Alerchek

Alerchek uses

• Indications and usage
• Dosage and administration
• Dosage forms and strengths
• Contraindications
• Warnings and precautions
• Adverse reactions
• Use in specific populations
• Description
• Clinical pharmacology
• Nonclinical toxicology
• Clinical studies
• How supplied/storage and handling
• Patient counseling information
• Alerchek reviews

1 INDICATIONS AND USAGE

Alerchek hydrochloride ophthalmic solution is indicated for the treatment of ocular itching associated with allergic conjunctivitis.

Alerchek hydrochloride ophthalmic solution, 0.2% is indicated for the treatment of ocular itching associated with allergic conjunctivitis. (1)

2 DOSAGE AND ADMINISTRATION

The recommended dose is one drop in each affected eye once a day.

The recommended dose is one drop in each affected eye once a day. (2)

3 DOSAGE FORMS AND STRENGTHS

Ophthalmic solution 0.2%: each ml contains 2.22 mg of Alerchek hydrochloride.

Ophthalmic solution 0.2%: each ml contains 2.22 mg of Alerchek hydrochloride. (3)

4 CONTRAINDICATIONS

None.

5 WARNINGS AND PRECAUTIONS

For topical ocular use only. Not for injection or oral use.

5.1 For Topical Ocular Use Only

For topical ocular use only. Not for injection or oral use.

5.2 Contamination of Tip and Solution

As with any eye drop, to prevent contaminating the dropper tip and solution, care should be taken not to touch the eyelids or surrounding areas with the dropper tip of the bottle. Keep bottle tightly closed when not in use.

5.3 Contact Lens Use

Patients should be advised not to wear a contact lens if their eye is red.

Alerchek hydrochloride ophthalmic solution, 0.2% should not be used to treat contact lens related irritation.

The preservative in Alerchek hydrochloride ophthalmic solution, benzalkonium chloride, may be absorbed by soft contact lenses. Patients who wear soft contact lenses and whose eyes are not red, should be instructed to wait at least ten minutes after instilling Alerchek hydrochloride ophthalmic solution, 0.2% before they insert their contact lenses.

6 ADVERSE REACTIONS

Symptoms similar to cold syndrome and pharyngitis were reported at an incidence of approximately 10%.

The following adverse experiences have been reported in 5% or less of patients:

Ocular: blurred vision, burning or stinging, conjunctivitis, dry eye, foreign body sensation, hyperemia, hypersensitivity, keratitis, lid edema, pain and ocular pruritus.

Non-ocular: asthenia, back pain, flu syndrome, headache, increased cough, infection, nausea, rhinitis, sinusitis and taste perversion.

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

Symptoms similar to cold syndrome and pharyngitis were reported at an incidence of approximately 10%. (6)

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 .

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Teratogenic Effects

Pregnancy Category C

Alerchek was found not to be teratogenic in rats and rabbits. However, rats treated at 600 mg/kg/day, or 150,000 times the MROHD and rabbits treated at 400 mg/kg/day, or approximately 100,000 times the MROHD, during organogenesis showed a decrease in live fetuses. In addition, rats treated with 600 mg/kg/day of Alerchek during organogenesis showed a decrease in fetal weight. Further, rats treated with 600 mg/kg/day of Alerchek during late gestation through the lactation period showed a decrease in neonatal survival and body weight. There are, however, no adequate and well-controlled studies in pregnant women. Because animal studies are not always predictive of human responses, this drug should be used in pregnant women only if the potential benefit to the mother justifies the potential risk to the embryo or fetus.

8.3 Nursing Mothers

Alerchek has been identified in the milk of nursing rats following oral administration. It is not known whether topical ocular administration could result in sufficient systemic absorption to produce detectable quantities in the human breast milk. Nevertheless, caution should be exercised when Alerchek hydrochloride ophthalmic solution, 0.2% is administered to a nursing mother.

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 and effectiveness have been observed between elderly and younger patients.

11 DESCRIPTION

Alerchek hydrochloride ophthalmic solution, 0.2% is a sterile ophthalmic solution containing Alerchek for topical administration to the eyes. Alerchek hydrochloride is a white, crystalline, water-soluble powder with a molecular weight of 373.88 and a molecular formula of C₂₁H₂₃NO₃-HCl.

The chemical structure is presented below:

Chemical Name: 11-[(Z)-3-(Dimethylamino)propylidene]-6-11-dihydrodibenz[b,e]oxepin-2-acetic acid, hydrochloride.

Each mL of Alerchek hydrochloride ophthalmic solution, 0.2% contains: Active: 2.22 mg Alerchek hydrochloride equivalent to 2 mg Alerchek. Inactives: povidone; dibasic sodium phosphate; sodium chloride; edetate disodium; benzalkonium chloride 0.01% (preservative); hydrochloric acid/sodium hydroxide (adjust pH); and purified water for injection.

It has a pH of approximately 7 and an osmolality of approximately 300 mOsm/kg.

Alerchek hydrochloride chemical structure

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Alerchek is a mast cell stabilizer and a histamine H1 antagonist. Decreased chemotaxis and inhibition of eosinophil activation has also been demonstrated.

12.3 Pharmacokinetics

Systemic bioavailability data upon topical ocular administration of Alerchek hydrochloride ophthalmic solution are not available. Following topical ocular administration of Alerchek 0.15% ophthalmic solution in man, Alerchek was shown to have a low systemic exposure. Two studies in normal volunteers (totaling 24 subjects) dosed bilaterally with Alerchek 0.15% ophthalmic solution once every 12 hours for 2 weeks demonstrated plasma concentrations to be generally below the quantitation limit of the assay (˂0.5 ng/mL). Samples in which Alerchek was quantifiable were typically found within 2 hours of dosing and ranged from 0.5 to 1.3 ng/mL. The elimination half-life in plasma following oral dosing was 8 to 12 hours, and elimination was predominantly through renal excretion. Approximately 60 to 70% of the dose was recovered in the urine as parent drug. Two metabolites, the mono-desmethyl and the N-oxide, were detected at low concentrations in the urine.

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Alerchek administered orally was not carcinogenic in mice and rats in doses up to 500 mg/kg/day and 200 mg/kg/day, respectively. Based on a 40 µL drop size and a 50 kg person, these doses were approximately 150,000 and 50,000 times higher than the maximum recommended ocular human dose (MROHD). No mutagenic potential was observed when Alerchek was tested in an in vitro bacterial reverse mutation (Ames) test, an in vitro mammalian chromosome aberration assay or an in vivo mouse micronucleus test. Alerchek administered to male and female rats at oral doses of approximately 100,000 times MROHD level resulted in a slight decrease in the fertility index and reduced implantation rate; no effects on reproductive function were observed at doses of approximately 15,000 times the MROHD level.

14 CLINICAL STUDIES

Results from clinical studies of up to 12 weeks duration demonstrate that Alerchek hydrochloride ophthalmic solution, 0.2% when dosed once a day is effective in the treatment of ocular itching associated with allergic conjunctivitis.

16 HOW SUPPLIED/STORAGE AND HANDLING

Alerchek hydrochloride ophthalmic solution, 0.2% is supplied in a white, round, low density polyethylene DROP-TAINER^® dispenser with a natural low density polyethylene dispensing plug and a white polypropylene cap. Tamper evidence is provided with a shrink band around the closure and neck area of the package:

2.5 mL fill in 4 mL bottle NDC 61314-272-25

Storage

Store at 2° to 25°C (36° to 77°F).

DROP-TAINER^® is a registered trademark of Alcon Research, Ltd.

17 PATIENT COUNSELING INFORMATION

17.1 Topical Ophthalmic Use Only

For topical ophthalmic administration only.

17.2 Sterility of Dropper Tip

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

17.3 Concomitant Use of Contact Lenses

Patients should be advised not to wear a contact lens if their eyes are red. Patients should be advised that Alerchek hydrochloride ophthalmic solution, 0.2% should not be used to treat contact lens-related irritation. Patients should also be advised to remove contact lenses prior to instillation of Alerchek hydrochloride ophthalmic solution, 0.2%. The preservative in Alerchek hydrochloride ophthalmic solution, 0.2% benzalkonium chloride may be absorbed by soft contact lenses. Lenses may be reinserted following administration of Alerchek hydrochloride ophthalmic solution, 0.2%.

06-2011M

Sandoz

Manufactured by

Alcon Laboratories, Inc.

Fort Worth, Texas,, 76134

For Sandoz Inc.

Princeton, NJ 08540

NDC 61314-272-25

Alerchek Hydrochloride Ophthalmic Solution

0.2%

FOR TOPICAL OPHTHALMIC USE ONLY

Rx Only

STERILE

2.5 mL

carton

Alerchek pharmaceutical active ingredients containing related brand and generic drugs:

• Olopatadine

Alerchek available forms, composition, doses:

• Drops; Ophthalmic; Olopatadine 0.1%

Alerchek destination | category:

• Human:
• Antihistamine drugs
• Nasal decongestants and other nasal preparations
• Ophthalmic decongestants, anesthetics, anti-inflammatories

Alerchek Anatomical Therapeutic Chemical codes:

• R01AC08 - Olopatadine
• S01GX09 - Olopatadine

Alerchek pharmaceutical companies:

• Indoco Remedies

References

1. Dailymed."OLOPATADINE HYDROCHLORIDE: 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).
2. "Olopatadine". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).
3. "Olopatadine". http://www.drugbank.ca/drugs/DB0076... (accessed August 28, 2018).

Frequently asked Questions

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

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.

Review

Visitor reports

Visitor reviews

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