Flurinol D

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Flurinol D uses

Flurinol D consists of Epinastine Hydrochloride, Pseudoephedrine Sulfate.

Epinastine Hydrochloride:


1 INDICATIONS AND USAGE

Flurinol D (Epinastine Hydrochloride) ® ophthalmic solution is indicated for the prevention of itching associated with allergic conjunctivitis.

Flurinol D (Epinastine Hydrochloride) ® is an H1 histamine receptor antagonist indicated for the prevention of itching associated with allergic conjunctivitis. (1)

2 DOSAGE AND ADMINISTRATION

The recommended dosage is one drop in each eye twice a day.

Treatment should be continued throughout the period of exposure (i.e., until the pollen season is over or until exposure to the offending allergen is terminated), even when symptoms are absent.

The recommended dosage is one drop in each eye twice a day. (2)

3 DOSAGE FORMS AND STRENGTHS

Solution containing 0.5 mg/mL epinastine HCl

Ophthalmic solution containing 0.5 mg/mL epinastine HCl. (3)

4 CONTRAINDICATIONS

None

None (4)

5 WARNINGS AND PRECAUTIONS

  • To minimize the risk of contamination, do not touch dropper tip to any surface. Keep bottle tightly closed when not in use.
  • Flurinol D (Epinastine Hydrochloride) ® should not be used to treat contact lens-related irritation. (5.2)
  • Remove contact lenses prior to instillation of Flurinol D (Epinastine Hydrochloride) ®. (5.2)

5.1 Contamination of Tip and Solution

Patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye, surrounding structures, fingers, or any other surface in order to avoid contamination of the solution by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions.

Bottle should be kept tightly closed when not in use.

5.2 Use with Contact Lenses

Patients should be advised not to wear a contact lens if their eye is red. Flurinol D ® ophthalmic solution should not be used to treat contact lens-related irritation.

The preservative in Flurinol D (Epinastine Hydrochloride) ®, benzalkonium chloride, may be absorbed by soft contact lenses. Contact lenses should be removed prior to instillation of Flurinol D (Epinastine Hydrochloride) ® ophthalmic solution and may be reinserted after 10 minutes following its administration.

5.3 Topical Ophthalmic Use Only

Flurinol D (Epinastine Hydrochloride) ® is for topical ophthalmic use only and not for injection or oral use.

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6 ADVERSE REACTIONS

The most common ocular adverse reactions ® treated eyes were burning sensation in the eye, folliculosis, hyperemia, and pruritus. The most common non-ocular adverse reactions, occurring in 10% of Flurinol D (Epinastine Hydrochloride) ® treated eyes, were infection (cold symptoms and upper respiratory infections). (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Allergan at 1-800-433-8871 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1 Clinical Studies Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.

The most frequently reported ocular adverse reactions occurring in approximately 1-10% of patients were burning sensation in the eye, folliculosis, hyperemia, and pruritus.

The most frequently reported non-ocular adverse reactions were infection (cold symptoms and upper respiratory infections), seen in approximately 10% of patients, and headache, rhinitis, sinusitis, increased cough, and pharyngitis, seen in approximately 1 - 3% of patients.

Some of these reactions were similar to the underlying disease being studied.

6.2 Postmarketing Experience

The following reactions have been identified during postmarketing use of Flurinol D (Epinastine Hydrochloride) ® in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. The reactions, which have been chosen for inclusion due to either their seriousness, frequency of reporting, possible causal connection to Flurinol D (Epinastine Hydrochloride) ®, or a combination of these factors, include: lacrimation increased.

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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Teratogenic Effects

Pregnancy Category C

In an embryofetal developmental study in pregnant rats, maternal toxicity with no embryofetal effects was observed at an oral dose that was approximately 150,000 times the maximum recommended ocular human dose of 0.0014 mg/kg/day on a mg/kg basis. Total resorptions and abortion were observed in an embryofetal study in pregnant rabbits at an oral dose that was approximately 55,000 times the MROHD. In both studies, no drug-induced teratogenic effects were noted.

Epinastine reduced pup body weight gain following an oral dose to pregnant rats that was approximately 90,000 times the MROHD.

There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Flurinol D (Epinastine Hydrochloride) ® ophthalmic solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

8.3 Nursing Mothers

A study in lactating rats revealed excretion of epinastine in the breast milk. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Flurinol D (Epinastine Hydrochloride) ® ophthalmic solution is administered to a nursing woman.

8.4 Pediatric Use

Safety and effectiveness in pediatric patients below the age of 2 years have not been established.

8.5 Geriatric Use

No overall differences in safety or effectiveness have been observed between elderly and younger patients.

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11 DESCRIPTION

Flurinol D (Epinastine Hydrochloride) ® (epinastine HCl ophthalmic solution) 0.05% is a clear, colorless, sterile isotonic solution containing epinastine HCl, an antihistamine and an inhibitor of histamine release from the mast cell for topical administration to the eyes.

Epinastine HCl is represented by the following structural formula:

Chemical Name:

3-Amino-9,13b-dihydro-1H-dibenz[c,f]imidazo[1,5-a]azepine hydrochloride

Each mL contains: Active: Epinastine HCl 0.05% (0.5 mg/mL) equivalent to epinastine 0.044% (0.44 mg/mL); Preservative: Benzalkonium chloride 0.01%; Inactives: Edetate disodium; purified water; sodium chloride; sodium phosphate, monobasic; and sodium hydroxide and/or hydrochloric acid (to adjust pH). Flurinol D (Epinastine Hydrochloride) ® has a pH of approximately 7 and an osmolality range of 250 to 310 mOsm/kg.

structural formula

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Epinastine is a topically active, direct H1-receptor antagonist and an inhibitor of the release of histamine from the mast cell. Epinastine is selective for the histamine H1-receptor and has affinity for the histamine H2-receptor. Epinastine also possesses affinity for the α1, α 2-, and 5-HT2–receptors.

12.3 Pharmacokinetics

Fourteen subjects, with allergic conjunctivitis, received one drop of Flurinol D (Epinastine Hydrochloride) ® ophthalmic solution in each eye twice daily for 7 days. On day 7, average maximum epinastine plasma concentrations of 0.04±0.014 ng/ml were reached after about two hours indicating low systemic exposure. While these concentrations represented an increase over those seen following a single dose, the day 1 and day 7 Area Under the Curve (AUC) values were unchanged indicating that there is no increase in systemic absorption with multiple dosing. Epinastine is 64% bound to plasma proteins. The total systemic clearance is approximately 56 L/hr and the terminal plasma elimination half-life is about 12 hours. Epinastine is mainly excreted unchanged. About 55% of an intravenous dose is recovered unchanged in the urine with about 30% in feces. Less than 10% is metabolized. The renal elimination is mainly via active tubular secretion.

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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

In 18-month or 2-year dietary carcinogenicity studies in mice or rats, respectively, epinastine was not carcinogenic at doses up to 40 mg/kg [approximately 30,000 times higher than the MROHD, assuming 100% absorption in humans and animals].

Epinastine in newly synthesized batches was negative for mutagenicity in the Ames/Salmonella assay and in vitro chromosome aberration assay using human lymphocytes. Positive results were seen with early batches of epinastine in two in vitro chromosomal aberration studies conducted in 1980s with human peripheral lymphocytes and with V79 cells, respectively. Epinastine was negative in the in vivo clastogenicity studies, including the mouse micronucleus assay and chromosome aberration assay in Chinese hamsters. Epinastine was also negative in the cell transformation assay using Syrian hamster embryo cells, V79/HGPRT mammalian cell point mutation assay, and in vivo/in vitro unscheduled DNA synthesis assay using rat primary hepatocytes.

Epinastine had no effect on fertility of male rats. Decreased fertility in female rats was observed at an oral dose up to approximately 90,000 times the MROHD.

14 CLINICAL STUDIES

Epinastine HCl 0.05% has been shown to be significantly superior to vehicle for improving ocular itching in patients with allergic conjunctivitis in clinical studies using two different models: (1) conjunctival antigen challenge (CAC) where patients were dosed and then received antigen instilled into the inferior conjunctival fornix; and (2) environmental field studies where patients were dosed and evaluated during allergy season in their natural habitat. Results demonstrated a rapid onset of action for epinastine HCl 0.05% within 3 to 5 minutes after conjunctival antigen challenge. Duration of effect was shown to be 8 hours, making a twice daily regimen suitable. This dosing regimen was shown to be safe and effective for up to 8 weeks, without evidence of tachyphylaxis.

16 HOW SUPPLIED/STORAGE AND HANDLING

Flurinol D (Epinastine Hydrochloride) ® (epinastine HCl ophthalmic solution) 0.05% is supplied sterile in opaque white LDPE plastic bottles with dropper tips and white high impact polystyrene (HIPS) caps as follows:

5 mL in 10 mL bottle NDC 0023-9201-05

Storage: Store at 15º-25ºC (59º-77ºF). Keep bottle tightly closed and out of the reach of children.

17 PATIENT COUNSELING INFORMATION

17.1 Sterility of Dropper Tip

Patients should be advised not to touch dropper tip to any surface, as this may contaminate the contents.

17.2 Concomitant Use of Contact Lenses

Patients should be advised not to wear a contact lens if their eye is red. Patients should be advised that Flurinol D (Epinastine Hydrochloride) ® should not be used to treat contact lens-related irritation. Patients should also be advised to remove contact lenses prior to instillation of Flurinol D (Epinastine Hydrochloride) ®. The preservative in Flurinol D (Epinastine Hydrochloride) ®, benzalkonium chloride, may be absorbed by soft contact lenses. Lenses may be reinserted after 10 minutes following administration of Flurinol D (Epinastine Hydrochloride) ®.

17.3 Topical Ophthalmic Use Only

For topical ophthalmic administration only.

Rx only

© 2012 Allergan, Inc.

Irvine, CA 92612, U.S.A.

Allergan corporate signature logo is a registered trademark of Allergan, Inc.

Flurinol D (Epinastine Hydrochloride) is a registered trademark of Boehringer Ingelheim International GmbH and is licensed to Allergan, Inc.

Made in the U.S.A.

72499US10

Logo

ALLERGAN NDC 0023-9201-05

Flurinol D (Epinastine Hydrochloride) ®

(epinastine HCI

ophthalmic solution) 0.05%

5 mL Rx only sterile

ALLERGAN

NDC 0023-9201-05

Flurinol D (Epinastine Hydrochloride) ®

(epinastine HCl

ophthalmic solution) 0.05%

Rx Only

5 mL sterile

Pseudoephedrine Sulfate:



Active ingredients (in each caplet)...Purpose

Guaifenesin 400 mg...Expectorant

Flurinol D (Pseudoephedrine Sulfate) hydrochloride 60 mg...Nasal decongestant

Uses

For temporarily relief of nasal congestion due to a cold, hay fever, or other upper respiratory allergies (allergic rhinitis), and to help loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.

Uses

  • temporarily relieves nasal congestion due to a cold, hay fever, or other upper respiratory allergies (allergic rhinitis).
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.

Warnings

Do not exceed recommended dosage.

Do not use if you are taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for two weeks after stopping the MAOI. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Do not take this product for persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or where cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.

A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor.

Ask a doctor before use if you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • difficulty in urinating due to an enlarged prostate gland

Stop use and ask a doctor if

  • you get nervous, dizzy, or sleepless
  • symptoms do not improve within 7 days or are accompanied by fever

If pregnant or breast-feeding, ask a health professional before use.

Keep this and all drugs out of reach of children. In case of overdose, get medical help or contact a poison control center immediately.

Directions

  • adults and children 12 years and older, 1 caplet every 4 to 6 hours, not more than 4 caplets in 24 hours
  • children 6 to under 12 years, ½ caplet every 4 to 6 hours, not more than 2 caplets in 24 hours
  • children under 6 years, consult a physician

Inactive ingredients

croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate, and starch

Questions?

1-800-324-1880, 7:30am - 4:00pm Central, Mon.-Fri., or visit us at www.bfascher.com

Flurinol D

Flurinol D pharmaceutical active ingredients containing related brand and generic drugs:

Active ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


Flurinol D available forms, composition, doses:

Form of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.


Flurinol D destination | category:

Destination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


Flurinol D Anatomical Therapeutic Chemical codes:

A medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


Flurinol D pharmaceutical companies:

Pharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


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References

  1. Dailymed."ELESTAT (EPINASTINE HYDROCHLORIDE) SOLUTION/ DROPS [ALLERGAN, INC.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. Dailymed."PSEUDOEPHEDRINE SULFATE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  3. "PSEUDOEPHEDRINE". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Flurinol D?

Depending on the reaction of the Flurinol D after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Flurinol D not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Flurinol D addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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Review

sdrugs.com conducted a study on Flurinol D, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Flurinol D consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

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The information was verified by Dr. Rachana Salvi, MD Pharmacology

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