Besivance 0.6% Opth Susp5ml
It is used to treat eye infections.
Drug Class
Ophthalmic anti-infective
Pharmacologic Class
Fluoroquinolone antibiotic
Pregnancy Category
Category C
FDA Approved
May 2009
DEA Schedule
Not Controlled
Overview
What is this medicine?
Besifloxacin is an antibiotic eye drop used to treat bacterial infections of the eye, specifically bacterial conjunctivitis (pink eye). It works by killing the bacteria that cause the infection.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. Continue using the medication as directed, even if your symptoms improve. This medication is for eye use only.
Administration Instructions
1. Wash your hands before and after using the medication to prevent contamination.
2. Avoid touching the container tip to your eye, lid, or surrounding skin, as this can introduce bacteria into the medication and lead to severe eye problems or vision loss.
3. Before each use, turn the container upside down and shake it once.
4. Tilt your head back and gently drop the medication into your eye.
5. After administering the dose, keep your eyes closed and apply pressure to the inner corner of your eye for 1 to 2 minutes to help the medication stay in your eye.
6. Replace the cap on the container after use.
Important Precautions
Avoid wearing contact lenses unless your doctor advises you to do so.
Do not put contact lenses back in your eyes if they are irritated or infected.
Storage and Disposal
Store this medication at room temperature, away from light and freezing temperatures. Keep all medications in a safe place, out of the reach of children and pets.
Missed Dose Instructions
If you miss a dose, use it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not use two doses at the same time or take extra doses.
To use this medication correctly, follow your doctor's instructions and read all the information provided. Continue using the medication as directed, even if your symptoms improve. This medication is for eye use only.
Administration Instructions
1. Wash your hands before and after using the medication to prevent contamination.
2. Avoid touching the container tip to your eye, lid, or surrounding skin, as this can introduce bacteria into the medication and lead to severe eye problems or vision loss.
3. Before each use, turn the container upside down and shake it once.
4. Tilt your head back and gently drop the medication into your eye.
5. After administering the dose, keep your eyes closed and apply pressure to the inner corner of your eye for 1 to 2 minutes to help the medication stay in your eye.
6. Replace the cap on the container after use.
Important Precautions
Avoid wearing contact lenses unless your doctor advises you to do so.
Do not put contact lenses back in your eyes if they are irritated or infected.
Storage and Disposal
Store this medication at room temperature, away from light and freezing temperatures. Keep all medications in a safe place, out of the reach of children and pets.
Missed Dose Instructions
If you miss a dose, use it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not use two doses at the same time or take extra doses.
Lifestyle & Tips
- Do not wear contact lenses while using this medication or if you have signs and symptoms of bacterial conjunctivitis.
- Avoid contaminating the dropper tip by not touching it to the eye or any other surface.
- Wash hands thoroughly before and after administering eye drops.
- Do not share eye drops with others.
- Complete the full course of treatment, even if symptoms improve, to prevent recurrence and antibiotic resistance.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
1 drop into the affected eye(s) 3 times a day, approximately 4 to 12 hours apart, for 5 to 7 days.
Condition-Specific Dosing:
bacterialConjunctivitis:
1 drop into the affected eye(s) 3 times a day, approximately 4 to 12 hours apart, for 5 to 7 days.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established for infants under 1 year of age.
Child:
1 drop into the affected eye(s) 3 times a day, approximately 4 to 12 hours apart, for 5 to 7 days (for patients 1 year of age and older).
Adolescent:
1 drop into the affected eye(s) 3 times a day, approximately 4 to 12 hours apart, for 5 to 7 days.
Dose Adjustments
Renal Impairment:
Mild:
No dosage adjustment necessary due to minimal systemic absorption.
Moderate:
No dosage adjustment necessary due to minimal systemic absorption.
Severe:
No dosage adjustment necessary due to minimal systemic absorption.
Dialysis:
No specific considerations due to minimal systemic absorption.
Hepatic Impairment:
Mild:
No dosage adjustment necessary due to minimal systemic absorption.
Moderate:
No dosage adjustment necessary due to minimal systemic absorption.
Severe:
No dosage adjustment necessary due to minimal systemic absorption.
Pharmacology
Mechanism of Action
Besifloxacin is a fluoroquinolone antibacterial that inhibits bacterial DNA gyrase and topoisomerase IV, enzymes essential for bacterial DNA replication, transcription, repair, and recombination. This leads to inhibition of bacterial growth and cell death.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption
Tmax:
Not applicable (minimal systemic absorption)
FoodEffect:
Not applicable (ophthalmic administration)
Distribution:
Vd:
Not applicable (minimal systemic absorption)
ProteinBinding:
Not applicable (minimal systemic absorption)
CnssPenetration:
No (minimal systemic absorption)
Elimination:
HalfLife:
Not applicable (minimal systemic absorption)
Clearance:
Not applicable (minimal systemic absorption)
ExcretionRoute:
Not applicable (minimal systemic absorption)
Unchanged:
Not applicable (minimal systemic absorption)
Pharmacodynamics
OnsetOfAction:
Rapid (within hours for symptomatic relief)
PeakEffect:
Not precisely quantified for ophthalmic effect, but clinical improvement typically seen within 2-5 days.
DurationOfAction:
Approximately 4-12 hours (based on dosing frequency)
Confidence:
Medium
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Changes in eyesight, eye pain, or severe eye irritation
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you have side effects that bother you or persist, contact your doctor for guidance.
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Changes in eyesight, eye pain, or severe eye irritation
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you have side effects that bother you or persist, contact your doctor for guidance.
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Worsening eye redness, pain, or discharge
- New or worsening blurred vision
- Severe eye irritation or itching after using the drops
- Signs of an allergic reaction (e.g., rash, hives, swelling of face/lips/tongue, difficulty breathing)
- Any new or unusual eye symptoms
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions between this medication and other substances.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that it is safe to take this medication with all your current medications and health conditions. Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions between this medication and other substances.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that it is safe to take this medication with all your current medications and health conditions. Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. When taking this drug, exercise caution when driving or performing tasks that require clear vision to ensure your safety. Do not exceed the prescribed duration of use, as this may increase the risk of a secondary infection. If you are pregnant, planning to become pregnant, or are breastfeeding, consult your doctor to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Unlikely to occur with ophthalmic administration due to minimal systemic absorption.
- Local irritation or redness may occur if excessive amounts are applied.
What to Do:
If accidentally ingested, drink fluids. If local irritation occurs, rinse eye with lukewarm water. Contact a poison control center (1-800-222-1222) or seek medical attention if symptoms are severe or persistent.
Drug Interactions
Monitoring
Baseline Monitoring
Ophthalmic examination (visual acuity, conjunctival injection, discharge)
Rationale: To assess the severity and nature of the bacterial conjunctivitis before initiating treatment.
Timing: Prior to first dose
Routine Monitoring
Clinical signs and symptoms of infection (redness, discharge, discomfort)
Frequency: Daily
Target: Resolution or improvement of symptoms
Action Threshold: Lack of improvement or worsening symptoms after 2-3 days of treatment, or development of new symptoms, warrants re-evaluation.
Adverse reactions (e.g., eye irritation, itching)
Frequency: Daily
Target: Absence or mild, tolerable reactions
Action Threshold: Severe or persistent irritation, allergic reactions, or other significant adverse effects.
Symptom Monitoring
- Eye redness
- Eye discharge (purulent or watery)
- Eye discomfort or pain
- Itching or burning sensation in the eye
- Blurred vision
- Sensitivity to light (photophobia)
- Swelling of eyelids
Special Patient Groups
Pregnancy
Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown adverse effects, but there are no adequate and well-controlled studies in pregnant women.
Trimester-Specific Risks:
First Trimester:
Potential risk based on animal data; minimal systemic absorption may limit risk.
Second Trimester:
Potential risk based on animal data; minimal systemic absorption may limit risk.
Third Trimester:
Potential risk based on animal data; minimal systemic absorption may limit risk.
Lactation
It is not known whether besifloxacin is excreted in human milk. Caution should be exercised when besifloxacin ophthalmic suspension is administered to a nursing mother. Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for besifloxacin and any potential adverse effects on the breastfed infant from besifloxacin or from the underlying maternal condition.
Infant Risk:
Not available (unknown if excreted in human milk); potential for theoretical risk due to fluoroquinolone class, but systemic absorption is minimal.
Pediatric Use
Approved for use in patients 1 year of age and older. Safety and effectiveness in infants younger than 1 year of age have not been established.
Geriatric Use
No overall differences in safety or effectiveness have been observed between elderly and younger patients. No dosage adjustment is necessary.
Clinical Information
Clinical Pearls
- Besivance is specifically formulated as a suspension, so it's important to shake the bottle well before each use to ensure uniform distribution of the active ingredient.
- Due to its minimal systemic absorption, besifloxacin ophthalmic suspension has a low potential for systemic drug interactions.
- Patients should be advised that bacterial conjunctivitis is highly contagious and to practice good hand hygiene and avoid touching their eyes.
- If more than one topical ophthalmic medication is being used, they should be administered at least 5 minutes apart to prevent washout.
- While generally well-tolerated, some patients may experience temporary blurred vision or mild irritation immediately after instillation.
Alternative Therapies
- Moxifloxacin ophthalmic (e.g., Vigamox)
- Gatifloxacin ophthalmic (e.g., Zymar, Zymaxid)
- Ciprofloxacin ophthalmic (e.g., Ciloxan)
- Ofloxacin ophthalmic (e.g., Ocuflox)
- Levofloxacin ophthalmic (e.g., Quixin, Iquix)
- Tobramycin ophthalmic
- Erythromycin ophthalmic ointment
Cost & Coverage
Average Cost:
Check current market prices (varies by pharmacy and generic availability) per 5ml bottle
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (for generic), Tier 3 or higher (for brand)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.