Cortop may be available in the countries listed below.
Carvedilol is reported as an ingredient of Cortop in the following countries:
Hydrocortisone 21-(sodium succinate) (a derivative of Hydrocortisone) is reported as an ingredient of Cortop in the following countries:
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Ambroxol-1A Pharma may be available in the countries listed below.
Ambroxol hydrochloride (a derivative of Ambroxol) is reported as an ingredient of Ambroxol-1A Pharma in the following countries:
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a-LEN-droe-nate
In the U.S.
Available Dosage Forms:
Therapeutic Class: Calcium Regulator
Chemical Class: Bisphosphonate
Alendronate is used to prevent and treat osteoporosis (thinning of the bone) in women after menopause. alendronate may also be used to increase bone mass in men who have osteoporosis, and in men and women to prevent and treat osteoporosis caused by long-term use of corticosteroids (cortisone-like medicine). It may also be used to treat Paget's disease of the bone.
alendronate is available only with your doctor's prescription.
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 alendronate, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to alendronate 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 alendronate in the pediatric population. However, use of alendronate in children is not recommended.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of alendronate in the elderly.
| 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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
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.
Using alendronate with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use alendronate, or give you special instructions about the use of food, alcohol, or tobacco.
The presence of other medical problems may affect the use of alendronate. Make sure you tell your doctor if you have any other medical problems, especially:
alendronate comes with a patient information insert. Read and follow the instructions on the insert carefully. Ask your doctor if you have any questions.
Take the alendronate tablet with a full glass (6 to 8 ounces) of plain water on an empty stomach. It should be taken as soon as you get out of bed in the morning and at least 30 minutes before any food, beverage, or other medicines. Food and beverages (e.g., mineral water, coffee, tea, or juice) will decrease the amount of alendronate absorbed by the body. Waiting longer than 30 minutes will allow more of the drug to be absorbed. Medicines such as antacids, calcium, or vitamin supplements will also decrease the absorption of alendronate.
If you are using alendronate oral liquid, drink at least 2 ounces (a quarter of a cup) of water immediately after taking the medicine. This will allow the medicine to reach your intestines and be absorbed by the body more quickly.
Swallow the tablet whole. Do not suck or chew on the tablet because it may cause throat irritation.
Do not lie down for at least 30 minutes after taking alendronate and before having your first food for the day. This will help alendronate reach your stomach faster. It will also help prevent irritation to your esophagus.
It is important that you eat a well-balanced diet with adequate amounts of calcium and vitamin D (found in milk or other dairy products). However, do not take any foods, beverages, or calcium supplements within 30 minutes or longer after taking the alendronate. To do so may keep alendronate from working properly.
Follow your dosing instructions given to you by your doctor closely. It may affect the way alendronate works if you do not. Do not stop using alendronate suddenly without asking your doctor.
Tell your doctor if you do weight-bearing exercises, smoke or drink excessively. Your doctor will need to take these into consideration in deciding your dose.
The dose of alendronate 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 alendronate. 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 alendronate, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
For patients taking the medicine each day: If you miss a dose or forget to use your medicine in the morning, skip the missed dose and take your medicine the next morning. Do not take two tablets on the same day. Return to your regular schedule the next day.
If you are on a weekly schedule and miss a dose of alendronate, take it the next morning after you remember. Resume your usual schedule taking the medicine on your chosen day the next week.
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.
If you will be taking alendronate for a long time, it is very important that your doctor check your progress at regular visits to make sure alendronate is working properly and watch for unwanted effects.
alendronate can irritate your esophagus. If you think alendronate has started to damage your esophagus, stop taking alendronate and call your doctor. Some symptoms of damage to the esophagus are heartburn (either new or worse than usual), pain when swallowing, pain in the center of your chest, trouble swallowing, or feeling that food gets stuck on the way to your stomach.
It is important that you tell all of your health care providers that you are taking alendronate. If you are having a dental procedure while taking alendronate, you may have an increased chance of having a severe problem with your jaw.
Make sure you tell your doctor about any new medical problems, especially with your teeth or jaws. Tell your doctor if you have severe bone, joint, or muscle pain while using alendronate.
alendronate may increase your risk of developing fractures of the thigh bone. This may be more common if you use it for a long time. Check with your doctor right away if you have a dull or aching pain in the thighs, groin, or hips.
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:
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: alendronate 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.
Regerd may be available in the countries listed below.
Omeprazole is reported as an ingredient of Regerd in the following countries:
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Assieme Mite Turbohaler Paranova may be available in the countries listed below.
Budesonide is reported as an ingredient of Assieme Mite Turbohaler Paranova in the following countries:
Formoterol is reported as an ingredient of Assieme Mite Turbohaler Paranova in the following countries:
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Aminoglutetimid may be available in the countries listed below.
Aminoglutethimide is reported as an ingredient of Aminoglutetimid in the following countries:
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Generic Name: dexamethasone (oral) (dex a METH a sone)
Brand Names: Baycadron, Dexamethasone Intensol, DexPak 10 Day Taperpak, DexPak 13 DayTaperpak, DexPak 6 DayTaperpak, Dexpak Jr. Taperpak, Zema Pak 10-Day, Zema Pak 13-Day, Zema Pak 6-Day
Dexamethasone is a steroid that prevents the release of substances in the body that cause inflammation.
Dexamethasone is used to treat many different conditions such as allergic disorders, skin conditions, ulcerative colitis, arthritis, lupus, psoriasis, or breathing disorders.
Dexamethasone may also be used for purposes not listed in this medication guide.
Before taking dexamethasone, tell your doctor about all of your medical conditions, and about all other medicines you are using. There are many other diseases that can be affected by steroid use, and many other medicines that can interact with steroids.
Your steroid medication needs may change if you have any unusual stress such as a serious illness, fever or infection, or if you have surgery or a medical emergency. Tell your doctor about any such situation that affects you during treatment.
Steroid medication can weaken your immune system, making it easier for you to get an infection or worsening an infection you already have or have recently had. Tell your doctor about any illness or infection you have had within the past several weeks.
Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using steroid medication.
Do not receive a "live" vaccine while you are taking dexamethasone. Vaccines may not work as well while you are taking a steroid.
Steroid medication can weaken your immune system, making it easier for you to get an infection. Steroids can also worsen an infection you already have, or reactivate an infection you recently had. Before taking this medication, tell your doctor about any illness or infection you have had within the past several weeks.
To make sure you can safely take dexamethasone, tell your doctor if you have any of these other conditions:
liver disease (such as cirrhosis);
kidney disease;
a thyroid disorder;
diabetes;
a history of malaria;
tuberculosis;
osteoporosis;
a muscle disorder such as myasthenia gravis;
glaucoma or cataracts;
herpes infection of the eyes;
stomach ulcers, ulcerative colitis, or diverticulitis;
depression or mental illness;
congestive heart failure; or
high blood pressure
Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.
Your doctor may occasionally change your dose to make sure you get the best results.
Your steroid medication needs may change if you have unusual stress such as a serious illness, fever or infection, or if you have surgery or a medical emergency. Tell your doctor about any such situation that affects you.
This medication can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using dexamethasone.
Call your doctor for instructions if you miss a dose of dexamethasone.
Long-term use of high steroid doses can lead to symptoms such as thinning skin, easy bruising, changes in the shape or location of body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.
Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using steroid medication.
problems with your vision;
swelling, rapid weight gain, feeling short of breath;
severe depression, unusual thoughts or behavior, seizure (convulsions);
bloody or tarry stools, coughing up blood;
pancreatitis (severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate);
low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling); or
dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).
Less serious side effects may include:
sleep problems (insomnia), mood changes;
acne, dry skin, thinning skin, bruising or discoloration;
slow wound healing;
increased sweating;
headache, dizziness, spinning sensation;
nausea, stomach pain, bloating;
muscle weakness; or
changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Many drugs can interact with dexamethasone. Below is just a partial list. Tell your doctor if you are using:
aspirin (taken on a daily basis or at high doses);
a diuretic (water pill);
a blood thinner such as warfarin (Coumadin);
cyclosporine (Gengraf, Neoral, Sandimmune);
insulin or diabetes medications you take by mouth;
ketoconazole (Nizoral);
rifampin (Rifadin, Rifater, Rifamate, Rimactane); or
seizure medications such as phenytoin (Dilantin) or phenobarbital (Luminal, Solfoton).
This list is not complete and other drugs may interact with dexamethasone. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.
See also: Zema Pak 6-Day side effects (in more detail)
Midane may be available in the countries listed below.
Cyproterone 17α-acetate (a derivative of Cyproterone) is reported as an ingredient of Midane in the following countries:
Ethinylestradiol is reported as an ingredient of Midane in the following countries:
International Drug Name Search
Ambroxolo may be available in the countries listed below.
Ambroxolo (DCIT) is also known as Ambroxol (Rec.INN)
International Drug Name Search
Glossary
| DCIT | Denominazione Comune Italiana |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
Class: Antineoplastic Agents
VA Class: AN500
Chemical Name: 2-Hydroxy-1,2,3-propanetricarboxylate (1:1) (Z)-2-[4-(4-chloro-1,2-diphenyl-1-butenyl)phenoxy]-N,N-dimethylethanamine
Molecular Formula: C26H28ClNO•C6H8O7
CAS Number: 89778-27-8
Brands: Fareston
Antineoplastic agent; a nonsteroidal estrogen agonist-antagonist that is structurally and pharmacologically related to tamoxifen.1 3 19 20
Palliative treatment of metastatic breast cancer in postmenopausal women with estrogen-receptor positive or estrogen-receptor unknown tumors1 4 11 15 21 (designated an orphan drug by FDA for this use).17 Not recommended for treatment of estrogen-receptor negative breast tumors.5 7 Similar efficacy and toxicity as tamoxifen.1 3 4 11 15 26 Not known whether toremifene offers a therapeutic advantage over tamoxifen for the treatment of advanced breast cancer in eligible patients.18 19 27
Under investigation for use as adjuvant therapy† for early-stage breast cancer in node-positive postmenopausal women.31 32 Results from trials to date suggest similar efficacy and toxicity as tamoxifen.31 32
Efficacy in treatment of advanced breast cancer in men† not demonstrated.29 30
Because of demonstrated cross-resistance with tamoxifen, usefulness of toremifene as second-line† endocrine therapy for treatment of metastatic breast cancer refractory to tamoxifen appears to be limited.3 13 14 19
Under investigation as a preventive agent for prostate cancer† in men with high-grade prostatic intraepithelial neoplasia and no evidence of prostate cancer.33
Administer orally without regard to meals.1
Available as toremifene citrate; dosage expressed in terms of toremifene.1
60 mg once daily for metastatic breast cancer.1 Continue therapy until disease progression occurs; in clinical studies, therapy was continued for a median duration of 5 months.1
Higher dosages (200 or 240 mg daily) associated with greater toxicity but provide no additional benefit in metastatic breast cancer.1 11 15
Use with caution and monitor liver function carefully.10 Dosage reduction may be necessary.10
Dosage adjustments not required.10
Dosage adjustments not required.9
Known hypersensitivity to toremifene or any ingredient in the formulation.1
Hypercalcemia and tumor flare reported (usually during the first weeks of therapy) in patients with metastatic breast cancer who have bone metastases.1 Tumor flare is a syndrome of diffuse musculoskeletal pain and erythema with increase and then regression in the size of tumor lesions; tumor flare does not represent tumor progression or imply failure of treatment.1
Monitor patients with bone metastases closely for hypercalcemia during first weeks of therapy.1 If hypercalcemia occurs, institute appropriate measures; if severe, discontinue toremifene.1
Monitor serum calcium concentrations periodically during therapy.1
Endometrial hyperplasia and endometrial cancer reported.1 30 Long-term therapy not recommended in patients with preexisting endometrial hyperplasia.1 30
Monitor carefully for uterine disorders.8 29 30 Gynecologic symptoms (i.e., menstrual irregularities, abnormal vaginal bleeding, changes in vaginal discharge, pelvic pain or pressure) should be promptly evaluated.1 29 (See Advice to Patients.)
May cause fetal harm.1 Embryotoxicity and fetotoxicity demonstrated in animals.1 If used during pregnancy or if patient becomes pregnant, apprise of potential fetal hazard and potential loss of pregnancy.1
Pulmonary embolism, thrombophlebitis, thrombosis, cerebrovascular accident, and TIA reported.1 Use not recommended in patients with history of thromboembolic disorders.1
Cardiac failure, MI, arrhythmia, angina pectoris, and edema reported.1
Leukopenia and thrombocytopenia reported rarely;1 monitor leukocyte and platelet counts in patients with leukopenia and thrombocytopenia.1
Monitor CBCs periodically during therapy.1
Increased hepatic enzyme concentrations (e.g., AST, alkaline phosphatase, bilirubin) and jaundice reported.1 Fatty liver and nonalcoholic steatohepatitis reported following long-term therapy with higher than recommended dosage (i.e., 80 mg daily).25
Obtain liver function tests periodically during therapy.1
Cataracts, dry eyes, abnormal visual fields, corneal keratopathy, glaucoma, abnormal vision/diplopia, and corneal opacity (corneal verticulata) reported.1 Blurred vision reported following therapy with higher than recommended dosages (i.e., 200 or 240 mg daily).1
Category D.1 (See Fetal/Neonatal Morbidity and Mortality under Cautions.)
Distributed into milk in rats; not known whether distributed into human milk.1 30 Discontinue nursing or the drug.30
Not labeled for use in children.1
No substantial differences in safety and efficacy relative to younger adults,1 but increased sensitivity cannot be ruled out.9
Decreased clearance in patients with hepatic impairment (i.e., cirrhosis, fibrosis).1 10 (See Elimination: Special Populations, under Pharmacokinetics.) Use with caution and monitor liver function carefully.10 Dosage reduction may be necessary.10
Hot flushes (flashes), sweating, nausea, vaginal discharge, dizziness, edema, vomiting, vaginal bleeding.1
Metabolized principally by CYP3A4.1
No formal drug interaction studies to date.1
Inhibitors of CYP3A4-6: Potential pharmacokinetic interaction (increased toremifene concentrations).1 29 30 Clinical importance unknown.1
Inducers of CYP3A4: Potential pharmacokinetic interaction (decreased toremifene concentrations).1 10 24
Drugs that decrease renal calcium excretion (e.g., thiazide diuretics): Potential pharmacologic interaction (increased risk of hypercalcemia).1
Drug | Interaction | Comments |
|---|---|---|
Anticoagulants, oral (e.g., warfarin) | Possible increased PT1 29 30 | Monitor PT; adjust anticoagulant dosage if necessary1 29 30 |
Anticonvulsants (e.g., carbamazepine, clonazepam, phenobarbital, phenytoin) | Possible decreased toremifene concentrations (due to increased clearance and decreased elimination half-life of toremifene)1 10 24 | Increase toremifene dosage if necessary1 10 24 |
Antifungals, azoles (e.g., ketoconazole) | Possible increased toremifene concentrations1 29 30 | Adjust toremifene dosage if necessary1 10 24 |
Macrolides (e.g., erythromycin) | Possible increased toremifene concentrations1 29 30 | Adjust toremifene dosage if necessary1 10 24 |
Rifampin | Decreased peak plasma concentration and AUC of toremifene24 | Increase toremifene dosage if necessary1 10 24 |
Well absorbed following oral administration, with peak plasma concentration usually attained within 3 hours.1
Steady-state concentrations are reached in about 4–6 weeks.1
Food does not appear to affect absorption.1
Crosses the placenta and accumulates in the fetus in rodents.1 Distributed into milk in rats; not known whether distributed into human milk.1
>99.5% (mainly albumin).1
Increased toremifene volume of distribution in geriatric female patients; however, no change in AUC.1 9
Extensively metabolized, principally via CYP3A4 to N-demethyltoremifene, which exhibits antiestrogenic effects but has weak antitumor potency in vivo.1
Excreted as metabolites principally in feces, with about 10% excreted in urine over 1 week.1
Toremifene: Approximately 5 days.1
N-demethyltoremifene: 6 days.1 Deaminohydroxy toremifene: 4 days.1
Elimination is slow due to enterohepatic circulation.1
Increased toremifene elimination half-life in patients with hepatic impairment (i.e., cirrhosis, fibrosis).1 10
Pharmacokinetics are not altered in patients with renal impairment.1 10
Increased toremifene elimination half-life in geriatric female patients; however, no change in clearance.1 9
25°C (may be exposed to 15–30°C); protect from heat and light.1
Acts as an estrogen antagonist on breast tissue and as a weak estrogen agonist on endometrium, bone, and lipids.1 3
In breast cancer, competitively binds to estrogen receptors and blocks tumor growth stimulated by estrogen.1 3 Also may inhibit tumor growth through other mechanisms (e.g., induction of apoptosis, regulation of oncogene expression and growth factors).3
Decreases total and LDL-cholesterol concentrations.3 6 16
Acts as an estrogen agonist on the uterus and exhibits proliferative and tumor-promoting effects on the endometrium.1
Importance of receiving routine gynecologic care and of immediately informing clinician if any new breast lumps or abnormal gynecologic symptoms, including menstrual irregularities, abnormal vaginal bleeding, change in vaginal discharge, or pelvic pain/pressure occur.1 29
Importance of informing patients with bone metastases about the typical manifestations of hypercalcemia and instructing patients to report promptly any symptoms to their clinician.1
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal supplements, as well as any concomitant illnesses.1
Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.1 Necessity for clinicians to advise women to avoid pregnancy during therapy and to advise pregnant women of risk to the fetus and of potential loss of pregnancy.1
Importance of informing patients of other important precautionary information.1 (See Cautions.)
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Oral | Tablets | 60 mg (of toremifene) | Fareston (with povidone) | GTx |
This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.
Fareston 60MG Tablets (GTX): 30/$580.02 or 90/$1725.87
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions March 2009. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
† Use is not currently included in the labeling approved by the US Food and Drug Administration.
1. GTx, Inc. Fareston (toremifene citrate) tablets prescribing information. Memphis, TN; 2004 Dec.
2. Jordan VC. Alternate antiestrogens and approaches to the prevention of breast cancer. J Cell Biochem. 1995; 22(Suppl):51-7.
3. Wiseman LR, Goa KL. Toremifene: a review of its pharmacological properties and clinical efficacy in the management of advanced breast cancer. Drugs. 1997; 54:141-60. [PubMed 9211086]
4. Pyrhonen S, Valavaara R, Modig H et al. Comparison of toremifene and tamoxifen in post-menopausal patients with advanced breast cancer: a randomized double-blind, the Nordic phase III study. Br J Cancer. 1997; 76:270-7. [PubMed 9231932]
5. Gradishar WJ, Jordan VC. Clinical potential of new antiestrogens. J Clin Oncol. 1997; 15:840-52. [IDIS 381300] [PubMed 9053512]
6. Saarto T, Blomqvist C, Ehnholm C et al. Antiatherogenic effects of adjuvant antiestrogens: a randomized trial comparing the effects of tamoxifen and toremifene on plasma lipid levels in postmenopausal women with node-positive breast cancer. J Clin Oncol. 1996; 14:429-33. [IDIS 362035] [PubMed 8636753]
7. Anon. Schering/Orion Fareston launch awaits resolution of labeling, promotional issues; European toremifene report cites need for long-term toxicity studies. F-D-C Rep. June 9, 1997: 6-7.
8. Tomas E, Kauppila A, Blanco G et al. Comparison between the effects of tamoxifen and toremifene on the uterus in postmenopausal breast cancer patients. Gynecol Oncol. 1995; 59:261-6. [PubMed 7590484]
9. Sotaniemi EA, Anttila MI. Influence of age on toremifene pharmacokinetics. Cancer Chemother Pharmacol. 1997; 40:185-8. [PubMed 9182842]
10. Anttila M, Laakso S, Nylanden P et al. Pharmacokinetics of the novel antiestrogenic agent toremifene in subjects with altered liver and kidney function. Clin Pharmacol Ther. 1995; 57:628-35. [IDIS 348949] [PubMed 7781262]
11. Hayes DF, Van Zyl JA, Hacking A et al. Randomized comparison of tamoxifen and two separate doses of toremifene in postmenopausal patients with metastatic breast cancer. J Clin Oncol. 1995; 13:2556-66. [IDIS 356136] [PubMed 7595707]
12. Pyrhonen S, Valavaara R, Vuorinen J et al. High dose toremifene in advanced breast cancer resistant to or relapsed during tamoxifen treatment. Breast Cancer Res Treat. 1994; 29:223-8. [PubMed 8049456]
13. Vogel CL, Shemano I, Schoenfelder J et al. Multicenter phase II efficacy trial of toremifene in tamoxifen-refractory patients with advanced breast cancer. J Clin Oncol. 1993; 11:345-50. [PubMed 8426212]
14. Stenbygaard LE, Herrstedt J, Thomsen JF et al. Toremifene and tamoxifen in advanced breast cancer: a double-blind cross-over trial. Breast Cancer Res Treat. 1993; 25:57-63. [PubMed 8518408]
15. Gershanovich M, Garin A, Baltina D et al. A phase III comparison of two toremifene doses to tamoxifen in postmenopausal women with advanced breast cancer. Breast Cancer Res Treat. 1997; 45:251-62. [PubMed 9386869]
16. Gylling H, Pyrhonen S, Mantyla E et al. Tamoxifen and toremifene lower serum cholesterol by inhibition of delta 8-cholesterol conversion to lathosterol in women with breast cancer. J Clin Oncol. 1995; 13:2900-5. [IDIS 357160] [PubMed 8523053]
17. Food and Drug Administration. Orphan designations pursuant to Section 526 of the Federal Food and Drug Cosmetic Act as amended by the Orphan Drug Act (P.L. 97-414). Rockville, MD; 1998 May.
18. Anon. Toremifene and letrozole for advanced breast cancer. Med Lett Drugs Ther. 1998; 40:43-5. [PubMed 9580744]
19. Buzdar AU, Hortobagyi GN. Tamoxifen and toremifene in breast cancer: comparison of safety and efficacy. J Clin Oncol. 1998; 16:348-53. [IDIS 397613] [PubMed 9440763]
20. Mitlak BH, Cohen FJ. In search of optimal long-term female hormone replacement: the potential of selective estrogen receptor modulators. Horm Res. 1997; 155-63.
21. Anon. Drugs of choice for cancer chemotherapy. Med Lett Drugs Ther. 2000; 42:83-92. [PubMed 10994034]
22. Food and Drug Administration. Labeling and prescription drug advertising; content and format for labeling for human prescription drugs. 21 CFR Parts 201 and 202. Final Rule. [Docket No. 75N-0066] Fed Regist. 1979; 44:37434-67.
23. Department of Health and Human Services, Food and Drug Administration. Subpart B—Labeling requirements for prescription drugs and/or insulin. (21 CFR Ch. 1 (4-1-87 Ed.)). 1987:18-24.
24. Kivisto KT, Villikka K, Nyman L et al. Tamoxifen and toremifene concentrations in plasma are greatly decreased by rifampin. Clin Pharmacol Ther. 1998; 64:648-54. [IDIS 416902] [PubMed 9871429]
25. Hamada N, Ogawa Y, Saibara T et al. Toremifene-induced fatty liver and NASH in breast cancer patients with breast-conservation treatment. Int J Oncol. 2000; 17:1119-23. [PubMed 11078796]
26. Pyrhonen S, Ellmen J, Vuorinen J et al. Meta-analysis of trials comparing toremifene with tamoxifen and factors predicting outcome of antiestrogen therapy in postmenopausal women with breast cancer. Breast Cancer Res Treat. 1999; 56:133-43. [PubMed 10573106]
27. Buzdar AU, Hortobagyi GN. Differences in toxicity findings for antiestrogens. J Clin Oncol. 1998; 16:2000.
28. O’Regan RM, Cisneros A, England GM et al. Effects of the antiestrogens tamoxifen, toremifene, and ICI 182,780 on endometrial cancer growth. J Natl Cancer Inst. 1998; 90:1552-8. [PubMed 9790548]
29. Reviewers’ comments (personal observations).
30. Shire, Newport, KY: Personal communication.
31. Holli K. Valavaara R, Blanco G et al. Safety and efficacy results of a randomized trial comparing adjuvant toremifene and tamoxifen in postmenopausal patients with node-positive breast cancer. Finnish Breast Cancer Group. J Clin Oncol. 2000;18:3487-94.
32. Pagani O, Gelber S, Price K et al. Toremifene and tamoxifen are equally effective for early-stage breast cancer: first results of International Breast Cancer Study Group Trials 12-93 and 14-93. Ann Oncol. 2004;15:1749-59.
33. Price D, Stein B, Sieber P et al. Toremifene for the prevention of prostate cancer in men with high grade prostatic intraepithelial neoplasia: results of a double-blind, placebo controlled, phase IIB clinical trial. J Urol. 2006; 176:965-71. [PubMed 16890670]
34. Bishop J, Murray R, Webster L et al. Phase I clinical and pharmacokinetics study of high-dose toremifene in postmenopausal patients with advanced breast cancer. Cancer Chemother Pharmacol. 1992; 30:174-8. [PubMed 1385761]
Apo-Calcitonin may be available in the countries listed below.
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To reduce the development of drug-resistant bacteria and maintain the effectiveness of vancomycin and other antibacterial drugs, vancomycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
Vancomycin Injection, USP in the GALAXY plastic container (PL 2040) contains vancomycin, added as Vancomycin Hydrochloride, USP. It is a tricyclic glycopeptide antibiotic derived from Amycolatopsis orientalis (formerly Nocardia orientalis). The molecular formula is C66H75Cl2N9O24• HCl and the molecular weight is 1,485.71. 500 mg of the base is equivalent to 0.34 mmol. Vancomycin Hydrochloride has the following structural formula:
Vancomycin Injection, USP in the GALAXY plastic container (PL 2040) is a frozen, iso-osmotic, sterile, nonpyrogenic premixed 100 mL, 150 mL, or 200 mL solution containing 500 mg, 750 mg, or 1 g Vancomycin respectively as Vancomycin Hydrochloride. Each 100 mL of solution contains approximately 5 g of Dextrose Hydrous, USP. The pH of the solution may have been adjusted with hydrochloric acid and/or sodium hydroxide. Thawed solutions have a pH in the range of 3.0 to 5.0. After thawing to room temperature, this solution is intended for intravenous use only.
This GALAXY container is fabricated from a specially designed multilayer plastic (PL 2040). Solutions are in contact with the polyethylene layer of this container and can leach out certain chemical components of the plastic in very small amounts within the expiration period. The suitability of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies.
In subjects with normal kidney function, multiple intravenous dosing of 1 g of vancomycin (15 mg/kg) infused over 60 minutes produces mean plasma concentrations of approximately 63 mcg/mL immediately after the completion of infusion, mean plasma concentrations of approximately 23 mcg/mL 2 hours after infusion, and mean plasma concentrations of approximately 8 mcg/mL 11 hours after the end of the infusion. Multiple dosing of 500 mg infused over 30 minutes produces mean plasma concentrations of about 49 mcg/mL at the completion of infusion, mean plasma concentrations of about 19 mcg/mL 2 hours after infusion, and mean plasma concentrations of about 10 mcg/mL 6 hours after infusion. The plasma concentrations during multiple dosing are similar to those after a single dose.
The mean elimination half-life of vancomycin from plasma is 4 to 6 hours in subjects with normal renal function. In the first 24 hours, about 75% of an administered dose of vancomycin is excreted in urine by glomerular filtration. Mean plasma clearance is about 0.058 L/kg/h, and mean renal clearance is about 0.048 L/kg/h. Renal dysfunction slows excretion of vancomycin. In anephric patients, the average half-life of elimination is 7.5 days. The distribution coefficient is from 0.3 to 0.43 L/kg. There is no apparent metabolism of the drug. About 60% of an intraperitoneal dose of vancomycin administered during peritoneal dialysis is absorbed systemically in 6 hours. Serum concentrations of about 10 mcg/mL are achieved by intraperitoneal injection of 30 mg/kg of vancomycin. However, the safety and efficacy of the intraperitoneal use of vancomycin has not been established in adequate and well-controlled trials (see PRECAUTIONS).
Total systemic and renal clearance of vancomycin may be reduced in the elderly.
Vancomycin is approximately 55% serum protein bound as measured by ultrafiltration at vancomycin serum concentrations of 10 to 100 mcg/mL. After IV administration of vancomycin, inhibitory concentrations are present in pleural, pericardial, ascitic, and synovial fluids; in urine; in peritoneal dialysis fluid; and in atrial appendage tissue. Vancomycin does not readily diffuse across normal meninges into the spinal fluid; but, when the meninges are inflamed, penetration into the spinal fluid occurs.
The bactericidal action of vancomycin results primarily from inhibition of cell-wall biosynthesis. In addition, vancomycin alters bacterial-cell-membrane permeability and RNA synthesis. There is no cross-resistance between vancomycin and other antibiotics. Vancomycin is not active in vitro against gram-negative bacilli, mycobacteria, or fungi.
The combination of vancomycin and an aminoglycoside acts synergistically in vitro against many strains of Staphylococcus aureus, Streptococcus bovis, enterococci, and the viridans group streptococci.
Vancomycin has been shown to be active against most strains of the following microorganisms, both in vitro and in clinical infections as described in the INDICATIONS AND USAGE section.
Diphtheroids
Enterococci (e.g., Enterococcus faecalis)
Staphylococci, including Staphylococcus aureus and Staphylococcus epidermidis (including heterogeneous methicillin-resistant strains)
Streptococcus bovis
Viridans group streptococci
The following in vitro data are available, but their clinical significance is unknown.
Vancomycin exhibits in vitro MIC’s of 1 mcg/mL or less against most (≥90%) strains of streptococci listed below and MIC’s of 4 mcg/mL or less against most (≥90%) strains of other listed microorganisms; however, the safety and effectiveness of vancomycin in treating clinical infections due to these microorganisms have not been established in adequate and well-controlled clinical trials.
Listeria monocytogenes
Streptococcus pyogenes
Streptococcus pneumoniae (including penicillin-resistant strains)
Streptococcus agalactiae
Actinomyces species
Lactobacillus species
When available, the clinical microbiology laboratory should provide the results of in vitro susceptibility test results for antimicrobial drugs used in local hospitals and practice areas to the physician as periodic reports that describe the susceptibility profile of nosocomial and community-acquired pathogens. These reports should aid the physician in selecting the most effective antimicrobial.
Quantitative methods are used to determine antimicrobial minimum inhibitory concentrations (MICs). These MICs provide estimates of the susceptibility of bacteria to antimicrobial compounds. The MICs should be determined using a standardized procedure. Standardized procedures are based on dilution method1,2 (broth, agar or microdilution) or equivalent using standardized inoculum and concentrations of vancomycin powder. The MIC values should be interpreted according to the criteria in Table 1.
Quantitative methods that require measurement of zone diameters also provide reproducible estimates of the susceptibility of bacteria to antimicrobial compounds. One such standardized procedure2,3 requires the use of standardized inoculum concentrations. This procedure uses paper disks impregnated with 30 mcg of vancomycin to test the susceptibility of microorganisms to vancomycin. Interpretation involves correlation of the diameter obtained in the disk test with the MIC for vancomycin. Reports from the laboratory providing results of the standard single-disk susceptibility test with a 30 mcg vancomycin disk should be interpreted according to the following criteria in Table 1.
| ||||||
| Minimum Inhibitory Concentrations (mcg/mL) | Disk Diffusion Diameters (mm) | |||||
| Pathogen | Susceptible (S) | Intermediate (I) | Resistant (R) | Susceptible (S) | Intermediate (I) | Resistant (R) |
Enterococci* | ≤4 | 8 – 16 | ≥32 | ≥17† | 15 – 16† | ≤14† |
Staphylococcus aureus | ≤2 | 4 – 8 | ≥16 | ≥15‡ | - | - |
Coagulase- negative staphylococci | ≤4 | 8 – 16 | ≥32 | ≥15‡ | - | - |
Streptococci other than S. pneumoniae | ≤1‡,§ | - | - | ≥17‡,¶ | - | - |
A report of “Susceptible” indicates that the pathogen is likely to be inhibited if the antimicrobial compound in the blood reaches the concentrations usually achievable. A report of “Intermediate” indicates that the result should be considered equivocal, and, if the microorganism is not fully susceptible to alternative, clinically feasible drugs, the test should be repeated. This category implies possible clinical applicability in body sites where the drug is physiologically concentrated or in situations where high dosage of drug can be used. This category also provides a buffer zone which prevents small uncontrolled technical factors from causing major discrepancies in interpretation. A report of “Resistant” indicates that the pathogen is not likely to be inhibited if the antimicrobial compound in the blood reaches the concentrations usually achievable; other therapy should be selected.
Standardized susceptibility test procedures require the use of laboratory control microorganisms to monitor and ensure the accuracy and precision of the supplies and reagents used in the assay, and the techniques of the individuals performing the test. Standard vancomycin powder should provide MIC values provided below. For the diffusion technique, the 30 mcg vancomycin disk should provide the following zone diameters with the quality control strains:
| ||
| Organism (ATCC#) | MIC range (mcg/mL) | Disk diffusion range (mm) |
| Enterococcus faecalis (29212) | 1-4 | Not applicable |
| Staphylococcus aureus (29213) | 0.5-2 | Not applicable |
| Staphylococcus aureus (25923) | Not applicable | 17 - 21 |
| Streptococcus pneumoniae (49619)* | 0.12-0.5 | 20 - 27 |
Vancomycin is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (beta-lactam-resistant) staphylococci. It is indicated for penicillin-allergic patients, for patients who cannot receive or who have failed to respond to other drugs, including the penicillins or cephalosporins, and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobial drugs. Vancomycin is indicated for initial therapy when methicillin-resistant staphylococci are suspected, but after susceptibility data are available, therapy should be adjusted accordingly.
Vancomycin is effective in the treatment of staphylococcal endocarditis. Its effectiveness has been documented in other infections due to staphylococci, including septicemia, bone infections, lower respiratory tract infections, skin and skin structure infections. When staphylococcal infections are localized and purulent, antibiotics are used as adjuncts to appropriate surgical measures.
Vancomycin has been reported to be effective alone or in combination with an aminoglycoside for endocarditis caused by Streptococcus viridans or S. bovis. For endocarditis caused by enterococci (e.g., E. faecalis), vancomycin has been reported to be effective only in combination with an aminoglycoside.
Vancomycin has been reported to be effective for the treatment of diphtheroid endocarditis. Vancomycin has been used successfully in combination with either rifampin, an aminoglycoside, or both in early-onset prosthetic valve endocarditis caused by S. epidermidis or diphtheroids.
Specimens for bacteriologic cultures should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to vancomycin.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of vancomycin and other antibacterial drugs, vancomycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Vancomycin is contraindicated in patients with known hypersensitivity to this antibiotic. Solutions containing dextrose may be contraindicated in patients with known allergy to corn or corn products.
Rapid bolus administration (e.g., over several minutes) may be associated with exaggerated hypotension, including shock, and, rarely, cardiac arrest. Vancomycin should be administered over a period of not less than 60 minutes to avoid rapid-infusion-related reactions. Stopping the infusion usually results in prompt cessation of these reactions.
Ototoxicity has occurred in patients receiving vancomycin. It may be transient or permanent. It has been reported mostly in patients who have been given excessive doses, who have an underlying hearing loss, or who are receiving concomitant therapy with another ototoxic agent, such as an aminoglycoside. Vancomycin should be used with caution in patients with renal insufficiency because the risk of toxicity is appreciably increased by high, prolonged blood concentrations.
Dosage of vancomycin must be adjusted for patients with renal dysfunction (see PRECAUTIONS and DOSAGE AND ADMINISTRATION).
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Vancomycin Injection, USP, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.
C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.
Prolonged use of vancomycin may result in the overgrowth of nonsusceptible microorganisms. Careful observation of the patient is essential. If superinfection occurs during therapy, appropriate measures should be taken. In rare instances, there have been reports of pseudomembranous colitis due to C. difficile developing in patients who received intravenous vancomycin.
In order to minimize the risk of nephrotoxicity when treating patients with underlying renal dysfunction or patients receiving concomitant therapy with an aminoglycoside, serial monitoring of renal function should be performed and particular care should be taken in following appropriate dosing schedules (see DOSAGE AND ADMINISTRATION).
Serial tests of auditory function may be helpful in order to minimize the risk of ototoxicity.
Reversible neutropenia has been reported in patients receiving vancomycin (see ADVERSE REACTIONS). Patients who will undergo prolonged therapy with vancomycin or those who are receiving concomitant drugs that may cause neutropenia should have periodic monitoring of the leukocyte count.
Vancomycin is irritating to tissue and must be given by a secure intravenous route of administration. Pain, tenderness, and necrosis occur with inadvertent extravasation. Thrombophlebitis may occur, the frequency and severity of which can be minimized by slow infusion of the drug and by rotation of venous access sites.
There have been reports that the frequency of infusion-related events (including hypotension, flushing, erythema, urticaria, and pruritus) increases with the concomitant administration of anesthetic agents. Infusion-related events may be minimized by the administration of vancomycin as a 60-minute infusion prior to anesthetic induction. The safety and efficacy of vancomycin administered by the intrathecal (intralumbar or intraventricular) route or by the intraperitoneal route have not been established by adequate and well-controlled trials.
Reports have revealed that administration of sterile vancomycin by the intraperitoneal route during continuous ambulatory peritoneal dialysis (CAPD) has resulted in a syndrome of chemical peritonitis. To date, this syndrome has ranged from a cloudy dialysate alone to a cloudy dialysate accompanied by variable degrees of abdominal pain and fever. This syndrome appears to be short-lived after discontinuation of intraperitoneal vancomycin.
Prescribing vancomycin in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
Concomitant administration of vancomycin and anesthetic agents has been associated with erythema and histamine-like flushing (see Usage in Pediatrics under PRECAUTIONS) and anaphylactoid reactions (see ADVERSE REACTIONS).
Concurrent and/or sequential systemic or topical use of other potentially neurotoxic and/or nephrotoxic drugs, such as amphotericin B, aminoglycosides, bacitracin, polymyxin B, colistin, viomycin, or cisplatin, when indicated, requires careful monitoring.
Animal reproduction studies have not been conducted with vancomycin. It is not known whether vancomycin can affect reproduction capacity. In a controlled clinical study, the potential ototoxic and nephrotoxic effects of vancomycin on infants were evaluated when the drug was administered to pregnant women for serious staphylococcal infections complicating intravenous drug abuse. Vancomycin was found in cord blood. No sensorineural hearing loss or nephrotoxicity attributable to vancomycin was noted. One infant whose mother received vancomycin in the third trimester experienced conductive hearing loss that was not attributed to the administration of vancomycin. Because the number of patients treated in this study was limited and vancomycin was administered only in the second and third trimesters, it is not known whether vancomycin causes fetal harm. Vancomycin should be given to a pregnant woman only if clearly needed.
Vancomycin is excreted in human milk. Caution should be exercised when vancomycin is administered to a nursing woman. Because of the potential for adverse events, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
In pediatric patients, it may be appropriate to confirm desired vancomycin serum concentrations. Concomitant administration of vancomycin and anesthetic agents has been associated with erythema and histamine-like flushing in pediatric patients (see PRECAUTIONS). The potential for toxic effects in pediatric patients from chemicals that may leach from the plastic containers into the single-dose, premixed intravenous preparation has not been determined.
The natural decrement of glomerular filtration with increasing age may lead to elevated vancomycin serum concentrations if dosage is not adjusted. Vancomycin dosage schedules should be adjusted in elderly patients (see DOSAGE AND ADMINISTRATION).
Patients should be counseled that antibacterial drugs including vancomycin, should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When vancomycin is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by vancomycin or other antibacterial drugs in the future.
Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.
During or soon after rapid infusion of vancomycin, patients may develop anaphylactoid reactions, including hypotension (see ANIMAL PHARMACOLOGY), wheezing, dyspnea, urticaria, or pruritus. Rapid infusion may also cause flushing of the upper body (“red neck”) or pain and muscle spasm of the chest and back. These reactions usually resolve within 20 minutes but may persist for several hours. Such events are infrequent if vancomycin is given by a slow infusion over 60 minutes. In studies of normal volunteers, infusion-related events did not occur when vancomycin was administered at a rate of 10 mg/min or less.
Renal failure, principally manifested by increased serum creatinine or BUN concentrations, especially in patients administered large doses of vancomycin, has been reported rarely. Cases of interstitial nephritis have also been reported rarely. Most of these have occurred in patients who were given aminoglycosides concomitantly or who had preexisting kidney dysfunction. When vancomycin was discontinued, azotemia resolved in most patients.
Onset of pseudomembranous colitis symptoms may occur during or after antibiotic treatment (see WARNINGS).
A few dozen cases of hearing loss associated with vancomycin have been reported. Most of these patients had kidney dysfunction or a preexisting hearing loss or were receiving concomitant treatment with an ototoxic drug. Vertigo, dizziness, and tinnitus have been reported rarely.
Reversible neutropenia, usually starting 1 week or more after onset of therapy with vancomycin or after a total dosage of more than 25 g, has been reported for several dozen patients. Neutropenia appears to be promptly reversible when vancomycin is discontinued. Thrombocytopenia has rarely been reported. Although a causal relationship has not been established, reversible agranulocytosis (granulocytes <500/mm3) has been reported rarely.
Inflammation at the injection site has been reported.
Infrequently, patients have been reported to have had anaphylaxis, drug fever, nausea, chills, eosinophilia, rashes including exfoliative dermatitis, Stevens-Johnson syndrome, and vasculitis in association with administration of vancomycin.
Chemical peritonitis has been reported following intraperitoneal administration of vancomycin (see PRECAUTIONS).
The following adverse reactions have been identified during post-approval use of vancomycin. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Drug Rash with Eosinophilia and Systemic Symptoms (DRESS)
Supportive care is advised, with maintenance of glomerular filtration. Vancomycin is poorly removed by dialysis.
Hemofiltration and hemoperfusion with polysulfone resin have been reported to result in increased vancomycin clearance. The median lethal intravenous dose is 319 mg/kg in rats and 400 mg/kg in mice.
To obtain up-to-date information about the treatment of overdose, a good resource is your certified Regional Poison Control Center. Telephone numbers of certified poison control centers are listed in the Physicians’ Desk Reference (PDR). In managing overdosage, consider the possibility of multiple drug overdoses, interaction among drugs, and unusual drug kinetics in your patient.
Vancomycin Injection, USP in the GALAXY plastic container (PL 2040) is intended for intravenous use only.
Vancomycin in the GALAXY Container (PL 2040 Plastic) is not to be administered orally. An infusion rate of 10 mg/min or less is associated with fewer infusion-related events (see ADVERSE REACTIONS). Infusion related events may occur, however, at any rate or concentration.
The usual daily intravenous dose is 2 g divided either as 500 mg every 6 hours or 1 g every 12 hours. Each dose should be administered at no more than 10 mg/min or over a period of at least 60 minutes, whichever is longer. Other patient factors, such as age or obesity, may call for modification of the usual intravenous daily dose.
The usual intravenous dosage of vancomycin is 10 mg/kg per dose given every 6 hours. Each dose should be administered over a period of at least 60 minutes. Close monitoring of serum concentrations of vancomycin may be warranted in these patients.
In pediatric patients up to the age of 1 month, the total daily intravenous dosage may be lower. In neonates, an initial dose of 15 mg/kg is suggested, followed by 10 mg/kg every 12 hours for neonates in the 1st week of life and every 8 hours thereafter up to the age of 1 month. Each dose should be administered over 60 minutes. In premature infants, vancomycin clearance decreases as postconceptional age decreases. Therefore, longer dosing intervals may be necessary in premature infants. Close monitoring of serum concentrations of vancomycin is recommended in these patients.
Dosage adjustment must be made in patients with impaired renal function. In the elderly, greater dosage reductions than expected may be necessary because of decreased renal function. Measurement of vancomycin serum concentrations can be helpful in optimizing therapy, especially in seriously ill patients with changing renal function. Vancomycin serum concentrations can be determined by use of microbiologic assay, radioimmunoassay, fluorescence polarization immunoassay, fluorescence immunoassay, or high-pressure liquid chromatography. If creatinine clearance can be measured or estimated accurately, the dosage for most patients with renal impairment can be calculated using the following table. The dosage of vancomycin per day in mg is about 15 times the glomerular filtration rate in mL/min:
| DOSAGE TABLE FOR VANCOMYCIN IN PATIENTS WITH IMPAIRED RENAL FUNCTION (Adapted from Moellering et al)4 | |
| Creatinine Clearance mL/min | Vancomycin Dose mg/24 h |
| 100 | 1,545 |
| 90 | 1,390 |
| 80 | 1,235 |
| 70 | 1,080 |
| 60 | 925 |
| 50 | 770 |
| 40 | 620 |
| 30 | 465 |
| 20 | 310 |
| 10 | 155 |
The initial dose should be no less than 15 mg/kg, even in patients with mild to moderate renal insufficiency. The table is not valid for functionally anephric patients. For such patients, an initial dose of 15 mg/kg of body weight should be given to achieve prompt therapeutic serum concentrations. The dose required to maintain stable concentrations is 1.9 mg/kg/24 h. In patients with marked renal impairment, it may be more convenient to give maintenance doses of 250 to 1,000 mg once every several days rather than administering the drug on a daily basis. In anuria, a dose of 1,000 mg every 7 to 10 days has been recommended.
When only the serum creatinine concentration is known, the following formula (based on sex, weight, and age of the patient) may be used to calculate creatinine clearance. Calculated creatinine clearances (mL/min) are only estimates. The creatinine clearance should be measured promptly.
| Men: | Weight (kg) x (140 – age in years) |
| 72 x serum creatinine concentration (mg/dL) | |
| Women: | 0.85 x above value |
The serum creatinine must represent a steady state of renal function. Otherwise, the estimated value for creatinine clearance is not valid. Such a calculated clearance is an overestimate of actual clearance in patients with conditions: (1) characterized by decreasing renal function, such as shock, severe heart failure, or oliguria; (2) in which a normal relationship between muscle mass and total body weight is not present, such as obese patients or those with liver disease, edema, or ascites; and (3) accompanied by debilitation, malnutrition, or inactivity. The safety and efficacy of vancomycin administration by the intrathecal (intralumbar or intraventricular) routes have not been established.
Intermittent infusion is the recommended method of administration.
Vancomycin Injection, USP in GALAXY plastic container (PL 2040) is for intravenous administration only.
Store in a freezer capable of maintaining a temperature at or below -20°C (-4°F).
Caution: Do not use plastic containers in series connections. Such use could result in an embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is complete.
Rx only.
Vancomycin Injection, USP is supplied as a frozen, iso-osmotic, premixed solution in a 100 mL, 150 mL underfilled /200 mL, or 200 mL single dose GALAXY plastic container (PL 2040) in the following vancomycin-equivalent dose:
| 2G3551 | 500 mg/100 mL container | NDC 0338-3551-48 |
| 2G3580 | 750 mg/150 mL (underfill) in 200 mL container | NDC 0338-3580-48 |
| 2G3552 | 1 g/200 mL container | NDC 0338-3552-48 |
Store at or below -20°C (-4°F).
See DIRECTIONS FOR USE OF Vancomycin Injection, USP in GALAXY plastic container (PL 2040).
Handle frozen product containers with care. Product containers may be fragile in the frozen state.
In animal studies, hypotension and bradycardia occurred in dogs receiving an intravenous infusion of vancomycin 25 mg/kg, at a concentration of 25 mg/mL and an infusion rate of 13.3 mL/min.
Baxter Healthcare Corporation
Deerfield, IL 60015 USA
Printed in USA
Baxter and Galaxy are registered trademarks of Baxter International Inc.
07-19-66-116
Revised, February 2011
Container Label
Baxter
Vancomycin
Injection, USP
750 mg
GALAXY
Single-Dose
Container
150 mL
Iso-osmotic
NDC 0338-3580-48
Code 2G3580
Sterile Nonpyrogenic
Each 100 mL contains: Vancomycin Hydrochloride, USP
equivalent to 500 mg vancomycin with approx. 5 g Dextrose
Hydrous, USP. pH may have been adjusted with hydrochloric acid
and/or sodium hydroxide.
pH range 3.0 to 5.0.
Dosage: Intravenously as directed by a physician. See package insert.
Cautions: Do not add supplementary medication. Must not be
used in series connections. Check for minute leaks and solution clarity.
Rx only
Store at or below -20°C (-4°F). Thaw at room temperature
(25°C/77°F) or under refrigeration (5°C/41°F). DO NOT FORCE
THAW BY IMMERSION IN WATER BATHS OR BY MICROWAVE
IRRADIATION. Thawed solution is stable for 30 days under
refrigeration or 72 hours at room temperature. Do not refreeze.
Baxter and GALAXY are trademarks of Baxter International Inc.
Baxter Healthcare Corporation, Deerfield, IL 60015 USA
PL 2040 Plastic
07-34-61-824
Carton Label
Baxter
Vancomycin Injection, USP
750 mg
NDC 0338-3580-48
Code 2G3580
3 - 150 mL Single Dose Containers Iso-osmotic
Store at or below -20°C/-4°F. Do not refreeze.
Baxter Healthcare Corporation
Deerfield, IL 60015 USA
*FOR BAR CODE POSITION ONLY
(01) 20303383580485
GALAXY Container
Sterile Nonpyrogenic
Each 100 mL contains: Vancomycin Hydrochloride, USP equivalent to 500 mg vancomycin with approx. 5 g Dextrose Hydrous, USP. pH may have been adjusted with hydrochloric acid and/or sodium hydroxide. pH range 3.0 to 5.0
Dosage:
