Celestoderm-V may be available in the countries listed below.
Betamethasone 17α-valerate (a derivative of Betamethasone) is reported as an ingredient of Celestoderm-V in the following countries:
Betamethasone valeroacetate (a derivative of Betamethasone) is reported as an ingredient of Celestoderm-V in the following countries:
International Drug Name Search
In the US, Pentagastrin is a member of the drug class miscellaneous uncategorized agents.
UK matches:
Rec.INN
V04CG04
0005534-95-2
C37-H49-N7-O9-S
767
Diagnostic agent, gastric function
Gastric secretory stimulant
L-Phenylalaninamide, N-[(1,1-dimethylethoxy)carbonyl]-ß-alanyl-L-tryptophyl-L-methionyl-L-α-aspartyl-
International Drug Name Search
Glossary
| BAN | British Approved Name |
| DCF | Dénomination Commune Française |
| IS | Inofficial Synonym |
| 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 |
Treating severe allergies, arthritis, asthma, certain blood disorders, and skin conditions. It may also be used for other conditions as determined by your doctor.
Orapred Solution is a corticosteroid. It works by modifying the body's immune response to various conditions and decreasing inflammation.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Orapred Solution. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
Some MEDICINES MAY INTERACT with Orapred Solution. Tell your health care provider if you are taking any other medicines, especially any of the following:
This may not be a complete list of all interactions that may occur. Ask your health care provider if Orapred Solution may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Use Orapred Solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Orapred Solution.
If you are on long-term or high dosage therapy and you suddenly stop taking Orapred Solution, you may have WITHDRAWAL symptoms, including fever, vomiting, appetite loss, diarrhea, nausea, dizziness, weight loss, weakness, general body discomfort, or joint or muscle pain.
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Acne; clumsiness; dizziness; facial flushing; feeling of a whirling motion; general body discomfort; headache; increased appetite; increased sweating; nausea; nervousness; sleeplessness; upset stomach.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; changes in body fat; changes in menstrual period; changes in skin color; chest pain; easy bruising or bleeding; infection (eg, fever, chills, sore throat); mental or mood changes (eg, depression); muscle pain, weakness, or wasting; seizures; severe nausea or vomiting; sudden severe dizziness or headache; swelling of feet or legs; tendon or bone pain; thinning of skin; unusual skin sensation; unusual weight gain; vision changes or other eye problems; vomit that looks like coffee grounds.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
See also: Orapred side effects (in more detail)
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.
Check with your pharmacist for storage instructions. Some brands of Orapred Solution (eg, Orapred) must be stored in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Others may be stored at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Do not freeze. Keep Orapred Solution out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Orapred Solution. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
meth-OX-a-len
Methoxsalen with UV radiation should be used only by physicians who have special competence in diagnosis and treatment of psoriasis and who have special training and experience in photochemotherapy. Photochemotherapy should be restricted to patients with severe, recalcitrant, disabling psoriasis which is not adequately responsive to other forms of therapy. Risks of therapy include ocular damage, aging of the skin, and skin cancer (including melanoma). The soft gelatin capsules should not be used interchangeably with regular methoxsalen hard gelatin capsules due to greater bioavailability and earlier photosensitization onset time .
In the U.S.
Available Dosage Forms:
Therapeutic Class: Antipsoriatic
Chemical Class: Psoralen
Methoxsalen belongs to the group of medicines called psoralens. It is used along with ultraviolet light (found in sunlight and some special lamps) in a treatment called PUVA to treat vitiligo, a disease in which skin color is lost, and psoriasis, a skin condition associated with red and scaly patches.
Methoxsalen is also used with ultraviolet light in the treatment of white blood cells. This treatment is called photopheresis and is used to treat the skin problems associated with mycosis fungoides, which is a type of lymphoma.
Methoxsalen may also be used for other conditions as determined by your doctor.
methoxsalen 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 the product labeling, methoxsalen 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 methoxsalen, the following should be considered:
Methoxsalen is a very strong medicine that increases the skin's sensitivity to sunlight. In addition to causing serious sunburns if not properly used, it has been reported to increase the chance of skin cancer and cataracts. Also, like too much sunlight, PUVA can cause premature aging of the skin. Therefore, methoxsalen should be used only as directed and it should not be used simply for suntanning. Before using methoxsalen, be sure that you have discussed its use with your doctor.
Tell your doctor if you have ever had any unusual or allergic reaction to methoxsalen 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.
Some of the side effects are more likely to occur in children up to 12 years of age, since these children may be more sensitive to the effects of methoxsalen.
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. There is no specific information comparing use of methoxsalen in the elderly with use in other age groups.
| 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 methoxsalen, 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 methoxsalen 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 methoxsalen. Make sure you tell your doctor if you have any other medical problems, especially:
Eating certain foods while you are taking methoxsalen may increase your skin's sensitivity to sunlight. To help prevent this, avoid eating limes, figs, parsley, parsnips, mustard, carrots, and celery while you are being treated with methoxsalen.
Methoxsalen usually comes with patient directions. Read them carefully before using methoxsalen.
methoxsalen may take 6 to 8 weeks to really help your condition. Do not increase the amount of methoxsalen you are taking or spend extra time in the sunlight or under an ultraviolet lamp. This will not make the medicine act any more quickly and may result in a serious burn.
If methoxsalen upsets your stomach:
The dose of methoxsalen 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 methoxsalen. 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.
Call your doctor or pharmacist for instructions.
If you are late in taking, or miss taking, a dose of methoxsalen, notify your doctor so your light treatment can be rescheduled. Remember that exposure to sunlight or ultraviolet light must take place a certain number of hours after you take the medicine or it will not work. For patients taking the hard gelatin capsules, this is 2 to 4 hours. For patients taking the soft gelatin capsules, this is 1½ to 2 hours. If you have any questions about this, check with your doctor.
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.
Your doctor should check your progress at regular visits to make sure methoxsalen is working and that it does not cause unwanted effects. Eye examinations should be included.
methoxsalen increases the sensitivity of your skin and lips to sunlight. Therefore, exposure to the sun, even through window glass or on a cloudy day, could cause a serious burn. If you must go out during the daylight hours:
If you have any questions about this, check with your health care professional.
Your skin may continue to be sensitive to sunlight for some time after treatment with methoxsalen. Use extra caution for at least 48 hours following each treatment if you plan to spend any time in the sun. In addition, do not sunbathe anytime during your course of treatment with methoxsalen.
For 24 hours after you take each dose of methoxsalen, your eyes should be protected during daylight hours with special wraparound sunglasses that totally block or absorb ultraviolet light (ordinary sunglasses are not adequate). This is to prevent cataracts. Your doctor will tell you what kind of sunglasses to use. These glasses should be worn even in indirect light, such as light coming through window glass or on a cloudy day.
methoxsalen may cause your skin to become dry or itchy. However, check with your doctor before applying anything to your skin to treat this problem.
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:
Treatment with methoxsalen usually causes a slight reddening of your skin 24 to 48 hours after the treatment. This is an expected effect and is no cause for concern. However, check with your doctor right away if your skin becomes sore and red or blistered.
There is an increased risk of developing skin cancer after use of methoxsalen. You should check your body regularly and show your doctor any skin sores that do not heal, new skin growths, and skin growths that have changed in the way they look or feel.
Premature aging of the skin may occur as a result of prolonged methoxsalen therapy. This effect is permanent and is similar to what happens when a person sunbathes for long periods of time.
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.
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.
Pantozol Control may be available in the countries listed below.
Pantoprazole sodium (a derivative of Pantoprazole) is reported as an ingredient of Pantozol Control in the following countries:
International Drug Name Search
In the US, Terramycin with Polymyxin B Sulfate (oxytetracycline/polymyxin b ophthalmic) is a member of the drug class ophthalmic anti-infectives and is used to treat Conjunctivitis - Bacterial and Eye Dryness/Redness.
US matches:
Oxytetracycline hydrochloride (a derivative of Oxytetracycline) is reported as an ingredient of Terramycin with Polymyxin B Sulfate in the following countries:
Polymyxin B sulfate (a derivative of Polymyxin B) is reported as an ingredient of Terramycin with Polymyxin B Sulfate in the following countries:
International Drug Name Search
Pilopos may be available in the countries listed below.
Pilocarpine nitrate (a derivative of Pilocarpine) is reported as an ingredient of Pilopos in the following countries:
International Drug Name Search
Pioglar may be available in the countries listed below.
Pioglitazone hydrochloride (a derivative of Pioglitazone) is reported as an ingredient of Pioglar in the following countries:
International Drug Name Search
Nydrazid may cause severe and sometimes fatal liver problems (eg, hepatitis). The risk of liver problems is greater in patients older than 35 years old. It may also be increased by daily use of alcohol, long-term liver problems, or unsanitary injectable drug use. Women, especially those who are black, are Hispanic, or have just had a baby, may also be at increased risk. Hepatitis can develop at any time during treatment, but usually occurs during the first 3 months. Your doctor will monitor your liver function and discuss your progress every month.
Contact your doctor right away if you develop unusual fatigue, weakness or fever that lasts longer than 3 days, general feeling of discomfort, loss of appetite, nausea, vomiting, numbness or tingling of the hands or feet, dark urine, yellowing of the skin or eyes, or stomach pain or tenderness. Your doctor may decide to slowly restart isoniazid after these symptoms disappear and lab tests return to normal.
Patients with active liver problems should not use Nydrazid.
Treating or preventing tuberculosis (TB). If you are using Nydrazid to treat TB, it should always be used along with another medicine.
Nydrazid is an antibacterial. It works by killing TB organisms.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Nydrazid. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
Some MEDICINES MAY INTERACT with Nydrazid. Tell your health care provider if you are taking any other medicines, especially any of the following:
This may not be a complete list of all interactions that may occur. Ask your health care provider if Nydrazid may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Use Nydrazid as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Nydrazid.
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Mild stomach upset.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); changes in vision; chills or fever; dark urine; general feeling of discomfort; increased thirst or urination; joint pain or swelling; loss of appetite; memory problems; mental or mood changes; nausea; seizures; stomach pain or tenderness; symptoms of low vitamin B6 levels (eg, confusion, cracks in the corners of the mouth, irritability, mouth redness or soreness, scaly rash); tingling or numbness in the hands or feet; unusual bruising or bleeding; unusual tiredness or weakness; vomiting; yellowing of the skin or eyes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
See also: Nydrazid side effects (in more detail)
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include blurred vision; dizziness; hallucinations; loss of consciousness; nausea; seizures; slurred speech; symptoms of high blood sugar (eg, confusion, increased thirst or urination, rapid breathing, unusual drowsiness); very slow breathing; vomiting.
Nydrazid is usually handled and stored by a health care provider. If you are using Nydrazid at home, store Nydrazid as directed by your pharmacist or health care provider. Keep Nydrazid out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Nydrazid. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
Zofistar may be available in the countries listed below.
Zofenopril is reported as an ingredient of Zofistar in the following countries:
Zofenopril calcium salt (a derivative of Zofenopril) is reported as an ingredient of Zofistar in the following countries:
International Drug Name Search
Treating painful and irritating symptoms of the urinary tract due to urinary tract infections or diagnostic procedures.
Belladonna Alkaloids/Methenamine/Methylene Blue/Phenyl Salicylate is a urinary antiseptic, analgesic, and anticholinergic combination. It works by helping to kill bacteria in the urine, decreasing pain and inflammation, and reducing muscle spasms in the urinary tract. These actions work together to help relieve discomfort while urinating.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Belladonna Alkaloids/Methenamine/Methylene Blue/Phenyl Salicylate. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
Some MEDICINES MAY INTERACT with Belladonna Alkaloids/Methenamine/Methylene Blue/Phenyl Salicylate. Tell your health care provider if you are taking any other medicines, especially any of the following:
This may not be a complete list of all interactions that may occur. Ask your health care provider if Belladonna Alkaloids/Methenamine/Methylene Blue/Phenyl Salicylate may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Use Belladonna Alkaloids/Methenamine/Methylene Blue/Phenyl Salicylate as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Belladonna Alkaloids/Methenamine/Methylene Blue/Phenyl Salicylate.
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Dry mouth; flushing; nausea; vomiting.
Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision; difficulty urinating; dizziness; fast or irregular heartbeat.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.
Store Belladonna Alkaloids/Methenamine/Methylene Blue/Phenyl Salicylate at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Belladonna Alkaloids/Methenamine/Methylene Blue/Phenyl Salicylate out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Belladonna Alkaloids/Methenamine/Methylene Blue/Phenyl Salicylate. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
Pleiamide may be available in the countries listed below.
Chlorpropamide is reported as an ingredient of Pleiamide in the following countries:
Metformin hydrochloride (a derivative of Metformin) is reported as an ingredient of Pleiamide in the following countries:
International Drug Name Search
Polhumin MIX-3 may be available in the countries listed below.
Insulin Injection, Biphasic Isophane human (a derivative of Insulin Injection, Biphasic Isophane) is reported as an ingredient of Polhumin MIX-3 in the following countries:
International Drug Name Search
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefadroxil tablets and other antibacterial drugs, Cefadroxil tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
Cefadroxil is a semisynthetic cephalosporin antibiotic intended for oral administration. It is a white to off-white crystalline powder. It is soluble in water and it is acid-stable. It is chemically designated as (6 R,7R) - 7 - [(R) - 2 - amino - 2 - (p - hydroxyphenyl)acetamido] - 3 - methyl - 8 - oxo - 5 - thia - 1 - azabicyclo[4.2.0]oct - 2 - ene - 2 - carboxylic acid monohydrate. It has the following structural formula:
C16H17N3O5S•H2O M.W. 381.40
Cefadroxil oral tablets available in a 1000 mg strength contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, and microcrystalline cellulose.
Cefadroxil is rapidly absorbed after oral administration. Following single doses of 500 mg and 1000 mg, average peak serum concentrations were approximately 16 and 28 mcg/mL, respectively. Measurable levels were present 12 hours after administration. Over 90% of the drug is excreted unchanged in the urine within 24 hours. Peak urine concentrations are approximately 1800 mcg/mL during the period following a single 500 mg oral dose. Increases in dosage generally produce a proportionate increase in Cefadroxil urinary concentration. The urine antibiotic concentration, following a 1 g dose, was maintained well above the MIC of susceptible urinary pathogens for 20 to 22 hours.
In vitro tests demonstrate that the cephalosporins are bactericidal because of their inhibition of cell-wall synthesis. Cefadroxil has been shown to be active against the following organisms both in vitro and in clinical infections (see INDICATIONS AND USAGE):
Beta-hemolytic streptococci
Staphylococci, including penicillinase-producing strains
Streptococcus (Diplococcus) pneumoniae
Escherichia coli
Proteus mirabilis
Klebsiella species
Moraxella (Branhamella) catarrhalis
Note: Most strains of Enterococcus faecalis (formerly Streptococcus faecalis) and Enterococcus faecium (formerly Streptococcus faecium) are resistant to Cefadroxil. It is not active against most strains of Enterobacter species, Morganella morganii (formerly Proteus morganii), and P. vulgaris. It has no activity against Pseudomonas species and Acinetobacter calcoaceticus (formerly Mima and Herellea species).
The use of antibiotic disk susceptibility test methods which measure zone diameter give an accurate estimation of antibiotic susceptibility. One such standard procedure1 which has been recommended for use with disks to test susceptibility of organisms to Cefadroxil uses the cephalosporin class (cephalothin) disk. Interpretation involves the correlation of the diameters obtained in the disk test with the minimum inhibitory concentration (MIC) for Cefadroxil.
Reports from the laboratory giving results of the standard single-disk susceptibility test with a 30 mcg cephalothin disk should be interpreted according to the following criteria:
| Zone diameter (mm) | Interpretation |
| ≥ 18 | (S) Susceptible |
| 15 to 17 | (I) Intermediate |
| ≤ 14 | (R) Resistant |
A report of “Susceptible” indicates that the pathogen is likely to be inhibited by generally achievable blood levels. A report of “Intermediate susceptibility” suggests that the organism would be susceptible if high dosage is used or if the infection is confined to tissue and fluids (e.g., urine) in which high antibiotic levels are attained. A report of “Resistant” indicates that achievable concentrations of the antibiotic are unlikely to be inhibitory and other therapy should be selected.
Standardized procedures require the use of laboratory control organisms. The 30 mcg cephalothin disk should give the following zone diameters:
| Organism | Zone Diameter (mm) |
| Staphylococcus aureus ATCC 25923 | 29 to 37 |
| Escherichia coli ATCC 25922 | 17 to 22 |
When using the NCCLS agar dilution or broth dilution (including microdilution) method2 or equivalent, a bacterial isolate may be considered susceptible if the MIC (minimum inhibitory concentration) value for cephalothin is 8 mcg/mL or less. Organisms are considered resistant if the MIC is 32 mcg/mL or greater. Organisms with an MIC value of less than 32 mcg/mL but greater than 8 mcg/mL are intermediate.
As with standard diffusion methods, dilution procedures require the use of laboratory control organisms. Standard cephalothin powder should give MIC values in the range of 0.12 mcg/mL and 0.5 mcg/mL for Staphylococcus aureus ATCC 29213. For Escherichia coli ATCC 25922, the MIC range should be between 4.0 mcg/mL and 16.0 mcg/mL. For Streptococcus faecalis ATCC 29212, the MIC range should be between 8.0 and 32.0 mcg/mL.
Cefadroxil tablets are indicated for the treatment of patients with infection caused by susceptible strains of the designated organisms in the following diseases:
Urinary tract infections caused by E. coli, P. mirabilis, and Klebsiella species.
Skin and skin structure infections caused by staphylococci and/or streptococci.
Pharyngitis and/or tonsillitis caused by Streptococcus pyogenes (Group A beta-hemolytic streptococci).
Note: Only penicillin by the intramuscular route of administration has been shown to be effective in the prophylaxis of rheumatic fever. Cefadroxil is generally effective in the eradication of streptococci from the oropharynx. However, data establishing the efficacy of Cefadroxil for the prophylaxis of subsequent rheumatic fever are not available.
Note: Culture and susceptibility tests should be initiated prior to and during therapy. Renal function studies should be performed when indicated.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefadroxil tablets and other antibacterial drugs, Cefadroxil tablets 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.
Cefadroxil tablets are contraindicated in patients with known allergy to the cephalosporin group of antibiotics.
BEFORE THERAPY WITH Cefadroxil IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO Cefadroxil, CEPHALOSPORINS, PENICILLINS, OR OTHER DRUGS. IF THIS PRODUCT IS TO BE GIVEN TO PENICILLIN-SENSITIVE PATIENTS, CAUTION SHOULD BE EXERCISED BECAUSE CROSS-SENSITIVITY AMONG BETA-LACTAM ANTIBIOTICS HAS BEEN CLEARLY DOCUMENTED AND MAY OCCUR IN UP TO 10% OF PATIENTS WITH A HISTORY OF PENICILLIN ALLERGY.
IF AN ALLERGIC REACTION TO Cefadroxil OCCURS, DISCONTINUE THE DRUG. SERIOUS ACUTE HYPERSENSITIVITY REACTIONS MAY REQUIRE TREATMENT WITH EPINEPHRINE AND OTHER EMERGENCY MEASURES, INCLUDING OXYGEN, INTRAVENOUS FLUIDS, INTRAVENOUS ANTIHISTAMINES, CORTICOSTEROIDS, PRESSOR AMINES, AND AIRWAY MANAGEMENT, AS CLINICALLY INDICATED.
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Cefadroxil, 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.
Cefadroxil should be used with caution in the presence of markedly impaired renal function (creatinine clearance rate of less than 50 mL/min/1.73 m2). (See DOSAGE AND ADMINISTRATION.) In patients with known or suspected renal impairment, careful clinical observation and appropriate laboratory studies should be made prior to and during therapy.
Prescribing Cefadroxil tablets 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.
Prolonged use of Cefadroxil may result in the overgrowth of nonsusceptible organisms. Careful observation of the patient is essential. If superinfection occurs during therapy, appropriate measures should be taken.
Cefadroxil should be prescribed with caution in individuals with history of gastrointestinal disease particularly colitis.
Patients should be counseled that antibacterial drugs including Cefadroxil tablets should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Cefadroxil tablets are 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 Cefadroxil tablets 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.
Positive direct Coombs’ tests have been reported during treatment with the cephalosporin antibiotics. In hematologic studies or in transfusion cross-matching procedures when antiglobulin tests are performed on the minor side or in Coombs’ testing of newborns whose mothers have received cephalosporin antibiotics before parturition, it should be recognized that a positive Coombs’ test may be due to the drug.
No long-term studies have been performed to determine carcinogenic potential. No genetic toxicity tests have been performed.
Reproduction studies have been performed in mice and rats at doses up to 11 times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to Cefadroxil monohydrate. 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.
Cefadroxil has not been studied for use during labor and delivery. Treatment should only be given if clearly needed.
Caution should be exercised when Cefadroxil monohydrate is administered to a nursing mother.
(See DOSAGE AND ADMINISTRATION.)
Of approximately 650 patients who received Cefadroxil for the treatment of urinary tract infections in three clinical trials, 28% were 60 years and older, while 16% were 70 years and older. Of approximately 1,000 patients who received Cefadroxil for the treatment of skin and skin structure infection in 14 clinical trials, 12% were 60 years and older while 4% were 70 years and over. No overall differences in safety were observed between the elderly patients in these studies and younger patients. Clinical studies of Cefadroxil for the treatment of pharyngitis or tonsillitis did not include sufficient numbers of patients 65 years and older to determine whether they respond differently from younger patients. Other reported clinical experience with Cefadroxil has not identified differences in responses between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
Cefadroxil is substantially excreted by the kidney, and dosage adjustment is indicated for patients with renal impairment (see DOSAGE AND ADMINISTRATION, Renal Impairment). Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
Onset of pseudomembranous colitis symptoms may occur during or after antibiotic treatment (see WARNINGS). Dyspepsia, nausea and vomiting have been reported rarely. Diarrhea has also occurred.
Allergies (in the form of rash, urticaria, angioedema, and pruritus) have been observed. These reactions usually subsided upon discontinuation of the drug. Anaphylaxis has also been reported.
Other reactions have included hepatic dysfunction including cholestasis and elevations in serum transaminase, genital pruritus, genital moniliasis, vaginitis, moderate transient neutropenia, fever. Agranulocytosis, thrombocytopenia, idiosyncratic hepatic failure, erythema multiforme, Stevens-Johnson syndrome, serum sickness, and arthralgia have been rarely reported.
In addition to the adverse reactions listed above which have been observed in patients treated with Cefadroxil, the following adverse reactions and altered laboratory tests have been reported for cephalosporin-class antibiotics:
Toxic epidermal necrolysis, abdominal pain, superinfection, renal dysfunction, toxic nephropathy, aplastic anemia, hemolytic anemia, hemorrhage, prolonged prothrombin time, positive Coombs’ test, increased BUN, increased creatinine, elevated alkaline phosphatase, elevated aspartate aminotransferase (AST), elevated alanine aminotransferase (ALT), elevated bilirubin, elevated LDH, eosinophilia, pancytopenia, neutropenia.
Several cephalosporins have been implicated in triggering seizures, particularly in patients with renal impairment, when the dosage was not reduced (see DOSAGE AND ADMINISTRATION and OVERDOSAGE). If seizures associated with drug therapy occur, the drug should be discontinued. Anticonvulsant therapy can be given if clinically indicated.
A study of children under six years of age suggested that ingestion of less than 250 mg/kg of cephalosporins is not associated with significant outcomes. No action is required other than general support and observation. For amounts greater than 250 mg/kg, induce gastric emptying.
In five anuric patients, it was demonstrated that an average of 63% of a 1 g oral dose is extracted from the body during a 6 to 8 hour hemodialysis session.
Cefadroxil tablets are acid-stable and may be administered orally without regard to meals. Administration with food may be helpful in diminishing potential gastrointestinal complaints occasionally associated with oral cephalosporin therapy.
For uncomplicated lower urinary tract infections (i.e., cystitis) the usual dosage is 1 or 2 g per day in a single (q.d.) or divided doses (b.i.d.).
For all other urinary tract infections the usual dosage is 2 g per day in divided doses (b.i.d.).
For skin and skin structure infections the usual dosage is 1 g per day in single (q.d.) or divided doses (b.i.d.).
Treatment of group A beta-hemolytic streptococcal pharyngitis and tonsillitis - 1 g per day in single (q.d.) or divided doses (b.i.d.) for 10 days.
For urinary tract infections, the recommended daily dosage for children is 30 mg/kg/day in divided doses every 12 hours. For pharyngitis, tonsillitis, and impetigo, the recommended daily dosage for children is 30 mg/kg/day in a single dose or in equally divided doses every 12 hours. For other skin and skin structure infections, the recommended daily dosage is 30 mg/kg/day in equally divided doses every 12 hours. In the treatment of beta-hemolytic streptococcal infections, a therapeutic dosage of Cefadroxil tablets should be administered for at least 10 days.
In patients with renal impairment, the dosage of Cefadroxil monohydrate should be adjusted according to creatinine clearance rates to prevent drug accumulation. The following schedule is suggested. In adults, the initial dose is 1000 mg of Cefadroxil tablets and the maintenance dose (based on the creatinine clearance rate [mL/min/1.73 m2]) is 500 mg at the time intervals listed below.
| Creatinine Clearances | Dosage Interval |
| 0 to 10 mL/min | 36 hours |
| 10 to 25 mL/min | 24 hours |
| 25 to 50 mL/min | 12 hours |
Patients with creatinine clearance rates over 50 mL/min may be treated as if they were patients having normal renal function.
Cefadroxil tablets USP, 1000 mg are available as white to off-white, oval-shaped tablets, debossed “93” on one side (with a bisect cut between the 9 and 3) and “4059” on the other side, containing Cefadroxil monohydrate equivalent to 1000 mg of Cefadroxil, packaged in bottles of 50 tablets.
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
Dispense in a tight container as defined in the USP. Use child-resistant closure (as required).
Manufactured By:
TEVA PHARMACEUTICALS USA
Sellersville, PA 18960
Rev. A 6/2007
NDC 0093-4059-53
Cefadroxil
Tablets USP
1000 mg*
*Each tablet contains:
Cefadroxil monohydrate equivalent
to 1000 mg Cefadroxil.
Rx only
50 TABLETS
TEVA
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| ANDA | ANDA062774 | 01/04/2011 | |
| Labeler - TEVA Pharmaceuticals USA Inc (118234421) |
