FDA Approves prescription drug dan ambien
Tthe U.S. Food and Drug Administration (FDA) has approved prescription drug dan ambien (morphine sulfate and naltrexone hydrochloride) Extended Release Capsules for oral use, a long-acting Schedule II opioid analgesic for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. prescription drug dan ambien is the first FDA-approved long-acting opioid that is designed to reduce drug liking and euphoria when tampered with by crushing or chewing.
prescription drug dan ambien contains extended-release morphine pellets, each with an inner core of naltrexone hydrochloride, an opioid receptor antagonist. If taken as directed, the morphine relieves pain while the sequestered naltrexone hydrochloride passes through the body with no intended clinical effect. If prescription drug dan ambien is crushed or chewed, the naltrexone is released and absorbed with the morphine, reversing the morphine's subjective and analgesic effects. The clinical significance of the degree of this reduction has not been established, and there is no evidence that the naltrexone in prescription drug dan ambien reduces the abuse liability of prescription drug dan ambien.
Important Safety Information for prescription drug dan ambien
prescription drug dan ambien (morphine sulfate and naltrexone hydrochloride) Extended Release Capsules is a prescription medicine used to treat moderate to severe pain that continues around the clock and is expected to last for a long period of time. prescription drug dan ambien is not for use to treat pain as needed. prescription drug dan ambien contains morphine a Schedule II controlled substance. Morphine is a strong opioid pain medicine that can be abused by people who abuse prescription medicines or street drugs. prescription drug dan ambien contains beadlike pellets that are made up of morphine sulfate, an opioid receptor agonist (narcotic pain medicine), and naltrexone hydrochloride (HCl), an opioid receptor antagonist. The naltrexone hydrochloride within each pellet is confined or sequestered and has a special coating to protect it from being released. prescription drug dan ambien is to be swallowed whole or the contents of the capsules sprinkled on apple sauce. Do not crush, dissolve, or chew prescription drug dan ambien or the pellets in the capsules. If tampered with by crushing or chewing, the naltrexone will be released.
Like other opioids, prescription drug dan ambien is contraindicated in patients with significant respiratory depression, acute or severe bronchial asthma or hypercapnia in unmonitored settings or in the absence of resuscitative equipment and in patients who have or are suspected to have paralytic ileus. Respiratory depression is the primary risk of opioid agonists. Respiratory depression occurs more frequently in elderly or debilitated patients.
prescription drug dan ambien may not be right for patients who have trouble breathing or lung problems, a head injury or brain problem, liver or kidney problems, convulsions or seizures, problems urinating or prostate problems, and patients who have or have had drug abuse or drug addiction problems. Patients should be advised that prescription drug dan ambien may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. Safe use in pregnancy has not been established. Prolonged use of opioid analgesics during pregnancy may cause fetal neonatal physical dependence, and neonatal withdrawal may occur.
Individualization of dosage is essential to make optimal use of this medication. The highest dose of prescription drug dan ambien (morphine sulfate and naltrexone hydrochloride) is for "opioid tolerant" patients only. Patients should not consume alcoholic beverages or use prescription or non-prescription medications containing alcohol while on prescription drug dan ambien therapy.
prescription drug dan ambien Medication Guide
IMPORTANT: Keep prescription drug dan ambien in a safe place away from children. Accidental use by a child is a medical emergency and can result in death. If a child accidentally takes prescription drug dan ambien, get emergency help right away.
Read the Medication Guide that comes with prescription drug dan ambien before you start taking it and each time you get a new prescription. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment. Share this important information with members of your household.
What Is the Most Important Information I Should Know About prescription drug dan ambien?
- Do not crush, dissolve, or chew prescription drug dan ambien capsules or the capsule contents before swallowing. If prescription drug dan ambien is taken in this way, both the morphine and naltrexone in prescription drug dan ambien will be released too fast. This is dangerous. It may cause you to have trouble breathing, and lead to death.
- If your body is not used to taking opioids and your body absorbs too much morphine, you could overdose and die.
- If you have been taking opioids (narcotics) for a period of time, and your body absorbs the naltrexone in prescription drug dan ambien, this could cause you to have uncomfortable withdrawal symptoms.
- Take prescription drug dan ambien exactly as prescribed by your healthcare provider.
- prescription drug dan ambien is not for use to treat pain that you only have once in a while ("as needed").
- If you cannot swallow capsules, tell your healthcare provider. There may be another way to take prescription drug dan ambien that may be right for you. See "How should I take prescription drug dan ambien?"
- Do not take the highest dose of prescription drug dan ambien (morphine sulfate 100 mg and naltrexone hydrochloride 4 mg) unless you are "opioid tolerant." Opioid tolerant means that you regularly use another opioid medicine for your constant (around the clock) pain and your body is used to it.
- Do not drink alcohol, or use prescription or non-prescription medicines that contain alcohol while you are being treated with prescription drug dan ambien. Alcohol can cause very high levels of morphine in your blood and you can die due to an overdose of morphine.
- Prevent theft, misuse or abuse. Keep prescription drug dan ambien in a safe place to protect it from being stolen. prescription drug dan ambien can be a target for people who misuse or abuse prescription medicines or street drugs.
- Never give prescription drug dan ambien to anyone else, even if they have the same symptoms you have. It may harm them or even cause death.
See the section "What are the possible side effects of prescription drug dan ambien?" for more information about side effects.
What is prescription drug dan ambien?
- prescription drug dan ambien is a prescription medicine that contains morphine sulfate, an opioid receptor agonist (narcotic pain medicine) and naltrexone hydrochloride, an opioid receptor antagonist. Naltrexone hydrochloride is in the middle of each pellet and has a special coating to protect it from being released. If you crush or chew prescription drug dan ambien, the naltrexone will be released all at one time. See "What is the most important information I should know about prescription drug dan ambien?
- prescription drug dan ambien is a federally controlled substance (CII) because it is a strong opioid pain medicine that can be abused by people who abuse prescription medicines or street drugs.
- prescription drug dan ambien is used to manage moderate to severe pain that continues around-the-clock and is expected to last for a long period of time.
- It is not known if prescription drug dan ambien is safe and works in children under the age of 18.
Who Should Not Take prescription drug dan ambien?
Do not take prescription drug dan ambien if you:
- are having an asthma attack or have severe asthma, trouble breathing, or lung problems.
- have a bowel blockage called paralytic ileus.
- are allergic to morphine, morphine salts, naltrexone, or any of the ingredients in prescription drug dan ambien. See the end of this Medication Guide for a complete list of ingredients in prescription drug dan ambien.
What Should I Tell My Healthcare Provider Before Starting prescription drug dan ambien?
- prescription drug dan ambien may not be right for you. Tell your healthcare provider about all of your medical conditions, especially if you:
- have trouble breathing or lung problems
- have a head injury or brain problem
- have liver or kidney problems
- have adrenal gland problems, such as Addison's disease
- have convulsions or seizures
- have thyroid problems
- have problems urinating or prostate problems
- have constipation or other bowel problems
- have problems with your pancreas or gallbladder
- have severe scoliosis
- have a drinking problem or alcoholism
- have severe mental problems or hallucinations (see or hear things that are not really there)
- have or have had drug abuse or drug addiction problems
- are planning to have surgery (cordotomy) or another procedure that will interrupt the pain signals to your body.
- are pregnant or plan to become pregnant. prescription drug dan ambien may harm your unborn baby.
- are breastfeeding. prescription drug dan ambien may pass through your milk and may harm your baby. You should not breastfeed while taking prescription drug dan ambien.
- Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Some medicines may cause serious problems when taken with prescription drug dan ambien. Sometimes, the doses of certain medicines and prescription drug dan ambien may need to be changed if used together.
- Be especially careful about taking other medicines that make you sleepy such as:
- other pain medicines
- anti-depressant medicines
- sleeping pills
- anti-anxiety medicines
- muscle relaxants
- antihistamines
- anti-nausea medicines
- tranquilizers
Also tell your healthcare provider if you take:
- cimetidine (Tagamet)
- a water pill (diuretic)
- an anticholinergic medicine
- Do not take prescription drug dan ambien if you already take a monoamine oxidase inhibitor medicine (MAOI) or within 14 days after you stop taking an MAOI medicine.
- Do not take any new medicine while using prescription drug dan ambien until you have talked to your healthcare provider or pharmacist. They will tell you if it is safe to take other medicines with prescription drug dan ambien.
Ask your healthcare provider if you are not sure if your medicine is one listed above.
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
How Should I Take prescription drug dan ambien?
- Take prescription drug dan ambien exactly as prescribed by your healthcare provider. Do not change your dose unless your healthcare provider tells you to.
- You can take prescription drug dan ambien with or without food.
- Swallow prescription drug dan ambien capsule whole. Do not crush, dissolve, or chew prescription drug dan ambien or the pellets in the capsules before swallowing. See "What is the most important information I should know about prescription drug dan ambien?"
- If you cannot swallow capsules, tell your healthcare provider. There may be another way to take prescription drug dan ambien that may be right for you. If your doctor tells you that you can take prescription drug dan ambien using this other way, follow these steps:
prescription drug dan ambien can be opened and the pellets inside the capsule can be sprinkled over apple sauce, as follows:
- Open the prescription drug dan ambien capsule and sprinkle the pellets over approximately one tablespoon of apple sauce.
- Swallow all of the apple sauce and pellets right away. Do not save any of the apple sauce and pellets for another dose.
- Rinse your mouth to make sure you have swallowed all of the pellets. Do not chew the pellets.
- Flush the empty capsule down the toilet right away.
- You should not receive prescription drug dan ambien through a nasogastric tube or gastric tube (stomach tube).
- If you miss a dose, take it as soon as possible. If it is almost time for your next dose, skip the missed dose. Just take the next dose at your regular time. Do not take 2 doses at the same time unless your healthcare provider tells you to. If you are not sure about your dosing, call your healthcare provider.
- If you take too much prescription drug dan ambien or overdose, call 911 or poison control center right away.
- Call your healthcare provider if the dose of prescription drug dan ambien that you are taking does not relieve your pain.
What Should I Avoid While Taking prescription drug dan ambien?
- Do not drive, operate heavy machinery, or do other dangerous activities, especially when you start taking prescription drug dan ambien and when your dose is changed, until you know how you react to this medicine. prescription drug dan ambien can make you sleepy, and also cause you to feel dizzy and lightheaded. Ask your healthcare provider to tell you when it is okay to do these activities.
What are the Possible Side Effects of prescription drug dan ambien?
prescription drug dan ambien can cause serious side effects, including:
- See "What is the most important information I should know about prescription drug dan ambien?"
- prescription drug dan ambien can cause serious breathing problems that can become life-threatening, especially if used the wrong way. Call your healthcare provider or get medical help right away if:
- your breathing slows down
- you have shallow breathing (little chest movement with breathing)
- you feel faint, dizzy, confused, or
- have any other unusual symptoms
- These can be symptoms that you have taken too much prescription drug dan ambien (overdose) or the dose is too high for you. These symptoms may lead to serious problems or death if not treated right away.
- prescription drug dan ambien can cause your blood pressure to drop. This can make you feel dizzy and faint if you get up too fast from sitting or lying down. Low blood pressure is also more likely to happen if you take other medicines that can also lower your blood pressure. Severe low blood pressure can happen if you lose blood or take certain other medicines.
- prescription drug dan ambien can cause physical dependence. Do not stop taking prescription drug dan ambien or any other opioid without talking to your healthcare provider. You could become sick with uncomfortable withdrawal symptoms because your body has become used to these medicines. Physical dependence is not the same as drug addiction.
- There is a chance of abuse or addiction with prescription drug dan ambien. The chance is higher if you are or have been addicted to or abused other medicines, street drugs, or alcohol, or if you have a history of mental problems.
- Serious allergic reactions. Rarely, severe allergic reactions happen in people who take a long-acting morphine medicine that is like prescription drug dan ambien. Get medical help right away if you have any of these symptoms of a severe allergic reaction:
- feel dizzy or faint
- trouble breathing
- pounding heart beat
- chest pain
- swelling of the face, throat, or tongue
- feeling of doom
The most common side effects of prescription drug dan ambien are
- constipation
- nausea
- sleepiness
- vomiting
- dizziness
- itching
- headache
These side effects may decrease with continued use. Talk to your healthcare provider if you continue to have these side effects. These are not all the possible side effects of prescription drug dan ambien. For a complete list, ask your healthcare provider or pharmacist.
Constipation (not often enough or hard bowel movements) is a common side effect of pain medicines (opioids) including prescription drug dan ambien and is unlikely to go away without treatment. Talk to your healthcare provider about dietary changes, and the use of laxatives (medicines to treat constipation) and stool softeners to prevent or treat constipation while taking prescription drug dan ambien.
Talk to your healthcare provider if you have any side effects that bother you or do not go away. These are not all the possible side effects of prescription drug dan ambien. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Selling or giving away this medicine is against the law
How should I store prescription drug dan ambien?
- See "What is the most important information I should know about prescription drug dan ambien?"
- Keep prescription drug dan ambien out of the reach of children.
- Keep prescription drug dan ambien in the container it comes in.
- Keep prescription drug dan ambien at room temperature between 59° to 86°F (15° to 30°C).
- After you stop taking prescription drug dan ambien, flush the unused capsules down the toilet.
General Information about prescription drug dan ambien
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use prescription drug dan ambien for conditions for which it was not prescribed. Do not give prescription drug dan ambien to other people, even if they have the same symptoms you have. It may harm them and even cause death. Sharing prescription drug dan ambien is against the law.
This medication guide summarizes the most important information about prescription drug dan ambien. If you would like more information, talk with your healthcare provider. Also, you can ask your pharmacist or healthcare provider for information about prescription drug dan ambien that is written for healthcare professionals. For more information call 1-800-776-3637 or go to www.kingpharm.com.
What are the ingredients in prescription drug dan ambien?
Active Ingredients: pellets of morphine sulfate and naltrexone hydrochloride
Inactive Ingredients common to all strengths: talc, ammonio methacrylate copolymer, sugar spheres, ethylcellulose, sodium chloride, polyethylene glycol, hydroxypropyl cellulose, dibutyl sebacate, methacrylic acid copolymer, diethyl phthalate, magnesium stearate, sodium lauryl sulfate, and ascorbic acid. The capsule shells contain gelatin, titanium dioxide, and grey ink, D&C yellow #10 (prescription drug dan ambien 20 mg/0.8 mg), FD&C red #3, FD&C blue #1 (prescription drug dan ambien 30 mg/1.2 mg), D&C red #28, FD&C red #40, FD&C blue #1 (prescription drug dan ambien 50 mg/2 mg), D&C red #28, FD&C red #40, FD&C blue #1 (prescription drug dan ambien 60 mg/2.4 mg), FD&C blue #1, FD&C red #40, FD&C yellow #6 (prescription drug dan ambien 80 mg/3.2 mg), D&C yellow #10, FD&C blue #1 (prescription drug dan ambien 100 mg/4 mg).
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