Thursday 20 October 2011

Vitamin E Svus




Vitamin E Svus may be available in the countries listed below.


Ingredient matches for Vitamin E Svus



Tocopherol, α-

Tocopherol, α- acetate (a derivative of Tocopherol, α-) is reported as an ingredient of Vitamin E Svus in the following countries:


  • Czech Republic

International Drug Name Search

Monday 17 October 2011

Acetylcysteine Teva




Acetylcysteine Teva may be available in the countries listed below.


Ingredient matches for Acetylcysteine Teva



Acetylcysteine

Acetylcysteine is reported as an ingredient of Acetylcysteine Teva in the following countries:


  • Belgium

International Drug Name Search

Ondansetron Martian




Ondansetron Martian may be available in the countries listed below.


Ingredient matches for Ondansetron Martian



Ondansetron

Ondansetron hydrochloride (a derivative of Ondansetron) is reported as an ingredient of Ondansetron Martian in the following countries:


  • Argentina

International Drug Name Search

Sunday 9 October 2011

bumetanide Injection



bue-MET-a-nide


Injection route(Solution)

Bumetanide is a potent diuretic which, if given in excessive amounts, can lead to a profound diuresis with water and electrolyte depletion. Therefore, careful medical supervision is required, and dose and dosage schedule have to be adjusted to the individual patient's needs .



Commonly used brand name(s)

In the U.S.


  • Bumex

Available Dosage Forms:


  • Solution

Therapeutic Class: Cardiovascular Agent


Pharmacologic Class: Diuretic, Loop


Uses For bumetanide


Bumetanide belongs to a group of medicines called loop diuretics or "water pills." Bumetanide is given to help treat fluid retention (edema) and swelling that is caused by congestive heart failure, liver disease, kidney disease, or other medical conditions. It works by acting on the kidneys to increase the flow of urine .


bumetanide is available only with your doctor's prescription .


Before Using bumetanide


In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For bumetanide, the following should be considered:


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to bumetanide 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.


Pediatric


Appropriate studies have not been performed on the relationship of age to the effects of bumetanide injection in the pediatric population. Safety and efficacy have not been established .


Geriatric


Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of bumetanide injection in the elderly. However, elderly patients are more likely to have age-related liver, kidney or heart problems, which may require an adjustment of dosage in patients receiving bumetanide injection .


Pregnancy








Pregnancy CategoryExplanation
All TrimestersCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding


There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.


Interactions with Medicines


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 bumetanide, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.


Using bumetanide 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.


  • Arsenic Trioxide

  • Bepridil

  • Digitoxin

  • Dofetilide

  • Droperidol

  • Ketanserin

  • Levomethadyl

  • Lithium

  • Metolazone

  • Sotalol

Using bumetanide with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.


  • Alacepril

  • Apazone

  • Aspirin

  • Benazepril

  • Bromfenac

  • Captopril

  • Celecoxib

  • Cilazapril

  • Delapril

  • Dibekacin

  • Diclofenac

  • Diflunisal

  • Enalaprilat

  • Enalapril Maleate

  • Etodolac

  • Fenoprofen

  • Flurbiprofen

  • Fosinopril

  • Germanium

  • Ginseng

  • Gossypol

  • Ibuprofen

  • Ibuprofen Lysine

  • Imidapril

  • Indomethacin

  • Kanamycin

  • Ketoprofen

  • Ketorolac

  • Licorice

  • Lisinopril

  • Magnesium Salicylate

  • Meclofenamate

  • Mefenamic Acid

  • Meloxicam

  • Moexipril

  • Nabumetone

  • Naproxen

  • Neomycin

  • Nepafenac

  • Oxaprozin

  • Pentopril

  • Perindopril

  • Piroxicam

  • Quinapril

  • Ramipril

  • Salicylic Acid

  • Salsalate

  • Spirapril

  • Streptomycin

  • Sulindac

  • Temocapril

  • Tolmetin

  • Trandolapril

  • Zofenopril

Interactions with Food/Tobacco/Alcohol


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.


Other Medical Problems


The presence of other medical problems may affect the use of bumetanide. Make sure you tell your doctor if you have any other medical problems, especially:


  • Anuria (not able to form urine) or

  • Liver disease, severe (e.g., hepatic coma)—Should not use in patients with these conditions .

  • Dehydration or

  • Gout or

  • Hearing problems or

  • Hyperuricemia (high uric acid in the blood) or

  • Hypocalcemia (low calcium in the blood) or

  • Hypokalemia (low potassium in the blood) or

  • Hypomagnesemia (low magnesium in the blood) or

  • Hypovolemia (low blood volume) or

  • Thrombocytopenia (low platelets in the blood)—Use with caution. bumetanide may make these conditions worse .

  • Diabetes—bumetanide may increase the amount of sugar in the blood .

  • Kidney disease, severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body .

Proper Use of bumetanide


A nurse or other trained health professional will give you bumetanide. bumetanide is given through a needle placed into one of your veins .


Precautions While Using bumetanide


Your doctor will only give you a few doses of bumetanide until your condition improves, and then you will be switched to another medicine that works the same way. If you have any concerns about this, talk to your doctor .


bumetanide Side Effects


Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.


Check with your doctor or nurse immediately if any of the following side effects occur:


More common
  • Abdominal pain

  • blurred vision

  • confusion

  • decreased urine output

  • dizziness

  • drowsiness

  • dry mouth

  • fast or irregular heartbeat

  • flushed, dry skin

  • fruit-like breath odor

  • headache

  • increased hunger

  • increased thirst

  • increased urination

  • irritability

  • joint pain, stiffness, or swelling

  • loss of appetite

  • loss of mental alertness

  • lower back, side, or stomach pain

  • mood or mental changes

  • muscle pain or cramps

  • nausea or vomiting

  • numbness or tingling in the hands, feet, or lips

  • shortness of breath

  • sweating

  • swelling of face, hands, feet, ankles, or lower legs

  • troubled breathing

  • unexplained weight loss

  • unusual tiredness or weakness

  • weak pulse

Rare
  • Agitation

  • back pain

  • black, tarry stools

  • bleeding gums

  • blood in the urine or stools

  • chest pain

  • convulsions (seizures)

  • deep or fast breathing with dizziness

  • dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly

  • fever

  • hallucinations

  • hives

  • increase in heart rate

  • increased blood pressure

  • numbness of feet, hands, and around the mouth

  • pinpoint red spots on the skin

  • rapid breathing

  • stiff neck

  • sunken eyes

  • trembling, jerking of hands

  • unusual bleeding or bruising

  • weight gain

  • wrinkled skin

Get emergency help immediately if any of the following symptoms of overdose occur:


Symptoms of overdose
  • Difficulty breathing

  • pain in chest, groin, or legs, especially the calves

  • severe, sudden headache

  • slurred speech

  • sudden loss of coordination

  • sudden, severe weakness or numbness in the arm or leg

  • sudden, unexplained shortness of breath

  • tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over affected area

  • unusual drowsiness, dullness, or feeling of sluggishness

  • vision changes

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:


Rare
  • Decreased interest in sexual intercourse

  • diarrhea

  • difficulty with moving

  • ear discomfort

  • feeling of constant movement of self or surroundings

  • inability to have or keep an erection

  • itching skin

  • loss in sexual ability, desire, drive, or performance

  • muscle or bone pain

  • muscle stiffness

  • nipple tenderness

  • pain, swelling, or redness in joints

  • rash

  • sensation of spinning

  • shorter than usual time to ejaculation of semen

  • trouble with hearing

  • upset stomach

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: bumetanide 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.


More bumetanide Injection resources


  • Bumetanide Injection Side Effects (in more detail)
  • Bumetanide Injection Use in Pregnancy & Breastfeeding
  • Drug Images
  • Bumetanide Injection Drug Interactions
  • Bumetanide Injection Support Group
  • 1 Review for Bumetanide Injection - Add your own review/rating


Compare bumetanide Injection with other medications


  • Ascites
  • Edema
  • Pulmonary Edema

Saturday 8 October 2011

Onfi


Pronunciation: KLOE-ba-zam
Generic Name: Clobazam
Brand Name: Onfi


Onfi is used for:

Treating a certain type of seizure disorder (Lennox-Gastaut syndrome [LGS]). It is used along with other medicines. It may also be used for other conditions as determined by your doctor.


Onfi is a benzodiazepine. Exactly how it works is not understood, but it is thought to involve the action of a certain chemical (gamma-aminobutyric acid [GABA]) in the brain and nervous system.


Do NOT use Onfi if:


  • you are allergic to any ingredient in Onfi

  • you are taking sodium oxybate (GHB)

Contact your doctor or health care provider right away if any of these apply to you.



Before using Onfi:


Some medical conditions may interact with Onfi. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:


  • if you are pregnant, planning to become pregnant, or are breast-feeding

  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

  • if you have allergies to medicines, foods, or other substances

  • if you have glaucoma or increased pressure in the eye, liver or kidney problems, myasthenia gravis, or the blood disorder porphyria

  • if you have a history of lung or breathing problems (eg, chronic obstructive pulmonary disease [COPD]), mood or mental problems (eg, depression), or suicidal thoughts or actions

  • if you have a history of alcohol or other substance abuse or dependence

Some MEDICINES MAY INTERACT with Onfi. Tell your health care provider if you are taking any other medicines, especially any of the following:


  • Clozapine, methadone, or sodium oxybate (GHB) because side effects, such as increased drowsiness, slow or shallow breathing, and confusion, may occur

  • Cimetidine, fluconazole, fluvoxamine, omeprazole, or ticlopidine because they may increase the risk of Onfi's side effects

  • Carbamazepine because it may decrease Onfi's effectiveness

  • Hydantoins (eg, phenytoin) because the risk of their side effects may be increased by Onfi

  • Hormonal birth control (eg, birth control pills) or tamoxifen because their effectiveness may be decreased by Onfi

This may not be a complete list of all interactions that may occur. Ask your health care provider if Onfi 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.


How to use Onfi:


Use Onfi as directed by your doctor. Check the label on the medicine for exact dosing instructions.


  • Onfi comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Onfi refilled.

  • Take Onfi by mouth with or without food.

  • Swallow Onfi whole. If you cannot swallow the tablet whole, you may crush it and mix it in applesauce. Swallow the mixture right away after mixing with the applesauce, followed by a glass of water. Do not store the mixture for future use.

  • If you miss a dose of Onfi, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Onfi.



Important safety information:


  • Onfi may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Onfi with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

  • Check with your doctor before you drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Onfi; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.

  • Do NOT change your dose or use more often than prescribed without checking with your doctor.

  • Do not suddenly stop taking Onfi without first talking with your doctor, especially if you have been taking Onfi regularly over a long period of time. You may have an increased risk of seizures or side effects (eg, mood changes, trouble sleeping). If you need to stop Onfi, your doctor may need to gradually lower your dose.

  • Carry an ID card at all times that says you have a seizure disorder and you take Onfi.

  • Patients who take Onfi may be at increased risk of suicidal thoughts or actions. The risk may be greater in patients who have had suicidal thoughts or actions in the past. Watch patients who take Onfi closely. Contact your doctor at once if new, worsened, or sudden symptoms, such as depressed mood; anxious, restless, or irritable behavior; panic attacks; or any unusual change in mood or behavior, occur. Contact your doctor right away if any signs of suicidal thoughts or actions occur.

  • Hormonal birth control (eg, birth control pills) may not work as well while you are using Onfi and for 28 days after you stop taking it. To prevent pregnancy, use an extra non-hormonal form of birth control (eg, condoms). Talk with your doctor or pharmacist about effective birth control.

  • Tell your doctor or dentist that you take Onfi before you receive any medical or dental care, emergency care, or surgery.

  • Use Onfi with caution in the ELDERLY; they may be more sensitive to its effects.

  • Onfi should be used with extreme caution in CHILDREN younger than 2 years old; safety and effectiveness in these children have not been confirmed.

  • PREGNANCY and BREAST-FEEDING: Onfi may cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Onfi while you are pregnant. Using Onfi late in pregnancy may increase the risk of breathing or feeding problems, very low body temperature, or withdrawal symptoms in the newborn. Onfi is found in breast milk. Do not breast-feed while using Onfi.

Some people who use Onfi for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction. If you stop taking Onfi suddenly, you may have WITHDRAWAL symptoms. These may include diarrhea, dry heaving, hallucinations, headache, irregular heartbeat, mental or mood problems (eg, anxiety, irritability, nervousness, panic attacks, restlessness), muscle pain and stiffness, nausea, seizures, stomach and muscle cramps, sweating, trouble concentrating or sleeping, tremor, weight loss, or vision changes (eg, blurred vision, sensitivity to light). Do not suddenly stop taking Onfi without first checking with your doctor.



Possible side effects of Onfi:


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:



Constipation; drooling; drowsiness; sluggishness; tiredness; vomiting.



Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); appetite changes; confusion; decreased coordination; difficult or painful urination; difficulty breathing; fever, chills, or persistent cough or sore throat; hallucinations; new or worsening mental or mood changes (eg, agitation, aggressiveness, behavior changes, depression, irritability, rage, restlessness); red, swollen, blistered, or peeling skin; shortness of breath; speech problems; suicidal thoughts or actions; trouble sleeping; trouble swallowing; unusual bruising or bleeding; unusual tiredness or weakness; vision changes (eg, blurred vision, double vision).



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: Onfi side effects (in more detail)


If OVERDOSE is suspected:


Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include coma; confusion; decreased coordination; fainting; severe drowsiness, dizziness, or light-headedness; slow or shallow breathing; sluggishness.


Proper storage of Onfi:

Store Onfi at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Onfi out of the reach of children and away from pets.


General information:


  • If you have any questions about Onfi, please talk with your doctor, pharmacist, or other health care provider.

  • Onfi is to be used only by the patient for whom it is prescribed. Do not share it with other people.

  • If your symptoms do not improve or if they become worse, check with your doctor.

  • Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Onfi. 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.



Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Onfi resources


  • Onfi Side Effects (in more detail)
  • Onfi Use in Pregnancy & Breastfeeding
  • Onfi Drug Interactions
  • Onfi Support Group
  • 0 Reviews for Onfi - Add your own review/rating


  • Onfi Consumer Overview

  • Onfi Advanced Consumer (Micromedex) - Includes Dosage Information

  • Clobazam Professional Patient Advice (Wolters Kluwer)



Compare Onfi with other medications


  • Lennox-Gastaut Syndrome

Thursday 6 October 2011

Baypress




Baypress may be available in the countries listed below.


Ingredient matches for Baypress



Nitrendipine

Nitrendipine is reported as an ingredient of Baypress in the following countries:


  • Austria

  • Belgium

  • Colombia

  • Czech Republic

  • Denmark

  • France

  • Greece

  • Hong Kong

  • Hungary

  • Italy

  • Luxembourg

  • Netherlands

  • Poland

  • Switzerland

  • Thailand

  • Turkey

International Drug Name Search

Tuesday 4 October 2011

Reno-Dip





Dosage Form: Injection


NOT FOR INTRATHECAL USE




Reno-Dip Description


Reno-Dip (Diatrizoate Meglumine Injection USP 30%) is a radiopaque contrast agent supplied as a sterile, aqueous solution for intravenous use, in 300 mL bottles. Each mL provides 300 mg diatrizoate meglumine; at manufacture, 0.4 mg edetate disodium sequestering agent is added per mL. The pH has been adjusted between 6.0 and 7.7 with meglumine and diatrizoic acid. Each mL of solution also contains approximately 0.049 mg (0.002 mEq) sodium and 141 mg organically bound iodine.



Reno-Dip - Clinical Pharmacology


Following intravenous administration, diatrizoate meglumine is rapidly transported through the blood-stream to the kidneys and is excreted unchanged in the urine by glomerular filtration. When urinary tract obstruction is severe enough to block glomerular filtration, the agent appears to be excreted by the tubular epithelium.


Diuresis commonly occurs, due primarily to the osmotic effects of the contrast agent.



Drip Infusion Pyelography


When a large volume of the contrast agent is administered in dilute form by intravenous drip infusion, the nephrographic phase of renal excretion is enhanced, and a dense, sustained nephrogram is usually obtained.


Following drip infusion of the contrast agent, the upper and lower urinary tract is opacified. Anatomically complete pyelograms and voiding cystograms may be obtained, and the entire course of the ureter may be seen in a single film. Filling defects may be visualized and the site of an obstruction may be clearly localized.


Renal accumulation is sufficiently rapid that optimal opacification of the kidney normally is reached by the time the infusion is completed, while filling of the collecting system is maximal within 20 or 30 minutes after the start of the infusion. Impairment of renal function commonly delays accumulation and excretion of the contrast agent, so that opacification may be delayed until three or more hours after the infusion; with severe impairment adequate opacification may not occur.


Because transport of the contrast agent is slowed by renal dysfunction, the ischemic kidney of renal vascular hypertension may be distinguished from the normal kidney. Renal ischemia produces a nephrogram which is slower to appear, less dense, and sustained for a markedly prolonged period of time.



Computed Tomography


Reno-Dip enhances computed tomographic brain scanning through augmentation of radiographic efficiency. The degree of enhancement of visualization of tissue density is directly related to the iodine content in an administered dose; peak iodine blood levels occur immediately following rapid infusion of the dose. These levels fall rapidly within five to ten minutes. This can be accounted for by the dilution in the vascular and extracellular fluid compartments which causes an initial sharp fall in plasma concentration. Equilibration with the extracellular compartments is reached in about ten minutes; thereafter, the fall becomes exponential. Maximum contrast enhancement frequently occurs after peak blood iodine levels are reached. The delay in maximum contrast enhancement can range from five to forty minutes, depending on the peak iodine levels achieved and the cell type of the lesion. This lag suggests that radiographic contrast enhancement is at least in part dependent on the accumulation of iodine within the lesion and outside the blood pool, although the mechanism by which this occurs is not clear. The radiographic enhancement of nontumoral lesions, such as arteriovenous malformations and aneurysms is probably dependent on the iodine content of the circulating blood pool.


In brain scanning, Reno-Dip (Diatrizoate Meglumine Injection USP 30%) does not accumulate in normal brain tissue due to the presence of the “blood-brain” barrier. The increase in X-ray absorption in normal brain is due to the presence of contrast agent within the blood pool. A break in the blood-brain barrier such as occurs in malignant tumors of the brain allows the accumulation of the contrast medium within the interstitial tumor tissue. Adjacent normal brain tissue does not contain the contrast medium.


In nonneural tissues (during computed tomography of the body), diatrizoate diffuses rapidly from the vascular into the extravascular space. Increase in X-ray absorption is related to blood flow, concentration of the contrast medium, and extraction of the contrast medium by interstitial tumor tissue since no barrier exists. Contrast enhancement is thus due to the relative differences in extravascular diffusion between normal and abnormal tissue, quite different from that in the brain.


The pharmacokinetics of diatrizoate in both normal and abnormal tissue have been shown to be variable. Contrast enhancement appears to be greatest soon after administration of the contrast medium, and following intra-arterial rather than intravenous administration. Thus, greatest enhancement can be detected by a series of consecutive two- to three-second scans performed just after injection (within 30 to 90 seconds), i.e., dynamic computed tomographic scanning.



Lower Extremity Venography


Following intravenous injection of Reno-Dip (Diatrizoate Meglumine Injection USP 30%) into a suitable plantar vein, the agent opacifies those vessels into which it is distributed, permitting visualization of deep and superficial veins in the lower extremities until hemodilution occurs.



Indications and Usage for Reno-Dip



Drip Infusion Pyelography


Reno-Dip is indicated for use in those patients in whom routine pyelography would not be expected to be, or has not been, satisfactory for diagnosis. It is not intended to replace retrograde pyelography where this procedure is indicated.



Computed Tomography


Reno-Dip (Diatrizoate Meglumine Injection USP 30%) is also indicated for radiographic contrast enhancement in computed tomography (CT) of the brain and body. Contrast enhancement may be advantageous in delineating or ruling out disease in suspicious areas which may otherwise not have been satisfactorily visualized.


Brain Tumors

Reno-Dip may be useful to demonstrate the presence and extent of certain malignancies such as: gliomas including malignant gliomas, glioblastomas, astrocytomas, oligodendrogliomas and gangliomas; ependymomas; medulloblastomas; meningiomas; neuromas; pinealomas; pituitary adenomas; craniopharyngiomas; germinomas; and metastatic lesions.


The usefulness of contrast enhancement for the investigation of the retrobulbar space and in cases of low grade or infiltrative glioma has not been demonstrated. In cases where lesions have calcified, there is less likelihood of enhancement. Following therapy, tumors may show decreased or no enhancement.


Non-Neoplastic Conditions of The Brain

The use of Reno-Dip may be beneficial in the enhancement of images of lesions not due to neoplasms. Cerebral infarctions of recent onset may be better visualized with the contrast enhancement, while some infarctions are obscured if a contrast medium is used. The use of Reno-Dip (Diatrizoate Meglumine Injection USP 30%) improved the contrast enhancement in approximately 60 percent of cerebral infarctions studied from one week to four weeks from the onset of symptoms.


Sites of active infection also will produce contrast enhancement following contrast medium administration.


Arteriovenous malformations and aneurysms will show contrast enhancement. In the case of these vascular lesions, the enhancement is probably dependent on the iodine content of the circulating blood pool.


Hematomas and intraparenchymal bleeders seldom demonstrate any contrast enhancement. However, in cases of intraparenchymal clot, for which there is no obvious clinical explanation, contrast medium administration may be helpful in ruling out the possibility of associated arteriovenous malformation.


The opacification of the inferior vermis following contrast medium administration has resulted in false-positive diagnoses in a number of normal studies.


Body Scanning

Reno-Dip may be used for enhancement of computed tomographic scans performed for detection and evaluation of lesions in the liver, pancreas, kidneys, aorta, mediastinum, abdominal cavity, pelvis and retroperitoneal space.


Enhancement of computed tomography with Reno-Dip may be of benefit in establishing diagnoses of certain lesions in these sites with greater assurance than is possible with CT alone, and in supplying additional features of the lesions (e.g., hepatic abscess delineation prior to percutaneous drainage). In other cases, the contrast agent may allow visualization of lesions not seen with CT alone (e.g., tumor extension), or may help to define suspicious lesions seen with unenhanced CT (e.g., pancreatic cyst).


Contrast enhancement appears to be greatest within 60-90 seconds after bolus administration of the contrast agent. Therefore, utilization of a continuous scanning technique (“dynamic CT scanning”) may improve enhancement and diagnostic assessment of tumor and other lesions such as an abscess, occasionally revealing unsuspected or more extensive disease. For example, a cyst may be distinguished from a vascularized solid lesion when pre-contrast and enhanced scans are compared; the non-perfused mass shows unchanged X-ray absorption (CT number). A vascularized lesion is characterized by an increase in CT number in the few minutes after a bolus of intravascular contrast agent; it may be malignant, benign or normal tissue, but would probably not be a cyst, hematoma, or other nonvascular lesion.


Because unenhanced scanning may provide adequate diagnostic information in the individual patient, the decision to employ contrast enhancement, which may be associated with risk and increased radiation exposure, should be based upon a careful evaluation of clinical, other radiological, and unenhanced CT findings.



Lower Extremity Venography


Reno-Dip (Diatrizoate Meglumine Injection USP 30%) is also indicated for lower extremity venography.



Contraindications


Reno-Dip is contraindicated for use in intrathecal procedures.


This preparation is contraindicated in patients with a hypersensitivity to salts of diatrizoic acid.


The administration of diatrizoate meglumine is contraindicated in patients with anuria.



Warnings



Severe Adverse Events — Inadvertent Intrathecal Administration


Serious adverse reactions have been reported due to the inadvertent intrathecal administration of iodinated contrast media that are not indicated for intrathecal use. These serious adverse reactions include: death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema. Special attention must be given to insure that this drug product is not inadvertently administered intrathecally.


The possibility exists for inadvertent administration into the intrathecal space during epidural administrations. Therefore, epidural administration procedures, such as pain management catheter placement, should not be performed with use of this product.



General


A definite risk exists in the use of intravascular contrast agents in patients who are known to have multiple myeloma. In such instances there has been anuria resulting in progressive uremia, renal failure and eventually death. Although neither the contrast agent nor dehydration has separately proved to be the cause of anuria in myeloma, it has been speculated that the combination of both may be the causative factor. The risk in myelomatous patients is not a contraindication to the procedures; however, partial dehydration in the preparation of these patients for the examination is not recommended since this may predispose to the precipitation of myeloma protein in the renal tubules. No form of therapy, including dialysis, has been successful in reversing this effect. Myeloma, which occurs most commonly in persons over age 40, should be considered before intravascular administration of a contrast agent.


Administration of radiopaque materials to patients known or suspected to have pheochromocytoma should be performed with extreme caution. If, in the opinion of the physician, the possible benefits of such procedures outweigh the considered risks, the procedures may be performed; however, the amount of radiopaque medium injected should be kept to an absolute minimum. The blood pressure should be assessed throughout the procedure and measures for treatment of a hypertensive crisis should be available.


Contrast media have been shown to promote the phenomenon of sickling in individuals who are homozygous for sickle cell disease when the material is injected intravenously or intra-arterially.


Diatrizoate meglumine should be used with extreme caution in patients with severe concomitant hepatic and renal disease, and those with severe hypertension or congestive heart failure.


Since iodine-containing contrast agents may alter the results of thyroid function tests dependent on iodine estimation, such tests, if indicated, should be performed prior to the administration of this preparation.


A history of sensitivity to iodine per se or to other contrast media is not an absolute contraindication to the use of diatrizoate meglumine, but calls for extreme caution in administration.


In patients with subarachnoid hemorrhage, a rare association between contrast administration and clinical deterioration, including convulsions and death, has been reported; therefore, administration of intravascular iodinated ionic contrast media in these patients should be undertaken with caution.



Precautions


Diagnostic procedures which involve the use of radiopaque contrast agents should be carried out under the direction of personnel with the prerequisite training and with a thorough knowledge of the particular procedure to be performed (see ADVERSE REACTIONS).


Severe, life-threatening reactions suggest hypersensitivity to the radiopaque agent, which has prompted the use of several pretesting methods, none of which can be relied upon to predict severe reactions. Many authorities question the value of any pretest. A history of bronchial asthma or allergy, a family history of allergy, or a previous reaction to a contrast agent warrant special attention. Such a history, by suggesting histamine sensitivity and a consequent proneness to reactions, may be more accurate than pretesting in predicting the likelihood of a reaction, although not necessarily the severity or type of reaction in the individual case.


The sensitivity test most often performed is the slow injection of 0.5 to 1 mL of the radiopaque medium, administered intravenously, prior to injection of the full diagnostic dose. It should be noted that the absence of a reaction to the test dose does not preclude the possibility of a reaction to the full diagnostic dose. If the test dose causes an untoward response of any kind, the necessity for continuing with the examination should be carefully reevaluated and, if it is deemed essential, the examination should be conducted with all possible caution. In rare instances reactions to the test dose itself may be extremely severe; therefore, close observation of the patient, and facilities for emergency treatment appear indicated.


The recommended rate of infusion should not be exceeded.


Renal toxicity has been reported in a few patients with liver dysfunction who were given oral cholecystographic agents followed by urographic agents. Diagnostic infusion studies should therefore be postponed in any patient with a known or suspected hepatic or biliary disorder who has recently taken a cholecystographic contrast agent.


The diuretic effect of the drip infusion procedure may hinder an assessment of residual urine in the bladder.


Consideration must be given to the functional ability of the kidneys before injecting diatrizoate meglumine. Adequate visualization may be difficult or impossible to attain in uremic patients or others with severely impaired renal function.


Acute renal failure has been reported with the use of contrast agents in patients with diabetic nephropathy and susceptible nondiabetic patients (often elderly with preexisting renal disease).


Contrast agents may interfere with some chemical determinations made on urine specimens; therefore, urine should be collected before administration of the contrast media or two or more days afterwards.


Caution should be exercised during lower extremity venography when thrombosis, phlebitis, total venous system obstruction, severe ischemia, or local infection is suspected. Extreme caution during injection of the agent is needed to avoid extravasation and fluoroscopy is recommended, particularly in patients with severe arterial or venous disease.



Usage In Pregnancy


The safety of diatrizoate meglumine for use during pregnancy has not been established; therefore, it should be used in pregnant patients only when, in the judgement of the physician, its use is deemed essential to the welfare of the patient.



Adverse Reactions


Adverse reactions accompanying the use of iodine-containing intravascular contrast agents are usually mild and transient although severe and life-threatening reactions, including fatalities, have occurred. Because of the possibility of severe reactions to the procedure and/or the radiopaque medium, appropriate emergency facilities and well-trained personnel should be available to treat both conditions. Emergency facilities and personnel should remain available for 30 to 60 minutes following the procedure since severe delayed reactions have been known to occur.


Nausea, vomiting, flushing, or a generalized feeling of warmth are the reactions most frequently encountered with intravenous administration of contrast agents. Such symptoms as chills, fever, sweating, headache, dizziness, pallor, weakness, severe retching and choking, wheezing, a rise or fall in blood pressure, ventricular fibrillation, cardiac arrest, facial or conjunctival petechiae, urticaria,pruritus, rash, and other eruptions, edema, cramps, tremors, itching, sneezing, lacrimation, etc., may occur. Antihistaminic agents may be of benefit; rarely such reactions may be severe enough to require discontinuation of dosage. Pulmonary edema, spasm, seizures, hemiparesis, syncope, and impairment of vision have also occurred. Neutropenia may also occur.


Severe reactions which may require emergency measures may take the form of a cardiovascular reaction characterized by peripheral vasodilatation with resultant hypotension and reflex tachycardia, apnea, dyspnea, agitation, and confusion and cyanosis progressing to unconsciousness. Or, the histamine-liberating effect of these compounds may induce an allergic-like reaction which may range in severity from rhinitis or angioneurotic edema to laryngeal or bronchial spasm or anaphylactoid shock.


Temporary renal shutdown or other nephropathy may occur.


Although local tissue tolerance to diatrizoate meglumine is usually good, intravenous injection of the medium in a more concentrated formulation has produced a few instances of a burning or stingingsensation or numbness and of venospasm or venous pain, and partial collapse of the injected vein.


Although not reported as resulting following lower extremity venography with diatrizoate meglumine, conditions such as thrombophlebitis, and the rare possibility of gangrene, should be considered as potential adverse reactions.



Reno-Dip Dosage and Administration


Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.


Reno-Dip (Diatrizoate Meglumine Injection USP 30%) should be at body temperature when administered and may need to be warmed before use.



Drip Infusion Pyelography


While preparation of the patient is not essential for drip infusion pyelography, it is advocated by some investigators. If desired, adults and older children may be given a laxative the night before the examination and a low residue diet the day before, to clear the gastrointestinal tract. Clinicians who feel that partial dehydration enhances radiographic contrast recommend a low liquid intake for 12 hours prior to the procedure; however, adequate hydration has improved the quality of films for other investigators. Preparatory partial dehydration is not recommended in infants, young children, the elderly, or azotemic patients (especially those with polyuria, oliguria, diabetes, advanced vascular disease, or preexisting dehydration). The undesirable dehydration in these patients may be accentuated by the osmotic diuretic action of the medium.


In uremic patients partial dehydration is not necessary and maintenance of adequate fluid intake is particularly desirable.


Cleansing enemas are not recommended, since they may increase residual gas in the bowel.


The recommended dose is 2 mL per pound of body weight. The preparation is given by continuous intravenous infusion, over a period of 8 minutes or longer (see PRECAUTIONS), through a needle with a large bore, usually a 17- or 18-gauge needle. In older patients and in patients with known or suspected cardiac decompensation, a slower rate of infusion is probably wise.


If nausea or flushing occurs during administration, the infusion should be slowed or briefly interrupted.


Films are taken before the onset of the infusion and at the desired intervals following its completion. When renal function is normal, a nephrogram may be taken as soon as the infusion is completed, and films of the collecting system at 10 and 20 minutes thereafter. Voiding cystourethrograms are usually optimal at 20 minutes after the infusion is completed. In hypertensive patients, early minute sequence films may be taken during the course of infusion, in addition to subsequent pyelograms. In patients with renal dysfunction, optimal visualization is usually delayed, and the late films are taken as indicated.


The nephrogram obtained by the drip infusion procedure may be dense enough to obscure the pelvocalyceal system in some cases. The presence of gas in the bowel may hamper early visualization of the renal collecting system. Tomographic “cuts” may help to overcome such difficulties.


Nephrotomography may begin when the infusion is completed. The sustained contrast achieved by the drip infusion technique eliminates the need for precise timing and teamwork that is necessary with ordinary nephrotomography. Thus, if nephrograms taken after infusion of the medium suggest the need for sectional films, or if preselected tomographic“cuts” are not sufficient, additional tomograms may be obtained at once, and without repetition of dosage.



Computed Tomography


Brain Scanning

The suggested dose is 2 mL per pound of body weight by intravenous drip over a period of eight minutes or longer; scanning may be performed during administration and/or immediately afterwards.


Body Scanning

The usual adult dose is 300 mL administered by intravenous infusion over a period of approximately 20 minutes; 150 mL may be infused immediately prior to scanning, and the balance during scanning. Scanning may also be performed immediately following completion of infusion of the entire dose.


Gastrografin® (Diatrizoate Meglumine and Diatrizoate Sodium Solution USP), an oral radiopaque contrast agent, may be useful as an adjunct to the procedure.


Patient Preparation

No special patient preparation is required for contrast enhancement of CT brain scanning or body scanning. However, it is advisable to insure that patients are well hydrated prior to examination.



Lower Extremity Venography


Appropriate premedication, which may include an analgesic, a barbiturate, or a tranquilizer may be administered prior to the examination.


Prior to the administration of the contrast agent, patients should be well hydrated and a preliminary radiograph taken. The patient should be placed on a tilt table, semi-erect (30° to 60°).


The usual dose per intravenous injection may range from 50 to 100 mL; the usual total dose per extremity ranges from 100 to 300 mL. The dose for children should be reduced in proportion to body weight. The dose may be given as a bolus injection or by steady drip infusion. Radiographs are taken at the start of injection/infusion and periodically thereafter at the discretion of the radiologist.


Following the procedure, the contrast agent may be removed from the venous system by flushing with either Dextrose Injection USP 5% or Sodium Chloride Injection USP 0.9%, or by leg massage and/or leg elevation.



How is Reno-Dip Supplied


Reno-Dip (Diatrizoate Meglumine Injection USP 30%) is available in packages of 10 single dose 300 mL bottles (NDC 0270-0809-75). An excess volume (1 mL) is available in each container for sensitivity testing.



Storage


The preparation should be protected from strong light and stored at 20-25°C (68-77°F) [See USP].



Manufactured for

Bracco Diagnostics Inc.

Princeton, NJ 08543

by SICOR Pharmaceuticals, Inc.

Irvine, CA 92618


Printed in USA

Rev September 2003








Reno-Dip 
diatrizoate meglumine  injection, solution










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)0270-0809
Route of AdministrationINTRAVENOUSDEA Schedule    











INGREDIENTS
Name (Active Moiety)TypeStrength
diatrizoate meglumine (diatrizoic acid)Active300 MILLIGRAM  In 1 MILLILITER
edetate disodiumInactive0.4 MILLIGRAM  In 1 MILLILITER


















Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains      














Packaging
#NDCPackage DescriptionMultilevel Packaging
10270-0809-7510 BOTTLE In 1 PACKAGEcontains a BOTTLE
1300 mL (MILLILITER) In 1 BOTTLEThis package is contained within the PACKAGE (0270-0809-75)

Revised: 12/2006Bracco Diagnostics Inc.

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