Exocine

Exocine

  • Active Ingredient: Ofloxacin
  • 400 mg, 200 mg
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What is Exocine?

The active ingredient of Exocine brand is ofloxacin. Ofloxacin is a fluoroquinolone (flor-o-KWIN-o-lone) antibiotic that fights bacteria in the body. Ofloxacin, USP is an off-white to pale yellow crystalline powder. The molecule exists as a zwitterion at the pH conditions in the small intestine. The relative solubility characteristics of Ofloxacin, USP at room temperature, as defined by USP nomenclature, indicate that Ofloxacin, USP is considered to be soluble in aqueous solutions with pH between 2 and 5. It is sparingly to slightly soluble in aqueous solutions with pH 7 (solubility falls to 4 mg/mL) and freely soluble in aqueous solutions with pH above 9. Ofloxacin, USP has the potential to form stable coordination compounds with many metal ions. This in vitro chelation potential has the following formation order: Fe +3 > Al +3 > Cu +2 > Ni +2 > Pb +2 > Zn +2 > Mg +2 > Ca +2 > Ba +2.

Used for

Exocine is used to treat diseases such as: Anthrax, Anthrax Prophylaxis, Bladder Infection, Bone infection, Bronchitis, Campylobacter Gastroenteritis, Cervicitis, Chancroid, Chlamydia Infection, Epididymitis, Non-Specific, Epididymitis, Sexually Transmitted, Gonococcal Infection, Disseminated, Gonococcal Infection, Uncomplicated, Joint Infection, Kidney Infections, Methicillin-Resistant Staphylococcus Aureus Infection, Mycobacterium avium-intracellulare, Treatment, Nongonococcal Urethritis, Pelvic Inflammatory Disease, Plague, Pneumonia, Prostatitis, Salmonella Enteric Fever, Salmonella Gastroenteritis, Shigellosis, Skin or Soft Tissue Infection, Traveler's Diarrhea, Tuberculosis, Active, Urinary Tract Infection.

Side Effect

Possible side effects of Exocine include: tender, swollen glands in the neck; loss of interest or pleasure; vomiting; unusual bleeding or bruising; difficult or painful urination; discharge or excessive tearing; cool, pale skin.

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How should this medicine be used?

Exocine comes as a tablet to take by mouth. It is usually taken with or without food twice a day for 3 days to 6 weeks. The length of treatment depends on the type of infection being treated. Your doctor will tell you how long to take Exocine. Take Exocine at around the same times every day and try to space your doses 12 hours apart. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take Exocine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

You should begin to feel better during the first few days of your treatment with Exocine. If your symptoms do not improve or if they get worse, call your doctor.

Take Exocine until you finish the prescription, even if you feel better. Do not stop taking Exocine without talking to your doctor unless you experience certain serious side effects that are listed in the IMPORTANT WARNING and SIDE EFFECT sections. If you stop taking Exocine too soon or if you skip doses, your infection may not be completely treated and the bacteria may become resistant to antibiotics.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long term studies to determine the carcinogenic potential of Exocine have not been conducted.

Exocine was not mutagenic in the Ames test, in vitro and in vivo cytogenic assay, sister chromatid exchange assay (Chinese hamster and human cell lines), unscheduled DMA synthesis (UDS) assay using human fibroblasts, the dominant lethal assay, or mouse micronucleus assay. Exocine was positive in the UDS test using rat hepatocyte, and in the mouse lymphoma assay.

In fertility studies in rats, Exocine did not affect male or female fertility or morphological or reproductive performance at oral dosing up to 360 mg/kg/day (equivalent to 4000 times the maximum recommended daily ophthalmic dose).

Exocine

Pharmacologic class: Fluoroquinolone

Therapeutic class: Anti-infective

Pregnancy risk category C

Exocine eye drops are used to treat bacterial eye infections. They work by helping to kill the bacteria which are causing the infection.

Before using Exocine eye drops,

  • tell your doctor and pharmacist if you are allergic to Exocine, benzalkonium chloride, ciprExocine (Cipro), enoxacin (Penetrex), levExocine (Levaquin), lomefloxacin (Maxaquin), norfloxacin (Noroxin), sparfloxacin (Zagam), cinoxacin (Cinobac), nalidixic acid (NegGram), or any other medications.
  • tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Be sure to mention any of the following: anticoagulants ('blood thinners') such as warfarin (Coumadin), cyclosporine (Neoral, Sandimmune), and theophylline (Theo-Dur). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
  • tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using Exocine ophthalmic, call your doctor.
  • you should know that Exocine solution contains benzalkonium chloride, which can be absorbed by soft contact lenses. Remove your contact lenses before instilling Exocine and put them back in 10 minutes after you instill the medication.

What Are Side Effects Associated with Using Exocine?

Common side effects of Exocine include:

Less common side effects of Exocine include:

This is not a complete list of side effects and other serious side effects may occur. Call your doctor for information and medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Exocine side effects

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Exocine can cause serious side effects, including tendon problems, side effects on your nerves (which may cause permanent nerve damage), serious mood or behavior changes (after just one dose), or low blood sugar (which can lead to coma).

Stop taking this medicine and call your doctor at once if you have:

low blood sugar--headache, hunger, sweating, irritability, dizziness, nausea, fast heart rate, or feeling anxious or shaky;

nerve symptoms in your hands, arms, legs, or feet--numbness, weakness, tingling, burning pain;

serious mood or behavior changes--nervousness, confusion, agitation, paranoia, hallucinations, memory problems, trouble concentrating, thoughts of suicide; or

signs of tendon rupture--sudden pain, swelling, bruising, tenderness, stiffness, movement problems, or a snapping or popping sound in any of your joints (rest the joint until you receive medical care or instructions).

In rare cases, Exocine may cause damage to your aorta, the main blood artery of the body. This could lead to dangerous bleeding or death. Get emergency medical help if you have severe and constant pain in your chest, stomach, or back.

Also, stop using Exocine and call your doctor at once if you have:

severe stomach pain, diarrhea that is watery or bloody;

fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out);

the first sign of any skin rash, no matter how mild;

muscle weakness, breathing problems;

little or no urination;

a seizure (convulsions);

increased pressure inside the skull--severe headaches, ringing in your ears, vision problems, pain behind your eyes; or

liver problems--upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects may include:

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

CONTRAINDICATIONS

Exocine ophthalmic solution is contraindicated in patients with a history of hypersensitivity to Exocine, to other quinolones, or to any of the components in this medication.

Short-Term Effects

  • See "What Are Side Effects Associated with Using Exocine?"

Important Information

Exocine can cause serious side effects, including tendon problems, nerve damage, serious mood or behavior changes, or low blood sugar.

Stop using Exocine and call your doctor at once if you have symptoms such as: headache, hunger, irritability, numbness, tingling, burning pain, confusion, agitation, paranoia, problems with memory or concentration, thoughts of suicide, or sudden pain or movement problems in any of your joints.

In rare cases, Exocine may cause damage to your aorta, which could lead to dangerous bleeding or death. Get emergency medical help if you have severe and constant pain in your chest, stomach, or back.

Microbiology

Exocine has in vitro activity against a broad range of gram-positive and gram-negative aerobic and anaerobic bacteria. Exocine is bactericidal at concentrations equal to or slightly greater than inhibitory concentrations. Exocine is thought to exert a bactericidal effect on susceptible bacterial cells by inhibiting DMA gyrase, an essential bacterial enzyme which is a critical catalyst in the duplication, transcription, and repair of bacterial DMA.

Cross-resistance has been observed between Exocine and other fluoroquinolones. There is generally no cross-resistance between Exocine and other classes of antibacterial agents such as beta-lactams or aminoglycosides. Exocine has been shown to be active against most strains of the following organisms both in vitro and clinically, in conjunctival and/or corneal ulcer infections as described in the INDICATIONS section.

The safety and effectiveness of Exocine ophthalmic solution in treating ophthalmologic infections due to the following organisms have not been established in adequate and well-controlled clinical trials. Exocine ophthalmic solution has been shown to be active in vitro against most strains of these organisms but the clinical significance in ophthalmologic infections is unknown.

Renal impairment

  • CrCl 20-50 mL/min: Give q24hr
  • CrCl Enter a drug name and Exocine

Exocine eye drops may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • eye burning or discomfort
  • eye stinging or redness
  • tearing eyes
  • sensitivity to light
  • blurred vision
  • dry eyes

What is Exocine? How does it work?

Exocine is an antibiotic that is used to treat bacterial infections. It belongs to the fluoroquinolone class of antibiotics which includes levExocine (Levaquin), ciprExocine (Cipro), gatifloxacin (Tequin), norfloxacin (Noroxin), moxifloxacin (Avelox), trovafloxacin (Trovan) and others. Exocine stops the multiplication of bacteria by inhibiting the reproduction and repair of their genetic material (DNA). The FDA approved Exocine in December 1990.

What are some things I need to know or do while I take Exocine?

  • Tell all of your health care providers that you take Exocine (ophthalmic). This includes your doctors, nurses, pharmacists, and dentists.
  • Use care when driving or doing other tasks that call for clear eyesight.
  • Bright lights may bother you. Wear sunglasses.
  • Do not use longer than you have been told. A second infection may happen.
  • Very bad and sometimes deadly allergic reactions have rarely happened with other forms of Exocine (ophthalmic) as well as drugs like this one. Talk with the doctor.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Exocine (ophthalmic) while you are pregnant.

What Is Exocine Ophthalmic?

Exocine is a fluoroquinolone (flor-o-KWIN-o-lone) antibiotic that fights bacteria in the body.

Exocine ophthalmic (for use in the eyes) is used to treat bacterial infections of the eyes.

Exocine ophthalmic is also used to treat an ulcer in the cornea of the eye.

Exocine will not treat a viral or fungal infection of the eye.

Exocine ophthalmic may also be used for purposes not listed in this medication guide.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

You should not use this medicine if you are allergic to Exocine or other fluoroquinolones (ciprExocine, gemifloxacin, levExocine, moxifloxacin, norfloxacin, and others).

Do not use this medicine to treat a viral or fungal infection in the eye. Exocine ophthalmic is for use in treating only bacterial infections of the eye.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether Exocine ophthalmic passes into breast milk or if it could affect the nursing baby. Tell your doctor if you are breast-feeding.

Exocine eye drops (solution) are not approved for use by anyone younger than 1 year old.

Getting the most from your treatment

  • Before you start the treatment, read the manufacturer's printed information leaflet from the pack. The manufacturer's leaflet will give you more information about the drops, and a full list of side-effects which you may experience from using them.
  • If your eyes have an obvious discharge or 'crust', it can help if you bathe them with cool clean water before using Exocine.
  • Use the drops regularly, exactly as your doctor tells you to. If the infection is severe, this is likely to be every 2-4 hours for the first two days. (Just use the drops while you are awake - you do not need to wake yourself up during the night to put them in.) On day three, reduce the frequency down to four times a day.
  • If your symptoms do not improve within a few days, or if they become worse, speak again with your doctor.
  • When you first put the drops into your eye, it may cause blurred vision. This should quickly clear, but make sure you can see clearly again before you drive or use machines or tools.
  • Take care to avoid spreading the infection from one eye to the other, and to other members of your family. Washing your hands regularly (particularly after touching your eyes), and not sharing towels or pillows will help to prevent the infection from spreading.
  • If the tip of the bottle touches your eye(s) when putting the drops in, it is a good idea to squeeze out two or three drops straightaway on to some tissue and rinse the tip with salt water.
  • Eye infections, or using Exocine eye drops, may cause your eyes to become more sensitive to sunlight than usual. Wearing sunglasses may help to protect your eyes.
  • If you are using any other eye drops, leave at least five minutes between applying each preparation. This is to prevent more liquid going into your eye than it can handle. Otherwise the drops will overflow from your eye and not have the intended effect.
  • Even when your eye appears normal again, there may still be some bacteria present. It is important to continue to use the drops for a further 48 hours once your eye appears normal. This will help to make sure that all the bacteria have been killed. It is likely that you may need to use the drops for about a week, but you should not use them for any longer than 10 days.
  • Do not wear contact lenses until your symptoms have completely gone. Wait for 24 hours after the last dose of eye drops before using your lenses again.

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