Eres may be available in the countries listed below.
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oh-LAN-za-peen
Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. Although the causes of death in clinical trials were varied, most of the deaths appeared to be either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature. Observational studies suggest that antipsychotic drugs may increase mortality. It is unclear from these studies to what extent the mortality findings may be attributed to the antipsychotic drug as opposed to patient characteristics. Olanzapine is not approved for the treatment of patients with dementia-related psychosis .
Patients are at risk for severe sedation (including coma) and/or delirium after each injection and must be observed for at least 3 hours in a registered facility with ready access to emergency response services. Because of this risk, olanzapine pamoate is available only through a restricted distribution program called olanzapine pamoate Patient Care Program and requires prescriber, healthcare facility, patient, and pharmacy enrollment. Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Olanzapine pamoate is not approved for the treatment of patients with dementia-related psychosis .
In the U.S.
Available Dosage Forms:
Therapeutic Class: Antipsychotic
Chemical Class: Thienobenzodiazepine
Olanzapine injection is used to treat agitation that occurs with schizophrenia and bipolar mania. olanzapine should not be used to treat behavioral problems in older adult patients who have dementia or Alzheimer's disease.
olanzapine is available only with your doctor's prescription.
Zyprexa Relprevv® is available only under a special restricted distribution program called Zyprexa Relprevv® patient care program.
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 olanzapine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to olanzapine 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 olanzapine 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 olanzapine injection in the elderly. However, elderly patients are more likely to have dementia or age-related liver, kidney, or heart problems, which may require caution or an adjustment in the dose for patients receiving olanzapine 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. When you are receiving olanzapine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using olanzapine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
Using olanzapine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Using olanzapine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
The presence of other medical problems may affect the use of olanzapine. Make sure you tell your doctor if you have any other medical problems, especially:
A nurse or other trained health professional will give you olanzapine in a clinic, community health center, or hospital. olanzapine is given as a shot into one of your muscles.
Your doctor may give you a few doses of olanzapine until your condition improves, and then switch you to an oral medicine that works the same way. If you have any concerns about this, talk to your doctor.
Use only the brand of olanzapine that your doctor prescribed. Different brands may not work the same way.
olanzapine should come with a medication guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.
Tell your doctor if you smoke tobacco. You might need a different amount of olanzapine if you smoke.
It is very important that your doctor check your progress while you are receiving olanzapine to make sure it is working properly. Blood tests may be needed to check for unwanted effects.
Olanzapine may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you or your caregiver notice any of these unwanted effects, tell your doctor right away.
olanzapine may increase your cholesterol and fats in the blood. If this condition occurs, your doctor may give you some medicines that can lower the amount of cholesterol and fats in the blood.
olanzapine may increase your weight. Your doctor may need to check your weight regularly during treatment with olanzapine.
olanzapine may increase the amount of sugar in your blood. Check with your doctor right away if you have increased thirst or increased urination. If you have diabetes, you may notice a change in the results of your urine or blood sugar tests. If you have any questions, check with your doctor.
Stop using olanzapine and check with your doctor right away if you have any of the following symptoms while receiving olanzapine: convulsions (seizures), difficulty with breathing, a fast heartbeat, a high fever, high or low blood pressure, increased sweating, loss of bladder control, severe muscle stiffness, unusually pale skin, or tiredness. These could be symptoms of a serious condition called neuroleptic malignant syndrome (NMS).
olanzapine may cause tardive dyskinesia (a movement disorder). Check with your doctor right away if you have any of the following symptoms while receiving olanzapine: lip smacking or puckering, puffing of the cheeks, rapid or worm-like movements of the tongue, uncontrolled chewing movements, or uncontrolled movements of the arms and legs.
Olanzapine injection may cause drowsiness, trouble with thinking, trouble with controlling body movements, or trouble with your vision. Make sure you know how you react to olanzapine before you drive, use machines, or do other jobs that require you to be alert, well-coordinated, or able to think or see well.
Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position. Getting up slowly may help. If this problem continues or gets worse, check with your doctor.
olanzapine may cause post-injection delirium/sedation syndrome. Tell your doctor right away if you have the following symptoms: convulsions (seizures), dizziness, drowsiness, sleepiness, or confusion as to time, place, or person after receiving the injection.
olanzapine can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
You might get overheated while using olanzapine. Drink plenty of water during hot weather, while exercising, or while using a hot tub or sauna. If your body gets too hot, you might feel dizzy, weak, tired, or confused. You might have an upset stomach or vomit. Call your doctor if drinking cool water and moving away from the heat does not cool you down.
Avoid drinking alcohol while you are receiving olanzapine.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines) and herbal or vitamin supplements.
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: olanzapine Intramuscular side effects (in more detail)
The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.
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Loperamid Sandoz may be available in the countries listed below.
Loperamide hydrochloride (a derivative of Loperamide) is reported as an ingredient of Loperamid Sandoz in the following countries:
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Rec.INN
C08CA08
0039562-70-4
C18-H20-N2-O6
360
Calcium channel blocker
3,5-Pyridinedicarboxylic acid, 1,4-dihydro-2,6-dimethyl-4-(3-nitrophenyl)-, ethyl methyl ester
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Glossary
| BAN | British Approved Name |
| DCF | Dénomination Commune Française |
| DCIT | Denominazione Comune Italiana |
| IS | Inofficial Synonym |
| JAN | Japanese Accepted Name |
| OS | Official Synonym |
| PH | Pharmacopoeia Name |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
| USAN | United States Adopted Name |
Betamethasone Dipropionate Ointment contains betamethasone dipropionate USP, a synthetic adrenocorticosteroid, for dermatologic use. Betamethasone, an analog of prednisolone, has high corticosteroid activity and slight mineralocorticoid activity. Betamethasone dipropionate is the 17,21-dipropionate ester of betamethasone.
Chemically, betamethasone dipropionate is 9-Fluoro-11 β, 17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate, with the empirical formula C28H37FO7, a molecular weight of 504.6, and the following structural formula:
Betamethasone dipropionate is a white to creamy white, odorless crystalline powder, insoluble in water.
Each gram of Betamethasone Dipropionate Ointment 0.05% contains: 0.64 mg betamethasone dipropionate USP (equivalent to 0.5 mg betamethasone) in an ointment base consisting of mineral oil and white petrolatum.
The corticosteroids are a class of compounds comprising steroid hormones, secreted by the adrenal cortex and their synthetic analogs. In pharmacologic doses corticosteroids are used primarily for their anti-inflammatory and/or immunosuppressive effects.
Topical corticosteroids, such as betamethasone dipropionate, are effective in the treatment of corticosteroid-responsive dermatoses primarily because of their anti-inflammatory, antipruritic, and vasoconstrictive actions. However, while the physiologic, pharmacologic, and clinical effects of the corticosteroids are well known, the exact mechanisms of their actions in each disease are uncertain. Betamethasone dipropionate, a corticosteroid, has been shown to have topical (dermatologic) and systemic pharmacologic and metabolic effects characteristic of this class of drugs.
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. (See DOSAGE AND ADMINISTRATION.)
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. (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.
Eighty pediatric patients ages 6 months to 12 years, with atopic dermatitis, were enrolled in an open-label, hypothalamic-pituitary-adrenal (HPA) axis safety study. Betamethasone Dipropionate Ointment was applied twice daily for 2 to 3 weeks over a mean body surface area of 58% (range 35% to 99%). In 15 of 53 (28%) evaluable patients, adrenal suppression was indicated by either a pre-stimulated cortisol concentration < 5 mcg/dL pre-stimulation cortisol, or a cosyntropin post-stimulation cortisol < 18 mcg/dL and an increase of < 7 mcg/dL from the baseline cortisol. Follow-up testing 2 weeks after study completion available for 2 of the 15 patients demonstrated a normally responsive HPA axis.
Studies performed with Betamethasone Dipropionate Ointment indicate that it is in the high range of potency as compared with other topical corticosteroids.
Betamethasone Dipropionate Ointment is a high-potency corticosteroid indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years and older.
Betamethasone Dipropionate Ointment is contraindicated in patients who are hypersensitive to betamethasone dipropionate, to other corticosteroids, or to any ingredient in these preparations.
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. Use of more than one corticosteroid-containing product at the same time may increase total systemic glucocorticoid exposure. (See DOSAGE AND ADMINISTRATION.)
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. In an open-label pediatric study of 53 evaluable patients, of the 15 patients who showed evidence of suppression, 2 patients were tested 2 weeks after discontinuation of Betamethasone Dipropionate Ointment, and both patients showed recovery of HPA axis function. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids.
Pediatric patients 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.
This information is intended to aid in the safe and effective use of this medication. It is not a disclosure of all possible adverse or intended effects.
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 that for which it was prescribed.
3. The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive. (See DOSAGE AND ADMINISTRATION.)
4. Patients should report any signs of local adverse reactions.
5. Other corticosteroid-containing products should not be used with Betamethasone Dipropionate Ointment without first talking to your physician.
The following tests may be helpful in evaluating HPA axis suppression:
Urinary-free cortisol test
ACTH stimulation test
Long-term animal studies have not been performed to evaluate the carcinogenic potential of betamethasone dipropionate.
Betamethasone was negative in the bacterial mutagenicity assay (Salmonella typhimurium and Escherichia coli), and in the mammalian cell mutagenicity assay (CHO/HGPRT). It was positive in the in-vitro human lymphocyte chromosome aberration assay, and equivocal in the in-vivo mouse bone marrow micronucleus assay. This pattern of response is similar to that of dexamethasone and hydrocortisone.
Reproductive studies with betamethasone dipropionate carried out in rabbits at doses of 1.0 mg/kg by the intramuscular route and in mice up to 33 mg/kg by the intramuscular route indicated no impairment of fertility except for dose-related increases in fetal resorption rates in both species. These doses are approximately 0.5 and 4 fold the estimated maximum human dose based on a mg/m2 comparison, respectively.
Pregnancy category C: Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels.
Betamethasone dipropionate has been shown to be teratogenic in rabbits when given by the intramuscular route at doses of 0.05 mg/kg. This dose is approximately 0.03 fold the estimated maximum human dose based on a mg/m2 comparison. The abnormalities observed included umbilical hernias, cephalocele and cleft palates.
Some 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.
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 prescribed for a nursing woman.
Betamethasone Dipropionate Ointment is not recommended in pediatric patients 12 years of age and younger. (See CLINICAL PHARMACOLOGYand ADVERSE REACTIONSSections.)
In an open-label study, 15 of 53 (28%) evaluable pediatric patients (aged 6 months – 12 years old) using Betamethasone Dipropionate Ointment for treatment of atopic dermatitis demonstrated HPA axis suppression. The proportion of patients with adrenal suppression in this study was progressively greater, the younger the age group. (See CLINICAL PHARMACOLOGY – Pharmacokinetics.)
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. The study described above supports this premise as adrenal suppression in 9-12 year olds, 6-8 year olds, 2-5 year olds, and 3 months – 1 year old was 17%, 27%, 29%, and 36%, respectively.
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.
The following local adverse reactions are reported infrequently when Betamethasone Dipropionate Ointment is used as recommended in the DOSAGE AND ADMINISTRATION section. 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, miliaria.
Adverse reactions reported to be possibly or probably related to treatment with betamethasone dipropionate ointment during a pediatric clinical study include signs of skin atrophy (telangiectasia, thinness, shininess, bruising, loss of skin markings). Cutaneous atrophy of the face occurred in 1/6 (17%) of infants, 2/9 (22%) of 2-5 year olds, and 2/6 (33%) of the 6-8 year olds. Non-facial atrophy occurred in 15%, 8%, and 9% of 2-5 year olds, 6-8 year olds, and 9-12 year olds, respectively. 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.
Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects. (See PRECAUTIONS.)
Apply a thin film of Betamethasone Dipropionate Ointment 0.05% to the affected skin areas once daily. In some cases, a twice-daily dosage may be necessary.
Betamethasone Dipropionate Ointment is not to be used with occlusive dressings.
Betamethasone Dipropionate Ointment 0.05% is available in 15 gram (0.53 oz) and 45 gram (1.59 oz) tubes.
Store between 15°-30°C (59°-86°F).
Manufactured by:
Actavis Mid Atlantic LLC
1877 Kawai Road
Lincolnton, NC 28092 USA
FORM NO. 0381
Rev. 2/06
VC2796
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Gentamicina Italfarmaco may be available in the countries listed below.
Gentamicin sulfate (a derivative of Gentamicin) is reported as an ingredient of Gentamicina Italfarmaco in the following countries:
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Glukosamin Copyfarm may be available in the countries listed below.
Glucosamine sulfate potassium chloride (a derivative of Glucosamine) is reported as an ingredient of Glukosamin Copyfarm in the following countries:
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In some countries, this medicine may only be approved for veterinary use.
Chloramphenicol is reported as an ingredient of Chloramphenicol-Spray in the following countries:
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Class: Anti-inflammatory Agents
Note: This monograph also contains information on Betamethasone, Betamethasone Dipropionate
ATC Class: D07BC01
VA Class: DE200
CAS Number: 378-44-9
Brands: Alphatrex, Betatrex, Beta-Val, Diprolene, Lotrisone, Luxiq, Maxivate, Taclonex
A synthetic fluorinated corticosteroid.101 102 103 104 105 106 108 112 113 114 115 116 117 b
Relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.101 102 104 106 105 107 108 109 110 111 112 113 114
Generally most effective in acute or chronic dermatoses (e.g., seborrheic or atopic dermatitis, localized neurodermatitis, anogenital pruritus, psoriasis, late phase of allergic contact dermatitis, inflammatory phase of xerosis).e
Topical therapy generally preferred over systemic therapy; fewer associated adverse systemic effects.e
Topical therapy generally only controls manifestations of dermatoses; eliminate cause if possible.e
Topical efficacy may be increased by using a higher concentration or occlusive dressing therapy.e (See Administration with Occlusive Dressing under Dosage and Administration.)
Response may vary from one topical corticosteroid preparation to another.e
Anti-inflammatory activity may vary considerably depending on the vehicle, drug concentration, site of application, disease, and individual patient.e
Cream and lotion (0.05% betamethasone dipropionate; 0.1% betamethasone valerate) are considered to have medium-range potency.101 103
Foam (0.12% betamethasone valerate) is considered to have medium-range potency.108
Ointment (0.05% betamethasone dipropionate) is considered to have high-range potency.102
Cream, lotion, and ointment (0.05% betamethasone dipropionate) in optimized (augmented) vehicle are considered to have high-range potency.104 106 b
Fixed-combination cream or lotion containing betamethasone dipropionate 0.05% and clotrimazole 1% is considered to have high-range potency.115
Gel (0.05% betamethasone dipropionate) in optimized (augmented) vehicle is considered to have super-high range potency.104
Used in fixed combination with clotrimazole in the treatment of symptomatic inflammatory tinea pedis, tinea cruris, and tinea corporis caused by Epidermophyton floccosum, Trichophyton rubrum, and T. mentagrophytes.115
Safety and efficacy of topical betamethasone preparations in fixed combination with clotrimazole for the treatment of infections caused by zoophilic dermatophytes (e.g., Microsporum canis) have not been established.115
Treatment failure of topical betamethasone preparations in fixed combination with clotrimazole in the treatment of M. canis infections has been reported.115
Used in fixed combination with calcipotriene for the topical treatment of plaque psoriasis (psoriasis vulgaris) in adults.116
Used in fixed combination with calcipotriene for the topical treatment of chronic, moderate to severe plaque psoriasis (psoriasis vulgaris) of the scalp in adults.117
Consider location of the lesion and the condition being treated when choosing a dosage form.e
Creams are suitable for most dermatoses, but ointments may also provide some occlusion and are usually used for the treatment of dry, scaly lesions.e
Lotions are probably best for treatment of weeping eruptions, especially in areas subject to chafing (e.g., axilla, foot, groin).e Lotions, gels, and aerosols may be used on hairy areas, particularly the scalp.e
Formulation affects percutaneous penetration and subsequent activity; extemporaneous preparation or dilution of commercially available products with another vehicle may decrease effectiveness.e
Patients applying a topical corticosteroid to a large surface area and/or to areas under occlusion should be evaluated periodically for evidence of hypothalamic-pituitary-adrenal (HPA)-axis suppression by appropriate endocrine testing (e.g., ACTH stimulation, plasma cortisol, urinary free cortisol).101 102 103 104 105 106 b (See Hypothalamic-Pituitary-Adrenal Axis Suppression and also see Systemic Effects, under Cautions.)
For dermatologic use only; avoid contact with eyes.101 102 103 104 105 106 112 113 114 116 117 b
Betamethasone dipropionate gel in optimized (augmented) vehicle and fixed-combination ointment or suspension containing betamethasone dipropionate and calcipotriene should not be used on the face, groin, or in the axillae.105 116 117
Cream or lotion containing betamethasone dipropionate in fixed combination with clotrimazole or, alternatively, ointment or suspension containing betamethasone dipropionate in fixed combination with calcipotriene is not intended for ophthalmic, oral, or intravaginal use.115 116 117
The area of skin to be treated may be thoroughly cleansed before topical application to reduce the risk of infection; however, some clinicians believe that, unless an occlusive dressing is used, cleansing of the treated area is unnecessary and may be irritating.e
Apply cream or ointment in a thin film to the affected area.101 102 104 112 113 b
Apply gel in a thin film and rub gently into affected area until absorbed.105
Apply betamethasone dipropionate and calcipotriene fixed-combination ointment and rub gently and completely into affected area.116 Wash hands thoroughly after application process.116
Apply foam to affected areas of the scalp.108 To dispense foam, invert container; dispense small amount of foam onto a cool surface (e.g., saucer) to prevent melting.108 Foam will melt immediately upon contact with warm skin; do not dispense directly onto hands.108 Gently massage foam into the entire affected area of scalp.108
Apply betamethasone dipropionate and calcipotriene fixed-combination suspension to affected areas of the scalp.117 Wash hands thoroughly after application process.117 Shake fixed-combination suspension well before each use.117
Apply a few drops of lotion to the affected area by holding the nozzle of the bottle close to the affected area and squeezing gently; massage lightly until absorbed.103 106 114
Shake lotion containing betamethasone valerate and lotion containing betamethasone dipropionate in fixed combination with clotrimazole well before each use.114 115
After a favorable response is achieved, frequency of application may be decreased to the minimum necessary to maintain control and to avoid relapse; discontinue if possible.d
Topical preparations of betamethasone dipropionate alone or in fixed combination with clotrimazole or calcipotriene should not be used with occlusive dressings.101 102 103 104 105 115 116 117 b However, when appropriate, occlusive dressings may be used as directed by a clinician to augment efficacy of betamethasone valerate preparations when treating resistant dermatoses.108 112 113 114 (See Occlusive Dressings under Cautions.)
Soak or wash the affected area to remove scales; apply a thin film of cream, lotion, or ointment; rub gently into the lesion; and apply another thin film.e Cover affected area with a thin, pliable plastic film and seal it to adjacent normal skin with adhesive tape or hold in place with a gauze or elastic bandage.e
If affected area is moist, incompletely seal the edges of the plastic film or puncture the film to allow excess moisture to escape.e For added moisture in dry lesions, apply cream, ointment, or lotion and cover with a dampened cloth before the plastic film is applied or briefly soak the affected area in water before application of the drug and plastic film.e
Thin polyethylene gloves may be used on the hands and fingers, plastic garment bags may be used on the trunk or buttocks, a tight shower cap may be used for the scalp, or whole-body suits may be used instead of plastic film to provide occlusion.e
The frequency of occlusive dressing changes depends on the condition being treated; cleansing of the skin and reapplication of the corticosteroid are essential at each dressing change.e
Occlusive dressing usually is left in place for 12–24 hours and therapy is repeated as needed.e Although occlusive dressing may be left in place for 3–4 days at a time in resistant conditions, most clinicians recommend intermittent use of occlusive dressings for 12 hours daily to reduce the risk of adverse effects (particularly infection) and systemic absorption and for greater convenience.e
The drug and an occlusive dressing may be used at night, and the drug or a bland emollient may be used without an occlusive dressing during the day.e
In patients with extensive lesions, sequential occlusion of only one portion of the body at a time may be preferable to whole-body occlusion.e (See Occlusive Dressings under Cautions.)
Available as betamethasone dipropionate and betamethasone valerate; dosage usually expressed in terms of betamethasone.101 102 103 104 105 112 113 114 115 116 117 b
Foam available as betamethasone valerate; dosage expressed in terms of betamethasone valerate.108
Administer the least amount of topical preparations that provides effective therapy.101 (See Pediatric Use under Cautions.)
Children ≥13 years of age: Apply 0.05% cream in a thin film to affected area, usually once daily or, if necessary, twice daily.101
Children ≥13 years of age: Apply 0.05% cream in optimized (augmented) vehicle or 0.05% ointment in a thin film to affected area once or twice daily.102 104 b
Children ≥13 years of age: Apply a few drops of 0.05% lotion to affected area once or twice daily.103
Children ≥12 years of age: Apply 0.05% gel in optimized (augmented) vehicle or 0.05% ointment in optimized (augmented) vehicle in a thin film to affected area once or twice daily.105
Children ≥12 years of age: Apply a few drops of 0.05% lotion in optimized (augmented) vehicle to affected area once or twice daily.106
Apply 0.1% cream or ointment to affected area 1–3 times daily; once- or twice-daily application often is effective.112 113
Apply a few drops of 0.1% lotion to affected area twice daily, in the morning and evening.114 Dosage may be increased in patients with resistant dermatoses; decrease frequency to once daily following clinical improvement.114
Apply 0.05% cream in a thin film to affected area, usually once daily or, if necessary, twice daily.101
Apply 0.05% cream in optimized (augmented) vehicle, 0.05% gel in optimized (augmented) vehicle, 0.05% ointment or ointment in optimized (augmented) vehicle in a thin film to affected area once or twice daily.102 104 105 b
Apply a few drops of 0.05% lotion or 0.05% lotion in optimized (augmented) vehicle to affected area once or twice daily.103 106 ”
Apply 0.1% cream or ointment to affected area 1–3 times daily; once- or twice-daily application is often effective.112 113
Apply 0.12% foam twice daily in the morning and evening.108 Discontinue when control is achieved; if response is inadequate within a 2-week course of therapy, consider reevaluation of diagnosis.108
Apply a few drops of 0.1% lotion to affected area twice daily, in the morning and evening.114 Dosage may be increased in patients with resistant dermatoses; decrease frequency to once daily following clinical improvement.114
Apply cream or lotion containing betamethasone 0.05% and clotrimazole 1% twice daily in the morning and evening.115
If response is inadequate within a 1-week (tinea corporis or tinea cruris) or 2-week (tinea pedis) course of therapy with the combination of betamethasone 0.05% and clotrimazole 1%, reevaluate diagnosis or discontinue combination preparation and consider clotrimazole alone.115 f
Apply ointment containing betamethasone 0.05% and calcipotriene 0.005% to the affected area(s) once daily.116
Apply suspension containing betamethasone 0.05% and calcipotriene 0.005% to affected area(s) of the scalp once daily for 2 weeks or until cleared.117
Maximum 45 g weekly with 0.05% cream in optimized (augmented) vehicle or with 0.05% ointment in optimized (augmented) vehicle.104
Maximum 50 g weekly with 0.05% gel in optimized (augmented) vehicle or 50 mL weekly with 0.05% lotion in optimized (augmented) vehicle; do not exceed 2 consecutive weeks of therapy.105
Maximum 45 g weekly with 0.05% cream in optimized (augmented) vehicle or with 0.05% ointment in optimized (augmented) vehicle.104
Maximum 50 g weekly with 0.05% gel in optimized (augmented) vehicle or 50 mL weekly with 0.05% lotion in optimized (augmented) vehicle; do not exceed 2 consecutive weeks of therapy.105
Maximum 45 g (cream) or 45 mL (lotion) weekly of the fixed combination of betamethasone 0.05% and clotrimazole 1%; do not exceed 2 consecutive weeks of therapy in the treatment of tinea cruris or tinea corporis or 4 weeks in the treatment of tinea pedis.115
Maximum 100 g weekly of the fixed-combination betamethasone 0.05% and calcipotriene 0.005% ointment.116 Do not apply to >30% of body surface area.116 Do not exceed 4 consecutive weeks of therapy.116
Maximum 100 g weekly of the fixed-combination betamethasone 0.05% and calcipotriene 0.005% suspension.117 Do not exceed 8 consecutive weeks of therapy.117
Known hypersensitivity to betamethasone dipropionate, betamethasone valerate, other corticosteroids, or any ingredient in the formulation.101 102 103 104 105 106 108 112 113 114 115 116 b
Betamethasone dipropionate and calcipotriene ointment or suspension: Known or suspected disorders of calcium metabolism.116 117
Betamethasone dipropionate and calcipotriene ointment or suspension: Erythrodermic, exfoliative, and pustular psoriasis.116 117
Allergic contact dermatitis may manifest as failure to heal rather than irritation as occurs with other topical preparations that do not contain corticosteroids; confirm with diagnostic patch testing.105 116
Discontinue therapy with betamethasone dipropionate and calcipotriene fixed-combination ointment if irritation occurs.116
Betamethasone is a potent topical corticosteroid and can be absorbed in sufficient amounts to produce systemic effects including HPA axis suppression.102 103 104 105 106 112 113 114 116 117 b (See Hypothalamic-Pituitary-Adrenal Axis Suppression and also see Systemic Effects, under Cautions.)
Topically applied corticosteroids can be absorbed in sufficient amounts to reversibly suppress the HPA axis.101 102 103 104 105 106 108 112 113 114 116 117 b e HPA-axis suppression has occurred following topical dosages as low as 7 g of the 0.05% betamethasone dipropionate cream in an optimized vehicle (3.5 mg of betamethasone) daily or following repeated application of 14 g of the 0.05% betamethasone dipropionate ointment in an optimized vehicle (7 mg of betamethasone) daily in patients with psoriasis.104 e
Perform periodic HPA-axis evaluation by appropriate testing (e.g., ACTH stimulation, morning plasma cortisol, urinary free cortisol), especially in patients applying a topical corticosteroid to a large surface area or to areas under occlusion.101 102 103 104 105 106 108 112 113 114 116 117 b e
If HPA-axis suppression occurs, withdraw the drug, reduce the frequency of application, discontinue occlusive therapy, and/or substitute a less potent corticosteroid.101 102 103 104 105 106 108 112 113 114 116 117 b e
HPA-axis function recovery generally is prompt and complete following drug discontinuance.101 102 103 104 105 106 108 112 113 114 116 117 b e
Rarely, glucocorticosteroid insufficiency may require systemic corticosteroid therapy.101 102 103 104 105 106 108 112 113 114 b e
Systemic absorption following topical administration may result in manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria in some patients.101 102 103 104 105 106 108 112 113 114 116 117 b e
Risk of adverse systemic effects increases with use of a high-potency topical corticosteroid, especially if applied to large areas of the body, for prolonged periods of time, with an occlusive dressing, and/or concurrently with other corticosteroid-containing preparations.101 102 103 104 105 106 108 112 113 114 116 117 b e
Infants and children may be more susceptible to adverse systemic effects.101 102 103 104 105 106 108 112 113 114 116 117 b e (See Pediatric Use under Cautions.)
Possible adverse local reactions (e.g., irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, striae, miliaria); may occur more frequently with the use of occlusive dressings, especially with prolonged therapy.108 113 114 115 116 117 e
Prolonged use of topical corticosteroids may cause atrophy of the epidermis and subcutaneous tissue;106 these effects are most likely to occur (even with short-term use) in intertriginous, flexor, and facial areas.106 Do not apply betamethasone and calcipotriene ointment or suspension to treatment areas with preexisting skin atrophy.116 117
If irritation occurs, discontinue drug and institute appropriate therapy.101 102 103 104 105 112 113 114 116
If concurrent skin infection is present or develops, initiate appropriate anti-infective therapy.101 102 103 104 105 106 108 112 113 114 116 117 b If infection does not respond promptly, discontinue topical corticosteroid therapy until the infection has been controlled.101 102 103 104 105 106 108 112 113 114 116 117 b
When topical corticosteroids and topical anti-infectives are used concomitantly, consider that the corticosteroid may mask clinical signs of bacterial, fungal, or viral infections; prevent recognition of ineffectiveness of the anti-infective; or suppress hypersensitivity reactions to ingredients in the formulation.e h In addition, consider the cautions, precautions, and contraindications associated with the anti-infective.e h
Treatment of fungal infections with topical preparations containing betamethasone dipropionate in fixed combination with clotrimazole may lead to clinical worsening and/or decreased cure rate due to suppression of the inflammatory response.115
Fungal infections, especially noninflammatory tinea infections, may be treated effectively without the risk corticosteroid-associated adverse effects by using a topical antifungal agent that does not contain a corticosteroid.115
Do not use occlusive dressings in patients with primary skin infection.e
Some manufacturers state that topical corticosteroids are contraindicated in patients with tuberculosis of the skin, dermatologic fungal infections, and cutaneous or systemic viral infection, including vaccinia and varicella and herpes simplex of the eye or adjacent skin;d however, most clinicians believe topical corticosteroids can be used with caution if the infection is treated.d
Betamethasone dipropionate preparations should not be used with occlusive dressings.101 103 104 105 115 116 117 b
Betamethasone valerate preparations should not be used with occlusive dressings unless directed by clinician.108 112 113 114
Adverse systemic reactions may occur with use of occlusive dressings on large areas of the body and for prolonged periods of time; monitor accordingly.d (See Hypothalamic-Pituitary-Adrenal Axis Suppression and also see Systemic Effects, under Cautions.)
Adverse local reactions may occur more frequently with the use of occlusive dressings, especially with prolonged therapy.108 113 114 115 117 e (See Local Effects under Cautions.)
Do not use occlusive dressings on weeping or exudative lesions.e
Do not use occlusive dressings in patients with primary skin infection.e
Remove occlusive dressings covering large areas if body temperature increases; thermal homeostasis may be impaired.e
Use plastic occlusive material with care to avoid the risk of suffocation.e
If an adequate response is not achieved when treating tinea with topical preparations containing betamethasone dipropionate in fixed combination with clotrimazole, perform appropriate microbiologic studies (e.g., KOH smear and/or culture) to reconfirm the clinical diagnosis before instituting additional courses of therapy with combination preparation.115
Betamethasone dipropionate gel in optimized (augmented) vehicle is not recommended for treatment of rosacea or perioral dermatitis.105
When used in fixed combination with calcipotriene or clotrimazole, consider the cautions, precautions, and contraindications associated with the concomitant agent.115 116 117
Category C.101 102 104 105 106 108 112 113 114 115 116 117 b
Not known whether topical betamethasone is distributed into milk.101 102 103 104 105 108 112 113 114 115 116 117 b Caution advised if topical betamethasone is used.101 102 103 104 105 106 108 112 113 114 115 116 117 b
Use of betamethasone dipropionate cream, cream in optimized (augmented) vehicle, lotion, and ointment not recommended in children ≤12 years of age; these dermatologic preparations may be used with caution in children ≥13 years of age.101 103 104
Use of betamethasone dipropionate gel in optimized (augmented) vehicle, lotion in optimized (augmented) vehicle, and ointment in optimized (augmented) vehicle not recommended in children <12 years of age; these dermatologic preparations may be used with caution in children ≥12 years of age.105 106 b
Safety and efficacy of betamethasone valerate foam not established in pediatric patients.108
Use of preparations containing betamethasone dipropionate in fixed combination with clotrimazole are not recommended for use in the treatment of diaper dermatitis or for use in children <17 years of age; safety and efficacy not established.115
Safety and efficacy of fixed-combination ointment or suspension containing betamethasone dipropionate and calcipotriene not established in pediatric patients.116 117
Adverse effects consistent with corticosteroid use have been observed in patients with diaper dermatitis treated with preparations containing betamethasone dipropionate in fixed combination with clotrimazole.115
Tight-fitting diapers or plastic pants should not be used on a child being treated with betamethasone valerate cream in the diaper area, since they may constitute occlusive dressings.112 113 114
Children are more susceptible to topical corticosteroid-induced HPA-axis suppression and Cushing’s syndrome than mature individuals because of a greater skin surface area-to-body weight ratio, especially when topical corticosteroids are applied to >20% of body surface area.101 102 103 104 105 106 108 112 113 114 116 117 b e The risk of adrenal suppression appears to increase with decreasing age.101 102 104 105 (See Systemic Effects under Cautions.)
Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol concentrations, lack of response to corticotropin (ACTH) stimulation.101 102 104 105 106 108 112 113 114
Children are also at greater risk of glucocorticosteroid insufficiency during and/or after withdrawal of treatment.108 e
Intracranial hypertension has occurred in children; manifestations include bulging fontanelles, headaches, and bilateral papilledema.101 102 104 105 106 108 112 113 114
Children are at greater risk of adverse atrophic dermatologic effects.
Striae has been reported in children treated inappropriately with topical corticosteroids.105 108
Topical corticosteroid therapy in children should be limited to the minimum amount necessary for therapeutic efficacy; chronic topical corticosteroid therapy may interfere with growth and development.101 102 103 104 105 108 112 113 114 b
Insufficient experience with preparations containing betamethasone dipropionate in fixed combination with clotrimazole in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults; skin atrophy and ulceration have been reported.115
Use with caution in geriatric patients with thinning skin; do not use with occlusion and/or for treatment of diaper dermatitis.115 e
No substantial differences in safety or efficacy of fixed-combination ointment or suspension containing betamethasone dipropionate and calcipotriene observed in geriatric patients relative to younger adults.116 117
Burning, stinging, itching, irritation, dry skin, erythema, folliculitis, hypertrichosis.101 103 104 105 108 112 114 113 115 b
Children: skin atrophy (telangiectasia, bruising, shininess), paresthesia (burning), erythema, erythematous rash.101 102 103 104
Drug or Test | Interaction |
|---|---|
Corticosteroids | Potential pharmacologic interaction with other corticosteroid-containing preparations101 102 103 104 115 116 117 |
Nitroblue-tetrazolium test for bacterial infection | Concurrent use of corticosteroids reportedly may result in false-negative resultse |
Topically applied betamethasone dipropionate and valerate can be absorbed through normal intact skin.101 102 103 104 105 106 108 112 113 114 115 116 b
Extent of systemic absorption of the drug is increased with lotion preparations and those formulated with an optimized (augmented) vehicle.101 102 103 104 105 106 b
Percutaneous penetration can be altered by using different vehicles and increases with decreasing age.101 102 103 104 105 106 108 112 113 114 115 116 b
Percutaneous penetration also can be increased by use of occlusive dressings and by presence of inflammation and/or other disease of the epidermal barrier (e.g., psoriasis, eczema).101 102 103 104 105 106 108 112 113 114 115 116 117 b
Not known whether topical betamethasone is distributed into milk.101
