Fromilide - instructions for use, reviews, analogs and forms of release (tablets 250 mg and 500 mg, granules for the preparation of suspension, prolonged action Uno) drug for the treatment of infections in adults, children and pregnancy
In this article, you can read the instructions for using the drug Fromromide. There are reviews of visitors to the site - consumers of this medication, as well as opinions of doctors of specialists on the use of antibiotic Fromilide in their practice. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Analogues of formylid with existing structural analogues.Use to treat infections caused by a variety of pathogens in adults, children, as well as during pregnancy and lactation.
Fromromide - Semisynthetic antibiotic group of macrolides. Inhibits the synthesis of proteins in a microbial cell. Basically, it has a bacteriostatic effect. In high concentrations has a bactericidal effect on Streptococcus pyogenes, Streptococcus pneumoniae and Moraxella catarrhalis.
It is active against intracellular microorganisms: Legionella pneumophila, Chlamydia trachomatis (Chlamydia), Chlamydia pneumoniae, Ureaplasma urealyticum, Mycoplasma pneumoniae; Gram-positive bacteria: Streptococcus pyogenes, Streptococcus pneumoniae, Streptococcus agalactiae, Streptococcus viridans, Staphylococcus aureus, Listeria monocytogenes, Corynebacterium spp., Bacillus spp .; Gram-negative bacteria: Haemophilus influenzae, Haemophilus ducreyi, Moraxella catarrhalis, Bordetella pertussis, Neisseria gonorrhoeae, Neisseria meningitidis, Borrelia burgdorferi, Pasteurella multocida, Campylobacter spp., Helicobacter pylori (Helicobacter); anaerobic bacteria: Eubacterium spp., Peptococcus spp., Propionibacterium spp., Clostridium perfringens, Bacteroides melaninogenicus. The drug is also active against Toxoplasma gondii (toxoplasma), Mycobacterium spp. (except Mycobacterium tuberculosis).
Composition
Clarithromycin + excipients.
Pharmacokinetics
After ingestion Ofromilid well absorbed from the digestive tract. Food slows down absorption, but does not significantly affect the bioavailability of clarithromycin. Cmax is achieved in less than 3 hours. Clarithromycin easily penetrates tissues (lungs, palatine tonsils, saliva, sputum and middle ear, skin and soft tissues of the body) and body fluids, where it reaches a concentration almost 10 times the concentration in the serum.Approximately 20% of clarithromycin is immediately metabolized in the liver with the participation of CYP3A4, CYP3A5 and CYP3A7 isoenzymes to form the main metabolite, 14-hydroxy-clarithromycin, which has a pronounced activity against Haemophilus influenzae. 20 to 30% of clarithromycin (40% when taking a suspension) is excreted unchanged in the urine, the rest is excreted as metabolites.
Indications
Treatment of infectious-inflammatory diseases caused by drug-susceptible pathogens, including:
- infection of the upper respiratory tract (acute and chronic tonsillopharyngitis, acute and chronic recurrent sinusitis, acute otitis media);
- infection of the lower respiratory tract (acute bacterial bronchitis, exacerbation of chronic bronchitis, community-acquired bacterial pneumonia, including pneumonia caused by atypical pathogens);
- infections of the skin and soft tissues;
- infections caused by mycobacteria (Mycobacterium avium complex, Mycobacterium kansasii, Mycobacterium marinum, Mycobacterium leprae);
- prevention of the spread of infections caused by the Mycobacterium avium (MAC) complex in HIV-infected patients with a CD4 T cell count (T helper lymphocytes) of not more than 100 / mm3;
- eradication of Helicobacter pylori in patients with duodenal ulcers or stomach ulcers (always in combination therapy).
Forms of release
Tablets coated with 250 mg and 500 mg.
Granules for the preparation of a suspension for oral administration.
The tablets of the prolonged action, covered with a cover of 500 mg (Fromiloid Uno).
Instructions for use and dosage
Tablets and suspension
The drug is taken orally. Tablets should be swallowed whole, not breaking, squeezed with a small amount of liquid.
Adults and children over the age of 12 and / or with a body weight> 33 kg are usually prescribed 250 mg every 12 hours.
For the treatment of acute sinusitis, severe infections, and in the case when infection is caused by Haemophilus influenzae, administered at 500 mg clarithromycin every 12 hours. The course of treatment is 7-14 days.
For the purpose of eradication of Helicobacter pylori Fromilid administered in a dose of 250-500 mg 2 times a day, typically for 7 days in combination with other drugs.
Children under the age of 12 years and / or with a body weight of less than 33 kg of the drug is administered in the form of a suspension at a dose of 15 mg / kg body weight per day, divided into 2 doses. After taking the suspension, it is recommended that the child drink some liquid.The suspension contains tiny granules that should not be chewed, because their contents have a bitter taste. The kit contains a syringe for oral administration of the drug. One filled syringe accommodates 5 ml of a suspension containing 125 mg of clarithromycin. The syringe should be rinsed after each use.
The course of treatment usually lasts for 7-14 days.
To treat and prevent the spread of infection caused by Mycobacterium avium complex, appoint 500 mg every 12 hours. The dose can be increased. The maximum daily dose is 2 g.
Children prescribe the drug at a dose of 15 mg / kg per day, divided into 2 divided doses. The dose of the drug should not exceed 500 mg every 12 hours. The maximum daily dose recommended for children is 1 g.
Treatment of infection caused by Mycobacterium avium complex, long, duration is 6 months or more.
In patients with renal insufficiency with QC less than 30 ml / min, or a serum creatinine content of more than 290 μmol / l (3.3 mg / dl), the dose should be reduced by a factor of 2 or doubled between doses. The maximum duration of treatment for patients in this group is 14 days.
Rules for the preparation of oral suspension
To prepare the suspension, 42 ml of water is necessary.Pre-shake the vial to make the granules scatter in it. Add 1/4 of the water in the vial and shake until the granules dissolve. Add the rest of the water and shake well. The volume of the finished suspension should reach the line of marking on the vial.
Uno Tablets
Tablets should be taken during meals: swallow whole, squeezed a small amount of liquid; do not break it.
Adults and children over the age of 12 years are prescribed 500 mg per day (1 tablet). To treat severe infections, the daily dose is increased to 1000 mg per day (2 tablets).
The duration of the course of treatment is usually 7-14 days.
Side effect
- nausea, vomiting;
- diarrhea;
- abdominal pain;
- stomatitis;
- glossitis;
- short-term discoloration of teeth and tongue;
- pancreatitis;
- pseudomembranous enterocolitis;
- cholestatic jaundice;
- hepatitis;
- cases of hepatic insufficiency and fatal outcome mainly on the background of severe co-morbidities and / or concomitant drug therapy;
- headache;
- paresthesia;
- drowsiness;
- hallucinations;
- convulsions;
- psychosis;
- dizziness;
- confusion of consciousness;
- feeling of fear;
- insomnia;
- nightmarish dreams;
- disorientation;
- leukopenia, neutropenia, thrombocytopenia;
- change in taste (dysgeusia);
- tinnitus;
- short-term hearing loss that occurs after the drug is discontinued;
- prolongation of QT interval on ECG;
- ventricular tachycardia of the "pirouette" type;
- dyspnea;
- arthralgia;
- myalgia;
- interstitial nephritis;
- kidney failure;
- skin rash;
- hives;
- itching;
- swelling of the face;
- anaphylactic shock;
- Stevens-Johnson syndrome;
- toxic epidermal necrolysis (Lyell's syndrome);
- Quincke angioedema;
- hemorrhage;
- candidiasis.
Contraindications
- hepatic failure of severe degree;
- hepatitis (in the anamnesis);
- porphyria;
- 1 trimester of pregnancy;
- lactation period;
- simultaneous therapy with terfenadine, cisapride, pimozide or astemizole;
- Children under 6 months of age (for the dosage form - granules for oral suspension) - there is insufficient experience with regard to efficacy and safety of use;
- children under 12 years of age and / or children weighing less than 33 kg (for the drug form - coated tablets);
- congenital intolerance to fructose,glucose / galactose malabsorption syndrome or sugarase-isomaltase enzyme deficiency (only for the dosage form - pellets for oral suspension);
- hypersensitivity to the components of the drug;
- increased sensitivity to other antibiotics from the macrolide group.
Application in pregnancy and lactation
The use of the drug in the first trimester of pregnancy is contraindicated.
The use of the drug, Formylid in the 2nd and 3rd trimesters of pregnancy, is only possible when the expected benefit of therapy for the mother exceeds the potential risk to the fetus.
If it is necessary to use the drug during lactation, breastfeeding should be stopped.
Use in children
Contraindication: children under 6 months of age (for the dosage form - granules for oral suspension) - there is insufficient experience with regard to efficacy and safety of use; Children under 12 years of age and / or children weighing less than 33 kg (for the drug form - film-coated tablets).
special instructions
When prescribing the drug, it should be noted that among the antibiotics of the macrolide group, there is cross-resistance.
Patients with impaired liver function of mild to moderate severity do not need to reduce the dose of the drug if the kidney function is normal. Patients with severe renal dysfunction should be reduced.
In the presence of chronic liver diseases it is necessary to carry out regular monitoring of serum enzymes.
With the simultaneous administration of drugs metabolized in the liver, it is recommended to monitor their concentration in the blood serum.
Treatment with antibiotics changes the normal flora of the intestine, so the development of superinfection caused by resistant microorganisms is possible.
The patient should be warned that with severe persistent diarrhea, which can be caused by pseudomembranous colitis, he should consult a doctor.
Periodic prothrombin time should be monitored periodically in patients receiving clarithromycin concomitantly with Warfarin or other oral anticoagulants.
125 mg of granules for the preparation of a suspension for ingestion of 125 mg / 5 ml contains 1.6 g of sucrose, so the drug is contraindicated in children with congenital intolerance to fructose,with glucose / galactose malabsorption syndromes or a deficiency of the enzyme sucrose-isomaltase.
Impact on the ability to drive vehicles and manage mechanisms
The drug does not affect the speed of psychomotor reactions when driving a car or working with mechanisms.
Drug Interactions
The fromilide is metabolized in the liver and can inhibit the activity of the cytochrome P450 isoenzymes. With the simultaneous use of clarithromycin and other drugs metabolized with the participation of these isozymes, it is possible to increase the concentration of these drugs in the serum and the development of side effects. With the simultaneous use of the preparation of Formylid with terfenadine, cisapride, pimozide and astemizole, the development of life-threatening arrhythmias is possible (these combinations are contraindicated).
It is recommended to monitor the concentrations in the blood plasma of theophylline, carbamazepine, digoxin, lovastatin, simvastatin, triazolam, midazolam, phenytoin, cyclosporine, disopyramide, rifabutin, tacrolimus, Itraconazole and ergot alkaloids; the risk of development of side effects of these medicines at their simultaneous application with clarithromycin is increased.
Periodic prothrombin time should be monitored periodically in patients receiving clarithromycin concomitantly with warfarin or other oral anticoagulants.
With the simultaneous use of the drug Fromilid and zidovudine, there is a decrease in the absorption of zidovudine (between intervals of these drugs an interval of at least 4 hours is required).
Simultaneous use of ritonavir and clarithromycin leads to a significant increase in the concentration of clarithromycin and a significant decrease in the concentration of its 14-hydroxyclarithromycin metabolite in the serum.
It is possible to develop cross-resistance between clarithromycin, Lincomycin and clindamycin.
Analogues of the drug Formylid
Structural analogs for the active substance:
- Arvitsin;
- Arvitsin retard;
- Binocular;
- Zimbactur;
- Kispar;
- Klabaks;
- Clarcat;
- Clarithromycin;
- Clarithrosine;
- Claricin;
- Claricite;
- Claromin;
- Class;
- Clacid;
- Clerimedes;
- Coater;
- Crixan;
- Seidon Sanovel;
- CP Clarene;
- Fromyloid Uno;
- Ecositrin.
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