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ALOCRIL
Overview
What is ALOCRIL?
ALOCRIL
Nedocromil sodium is represented by the following structural formula:
What does ALOCRIL look like?
What are the available doses of ALOCRIL?
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What should I talk to my health care provider before I take ALOCRIL?
Sorry No records found
How should I use ALOCRIL?
ALOCRIL
®
The recommended dosage is one or two drops in each eye twice a day.
ophthalmic solution should be used at regular intervals.
Treatment should be continued throughout the period of exposure (i.e., until the pollen season is over or until exposure to the offending allergen is terminated), even when symptoms are absent.
What interacts with ALOCRIL?
ALOCRIL
®
What are the warnings of ALOCRIL?
Sorry No Records found
What are the precautions of ALOCRIL?
Information for Patients
Patients should be advised to follow the patient instructions listed on the Information for Patients sheet.
Users of contact lenses should refrain from wearing lenses while exhibiting the signs and symptoms of allergic conjunctivitis.
Patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye, surrounding structures, fingers, or any other surface in order to avoid contamination of the solution by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions.
Carcinogenesis, Mutagenesis, and Impairment of Fertility
A two-year inhalation carcinogenicity study of nedocromil sodium at a dose of 24 mg/kg/day (approximately 400 times the maximum recommended human daily ocular dose on a mg/kg basis) in Wistar rats showed no carcinogenic potential.
Nedocromil sodium showed no mutagenic potential in the Ames Salmonella/microsome plate assay, mitotic gene conversion in , mouse lymphoma forward mutation and mouse micronucleus assays.
Reproduction and fertility studies in mice and rats showed no effects on male and female fertility at a subcutaneous dose of 100 mg/kg/day (more than 1600 times the maximum recommended human daily ocular dose).
Pregnancy
Reproduction studies performed in mice, rats and rabbits using a subcutaneous dose of 100 mg/kg/day (more than 1600 times the maximum human daily ocular dose on a mg/kg basis) revealed no evidence of teratogenicity or harm to the fetus due to nedocromil sodium. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response,
ophthalmic solution should be used during pregnancy only if clearly needed.
Nursing Mothers
After intravenous administration to lactating rats, nedocromil was excreted in milk. 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
ophthalmic solution is administered to a nursing woman.
Pediatric Use
Safety and effectiveness in children below the age of 3 years have not been established.
Geriatric Use
No overall differences in safety or effectiveness have been observed between elderly and younger patients.
What are the side effects of ALOCRIL?
The most frequently reported adverse experience was headache (~40%).
Ocular burning, irritation and stinging, unpleasant taste, and nasal congestion have been reported to occur in 10 – 30% of patients. Other events occurring between 1 – 10% included asthma, conjunctivitis, eye redness, photophobia, and rhinitis.
Some of these events were similar to the underlying ocular disease being studied.
What should I look out for while using ALOCRIL?
ALOCRIL
®
What might happen if I take too much ALOCRIL?
Sorry No Records found
How should I store and handle ALOCRIL?
Pharmacist:ALOCRIL5 mL in 10 mL bottle NDC 0023-8842-05ALOCRIL5 mL in 10 mL bottle NDC 0023-8842-05
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Nedocromil sodium is a mast cell stabilizer. Nedocromil sodium inhibits the release of mediators from cells involved in hypersensitivity reactions. Decreased chemotaxis and decreased activation of eosinophils have also been demonstrated.
In vitro
Non-Clinical Toxicology
ALOCRIL®
In addition, certain drugs inhibit the activity of this isozyme and make normal metabolizers resemble poor metabolizers. An individual who is stable on a given dose of TCA may become abruptly toxic when given one of these inhibiting drugs as concomitant therapy. The drugs that inhibit cytochrome P450 2D6 include some that are not metabolized by the enzyme (quinidine; cimetidine) and many that are substrates for P450 2D6 (many other antidepressants, phenothiazines, and the Type 1C antiarrhythmics propafenone and flecainide). While all the selective serotonin reuptake inhibitors (SSRIs), e.g., fluoxetine, sertraline, and paroxetine, inhibit P450 2D6, they may vary in the extent of inhibition. The extent to which SSRI-TCA interactions may pose clinical problems will depend on the degree of inhibition and the pharmacokinetics of the SSRI involved. Nevertheless, caution is indicated in the co-administration of TCAs with any of the SSRIs and also in switching from one class to the other. Of particular importance, sufficient time must elapse before initiating TCA treatment in a patient being withdrawn from fluoxetine, given the long half-life of the parent and active metabolite (at least 5 weeks may be necessary).
Concomitant use of tricyclic antidepressants with drugs that can inhibit cytochrome P450 2D6 may require lower doses than usually prescribed for either the tricyclic antidepressant or the other drug. Furthermore, whenever one of these other drugs is withdrawn from co-therapy, an increased dose of tricyclic antidepressant may be required. It is desirable to monitor TCA plasma levels whenever a TCA is going to be co-administered with another drug known to be an inhibitor of P450 2D6.
The plasma concentration of imipramine hydrochloride may increase when the drug is given concomitantly with hepatic enzyme inhibitors (e.g., cimetidine, fluoxetine) and decrease by concomitant administration of hepatic enzyme inducers (e.g., barbiturates, phenytoin), and adjustment of the dosage of imipramine hydrochloride may therefore be necessary.
In occasional susceptible patients or in those receiving anticholinergic drugs (including antiparkinsonism agents) in addition, the atropine-like effects may become more pronounced (e.g., paralytic ileus). Close supervision and careful adjustment of dosage is required when imipramine hydrochloride is administered concomitantly with anticholinergic drugs.
Avoid the use of preparations, such as decongestants and local anesthetics, that contain any sympathomimetic amine (e.g., epinephrine, norepinephrine), since it has been reported that tricyclic antidepressants can potentiate the effects of catecholamines.
Caution should be exercised when imipramine hydrochloride is used with agents that lower blood pressure. Imipramine hydrochloride may potentiate the effects of CNS depressant drugs.
Patients should be warned that imipramine hydrochloride may enhance the CNS depressant effects of alcohol. (See .)
Patients should be advised to follow the patient instructions listed on the Information for Patients sheet.
Users of contact lenses should refrain from wearing lenses while exhibiting the signs and symptoms of allergic conjunctivitis.
Patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye, surrounding structures, fingers, or any other surface in order to avoid contamination of the solution by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions.
The most frequently reported adverse experience was headache (~40%).
Ocular burning, irritation and stinging, unpleasant taste, and nasal congestion have been reported to occur in 10 – 30% of patients. Other events occurring between 1 – 10% included asthma, conjunctivitis, eye redness, photophobia, and rhinitis.
Some of these events were similar to the underlying ocular disease being studied.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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