Brand Name
Iopidine
Generic Name
Apraclonidine
View Brand Information FDA approval date: July 19, 2009
Classification: alpha-Adrenergic Agonist
Form: Solution
What is Iopidine (Apraclonidine)?
IOPIDINE 1% Ophthalmic Solution is indicated to control or prevent post-surgical elevations in IOP that occur in patients after argon laser trabeculoplasty, argon laser iridotomy or Nd:YAG posterior capsulotomy.
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Brand Information
IOPIDINE 1% (apraclonidine hydrochloride ophthalmic solution)
1DESCRIPTION
IOPIDINE 1% Ophthalmic Solution contains apraclonidine hydrochloride, an alpha adrenergic agonist, in a sterile isotonic solution
Each mL of IOPIDINE 1% Ophthalmic Solution contains:
Actives: apraclonidine hydrochloride 11.5 mg equivalent to apraclonidine base
10 mg.
10 mg.
Inactives:sodium chloride, sodium acetate, sodium hydroxide and/or hydrochloric acid (pH 4.4‑7.8), purified water and benzalkonium
chloride 0.01% (preservative). Osmolality is 260‑320 mOsm.
chloride 0.01% (preservative). Osmolality is 260‑320 mOsm.
2CLINICAL PHARMACOLOGY
Apraclonidine is a relatively selective, alpha adrenergic agonist and does not have significant membrane stabilizing (local anesthetic) activity. When instilled into the eye, IOPIDINE 1% (apraclonidine hydrochloride ophthalmic solution) has the action of reducing intraocular pressure (IOP). Ophthalmic apraclonidine has minimal effect on cardiovascular parameters.
Optic nerve head damage and visual field loss may result from an acute elevation in IOP that can occur after argon or Nd:YAG laser surgical procedures. Elevated IOP, whether acute or chronic in duration, is a major risk factor in the pathogenesis of visual field loss. The higher the peak or spike of IOP, the greater the likelihood of visual field loss and optic nerve damage especially in patients with previously compromised optic nerves. The onset of action with IOPIDINE 1% Ophthalmic Solution can usually be noted within one hour and the maximum IOP reduction usually occurs three to five hours after application of a single dose. The precise mechanism of the ocular hypotensive action of IOPIDINE 1% Ophthalmic Solution is not completely established at this time. Aqueous fluorophotometry studies in man suggest that its predominant action may be related to a reduction of aqueous formation. Controlled clinical studies of patients requiring argon laser trabeculoplasty, argon laser iridotomy or Nd:YAG posterior capsulotomy showed that IOPIDINE 1% Ophthalmic Solution controlled or prevented the post-surgical IOP rise typically observed in patients after undergoing those procedures. After surgery, the mean IOP was 1.2 to 4 mmHg below the corresponding pre-surgical baseline pressure before IOPIDINE Ophthalmic Solution treatment. With placebo treatment, post-surgical pressures were 2.5 to 8.4 mmHg higher than their corresponding pre-surgical baselines. Overall, only 2% of patients treated with IOPIDINE* 1% Ophthalmic Solution had severe IOP elevations (spike greater than or equal to 10 mmHg) during the first three hours after laser surgery, whereas 23% of placebo-treated patients responded with severe pressure spikes (Table 1). Of the patients that experienced a pressure spike after surgery, the peak IOP was above 30 mmHg in most patients (Table 2) and was above 50 mmHg in seven placebo-treated patients and one IOPIDINE 1% Ophthalmic Solution-treated patient.
Table 1: Incidence of IOP Spikes Greater Than or Equal to 10 mmHg
aN = Number Spikes/Number Eyes.
Table 2: Magnitude of Post-surgical IOP in Trabeculoplasty, Iridotomy and Nd:YAG Capsulotomy Patients With Severe Pressure Spikes Greater than or Equal to 10 mmHg
Maximum Postsurgical IOP (mmHg)
3INDICATIONS AND USAGE
IOPIDINE 1% Ophthalmic Solution is indicated to control or prevent
4CONTRAINDICATIONS
IOPIDINE 1% Ophthalmic Solution is contraindicated for patients
5WARNINGS
FOR TOPICAL OPHTHALMIC USE ONLY. Not for injection or oral ingestion.
Topical administration of apraclonidine have been reported to cause cardiovascular collapse requiring intubation and ventilation in pediatric patients 6 years and younger, including neonates. Systemic adverse reactions such as prolonged lethargy and unresponsiveness, apnea, hypoxia, respiratory failure, bradycardia, hypertension, hypotension, hypothermia, hypotonia, pallor have also been reported. Appropriate monitoring in a clinical setting should be in place.
6PRECAUTIONS
PRECAUTIONS
6.1GENERAL
Since IOPIDINE* 1% Ophthalmic Solution is a potent depressor of IOP,
6.2INFORMATION FOR PATIENTS
Apraclonidine can cause dizziness and somnolence. Patients who engage
6.3DRUG INTERACTIONS
Interactions with other agents have not been investigated.
6.4CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY
No significant change in tumor incidence or type was observed
6.5PREGNANCY
Apraclonidine HCl has been shown to have an embryocidal effect in
6.6NURSING MOTHERS
It is not known if topically applied IOPIDINE 1% Ophthalmic Solution is
6.7PEDIATRIC USE
Safety and effectiveness in pediatric patients have not been established.
During postmarketing surveillance, cardiovascular collapse requiring intubation and ventilation, prolonged lethargy and unresponsiveness, apnea, hypoxia, respiratory failure, bradycardia, hypertension, hypotension, hypothermia, hypotonia, and pallor have been reported in pediatric patients 6 years and younger, including neonates, following topical administration of apraclonidine (see WARNINGS).
6.8GERIATRIC USE
No overall differences in safety or effectiveness have been observed
7ADVERSE REACTIONS
The following adverse events, occurring in less than 2% of patients, were
Gastrointestinal
Abdominal pain, diarrhea, stomach discomfort, emesis
Cardiovascular
Bradycardia, vasovagal attack, palpitations, orthostatic
episode
Central Nervous System
Insomnia, dream disturbances, irritability, decreased libido.
Other
Taste abnormalities, dry mouth, nasal burning or dryness,
headache, head cold sensation, chest heaviness or burning,
clammy or sweaty palms, body heat sensation, shortness
of breath, increased pharyngeal secretion, extremity pain
or numbness, fatigue, paresthesia, pruritus not associated
with rash.
Clinical Practice
The following events have been identified during postmarketing use of IOPIDINE 1% 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 IOPIDINE 1% Ophthalmic Solution, or a combination of these factors, include
• Hypersensitivity.
• Cardiovascular collapse requiring intubation and ventilation, prolonged lethargy and unresponsiveness, apnea, hypoxia, respiratory failure, hypertension, hypotension, hypothermia, hypotonia, and pallor have been reported in pediatric patients 6 years and younger, including neonates, following topical administration of apraclonidine.
Abdominal pain, diarrhea, stomach discomfort, emesis
Cardiovascular
Bradycardia, vasovagal attack, palpitations, orthostatic
episode
Central Nervous System
Insomnia, dream disturbances, irritability, decreased libido.
Other
Taste abnormalities, dry mouth, nasal burning or dryness,
headache, head cold sensation, chest heaviness or burning,
clammy or sweaty palms, body heat sensation, shortness
of breath, increased pharyngeal secretion, extremity pain
or numbness, fatigue, paresthesia, pruritus not associated
with rash.
Clinical Practice
The following events have been identified during postmarketing use of IOPIDINE 1% 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 IOPIDINE 1% Ophthalmic Solution, or a combination of these factors, include
• Hypersensitivity.
• Cardiovascular collapse requiring intubation and ventilation, prolonged lethargy and unresponsiveness, apnea, hypoxia, respiratory failure, hypertension, hypotension, hypothermia, hypotonia, and pallor have been reported in pediatric patients 6 years and younger, including neonates, following topical administration of apraclonidine.
8OVERDOSAGE
Ingestion of IOPIDINE* 0.5% Ophthalmic Solution has been reported to
9DOSAGE AND ADMINISTRATION
One drop of IOPIDINE* 1% Ophthalmic Solution should be instilled in the
10HOW SUPPLIED
IOPIDINE 1% Ophthalmic Solution as base is a sterile, isotonic, aqueous
12 pouches per carton NDC 82667‑200‑01
Storage:Store at 2°C to 25°C (36°F‑77°F).
Protect from light.
Protect from light.
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