Ketotifen (Oral)

Generic name: ketotifen (kee-toe-TYE-fen)
Drug class: Ophthalmic antihistamines and decongestants

Pharmacologic Class: Mast Cell Stabilizer

Chemical Class: Piperidine

Ketotifen is a type of asthma medication which, when taken every day and used along with other antiasthma medications, may reduce the frequency, severity, and duration of asthma symptoms or attacks in children. It may also lead to a reduction in daily requirements of other antiasthma medications. Ketotifen is not effective for the prevention or treatment of acute asthma attacks. Ketotifen works by inhibiting certain substances in the body that are known to cause inflammation and symptoms of asthma.

Ketotifen is available only with your doctor's prescription.

Before using ketotifen

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 ketotifen, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to ketotifen 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

Ketotifen has been tested in children and, in effective doses, has not been shown to cause different side effects or problems than it does in adults.

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 ketotifen in the elderly with use in other age groups.

Breastfeeding

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. When you are taking ketotifen, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using ketotifen with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amifampridine
• Bupropion
• Donepezil
• Pitolisant

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.

Other medical problems

The presence of other medical problems may affect the use of ketotifen. Make sure you tell your doctor if you have any other medical problems, especially:

• Diabetes mellitus (sugar diabetes)—May alter low-sugar diet (syrup contains carbohydrates)

• Epilepsy—May increase risk of convulsions (seizures)

Proper use of ketotifen

Make certain your health care professional knows if you are on any special diet, such as a low-sugar diet. The syrup contains carbohydrates.

Ketotifen is used to help prevent asthma attacks. It will not relieve an asthma attack that has already started.

Ketotifen must be taken continuously in order to be effective.

Continue taking your current asthma medications until instructed otherwise by your doctor.

Ketotifen may be taken with or without food.

Dosing

The dose of ketotifen 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 ketotifen. 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.

• For oral dosage form (tablets and syrup):
  • For asthma:
    • Adults and children 3 years of age and older—The usual dose is 1 milligram (mg) (1 tablet or 5 milliliters [mL] of syrup) twice daily, once in the morning and once in the evening.
    • Infants and children from 6 months to 3 years of age—Dose is based on body weight and must be determined by the doctor. It is usually 0.25 mL (50 mcg or 0.05 mg) of syrup per kilogram (kg) (110 micrograms [mcg] or 0.110 mg per pound) of body weight twice daily, once in the morning and once in the evening.

Missed dose

If you miss a dose of ketotifen, 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

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions while using ketotifen

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. If your symptoms worsen, you should check with your doctor.

Ketotifen may cause some people to become drowsy, dizzy, or less alert than they are normally. Make sure you know how you react to ketotifen before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert.

Ketotifen may cause some people to become excited, irritable, or nervous or to have trouble in sleeping. These are symptoms of central nervous system stimulation and are especially likely to occur in children.

For patients with diabetes:

• The syrup form of ketotifen may affect blood sugar levels. If you notice a change in the results of your blood or urine sugar tests or if you have any questions, check with your doctor.

Ketotifen side effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

Less common

• Chills
• cough
• diarrhea
• fever
• general feeling of discomfort or illness
• headache
• joint pain
• loss of appetite
• muscle aches and pains
• nausea
• runny nose
• shivering
• sore throat
• sweating
• trouble sleeping
• unusual tiredness or weakness
• vomiting

Rare

• Abdominal or stomach pain
• blistering, itching, peeling, or redness of skin
• bloody or cloudy urine
• clay-colored stools
• convulsions
• dark urine
• difficult, burning, or painful urination
• dizziness
• frequent urge to urinate
• muscle spasm or jerking of all extremities
• rash
• sudden loss of consciousness
• unpleasant breath odor
• vomiting of blood
• yellow eyes or skin

Symptoms of overdose

Get emergency help immediately if any of the following symptoms of overdose occur:

• Blurred vision
• confusion
• convulsions
• disorientation
• dizziness
• drowsiness (severe)
• faintness or lightheadedness when getting up from a lying or sitting position
• fast, pounding, or irregular heartbeat or pulse
• hyperexcitability
• loss of consciousness
• palpitations
• sweating
• unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Weight gain

Less common or rare

• Bloody nose
• drowsiness
• dryness of mouth
• excitation
• increased appetite
• irritability
• nervousness
• swelling of eyelids
• unexplained nosebleeds

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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