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|Stimate Spray

Stimate Spray

Stimate Spray is used for:

Treating bleeding episodes in patients with hemophilia or certain types of von Willebrand disease. It may also be used for other conditions as determined by your doctor.

Stimate Spray is an antidiuretic hormone. It works by increasing the amount of a blood factor necessary for normal blood clotting.

Do NOT use Stimate Spray if:

• you are allergic to any ingredient in Stimate Spray
• you have certain bleeding disorders (type IIB or platelet-type von Willebrand disease)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Stimate Spray:

Some medical conditions may interact with Stimate Spray. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have moderate to severe kidney problems

Some MEDICINES MAY INTERACT with Stimate Spray. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Loperamide because it increases the actions and side effects of Stimate Spray and could increase the possibility of water intoxication (symptoms include headache, nausea, vomiting, or seizures)

This may not be a complete list of all interactions that may occur. Ask your health care provider if this medicine may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Stimate Spray:

Use Stimate Spray as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Carefully read and follow the patient instructions for use of the spray pump before using Stimate Spray.
• Stimate Spray is to be used only in the nose.
• The pump must be primed before the first use. To prime the pump, press down 4 times.
• Throw the bottle away after 25 sprays. Do not try to transfer the remaining medicine to another bottle.
• If you miss a dose of Stimate Spray, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Stimate Spray.

Important safety information:

• Very carefully follow the fluid intake instructions given to you by your doctor. Serious side effects may occur if you drink too much liquid while taking Stimate Spray, especially in children and elderly patients.
• Do not use more of Stimate Spray or use it for longer than recommended because serious side effects may occur.
• LAB TESTS, including urine volume, may be performed to monitor your progress. Be sure to keep all doctor and lab appointments.
• Use Stimate Spray with caution in the ELDERLY because they may be more sensitive to its effects. They should carefully follow limited fluid intake according to their doctor"s instructions.
• Stimate Spray is not recommended for use in CHILDREN younger than 11 months of age. Safety and effectiveness in this age group have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Stimate Spray during pregnancy. It is unknown if Stimate Spray is excreted in breast milk. If you are or will be breast-feeding while you are using Stimate Spray, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Stimate Spray:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Chills; cough; dizziness; flushing; headache; itchy or light-sensitive eyes; nasal congestion; nausea; nosebleed; runny nose; sleepiness; sleeplessness; sore throat; stomach cramps; upper respiratory tract infection; warm feeling; weakness.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); agitation; changes in heart rate; chest pain; confusion; ongoing headache; prolonged nausea and vomiting; scarring or swelling of the nose; seizures; swelling of the head of the penis; unusual tiredness; unusual weight gain.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include facial flushing; fluid retention (decreased urination, ongoing headache, prolonged nausea or vomiting, seizures); irritation of the tissue in the nose and mouth; shortness of breath; stomach pain. Stimate Spray may be harmful if swallowed.

Store Stimate Spray in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). When traveling, Stimate Spray may be kept out of the refrigerator for up to 3 weeks if stored at room temperature at 77 degrees F (25 degrees C). Store away from heat, moisture, and light. Store the bottle in an upright position. Keep Stimate Spray out of the reach of children and away from pets.

General information:

• If you have any questions about Stimate Spray, please talk with your doctor, pharmacist, or other health care provider.
• Stimate Spray is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Stimate Spray. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.