Celiprol may be available in the countries listed below.
Ingredient matches for Celiprol
Celiprolol is reported as an ingredient of Celiprol in the following countries:
- Tunisia
International Drug Name Search
Celiprol may be available in the countries listed below.
Celiprolol is reported as an ingredient of Celiprol in the following countries:
International Drug Name Search
Topiramat-CT may be available in the countries listed below.
Topiramate is reported as an ingredient of Topiramat-CT in the following countries:
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Benzoylperoxid Riemser may be available in the countries listed below.
Benzoyl Peroxide is reported as an ingredient of Benzoylperoxid Riemser in the following countries:
International Drug Name Search
Noprilex may be available in the countries listed below.
Paroxetine hydrochloride (a derivative of Paroxetine) is reported as an ingredient of Noprilex in the following countries:
International Drug Name Search
In the US, Hydromorphone (hydromorphone systemic) is a member of the drug class narcotic analgesics and is used to treat Anesthetic Adjunct, Cough and Pain.
US matches:
Rec.INN
N02AA03
0000466-99-9
C17-H19-N-O3
285
Opioid analgesic
Morphinan-6-one, 4,5-epoxy-3-hydroxy-17-methyl-, (5α)-
International Drug Name Search
Glossary
BAN | British Approved Name |
BANM | British Approved Name (Modified) |
DCF | Dénomination Commune Française |
DCIT | Denominazione Comune Italiana |
IS | Inofficial Synonym |
OS | Official Synonym |
PH | Pharmacopoeia Name |
Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
WHO | World Health Organization |
Tritazide may be available in the countries listed below.
Hydrochlorothiazide is reported as an ingredient of Tritazide in the following countries:
Ramipril is reported as an ingredient of Tritazide in the following countries:
International Drug Name Search
Azitromycine Actavis may be available in the countries listed below.
Azithromycin is reported as an ingredient of Azitromycine Actavis in the following countries:
International Drug Name Search
Aceterin may be available in the countries listed below.
Cetirizine dihydrochloride (a derivative of Cetirizine) is reported as an ingredient of Aceterin in the following countries:
International Drug Name Search
Worming Cream may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Piperazine citrate (a derivative of Piperazine) is reported as an ingredient of Worming Cream in the following countries:
International Drug Name Search
Tramadol STADA may be available in the countries listed below.
Tramadol hydrochloride (a derivative of Tramadol) is reported as an ingredient of Tramadol STADA in the following countries:
International Drug Name Search
Medimacrol may be available in the countries listed below.
Azithromycin dihydrate (a derivative of Azithromycin) is reported as an ingredient of Medimacrol in the following countries:
International Drug Name Search
Alka-Selzer may be available in the countries listed below.
Acetylsalicylic Acid is reported as an ingredient of Alka-Selzer in the following countries:
Sodium Bicarbonate is reported as an ingredient of Alka-Selzer in the following countries:
International Drug Name Search
Ranitin may be available in the countries listed below.
Ranitidine is reported as an ingredient of Ranitin in the following countries:
Ranitidine hydrochloride (a derivative of Ranitidine) is reported as an ingredient of Ranitin in the following countries:
International Drug Name Search
In some countries, this medicine may only be approved for veterinary use.
In the US, Glycerol is a member of the drug class laxatives and is used to treat Constipation and Cough.
Rec.INN
A06AG04,A06AX01
0000056-81-5
C3-H8-O3
92
Laxative, Enema
Laxative, lubricant
Laxative, osmotically acting
1,2,3-Propanetriol
International Drug Name Search
Glossary
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) |
Edetate Disodium may be available in the countries listed below.
Edetic Acid disodium salt (a derivative of Edetic Acid) is reported as an ingredient of Edetate Disodium in the following countries:
International Drug Name Search
Folinato Calcico Genfarma may be available in the countries listed below.
Calcium Folinate is reported as an ingredient of Folinato Calcico Genfarma in the following countries:
International Drug Name Search
Flunarin may be available in the countries listed below.
Flunarizine is reported as an ingredient of Flunarin in the following countries:
Flunarizine dihydrochloride (a derivative of Flunarizine) is reported as an ingredient of Flunarin in the following countries:
International Drug Name Search
dye-FLOO-ni-sal
NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may be increased in patients with cardiovascular disease or risk factors for cardiovascular disease. Diflunisal is contraindicated for the treatment of perioperative pain in the setting of CABG surgery. NSAIDs can also cause an increased risk of serious gastrointestinal adverse events especially in the elderly, including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal .
In the U.S.
Available Dosage Forms:
Therapeutic Class: Analgesic
Pharmacologic Class: NSAID
Chemical Class: Salicylate, Non-Aspirin
Diflunisalis a nonsteroidal anti-inflammatory drug (NSAID) used to treat mild to moderate pain, and helps to relieve symptoms of arthritis (osteoarthritis and rheumatoid arthritis), such as inflammation, swelling, stiffness, and joint pain. diflunisal does not cure arthritis and will help you only as long as you continue to take it .
diflunisal 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 diflunisal, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to diflunisal 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 diflunisal in children below 12 years of age. Safety and efficacy have not been established .
Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of diflunisal in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require adjustment of dosage in patients receiving diflunisal .
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 diflunisal, 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 diflunisal with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
Using diflunisal with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Using diflunisal 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 diflunisal. Make sure you tell your doctor if you have any other medical problems, especially:
For safe and effective use of diflunisal, do not take more of it, do not take it more often, and do not take it for a longer time than ordered by your doctor. Taking too much of diflunisal may increase the chance of unwanted effects, especially in elderly patients .
When used for severe or continuing arthritis, diflunisal must be taken regularly as ordered by your doctor in order for it to help you. diflunisal usually begins to work within one week, but in severe cases up to two weeks or even longer may pass before you begin to feel better. Also, several weeks may pass before you feel the full effects of diflunisal.
Swallow the tablet whole with a full glass of water. Do not crush or chew it .
To lessen stomach upset, you may take diflunisal with food.
The dose of diflunisal 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 diflunisal. 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 diflunisal, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects .
diflunisal may raise your risk of having a heart attack or stroke. This is more likely in people who already have heart disease. People who use diflunisal for a long time might also have a higher risk .
diflunisal may cause bleeding in your stomach or intestines. These problems can happen without warning signs. This is more likely if you have had a stomach ulcer in the past, if you smoke or drink alcohol regularly, if you are over 60 years old, if you are in poor health, or if you are using certain other medicines (a steroid or a blood thinner) .
diflunisal can cause a rare but serious illness called Reye's syndrome. It occurs mostly in children and teenagers, but can affect someone at any age. Do not give diflunisal to anyone who has chicken pox or symptoms of a virus or the flu, unless your doctor has told you to. If a child has behavior changes along with nausea and vomiting while using diflunisal, .
Serious skin reactions can occur during treatment with diflunisal. Check with your doctor right away if you have any of the following symptoms while taking diflunisal: blistering, peeling, loosening of skin, chills, cough, diarrhea, fever, itching, joint or muscle pain, red skin lesions, sore throat, sores ulcers, white spots in mouth or on lips, or unusual tiredness or weakness .
Possible warning signs of some serious side effects that can occur during treatment with diflunisal may include swelling of the face, fingers, feet, and/or lower legs; severe stomach pain, black, tarry stools, and/or vomiting of blood or material that looks like coffee grounds; unusual weight gain; yellow skin or eyes; decreased urination; bleeding or bruising; and/or skin rash. Also, signs of serious heart problems could occur such as chest pain, tightness in chest, fast or irregular heartbeat, unusual flushing or warmth of skin, weakness, or slurring of speech. Stop taking diflunisal and check with your doctor immediately if you notice any of these warning signs .
diflunisal may also cause a serious type of allergic reaction called anaphylaxis. Although this is rare, it may occur more often in patients who are allergic to aspirin or to any of the nonsteroidal anti-inflammatory drugs. Anaphylaxis requires immediate medical attention. The most serious signs of this reaction are very fast or irregular breathing, gasping for breath, wheezing, or fainting. Other signs may include changes in color of the skin of the face; very fast but irregular heartbeat or pulse; hive-like swellings on the skin; and puffiness or swellings of the eyelids or around the eyes. If these effects occur, get emergency help at once .
Using diflunisal while you are pregnant can harm your unborn baby. If you think you have become pregnant while using diflunisal, tell your doctor right away .
Check with your doctor immediately if blurred vision, difficulty in reading, or any other change in vision occurs during or after your treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor) .
Before having any kind of surgery or medical tests, tell your doctor that you are taking diflunisal. It may be necessary for you to stop treatment for a while, or to change to a different nonsteroidal anti-inflammatory drug before your procedure .
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: diflunisal side effects (in more detail)
The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.
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Salobel may be available in the countries listed below.
Allopurinol is reported as an ingredient of Salobel in the following countries:
International Drug Name Search
Tobi is a brand name of tobramycin, approved by the FDA in the following formulation(s):
No. There is currently no therapeutically equivalent version of Tobi available.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Tobi. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.
See also: About generic drugs.
Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.
Felodipin Hexal may be available in the countries listed below.
Felodipine is reported as an ingredient of Felodipin Hexal in the following countries:
International Drug Name Search
Neomerck may be available in the countries listed below.
Ciclosporin is reported as an ingredient of Neomerck in the following countries:
International Drug Name Search
Lopena may be available in the countries listed below.
Loperamide hydrochloride (a derivative of Loperamide) is reported as an ingredient of Lopena in the following countries:
International Drug Name Search
Dexambutol may be available in the countries listed below.
Ethambutol dihydrochloride (a derivative of Ethambutol) is reported as an ingredient of Dexambutol in the following countries:
International Drug Name Search
Nörotrop may be available in the countries listed below.
Piracetam is reported as an ingredient of Nörotrop in the following countries:
International Drug Name Search
Rhinos Junior may be available in the countries listed below.
Chlorphenamine maleate (a derivative of Chlorphenamine) is reported as an ingredient of Rhinos Junior in the following countries:
Pseudoephedrine hydrochloride (a derivative of Pseudoephedrine) is reported as an ingredient of Rhinos Junior in the following countries:
International Drug Name Search
Gonif may be available in the countries listed below.
Cefuroxime sodium salt (a derivative of Cefuroxime) is reported as an ingredient of Gonif in the following countries:
International Drug Name Search
Rec.INN
N05BA11
0002955-38-6
C19-H17-Cl-N2-O
324
Anxiolytic agent
Benzodiazepine derivative
2H-1,4-Benzodiazepin-2-one, 7-chloro-1-(cyclopropylmethyl)-1,3-dihydro-5-phenyl-
International Drug Name Search
Glossary
BAN | British Approved Name |
DCF | Dénomination Commune Française |
DCIT | Denominazione Comune Italiana |
IS | Inofficial Synonym |
JAN | Japanese Accepted Name |
OS | Official Synonym |
PH | Pharmacopoeia Name |
Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
USAN | United States Adopted Name |
Generic Name: brompheniramine, dextromethorphan, and phenylephrine (brome fen IR a meen, dex troe metho OR fan, fen il EFF rin)
Brand Names: Alacol DM, Alahist DM, BP Allergy DM, BPM PE DM, Bromatan-DM, Bromtuss DM, BroveX PEB DM, Children's Cold & Cough DM, Cold & Cough Childrens, Dimaphen DM, Dimetapp Cold & Cough, Dimetapp DM Cold & Cough, DuraTan DM, Duravent DPB, Lohist-DM, Lortuss DM (obsolete), Tusdec-DM
Brompheniramine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.
Dextromethorphan is a cough suppressant. It affects the signals in the brain that trigger cough reflex.
Phenylephrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).
Brompheniramine, dextromethorphan, and phenylephrine is used to treat sneezing, cough, runny or stuffy nose, itchy or watery eyes, hives, skin rash, itching, and other symptoms of allergies and the common cold.
Dextromethorphan will not treat a cough that is caused by smoking, asthma, or emphysema.
Brompheniramine, dextromethorphan, and phenylephrine may also be used for other purposes not listed in this medication guide.
Before taking this medication, tell your doctor if you are allergic to brompheniramine, dextromethorphan, or phenylephrine, or if you have:
diabetes;
glaucoma;
heart disease or high blood pressure;
diabetes;
a thyroid disorder;
a stomach ulcer or a stomach obstruction,
emphysema or chronic bronchitis; or
an enlarged prostate or urination problems.
If you have any of these conditions, you may need a dose adjustment or special tests to safely take this medication.
Artificially-sweetened liquid forms of cough-and-cold medications may contain phenylalanine. This would be important to know if you have phenylketonuria (PKU). Check the ingredients and warnings on the medication label if you are concerned about phenylalanine.
Use this medication exactly as directed on the label or as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor.
Measure the liquid form of this medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one.
This medication can cause you to have unusual results with allergy skin tests. Tell any doctor who treats you that you are taking an antihistamine.
If you need to have any type of surgery, tell the surgeon ahead of time if you have taken a cold medicine within the past few days.
Since cough or cold medicine is usually taken only as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.
Overdose symptoms may include feeling restless or nervous, nausea, vomiting, stomach pain, dizziness, drowsiness, dry mouth, warmth or tingly feeling, or seizure (convulsions).
Avoid using other medicines that make you sleepy (such as sleeping pills, pain medication, muscle relaxers, and medicine for seizures, depression or anxiety). They can add to sleepiness caused by brompheniramine, dextromethorphan, and phenylephrine.
Avoid taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor's advice. Taking a stimulant together with a decongestant can increase your risk of unpleasant side effects.
fast, pounding, or uneven heartbeat;
confusion, hallucinations, unusual thoughts or behavior;
severe dizziness, anxiety, restless feeling, or nervousness;
increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure);
confusion, hallucinations, unusual thoughts or behavior;
slow, shallow breathing;
urinating less than usual or not at all;
easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms; or
nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Less serious side effects may include:
blurred vision;
dry mouth;
nausea, stomach pain, constipation;
mild loss of appetite, stomach upset;
warmth, tingling, or redness under your skin;
sleep problems (insomnia);
restless or excitability (especially in children);
skin rash or itching;
dizziness, drowsiness;
problems with memory or concentration; or
ringing in your ears.
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.
Before taking this medication, tell your doctor if you are using any of the following drugs:
an antidepressant;
a diuretic (water pill);
medication to treat irritable bowel syndrome;
celecoxib (Celebrex);
cinacalcet (Sensipar);
darifenacin (Enablex);
imatinib (Gleevec);
quinidine (Quinaglute, Quinidex);
ranolazine (Ranexa)
ritonavir (Norvir);
sibutramine (Meridia);
terbinafine (Lamisil);
medicines to treat high blood pressure;
aspirin or salicylates (such as Disalcid, Doan's Pills, Dolobid, Salflex, Tricosal, and others);
bladder or urinary medications such as oxybutynin (Ditropan, Oxytrol) or tolterodine (Detrol); or
a beta-blocker such as atenolol (Tenormin), carteolol (Cartrol), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal), sotalol (Betapace), timolol (Blocadren), and others.
This list is not complete and there may be other drugs that can interact with brompheniramine, dextromethorphan, and phenylephrine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.
See also: Bromtuss DM side effects (in more detail)
Quinupristin Mesilate may be available in the countries listed below.
Quinupristin Mesilate (BANM) is known as Quinupristin in the US.
International Drug Name Search
Glossary
BANM | British Approved Name (Modified) |
Pexol may be available in the countries listed below.
Pentoxifylline is reported as an ingredient of Pexol in the following countries:
International Drug Name Search
In some countries, this medicine may only be approved for veterinary use.
Rec.INN
0009003-11-6
Laxative
Oxirane, methyl-, polymer with oxirane, block
International Drug Name Search
Glossary
BAN | British Approved Name |
IS | Inofficial Synonym |
OS | Official Synonym |
PH | Pharmacopoeia Name |
Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
USAN | United States Adopted Name |
Each 5 mL (teaspoonful) contains:
Dexamethasone, USP……….……….…………………………. 0.5 mg
Also contains:
Benzoic Acid, USP……………………………………………….. 0.1%
(as preservative)
Alcohol……………………………………………………………. 5.1%
Inactive Ingredients: Artificial Raspberry Flavor; Citric Acid, USP; FD&C Red No. 40; Liquid Sugar; Propylene Glycol, USP and Purified Water, USP. It may also contain Sodium Citrate, USP.
Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract.
Dexamethasone, a synthetic adrenocortical steroid, is a white to practically white, odorless, crystalline powder. It is stable in air. It is practically insoluble in water. The molecular weight is 392.47. It is designated chemically as 9-fluoro-11β,17,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione. The molecular formula is C22H29FO5 and the structural formula is:
Naturally occurring glucocorticoids, (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states. Their synthetic analogs, including dexamethasone, are primarily used for their potent anti-inflammatory effects in disorders of many organ systems.
Glucocorticoids cause profound and varied metabolic effects. In addition, they modify the body's immune responses to diverse stimuli.
At equipotent anti-inflammatory doses, dexamethasone almost completely lacks the sodium-retaining property of hydrocortisone and closely related derivatives of hydrocortisone.
Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance).
As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:
During an exacerbation or as maintenance therapy in selected cases of:
Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment:
Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa, such as:
For palliative management of:
To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus
To tide the patient over a critical period of the disease in:
In patients on corticosteroid therapy subjected to unusual stress, increased dosage of rapidly acting corticosteroids before, during, and after the stressful situation is indicated.
Drug-induced secondary adrenocortical insufficiency may result from too rapid withdrawal of corticosteroids and may be minimized by gradual reduction of dosage. This type of relative insufficiency may persist for months after discontinuation of therapy; therefore, in any situation of stress occurring during that period, hormone therapy should be reinstituted. If the patient is receiving steroids already, dosage may have to be increased. Since mineralocorticoid secretion may be impaired, salt and/or a mineralocorticoid should be administered concurrently.
Corticosteroids may mask some signs of infection, and new infections may appear during their use. There may be decreased resistance and inability to localize infection when corticosteroids are used. Moreover, corticosteroids may affect the nitroblue-tetrazolium test for bacterial infection and produce false-negative results.
In cerebral malaria, a double-blind trial has shown that the use of corticosteroids is associated with prolongation of coma and a higher incidence of pneumonia and gastrointestinal bleeding.
Corticosteroids may activate latent amebiasis. Therefore, it is recommended that latent or active amebiasis be ruled out before initiating corticosteroid therapy in any patient who has spent time in the tropics or any patient with unexplained diarrhea.
Prolonged use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to fungi or viruses.
Since adequate human reproduction studies have not been done with corticosteroids, use of these drugs in pregnancy or in women of childbearing potential requires that the anticipated benefits be weighed against the possible hazards to the mother and embryo or fetus. Infants born of mothers who have received substantial doses of corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism.
Corticosteroids appear in breast milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other unwanted effects. Mothers taking pharmacologic doses of corticosteroids should be advised not to nurse.
Average and large doses of hydrocortisone or cortisone can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium. These effects are less likely to occur with the synthetic derivatives except when used in large doses. Dietary salt restriction and potassium supplementation may be necessary. All corticosteroids increase calcium excretion.
Administration of live virus vaccines, including smallpox, is contraindicated in individuals receiving immunosuppressive doses of corticosteroids. If inactivated viral or bacterial vaccines are administered to individuals receiving immunosuppressive doses of corticosteroids, the expected serum antibody response may not be obtained. However, immunization procedures may be undertaken in patients who are receiving corticosteroids as replacement therapy, e.g., for Addison's disease.
Persons who are on drugs which suppress the immune system are more susceptible to infections than healthy individuals. Chickenpox and measles, for example, can have more serious or even fatal course in non-immune children or adults on corticosteroids. In such children or adults who have not had these diseases, particular care should be taken to avoid exposure. How the dose, route and duration of corticosteroid administration affects the risk of developing a disseminated infection is not known. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. If exposed to chickenpox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated. (See the respective package inserts for complete VZIG and IG prescribing information.) If chickenpox develops, treatment with antiviral agents may be considered.
The use of Baycadron™ Elixir in active tuberculosis should be restricted to those cases of fulminating or disseminated tuberculosis in which the corticosteroid is used for the management of the disease in conjunction with an appropriate antituberculous regimen.
If corticosteroids are indicated in patients with latent tuberculosis or tuberculin reactivity, close observation is necessary as reactivation of the disease may occur. During prolonged corticosteroid therapy, these patients should receive chemoprophylaxis.
Literature reports suggest an apparent association between use of corticosteroids and left ventricular free wall rupture after a recent myocardial infarction; therefore, therapy with corticosteroids should be used with great caution in these patients.
Following prolonged therapy, withdrawal of corticosteroids may result in symptoms of the corticosteroid withdrawal syndrome including fever, myalgia, arthralgia, and malaise. This may occur in patients even without evidence of adrenal insufficiency.
There is an enhanced effect of corticosteroids in patients with hypothyroidism and in those with cirrhosis.
Corticosteroids should be used cautiously in patients with ocular herpes simplex because of possible corneal perforation.
The lowest possible dose of corticosteroid should be used to control the condition under treatment, and when reduction in dosage is possible, the reduction should be gradual.
Psychic derangements may appear when corticosteroids are used, ranging from euphoria, insomnia, mood swings, personality changes, and severe depression, to frank psychotic manifestations. Also, existing emotional instability or psychotic tendencies may be aggravated by corticosteroids.
Aspirin should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia.
Steroids should be used with caution in nonspecific ulcerative colitis, if there is a probability of impending perforation, abscess, or other pyogenic infection, diverticulitis, fresh intestinal anastomoses, active or latent peptic ulcer, renal insufficiency, hypertension, osteoporosis and myasthenia gravis. Fat embolism has been reported as a possible complication of hypercortisonism.
When large doses are given, some authorities advise that corticosteroids be taken with meals and antacids taken between meals to help to prevent peptic ulcer.
Growth and development of infants and children on prolonged corticosteroid therapy should be carefully observed.
Steroids may increase or decrease motility and number of spermatozoa in some patients.
Phenytoin, phenobarbital, ephedrine, and rifampin may enhance the metabolic clearance of corticosteroids, resulting in decreased blood levels and lessened physiologic activity, thus requiring adjustment in corticosteroid dosage. These interactions may interfere with dexamethasone suppression tests which should be interpreted with caution during administration of these drugs.
False-negative results in the dexamethasone suppression test (DST) in patients being treated with indomethacin have been reported. Thus, results of the DST should be interpreted with caution in these patients.
The prothrombin time should be checked frequently in patients who are receiving corticosteroids and coumarin anticoagulants at the same time because of reports that corticosteroids have altered the response to these anticoagulants. Studies have shown that the usual effect produced by adding corticosteroids is inhibition of response to coumarins, although there have been some conflicting reports of potentiation not substantiated by studies.
When corticosteroids are administered concomitantly with potassium-depleting diuretics, patients should be observed closely for development of hypokalemia.
Persons who are on immunosuppressant doses of corticosteroids should be warned to avoid exposure to chickenpox or measles. Patients should also be advised that if they are exposed, medical advice should be sought without delay.
Fluid and Electrolyte Disturbances:
Musculoskeletal:
Gastrointestinal:
Dermatologic:
Neurologic:
Endocrine:
Ophthalmic:
Metabolic:
Cardiovascular:
Other:
Reports of acute toxicity and/or death following overdosage of glucocorticoids are rare. In the event of overdosage, no specific antidote is available; treatment is supportive and symptomatic.
The oral LD50 of dexamethasone in female mice was 6.5 g/kg.
DOSAGE REQUIREMENTS ARE VARIABLE AND MUST BE INDIVIDUALIZED ON THE BASIS OF THE DISEASE AND THE RESPONSE OF THE PATIENT.
The initial dosage varies from 0.75 to 9 mg a day depending on the disease being treated. In less severe diseases doses lower than 0.75 mg may suffice, while in severe diseases doses higher than 9 mg may be required. The initial dosage should be maintained or adjusted until the patient's response is satisfactory. If satisfactory clinical response does not occur after a reasonable period of time, discontinue Baycadron™ Elixir and transfer the patient to other therapy.
After a favorable initial response, the proper maintenance dosage should be determined by decreasing the initial dosage in small amounts to the lowest dosage that maintains an adequate clinical response.
Patients should be observed closely for signs that might require dosage adjustment, including changes in clinical status resulting from remissions or exacerbations of the disease, individual drug responsiveness, and the effect of stress (e.g., surgery, infection, trauma). During stress it may be necessary to increase dosage temporarily.
If the drug is to be stopped after more than a few days of treatment, it usually should be withdrawn gradually.
The following milligram equivalents facilitate changing to Baycadron™ Elixir from other glucocorticoids:
Baycadron™ ELIXIR | METHYLPREDNISOLONE AND TRIAMCINOLONE | PREDNISOLONE AND PREDNISONE | HYDROCORTISONE | CORTISONE |
---|---|---|---|---|
0.75 mg = | 4 mg = | 5 mg = | 20 mg = | 25 mg |
Baycadron™ Elixir (Dexamethasone Elixir, USP 0.5 mg/5 mL) is supplied as a clear, red, raspberry-flavored liquid in the following size:
8 fl oz (No Dropper) (237 mL)
Store at 20° to 25°C (68° to 77°F). [See USP Controlled RoomTemperature].
KEEP TIGHTLY CLOSED
AVOID FREEZING
Dispense in a tight container as defined in the USP.
Rx Only
Product No.: 8810
Manufactured For:
Wockhardt USA, LLC
Parsippany, NJ 07054
Manufactured By:
Morton Grove Pharmaceuticals, Inc.
Morton Grove, IL 60053
28810
ISS. 12-08
WOCKHARDT
NDC 64679-810-30
Baycadron™
ELIXIR
(Dexamethasone Elixir,
USP 0.5 mg/5 mL)
PROFESSIONAL SAMPLE –
NOT FOR RESALE
Rx Only
NET: 1 fl oz (30 mL)
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Marketing Information | |||
Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
ANDA | ANDA088254 | 07/27/1983 |
Labeler - Wockhardt USA, LLC (170508365) |