FDA Approves 37.5 adipex mg p
Tthe U.S. Food and Drug Administration (FDA) has approved 37.5 adipex mg p (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. 37.5 adipex mg p is the first FDA-approved long-acting opioid that is designed to reduce drug liking and euphoria when tampered with by crushing or chewing.
37.5 adipex mg p 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 37.5 adipex mg p 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 37.5 adipex mg p reduces the abuse liability of 37.5 adipex mg p.
Important Safety Information for 37.5 adipex mg p
37.5 adipex mg p (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. 37.5 adipex mg p is not for use to treat pain as needed. 37.5 adipex mg p 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. 37.5 adipex mg p 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. 37.5 adipex mg p is to be swallowed whole or the contents of the capsules sprinkled on apple sauce. Do not crush, dissolve, or chew 37.5 adipex mg p or the pellets in the capsules. If tampered with by crushing or chewing, the naltrexone will be released.
Like other opioids, 37.5 adipex mg p 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.
37.5 adipex mg p 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 37.5 adipex mg p 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 37.5 adipex mg p (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 37.5 adipex mg p therapy.
37.5 adipex mg p Medication Guide
IMPORTANT: Keep 37.5 adipex mg p 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 37.5 adipex mg p, get emergency help right away.
Read the Medication Guide that comes with 37.5 adipex mg p 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 37.5 adipex mg p?
- Do not crush, dissolve, or chew 37.5 adipex mg p capsules or the capsule contents before swallowing. If 37.5 adipex mg p is taken in this way, both the morphine and naltrexone in 37.5 adipex mg p 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 37.5 adipex mg p, this could cause you to have uncomfortable withdrawal symptoms.
- Take 37.5 adipex mg p exactly as prescribed by your healthcare provider.
- 37.5 adipex mg p 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 37.5 adipex mg p that may be right for you. See "How should I take 37.5 adipex mg p?"
- Do not take the highest dose of 37.5 adipex mg p (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 37.5 adipex mg p. 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 37.5 adipex mg p in a safe place to protect it from being stolen. 37.5 adipex mg p can be a target for people who misuse or abuse prescription medicines or street drugs.
- Never give 37.5 adipex mg p 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 37.5 adipex mg p?" for more information about side effects.
What is 37.5 adipex mg p?
- 37.5 adipex mg p 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 37.5 adipex mg p, the naltrexone will be released all at one time. See "What is the most important information I should know about 37.5 adipex mg p?
- 37.5 adipex mg p 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.
- 37.5 adipex mg p 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 37.5 adipex mg p is safe and works in children under the age of 18.
Who Should Not Take 37.5 adipex mg p?
Do not take 37.5 adipex mg p 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 37.5 adipex mg p. See the end of this Medication Guide for a complete list of ingredients in 37.5 adipex mg p.
What Should I Tell My Healthcare Provider Before Starting 37.5 adipex mg p?
- 37.5 adipex mg p 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. 37.5 adipex mg p may harm your unborn baby.
- are breastfeeding. 37.5 adipex mg p may pass through your milk and may harm your baby. You should not breastfeed while taking 37.5 adipex mg p.
- 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 37.5 adipex mg p. Sometimes, the doses of certain medicines and 37.5 adipex mg p 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 37.5 adipex mg p 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 37.5 adipex mg p until you have talked to your healthcare provider or pharmacist. They will tell you if it is safe to take other medicines with 37.5 adipex mg p.
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 37.5 adipex mg p?
- Take 37.5 adipex mg p exactly as prescribed by your healthcare provider. Do not change your dose unless your healthcare provider tells you to.
- You can take 37.5 adipex mg p with or without food.
- Swallow 37.5 adipex mg p capsule whole. Do not crush, dissolve, or chew 37.5 adipex mg p or the pellets in the capsules before swallowing. See "What is the most important information I should know about 37.5 adipex mg p?"
- If you cannot swallow capsules, tell your healthcare provider. There may be another way to take 37.5 adipex mg p that may be right for you. If your doctor tells you that you can take 37.5 adipex mg p using this other way, follow these steps:
37.5 adipex mg p can be opened and the pellets inside the capsule can be sprinkled over apple sauce, as follows:
- Open the 37.5 adipex mg p 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 37.5 adipex mg p 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 37.5 adipex mg p or overdose, call 911 or poison control center right away.
- Call your healthcare provider if the dose of 37.5 adipex mg p that you are taking does not relieve your pain.
What Should I Avoid While Taking 37.5 adipex mg p?
- Do not drive, operate heavy machinery, or do other dangerous activities, especially when you start taking 37.5 adipex mg p and when your dose is changed, until you know how you react to this medicine. 37.5 adipex mg p 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 37.5 adipex mg p?
37.5 adipex mg p can cause serious side effects, including:
- See "What is the most important information I should know about 37.5 adipex mg p?"
- 37.5 adipex mg p 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 37.5 adipex mg p (overdose) or the dose is too high for you. These symptoms may lead to serious problems or death if not treated right away.
- 37.5 adipex mg p 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.
- 37.5 adipex mg p can cause physical dependence. Do not stop taking 37.5 adipex mg p 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 37.5 adipex mg p. 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 37.5 adipex mg p. 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 37.5 adipex mg p 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 37.5 adipex mg p. 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 37.5 adipex mg p 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 37.5 adipex mg p.
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 37.5 adipex mg p. 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 37.5 adipex mg p?
- See "What is the most important information I should know about 37.5 adipex mg p?"
- Keep 37.5 adipex mg p out of the reach of children.
- Keep 37.5 adipex mg p in the container it comes in.
- Keep 37.5 adipex mg p at room temperature between 59° to 86°F (15° to 30°C).
- After you stop taking 37.5 adipex mg p, flush the unused capsules down the toilet.
General Information about 37.5 adipex mg p
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use 37.5 adipex mg p for conditions for which it was not prescribed. Do not give 37.5 adipex mg p to other people, even if they have the same symptoms you have. It may harm them and even cause death. Sharing 37.5 adipex mg p is against the law.
This medication guide summarizes the most important information about 37.5 adipex mg p. If you would like more information, talk with your healthcare provider. Also, you can ask your pharmacist or healthcare provider for information about 37.5 adipex mg p 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 37.5 adipex mg p?
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 (37.5 adipex mg p 20 mg/0.8 mg), FD&C red #3, FD&C blue #1 (37.5 adipex mg p 30 mg/1.2 mg), D&C red #28, FD&C red #40, FD&C blue #1 (37.5 adipex mg p 50 mg/2 mg), D&C red #28, FD&C red #40, FD&C blue #1 (37.5 adipex mg p 60 mg/2.4 mg), FD&C blue #1, FD&C red #40, FD&C yellow #6 (37.5 adipex mg p 80 mg/3.2 mg), D&C yellow #10, FD&C blue #1 (37.5 adipex mg p 100 mg/4 mg).
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