STADIUM 400 мг Фильм-coated таблетки
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Инструкция по применению STADIUM
Содержание инструкции
STADIUM 400 mg film-coated tablets
Cefixima
Equivalent medicinal product
PHARMACOTHERAPEUTIC CATEGORY
Systemic antibacterial, belonging to the class of cephalosporins.
THERAPEUTIC INDICATIONS
STADIUM is indicated in the treatment of infections sustained by microorganisms sensitive to
cefixima and in particular:
Exacerbations of chronic bronchitis
Community-acquired pneumonia
Uncomplicated lower urinary tract infections
Uncomplicated pyelonephritis.
In the treatment of:
Otitis media
Sinusitis
Pharyngitis.
CONTRAINDICATIONS
Hypersensitivity to the active ingredient, to other cephalosporins, to soy or to any of the
excipients. The medicinal product is also generally contraindicated in subjects with hypersensitivity
to penicillins and cephalosporins (see “Precautions for use”).
PRECAUTIONS FOR USE
STADIUM must be administered with caution in patients who have shown hypersensitivity to
other medicinal products. Cephalosporins must be administered with caution in patients sensitive to
penicillins, as there is some evidence of partial cross-allergenicity between penicillins and
cephalosporins.
Some patients have shown severe reactions (including anaphylaxis) to both classes of drugs.
Particular caution is recommended in patients who have developed allergic reactions to
penicillins or other beta-lactam antibiotics, as cross-reactions may occur (for
contraindications relating to known hypersensitivity reactions, see “Contraindications”).
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If severe hypersensitivity reactions or anaphylactic reactions occur after the administration of
cefixima, the use of cefixima must be discontinued immediately and appropriate emergency
measures must be taken.
Renal insufficiency
STADIUM must be administered with caution in patients with creatinine clearance < 20
ml/min (see “Dosage, method and duration of administration”). There are insufficient data regarding
the use of cefixima in children and adolescents with renal insufficiency. Therefore, the use of cefixima
is not recommended in these patient groups.
Renal function must be monitored during combination therapy with cefixima and
aminoglycoside antibiotics, polymyxin B, colistin or high doses of loop diuretics (e.g.
furosemide) due to the possibility of additional renal impairment. This applies in
particular to patients who already have reduced renal function (see “Interactions”).
INTERACTIONS
Inform your doctor or pharmacist if you have recently taken any other medicines, including those without
a prescription. The concomitant administration of potentially nephrotoxic substances
(such as aminoglycoside antibiotics, colistin, polymyxin and viomycin) and potent diuretics (e.g.
etacrynate or furosemide) increases the risk of impaired
renal function (see “Precautions for use”).
Nifedipine, a calcium antagonist, may increase the bioavailability of cefixima by up to 70%.
As with other cephalosporins, increases in prothrombin time have been noted in a few patients.
Therefore, caution should be exercised in patients undergoing anticoagulant therapy.
The administration of cefixima may reduce the effectiveness of oral contraceptives. Therefore, it
is recommended to adopt additional non-hormonal contraceptive measures.
SPECIAL WARNINGS
Treatment with STADIUM at the recommended dose (400 mg/day) may significantly alter
the normal flora of the colon and lead to a superinfection with Clostridium. Studies indicate that
a toxin produced by Clostridium difficileis the main cause of antibiotic-associated diarrhea.
In patients who develop severe, persistent diarrhea during or after use of cefixima, the risk of
pseudomembranous colitis, which is life-threatening, must be considered. The use of
STADIUM must be discontinued and appropriate treatment measures must be instituted. The
treatment of pseudomembranous colitis includes sigmoidoscopy, appropriate bacteriological tests, administration of fluid, electrolyte and protein supplements. If the colitis does not
improve after discontinuation of the medicine, or if the symptoms are severe, oral vancomycin is the
drug of first choice in the treatment of antibiotic-associated pseudomembranous colitis,
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produced by C. difficile. Other causes of colitis must be excluded. The use of medicines that
inhibit intestinal peristalsis is contraindicated.
Influence on diagnostic laboratory tests
False positive reactions for the presence of glucose in urine may occur with Benedict or Fehling solutions or with copper sulfate tablets, but not with tests based on enzymatic reactions with glucose oxidase.
False positive Coombs tests have been reported during treatment with cephalosporins,
therefore it should be borne in mind that a positive Coombs test may be due to the drug.
The tablet coating contains 0.6 mg of soy lecithin.
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
Pregnancy
There are no adequate data on the use of cefixima in pregnant women. Animal studies do not indicate direct or indirect harmful effects on pregnancy, embryonic/fetal development, delivery or
postnatal development. STADIUM should not be used in pregnant women unless
considered essential by the doctor.
Breastfeeding
There are no data on the passage of the drug into breast milk. Animal studies have
shown excretion of cefixima in milk. A decision must be made whether to continue/discontinue
breastfeeding or continue/discontinue therapy with cefixima, taking into account the benefit
of breastfeeding for the child and the benefit of therapy with cefixima for the mother.
However, until further clinical experience is available, STADIUM should not
be prescribed to breastfeeding women.
Effects on ability to drive and operate machinery
Cefixima has no known effects on the ability to drive and operate machinery. However, side effects (see also paragraph “Undesirable effects”) may occur,
which may affect the ability to drive or operate machinery.
DOSAGE, METHOD AND DURATION OF ADMINISTRATION
Adults
The recommended dose in adults is 400 mg/day taken in a single dose (see
“Precautions for use”).
The usual duration of treatment is 7 days. If necessary, it may be continued for up to 14 days.
Elderly patients
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Elderly patients can be treated with the same dose as adults. In severe renal impairment, renal function should be assessed and the dose adjusted (see “Precautions for
use”).
Adolescents ≥ 12 years of age
Adolescents > 12 years can receive the same dose recommended for adults.
Children from 6 months to 11 years of age
In children from 6 months to 11 years, cefixima is recommended to be administered in the form of an oral suspension. The recommended dosage in children is 8 mg/kg/day, administered as a single dose or
divided into two doses.
Children under 6 months of age
The safety and efficacy of cefixima have not been evaluated in children under 6 months of age.
Renal insufficiency
STADIUM can be administered in the presence of impaired renal function. The
normal dose and regimen can be used in patients with creatinine clearance > 20 ml/minute. In patients with creatinine clearance <20 ml minute, it is
recommended not to exceed a dose of 200 mg once a day. The dose and regimen in
patients undergoing chronic ambulatory peritoneal dialysis or hemodialysis should follow the same
recommendations as patients with creatinine clearance less than 20 ml/minute.
Data relating to use in children and adolescents with renal insufficiency are insufficient. Therefore
the use of cefixima is not recommended in these patient groups.
Method of administration
STADIUM tablets are for oral use only. STADIUM tablets should be
taken with sufficient water.
STADIUM can be taken with or without food.
OVERDOSAGE
Up to 2 grams per day (equivalent to 5 tablets of 400 mg), STADIUM has shown the same tolerability observed in patients treated with the recommended therapeutic doses in healthy volunteers.
However, in case of accidental ingestion/intake of an excessive dose of
STADIUM, immediately inform your doctor or go to the nearest hospital.
WHAT TO DO IF YOU FORGET TO TAKE A DOSE OR MORE
If the patient forgets the daily dose at the scheduled time (e.g. in the evening), they should take it as soon as possible (e.g. the next morning: in this case, two doses will be taken on the same day).
UNDESIRABLE EFFECTS
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If you have any doubts about the use of STADIUM, consult your doctor or pharmacist.
Like all medicines, Cefixima can cause side effects, although not everyone will experience them.
The following side effects are important and, if they occur, require immediate intervention.
You should stop taking Cefixima and consult your doctor immediately if
the following symptoms appear:
Very rare undesirable effects (affecting less than 1 in 10,000 patients)include:
- Severe watery diarrhea, which may also contain blood
- Sudden severe allergic reactions (anaphylactic shock) such as skin rash or hives, itching, swelling of the face, lips, tongue or other parts of the body, feeling of tightness in the chest, wheezing and collapse.
- Severe skin disease with blistering on the skin, in the mouth, in the eyes and on the genitals (Stevens Johnson Syndrome, Toxic Epidermal Necrolysis).
The following side effects have also been reported:
Common undesirable effects (affecting less than 1 in 10 patients)include:
- Diarrhea.
Uncommon undesirable effects (affecting less than 1 in 100 patients)include:
- Headache
- Nausea
- Vomiting
- Abdominal pain (stomach)
- Changes in blood tests concerning liver function
- Skin rash.
Rare undesirable effects (affecting less than 1 in 1000 patients)include:
- Increased risk of having infections caused by germs on which Cefixima does not act, for example thrush
- Increased number of white blood cells called eosinophils
- Allergic reaction
- Loss of appetite
- Dizziness
- Flatulence (air in the intestine)
- Itching
- Inflammation of mucous membranes such as those of the mouth and/or internal surfaces
- Fever
- Changes in blood tests that measure kidney function.
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Very rare undesirable effects (affecting less than 1 in 10,000 patients)include:
- Decrease in the number of different blood cells (symptoms may include fatigue, new infections and easy bruising or bleeding)
- Allergic reactions characterized by skin rash, fever, joint pain and enlargement of organs
- Restlessness and increased activity
- Liver problems, including jaundice (yellowing of the skin and whites of the eyes)
- Inflammation of the kidneys.
If any of these side effects worsen, or if you notice any
EXPIRY DATE AND STORAGE
STADIUM must be used within the expiry date indicated on the packaging and on the
blister.
DO NOT EXCEED THE EXPIRY DATE. This date is valid only if the packaging
is intact.
Keep the medicine out of the reach and sight of children.
Store the product at a temperature not exceeding 25 °C.
The expiry date indicated refers to the product in intact packaging, stored correctly.
COMPOSITION
One film-coated tablet contains:
Active ingredient:cefixima trihydrate 447.68 mg, equivalent to 400 mg of anhydrous cefixima.
Excipients:anhydrous calcium hydrogen phosphate, pregelatinized starch, hydroxypropylcellulose,
microcrystalline cellulose, magnesium stearate. Coating: polyvinyl alcohol, titanium dioxide,
talc, soy lecithin, xanthan gum.
PHARMACEUTICAL FORM AND CONTENT
Film-coated tablets, 5 tablets.
MARKETING AUTHORISATION HOLDER
S.F. GROUP S.R.L.
VIA TIBURTINA, 1143, 00156 - ROME
PRODUCER RESPONSIBLE FOR BATCH RELEASE
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far, Birzebbugia, BBG 3000, Malta
25/11/2011
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- Страна регистрации
- Форма выпускаFilm-coated tablet, 400 MG
- Код АТХJ01DD08
- 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 STADIUMФорма выпуска: Film-coated tablet, 400 MGДействующее вещество: цефиксимПроизводитель: AUROBINDO PHARMA (ITALIA) S.R.L.Отпускается по рецептуФорма выпуска: Film-coated tablet, 400 MGДействующее вещество: цефиксимПроизводитель: DOC GENERICI SRLОтпускается по рецептуФорма выпуска: Film-coated tablet, 400 MGДействующее вещество: цефиксимПроизводитель: MYLAN S.P.A.Отпускается по рецепту
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Действующее вещество STADIUM — цефиксим. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.
STADIUM производится компанией S.F. GROUP 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 STADIUM с учетом вашей ситуации и местных правил. Вы можете записаться на онлайн-консультацию, чтобы обсудить возможные варианты.
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Другие лекарства с тем же действующим веществом (цефиксим) включают KEFIXIMA AUROBINDO, KEFIXIMA DOK JENERIKI, KEFIXIMA MYLAN. Они могут отличаться торговым названием или формой выпуска, но содержат одинаковый терапевтический компонент. Перед изменением лечения рекомендуется проконсультироваться с врачом.
