Sumamed forte, 200 mg/5 ml banana flavor 16.74g

Indications

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

Active ingredient

Composition

1 g of powder for preparation of suspension for oral administration contains:

the active ingredient azithromycin dihydrate – 50.094 mg1), in terms of azithromycin 47.790 mg; excipients: sucrose 898,206 mg/ 902,706 mg/ 904,206 mg2), sodium phosphate (tri-base anhydrous sodium phosphate) 20,000 mg/20,000 mg/20,000 mg, hyprolose (hydroxypropyl cellulose) 1,600 mg/1,600 mg/1,600 mg, xanthan gum 1,600 mg/1,600 mg/1,600 mg, banana flavoring 12,000 mg/0/0, vanilla flavoring 4,500 mg/0/0, strawberry flavoring 0/12,000 mg/0, raspberry flavoring 0/0/10,500 mg, titanium dioxide 5,000 mg/5,000 mg/5,000 mg, colloidal anhydrous silicon dioxide 7,000 mg/ 7,000 mg/7,000 mg.

1) values are indicated based on the theoretical activity of azithromycin of 95.4%.

2)the amount of sucrose may vary depending on the actual activity of azithromycin.

How to take, the dosage

Ingestion, once a day, 1 hour before or 2 hours after a meal. After taking Sumamed® forte the child should always be offered a few sips of water so that he can swallow the rest of the suspension.

Before each administration of the drug the contents of the bottle should be shaken thoroughly until a homogeneous suspension is obtained. If the desired volume of suspension has not been withdrawn from the bottle within 20 minutes after shaking, the suspension should be shaken again, the desired volume taken away and given to the child.

The required dose is taken using a 1 ml syringe with a nominal capacity of 5 ml (200 mg azithromycin) of suspension or a measuring spoon with a nominal capacity of 2.5 ml (100 mg azithromycin) or 5 ml (200 mg azithromycin) of suspension in the carton box with the bottle.

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

Infections of the upper and lower respiratory tract, ENT organs, skin and soft tissue

At the rate of 10 mg/kg body weight once daily for 3 days (course dose of 30 mg/kg).

For precise dosing of Sumamed® forte according to the child’s body weight, use the table below.

Body weight

Volume of suspension (ml) per 1 treatment

10-14 kg

2.5 ml of suspension (100 mg azithromycin)

5.0 ml of suspension (200 mg azithromycin)

25-34 kg

7.5 ml of suspension (300 mg azithromycin)

35-44 kg

10.0 ml of suspension (400 mg azithromycin)

at least 45 kg

12.5 ml of suspension (500 mg azithromycin)

(corresponds to the dose for adult patients)

In 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 weighing less than 10 kg should take Sumamed ® in the form of powder for oral suspension at a concentration of 100 mg/5 ml.

In Lyme disease (initial stage of borreliosis) – erythema migrans (erythema migrans)

On day 1 at a dose of 20 mg/kg/day, then from day 2 to day 5 at a dose of 10 mg/kg/day (course dose 60 mg/kg).

In patients with impaired renal function:In patients with a GFR of 10-80 ml/min, no dose adjustment is required.

In impaired hepatic function: When used in patients with mild to moderate hepatic impairment, no dose adjustment is required.

Elderly patients:Dose adjustment is not required. In elderly patients, special caution is recommended when using Sumamed® forte due to the possible presence of proarrhythmogenic factors that may increase the risk of cardiac and pirouette arrhythmias.

Suspension preparation and storage method

.To the content of the vial intended for the preparation of 15 ml of suspension (nominal volume), using a syringe for dosing, add 9.5 ml of water. Shake until a homogeneous suspension is obtained. The volume of the resulting suspension will be about 20 ml, which exceeds the nominal volume by about 5 ml. This is to compensate for the unavoidable loss of suspension during dosing the drug. The prepared suspension can be stored at a temperature not exceeding 25 ° C. Shelf life of the prepared suspension is 5 days.

The contents of the bottle intended for preparation of 30 ml of suspension (nominal volume) with a syringe for dosing add 16.5 ml of water. Shake until a homogeneous suspension is obtained. The volume of the resulting suspension will be about 35 ml, which exceeds the nominal volume by about 5 ml. This is to compensate for the unavoidable loss of suspension during dosing the drug. The prepared suspension can be stored at a temperature not exceeding 25 ° C. Shelf life of the prepared suspension is 10 days.

The contents of the bottle intended for preparation of 37.5 ml of suspension (nominal volume) is added with 20 ml of water using a syringe for dosing. 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 about 5 ml. This is to compensate for the unavoidable loss of the suspension when dispensing the drug. The prepared suspension can be stored at a temperature not exceeding 25 °С. Shelf life of the prepared suspension is 10 days.

Interaction

Antacid drugs

The antacid drugs do not affect the bioavailability of azithromycin, but decrease 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 meals.

Cetirizine

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

Didanosine (didezoxynosine)

The concomitant use of azithromycin (1200 mg/day) and didanosine (400 mg/day) in 6 HIV-infected patients showed no change in the pharmacokinetic readings of didanosine compared with 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 results in higher serum P-glycoprotein substrate concentrations. Thus, when concomitant use of azithromycin and digoxin, it is necessary to consider the possibility of increasing the concentration of digoxin in the blood serum.

Zidovudine

The concomitant use of azithromycin (single administration of 1000 mg and multiple administration of 1200 mg or 600 mg) has little effect on pharmacokinetics, including renal excretion of zidovudine or its glucuronide metabolite. However, azithromycin administration caused an increase in the concentration of phosphorylated zidovudine, the clinically active metabolite in peripheral blood mononuclear cells. The clinical significance of this fact is unclear.

Azithromycin interacts weakly with cytochrome P450 isoenzymes. Azithromycin has not been found to be involved in pharmacokinetic interactions similar to erythromycin and other macrolides. Azithromycin is not an inhibitor and inducer of cytochrome P450 isoenzymes.

Sorgonum alkaloids

In view of the theoretical possibility of ergotism, concomitant use of azithromycin with derivatives of ergot alkaloids is not recommended.

Pharmacokinetic studies have been performed on the concomitant use of azithromycin and drugs metabolized by cytochrome P450 isoenzymes.

Atorvastatin

Concomitant use of atorvastatin (10 mg daily) and azithromycin (500 mg daily) did not cause changes in plasma concentrations of atorvastatin (based on HMK-CoA reductase inhibition analysis). However, in the post-registration period there were isolated reports of cases of rhabdomyolysis in patients receiving azithromycin and statins simultaneously.

Carbamazepine

Pharmacokinetic studies with healthy volunteers showed no significant effect on plasma concentrations of carbamazepine and its active metabolite in patients receiving azithromycin concomitantly.

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 found, provided that cimetidine was used 2 hours before azithromycin.

Indirect-acting anticoagulants (coumarin derivatives)

In pharmacokinetic studies, azithromycin did not affect the anticoagulant effect of a single dose of 15 mg warfarin taken by healthy volunteers. Potentiation of anticoagulant effect has been reported after concomitant use of azithromycin and indirect anticoagulants (coumarin derivatives). Despite the fact that causal relationship has not been established, the need for frequent monitoring of prothrombin time when using azithromycin in patients receiving oral anticoagulants of indirect action (coumarin derivatives) should be considered.

Cyclosporine

. In a pharmacokinetic study involving healthy volunteers who took oral azithromycin (500 mg/day once) for 3 days followed by cyclosporine (10 mg/kg/day once), there was a significant increase in maximum plasma concentration (Cmax) and the area under the concentration-time curve (AUC0-5) of cyclosporine. Caution should be exercised when concomitant use of these drugs. If concomitant use of these drugs is necessary, it is necessary to monitor plasma concentrations of cyclosporine and adjust the dose accordingly.

Efavirenz

The concomitant use of azithromycin (600 mg/day once daily) 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 daily) did not alter the pharmacokinetics of fluconazole (800 mg once daily). Total exposure and half-life of azithromycin were not altered by concomitant use of fluconazole, but there was a decrease in Cmax of azithromycin (by 18%), which had no clinical significance.

Indinavir

Concomitant use of azithromycin (1200 mg once) had no statistically significant effect on the pharmacokinetics of indinavir (800 mg three times daily for 5 days).

Methylprednisolone

Asithromycin has no significant effect on the pharmacokinetics of methylprednisolone.

Nelfinavir

The simultaneous use of azithromycin (1200 mg) and nelfinavir (750 mg 3 times daily) causes increased equilibrium serum concentrations of azithromycin. No clinically significant adverse effects have been observed and no dose adjustment of azithromycin is required when used concomitantly with nelfinavir.

Rifabutin

The concomitant use of azithromycin and rifabutin has no effect on the serum concentration of either drug. Neutropenia was sometimes observed when azithromycin and rifabutin were used concomitantly. Although neutropenia has been associated with the use of rifabutin, a causal relationship between the use of a combination of azithromycin and rifabutin and neutropenia has not been established. Sildenafil

There is no evidence of an effect of azithromycin (500 mg/day daily for 3 days) on the AUC and Cmax of sildenafil or its major circulating metabolite when used in healthy volunteers.

Terfenadine

In pharmacokinetic studies there has been no evidence of interaction between azithromycin and terfenadine. There have been isolated cases reported in which the possibility of such an interaction could not be ruled out completely, but there has not been any concrete evidence that such an interaction has occurred.

The concomitant use of terfenadine and macrolides has been found to cause arrhythmias and prolongation of the QT interval.

Theophylline

No interaction between azithromycin and theophylline has been identified.

Triazolam/midazolam

. No significant changes in pharmacokinetic parameters have been observed with concomitant use of azithromycin with triazolam or midazolam at therapeutic doses

Trimethoprim/sulfamTrimethoprim/sulfamethoxazole

The concomitant use of trimethoprim/sulfamethoxazole with azithromycin showed no significant effect on Cmax, total exposure or renal excretion of trimethoprim or sulfamethoxazole. Serum azithromycin concentrations were consistent with those found in other studies.

Special Instructions

When using Sumamed® forte in patients with diabetes mellitus and also on a low-fat diet, it should be taken into account that the suspension contains sucrose (0.32 IU/ 5 ml).

If a dose of Sumamed® forte is missed, the missed dose should be taken as soon as possible and the next ones should be taken 24 hours apart.

Sumamed® forte should be taken at least one hour before or two hours after taking antacids.

Sumamed® Forte should be used with caution in patients with mild to moderate hepatic impairment because of the possibility of fulminant hepatitis and severe hepatic impairment.

In patients with symptoms of hepatic impairment, such as rapidly increasing asthenia, jaundice, darkened urine, bleeding tendency, hepatic encephalopathy, therapy with Sumamed® forte should be discontinued and liver function testing should be performed.

In patients with impaired renal function: In patients with a GFR of 10-80 ml/min, no dose adjustment is required; therapy with Sumamed® forte should be performed with caution under monitoring of renal function.

As with other antibacterials, therapy with Sumamed® forte should regularly screen patients for the presence of non-susceptible microorganisms and signs of superinfections, including fungal infections.

Sumamed® forte should not be used for longer courses than directed, since the pharmacokinetic properties of azithromycin allow a short and simple dosing regimen to be recommended.

There are no data on possible interactions between azithromycin and ergotamine and dihydroergotamine derivatives, but because of the development of ergotism when using macrolides with ergotamine and dihydroergotamine derivatives simultaneously, this combination is not recommended.

Long-term use of Sumamed® forte may cause pseudomembranous colitis caused by Clostridium difficile, both as mild diarrhea and severe colitis. If antibiotic-associated diarrhea develops against the background of Sumamed® forte, as well as 2 months after the end of therapy, clostridial pseudomembranous colitis should be excluded. Do not use drugs that inhibit intestinal peristalsis.

In treatment with macrolides, including azithromycin, prolongation of cardiac repolarization and QT interval have been observed, increasing the risk of cardiac arrhythmias, including pirouette-type arrhythmias, which may lead to cardiac arrest.

We should use Sumamed® forte with caution in patients with proarrhythmogenic factors (especially elderly patients), including congenital or acquired prolongation of the QT interval; in patients taking class IA (quinidine, procainamide), class III (dofetilide, amiodarone and sotalol) antiarrhythmic drugs, cisapride, terfenadine, antipsychotics (pimozide), antidepressants (citalopram), fluoroquinolones (moxifloxacin and levofloxacin), with disorders of fluid and electrolyte balance, especially in case of hypokalemia or hypomagnesemia, clinically significant bradycardia, cardiac arrhythmia or severe heart failure.

The use of Sumamed® forte may provoke the development of myasthenic syndrome or cause exacerbation of myasthenia gravis.

. As in the case of erythromycin and other macrolides, there have been isolated cases of serious allergic reactions, including angioedema and anaphylaxis (rarely fatal), dermatological reactions, including acute generalized exanthematous pustulosis (OGEP), Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, drug rash with eosinophilia and systemic manifestations (DRESS syndrome). See section “Side effects”.

Some of the reactions were recurrent and required longer follow-up and treatment.

If an allergic reaction develops, the drug should be discontinued and appropriate treatment initiated. It should be noted that after withdrawal of symptomatic therapy, symptoms of an allergic reaction may return.

Influence on driving and operating ability

In case of adverse effects of the nervous system and eyesight, caution should be exercised when performing activities requiring increased concentration and rapid psychomotor reactions.

Synopsis

Contraindications

Hypersensitivity to azithromycin, erythromycin, other macrolides or ketolides, or other drug components; severe hepatic impairment (Child-Pugh class C); sucrose/isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption; childhood age

Side effects

The frequency of side effects is classified in accordance with the recommendations of the World Health Organization: very often – at least 10%; often – at least 1%, but less than 10%; infrequent – at least 0.1%, but less than 1%; rare – at least 0.01%, but less than 0.1%; very rare – less than 0.01%; unknown frequency – cannot be estimated based on available data.

Infectious diseases: infrequent – candidiasis, including oral mucosa, vaginal infection, pneumonia, fungal infection, bacterial infection, pharyngitis, gastroenteritis, respiratory diseases, rhinitis; unknown frequency – pseudomembranous colitis.

With the blood and lymphatic system: infrequent – leukopenia, neutropenia, eosinophilia; very rare – thrombocytopenia, hemolytic anemia.

Metabolism and nutrition: infrequent – anorexia.

Allergic reactions: infrequent – angioedema, hypersensitivity reaction; unknown frequency – anaphylactic reaction.

Nervous system disorders: Frequent – headache; infrequent – dizziness, impaired sense of taste, paresthesias, somnolence, insomnia, nervousness; rare – agitation; unknown frequency – hypoesthesia, anxiety, aggression, fainting, seizures, psychomotor hyperactivity, loss of smell, perverse sense of smell, loss of taste, myasthenia, delirium, hallucinations.

Visual organ: infrequent visual impairment.

Hearing organ and labyrinth disorders: infrequent – hearing disorder, vertigo; unknown frequency – hearing disorder, including deafness and/or tinnitus.

Cardiovascular system: infrequent – palpitations, “rushes” of blood to the face; unknown frequency – decreased blood pressure, increased QT interval in the electrocardiogram, arrhythmia type “pirouette”, ventricular tachycardia.

Respiratory system disorders: infrequent – shortness of breath, nasal bleeding.

From the gastrointestinal tract: very often – diarrhea; often – nausea, vomiting, abdominal pain; infrequently – flatulence, dyspepsia, constipation, gastritis, dysphagia, bloating, dry oral mucosa, belching, oral mucosa ulcers, increased salivary gland secretion; very rarely – color change of tongue, pancreatitis.

Hepatic and biliary tract: infrequent – hepatitis; rare – liver dysfunction, cholestatic jaundice; unknown frequency – liver failure (in rare cases – fatal, mostly with severe liver dysfunction); liver necrosis, fulminant hepatitis.

Skin and subcutaneous tissue: infrequent – skin rash, itching, urticaria, dermatitis, dry skin, sweating; rare – photosensitization reaction, acute generalized exanthematous pustulosis (OGEP); unknown frequency – Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, drug rash with eosinophilia and systemic manifestations (DRESS syndrome).

Musculoskeletal system: infrequent osteoarthritis, myalgia, back pain, neck pain; unknown frequency – arthralgia.

Kidney and urinary tract disorders: infrequent dysuria, renal pain; unknown frequency – interstitial nephritis, acute renal failure.

Gender and mammary gland disorders: infrequent – metrorrhagia, impaired testicular function.

Others: infrequent – edema, asthenia, malaise, feeling of fatigue, facial edema, chest pain, fever, peripheral edema.

Laboratory findings: often – decreased lymphocyte count, increased eosinophil count, increased basophil count, increased monocyte count, increased neutrophil count, decreased plasma bicarbonate concentration; infrequent – increased activity of aspartate aminotransferase, alanine aminotransferase, increased concentration of bilirubin in blood plasma, increased concentration of urea in blood plasma, increased concentration of creatinine in blood plasma, changes in plasma potassium, increased plasma alkaline phosphatase activity, increased plasma chloride concentration, increased blood glucose concentration, increased platelet count, decreased hematocrit, increased plasma bicarbonate concentration, change in plasma sodium concentration.

Overdose

Pregnancy use

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