DRUGS & SUPPLEMENTS

Alfadrops-DS

Name: Alfadrops-DS drug & pharmaceuticals. Available Forms, Doses, Prices
Creator: sdrugs.com
Published: 2021-11-11T10:10:10+00:00

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Alfadrops-DS uses

Indications and usage
Contraindications
Warnings
Precautions
Information for patients
Drug interactions
Carcinogenesis, mutagenesis, impairment of fertility
Pregnancy
Nursing mothers
Pediatric use
Geriatric use
Adverse reactions
Overdosage
Dosage and administration
How supplied
Alfadrops-DS reviews

INDICATIONS AND USAGE

Alfadrops-DS 0.5% Ophthalmic Solution (apraclonidine ophthalmic solution) is indicated for short-term adjunctive therapy, in patients on maximally tolerated medical therapy, who require additional IOP reduction. Patients on maximally tolerated medical therapy, who are treated with Alfadrops-DS 0.5% Ophthalmic Solution to delay surgery, should have frequent follow-up examinations and treatment should be discontinued if the IOP rises significantly.

The addition of Alfadrops-DS 0.5% Ophthalmic Solution to patients already using two aqueous suppressing drugs (i.e., beta-blocker plus carbonic anhydrase inhibitor) as part of their maximally tolerated medical therapy may not provide additional benefit. This is because Alfadrops-DS 0.5% Ophthalmic Solution is an aqueous suppressing drug and the addition of a third aqueous suppressant may not significantly reduce IOP.

The IOP lowering efficacy of Alfadrops-DS 0.5% Ophthalmic Solution diminishes over time in some patients. This loss of effect, or tachyphylaxis, appears to be an individual occurrence with a variable time of onset and should be closely monitored. The benefit for most patients is less than one month.

CONTRAINDICATIONS

Alfadrops-DS 0.5% Ophthalmic Solution is contraindicated in patients with hypersensitivity to Alfadrops-DS or any other component of this medication, as well as systemic clonidine. It is also contraindicated in patients receiving monoamine oxidase (MAO) inhibitors.

WARNINGS

Not for injection or oral ingestion. FOR TOPICAL OPHTHALMIC USE ONLY.

PRECAUTIONS

General

Glaucoma patients on maximally tolerated medical therapy who are treated with Alfadrops-DS 0.5% Ophthalmic Solution to delay surgery should have their visual fields monitored periodically.

Although the topical use of Alfadrops-DS 0.5% Ophthalmic Solution has not been studied in renal failure patients, structurally related clonidine undergoes a significant increase in half-life in patients with severe renal impairment. Close monitoring of cardiovascular parameters in patients with impaired renal function is advised if they are candidates for topical Alfadrops-DS therapy. Close monitoring of cardiovascular parameters in patients with impaired liver function is also advised as the systemic dosage form of clonidine is partly metabolized in the liver.

While the topical administration of Alfadrops-DS 0.5% Ophthalmic Solution had minimal effect on heart rate or blood pressure in clinical studies evaluating glaucoma patients, the preclinical pharmacology profile of this drug suggests that caution should be observed in treating patients with severe, uncontrolled cardiovascular disease, including hypertension. The possibility of a vasovagal attack should be considered and caution should be exercised in patients with a history of such episodes.

Alfadrops-DS 0.5% Ophthalmic Solution should be used with caution in patients with coronary insufficiency, recent myocardial infarction, cerebrovascular disease, chronic renal failure, Raynaud's disease, or thromboangiitis obliterans. Caution and monitoring of depressed patients are advised since Alfadrops-DS has been infrequently associated with depression.

Alfadrops-DS can cause dizziness and somnolence. Patients who engage in hazardous activities requiring mental alertness should be warned of the potential for a decrease in mental alertness while using Alfadrops-DS.

Topical ocular administration of two drops of 0.5%, 1.0%, and 1.5% Alfadrops-DS ophthalmic solution to New Zealand albino rabbits three times daily for one month resulted in sporadic and transient instances of minimal corneal edema in the 1.5% group only; no histopathological changes were noted in those eyes.

Use of Alfadrops-DS 0.5% Ophthalmic Solution can lead to an allergic-like reaction characterized wholly or in part by the symptoms of hyperemia, pruritus, discomfort, tearing, foreign body sensation, and edema of the lids and conjunctiva. If ocular allergic-like symptoms occur, Alfadrops-DS 0.5% Ophthalmic Solution therapy should be discontinued.

Information for Patients

Do not touch dropper tip to any surface as this may contaminate the contents.

The preservative in Alfadrops-DS 0.5% Ophthalmic Solution, benzalkonium chloride, may be absorbed by soft contact lenses. Contact lenses should be removed during instillation of Alfadrops-DS 0.5% Ophthalmic Solution but may be reinserted 15 minutes after instillation.

Drug Interactions

Alfadrops-DS should not be used in patients receiving MAO inhibitors . Although no specific drug interactions with topical glaucoma drugs or systemic medications were identified in clinical studies of IOPIDINE® 0.5% Ophthalmic Solution, the possibility of an additive or potentiating effect with CNS depressants (alcohol, barbiturates, opiates, sedatives, anesthetics) should be considered. Tricyclic antidepressants have been reported to blunt the hypotensive effect of systemic clonidine. It is not known whether the concurrent use of these agents with Alfadrops-DS can lead to a reduction in IOP lowering effect. No data on the level of circulating catecholamines after Alfadrops-DS withdrawal are available. Caution, however, is advised in patients taking tricyclic antidepressants which can affect the metabolism and uptake of circulating amines.

An additive hypotensive effect has been reported with the combination of systemic clonidine and neuroleptic therapy. Systemic clonidine may inhibit the production of catecholamines in response to insulin-induced hypoglycemia and mask the signs and symptoms of hypoglycemia.

Since Alfadrops-DS may reduce pulse and blood pressure, caution in using drugs such as beta-blockers (ophthalmic and systemic), antihypertensives, and cardiac glycosides is advised. Patients using cardiovascular drugs concurrently with Alfadrops-DS 0.5% Ophthalmic Solution should have pulse and blood pressures frequently monitored. Caution should be exercised with simultaneous use of clonidine and other similar pharmacologic agents.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No significant change in tumor incidence or type was observed following two years of oral administration of Alfadrops-DS HCl to rats and mice at dosages of 1.0 and 0.6 mg/kg, up to 20 and 12 times, respectively, the maximum dose recommended for human topical ocular use.

Alfadrops-DS HCl was not mutagenic in a series of in vitro mutagenicity tests, including the Ames test, a mouse lymphoma forward mutation assay, a chromosome aberration assay in cultured Chinese hamster ovary (CHO) cells, a sister chromatid exchange assay in CHO cells, and a cell transformation assay.

An in vivo mouse micronucleus assay conducted with Alfadrops-DS HCl also provided no evidence of mutagenicity.

Reproduction and fertility studies in rats showed no adverse effect on male or female fertility at a dose of 0.5 mg/kg (5 to 10 times the maximum recommended human dose).

Pregnancy

Alfadrops-DS HCl has been shown to have an embryocidal effect in rabbits when given in an oral dose of 3.0 mg/kg (60 times the maximum recommended human dose). Dose related maternal toxicity was observed in pregnant rats at 0.3 mg/kg (6 times the maximum recommended human dose). There are no adequate and well controlled studies in pregnant women. Alfadrops-DS 0.5% Ophthalmic Solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

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 Alfadrops-DS 0.5% Ophthalmic Solution is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

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

ADVERSE REACTIONS

In clinical studies the overall discontinuation rate related to Alfadrops-DS 0.5% Ophthalmic Solution was 15%. The most commonly reported events leading to discontinuation included (in decreasing order of frequency) hyperemia, pruritus, tearing, discomfort, lid edema, dry mouth, and foreign body sensation.

The following adverse reactions (incidences) were reported in clinical studies of Alfadrops-DS 0.5% Ophthalmic Solution as being possibly, probably, or definitely related to therapy:

Ocular

The following adverse reactions were reported in 5% to 15% of the patients: discomfort, hyperemia, and pruritus.

The following adverse reactions were reported in 1% to 5% of the patients: blanching, blurred vision, conjunctivitis, discharge, dry eye, foreign body sensation, lid edema and tearing.

The following adverse reactions were reported in less than 1% of the patients: abnormal vision, blepharitis, blepharoconjunctivitis, conjunctival edema, conjunctival follicles, corneal erosion, corneal infiltrate, corneal staining, edema, irritation, keratitis, keratopathy, lid disorder, lid erythema, lid margin crusting, lid retraction, lid scales, pain, photophobia.

Nonocular

Dry mouth occurred in approximately 10% of the patients.

The following adverse reactions were reported in less than 3% of the patients: abnormal coordination, asthenia, arrhythmia, asthma, chest pain, constipation, contact dermatitis, depression, dermatitis, dizziness, dry nose, dyspnea, facial edema, headache, insomnia, malaise, myalgia, nausea, nervousness, paresthesia, parosmia, peripheral edema, pharyngitis, rhinitis, somnolence and taste perversion.

Clinical Practice

The following events have been identified during postmarketing use of IOPIDINE® 0.5% Ophthalmic Solution in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. The events, which have been chosen for inclusion due to either their seriousness, frequency of reporting, possible causal connection to Alfadrops-DS 0.5% Ophthalmic Solution, or a combination of these factors, include bradycardia.

OVERDOSAGE

Ingestion of Alfadrops-DS 0.5% Ophthalmic Solution has been reported to cause bradycardia, drowsiness and hypothermia.

Accidental or intentional ingestion of oral clonidine has been reported to cause apnea, arrhythmias, asthenia, bradycardia, conduction defects, diminished or absent reflexes, dryness of the mouth, hypotension, hypothermia, hypoventilation, irritability, lethargy, miosis, pallor, respiratory depression, sedation or coma, seizure, somnolence, transient hypertension and vomiting.

Treatment of an oral overdose includes supportive and symptomatic therapy; a patent airway should be maintained. Hemodialysis is of limited value since a maximum of 5% of circulating drug is removed.

DOSAGE AND ADMINISTRATION

One to two drops of Alfadrops-DS 0.5% Ophthalmic Solution should be instilled in the affected eye(s) three times daily. Since Alfadrops-DS 0.5% Ophthalmic Solution will be used with other ocular glaucoma therapies, an approximate 5 minute interval between instillation of each medication should be practiced to prevent washout of the previous dose. NOT FOR INJECTION INTO THE EYE. NOT FOR ORAL INGESTION.

HOW SUPPLIED

Alfadrops-DS 0.5% Ophthalmic Solution as base in a sterile, isotonic, aqueous solution containing Alfadrops-DS hydrochloride.

Supplied in plastic ophthalmic DROP-TAINER® dispenser as follows:

5 mL NDC 0065-0665-05

10 mL NDC 0065-0665-10

Storage: Store between 2°C to 25°C (36°F-77°F).

Protect from freezing and light.

Distributed by:

ALCON LABORATORIES, INC.

Fort Worth, Texas 76134 USA

T2017-48

April 2017

Alfadrops-DS pharmaceutical active ingredients containing related brand and generic drugs:

Apraclonidine Hydrochloride

Alfadrops-DS available forms, composition, doses:

Drops; Ophthalmic; Apraclonidine Hydrochloride 1%

Alfadrops-DS destination | category:

Human:
Antiglaucoma preparations
EENT drugs, miscellaneous

Alfadrops-DS Anatomical Therapeutic Chemical codes:

S01EA03 - Apraclonidine

Alfadrops-DS pharmaceutical companies:

Cipla

References

Dailymed."IOPIDINE (APRACLONIDINE HYDROCHLORIDE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
"apraclonidine". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).
"apraclonidine". http://www.drugbank.ca/drugs/DB0096... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Alfadrops-DS?

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

Review

sdrugs.com conducted a study on Alfadrops-DS, 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 Alfadrops-DS 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.