Ravenol may be available in the countries listed below.
Ingredient matches for Ravenol
Sulodexide is reported as an ingredient of Ravenol in the following countries:
- Italy
International Drug Name Search
Ravenol may be available in the countries listed below.
Sulodexide is reported as an ingredient of Ravenol in the following countries:
International Drug Name Search
Salislon may be available in the countries listed below.
Cefadroxil is reported as an ingredient of Salislon in the following countries:
International Drug Name Search
Tarizart may be available in the countries listed below.
Ofloxacin is reported as an ingredient of Tarizart in the following countries:
International Drug Name Search
Fansulide may be available in the countries listed below.
Nimesulide is reported as an ingredient of Fansulide in the following countries:
International Drug Name Search
Fractopon may be available in the countries listed below.
Aceclofenac is reported as an ingredient of Fractopon in the following countries:
International Drug Name Search
In some countries, this medicine may only be approved for veterinary use.
Prop.INN
0000633-47-6
C13-H24-N2-O2
240
Analeptic
2-Butenamide, N-[1-[(dimethylamino)carbonyl]propyl]-N-propyl-
International Drug Name Search
Glossary
BAN | British Approved Name |
DCF | Dénomination Commune Française |
DCIT | Denominazione Comune Italiana |
OS | Official Synonym |
Prop.INN | Proposed International Nonproprietary Name (World Health Organization) |
Cétornan may be available in the countries listed below.
Ornithine oxoglurate (a derivative of Ornithine) is reported as an ingredient of Cétornan in the following countries:
International Drug Name Search
Drakern may be available in the countries listed below.
Ketotifen fumarate (a derivative of Ketotifen) is reported as an ingredient of Drakern in the following countries:
International Drug Name Search
Thiogamma Turbo-Set may be available in the countries listed below.
Thioctic Acid meglumine (a derivative of Thioctic Acid) is reported as an ingredient of Thiogamma Turbo-Set in the following countries:
International Drug Name Search
Terazosina Hexal may be available in the countries listed below.
Terazosin hydrochloride (a derivative of Terazosin) is reported as an ingredient of Terazosina Hexal in the following countries:
International Drug Name Search
Siphene may be available in the countries listed below.
Clomifene citrate (a derivative of Clomifene) is reported as an ingredient of Siphene in the following countries:
International Drug Name Search
Telavancin Hydrochloride may be available in the countries listed below.
Telavancin Hydrochloride (USAN) is known as Telavancin in the US.
International Drug Name Search
Glossary
USAN | United States Adopted Name |
Uroxatral is a brand name of alfuzosin, approved by the FDA in the following formulation(s):
A generic version of Uroxatral has been approved by the FDA. However, this does not mean that the product will necessarily be commercially available - possibly because of drug patents and/or drug exclusivity. The following products are equivalent to Uroxatral and have been approved by the FDA:
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Uroxatral. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.
See also: About generic drugs.
Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.
Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.
Zidicef may be available in the countries listed below.
Ceftazidime is reported as an ingredient of Zidicef in the following countries:
International Drug Name Search
Diazepam Alter may be available in the countries listed below.
Diazepam is reported as an ingredient of Diazepam Alter in the following countries:
International Drug Name Search
In the US, Droxia (hydroxyurea systemic) is a member of the drug class antimetabolites and is used to treat Anemia - Sickle Cell, Chronic Myelogenous Leukemia, Polycythemia Vera and Solid Tumors.
US matches:
Hydroxycarbamide is reported as an ingredient of Droxia in the following countries:
International Drug Name Search
Siozwo Nasengel may be available in the countries listed below.
Xylometazoline hydrochloride (a derivative of Xylometazoline) is reported as an ingredient of Siozwo Nasengel in the following countries:
International Drug Name Search
See also: Generic Duragesic-100, Generic Duragesic-12, Generic Duragesic-25, Generic Duragesic-50
Duragesic-75 is a brand name of fentanyl, approved by the FDA in the following formulation(s):
Yes. The following products are equivalent to Duragesic-75:
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Duragesic-75. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.
See also: About generic drugs.
There are no current U.S. patents associated with Duragesic-75.
Pentamol may be available in the countries listed below.
Salbutamol sulfate (a derivative of Salbutamol) is reported as an ingredient of Pentamol in the following countries:
International Drug Name Search
Scabicin may be available in the countries listed below.
Crotamiton is reported as an ingredient of Scabicin in the following countries:
International Drug Name Search
In the US, Actimmune (interferon gamma-1b systemic) is a member of the drug class interferons and is used to treat Chronic Granulomatous Disease, Cutaneous T-cell Lymphoma, Idiopathic Pulmonary Fibrosis, Osteopetrosis and Rheumatoid Arthritis.
US matches:
Interferon gamma Interferon gamma-1b (a derivative of Interferon gamma) is reported as an ingredient of Actimmune in the following countries:
International Drug Name Search
Silvamed may be available in the countries listed below.
Sulfadiazine silver (a derivative of Sulfadiazine) is reported as an ingredient of Silvamed in the following countries:
International Drug Name Search
Renadinac may be available in the countries listed below.
Diclofenac sodium salt (a derivative of Diclofenac) is reported as an ingredient of Renadinac in the following countries:
International Drug Name Search
In the US, Nitrong is a member of the following drug classes: antianginal agents, vasodilators and is used to treat Angina, Angina Pectoris Prophylaxis, Heart Attack, Heart Failure and High Blood Pressure.
Nitroglycerin is reported as an ingredient of Nitrong in the following countries:
International Drug Name Search
Dilabar may be available in the countries listed below.
Captopril is reported as an ingredient of Dilabar in the following countries:
International Drug Name Search
Generic Name: tramadol (TRAM a dol)
Brand Names: ConZip, Rybix ODT, Ryzolt, Ultram, Ultram ER
Tramadol is a narcotic-like pain reliever.
Tramadol is used to treat moderate to severe pain. Tramadol extended-release is used to treat moderate to severe chronic pain when treatment is needed around the clock.
Tramadol may also be used for purposes not listed in this medication guide.
Seizures (convulsions) have occurred in some people taking tramadol. Tramadol may be more likely to cause a seizure if you have a history of seizures or head injury, a metabolic disorder, or if you are taking certain medicines such as antidepressants, muscle relaxers, narcotic, or medicine for nausea and vomiting.
Do not take tramadol while you are intoxicated (drunk) or taking any of the following:
alcohol or street drugs;
narcotic pain medicine;
sedatives or tranquilizers (such as Valium);
medicine for depression or anxiety; or
medicine for mental illness (such as bipolar disorder, schizophrenia).
Seizures have occurred in some people taking tramadol. Talk with your doctor about your seizure risk, which may be higher if you have:
a history of drug or alcohol addiction;
a history of epilepsy or other seizure disorder;
a history of head injury;
a metabolic disorder; or
if you are also taking an antidepressant, muscle relaxer, narcotic, antipsychotic, or medicine for nausea and vomiting.
To make sure you can safely take tramadol, tell your doctor if you have any of these other conditions:
kidney disease (or if you are on dialysis);
cirrhosis or other liver disease;
a stomach disorder; or
a history of depression, mental illness, or thoughts of suicide.
Rybix ODT may contain phenylalanine. Talk to your doctor before using this form of tramadol if you have phenylketonuria (PKU).
Take exactly as prescribed. Never take tramadol in larger amounts, or for longer than recommended by your doctor. Follow the directions on your prescription label. Tell your doctor if the medicine seems to stop working as well in relieving your pain.
Tramadol can be taken with or without food, but take it the same way each time.
To take tramadol orally disintegrating tablets (Rybix ODT):
Keep the tablet in its blister pack until you are ready to take it.
Using dry hands, remove the tablet and place it in your mouth. It will begin to dissolve right away.
Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing.
Swallow several times as the tablet dissolves. If desired, you may drink liquid to help swallow the dissolved tablet.
If you use the tramadol extended-release tablet, the tablet shell may pass into your stools (bowel movements). This is normal and does not mean that you are not receiving enough of the medicine.
Keep track of the amount of medicine used from each new bottle. Tramadol is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.
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, shallow breathing, muscle weakness, slow heartbeat, cold or clammy skin, fainting, or seizure.
agitation, hallucinations, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting;
seizure (convulsions);
a red, blistering, peeling skin rash; or
shallow breathing, weak pulse.
Less serious side effects may include:
dizziness, spinning sensation;
constipation, upset stomach;
headache;
drowsiness; or
feeling nervous or anxious.
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.
You may be more likely to have a seizure (convulsions) if you take tramadol while you are using certain other medicines. Do not take tramadol without telling your doctor if you also use any of the following medications:
an MAO inhibitor such as isocarboxazid (Marplan), tranylcypromine (Parnate), phenelzine (Nardil), or selegiline (Eldepryl, Emsam); or
an antidepressant such as amitriptyline (Elavil, Vanatrip), citalopram (Celexa), clomipramine (Anafranil), desipramine (Norpramin), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), imipramine (Tofranil), nortriptyline (Pamelor), paroxetine (Paxil), or sertraline (Zoloft).
Tell your doctor about all other medicines you use, especially:
carbamazepine (Carbatrol, Equetro, Tegretol);
lithium (Eskalith, LithoBid);
ADHD medications (Adderall, Ritalin, Strattera);
an antibiotic such as clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole), linezolid (Zyvox), rifampin (Rifadin, Rimactane, Rifater); or telithromycin (Ketek);
antifungal medication such as clotrimazole (Mycelex Troche), itraconazole (Sporanox), ketoconazole (Nizoral), miconazole (Oravig), or voriconazole (Vfend);
cancer medications such as gefitinib (Iressa), imatinib (Gleevec), or nilotinib (Tasigna);
a heart rhythm medication such as amiodarone (Cordarone, Pacerone), flecainide (Tambocor), propafenone (Rythmol), or quinidine (Quin-G);
heart or blood pressure medication such as diltiazem (Cartia, Cardizem), felodipine (Plendil), nifedipine (Nifedical, Procardia), verapamil (Calan, Covera, Isoptin, Verelan), and others;
HIV/AIDS medicine such as atazanavir (Reyataz), delavirdine (Rescriptor), fosamprenavir (Lexiva), indinavir (Crixivan), nelfinavir (Viracept), saquinavir (Invirase), or ritonavir (Norvir, Kaletra); or
migraine headache medicine such as sumatriptan (Imitrex, Treximet).
See also: Rybix ODT side effects (in more detail)
Konsuben may be available in the countries listed below.
Sodium Picosulfate monohydrate (a derivative of Sodium Picosulfate) is reported as an ingredient of Konsuben in the following countries:
International Drug Name Search
Féliderm may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Megestrol 17α-acetate (a derivative of Megestrol) is reported as an ingredient of Féliderm in the following countries:
International Drug Name Search
Avicas may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Febantel is reported as an ingredient of Avicas in the following countries:
International Drug Name Search
Arret may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Loperamide hydrochloride (a derivative of Loperamide) is reported as an ingredient of Arret in the following countries:
International Drug Name Search
Levocomp may be available in the countries listed below.
Carbidopa monohydrate (a derivative of Carbidopa) is reported as an ingredient of Levocomp in the following countries:
Levodopa is reported as an ingredient of Levocomp in the following countries:
International Drug Name Search
Tedol may be available in the countries listed below.
Ketoconazole is reported as an ingredient of Tedol in the following countries:
International Drug Name Search
Digoxin Dak may be available in the countries listed below.
Digoxin is reported as an ingredient of Digoxin Dak in the following countries:
International Drug Name Search
Benzosept may be available in the countries listed below.
Benzododecinium bromide (a derivative of Benzododecinium) is reported as an ingredient of Benzosept in the following countries:
International Drug Name Search
In the US, Americaine (benzocaine topical) is a member of the drug class topical anesthetics and is used to treat Anal Itching and Hemorrhoids.
US matches:
Benzocaine is reported as an ingredient of Americaine in the following countries:
International Drug Name Search
Impamid may be available in the countries listed below.
Indapamide is reported as an ingredient of Impamid in the following countries:
International Drug Name Search
Potassium Chloride is reported as an ingredient of K+ Care in the following countries:
Potassium Hydrogencarbonate is reported as an ingredient of K+ Care in the following countries:
International Drug Name Search
Artose may be available in the countries listed below.
Celecoxib is reported as an ingredient of Artose in the following countries:
International Drug Name Search
Supdel may be available in the countries listed below.
Ketotifen fumarate (a derivative of Ketotifen) is reported as an ingredient of Supdel in the following countries:
International Drug Name Search
Fluoxetina Decrox may be available in the countries listed below.
Fluoxetine hydrochloride (a derivative of Fluoxetine) is reported as an ingredient of Fluoxetina Decrox in the following countries:
International Drug Name Search
Fosmalin may be available in the countries listed below.
Fosfomycin is reported as an ingredient of Fosmalin in the following countries:
International Drug Name Search
Glicerolo may be available in the countries listed below.
Glycerol is reported as an ingredient of Glicerolo in the following countries:
International Drug Name Search
Axigem may be available in the countries listed below.
Gemcitabine hydrochloride (a derivative of Gemcitabine) is reported as an ingredient of Axigem in the following countries:
International Drug Name Search
Saspryl may be available in the countries listed below.
Acetylsalicylic Acid is reported as an ingredient of Saspryl in the following countries:
International Drug Name Search
Estival may be available in the countries listed below.
Carbocisteine is reported as an ingredient of Estival in the following countries:
International Drug Name Search
Decostriol may be available in the countries listed below.
Calcitriol is reported as an ingredient of Decostriol in the following countries:
International Drug Name Search
Phil Pharmawealth Omeprazole may be available in the countries listed below.
Omeprazole is reported as an ingredient of Phil Pharmawealth Omeprazole in the following countries:
International Drug Name Search
Treating high blood pressure and treating signs and symptoms of benign prostatic hyperplasia (BPH).
Doxazosin is an alpha-blocker. It works by relaxing muscles in the blood vessels, resulting in lowering of blood pressure. In men with BPH, alpha-blockers work by relaxing muscles around the urethra (the tube that drains urine from the bladder), which improves urinary symptoms.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Doxazosin. Tell your health care provider if you have any medical conditions, especially if any of the following apply to you:
Some MEDICINES MAY INTERACT with Doxazosin. 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 Doxazosin 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 Doxazosin 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 Doxazosin.
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:
Dizziness; drowsiness; lightheadedness; nasal congestion; tiredness; weakness.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; fainting; irregular heartbeat; prolonged, painful erection; severe or prolonged dizziness or headache; shortness of breath; swelling of the ankles, feet, or hands; vision changes.
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: Doxazosin 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 severe drowsiness; severe headache or dizziness.
Store Doxazosin at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Doxazosin out of reach of children and away from pets.
This information is a summary only. It does not contain all information about Doxazosin. 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.
Votalin Emulgel may be available in the countries listed below.
Diclofenac diethylamine (a derivative of Diclofenac) is reported as an ingredient of Votalin Emulgel in the following countries:
International Drug Name Search
Pentatop may be available in the countries listed below.
Cromoglicic Acid disodium salt (a derivative of Cromoglicic Acid) is reported as an ingredient of Pentatop in the following countries:
International Drug Name Search
Neo-Tiroimade may be available in the countries listed below.
Liothyronine sodium salt (a derivative of Liothyronine) is reported as an ingredient of Neo-Tiroimade in the following countries:
International Drug Name Search
Paracetamolo Unifarm may be available in the countries listed below.
Paracetamol is reported as an ingredient of Paracetamolo Unifarm in the following countries:
International Drug Name Search
Captopril-Actavis plus may be available in the countries listed below.
Captopril is reported as an ingredient of Captopril-Actavis plus in the following countries:
Hydrochlorothiazide is reported as an ingredient of Captopril-Actavis plus in the following countries:
International Drug Name Search
Insulin Human, Isophane may be available in the countries listed below.
Insulin Human, Isophane (USP) is also known as Insulin, Isophane (Rec.INN)
International Drug Name Search
Glossary
Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
USP | Pharmacopoeia of the United States |
Sinvastatina Generis may be available in the countries listed below.
Simvastatin is reported as an ingredient of Sinvastatina Generis in the following countries:
International Drug Name Search
Sertralin Bluefish may be available in the countries listed below.
Sertraline hydrochloride (a derivative of Sertraline) is reported as an ingredient of Sertralin Bluefish in the following countries:
International Drug Name Search
Treating certain skin conditions (eg, seborrheic dermatitis) and certain bacterial infections of the skin. It may also be used for other conditions as determined by your doctor.
Rosula NS Medicated Pads are a sulfonamide antibiotic. It works by killing bacteria.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Rosula NS Medicated Pads. 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 Rosula NS Medicated Pads. 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 Rosula NS Medicated Pads 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 Rosula NS Medicated Pads 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 Rosula NS Medicated Pads.
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:
Irritation, stinging, or burning of the skin.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody diarrhea; fever; joint pain; red, swollen, or blistered skin; severe diarrhea; sores in the mouth; stomach cramps/pain.
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: Rosula NS 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. Rosula NS Medicated Pads may be harmful if swallowed. Symptoms of ingestion may include change in the amount of urine; nausea; vomiting.
Store Rosula NS Medicated Pads 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. Do not freeze. Keep Rosula NS Medicated Pads out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Rosula NS Medicated Pads. 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.
Niconas may be available in the countries listed below.
Etodolac is reported as an ingredient of Niconas in the following countries:
International Drug Name Search
Siloxan may be available in the countries listed below.
Simeticone is reported as an ingredient of Siloxan in the following countries:
International Drug Name Search
Flexfree may be available in the countries listed below.
Felbinac is reported as an ingredient of Flexfree in the following countries:
International Drug Name Search
Microsol may be available in the countries listed below.
Lithium bromide (a derivative of Lithium) is reported as an ingredient of Microsol in the following countries:
International Drug Name Search
Definition of Pseudotumor Cerebri: Pseudotumor cerebri literally means "false brain tumor." It is likely due to high pressure within the skull caused by the buildup or poor absorption of cerebrospinal fluid (CSF). The disorder is most common in women between the ages of 20 and 50. Symptoms of pseudotumor cerebri, which include headache, nausea, vomiting, and pulsating sounds within the head, closely mimic symptoms of large brain tumors.
The following drugs and medications are in some way related to, or used in the treatment of Pseudotumor Cerebri. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.
Micromedex Care Notes:
Medical Encyclopedia:
Ticlopidine Poli may be available in the countries listed below.
Ticlopidine hydrochloride (a derivative of Ticlopidine) is reported as an ingredient of Ticlopidine Poli in the following countries:
International Drug Name Search
Sparfloxacine may be available in the countries listed below.
Sparfloxacine (DCF) is known as Sparfloxacin in the US.
International Drug Name Search
Glossary
DCF | Dénomination Commune Française |
Femigoa may be available in the countries listed below.
Ethinylestradiol is reported as an ingredient of Femigoa in the following countries:
Levonorgestrel is reported as an ingredient of Femigoa in the following countries:
International Drug Name Search
Spironolactone Apotex may be available in the countries listed below.
Spironolactone is reported as an ingredient of Spironolactone Apotex in the following countries:
International Drug Name Search
Ethinyloestradiol may be available in the countries listed below.
Ethinylestradiol is reported as an ingredient of Ethinyloestradiol in the following countries:
International Drug Name Search
Vermitox may be available in the countries listed below.
Mebendazole is reported as an ingredient of Vermitox in the following countries:
International Drug Name Search
Vectoryl Plus may be available in the countries listed below.
Indapamide is reported as an ingredient of Vectoryl Plus in the following countries:
Perindopril erbumine (a derivative of Perindopril) is reported as an ingredient of Vectoryl Plus in the following countries:
International Drug Name Search
Octilia may be available in the countries listed below.
Tetryzoline is reported as an ingredient of Octilia in the following countries:
Tetryzoline hydrochloride (a derivative of Tetryzoline) is reported as an ingredient of Octilia in the following countries:
International Drug Name Search
Sibulin may be available in the countries listed below.
Sibutramine hydrochloride monohydrate (a derivative of Sibutramine) is reported as an ingredient of Sibulin in the following countries:
International Drug Name Search
Orivate may be available in the countries listed below.
Oxybutynin hydrochloride (a derivative of Oxybutynin) is reported as an ingredient of Orivate in the following countries:
International Drug Name Search
Liquid Barosperse is a vanilla flavored barium sulfate suspension. It is a contrast medium developed for use in x-ray diagnosis of the gastrointestinal tract.
The product contains 60% w/v barium sulfate USP, suspending agents, flavoring, citric acid, simethicone, potassium sorbate, saccharin sodium and water. Barium sulfate has the empirical formula of BaSO4.
Barium sulfate is an insoluble material which, because of its density, provides a positive contrast during x-ray examination. Barium sulfate is an inert radiopaque material which is not absorbed or metabolized and is eliminated intact from the body in a manner similar to other non-absorbed inorganic materials. Excretion rate is a function of gastrointestinal transit time.
Liquid Barosperse is indicated for use as a contrast medium in x-ray diagnosis of the gastrointestinal tract. The suspension may be administered without dilution for esophageal swallow or filled stomach examinations. Aqueous dilutions may be administered rectally for routine filled colon studies or given orally for filled stomach or enteroclysis procedures.
Barium sulfate products are contraindicated in patients with known or suspected obstruction of the colon, known or suspected gastrointestinal tract perforation, suspected tracheoesophageal fistula, obstructing lesions of the small intestine, pyloric stenosis, inflammation or neoplastic lesions of the rectum, recent rectal biopsy, or known hypersensitivity to barium sulfate formulations.
Barium sulfate suspensions should not be used for infants with swallowing disorders or for newborns with complete duodenal or jejunal obstruction or when distal small bowel or colon obstruction is suspected. Barium sulfate suspension is not recommended for very small preterm infants and young babies requiring small volumes of contrast media or for infants and young children when there is a possibility of leakage from the gastrointestinal tract, such as necrotizing enterocolitis, unexplained pneumoperitoneum, gasless abdomen, other bowel perforation, esophageal perforation or post operative anastomosis.
Known hypersensitivity or allergy to latex is a contraindication for the use of balloon retention enema tips containing latex. The use of a retention cuff enema tip is not necessary or desirable in patients with normal sphincter tone. The presence of adequate sphincter tone can be judged by preliminary rectal digital examination.
Serious adverse reactions, including death, have been reported with the administration of barium sulfate formulations and are usually associated with the technique of administration, the underlying pathological condition and/or patient hypersensitivities.
Vomiting following oral administration of barium sulfate may lead to aspiration pneumonitis. Oral administration of barium sulfate suspension by an infant sucking a bottle and administration of large quantities by catheter are reported to be likely to result in aspiration into the tracheobronchial tree. Cardiopulmonary arrest leading to fatality has been reported in infants following aspiration. Aspiration of smaller amounts may cause inflammation.
Barium sulfate preparations used as radiopaque media contain a number of additives to provide diagnostic properties and patient palatability. Allergic responses following the use of barium sulfate suspensions have been reported. Skin irritation, redness, inflammation and hives have been reported for infants and small children following spillage of barium sulfate suspension on their skin. These responses are thought to be caused by the flavors and/or preservatives used in the product.
Barium sulfate suspension has been reported to cause obstruction of the small bowel (impaction) in pediatric patients with cystic fibrosis. It has also been reported to cause fluid overload from the absorption of water during studies in infants when Hirschsprung’s Disease is suspected.
Barium sulfate suspension intravasation can be a serious complication. Mortality has been reported as a result of vaginal or rectal intravasation and is believed to be due to massive pulmonary embolism occurring within minutes of the inciting event.
In patients with increased cranial pressure, barium sulfate suspension enemas present an additional risk of further increasing intracranial pressure.
Care must be taken during the insertion of an enema tip into the patient to prevent application of pressure to the vagus nerve which can lead to vasovagal reactions and syncopal episodes. Cardiac arrhythmia or other cardiovascular side effects can occur as a result of colon distention.
Diagnostic procedures which involve the use of radiopaque contrast agents should be carried out under the direction of personnel with the requisite training and with a thorough knowledge of the particular procedure to be performed. A history of bronchial asthma, atopy, as evidenced by hay fever and eczema, a family history of allergy, or a previous reaction to a contrast agent warrant special attention. Caution should be exercised with the use of radiopaque media in severely debilitated patients and in those with marked hypertension or advanced cardiac disease.
Anaphylactic and allergic reactions have been reported during double contrast examinations in which glucagon has been used.
An increased risk of perforation has been reported in neonates with intussusception. In patients with cystic fibrosis or blind loops of the bowel or ileus, there is a risk of inspissation leading to partial or complete obstruction.
In neonates and infants with motility disorders such as Hirschsprung’s Disease, retention of large amounts of barium sulfate suspension may result in absorption of water from the suspension and fluid overload. The addition of small amounts of salt to the barium sulfate suspension has been reported to reduce the problem.
Ingestion of barium sulfate suspension is not recommended in patients with a history of food aspiration. If barium sulfate suspension is aspirated into the larynx, further administration of the suspension should be immediately discontinued.
Patient preparation for diagnostic gastrointestinal examinations frequently requires cathartics and a liquid diet. The various preparations can result in water loss for the patient. Patients should be rehydrated quickly following a barium sulfate suspension examination of the gastrointestinal tract. In patients with reduced colon motility, saline cathartics may be required after the barium sulfate suspension enema. Saline cathartics are recommended on a routine basis in patients with a history of constipation unless clinically contraindicated.
Where enema tips are used, care must be taken during insertion into the patient, since forceful or too deep insertion may cause tearing or perforation of the rectum. Insertion of an enema tip should be done only after digital examination by qualified medical personnel. When balloon retention tips are used, care should be taken to avoid overinflation of the balloon, since overfilling or asymmetrical filling may cause displacement of the tip. Such a displacement can lead to rectal perforation or barium sulfate granulomas. Inflation of the balloon should be done under fluoroscopic control by qualified medical personnel. Do not unnecessarily move the enema tip once inserted.
A specially designed enema tip is required for a barium sulfate suspension examination of a colostomy patient.
Intubation of an enteroclysis catheter should be done by qualified medical personnel. Perforation of the duodenum has been reported.
Because of reported anaphylactoid reactions to latex, the use of non-latex gloves during the procedure should be considered.
Safe use of barium sulfate during pregnancy has not been established. Barium sulfate should be used in pregnant women only if the possible benefits outweigh the potential risks. Elective radiography of the abdomen is considered to be contraindicated during pregnancy due to the risk to the fetus from radiation exposure. Radiation is known to cause harm to the unborn fetus exposed in utero.
The radiographic contrast agents used for examination of children do not differ substantially from those used for adults. The variation in physical sizes of pediatric patients requires more thorough attention to individualizing dosage. The volume of barium sulfate suspension and the barium sulfate content required will also depend upon the technique used and the clinical need.
Adverse reactions accompanying the use of barium sulfate formulations are infrequent and usually mild, though severe reactions (approximately 1 in 500,000) and fatalities (approximately 1 in 2,000,000) have occurred. Procedural complications are rare, but may include aspiration pneumonitis, barium sulfate impaction, granuloma formation, intravasation, embolization and peritonitis following intestinal perforation, vasovagal and syncopal episodes, and fatalities. EKG changes have been shown to occur following or during barium sulfate suspension enemas. It is of the utmost importance to be completely prepared to treat any such occurrence.
Due to the increased likelihood of allergic reactions in atopic patients, a complete history of known and suspected allergies as well as allergic-like symptoms, such as rhinitis, bronchial asthma, eczema and urticaria, must be obtained prior to any medical procedure.
Aspiration of large amounts of barium sulfate suspension may cause pneumonitis or nodular granulomas of interstitial lung tissues and lymph nodes; asphyxiation and death have been reported.
Transient bacteremia, beginning almost immediately and lasting up to 15 minutes, may also occur during rectal administration of barium sulfate suspension, and rarely septicemia has been reported.
A rare mild allergic reaction would most likely be generalized pruritis, erythema or urticaria (approximately 1 in 100,000 reactions). Such reactions will respond to an antihistamine. More serious reactions (approximately 1 in 500,000) may result in laryngeal edema, bronchospasm or hypotension.
Severe reactions which may require emergency measures are often characterized by peripheral vasodilation, hypotension, reflex tachycardia, dyspnea, bronchospasm, agitation, confusion and cyanosis, progressing to unconsciousness. Treatment should be initiated immediately according to established standard of care.
Apprehensive patients may develop weakness, pallor, tinnitus, diaphoresis and bradycardia following the administration of any diagnostic agent. Such reactions are usually non-allergic in nature.
Allergic reactions to the enema accessories, in particular to retention catheters (tips) with latex cuffs, can occur. Such reactions could occur immediately and result in the previously mentioned acute allergic-like responses or might be delayed in appearance and result in a contact dermatitis. Known atopic patients, particularly those with a history of asthma or eczema, should be evaluated for alternative methods of administration in order to avoid these adverse reactions. These plastic/rubber accessories are disposable, single-use devices that must not be reused or left in the body cavity for an extended period of time.
The following adverse experiences have been reported in patients receiving products containing barium sulfate. These adverse experiences are listed alphabetically: abdominal cramping, abdominal pain, diarrhea, fever, foreign body trauma relating to procedural complications, headache, laryngeal burning and irritation, leukocytosis, procedural site reactions, rash, and vomiting.
In rare instances, immediate repeat oral examinations utilizing standard dosages may lead to severe stomach cramps and diarrhea. Cases reported implicate a total dose in the range of 30 ounces (900 mL) of suspension. Instances of this type have resolved spontaneously and they are not considered to be life-threatening.
Successful examination of the upper gastrointestinal tract requires that the stomach be empty and essentially free of fluid. This can usually be accomplished by instructing the patient to abstain from eating or drinking anything after the evening meal before the examination. The preparation for small bowel examinations, done separately or combined with an upper gastrointestinal series, is the same.
For examinations of the colon, the patients should be given a low solid diet for a minimum of 24 hours before the examination. Laxatives should also be used to clean the colon. In order to obtain thorough cleansing of the colon, a 2 liter water enema one hour before the examination may be necessary.
Individual technique will determine the suspension quantity and barium sulfate content to be used. The following dilutions are suggested for Liquid Barosperse.
EXAMINATION | DILUTION FORMULA | % BARIUM SULFATE (w/v) |
Filled Stomach | Use undiluted or | 60% |
3 parts Liquid Barosperse to 1 part water | 45% | |
Esophageal Swallow | Use undiluted | 60% |
Enteroclysis | 3 Parts Liquid Barosperse to 1 part water | 45% |
Routine Filled Colon | 1 part Liquid Barosperse to 2 parts water | 20% |
Shake well before using.
It is recommended that Liquid Barosperse be served chilled for upper gastrointestinal studies. This will give a more rapid transit of Liquid Barosperse from the stomach into the small bowel. For lower gastrointestinal studies, Liquid Barosperse should be administered at room temperature to body temperature.
The quantity of suspension used and the barium sulfate concentration will depend upon patient size, technique used and clinical need.
For single patient use only. Properly discard unused portion.
Catalog No. 179312. NDC 68240-325-24. 355 mL bottles. Twenty-four (24) bottles and twenty-four (24) straws per case.
Store at 25ºC (77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF). Protect from freezing.
Liquid Barosperse is a trademark of Mallinckrodt Inc. or its subsidiaries.
DIN: 02196190
Distributed in Canada by:
tyco Healthcare
Pointe-Claire, QC, Canada H9R 5H8
Establishment License # 100689-A
Made in Mexico
Manufactured by:
Mallinckrodt Inc.
St. Louis, MO 63042 USA
www.Mallinckrodt.com
MID 1304685
Rev. 02/2009
tyco
Healthcare
Mallinckrodt
L A F A Y E T T E
Catalog No. 179312
O3™ ANTIMICROBIAL TECHNOLOGY
UPPER G.I. EXAMS
Rx only
355 mL
LIQUID BAROSPERSE
Barium Sulfate Suspension USP
NDC 68240-325-24
Catalog No. 179312
A vanilla flavored 60% w/v barium sulfate USP suspension for use in x-ray diagnosis of the gastrointestinal tract.
Contents: Barium sulfate USP, suspending agents, flavoring, citric acid, simethicone, potassium sorbate, saccharin sodium and water.
Contraindications: Do not use in patients with suspected gastrointestinal tract
perforation or known hypersensitivity to barium sulfate formulations.
Dosage and Administration: See package insert for complete instructions. See box below for mixing directions. Individual technique will determine the suspension quantity and barium sulfate content to be used. The following dilutions are suggested for Liquid Barosperse.
EXAMINATION | DILUTION FORMULA | % BARIUM SULFATE (w/v) |
Filled Stomach | Use undiluted or | 60% |
3 parts Liquid Barosperse to 1 part water | 45% | |
Esophageal Swallow | Use undiluted | 60% |
Enteroclysis | 3 Parts Liquid Barosperse to 1 part water | 45% |
Routine Filled Colon | 1 part Liquid Barosperse to 2 parts water | 20% |
For single patient use only. Properly discard unused portion.
Storage: Store at 25ºC (77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF). Protect from freezing. Shake well before using.
Net Contents: 355 mL (12 fl. oz.)
DIN: 02196190
Distributed in
Canada by:
tyco Healthcare
Pointe-Claire, QC
Canada H9R 5H8
Establishment
License # 100689-A
Made in Mexico
Manufactured by:
Mallinckrodt Inc.
St. Louis, MO 63042 USA
www.Mallinckrodt.com
MID 1170125
Rev. 02/2009
tyco/Healthcare
MALLINCKRODT
LIQUID BAROSPERSE barium sulfate suspension | ||||||||||||||||||||||
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Marketing Information | |||
Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
unapproved drug other | 06/01/2009 | 09/30/2012 |
Labeler - Mallinckrodt, Inc. (810407189) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Mallinckrodt Medical, S.A. de C.V. | 810407189 | analysis, manufacture |