Instructions Sumamed forte powder for oral suspension with strawberry flavor 1200 mg bottle 30 ml
Composition
active substance: azithromycin;
1 dose (5 ml) of suspension contains 200 mg of azithromycin in the form of azithromycin dihydrate;
auxiliary substances: sucrose, sodium phosphate, hydroxypropyl cellulose, xanthan gum, colloidal anhydrous silicon dioxide,
flavor(s) and/or dye:
banana flavoring, cherry flavoring, vanilla flavoring
or
titanium dioxide (E 171), banana flavoring, vanilla flavoring,
or
titanium dioxide (E 171), strawberry flavoring,
or
titanium dioxide (E 171), raspberry flavoring.
Medicinal form
Powder for oral suspension.
Main physical and chemical properties: white or yellowish-white powder with a characteristic smell of cherry and banana or banana, or strawberry, or raspberry.
The reconstituted suspension is a homogeneous suspension of yellowish-white color with a characteristic smell of cherry and banana or banana, or strawberry, or raspberry.
Pharmacotherapeutic group
Antibacterial agents for systemic use. Macrolides, lincosamides and streptogramins. Azithromycin. ATX code J01F A10.
Pharmacological properties
Pharmacodynamics
Azithromycin is a macrolide antibiotic that belongs to the group of azalides. The molecule is formed as a result of the introduction of a nitrogen atom into the lactone ring of erythromycin A. The mechanism of action of azithromycin is inhibition of bacterial protein synthesis due to binding to the 50S ribosomal subunit and inhibition of peptide translocation.
Mechanism of resistance.
Complete cross-resistance exists in Streptococcus pneumoniae, group A beta-hemolytic streptococcus, Enterococcus faecalis, and Staphylococcus aureus, including methicillin-resistant Staphylococcus aureus (MRSA), to erythromycin, azithromycin, other macrolides, and lincosamides.
The prevalence of acquired resistance for selected species may vary depending on location and time, so local information about resistance is needed, especially when treating severe infections. If necessary, you can seek qualified advice if the local prevalence of resistance is such that the effectiveness of the drug for the treatment of at least some types of infections is doubtful.
Spectrum of antimicrobial action of azithromycin
| Usually sensitive species |
| Aerobic gram-positive bacteria |
| Methicillin-sensitive Staphylococcus aureus |
| Streptococcus pneumoniae is penicillin-sensitive |
| Streptococcus pyogenes |
| Aerobic gram-negative bacteria |
Haemophilus influenzae Haemophilus parainfluenzae |
| Legionella pneumophila |
| Moraxella catarrhalis |
| Pasteurella multocida |
| Anaerobic bacteria |
| Clostridium perfringens |
| Fusobacterium spp. |
| Prevotella spp. |
| Porphyriomonas spp. |
| Other microorganisms |
Chlamydia trachomatis Chlamydia pneumoniae Mycoplasma pneumoniae |
| Species for which acquired resistance may be a problem |
| Aerobic gram-positive bacteria |
| Streptococcus pneumoniae with intermediate sensitivity to penicillin and penicillin-resistant |
| Innately resistant organisms |
| Aerobic gram-positive bacteria |
| Enterococcus faecalis |
| Staphylococci MRSA, MRSE* |
| Anaerobic bacteria |
| Group of bacteroides Bacteroides fragilis |
*Methicillin-resistant Staphylococcus aureus has a very high prevalence of acquired resistance to macrolides and was listed here due to rare sensitivity to azithromycin.
Pharmacokinetics
Bioavailability after oral administration is approximately 37%. The maximum concentration in blood serum is reached 2-3 hours after taking the drug.
When taken internally, azithromycin is distributed throughout the body. In pharmacokinetic studies, it was shown that the concentration of azithromycin in tissues is significantly higher (by 50 times) than in blood plasma, which indicates a strong binding of the drug to tissues.
Binding to blood serum proteins varies depending on plasma concentrations and ranges from 12% at 0.5 μg/ml to 52% at 0.05 μg/ml in blood serum. The imaginary volume of distribution in the equilibrium state (VVss) was 31.1 l/kg.
The final plasma half-life completely reflects the half-life from tissues within 2-4 days.
Approximately 12% of an intravenous dose of azithromycin is excreted unchanged in the urine during the next three days. Particularly high concentrations of unchanged azithromycin were found in human bile. Ten metabolites were also found in the bile, which were formed as a result of N - and O-demethylation, hydroxylation of desosamine and aglycon rings, and cleavage of the cladinose conjugate. A comparison of the results of liquid chromatography and microbiological analyzes showed that the metabolites of azithromycin are not microbiologically active.
Indications for use
infections of ENT organs (bacterial pharyngitis/tonsillitis, sinusitis, otitis media);
respiratory tract infections (bacterial bronchitis, nosocomial pneumonia);
skin and soft tissue infections: erythema migrans (initial stage of Lyme disease), erysipelas, impetigo, secondary pyodermatoses.
Contraindications
Increased sensitivity to azithromycin, erythromycin, to any macrolide or ketolide antibiotic, as well as to any other component of the drug.
Interaction with other medicinal products and other types of interactions
When studying the effect of simultaneous use of antacids on the pharmacokinetics of azithromycin, no changes in bioavailability were observed, although the plasma peak concentration of azithromycin decreased by approximately 25%. Azithromycin and antacids should not be taken at the same time.
In healthy volunteers, no pharmacokinetic interaction or significant changes in the QT interval were observed during the simultaneous use of azithromycin for 5 days with cetirizine 20 mg in the steady state.
With the simultaneous use of daily doses of 1200 mg of azithromycin with 400 mg of didanosine per day in six HIV-positive volunteers, no effect on the pharmacokinetics of didanosine in the steady state compared to placebo was revealed.
It has been reported that concomitant use of macrolide antibiotics, including azithromycin and substrates of P-glycoprotein, such as digoxin and colchicine, leads to an increase in the level of the substrate of P-glycoprotein in blood serum. Consequently, with the simultaneous use of azithromycin and a substrate of P-glycoprotein, such as digoxin, it is necessary to take into account the possibility of an increase in the concentration of the substrate in the blood serum.
Single doses of 1000 mg and multiple doses of 1200 mg or 600 mg of azithromycin had an insignificant effect on plasma pharmacokinetics or urinary excretion of zidovudine or its glucuronide metabolites. However, taking azithromycin increased the concentration of phosphorylated zidovudine, a clinically active metabolite, in mononuclear cells in the peripheral circulation. The clinical significance of these data is unclear, but may be useful for patients.
Azithromycin has no significant interaction with the hepatic cytochrome P450 system. It is believed that the drug does not have a pharmacokinetic drug interaction characteristic of erythromycin and other macrolides. Azithromycin does not cause induction or inactivation of hepatic cytochrome P450 through the cytochrome-metabolite complex.
Horns considering the theoretical possibility of ergotism, simultaneous administration of azithromycin with ergot derivatives is not recommended.
Pharmacokinetic studies of the use of azithromycin and the following drugs, the metabolism of which to a large extent occurs with the participation of cytochrome P450, were conducted.
Simultaneous use of atorvastatin (10 mg per day) and azithromycin (500 mg per day) did not cause changes in the concentrations of atorvastatin in blood plasma (based on HMG CoA-reductase inhibition analysis). However, in the post-marketing period, cases of rhabdomyolysis were reported in patients who used azithromycin with statins.
In the study of pharmacokinetic interaction in healthy volunteers, azithromycin did not have a significant effect on plasma levels of carbamazepine or its active metabolites.
In the pharmacokinetic study of the effect of a single dose of cimetidine taken 2 hours before taking azithromycin on the pharmacokinetics of azithromycin, no changes in the pharmacokinetics of azithromycin were observed.
Oral anticoagulants of the coumarin type. In a pharmacokinetic interaction study, azithromycin did not alter the anticoagulant effect of a single dose of 15 mg of warfarin administered to healthy volunteers. In the post-marketing period, there were reports of potentiation of the anticoagulant effect after the simultaneous use of azithromycin and oral anticoagulants of the coumarin type. Although a causal relationship has not been established, the need for frequent monitoring of prothrombin time should be considered when prescribing azithromycin to patients receiving oral anticoagulants of the coumarin type.
In a pharmacokinetic study with the participation of healthy volunteers who received an oral dose of azithromycin 500 mg/day for 3 days, and then a single oral dose of cyclosporine 10 mg/kg, a significant increase in Cmax and AUC0-5 of cyclosporine was demonstrated. Therefore, caution should be exercised when using these drugs simultaneously. If simultaneous use of these drugs is necessary, cyclosporine levels should be monitored and the dose adjusted accordingly.
Efavirenz The simultaneous use of a single dose of 600 mg of azithromycin and 400 mg of efavirenz daily for 7 days did not cause any clinically significant pharmacokinetic interaction.
Indinavir. simultaneous use of a single dose of 1200 mg of azithromycin does not have a statistically significant effect on the pharmacokinetics of indinavir, which is taken in a dose of 800 mg three times a day for 5 days.
Methylprednisolone. In the study of pharmacokinetic interaction in healthy volunteers, azithromycin did not significantly affect the pharmacokinetics of methylprednisolone.
Midazolam. In healthy volunteers, the simultaneous use of azithromycin 500 mg per day for 3 days did not cause clinically significant changes in the pharmacokinetics and pharmacodynamics of midazolam, which was administered as a single dose of 15 mg.
Nelfinavir. simultaneous use of azithromycin (1200 mg) and nelfinavir in equilibrium concentrations (750 mg three times a day) causes an increase in the concentration of azithromycin. Clinically significant side effects were not observed, so there is no need to adjust the dose.
Simultaneous use of azithromycin and rifabutin did not affect the concentration of these drugs in blood serum. Neutropenia was observed in subjects taking azithromycin and rifabutin simultaneously. Although neutropenia was associated with the use of rifabutin, a causal relationship with the simultaneous use of azithromycin was not established.
Sildenafil. In healthy male volunteers, there was no evidence of an effect of azithromycin (500 mg per day for 3 days) on the value of AUC and Cmax of sildenafil or its main circulating metabolite.
Pharmacokinetic studies did not report an interaction between azithromycin and terfenadine. In some cases, the possibility of such interaction cannot be completely excluded; however, there is no specific data on the existence of such an interaction.
There are no data on a clinically significant pharmacokinetic interaction with the simultaneous use of azithromycin and theophylline in healthy volunteers.
Triazolam. Simultaneous use of azithromycin 500 mg on the first day and 250 mg on the second day with 0.125 mg of triazolam by healthy volunteers did not significantly affect all pharmacokinetic indicators of triazolam compared to the use of triazolam and placebo.
Concomitant administration of double concentration trimethoprim/sulfamethoxazole (160 mg/800 mg) for 7 days with azithromycin 1200 mg on the seventh day had no significant effect on peak concentrations, total exposure, or urinary excretion of trimethoprim or sulfamethoxazole. The values of azithromycin concentrations in blood serum corresponded to those observed in other studies.
Hydroxychloroquine. Azithromycin should be used with caution in patients receiving medications that prolong the QT interval and may cause cardiac arrhythmia, such as hydroxychloroquine.
Features of use
As with erythromycin and other macrolide antibiotics, isolated serious allergic reactions, including angioneurotic edema and anaphylaxis (in isolated cases with a fatal outcome), dermatological reactions, including acute generalized exanthematous pustule, have been reported. Some of these reactions caused by azithromycin caused recurrent symptoms and required longer monitoring and treatment.
Since the liver is the main route of elimination of azithromycin, it is necessary to carefully prescribe azithromycin to patients with serious liver diseases. Cases of fulminant hepatitis, which causes life-threatening liver failure when taking azithromycin, have been reported. Perhaps some patients had a history of liver disease or used other hepatotoxic drugs.
It is necessary to perform liver function tests/tests in case of development of signs and symptoms of liver dysfunction, for example asthenia, which develops quickly and is accompanied by yellow, dark urine, bleeding tendency or hepatic encephalopathy. In case of detection of impaired liver function, the use of azithromycin should be discontinued.
In patients taking ergot derivatives, the simultaneous use of some macrolide antibiotics contributes to the rapid development of ergotism. There are no data on the possibility of interaction between ergot derivatives and azithromycin. However, due to the theoretical possibility of ergotism, azithromycin should not be prescribed simultaneously with ergot derivatives.
As with other antibiotics, monitoring for signs of superinfection caused by non-susceptible organisms, including fungi, is recommended.
difficile produces toxins A and B, which contribute to the development of CDAD. Strains of C. difficile, hyperproducing toxins, are the reason for the increased level of morbidity and mortality, since these infections can be resistant to antimicrobial therapy and require colectomy. It is necessary to consider the possibility of development of CDAD in all patients with diarrhea caused by the use of antibiotics. It is necessary to carefully take a medical history, since, as reported, CDAD can occur within two months after taking antibacterial drugs.
A 33% increase in systemic exposure to azithromycin was observed in patients with severe renal dysfunction (glomerular filtration rate <10 ml/min).
Prolongation of cardiac repolarization and QT interval, which increased the risk of developing cardiac arrhythmia and ventricular flutter/fibrillation (torsade de pointes), was observed during treatment with other macrolide antibiotics, including azithromycin. Since conditions accompanied by an increased risk of ventricular arrhythmias (including torsade de pointes) can lead to cardiac arrest, azithromycin should be prescribed with caution to patients with existing proarrhythmic conditions (especially women and elderly patients), in particular to patients:
with congenital or registered prolongation of the QT interval;
who are currently being treated with other active substances that are known to prolong the QT interval, for example antiarrhythmic drugs of classes IA (quinidine and procainamide) and III (dofetilide, amiodarone and sotalol), cisapride and terfenadine, antipsychotics such as pimozide; antidepressants such as citalopram and fluoroquinolones such as moxifloxacin and levofloxacin;
with a violation of electrolyte exchange, especially in the case of hypokalemia and hypomagnesemia;
with clinically relevant bradycardia, cardiac arrhythmia or severe heart failure.
Aggravation of symptoms of myasthenia gravis or new development of myasthenic syndrome in patients treated with azithromycin have been reported.
In the treatment of pharyngitis/tonsillitis caused by Streptococcus pyogenes, the drug of choice is usually penicillin, which is also used for prophylaxis in acute rheumatic fever. Azithromycin is generally effective in the treatment of streptococcal infection in the oropharynx, but there are no data demonstrating the effectiveness of azithromycin in the prevention of a rheumatic attack.
The safety and effectiveness of intravenous use of azithromycin for the treatment of infections in children has not been established.
Safety and effectiveness for the prevention or treatment of Mycobacterium Avium Complex in children have not been established.
Azithromycin in the form of powder for oral suspension contains sucrose. Patients who have rare hereditary problems associated with fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase deficiency should not use this medicine.
Azithromycin in the form of powder for oral suspension contains 83.7 mg/dose of sodium phosphate. Caution should be exercised when administering to patients on a sodium-controlled diet.
Use during pregnancy and breastfeeding
Pregnancy
There are no adequate data on the use of azithromycin in pregnant women. In studies of reproductive toxicity in animals, teratogenic harmful effects of azithromycin on the fetus were not noted, however, the drug penetrated the placenta. The safety of azithromycin use during pregnancy has not been confirmed. Therefore, azithromycin is prescribed during pregnancy only if the benefit outweighs the risk.
breastfeeding
It has been reported that azithromycin penetrates into human breast milk, but appropriate and properly controlled clinical studies that would make it possible to characterize the pharmacokinetics of azithromycin excretion into human breast milk have not been conducted.
Fertility
Fertility studies were conducted on rats; the pregnancy rate decreased after the introduction of azithromycin. The relevance of these data to humans is unknown.
The ability to influence the speed of reaction when driving a motor vehicle or other mechanisms
There is no evidence that azithromycin can impair the ability to drive vehicles or operate other mechanisms, but the possibility of side effects such as delirium, hallucinations, dizziness, drowsiness, fainting, convulsions, which may affect the ability to drive vehicles or operate other mechanisms, should be taken into account.
Method of application and dosage
Sumamed® forte, powder for oral suspension, is used once a day at least 1 hour before or 2 hours after a meal.
If you miss 1 dose of the drug, the missed dose should be taken as early as possible, and the next dose should be taken at intervals of 24 hours.
Dose measurement
The package contains a graduated syringe for oral dosing. The volume of the syringe is 5 ml.
Children
For infections of the ENT organs and respiratory tract, skin and soft tissues (except for chronic migratory erythema), the daily dose of azithromycin is 10 mg/kg of body weight, which corresponds to 0.25 ml/kg of body weight of the finished suspension.
Depending on the body weight of the child, such a suspension dosing scheme is recommended
| Body weight (kg) | Daily dose suspension (ml) | Multiplicity reception | Contents azithromycin in a daily dose of suspension |
| 15-24 | 5 | 1 time/day | 200 mg |
| 25-34 | 7.5 | 300 mg | |
| 35-44 | 10 | 400 mg | |
| ≥45 | 12.5 | 500 mg | |
Preparation and use of suspension and suspension
It is necessary to add distilled or boiled and cooled water to the bottle containing the powder.
Press the bottle cap down and turn it counter-clockwise.
Measure the appropriate amount of water (9.5 or 16.5 or 20.0 ml) from a clean container using a dosing syringe and add to the powder bottle:
Vial with powder for oral suspension 200 mg/5 ml of 15 ml: add 9.5 ml of water to the contents of the vial. Shake the contents of the vial thoroughly until a homogeneous suspension is obtained. The volume of the obtained suspension is about 20 ml*.
Bottle with powder for oral suspension 200 mg/5 ml in 30 ml: add 16.5 ml of water to the contents of the bottle. shake the contents of the vial thoroughly until a homogeneous suspension is obtained. The volume of the obtained suspension is about 35 ml*.
Vial with powder for oral suspension 200 mg/5 ml of 37.5 ml: add 20 ml of water to the contents of the vial. Shake the contents of the vial thoroughly until a homogeneous suspension is obtained. The volume of the obtained suspension is about 42.5 ml*.
*After dissolving the powder, the bottle will contain an additional 5 ml of suspension (to compensate for possible losses of the suspension during use).
Bottle volume
(see label)** | The amount of water that must be added to the bottle to obtain a suspension (ml) |
| 15 ml | 9.5 |
| 30 ml | 16.5 |
| 37.5 ml | 20 |
**Information on the volume of the bottle is placed on the box and label of the bottle.
Immerse the syringe in the suspension and, pulling the piston up, measure the required amount of suspension.
If there are air bubbles in the syringe, you should return the drug to the vial and repeat procedure 3.
Position the baby as for feeding.
Put the tip of the syringe in the child's mouth and slowly squeeze out the contents.
Give the child the opportunity to gradually swallow the entire amount.
After taking the drug, give the child a little tea or juice to wash away and swallow the rest of the suspension in the oral cavity.
Disassemble the used syringe, rinse with running water, dry and store in a dry and clean place together with the drug.
After the child has taken the last dose of the drug, the syringe and vial should be disposed of.
With migrans erythema, the duration of treatment is 5 days. It should be taken on the 1st day
20 mg/kg body weight of azithromycin, which corresponds to 0.5 ml/kg of the finished suspension. From the 2nd to the 5th day, take 10 mg/kg of body weight, which corresponds to 0.25 ml/kg of the finished suspension.
The total course dose is 60 mg/kg.
| Days of treatment | 1 | 2 | 3 | 4 | 5 |
| Daily dose (ml/kg) | 0.5 | 0.25 | 0.25 | 0.25 | 0.25 |
It has been shown that azithromycin is effective in the treatment of streptococcal pharyngitis in children in the form of a single dose of 10 mg/kg or 20 mg/kg for 3 days. When comparing these two doses in clinical studies, similar clinical effectiveness was revealed, although bacterial eradication was more significant at a daily dose of 20 mg/kg. However, penicillin is usually the drug of choice for the prevention of pharyngitis caused by Streptococcus pyogenes and rheumatic polyarthritis, which occurs as a secondary disease.
Adults
For infections of the ENT organs and respiratory tract, skin and soft tissues (except for chronic migratory erythema), the total dose of azithromycin is 1500 mg: 500 mg once a day. The duration of treatment is 3 days.
With migrans erythema, the total dose of azithromycin is 3 g: on the 1st day, 1 g should be taken, then 500 mg once a day from the 2nd to the 5th day. The duration of treatment is 5 days.
Elderly patients
There is no need to change the dosage for elderly patients.
Since elderly patients may be at risk of impaired cardiac conduction, it is recommended to be cautious when using azithromycin due to the risk of cardiac arrhythmia and torsade de pointes.
Patients with impaired kidney function
In patients with minor impairment of kidney function (glomerular filtration rate 10-80 ml/min), the same dosage can be used as in patients with normal kidney function. Azithromycin should be prescribed with caution to patients with severe renal impairment (glomerular filtration rate < 10 ml/min).
Patients with impaired liver function
Since azithromycin is metabolized in the liver and excreted with bile, the drug should not be used in patients with severe liver dysfunction. Studies related to the treatment of such patients with the use of azithromycin have not been conducted.
Children
Sumamed® (100 mg/5 ml) is recommended for children weighing less than 15 kg. Sumamed® forte is used for children with a body weight of more than 15 kg.
Overdose
The experience of clinical use of azithromycin indicates that the side effects that develop when taking higher than recommended doses of the drug are similar to those observed when using ordinary therapeutic doses. They can include diarrhea, nausea, vomiting, reversible hearing loss. In case of overdose, if necessary, it is recommended to take activated charcoal and carry out general symptomatic and supportive medical measures.
Adverse reactions
In the following table, in accordance with the class of systems and organs and the frequency of occurrence, adverse reactions determined in clinical studies and in the period of post-marketing surveillance, which were observed when using all dosage forms of azithromycin, are indicated. Adverse reactions recorded during postmarketing surveillance are highlighted in italics. The frequency groups were defined according to the following scale: very often (≥ 1/10); often (≥ 1/100 to < 1/10); infrequent (≥ 1/1000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000); unknown (cannot be determined based on available data). Within each group by frequency, undesirable phenomena are listed in order of decreasing severity.
Adverse reactions possibly or probably related to azithromycin based on data obtained during clinical trials and during the period of post-marketing surveillance
| Class of systems and organs | Adverse reaction | Frequency |
| Infections and invasions | Candidiasis, vaginal infections, pneumonia, fungal infection, bacterial infection, pharyngitis, gastroenteritis, impaired respiratory function, rhinitis, oral candidiasis | Infrequently |
| Pseudomembranous colitis | Unknown | |
| From the blood and lymphatic system | Leukopenia, neutropenia, eosinophilia | Infrequently |
| Thrombocytopenia, hemolytic anemia | Unknown | |
| From the side of the immune system | Angioedema, hypersensitivity reactions | Infrequently |
| Anaphylactic reaction | Unknown | |
| From the side of metabolism | Anorexia | Infrequently |
| From the side of the psyche | Nervousness, insomnia, insomnia | Infrequently |
| Agitation | Rarely. | |
| Aggressiveness, anxiety, delirium, hallucinations | Unknown | |
| From the nervous system | Headache | Often |
| Dizziness, drowsiness, dysgeusia, paresthesia | Infrequently | |
| Fainting, convulsions, hypoesthesia, psychomotor hyperactivity, anosmia, ageusia, parosmia, myasthenia gravis | Unknown | |
| From the side of the organs of vision | Visual impairment | Infrequently |
| From the hearing organs | Hearing disorders, vertigo | Infrequently |
| Hearing impairment, including deafness and/or tinnitus | Unknown | |
| From the heart | Palpitations | Infrequently |
| Ventricular flutter/fibrillation (torsade de pointes), arrhythmia, including ventricular tachycardia, prolongation of the QT interval on the ECG | Unknown | |
| From the side of blood vessels | Tides | Infrequently |
| Arterial hypotension | Unknown | |
| From the respiratory system | Dyspnea, nosebleeds | Infrequently |
| From the digestive tract | Diarrhea | Very often |
| Vomiting, abdominal pain, nausea | Often | |
| Constipation, flatulence, dyspepsia, gastritis, dysphagia, flatulence, dry mouth, belching, mouth ulcers, hypersecretion of saliva | Infrequently | |
| Pancreatitis, tongue color change | Unknown | |
| From the hepatobiliary system | Violation of liver function, cholestatic jaundice | Rarely |
| Liver failure (rarely fatal), fulminant hepatitis, liver necrosis | Unknown | |
| From the side of the skin and subcutaneous tissue | Eruptions, itching, urticaria, dermatitis, dry skin, hyperhidrosis, dry skin | Infrequently |
| Photosensitivity, acute generalized exanthematous pustule | Rarely | |
| Stevens-Johnson syndrome, toxic epidermal necrolysis, polymorphic erythema, drug reaction with eosinophilia and systemic symptoms | Unknown | |
| From the side of the musculoskeletal system | Osteoarthritis, myalgia, back pain, neck pain | Infrequently |
| Arthralgia | Unknown | |
| From the urinary system | Dysuria, pain in the kidneys | Infrequently |
| Acute renal failure, interstitial nephritis | Unknown | |
| From the reproductive system and mammary glands | Uterine bleeding, testicular disorders | Infrequently |
| General disorders and local reactions | Edema, asthenia, malaise, fatigue, facial edema, chest pain, hyperthermia, pain, peripheral edema | Infrequently |
| Decreased amount of lymphocytes, increased amount of eosinophils, decreased blood bicarbonate level, increased level of basophils, increased level of monocytes, increased level of neutrophils | Often |
| Increased level of aspartate aminotransferase, alanine aminotransferase, blood bilirubin, blood urea, blood creatinine; changes in blood potassium indicators, increased levels of alkaline phosphatase, chloride, glucose, platelets; decrease in hematocrit level; increase in the level of bicarbonate, deviation from the norm of the level of sodium | Infrequently | |
| Damage and poisoning | Complications after the procedure | Infrequently |
Information about adverse reactions, possibly related to the prevention and treatment of Mycobacterium Avium Complex, is based on data from clinical studies and observed in the post-marketing period. These adverse reactions differ in type or frequency from those reported with the use of fast-acting dosage forms and long-acting dosage forms.
Adverse reactions, possibly related to the prevention and treatment of Mycobacterium Avium Complex
| Class of systems and organs | Adverse reaction | Frequency | | |
| From the side of metabolism | Anorexia | Often | | |
| From the nervous system | Dizziness, headache, paresthesia, dysgeusia | Often | | |
| Hypoesthesia | Infrequently | | | |
| From the side of the organs of vision | Visual impairment | Often | | |
| From the hearing organs | Deafness | Often | | |
| Impaired hearing, ringing in the ears | Infrequently | | | |
| From the heart | Palpitations | Infrequently | | |
| From the digestive tract | Diarrhea, abdominal pain, nausea, flatulence, gastrointestinal discomfort, frequent loose stools | Very often | | |
| From the hepatobiliary system | Hepatitis | Infrequently | | |
| From the side of the skin and subcutaneous tissue | Rashes, itching | Often | | |
| Stevens-Johnson syndrome, photosensitivity | Infrequently | | | |
| From the side of the musculoskeletal system | Arthralgia | Often | | |
| General disorders and local reactions | Increased fatigue | Often | | |
| Asthenia, malaise | Infrequently | | | |
Expiration date
2 years.
The shelf life of the finished suspension is 5 days (15 ml), 10 days (30 ml, 37.5 ml).
Storage conditions
Store at a temperature not higher than 25 °C in a place inaccessible to children.
Store the prepared suspension at a temperature not higher than 25 °C.
Packaging
1 bottle with powder for oral suspension of 15 ml (600 mg) or 30 ml (1200 mg) or 37.5 ml (1500 mg) together with a syringe for dosing in a box.
Leave category
According to the recipe.
Manufacturer
PLYVA Hrvatska d.o.o.
The location of the manufacturer and the address of the place of implementation of its activity
Prylaz baruna Filipovycha 25, 10000 Zagreb, Croatia.
