Sumamox - instructions for use, dose, side effects, contraindications

Active substance: azithromycin dihydrate 262.0 mg (equivalent 250 mg azithromycin) Excipients: lactose monohydrate 180.0 mg, sodium lauryl sulfate 10.0 mg, corn starch 30.0 mg, magnesium stearate 10.0 mg, dye crimson [Ponso 4R] Е 124 0,0015 mg.

Capsule shell: sodium lauryl sulfate 0.086 mg, methyl parahydroxybenzoate 0.87 mg, propyl parahydroxybenzoate 0.315 mg, gelatin 101.54 mg.

Dyestuff caps capsules: dye brilliant blue E 133 0.44 mg, azorubin dye E 122 0.012 mg, titanium dioxide E 171 2.3 mg.

Dyes of the capsule body: colorant blue E 133 0.008 mg, quinoline yellow color E 104 0.0001 mg, titanium dioxide E 171 2.43 mg.

Description:

Hard gelatin capsules No. 0 with a smooth surface without damage and visible air or mechanical inclusions. The color of the case is blue and the caps are blue. The contents of the capsules are white or almost white powder.

Pharmacotherapeutic group:Antibiotic - azalide

ATX: & nbsp

J.01.F.A.10 Azithromycin

Pharmacodynamics:

Azithromycin is a macrolide antibiotic of the azalide group. Reversibly communicating with 50S-subunit of ribosomes of bacterial cells, disrupts the translocation of the growing polypeptide chain from the aminoacyl region to the peptidyl, which leads to suppression of protein synthesis in bacterial cells.

Sensitive: aerobic Gram-positive microorganisms - Staphylococcus aureus - (methicillin-sensitive), Streptococcus pneumoniae (penicillin-sensitive), Streptococcus pyogenes; aerobic gram-negative microorganisms Haemophilus influenzae, Haemophilus parainfluenzae, Legionella pneumophila, Moraxella catarrhalis, Pasteurella multocida, Neisseria gonorrhoeae; anaerobic microorganisms - Clostridium , perfringens, Fusobacterium spp., Prevotellaspp., Porphyromonas spp.; other - Chlamydia trachomatis, Chlamydia pneumoniae, Chlamydia psittaci, Mycoplasma pneumoniae, Mycoplasma hominis, Borrelia burgdorferi.

Moderately sensitive or insensitive: aerobic Gram-positive microorganisms - Streptococcus pneumoniae (moderately sensitive or resistant to penicillin).

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

Pharmacokinetics:

After oral administration, the bioavailability is -37%, the maximum concentration in the blood plasma (Cmax) is created in 2-3 hours, the volume of distribution is 31 l / kg. Binding to plasma proteins is inversely proportional to the concentration in the blood and is 12-52%. Penetrates through cell membranes (effective infections caused by intracellular pathogens). It is transported by phagocytes, polymorphonuclear leukocytes and macrophages to the site of infection, where it is released in the presence of bacteria. Easily passes through the histohematological barriers and enters the tissues. The concentration in tissues and cells is 50 times higher than in plasma, and in the focus of infection - 24-34% more than in healthy tissues. Slowly removed from the tissues and has a long half-life of 2-4 days. The therapeutic concentration of azithromycin persists up to 5-7 days after the last dose. Azithromycin is output basically in the unchanged form - 50% intestine, 12% kidney. In the liver, demethylated, losing activity. In the metabolism of azithromycin, isozymes participate: CYP3A4, CYP3A5, CYP3A7, of which it is an inhibitor. Have patients with renal failure (creatinine clearance (CC) less than 10 ml / min), the half-life of azithromycin increases by 33%. Eating significantly changes the pharmacokinetics: Cmah increases by 31%, the indicator area under the concentration-time curve (AUC) does not change. In elderly men (65-85 years) the pharmacokinetic parameters do not change, in women C increasesmah by 30-50%.

Indications:

Infectious-inflammatory diseases caused by susceptible to azithromycin microorganisms:

Infections of the upper respiratory tract and ENT organs (pharyngitis, tonsillitis, sinusitis, otitis media);

Infections of the lower respiratory tract (acute bronchitis, exacerbation of chronic bronchitis, community-acquired pneumonia, including caused by atypical pathogens);

Infections of the skin and soft tissues (simple eels of medium severity, erysipelas, impetigo, secondarily infected dermatoses);

initial stage Lyme disease (borreliosis), migratory, erythema (erythema migrans);

Uncomplicated urinary tract infections caused by Chlamidia trachomatis (urethritis, cervicitis).

Contraindications:

Hypersensitivity to azithromycin, other macrolides, components of the drug, simultaneous use with ergot derivatives, severe hepatic / renal failure, children under 12 years of age. Lactose intolerance, lactase deficiency or glucose-galactase malabsorption.

Carefully:

The syndrome of an elongated interval Q-T, chronic renal failure (CC more 40 ml / min), simultaneous administration with terfenadine, warfarin, digoxin, drugs that extend the interval Q-T.

Pregnancy and lactation:

The use of the drug during pregnancy is possible only in cases where the intended benefit to the mother exceeds the potential risk to the fetus. When The need to use the drug during lactation should address the issue of

terminating breastfeeding.

Dosing and Administration:

Inside, 1 time per day, at least 1 hour before or 2 hours after meals.

Adults (including the elderly) and children over 12 years of age with a body weight of over 45 kg.

In infections of the upper and lower respiratory tract; ENT organs, skin and soft tissues:

500 mg (2 capsules) 1 time per day for 3 days (course dose 1.5 g)

The initial stage of Lyme disease:

1 time per day for 5 days: 1st day - 1.0 g (4 capsules), then from 2 to 5 days - 500 mg (2 capsules) (course dose 3.0 g)

In uncomplicated infections of the genitourinary tract caused by Chlamidia trachomatis (urethritis, cervicitis):

1 g (4 capsules) once.

With acne: the course dose is 6 g: 500 mg (2 capsules) 1 time per day for 3 days, then 500 mg once a week for 9 weeks.

The appointment of patients with impaired renal function:

For patients with moderate impairment of kidney function (CK> 40 ml / min) dose adjustment is not needed.

Side effects:

From the hematopoiesis: lymphocytopenia, eosinophilia, leukopenia, thrombocytopenia, transient neutropenia, hemolytic anemia.

From the nervous system: dizziness, vertigo, drowsiness, headache, seizures, paresthesia, hyposthenia, asthenia, insomnia, hyperactivity, aggressiveness anxiety, anxiety, nervousness.

From the sense organs: hearing impairment, deafness, ringing in the ears, distortion of taste or smell, reduced visual acuity.

From the cardiovascular system: palpitation, arrhythmia (including ventricular tachycardia, pirouette tachycardia), lengthening of the interval Q-T.

From the digestive system: nausea, vomiting, diarrhea, abdominal pain or spasms in the abdomen, unformed stool, flatulence, digestive disorders, gastritis, anorexia, constipation, discoloration of the tongue, pseudomembranous colitis, hepatitis, cholestatic jaundice, impaired functional liver tests, liver necrosis and liver failure (up to a lethal outcome).

From the musculoskeletal system: arthralgia.

From the genitourinary system: vaginitis, interstitial nephritis, acute renal failure.

Allergic reactions: itching and rash, angioedema edema, hives, photosensitivity, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, anaphylactic reactions.

Laboratory indicators: increased serum levels of bilirubin, urea, creatinine, potassium ions, decreased serum bicarbonate concentrations.

Other: candidiasis, chest pain, swelling, fainting; exacerbation of myasthenia gravis gravis.

Overdose:

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

Treatment: reception of activated carbon, maintenance of vital body functions.

Interaction:

Antacids reduce the maximum concentration of azithromycin by 30%, so azithromycin should be taken 1 hour before or 2 hours after taking antacids.

When used simultaneously with cyclosporine, the concentration of cyclosporin in the blood should be monitored.

With simultaneous application with indirect anticoagulants may increase frequency of bleeding, prothrombin time and international normalized ratio (INR) should be monitored.

With simultaneous use with digoxin, an increase in the concentration in the blood of the latter is possible, therefore, the concentration of digoxin in the blood should be monitored. With simultaneous application from ergotism can develop ergotism; simultaneous use is not recommended.

The simultaneous use of macrolides and theophylline in some cases led to an increase in the concentration of the latter.

Azithromycin increases the content of zidovudine triphosphate (an active metabolite of zidovudine) in mononuclear cells; the clinical significance of this phenomenon is unknown.

Simultaneous use with rifabutin can lead to neutropenia.

At simultaneous reception fluconazole reduces the maximum concentration azithromycin by 18%.

Special instructions:

In case of missed intake of a single dose of the drug, the missed dose should be taken as soon as possible, and the subsequent dose - with interruptions of 24 hours.

With pharyngitis and tonsillitis caused by Streptococcus pyogenes, antibiotics of choice are penicillins. The effectiveness of azithromycin for the prevention of rheumatic fever is unknown.

When using azithromycin, as well as with the use of other antibiotics there is a risk of developing superinfection (including fungal).

With prolonged use of azithromycin, the development of pseudomembranous colitis caused by Clostridium difficile. With the development of diarrhea in the backgroundreception of azithromycin, and also after 2 months after the end of therapy, clostridial pseudomembranous colitis should be excluded.

Effect on the ability to drive transp. cf. and fur:In case of adverse reactions from the nervous system, patients are advised to refrain from controlling the car and other mechanisms, and also to exercise caution when engaging in activities,requiring increased concentration of attention and speed of psychomotor reactions.

Form release / dosage:Capsules 250 mg.

Packaging:

6 capsules per blister of aluminum foil and polyvinyl chloride (Al / PVC).

1 blister together with instructions for use are placed in a cardboard box.

Storage conditions:

In dry, the dark place at a temperature of no higher than 25C.

Keep out of the reach of children.

Shelf life:

2 years.

Do not take it after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:П N014489 / 01-2002

Date of registration:30.10.2008

The owner of the registration certificate:Oxford Laboratories Pvt. Ltd.Oxford Laboratories Pvt. Ltd. India

Manufacturer: & nbsp

OXFORD Laboratories, Pvt. Ltd. India

Representation: & nbspOXFORD LABORATORY Pvt. Ltd. OXFORD LABORATORY Pvt. Ltd. India

Information update date: & nbsp14.08.2015

Illustrated instructions

Instructions

Sumamox (Sumamox)