Perfluorhexyloctane
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Alen Antony Pathil, M.D.[2]
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NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Overview
Perfluorhexyloctane is a semifluorinated alkane that is FDA approved for the treatment of signs and symptoms of dry eye disease (DED).. Common adverse reactions include blurred vision..
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
MIEBO (perfluorohexyloctane ophthalmic solution) is indicated for the treatment of the signs and symptoms of dry eye disease.
Off-Label Use and Dosage (Adult)
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Perfluorhexyloctane FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Contraindications
none
Warnings
Patients wearing contact lens are advised not to use MEIBO while wearing the lens. Patients are advised to remove the lens while administering the Meibo and placed back after 30 mins of administering it.
Adverse Reactions
Clinical Trials Experience
in a clinical trial with patients with dry eyes, 614 patients received at least one dose of MIEBO in two randomized controlled clinical trials across 68 sites in the United States. The most common ocular adverse reaction was blurred vision and conjunctival redness, which was constituted 1-3% of individuals.
Postmarketing Experience
There is limited information regarding Perfluorhexyloctane Postmarketing Experience in the drug label.
Drug Interactions
none
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA): A no adequate studies indicating developments toxicity for pregnant patients receiving Meibo during pregancy period.
In the animal studies, oral administration of perfluorohexyloctane during the period of organogenesis showed no adverse maternal or developmental effects in rats at doses up to 162 times the recommended human ophthalmic dose (RHOD). Maternal toxicity, miscarriages and reduced fetal weights were observed in rabbits at all doses tested, with the lowest dose as 41 times the RHOD.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Perfluorhexyloctane in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Perfluorhexyloctane during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Perfluorhexyloctane in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Perfluorhexyloctane in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Perfluorhexyloctane in geriatric settings.
Gender
There is no FDA guidance on the use of Perfluorhexyloctane with respect to specific gender populations.
Race
There is no FDA guidance on the use of Perfluorhexyloctane with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Perfluorhexyloctane in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Perfluorhexyloctane in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Perfluorhexyloctane in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Perfluorhexyloctane in patients who are immunocompromised.
Administration and Monitoring
Administration
One drop of MIEBO is instilled four times daily into affected eye(s).
Contact lenses should be removed prior to and for at least 30 minutes after the administration of MIEBO.
Monitoring
There is limited information regarding Perfluorhexyloctane Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Perfluorhexyloctane and IV administrations.
Overdosage
There is limited information regarding Perfluorhexyloctane overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Perfluorhexyloctane Pharmacology in the drug label.
Mechanism of Action
Perfluorohexyloctane is a semifluorinated alkane which forms a monolayer at the air-liquid interface of the tear film which can be expected to reduce evaporation. However, the exact mechanism of action for MIEBO in DED is not known.
Structure
The active ingredient is 1,1,1,2,2,3,3,4,4,5,5,6,6-tridecafluorotetradecane and is a semifluorinated alkane. It has a molecular formula of C14H17F13 and a molecular weight of 432.26 g/mol.
Pharmacodynamics
There is limited information regarding Perfluorhexyloctane Pharmacodynamics in the drug label.
Pharmacokinetics
There hasn't been adequate studies to assess the pharmacokinetics of perfluorohexyloctane. Furthermore, a single pharmacokinetics study showed low systemic perfluorohexyloctane blood levels after topical ocular administration. Perfluorohexyloctane was not metabolized by human liver microsomes in vitro.
Nonclinical Toxicology
There is limited information regarding Perfluorhexyloctane Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Perfluorhexyloctane Clinical Studies in the drug label.
How Supplied
MIEBO (perfluorohexyloctane ophthalmic solution) is supplied as a sterile, clear and colorless liquid in multiple-dose 5 mL polypropylene bottles with dropper tips and screw caps, packaged in a carton,
Storage
MIEBO is stored at 15ºC to 25ºC (59ºF to 77ºF). After opening, MIEBO can be used until the expiration date on the bottle.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Perfluorhexyloctane Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Perfluorhexyloctane interaction has not been established. Talk to your doctor regarding the effects of taking alcohol with this medication.
Brand Names
MIEBO
Look-Alike Drug Names
There is limited information regarding Perfluorhexyloctane Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.