Drugs Details

Drugs Info of Lastacaft
Drugs Details
  • Drugs Type  : Multum
  • Date : 30th Dec 2014 12:30 am
  • Brand Name : Lastacaft
  • Generic Name : alcaftadine ophthalmic (Pronunciation: al KAF ta deen off THAL mik)
Descriptions

LASTACAFT® is a sterile, topically administered H1 receptor antagonist containing alcaftadine for ophthalmic use.

Alcaftadine is a white to yellow powder with an empirical formula of C19H21N3O and a molecular weight of 307.39.

Contains:

Active: alcaftadine 0.25% (2.5 mg/mL)

Inactives: benzalkonium chloride 0.005% as a preservative; edetate disodium; sodium phosphate, monobasic; purified water; sodium chloride; sodium hydroxide and/or hydrochloric acid (to adjust pH)

Chemical Name: 6,11-dihydro-11-(1-methyl-4-piperidinylidene)-5H-imidazo[2,1-b] [3] benzazepine-3-carboxaldehyde

Structural Formula:

 

LASTACAFT® (alcaftadine) Structural Formula Illustration

The drug product has a pH of approximately 7 and an osmolality of approximately 290 mOsm/kg.

What are the possible side effects of alcaftadine ophthalmic (Lastacaft)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using alcaftadine ophthalmic and call your doctor at once if you have severe burning, stinging, or other irritation after using the eye drops.

Less serious side effects may include:

  • mild burnng, stinging, or irritation;
  • eye redness or itching;
  • runny or stuffy nose, sore throat, flu symptoms; or
  • headache.

This is not a complete list of side effects and...

Read All Potential Side Effects and See Pictures of Lastacaft »

What are the precautions when taking alcaftadine ophthalmic solution (Lastacaft)?

Before using alcaftadine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: contact lens use.

After you apply this drug, your vision may be temporarily unclear. Do not drive, use machinery, or do any activity that requires clear vision until you are sure you can perform such activities safely.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

If you develop an eye infection...

Read All Potential Precautions of Lastacaft »


This monograph has been modified to include the generic and brand name in many instances.

Indications

LASTACAFT® is an H1 histamine receptor antagonist indicated for the prevention of itching associated with allergic conjunctivitis.

Dosage Administration

Instill one drop in each eye once daily. If more than 1 topical ophthalmic medicinal product is being used, each one should be administered at least 5 minutes apart.

How Supplied

Dosage Forms And Strengths

Topical ophthalmic solution containing alcaftadine, 0.25% (2.5 mg/mL).

Storage And Handling

LASTACAFT® (alcaftadine ophthalmic solution) 0.25% is supplied in an opaque, white low-density polyethylene bottle with a white polypropylene cap.

3 mL fill in 5 mL bottle NDC 0023-4290-03

Storage

Store at 15°-25°C (59°-77°F).

Manufactured for Allergan, Inc., Irvine, CA 92612, U.S.A. by Par Sterile Products, LLC, Rochester, MI 48307. Revised: June 2014

Last reviewed on RxList: 12/22/2014
This monograph has been modified to include the generic and brand name in many instances.

Side Effects

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Clinical Studies Experience

The most frequent ocular adverse reactions, occurring in less than 4% of eyes treated with LASTACAFT®, were eye irritation, burning and/or stinging upon instillation, eye redness and eye pruritus.

Non-ocular Adverse Reactions

The most frequent non-ocular adverse reactions, occurring in less than 3% of subjects with eyes treated with LASTACAFT®, were nasopharyngitis and headache. Some of these events were similar to the underlying disease being studied.

Postmarketing Experience

The following adverse reactions have been identified during postmarketing use of LASTACAFT® in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These reactions include: eye discharge, eye swelling, erythema of eyelid, eyelid edema, hypersensitivity, and somnolence.

Read the Lastacaft (alcaftadine ophthalmic solution) Side Effects Center for a complete guide to possible side effects

Interactions

No information provided.


This monograph has been modified to include the generic and brand name in many instances.

Warnings

Included as part of the PRECAUTIONS section.

Precautions

Potential For Eye Injury And Contamination

To minimize eye injury and contamination of the dropper tip and solution, care should be taken not to touch the eyelids or surrounding areas with the dropper tip of the bottle. Keep bottle tightly closed when not in use.

Contact Lens Use

Patients should be advised not to wear a contact lens if their eye is red.

LASTACAFT® should not be used to treat contact lens-related irritation.

LASTACAFT® should not be instilled while wearing contact lenses. Remove contact lenses prior to instillation of LASTACAFT®. The preservative in LASTACAFT®, benzalkonium chloride, may be absorbed by soft contact lenses. Lenses may be reinserted after 10 minutes following administration of LASTACAFT® .

Topical Ophthalmic Use Only

LASTACAFT® is for topical ophthalmic use only.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment Of Fertility

Alcaftadine was not mutagenic or genotoxic in the Ames test, the mouse lymphoma assay or the mouse micronucleus assay.

Alcaftadine was found to have no effect on fertility of male and female rats at oral doses up to 20 mg/kg/day (approximately 200 times the plasma exposure at the recommended human ocular dose).

Use In Specific Populations

Pregnancy

Pregnancy Category B

Reproduction studies performed in rats and rabbits revealed no evidence of impaired female reproduction or harm to the fetus due to alcaftadine. Oral doses in rats and rabbits of 20 and 80 mg/kg/day, respectively, produced plasma exposure levels approximately 200 and 9000 times the plasma exposure at the recommended human ocular dose. There are however, no adequate and well controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers

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 LASTACAFT® is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in pediatric patients below the age of 2 years have not been established.

Geriatric Use

No overall differences in safety or effectiveness were observed between elderly and younger subjects.


This monograph has been modified to include the generic and brand name in many instances.

OverDose

No information provided.

ContrainDications

LASTACAFT® is contraindicated in patients with hypersensitivity to any component in the product.


This monograph has been modified to include the generic and brand name in many instances.

Clinical Pharamacology

Mechanism Of Action

Alcaftadine is an H1 histamine receptor antagonist and inhibitor of the release of histamine from mast cells. Decreased chemotaxis and inhibition of eosinophil activation has also been demonstrated.

Pharmacokinetics

Absorption

Following bilateral topical ocular administration of alcaftadine ophthalmic solution, 0.25%, the mean plasma Cmax of alcaftadine was approximately 60 pg/mL and the median Tmax occurred at 15 minutes. Plasma concentrations of alcaftadine were below the lower limit of quantification (10 pg/mL) by 3 hours after dosing. The mean Cmax of the active carboxylic acid metabolite was approximately 3 ng/mL and occurred at 1 hour after dosing. Plasma concentrations of the carboxylic acid metabolite were below the lower limit of quantification (100 pg/mL) by 12 hours after dosing. There was no indication of systemic accumulation or changes in plasma exposure of alcaftadine or the active metabolite following daily topical ocular administration.

Distribution

The protein binding of alcaftadine and the active metabolite are 39.2% and 62.7%, respectively.

Metabolism

The metabolism of alcaftadine is mediated by non-CYP450 cytosolic enzymes to the active carboxylic acid metabolite.

Excretion

The elimination half-life of the carboxylic acid metabolite is approximately 2 hours following topical ocular administration. Based on data following oral administration of alcaftadine, the carboxylic acid metabolite is primarily eliminated unchanged in the urine.

In vitro studies showed that neither alcaftadine nor the carboxylic acid metabolite substantially inhibited reactions catalyzed by major CYP450 enzymes.

Clinical Studies

Clinical efficacy was evaluated in conjunctival allergen challenge (CAC) studies. LASTACAFT® was more effective than its vehicle in preventing ocular itching in patients with allergic conjunctivitis induced by an ocular allergen challenge, both at 3 minutes post-dosing and at 16 hours post-dosing of LASTACAFT® .

The safety of LASTACAFT® was evaluated in a randomized clinical study of 909 subjects over a period of 6 weeks.


This monograph has been modified to include the generic and brand name in many instances.

Patient Information

Potential For Eye Injury And Sterility Of Dropper Tip

To minimize eye injury and contamination of the dropper tip and solution, patients should be advised to not touch the eyelids or surrounding areas with the dropper tip, as this may contaminate the contents.

Concomitant Use With Other Ophthalmic Products Or Contact Lenses

If more than one topical ophthalmic drug is being used, the drugs should be administered at least five minutes apart.

Patients should be advised not to wear a contact lens if their eye is red. Patients should be advised that LASTACAFT® should not be used to treat contact lens-related irritation. Patients should also be advised to remove contact lenses prior to instillation of LASTACAFT®. The preservative in LASTACAFT®, benzalkonium chloride, may be absorbed by soft contact lenses. Lenses may be reinserted after 10 minutes following administration of LASTACAFT® .

Topical Ophthalmic Use Only

For topical ophthalmic administration only.


This monograph has been modified to include the generic and brand name in many instances

Consumer Overview Uses

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

 

ALCAFTADINE - OPHTHALMIC

 

(al-KAF-ta-deen)

 

COMMON BRAND NAME(S): Lastacaft

 

USES: This medication is used to prevent itching of the eyes due to allergies. Alcaftadine is an antihistamine. It works by blocking a certain natural substance (histamine) that causes allergic symptoms.

Do not use this medication to treat red or irritated eyes due to wearing contact lenses. Contact your doctor for further instructions if this occurs.

 

HOW TO USE: Apply this medication in both eyes as directed by your doctor, usually once a day.

Wash your hands before each use. To avoid contamination, do not touch the dropper tip or let it touch your eye or any other surface.

The preservative in this product may be absorbed by contact lenses. If you wear contact lenses, remove them before using this medication and keep them out of your eyes for at least 10 minutes after each dose. Do not wear contact lenses if your eyes are red.

Tilt your head back, look upward, and pull down the lower eyelid to make a pouch. Hold the dropper directly over your eye and place one drop into the pouch as directed by your doctor. Look downward, gently close your eyes, and place one finger at the corner of your eye (near the nose). Apply gentle pressure for 1 to 2 minutes before opening your eyes. This will prevent the medication from draining out. Try not to blink or rub your eye. Repeat these steps for your other eye.

Do not rinse the dropper. Replace the dropper cap after each use.

If you are using another kind of eye medication (for example, other drops or ointments), wait at least 5 minutes before applying other medications. Use eye drops before eye ointments to allow the drops to enter the eye.

Use this medication regularly to get the most benefit from it. To help you remember, use it at the same time each day.

Do not use this product if it becomes contaminated (for example, drops turn a dark color). Using contaminated eye medication can cause infection, serious damage to the eye, and loss of vision. Contact your doctor or pharmacist for more information.

Tell your doctor if your condition does not improve in a few days or if it worsens.

Consumer Overview Side Effect

SIDE EFFECTS: Mild and temporary burning/stinging of the eyes may occur when you apply this medication. If this effect persists or worsens, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

 

Read the Lastacaft (alcaftadine ophthalmic solution) Side Effects Center for a complete guide to possible side effects

Learn More »

PRECAUTIONS: Before using alcaftadine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: contact lens use.

After you apply this drug, your vision may be temporarily unclear. Do not drive, use machinery, or do any activity that requires clear vision until you are sure you can perform such activities safely.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

If you develop an eye infection or eye injury, or require eye surgery, ask your doctor if you should continue to use your current bottle of alcaftadine eye drops or start a new bottle.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

Consumer Overview Missed Dose

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

 

OVERDOSE: This medicine may be harmful if swallowed. If swallowing or overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

 

NOTES: Do not share this medication with others.

Ask your doctor about additional ways to reduce your symptoms (such as minimizing your exposure to allergens, using cold compresses and lubricating eye drops).

 

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

 

STORAGE: Keep the bottle tightly closed and store at room temperature. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

 

Information last revised March 2013. Copyright(c) 2013 First Databank, Inc.

Patient Detailed Side Effect

Generic Name: alcaftadine ophthalmic (Pronunciation: al KAF ta deen off THAL mik)

  • What is alcaftadine ophthalmic (Lastacaft)?
  • What are the possible side effects of alcaftadine ophthalmic (Lastacaft)?
  • What is the most important information I should know about alcaftadine ophthalmic (Lastacaft)?
  • What should I discuss with my healthcare provider before using alcaftadine ophthalmic (Lastacaft)?
  • How should I use alcaftadine ophthalmic (Lastacaft)?
  • What happens if I miss a dose (Lastacaft)?
  • What happens if I overdose (Lastacaft)?
  • What should I avoid while using alcaftadine ophthalmic (Lastacaft)?
  • What other drugs will affect alcaftadine ophthalmic (Lastacaft)?
  • Where can I get more information?

What is alcaftadine ophthalmic (Lastacaft)?

Alcaftadine is an antihistamine that reduces the effects of natural chemical histamine in the body. Histamine can produce symptoms such as itchy or watery eyes.

Alcaftadine ophthalmic (for the eyes) is used to prevent itching in the eyes caused by allergies.

Alcaftadine ophthalmic should not be used to treat eye irritation caused by contact lenses.

Alcaftadine ophthalmic may also be used for purposes not listed in this medication guide.

What are the possible side effects of alcaftadine ophthalmic (Lastacaft)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using alcaftadine ophthalmic and call your doctor at once if you have severe burning, stinging, or other irritation after using the eye drops.

Less serious side effects may include:

  • mild burnng, stinging, or irritation;
  • eye redness or itching;
  • runny or stuffy nose, sore throat, flu symptoms; or
  • headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the Lastacaft (alcaftadine ophthalmic solution) Side Effects Center for a complete guide to possible side effects

Learn More »

What is the most important information I should know about alcaftadine ophthalmic (Lastacaft)?

To make sure you can safely usar alcaftadine ophthalmic, tell your doctor about any medical conditions that affect your eyes.

Alcaftadine ophthalmic should not be used to treat eye irritation caused by contact lenses.

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

Alcaftadine ophthalmic should not be used in a child younger than 2 years old.

Do not allow the tip of the dropper to touch any surface, including your eyes or hands. If the dropper becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye.

Stop using alcaftadine ophthalmic and call your doctor at once if you have severe burning, stinging, or other irritation after using the eye drops.

Side Effects Centers
  • Lastacaft

Patient Detailed How Take

What should I discuss with my healthcare provider before using alcaftadine ophthalmic (Lastacaft)?

You should not use this medication if you are allergic to alcaftadine.

To make sure you can safely usar alcaftadine ophthalmic, tell your doctor about any medical conditions that affect your eyes.

FDA pregnancy category B. Alcaftadine ophthalmic is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether alcaftadine ophthalmic passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Alcaftadine ophthalmic should not be used in a child younger than 2 years old.

How should I use alcaftadine ophthalmic (Lastacaft)?

Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

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

Wash your hands before using eye medication.

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 as you squeeze out a drop, then close your eye.
  • Use only the number of drops your doctor has prescribed.
  • Gently press your finger to the inside corner of the eye (near your nose) for about 1 minute to keep the liquid from draining into your tear duct.
  • Wait at least 10 minutes before using any other eye drops that your doctor has prescribed.

Do not allow the tip of the dropper to touch any surface, including your eyes or hands. If the dropper becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye.

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

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

Side Effects Centers
  • Lastacaft

Patient Detailed Avoid Taking

What happens if I miss a dose (Lastacaft)?

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.

What happens if I overdose (Lastacaft)?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using alcaftadine ophthalmic (Lastacaft)?

Do not use other eye medications during treatment with alcaftadine ophthalmic unless your doctor tells you to.

What other drugs will affect alcaftadine ophthalmic (Lastacaft)?

It is not likely that other drugs you take orally or inject will have an effect on alcaftadine ophthalmic used in the eyes. But many drugs can interact with each other. Tell your doctor about all medicines you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about alcaftadine ophthalmic.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2013 Cerner Multum, Inc. Version: 1.01. Revision date: 8/10/2011.

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Side Effects Centers
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