DRUGS & SUPPLEMENTS
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)
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
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.
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.
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.
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
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%.
Alcon Laboratories, Inc.
Fort Worth, Texas,, 76134
For Sandoz Inc.
Princeton, NJ 08540
Alerchek Hydrochloride Ophthalmic Solution
FOR TOPICAL OPHTHALMIC USE ONLY
Alerchek 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.
Alerchek 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.
Alerchek 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.
Alerchek 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.
Alerchek 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.
Frequently asked QuestionsCan i drive or operate heavy machine after consuming Alerchek?
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.Is Alerchek 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.
ReviewsDrugs.com conducted a study on Alerchek, 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 Alerchek 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.
The information was verified by Dr. Arunabha Ray, MD Pharmacology