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brand of augmented betamethasone dipropionate1
Lotion 0.05% (potency expressed as betamethasone)
For Dermatologic Use Only — Not for Ophthalmic Use
PRODUCT INFORMATION
DIPROLENE® (augmented betamethasone dipropionate) Lotion contains betamethasone dipropionate, USP, a synthetic adrenocorticosteroid, for dermatologic use. Betamethasone, an analog of prednisolone, has a high degree of corticosteroid activity and a slight degree of mineralocorticoid activity. Betamethasone dipropionate is the 17, 21-dipropionate ester of betamethasone.
Chemically, betamethasone dipropionate is 9-fluoro-11β,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:
It is a white to creamy-white, odorless powder insoluble in water; freely soluble in acetone and in chloroform; sparingly soluble in alcohol.
Each gram of Diprolene Lotion 0.05% contains 0.643 mg betamethasone dipropionate, USP (equivalent to 0.5 mg betamethasone), in an augmented lotion base of purified water; isopropyl alcohol (30%); hydroxypropyl cellulose; propylene glycol; sodium phosphate; phosphoric acid and sodium hydroxide used to adjust the pH.
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.
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 through normal intact skin. Inflammation and/or other disease processes in the skin may increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids (see DOSAGE AND ADMINISTRATION).
Once absorbed through the skin, topical corticosteroids enter pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees, are metabolized primarily in the liver, and excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.
Studies performed with DIPROLENE® Lotion indicate that it is in the super-high range of potency as compared with other topical corticosteroids.
DIPROLENE® Lotion is a super-high potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years of age and older. The total dose should not exceed 50 mL per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis.
DIPROLENE® Lotion is contraindicated in patients who are hypersensitive to betamethasone dipropionate, to other corticosteroids, or to any ingredient in this preparation.
Systemic absorption of topical corticosteroids has produced reversible 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 corticosteroids, 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. Patients should not be treated with amounts of DIPROLENE® Lotion greater than 50 mL per week because of the potential for the drug to suppress HPA axis. Patients receiving super-potent corticosteroids should not be treated for more than 2 weeks at a time and only small areas should be treated at any one time due to the increased risk of HPA axis suppression.
Diprolene Lotion was applied once daily at 7 mL per day for 21 days to diseased scalp and body skin in patients with scalp psoriasis to study its effects on the HPA axis. In 2 out of 11 patients, the drug lowered plasma cortisol levels below normal limits. HPA axis suppression in these patients was transient and returned to normal within a week. In one of these patients, plasma cortisol levels returned to normal while treatment continued.
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 section).
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.
Diprolene Lotion should not be used in the treatment of rosacea or perioral dermatitis, and it should not be used on the face, groin, or in the axillae.
Patients using topical corticosteroids should receive the following information and instructions. 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.
The following tests may be helpful in evaluating patients for HPA axis suppression:
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. Studies in rabbits, mice, and rats using intramuscular doses up to 1, 33, and 2 mg/kg, respectively, resulted in dose-related increases in fetal resorptions in rabbits and mice.
Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. 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 0.2 times the human topical dose of Diprolene Lotion in mg/m2 of body surface area, assuming 100% absorption and the use in a 60 kg person of 7 g per day. The abnormalities observed included umbilical hernias, cephalocele, and cleft palate. There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Diprolene Lotion should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when Diprolene Lotion is administered to a nursing woman.
Use of Diprolene Lotion, 0.05%, in pediatric patients 12 years of age and younger is not recommended (see CLINICAL PHARMACOLOGY and ADVERSE REACTIONS).
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. Chronic corticosteroid therapy may interfere with the growth and development of children.
Seven clinical studies of Diprolene Lotion evaluated 407 subjects of which 56 subjects were 65 years of age and over and 9 subjects were 75 years of age and over. No overall differences in safety or effectiveness were observed in these clinical studies between geriatric subjects and younger subjects. There was a numerical difference for application site reactions (most frequently reported events were burning and stinging) which occurred in 15% (10/65) of geriatric subjects and 11% (38/342) of subjects less than 65 years of age. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. However, greater sensitivity of some older individuals cannot be ruled out.
The local adverse reactions which were reported with DIPROLENE® Lotion during controlled clinical trials were as follows: erythema, folliculitis, pruritus, and vesiculation each occurring in less than 1% of patients.
The following additional local adverse reactions have been reported with topical corticosteroids, and they may occur more frequently with the use of occlusive dressings and higher potency corticosteroids. These reactions are listed in an approximately decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, and miliaria.
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 DIPROLENE® Lotion can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS).
Apply a few drops of DIPROLENE® Lotion to the affected skin once or twice daily and massage lightly until the lotion disappears.
Diprolene Lotion is a super-high potency topical corticosteroid. Treatment with Diprolene Lotion should be limited to two weeks, and amounts greater than 50 mL per week should not be used.
As with other highly active corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary.
Diprolene Lotion should not be used with occlusive dressings. Diprolene Lotion should not be applied to the diaper area if the patient requires diapers or plastic pants as these garments may constitute occlusive dressing.
DIPROLENE® Lotion 0.05% is supplied in 30-mL (29 g) (NDC 0085-0962-01) and 60-mL (58 g) (NDC 0085-0962-02) plastic squeeze bottles; boxes of one.
Store at 25°C (77°F); excursions permitted to 15°–30°C (59°–86°F) [see USP Controlled Room Temperature].
Rev. 5/07
Copyright © 1988, 2004, Schering Corporation. All rights reserved.
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Cefalexina Sant Gall may be available in the countries listed below.
Cefalexin monohydrate (a derivative of Cefalexin) is reported as an ingredient of Cefalexina Sant Gall in the following countries:
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SPMC Amoxycillin may be available in the countries listed below.
Amoxicillin is reported as an ingredient of SPMC Amoxycillin in the following countries:
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Generic Name: oxazepam (ox A ze pam)
Brand Names: Serax
Oxazepam is in a group of drugs called benzodiazepines (ben-zoe-dye-AZE-eh-peens). Oxazepam affects chemicals in the brain that may become unbalanced and cause anxiety.
Oxazepam is used to treat anxiety disorders or alcohol withdrawal symptoms.
Oxazepam may also be used for other purposes not listed in this medication guide.
Before taking oxazepam, tell your doctor if you have any breathing problems, glaucoma, porphyria, kidney or liver disease, or a history of depression, suicidal thoughts, or addiction to drugs or alcohol.
Treatments for depression are getting better everyday and there are things you can start doing right away.
Avoid using other medicines that make you sleepy. They can add to sleepiness caused by oxazepam.
Before taking oxazepam, tell your doctor if you are allergic to any drugs, or if you have:
glaucoma;
asthma, emphysema, bronchitis, chronic obstructive pulmonary disorder (COPD), or other breathing problems;
kidney or liver disease;
a history of depression or suicidal thoughts or behavior; or
a history of drug or alcohol addiction.
If you have any of these conditions, you may need a dose adjustment or special tests to safely take this medication.
Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.
Your doctor may occasionally change your dose to make sure you get the best results from this medication.
Your symptoms may return when you stop using oxazepam after using it over a long period of time. You may also have seizures or withdrawal symptoms when you stop using oxazepam. Withdrawal symptoms may include tremor, sweating, trouble sleeping, muscle cramps, stomach pain, vomiting, diarrhea, confusion, unusual thoughts or behavior, and seizure (convulsions).
To be sure this medication is not causing harmful effects, your doctor will need to check your progress on a regular basis. Do not miss any scheduled visits to your doctor.
Keep track of how many pills have been used from each new bottle of this medicine. Benzodiazepines are drugs of abuse and you should be aware if any person in the household is using this medicine improperly or without a prescription.
See also: Oxazepam dosage (in more detail)
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 extreme drowsiness, confusion, weakness or tired feeling, muscle weakness, loss of balance or coordination, feeling light-headed, fainting, or coma.
Tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures or depression). They can add to sleepiness caused by oxazepam.
confusion;
unusual risk-taking behavior, decreased inhibitions, no fear of danger;
hyperactivity, agitation, hostility;
hallucinations;
feeling lightheaded, fainting;
jaundice (yellowing of the skin or eyes); or
problems with urination.
Less serious side effects may include:
drowsiness, dizziness;
amnesia or forgetfulness, trouble concentrating;
slurred speech;
swelling;
headache;
skin rash;
nausea, vomiting, constipation;
irregular menstrual periods; or
loss of interest in sex.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
Usual Adult Dose for Anxiety:
For mild to moderate anxiety: 10 to 15 mg orally 3 to 4 times a day.
For severe anxiety: 15 to 30 mg orally 3 to 4 times a day.
Usual Adult Dose for Alcohol Withdrawal:
15 to 30 mg orally 3 to 4 times a day for alcoholics with acute inebriation, tremulousness, or anxiety on withdrawal.
Usual Geriatric Dose for Anxiety:
Initial dose: 10 mg orally 3 times a day.
If necessary, increase cautiously to 15 mg orally 3 to 4 times a day.
Usual Pediatric Dose for Anxiety:
The safety and efficacy of oxazepam in children
>= 6 years to 12 years: 1 mg/kg/day.
>= 13 years: For mild to moderate anxiety: 10 to 15 mg orally 3 to 4 times a day.
For severe anxiety: 15 to 30 mg orally 3 to 4 times a day.
Before taking oxazepam, tell your doctor if you are using any of the following drugs:
a barbiturate such as amobarbital (Amytal), butabarbital (Butisol), mephobarbital (Mebaral), secobarbital (Seconal), or phenobarbital (Luminal, Solfoton);
an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate);
medicines to treat psychiatric disorders, such as chlorpromazine (Thorazine), haloperidol (Haldol), mesoridazine (Serentil), pimozide (Orap), or thioridazine (Mellaril);
narcotic medications such as butorphanol (Stadol), codeine, hydrocodone (Lortab, Vicodin), levorphanol (Levo-Dromoran), meperidine (Demerol), methadone (Dolophine, Methadose), morphine (Kadian, MS Contin, Oramorph), naloxone (Narcan), oxycodone (OxyContin), propoxyphene (Darvon, Darvocet); or
antidepressants such as amitriptyline (Elavil, Etrafon), amoxapine (Asendin), citalopram (Celexa), clomipramine (Anafranil), desipramine (Norpramin), doxepin (Sinequan), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), imipramine (Janimine, Tofranil), nortriptyline (Pamelor), paroxetine (Paxil), protriptyline (Vivactil), sertraline (Zoloft), or trimipramine (Surmontil).
This list is not complete and there may be other drugs that can interact with oxazepam. 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: oxazepam side effects (in more detail)
Rispéridone may be available in the countries listed below.
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DCF | Dénomination Commune Française |
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