With caution, the drug should be prescribed for moderate impaired liver function, impaired renal function (CC> 40 ml / min), patients with prolonged QT interval, receiving therapy with antiarrhythmic drugs of classes IA and III, cisapride, with hypokalemia or hypomagnesemia, clinically significant bradycardia, arrhythmias, or severe heart failure simultaneously with terfenadine, warfarin, digoxin in patients with diabetes mellitus.
Use during pregnancy and lactation
During pregnancy, the use of the drug is possible only if if the potential benefit of therapy to the mother outweighs the potential risk to the fetus.
If necessary, use the drug during lactation, breastfeeding should be suspended.
Special instructions
If you miss one dose of the drug, you should take the missed dose as soon as possible, and subsequent ones with interruptions of 24 hours.
Sumamed ® forte should be used with caution in patients with impaired liver function, due to the possibility of developing fulminant hepatitis and severe liver failure. In the presence of symptoms of impaired liver function, such as rapidly growing asthenia, jaundice, dark urine, a tendency to bleeding, hepatic encephalopathy, Sumamed ® forte therapy should be discontinued and a study of the functional state of the liver should be carried out.
For moderate renal impairment (CC> 40 ml / min), Sumamed ® Forte should be treated with caution under the control of renal function.
In the terminal stage of renal failure (CC
It must be remembered that for the prevention of pharyngitis / tonsillitis caused by Streptococcus pyogenes, and for the prevention of acute rheumatic fever, the drug of choice is usually penicillin.
As with the use of other antibacterial drugs, patients treated with Sumamed ® forte should be examined regularly for unresponsive microorganisms and signs of superinfection, including fungal.
Sumamed ® forte should not be used in longer courses than indicated in the instructions, as The pharmacokinetic properties of azithromycin make it possible to recommend a short and convenient dosage regimen.
There is no evidence of a possible interaction between azithromycin and derivatives of ergotamine and dihydroergotamine, but due to the development of ergotism while using macrolides with derivatives of ergotamine and dihydroergotamine, this combination is contraindicated.
With prolonged use of Sumamed ® forte, pseudomembranous colitis caused by Clostridium difficile may develop, both in the form of mild diarrhea and severe colitis. With the development of diarrhea while taking azithromycin, and also 2 months after the end of therapy, pseudomembranous colitis caused by Clostridium difficile should be excluded.
Syndrome of delayed ventricular repolarization – QT interval elongation syndrome – increases the risk of arrhythmias, including arrhythmias such as pirouette against the background of macrolides, as well as the drug Sumamed ® forte. Caution is required when using azithromycin in patients with a prolonged QT interval receiving antiarrhythmic therapy of classes IA, III, cisapride, with hypokalemia or hypomagnesemia, clinically significant bradycardia, arrhythmia, or severe heart failure.
The use of the drug Sumamed ® forte can provoke the development of myasthenic syndrome or cause an exacerbation of myasthenia gravis.
When applying Sumamed ® Forte in patients with diabetes mellitus, as well as following a low-calorie diet, it must be taken into account that the suspension contains sucrose (0.32 XE / 5 ml).
Influence on the ability to drive vehicles and control mechanisms
When developing undesirable effects on the part of the nervous system and organ of vision, patients should be careful when performing actions requiring increased concentration of attention and speed of psychomotor reactions.
Composition
For 1 g of powder: azithromycin dihydrate 50.094 mg, which corresponds to the content of azithromycin 47.79 mg.
Excipients: sucrose – 897.206 mg, sodium phosphate – 20 mg, hyprolose – 1.6 mg, xanthan gum – 1.6 mg, cherry flavor – 4.5 mg, banana flavor – 7.5 mg, vanilla flavor – 10.5 mg, colloidal silicon dioxide – 7 mg .
Dosage and administration
The drug is administered orally 1 time / day, 1 hour before or 2 hours after eating. After taking Sumamed ® forte, the child must be invited to drink a few sips of water so that he can swallow the rest of the suspension.
Before each use of the drug, the contents of the vial are thoroughly shaken until a homogeneous suspension is obtained, if the required volume of the suspension has not been taken from the vial within 20 minutes after shaking, the suspension should be shaken again, the required volume taken and given to the child.
The required dose is measured using a dosing syringe with a division rate of 1 ml and a nominal suspension capacity of 5 ml (200 mg of azithromycin) or a measuring spoon with a nominal suspension capacity of 2.5 ml (100 mg of azithromycin) or 5 ml (200 mg of azithromycin) embedded in cardboard packaging with a bottle.
After use, the syringe (having previously disassembled it) and a measuring spoon are washed with running water, dried and stored in a dry place until the next dose of Sumamed ® forte.
In infectious and inflammatory diseases of the upper and lower respiratory tract, skin and soft tissues, the drug is prescribed at a rate of 10 mg / kg body weight 1 time / day for 3 days, the course dose is 30 mg / kg.
For pharyngitis / tonsillitis caused by Streptococcus pyogenes, Sumamed ® Forte is used at a dose of 20 mg / kg / day for 3 days (course dose of 60 mg / kg). The maximum daily dose is 500 mg.
Children with a body weight of up to 10 kg should be prescribed Sumamed ® in powder form for the preparation of an oral suspension with a concentration of 100 mg / 5 ml.
In Lyme disease (the initial stage of borreliosis) – erythema migrans (erythema migrans), the drug is prescribed on the 1st day at a dose of 20 mg / kg / day, then from 2 to 5 days at a dose of 10 mg / kg / day (course dose – 60 mg / kg).
Dose adjustment is not required in patients with impaired renal function (CC> 40 ml / min).
Dose adjustment is not required in patients with moderate hepatic impairment.
Rules for the preparation and storage of suspension
To the contents of the bottle intended for the preparation of 37.5 ml of suspension (nominal volume), using a syringe for dosing, add 20 ml of water. Shake until a homogeneous suspension is obtained. The volume of the resulting suspension will be about 42.5 ml, which exceeds the nominal volume by approximately 5 ml. This is intended to compensate for the inevitable loss of suspension during dosing. The prepared suspension can be stored at a temperature not exceeding 25 ° C for no more than 10 days.
Side effects
Determination of the frequency of adverse reactions (according to WHO recommendations): very often (? 10%), often (? 1% –
Infectious diseases: infrequently – candidiasis, including the mucous membrane of the oral cavity and genitals very rarely – pseudomembranous colitis.
From the side of metabolism: often anorexia.
Allergic reactions: often – itching, skin rash infrequently – hypersensitivity reaction, photosensitivity reaction, urticaria, Stevens-Johnson syndrome, angioedema very rarely – anaphylactic reactivity erythema multiforme, toxic epidermal necrolysis.
From the hemopoietic system: often – eosinophilia, lymphopenia infrequently – leukopenia, neutropenia very rarely – thrombocytopenia, hemolytic anemia.
From the nervous system: often – headache, dizziness, paresthesia, violation of taste sensations infrequently – hypesthesia, drowsiness, insomnia very rarely – anxiety, aggression, fainting, convulsions, psychomotor hyperactivity, loss of smell (or anosmia) and taste sensations, myasthenia gravis , anxiety.
From the side of the organ of vision: often – a violation of the clarity of visual perception.
On the part of the hearing organ and labyrinth disorders: often – deafness, infrequently – tinnitus rarely – vertigo.
From the cardiovascular system: infrequently – palpitations are very rare – decreased blood pressure, increased QT interval, arrhythmia type pirouette, ventricular tachycardia.
From the digestive system: very often – nausea, flatulence, abdominal pain, diarrhea often – dyspepsia, vomiting infrequently – constipation, gastritis very rarely – discoloration of the tongue, pancreatitis.
From the liver and biliary tract: infrequently – increased activity of hepatic transaminases, increased bilirubin concentration, hepatitis rarely – impaired liver function very rarely – cholestatic jaundice, liver failure (in rare cases with fatal outcome mainly due to severe impairment of liver function) liver, fulminant hepatitis.
From the musculoskeletal system: often – arthralgia.
From the urinary system: infrequently – an increase in the concentration of urea and creatinine in blood plasma
is very rare – interstitial nephritis, acute renal failure.
Other: often – weakness infrequently – chest pain, peripheral edema, asthenia, malaise, changes in potassium concentration.
Drug interaction
Antacids do not affect the bioavailability of azithromycin, but reduce Cmax in the blood by 30%, so Sumamed ® forte should be taken. at least 1 hour before or 2 hours after taking these drugs and food.
With the simultaneous use of azithromycin does not affect the concentration in the blood of carbamazepine, cimetidine, didanosine, efavirenz, fluconazole, indinavir, midazolam, theophylline, triazolam, trimethoprim / sulfamethoxazole, cetirizine, sildenafiline, ritorvaphenisine, ritorvabinisin, atorvaphenolitin, ritorvabinisin, atorvaphenolitin, atorvaphenolitin.
If concomitant use with cyclosporine is necessary, it is recommended to control the concentration of cyclosporin in the blood.
With the simultaneous use of digoxin and azithromycin, it is necessary to control the concentration of digoxin in the blood, because many macrolides increase digoxin absorption in the intestine.
If necessary, simultaneous use with anticoagulants of indirect action (coumarin-type anticoagulants, including warfarin) careful monitoring of prothrombin time is recommended.
The simultaneous use of terfenadine and macrolide antibiotics has been shown to cause arrhythmia and lengthen the QT interval. Based on this, the development of such complications cannot be ruled out with the simultaneous use of terfenadine and azithromycin.
With simultaneous use with nelfinavir, an increase in the concentration of azithromycin in blood plasma is possible, not accompanied by a significant increase in adverse reactions and does not require dose adjustment of the drugs.
Consideration should be given to the possibility of inhibiting the CYP3A4 isoenzyme with azithromycin while being used with cyclosporine, terfenadine, ergot alkaloids, cisapride, pimozide, quinidine, astemizole, and other drugs that metabolize with this isoenzyme.
With simultaneous use with zidovudine, azithromycin does not affect the pharmacokinetic parameters of zidovudine in the blood plasma or the excretion by the kidneys of its and its metabolite glucuronide. Nevertheless, the concentration of the active metabolite, phosphorylated zidovudine, in the mononuclear cells of peripheral vessels increases. The clinical significance of this fact is not clear.
With the simultaneous use of macrolides with derivatives of ergotamine and dihydroergotamine, their toxic effects may occur.
Overdose
Symptoms (similar to side effects that occur when taking the drug at recommended doses): severe nausea, temporary hearing loss, vomiting, diarrhea.
Treatment: activated carbon intake, symptomatic therapy, control of vital functions.
Storage Conditions
The product should be stored out of reach of children at a temperature not exceeding 25 ° C.
Shelf life
2 years.
Deystvuyushtee substance
Azithromycin
Dosage Form
oral suspension
Pliva Hrvatska d.o., Croatia
