Tiptipot Afalpi may be available in the countries listed below.
Pseudoephedrine hydrochloride (a derivative of Pseudoephedrine) is reported as an ingredient of Tiptipot Afalpi in the following countries:
International Drug Name Search
In the US, Gadobenate Dimeglumine (gadobenate dimeglumine systemic) is a member of the drug class magnetic resonance imaging contrast media and is used to treat CNS Magnetic Resonance Imaging.
US matches:
Gadobenate Dimeglumine (USAN) is also known as Gadobenic Acid (Rec.INN)
International Drug Name Search
Glossary
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
| USAN | United States Adopted Name |
Mesigyna may be available in the countries listed below.
Estradiol 17ß-valerate (a derivative of Estradiol) is reported as an ingredient of Mesigyna in the following countries:
Norethisterone enantate (a derivative of Norethisterone) is reported as an ingredient of Mesigyna in the following countries:
International Drug Name Search
Aserin may be available in the countries listed below.
Sertraline hydrochloride (a derivative of Sertraline) is reported as an ingredient of Aserin in the following countries:
International Drug Name Search
Vasta may be available in the countries listed below.
Simvastatin is reported as an ingredient of Vasta in the following countries:
International Drug Name Search
Efectus may be available in the countries listed below.
Cefepime Hydrochloride (a derivative of Cefepime) is reported as an ingredient of Efectus in the following countries:
International Drug Name Search
Diltiazem CristerS may be available in the countries listed below.
Diltiazem hydrochloride (a derivative of Diltiazem) is reported as an ingredient of Diltiazem CristerS in the following countries:
International Drug Name Search
Dermac Jabon may be available in the countries listed below.
Acediasulfone Sodium is reported as an ingredient of Dermac Jabon in the following countries:
International Drug Name Search
Generic Name: brompheniramine and pseudoephedrine (BROM fen EER a meen and SOO doe ed FED rin)
Brand Names: Andehist NR Syrup, Bidhist-D, Bromaline, Bromhist Pediatric Drops, Bromhist-NR, BroveX PD, BroveX PSE, Brovex SR, Di-Bromm, Histex SR, J-TanD PD, Lodrane 12D, Lodrane 24D, Lodrane D, Lodrane Liquid, LoHist-12D, LoHist-PD, Q-Tapp, Sildec, Touro Allergy, Ultrabrom, Ultrabrom PD
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.
Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).
The combination of brompheniramine and pseudoephedrine 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.
Brompheniramine and pseudoephedrine may also be used for other purposes not listed in this medication guide.
There are many brands and forms of this medicine available and not all brands are listed on this leaflet.
Ask a doctor or pharmacist if it is safe for you to take brompheniramine and pseudoephedrine if you have:
diabetes;
glaucoma;
heart disease or high blood pressure;
diabetes;
a thyroid disorder;
an enlarged prostate; or
problems with urination.
Artificially-sweetened liquid forms of cold medicine 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 has been prescribed by your doctor. Do not use the medication in larger amounts, or use it for longer than recommended. Cold medicine is usually taken only for a short time until your symptoms clear up.
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 for one.
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.
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.
Since cold or allergy 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 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;
easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms; or
urinating less than usual or not at all.
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.
Tell your doctor about all other medications you use, especially:
medicines to treat high blood pressure;
a diuretic (water pill);
medication to treat irritable bowel syndrome;
bladder or urinary medications such as oxybutynin (Ditropan, Oxytrol) or tolterodine (Detrol);
aspirin or salicylates (such as Disalcid, Doan's Pills, Dolobid, Salflex, Tricosal, and others);
a beta-blocker such as atenolol (Tenormin), carteolol (Cartrol), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal), sotalol (Betapace), timolol (Blocadren), and others; or
antidepressants such as amitriptyline (Elavil), clomipramine (Anafranil), imipramine (Janimine, Tofranil), and others.
This list is not complete and there may be other drugs that can interact with brompheniramine and pseudoephedrine. 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: Bidhist-D side effects (in more detail)
Devotan may be available in the countries listed below.
Gliquidone is reported as an ingredient of Devotan in the following countries:
International Drug Name Search
Mifégyne may be available in the countries listed below.
Mifepristone is reported as an ingredient of Mifégyne in the following countries:
International Drug Name Search
Neriproct may be available in the countries listed below.
Diflucortolone 21-valerate (a derivative of Diflucortolone) is reported as an ingredient of Neriproct in the following countries:
Lidocaine is reported as an ingredient of Neriproct in the following countries:
International Drug Name Search
In some countries, this medicine may only be approved for veterinary use.
Sulfafurazole is reported as an ingredient of Soxisol in the following countries:
International Drug Name Search
Atenolol Mylan may be available in the countries listed below.
Atenolol is reported as an ingredient of Atenolol Mylan in the following countries:
International Drug Name Search
Antivery may be available in the countries listed below.
Meclozine dihydrochloride (a derivative of Meclozine) is reported as an ingredient of Antivery in the following countries:
International Drug Name Search
Generic Name: ocular lubricant (OK yoo lar LOO bri kant)
Brand Names: Artificial Tears, Celluvisc, Clear Eyes CLR, Comfort Tears, Dry Eye Relief, GenTeal, Isopto Tears, Lacri-Lube S.O.P., Lacrisert, Lubricant Eye Drops, Moisture Drops, Oasis Tears, Opti-Free Rewetting Drops, optive, Refresh, Soothe, Sterilube, Systane, Systane Balance, Tears Again, Tears Naturale, Tears Renew, TheraTears, Ultra Fresh, Visine Tears
There are many brands and forms of ocular lubricant available and not all are listed on this leaflet.
Ocular lubricant is a solution specially formulated to moisten the eyes.
Ocular lubricant may also be used for purposes not listed in this medication guide.
There are many brands and forms of ocular lubricant available and not all are listed on this leaflet.
Ask a doctor or pharmacist if it is safe for you to use this medicine if you have any type of infection in your eye.
Do not allow the dropper or tube tip to touch any surface, including the eyes or hands. If the dropper or tube becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye.
This medication may cause blurred vision. Be careful if you drive or do anything that requires you to be able to see clearly.
Ask a doctor or pharmacist if it is safe for you to use this medicine if you have any type of infection in your eye.
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.
To apply the eye drops:
Tilt your head back slightly and pull down your lower eyelid to create a small pocket. Hold the dropper above the eye with the tip down. Look up and away from the dropper as you squeeze out a drop, then close your eye.
Use only the number of drops your doctor has prescribed.
Gently press your finger to the inside corner of the eye (near your nose) for about 1 minute to keep the liquid from draining into your tear duct. If you use more than one drop in the same eye, wait about 5 minutes before putting in the next drop.
Do not use the eye drops if the liquid has changed colors or has particles in it.
To apply the ointment:
Tilt your head back slightly and pull down your lower eyelid to create a small pocket. Hold the ointment tube with the tip pointing toward this pocket. Look up and away from the tip.
Squeeze out a ribbon of ointment 1/2-inch long into the lower eyelid pocket without touching the tip of the tube to your eye. Look down and close your eyes for a few minutes. Rolling your eyes around gently will help spread the ointment evenly.
After opening your eyes, you may have blurred vision for a short time. Avoid driving or doing anything that requires you to be able to see clearly.
Do not allow the dropper or tube tip to touch any surface, including the eyes or hands. If the dropper or tube becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye.
Since ocular lubricant is used on an as needed basis, you are not likely to miss a dose.
An overdose of ocular lubricant is not expected to be dangerous.
This medication may cause blurred vision. Be careful if you drive or do anything that requires you to be able to see clearly.
Avoid using other medications in your eyes during treatment with ocular lubricant unless your doctor tells you to.
severe burning, stinging, or eye irritation after using the medication;
eye pain; or
vision changes.
Less serious side effects may include:
mild eye burning or irritation;
itching or redness of your eyes;
watery eyes;
blurred vision; 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.
It is not likely that other drugs you take orally or inject will have an effect on ocular lubricant used in the eyes. 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.
Merotik may be available in the countries listed below.
Meropenem is reported as an ingredient of Merotik in the following countries:
International Drug Name Search
Dextrox may be available in the countries listed below.
Dextromethorphan is reported as an ingredient of Dextrox in the following countries:
International Drug Name Search
Questran Loc may be available in the countries listed below.
Colestyramine is reported as an ingredient of Questran Loc in the following countries:
International Drug Name Search
Avidal may be available in the countries listed below.
Metronidazole is reported as an ingredient of Avidal in the following countries:
International Drug Name Search
Norfloxacin Sandoz may be available in the countries listed below.
Norfloxacin is reported as an ingredient of Norfloxacin Sandoz in the following countries:
International Drug Name Search
Oxy Salicylic Acid may be available in the countries listed below.
Salicylic Acid is reported as an ingredient of Oxy Salicylic Acid in the following countries:
International Drug Name Search
Venlafaxin Heumann may be available in the countries listed below.
Venlafaxine hydrochloride (a derivative of Venlafaxine) is reported as an ingredient of Venlafaxin Heumann in the following countries:
International Drug Name Search
Factor Laxante Ilab may be available in the countries listed below.
Sodium Picosulfate is reported as an ingredient of Factor Laxante Ilab in the following countries:
International Drug Name Search
Paracetamol Serra may be available in the countries listed below.
Paracetamol is reported as an ingredient of Paracetamol Serra in the following countries:
International Drug Name Search
Indomed may be available in the countries listed below.
Indometacin is reported as an ingredient of Indomed in the following countries:
International Drug Name Search
Papaverina Cloridrato may be available in the countries listed below.
Papaverine hydrochloride (a derivative of Papaverine) is reported as an ingredient of Papaverina Cloridrato in the following countries:
International Drug Name Search
In some countries, this medicine may only be approved for veterinary use.
Phenylbutazone is reported as an ingredient of EquiBute in the following countries:
International Drug Name Search
Placis may be available in the countries listed below.
Cisplatin is reported as an ingredient of Placis in the following countries:
International Drug Name Search
Dimitone may be available in the countries listed below.
Carvedilol is reported as an ingredient of Dimitone in the following countries:
International Drug Name Search
Bonalon may be available in the countries listed below.
Alendronic Acid sodium trihydrate (a derivative of Alendronic Acid) is reported as an ingredient of Bonalon in the following countries:
International Drug Name Search
Azitromicina Merck may be available in the countries listed below.
Azithromycin is reported as an ingredient of Azitromicina Merck in the following countries:
Azithromycin dihydrate (a derivative of Azithromycin) is reported as an ingredient of Azitromicina Merck in the following countries:
International Drug Name Search
Mefenacid Domesco may be available in the countries listed below.
Mefenamic Acid is reported as an ingredient of Mefenacid Domesco in the following countries:
International Drug Name Search
Bioglan Fluoxetine may be available in the countries listed below.
Fluoxetine hydrochloride (a derivative of Fluoxetine) is reported as an ingredient of Bioglan Fluoxetine in the following countries:
International Drug Name Search
Omeprazol-Stada may be available in the countries listed below.
Omeprazole is reported as an ingredient of Omeprazol-Stada in the following countries:
International Drug Name Search
Bonamine may be available in the countries listed below.
Meclozine dihydrochloride (a derivative of Meclozine) is reported as an ingredient of Bonamine in the following countries:
International Drug Name Search
Tamsulosine Merck may be available in the countries listed below.
Tamsulosin hydrochloride (a derivative of Tamsulosin) is reported as an ingredient of Tamsulosine Merck in the following countries:
International Drug Name Search
Leucodinine B may be available in the countries listed below.
Mequinol is reported as an ingredient of Leucodinine B in the following countries:
International Drug Name Search
Acido Alendronico Tetrafarma may be available in the countries listed below.
Alendronic Acid is reported as an ingredient of Acido Alendronico Tetrafarma in the following countries:
International Drug Name Search
Ergonex may be available in the countries listed below.
Caffeine is reported as an ingredient of Ergonex in the following countries:
Ergotamine is reported as an ingredient of Ergonex in the following countries:
International Drug Name Search
GenRX Clomipramine may be available in the countries listed below.
Clomipramine hydrochloride (a derivative of Clomipramine) is reported as an ingredient of GenRX Clomipramine in the following countries:
International Drug Name Search
Alcevan may be available in the countries listed below.
Amoxicillin is reported as an ingredient of Alcevan in the following countries:
International Drug Name Search
Treating irritable bowel syndrome and intestinal inflammation in combination with other medicines. It may also be used along with other medicines to treat intestinal ulcers. It may also be used for other conditions as determined by your doctor.
Donnatal Extentabs Controlled-Release Tablets are an anticholinergic and barbiturate combination. It works by decreasing the motion of the muscles in the stomach and intestine and providing mild sedation.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Donnatal Extentabs Controlled-Release Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
Some MEDICINES MAY INTERACT with Donnatal Extentabs Controlled-Release Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:
This may not be a complete list of all interactions that may occur. Ask your health care provider if Donnatal Extentabs Controlled-Release Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Use Donnatal Extentabs Controlled-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Donnatal Extentabs Controlled-Release Tablets.
When used for long periods of time or at high doses, Donnatal Extentabs Controlled-Release Tablets 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 Donnatal Extentabs Controlled-Release Tablets stops working well. Do not take more than prescribed.
Some people who use Donnatal Extentabs Controlled-Release Tablets 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 Donnatal Extentabs Controlled-Release Tablets suddenly, you may have WITHDRAWAL symptoms. These may include anxiety, nausea, sleeplessness, body aches, seizures, and delirium.
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:
Bloated feeling; blurred vision; clumsiness; constipation; decreased sweating; dizziness; drowsiness; dry mouth; excessive daytime drowsiness ("hangover effect"); feeling of a whirling motion; headache; lightheadedness; nausea; nervousness; tired feeling; trouble sleeping.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); agitation; confusion; diarrhea; difficulty focusing eyes; disorientation; exaggerated feeling of well-being; excitement; fainting; fast or irregular heartbeat; hallucinations; loss of coordination; loss of taste; memory loss; muscle pain; pounding in the chest; severe or persistent trouble sleeping; trouble urinating; unusual weakness; very slow breathing; vision changes; vomiting.
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: Donnatal Extentabs 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 change in size of pupil; deep sleep; hot, dry skin; loss of consciousness; severe dry mouth; severe or persistent headache or nausea; slowed or fast breathing; trouble swallowing; vomiting.
Store Donnatal Extentabs Controlled-Release Tablets at room temperature, between 68 and 77 degrees F (20 and 25 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Donnatal Extentabs Controlled-Release Tablets out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Donnatal Extentabs Controlled-Release Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
Gluthion may be available in the countries listed below.
Glutathione is reported as an ingredient of Gluthion in the following countries:
International Drug Name Search
Ephedrine Sulphate may be available in the countries listed below.
Ephedrine Sulphate (BANM) is known as Ephedrine in the US.
International Drug Name Search
Glossary
| BANM | British Approved Name (Modified) |
Trazograf may be available in the countries listed below.
Diatrizoic acid meglumine and sodium salt (a derivative of Diatrizoic acid) is reported as an ingredient of Trazograf in the following countries:
International Drug Name Search
In the US, Sotret (isotretinoin systemic) is a member of the following drug classes: miscellaneous antineoplastics, miscellaneous uncategorized agents and is used to treat Acne, Acute Nonlymphocytic Leukemia, Granuloma Annulare, Melanoma - Metastatic and Rosacea.
US matches:
Isotretinoin is reported as an ingredient of Sotret in the following countries:
International Drug Name Search
Pasquam may be available in the countries listed below.
Dexpanthenol is reported as an ingredient of Pasquam in the following countries:
International Drug Name Search
Bisopollon may be available in the countries listed below.
Bromhexine hydrochloride (a derivative of Bromhexine) is reported as an ingredient of Bisopollon in the following countries:
International Drug Name Search
Medrosterona may be available in the countries listed below.
Medroxyprogesterone 17α-acetate (a derivative of Medroxyprogesterone) is reported as an ingredient of Medrosterona in the following countries:
International Drug Name Search
Ciprofloxacino Davur may be available in the countries listed below.
Ciprofloxacin hydrochloride (a derivative of Ciprofloxacin) is reported as an ingredient of Ciprofloxacino Davur in the following countries:
International Drug Name Search
Indoor Outdoor may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Cyfluthrin is reported as an ingredient of Indoor Outdoor in the following countries:
International Drug Name Search
Urobactrim may be available in the countries listed below.
Sulfamethoxazole is reported as an ingredient of Urobactrim in the following countries:
Trimethoprim is reported as an ingredient of Urobactrim in the following countries:
International Drug Name Search
Cysticide may be available in the countries listed below.
Praziquantel is reported as an ingredient of Cysticide in the following countries:
International Drug Name Search
In some countries, this medicine may only be approved for veterinary use.
Rec.INN
0000050-34-0
C23-H30-Br-N-O3
448
Antispasmodic agent
Parasympatholytic agent
Gastric acid secretion inhibitor
2-Propanaminium, N-methyl-N-(1-methylethyl)-N-[2-[(9H-xanthen-9-ylcarbonyl)oxy]ethyl]-, bromide
International Drug Name Search
Glossary
| BAN | British Approved Name |
| 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) |
Azathioprin-ratiopharm may be available in the countries listed below.
Azathioprine is reported as an ingredient of Azathioprin-ratiopharm in the following countries:
International Drug Name Search
Flexibel may be available in the countries listed below.
Chondroitin Polysulfate is reported as an ingredient of Flexibel in the following countries:
Glucosamine sulfate (a derivative of Glucosamine) is reported as an ingredient of Flexibel in the following countries:
International Drug Name Search
Rx Only
FOR DERMATOLOGIC USE ONLY NOT FOR OPHTHALMIC USE
Betamethasone Valerate Lotion contains betamethasone valerate USP, a synthetic adrenocortico-steroid for dermatologic use. Betamethasone, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity.
Betamethasone valerate is a white to practically white odorless crystalline powder practically insoluble in water, freely soluble in acetone and chloroform, soluble in alcohol, and slightly soluble in benzene and ether. Chemically, it is 9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17-valerate. The structural formula is:
Each gram of the 0.1% Lotion contains 1.2 mg of betamethasone valerate (equivalent to 1 mg betamethasone) in a vehicle of isopropyl alcohol and water slightly thickened with carbomer 934P. Phosphoric acid or sodium hydroxide is used to adjust the pH.
Topical corticosteroids share anti-inflammatory, anti-pruritic, and vasoconstrictive actions.
The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man.
Pharmacokinetics: The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings.
Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. Thus, occlusive dressings may be a valuable therapeutic adjunct for treatment of resistant dermatoses.
Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.
Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of cortico-steroid-responsive dermatoses.
Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
General: Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients.
Conditions which augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings.
Therefore, patients receiving a large dose of a potent topical steroid applied to a large surface area should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid.
Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids.
Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (See PRECAUTIONS—Pediatric Use).
If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted.
In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled.
Information for Patients: Patients using topical corticosteroids should receive the following information and instructions:
Laboratory tests: The following tests may be helpful in evaluating the HPA axis suppression:
Carcinogenesis, Mutagenesis and Impairment of Fertility: Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids.
Studies to determine mutagenicity with prednisolone and hydrocortisone have revealed negative results.
Pregnancy: Teratogenic Effects—Pregnancy Category C. Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time.
Nursing Mothers: It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman.
Pediatric Use: Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body weight ratio.
Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.
Administration of topical corticosteroids to pediatric patients should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of children.
The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae and miliaria
Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (See PRECAUTIONS).
Apply a few drops of Betamethasone Valerate Lotion to the affected area and massage lightly until it disappears. Apply twice daily, in the morning and at night. Dosage may be increased in stubborn cases. Following improvement, apply once daily. For the most effective and economical use, apply nozzle very close to affected area and gently squeeze bottle.
Betamethasone Valerate
Lotion USP, 0.1%
is supplied as follows:
60ml bottles NDC 54879-004-60
Shake well before using.
Store at controlled room temperature 15° - 30°C (59° - 86°F).
Manufactured for :
STI Pharma LLC
Langhorne, PA 19047
Manufactured & Distributed by:
G&W Labs
S. Plainfield, NJ 07080
Revision 09/2011
NDC 54879-004-60
STI Pharma LLC
Betamethasone Valerate Lotion USP, 0.1%
(Potency expressed as betamethasone)
60ml
FOR DERMATOLOGIC USE ONLY
NOT OPHTHALMIC USE
Rx only
STI Pharma LLC
NDC 54879-004-60
STI Pharma LLC
Betamethasone Valerate Lotion USP, 0.1%
(Potency expressed as betamethasone)
60ml
FOR DERMATOLOGIC USE ONLY
NOT OPHTHALMIC USE
Each gram contains 1.2 mg
betamethasone valerate (equivalent
to 1 mg betamethasone) in a vehicle
of isopropyl alcohol and water slightly
thickened with carbomer 934P.
Phosphoric acid or sodium hydroxide is used
to adjust pH.
Rx only
STI Pharma LLC
| BETAMETHASONE VALERATE betamethasone valerate lotion | ||||||||||||||||||||
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| ANDA | ANDA070052 | 07/31/1985 | |
| Labeler - STI Pharma (832714070) |
Terivalidin may be available in the countries listed below.
Terizidone is reported as an ingredient of Terivalidin in the following countries:
International Drug Name Search
Hydramox may be available in the countries listed below.
Amoxicillin trihydrate (a derivative of Amoxicillin) is reported as an ingredient of Hydramox in the following countries:
International Drug Name Search
Soxime may be available in the countries listed below.
Cefuroxime axetil (a derivative of Cefuroxime) is reported as an ingredient of Soxime in the following countries:
International Drug Name Search
Radiosélectan urinaire may be available in the countries listed below.
Diatrizoic acid meglumine and sodium salt (a derivative of Diatrizoic acid) is reported as an ingredient of Radiosélectan urinaire in the following countries:
International Drug Name Search
Generic Name: acetaminophen and phenyltoloxamine (a seet a MIN oh fen and FEN il toe LOX a meen)
Brand Names: Aceta-Gesic, Acuflex, Alpain, Apagesic, BeFlex, BP Poly-650, Dologesic, Flextra-650, Flextra-DS, Hyflex-650, Hyflex-DS, Lagesic, Major-gesic, Percogesic, Phenagesic, Phenylgesic, Q Flex, Relagesic, RhinoFlex, RhinoFlex 650, Staflex, Vistra, Vitoxapap, Zgesic
Acetaminophen is a pain reliever and a fever reducer.
Phenyltoloxamine is an antihistamine that reduces the effects of natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.
Acetaminophen and phenyltoloxamine is used to treat runny nose, sneezing, and pain or fever caused by the common cold, flu, or seasonal allergies.
Acetaminophen and phenyltoloxamine may also be used for purposes not listed in this medication guide.
Ask a doctor or pharmacist if it is safe for you to take this medicine if you have liver or kidney disease, diabetes, glaucoma, urination problems, an enlarged prostate, heart disease, high blood pressure, a stomach ulcer, or an overactive thyroid.
Ask a doctor or pharmacist if it is safe for you to take this medicine if you have:
kidney disease;
diabetes;
glaucoma;
urination problems;
an enlarged prostate;
heart disease or high blood pressure;
a stomach ulcer; or
an overactive thyroid.
One tablet of this medicine may contain up to 650 mg of acetaminophen. Know the amount of acetaminophen in the specific product you are taking.
Call your doctor if your symptoms do not improve, or if you have a fever for longer than 3 days.
This medication can cause unusual results with allergy skin tests. Tell any doctor who treats you that you are taking an antihistamine.
Since cold or allergy medicine is taken when 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.
The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.
Overdose symptoms may also include feeling very restless, extreme drowsiness, warmth or tingly feeling, or seizure (convulsions).
fast, pounding, or uneven heartbeat;
confusion, hallucinations, unusual thoughts or behavior;
severe dizziness, anxiety, restless feeling, nervousness;
urinating less than usual or not at all;
nausea, pain in your upper stomach, itching, loss of appetite, dark urine, clay colored stools, jaundice (yellowing of the skin or eyes); or
easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms.
Less serious side effects may include:
dizziness, drowsiness;
blurred vision;
dry mouth, nose, or throat;
mild stomach pain, constipation; or
problems with memory or concentration.
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 acetaminophen and phenyltoloxamine. 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: Relagesic side effects (in more detail)
