Alocril

Name: Alocril

Nedocromil Ophthalmic Interactions

Do not use other eye medications unless your doctor tells you to.

It is not likely that other drugs you take orally or inject will have an effect on nedocromil used in the eyes. But many drugs can interact with each other. Tell each of your healthcare providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.

Nedocromil Ophthalmic Dosage

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Do not use this medicine while wearing contact lenses. Nedocromil ophthalmic may contain a preservative that can discolor soft contact lenses. Wait at least 15 minutes after using this medicine before putting in your contact lenses.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Wash your hands before using the eye drops.

To apply the eye drops:

  • Tilt your head back slightly and pull down your lower eyelid to create a small pocket. Hold the dropper above the eye with the tip down. Look up and away from the dropper and squeeze out a drop.
  • Blink several times to make sure the solution spreads over your eye. Then close your eyes and wipe away any excess solution with a clean tissue.
  • Use only the number of drops your doctor has prescribed. If you use more than one drop, wait about 5 minutes between drops.
  • Wait at least 10 minutes before using any other eye drops your doctor has prescribed.

Do not touch the tip of the eye dropper or place it directly on your eye. A contaminated dropper can infect your eye, which could lead to serious vision problems.

Do not use the eye drops if the liquid has changed colors or has particles in it. Call your pharmacist for new medicine.

Use this medicine for the full length of time you are exposed to allergens, even if you have no symptoms.

Store at room temperature away from moisture and heat. Do not freeze. Keep the bottle tightly closed when not in use.

An overdose of nedocromil ophthalmic is not expected to be dangerous. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if anyone has accidentally swallowed the medication.

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Overdose

No information provided.

Uses For Alocril

Nedocromilis used to treat the itching in your eyes that happens with allergies.

Nedocromil works by acting on certain inflammatory cells to prevent them from releasing substances that cause allergic symptom.

This medicine is available only with your doctor's prescription.

Proper Use of Alocril

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

Nedocromil is used to help treat the itching that occurs with allergic conjunctivitis. To use the ophthalmic solution (eye drops)form of this medicine:

  • First, wash your hands. Tilt the head back and, pressing your finger gently on the skin just beneath the lower eyelid, pull the lower eyelid away from the eye to make a space. Drop the medicine into this space. Let go of the eyelid and gently close the eyes. Blink a few times to make sure the eye is covered with the medicine.
  • To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). Also, keep the container tightly closed.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Uses of Alocril

  • It is used to treat eye irritation.

What are some other side effects of Alocril?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Headache.
  • Burning.
  • Stinging.
  • Eye irritation.
  • Stuffy nose.
  • Bad taste in your mouth.
  • Bright lights may bother you. Wear sunglasses.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Alocril - Clinical 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 studies with adult human bronchoalveolar cells showed that nedocromil sodium inhibits histamine release from a population of mast cells having been defined as belonging to the mucosal sub type and inhibits beta-glucuronidase release from macrophages.

Pharmacokinetics and Bioavailability

Nedocromil sodium exhibits low systemic absorption. When administered as a 2% ophthalmic solution in adult human volunteers, less than 4% of the total dose was systemically absorbed following multiple dosing. Absorption is mainly through the nasolacrimal duct rather than through the conjunctiva. It is not metabolized and is eliminated primarily unchanged in urine (70%) and feces (30%).

Precautions

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 Saccharomyces cerevisiae, 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

Teratogenic Effects: Pregnancy Category B

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, Alocril® 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 Alocril® 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.

Alocril Dosage and Administration

The recommended dosage is one or two drops in each eye twice a day. Alocril® 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.

Warnings

Contraindications

Hypersensitivity to drug or component of the formulation

Cautions

Refrain from wearing contacts while exhibiting symptoms of allergic conjunctivitis

Avoid contact with tip of dispenser to prevent contamination

Who should not use nedocromil ophthalmic (alocril)?

Do not use nedocromil ophthalmic if you have a bacterial, viral, or fungal infection in your eye unless you are also receiving proper anti-infective treatment.

Nedocromil ophthalmic is in the FDA pregnancy category B. This means that it is unlikely to harm an unborn baby. Do not use nedocromil ophthalmic without first talking to your doctor if you are pregnant.

It is not known whether nedocromil passes into breast milk. Do not use nedocromil ophthalmic without first talking to your doctor if you are breast-feeding a baby.

Nedocromil ophthalmic is not approved for use by children younger than 3 years of age.

What happens if i miss a dose (alocril)?

Apply the missed dose as soon as you remember. However, if it is almost time for your next regularly scheduled dose, skip the missed dose and apply the next one as directed. Do not use a double dose of this medication.

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