Bula do remedy Rotram

the package insert of the medicine Rotram. Therapeutic class of the Systemic Antibiotics. Active principlesRoxithromycin.

what For?

As the antibacterial germs defined above as sensitive in infections, notably in Otorhinolaryngology, Pulmonology, and Dermatology. In genital infections, except those caused by gonococcal, and in the prophylaxis of meningococcal meningitis in contactantes.

Contraindications

When should I not use?

Rotram tablets is contraindicated for patients who have allergy to macrolide or are in concurrent use of alkaloids of the ergot.

Dosage

How to use?

Adults 1 tablet of 300 mg once a day preferably before meals for 5 days or at the physician’s discretion.

Children’s total daily Dose of 5 to 10 mg/kg of weight in a single outlet daily for 5 days or at the physician’s discretion.

we RECOMMEND THAT TABLETS OF 50 OR 100 mg to BE DILUTED IN WATER in A TABLESPOON OR DESSERT.

As a general rule, it is suggested that:
Age Weight regimen Suggestive
Up to 1 year 5 to 9 kg 1 2 tablets 50 mg on the single-socket
daily
Up to 6 years 10 to 19 kg 1 to 2 tablets of 50 or 100 mg into the outlet
single daily
Up to 10 years 20 to 29 lbs 1 to 2 tablets of 100 mg in single-socket
daily
Greater than 10 years > 30 kg 1 tablet of 300 mg in single-socket daily

Side Effects

What are the evils that can cause me?

Manifestations of the digestive tract: nausea, vomiting, epigastralgias, diarrhea.

the uncomplicated skin Manifestations of nature allergic: increase in transition as possible, of the transaminases and may evolve unusually for a cholestatic hepatitis.

Warnings and Precautions

what should I know before using?

In cases of liver failure, the administration of ROTRAM (roxithromycin) is not recommended. If it is required, then it must be accompanied by liver tests regular and, eventually, a reduction of dosage. The renal elimination of the molecule active is small, which allows you to keep the dosage in case of renal failure. In the elderly, the half-life is lengthened. However, after repeated administration of 150 mg every 12 hours, plasma concentrations peak and the area under the curve (in the steady state, between two outlets of roxithromycin) do not differ from those obtained in young people. Therefore it is not necessary to modify the dosing in the elderly.

Use during pregnancy and lactation
Pregnancy The results of studies conducted in animals have not shown teratogenic effects. In the absence of clinical data, these experimental results do not allow to predict malformations in the human species.

Breastfeeding The passage of the drug into the breast milk is very low.

Overdose

what to do if someone use a larger amount than is recommended?

In the dog, after oral administration of a single dose of 2,000 mg/kg, were observed vomiting abundant, diarrhea, apathy, and decreased motor activity. In case of an overdose, proceed to gastric lavage and symptomatic treatment. There is no specific antidote.

Drug Interactions

Were described manifestations of ergotismo with the possibility of necrosis of the extremities after the simultaneous use of macrolides and products of ergotamine, or other derived vasoconstrictors of the ergot of rye. In cases of association with bromocriptine, it will be necessary to consider the rate increase plasma bromocriptine, with possible increased activity antiparkinsoniana or the appearance of signs of superdose dopaminergic (dyskinesias). Roxithromycin is likely to be a factor of increased rates of circulating of cyclosporine (inhibition of its catabolism) and serum creatinine. In the case of association of these medications, you should decrease the doses of cyclosporine and monitor renal function; on the other hand, it is convenient to measure the rates of circulating cyclosporine and adapt the dosage during the association and after its termination.

Introduction

R The T R A M *
ROXITHROMYCIN
Tablets

Technical Information

ROTRAM (roxithromycin) is an antibiotic that is bactericidal semi-synthetic family of macrolide that acts by inhibiting the protein synthesis of the bacterial cell. Your spectrum antibacterial natural is the following:
Species usually sensitive: Streptococcus aureus; Streptococcus mitis, sanguis, viridans; Streptococcus agalactiae; Pneumococcus; Meningococcus; Bordetella pertussis; Branhamella catarrhalis; Corynebacterium diphteriae; Listeria monocytogenes; Clostridium; Mycoplasma pneumoniae; Pasteurella multocida; Chlamydia trachomatis, and psittaci; Ureaplasma urealyticum; Legionella pneumophila; Campylobacter; Gardnerella vaginalis.

Species variably sensitive: Haemophilus influenzae; Bacteroides fragilis; Vibrio cholerae; Staph. aureus, Gonococcus.

hardy Species: Enterobacteriaceae; Pseudomonas.

pharmacokinetics
Absorption rapid Absorption. The antibiotic is found in serum from the 15 in the minute; the peak in serum is 1 to 2 hours after oral administration. It has been demonstrated that the taking of a pill 15 minutes before a meal does not produce modifications in the pharmacokinetic in the normal individual.

Distribution The pharmacokinetics parameters after single-socket of a tablet in the normal individual, are the following: maximum plasma concentration of on average 6.6 mg/l; concentration (12 hours after the 1 jack) in an average of 1.8 mg/l. the Half-life of elimination average of 10.5 hours. After administration of repeated doses in the normal individual of 150mg (every 12 hours during 10 days) on the serum level, the state of equilibrium is reached between the second and the fourth day. The plasma concentrations at equilibrium are the following: maximum concentration of 9.3 mg/l; the minimum concentration of 3.6 mg/l. Diffusion tissue good, especially in the lung tissue (5,6) and 3.7 mg/kg); in tonsils (2.6 and 1.7 mg/kg); in the prostatic tissue (2.8 to 2.4 mg/kg). These tissue concentrations are reported respectively 6 and 12 hours after taken repeated 150 mg roxithromycin. Binding to plasma protein: 96%; roxithromycin fixed itself primarily to alpha 1-acid glycoprotein. This binding is saturable and decreases to a concentration of roxithromycin more than 4 mg/l. it was Found a passage very weak roxithromycin for milk: less than 0.05% of the amount present in the administered dose.

Biotransformation roxithromycin is relatively little biotransformada: more than 50% of the product is excreted unmodified. Three structures have been identified in the urine and in the stool: a descladinose roxithromycin is derived more abundant, and the N-mono and N-didemetil roxitromicinas, metabolites smaller. The proportions of roxithromycin and its three derivatives are close in the urine and in the faeces.

Excretion elimination is primarily fecal; after oral administration of roxithromycin radiomarcada with carbon 14, radioactivity urinary represents, in 72 hours, only 12% of the total excreted in the urine and in the faeces.

Patient Information

Rotram is an antibiotic that is bactericidal semi-synthetic family of macrolide that acts by inhibiting the protein synthesis of the bacterial cell.

Rotram Tablets should be stored at temperature between 2 °C and 30 °C, protected from light and moisture.

The validity period is 24 months and is engraved on the outer packaging. In the case of maturity, discard the product.

Tell your doctor the occurrence of pregnancy during treatment or after its termination.

Inform your doctor if you are breast-feeding.

The soluble tablets are produced with differentiated technology where the special coating smoothes out the bitter taste.

The soluble tablets, white in color, should be diluted in water before swallowed. We recommend diluting each tablet in water, a tablespoon or dessert. After dissolving the product, the child should take it immediately in the spoon or mixed with milk, juice, etc.

Some of the beads are in solution. Don’t try to knead or dissolve these granules.

After ingesting the product, the child can take liquid to help swallow the beads that may have remained in the mouth.

Follow the guidance of your doctor, always respecting the schedules, doses and duration of treatment.

do Not stop treatment without the knowledge of your doctor.

Tell your doctor the appearance of reactions unpleasant such as nausea, vomiting, epigastralgias, diarrhea.

ALL MEDICINE SHOULD BE KEPT OUT of the REACH OF CHILDREN.

Tell your doctor about any medicine you are using, before the beginning or during the treatment.

This product is contraindicated for patients who feature allergy to macrolides, or are in concurrent use of alkaloids of the ergot.

do NOT TAKE MEDICINE WITHOUT THE KNOWLEDGE OF YOUR DOCTOR, CAN BE DANGEROUS TO HEALTH.

the Pharmaceutical Form/presentation

USE of ADULT AND PEDIATRIC
ROTRAM * 300 mg Each film-coated tablet contains 300 mg of roxithromycin. Components inactive: talc, croscarmelose sodium, magnesium stearate, microcrystalline cellulose, silicon dioxide, cellactose, eudragit L-100, trietilcitrato, glycerin, titanium dioxide, blue dye FDC n the 1.

Cartridge with 5 or 7 tablets of blue color.

ROTRAM * 100 mg Each tablet soluble ccontains 100 mg of roxithromycin. Components inactive: talc, croscarmelose sodium, magnesium stearate, microcrystalline cellulose, silicon dioxide, citric acid, aspartame, saccharin sodium, aroma of cherry, sorbitol, maize starch.

Cartridge with 10 tablets of white color.

ROTRAM * 50 mg Each tablet soluble contains 50 mg of roxithromycin. Components inactive: talc, croscarmelose sodium, magnesium stearate, microcrystalline cellulose, silicon dioxide, citric acid, aspartame, saccharin sodium, aroma of cherry, sorbitol, maize starch.

Cartridge with 10 tablets of white color.

Laboratory

Ind. Quím. and Farm. Schering-Plough S. A.

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Attention: the remedy of The earth is a space character only, with issues related to health and well-being, The information here disclosed shall not be used as a substitute for a doctor’s prescription for the treatment of any disease.