Consists of Clobetasol Topical, Miconazole Topical, Neomycin Topical
Actions of Clobetasol Topical (Cebate gm Active Cream) in details
Like other topical corticosteroids Clobetasol Topical (Cebate gm Active Cream)® (clobetasol propionate) Spray, 0.05% has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids in general is unclear. However, corticosteroids are thought to act by induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.
How should I take Clobetasol Topical (Cebate gm Active Cream)?
This section provides information on the proper use of a number of products that contain clobetasol. It may not be specific to Clobetasol Topical (Cebate gm Active Cream). Please read with care.
It is very important that you use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may cause unwanted side effects or skin irritation.
This medicine is for use on the skin only. Do not get it in your eyes, nose, mouth, or vagina. Do not use it on skin areas that have cuts, scrapes, or burns. If it does get on these areas, rinse it off right away with water.
To help clear up your skin or scalp problem completely, it is very important that you keep using this medicine for the full time of treatment. Do not miss any doses.
This medicine should only be used for skin conditions that your doctor is treating. Check with your doctor before using it for other conditions, especially if you think that a skin infection may be present. This medicine should not be used to treat certain kinds of skin infections or conditions, such as severe burns.
Do not use this medicine on the face, groin, or underarms, or have skin thinning unless directed to do so by your doctor.
To use the cream, foam, gel, lotion, ointment, or spray:
- Wash your hands with soap and water before and after using this medicine.
- Apply a thin layer of this medicine to the affected area of the skin. Rub it in gently.
- With the lotion, protect the skin from water, clothing, or anything that causes rubbing until the medicine has dried. Also, shake the lotion well before using it.
- With the foam, do not dispense directly from the can into your hands, unless the hands are the affected area.
- Do not bandage or otherwise wrap the skin being treated unless directed to do so by your doctor.
To use the foam, scalp solution, or shampoo:
- Wash your hands with soap and water before and after using this medicine.
- Apply a thin layer of this medicine to the affected area of the scalp. Rub it in gently.
- Do not cover the scalp (eg, shower cap, bathing cap) while it is being treated.
- With the shampoo, do not wet your hair before using it. And if the shampoo gets on any part of your body other than your scalp, rinse the area well with water.
- Do not use the shampoo for more than 4 weeks, the foam and scalp solution for more than 2 weeks unless your doctor has told you to.
This medicine comes with a patient information insert. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For redness, itching, and swelling of the skin:
- For topical dosage forms (cream, gel, or ointment):
- Adults—Apply to the affected area of the skin two times per day.
- Children 12 to 17 years of age—Apply to the affected area of the skin two times per day.
- Children younger than 12 years of age—Use is not recommended.
- For topical dosage form (lotion):
- Adults—Apply to the affected area of the skin two times per day.
- Children—Use is not recommended.
- For topical dosage forms (cream, gel, or ointment):
- For plaque psoriasis:
- For topical dosage form (cream):
- Adults—Apply to the affected area of the skin two times per day.
- Children younger than 16 years of age—Use is not recommended.
- For topical dosage form (foam):
- Adults—Apply to the affected area of the skin two times per day, once in the morning and once at night.
- Children 12 to 17 years of age—Apply to the affected area of the skin two times per day, once in the morning and once at night.
- Children younger than 12 years of age—Use is not recommended.
- For topical dosage form (spray):
- Adults—Spray to the affected area of the skin two times per day.
- Children—Use is not recommended.
- For topical dosage form (cream):
- For scalp problems:
- For topical dosage forms (foam or scalp solution):
- Adults—Apply to the affected area of the scalp two times per day, once in the morning and once at night.
- Children 12 to 17 years of age—Apply to the affected area of the scalp two times per day, once in the morning and once at night.
- Children younger than 12 years of age—Use is not recommended.
- For topical dosage form (shampoo):
- Adults—Apply to the affected area of the scalp once a day.
- Children—Use is not recommended.
- For topical dosage forms (foam or scalp solution):
Missed Dose
If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.
Storage
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Store the foam can at room temperature, away from heat and direct light. Do not keep this medicine inside a car where it could be exposed to extreme heat. Do not poke holes in the canister or throw it into a fire, even if the canister is empty.
Store the Clobetasol Topical (Cebate gm Active Cream)® E cream at room temperature, away from heat, moisture, and direct light. Do not refrigerate. Keep from freezing.
Clobetasol Topical (Cebate gm Active Cream) administration
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 for longer than recommended.
Topical steroid medicine can be absorbed through the skin, which may cause steroid side effects throughout the body.
Wash your hands before and after using clobetasol topical, unless you are using the medication to treat the skin on your hands.
Apply a small amount to the affected area and rub it gently into the skin. Do not use this medication over a large area of skin.
Do not cover treated skin areas with a bandage or other covering unless your doctor has told you to. If you are treating the diaper area of a baby, do not use plastic pants or tight-fitting diapers. Covering the skin that is treated with clobetasol topical can increase the amount of medicine your skin absorbs, which may lead to unwanted side effects. Follow your doctor's instructions.
Contact your doctor if your condition does not improve within 2 weeks of using this medicine, or if you develop signs of a bacterial, fungal, or viral skin infection. It is important to use clobetasol topical regularly to get the most benefit.
If you use this medication long-term, your blood will need to be tested often. Visit your doctor regularly.
Store at room temperature away from moisture and heat. Keep from freezing.
Clobetasol Topical (Cebate gm Active Cream) pharmacology
Mechanism of Action
Corticosteroids play a role in cellular signaling, immune function, inflammation, and protein regulation; however, the precise mechanism of action in corticosteroid-responsive dermatoses is unknown.
The contribution to efficacy by individual components of the vehicle has not been established.
Pharmacodynamics
In a study evaluating the potential for HPA axis suppression, using the cosyntropin stimulation test, Clobetasol Topical (Cebate gm Active Cream) (clobetasol propionate foam) Foam demonstrated reversible adrenal suppression after two weeks of twice daily use in patients with atopic dermatitis of at least 30% body surface area (BSA). The proportion of subjects twelve years of age and older demonstrating HPA axis suppression was 16.2% (6 out of 37). In this study HPA axis suppression was defined as serum cortisol level ≤ 18 mcg/dL 30-min post cosyntropin stimulation. The laboratory suppression was transient; in all subjects serum cortisol levels returned to normal when tested 4 weeks post treatment.
Pharmacokinetics
Topical corticosteroids can be absorbed from intact healthy skin. The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the product formulation and the integrity of the epidermal barrier. Occlusion, inflammation, and/or other disease processes in the skin may increase percutaneous absorption. The use of pharmacodynamic endpoints for assessing the systemic exposure of topical corticosteroids may be necessary due to the fact that circulating levels are often below the level of detection. Once absorbed through the skin, topical corticosteroids are metabolized, primarily in the liver, and are then excreted by the kidneys. Some corticosteroids and their metabolites are also excreted in the bile.
Following twice daily application of Clobetasol Topical (Cebate gm Active Cream) (clobetasol propionate foam) Foam for one week to 32 adult patients with mild to moderate plaque-type psoriasis, mean peak plasma concentrations (±SD) of 59 ± 36 pg/mL of clobetasol were observed at around 5 hours post-dose on day 8.
Clinical Studies
In a randomized study of subjects 12 years of age and older with moderate to severe atopic dermatitis, 251 subjects were treated with Clobetasol Topical (Cebate gm Active Cream) (clobetasol propionate foam) Foam and 126 subjects were treated with Vehicle Foam. Subjects were treated twice daily for two weeks. At the end of treatment, 131 of 251 subjects (52%) treated with Clobetasol Topical (Cebate gm Active Cream) (clobetasol propionate foam) Foam compared with 18 of 126 subjects (14%) treated with Vehicle Foam achieved treatment success. Treatment success was defined by an Investigator's Static Global Assessment (ISGA) score of clear (0) or almost clear (1) with at least 2 grades improvement from baseline, and scores of absent or minimal (0 or 1) for erythema and induration/papulation.
In an additional randomized study of subjects 12 years of age and older with mild to moderate plaque-type psoriasis, 253 subjects were treated with Clobetasol Topical (Cebate gm Active Cream) (clobetasol propionate foam) Foam and 123 subjects were treated with Vehicle Foam. Subjects were treated twice daily for two weeks. At the end of treatment, 41 of 253 subjects (16%) treated with Clobetasol Topical (Cebate gm Active Cream) (clobetasol propionate foam) Foam compared with 5 of 123 subjects (4%) treated with Vehicle Foam achieved treatment success. Treatment success was defined by an Investigator's Static Global Assessment (ISGA) score of clear (0) or almost clear (1) with at least 2 grades improvement from baseline, scores of none or faint/minimal (0 or 1) for erythema and scaling, and a score of none (0) for plaque thickness.
Actions of Miconazole Topical (Cebate gm Active Cream) in details
Miconazole is an imidazole that belongs to the class of medications called as antifungal agents. It works by interfering with the formation of the fungal cell membrane and weakening it, thereby killing the sensitive fungi.
How should I take Miconazole Topical (Cebate gm Active Cream)?
This section provides information on the proper use of a number of products that contain miconazole. It may not be specific to Miconazole Topical (Cebate gm Active Cream). Please read with care.
Keep this medicine away from the eyes.
Apply enough miconazole to cover the affected area, and rub in gently.
To use the aerosol powder form of miconazole:
- Shake well before using.
- From a distance of 6 to 10 inches, spray the powder on the affected areas. If it is used on the feet, spray it between the toes, on the feet, and in the socks and shoes.
- Do not inhale the powder.
- Do not use near heat, near open flame, or while smoking.
To use the aerosol solution form of miconazole:
- Shake well before using.
- From a distance of 4 to 6 inches, spray the solution on the affected areas. If it is used on the feet, spray it between the toes and on the feet.
- Do not inhale the vapors from the spray.
- Do not use near heat, near open flame, or while smoking.
To use the powder form of miconazole:
- If the powder is used on the feet, sprinkle it between the toes, on the feet, and in the socks and shoes.
When miconazole is used to treat certain types of fungus infections of the skin, an occlusive dressing (airtight covering, such as kitchen plastic wrap) should not be applied over this medicine. To do so may cause irritation of the skin. Do not apply an occlusive dressing over this medicine unless you have been directed to do so by your doctor.
To help clear up your infection completely, keep using this medicine for the full time of treatment, even if your condition has improved. Do not miss any doses.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For aerosol powder, aerosol solution, cream, and powder dosage forms:
- For fungus infections:
- Adults and children—Apply to the affected area(s) of the skin two times a day, morning and evening.
- For fungus infections:
- For cream and lotion dosage forms:
- For sun fungus:
- Adults and children—Apply to the affected area(s) of the skin once a day.
- For sun fungus:
Missed Dose
If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Store the canister at room temperature, away from heat and direct light. Do not freeze. Do not keep this medicine inside a car where it could be exposed to extreme heat or cold. Do not poke holes in the canister or throw it into a fire, even if the canister is empty.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Miconazole Topical (Cebate gm Active Cream) administration
Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.
Miconazole buccal is used each morning for 14 days in a row. Follow your doctor's instructions.
Brush your teeth before putting in a buccal tablet. Make sure your hands are dry before handling the tablet.
Place the rounded side of the tablet against your upper gum near your back teeth. Close your mouth and press your finger gently against the side of your cheek for 30 seconds to make sure the tablet stays in place.
Leave the tablet in place until the next morning. Switch the sides of your mouth each morning when using a new tablet.
If any pieces of the tablet remain in your mouth the next morning, rinse your mouth with water before using a new tablet.
Do not crush, chew, or break a miconazole buccal tablet. Do not swallow the tablet whole.
You may eat and drink normally while the tablet is in place, but avoid chewing gum.
During the first 6 hours after placing a buccal tablet in your mouth, if the tablet comes loose try putting it back into place. If it still comes loose, put in a new tablet. If you accidentally swallow a tablet within the first 6 hours of wearing time, drink a full glass of water and put in a new tablet.
After the first 6 hours, if a tablet comes loose or you accidentally swallow it, do not put in a new tablet. Wait until it is time for your next dose to put in a new tablet.
Store at room temperature away from moisture and heat.
Miconazole Topical (Cebate gm Active Cream) pharmacology
Miconazole Topical (Cebate gm Active Cream) interacts with 14-α demethylase, a cytochrome P-450 enzyme necessary to convert lanosterol to ergosterol. As ergosterol is an essential component of the fungal cell membrane, inhibition of its synthesis results in increased cellular permeability causing leakage of cellular contents. Miconazole Topical (Cebate gm Active Cream) may also inhibit endogenous respiration, interact with membrane phospholipids, inhibit the transformation of yeasts to mycelial forms, inhibit purine uptake, and impair triglyceride and/or phospholipid biosynthesis.
Actions of Neomycin Topical (Cebate gm Active Cream) in details
Neomycin Topical (Cebate gm Active Cream) belongs to the class of medications called as antibiotics. It prevents the bacterial growth by stopping the production of essential protein in the bacterial cells, thereby relieving the associated symptoms.
How should I take Neomycin Topical (Cebate gm Active Cream)?
Never take Neomycin Topical (Cebate gm Active Cream) in larger amounts than recommended, or for longer than 2 weeks. High doses or long-term use of Neomycin Topical (Cebate gm Active Cream) can cause serious kidney problems, or hearing loss that may not be reversible. The longer you take Neomycin Topical (Cebate gm Active Cream), the more likely you are to develop these serious side effects. Follow the directions on your prescription label.
Measure liquid medicine with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.
Take this medicine for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics. Neomycin Topical (Cebate gm Active Cream) will not treat a viral infection such as the common cold or flu.
To be sure this medication is not causing harmful effects, your kidney function, and your nerve and muscle function will need to be tested often. You may also need hearing tests. Neomycin Topical (Cebate gm Active Cream) can have long lasting effects on your body. Do not miss any follow up visits to your doctor for blood or urine tests.
If you are taking Neomycin Topical (Cebate gm Active Cream) for hepatic coma, your treatment may also include a special diet. It is very important to follow the diet plan created for you by your doctor. You should become very familiar with the list of foods you should avoid to help control your condition.
If you need surgery, tell the surgeon ahead of time that you are using Neomycin Topical (Cebate gm Active Cream). Neomycin Topical (Cebate gm Active Cream) can interact with certain medicines that may be given during surgery.
Store at room temperature away from moisture and heat. Do not allow the liquid form of this medicine to freeze.
Neomycin Topical (Cebate gm Active Cream) administration
Never take Neomycin Topical (Cebate gm Active Cream) in larger amounts than recommended, or for longer than 2 weeks. High doses or long-term use of Neomycin Topical (Cebate gm Active Cream) can cause serious kidney problems, or hearing loss that may not be reversible. The longer you take Neomycin Topical (Cebate gm Active Cream), the more likely you are to develop these serious side effects. Follow the directions on your prescription label.
Measure liquid medicine with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.
Take this medicine for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics. Neomycin Topical (Cebate gm Active Cream) will not treat a viral infection such as the common cold or flu.
To be sure this medication is not causing harmful effects, your kidney function, and your nerve and muscle function will need to be tested often. You may also need hearing tests. Neomycin Topical (Cebate gm Active Cream) can have long lasting effects on your body. Do not miss any follow up visits to your doctor for blood or urine tests.
If you are taking Neomycin Topical (Cebate gm Active Cream) for hepatic coma, your treatment may also include a special diet. It is very important to follow the diet plan created for you by your doctor. You should become very familiar with the list of foods you should avoid to help control your condition.
If you need surgery, tell the surgeon ahead of time that you are using Neomycin Topical (Cebate gm Active Cream). Neomycin Topical (Cebate gm Active Cream) can interact with certain medicines that may be given during surgery.
Store at room temperature away from moisture and heat. Do not allow the liquid form of this medicine to freeze.
Neomycin Topical (Cebate gm Active Cream) pharmacology
Aminoglycosides like Neomycin Topical (Cebate gm Active Cream) "irreversibly" bind to specific 30S-subunit proteins and 16S rRNA. Specifically Neomycin Topical (Cebate gm Active Cream) binds to four nucleotides of 16S rRNA and a single amino acid of protein S12. This interferes with decoding site in the vicinity of nucleotide 1400 in 16S rRNA of 30S subunit. This region interacts with the wobble base in the anticodon of tRNA. This leads to interference with the initiation complex, misreading of mRNA so incorrect amino acids are inserted into the polypeptide leading to nonfunctional or toxic peptides and the breakup of polysomes into nonfunctional monosomes.
References
- DailyMed. "MICONAZOLE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- DailyMed. "HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- NCIt. "Framycetin Sulfate: NCI Thesaurus (NCIt) provides reference terminology for many systems. It covers vocabulary for clinical care, translational and basic research, and public information and administrative activities.". https://ncit.nci.nih.gov/ncitbrowser... (accessed September 17, 2018).
Reviews
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Information checked by Dr. Sachin Kumar, MD Pharmacology
