Triptodur 22.5 mg IM suspension

Generic name:
Triptorelin 6 month pediatric (22.5 mg) - injection

Pronunciation
(TRIP-toe-REL-in)

Brand name(s)
Triptodur

Triptorelin is used to stop early puberty (precocious puberty) in children. It helps to delay sexual development (such as growth of the breasts/testicles) and the start of menstrual periods. It also helps slow down early bone growth to increase the likelihood of reaching normal adult height. Triptorelin works by decreasing the amount of sex hormones that a child's body makes (estrogen in girls, testosterone in boys).

Read the Medication Guide provided by your pharmacist before you start using triptorelin and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

This medication is given by injection into the muscle of your buttocks or thighs by a health care professional as directed by your doctor, usually once every 6 months.

Use this medication regularly to get the most benefit from it. To help you remember, mark your calendar to keep track of when you should receive the next dose.

During the first few weeks of treatment, hormone levels will actually go up before they go down. This is a normal response to this medication. You may notice worsening symptoms of early puberty (such as menstrual periods) at the start of treatment. However, you should see an improvement in symptoms usually within 1 to 2 months. Tell your doctor promptly if new or worsened symptoms develop after starting treatment.

Pain/redness/itching/swelling at the injection site, hot flashes (flushing), headache, or vaginal bleeding may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor 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.

Tell your doctor right away if you have any serious side effects, including:

• mental/mood changes (such as depression, thoughts of suicide, mood swings, aggression)

Get medical help right away if you have any very serious side effects, including:

• seizures

Children using triptorelin may be at risk for increased pressure around the brain (intracranial hypertension). Get medical help right away if your child has any of these very serious side effects:

• nausea/vomiting that doesn't stop
• headache that is severe or doesn't go away
• eye pain
• vision changes (such as blurred/double vision, decreased vision)
• ringing in the ears

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 or at www.fda.gov/medwatch.

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

Before using triptorelin, tell your doctor or pharmacist if you are allergic to it; or to other GnRH-type drugs (such as leuprolide); 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:

• mental/mood problems (such as depression)
• seizures

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

This medication must not be used during pregnancy. It may harm an unborn baby. If you become pregnant or think you may be pregnant, tell your doctor right away.

It is unknown if triptorelin passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this medication. Consult your doctor before breastfeeding.

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.

This medication may interfere with certain lab tests, possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Lab and/or medical tests (such as hormone levels, height measurements, bone tests) should be done while using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

Not applicable. This medication is given in a doctor's office and will not be stored at home.

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.