Cellufresh may be available in the countries listed below.
Carmellose sodium salt (a derivative of Carmellose) is reported as an ingredient of Cellufresh in the following countries:
International Drug Name Search
Generic Name: buprenorphine (oral) (byoo pre NOR feen)
Brand Names: Subutex
Buprenorphine is an opioid (narcotic) medication that is similar to morphine.
Buprenorphine is used to treat narcotic addiction.
Buprenorphine may also be used for purposes not listed in this medication guide.
Like other narcotic medicines, buprenorphine can slow your breathing. Death may occur if breathing becomes too weak.
To make sure you can safely take buprenorphine, tell your doctor if you have any of these other conditions:
asthma, COPD, sleep apnea, or other breathing disorders;
liver disease (especially hepatitis B or C);
kidney disease;
a thyroid disorder;
stomach problems;
enlarged prostate, urination problems;
gallbladder disease;
curvature of the spine;
Addison's disease (an adrenal gland disorder);
a history of mental illness, personality disorder, or psychotic episode;
a history of drug or alcohol addiction; or
a history of seizures, head injury, or brain tumor.
The buprenorphine sublingual tablet should be placed under the tongue and allowed to dissolve. Do not chew the tablet or swallow it whole. If your doctor has prescribed more than 2 tablets per dose, place the correct number of tablets under your tongue at the same time and allow them to dissolve completely.
To be sure this medication is not causing harmful effects, your liver function will need to be checked with frequent blood tests. Visit your doctor regularly.
See also: Buprenorphine dosage (in more detail)
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
Overdose symptoms may include extreme drowsiness or weakness, cold or clammy skin, pinpoint pupils, fainting, slow heart rate, weak pulse, weak or shallow slowed breathing (breathing may stop).
Like other narcotic medicines, buprenorphine can slow your breathing. Death may occur if breathing becomes too weak.
slow or shallow breathing;
feeling light-headed, fainting;
confusion, unusual thoughts or behavior; or
nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Less serious side effects may be more likely to occur, such as:
headache;
stomach pain, nausea, vomiting, constipation;
warmth or tingly feeling;
chills, increased sweating;
weakness;
back pain;
anxiety, depression;
sleep problems (insomnia); or
runny nose.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Usual Adult Dose for Opiate Dependence:
Initial dose: 8 mg sublingually on day 1.
Maintenance dose: Rapidly titrate to the recommended target dose of 16 mg/day. In clinical trials, patients received 8 mg on day 1 and 16 mg on day 2 and thereafter. Further dose adjustments may be made in 2 mg to 4 mg increments up to a level that suppresses opioid withdrawal symptoms and holds the patient in treatment. The usual daily range is 4 mg to 24 mg sublingually.
The tablets should be placed under the tongue at the same time and allowed to dissolve. If patients are taking more than 2 tablets per dose and cannot hold more than 2 under the tongue comfortably, they should use 2 tablets at a time, allowing them to dissolve completely before taking more tablets.
For patients taking heroin or short-acting opioids, the first dose should be administered at least 4 hours after the patient last used opioids or preferably when early withdrawal symptoms appear.
Withdrawal symptoms may occur during buprenorphine induction treatment of patients taking methadone or long-acting opioids, especially high opioid doses or when buprenorphine is administered shortly after the last opioid dose. The optimal time for the first dose has not been reported.
The optimal method of tapering to discontinuation has not been reported.
Usual Adult Dose for Pain:
IM or IV:
Initial: 0.3 mg slow IM or IV every 6 hours as needed. May repeat once 30 to 60 minutes after the initial dose. Maximum single dose: 0.6 mg (IM only)
Transdermal patches: Apply 1 patch to a hairless or nearly hairless intact skin site. There are 8 possible application sites: upper outer arm, upper chest, upper back, and side of the chest (on both sides of the body). The patch is worn for 7 days. Maximum dose: 20 mcg/hour
Usual Pediatric Dose for Pain:
Less than 2 years: Safety and effectiveness have not been established.
2 to 12 years: 2 to 6 mcg/kg IM or slow IV every 4 to 6 hours.
13 to 18 years: 0.3 mg IM or slow IV every 6 hours; may repeat dose in 30 to 60 minutes.
Tell your doctor about all other medicines you use, especially:
conivaptan (Vaprisol);
imatinib (Gleevec);
isoniazid (for treating tuberculosis);
nefazodone;
an antibiotic such as clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole), rifampin (Rifadin, Rifater, Rifamate, Rimactane), or telithromycin (Ketek);
antifungal medication such as itraconazole (Sporanox), ketoconazole (Nizoral), or miconazole (Oravig);
heart or blood pressure medication such as nicardipine (Cardene) or quinidine (Quin-G);
HIV/AIDS medicine such as atazanavir (Reyataz), delavirdine (Rescriptor), indinavir (Crixivan), nelfinavir (Viracept), saquinavir (Invirase), or ritonavir (Norvir, Kaletra); or
a sedative such as diazepam (Valium), midazolam (Versed), alprazolam (Xanax) lorazepam (Ativan), clorazepate (Tranxene), triazolam (Halcion), flurazepam (Dalmane), or temazepam (Restoril).
This list is not complete and other drugs may interact with buprenorphine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.
See also: buprenorphine side effects (in more detail)
Doxapram hydrochloride (a derivative of Doxapram) is reported as an ingredient of Doxapram Hydrochloride Injection in the following countries:
International Drug Name Search
Otofa may be available in the countries listed below.
Rifamycin is reported as an ingredient of Otofa in the following countries:
Rifamycin sodium salt (a derivative of Rifamycin) is reported as an ingredient of Otofa in the following countries:
International Drug Name Search
Ixacor may be available in the countries listed below.
Ezetimibe is reported as an ingredient of Ixacor in the following countries:
International Drug Name Search
de-fer-OX-a-meen
In the U.S.
Available Dosage Forms:
Therapeutic Class: Heavy Metal Chelator
Deferoxamine injection is used to remove excess iron from the body in anemia or thalassemia patients who have many blood transfusions. It is also used with other medicines to treat acute iron poisoning, especially in small children.
Deferoxamine combines with iron in the blood. The combination of iron and deferoxamine is then removed from the body by the kidneys. If you have too much iron in the body, it can damage various organs and tissues.
deferoxamine is to be administered only by or under the immediate supervision of your doctor.
Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in product labeling, deferoxamine is used in certain patients with the following medical condition:
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For deferoxamine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to deferoxamine 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.
Appropriate studies have not been performed on the relationship of age to the effects of deferoxamine injection in children younger than 3 years of age. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of deferoxamine injection in the elderly. However, elderly patients are more likely to have vision or hearing problems, and age-related kidney or heart problems, which may require caution and an adjustment in the dose for patients receiving deferoxamine injection.
| Pregnancy Category | Explanation | |
|---|---|---|
| All Trimesters | C | Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. |
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving deferoxamine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using deferoxamine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
The presence of other medical problems may affect the use of deferoxamine. Make sure you tell your doctor if you have any other medical problems, especially:
A nurse or other trained health professional will give you deferoxamine in a hospital or clinic. You may also be taught how to give your medicine at home. deferoxamine is given as a shot under your skin, into a muscle, or into a vein.
Deferoxamine may sometimes be given at home to patients who do not need to be in the hospital. If you are receiving deferoxamine at home, make sure you clearly understand and carefully follow your doctor's instructions.
Use a new needle, unopened vial, or syringe each time you inject your medicine.
You might not use all of the medicine in each vial (glass container). Use each vial only one time. Do not save an open vial. If the medicine in the vial has changed color, or if you see particles in it, do not use it.
Do not take vitamin C supplements unless your doctor has told you to do so.
The dose of deferoxamine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of deferoxamine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
Call your doctor or pharmacist for instructions.
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.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Do not refrigerate. Keep from freezing.
Store the medicine that has been mixed at room temperature and use it within 3 hours. Throw away any mixed medicine that has not been used within this time.
It is very important that your doctor check the progress of you or your child at regular visits to make sure that deferoxamine is working properly and to decide if you should continue to use it. Blood and urine tests must be done regularly to check for unwanted effects .
Deferoxamine may cause some people to have hearing and vision problems within a few weeks after they start using it. This usually occurs if you are receiving high doses of deferoxamine and using it for a long period of time. If you or your child notice any problems with your hearing or vision, such as blurred vision, difficulty with night vision, or difficulty with seeing colors, check with your doctor as soon as possible.
Check with your doctor right away if you or your child have the following symptoms while using deferoxamine: agitation, confusion, decreased urine output, lethargy, muscle twitching, rapid weight gain, seizures, or swelling of the face, ankles, or hands. These may be symptoms of a serious kidney problem.
deferoxamine may cause slow growth. If your child is using deferoxamine, the doctor will need to keep track of your child's height and weight every 3 months to make sure that your child is growing properly.
Stop using deferoxamine and check with your doctor right away if you or your child develop fever, shortness of breath, chest pain or tightness, trouble with breathing, or wheezing. These could be symptoms of a serious lung condition called acute respiratory distress syndrome.
Before you have any medical tests, tell the medical doctor in charge that you or your child are using deferoxamine. The results of some tests (e.g., magnetic resonance imaging or MRI) may be affected by deferoxamine.
deferoxamine may make you dizzy, drowsy, lightheaded, or trouble in hearing or seeing clearly. Make sure you know how you react to deferoxamine before you drive, use machines, or do other jobs that require you to be alert or able to see well.
deferoxamine may cause your urine to turn red in color. This is normal and is nothing to worry about.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur:
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
See also: deferoxamine Injection side effects (in more detail)
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