Carbenicillina may be available in the countries listed below.
Carbenicillina (DCIT) is known as Carbenicillin in the US.
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Glossary
| DCIT | Denominazione Comune Italiana |
Sotalol NM Pharma may be available in the countries listed below.
Sotalol hydrochloride (a derivative of Sotalol) is reported as an ingredient of Sotalol NM Pharma in the following countries:
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Relieving symptoms of sinus congestion and cough due to colds, upper respiratory infections, and allergies. It may also be used for other conditions as determined by your doctor.
Respi-Tann Chewable Tablets are a decongestant and cough suppressant combination. The decongestant works by constricting blood vessels and reducing swelling in the nasal passages. The cough suppressant works in the brain to help decrease the cough reflex to reduce a dry cough.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Respi-Tann Chewable Tablets. 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 Respi-Tann Chewable Tablets. 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 Respi-Tann Chewable Tablets 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 Respi-Tann Chewable Tablets 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 Respi-Tann Chewable Tablets.
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Constipation; diarrhea; dizziness; drowsiness; excitability; headache; loss of appetite; nausea; nervousness or anxiety; trouble sleeping; upset stomach; vomiting; weakness.
Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty urinating or inability to urinate; fast or irregular heartbeat; hallucinations; seizures; severe dizziness, lightheadedness, or headache; tremor; vision changes.
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: Respi-Tann 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; confusion; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; unusually fast, slow, or irregular heartbeat; vomiting.
Store Respi-Tann Chewable Tablets at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Respi-Tann Chewable Tablets out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Respi-Tann Chewable Tablets. 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.
Vancomicina Combino Pharm may be available in the countries listed below.
Vancomycin is reported as an ingredient of Vancomicina Combino Pharm in the following countries:
Vancomycin hydrochloride (a derivative of Vancomycin) is reported as an ingredient of Vancomicina Combino Pharm in the following countries:
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CTC Spray may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Chlortetracycline hydrochloride (a derivative of Chlortetracycline) is reported as an ingredient of CTC Spray in the following countries:
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Cromogen Easi-Breath may be available in the countries listed below.
Cromoglicic Acid disodium salt (a derivative of Cromoglicic Acid) is reported as an ingredient of Cromogen Easi-Breath in the following countries:
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Class: Immunosuppressive Agents
VA Class: IM600
CAS Number: 179045-86-4
Brands: Simulect
Should be prescribed only by clinicians experienced in immunosuppressive therapy and the management of organ transplant patients.1
The clinician responsible for the administration of basiliximab should have complete information necessary for follow-up of the patient.1
Should only be administered by medical personnel trained in administration of the drug and who have adequate laboratory and supportive medical resources.1
Immunosuppressive agent; recombinant DNA-derived chimeric (human-murine) monoclonal antibody.1 2 3 4 5
Prevention of renal allograft rejection.1 2 3 5
Manufacturer recommends use in conjunction with cyclosporine and corticosteroids.1
Efficacy in preventing acute rejection of a second renal allograft or other solid organ transplants (e.g., liver transplantation) has not been demonstrated.1
Administer only by direct IV (“bolus”) injection or IV infusion via a central or peripheral line.1 7
Direct IV injection may be associated with nausea, vomiting, and local reactions, including pain.1 7
Administer in conjunction with cyclosporine and corticosteroid therapy.1
Administer only when it has been determined that the patient will receive the graft and concomitant immunosuppressive therapy.1
10 mg vial: add 2.5 mL of sterile water for injection.a Reconstituted solution is isotonic; may administer by direct IV injection or dilute for IV infusion.a
20 mg vial: add 5 mL of sterile water for injection.1 Reconstituted solution is isotonic; may administer by direct IV injection or dilute for IV infusion.1
Shake vial gently to dissolve.1
10 mg vial: for IV infusion, dilute reconstituted solution to 25 mL with 0.9% sodium chloride or 5% dextrose injection.a
20 mg vial: for IV infusion, dilute reconstituted solution to 50 mL with 0.9% sodium chloride or 5% dextrose injection.1
Gently invert the IV bag to mix the solution without foaming; do not shake.1
For IV infusion, administer over 20–30 minutes.1
Weight < 35 kg: 2 doses, 10 mg each, by direct IV injection or IV infusions.1 7
Weight ≥ 35 kg: 2 doses, 20 mg each.1 7
Administer first dose within 2 hours prior to transplantation, second dose 4 days after transplantation.1 2 3 5
Withhold second dose if complications (e.g., severe hypersensitivity reactions, graft loss) occur after the first dose.1
2 doses, 20 mg each, by direct IV injection or IV infusion.
Administer first dose within 2 hours prior to transplantation, second dose 4 days after transplantation.1 2 3 5
Withhold second dose if complications (e.g., severe hypersensitivity reactions, graft loss) occur after the first dose.1
Not determined; at least one pediatric renal transplant patient received single 20-mg dose (2.3 mg/kg) without adverse events.1
Not determined; single doses up to 60 mg or divided doses over 3-5 days of up to 120 mg given without serious adverse effects.1
Dosage adjustment is not required for geriatric patients; in general, use immunosupressive agents with caution.1
Known hypersensitivity to basiliximab or any ingredient in the formulation.1
(See Boxed Warning.)
Monitor patients for lymphoproliferative disorders and/or opportunistic infections; risk is increased with immunosuppressive therapy.1
Neither complication occurred more often with basiliximab than with placebo in clinical trials.1
Severe, acute (onset within 24 hours) hypersensitivity reactions, including anaphylaxis, have occurred after initial basiliximab exposure and subsequent reexposure.1
Drugs to treat severe hypersensitivity reactions, including anaphylaxis, should be immediately available.1
In patients who have previously received the drug, a subsequent course of therapy with basiliximab should be given with extreme caution; risks of subsequent administration not known.1
If hypersensitivity reaction occurs, immediately and permanently discontinue basiliximab and institute appropriate therapy as indicated (e.g., epinephrine, corticosteroids, maintenance of an adequate airway and oxygen).1
Patients who have a severe hypersensitivity reaction to basiliximab should not receive the drug again.1
Not known whether the immune response to vaccines, infection, and other antigens is impaired during therapy or will remain impaired following therapy.1
An anti-idiotype antibody response has been detected in renal-transplant patients treated with basiliximab.1 5 No deleterious clinical effect and no evidence of faster basiliximab clearance or shorter duration of basiliximab saturation of IL-2Rα detected in the presence of anti-idiotype antibody.1 Clinical data suggest that subsequent use of muromonab-CD3 or other murine anti-lymphocytic antibody preparations is not precluded.1
Category B.1
Manufacturer recommends use of effective contraception before, during, and for 4 months following basiliximab use in women of childbearing potential.1
Not known whether basiliximab is distributed into milk.1 Discontinue nursing or the drug.1
Use in children 1–16 years of age for prevention of renal allograft rejection is supported by limited data from a pediatric safety and pharmacokinetic study.1 7
Limited data in patients ≥65 years of age suggest an adverse effect profile similar to that in younger adults; use immunosuppressive drugs with caution in such patients.1 7
Constipation, nausea, diarrhea, abdominal pain, vomiting, dyspepsia, hyperkalemia, hypokalemia, hyperglycemia, hyperuricemia, hypophosphatemia, hypercholesterolemia, headache, tremor, urinary tract infection, pain, peripheral edema, fever, viral infection, hypertension, dyspnea, upper respiratory tract infection, surgical wound complications, acne, insomnia, anemia.1 2 3
Drug | Interaction | Comments |
|---|---|---|
Immunosuppressive triple-agent regimen (azathioprine or mycophenolate mofetil with cyclosporine and corticosteroids) | Clearance of basiliximab reduced by 22% with azathioprine or by 51% with mycophenolate mofetil triple regimen; however, clearance consistent with dual regimens1 | Basiliximab dosage adjustment unnecessary1 |
Antilymphocyte globulin | No increase in adverse effects1 | |
Antithymocyte globulin | No increase in adverse effects1 | |
Azathioprine | No increase in adverse effects1 | |
Corticosteroids | No increase in adverse effects1 | |
Cyclosporine | No increase in adverse effects1 | |
Mycophenolate mofetil | No increase in adverse effects1 | |
Muromonab-CD3 | No increase in adverse effects1 |
Duration of clinically important IL-2 receptor blockade by basiliximab is unknown.a
Duration of basiliximab IL-2 Rα saturation when added to double regimen (cyclosporine and corticosteroids) averages 36 days in children and adults.a
Duration of basiliximab IL-2 Rα saturation varies with regimen; when added to triple regimens (cyclosporine and corticosteroids plus azathioprine or mycophenolate mofetil), duration averages 50 days with azathioprine regimen and 59 days with mycophenolate mofetil regimen.a
Generally, immune globulin molecules cross the placenta; not known whether basiliximab crosses placenta or is distributed into milk.a
Adults: average 7.2 days.a
Children 1–11 years of age: average 9.5 days.a
Children 12–16 years of age: average 9.1 days.a
In adults (20–69 years of age), half-life not affected by age.a
2–8°C.1
Use immediately or within 4 hours of preparation if stored at 15–30°C.1 7
Alternatively, may be stored at 2–8°C for up to 24 hours after preparation.1 7
Discard unused solutions within 24 hours.1
Manufacturer makes no storage recommendation.a
For information on systemic interactions resulting from concomitant use, see Interactions.
Compatible |
|---|
5% Dextrose Injection |
0.9% Sodium Chloride Injection |
Incompatibility not observed with polyvinyl chloride bags or infusion sets.1
Unknown whether basiliximab is compatible with other IV drugs.1
Do not mix with other drugs or infuse simultaneously with other drugs in the same IV line.1
A recombinant DNA-derived chimeric (human-murine) monoclonal antibody immunosuppressive agent.1 2 3 4 5
Competitively inhibits IL-2-mediated lymphocyte activation, integral to the cell-mediated immune response involved in allograft rejection.1 2
Binds with high affinity to IL-2Rα and inhibits binding of IL-2 to antigenically stimulated T lymphocytes.1 2
Importance of understanding potential benefits of basiliximab and risks of immunosuppressive therapy.1
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs as well as any concomitant illnesses.1
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1
Importance of informing patients of other important precautionary information. (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 |
|---|---|---|---|---|
Parenteral | Injection | 10 mg | Simulect | Novartis |
20 mg | Simulect | Novartis |
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 May 2004. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
1. Novartis Pharmaceuticals Corporation. Simulect (basiliximab) for injection prescribing information. East Hanover, NJ; 2000 Jun.
2. Nashan B, Moore R, Amlot P et al. Randomised trial of basiliximab versus placebo for control of acute cellular rejection in renal allograft recipients. Lancet. 1997; 350:1193-8. [IDIS 394766] [PubMed 9652559]
3. Kahan BD, Rajagopalan PR, Hall M. Reduction of the occurrence of acute cellular rejection among renal allograft recipients treated with basiliximab, a chimeric anti-interleukin-2-receptor monoclonal antibody. Transplantation. 1999; 67:276-84. [IDIS 422843] [PubMed 10075594]
4. Kovarik JM, Kahan BD, Rajagopalan PR et al. Population pharmacokinetics and exposure-response relationships for basiliximab in kidney transplantation. Transplantation. 1999; 68:1288-94. [IDIS 439006] [PubMed 10573065]
5. Onrust SV, Wiseman LR. Basiliximab. Drugs. 1999; 57:207-13. [PubMed 10188761]
6. Ponticelli C, Yussim A, Cambi V et al. Basiliximab significantly reduces acute rejection in renal transplant patients given triple therapy with azathioprine. Transplant Proc. 2001; 33:1009-10. [IDIS 461658] [PubMed 11267167]
7. Novartis Pharmaceuticals Corporation: Personal communication.
a. Novartis. Simulect (basiliximab) prescribing information. East Hanover, NJ; 2003 Jan.
Ceferro may be available in the countries listed below.
Ferrous Sulfate is reported as an ingredient of Ceferro in the following countries:
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Lucrin may be available in the countries listed below.
Leuprorelin acetate (a derivative of Leuprorelin) is reported as an ingredient of Lucrin in the following countries:
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Tylatrat may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Tylosin tartrate (a derivative of Tylosin) is reported as an ingredient of Tylatrat in the following countries:
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Doloflam may be available in the countries listed below.
Ibuprofen is reported as an ingredient of Doloflam in the following countries:
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Generic Name: calcipotriene topical (cal sih poh TRY een)
Brand Names: Dovonex
Calcipotriene is a synthetic topical form of vitamin D. It is involved in the growth and development of skin cells.
Calcipotriene topical is used to treat plaque psoriasis (psoriasis with scaly patches).
Calcipotriene topical may also be used for purposes other than those listed in this medication guide.
Avoid abrasive, harsh, or drying soaps and cleansers while using calcipotriene topical.
Do not use more than 100 grams of calcipotriene in a week.
Apply calcipotriene topical exactly as directed by your doctor. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.
Wash your hands before and after applying this medication, unless you are using it to treat a hand condition.
Clean and dry the area of skin where you will apply calcipotriene topical. Apply the medication only to the affected area.
Calcipotriene topical is usually applied once or twice a day.
Do not apply more calcipotriene topical than is prescribed by your doctor. Never apply more than 100 grams in a week.
Apply the missed dose as soon as you remember. However, if it is almost time for your next dose, skip the dose you missed and apply only your next regularly scheduled dose.
Symptoms of an overdose of calcipotriene topical include weakness, fatigue, drowsiness, dizziness, headache, decreased appetite, nausea, vomiting, and high levels of calcium in the blood.
Avoid using other topical products at the same time as calcipotriene topical unless they are prescribed by your doctor. Some topical medicines may interfere with the effects or absorption of calcipotriene topical.
Avoid washing the area you are treating more than three times a day. Too much washing may cause your skin to become very dry or irritated.
Avoid using harsh, abrasive, or irritating cleansers, perfumes, or cosmetics on the area you are treating.
You may experience some irritation of the skin, such as burning, itching, redness, swelling, dryness, or peeling while you are using calcipotriene topical. These side effects sometimes lessen with continued treatment. Notify your doctor if you experience these side effects.
If you notice a change in your skin color, contact your doctor.
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.
Avoid using harsh, abrasive, or irritating cleansers, perfumes, or cosmetics on the area you are treating.
Other medicines, especially other topical medicines, may interact with calcipotriene topical. Talk to your doctor and pharmacist before using any prescription or over-the-counter medicines.
See also: Dovonex side effects (in more detail)
In the US, Betapace (sotalol systemic) is a member of the following drug classes: group III antiarrhythmics, non-cardioselective beta blockers and is used to treat Ventricular Arrhythmia.
US matches:
Sotalol hydrochloride (a derivative of Sotalol) is reported as an ingredient of Betapace in the following countries:
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Cupid may be available in the countries listed below.
Sildenafil citrate (a derivative of Sildenafil) is reported as an ingredient of Cupid in the following countries:
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Lisi-Hennig may be available in the countries listed below.
Lisinopril dihydrate (a derivative of Lisinopril) is reported as an ingredient of Lisi-Hennig in the following countries:
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Sunrythm may be available in the countries listed below.
Pilsicainide hydrochloride (a derivative of Pilsicainide) is reported as an ingredient of Sunrythm in the following countries:
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Calprimum may be available in the countries listed below.
Calcium Carbonate is reported as an ingredient of Calprimum in the following countries:
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Sulfatiazol may be available in the countries listed below.
Sulfathiazole is reported as an ingredient of Sulfatiazol in the following countries:
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Ceftrian may be available in the countries listed below.
Ceftriaxone disodium salt (a derivative of Ceftriaxone) is reported as an ingredient of Ceftrian in the following countries:
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Rami-Q comp. may be available in the countries listed below.
Hydrochlorothiazide is reported as an ingredient of Rami-Q comp. in the following countries:
Ramipril is reported as an ingredient of Rami-Q comp. in the following countries:
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Felodipin Sandoz may be available in the countries listed below.
Felodipine is reported as an ingredient of Felodipin Sandoz in the following countries:
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Spironolactone Ratiopharm may be available in the countries listed below.
Spironolactone is reported as an ingredient of Spironolactone Ratiopharm in the following countries:
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Morphin and Antropine may be available in the countries listed below.
Atropine sulfate (a derivative of Atropine) is reported as an ingredient of Morphin and Antropine in the following countries:
Morphine hydrochloride (a derivative of Morphine) is reported as an ingredient of Morphin and Antropine in the following countries:
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Spiropent may be available in the countries listed below.
Clenbuterol hydrochloride (a derivative of Clenbuterol) is reported as an ingredient of Spiropent in the following countries:
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Glitisol may be available in the countries listed below.
Glibenclamide is reported as an ingredient of Glitisol in the following countries:
Thiamphenicol is reported as an ingredient of Glitisol in the following countries:
Thiamphenicol glycinate hydrochloride (a derivative of Thiamphenicol) is reported as an ingredient of Glitisol in the following countries:
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Pranoprofène may be available in the countries listed below.
Pranoprofène (DCF) is also known as Pranoprofen (Rec.INN)
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Glossary
| DCF | Dénomination Commune Française |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
Generic Name: ramelteon (ram EL tee on)
Brand Names: Rozerem
Ramelteon is a sedative, also called a hypnotic. It works by affecting certain substances in your body that help regulate your "sleep-wake cycle."
Ramelteon is used to treat insomnia that is associated with having trouble falling asleep.
Unlike some other sleep medications, ramelteon is not known to be habit-forming.
Ramelteon may also be used for purposes not listed in this medication guide.
You should not take ramelteon if you are also taking the antidepressant fluvoxamine (Luvox).
Before taking ramelteon, tell your doctor if you have liver disease, sleep apnea, a breathing disorder such as chronic obstructive pulmonary disease, or a history of depression, mental illness, or suicidal thoughts.
Take ramelteon 30 minutes before your normal bedtime. After you take ramelteon, avoid doing anything other than getting ready for bed.
Avoid taking ramelteon together with or just after eating a high-fat meal. This will make it harder for your body to absorb the medication.
You should not take ramelteon if you are also taking the antidepressant fluvoxamine (Luvox).
To make sure you can safely take ramelteon, tell your doctor if you have any of these other conditions:
sleep apnea (breathing stops while you are asleep);
a breathing disorder such as chronic obstructive pulmonary disease (COPD); or
a history of depression, mental illness, or suicidal thoughts.
Ramelteon may affect the levels of male or female hormones (testosterone or prolactin). This may affect menstrual periods in women, sexual desire in men, or fertility (ability to have children) in either a man or a woman.
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.
Take ramelteon 30 minutes before your normal bedtime. After you take ramelteon, avoid doing anything other than getting ready for bed.
Avoid taking ramelteon together with or just after eating a high-fat meal. This will make it harder for your body to absorb the medication.
Talk with your doctor if your insomnia does not improve after 7 days of using ramelteon. You may need to be checked for other medical illnesses that may cause insomnia.
See also: Rozerem dosage (in more detail)
Since ramelteon is usually taken as needed, you may not be on a dosing schedule. Ramelteon should be taken only within 30 minutes of your normal bedtime. Do not take extra medicine to make up a missed dose.
unusual thoughts or behavior, hallucinations, worsening depression, thoughts about hurting yourself;
a missed menstrual period;
nipple discharge; or
loss of interest in sex.
Less serious side effects may include:
drowsiness, tired feeling;
dizziness;
nausea; or
worsening sleep problems.
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.
Tell your doctor about all other medicines you use, especially:
donepezil (Aricept);
doxepin (Sinequan, Silenor);
methoxsalen (Oxsoralen);
primaquine or thiabendazole (Mintezol);
rifampin (Rifadin, Rifater, Rifamate, Rimactane);
an antibiotic such as ciprofloxacin (Cipro), norfloxacin (Noroxin), or ofloxacin (Floxin);
heart rhythm medication such as amiodarone (Cordarone, Pacerone) or mexiletine (Mexitil); or
an antifungal medication such as fluconazole (Diflucan) or ketoconazole (Nizoral).
This list is not complete and other drugs may interact with ramelteon. 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: Rozerem side effects (in more detail)
Soludrill Expectorant may be available in the countries listed below.
Carbocisteine is reported as an ingredient of Soludrill Expectorant in the following countries:
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Solvipect may be available in the countries listed below.
Guaifenesin is reported as an ingredient of Solvipect in the following countries:
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CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.
DESCRIPTION: Dexamethasone Solution is a synthetic analogue of prednisolone, having similar but more potent anti-inflammatory therapeutic action and diversified hormonal and metabolic effects. Modification of the basic corticoid structure as achieved in Dexium offers enhanced anti-inflammatory effect compared to older corticosteroids. The dosage of Dexium required is markedly lower than that of prednisone and prednisolone. Dexium is not species-specific; however, the veterinarian should read the sections on INDICATIONS, DOSAGE, SIDE EFFECTS, CONTRAINDICATIONS, PRECAUTIONS, and WARNINGS before this drug is used. Dexium is intended for intravenous or intramuscular administration. Each mL contains 2 mg dexamethasone, 500 mg polyethylene glycol 400, 9 mg benzyl alcohol, 1.8 mg methylparaben and 0.2 mg propylparaben as preservatives, 4.75% alcohol, HCl to adjust pH to approximately 4.9, water for injection q.s.
EXPERIMENTAL STUDIES: Experimental animal studies on dexamethasone have revealed it possesses greater anti-inflammatory activity than many steroids. Veterinary clinical evidence indicates dexamethasone has approximately 20 times the anti-inflammatory activity of prednisolone and 70 to 80 times that of hydrocortisone. Thymus involution studies show dexamethasone possesses 25 times the activity of prenisolone. In reference to mineralcorticoid activity, dexamethasone does not caused significant sodium or water retention. Metabolic balance studies show that animals on controlled and limited protein intake will exhibit nitrogen losses on exceedingly high dosages.
INDICATIONS: Dexium is indicated for the treatment of primary bovine ketosis and as an anti-inflammatory agent in the bovine and equine. As supportive therapy, Dexium may be used in the management of various rheumatic, allergic, dermatologic, and other diseases known to be responsive to anti-inflammatory corticosteroids. Dexium may be used intravenously as supportive therapy when an immediate hormonal response is required.
Bovine Ketosis: Dexium is offered for the treatment of primary ketosis. The gluconeogenic effects of Dexium, when administered intramuscularly, are generally noted within the first 6 to 12 hours. When Dexium is used intravenously, the effects may be noted sooner. Blood sugar levels rise to normal levels rapidly and generally rise to above normal levels within 12 to 24 hours. Acetone bodies are reduced to normal concentrations usually within 24 hours. The physical attitude of animals treated with Dexium brightens and appetite improves, usually within 12 hours. Milk production, which is suppressed as a compensatory reaction in this condition, begins to increase. In some instances, it may even surpass previous peaks. The recovery process usually takes from 3 to 7 days.
Supportive Therapy: Dexium may be used as supportive therapy in mastitis, metritis, traumatic gastritis, and pyelonephritis, while appropriate primary therapy is administered. In these cases, the corticosteroid combats accompanying stress and enhances the feeling of general well-being. Dexium may also be used as supportive therapy in inflammatory conditions such as arthritic conditions, snake bite, acute mastitis, shipping fever, pneumonia, laminitis, and retained placenta.
Equine: Dexium is indicated for the treatment of acute musculoskeletal inflammations, such as bursitis, carpitis, osselets, tendonitis, myositis, and sprains. If boney changes exist in any of these conditions, joints or accessory structures, a response to Dexium cannot be expected. In addition, Dexium may be used as supportive therapy in fatigue, heat exhaustion, influenza, laminitis, and retained placenta provided that the primary cause is determined and corrected.
ADMINISTRATION AND DOSAGE: Therapy with Dexium, as with any other potent corticosteroid, should be individualized according to the severity of the condition being treated, anticipated duration of steroid therapy, and animals threshold or tolerance for steroid excess. Treatment may be changed over to Dexium from any other glucocorticoid with proper reduction or adjustment of doage.
Bovine: Dexium: 5 - 20 mg intravenously or intramuscularly.
Equine: Dexium: 2.5 - 5 mg intravenously or intramuscularly.
PRECAUTIONS: Animals receiving Dexium should be under close observation. Because of the anti-inflammatory action of corticosteroids, signs of infection may be masked and it may be necessary to stop treatment until a further diagnosis is made. Overdosage of some glucocorticoids may result in sodium retention, fluid retention, potassium loss, and weight gain.
Dexium may be administered to animals with acute or chronic bacterial infections providing the infections are controlled with appropriate antibiotic or chemotherapeutic agents.
Doses greater than those recommended in horses may produce transient drowsiness or lethargy in some horses. The lethargy usually abates in 24 hours. Use of corticosteroids, depending on the dose, duration, and specified steroid, may result in inhibition of endogenous steroid production following drug withdrawal. In patients presently receiving or recently withdrawn from systemic corticosteroid treatments, therapy with a rapidly acting corticosteroid should be considered in unusually stressful situations.
WARNINGS: Clinical and experimental data have demonstrated that corticosteroids administered orally or parenterally to animals may induce the first stage of parturition when administered during the last trimester of pregnancy and may precipitate premature parturition followed by dystocia, fetal death, retained placenta, and metritis.
Additionally, corticosteroids administered to dogs, rabbits, and rodents, during pregnancy have produced cleft palate. Other congenital anomalies including deformed forelegs, phocomelia, and anasarca have been reported in offspring of dogs which received corticosteroids during pregnancy.
A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.
SIDE EFFECTS: Side effects, such as SAP and SGPT enzyme elevations, weight loss, anorexia, polydipsia, and polyuria, have occurred following corticosteroids in dogs. Vomiting and diarrhea (occassionally bloody) have been observed in cats and dogs. Cushing's syndrome in dogs has been reported in association with prolonged or repeated steroid therapy. Corticosteroids reportedly cause laminitis in horses.
HOW SUPPLIED: Dexium, 2 mg per mL, 100 mL multiple dose vial.
STORAGE: Store between 2 degrees and 30 degrees C (36 degrees and 86 degrees F).
Dexium
Dexamethasone Solution
Veterinary 2 mg per mL Sterile
CAUTION: Federal (U.S.A.) law restricts this drug to use by or on the order of a licensed veterinarian.
ANADA #200-312, Approved by FDA
Net Contents: 100 mL
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| ANADA | ANADA200312 | 10/20/2003 | |
| Labeler - Bimeda, Inc. Division of Cross Vetpharm Group (043653216) |
| Registrant - Bimeda, Inc. Division of Cross Vetpharm Group (043653216) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Bimeda-MTC Animal Health, Division of Cross Vetpharm Group | 256232216 | manufacture | |
Fungipan may be available in the countries listed below.
Ketoconazole is reported as an ingredient of Fungipan in the following countries:
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Somalgyl may be available in the countries listed below.
Metamizole magnesium (a derivative of Metamizole) is reported as an ingredient of Somalgyl in the following countries:
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Rolan may be available in the countries listed below.
Mefenamic Acid is reported as an ingredient of Rolan in the following countries:
Ranitidine is reported as an ingredient of Rolan in the following countries:
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Mequitazina may be available in the countries listed below.
Mequitazina (DCIT) is also known as Mequitazine (Rec.INN)
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Glossary
| DCIT | Denominazione Comune Italiana |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
Paracetamol Hänseler may be available in the countries listed below.
Paracetamol is reported as an ingredient of Paracetamol Hänseler in the following countries:
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Treating acne.
Benzoyl Peroxide Wash is a keratolytic agent with antibacterial actions. The effectiveness of benzoyl peroxide appears to be due to its antibacterial, peeling (keratolytic), and drying actions.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Benzoyl Peroxide Wash. 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 Benzoyl Peroxide Wash. However, no specific interactions with Benzoyl Peroxide Wash are known at this time.
Ask your health care provider if Benzoyl Peroxide Wash 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 Benzoyl Peroxide Wash 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 Benzoyl Peroxide Wash.
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:
Dryness; feeling of warmth; irritation; itching; peeling; redness; stinging.
Severe allergic reactions (rash; hives; itching; dizziness; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); excessive burning, itching, irritation, peeling, redness, or tenderness of your skin; extreme dryness; swelling.
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: Benzoyl Peroxide 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 excessive scaling; flushing; redness; swelling.
Store at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store in a tightly closed container, away from fire, flame, heat, moisture, and light. Keep Benzoyl Peroxide Wash out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Benzoyl Peroxide Wash. 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.
Natecal may be available in the countries listed below.
Calcium Carbonate is reported as an ingredient of Natecal in the following countries:
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Streptokinaza may be available in the countries listed below.
Streptokinase is reported as an ingredient of Streptokinaza in the following countries:
International Drug Name Search
Clavoxine may be available in the countries listed below.
Amoxicillin trihydrate (a derivative of Amoxicillin) is reported as an ingredient of Clavoxine in the following countries:
Clavulanic Acid potassium (a derivative of Clavulanic Acid) is reported as an ingredient of Clavoxine in the following countries:
International Drug Name Search
Klofen-L may be available in the countries listed below.
Diclofenac is reported as an ingredient of Klofen-L in the following countries:
International Drug Name Search
Isorem may be available in the countries listed below.
Isosorbide Dinitrate is reported as an ingredient of Isorem in the following countries:
International Drug Name Search
Rifamate may cause severe and sometimes fatal liver problems (eg, hepatitis). The risk of liver problems is greater in patients over 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.
Patients with active liver problems should not use Rifamate.
Treating tuberculosis (TB) of the lungs.
Rifamate is a combination of 2 antibacterial agents. It works by killing TB bacteria.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Rifamate. 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 Rifamate. 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 Rifamate 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 Rifamate 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 Rifamate.
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:
Diarrhea; dizziness; drowsiness; gas; headache; heartburn; mild stomach upset or cramps; nausea; trouble sleeping.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody or dark urine; change in the amount of urine produced; changes in vision; dark, tarry, or bloody stools; fever, chills, or sore throat; general feeling of discomfort; increased thirst or urination; joint pain or swelling; loss of appetite; memory problems; menstrual changes; mental or mood changes; muscle pain or weakness; seizures; severe diarrhea, nausea, or stomach cramps; shortness of breath; stomach pain or tenderness; swelling of the hands or legs; 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: Rifamate 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; hallucinations; loss of consciousness; seizures; severe dizziness or nausea; sluggishness; slurred speech; stomach pain or tenderness; symptoms of high blood sugar (eg, confusion, increased thirst or urination, rapid breathing, unusual drowsiness); very slow breathing; vomiting; yellowing of the skin or eyes.
Store Rifamate between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Rifamate out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Rifamate. 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.
