Drug Interaction:
Interacting drugs- summary
Apraclonidine+ -
Cardiovascular
apraclonidine may reduce pulse and blood pressure, caution in using cardiovascular drugs is adviced.
Patients using cardiovascular drugs concurrently with apraclonidine 0.5% should have pulse and blood pressures frequently checked
MAO inhibitors
apraclonidine should not be used in patients receiving MAO inhibitors
Indication:
Reduce inflated Intra-ocular pressure(IOP)
Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publiction)
Name of Drug Indication Date of Approval
Apraclonidine Hcl alpha-2 Adrenergic Agonist 15-03-2002
(Ophthalmic )
Adverse Reaction:
Opthalmic- Upper lid elevation,, mydriasis, burning discomfort, foreign body sensation, dryness, itching, hypotony, blurred or diminished vision, allergic responsde, conjunctival microhemorrhage.
GI- abdominal pain, duarrhea, stomach discomfort, emesis, dry mouth, nausea.
Cardiovascular- bradycardi, vasovagal attackk, palpitations, orthostatic episode
CNS- insomnia, dream disturbances, irritability, decreased libido, headache, paresthesia.
Hypersensitivity- use can lead to allergic-like reactions.
Miscellaneous- taste abnormalities, nasal burning,dryness, head cold sensation, ckest heaviness or burning, clammy or sweaty palms, body heat sensation, shortness of breath, increased pharyngeal secretion, extremity pain or numbness, fatigue, pruritus not associated with rash.
Contra-Indications:
Hypersens to any component of this medication or to clonidine, concurrent monoamine oxidase inhibitor therapy.
Special preacutions-
Concomittant therapy- the addition of apraclonidine 0.5% to patients already using two aqueous suppressing drugs (eg,. beta-blocker plus carbonic anhydrase inhibitor) as part of maximaly tolerated medical therapy may not significantly reduce IOP.
Tachyphyaxis- the IOP lowering efficacy of apraclonidine 0.5% diminishes over time in some patients. The loss of effect or tachphylaxis appaeras to be an individual occurence with avariable time of onset and should be closely monitored.
Hypersentivity- aprclonidine can lead to an allergic-like reaction characterized wholly or n part by the symptoms of hyperemia, pruritus,discomfort, taerring,foreign body sensation andedema of the lids and conjuntiva. If occular allergic-like reaction occur, discontinue therapy.
Renal/heaptic functin impairment- although the topical use of aprclonidine had not been studied in renal failure patients, structurally related clonidine undergoes a significant increase in half-lfe in patients with severe renal impairment.Close monitoring of cardiovascular parameters in patients with impaired renal function, is adviced if they are candidates for topical apraclonidine therapy.
Pregnancy- use during pregnancy only if potentail benefit justifies the potentail risk to the fetus.
Lactation- Consider discontiuning nursing for the day on which apraclonodine is used.
Children- safety and efficacy for use in children have not been established.
Dosages/ Overdosage Etc:
Indication
Treatment of chronic glaucoma
Dosage:
Instil 1 drop in scheduled operative eye 1 hour before initiating anterior segment laser surgery. Instil second drop into the same eye upon completion of surgery .
Missed dose-
1. If you miss a dose of this medicine, take it as soon as possible.
2. However, if it is almost time for next dose, skip the missed dose and go back to your regular dosing schedule.
3. Do not double doses.
Patient Information:
Apraclonidine- Ophthalmic
1. Do not touch dropper tip to any surface as this may contaminate the contents
2. Apraclonidine can cause dizziness and somnolence. Patients who engage in hazardous activites requiring mental alertness should be warned of the potential for a decrease in mental alertness, physical dexterity or coordination while using apraclonidine
3.Allergies-
Tell your doctor if you have ever had any unusual or allergic reaction to apraclonidine
or clonidine. Also tell your healthcare provider if you are allergic to any other substances, such as preservatives or dyes.
2.Pregnancy-
Apraclonidine has not been studied in pregnant women. However, apraclonidine
has shown to cause death of the fetus when given by mouth to pregnant rabbits
in doses that are many times larger than the human dose. Before using this
medicine, make sure your doctor knows if you are pregnant or if you may become
pregnant.
3. Breast-feeding-
It is not known whether aprclonidine passes into breast milk. Although most
medicines pass into breast milk in small amonts, many of them may be used
safely while breast-feeding. Mothers who are using 0.5% apraclonidine and
who wish to breast-feed should discuss this with their doctor. For mothers
who are treated with 1% apraclonidine during eye surgery , your doctor
may want you to stop breast-feeding during the day of surgery.
4.Children-
Studies on this medicine have been done only in adult patients, and there
is no specific information comparing apraclonidine in children with use in
other age groups.
5.Older adults-
Many medicines have not been studied specifically in older people. Therefore, it
may not be known whether they work exactly the same way they do in younger
adults, or if they cause different side effects or problems in older people
Although there is no specific information comparing use of apraclonidine
in the elderly to use in other age groups.
6.Other medicines-
Although certain medicines should not be used together at all, in other cases two
different medicines may be used together even interaction might occur. In such
cases your doctor may want to change the dose , or other precautions may be
necessary.
Tell your doctor if you are using any other prescription or nonprescription
(over- the- counter OTC) medicine
7.Other medical problems-
The presence of other medical problems may affect the use of apraclonidine.
Make sure you tell your doctor if you have other any other medical problems,
especially-
Depression or
Heart or blood vessel disease or
high blood pressure - apraclonidine may make the condition worse
Kidney disease- or
Liver disease - higher blood levels of apraclonidine may result, which may
lead to increased side effects
Unusual reaction to a medicine that reduces the pressure within the eye-
apraclonidine is a strong reducer of eye pressure and could also cause
this reaction
Vasovagal attack( history of ) - the signs and symptoms are paleness, nausea,
sweating, slow heartbeat, sudden and severe tiredness or weakness, and
possibly fainting, usually brought on by emotional stress caused by fear or
pain. Apraclonidine may cause this reaction to happen
Pharmacology/ Pharmacokinetics:
Pharmacology:
Apraclonidine has the action of reducing elevated as well as normal intraocular pressure(IOP) whether accompanied by glaucoma or not.
Pharmacokinetics:
Topical use of aparclonidine 0.5% leads to to systemic absorption. The half-life of apraclonidine is estimated to be 8 hrs.
Pregnancy and lactation:
Pregnancy:
Use during pregnancy only if needed.
Lactation:
Consider discontinuing apraclonidine when administering to nursing women
Children-
Safety and efficacy for use in children have not been established.