Sumamox - Instructions For Use, Price, 500 Mg Tablets, Reviews

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Sumamox

Sumamox: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. In case of impaired renal function
12. 12. For violations of liver function
13. 13. Use in the elderly
14. 14. Drug interactions
15. 15. Analogs
16. 16. Terms and conditions of storage
17. 17. Terms of dispensing from pharmacies
18. 18. Reviews
19. 19. Price in pharmacies

Latin name: Sumamox

ATX code: J01FA10

Active ingredient: azithromycin (Azithromycin)

Manufacturer: Oxford Laboratories Pvt. Ltd. (Oxford Laboratories Pvt. Ltd.) (India)

Description and photo update: 2020-17-01

Sumamox is an antibacterial drug.

Release form and composition

Dosage forms:

• film-coated tablets (500 mg): core and shell of white or almost white color, in the form of caplets (capsules), a dividing line is applied on both sides (3 pcs. in blisters, in a cardboard box 1 blister and instructions for the preparation);
• capsules (250 mg): No. 0, gelatinous, hard, the surface is smooth (visible damage and mechanical or air inclusions are absent), the body is blue, and the lid is blue; the contents of the capsules are a powdery mass of white or almost white color (6 pcs. in blisters, in a cardboard box 1 blister and instructions for the use of Sumamox).

1 tablet contains:

• active substance: azithromycin dihydrate - 524 mg, which is equivalent to 500 mg of azithromycin;
• auxiliary components: corn starch, corn starch for paste, sodium carboxymethyl starch, calcium phosphate, croscarmellose sodium, magnesium stearate, talc;
• film shell: coating for tablets "Tabcoat white" - macrogol, hypromellose, titanium dioxide (E171), talc.

1 capsule contains:

• active substance: azithromycin dihydrate - 262 mg, which is equivalent to 250 mg of azithromycin;
• auxiliary components: lactose monohydrate, corn starch, sodium lauryl sulfate, Ponso 4R (E124) crimson dye, magnesium stearate;
• shell: gelatin, sodium lauryl sulfate, methyl parahydroxybenzoate, titanium dioxide (E171), propyl parahydroxybenzoate, brilliant blue dye (E133); additionally: cap - azorubin dye (E122), body - quinoline yellow dye (E104).

Pharmacological properties

Pharmacodynamics

Sumamox is an antibacterial drug, macrolide. Its active substance, azithromycin, belongs to the pharmacological group of azalides. The mechanism of action of Sumamox is due to the property of azithromycin to reversibly bind to the 50S-subunit of ribosomes of bacterial cells. This leads to disruption of the translocation of the growing polypeptide chain from the aminoacyl zone to the peptidyl zone, which causes suppression of protein synthesis in bacterial cells.

The penetration of azithromycin through the cell membranes contributes to the effectiveness of Sumamox in infections caused by intracellular pathogens.

The following bacteria are susceptible to Sumamox:

• aerobic gram-positive microorganisms: Streptococcus pneumoniae (not resistant to penicillin), Staphylococcus aureus (not resistant to methicillin), Streptococcus pyogenes;
• aerobic gram-negative microorganisms: Neisseria gonorrhoeae, Haemophilus parainfluenzae, Haemophilus influenzae, Moraxella catarrhalis, Legionella pneumophila, Pasteurella multocida;
• anaerobic microorganisms: Fusobacterium spp. (speciales), Clostridium perfringens, Porphyromonas spp., Prevotella spp.;
• others: Chlamydia pneumoniae, Chlamydia trachomatis, Chlamydia psittaci, Mycoplasma hominis, Mycoplasma pneumoniae, Borrelia burgdorferi.

Aerobic gram-positive microorganisms - Streptococcus pneumoniae (insensitive or moderately sensitive to penicillin) are resistant to azithromycin or show moderate sensitivity.

Sumamox-resistant bacteria:

• aerobic gram-positive microorganisms: Staphylococcus spp. (methicillin resistant), Enterococcus faecalis;
• anaerobes: Streptococcus pneumoniae, Bacteroides fragilis, beta-hemolytic Streptococcus spp. (group A), Enterococcus faecalis and Staphylococcus aureus (including strains resistant to methicillin), anaerobes resistant to lincosamides, erythromycin and other macrolides.

Pharmacokinetics

After oral administration of Sumamox tablets or capsules, the maximum concentration (_Cmax) of azithromycin in the blood plasma is reached after 2-3 hours. With simultaneous food intake, _Cmax increases by 31%, AUC (area under the concentration-time curve) does not change. Bioavailability - 37%.

Plasma protein binding is 12–52%, it is inversely proportional to the level of azithromycin concentration in the blood. The volume of distribution is 31 l / kg.

The release of azithromycin occurs at the site of infection, in the presence of bacteria, where it is transported by polymorphonuclear leukocytes, phagocytes and macrophages. Easily enters tissues, overcoming histohematogenous barriers. In the focus of infection, the concentration level of azithromycin is 24–34% higher than in healthy tissues, and in tissues and cells it is 50 times higher than in blood plasma.

Azithromycin is an inhibitor of the following isoenzymes involved in its metabolism: CYP3A4, CYP3A5 and CYP3A7. In the liver, it is demethylated and loses activity.

It is removed from tissues slowly, the half-life (T _1/2) is long and can range from 2 to 4 days. After taking the last dose, the therapeutic concentration of the drug in the body is maintained for 5–7 days.

It is excreted mainly unchanged: through the kidneys - 12%, through the intestines - 50%.

In renal failure with creatinine clearance (CC) less than 10 ml / min, T _1/2 increases by 33%.

Pharmacokinetic parameters in men aged 65–85 years do not change, in women - C _max increases by 30–50%.

Indications for use

The use of Sumamox is indicated for the treatment of the following infectious and inflammatory diseases caused by bacteria sensitive to azithromycin:

• tonsillitis, pharyngitis, sinusitis, otitis media;
• chronic bronchitis in the acute stage, acute bronchitis, community-acquired pneumonia (including cases with atypical pathogens);
• simple acne of moderate severity, impetigo, erysipelas, secondarily infected dermatoses;
• uncomplicated forms of urethritis or cervicitis caused by Chlamydia trachomatis;
• erythema migrans - the initial stage of borreliosis (Lyme disease).

Contraindications

Absolute:

• concomitant therapy with ergot derivatives;
• severe hepatic and / or renal impairment;
• breast-feeding;
• age up to 12 years;
• established hypersensitivity to other macrolides;
• individual intolerance to the components of Sumamox capsules and tablets.

In addition, the drug in the form of capsules is contraindicated for use in case of lactose intolerance, lactase deficiency or glucose-galactose malabsorption.

It is recommended to take Sumamox with caution in patients with chronic renal failure (CC more than 40 ml / min), long QT interval syndrome, with concomitant therapy with terfenadine, digoxin, warfarin, agents that can cause QT interval prolongation during pregnancy.

Sumamox, instructions for use: method and dosage

Sumamox capsules and tablets are taken orally 1 hour before or 2 hours after meals.

Frequency rate of admission - 1 time per day.

The recommended dosage of Sumamox for patients over the age of 12 years and with a body weight of more than 45 kg (including elderly patients):

• infections of the upper and lower respiratory tract, ENT organs, skin and soft tissues: the course dose is 1500 mg - Sumamox dose 500 mg (2 capsules or 1 tablet) once a day, the duration of the course of treatment is 3 days;
• uncomplicated urinary tract infections (urethritis, cervicitis) caused by Chlamydia trachomatis: once - 1000 mg (4 capsules or 2 tablets);
• the initial stage of Lyme disease: the course dose is 3000 mg - on the first day, 1000 mg is taken once a day, then 500 mg for the next four days. The general course of therapy is 5 days;
• acne: the course dose is 6000 mg - 500 mg once a day for 3 days, then the dose of Sumamox 500 mg once a week for 9 weeks.

With moderate impairment of renal function (CC more than 40 ml / min), dose adjustment of Sumamox is not required.

Side effects

• on the part of hematopoietic organs: thrombocytopenia, lymphocytopenia, hemolytic anemia, leukopenia, eosinophilia, transient neutropenia;
• on the part of the cardiovascular system: palpitations, prolongation of the QT interval, arrhythmias (including ventricular or pirouette tachycardia);
• from the nervous system: drowsiness, insomnia, dizziness, hyperactivity, aggressiveness, headache, anxiety, anxiety, nervousness, asthenia, vertigo, paresthesia, hyposthesia, convulsions;
• from the digestive system: discoloration of the tongue, nausea, vomiting, flatulence, abdominal pain or abdominal cramps, loose stools, diarrhea, constipation, indigestion, anorexia, gastritis, pseudomembranous colitis, impaired liver function tests, cholestatic jaundice, liver necrosis, hepatitis, liver failure (including fatal);
• from the senses: perversion of taste or smell, ringing in the ears, hearing impairment, deafness, decreased visual acuity;
• on the part of the musculoskeletal system: arthralgia;
• from the genitourinary system: acute renal failure, interstitial nephritis, vaginitis;
• allergic reactions: itching, rash, urticaria, angioedema, anaphylactic reactions, photosensitivity, Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis;
• laboratory indicators: in blood serum - a decrease in the level of bicarbonates, an increase in the concentration of urea, creatinine, bilirubin and / or potassium ions;
• others: exacerbation of myasthenia gravis, chest pain, candidiasis, edema, fainting.

Overdose

Symptoms: nausea and vomiting, temporary hearing loss, diarrhea.

Treatment: taking activated carbon, prescribing symptomatic therapy aimed at maintaining the vital functions of the body.

special instructions

If you are late in taking the next dose at the set time, it should be taken as early as possible, then the therapy is continued in accordance with the recommendations - with an interval of 24 hours.

The antibiotic of choice for streptococcus pyogenes pharyngitis or tonsillitis is penicillins.

It should be borne in mind that against the background of the use of azithromycin, the development of such a side effect as superinfection (including fungal superinfection) is possible.

Long-term use of Sumamox is associated with the risk of developing pseudomembranous colitis caused by Clostridium difficile. Therefore, if diarrhea occurs during the treatment period or within 60 days after its end, appropriate research should be carried out first to exclude or confirm Clostridial pseudomembranous colitis.

Influence on the ability to drive vehicles and complex mechanisms

Due to the fact that Sumamox can cause adverse reactions from the nervous system, patients are advised to be careful, and if drowsiness, dizziness, headache or seizures appear, avoid all activities that require increased concentration of attention or high speed of psychomotor reactions, including management vehicles and complex mechanisms.

Application during pregnancy and lactation

The use of Sumamox is contraindicated during lactation, therefore, if it is necessary to prescribe the drug, breastfeeding should be temporarily stopped.

The use of azithromycin during pregnancy is allowed only in cases where, in the opinion of the doctor, the expected therapeutic effect for the mother is higher than the potential risk for the fetus.

Pediatric use

The use of Sumamox is contraindicated for the treatment of children under the age of 12 years.

With impaired renal function

The use of Sumamox is contraindicated in severe renal failure.

It is recommended to take pills or capsules with caution in patients with chronic renal failure (CC more than 40 ml / min), dose adjustment is not required.

For violations of liver function

The use of Sumamox is contraindicated in severe liver failure.

Use in the elderly

For elderly patients, dose adjustment of Sumamox is not required.

Drug interactions

• antacids: a combination with antacids causes a decrease in the C _{max of} azithromycin by 30%, and therefore Sumamox capsules or tablets should be taken 2 hours after or 1 hour before taking antacids;
• cyclosporine: against the background of concomitant therapy with cyclosporine, monitoring of its concentration in the blood is required;
• indirect anticoagulants: the combination with indirect anticoagulants is associated with the risk of an increased frequency of bleeding, therefore, it is necessary to monitor the INR (international normalized ratio) and prothrombin time;
• digoxin: azithromycin can increase the level of digoxin in the blood, therefore, treatment is recommended to be accompanied by monitoring the concentration of digoxin in the blood;
• ergotamine: the interaction of Sumamox with ergotamine can cause the development of ergotism, so they should not be combined;
• theophylline: there is a risk of increased theophylline concentration;
• rifabutin: increases the risk of developing neutropenia;
• fluconazole: interaction with fluconazole causes a decrease in the C _{max of} azithromycin by 18%.

Analogs

Sumamox analogs are Azithromycin, Azithromycin Avexim, Azithromycin Zentiva, Azithromycin Sandoz, Azithromycin-Akrikhin, Azithromycin-J, Azibiot, Azivok, Azidrop, Azitral, Azitrox, AzitRus, Zetamax retard, ZI-ZI-Factor, ZI-Faktor, Sumamed, Sumametsin, Tremak-Sanovel, Hemomycin, Ecomed, etc.

Terms and conditions of storage

Keep out of the reach of children.

Store at temperatures up to 25 ° C, protected from moisture and light.

Shelf life is 2 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Sumamoks

Reviews about Sumamoks are few. Doctors estimate the effectiveness and safety of the drug slightly above average.

Price for Sumamox in pharmacies

The price of Sumamox for a package containing 6 capsules or 3 tablets can range from 153 rubles.

Anna Kozlova Medical journalist About the author

Education: Rostov State Medical University, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!