ROVIDOR [Spiramycin] 3 million units Film-coated tablets
![ROVIDOR [Spiramycin] 3 million units Film-coated tablets](https://livemedicine.biz/image/cache/catalog/upload/Rovidor-1350x1350.jpg "ROVIDOR [Spiramycin] 3 million units Film-coated tablets")
instructions for the medical use of
the medicinal product
ROVIDOR
Tradename: Rovidor, Ровидор
International non-proprietary name
or generic name: Spiramycin, Спирамицин
Composition per 1
tablet:
active substance: spiramycin 3,000,000 IU.
excipients: magnesium stearate,
sodium starch glycolate (DST), lactose monohydrate, hypromellose (HPMC),
titanium dioxide, purified talc, virgin castor oil, ethanol 96%, purified
water.
Dosage form: film-coated
tablet, cream-colored, round with a solid edge.
Pharmacotherapeutic group:
Antibacterial agents for systemic use.
ATX code: J01FA02
Antibiotic of the
macrolide group. It has a bacteriostatic effect, disrupting intracellular
protein synthesis.
Active against
gram-positive bacteria: Staphylococcus spp. (including strains producing
penicillinase), Streptococcus spp. (including Streptococcus pneumoniae),
Corynebacterium diphtheriae, Listeria monocytogenes; gram-negative bacteria:
Neisseria meningitidis, Neisseria gonorrhoeae, Bordetella pertussis, Legionella
spp., Campylobacter spp.; anaerobic bacteria: Clostridium spp.
Spiramycin is also
active against Mycoplasma pneumoniae, Chlamydia spp., Treponema spp.,
Leptospira spp., Toxoplasma gondii.
Haemophilus
influenzae, Bacteroides fragilis, Staphylococcus aureus are moderately
sensitive to spiramycin.
Enterobacter spp.,
Pseudomonas spp. are resistant to spiramycin.
Absorption of spiramycin is incomplete, bioavailability when taken
orally is 33–39% (from 10% to 69%). Eating reduces bioavailability by 50% and
increases serum Tmax. Binding to blood proteins is 10–25%. Tmax when taken
orally - 3-4 hours, when administered intravenously - by the end of the
infusion. Diffuses well into biological fluids (saliva), organs and tissues.
The concentration in the lung tissue after taking 5 million IU is 20-60 mcg/g,
in the tonsils - 20-80 mcg/g, in the paranasal sinuses (with inflammation) -
75-110 mcg/g, in bone tissue - 5-100 mcg/g , spleen, liver and kidneys - 5–7
mcg/g. Spiramycin passes through the placenta and reaches concentrations in it
that are up to 5 times higher than those in blood serum and penetrates into
breast milk. Does not pass through the BBB. Metabolized in the liver. T1/2 when
taken orally - 5.5-8 hours, with intravenous administration - approximately
4.5-6.2 hours - in young people (18-32 years), approximately 9.8-13.5 hours -
in older people (73 years - 85 years). Excreted mainly through bile (more than
80% of the dose), urine (4–14%) and feces.
Infectious and inflammatory
diseases caused by microorganisms sensitive to the drug:
• acute and chronic
pharyngitis caused by beta-hemolytic streptococcus A (as an alternative to
treatment with beta-lactam antibiotics, especially in case of contraindications
to their use);
• acute sinusitis;
• acute and chronic
tonsillitis caused by microorganisms sensitive to spiramycin;
• acute bronchitis caused by a
bacterial infection that develops after acute viral bronchitis;
• exacerbation of chronic
bronchitis;
• community-acquired pneumonia
in patients without risk factors for unfavorable outcome, severe clinical
symptoms and clinical signs of pneumococcal etiology of pneumonia;
• pneumonia caused by atypical
pathogens (such as Chlamydia pneumoniae, Chlamydia trachomatis, Mycoplasma
pneumoniae, Legionella spp.) or suspicion of it (regardless of the severity and
the presence or absence of risk factors for an unfavorable outcome);
• infections of the skin and
subcutaneous tissue, including impetigo, impetiginization, ecthyma, infectious
dermohypodermatitis (especially erysipelas), secondary infected dermatoses,
erythrasma;
• oral infections (including
stomatitis, glossitis);
• non-gonococcal infections of
the genital organs;
• toxoplasmosis, incl. during
pregnancy;
• infections of the
musculoskeletal system and connective tissue, including periodontium.
Prevention of relapses of
rheumatism in patients with allergies to beta-lactam antibiotics.
Eradication of Neisseria
meningitidis from the nasopharynx (if rifampicin is contraindicated) for the
prevention (but not treatment) of meningococcal meningitis:
• in patients after treatment
and before leaving quarantine;
• in patients who, within 10
days before hospitalization, were in contact with persons who released
Neisseria meningitidis in saliva into the environment.
• hypersensitivity to spiramycin or any of the
excipients;
• children and adolescents under 18 years of age.
Method of administration and dosage
The
tablets are taken orally with a sufficient amount of water.
Adults -
2-3 tablets. 3 million ME (i.e. 6-9 million ME) per day in 2 or 3 doses. The
maximum daily dose is 9 million ME. Prevention of meningococcal meningitis - 3
million IU 2 times per day for 5 days.
Use during pregnancy and breastfeeding
The drug can be used during pregnancy
according to indications.
Spiramycin is excreted in breast milk,
so if it is necessary to use it during lactation, the issue of stopping
breastfeeding should be decided.
From
the digestive system: nausea,
vomiting, diarrhea, abdominal pain; in isolated cases - cholestatic jaundice,
pseudomembranous colitis.
Allergic
reactions: skin rash,
itching; very rarely Quincke's edema, anaphylactic shock.
From
the central and peripheral nervous system: periodic and transient paresthesias.
If
any of the side effects indicated in the instructions get worse, or you notice
any other side effects not listed in the instructions, tell your doctor.
Special instructions and precautions
Before using the drug,
consult your doctor.
During treatment with the
drug in patients with liver disease, it is necessary to periodically monitor
its function.
If, at the beginning of
treatment, generalized erythema and pustules occur, accompanied by high body
temperature, acute generalized exanthematous pustulosis should be assumed; if
such a reaction occurs, then treatment should be stopped, and further use of
spiramycin, both in monotherapy and in combination, is contraindicated.
Interaction with other medicinal products
Inhibition
of carbidopa absorption by spiramycin with a decrease in plasma levodopa
concentrations. When prescribing spiramycin simultaneously, clinical monitoring
and dose adjustment of levodopa is necessary.
Numerous
cases of increased activity of indirect anticoagulants in patients taking
antibiotics have been recorded. The type of infection or severity of the
inflammatory reaction, age and general condition of the patient are
predisposing risk factors. Under these circumstances, it is difficult to
determine the extent to which the infection itself or its treatment plays a role
in altering MHO. However, when using some groups of antibiotics, this effect is
observed more often, in particular when using fluoroquinolones, macrolides,
cyclines, the combination of sulfamethoxazole + trimethoprim, and some
cephalosporins.
Symptoms: possible - nausea,
vomiting, diarrhea.
Treatment: symptomatic therapy. There
is no specific antidote.
2 blisters of 5 film-coated tablets along with
instructions for use in a box.
Store in a dry place, at a temperature not exceeding
30°C, protected from light.
Keep out of the reach of children!
36 months.
By prescription.
The
holder of trade mark and Marketing Authorization is:
«LIVE MEDICINE ILAÇ VE TIC. LTD.
ŞTI.», Gökevler Mah.2312. Sk. Burc Istanbul 18 Esenyurt, ISTANBUL, TURKEY.