Sumamed forte powder for suspension 200mg/5ml 15ml

Indications

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

- infections of the upper respiratory tract and ear, including 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, incl. erysipelas, impetigo, secondary infected dermatosis;

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

Dosing regimen

The drug is administered orally 1 time / day, 1 hour before or 2 hours after a meal. After taking the drug Sumamed ^® Forte, the child must offer 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 removed from the vial within 20 minutes after agitation, the suspension should be shaken again, selected the required volume and given to the child.

The required dose is measured using a dosing syringe with a graduation rate of 1 ml and a nominal suspension capacity of 5 ml (200 mg azithromycin) or a measuring spoon with a nominal suspension capacity of 2.5 ml (100 mg azithromycin) or 5 ml (200 mg azithromycin) enclosed in cardboard packing together with a bottle.

After use, the syringe (having previously disassembled it) and the measuring spoon are washed with running water, dried and stored in a dry place until the next dose of Sumamed^® forte.

At infectious and inflammatory diseases of the upper and lower respiratory tract, skin and soft tissues the drug is prescribed at the rate of 10 mg / kg of body weight 1 time / day for 3 days, the course dose is 30 mg / kg.

For accurate dosing of the drug Sumamed^® Forte in accordance with the body weight of the child should use the table below.

At pharyngitis / tonsillitis caused by Streptococcus pyogenes, Sumamed^® Forte is used in a dose of 20 mg / kg / day for 3 days (course dose 60 mg / kg). The maximum daily dose is 500 mg.

Children weighing up to 10 kg should be appointed Sumamed^® in powder form for the preparation of oral suspension with a concentration of 100 mg / 5 ml.

At 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 (the course dose is 60 mg / kg).

Patients with impaired renal function (CC> 40 ml / min) dose adjustment is not required.

Patients with moderate liver dysfunction dose adjustment is not required.

Rules for the preparation and storage of suspensions

To the contents of the vial intended to prepare 15 ml of suspension (nominal volume), 9.5 ml of water are added using a dosing syringe. Shaken to obtain a homogeneous suspension. The volume of the suspension obtained will be about 20 ml, which exceeds the nominal volume by approximately 5 ml. This is intended to compensate for the inevitable loss of suspension when dispensing the drug. The prepared suspension can be stored at a temperature not exceeding 25 ° C for no more than 5 days.

To the contents of the vial intended to prepare 30 ml of suspension (nominal volume), Using a syringe for dosing add 16.5 ml of water. Shaken to obtain a homogeneous suspension. The volume of the suspension obtained will be about 35 ml, which exceeds the nominal volume by approximately 5 ml. This is intended to compensate for the inevitable loss of suspension when dispensing the drug. The prepared suspension can be stored at a temperature not exceeding 25 ° C for no more than 10 days.

To the contents of the vial intended for the preparation of 37.5 ml suspension (nominal volume), Using a syringe for dosing, add 20 ml of water. Shaken to obtain a homogeneous suspension. The volume of the suspension obtained 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 when dispensing the drug. The prepared suspension can be stored at a temperature not exceeding 25 ° C for no more than 10 days.

Adverse Effects

Determination of the frequency of adverse reactions (as recommended by WHO): very often (≥10%), often (≥1% - <10%), infrequently (≥0.1% - <1%), rarely (≥0.01% - <0.1%), very rarely, including isolated cases (<0.01%).

Infectious diseases: infrequently - candidiasis, incl. oral mucosa and genitalia; very rarely - pseudomembranous colitis.

Metabolism: often - anorexia.

Allergic reactions: often - pruritus, skin rash; infrequently - hypersensitivity reaction, photosensitivity reaction, urticaria, Stevens-Johnson syndrome, angioedema; very rarely - anaphylactic reaction, 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, disturbance of taste; infrequently - hypoesthesia, drowsiness, insomnia; very rarely - anxiety, aggression, fainting, convulsions, psychomotor hyperactivity, loss of smell (or anosmia) and taste, myasthenia, anxiety.

On the part of the organ of vision: often - a violation of the clarity of visual perception.

On the part of the organ of hearing and labyrinth disorders: often - deafness, infrequently - tinnitus; rarely - vertigo.

Since the cardiovascular system: infrequently - a feeling of heartbeat; very rarely - decrease in blood pressure, an increase in the QT interval, arrhythmia of the "pirouette" type, ventricular tachycardia.

From the digestive system: very often - nausea, flatulence, abdominal pain, diarrhea; often - dyspepsia, vomiting; infrequently - constipation, gastritis; very rarely - a change in the color of the mucous membrane of the tongue, pancreatitis.

Liver and biliary tract: infrequently - increased activity of hepatic transaminases, increased concentration of bilirubin, hepatitis; rarely, liver dysfunction; very rarely - cholestatic jaundice, liver failure (in rare cases with a fatal outcome mainly against the background of severe liver dysfunction); liver necrosis, fulminant hepatitis.

From the musculoskeletal system: often - arthralgia.

From the urinary system: infrequently - an increase in the concentration of urea and creatinine in the blood plasma;
very rarely - interstitial nephritis, acute renal failure.

Other: often - weakness; infrequently - chest pain, peripheral edema, asthenia, malaise, change in potassium concentration.

Contraindications

- severe liver dysfunction (no data on efficacy and safety);

- renal dysfunction (CC <40 ml / min) (no data on efficacy and safety);

- children's age up to 6 months;

- lactation period (breastfeeding);

- deficiency of sucrase / isomaltase, fructose intolerance, glucose-galactose malabsorption;

- hypersensitivity to the drug;

- Hypersensitivity to other macrolide antibiotics.

WITH caution the drug should be prescribed for moderate liver dysfunction, kidney dysfunction (CC> 40 ml / min), patients with lengthening of the QT interval, receiving therapy with antiarrhythmic drugs of classes IA and III, cisapride, with hypokalemia or hypomagnesia, clinically significant bradycardia, arrhythmia or severe heart failure ; simultaneously with terfenadine, Warfarin, Digoxin ; patients with diabetes.

Use during pregnancy and lactation

In pregnancy, the use of the drug is possible only if the potential benefit of therapy for the mother outweighs the possible risk to the fetus.

If necessary, the use of the drug during lactation breastfeeding should be suspended.

Application for violations of the liver

For severe violations of liver function, the drug is contraindicated. WITH caution should be prescribed for mild and moderate violations of the liver.

Application for violations of kidney function

In severe impaired renal function, the drug is contraindicated. WITH caution It should be prescribed for mild and moderate renal dysfunction.

Use in children

Children 6 months and older It is recommended to prescribe the drug in the form of a suspension for oral administration or 125 mg tablets.

special instructions

In case of skipping a single dose of the drug - the missed dose should be taken as early as possible, and the next - with intervals of 24 hours.

Sumamed^® Forte should be used with caution in patients with impaired liver function, due to the possibility of the development of fulminant hepatitis and severe liver failure. If there are symptoms of abnormal liver function, such as rapidly increasing asthenia, jaundice, darkening of the urine, bleeding tendency, hepatic encephalopathy, drug therapy Sumamed^® Forte should stop and conduct a study of the functional state of the liver.

With moderate renal dysfunction (CC> 40 ml / min) drug therapy Sumamed^® Forte should be carried out with caution under the control of the state of renal function.

In end-stage renal disease (CC <10 ml / min), there is an increase in plasma Azithromycin concentration by 33%.

It must be remembered that for the prevention of pharyngitis / tonsillitis caused by Streptococcus pyogenes, as well as for the prevention of acute rheumatic fever, penicillin is usually the drug of choice.

As with the use of other antibacterial drugs, with drug therapy Sumamed^® Forte should regularly examine patients for the presence of refractory microorganisms and signs of the development of superinfections, including fungal.

Drug Sumamed^® Forte should not be used longer courses than indicated in the instructions, because The pharmacokinetic properties of azithromycin allow us to recommend a short and convenient dosage regimen.

There is no evidence of a possible interaction between azithromycin and ergotamine and dihydroergotamine derivatives,but due to the development of ergotism with simultaneous use of macrolides with ergotamine and dihydroergotamine derivatives, this combination is contraindicated.

With long-term use of the drug Sumamed^® Forte may develop pseudomembranous colitis caused by Clostridium difficile, both in the form of mild diarrhea and severe colitis. With the development of diarrhea during the administration of azithromycin, as well as 2 months after the end of therapy, pseudomembranous colitis caused by Clostridium difficile should be excluded.

The syndrome of delayed repolarization of the ventricles - a syndrome of lengthening the QT interval - increases the risk of developing arrhythmias, including arrhythmias such as "pirouette" while taking macrolides, as well as the drug Sumamed^® forte. Caution is needed when using azithromycin in patients with prolonged QT intervals receiving therapy with antiarrhythmic drugs of classes I A, III, cisapride, with hypokalemia or hypomagnesia, clinically significant bradycardia, arrhythmia, or severe heart failure.

Use of the drug Sumamed^® forte can provoke the development of myasthenic syndrome or cause exacerbation of myasthenia.

When applying sumamed^® Forte in patients with diabetes mellitus, as well as when observing a low-calorie diet, it is necessary to take into account that sucrose is included in the suspension (0.32 XE / 5 ml).

Influence on ability to drive motor transport and control mechanisms

With the development of undesirable effects on the part of the nervous system and the organ of vision, patients should take care when performing actions that require high concentration of attention and quickness of psychomotor reactions.

Overdose

Symptoms (similar to side effects that occur when taking the drug in recommended doses): severe nausea, temporary hearing loss, vomiting, diarrhea.

Treatment: reception of Activated carbon, conducting symptomatic therapy, monitoring vital functions.

Drug interaction

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

With simultaneous use of azithromycin does not affect the blood concentration of Carbamazepine, cimetidine, didanosine, efavirenz, Fluconazole, indinavir, midazolam, theophylline, triazolam, trimethoprim / sulfamethoxazole, Cetirizine, Sildenafil, Atorvastatin, rifabutin, methylprednisolone.

If necessary, the simultaneous use of cyclosporine is recommended to control the concentration of cyclosporine in the blood.

With simultaneous use of digoxin and azithromycin, it is necessary to control the concentration of digoxin in the blood, since Many macrolides increase digoxin absorption in the intestine.

If necessary, simultaneous use with indirect anticoagulants (coumarin-type anticoagulants, including warfarin), it is recommended that prothrombin time be carefully monitored.

It was found that the simultaneous use of terfenadine and macrolide-class antibiotics causes arrhythmia and prolongation of the QT interval. Based on this, it is impossible to exclude the development of such complications with simultaneous use of terfenadine and azithromycin.

With the simultaneous use of nelfinavir may increase the concentration of azithromycin in the blood plasma, not accompanied by a significant increase in adverse reactions and not requiring dose adjustment drugs.

The possibility of inhibiting the isoenzyme of CYP3A4 azithromycin with simultaneous use with cyclosporine, terfenadine, ergot alkaloids, cisapride, pimozide, quinidine, astemizole and other drugs whose metabolism occurs with the participation of this isoenzyme should be taken into account.

With simultaneous use with zidovudine, azithromycin does not affect the pharmacokinetic parameters of zidovudine in the blood plasma or the kidney excretion of it and its metabolite glucuronide. However, the concentration of the active metabolite, phosphorylated zidovudine, increases in mononuclear cells of peripheral vessels. The clinical significance of this fact is not clear.

With the simultaneous use of macrolides with ergotamine and dihydroergotamine derivatives, their toxic action is possible.

Terms and conditions of storage

The drug should be stored out of reach of children at a temperature not exceeding 25 ° C.