Basti-Mag may be available in the countries listed below.
Magnesium Hydrogen Aspartate dihydrate (a derivative of Magnesium Hydrogen Aspartate) is reported as an ingredient of Basti-Mag in the following countries:
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In the US, Procrit (epoetin alfa systemic) is a member of the drug class recombinant human erythropoietins and is used to treat Anemia, Anemia Associated with Chronic Renal Failure, Anemia Prior to Surgery, Anemia - Chemotherapy Induced and Anemia - Drug Induced.
US matches:
Epoetin Alfa is reported as an ingredient of Procrit in the following countries:
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Rec.INN
V03AB35
0343306-71-8
C72-H112-O48-S8
2002
Antidote
Pharmaceutic aid
Cyclooctakis-(1->4)-[6-S-(2-carboxyethyl)-6-thio-α-D-glucopyranosyl] (IUPAC, WHO)
International Drug Name Search
Glossary
| IS | Inofficial Synonym |
| JAN | Japanese Accepted Name |
| OS | Official Synonym |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
| USAN | United States Adopted Name |
Generic Name: phentolamine (Injection route)
fen-TOL-a-meen
In the U.S.
Available Dosage Forms:
Therapeutic Class: Antihypertensive
Pharmacologic Class: Alpha-Adrenergic Blocker
Phentolamine given by injection causes blood vessels to expand, thereby increasing blood flow. When injected into the penis (intracavernosal), it increases blood flow to the penis, which results in an erection.
This medicine should not be used as a sexual aid by men who do not have erectile dysfunction. If the medicine is not used properly, permanent damage to the penis and loss of the ability to have erections could result.
Phentolamine may also be used to reverse the effects of an anesthetic medicine in soft tissues, such as the lips and tongue. It may be used to help quickly restore normal sensation and function in patients who have received local dental anesthesia .
Phentolamine 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 this use is not included in product labeling, phentolamine 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.
Appropriate studies have not been performed on the relationship of age to the effects of phentolamine for the reversal of soft-tissue anesthesia in children younger than 6 years of age. Safety and efficacy have not been established .
Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. Although there is no specific information comparing the use of phentolamine for erectile dysfunction in the elderly, it is not expected to cause different side effects or problems in older people than it does in younger adults.
| Pregnancy Category | Explanation | |
|---|---|---|
| All Trimesters | C | Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. |
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are 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 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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
The presence of other medical problems may affect the use of this 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 phentolamine. It may not be specific to OraVerse. Please read with care.
To give the injection:
This medicine usually begins to work in about 10 minutes. You should attempt intercourse within 2 hours after injecting the medicine.
To reverse the effects of a soft-tissue anesthetic medicine, a dentist or other trained health professional will give you this medicine. This medicine is usually injected at the same spot where you have received the local dental anesthesia .
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.
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.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Use the injection exactly as directed by your doctor. Do not use more of it and do not use it more often than ordered. If too much is used, the erection may become so strong that it lasts too long and does not reverse when it should. This condition is called priapism, and it can be very dangerous. If the effect is not reversed, the blood supply to the penis may be cut off and permanent damage may occur.
Contact your doctor immediately if the erection lasts for longer than 4 hours or if it becomes painful. This may be a sign of priapism and must be treated right away to prevent permanent damage.
If you notice bleeding at the site when you inject the medicine, put pressure on the spot until the bleeding stops. If it doesn't stop, check with your doctor.
It is important for you to examine your penis regularly. Check with your doctor if you find a lump where the medicine has been injected or if you notice that your penis is becoming curved. These may be signs that unwanted tissue is growing (called fibrosis), which should be seen by your doctor.
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
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:
Phentolamine injected into the penis may cause tingling at the tip of the penis. This is no cause for concern.
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: OraVerse side effects (in more detail)
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Curadies Paracetamol may be available in the countries listed below.
Paracetamol is reported as an ingredient of Curadies Paracetamol in the following countries:
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Bendarabin may be available in the countries listed below.
Fludarabine phosphate (a derivative of Fludarabine) is reported as an ingredient of Bendarabin in the following countries:
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Bactroban Cream (mupirocin calcium cream, 2%) contains the dihydrate crystalline calcium hemi-salt of the antibiotic mupirocin. Chemically, it is (αE,2S,3R,4R,5S) - 5 - [(2S,3S,4S,5S) - 2,3 - Epoxy - 5 - hydroxy - 4 - methylhexyl]tetrahydro - 3,4 - dihydroxy - β - methyl - 2H - pyran - 2 - crotonic acid, ester with 9-hydroxynonanoic acid, calcium salt (2:1), dihydrate.
The molecular formula of mupirocin calcium is (C26H43O9)2Ca•2H2O, and the molecular weight is 1075.3. The molecular weight of mupirocin free acid is 500.6. The structural formula of mupirocin calcium is:
Bactroban Cream is a white cream that contains 2.15% w/w mupirocin calcium (equivalent to 2.0% mupirocin free acid) in an oil and water-based emulsion. The inactive ingredients are benzyl alcohol, cetomacrogol 1000, cetyl alcohol, mineral oil, phenoxyethanol, purified water, stearyl alcohol, and xanthan gum.
Systemic absorption of mupirocin through intact human skin is minimal. The systemic absorption of mupirocin was studied following application of Bactroban Cream 3 times daily for 5 days to various skin lesions (>10 cm in length or 100 cm2 in area) in 16 adults (aged 29 to 60 years) and 10 children (aged 3 to 12 years). Some systemic absorption was observed as evidenced by the detection of the metabolite, monic acid, in urine. Data from this study indicated more frequent occurrence of percutaneous absorption in children (90% of patients) compared to adults (44% of patients); however, the observed urinary concentrations in children (0.07 - 1.3 mcg/mL [1 pediatric patient had no detectable level]) are within the observed range (0.08 - 10.03 mcg/mL [9 adults had no detectable level]) in the adult population. In general, the degree of percutaneous absorption following multiple dosing appears to be minimal in adults and children. Any mupirocin reaching the systemic circulation is rapidly metabolized, predominantly to inactive monic acid, which is eliminated by renal excretion.
Mupirocin is an antibacterial agent produced by fermentation using the organism Pseudomonas fluorescens. It is active against a wide range of gram-positive bacteria including methicillin-resistant Staphylococcus aureus (MRSA). It is also active against certain gram-negative bacteria. Mupirocin inhibits bacterial protein synthesis by reversibly and specifically binding to bacterial isoleucyl transfer-RNA synthetase. Due to this unique mode of action, mupirocin demonstrates no in vitro cross-resistance with other classes of antimicrobial agents.
Resistance occurs rarely; however, when mupirocin resistance does occur, it appears to result from the production of a modified isoleucyl-tRNA synthetase. High-level plasmid-mediated resistance (MIC >1024 mcg/mL) has been reported in some strains of Staphylococcus aureus and coagulase-negative staphylococci.
Mupirocin is bactericidal at concentrations achieved by topical application. The minimum bactericidal concentration (MBC) against relevant pathogens is generally 8-fold to 30-fold higher than the minimum inhibitory concentration (MIC). In addition, mupirocin is highly protein bound (>97%), and the effect of wound secretions on the MICs of mupirocin has not been determined.
Mupirocin has been shown to be active against most strains of S. aureus and Streptococcus pyogenes, both in vitro and in clinical studies. (See INDICATIONS AND USAGE.) The following in vitro data are available, BUT THEIR CLINICAL SIGNIFICANCE IS UNKNOWN. Mupirocin is active against most strains of Staphylococcus epidermidis and Staphylococcus saprophyticus.
Bactroban Cream is indicated for the treatment of secondarily infected traumatic skin lesions (up to 10 cm in length or 100 cm2 in area) due to susceptible strains of S. aureus and S. pyogenes.
Bactroban Cream is contraindicated in patients with known hypersensitivity to any of the constituents of the product.
Avoid contact with the eyes.
In the event of a sensitization or severe local irritation from Bactroban Cream, usage should be discontinued, and appropriate alternative therapy for the infection instituted.
As with other antibacterial products, prolonged use may result in overgrowth of nonsusceptible microorganisms, including fungi. (See DOSAGE AND ADMINISTRATION.)
Bactroban Cream is not formulated for use on mucosal surfaces.
• Use this medication only as directed by your healthcare provider. It is for external use only. Avoid contact with the eyes.
• The treated area may be covered by gauze dressing if desired.
• Report to your healthcare provider any signs of local adverse reactions. The medication should be stopped and your healthcare provider contacted if irritation, severe itching, or rash occurs.
• If no improvement is seen in 3 to 5 days, contact your healthcare provider.
The effect of the concurrent application of topical mupirocin calcium cream and other topical products has not been studied.
Long-term studies in animals to evaluate carcinogenic potential of mupirocin calcium have not been conducted.
Results of the following studies performed with mupirocin calcium or mupirocin sodium in vitro and in vivo did not indicate a potential for mutagenicity: Rat primary hepatocyte unscheduled DNA synthesis, sediment analysis for DNA strand breaks, Salmonella reversion test (Ames), Escherichia coli mutation assay, metaphase analysis of human lymphocytes, mouse lymphoma assay, and bone marrow micronuclei assay in mice.
Fertility studies were performed in rats with mupirocin administered subcutaneously at doses up to 49 times a human topical dose of 1 gram/day (approximately 20 mg mupirocin per day) on a mg/m2 basis and revealed no evidence of impaired fertility from mupirocin sodium.
Teratogenic Effects: Pregnancy Category B. Teratology studies have been performed in rats and rabbits with mupirocin administered subcutaneously at doses up to 78 and 154 times, respectively, a human topical dose of 1 gram/day (approximately 20 mg mupirocin per day) on a mg/m2 basis and revealed no evidence of harm to the fetus due to mupirocin. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy 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 Bactroban Cream is administered to a nursing woman.
The safety and effectiveness of Bactroban Cream have been established in the age groups 3 months to 16 years. Use of Bactroban Cream in these age groups is supported by evidence from adequate and well-controlled studies of Bactroban Cream in adults with additional data from 93 pediatric patients studied as part of the pivotal trials in adults. (See CLINICAL STUDIES.)
In 2 well-controlled studies, 30 patients older than 65 years were treated with Bactroban Cream. No overall difference in the efficacy or safety of Bactroban Cream was observed in this patient population when compared to that observed in younger patients.
In 2 randomized, double-blind, double-dummy trials, 339 patients were treated with topical Bactroban Cream plus oral placebo. Adverse events thought to be possibly or probably drug-related occurred in 28 (8.3%) patients. The incidence of those events that were reported in at least 1% of patients enrolled in these trials were: Headache (1.7%), rash, and nausea (1.1% each).
Other adverse events thought to be possibly or probably drug-related which occurred in less than 1% of patients were: Abdominal pain, burning at application site, cellulitis, dermatitis, dizziness, pruritus, secondary wound infection, and ulcerative stomatitis.
In a supportive study in the treatment of secondarily infected eczema, 82 patients were treated with Bactroban Cream. The incidence of adverse events thought to be possibly or probably drug-related was as follows: Nausea (4.9%), headache, and burning at application site (3.6% each), pruritus (2.4%) and 1 report each of abdominal pain, bleeding secondary to eczema, pain secondary to eczema, hives, dry skin, and rash.
Intravenous infusions of 252 mg, as well as single oral doses of 500 mg of mupirocin, have been well tolerated in healthy adult subjects. There is no information regarding overdose of Bactroban Cream.
A small amount of Bactroban Cream should be applied to the affected area 3 times daily for 10 days. The area treated may be covered with gauze dressing if desired. Patients not showing a clinical response within 3 to 5 days should be re-evaluated.
The efficacy of topical Bactroban Cream for the treatment of secondarily infected traumatic skin lesions (e.g., lacerations, sutured wounds, and abrasions not more than 10 cm in length or 100 cm2 in total area) was compared to that of oral cephalexin in 2 randomized, double-blind, double-dummy clinical trials. Clinical efficacy rates at follow-up in the per protocol populations (adults and pediatric patients included) were 96.1% for Bactroban Cream (n = 231) and 93.1% for oral cephalexin (n = 219). Pathogen eradication rates at follow-up in the per protocol populations were 100% for both Bactroban Cream and oral cephalexin.
Pediatrics: There were 93 pediatric patients aged 2 weeks to 16 years enrolled per protocol in the secondarily infected skin lesion studies, although only 3 were less than 2 years of age in the population treated with Bactroban Cream. Patients were randomized to either 10 days of topical Bactroban Cream 3 times daily or 10 days of oral cephalexin (250 mg 4 times daily for patients >40 kg or 25 mg/kg/day oral suspension in 4 divided doses for patients ≤40 kg). Clinical efficacy at follow-up (7 to 12 days post-therapy) in the per protocol populations was 97.7% (43/44) for Bactroban Cream and 93.9% (46/49) for cephalexin. Only 1 adverse event (headache) was thought to be possibly or probably related to drug therapy with Bactroban Cream in the intent-to-treat pediatric population of 70 children (1.4%).
Bactroban Cream is supplied in 15-gram and 30-gram tubes.
NDC 0029-1527-22 (15-gram tube)
NDC 0029-1527-25 (30-gram tube)
Store at or below 25°C (77°F). Do not freeze.
GlaxoSmithKline
Research Triangle Park, NC 27709
Bactroban Cream is a registered trademark of GlaxoSmithKline.
©2005, GlaxoSmithKline. All rights reserved.
May 2005 BB:L7B
Principal Display Panel
NDC 0029-1527-22
Bactroban Cream®
MUPIROCIN CALCIUM CREAM 2%
15 grams (Net Wt.)
Rx only
Store at or below 25oC (77oF). Do not freeze.
Each gram contains 21.5 mg mupirocin calcium in a mineral oil cream base.
Dosage: For dermatologic use only. Apply a small amount of cream to the affected area three times daily for 10 days. Patients not showing clinical response within 3 to 5 days should be re-evaluated. See accompanying prescribing information.
GlaxoSmithKline
Research Triangle Park, NC 27709
Made in England
©2005, GlaxoSmithKline
10000000017887 Rev. 10/05
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| NDA | NDA050746 | 01/23/1998 | |
| Labeler - GlaxoSmithKline LLC (167380711) |
Bechilar may be available in the countries listed below.
Dextromethorphan hydrobromide (a derivative of Dextromethorphan) is reported as an ingredient of Bechilar in the following countries:
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Bromazepam Lannacher may be available in the countries listed below.
Bromazepam is reported as an ingredient of Bromazepam Lannacher in the following countries:
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Rifan may be available in the countries listed below.
Rifampicin is reported as an ingredient of Rifan in the following countries:
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Levotrex may be available in the countries listed below.
Levocetirizine dihydrochloride (a derivative of Levocetirizine) is reported as an ingredient of Levotrex in the following countries:
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Ceftazidima ratiopharm may be available in the countries listed below.
Ceftazidime pentahydrate (a derivative of Ceftazidime) is reported as an ingredient of Ceftazidima ratiopharm in the following countries:
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Naloxona Gemepe may be available in the countries listed below.
Naloxone hydrochloride (a derivative of Naloxone) is reported as an ingredient of Naloxona Gemepe in the following countries:
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Osmofundin may be available in the countries listed below.
Mannitol is reported as an ingredient of Osmofundin in the following countries:
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Bacampicin may be available in the countries listed below.
Bacampicillin is reported as an ingredient of Bacampicin in the following countries:
Bacampicillin hydrochloride (a derivative of Bacampicillin) is reported as an ingredient of Bacampicin in the following countries:
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Definition of Prostatitis: Inflammation of the prostate.
The following drugs and medications are in some way related to, or used in the treatment of Prostatitis. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.
Medical Encyclopedia:
Harvard Health Guide:
Isofluorano may be available in the countries listed below.
Isoflurane is reported as an ingredient of Isofluorano in the following countries:
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