Bula do remedy Rulid D

the package insert of the medicine Rulid D. Active principles Roxithromycin. Sale under medical prescription.

what For?

Infections caused by micro-organisms sensitive, such as:
. infections of the upper respiratory tract, for example: tonsillitis, pharyngitis, and acute sinusitis.

. infections of the lower respiratory tract, for example: pneumonia, bronchitis, pneumonia, atypical.

. infections of skin and soft tissue.

Contraindications

When should I not use?

Hypersensitivity to the macrolides and concomitant use with alkaloids vasoconstrictors of ergot, particularly ergotamine and diidroergotamina.

Dosage

How to use?

The average dose used in the paediatric clinical trials was 6 mg/kg/day.

The recommended dose is 5 to 8 mg/kg/day orally, divided into two jacks (morning and night).

treatment should not be prolonged for more than 10 days.

according To the child’s weight, the dose should be the following:
Weight (kg) daily Dose (mg/day) Number of tablets
Morning Night
6 – 11 50 ½ len, ½ len
12 – 23 100 1 comp 1 comp
24 – 40 200 2 comp 2 comp
For children weighing over 40 kg, the dose should be 150 mg twice a day. In this case, it is recommended to administer the tablets common.

RULID D should be administered preferably before meals. Add the recommended dose RULID D to the spoon that accompanies the product containing water. In the absence of the spoon, this may be replaced by a spoonful of dessert. Wait for the tablet to dissolve into small granules. Administer the suspension to a child, then a little bit of water.

Side Effects

What are the evils that can cause me?

gastrointestinal Symptoms: nausea, vomiting, with epigastric pain, diarrhoea (rarely with blood).

In isolated cases were observed for symptoms of pancreatitis. The majority of the patients received other substances, to which the pancreatitis is an adverse reaction known.

hypersensitivity Reactions: as well as to other macrolide antibiotics can occur rash, urticaria, angioedema, exceptionally, can occur purpura, bronchospasm and anaphylactic shock.

Feeling dizzy, headache, paresthesia.

moderate Increases in transaminases glutamic acid – pyruvic transaminase and glutamic – oxaloacetic transaminase and/or alkaline phosphatase. Cholestatic hepatitis and, more rarely, damage hepatocellular acute can occur.

there May be overgrowth of fungi.

as Well as for other macrolides, there have been reported cases of disorders of taste and/or smell.

Warnings and Precautions

what should I know before using?

In case of hepatic insufficiency, the administration of RULID D is not recommended. If required, it should be accompanied by regular tests of liver function and, possibly, reduction of the daily dose.

The renal elimination of roxithromycin and its metabolites is approximately 10 % of the oral dose. Therefore, in cases of renal insufficiency, the dosage should not be modified.

In studies with young animals, have been reported abnormalities in the growth curve, when used in doses of at least 10 times those used for the therapeutic indications. Therefore, it is recommended that the dose of 5 to 8 mg / kg / day is administered for maximum time of 10 days.

Overdose

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

After oral administration of a single dose of 2,000 mg/kg in dogs, were observed the following symptoms: vomiting, profuse diarrhea, apathy, and decreased motor activity.

In case of an overdose to proceed to gastric lavage and symptomatic treatment. there is no specific antidote.