Non-drowsy Sinutab may be available in the countries listed below.
Paracetamol is reported as an ingredient of Non-drowsy Sinutab in the following countries:
Pseudoephedrine hydrochloride (a derivative of Pseudoephedrine) is reported as an ingredient of Non-drowsy Sinutab in the following countries:
International Drug Name Search
Pelox may be available in the countries listed below.
Pefloxacin is reported as an ingredient of Pelox in the following countries:
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Bicalutamid AbZ may be available in the countries listed below.
Bicalutamide is reported as an ingredient of Bicalutamid AbZ in the following countries:
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Cisplatine Ebewe may be available in the countries listed below.
Cisplatin is reported as an ingredient of Cisplatine Ebewe in the following countries:
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Persantin Depot may be available in the countries listed below.
Dipyridamole is reported as an ingredient of Persantin Depot in the following countries:
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Biogelat Vitamin E may be available in the countries listed below.
Tocopherol, α- acetate (a derivative of Tocopherol, α-) is reported as an ingredient of Biogelat Vitamin E in the following countries:
International Drug Name Search
Lorazepam Medical may be available in the countries listed below.
Lorazepam is reported as an ingredient of Lorazepam Medical in the following countries:
International Drug Name Search
Dysect may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Cypermethrin is reported as an ingredient of Dysect in the following countries:
International Drug Name Search
In the US, Allermax (diphenhydramine systemic) is a member of the following drug classes: anticholinergic antiemetics, anticholinergic antiparkinson agents, antihistamines, miscellaneous anxiolytics, sedatives and hypnotics and is used to treat Allergic Reactions, Cold Symptoms, Cough, Extrapyramidal Reaction, Hay Fever, Insomnia, Motion Sickness, Nausea/Vomiting, Pruritus and Urticaria.
US matches:
Diphenhydramine hydrochloride (a derivative of Diphenhydramine) is reported as an ingredient of Allermax in the following countries:
International Drug Name Search
In the US, Proloprim (trimethoprim systemic) is a member of the drug class urinary anti-infectives and is used to treat Bladder Infection, Otitis Media, Pneumocystis Pneumonia and Prevention of Bladder infection.
US matches:
Trimethoprim is reported as an ingredient of Proloprim in the following countries:
International Drug Name Search
Micro-Kalium may be available in the countries listed below.
Potassium Chloride is reported as an ingredient of Micro-Kalium in the following countries:
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Lidocaina Apolo may be available in the countries listed below.
Lidocaine hydrochloride (a derivative of Lidocaine) is reported as an ingredient of Lidocaina Apolo in the following countries:
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Athenentol may be available in the countries listed below.
Anetholtrithion is reported as an ingredient of Athenentol in the following countries:
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Cardace Comp may be available in the countries listed below.
Hydrochlorothiazide is reported as an ingredient of Cardace Comp in the following countries:
Ramipril is reported as an ingredient of Cardace Comp in the following countries:
International Drug Name Search
Generic Name: methotrexate (Oral route, Injection route)
meth-oh-TREX-ate
Only for life-threatening neoplastic disease or severe rheumatoid arthritis and psoriasis unresponsive to other therapies. Death, fetal death and/or congenital anomalies, lung disease, tumor lysis syndrome, fatal skin reactions, and Pneumocystis carinii pneumonia have been reported. Monitor for bone marrow, liver, lung, and kidney toxicities. Unexpectedly severe (sometimes fatal) bone marrow suppression, aplastic anemia, and gastrointestinal toxicity have been reported with concomitant administration of methotrexate (usually in high dosage) along with some nonsteroidal anti-inflammatory drugs (NSAIDs). Hepatotoxicity, fibrosis, and cirrhosis occur with prolonged use. Diarrhea and ulcerative stomatitis require interruption of therapy. Methotrexate elimination is reduced in patients with impaired renal functions, ascites, or pleural effusions. Increased risk of soft tissue necrosis and osteosarcoma with concomitant radiotherapy. Malignant lymphoma may occur. Use extreme caution with high dose regimen for osteosarcoma. Do not use formulations/diluents with preservatives for intrathecal or high dose therapy .
Only for life-threatening neoplastic disease or severe rheumatoid arthritis and psoriasis unresponsive to other therapies. Death, fetal death and/or congenital anomalies, lung disease, tumor lysis syndrome, fatal skin reactions, and Pneumocystis carinii pneumonia have been reported. Monitor for bone marrow, liver, lung, and kidney toxicities. Unexpectedly severe (sometimes fatal) bone marrow suppression, aplastic anemia, and gastrointestinal toxicity have been reported with concomitant administration of methotrexate (usually in high dosage) along with some nonsteroidal anti-inflammatory drugs (NSAIDs). Hepatotoxicity, fibrosis, and cirrhosis occur with prolonged use. Diarrhea and ulcerative stomatitis require interruption of therapy. Methotrexate elimination is reduced in patients with impaired renal functions, ascites, or pleural effusions. Increased risk of soft tissue necrosis and osteosarcoma with concomitant radiotherapy. Malignant lymphoma may occur .
In the U.S.
Available Dosage Forms:
Therapeutic Class: Antineoplastic Agent
Pharmacologic Class: Antimetabolite
Methotrexate belongs to the group of medicines known as antimetabolites. It is used to treat cancer of the breast, head and neck, lung, blood, bone, and lymph, and tumors in the uterus. It may also be used to treat other kinds of cancer, as determined by your doctor.
Methotrexate blocks an enzyme needed by the cell to live. This interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal body cells may also be affected by methotrexate, other effects will also occur. Some of these may be serious and must be reported to your doctor. Other effects, like hair loss, may not be serious but may cause concern. Some effects may not occur for months or years after the medicine is used.
Before you begin treatment with methotrexate, you and your doctor should talk about the good this medicine will do as well as the risks of using it.
Methotrexate is available only with your doctor's prescription.
Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, methotrexate is used in certain patients with the following medical conditions:
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 this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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.
Newborns and other infants may be more sensitive to the effects of methotrexate. However, in other children it is not expected to cause different side effects or problems than it does in adults.
Side effects may be more likely to occur in the elderly, who are usually more sensitive to the effects of methotrexate.
| Pregnancy Category | Explanation | |
|---|---|---|
| All Trimesters | X | Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit. |
Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.
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 taking this medicine, 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 this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
Using this medicine 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.
Using this medicine 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.
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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
This section provides information on the proper use of a number of products that contain methotrexate. It may not be specific to Rheumatrex Dose Pack. Please read with care.
Take this medicine only as directed by your doctor. Do not take more or less of it, and do not take it more often than your doctor ordered. The exact amount of medicine you need has been carefully worked out. Taking too much may increase the chance of side effects, while taking too little may not improve your condition.
Methotrexate is often given together with certain other medicines. If you are using a combination of medicines, make sure that you take each one at the proper time and do not mix them. Ask your health care professional to help you plan a way to remember to take your medicines at the right times.
While you are using methotrexate, your doctor may want you to drink extra fluids so that you will pass more urine. This will help the drug to pass from the body, and will prevent kidney problems and keep your kidneys working well.
Methotrexate commonly causes nausea and vomiting. Even if you begin to feel ill, do not stop using this medicine without first checking with your doctor. Ask your health care professional for ways to lessen these effects.
If you vomit shortly after taking a dose of methotrexate, check with your doctor. You will be told whether to take the dose again or to wait until the next scheduled dose.
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Call your doctor or pharmacist for instructions.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.
Do not drink alcohol while using this medicine. Alcohol can increase the chance of liver problems.
Some patients who take methotrexate may become more sensitive to sunlight than they are normally. When you first begin taking methotrexate, avoid too much sun and do not use a sunlamp until you see how you react to the sun, especially if you tend to burn easily. In case of a severe burn, check with your doctor.
Do not take medicine for inflammation or pain (aspirin or other salicylates, diclofenac, diflunisal, fenoprofen, ibuprofen, indomethacin, ketoprofen, meclofenamate, mefenamic acid, naproxen, phenylbutazone, piroxicam, sulindac, suprofen, tolmetin) without first checking with your doctor. These medicines may increase the effects of methotrexate, which could be harmful.
While you are being treated with methotrexate, and after you stop treatment with it, do not have any immunizations (vaccinations) without your doctor's approval. Methotrexate may lower your body's resistance and there is a chance you might get the infection the immunization is meant to prevent. In addition, other persons living in your household should not take oral polio vaccine since there is a chance they could pass the polio virus on to you. Also, avoid other persons who have taken oral polio vaccine within the last several months. Do not get close to them, and do not stay in the same room with them for very long. If you cannot take these precautions, you should consider wearing a protective face mask that covers the nose and mouth.
Methotrexate can lower the number of white blood cells in your blood temporarily, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:
Along with their needed effects, medicines like methotrexate can sometimes cause unwanted effects such as blood problems, kidney problems, stomach or liver problems, loss of hair, and other side effects. These and others are described below. Also, because of the way these medicines act on the body, there is a chance that they might cause other unwanted effects that may not occur until months or years after the medicine is used. These delayed effects may include certain types of cancer, such as leukemia. Discuss these possible effects with your doctor.
Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Check with your doctor as soon as possible if any of the following side effects occur:
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
This medicine may cause a temporary loss of hair in some people. After treatment with methotrexate has ended, normal hair growth should return.
After you stop using this medicine, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
See also: Rheumatrex Dose Pack 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.
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Resyl mit Codein may be available in the countries listed below.
Codeine phosphate hemihydrate (a derivative of Codeine) is reported as an ingredient of Resyl mit Codein in the following countries:
Guaifenesin is reported as an ingredient of Resyl mit Codein in the following countries:
International Drug Name Search
Clotri-Denk may be available in the countries listed below.
Clotrimazole is reported as an ingredient of Clotri-Denk in the following countries:
International Drug Name Search
Fenfluramine Hydrochloride may be available in the countries listed below.
Fenfluramine Hydrochloride (BANM, USAN) is known as Fenfluramine in the US.
International Drug Name Search
Glossary
| BANM | British Approved Name (Modified) |
| USAN | United States Adopted Name |
Emoclot D.I. may be available in the countries listed below.
Coagulation Factor VIII , Human (rDNA) Octocog Alfa (a derivative of Coagulation Factor VIII , Human (rDNA)) is reported as an ingredient of Emoclot D.I. in the following countries:
International Drug Name Search
Urchil may be available in the countries listed below.
Ursodeoxycholic Acid is reported as an ingredient of Urchil in the following countries:
International Drug Name Search
Triptafen may be available in the countries listed below.
UK matches:
Amitriptyline hydrochloride (a derivative of Amitriptyline) is reported as an ingredient of Triptafen in the following countries:
Perphenazine is reported as an ingredient of Triptafen in the following countries:
International Drug Name Search
Glossary
| SPC | Summary of Product Characteristics (UK) |
Loron may be available in the countries listed below.
UK matches:
Clodronic Acid disodium tetrahydrate (a derivative of Clodronic Acid) is reported as an ingredient of Loron in the following countries:
International Drug Name Search
Glossary
| SPC | Summary of Product Characteristics (UK) |
Skanoorin may be available in the countries listed below.
Sulindac is reported as an ingredient of Skanoorin in the following countries:
International Drug Name Search
In some countries, this medicine may only be approved for veterinary use.
In the US, Lactulose (lactulose systemic) is a member of the drug class laxatives and is used to treat Constipation - Acute, Constipation - Chronic and Hepatic Encephalopathy.
US matches:
UK matches:
Rec.INN
A06AD11
0004618-18-2
C12-H22-O11
342
Drug for metabolic disease treatment
Laxative, osmotically acting
D-Fructose, 4-O-ß-D-galactopyranosyl-
International Drug Name Search
Glossary
| BAN | British Approved Name |
| DCF | Dénomination Commune Française |
| DCIT | Denominazione Comune Italiana |
| JAN | Japanese Accepted Name |
| OS | Official Synonym |
| PH | Pharmacopoeia Name |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
| SPC | Summary of Product Characteristics (UK) |
| USAN | United States Adopted Name |
Taroctyl may be available in the countries listed below.
Chlorpromazine hydrochloride (a derivative of Chlorpromazine) is reported as an ingredient of Taroctyl in the following countries:
International Drug Name Search
Dicloxal Ox may be available in the countries listed below.
Oxacillin is reported as an ingredient of Dicloxal Ox in the following countries:
International Drug Name Search
Cincelakin may be available in the countries listed below.
Ambroxol hydrochloride (a derivative of Ambroxol) is reported as an ingredient of Cincelakin in the following countries:
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Lansoprol may be available in the countries listed below.
Lansoprazole is reported as an ingredient of Lansoprol in the following countries:
International Drug Name Search
Huminsulin R may be available in the countries listed below.
Insulin Injection, Soluble human (a derivative of Insulin Injection, Soluble) is reported as an ingredient of Huminsulin R in the following countries:
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Meditam may be available in the countries listed below.
Piracetam is reported as an ingredient of Meditam in the following countries:
International Drug Name Search
Indometacin Farnesil may be available in the countries listed below.
Indometacin Farnesil (JAN) is also known as Indometacin (Rec.INN)
International Drug Name Search
Glossary
| JAN | Japanese Accepted Name |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
Locimez may be available in the countries listed below.
Omeprazole is reported as an ingredient of Locimez in the following countries:
International Drug Name Search
Daomin may be available in the countries listed below.
Metformin hydrochloride (a derivative of Metformin) is reported as an ingredient of Daomin in the following countries:
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Tamoxifen Actavis may be available in the countries listed below.
Tamoxifen citrate (a derivative of Tamoxifen) is reported as an ingredient of Tamoxifen Actavis in the following countries:
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Penicilina G Benzatina L.CH. may be available in the countries listed below.
Benzylpenicillin benzathine (a derivative of Benzylpenicillin) is reported as an ingredient of Penicilina G Benzatina L.CH. in the following countries:
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Venlafaxin Spirig may be available in the countries listed below.
Venlafaxine hydrochloride (a derivative of Venlafaxine) is reported as an ingredient of Venlafaxin Spirig in the following countries:
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Bacimycin may be available in the countries listed below.
Bacitracin is reported as an ingredient of Bacimycin in the following countries:
Neomycin sulfate (a derivative of Neomycin) is reported as an ingredient of Bacimycin in the following countries:
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Readigal may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Dimpylate is reported as an ingredient of Readigal in the following countries:
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Lindacyn may be available in the countries listed below.
Clindamycin hydrochloride (a derivative of Clindamycin) is reported as an ingredient of Lindacyn in the following countries:
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CarLich may be available in the countries listed below.
Carvedilol is reported as an ingredient of CarLich in the following countries:
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Fosinoprilnatrium Teva may be available in the countries listed below.
Fosinopril sodium salt (a derivative of Fosinopril) is reported as an ingredient of Fosinoprilnatrium Teva in the following countries:
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Lorzaar Orifarm may be available in the countries listed below.
Losartan potassium salt (a derivative of Losartan) is reported as an ingredient of Lorzaar Orifarm in the following countries:
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Carbocain may be available in the countries listed below.
Mepivacaine hydrochloride (a derivative of Mepivacaine) is reported as an ingredient of Carbocain in the following countries:
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Androblock may be available in the countries listed below.
Bicalutamide is reported as an ingredient of Androblock in the following countries:
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Cencamat may be available in the countries listed below.
Cimetidine is reported as an ingredient of Cencamat in the following countries:
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Piperazin Jacoby may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Piperazine citrate (a derivative of Piperazine) is reported as an ingredient of Piperazin Jacoby in the following countries:
International Drug Name Search
Ciproactin may be available in the countries listed below.
Ciprofloxacin hydrochloride (a derivative of Ciprofloxacin) is reported as an ingredient of Ciproactin in the following countries:
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Definition of Phenylketonuria: Phenylketonuria (PKU) is a rare hereditary condition in which the amino acid phenylalanine is not properly metabolized. PKU can cause severe mental retardation if not treated.
The following drugs and medications are in some way related to, or used in the treatment of Phenylketonuria. 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:
Sotalolo Hexal may be available in the countries listed below.
Sotalol hydrochloride (a derivative of Sotalol) is reported as an ingredient of Sotalolo Hexal in the following countries:
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HCQS may be available in the countries listed below.
Hydroxychloroquine is reported as an ingredient of HCQS in the following countries:
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Loricid may be available in the countries listed below.
Allopurinol is reported as an ingredient of Loricid in the following countries:
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Merck-Fosinopril may be available in the countries listed below.
Fosinopril sodium salt (a derivative of Fosinopril) is reported as an ingredient of Merck-Fosinopril in the following countries:
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Adiprine may be available in the countries listed below.
Salicylic Acid is reported as an ingredient of Adiprine in the following countries:
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Hipnodem may be available in the countries listed below.
Zaleplon is reported as an ingredient of Hipnodem in the following countries:
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Concentrated Dextrose for
Intravenous Administration
NOTE: This solution is hypertonic — See WARNINGS and PRECAUTIONS.
LifeShield™ Abboject® Syringe
Fliptop Container
Ansyr™ Plastic Syringe
Ansyr™ II Plastic Syringe
Rx only
50% Dextrose Injection, USP is a sterile, nonpyrogenic, hypertonic solution of dextrose in water for injection for intravenous injection as a fluid and nutrient replenisher.
Each mL of fluid contains 0.5 g dextrose, hydrous which delivers 3.4 kcal/gram. The solution has an osmolarity of 2.53 mOsmol/mL (calc.), a pH of 4.2 (3.2 to 6.5) and may contain sodium hydroxide and/or hydrochloric acid for pH adjustment.
The solution contains no bacteriostat, antimicrobial agent or added buffer (except for pH adjustment) and is intended only for use as a single-dose injection. When smaller doses are required, the unused portion should be discarded with the entire unit.
Dextrose, USP is chemically designated C6H12O6 • H2O (D-glucose monohydrate), a hexose sugar freely soluble in water. Dextrose, hydrous has the following structural formula:
Water for Injection, USP is chemically designated H2O.
The syringe is molded from a specially formulated polypropylene. Water permeates from inside the container at an extremely slow rate which will have an insignificant effect on solution concentration over the expected shelf life. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the syringe material.
When administered intravenously this solution restores blood glucose levels in hypoglycemia and provides a source of carbohydrate calories.
Carbohydrate in the form of dextrose may aid in minimizing liver glycogen depletion and exerts a protein-sparing action. Dextrose injection undergoes oxidation to carbon dioxide and water.
Water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight. Average normal adult requirement ranges from two to three liters (1.0 to 1.5 liters each for insensible water loss by perspiration and urine production).
Water balance is maintained by various regulatory mechanisms. Water distribution depends primarily on the concentration of electrolytes in the body compartments and sodium (Na+) plays a major role in maintaining physiologic equilibrium.
50% Dextrose Injection is indicated in the treatment of insulin hypoglycemia (hyperinsulinemia or insulin shock) to restore blood glucose levels.
The solution is also indicated, after dilution, for intravenous infusion as a source of carbohydrate calories in patients whose oral intake is restricted or inadequate to maintain nutritional requirements. Slow infusion of hypertonic solutions is essential to insure proper utilization of dextrose and avoid production of hyperglycemia.
A concentrated dextrose solution should not be used when intracranial or intraspinal hemorrhage is present, nor in the presence of delirium tremens if the patient is already dehydrated.
Dextrose injection without electrolytes should not be administered simultaneously with blood through the same infusion set because of the possibility that pseudoagglutination of red cells may occur.
50% Dextrose Injection is hypertonic and may cause phlebitis and thrombosis at the site of injection.
Significant hyperglycemia and possible hyperosmolar syndrome may result from too rapid administration. The physician should be aware of the symptoms of hyperosmolar syndrome, such as mental confusion and loss of consciousness, especially in patients with chronic uremia and those with known carbohydrate intolerance.
The intravenous administration of this solution can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema.
Additives may be incompatible. Consult with pharmacist if available. When introducing additives, use aseptic technique, mix thoroughly and do not store.
For peripheral vein administration:
The solution should be given slowly, preferably through a small bore needle into a large vein, to minimize venous irritation.
For central venous administration:
Concentrated dextrose should be administered via central vein only after suitable dilution.
Do not use unless the solution is clear and seal is intact. Discard unused portion.
Electrolyte deficits, particularly in serum potassium and phosphate, may occur during prolonged use of concentrated dextrose solutions. Blood electrolyte monitoring is essential and fluid and electrolyte imbalances should be corrected. Essential vitamins and minerals also should be provided as needed.
To minimize hyperglycemia and consequent glycosuria, it is desirable to monitor blood and urine glucose and if necessary, add insulin.
When a concentrated dextrose infusion is abruptly withdrawn, it is advisable to follow with the administration of 5% or 10% dextrose injection to avoid rebound hypoglycemia.
Solutions containing dextrose should be used with caution in patients with known subclinical or overt diabetes mellitus.
Care should be exercised to insure that the needle is well within the lumen of the vein and that extravasation does not occur. If thrombosis should occur during administration, the injection should be stopped and corrective measures instituted.
Concentrated dextrose solutions should not be administered subcutaneously or intramuscularly.
Studies with solutions in polypropylene syringes have not been performed to evaluate carcinogenic potential, mutagenic potential or effects on fertility.
Animal reproduction studies have not been conducted with dextrose. It is also not known whether dextrose can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Dextrose should be given to a pregnant woman only if clearly needed.
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when 50% Dextrose Injection, USP is administered to a nursing mother.
Hyperosmolar syndrome, resulting from excessively rapid administration of concentrated dextrose may cause mental confusion and/or loss of consciousness.
Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation and hypervolemia.
If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.
In the event of overhydration or solute overload during therapy, re-evaluate the patient and institute appropriate corrective measures. See WARNINGS and PRECAUTIONS.
For peripheral vein administration:
Injection of the solution should be made slowly.
The maximum rate at which dextrose can be infused without producing glycosuria is 0.5 g/kg of body weight/hour. About 95% of the dextrose is retained when infused at a rate of 0.8 g/kg/hr.
In insulin-induced hypoglycemia, intravenous injection of 10 to 25 grams of dextrose (20 to 50 mL of 50% dextrose) is usually adequate. Repeated doses and supportive treatment may be required in severe cases. A specimen for blood glucose determination should be taken before injecting the dextrose. In such emergencies, dextrose should be administered promptly without awaiting pretreatment test results.
For central venous administration:
For total parenteral nutrition 50% Dextrose Injection, USP is administered by slow intravenous infusion (a) after admixture with amino acid solutions via an indwelling catheter with the tip positioned in a large central vein, preferably the superior vena cava, or (b) after dilution with sterile water for injection. Dosage should be adjusted to meet individual patient requirements.
Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid balance, electrolyte concentrations and acid-base balance during prolonged parenteral therapy or whenever the condition of the patient warrants such evaluation.
The maximum rate of dextrose administration which does not result in glycosuria is the same as cited above.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See CONTRAINDICATIONS.
50% Dextrose Injection, USP is supplied in single-dose containers as follows:
NDC No. | Container | Size |
0409-4902-34 | Lifeshield Abboject® Unit of Use | 25 g in 50 mL |
0409-6648-02 | Fliptop Vial | 25 g in 50 mL |
0409-7517-15 | Ansyr™ Plastic Syringe | 25 g in 50 mL |
0409-7517-16 | Ansyr™ II Plastic Syringe | 25 g in 50 mL |
Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]
Revised: October, 2009
Printed in USA
EN-2278
Hospira, Inc., Lake Forest, IL 60045 USA
Abboject® is a trademark of the Abbott group of companies.
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| NDA | NDA019445 | 06/29/2011 | |
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| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| NDA | NDA019445 | 06/29/2011 | |
| DEXTROSE dextrose monohydrate injection, solution | ||||||||||||||||||||||||||||||||
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| NDA | NDA019445 | 06/29/2011 | |
| Labeler - Hospira, Inc. (141588017) |
