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Febratic Chewable Tablets 9895

The document describes the indications, dosages, and warnings for the use of ibuprofen in 200 mg chewable tablets for the treatment of fever and pain in children. It recommends doses of 100 to 400 mg depending on the child's age and weight, 3 to 4 times a day. It warns about possible gastrointestinal adverse effects and other interactions with other medications.
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0% found this document useful (0 votes)
30 views2 pages

Febratic Chewable Tablets 9895

The document describes the indications, dosages, and warnings for the use of ibuprofen in 200 mg chewable tablets for the treatment of fever and pain in children. It recommends doses of 100 to 400 mg depending on the child's age and weight, 3 to 4 times a day. It warns about possible gastrointestinal adverse effects and other interactions with other medications.
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd

Children aged 9 to 10 years (27 to 33 kilograms in weight):

1 to 1 and 1/2 tablets (200 mg to 300 mg) three or four times a day, at regular intervals.

Febratic
Children aged 11 years (34 to 43 kilograms in weight):
1 and 1/2 tablets (300 mg) three or four times a day, at regular intervals.
Children from 12 years old and up:
2 tablets (400 mg) three or four times a day, at regular intervals.
In the case that the fever is above 38°, each dose can be 10 mg/kg, always without
exceed 40 mg / kg / day. For example, a child weighing 20 kg will receive a dose of 1 tablet;

Ibuprofen
one of 30 kg, dose of 1 and 1/2 tablet; 1 of 40 kg, dose of 2 tablets.
Chewable tablets can be chewed or slowly dissolved in the mouth.
They can also be administered dissolved in a little water, milk, or non-alcoholic beverages.
Older children and adults with good swallowing can ingest them whole.
According to the intensity of the symptoms, the recommended dose is 20 to 40 mg/kg/day.
Oral route divided into three or four daily doses, at regular intervals.
Maximum recommended dose: 40 mg / kg / day.
Chewable tablets 200 mg Do not administer more than four times a day.
Clinical studies have shown that Ibuprofen can be used as an antipyretic without
inconveniences in children over 6 months.
Formula
Contraindications
Eachchewabletabletcontains:Ibuprofen(asmicroencapsulatedibuprofen)
Hypersensitivity to Ibuprofen. History of angioedema, bronchospasm, or reactions
200mg.Excipients:Mannitol;Aspartame;Alluraredaluminumlakedye;Essence
allergic to aspirin or other antipyretics or analgesics. It should not be administered during the
defrutilaenpolvo;Esenciadebananaenpolvo;Esenciadelimónenpolvo;Estearatode
pregnancy, unless the doctor has expressly indicated it. Phenylketonuria.
magnesio;Lactosa;Celulosamicrocristalina;Croscarmelosasódica.
Warnings
Therapeuticaction Although Ibuprofen is one of the non-steroidal anti-inflammatory drugs with the lowest gastrointestinal toxicity,
Antipyretic. Analgesic. Non-steroidal anti-inflammatory. It is advised not to administer it to patients with a history of peptic ulcer or gastrointestinal bleeding.
Due to the presence of aspartame, it should not be administered to phenylketonurics.
Instructions
Feverish episodes. Mild to moderate pain. Post-traumatic inflammatory conditions. Osteoarthritis. Precautions
Rheumatoid arthritis. As with other nonsteroidal anti-inflammatory drugs (NSAIDs), with Febratic, you should be aware of the
following precautions:
Pharmacologicalaction It is advised not to administer it to patients with a history of asthma or nasal polyposis syndrome.
Ibuprofen is a non-steroidal anti-inflammatory drug derived from propionic acid. It works by AlthoughIbuprofenhasalesserantiplateleteffectthanaspirin,
inhibition of prostaglandin synthesis. should be used with caution in patients with coagulation disorders or who are
theyareonanticoagulanttreatment.
Pharmacokinetics: It can cause fluid retention and edema, therefore it should be used with caution in
Ibuprofenisrapidlyabsorbedorally,reachingmaximumplasmaconcentration. patients with high blood pressure or heart failure.
between 1 and 2 hours after administration.Absorption is not significantly altered by Itcancausechangesintransaminaselevelsinthefirstmonthsoftreatment.
foods (decrease the speed but not the magnitude of absorption) nor by antacids. which usually regress when treatment is discontinued. Hepatotoxicity has rarely been reported.
It shows high binding (> 99%) to plasma proteins. It undergoes rapid metabolism and Ibuprofen seems to be the anti-inflammatory with the lowest risk of hepatotoxicity.
most of the dose is recovered in the urine within 24 hours of administration under the Therefore, if strictly necessary, it is the NSAID of choice in patients at risk of
formofmetabolites(62%),freeIbuprofen(1%)orconjugated(14%).Therestisrecoveredin hepatotoxicity.
fecesasmetabolitesorunabsorbedIbuprofen. Scotomas,alterationofcolorvisionand/ordecreasedvisionhaverarelybeenreported.
visualacuity.Thesedefectswerereversibleupondiscontinuingthemedication.
Dosageandmethodofadministration In at-risk patients (with real or effective hypovolemia or with previous renal insufficiency) there
As a guideline, the recommended doses are: it can trigger acute renal failure or an exacerbation of renal failure
Children from 2 to 3 years old (11 to 16 kilograms in weight): preexistingconditionsthatusuallyreverseupondiscontinuationofthemedication.Rarelyhavetheybeenreported.
1/2 tablet (100 mg) three or four times a day, at regular intervals. casesofinterstitialnephritisornephroticsyndrome.
Children from 4 to 5 years old (17 to 21 kilograms of weight): Aseptic meningitis cases have rarely been reported. 50% of the cases have been women.
1/2a 1 tablet (100 mg - 200 mg) three or four times a day, at regular intervals. with systemic lupus erythematosus, who have improved after the discontinuation of the medication.
Children from 6 to 8 years old (22 to 26 kilograms of weight): A decrease in hemoglobin and hematocrit has been observed, especially during the
1 tablet (200 mg) three or four times a day, at regular intervals. chronic treatment and with high doses.
Pregnancy: It should not be administered during pregnancy unless indicated by a doctor. Presentation
expressly. Febratic Chewable Tablets 200 mg: Package containing 20 chewable tablets.
Breastfeeding:There are not enough studies on the elimination of Ibuprofen in breast milk. It should not be
Oblong tablets, mottled pink color, scored, coded
administered during breastfeeding.
IP 200 on one side and with Roemmers identification Isotype on the other.
Pediatric use: The efficacy and safety of Ibuprofen in children under has not been established.
6 months old, therefore, Febratic is not recommended for them.
Instructionsforsplittingthescoredtablet:
If it were necessary -by medical prescription- to split the tablet,
Druginteractions
the following procedure is recommended:
As with all NSAIDs, interactions with other drugs may occur with Ibuprofen.
Place the tablet on a flat and rigid surface.
medications.
Apply pressure with the fingertips of both hands,
Oral anticoagulants and heparin: It could increase the risk of bleeding. simultaneously, on the sides of the groove until breaking it.
Lithium: Ibuprofen can cause an increase in plasma levels of lithium, as well as a
reduction of its renal clearance.
Diuretics: In some patients, Ibuprofen may reduce the natriuretic effect of furosemide.
and of the thiazides.
Other NSAIDs: They can increase the potential adverse effects inherent to this class of
medications.
Methotrexate: Ibuprofen, like most NSAIDs, decreases renal elimination.
frommethotrexateproducingelevatedandprolongedplasmalevels,andincreasingtherisk
Otherpresentations
oftoxicity.Ifconcomitantuseisnecessary,itisrecommendedthatthetreatmentwithNSAIDs
Febratic Suspension: Container containing 100 ml.
be discontinued for a period of 12 to 24 hours before and at least until 12 hours after
Febratic 400 Tablets: Packages containing 10 and 20 tablets.
the administration of a high-dose methotrexate infusion or until the concentration
Febratic 4% Suspension: Container containing 100 ml.
theplasmalevelsofmethotrexatehavedecreasedtonon-toxiclevels.
Gold sales: Although NSAIDs are commonly used simultaneously with compounds of
gold in the treatment of arthritis, the possibility of concomitant use must be taken into account
Sale on prescription.
it may increase the risk of adverse renal effects.
Argentinian Industry.
Adversereactions Medication authorized by the Ministry of Health. Certificate No. 49,388.
The most common adverse reactions are gastrointestinal (4 to 16%): Nausea, pain Technical Director: Mirta Beatriz Fariña, Pharmacist.
epigastric, heartburn, diarrhea, vomiting, indigestion, abdominal pain, constipation, and flatulence. Prepared at José E. Rodó 6424, C1440AKJ Autonomous City of Buenos Aires.
They are followed in order of frequency by: Disorders at the level of the central nervous system (vertigo, headache, Date of last update: January 2002.
nervousness); dermatological (maculopapular rash, itching); sensory organ (tinnitus);
hematological (leukopenia, agranulocytosis, anemia, thrombocytopenia, eosinophilia, decrease in the Medicinal product. Keep out of reach of children.
hemoglobin and hematocrit); general (decreased appetite); cardiovascular (edema); allergic Store in a dry place at a temperature below 30ºC.
(anaphylaxis, bronchospasm); renal (acute renal failure); others: Dryness of mucous membranes and rhinitis.
Information for professionals and users: 0-800-333-5658
Overdose
Toxicity depends on the amount of drug ingested and the time that has passed since its ingestion.
The most commonly reported symptoms in uncommon cases of ibuprofen overdose Roemmers S.A.I.C.F.
Theywere:Abdominalpain,nausea,vomiting,lethargy,anddrowsiness.Othersymptomsinclude:Headache, Fray Justo Sarmiento 2350, B1636AKJ Olivos, Province of Buenos Aires.
tinnitus and, very rarely, CNS depression, coma, acute renal failure, apnea, and toxicity
cardiovascular (hypotension, bradycardia, tachycardia and atrial fibrillation). www.roemmers.com.ar
Acute poisoning primarily requires supportive treatment. In cases of overdose
acute, due to the ingestion of doses less than 100 to 200 mg/kg in children, evacuation is recommended
gastricbyinducingvomiting.Withdosesof200to400mg/kgitshouldbeperformedimmediately
gastric lavage. The administration of activated charcoal can decrease the absorption of the drug.
The necessary support measures are advised. Depending on the patient's condition, it may be necessary
controlhypotension,acidosis,orgastrointestinalbleeding.Moreover,sinceitisadrug
acid that is excreted in the urine, it is recommended to administer alkalies and induce diuresis.
In the event of an overdose, go to the nearest hospital or contact
with the Toxicology Centers: Ricardo Gutiérrez Children's Hospital: (011) 4962-6666 / 2247,
Hospital A. Posadas

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