Xorimax

Xorimax

cefuroxime

Manufacturer:

Sandoz

Distributor:

Zuellig
/
Agencia Lei Va Hong
Full Prescribing Info
Contents
Cefuroxime axetil.
Description
Each film-coated tablet contains cefuroxime axetil 300.72 mg equivalent to cefuroxime 250 mg. It also contains the following excipients: Tablet Core: Sodium lauryl sulfate, copovidone, croscarmellose sodium (E468), magnesium stearate (E470B), anhydrous colloidal silicon dioxide (E551), mannitol (E421), microcrystalline cellulose (E460), crospovidone (E1202) and talc (E553B). Tablet Coating: Mannitol (E421), soluble (potato) starch, talc (E553B), titanium dioxide (E171) and aspartame (E951).
Action
Xorimax belongs to a group of antibiotics that are called cephalosporins. These type of antibiotics are similar to penicillin. Xorimax kills bacteria and it can be used against various infections.
Like all antibiotics, Xorimax is only effective against certain types of bacteria and suitable for treating certain types of infection.
Indications/Uses
Treatment of ear, sinus and throat infections; chest infections eg, bronchitis; bladder infections; skin and soft tissue infections [eg, furuncles, impetigo (an infection on the surface of the skin)]; early Lyme disease (from a tick bite) and to prevent late complications in adults and children >12 years.
Dosage/Direction for Use
Tablet: Adults and Children >12 years: Upper Respiratory Tract Infections eg, Tonsillitis, Otitis Media, Sinusitis and Pharyngitis: 250 or 500 mg twice daily for 5-10 days.
Lower Respiratory Tract Infections eg, Bronchitis and Pneumonia: 500 mg twice daily for 5-10 days.
Bladder Infections: 125 or 250 mg twice daily for 5-10 days.
Skin Infections: 250 or 500 mg twice daily for 5-10 days.
Treatment of Early Lyme Disease: 500 mg twice daily for 20 days.
Children 5-12 years: For the conditions listed previously: 125 or 250 mg twice daily for 5-10 days.
Acute Otitis Media: 250mg twice daily for 5-10 days.
No experience for usage for children <3 yrs.
The tablets should be taken after meals to improve the absorption of cefuroxime axetil into the body.
Suspension: Xorimax suspension is recommended for children <5 years.
Children 3 months to 5 years: The daily dose is adjusted according to the weight of the child. Mild Infections: Total amount 20 mg/kg/day body weight.
Moderate Infections and Ear Infections: Total amount 30 mg/kg/day.
To be given in 2 divided doses. Each dose is given every 12 hrs after a meal.
Tables 1 and 2 provides a guide to usual doses:

Click on icon to see table/diagram/image


Click on icon to see table/diagram/image

Maximum Dose: 2-12 years: 250 mg (10 mL) twice daily. 3 months to 2 years: 125 mg (5 mL) twice daily.
Children 5-12 years: 5 mL/1 measuring spoon to 10 mL/2 measuring spoons twice daily.
Children Weighing at least 20 kg: 10 mL twice daily or 1 tablet twice daily.
In children with kidney problems, the physician may prescribe a different dose than usual or taking doses less often than twice daily.
Duration of Treatment: The duration of treatment depends on the severity of the disease. It is usually 7-10 days, and longer in some cases. If treatment with Xorimax was discontinued too soon, the infection might recur.
Missed Dose: Take the missed dose as soon as remembered. It is not recommended to take a double dose to make up for missed doses.
Duration of Treatment: It is important to take Xorimax until the prescribed course is finished.
Overdosage
Overdose with Xorimax can lead to convulsions.
Contraindications
Hypersensitivity to cefuroxime axetil or to any of the other ingredients of Xorimax; and to any other cephalosporin or penicillin type of antibiotic.
Special Precautions
If severe and persistent diarrhea occurred during or after using Xorimax, avoid using medicines that inhibit peristalsis.
Abdominal complaints eg, vomiting and diarrhoea. It is possible that insufficient cefuroxime axetil will be absorbed by the body; and IV cefuroxime is recommended.
Occurrence of fever a short time after using Xorimax for the treatment of Lyme disease (a sign of Jarisch-Herxheimer disease).
In patients taking medicines that decrease stomach acidity, it is possible that insufficient cefuroxime axetil will be absorbed by the body (see Interactions).
Use in children: There is no experience in the use of Xorimax in children <3 months.
Some children have experienced mild to moderate hearing loss during treatment with cefuroxime sodium.
A course of Xorimax can temporarily increase the chance of acquiring infections caused by other microorganisms eg, thrush may occur.
Xorimax oral suspension contains sucrose. Patients with an intolerance to some sugars. One measuring spoonful (5 mL) of Xorimax suspension contains sucrose 2 g equivalent to 0.17 BU. This should be taken into account in patients with diabetes.
Xorimax oral suspension also contains aspartame (E951), a source of phenylalanine, which may be harmful to patients with phenylketonuria.
It also contains soy-lecithin. Patients allergic to soya or peanut should not take Xorimax.
Effects on the Ability to Drive or Operate Machinery: Xorimax does not affect ability to drive or operate machinery.
Use in pregnancy & lactation: Xorimax is not known to harm the unborn child, but it should only be given to a pregnant woman when necessary.
Xorimax should not be given to women who are breastfeeding as small amounts of cefuroxime are excreted in the milk.
Use In Pregnancy & Lactation
Xorimax is not known to harm the unborn child, but it should only be given to a pregnant woman when necessary.
Xorimax should not be given to women who are breastfeeding as small amounts of cefuroxime are excreted in the milk.
Side Effects
Severe allergic reactions to Xorimax are very rare (<1/10,000) or rare (<1/1000). These can include high fever; joint pain, swelling of eyelids, face or lips; severe skin rashes that can blister and may involve the eyes, mouth and throat, and genitals; loss of consciousness (fainting); severe diarrhoea or if there is blood in stool.
All of these reactions requires urgent medical attention. If any of these reactions occur, discontinue Xorimax.
Common side effects (<1/10) include: Fever and a feeling of generally being unwell shortly after taking Xorimax for the treatment of Lyme disease (Jarisch-Herxheimer reaction).
Gastrointestinal Disorders: Diarrhoea, nausea and vomiting.
Skin rash with or without severe itching and wheal formation (urticaria).
Renal and Urinary Disorders: In patients with renal impairment, changes in kidney function may occur (higher levels of creatinine and urea).
Uncommon side effects (<1/100) include: Nervous System Disorders: Headaches, dizziness.
Renal and Urinary Tract Disorders: Blood in the urine, fever and pain in the side (acute interstitial nephritis).
Rare side effects (<1/1000) include: Blood and Lymphatic System Disorders: Abnormal blood count eg, decreased haemoglobin level, leucopenia, neutropenia, eosinophilia, decrease in the number of small cells needed for blood clotting. This may result in easy bleeding or bruising.
Immune System Disorders: Allergic reactions with fever, swelling of joints, muscle pain, skin rash.
Liver and Bile Ducts: Changes in blood tests that evaluates hepatic function (AST, ALT, LDH, temporary increase in bilirubin).
General: Drug fever.
Very rare side effects (<1/10,000) include: Blood and Lymphatic System Disorders: Anaemia.
Nervous System Disorders: Restlessness, nervousness, confusion.
Liver and Bile Ducts: Jaundice.
Skin and Subcutaneous Tissue Disorders: Erythema multiforme.
Certain tests for determining some substances in the blood might show different results while taking Xorimax (Coombs' test).
Drug Interactions
Antacids (drugs that decrease stomach acidity eg, for heartburn); antibiotics eg, tetracyclines, macrolides, chloramphenicol, aminoglycosides; probenecid; diuretics; antifungal (amphotericin).
Storage
Suspension: Store reconstituted solution in a refrigerator (2-8°C) and keep the container tightly closed. Discard any remaining suspension after 14 days.
Suspension and Tablet: Do not store above 30°C.
MIMS Class
ATC Classification
J01DC02 - cefuroxime ; Belongs to the class of second-generation cephalosporins. Used in the systemic treatment of infections.
Presentation/Packing
Film-coated tab 250 mg (white to slightly yellowish, capsule-shaped, with a break line on both sides) x 100's.
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