Rosuvastatin Calcium may be available in the countries listed below.
Rosuvastatin Calcium (BANM, USAN) is known as Rosuvastatin in the US.
International Drug Name Search
Glossary
| BANM | British Approved Name (Modified) |
| USAN | United States Adopted Name |
Treating high blood pressure and/or improving survival rates in patients who have left ventricular systolic dysfunction and congestive heart failure following a heart attack. It is sometimes used with other medicines. It may also be used for other conditions as determined by your doctor.
Eplerenone is a mineralocorticoid receptor blocker. It works by blocking aldosterone. This widens blood vessels and reduces fluid and sodium retention, lowering blood pressure to help prevent strokes, heart attacks, and kidney problems.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Eplerenone. 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 Eplerenone. Tell your health care provider if you are taking any other medicines, especially any of the following:
Nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen, naproxen) because the effects of Eplerenone when used to treat high blood pressure may be decreased
Imidazoles (eg, ketoconazole, itraconazole), ketolide or macrolide antibiotics (eg, clarithromycin, troleandomycin), nefazodone, protease inhibitors (eg, ritonavir , nelfinavir), or verapamil because the side effects of Eplerenone may be increased
Amiloride, angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril), angiotensin-receptor blockers (eg, valsartan), potassium supplements, spironolactone, or triamterene because the risk of abnormal heartbeat due to high blood potassium levels may be increased
Lithium because it may increase lithium blood levels
This may not be a complete list of all interactions that may occur. Ask your health care provider if Eplerenone 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 Eplerenone as directed by your doctor. Check the label on the medicine for exact dosing instructions. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Eplerenone.
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:
Cough; diarrhea; dizziness; flu-like symptoms (fever, chills, muscle ache, tiredness); headache; stomach pain.
Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal vaginal discharge; chest pain; enlarged or swollen breasts; irregular heartbeat; severe muscle weakness.
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: Eplerenone 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 irregular heartbeat; severe dizziness; severe muscle weakness.
Store Eplerenone at 77 degrees F (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 Eplerenone out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Eplerenone. 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.
Ranidin may be available in the countries listed below.
Ranitidine is reported as an ingredient of Ranidin in the following countries:
Ranitidine hydrochloride (a derivative of Ranitidine) is reported as an ingredient of Ranidin in the following countries:
International Drug Name Search
Generic Name: prenatal multivitamins (PRE nay tal VYE ta mins)
Brand Names: Advance Care Plus, Bright Beginnings, Cavan Folate, Cavan One, Cavan-Heme OB, Cenogen Ultra, CitraNatal Rx, Co Natal FA, Complete Natal DHA, Complete-RF, CompleteNate, Concept OB, Docosavit, Dualvit OB, Duet, Edge OB, Elite OB 400, Femecal OB, Folbecal, Folcaps Care One, Folivan-OB, Foltabs, Gesticare, Icar Prenatal, Icare Prenatal Rx, Inatal Advance, Infanate DHA, Kolnatal DHA, Lactocal-F, Marnatal-F, Maternity, Maxinate, Mission Prenatal, Multi-Nate 30, Multinatal Plus, Nata 29 Prenatal, Natachew, Natafort, Natelle, Neevo, Nestabs, Nexa Select with DHA, Novanatal, NovaStart, O-Cal Prenatal, OB Complete, OB Natal One, Ob-20, Obtrex DHA, OptiNate, Paire OB Plus DHA, PNV Select, PNV-Total, PR Natal 400, Pre-H-Cal, Precare, PreferaOB, Premesis Rx, PrenaCare, PrenaFirst, PrenaPlus, Prenatabs OBN, Prenatabs Rx, Prenatal 1 Plus 1, Prenatal Elite, Prenatal Multivitamins, Prenatal Plus, Prenatal S, Prenatal-U, Prenate Advanced Formula, Prenate DHA, Prenate Elite, Prenavite FC, PreNexa, PreQue 10, Previte Rx, PrimaCare, Pruet DHA, RE OB Plus DHA, Renate, RightStep, Rovin-NV, Se-Care, Se-Natal One, Se-Plete DHA, Se-Tan DHA, Select-OB, Seton ET, Strongstart, Stuart Prenatal with Beta Carotene, Tandem OB, Taron-BC, Tri Rx, TriAdvance, TriCare, Trimesis Rx, Trinate, Triveen-PRx RNF, UltimateCare Advance, Ultra-Natal, Vemavite PRX 2, VeNatal FA, Verotin-BY, Verotin-GR, Vinacal OR, Vinatal Forte, Vinate Advanced (New Formula), Vinate AZ, Vinate Care, Vinate Good Start, Vinate II (New Formula), Vinate III, Vinate One, Vitafol-OB, VitaNatal OB plus DHA, Vitaphil, Vitaphil Aide, Vitaphil Plus DHA, Vitaspire, Viva DHA, Vol-Nate, Vol-Plus, Vol-Tab Rx, Vynatal F.A., Zatean-CH, Zatean-PN
There are many brands and forms of prenatal vitamin available and not all brands are listed on this leaflet.
Prenatal vitamins are a combination of many different vitamins that are normally found in foods and other natural sources.
Prenatal vitamins are used to provide the additional vitamins needed during pregnancy. Minerals may also be contained in prenatal multivitamins.
Prenatal vitamins may also be used for purposes not listed in this medication guide.
There are many brands and forms of prenatal vitamin available and not all brands are listed on this leaflet.
Many multivitamin products also contain minerals such as calcium, iron, magnesium, potassium, and zinc. Minerals (especially taken in large doses) can cause side effects such as tooth staining, increased urination, stomach bleeding, uneven heart rate, confusion, and muscle weakness or limp feeling. Read the label of any multivitamin product you take to make sure you are aware of what it contains.
Overdose symptoms may include stomach pain, vomiting, diarrhea, constipation, loss of appetite, hair loss, peeling skin, tingly feeling in or around your mouth, changes in menstrual periods, weight loss, severe headache, muscle or joint pain, severe back pain, blood in your urine, pale skin, and easy bruising or bleeding.
Before taking prenatal vitamins, tell your doctor about all of your medical conditions.
Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.
Many multivitamin products also contain minerals such as calcium, iron, magnesium, potassium, and zinc. Minerals (especially taken in large doses) can cause side effects such as tooth staining, increased urination, stomach bleeding, uneven heart rate, confusion, and muscle weakness or limp feeling. Read the label of any multivitamin product you take to make sure you are aware of what it contains.
Swallow the regular tablet or capsule whole. Do not break, chew, crush, or open it.
The chewable tablet must be chewed or allowed to dissolve in your mouth before swallowing. You may also allow the chewable tablet to dissolve in drinking water, fruit juice, or infant formula (but not milk or other dairy products). Drink this mixture right away.
Use prenatal vitamins regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
Overdose symptoms may include stomach pain, vomiting, diarrhea, constipation, loss of appetite, hair loss, peeling skin, tingly feeling in or around your mouth, changes in menstrual periods, weight loss, severe headache, muscle or joint pain, severe back pain, blood in your urine, pale skin, and easy bruising or bleeding.
Avoid the regular use of salt substitutes in your diet if your multivitamin contains potassium. If you are on a low-salt diet, ask your doctor before taking a vitamin or mineral supplement.
When taken as directed, prenatal vitamins are not expected to cause serious side effects. Less serious side effects may include:
upset stomach;
headache; or
unusual or unpleasant taste in your mouth.
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.
Vitamin and mineral supplements can interact with certain medications, or affect how medications work in your body. Before taking a prenatal vitamin, tell your doctor if you also use:
diuretics (water pills);
heart or blood pressure medications;
tretinoin (Vesanoid);
isotretinoin (Accutane, Amnesteen, Clavaris, Sotret);
trimethoprim and sulfamethoxazole (Cotrim, Bactrim, Gantanol, Gantrisin, Septra, TMP/SMX); or
an NSAID (non-steroidal anti-inflammatory drug) such as ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Cataflam, Voltaren), indomethacin (Indocin), meloxicam (Mobic), and others.
This list is not complete and other drugs may interact with prenatal vitamins. 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.
Cleansing skin and wound areas. It may also be used for other conditions as determined by your doctor.
Betasept Liquid is a topical antimicrobial. It works by reacting with the microbial cell surface, destroying the cell membrane, and killing the cell.
Contact your doctor or health care provider right away if any of these apply to you.
Tell your health care provider if you have any medical conditions, especially if any of the following apply to you:
Some MEDICINES MAY INTERACT with Betasept Liquid. However, no specific interactions with Betasept Liquid are known at this time.
Ask your health care provider if Betasept Liquid 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 Betasept Liquid 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 Betasept Liquid.
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:
Skin irritation, itching, or redness.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).
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: Betasept 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. Betasept Liquid may be harmful if swallowed.
Store Betasept Liquid at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Avoid excessive heat above 104 degrees F (40 degrees C), and light. Keep Betasept Liquid out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Betasept Liquid. 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.
Generic Name: hydrocortisone, neomycin, and polymyxin B otic (HYE droe KOR ti sone, NEE oh MYE sin, POL ee MIX in B)
Brand Names: Cort-Biotic, Cortatrigen, Cortatrigen Modified, Cortisporin Otic, Cortomycin, Oti-Sone, Pediotic
Hydrocortisone is a steroid. It reduces the actions of chemicals in the body that cause inflammation, redness, and swelling.
Neomycin and polymyxin B are antibiotics that fight bacteria.
The combination of hydrocortisone, neomycin, and polymyxin B otic (for the ears) is used to treat ear infections caused by bacteria.
This medication will not treat a viral infection such as herpes or shingles.
Hydrocortisone, neomycin, and polymyxin B otic may also be used for other purposes not listed in this medication guide.
Before using this medication, tell your doctor if you have herpes (simplex or zoster), chickenpox or small pox, any ear infection that causes blistering, asthma or sulfite allergy, or if you are allergic to an antibiotic similar to neomycin, such as amikacin (Amikin), gentamicin (Garamycin), kanamycin (Kantrex), netilmicin (Netromycin), paromomycin (Humatin, Paromycin), streptomycin, or tobramycin (Nebcin, Tobi).
Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Talk with your doctor if your symptoms do not improve after 1 week of using this medication.
a ruptured ear drum; or
an ear infection caused by chickenpox, or herpes infection (simplex or zoster).
If you have any of these other conditions, you may need a dose adjustment or special tests to safely use this medication:
herpes (simplex or zoster);
chickenpox or small pox;
any ear infection that causes blistering;
asthma or sulfite allergy; or
if you are allergic to an antibiotic similar to neomycin, such as amikacin (Amikin), gentamicin (Garamycin), kanamycin (Kantrex), netilmicin (Netromycin), paromomycin (Humatin, Paromycin), streptomycin, or tobramycin (Nebcin, Tobi).
Use this medication exactly as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended. Follow the directions on your prescription label.
Before using this medication, clean and dry your ear canal with sterile cotton.
This medication is usually given as 4 to 5 drops into the affected ear every 6 to 8 hours. Children may need to use fewer drops. Follow your doctor's instructions about how much medication you should use and how often.
To use the ear drops, first remove the cap from the dropper bottle. Lie down or tilt your head with your ear facing upward. Pull back on your ear gently to open up the ear canal. If giving this medicine to a child, pull down on the earlobe to open the ear canal. Hold the dropper upside down over the ear canal and drop the correct number of drops into the ear.
Do not place the dropper tip into your ear or allow the tip to touch any surface. It may become contaminated.
After using the ear drops, stay lying down or with your head tilted for at least 5 minutes.
As an alternative to dropping the medicine into your ear, you may insert a small piece of cotton into the ear canal and then drop the medicine directly onto the cotton to soak it. Leave the cotton in the ear and keep it moist by adding more of the medication every 4 to 8 hours. Replace the cotton at least every 24 hours. Follow your doctor's instructions about the use of cotton with this medication.
Wipe the ear dropper tip with a clean tissue. Do not wash the tip with water or soap.
Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Talk with your doctor if your symptoms do not improve after 1 week of using this medication.
Use the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up the missed dose.
Overdose symptoms may include hearing problems, or urinating less than usual.
skin rash, redness, swelling, itching, dryness, scaling, or other irritation in or around the ear;
severe burning, stinging, or other irritation when using the medication;
new signs of infection;
hearing loss; or
urinating less than usual or not at all.
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.
It is not likely that other drugs you take orally or inject will have an effect on hydrocortisone, neomycin, and polymyxin B used in the ears. But many drugs can interact with each other. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.
See also: Cortomycin side effects (in more detail)
In some countries, this medicine may only be approved for veterinary use.
In the US, Chlorpromazine (chlorpromazine systemic) is a member of the following drug classes: phenothiazine antiemetics, phenothiazine antipsychotics and is used to treat Hiccups, Light Sedation, Mania, Nausea/Vomiting, Porphyria, Psychosis and Tetanus.
US matches:
UK matches:
Rec.INN
N05AA01
0000050-53-3
C17-H19-Cl-N2-S
318
Neuroleptic
10H-Phenothiazine-10-propanamine, 2-chloro-N,N-dimethyl-
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) |
| SPC | Summary of Product Characteristics (UK) |
Burnazin may be available in the countries listed below.
Sulfadiazine silver (a derivative of Sulfadiazine) is reported as an ingredient of Burnazin in the following countries:
International Drug Name Search
Ridauran may be available in the countries listed below.
Auranofin is reported as an ingredient of Ridauran in the following countries:
International Drug Name Search
Rupurut may be available in the countries listed below.
Hydrotalcite is reported as an ingredient of Rupurut in the following countries:
International Drug Name Search
Robicillin VK may be available in the countries listed below.
Phenoxymethylpenicillin potassium (a derivative of Phenoxymethylpenicillin) is reported as an ingredient of Robicillin VK in the following countries:
International Drug Name Search
Definition of Angiostrongylosis:
Infection of animals and man with nematodes of the genus Angiostrongylus.
Synonym: eosinophilic meningitis.
The following drugs and medications are in some way related to, or used in the treatment of Angiostrongylosis. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.
Briem may be available in the countries listed below.
Benazepril hydrochloride (a derivative of Benazepril) is reported as an ingredient of Briem in the following countries:
International Drug Name Search
Preventing and treating Pneumocystis carinii pneumonia (PCP) in patients who cannot take trimethoprim/sulfamethoxazole. It may also be used for other conditions as determined by your doctor.
Atovaquone is an antiprotozoal. How it works to stop the growth of the protozoa is not fully understood. It may interfere with the metabolism of the protozoa by slowing or stopping its growth, which helps you to fight the infection.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Atovaquone. 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 Atovaquone. 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 Atovaquone 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 Atovaquone 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 Atovaquone.
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; difficulty sleeping; dizziness; headache; increased cough; increased sweating; indigestion; loss of appetite; muscle pain; nausea; runny or stuffy nose; stomach pain; vomiting; weakness.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest or throat; swelling of the mouth, face, lips, or tongue; unusual hoarseness); anxiety; change in the amount of urine produced; dark urine; depression; fever; flu-like symptoms; pale stools; red, swollen, blistered, or peeling skin; severe or persistent stomach pain; shortness of breath; unusual bruising or bleeding; white patches in the mouth; yellowing of the eyes or skin.
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: Atovaquone 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.
Store Atovaquone at room temperature, between 59 and 77 degrees F (15 and 25 degrees C), in a tightly sealed container. Store away from heat, moisture, and light. Do not freeze. Do not store in the bathroom. Keep Atovaquone out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Atovaquone. 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.
Ridect may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Permethrin is reported as an ingredient of Ridect in the following countries:
International Drug Name Search
Naproxen Merck may be available in the countries listed below.
Naproxen is reported as an ingredient of Naproxen Merck in the following countries:
International Drug Name Search
TobraDex® (tobramycin and dexamethasone ophthalmic suspension) is a sterile, multiple dose antibiotic and steroid combination for topical ophthalmic use.
The chemical structures for tobramycin and dexamethasone are presented below:
Tobramycin
Empirical Formula: C18H37N5O9
Chemical Name: O - 3 - Amino - 3 - deoxy - α - D - glucopyranosyl - (1→4) - O - [2,6 - diamino - 2,3,6 - trideoxy - α - D - ribo - hexopyranosyl - (1→6)] - 2 - deoxy - L - streptamine
Dexamethasone
Empirical Formula: C22H29FO5
Chemical Name: 9-Fluoro-11β,17,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione
Each mL of TobraDex® (tobramycin and dexamethasone ophthalmic suspension) contains: Actives: tobramycin 0.3% (3 mg) and dexamethasone 0.1% (1 mg). Preservative: benzalkonium chloride 0.01%. Inactives: tyloxapol, edetate disodium, sodium chloride, hydroxyethyl cellulose, sodium sulfate, sulfuric acid and/or sodium hydroxide (to adjust pH) and purified water.
Corticoids suppress the inflammatory response to a variety of agents and they probably delay or slow healing. Since corticoids may inhibit the body's defense mechanism against infection, a concomitant antimicrobial drug may be used when this inhibition is considered to be clinically significant. Dexamethasone is a potent corticoid.
The antibiotic component in the combination (tobramycin) is included to provide action against susceptible organisms. In vitro studies have demonstrated that tobramycin is active against susceptible strains of the following microorganisms:
Staphylococci, including S. aureus and S. epidermidis (coagulase-positive and coagulase-negative), including penicillin-resistant strains.
Streptococci, including some of the Group A-beta-hemolytic species, some nonhemolytic species, and some Streptococcus pneumoniae.
Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Enterobacter aerogenes, Proteus mirabilis, Morganella morganii, most Proteus vulgaris strains, Haemophilus influenzae and H. aegyptius, Moraxella lacunata, Acinetobacter calcoaceticus and some Neisseria species.
Bacterial susceptibility studies demonstrate that in some cases microorganisms resistant to gentamicin remain susceptible to tobramycin.
No data are available on the extent of systemic absorption from TobraDex® (tobramycin and dexamethasone ophthalmic suspension); however, it is known that some systemic absorption can occur with ocularly applied drugs. If the maximum dose of TobraDex® (tobramycin and dexamethasone ophthalmic suspension) is given for the first 48 hours (two drops in each eye every 2 hours) and complete systemic absorption occurs, which is highly unlikely, the daily dose of dexamethasone would be 2.4 mg. The usual physiologic replacement dose is 0.75 mg daily. If TobraDex® (tobramycin and dexamethasone ophthalmic suspension) is given after the first 48 hours as two drops in each eye every 4 hours, the administered dose of dexamethasone would be 1.2 mg daily.
TobraDex® (tobramycin and dexamethasone ophthalmic suspension) is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists.
Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns, or penetration of foreign bodies.
The use of a combination drug with an anti-infective component is indicated where the risk of superficial ocular infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye.
The particular anti-infective drug in this product is active against the following common bacterial eye pathogens:
Staphylococci, including S. aureus and S. epidermidis (coagulase-positive and coagulase-negative), including penicillin-resistant strains.
Streptococci, including some of the Group A-beta-hemolytic species, some nonhemolytic species, and some Streptococcus pneumoniae.
Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Enterobacter aerogenes, Proteus mirabilis, Morganella morganii, most Proteus vulgaris strains, Haemophilus influenzae and H. aegyptius, Moraxella lacunata, Acinetobacter calcoaceticus and some Neisseria species.
Epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, and many other viral diseases of the cornea and conjunctiva. Mycobacterial infection of the eye. Fungal diseases of ocular structures. Hypersensitivity to a component of the medication.
FOR TOPICAL OPHTHALMIC USE ONLY. NOT FOR INJECTION INTO THE EYE. Sensitivity to topically applied aminoglycosides may occur in some patients. If a sensitivity reaction does occur, discontinue use.
Prolonged use of steroids may result in glaucoma, with damage to the optic nerve, defects in visual acuity and fields of vision, and posterior subcapsular cataract formation. Intraocular pressure should be routinely monitored even though it may be difficult in pediatric patients and uncooperative patients. Prolonged use may suppress the host response and thus increase the hazard of secondary ocular infections. In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids. In acute purulent conditions of the eye, steroids may mask infection or enhance existing infection.
The possibility of fungal infections of the cornea should be considered after long-term steroid dosing. As with other antibiotic preparations, prolonged use may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, appropriate therapy should be initiated. When multiple prescriptions are required, or whenever clinical judgement dictates, the patient should be examined with the aid of magnification, such as slit lamp biomicroscopy and, where appropriate, fluorescein staining.
Cross-sensitivity to other aminoglycoside antibiotics may occur; if hypersensitivity develops with this product, discontinue use and institute appropriate therapy.
Do not touch dropper tip to any surface, as this may contaminate the contents. Contact lenses should not be worn during the use of this product.
No studies have been conducted to evaluate the carcinogenic or mutagenic potential. No impairment of fertility was noted in studies of subcutaneous tobramycin in rats at doses of 50 and 100 mg/kg/day.
Corticosteroids have been found to be teratogenic in animal studies. Ocular administration of 0.1% dexamethasone resulted in 15.6% and 32.3% incidence of fetal anomalies in two groups of pregnant rabbits. Fetal growth retardation and increased mortality rates have been observed in rats with chronic dexamethasone therapy. Reproduction studies have been performed in rats and rabbits with tobramycin at doses up to 100 mg/kg/day parenterally and have revealed no evidence of impaired fertility or harm to the fetus. There are no adequate and well controlled studies in pregnant women. TobraDex® (tobramycin and dexamethasone ophthalmic suspension) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when TobraDex® (tobramycin and dexamethasone ophthalmic suspension) is administered to a nursing woman.
Safety and effectiveness in pediatric patients below the age of 2 years have not been established.
No overall differences in safety or effectiveness have been observed between elderly and younger patients.
Adverse reactions have occurred with steroid/anti-infective combination drugs which can be attributed to the steroid component, the anti-infective component, or the combination. Exact incidence figures are not available. The most frequent adverse reactions to topical ocular tobramycin [TOBREX® (tobramycin ophthalmic solution)] are hypersensitivity and localized ocular toxicity, including lid itching and swelling, and conjunctival erythema. These reactions occur in less than 4% of patients. Similar reactions may occur with the topical use of other aminoglycoside antibiotics. Other adverse reactions have not been reported; however, if topical ocular tobramycin is administered concomitantly with systemic aminoglycoside antibiotics, care should be taken to monitor the total serum concentration. The reactions due to the steroid component are: elevation of intraocular pressure (IOP) with possible development of glaucoma, and infrequent optic nerve damage; posterior subcapsular cataract formation; and delayed wound healing.
Secondary Infection. The development of secondary infection has occurred after use of combinations containing steroids and antimicrobials. Fungal infections of the cornea are particularly prone to develop coincidentally with long-term applications of steroids. The possibility of fungal invasion must be considered in any persistent corneal ulceration where steroid treatment has been used. Secondary bacterial ocular infection following suppression of host responses also occurs.
Clinically apparent signs and symptoms of an overdosage of TobraDex® (tobramycin and dexamethasone ophthalmic suspension) punctate keratitis, erythema, increased lacrimation, edema and lid itching may be similar to adverse reaction effects seen in some patients.
One or two drops instilled into the conjunctival sac(s) every four to six hours. During the initial 24 to 48 hours, the dosage may be increased to one or two drops every two (2) hours. Frequency should be decreased gradually as warranted by improvement in clinical signs. Care should be taken not to discontinue therapy prematurely.
Not more than 20 mL should be prescribed initially and the prescription should not be refilled without further evaluation as outlined in PRECAUTIONS above.
Sterile ophthalmic suspension in 2.5 mL (NDC 0065-0647-25), 5 mL (NDC 0065-0647-05) and 10 mL (NDC 0065-0647-10) DROP-TAINER® dispensers.
STORAGE: Store at 8°-27°C (46°-80°F).
Store suspension upright and shake well before using.
Rx Only
©2002, 2006, 2010 Alcon, Inc.
ALCON LABORATORIES, INC.
Fort Worth, Texas 76134 USA
Printed in USA
Revised: April 2010
9001599-0410
NDC 0065-0647-25
Alcon®
TobraDex®
(tobramycin and
dexamethasone
ophthalmic
suspension)
2.5 mL Sterile
| TobraDex tobramycin and dexamethasone suspension | ||||||||||||||||||||||
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| NDA | NDA050592 | 09/15/1988 | |
| Labeler - Alcon Laboratories, Inc. (008018525) |
| Registrant - Alcon Laboratories, Inc. (008018525) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Alcon Laboratories, Inc. | 008018525 | MANUFACTURE | |
Ranflutin may be available in the countries listed below.
Fluoxetine hydrochloride (a derivative of Fluoxetine) is reported as an ingredient of Ranflutin in the following countries:
International Drug Name Search
Ranitex may be available in the countries listed below.
Ranitidine hydrochloride (a derivative of Ranitidine) is reported as an ingredient of Ranitex in the following countries:
International Drug Name Search
Donadin may be available in the countries listed below.
Povidone-Iodine is reported as an ingredient of Donadin in the following countries:
International Drug Name Search
0007440-69-9
Bi
208
Dermatological agent
Astringent agent
Treatment of peptic ulcer
Antidiarrhoeal agent
Intestinal adsorbent
International Drug Name Search
Glossary
| IS | Inofficial Synonym |
Treating pain following surgery. It may also be used for other conditions as determined by your doctor.
Morphine Suspension is a narcotic pain reliever. It works in the brain to decrease pain. It may also affect other body systems (eg, breathing and circulatory systems) at higher doses.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Morphine Suspension. 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 Morphine Suspension. 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 Morphine Suspension 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 Morphine Suspension 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 Morphine Suspension.
When used for long periods of time or at high doses, Morphine Suspension may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Morphine Suspension stops working well. Do not take more than prescribed.
Some people who use Morphine Suspension for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction.
If you stop taking Morphine Suspension suddenly, you may have WITHDRAWAL symptoms. These may include anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea; vomiting; pain; rigid muscles; rapid heartbeat; seeing, hearing, or feeling things that are not there; shivering or tremors; sweating; and trouble sleeping.
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; dizziness; drowsiness; headache; lightheadedness; nausea; vomiting; weakness.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); confusion; delirium; difficulty urinating; disorientation; fainting; fast, slow, or irregular heartbeat; fever; flushing of the face; hallucinations; mood or mental changes; numbness or tingling; seizures; severe dizziness or lightheadedness; severe drowsiness; severe or persistent vomiting or constipation, shortness of breath; slowed or difficult breathing; tremor; trouble sleeping; unusual sweating; 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.
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include cold and clammy skin; convulsions; deep sleep; dizziness; lightheadedness; loss of consciousness; severe drowsiness; slowed breathing; slowed heartbeat.
Morphine Suspension is usually handled and stored by a health care provider. If you are using Morphine Suspension at home, store Morphine Suspension as directed by your pharmacist or health care provider.
This information is a summary only. It does not contain all information about Morphine Suspension. 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.