DRUGS & SUPPLEMENTS

Intragat

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Intragat uses


1 INDICATIONS AND USAGE

Intragat ophthalmic solution 0.5% is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms:

Aerobic Gram-Positive Bacteria:

Staphylococcus aureus

Staphylococcus epidermidis

Streptococcus mitis group*

Streptococcus oralis *

Streptococcus pneumoniae

Aerobic Gram-Negative Bacteria:

Haemophilus influenzae

*Efficacy for this organism was studied in fewer than 10 infections.

Intragat ophthalmic solution is a topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms:

Haemophilus influenzae, Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus mitis group* , Streptococcus oralis * , Streptococcus pneumoniae

*Efficacy for this organism was studied in fewer than 10 infections. (1)

2 DOSAGE AND ADMINISTRATION

Patients 1 year of age or older: Instill one drop every two hours in the affected eye(s) while awake, up to 8 times on Day 1. Instill one drop two to four times daily in the affected eye(s) while awake on Days 2 through 7.

Patients 1 year of age or older: Instill one drop every two hours in the affected eye(s) while awake, up to 8 times on Day 1. Instill one drop two to four times daily in the affected eye(s) while awake on Days 2 through 7. (2)

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3 DOSAGE FORMS AND STRENGTHS

Four (4) mL bottle containing 2.5 mL of a 0.5% sterile topical ophthalmic solution.

4 mL size bottle filled with 2.5 mL of Intragat ophthalmic solution, 0.5%. (3)

4 CONTRAINDICATIONS

None

None

5 WARNINGS AND PRECAUTIONS

  • Topical Ophthalmic Use Only
  • Growth of Resistant Organisms with Prolonged Use (5.2)
  • Avoidance of Contact Lenses. Patients should not wear contact lenses if they have signs or symptoms of bacterial conjunctivitis or during the course of therapy with Intragat ophthalmic solution (5.3)

5.1 Topical Ophthalmic Use Only

Intragat ophthalmic solution should not be introduced directly into the anterior chamber of the eye.

5.2 Growth of Resistant Organisms with Prolonged Use

As with other anti-infectives, prolonged use of Intragat ophthalmic solution 0.5% may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, discontinue use and institute alternative therapy. Whenever clinical judgment dictates, the patient should be examined with the aid of magnification, such as slit lamp biomicroscopy and where appropriate, fluoroscein staining.

5.3 Avoidance of Contact Lens Wear

Patients should be advised not to wear contact lenses if they have signs and symptoms of bacterial conjunctivitis or during the course of therapy with Intragat ophthalmic solution [see PATIENT COUNSELING INFORMATION (17.2)].

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6 ADVERSE REACTIONS

Most common adverse reactions occurring in ≥ 1 % of patients included worsening of conjunctivitis, eye irritation, dysgeusia, and eye pain.

To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or 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.

In clinical studies with Intragat, the most frequently reported adverse reactions occurring in ≥ 1% of patients in the Intragat study population (N=717) were: worsening of the conjunctivitis, eye irritation, dysgeusia, and eye pain.

Additional adverse events reported with other formulations of Intragat ophthalmic solution include chemosis, conjunctival hemorrhage, dry eye, eye discharge, eyelid edema, headache, increased lacrimation, keratitis, papillary conjunctivitis, and reduced visual acuity.

7 DRUG INTERACTIONS

Specific drug interaction studies have not been conducted with Intragat ophthalmic solution.

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Pregnancy Category C

Teratogenic Effects: There were no teratogenic effects observed in rats or rabbits following oral Intragat doses up to 50 mg/kg/day. However, skeletal/craniofacial malformations or delayed ossification, atrial enlargement, and reduced fetal weight were observed in fetuses from rats given ≥150 mg/kg/day (approximately 3000-fold higher than the maximum recommended ophthalmic dose). In a perinatal/postnatal study, increased late post-implantation loss and neonatal/perinatal mortalities were observed at 200 mg/kg/day (approximately 4000-fold higher than the maximum recommended ophthalmic dose).

Because there are no adequate and well-controlled studies in pregnant women, Intragat ophthalmic solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

8.3 Nursing Mothers

Intragat is excreted in the breast milk of rats. 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 Intragat ophthalmic solution is administered to a nursing woman.

8.4 Pediatric Use

The safety and effectiveness of Intragat ophthalmic solution in infants below one year of age have not been established. Intragat ophthalmic solution has been demonstrated in clinical trials to be safe and effective for the treatment of bacterial conjunctivitis in pediatric patients one year or older [see CLINICAL STUDIES ].

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

Intragat sterile ophthalmic solution is an 8-methoxyfluoroquinolone anti-infective for the treatment of bacterial conjunctivitis. Its chemical name is (±)-1-Cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-7-(3-methyl-1-piperazinyl)-4-oxo-3-quinolinecarboxylic acid, sesquihydrate. Its molecular formula is C19H22FN3O4 · 1½H2O, and its molecular weight is 402.42. Its chemical structure is:

Intragat ophthalmic solution is a clear, pale yellow to greenish yellow, sterile, preserved aqueous solution with an osmolality of 270 to 310 mOsm/kg and a pH of 5.3-5.6.

Intragat ophthalmic solution contains Active: Intragat, anhydrous 0.5% (5 mg/mL); Inactives: benzalkonium chloride 0.005%; edetate disodium dihydrate; purified water; and sodium chloride. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

Structure formula

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Intragat is a fluoroquinolone antibacterial [see CLINICAL PHARMACOLOGY ].

12.3 Pharmacokinetics

Intragat ophthalmic solution 0.3% or 0.5% was administered to one eye of 6 healthy male subjects each in an escalated dosing regimen starting with a single 2 drop dose, then 2 drops 4 times daily for 7 days, and finally 2 drops 8 times daily for 3 days. At all time points, serum Intragat levels were below the lower limit of quantification (5 ng/mL) in all subjects.

12.4 Microbiology

Intragat is an 8-methoxyfluoroquinolone with a 3-methylpiperazinyl substituent at C7. The antibacterial action of Intragat results from inhibition of DNA gyrase and topoisomerase IV. DNA gyrase is an essential enzyme that is involved in the replication, transcription, and repair of bacterial DNA. Topoisomerase IV is an enzyme known to play a key role in the partitioning of the chromosomal DNA during bacterial cell division. The mechanism of action of fluoroquinolones including Intragat is different from that of aminoglycoside, macrolide, and tetracycline antibiotics. Therefore, Intragat may be active against pathogens that are resistant to these antibiotics and these antibiotics may be active against pathogens that are resistant to Intragat. There is no cross-resistance between Intragat and the aforementioned classes of antibiotics. Cross resistance has been observed between systemic Intragat and some other fluoroquinolones.

Resistance to Intragat in vitro develops via multiple-step mutations. Resistance to Intragat in vitro occurs at a general frequency of 1 x 10-7 to 10-10.

Intragat has been shown to be active against most isolates of the following organisms both microbiologically and clinically, in conjunctival infections as described in the INDICATIONS AND USAGE, Section 1 .

Aerobic Gram-Positive Bacteria:

Staphylococcus aureus

Staphylococcus epidermidis

Streptococcus mitis group*

Streptococcus oralis *

Streptococcus pneumoniae

Aerobic Gram-Negative Bacteria:

Haemophilus influenzae

*Efficacy for this organism was studied in fewer than 10 infections.

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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

There was no increase in neoplasms among B6C3F1 mice given Intragat in the diet for 18 months at doses averaging 81 mg/kg/day in males and 90 mg/kg/day in females. These doses are approximately 1600-fold and 1800-fold higher, respectively, than the maximum recommended ophthalmic dose of 0.05 mg/kg/day in a 50 kg human.

There was no increase in neoplasms among Fischer 344 rats given Intragat in the diet for 2 years at doses averaging 47 mg/kg/day in males and 139 mg/kg/day in females (900- and 2800-fold higher, respectively, than the maximum recommended ophthalmic dose). A statistically significant increase in the incidence of large granular lymphocyte (LGL) leukemia was seen in males treated with a high dose of approximately 2000-fold higher than the maximum recommended ophthalmic dose. Fischer 344 rats have a high spontaneous background rate of LGL leukemia and the incidence in high-dose males only slightly exceeded the historical control range established for this strain.

In genetic toxicity tests, Intragat was positive in 1 of 5 strains used in bacterial reverse mutation assays: Salmonella strain TA102. Intragat was positive in in vitro mammalian cell mutation and chromosome aberration assays. Intragat was positive in in vitro unscheduled DNA synthesis in rat hepatocytes but not human leukocytes. Intragat was negative in in vivo micronucleus tests in mice, cytogenetics test in rats, and DNA repair test in rats. The findings may be due to the inhibitory effects of high concentrations on eukaryotic type II DNA topoisomerase.

There were no adverse effects on fertility or reproduction in rats given Intragat orally at doses up to 200 mg/kg/day (approximately 4000-fold higher than the maximum recommended ophthalmic dose for Intragat ophthalmic solution).

14 CLINICAL STUDIES

In two randomized, double-masked, multicenter clinical trials, where patients 1-89 years of age were dosed for 5 days, Intragat ophthalmic solution was clinically superior to its vehicle on day 6 in patients with conjunctivitis and positive conjunctival cultures. Clinical outcomes for the trials demonstrated clinical success (resolution of conjunctival hyperaemia and conjunctival discharge) of 58% (193/333) for the gatifloxacin-treated groups versus 45% (148/325) for the vehicle-treated groups. Microbiological outcomes for the same clinical trials demonstrated a statistically superior eradication rate for causative pathogens of 90% (301/333) for Intragat versus 70% (228/325) for vehicle. Please note that microbiological eradication does not always correlate with clinical outcome in anti-infective trials.

16 HOW SUPPLIED/STORAGE AND HANDLING

Intragat ophthalmic solution 0.5% is supplied sterile in LDPE DROP-TAINERs white bottles with natural LDPE dispensing plugs and tan polypropylene (PP) closure in the following size:

2.5 mL in 4 mL bottle: NDC 61314-672-25

Storage: Store at 20° to 25°C (68° to 77°F).

Protect from freezing.

17 PATIENT COUNSELING INFORMATION

17.1 Avoiding Contamination of the Product

Patients should be instructed to avoid contaminating the applicator tip with material from the eye, fingers, or other source.

17.2 Avoidance of Contact Lens Wear

Patients should be advised not to wear contact lenses if they have signs and symptoms of bacterial conjunctivitis.

Manufactured by Alcon Laboratories, Inc.

Fort Worth, Texas 76134 for

Sandoz Inc.

Princeton, NJ 08540

Rev. 04/2016

0.5 % Carton

NDC 61314-672-25

Intragat

Ophthalmic

Solution

0.5%

For Use in the Eyes Only

2.5 mL

SANDOZ

2.5-mL

Intragat pharmaceutical active ingredients containing related brand and generic drugs:

infoActive 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.


Intragat available forms, composition, doses:

infoForm 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.


Intragat destination | category:

infoDestination 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.


Intragat Anatomical Therapeutic Chemical codes:

infoA 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.


Intragat pharmaceutical companies:

infoPharmaceutical 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."GATIFLOXACIN SOLUTION/ DROPS [SANDOZ INC]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. Dailymed."GATIFLOXACIN: 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. "Gatifloxacin". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Intragat?

Depending on the reaction of the Intragat after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Intragat 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 Intragat 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 Intragat, 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 Intragat 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. Arunabha Ray, MD Pharmacology

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