Alaway

Name: Alaway

Manufacturer

  • Bausch & Lomb Incorporated

Before Using Alaway

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of ketotifen in children younger than 3 years of age with use in other age groups.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of ophthalmic ketotifen in the elderly with use in other age groups.

Pregnancy

Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Change in eyesight, eye pain, or very bad eye irritation.
  • Eye redness.

For Healthcare Professionals

Applies to ketotifen ophthalmic: ophthalmic solution

Ocular

Common (1% to 10%): Irritation, pain, punctate keratitis, punctate corneal epithelial erosion
Uncommon (0.1% to 1%): Blurred vision, dry eye, eyelid disorder, conjunctivitis, photophobia, conjunctival hemorrhage
Postmarketing reports: Swelling, eyelid pruritus, edema[Ref]

Ketotifen instillation was associated with mild to moderate burning or stinging in 98% of patients (n=35) in one trial.[Ref]

Nervous system

Uncommon (0.1% to 1%): Headache, somnolence
Postmarketing reports: Dizziness[Ref]

Respiratory

Postmarketing reports: Exacerbation of asthma[Ref]

General

The most commonly reported adverse effects have included eye irritation, eye pain, punctate keratitis, and punctate corneal epithelial erosion.[Ref]

Dermatologic

Uncommon (0.1% to 1%): Rash, eczema, urticaria
Postmarketing reports: Contact dermatitis, facial edema, exacerbation of eczema[Ref]

Gastrointestinal

Uncommon (0.1% to 1%): Dry mouth[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Hypersensitivity, allergic reactions
Postmarketing reports: Exacerbation of preexisting allergic conditions[Ref]

Some side effects of Alaway may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Renal Dose Adjustments

No adjustment recommended

Liver Dose Adjustments

No adjustment recommended

Ketotifen Levels and Effects while Breastfeeding

Summary of Use during Lactation

Because absorption from the eye is limited, ketotifen would not be expected to cause any adverse effects in breastfed infants after maternal use of ketotifen eye drops. To substantially diminish the amount of drug that reaches the breastmilk after using eye drops, place pressure over the tear duct by the corner of the eye for 1 minute or more, then remove the excess solution with an absorbent tissue.

Drug Levels

Maternal Levels. Relevant published information was not found as of the revision date.

Infant Levels. Relevant published information was not found as of the revision date.

Effects in Breastfed Infants

Relevant published information was not found as of the revision date.

Effects on Lactation and Breastmilk

Relevant published information was not found as of the revision date.

Alternate Drugs to Consider

Cromolyn

References

Administrative Information

LactMed Record Number

637

Last Revision Date

20130907

Disclaimer

Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.

(web3)