Uvix

Contraindications

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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.

Undesirable effects

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).

Therapeutic indications

An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.

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.

Name of the medicinal product

Uvix

Special warnings and precautions for use

There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.

Use Uvix as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Uvix. Talk to your pharmacist if you have questions about this information.
• Shake well before each use.
• Uvix is only for the ear. Do not get it in your eyes, nose, or mouth.
• Wash hands before and after using Uvix.
• Before using, hold the ear drop container in your hand for a few minutes to avoid dizziness that may result from putting cold drops into the ear.
• If possible, it may be easier to have another person place the drops in your ear.
• To use Uvix for a middle ear infection in a child with ear tubes, the child should lie down so that the affected ear faces up. Place the dropper directly over the ear and drop the correct number of drops into the ear canal. Gently press the cartilage flap covering the opening to the ear 5 times in a pumping motion. This will allow the medicine to pass into the middle ear. Keep the ear facing up for at least 60 seconds so the medicine can run to the bottom of the ear canal.
• To use ear drops for an outer ear infection, lie down or tilt your head so that the affected ear faces up. Gently pull the earlobe up and back to straighten the ear canal. Drop the medicine into the ear canal. Keep the ear facing up for at least 60 seconds so the medicine can run to the bottom of the ear canal. A clean cotton plug may be gently inserted into the ear canal to prevent medicine from leaking out.
• To prevent germs from contaminating your medicine, do not touch the applicator to any surface, including the ear. Keep the container tightly closed.
• To clear up your infection completely, use Uvix for the full course of treatment. Keep using it even if you feel better in a few days.
• If you miss a dose of Uvix, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Uvix.

Dosage (Posology) and method of administration

Usual Adult Dose for Otitis Externa

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.

Interaction with other medicinal products and other forms of interaction

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.