Ketotifen (Oral)

Ketotifen is a type of asthma medication. When taken every day and used with other antiasthma medications, it may help lower how often, how severe, and how long asthma symptoms or attacks last in children. It may also decrease the daily need for other antiasthma medications. Ketotifen is not effective for preventing or treating sudden asthma attacks. It works by blocking certain substances in the body that cause inflammation and asthma symptoms.

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

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 taking it. If your symptoms worsen, you should check with your doctor.

This medicine may cause some people to feel drowsy, dizzy, or less alert than usual. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you feel dizzy or are not alert.

This medicine may cause some people to feel excited, irritable, or nervous or to have trouble sleeping. These are signs of central nervous system stimulation and are especially likely to happen in children.

For patients with diabetes:

• The syrup form of this medicine 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.

In deciding to use a medicine, you and your doctor need to consider the risks of taking the medicine against the benefits it will provide. For this medicine, think about the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know about any other allergies you may have, such as to foods, dyes, preservatives, or animals. For over-the-counter products, carefully read the label or package ingredients.

Pediatric

This medicine has been tested in children and, at effective doses, has not shown different side effects or issues compared to adults.

Geriatric

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

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Consider the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together, even if an interaction might happen. In these situations, your doctor may adjust the dose, or other precautions might be necessary. It is very important for your healthcare professional to know if you are taking any of the following medicines while using this medicine. The following interactions are based on their potential significance and do not include all possible interactions.

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may change the dose or frequency of one or both medicines.

• Amifampridine
• Bupropion
• Donepezil
• Pitolisant

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used around mealtime or with certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also cause interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may affect the use of this medicine. Make sure to inform your doctor if you have any other medical conditions, especially:

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

• Epilepsy—May increase the risk of convulsions (seizures)

Along with its needed effects, a medicine may cause some unwanted effects. Not all of these side effects may occur, but if they do, 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. Your health care professional may also 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, 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.

Pharmacologic Class: Mast Cell Stabilizer

Chemical Class: Piperidine

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 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.

• 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 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

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.