Indications for Sumamed and contraindications for use
The instructions clarify that the antibiotic is used for infectious and inflammatory diseases provoked by pathogens sensitive to it. The list of infections is presented:
- sinusitis, sinusitis, otitis media, tonsillitis;
- acute and aggravated chronic bronchitis, pneumonia;
- moderate form of anke;
- early stages of Lyme disease;
- pathologies of the genitourinary tract caused by chlamydia.
Sumamed is contraindicated in patients with individual intolerance to the component composition, renal, hepatic dysfunction. The medicine is not prescribed to children under 12 years of age (in 500 mg tablets) or under 3 years of age (in 125 mg tablets). Syrup is prohibited for babies until the first six months of life.
Particular caution is needed when treating patients with myasthenia gravis, mild renal and liver dysfunction, slow heartbeat, and arrhythmic abnormalities. Physician supervision is required during complex therapy with antiarrhythmic drugs.
Sumamed during breastfeeding: how it affects the baby
Sumamed should be used during lactation if absolutely necessary, since this antibiotic is excreted in breast milk.
Breastfed infants should be monitored for gastrointestinal side effects (eg, diarrhea, fungal infections, sensitization). In infants exposed within the first 90 days after birth, the risk of developing hypertrophic pyloric stenosis in children may be 3.5 times higher than in infants who are not exposed. If there are no alternative treatments, breastfeeding should be stopped while using Sumamed.
Taking Sumamed during breastfeeding is indicated only after prior consultation with a doctor.
Sources
- Azithromecin / Drags.com (English)
- Association between prescription of macrolide antibiotics during pregnancy and adverse outcomes in children / PubMed (English)
- Antibiotic use during pregnancy and the risk of spontaneous abortion / PubMed (English)
Adverse reactions
During therapeutic procedures with Sumamed, the occurrence of non-standard effects with symptoms is noted:
- thrombocytopenia, hemolytic anemia;
- candidiasis, pharyngitis, gastroenteritis, rhinitis;
- pneumonia, respiratory diseases;
- attacks of dizziness, cephalalgia, sleep disorders;
- nettle fever, Quincke's edema;
- decreased visual and hearing acuity, vertigo;
- tachycardia, arterial hypotension;
- dyspeptic disorders, flatulence, gastritis;
- dysphagia, shortness of breath, hepatitis;
- liver dysfunction, cholestatic jaundice;
- dermatitis, hyperhidrosis, erythema multiforme;
- myalgia, osteoarthritis, arthralgia, dysuria;
- intertial nephritis, asthenia, febrile conditions.
Patients may experience swelling in the face, kidney pain, chest pain, and nosebleeds.
An overdose of the drug is manifested by nausea, vomiting, diarrhea, and temporary hearing loss. Intoxication requires symptomatic treatment.
Nuances of therapy with Sumamed
The instructions recommend taking medications 60 minutes before meals or 2 hours after them. The dose is taken once a day, without chewing or breaking the integrity of the tablets:
- infections of the ENT organs - 500 mg for 72 hours, a similar dosage is prescribed for damage to the skin and soft tissues;
- migrating erythema - on the first day - 1000 mg, the next 4 days - 500 mg of antibiotic;
- pathologies of the urinary system - a single dose of 1 g of medication;
- acne - 500 mg, therapy lasts three days, then a similar dose - once a week.
In childhood, Sumamed dosages vary:
- infectious pathologies of the skin and respiratory tract – 10 mg per kilogram of body weight, with a duration of therapy of no more than 72 hours;
- tonsillitis, pharyngitis – 20 mg per kilogram of weight, for 3 days;
- Lyme disease - the first day - 20 mg/kg, the next 4 days - 10 mg/kg body weight.
Children's suspension is prescribed for babies over 6 months and under 3 years. For a child weighing up to 15 kg, the syrup is taken with a syringe; for children weighing up to 15 kg, using a measuring spoon. Dosages and course of therapy are similar to the above tablet rates.
Sumamed during pregnancy: benefits and risks for mother and child
Sumamed is contraindicated during pregnancy, as it is an antibiotic, the use of which should be carried out according to the recommendations of the attending physician, and also when the benefit to the mother outweighs the risk to the fetus.
A study of Sumamed in animals did not reveal a teratogenic effect. Taking the drug by a limited number of pregnant women has not shown an increase in the incidence of malformations or other (direct, indirect) harmful effects on the fetus. However, you should not take Sumamed unless clearly necessary. There are currently no studies of Sumamed on pregnant women. However, the main substance of this antibacterial drug is azithromycin from the group of macrolides, the results of which are broader than those of Sumamed.
Antibiotics and the likelihood of miscarriage
Antibiotics are widely used during pregnancy, but evidence of their safety for the fetus remains limited.
In this regard, experts from the University of Montreal assessed the relationship between exposure to antibiotics during pregnancy and the risk of miscarriage or pathologies during pregnancy. This study followed a group of pregnant women from Quebec from 1998 to 2009, excluding elective abortions and pregnancies exposed to toxic drugs. Antibiotic use was defined according to prescriptions filled between the first and last day of pregnancy. The results of the study showed a connection between the increased risk of miscarriages in early pregnancy and the use of macrolides (with the exception of erythromycin) and other groups of antibiotics.
Developmental defects caused by antibiotics
The Institute of Child Health at University College London conducted a study that assessed the association between the use of macrolide antibiotics during pregnancy and serious developmental defects in children (cerebral palsy, epilepsy, attention deficit hyperactivity disorder and the likelihood of autism).
This study involved 104,605 children born from 1990 to 2016 to women who were prescribed macrolide antibiotics. The experiment revealed serious developmental defects in 186 of 8632 children (21.55 per 1000) whose mothers were prescribed macrolides.
The study found that the use of macrolides in the first trimester of pregnancy was associated with an increased risk of any serious malformations, especially those of the cardiovascular system. They also found that throughout pregnancy (regardless of the trimesters), the risk of genital malformations increased. These studies demonstrated that the use of macrolides should be used with caution during pregnancy and, if possible, use antibacterial drugs from other groups, after consulting with a doctor.
Features of interaction
The instructions draw attention to the following nuances when combining Sumamed:
- with anthracidals - the concentration of azithromycin is reduced by 30%;
- substrates of P-glycoprotein – leads to an increase in its concentration in the bloodstream;
- Zidovudine – a slight effect on the metabolism and absorption of its active components is recorded;
- ergot alkaloids – not recommended due to the risk of developing ergotism;
- cyclosporines – regular checking of their blood levels and dose adjustment are required;
- Rifabutin - there is a possibility of developing neutropenia.
Use together with Terfenadine may lead to arrhythmic disorders. Therapy is carried out with extreme caution.
Sumamed® (Sumamed®)
Antacids
Antacids do not affect the bioavailability of azithromycin, but reduce 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 eating.
Cetirizine
Concomitant use of azithromycin with cetirizine (20 mg) for 5 days in healthy volunteers did not lead to pharmacokinetic interaction or a significant change in the QT interval.
Didanosine (dideoxyinosine)
The simultaneous use of azithromycin (1200 mg/day) and didanosine (400 mg/day) in 6 HIV-infected patients did not reveal changes in the pharmacokinetic indications of didanosine compared to the placebo group.
Digoxin (P-glycoprotein substrates)
Concomitant use of macrolide antibiotics, including azithromycin, with P-glycoprotein substrates, such as digoxin, leads to increased concentrations of P-glycoprotein substrate in the blood serum. Thus, with the simultaneous use of azithromycin and digoxin, it is necessary to take into account the possibility of increasing the concentration of digoxin in the blood serum.
Zidovudine
Concomitant use of azithromycin (single dose of 1000 mg and multiple doses of 1200 mg or 600 mg) has a minor effect on the pharmacokinetics, including renal excretion of zidovudine or its glucuronide metabolite. However, the use of azithromycin caused an increase in the concentration of phosphorylated zidovudine, a clinically active metabolite in peripheral blood mononuclear cells. The clinical significance of this fact is unclear.
Azithromycin interacts weakly with isoenzymes of the cytochrome P450 system. Azithromycin has not been shown to participate in pharmacokinetic interactions similar to erythromycin and other macrolides. Azithromycin is not an inhibitor or inducer of cytochrome P450 isoenzymes.
Ergot alkaloids
Given the theoretical possibility of ergotism, the simultaneous use of azithromycin with ergot alkaloid derivatives is not recommended.
Pharmacokinetic studies were conducted on the simultaneous use of azithromycin and drugs whose metabolism occurs with the participation of isoenzymes of the cytochrome P450 system.
Atorvastatin
Concomitant use of atorvastatin (10 mg daily) and azithromycin (500 mg daily) did not cause changes in atorvastatin plasma concentrations (based on an HMC-CoA reductase inhibition assay). However, in the post-marketing period, isolated case reports of rhabdomyolysis have been received in patients receiving concomitant azithromycin and statins.
Carbamazepine
Pharmacokinetic studies involving healthy volunteers did not reveal a significant effect on the plasma concentrations of carbamazepine and its active metabolite in patients receiving concomitant azithromycin.
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 detected when cimetidine was used 2 hours before azithromycin.
Indirect anticoagulants (coumarin derivatives)
In pharmacokinetic studies, azithromycin did not affect the anticoagulant effect of a single 15 mg dose of warfarin administered to healthy volunteers. Potentiation of the anticoagulant effect has been reported after simultaneous use of azithromycin and indirect anticoagulants (coumarin derivatives). Although a causal relationship has not been established, the need for frequent monitoring of prothrombin time should be considered when using azithromycin in patients receiving indirect oral anticoagulants (coumarin derivatives).
Cyclosporine
In a pharmacokinetic study involving healthy volunteers who took azithromycin (500 mg/day once) orally for 3 days and then cyclosporine (10 mg/kg/day once), a significant increase in maximum plasma concentration (Cmax) and area under the concentration-time curve (AUC0-5) of cyclosporine. Caution is advised when using these drugs together. If simultaneous use of these drugs is necessary, it is necessary to monitor the concentration of cyclosporine in the blood plasma and adjust the dose accordingly.
Efavirenz
Concomitant use of azithromycin (600 mg/day once) 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) did not change the pharmacokinetics of fluconazole (800 mg once). The total exposure and half-life of azithromycin did not change with simultaneous use of fluconazole, however, a decrease in Cmax of azithromycin was observed (by 18%), which had no clinical significance.
Indinavir
Concomitant use of azithromycin (1200 mg once) did not cause a statistically significant effect on the pharmacokinetics of indinavir (800 mg three times a day for 5 days).
Methylprednisolone
Azithromycin does not have a significant effect on the pharmacokinetics of methylprednisolone.
Nelfinavir
The simultaneous use of azithromycin (1200 mg) and nelfinavir (750 mg 3 times a day) causes an increase in the equilibrium concentrations of azithromycin in the blood serum. No clinically significant side effects were observed and no dose adjustment of azithromycin was required when used concomitantly with nelfinavir.
Rifabutin
The simultaneous use of azithromycin and rifabutin does not affect the concentration of each drug in the blood serum. Neutropenia has sometimes been observed with simultaneous use of azithromycin and rifabutin. Although neutropenia has been associated with the use of rifabutin, a causal relationship between the use of the combination of azithromycin and rifabutin and neutropenia has not been established.
Sildenafil
When used in healthy volunteers, there was no evidence of the effect of azithromycin (500 mg/day daily for 3 days) on the AUC and Cmax of sildenafil or its main circulating metabolite.
Terfenadine
In pharmacokinetic studies, there was no evidence of interaction between azithromycin and terfenadine. There have been isolated cases reported where the possibility of such an interaction could not be completely excluded, but there was no concrete evidence that such an interaction occurred.
It has been found that the simultaneous use of terfenadine and macrolides can cause arrhythmia and prolongation of the QT interval.
Theophylline
No interaction has been detected between azithromycin and theophylline.
Triazolam/midazolam
No significant changes in pharmacokinetic parameters were detected with simultaneous use of azithromycin with triazolam or midazolam in therapeutic doses.
Trimethoprim/sulfamethoxazole
Concomitant use of trimethoprim/sulfamethoxazole with azithromycin did not reveal a significant effect on Cmax, total exposure or renal excretion of trimethoprim or sulfamethoxazole. Azithromycin serum concentrations were consistent with those found in other studies.
Analogs
If adverse reactions occur, Sumamed is replaced with a drug with typical characteristics. The list of analogues is presented:
- Azax;
- Azitrox;
- Azithromycin;
- Asicin;
- Zitrox;
- Zomax.
The cost of substitutes depends on the country of origin and the pharmacy markup. The choice of a suitable drug is the responsibility of the attending physician; independent selection of analogues is prohibited.
Reviews
Opinions about the drug vary. In reviews of Sumamed one can find a positive attitude due to its convenient administration and rapid recovery from bronchitis, sinusitis or tonsillitis. Kids like the suspension; they are not fussy about its taste.
Some patients make complaints about adverse reactions that have occurred. For some, the therapy provoked diarrhea and discomfort in the intestinal area. The majority noted that Sumamed does not provoke the formation of allergic reactions.
