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PubMed2002

Safety, tolerability, and pharmacokinetics of escalating high doses of ivermectin in healthy adult subjects.

Safety and pharmacokinetics (PK) of the antiparasitic drug ivermectin, administered in higher and/or more frequent doses than currently approved for human use, were evaluated in a double-blind, placebo-controlled, dose escalation study. Subjects (n = 68) were assigned to one of four panels (3:1, ivermectin/placebo): 30 or 60 mg (three times a week) or 90 or 120 mg (single dose). The 30 mg panel (range: 34 7-594 microg/kg) also received a single dose with food after a 1-week washout. Safety assessments addressed both known ivermectin CNS effects and general toxicity. The primary safety endpoint was mydriasis, accurately quantitated by pupillometry. Ivermectin was generally well tolerated, with no indication of associated CNS toxicity for doses up to 10 times the highest FDA-approved dose of 200 microg/kg. All dose regimens had a mydriatic effect similar to placebo. Adverse experiences were similar between ivermectin and placebo and did not increase with dose. Following single doses of 30 to 120 mg, AUC and Cmax were generally dose proportional, with t(max) approximately 4 hours and t1/2 approximately 18 hours. The geometric mean AUC of 30 mg ivermectin was 2.6 times higher when administered with food. Geometric mean AUC ratios (day 7/day 1) were 1.24 and 1.40 for the 30 and 60 mg doses, respectively, indicating that the accumulation of ivermectin given every fourth day is minimal. This study demonstrated that ivermectin is generally well tolerated at these higher doses and more frequent regimens.

Administration, Oral↗
PubMed2000

Effects of pentagastrin and the cold pressor test on the acoustic startle response and pupillary function in man.

Pentagastrin, a cholecystokinin2 (CCK2) receptor agonist, evokes autonomic and subjective features of anxiety in healthy volunteers. The present experiments examined the effects of pentagastrin on two responses with known sensitivity to another anxiogenic procedure (threat of electric shock): the acoustic startle response and the pupillary light reflex. The effects of pentagastrin were compared with those of the cold pressor test, a procedure known to elicit sympathetic activation. Twelve healthy males (18-35 years) participated in two experiments each consisting of two sessions in which they received (1) pentagastrin (0.3 microg/kg, i.v.) and a control infusion (saline), and (2) cold pressor test (90 s hand immersion at 4 degrees C) and a control immersion (37 degrees C), using a balanced single-blind protocol. Electromyographic responses of the orbicularis oculi to 40 ms, 1 kHz, 115 dB tones ('startle responses') [Experiment 1], and miotic responses to 200 ms, 0.43 mW/cm2 light pulses [Experiment 2] were recorded before, during and after the infusions and hand immersions. Heart rate, blood pressure and subjective feelings were also recorded. The amplitude of the startle response was not significantly affected by pentagastrin, but was reduced during the cold pressor test. Resting pupil diameter increased during both pentagastrin infusion and the cold pressor test, but neither procedure altered the amplitude of the light reflex. Tachycardia, increased blood pressure and subjective anxiety were induced by both pentagastrin and the cold pressor test. The cardiovascular and mydriatic effects of pentagastrin and the cold pressor test are consistent with the known ability of these treatments to induce sympathetic activation. The anxiety induced by these treatments, unlike anxiety induced by threat of electric shock, was not accompanied by potentiation of the startle response or reduction of the miotic response. The results indicate that different anxiogenic procedures do not have equivalent effects on these reflexes.

Adolescent↗
PubMed1983

Does lithium balance the neuronal bilateral asymmetries in cluster headache?

Pupil size was measured using a pupillograph, and an asymmetric responsiveness to tyramine, instilled bilaterally, was observed in asymptomatic cluster headache patients. Relatives of cluster headache patients showed an anisocoric mydriasis to tyramine, too. This asymmetry was caused by a less marked mydriatic response of one side which, in the cluster headache sufferers, corresponds to the symptomatic side. After three months of treatment with lithium carbonate (900 mg/die), a bilateral decrease of pupil size was noted, possibly due to a reduced sympathergic tone. After six months of continued treatment an unknown mechanism, likely adaptive in nature, attenuated the effect of lithium on pupil size. Lithium also induced a symmetric response to tyramine by increasing tyramine mydriasis on the symptomatic pupil while reducing it on the asymptomatic pupil. It is postulated that lithium improves cluster headache by correcting abnormal bilateral asymmetries in central neuronal systems which regulate autonomic function and pain sensitivity of the structures involved in the cluster attack.

Cluster Headache↗
PubMed1990

The potential for mental status changes associated with systemic absorption of anticholinergic ophthalmic medications: concerns in the elderly.

Several cases have been reported of anticholinergic toxicity following the administration of commonly used parasympatholytic cycloplegics and mydriatics. Cases have been reported in children, adults, and the elderly. The risk of developing mental status changes secondary to anticholinergic ophthalmic medications is of particular concern in the elderly. Drug-induced mental status or behavior changes should not be mistaken for exacerbation of an underlying disorder or the onset of a new disease (e.g., Alzheimer's disease, dementia). Clinicians should be aware of these potential complications, monitor for changes in mental status, and take appropriate action.

Absorption↗
PubMedDate not supplied

Aqueous flare intensity in relation to different stages of diabetic retinopathy.

PURPOSE: To compare laser flare intensity in patients with diabetes mellitus (DM) type I and type II to different stages of diabetic retinopathy (DR) and controls. METHODS: This study comprised 88 consecutive patients with DM type I and 40 controls in the same age range, divided into two age groups: 20-34 years and 35-50 years; 108 consecutive patients with DM type II and 32 controls were also divided into two age groups: 45-59 years and 60-75 years. Patients with glaucoma, exfoliation syndrome, media opacities, uveitis, within 96 hours after laser photocoagulation, treatment with topical and systemic drugs which can affect aqueous protein concentration, were excluded. One eye was randomly selected from each diabetic patient and control. Flare intensity was measured with a laser flare meter without mydriatic drops, and was then correlated with the stages of DR within each age group. RESULTS: Eyes with advanced DR, such as moderate-severe, severe non-proliferative DR and proliferative DR (PDR), had significantly higher flare intensity than controls and eyes without retinopathy in all age groups (p<0.05). Flare intensity values were similar for controls and eyes with mild-moderate DR in all age groups except the older patients with DM type II, particularly those with clinically significant macular edema (CSME) (p<0.05). Eyes with regressed proliferative DR and no indication for laser photocoagulation had significantly lower flare values than eyes with an indication for therapy (p<0.05). Eyes with iris rubeosis (IR) had significantly higher flare than those without IR (p<0.05). Flare values were significantly correlated with the duration of diabetes in DM types I and II (p<0.05). CONCLUSIONS: Flare intensity was increased in eyes with mild-moderate DR with CSME, and in eyes with advanced and severe stages of DR. Aqueous flare was related to the duration of diabetes.

Adult↗
PubMed1985

The effect of desipramine upon melatonin and cortisol secretion in depressed and normal subjects.

Melatonin and cortisol values in plasma were measured hourly over 24 hours in six depressed patients and six normal volunteers before treatment and after one and three weeks of treatment with desipramine. The normal volunteers were further tested one week after withdrawal of desipramine. The mydriatic effects of tyramine and phenylephrine eye drops were also recorded in the normal volunteers. In neither group of subjects did desipramine treatment reduce melatonin secretion, suggesting that functionally significant down-regulation of beta andrenoceptors was not caused by this treatment. Melatonin secretion was significantly increased after three weeks of treatment in depressed patients. This increase was not found in normal subjects.

Adolescent↗
PubMed1990

Positive diagnosis of self-medication with homatropine eye drops.

A 25-year-old man with a variety of unusual ocular symptoms was fully investigated and no abnormality discovered. The suspicion of self-medication with a mydriatic was confirmed when homatropine was isolated in his tears. We describe a method for collecting tears which allowed biochemical confirmation at leisure.

Adult↗
PubMedDate not supplied

Corneal injuries during general anesthesia.

A corneal abrasion is the most common eye complication during general anesthesia and recovery. It is painful, may progress to inflammation of the uveal tract, and in the presence of contamination may lead to a serious infection. Both eyes may be involved, as the two reported cases show. Possible causes include mask friction on the open eye or other careless technics. Treatment includes local application of an antibiotic ointment and an eye pressure patch. In addition, a cycloplegic and mydriatic solution is instilled to prevent synechiae (in the presence of a secondary iridocyclitis) and to relieve the pain associated with spasm of the iris and ciliary muscle. Topical application of local anesthetics should be avoided, as they delay regeneration of corneal epithelium and may promote keratitis.

Adult↗
PubMed1994

Agents for the treatment of overactive detrusor. VII. Synthesis and pharmacological properties of 2,3- and 3,4-diphenylcyclopentylamines, 2,3-diphenyl-2-cyclopentenylamines, and related compounds.

As part of our search for new agents for the treatment of overactive detrusor, 2,3- and 3,4-diphenylcyclopentylamines (3), 2,3-diphenyl-2-cyclopentenylamines (4), and related compounds (5 and 18) were synthesized and evaluated for inhibitory activity (i.v.) against urinary bladder rhythmic contraction in rats. Among them, some compounds involving N-tert-butyl-2,3-diphenyl-2-cyclopentenylamine (4b) exhibited inhibitory activity against bladder contraction superior to that of terodiline (2). Mydriatic activity (i.v.) of compound 4b in rats, an index of its side effects due to antimuscarinic activity, was found to be relatively weak in comparison with its inhibitory activity against bladder contraction. The pharmacological profile of 4b was examined in comparison with that of terodiline. Most of the objective amines (3, 4, 5) were synthesized by preparation of Schiff bases from the corresponding cyclic ketones (6, 7, 8) and amines in the presence of TiCl4 in CH2Cl2 and subsequent reduction with NaBH4 in the presence of MeOH in one pot (method A).

Amines↗
PubMed2002

Hand-held digital video-camera for eye examination and follow-up.

We developed a hand-held digital colour video-camera for eye examination in primary care. The device weighed 550 g. It featured a charge-coupled device (CCD) and corrective optics. Both colour video and digital still images could be taken. The video-camera was connected to a PC with software for database storage, image processing and telecommunication. We studied 88 normal subjects (38 male, 50 female), aged 7-62 years. It was not necessary to use mydriatic eye drops for pupillary dilation. Satisfactory digital images of the whole face and the anterior eye were obtained. The optic disc and the central part of the ocular fundus could also be recorded. Image quality of the face and the anterior eye were excellent; image quality of the optic disc and macula were good enough for tele-ophthalmology. Further studies are needed to evaluate the usefulness of the equipment in different clinical conditions.

Adolescent↗
PubMed1999

Iritis associated with intravenous cidofovir.

OBJECTIVE: To report two patients with AIDS and cytomegalovirus retinitis who developed iritis after receiving intravenous cidofovir. Both experienced recurrent symptoms upon rechallenge. CASE SUMMARIES: Two HIV-positive patients with cytomegalovirus retinitis infections previously controlled with intravenous ganciclovir or foscarnet were treated with intravenous cidofovir. Symptoms of iritis developed after the second or third dose of cidofovir. One patient experienced symptoms unilaterally, while the other patient had bilateral symptoms. In both patients, the iritis resolved with topical ophthalmic therapy, but recurred following subsequent infusions of cidofovir. Therapy with cidofovir was discontinued, and no further recurrences of iritis were noted. One patient had post-inflammatory fixed dilated pupils. CONCLUSIONS: Iritis can uncommonly occur in patients receiving intravenous cidofovir and oral probenecid. With prompt drug discontinuation and administration of topical corticosteroids and/or mydriatic agents, symptoms are usually reversible.

AIDS-Related Opportunistic Infections↗
PubMed2003

Intracapsular lens removal in a Przewalski's wild horse (Equus caballus przewalskii).

A 11.5-yr-old female Przewalski's wild horse (Equus caballus przewalskii) presented for unilateral blepharitis and drainage from the left eye. The left cornea was not ulcerated, and intraocular evaluation was hampered by severe corneal edema. The left eye appeared to respond positively to treatment with anti-inflammatories and a topical mydriatic agent. During the ensuing 2 yr, there were minor episodes of epiphora from the left eye. The discharge then increased, and a luxated lens was noted during an examination by a veterinary ophthalmologist as part of the preshipment examination. Initially, the lens was located in the anterior compartment but was in the vitreal compartment at the time of surgery, complicating the intracapsular extraction. After successful removal of the lens, the horse was transferred to a new institution without incident, where it appears to have adapted well to its probable loss of vision in the left eye. No further episodes of uveitis, corneal edema, or epiphora have been reported, and the horse has successfully foaled at the new institution.

Animals↗
PubMed1998

Ultrastructural changes of the myoepithelium of the dilator pupillae during miosis and mydriasis in the rat iris.

Changes in the three-dimensional structures of the myoepithelium of the dilator pupillae (MDP) during mydriasis and miosis were investigated in the rat by scanning electron microscopy (SEM) and transmission electron microscopy (TEM). Following fixation, SEM specimens were treated with sodium hydroxide to expose the muscle surface. Significant morphological differences were noted in the anterior surface of the MDP between mydriasis and miosis. In the mydriatic eye, a highly rugged structure with numerous linear folds was oriented circularly or obliquely together with spherical bulges. These structures, presumably corresponding to the highly contractile portion of the myoepithelial cells, were more prominent near the pupillary margin than near the ciliary margin, indicating that the MDP may contract much more strongly in the pupillary margin. In the miotic eye, the anterior surface of the MDP showed less conspicuous linear folds in the pupillary area, and was almost flat in the ciliary area. Radially oriented ridges were observed only in the pupillary area. These findings suggest that the contraction of the sphincter pupillae in miosis induces a stretching of the MDP toward the pupil and a circular shrinkage of the MDP. Ultrastructural changes of the MDP particularly near the pupillary margin may play an important role in regulation of the pupil diameter as a diaphragm of the eye because morphological changes such as the linear folds, spherical bulges, and ridges were more prominent near the pupillary margin than those near the ciliary margin.

Animals↗
PubMed1991

Practical treatment recommendations for pharmacotherapy of Behçet's syndrome.

Behçet's syndrome is a disease of unknown aetiology classified among the vasculitides. It runs a course of exacerbations and remissions which gradually abate with time. Eye disease, the most frequent cause of serious morbidity, may lead to blindness in 20% of those affected. The syndrome may occasionally be fatal due to vasculitis leading to arterial occlusion, ruptured arterial aneurysms or pulmonary vasculitis, or involvement of the central nervous system. Immunosuppressive drugs have been shown to be moderately successful in inducing and maintaining remissions. Azathioprine at a dose of 2.5 mg/kg/day has been shown to control the progression of existing, and the development of new, eye disease. Cyclosporin A is also beneficial in controlling active eye disease and although it has a more rapid action than azathioprine, its toxicity limits its long term use. Colchicine, although widely prescribed, has been shown in a controlled trial to be effective only in reducing the development of erythema nodosum and arthralgia. Systemic corticosteroids, once widely used, are now reserved only for the most severe cases of inflammatory eye disease and vasculitis, where they are frequently used as intravenous pulse therapy. Local mydriatics are used to prevent synechiae. Local treatment with corticosteroids, sometimes in conjunction with antibiotics, control oral and genital ulcers which may also be controlled by immunosuppressives, which are reserved for the most severe cases. Thrombophlebitis usually only requires antiplatelet agents, whereas arteritis is treated conventionally with a combination of corticosteroids and immunosuppressive drugs, usually cyclophosphamide.

Administration, Oral↗
PubMed2002

Management of uveitis in pediatric patients: special considerations.

Uveitis refers to inflammation involving the uvea or middle coat of the eye. This condition occurs uncommonly, particularly in persons aged <or=16 years. However, pediatric uveitis deserves special consideration for reasons that include the relatively poor prognosis, unique systemic associations, and various age-related treatment considerations. Accurate diagnosis requires history from both patient and parents, a complete ophthalmic examination that may require general anesthesia, and carefully selected investigations. Infections and masquerade syndromes, such as leukemia and retinoblastoma, must be excluded before treatment is commenced with immunosuppressive agents. Noninfectious anterior uveitis generally responds to topical corticosteroid and mydriatic therapy. Although used frequently in adults with posterior uveitis, periocular corticosteroid injections may require a general anesthetic, and systemic corticosteroids may cause serious adverse effects, including growth retardation, in pediatric patients. Consequently, in children, one or more corticosteroid-sparing immunosuppressive drugs are usually employed for vision-threatening noninfectious posterior eye inflammation. Methotrexate is the most commonly used systemic immunosuppressive agent for pediatric uveitis. It is effective in small retrospective clinical series, generally well tolerated, easy to administer, and inexpensive. Cyclosporin has also been used successfully in children with uveitis, being associated with a low risk of renal toxicity when used at standard doses. Although prescribed for severe ocular inflammation in adults, alkylating agents are generally contraindicated in children owing to risks including secondary malignancy, sterility and bone marrow suppression. Drugs that inhibit tumor necrosis factor-alpha have recently been used successfully to treat children with uveitis; however, in some patients there may be a risk of potentiating the ocular inflammation. Randomized clinical trials would provide valuable information about the relative efficacy of the various available treatment options.

Child↗
PubMed2004

Cerebral infarction following pituitary apoplexy--case report.

A 29-year-old man presented with lethargy, headache, high fever, and visual disturbance. Neurological examination showed mydriatic pupil, ptosis, diminished light reflex, and ophthalmoplegia on the left. Magnetic resonance (MR) imaging showed the typical findings of pituitary apoplexy, and cerebral angiography disclosed mild narrowing of the A1 segment of the left anterior cerebral artery (ACA). Transsphenoidal tumor resection was performed. Transient severe right hemiparesis occurred directly after the operation. Computed tomography demonstrated cerebral infarction in the territory of the left Heubner's and medial lenticulostriate arteries. Pituitary apoplexy followed by cerebral infarction is very rare. Vasospasm of the perforating arteries of the ACA probably caused the cerebral infarction. Subarachnoid blood or vasoactive agents released from the tumor were the most likely cause of the vasospasm. MR imaging findings of contrast enhancement around the vessels may indicate reactive processes around the vessels.

Adult↗
PubMedDate not supplied

Dilated pupil during endoscopic sinus surgery: what does it mean?

Endoscopic sinus surgery has become the standard of care for the surgical management of chronic sinus disease. Sinus disease and its surgical treatment carry the risk of orbital complications, irrespective of the approach. Orbital complications associated with sinus surgery include nasolacrimal duct damage, extraocular muscle injury, intraorbital hemorrhage/emphysema, and direct optic nerve damage, resulting in blindness. The finding of an unequal pupil at the end of a procedure would be a cause of considerable concern, but it is most likely due to the topical contamination of the eye with a mydriatic pharmacological agent commonly used in endoscopic sinus surgery.

Chronic Disease↗
PubMed1990

A subchronic toxicity study of two inhaled aerosolized atropine sulfate formulations in rats and dogs.

The potential subchronic (21 days) toxicity of inhaled metered aerosol formulations (solution and suspension) of atropine sulfate was investigated in rats and dogs. The doses administered to rats were 0.78 and 2.5 mg/kg/day (solution) or 1.4 and 3.2 mg/kg/day (suspension). In the dog, the daily doses achieved were 0.5 and 1.3 mg/kg/day, regardless of formulation. In both species, sham control animals inhaled air only and vehicle control animals inhaled either placebo solution or placebo suspension. There was no mortality or other evidence of a toxic effect of atropine sulfate. The expected mydriatic effect of atropine sulfate was seen in both species and, similarly, the pupillary light reflex was impaired in rats and dogs receiving either formulation of atropine sulfate at both dose levels. Reduced salivation was also noted and ophthalmologic examinations in both species were unremarkable. In dogs, atropine sulfate (high-dose) caused tachycardia but there was no evidence of an adverse effect on the electrocardiogram or on systolic blood pressure. In both species, atropine sulfate did not alter body weight, food consumption or clinical pathology parameters. Necropsy observations and histopathological findings revealed no effect of atropine sulfate in either species although, in the rat, adrenal gland hypertrophy in both sexes followed inhalation of the suspension at both dose levels. With this possible exception, nothing but the expected pharmacological effects of atropine sulfate were seen in either rats or dogs.

Administration, Inhalation↗