See also:
What is the most important information I should know about Uvix?
It is contraindicated in-patients who are hypersensitive to Uvix or
other drugs from the same class of quinolones or gyrase inhibitors. Also
in-patients who are suffering from seizures (epileptics) and patients with
other existing damage to the central nervous system.
See also:
What are the possible side effects of Uvix?
Nausea, vomiting, dyspepsia, abdominal pain, diarrhoea, headache, dizziness,
sleep disorders, rash (rarely Stevens-Johnson syndrome and toxic epidermal necrolysis), pruritus, flatulence, dysphagia, tremor, hyperglycaemia,
altered prothrombin concentration, casualties, petechiae,
haemorrhagic bullae, tinnitus, tenosynovitis, tachycardia, oedema, syncope,
hot flushes and sweating. Less frequent adverse reactions include
anorexia, increase in blood urea and creatinine, drowsiness, restlessness,
asthenia, depression, confusion, hallucinations, convulsions, paraesthesia,
photosensitivity, hypersensitivity reactions including fever, urticaria,
angioedema, arthralgia, myalgia, and anaphylaxis; blood disorders
(including eosinophilia, leucopenia, thrombocytopenia); disturbances in
vision, hearing, taste and smell. Also isolated reports of tendon inflammation
and damage especially in the elderly and in those taking corticosteroids.
Other adverse reactions that have been reported include haemolytic
anaemia, renal failure, interstitial nephritis and hepatic dysfunction
including hepatitis and cholestatic jaundice.
USE DURING PREGNANCY AND LACTATION:
Uvix must not be prescribed to pregnant women or to nursing mothers,
since there is no experience with the drug safety in these patients
groups and since animal studies indicate that damage to articular cartilage in
the immature organism can not be fully excluded. Animal studies have not
yielded any evidence of teratogenic effects (malformations).
Lower Respiratory Tract Infections caused by Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Proteus mirabilis, Pseudomonas aeruginosa, Haemophilus influenzae, Haemophilus parainfluenzae, or Streptococcus pneumoniae. Also, Moraxella catarrhalis for the treatment of acute exacerbations of chronic bronchitis.
Bone and Joint Infections caused by Enterobacter cloacae, Serratia marcescens, or Pseudomonas aeruginosa.
Skin and Skin Structure Infections caused by Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Proteus mirabilis, Proteus vulgaris, Providencia stuartii, Morganella morganii, Citrobacter freundii, Pseudomonas aeruginosa, Staphylococcus aureus (methicillin-susceptible), Staphylococcus epidermidis, or Streptococcus pyogenes.
Typhoid Fever (Enteric Fever) caused by Salmonella typhi.
Urinary Tract Infections caused by Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Serratia marcescens, Proteus mirabilis, Providencia rettgeri, Morganella morganii, Citrobacter diversus, Citrobacter freundii, Pseudomonas aeruginosa, Staphylococcus epidermidis, Staphylococcus saprophyticus, or Enterococcus faecalis.
Acute Uncomplicated Cystitis in females caused by Escherichia coli or Staphylococcus saprophyticus.
Chronic Bacterial Prostatitis caused by Escherichia coli or Proteus mirabilis.
Acute Sinusitis caused by Haemophilus influenzae, Streptococcus pneumoniae, or Moraxella catarrhalis.
Complicated Intra-Abdominal Infections (used in combination with metronidazole) caused by Escherichia coli, Pseudomonas aeruginosa, Proteus mirabilis, Klebsiella pneumoniae, or Bacteroides fragilis.
Infectious Diarrhoea caused by Escherichia coli (enterotoxigenic strains), Campylobacter jejuni, Shigella boydii, Shigella dysenteriae, Shigella flexneri or Shigella sonnei when antibacterial therapy is indicated.
Uncomplicated cervical and urethral gonorrhoea due to Neisseria gonorrhoeae.
Uvix and Dexamethasone (Uvix) is a combination of two medicines used to treat ear infections. One of the medicines is an antibiotic (medicine used to fight infection) and the other is a corticosteroid (cortisone-like medicine). The antibiotic (Uvix) is used to fight ear infections. The corticosteroid (Dexamethasone (Uvix)) is used to relieve the redness, itching, and swelling caused by ear infections.
Uvix and Dexamethasone (Uvix) is used to treat middle ear infection with drainage through a tube in children 6 months of age and older. A middle ear infection is an infection caused by bacteria behind the eardrum. People who have a tube in the eardrum may notice drainage from the ear canal.
Uvix and Dexamethasone (Uvix) is also used to treat outer ear canal infections in patients 6 months of age or older. An outer ear canal infection, also known as “Swimmer's Ear,” is a bacterial infection of the outer ear canal. The ear canal and outer part of the ear may swell, turn red, and be painful. Also, a fluid discharge may appear in the ear canal.
Uvix and Dexamethasone (Uvix) is available only with your doctor's prescription.
Use Uvix as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Uvix.
4 drops in the affected ear{s} twice daily for 7 days
Usual Pediatric Dose for Otitis Media
>=6 months: 4 drops in the affected ear{s} twice daily for 7 days
Usual Pediatric Dose for Otitis Externa
>=6 months: 4 drops in the affected ear{s} twice daily for 7 days
Renal Dose Adjustments
No adjustment recommended
Liver Dose Adjustments
No adjustment recommended
Precautions
Uvix-Dexamethasone (Uvix) otic is contraindicated in patients with viral infections, including herpes simplex, of the external ear canal.
This drug is not approved for ophthalmic use.
Superinfection with nonsusceptible organisms (i.e., yeasts, fungi) may occur with antimicrobial therapy. Cultures should be obtained and used to guide therapy if there is no improvement after 1 week of treatment. Further evaluation to exclude other causes is necessary if otorrhea is still present after a course of therapy or occurs two or more times within 6 months.
The drug should be discontinued immediately at the first appearance of a skin rash or other signs of hypersensitivity.
Systemically administered fluoroquinolones (at doses larges than those given or absorbed otically) have been associated with an increased incidence of osteochondrosis and arthropathy in juvenile animals.
Dialysis
No adjustment recommended
Other Comments
Before administration, the suspension should be warmed by rolling the container in the hand for 1 to 2 minutes, then shaken well. The patient should lie down with the affected ear upward while the drops are instilled and remain in this position for 60 seconds to allow the suspension to penetrate the ear. The outer ear lobe should be gently pulled upward and backward to allow the drops to flow into the ear canal.
This procedure should be repeated for the other ear, if necessary.
Patients should be advised to avoid getting the infected ear(s) wet while bathing and to avoid swimming (unless otherwise instructed by their physician).
To avoid contamination, the tip of the container should not be allowed to touch the ear, fingers, or other surfaces.
The container should be protected from light.
The unused portion should be discarded after completion of therapy.
Concomitant administration of Uvix and iron, sucralfate, or
antacid containing magnesium, aluminum or calcium reduces the absorption
of Uvix. Therefore, Uvix should be taken 1
hr. before or 4 hrs. after taking these products.
Concomitant administration of Uvix and theophylline can cause
an undesirable rise in the serum theophylline concentration which may
lead to theophylline-determined side effects.
Animal studies show that the combination of very high doses of quinolones
(gyrase inhibitors) and certain anti-inflammatory drugs (nonsteroidal
anti-inflammatories) can provoke convulsions. This is not, however,
the case with drugs containing acetylsalicylic acid.
Concomitant administration of Uvix and warfarin can intensify
the action of the warfarin.
After concomitant administration of Uvix and glibenclamide, the
action of the glibenclamide can be intensified in isolated cases lowering
of blood glucose (hypoglycaemia).
Probenecid influences the excretion of Uvix in the urine. After
concomitant administration of Uvix and probenecid, the concentration
of Uvix in the blood (serum) rises.
Metoclopramide reduces the uptake of Uvix into circulation,
leading to maximum concentrations in the blood (serum) within a short
time.
