Lamuzid may be available in the countries listed below.
Lamivudine is reported as an ingredient of Lamuzid in the following countries:
Zidovudine is reported as an ingredient of Lamuzid in the following countries:
International Drug Name Search
Furorese may be available in the countries listed below.
Furosemide is reported as an ingredient of Furorese in the following countries:
Furosemide sodium (a derivative of Furosemide) is reported as an ingredient of Furorese in the following countries:
International Drug Name Search
Treating certain stomach, intestinal, and bladder conditions, including spasms. It is used to control stomach secretions and cramps. It is used to relieve the symptoms of colic, runny nose, and Parkinson-like problems. It is used to treat excessive sweating or saliva production. It may also be used for other conditions as determined by your doctor.
Hyoscyamine is an anticholinergic agent. It works by decreasing the motion of muscles in the stomach, intestines, and bladder. It also decreases the production of stomach acid.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Hyoscyamine. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
Some MEDICINES MAY INTERACT with Hyoscyamine. Tell your health care provider if you are taking any other medicines, especially any of the following:
This may not be a complete list of all interactions that may occur. Ask your health care provider if Hyoscyamine 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.
Use Hyoscyamine as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Hyoscyamine.
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:
Bloated feeling; blurred vision; constipation; decreased sweating; dizziness; drowsiness; dry mouth; enlarged pupils; excitability; headache; nausea; nervousness; trouble sleeping; weakness.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); agitation; behavior changes; confusion; decreased sexual ability; diarrhea; difficulty focusing eyes; disorientation; exaggerated sense of well-being; fast or irregular heartbeat; hallucinations; loss of consciousness; loss of coordination; memory loss; mental or mood changes; severe or persistent trouble sleeping; speech changes; taste changes or loss; trouble urinating; unusual tiredness or weakness; vision changes; 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. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
See also: Hyoscyamine side effects (in more detail)
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include disorientation; excessive thirst or excitability; fever; hot, dry skin; seizures; severe dry mouth; severe or persistent blurred vision, dizziness, headache, nausea, or vomiting; trouble breathing or swallowing.
Store Hyoscyamine at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Hyoscyamine out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Hyoscyamine. 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.
TYE-foid VAX-een, in-AK-ti-vay-ted
Typhoid fever is a serious disease that can cause death. It is caused by a germ called Salmonella typhi and is spread most often through infected food or water. Typhoid may also be spread by close person-to-person contact with infected persons (such as occurs with persons living in the same household). Some infected persons do not appear to be sick, but they can still spread the germ to others.
Typhoid fever is rare in the U.S. and in other areas of the world that have good water and sewage (waste) systems. However, it is a problem in parts of the world that do not have such systems. If you are traveling to certain countries, or to remote, out-of-the-way areas, typhoid vaccine will help protect you from typhoid fever. The U.S. Centers for Disease Control (CDC) currently recommend caution in the following areas of the world:
Typhoid vaccine given by injection helps prevent typhoid fever but does not provide 100% protection. Therefore, it is very important to avoid infected persons and food and water that may be infected, even if you have received the vaccine.
To get the best possible protection against typhoid, you should complete the vaccine dosing schedule at least 1 week before you travel to areas where you may be exposed to typhoid.
Also, if you will be traveling regularly to parts of the world where typhoid is a problem, you should get a booster (repeat) dose of the vaccine every 3 years.
Typhoid vaccine is to be used only by or under the supervision of a doctor.
In deciding to use a vaccine, the risks of taking the vaccine must be weighed against the good it will do. This is a decision you and your doctor will make. For this vaccine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to typhoid vaccine, inactivated 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.
Typhoid vaccine is not recommended for infants and children up to 6 months of age. For infants and children 6 months of age and over, this vaccine is not expected to cause different side effects or problems than it does in adults.
Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of typhoid vaccine in the elderly with use in other age groups, this vaccine is not expected to cause different side effects or problems in older people than it does in younger adults.
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 this vaccine, 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.
Receiving this vaccine 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 this vaccine. Make sure you tell your doctor if you have any other medical problems, especially:
It is important that you complete the full vaccine dosing schedule. If all the doses are not taken or if doses are not taken at the correct times, the vaccine may not work properly.
The dose of typhoid vaccine, inactivated 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 typhoid vaccine, inactivated. 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.
Along with its needed effects, a vaccine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention. It is very important that you tell your doctor about any side effects that occur after a dose of typhoid vaccine, even though the side effect may have gone away without treatment. Some types of side effects may mean that you should not receive any more doses of typhoid vaccine.
Check with your doctor 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: typhoid vaccine, inactivated Subcutaneous, Injection side effects (in more detail)
The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.
The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.
Clavurol may be available in the countries listed below.
Amoxicillin trihydrate (a derivative of Amoxicillin) is reported as an ingredient of Clavurol in the following countries:
Clavulanic Acid potassium (a derivative of Clavulanic Acid) is reported as an ingredient of Clavurol in the following countries:
International Drug Name Search
Generic Name: barium sulfate (oral and rectal) (BER ee um SUL fate)
Brand Names: Anatrast, Bar-Test, Baricon, Baro-Cat, Barosperse, Bear-E-Yum GI, CheeTah, CheeTah Butterscotch, CheeTah Chocolaty-Fudge, CheeTah Orange, CheeTah Raspberry, Digibar 190, E-Z AC, E-Z Disk, E-Z Dose Kit with Polibar Plus, E-Z Paste, E-Z-Cat, E-Z-Cat Dry, E-Z-HD, E-Z-Paque, Enecat, Eneset 2, Enhancer, Entero VU, Entero-H, Entrobar, Esopho-Cat, Intropaste, Liqui-Coat HD, Liquid Barosperse, Liquid E-Z Paque, Liquid Polibar, Liquid Polibar Plus, Maxibar, Medebar Plus, Medebar Super 250, Polibar ACB, Readi-Cat, Readi-Cat 2, Scan C, Sitzmarks, Smoothie Readi-Cat 2, Sol-O-Pake, Tagitol V, Tonojug, Tonopaque, Varibar Honey, Varibar Nectar, Varibar Pudding, Varibar Thin, Varibar Thin Honey, Volumen
Barium sulfate is in a group of drugs called contrast agents. Barium sulfate works by coating the inside of your esophagus, stomach, or intestines which allows them to be seen more clearly on a CT scan or other radiologic (x-ray) examination.
Barium sulfate is used to help diagnose certain disorders of the esophagus, stomach, or intestines.
Barium sulfate may also be used for purposes not listed in this medication guide.
Before you use barium sulfate, tell your doctor if you have any allergies, or if you have asthma, cystic fibrosis, heart disease or high blood pressure, rectal cancer, a colostomy, a blockage in your stomach or intestines, a condition called pseudotumor cerebri, or if you have recently had a rectal biopsy or surgery on your esophagus, stomach, or intestines.
Carefully follow your doctor's instructions about what to eat or drink within the 24-hour period before your test.
To make sure you can safely use barium sulfate, tell your doctor if you have any of these other conditions:
asthma, eczema, or allergies;
a blockage in your stomach or intestines;
cystic fibrosis;
a colostomy;
rectal cancer;
heart disease or high blood pressure;
Hirschsprung's disease (a disorder of the intestines);
a condition called pseudotumor cerebri (high pressure inside the skull that may cause headaches, vision loss, or other symptoms);
a recent history of surgery on your esophagus, stomach, or intestines;
a history of perforation (a hole or tear) in your esophagus, stomach, or intestines;
if you have recently had a rectal biopsy;
if you have ever choked on food by accidentally inhaling it into your lungs;
if you are allergic to simethicone (Gas-X, Phazyme, and others); or
if you are allergic to latex rubber.
Use this medication exactly as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended.
Barium sulfate comes in tablets, paste, cream, or liquid forms.
In some cases, barium sulfate is taken by mouth. The liquid form may also be used as a rectal enema.
You may need to begin using this medication at home a day before your medical test. Follow your doctor's instructions about how much of the medication to use and how often.
If you are receiving barium sulfate as a rectal enema, a healthcare professional will give you the medication at the clinic or hospital where your testing will take place.
Dissolve the barium sulfate powder in a small amount of water. Stir this mixture and drink all of it right away. To make sure you get the entire dose, add a little more water to the same glass, swirl gently and drink right away.
Carefully follow your doctor's instructions about what to eat or drink within the 24-hour period before your test.
If you are using barium sulfate at home, call your doctor for instructions if you miss a dose.
Overdose symptoms may include severe stomach pain, ongoing diarrhea, confusion, or weakness.
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
severe stomach pain;
severe cramping, diarrhea, or constipation;
sweating;
ringing in your ears;
confusion, fast heart rate; or
pale skin, weakness.
Less serious side effects may include:
mild stomach cramps;
nausea, vomiting;
loose stools or mild constipation.
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.
There may be other drugs that can interact with barium sulfate. 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: Bar-Test side effects (in more detail)
Class Name: aminoglycoside (Inhalation route, Irrigation route, Parenteral route)
Commonly used brand name(s):
In the U.S.
Available Dosage Forms:
Aminoglycosides are used to treat serious bacterial infections. They work by killing bacteria or preventing their growth.
Aminoglycosides are given by injection to treat serious bacterial infections in many different parts of the body. In addition, some aminoglycosides may be given by irrigation (applying a solution of the medicine to the skin or mucous membranes or washing out a body cavity) or by inhalation into the lungs. Streptomycin may also be given for tuberculosis (TB). These medicines may be given with 1 or more other medicines for bacterial infections, or they may be given alone. Aminoglycosides may also be used for other conditions as determined by your doctor. However, aminoglycosides will not work for colds, flu, or other virus infections.
Aminoglycosides given by injection are usually used for serious bacterial infections for which other medicines may not work. However, aminoglycosides may also cause some serious side effects, including damage to your hearing, sense of balance, and kidneys. These side effects may be more likely to occur in elderly patients and newborn infants. You and your doctor should talk about the good these medicines may do as well as the risks of receiving them.
Aminoglycosides are to be administered only by or under the immediate supervision of your doctor.
Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group 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.
Children are especially sensitive to the effects of aminoglycosides. Damage to hearing, sense of balance, and kidneys is more likely to occur in premature infants and neonates.
Elderly people are especially sensitive to the effects of aminoglycosides. Serious side effects, such as damage to hearing, sense of balance, and kidneys may occur in elderly patients.
Studies on most of the aminoglycosides have not been done in pregnant women. Some reports have shown that aminoglycosides, especially streptomycin and tobramycin, may cause damage to the infant's hearing, sense of balance, and kidneys if the mother was receiving the medicine during pregnancy. However, this medicine may be needed in serious diseases or other situations that threaten the mother's life. Be sure you have discussed this with your doctor.
Aminoglycosides pass into breast milk in small amounts. However, they are not absorbed very much when taken by mouth. To date, aminoglycosides have not been reported to cause problems in nursing babies.
Using medicines in this class 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 medicines in this class. Make sure you tell your doctor if you have any other medical problems, especially:
To help clear up your infection completely, aminoglycosides must be given for the full time of treatment, even if you begin to feel better after a few days. Also, this medicine works best when there is a certain amount in the blood or urine. To help keep the correct level, aminoglycosides must be given on a regular schedule.
The dose medicines in this class 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 these medicines. 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.
The dose of most aminoglycosides is based on body weight and must be determined by your doctor. The medicine is injected into a muscle or vein. Depending on the aminoglycoside prescribed, doses are given at different times and for different lengths of time. These times are as follows:
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 immediately if any of the following side effects occur:
In addition, leg cramps, skin rash, fever, and convulsions (seizures) may occur when gentamicin is given by injection into the muscle or a vein, and into the spinal fluid.
After you stop using this medicine, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:
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.
The information contained in the Thomson Healthcare (Micromedex) products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.
The use of the Thomson Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Healthcare does not assume any responsibility or risk for your use of the Thomson Healthcare products.
DESCRIPTION
Urea 35% Hydrating Topical Foam is a keratolytic emollient in a water and lipid based foam containing lactic acid which is a gentle, but potent, tissue softener for skin and nails.
Each gram of Urea 35% Hydrating Topical Foam contains Urea 35% as the active ingredient, and the following inactive ingredients: dimethicone, ethylparaben, glycerin, lactic acid,
methylparaben, phenoxyethanol, polysorbate 20, povidone, propylene glycol, propylparaben, purified water, stearic acid, trolamine, and in propellants butane and propane.
CHEMICAL STRUCTURE
Urea has the following chemical structure:
CLINICAL PHARMACOLOGY
Topically applied urea dissolves the intercellular matrix of the skin which results in enhanced shedding of scaly, dry skin and thus a softening of the hyperkeratotic areas of the skin.
Urea topically applied to the nail plate has a similar effect on the intercellular matrix of the nail plate.
PHARMACOKINETICS
The mechanism of action of topically applied urea is not yet known.
INDICATIONS AND USAGE
For enzymatic debridement and promotion of normal healing of surface lesions, particularly where healing is retarded by local infection, necrotic tissue, fibrinous or purulent debris,
or eschar. Topically applied urea is useful for the treatment of hyperkeratotic conditions such as dermatitis, psoriasis, xerosis, ichthyosis, eczema, keratosis, keratoderma, and dry,
rough skin, as well as corns and calluses and damaged, ingrown and devitalized nails.
CONTRAINDICATIONS
Known hypersensitivity to any of the listed ingredients.
WARNINGS
Urea 35% Hydrating Topical Foam is for external use only. It is not for ophthalmic, oral, anal or intravaginal use. Contact with eyes, lips, and all mucous membranes should be
avoided. Urea 35% Hydrating Topical Foam should not be used by persons who have a known hypersensitivity to urea or any of the other listed ingredients.
PRECAUTIONS
Urea 35% Hydrating Topical Foam should be used only as directed by a physician and should not be used to treat any condition other than that for which it is prescribed. If redness
or irritation occurs, discontinue use and consult with a prescribing physician.
Pregnancy (Category B) – Animal reproduction studies have not been performed with topically applied urea and it is not known whether Urea 35% Hydrating Topical Foam can
cause fetal harm when administered to a pregnant woman. Nevertheless, Urea 35% Hydrating Topical Foam should be used by a pregnant woman only if necessary.
Nursing Mothers – It is not known whether topically applied urea is excreted in human milk. Due to the fact that many drugs are excreted in human milk, caution should be
exercised by physicians when administering Urea 35% Hydrating Topical Foam to nursing mothers.
ADVERSE REACTIONS
Transient stinging, burning, itching or irritation is possible.
DOSAGE AND ADMINISTRATION
Unless otherwise directed by a prescribing physician, Urea 35% Hydrating Topical Foam should be applied to affected area twice a day. Urea 35% Hydrating Topical Foam should
be rubbed into the skin until it is completely absorbed.
HOW SUPPLIED
Urea 35% Hydrating Topical Foam is supplied in a 150 gram or 5.3 ounce aerosolized canister bearing the NDC Number 42192-115-15.
Enter section text here
NDC 42192-115-15
Urea 35% Hydrating
Topical Foam
Rx Only
Net Wt. 5.3 oz. (150 g)
NDC 42192-115-15
Rx Only
Net Wt. 5.3 oz. (150 g)
Dosage and Administration: Clean and dry affected
skin. Then apply Urea 35% Hydrating Topical Foam
topically to cover affected skin twice per day, or as
directed by a physician. Rub in until completely absorbed.
Shake vigorously before each application and invert
can to administer.
Store at room temperature 59° - 77°F (15° - 25°C).
See prescribing information for additional details.
Ingredients: urea 35%, dimethicone, ethylparaben,
glycerin, lactic acid, methylparaben, phenoxyethanol,
polysorbate 20, povidone, propylene glycol, propylparaben,
purified water, stearic acid, trolamine, and in
propellants butane and propane.
Warning: Contents under pressure. Do not puncture or
incinerate. Do not expose to temperatures over 120°F
(48°C) even when empty.
Keep out of reach of children.
Manufactured for:
Acella Pharmaceuticals, LLC
Alpharetta, GA 30009
1-800-541-4802
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| unapproved drug other | 11/09/2010 | ||
| Labeler - Acella Pharmaceuticals (825380939) |
| Registrant - Acella Pharmaceuticals (825380939) |
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| Name | Address | ID/FEI | Operations |
| Acella Pharmaceuticlas | 825380939 | manufacture | |
Ceevit may be available in the countries listed below.
Ascorbic Acid is reported as an ingredient of Ceevit in the following countries:
International Drug Name Search
U40 Foam is a keratolytic emollient in a water and lipid-based foam which is a gentle, but potent, tissue softener for skin and nails.
U40 Foam contains the active ingredient: Urea 40%. The inactive ingredients are: Carbomer, Colloidal Oatmeal, Dimethicone, Ethylparaben, Glycerine, Laureth 4, Methylparaben, Phenoxyethanol, Polysorbate 20, Propylparaben, Propylene Glycol, Purified Water, Stearic Acid and Triethanolamine and in propellants Butane and Propane.
CHEMICAL STRUCTURE
Urea has the following chemical structure:
Urea, topically applied, dissolves the intercellular matrix of the skin which can result in enhanced shedding of scaly, dry skin which causes a softening of the hyperkeratotic areas of the skin. Applied to the nail plate topically, urea has a similar effect on the intercellular matrix of the nail plate.
The mechanism of action of topically applied urea is not yet known.
For enzymatic debridement and promotion of normal healing of surface lesions, particularly where healing is halted by local infection, necrotic tissue, fibrinous or purulent debris or eschar. Urea, topically applied, is useful for the treatment of hyperkeratotic conditions such as dermatitis, xerosis, ichthyosis, psoriasis, eczema, keratosis, keratoderma and dry, rough skin, as well as corns and calluses. It is also useful in the treatment of damaged, ingrown and devitalized nails.
Known hypersensitivity to any of the listed ingredients.
U40 Foam, NDC 49769-354-75, is supplied as (2) 2.63 oz (75 g), net wt. 5.26 oz (150 g), aerosolized canisters in a carton, NDC 49769-354-15.
U40 Foam is supplied in a 2.5 oz (70 g) aerosolized canister, NDC 49769-354-70.
Store at controlled room temperature 15ºC - 25ºC (59ºF - 77ºF).
Manufactured for
Kylemore Pharmaceuticals
Port St. Joe, FL 32456
Iss. 12/09
354-10
U40 Foam (75g) labeling:
U40 Foam (70g) labeling:
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| unapproved drug other | 01/05/2010 | 06/30/2012 | |
| Labeler - Kylemore Pharmaceuticals, LLC (831892471) |
Corifact, Factor XIII (FXIII) Concentrate (Human) is indicated for routine prophylactic treatment of congenital FXIII deficiency. The effectiveness of Corifact is based on maintaining a trough FXIII activity level of approximately 5% to 20%. There are no controlled trials demonstrating a direct benefit on treatment of bleeding episodes with Corifact.
Corifact dosing regimen should be individualized based on body weight, laboratory values, and the patient's clinical condition.
Initial dose
Subsequent dosing
| Factor XIII Activity Trough Level (%) | Dosage Change |
|---|---|
| One trough level of <5% | Increase by 5 units per kg |
| Trough level of 5% to 20% | No change |
| Two trough levels of >20% | Decrease by 5 units per kg |
| One trough level of >25% | Decrease by 5 units per kg |
The potency expressed in units is determined using the Berichrom activity assay, referenced to the current International Standard for Blood Coagulation Factor XIII, Plasma. Therefore, a unit herein is equivalent to an International Unit.
The procedures below are provided as general guidelines for the preparation and reconstitution of Corifact.
Reconstitute Corifact at room temperature as follows:
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Corifact is available as a single-use vial containing 1000-1600 units of FXIII as a lyophilized concentrate. A 20 mL vial of Sterile Water for Injection, USP, is provided for reconstitution.
The actual units of potency of FXIII are stated on each Corifact vial label and carton.
Corifact is contraindicated in patients with known anaphylactic or severe systemic reactions to human plasma-derived products or to any components in Corifact (see Description [11]).
Hypersensitivity reactions (including allergy, rash, pruritus, and erythema) have been observed with Corifact. If signs or symptoms of anaphylaxis or hypersensitivity reactions (including urticaria, rash, tightness of the chest, wheezing, hypotension) occur, immediately discontinue administration (see Patient Counseling Information [17]) and institute appropriate treatment.
Development of inhibitory antibodies against FXIII has been detected in patients receiving Corifact. Monitor patients for possible development of inhibitory antibodies. Presence of inhibitory antibodies may manifest as an inadequate response to treatment. If expected plasma FXIII activity levels are not attained, or if breakthrough bleeding occurs while receiving prophylaxis, an assay that measures FXIII inhibitory antibody concentrations should be performed. One case of inhibitory antibodies against FXIII has been reported in the clinical studies (see Clinical Trials Experience [6.1]). Cases of inhibitory antibodies against FXIII in patients with congenital FXIII deficiency have also been reported in postmarketing surveillance.
Thromboembolic complications have been reported in postmarketing surveillance (see Postmarketing Experience [6.2]). Benefits and risks should be carefully assessed in pregnant women because of their hypercoagulable state and potential for increased risk of thromboembolic events.
Corifact is made from human plasma. Because this product is made from human blood, it may carry a risk of transmitting infectious agents, e.g., viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent. There is also the possibility that unknown infectious agents may be present in such products. The risk that such products could transmit viruses has been reduced by screening plasma donors for prior exposure to certain viruses, by testing for the presence of certain current virus infections, and by inactivating and removing certain viruses during manufacture (see Description [11]). Despite these measures, such products may still potentially transmit disease.
Consider appropriate vaccination (against hepatitis A and B virus) for patients in regular/repeated receipt of Corifact. All infections thought by a physician to have been possibly transmitted by this product should be reported by the physician or other healthcare provider to the CSL Behring Pharmacovigilance Department at 1-866-915-6958 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
The most common adverse reactions reported in clinical trials in greater than one subject (frequency >1%) following Corifact treatment are hypersensitivity reactions (including allergy, rash, pruritus, and erythema), chills/rise in temperature, arthralgia, headache, elevated thrombin-antithrombin levels, and an increase in hepatic enzymes. Adverse reactions are those adverse events (AEs) considered to be "at least possibly related" to the infusion of Corifact.
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Twelve clinical studies were conducted and included 187 unique subjects, 90 subjects were <16 years of age (see Pediatric Use [8.4]). These 187 subjects received a total of approximately 3930 infusions of Corifact.
The most common adverse events reported in clinical trials in greater than three subjects (frequency >2%) are flu-like syndrome, abdominal pain, diarrhea, contusion, joint injury, limb injury, road traffic accident, upper respiratory tract infection, arthralgia, headache, epistaxis, vomiting, fever, hematoma, head injury, and rash. Adverse events (AEs) are defined as treatment-emergent AEs that started after the first Corifact study infusion.
In the 12-week prospective, open-label, multicenter, pharmacokinetic and safety study conducted in 7 females and 7 males with congenital FXIII deficiency, ranging in age from 5 to 42 years (3 children, 2 adolescents, and 9 adults), there were no reports of deaths, life-threatening events, or adverse events that led to discontinuation or withdrawal from the study. No breakthrough bleeding episodes were reported in this study.
A case of neutralizing antibodies against FXIII was reported in the ongoing postmarketing clinical study. The patient received prophylactic treatment with Corifact for ten years. Concomitant medications included interferon for hepatitis C infection. This patient presented with bruising, and post-infusion FXIII levels were found to be lower than expected. Over several weeks, FXIII recovery values decreased, so the dose and frequency of treatments were increased. Neutralizing antibodies to FXIII were detected, interferon treatment was discontinued, and the subject underwent plasmapheresis. Within a month, neutralizing antibodies were no longer detectable, FXIII recovery levels improved, and the previous prophylactic regimen was resumed.
Because postmarketing reporting of adverse reactions is voluntary and from a population of uncertain size, it is not always possible to reliably estimate the frequency of these reactions or establish a causal relationship to product exposure.
The adverse reactions spontaneously reported after administration of Corifact during postmarketing surveillance outside the US since 1993, identified by system organ class are provided in Table 2.
| MedDRA System Organ Class | MedDRA Preferred Term/Symptoms |
|---|---|
| |
| Immune system disorders | Allergic/anaphylactic reaction (including cutaneous reactions, alteration in blood pressure, nausea, dyspnea, fever, and chills) |
| General disorders and administration site conditions | Pyrexia |
| Blood and lymphatic system disorders | Factor XIII inhibitor formation |
| Vascular disorders | Thrombosis, embolism |
| Infections and infestations | Transmission of an infectious agent via medicinal products* made from human plasma (see Transmission of Infectious Agents [5.4]) |
Pregnancy Category C. Animal reproduction studies have not been conducted with Corifact. Safety and effectiveness in pregnancy have not been established. Corifact should be given to a pregnant woman only if clearly needed (see WARNINGS AND PRECAUTIONS/Thromboembolic Risk [5.3]).
Corifact has not been studied for use during labor and delivery. Safety and effectiveness in labor and delivery have not been established.
It is not known whether Corifact is excreted in human milk. Use Corifact only if clearly needed when treating nursing women.
Of the 187 unique subjects in the Corifact clinical studies, 90 were subjects <16 years of age at the time of enrollment (<1 month, n=2; 1 month to <2 years, n=14; 2 to 11 years, n=52; 12 to <16 years, n=22). In the pharmacokinetic study (see Pharmacokinetics [12.3]), 5 of the 14 subjects ranged in age from 2 to <16 years. Subjects less than 16 years had a shorter half-life (5.7 ± 1.00 days) and faster clearance (0.29 ± 0.12 mL/hr/kg) compared to adults (half-life: 7.1 ± 2.74 days, clearance: 0.22 ± 0.07 mL/hr/kg). The number of subjects less than 16 years of age limits the statistical interpretation. There were no apparent differences in the safety profile in children as compared to adults. All pediatric subjects were treated for congenital Factor XIII deficiency.
The safety and efficacy of Corifact in the geriatric population have not been established due to an insufficient number of subjects.
Corifact is a heat-treated, lyophilized FXIII (coagulation factor XIII) concentrate made from pooled human plasma. Each vial contains 1000-1600 units FXIII, 120 to 200 mg human albumin, 120 to 320 mg total protein, 80 to 120 mg glucose and 140 to 220 mg sodium chloride. Sodium hydroxide may have been used to adjust the pH.
All plasma used in the manufacture of Corifact is obtained from US donors and is tested using serological assays for hepatitis B surface antigen and antibodies to HIV-1/2 and HCV. The plasma is tested with Nucleic Acid Testing (NAT) for HCV, HIV-1, HAV and HBV and found to be non-reactive (negative), and the plasma is also tested by NAT for Human Parvovirus B19. Only plasma that passed virus screening is used for production, and the limit for Parvovirus B19 in the fractionation pool is set not to exceed 104 International Units of Parvovirus B19 DNA per mL.
Corifact is manufactured from cryo-depleted plasma into an ethanol precipitate, which is then purified by precipitation/adsorption, ion exchange chromatography and heat-treatment (+60°C for 10 hours in an aqueous solution) steps. The sterile filtered final bulk solution is filled into vials and lyophilized. Three manufacturing steps were independently validated in a series of in vitro experiments for their capacity to inactivate or remove both enveloped and non-enveloped viruses. Table 3 shows the virus clearance capacity of the Corifact manufacturing process, expressed as mean log10 reduction factor.
| Manufacturing Step | Virus Reduction Factor (log10) | |||||
|---|---|---|---|---|---|---|
| Enveloped Viruses | Non-Enveloped Viruses | |||||
| HIV | BVDV | WNV | HSV-1 | HAV | CPV | |
| HIV, Human immunodeficiency virus type 1, model for HIV-1 and HIV-2 | ||||||
| BVDV, bovine viral diarrhea virus, model for HCV | ||||||
| WNV, West Nile virus | ||||||
| HSV-1, herpes simplex virus type 1, model for large enveloped DNA viruses | ||||||
| HAV, Hepatitis A virus | ||||||
| CPV, canine parvovirus, model for B19V | ||||||
| n.d., not done | ||||||
| ||||||
| Al(OH)3 Adsorption / Vitacel® Defibrination | ≥5.8 | 2.8 | n.d. | ≥7.6 | 1.3 | [0.4]* |
| Ion Exchange Chromatography | 5.0 | 3.4 | n.d. | n.d. | 3.4 | 3.7 |
| Heat Treatment | ≥5.8 | ≥8.1 | ≥7.4 | ≥7.6 | 4.3 | 1.0† |
| Cumulative Virus Reduction (log10) | ≥16.6 | ≥14.3 | ≥7.4 | ≥15.2 | 9.0 | 4.7 |
Corifact (FXIII) is an endogenous plasma glycoprotein consisting of two A-subunits and two B-subunits. FXIII circulates in blood and is present in platelets, monocytes, and macrophages. FXIII appears in 2 forms, a heterotetrameric (A2B2) plasma protein with a molecular weight of about 320 kilodaltons and a homodimeric (A2) cellular form. FXIII is a proenzyme that is activated, in the presence of calcium ion, by thrombin cleavage of the A-subunit to become activated FXIII (FXIIIa). Intracellularly, the homodimeric form of only the A-subunits (A2) is found. The B-subunits in plasma have no enzymatic activity, and function as carrier molecules for the A-subunits. They stabilize the structure of the A-subunits and protect them from proteolysis.
FXIIIa promotes cross-linking of fibrin during coagulation and is essential to the physiological protection of the clot against fibrinolysis. FXIIIa is a transglutaminase enzyme that catalyzes the cross-linking of the fibrin α- and γ-chains for fibrin stabilization and renders the fibrin clot more elastic and resistant to fibrinolysis.2,3 FXIIIa also cross-links α2-plasmin inhibitor to the α-chain of fibrin, resulting in protection of the fibrin clot from degradation by plasmin. Cross-linked fibrin is the end result of the coagulation cascade, and provides tensile strength to a primary hemostatic platelet plug.3
In clinical studies, the intravenous administration of Corifact demonstrated an increase in plasma levels of FXIII lasting approximately 28 days.
In the pharmacokinetic study, after the third 40 units per kg dose (steady state), the mean increase in FXIII activity levels was 83% with a range of 48 to 114% over the baseline (see Pharmacokinetics [12.3]).
A 12-week prospective, open-label, multicenter pharmacokinetic and safety study was conducted in 7 females and 7 males with congenital FXIII deficiency, ranging in age from 5 to 42 years (3 children, 2 adolescents, 9 adults). One adult male did not complete the pharmacokinetic study.
Each subject received 40 units per kg Corifact intravenously every 28 days for a total of three doses administered at approximately 250 units per min. Blood samples for doses 1 and 2 were drawn from patients to determine the FXIII activity level at baseline and 30 and 60 minutes after the infusion. Following the infusion of the third dose of Corifact, blood samples were drawn at regular intervals up to 28 days to determine the pharmacokinetic parameters. The pharmacokinetic parameters based on baseline adjusted FXIII activity (Berichrom assay) are shown in Table 4.
| Parameters | Mean ±SD |
|---|---|
| AUC ss(0-inf) = Area under the plasma concentration curve from time 0 to infinity at steady state | |
| Css, max: Peak concentration at steady state | |
| Css, min: Trough concentration at steady state | |
| Tmax: Time to peak concentration | |
| CL: Clearance | |
| Vss: Volume of distribution at steady state | |
| MRT = Mean residence time | |
| SD = Standard deviation | |
| |
| AUC ss, 0-inf (units∙hr/mL) | 184.0 ±65.78 |
| Css, max (units/mL)* | 0.9 ±0.20 |
| Css, min (units/mL)* | 0.05 ±0.05 |
| Tmax (hr) | 1.7 ±1.44 |
| Half-life [days] | 6.6 ±2.29 |
| CL [mL/hr/kg] | 0.25 ±0.09 |
| Vss [mL/kg] | 51.1 ±12.61 |
| MRT [days] | 10.0 ±3.45 |
Due to the small sample size, the impact of age, gender, and race on the pharmacokinetics of Corifact could not be reliably evaluated.
Corifact was studied in an acute toxicity study in mice and rats at doses up to 3550 units per kg and 1420 units per kg, respectively. Repeat dose toxicity was studied in rats at daily doses up to 350 units per kg for a period of 14 days. No signs of toxicity were observed in the single dose and repeat dose studies.
A local tolerance study demonstrated no clinical or histopathological changes at the injection site after intravenous, intra-arterial or para-venous administration of Corifact to rabbits.
A thrombogenicity test was performed in rabbits at doses up to 350 units per kg. Corifact showed no thrombogenic potential at the doses tested.
The pharmacokinetic study evaluated three doses at 40 units per kg every 28 days for each subject (see Pharmacokinetics [12.3]). Blood sampling before and after infusion for the first two doses was to determine FXIII activity and a complete PK analysis was conducted after the third dose (steady state). FXIII activity levels were determined by the Berichrom activity assay.
Maintaining the FXIII activity trough level between 5% and 20% is predicted to provide a clinical benefit. The clinical benefit will be verified in a post-marketing study to measure the prevention of spontaneous bleeding episodes with routine prophylactic treatment for patients with congenital FXIII deficiency. Dosing will be individualized and adjusted with the objective to maintain FXIII activity trough levels of 5% to 20%.
Each product package consists of the following:
| NDC Number | Component |
|---|---|
| 63833-518-02 | Carton (kit) contains one 1000-1600 units Corifact in a single-use vial [NDC 63833-528-01], one 20 mL vial of Sterile Water for Injection, USP [NDC 63833-734-65], one Mix2Vial filter transfer set, and one alcohol swab. |
Manufactured by:
CSL Behring GmbH
35041 Marburg Germany
US License No. 1765
Distributed by:
CSL Behring LLC
Kankakee, IL 60901 USA
Berichrom® Factor XIII assay is a trademark of Siemens Healthcare Diagnostics.
Vitacel® is a trademark of J. Rettenmaier & Söhne GmbH and Co.
Mix2Vial™ is a trademark of West Pharmaceuticals Services, Inc. or one of its subsidiaries.
Corifact
Factor XIII Concentrate (Human)
FDA-Approved Patient Labeling – Patient Product Information (PPI)
This leaflet summarizes important information about Corifact. Please read it carefully before using Corifact and each time you get a refill. There may be new information provided. This information does not take the place of talking with your healthcare provider, and it does not include all of the important information about Corifact. If you have any questions after reading this, ask your healthcare provider.
What is Corifact?
Corifact is an injectable medicine used for routine prophylactic treatment of congenital Factor XIII (FXIII) deficiency in adults and pediatric patients. Corifact is a coagulation FXIII concentrate made from human plasma, and has important functions in hemostasis (stopping of bleeding).
Who should not use Corifact?
You should not use Corifact if you have experienced hypersensitivity reactions, including anaphylactic or severe systemic reactions to human plasma-derived products.
What should I tell my healthcare provider before Corifact is given?
Tell your healthcare provider about all of your medical conditions, including:
Tell your healthcare provider and pharmacist about all of the medicines you take, including all prescription and non-prescription medicines such as over-the-counter medicines, supplements, or herbal remedies.
How is Corifact given?
Corifact is administered into your vein (intravenous injection). Before infusing, Corifact is dissolved using sterile water provided in the package. Your healthcare provider will prescribe the dose that you receive.
What could be the possible side effects of Corifact?
Call your healthcare provider or the emergency department right away if you have any of the following symptoms after using Corifact:
Other possible side effects may include:
Because Corifact is made from human blood, it may carry a risk of transmitting infectious agents, e.g., viruses, and, theoretically, the Creutzfeldt-Jakob (CJD) agent.
These are not all the possible side effects of Corifact.
Tell your healthcare provider about any side effect that bothers you or that does not go away. You can also report side effects to the FDA at 1-800-FDA-1088.
What else should I know about Corifact?
Medicines are sometimes prescribed for purposes other than those listed here. Do not use Corifact for a condition for which it is not prescribed. Do not share Corifact with other people, even if they have the same symptoms that you have.
This leaflet summarizes the most important information about Corifact. If you would like more information, talk to your healthcare provider. You can ask your healthcare provider or pharmacist for information about Corifact that was written for healthcare professionals.
Talk to your healthcare provider before traveling.
This Patient Package Insert has been approved by the US Food and Drug Administration.
PRINCIPAL DISPLAY PANEL - 1000-1600 iU Kit
NDC 63833-518-02
FXIII Concentrate (Human)
Corifact™
For Intravenous Use Only
Rx only
FXIII
units per vial
EXP:
LOT:
CSL Behring
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