ASSORAL 150 mg Фильм-Coated Таблетки
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Инструкция по применению ASSORAL
Содержание инструкции
ASSORAL 150 mg film-coated tablets, 300 mg film-coated tablets
roxithromycin
COMPOSITION
ASSORAL 150 mg film-coated tablets
One ASSORAL tablet contains:
Active ingredient:Roxithromycin 150 mg
Excipients:Polyethylene glycol-polypropylene glycol copolymer, Povidone, Hydroxypropylcellulose, Anhydrous colloidal silica, Corn starch, Magnesium stearate, Talc, Propylene glycol, Anhydrous glucose,
Hypromellose, Titanium dioxide.
ASSORAL 300 mg film-coated tablets
One ASSORAL tablet contains:
Active ingredient:Roxithromycin 300 mg
Excipients:Polyethylene glycol-polypropylene glycol copolymer, Povidone, Hydroxypropylcellulose, Anhydrous colloidal silica, Corn starch, Magnesium stearate, Talc, Propylene glycol, Anhydrous glucose,
Hypromellose, Titanium dioxide.
PHARMACEUTICAL FORM and CONTENT
Film-coated tablets.
Box of 12 tablets of 150 mg.
Box of 6 tablets of 300 mg.
PHARMACOTHERAPEUTIC CATEGORY
Roxithromycin is a semisynthetic antibacterial antibiotic belonging to the macrolide family
with therapeutic characteristics substantially corresponding to those of other macrolides
(erythromycin).
MARKETING AUTHORISATION HOLDER
I.B.N. SAVIO S.r.l. - Via del Mare, 36 – 00040 Pomezia – (Rm)
Under license from Aventis Group
MANUFACTURER AND FINAL CONTROL
USIPHAR
56, Route de Choise Au Bac
60205 Compiègne – France
OR
I.B.N. Savio S.r.l.
Via E. Bazzano, 14
Ronco Scrivia (GE)
OR
S&B S.r.l. – Pharmaceutical Workshop
Via del Mare, 36
Pomezia (RM)
THERAPEUTIC INDICATIONS
Infections caused by bacteria sensitive to it, especially in conditions:
- ENT
- Bronchopulmonary
- Odontostomatological
- Genital, except for gonococcal infections
- Skin
- In the prophylaxis of meningococcal meningitis in at-risk contacts.
CONTRAINDICATIONS
Hypersensitivity to the active ingredient, to other macrolides or to any of the excipients.
Association with ergotamine-based products or with other alkaloids of ergot.
In patients with severe hepatic insufficiency, the 300 mg tablets are contraindicated.
PRECAUTIONS FOR USE
Cases of severe vasospasm (ergotism) with possible necrosis of the extremities have been reported in
cases of association of macrolides with vasoconstrictor alkaloids of ergot. Therefore, it is always
necessary to verify that there is no ongoing therapy with such drugs before prescribing
roxithromycin (see “ Interactions”).
In patients with severe hepatic insufficiency (e.g. hepatic cirrhosis with jaundice and/or ascites), the dosage
must be reduced by half (e.g. 150 mg per day in adults).
If necessary, it is advisable to periodically monitor liver function indices and
eventually reduce the dosage.
Renal excretion of roxithromycin and its metabolites occurs for 10% of the administered oral dose.
The dosage should remain unchanged in patients with renal insufficiency.
No dosage adjustment is necessary in elderly patients.
The tablets contain glucose, so in case of ascertained sugar intolerance, contact your
doctor before taking the medicine.
INTERACTIONS
Contraindicated associations
Vasoconstrictor alkaloids of ergot (see section Precautions for use).
Associations not recommended
Terfenadine
Some macrolides show a pharmacokinetic interaction with terfenadine leading to increased
serum levels of the latter. This can cause severe ventricular arrhythmias, typically torsades de
pointes. Although this interaction has not been demonstrated with roxithromycin and studies conducted in a
limited number of healthy volunteers have not shown pharmacokinetic interactions or relevant electrocardiographic alterations, the association of roxithromycin and terfenadine is not recommended.
Astemizole, cisapride, pimozide
Other drugs such as astemizole, cisapride or pimozide, metabolized by the hepatic CYP3A isozyme, are
associated with prolongation of the QT interval and/or cardiac arrhythmias (typically torsades de
pointes) as a result of increased serum concentration due to interaction with drugs that inhibit
significantly the isozyme, including some macrolide antibiotics. Although roxithromycin possesses
minimal or no ability to bind to CYP3A, and therefore to inhibit the metabolism of other drugs by
the isozyme, it is not possible to establish with certainty the potential for clinical interaction of
roxithromycin with the aforementioned drugs. Therefore, the association of roxithromycin
with these drugs is not recommended.
Precautions for use
No interaction with warfarin has been detected in studies in healthy volunteers; however, in patients
treated with roxithromycin and vitamin K antagonists, increases in prothrombin time or the International Normalized Ratio (INR) have been reported, which may also be caused
by the infectious episode. It is considered prudent to monitor the INR during concomitant treatment
with roxithromycin and vitamin K antagonists.
An in vitro study has shown that roxithromycin can displace disopyramide from binding to
plasma proteins; this effect can result in vivo in increased levels of free disopyramide.
Consequently, the ECG and, if possible, serum levels of disopyramide should be monitored.
Digoxin and other cardiac glycosides
A study in healthy volunteers has shown that roxithromycin can increase the absorption of
digoxin. This effect, common also to other macrolides, can very rarely give rise to episodes
of toxicity of cardiac glycosides. This can manifest with symptoms such as nausea, vomiting, diarrhea,
headache or dizziness; toxicity of cardiac glycosides can also lead to disturbances of conduction
and/or cardiac rhythm. Therefore, in patients treated with roxithromycin and digoxin or other cardiac glycoside,
an electrocardiographic monitoring and, if possible, serum levels of the
glycoside should be performed; this becomes mandatory in case of appearance of symptoms that may suggest a
glycoside overdose.
Associations to be considered
As with other macrolide antibiotics, roxithromycin can increase the area under the concentration-time
curve and the half-life of midazolam; therefore, the effects of midazolam may be increased and prolonged in patients treated with roxithromycin. There is no conclusive data regarding
an interaction between roxithromycin and triazolam.
A slight increase in plasma concentrations of theophylline or cyclosporine A has been detected, but
this generally does not require modifications of the normal dosage.
SPECIAL WARNINGS
Pregnancy
Studies conducted in various animal species have not shown teratogenic or fetotoxic effects at doses up to
200 mg/kg/day, or 40 times the therapeutic dose in humans.
The safety of roxithromycin for the human fetus has not been established.
It is nevertheless not recommended for use during the first trimester of pregnancy. During the remaining periods, the product should
be administered only when necessary, under the direct control of the doctor.
Breast-feeding
Small amounts of roxithromycin are excreted in breast milk; therefore, breast-feeding or therapy in the mother should be discontinued.
Effects on ability to drive and operate machinery
Particular caution should be exercised when driving due to the possibility of experiencing dizzying sensations.
The medicine is not contraindicated for subjects affected by celiac disease.
DOSAGE, MODE AND TIME OF ADMINISTRATION
Adults
300 mg per day: one tablet (150 mg) every 12 hours or one tablet (300 mg) in a single
administration every 24 hours, preferably before meals.
OVERDOSE
In dogs, after oral administration of a single dose of 2000 mg/kg, the following were observed: considerable vomiting,
diarrhea, apathy, decreased motor activity.
In case of overdose, gastric lavage and symptomatic treatment are recommended. There is no
specific antidote.
UNDESIRABLE EFFECTS
- Gastrointestinal disorders: nausea, vomiting, gastralgia, diarrhea and, very rarely, bleeding.
- In isolated cases, symptoms of pancreatitis have been observed; most were patients who were also taking other drugs for which pancreatitis is a well-known adverse reaction.
- Hypersensitivity reactions such as with other macrolides: rash, urticaria, angioedema; exceptionally purpura, bronchospasm, anaphylactic shock.
- Dizziness, headache, paresthesia.
- Modest increases in SGOT and SGPT transaminases and/or alkaline phosphatase. Cholestatic hepatitis or more rarely acute hepatocellular damage.
- As with other macrolides, taste and smell disorders have been reported.
- Superinfections: as with other antibiotics, the use of roxithromycin, particularly if prolonged, can cause the growth of organisms that are not sensitive. Constant assessment of the patient's clinical condition is essential. If a superinfection occurs during therapy, appropriate measures should be taken.
- Ear and vestibular disorders: transient hearing loss, hypoacusis, vertigo and tinnitus.
These undesirable effects are generally transient. When they occur, however, it is advisable
to consult a doctor.
It is important to inform the doctor or pharmacist of the appearance of any undesirable effect even
EXPIRY DATE AND STORAGE
Expiry date: see the expiry date indicated on the packaging.
The expiry date indicated refers to the product in intact packaging and stored correctly.
ATTENTION: do not use the medicine after the expiry date indicated on the packaging.
Keep the medicine out of reach of children.
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- Страна регистрации
- Форма выпускаFilm-coated tablet, 150 MG
- Код АТХJ01FA06
- Действующее вещество
- Отпускается по рецептуДа
- Производитель
- Информация на этой странице носит справочный характер и не является медицинской консультацией. Перед началом приема лекарства обязательно проконсультируйтесь с врачом.
- Аналоги ASSORALФорма выпуска: Film-coated tablet, 150 MGДействующее вещество: roxithromycinПроизводитель: AMDIPHARM LTDОтпускается по рецептуФорма выпуска: Film-coated tablet, 500 MGДействующее вещество: АзитромицинПроизводитель: GENETIC S.P.A.Отпускается по рецептуФорма выпуска: Film-coated tablet, 500 MGДействующее вещество: АзитромицинПроизводитель: DYMALIFE PHARMACEUTICAL S.R.L.Отпускается по рецепту
Аналоги ASSORAL в других странах
Лекарства с тем же действующим веществом, доступные в других странах.
Аналог ASSORAL в Польша
Аналог ASSORAL в Испания
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Часто задаваемые вопросы
ASSORAL требует рецепта в Италия. Вы можете уточнить у врача онлайн, подходит ли это лекарство для вашей ситуации.
Действующее вещество ASSORAL — roxithromycin. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.
ASSORAL производится компанией I.B.N. SAVIO S.R.L. Упаковка и торговое название могут отличаться в зависимости от дистрибьютора.
Врачи, включая Семейные врачи, Психиатры, Дерматологи, Кардиологи, Эндокринологи, Гастроэнтерологи, Пульмонологи, Нефрологи, Ревматологи, Гематологи, Инфекционисты, Аллергологи, Гериатры, Педиатры, Онкологи, могут оценить целесообразность применения ASSORAL с учетом вашей ситуации и местных правил. Вы можете записаться на онлайн-консультацию, чтобы обсудить возможные варианты.
Польша имеет хорошо развитую систему здравоохранения в крупных городах, таких как Варшава, Краков, Вроцлав и Гданьск. Аптеки широко доступны и работают в соответствии с действующим законодательством, обеспечивая доступ к рецептурным препаратам.
Вы можете купить ASSORAL в Варшаве, Кракове, Вроцлаве или Гданьске в любой аптеке при наличии действующего рецепта.
Чтобы получить рецепт, вы можете воспользоваться Oladoctor:
Другие лекарства с тем же действующим веществом (roxithromycin) включают RULID, ATSAKID, ATSEPTIN. Они могут отличаться торговым названием или формой выпуска, но содержат одинаковый терапевтический компонент. Перед изменением лечения рекомендуется проконсультироваться с врачом.
