Fluorouracil medac may be available in the countries listed below.
Fluorouracil is reported as an ingredient of Fluorouracil medac in the following countries:
International Drug Name Search
Treating acne.
Dapsone Gel is a sulfone antibiotic. Exactly how Dapsone Gel works to treat acne is not known.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Dapsone Gel. 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 Dapsone Gel. 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 Dapsone Gel 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 Dapsone Gel 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 Dapsone Gel.
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, oiliness, peeling, or redness of the skin.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); dark urine; fever, chills, or persistent sore throat; mental or mood changes; numbness, tingling, or burning of the hands or feet; red, swollen, blistered, or peeling skin; severe stomach pain or vomiting; shortness of breath; sudden back pain; suicidal thoughts or attempts; unusual tiredness or weakness; yellow or pale 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.
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Dapsone Gel may be harmful if swallowed.
Store Dapsone Gel at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Do not freeze. Store with cap tightly closed away from heat, moisture, and light. Keep Dapsone Gel out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Dapsone Gel. 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.
Axycef may be available in the countries listed below.
Cefuroxime is reported as an ingredient of Axycef in the following countries:
International Drug Name Search
Zinat may be available in the countries listed below.
Cefuroxime axetil (a derivative of Cefuroxime) is reported as an ingredient of Zinat in the following countries:
International Drug Name Search
Nibelon may be available in the countries listed below.
Flurbiprofen is reported as an ingredient of Nibelon in the following countries:
International Drug Name Search
Normicor may be available in the countries listed below.
Simvastatin is reported as an ingredient of Normicor in the following countries:
International Drug Name Search
In some countries, this medicine may only be approved for veterinary use.
Erythromycin phosphate (a derivative of Erythromycin) is reported as an ingredient of Gallimycin in the following countries:
Erythromycin thiocyanate (a derivative of Erythromycin) is reported as an ingredient of Gallimycin in the following countries:
International Drug Name Search
Laprotone may be available in the countries listed below.
Lansoprazole is reported as an ingredient of Laprotone in the following countries:
International Drug Name Search
roe-mi-PLOE-stim
In the U.S.
Available Dosage Forms:
Pharmacologic Class: Thrombopoietin Receptor Agonist
Romiplostim injection is used to treat low blood platelet counts (thrombocytopenia) and help prevent bleeding in patients with a blood disorder called idiopathic thrombocytopenic purpura (ITP). romiplostim is used after a splenectomy (surgery to remove the spleen) or when other medicines, such as steroids or immunoglobulins, have not worked well enough. Platelets help clot the blood, so a person with thrombocytopenia may have bleeding problems. Romiplostim works by stimulating the bone marrow to produce more platelets.
romiplostim 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 romiplostim, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to romiplostim 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 romiplostim injection in the pediatric population. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of romiplostim injection in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving romiplostim injection.
| Pregnancy Category | Explanation | |
|---|---|---|
| All Trimesters | C | Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. |
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. 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 romiplostim. Make sure you tell your doctor if you have any other medical problems, especially:
A doctor or other trained health professional will give you romiplostim. romiplostim is given as a shot under your skin.
romiplostim will come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.
Call your doctor or pharmacist for instructions.
It is very important that your doctor check your progress at regular visits to make sure romiplostim is working properly. Blood tests will be needed to check for unwanted effects.
It is important to tell your doctor if you become pregnant. Your doctor may want you to join a pregnancy registry for patients receiving romiplostim.
Using romiplostim for a long time may cause changes in your bone marrow. These changes may lead to a serious condition called bone marrow fibrosis, where your body produces less blood cells. Your doctor will check for this unwanted effect.
Blood clotting problems may occur while you are receiving romiplostim. Check with your doctor right away if you have pain, swelling, or tenderness in your leg, or shortness of breath and pain in your chest.
Do not stop receiving romiplostim without checking first with your doctor. Stopping romiplostim suddenly may cause the number of platelets to go below the number you had before you started receiving the medicine. This will increase your risk for bleeding. Your doctor will check your platelet levels and progress when you stop receiving the medicine.
Portal vein thrombosis (a blood clotting problem) occurs in patients receiving romiplostim. It usually occurs in patients with low platelet counts caused by liver problems (including cirrhosis). Check with your doctor right away if you have abdominal or stomach pain, blood in the stool, or if you are vomiting blood.
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 or nurse 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: romiplostim Subcutaneous side effects (in more detail)
The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.
The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.
Drill toux sèche sans sucre adulte sirop may be available in the countries listed below.
Dextromethorphan hydrobromide (a derivative of Dextromethorphan) is reported as an ingredient of Drill toux sèche sans sucre adulte sirop in the following countries:
International Drug Name Search
Megaxin may be available in the countries listed below.
Moxifloxacin is reported as an ingredient of Megaxin in the following countries:
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Definition of Pleuropulmonary Infection: Infection of the lungs.
Micromedex Care Notes:
Medical Encyclopedia:
Orasorbil may be available in the countries listed below.
Isosorbide Mononitrate is reported as an ingredient of Orasorbil in the following countries:
International Drug Name Search
Generic Name: docusate (DOK ue sate)
Brand Names: Calcium Stool Softener, Colace, Correctol Softgel Extra Gentle, D-S Caps, Diocto, Doc-Q-Lace, Docu, Docu Soft, Doculase, Docusoft S, DocuSol, DOK, DOS, DSS, Dulcolax Stool Softener, Enemeez Mini, Fleet Sof-Lax, Kao-Tin, Kaopectate Stool Softener, Kasof, Phillips Stool Softener, Silace, Sur-Q-Lax
Docusate is a stool softener. It makes bowel movements softer and easier to pass.
Docusate is used to treat or prevent constipation, and to reduce pain or rectal damage caused by hard stools or by straining during bowel movements.
Docusate may also be used for other purposes not listed in this medication guide.
Ask a doctor or pharmacist before using docusate if you are on a low-salt diet, if you are pregnant or breast-feeding, or if you have recently had a sudden change in your bowel habits lasting for longer than 2 weeks.
Ask a doctor or pharmacist if it is safe for you to take docusate:
if you are on a low-salt diet; or
if you have recently had a sudden change in your bowel habits lasting for longer than 2 weeks.
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.
Measure liquid medicine with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one. Mix the liquid with 6 to 8 ounces of milk, fruit juice, or infant formula and drink the mixture right away.
Try to empty your bowel and bladder just before using the enema.
Twist off the applicator tip. Lie down on your left side with your knees bent, and gently insert the tip of the enema applicator into the rectum. Squeeze the tube to empty the entire contents into the rectum. Throw away the tube, even if there is still some medicine left in it.
After using docusate, you should have a bowel movement within 12 to 72 hours. Call your doctor if you have not had a bowel movement within 1 to 3 days.
Since docusate is used as needed, you may not be on a dosing schedule. If you are using the medication regularly, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.
Overdose symptoms may include nausea, vomiting or stomach pain.
Avoid using the bathroom just after using docusate enema.
rectal bleeding or irritation;
numbness or a rash around your rectum;
severe diarrhea or stomach cramps; or
continued constipation.
Less serious side effects may include:
mild diarrhea; or
mild nausea.
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.
There may be other drugs that can interact with docusate. 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: DSS side effects (in more detail)
Alendronato Teva may be available in the countries listed below.
Alendronic Acid sodium trihydrate (a derivative of Alendronic Acid) is reported as an ingredient of Alendronato Teva in the following countries:
International Drug Name Search
Epidemac may be available in the countries listed below.
Epirubicin hydrochloride (a derivative of Epirubicin) is reported as an ingredient of Epidemac in the following countries:
International Drug Name Search
Eliprim Balsámico may be available in the countries listed below.
Guaifenesin is reported as an ingredient of Eliprim Balsámico in the following countries:
Sulfamethoxazole is reported as an ingredient of Eliprim Balsámico in the following countries:
Trimethoprim is reported as an ingredient of Eliprim Balsámico in the following countries:
International Drug Name Search
Nalgesin may be available in the countries listed below.
Naproxen is reported as an ingredient of Nalgesin in the following countries:
Naproxen sodium salt (a derivative of Naproxen) is reported as an ingredient of Nalgesin in the following countries:
International Drug Name Search
Spironolactone RPG may be available in the countries listed below.
Spironolactone is reported as an ingredient of Spironolactone RPG in the following countries:
International Drug Name Search
Generic Name: chlorpheniramine and pseudoephedrine (klor fen EER a meen and soo doe e FED rin)
Brand Names: AccuHist Drops, Allerest Maximum Strength, Brexin L.A., Colfed-A, D-Amine-SR, Dayquil Allergy, Deconamine, Dicel, Dicel Chewables, Dura-Tap/PD, Durafed, Duratuss DA, Dynahist-ER Pediatric, Genaphed Plus, Histade, Histex, Kronofed-A, Kronofed-A-Jr, LoHist-D, Mintex, Neutrahist Drops, Re2+30, Rescon-Ed, Suclor, SudaHist, Sudal-12 Chewable, Sudal-12 Tannate, Sudogest Cold & Allergy, SudoGest Sinus & Allergy, Tavist-DA, Triaminic Cold and Allergy, Triaminic Softchew Cold and Allergy, Triaminic Softchews Allergy Runny Nose and Congestion
Chlorpheniramine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.
Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).
The combination of chlorpheniramine and pseudoephedrine is used to treat symptoms of the common cold or seasonal allergies, including sneezing, runny or stuffy nose, and itchy, watery eyes.
Chlorpheniramine and pseudoephedrine may also be used for other purposes not listed in this medication guide.
There are many brands and forms of this medication available and not all brands are listed on this leaflet.
Do not use this medication during an asthma attack.
Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.
severe or uncontrolled high blood pressure;
severe coronary artery disease;
narrow angle glaucoma;
a stomach ulcer;
if you are unable to urinate; or
if you are having an asthma attack.
Ask a doctor or pharmacist if it is safe for you to take this medication if you have:
diabetes;
glaucoma;
circulation problems;
heart disease or high blood pressure;
overactive thyroid;
a seizure disorder such as epilepsy;
asthma, emphysema or chronic bronchitis; or
urination problems or an enlarged prostate.
Artificially sweetened liquid cold medicine may contain phenylalanine. If you have phenylketonuria (PKU), check the medication label to see if the product contains phenylalanine.
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. Cold medicine is usually taken only for a short time until your symptoms clear up.
The chewable tablet must be chewed before swallowing.
Measure liquid medicine with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.
Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.
This medication can cause unusual results with allergy skin tests. Tell any doctor who treats you that you are taking an antihistamine.
If you need surgery, tell the surgeon ahead of time if you have taken a cold medicine within the past few days.
Since cold medicine is taken 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. 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 some of the serious side effects listed in this medication guide.
Avoid taking this medication if you also take diet pills, caffeine pills, or other stimulants (such as ADHD medications). Taking a stimulant together with a decongestant can increase your risk of unpleasant side effects.
fast or pounding heartbeats;
confusion, hallucinations, unusual thoughts or behavior;
severe dizziness, anxiety, restless feeling, nervousness;
urinating less than usual or not at all;
easy bruising or bleeding, unusual weakness; or
seizure (black-out or convulsions).
Less serious side effects may include:
blurred vision;
dry nose or mouth;
nausea, stomach pain, constipation, loss of appetite;
dizziness, drowsiness;
problems with memory or concentration;
ringing in your ears; or
feeling restless or excited (especially in children).
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 medications you use, especially:
mecamylamine (Inversine);
methyldopa (Aldomet);
reserpine;
a beta-blocker such as atenolol (Tenormin, Tenoretic), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), and others;
a barbiturate such as butabarbital (Butisol), secobarbital (Seconal), pentobarbital (Nembutal), or phenobarbital (Solfoton); or
an antidepressant such as amitriptyline (Elavil, Vanatrip), doxepin (Sinequan), nortriptyline (Pamelor), and others.
This list is not complete and other drugs may interact with chlorpheniramine and pseudoephedrine. 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.
Omnipred® (prednisolone acetate ophthalmic suspension) is an adrenocortical steroid product prepared as sterile ophthalmic suspension. The active ingredient is represented by the chemical structure:
Established name: Prednisolone Acetate
Chemical name: Pregna-1,4-diene-3,20-dione, 21-(acetyloxy)-11,17-dihydroxy-,(11β)-.
Each mL contains: Active: prednisolone acetate 1.0%. Preservative: benzalkonium chloride 0.01%.
Vehicle: hypromellose. Inactives: dibasic sodium phosphate, polysorbate 80, edetate disodium, glycerin, citric acid and/or sodium hydroxide (to adjust pH), purified water.
Corticosteroids inhibit the inflammatory response to a variety of inciting agents and probably delay or slow healing. They inhibit the edema, fibrin deposition, capillary dilation, leukocyte migration, capillary proliferation, fibroblast proliferation, deposition of collagen, and scar formation associated with inflammation. There is no generally accepted explanation for the mechanism of action of ocular corticosteroids. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.
Corticosteroids are capable of producing a rise in intraocular pressure.
Steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitides, when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation; corneal injury from chemical, radiation, or thermal burns, or penetration of foreign bodies.
Omnipred® (prednisolone acetate ophthalmic suspension) is contraindicated in most viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures. Omnipred® (prednisolone acetate ophthalmic suspension) is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.
FOR TOPICAL OPHTHALMIC USE ONLY. Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision, and in posterior subcapsular cataract formation. Prolonged use may also suppress the host immune response and thus increase the hazard of secondary ocular infections. Various ocular diseases and long-term use of topical corticosteroids have been known to cause corneal and scleral thinning. Use of topical corticosteroids in the presence of thin corneal or scleral tissue may lead to perforation. Acute purulent infections of the eye may be masked or activity enhanced by the presence of corticosteroid medication. If this product is used for 10 days or longer, intraocular pressure should be routinely monitored even though it may be difficult in children and uncooperative patients. Steroids should be used with caution in the presence of glaucoma.
Intraocular pressure should be checked frequently.
The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation.
Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex). Employment of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution; frequent slit lamp microscopy is recommended.
Corticosteroids are not effective in mustard gas keratitis and Sjogren's keratoconjunctivitis.
The initial prescription and renewal of the medication order should be made by a physician only after examination of the patient with the aid of magnification, such as slit lamp biomicroscopy and, where appropriate, fluorescein staining. If signs and symptoms fail to improve after two days, the patient should be re-evaluated.
As fungal infections of the cornea are particularly prone to develop coincidentally with long-term local corticosteroid applications, fungal invasion should be suspected in any persistent corneal ulceration where a corticosteroid has been used or is in use. Fungal cultures should be taken when appropriate.
If this product is used for 10 days or longer, intraocular pressure should be monitored (SEE WARNINGS).
If inflammation or pain persists longer than 48 hours or becomes aggravated, the patient should be advised to discontinue use of the medication and consult a physician.
This product is sterile when packaged. To prevent contamination, care should be taken to avoid touching the bottle tip to eyelids or to any other surface. The use of this bottle by more than one person may spread infection. Keep bottle tightly closed when not in use. Keep out of the reach of children.
No studies have been conducted in animals or in humans to evaluate the potential of these effects.
Pregnancy Category C. Prednisolone has been shown to be teratogenic in mice when given in doses 1-10 times the human dose.
Dexamethasone, hydrocortisone and prednisolone were ocularly applied to both eyes of pregnant mice five times per day on days 10 through 13 of gestation. A significant increase in the incidence of cleft palate was observed in the fetuses of the treated mice. There are no adequate and well controlled studies in pregnant women. Omnipred® (prednisolone acetate ophthalmic suspension) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Because of the potential for serious adverse reactions in nursing infants from prednisolone acetate, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Safety and effectiveness in pediatric patients have not been established.
No overall differences in safety or effectiveness have been observed between elderly and younger patients.
Adverse reactions include, in decreasing order of frequency, elevation of intraocular pressure (IOP) with possible development of glaucoma and infrequent optic nerve damage, posterior subcapsular cataract formation, and delayed wound healing.
Although systemic effects are extremely uncommon, there have been rare occurrences of systemic hypercorticoidism after use of topical steroids.
Corticosteroid-containing preparations have also been reported to cause acute anterior uveitis and perforation of the globe.
Keratitis, conjunctivitis, corneal ulcers, mydriasis, conjunctival hyperemia, loss of accommodation and ptosis have occasionally been reported following local use of corticosteroids.
The development of secondary ocular infection (bacterial, fungal and viral) has occurred. Fungal and viral infections of the cornea are particularly prone to develop coincidentally with long-term applications of steroid. The possibility of fungal invasion should be considered in any persistent corneal ulceration where steroid treatment has been used (SEE WARNINGS).
SHAKE WELL BEFORE USING. Two drops topically in the eye(s) four times daily. In cases of bacterial infections, concomitant use of anti-infective agents is mandatory. Care should be taken not to discontinue therapy prematurely. If signs and symptoms fail to improve after two days, the patient should be re-evaluated (SEE PRECAUTIONS).
The dosing of Omnipred® suspension may be reduced, but care should be taken not to discontinue therapy prematurely.
In chronic conditions, withdrawal of treatment should be carried out by gradually decreasing the frequency of applications.
Omnipred® (prednisolone acetate ophthalmic suspension) is supplied in a white, round low density polyethylene DROP-TAINER® dispenser with a natural low density polyethylene dispensing plug and pink polypropylene cap. Tamper evidence is provided with a shrink band around the closure and neck area of the package.
Omnipred® suspension:
5 mL NDC 0065-0638-27
10 mL NDC 0065-0638-25
STORAGE: STORE at 8° - 24°C (46° - 75°F) in an UPRIGHT position.
Rx Only
ALCON LABORATORIES, INC.
Fort Worth, Texas 76134 USA
Printed in USA
©2006-2008 Alcon, Inc.
Revised: October 2007
9004078-1008
NDC 0065-0638-27 STERILE
Omnipred®
(prednisolone
acetate ophthalmic
suspension) 1%
5 mL Alcon®
| Omnipred prednisolone acetate suspension | ||||||||||||||||||||
| ||||||||||||||||||||
| ||||||||||||||||||||
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| ||||||||||||||||||||
| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| NDA | NDA017469 | 11/06/2007 | |
| Labeler - Alcon Laboratories, Inc. (008018525) |
| Registrant - Alcon Laboratories, Inc. (008018525) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Alcon Laboratories, Inc. | 008018525 | MANUFACTURE | |
Vinces may be available in the countries listed below.
Vincristine sulfate (a derivative of Vincristine) is reported as an ingredient of Vinces in the following countries:
International Drug Name Search
Atenolol Merck may be available in the countries listed below.
Atenolol is reported as an ingredient of Atenolol Merck in the following countries:
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Vet-Cillin may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Amoxicillin trihydrate (a derivative of Amoxicillin) is reported as an ingredient of Vet-Cillin in the following countries:
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Retipon may be available in the countries listed below.
Thioctic Acid is reported as an ingredient of Retipon in the following countries:
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Pilokarpin Unimed Pharma may be available in the countries listed below.
Pilocarpine hydrochloride (a derivative of Pilocarpine) is reported as an ingredient of Pilokarpin Unimed Pharma in the following countries:
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Verapamil HCl Dexcel may be available in the countries listed below.
Verapamil hydrochloride (a derivative of Verapamil) is reported as an ingredient of Verapamil HCl Dexcel in the following countries:
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Ralovera may be available in the countries listed below.
Medroxyprogesterone 17α-acetate (a derivative of Medroxyprogesterone) is reported as an ingredient of Ralovera in the following countries:
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Viltern may be available in the countries listed below.
Betamethasone 17α,21-dipropionate (a derivative of Betamethasone) is reported as an ingredient of Viltern in the following countries:
International Drug Name Search
Paracetamol / Codeine Sandoz may be available in the countries listed below.
Codeine phosphate hemihydrate (a derivative of Codeine) is reported as an ingredient of Paracetamol / Codeine Sandoz in the following countries:
Paracetamol is reported as an ingredient of Paracetamol / Codeine Sandoz in the following countries:
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Lanodip may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Povidone-Iodine is reported as an ingredient of Lanodip in the following countries:
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Neo Lotan may be available in the countries listed below.
Losartan potassium salt (a derivative of Losartan) is reported as an ingredient of Neo Lotan in the following countries:
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Ceroxim may be available in the countries listed below.
Cefuroxime axetil (a derivative of Cefuroxime) is reported as an ingredient of Ceroxim in the following countries:
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Alfacalcidol Alvia may be available in the countries listed below.
Alfacalcidol is reported as an ingredient of Alfacalcidol Alvia in the following countries:
International Drug Name Search
Tetrazepam-Teva may be available in the countries listed below.
Tetrazepam is reported as an ingredient of Tetrazepam-Teva in the following countries:
International Drug Name Search
Piones may be available in the countries listed below.
Hyaluronic Acid sodium salt (a derivative of Hyaluronic Acid) is reported as an ingredient of Piones in the following countries:
International Drug Name Search
Pramide may be available in the countries listed below.
Metoclopramide is reported as an ingredient of Pramide in the following countries:
Pyrazinamide is reported as an ingredient of Pramide in the following countries:
International Drug Name Search
Viartril may be available in the countries listed below.
Diclofenac sodium salt (a derivative of Diclofenac) is reported as an ingredient of Viartril in the following countries:
Glucosamine sulfate (a derivative of Glucosamine) is reported as an ingredient of Viartril in the following countries:
International Drug Name Search
Netildex may be available in the countries listed below.
Dexamethasone 21-(disodium phosphate) (a derivative of Dexamethasone) is reported as an ingredient of Netildex in the following countries:
Netilmicin sulfate (a derivative of Netilmicin) is reported as an ingredient of Netildex in the following countries:
International Drug Name Search
Norflok may be available in the countries listed below.
Norfloxacin is reported as an ingredient of Norflok in the following countries:
International Drug Name Search
Norfloxacine Biogaran may be available in the countries listed below.
Norfloxacin is reported as an ingredient of Norfloxacine Biogaran in the following countries:
International Drug Name Search
Ranopine may be available in the countries listed below.
Ranitidine hydrochloride (a derivative of Ranitidine) is reported as an ingredient of Ranopine in the following countries:
International Drug Name Search
Long-acting beta-agonists such as Brovana have been rarely associated with an increased risk of asthma-related death. Long-acting beta-agonists should not be used in asthma patients without another long-term asthma-control medicine (eg, inhaled corticosteroids). Brovana has not been approved to treat asthma. Safety and effectiveness of Brovana in patients with asthma have not been confirmed.
Long-term treatment of chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. It may also be used for other conditions as determined by your doctor.
Brovana is a long-acting beta-agonist bronchodilator. It works by widening the airways in the lungs, which helps you breathe more easily.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Brovana. 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 Brovana. 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 Brovana 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 Brovana 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 Brovana.
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:
Back pain; diarrhea; dry mouth; headache; nausea; nervousness; stuffy nose; tiredness; tremor; trouble sleeping; vomiting.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, tongue, or throat; unusual hoarseness); chest pain; fast or irregular heartbeat; fever, chills, or persistent sore throat; leg swelling; new or worsening breathing problems (eg, increased chest tightness, coughing, shortness of breath, wheezing); severe or persistent headache, dizziness, tremor, or nervousness; severe or persistent muscle pain or cramps; symptoms of high blood sugar (eg, increased thirst, urination, or hunger; unusual weakness or drowsiness; confusion); trouble speaking.
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: Brovana 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 chest pain; fast or irregular heartbeat; severe or persistent dizziness, dry mouth, fatigue, headache, muscle pain or cramps, nausea, nervousness, trouble sleeping, or tremors; severe or persistent symptoms of high blood sugar (eg, increased thirst, urination, or hunger; drowsiness; flushing of the skin; confusion; fruit-like breath odor).
Store Brovana in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Unopened pouches may be stored at room temperature, between 68 and 77 degrees F (20 and 25 degrees C), for up to 6 weeks. If Brovana is stored at room temperature, throw it away after 6 weeks. Do not use Brovana if it is past the expiration date on the container. Store Brovana away form heat, moisture, and light. Keep Brovana out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Brovana. 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.
