Stadol NS

Name: Stadol NS

How should this medicine be used?

Butorphanol nasal spray comes as a solution (liquid) to spray in the nose. It is usually used as needed for pain, but not more often than once every 3 to 4 hours. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand.

Butorphanol nasal spray should relieve your pain soon after you use it. If you are using a low starting dose of butorphanol nasal spray, your doctor may tell you that you may use a second dose if you still have pain 60 to 90 minutes after your first dose. Do not use this second dose unless your doctor tells you that you may. Call your doctor if you still have pain after using butorphanol nasal spray as prescribed. Also call your doctor if you have used butorphanol nasal spray for some time and find that it no longer works as well as it did at the beginning of your treatment.

Butorphanol nasal spray may be habit-forming. Use butorphanol nasal spray exactly as directed. Do not use a larger dose or use it more often or for a longer time than prescribed by your doctor. Call your doctor if you develop a strong desire to use more medication than prescribed.

Do not stop using butorphanol nasal spray without talking to your doctor. If you suddenly stop using butorphanol nasal spray, you may experience withdrawal symptoms such as nervousness, agitation, shakiness, diarrhea, chills, sweats, difficulty falling asleep or staying asleep, loss of coordination,confusion, or hallucinations (seeing things or hearing voices that do not exist). Your doctor will probably decrease your dose gradually.

Before you use butorphanol nasal spray for the first time, read the written directions provided by the manufacturer. Ask your doctor or pharmacist if you have any questions about how to use butorphanol nasal spray.

To use butorphanol nasal spray, follow these directions:

  1. Wash your hands.
  2. Gently blow your nose.
  3. Remove the clear cover and protective clip from the bottle.
  4. If you are using a new pump or a pump that has not been used in 48 hours or longer, you must prime the pump before use. Hold the bottle so that the nozzle is between your first and second fingers and your thumb is on the bottom. Be sure that the bottle is aimed away from you, other people, and animals. Pump the bottle firmly and quickly (up to 8 strokes) until a fine spray appears.
  5. Insert the tip of the sprayer approximately 1/4 inch (0.6 cm) into one nostril, pointing the tip toward the back of your nose.
  6. Close your other nostril with your finger and tilt your head slightly forward.
  7. Pump the spray firmly and quickly one time and sniff gently with your mouth closed.
  8. Remove the sprayer from your nose. Tilt your head backward and sniff gently for a few seconds.
  9. Replace the protective clip and cover on the spray bottle. Put the bottle back in the child-resistant storage container.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with butorphanol nasal spray and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/cder) to obtain the Medication Guide.

What side effects can this medication cause?

Butorphanol nasal spray may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • drowsiness
  • excessive tiredness
  • difficulty falling asleep or staying asleep
  • unusual dreams
  • constipation
  • stomach pain
  • feeling hot
  • flushing
  • pain, burning, numbness, or tingling in the hands or feet
  • uncontrollable shaking of a part of the body
  • nervousness
  • hostility
  • intense happiness
  • feeling of floating
  • feeling of sadness, unpleasantness, or discomfort
  • blurred vision
  • ringing in the ears
  • ear pain
  • unpleasant taste
  • dry mouth
  • difficulty urinating
  • nosebleed
  • stuffy or irritated nose
  • sore throat

Some side effects can be serious. If you experience any of the following symptoms, call your doctor immediately:

  • slowed breathing
  • agitation, hallucinations (seeing things or hearing voices that do not exist), fever, sweating, confusion, fast heartbeat, shivering, severe muscle stiffness or twitching, loss of coordination, nausea, vomiting, or diarrhea
  • nausea, vomiting, loss of appetite, weakness, or dizziness
  • inability to get or keep an erection
  • irregular menstruation
  • decreased sexual desire
  • difficulty breathing
  • fainting
  • irregular or pounding heartbeat
  • headache
  • lightheadedness
  • rash
  • hives

Butorphanol nasal spray may cause other side effects. Call your doctor if you have any unusual problems while you are using this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about storage and disposal of this medication?

Store butorphanol nasal spray in its child-resistant container, tightly closed and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Dispose of butorphanol nasal spray as soon as it becomes outdated or is no longer needed.

Store butorphanol nasal spray in a safe place where no one can use it accidentally or on purpose.

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

How to use

Read the Medication Guide and the Patient Information Leaflet provided by your pharmacist before you start using butorphanol and each time you get a refill. If you have any questions, ask your doctor or pharmacist.This medication is a nasal spray. Have your doctor or pharmacist show the proper way to use the nasal spray. For best results, blow your nose gently before using. Follow the patient instruction leaflet for priming the pump before first use. If the spray has not been used in 48 hours, you may need to prime the pump again before use.Use 1 spray in 1 nostril or as directed by your doctor. If you still have pain after 60-90 minutes, your doctor may direct you to use a second spray in the other nostril. If needed, butorphanol may be used again in 3-4 hours after the second spray or as directed by your doctor. Some people will need 2 sprays (1 in each nostril) at the same time. In this case, they should remain lying down because there is a higher risk of drowsiness and dizziness with this higher dose. Follow your doctor's directions carefully.The dosage is based on your medical condition and response to therapy. Do not increase the dose or use it more often than directed by your doctor. Pain medications work best if they are used as the first signs of pain occur. If you wait until the pain has worsened, the medication may not work as well.This drug can cause a drop in blood pressure, especially within the first hour after use. This can cause dizziness, lightheadedness, and fainting. To lower this risk, remain sitting or lying down after using this medication.If you use a nasal decongestant spray (e.g., oxymetazoline), the decongestant may make this pain medication work more slowly. Ask your doctor or pharmacist about using these 2 medications.If nausea occurs, consult your doctor or pharmacist for ways to decrease it (e.g., antihistamines, lying down with as little head movement as possible).This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (such as restlessness, runny nose, watering eyes, trouble sleeping, severe abdominal/muscle pain, nausea, vomiting, rapid breathing, and fast heartbeat) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions immediately.Rarely, abnormal drug-seeking behavior (addiction) is possible with this medication. Do not increase your dose, use it more frequently, or use it for a longer time than prescribed. Properly stop the medication when so directed.When used for an extended period, this medication may not work as well and may require different dosing. Talk with your doctor if this medication stops working well.Inform your doctor if your pain persists or worsens.

Side effects

Drowsiness, dizziness, blurred vision, flushing, headache, nausea, vomiting, constipation, nasal irritation/congestion, trouble sleeping, dry mouth, and sweating may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.To prevent constipation, maintain a diet adequate in fiber, drink plenty of water, and exercise. If you become constipated while using this drug, consult your pharmacist for help with selecting a laxative (e.g., stimulant-type with stool softener).Remember that your doctor has prescribed this medication because he or she 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.Butorphanol can cause withdrawal reactions in people who are physically dependent on narcotics. The seriousness of the withdrawal symptoms depends on the level of dependence and the dose of butorphanol. Tell your doctor immediately if you develop symptoms such as anxiety, agitation, trouble sleeping, sweating, stomach cramps, and diarrhea.Tell your doctor right away if you have any serious side effects, including: bleeding from the nose, mental/mood changes (e.g., anxiety, confusion, hallucinations), fast/slow/irregular heartbeat, severe stomach/abdominal pain, change in the amount of urine.Get medical help right away if you have any very serious side effects, including: difficult/slow/shallow breathing, seizures.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.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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.

Breastfeeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

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.

Ask your healthcare professional how you should dispose of any medicine you do not use.

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