Qinolon may be available in the countries listed below.
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Ofloxacin is reported as an ingredient of Qinolon in the following countries:
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Beparine
Beparine may be available in the countries listed below.
Ingredient matches for Beparine
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Chlocodemin
Chlocodemin may be available in the countries listed below.
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Dexchlorpheniramine maleate (a derivative of Dexchlorpheniramine) is reported as an ingredient of Chlocodemin in the following countries:
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Emtryl
Emtryl may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
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Dimetridazole
Dimetridazole is reported as an ingredient of Emtryl in the following countries:
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Fluocinolone Oil (Body Oil)
Pronunciation: FLOO-oh-SIN-oh-lone
Generic Name: Fluocinolone
Brand Name: Derma-Smoothe/FS Body Oil
Fluocinolone Oil (Body Oil) is used for:
Treating inflammation of the skin. It may also be used for other conditions as determined by your doctor.
Fluocinolone Oil (Body Oil) is a topical corticosteroid. Exactly how it works is unknown.
Do NOT use Fluocinolone Oil (Body Oil) if:
- you are allergic to any ingredient in Fluocinolone Oil (Body Oil)
Contact your doctor or health care provider right away if any of these apply to you.
Before using Fluocinolone Oil (Body Oil):
Some medical conditions may interact with Fluocinolone Oil (Body Oil). Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you are allergic to peanuts
- if you have measles, chickenpox, or tuberculosis
- if you have hardening or thinning of the skin, or a skin infection
- if you have recently been vaccinated or you have had a positive tuberculin skin test
Some MEDICINES MAY INTERACT with Fluocinolone Oil (Body Oil). Because little, if any, of Fluocinolone Oil (Body Oil) is absorbed into the blood, the risk of it interacting with another medicine is low.
Ask your health care provider if Fluocinolone Oil (Body Oil) 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.
How to use Fluocinolone Oil (Body Oil):
Use Fluocinolone Oil (Body Oil) as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- For adults: Apply a thin layer of Fluocinolone Oil (Body Oil) to the affected area 3 times a day or as directed by your doctor.
- For children: Moisten the affected area, and then apply a thin layer of Fluocinolone Oil (Body Oil) twice a day for up to 4 weeks or as directed by your doctor.
- Wash your hands after applying Fluocinolone Oil (Body Oil), unless your hands are part of the treated area.
- If you miss a dose of Fluocinolone Oil (Body Oil), use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.
Ask your health care provider any questions you may have about how to use Fluocinolone Oil (Body Oil).
Important safety information:
- Fluocinolone Oil (Body Oil) is for external use only. Do not get it in your eyes. If you get Fluocinolone Oil (Body Oil) in your eyes, wash them right away with water.
- Fluocinolone Oil (Body Oil) contains refined peanut oil. However, Fluocinolone Oil (Body Oil) has not been known to cause an allergic reaction in patients who have a peanut allergy. If you are allergic to peanuts and have questions about using Fluocinolone Oil (Body Oil), check with your doctor.
- If your condition does not improve within 2 weeks or if it gets worse, contact your doctor.
- Do not use Fluocinolone Oil (Body Oil) on the face, under the arms, or on the groin unless directed otherwise by your doctor.
- Fluocinolone Oil (Body Oil) has a corticosteroid in it. Before you start any new medicine, check the label to see if it has a corticosteroid in it too. If it does or if you are not sure, check with your doctor or pharmacist.
- Do NOT use more than the recommended dose or use for longer than prescribed without checking with your doctor.
- Do not use Fluocinolone Oil (Body Oil) for any conditions other than the one for which it was prescribed.
- Check with your doctor before having vaccinations while using Fluocinolone Oil (Body Oil).
- Fluocinolone Oil (Body Oil) is not approved to treat diaper rash. Do not apply Fluocinolone Oil (Body Oil) to the diaper area of a child.
- Corticosteroids may affect growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they use Fluocinolone Oil (Body Oil).
- The body oil should not be used in children younger than 3 months old; safety and effectiveness in these children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Fluocinolone Oil (Body Oil) while you are pregnant. It is not known if Fluocinolone Oil (Body Oil) is found in breast milk after topical use. If you are or will be breast-feeding while you use Fluocinolone Oil (Body Oil), check with your doctor. Discuss any possible risks to your baby.
Possible side effects of Fluocinolone Oil (Body Oil):
All medicines may cause side effects, but many people have no, or minor, side effects. No COMMON side effects have been reported with the scalp oil after topical use. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Cough; lightening of the skin; mild fever; nose or throat inflammation; runny nose.
Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); acne-like rash; inflamed hair follicles; inflammation around the mouth; irritation, burning, redness, or swelling; thinning, softening, or discoloration of the 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.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include increased thirst or urination; muscle weakness; unusual weight gain, especially in the face.
Proper storage of Fluocinolone Oil (Body Oil):
Store Fluocinolone Oil (Body Oil) 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 Fluocinolone Oil (Body Oil) out of the reach of children and away from pets.
General information:
- If you have any questions about Fluocinolone Oil (Body Oil), please talk with your doctor, pharmacist, or other health care provider.
- Fluocinolone Oil (Body Oil) is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information is a summary only. It does not contain all information about Fluocinolone Oil (Body Oil). 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.
Issue Date: February 1, 2012
Database Edition 12.1.1.002
Copyright © 2012 Wolters Kluwer Health, Inc.
More Fluocinolone Oil (Body Oil) resources
- Fluocinolone Oil (Body Oil) Use in Pregnancy & Breastfeeding
- Fluocinolone Oil (Body Oil) Drug Interactions
- Fluocinolone Oil (Body Oil) Support Group
- 3 Reviews for Fluocinolone (Body) - Add your own review/rating
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Hydrocortisone Lotion
Each mL of Hydrocortisone Lotion USP, 2.5% contains 25 mg of hydrocortisone, USP in a vehicle consisting of carbomer homopolymer type C, ceteareth-20, cetyl alcohol, dehydroacetic acid, DMDM hydantoin, fragrance, glyceryl stearate, isopropyl palmitate, lactic acid, light mineral oil, myristyl alcohol, myristyl lactate, PEG-100 stearate, purified water, sodium hydroxide, sodium PCA, and stearyl alcohol.
Chemically, hydrocortisone is [Pregn-4-ene-3,20-dione, 11, 17, 21-trihydroxy-, (11β)-] with the molecular formula C21H30O5 and is represented by the following structural formula:
Its molecular weight is 362.46 and its CAS Registry Number is 50-23-7. The topical corticosteroids, including hydrocortisone, constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents.
Hydrocortisone Lotion - Clinical Pharmacology
Topical corticosteroids share anti-inflammatory, antipruritic 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 (see DOSAGE AND ADMINISTRATION).
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.
Indications and Usage for Hydrocortisone Lotion
Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Contraindications
Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
Precautions
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 or under an occlusive dressing 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 the Patient -
Patients using topical corticosteroids should receive the following information and instructions:
1. This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.
2. Patients should be advised not to use this medication for any disorder other than for which it was prescribed.
3. The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by the physician.
4. Patients should report any signs of local adverse reactions, especially under occlusive dressings.
5. Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on a child being treated in the diaper area, as these garments may constitute occlusive dressings.
Laboratory Tests -
The following tests may be helpful in evaluating the HPA axis suppression:
Urinary free cortisol test
ACTH stimulation test
Carcinogenesis, Mutagenesis, 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 pediatric patients receiving topical corticosteroids. Manifestations of adrenal suppression in pediatric patients 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 pediatric patients.
Adverse Reactions
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.
Overdosage
Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS).
Hydrocortisone Lotion Dosage and Administration
Shake well before using. Topical corticosteroids are generally applied to the affected area as a thin film from two to four times daily depending on the severity of the condition. Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions.
If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.
How is Hydrocortisone Lotion Supplied
Hydrocortisone Lotion USP, 2.5% is available as follows:
2 fl oz (59 mL) bottle (NDC 45802-937-16)
4 fl oz (118 mL) bottle (NDC 45802-937-26)
Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. Keep tightly closed. Keep out of the reach of children.
Manufactured by Perrigo
Bronx, NY 10457
Distributed By
Perrigo®
Allegan, MI 49010 • www.perrigo.com
Rev. 01/11
3X100 RC J2
PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
Rx Only
Hydrocortisone Lotion USP, 2.5%
For Topical Use Only
Hydrocortisone Lotion USP, 2.5% Label
| HYDROCORTISONE hydrocortisone lotion | ||||||||||||||||||||||||||||||||||||
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| ANDA | ANDA089074 | 05/23/2008 | |
| Labeler - Perrigo New York Inc (078846912) |
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Acecor
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Acebutolol
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