Minirin Spray (Refrigerated)

Minirin Spray (Refrigerated) is used for:

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Managing temporarily increased thirst and urination caused by head injury or certain types of brain surgery, or to manage certain types of diabetes (cranial diabetes insipidus). It may also be used for other conditions as determined by your doctor.

Minirin Spray (Refrigerated) is an antidiuretic hormone. It works by causing the kidneys to produce less urine.

Do NOT use Minirin Spray (Refrigerated) if:

• you are allergic to any ingredient in Minirin Spray (Refrigerated)
• you have moderate to severe kidney problems
• you have or have a history of low blood sodium levels (salt depletion)

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

Before using Minirin Spray (Refrigerated):

Some medical conditions may interact with Minirin Spray (Refrigerated). 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 nasal problems (eg, scarring, swelling, congestion, blockage, discharge, severe runny nose)
• if you have severe drowsiness
• if you have a history of kidney problems, heart problems (eg, heart blood vessel problems), or high blood pressure
• if you have cystic fibrosis, dehydration, fever, severe infection, vomiting or diarrhea, swelling or fluid retention, or abnormal blood electrolyte levels
• if you are exposed to very hot weather, are physically active, or drink a lot of water
• if you have recently had surgery in the head area

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

• Carbamazepine, chlorpromazine, lamotrigine, narcotic analgesics (eg, codeine), nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen), oxybutynin, selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine), or tricyclic antidepressants (eg, imipramine) because the risk of fluid overload with low blood sodium levels may be increased

Ask your health care provider if Minirin Spray (Refrigerated) 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 Minirin Spray (Refrigerated):

Use Minirin Spray (Refrigerated) as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Minirin Spray (Refrigerated). Talk to your pharmacist if you have questions about this information.
• Minirin Spray (Refrigerated) should only be used in the nose. Do not get it in your eyes or mouth. If you get it in your eyes, rinse at once with cool tap water.
• The pump must be primed before the first use. To prime the pump, point the nozzle away from yourself and others and press down 4 times.
• If the pump has not been used for over a week, reprime the pump by pressing down once.
• To use, gently blow your nose. Tilt the bottle so that the tube inside draws from the deepest amount of medicine.
• Sit down and tilt your head back slightly. Place the tip of the spray container into the nose. Using a finger from your other hand, press against the opposite nostril to close if off. Breathe gently through the open nostril and squeeze the spray container. If you are using more than 1 spray, wait for 1 to 2 minutes between sprays.
• Alternate between nostrils with each spray as directed by your doctor.
• After using the medicine, rinse the tip of the spray unit in hot water and dry with a clean tissue to prevent contamination.
• Replace the cap on the bottle after each use.
• The bottle contains 50 sprays. Keep track of how many sprays you use, and throw the bottle away after 50 sprays. Do not try to use more than 50 sprays from the bottle, because you may not get the correct amount of medicine in each spray. Do not try to transfer the remaining medicine to another bottle.
• If you miss a dose of Minirin Spray (Refrigerated), use 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 use 2 doses at once.

Ask your health care provider any questions you may have about how to use Minirin Spray (Refrigerated).

Important safety information:

• Minirin Spray (Refrigerated) may cause dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Minirin Spray (Refrigerated) with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Follow the fluid intake instructions given to you by your health care provider very carefully. Serious side effects may occur if you drink too much liquid while taking Minirin Spray (Refrigerated).
• Check with your doctor if you experience infection, fever, vomiting, or diarrhea. Tell your doctor if you will be exposed to very hot weather, will be physically active, or will be increasing your water intake for any reason. The risk of low blood sodium levels may be increased.
• Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
• Tell your doctor or dentist that you take Minirin Spray (Refrigerated) before you receive any medical or dental care, emergency care, or surgery.
• Lab tests, including urine volume or blood electrolyte levels, may be performed while you use Minirin Spray (Refrigerated). These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Use Minirin Spray (Refrigerated) with caution in the ELDERLY and in CHILDREN; they may be more sensitive to its effects, especially water overload. Signs of water overload may include severe or persistent nausea or headache, vomiting, or unusual weight gain.
• Minirin Spray (Refrigerated) should be used with extreme caution in CHILDREN younger than 6 years old if used for nighttime bedwetting; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Minirin Spray (Refrigerated) while you are pregnant. It is not known if Minirin Spray (Refrigerated) is found in breast milk. If you are or will be breast-feeding while you are using Minirin Spray (Refrigerated), check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Minirin Spray (Refrigerated):

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:

Runny or stuffy nose.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); confusion; fainting; loss of appetite; mental or mood changes (eg, agitation, irritability); muscle weakness, spasms, or cramps; nausea; personality changes; recurrent or severe nosebleeds; seizures; severe or persistent nasal pain; swelling; unusual headache or restlessness; unusual tiredness or sluggishness; unusual weight gain; vomiting.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects 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), or emergency room immediately. Minirin Spray (Refrigerated) may be harmful if swallowed.

Store Minirin Spray (Refrigerated) in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Storage for up to 3 weeks at room temperature, between 68 and 77 degrees F (20 and 25 degrees C), is permitted. Store away from heat, moisture, and light. Keep Minirin Spray (Refrigerated) out of the reach of children and away from pets.

General information:

• If you have any questions about Minirin Spray (Refrigerated), please talk with your doctor, pharmacist, or other health care provider.
• Minirin Spray (Refrigerated) 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 Minirin Spray (Refrigerated). 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.

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