Clotrol F Tube
Clotrol F Tube Uses, Dosage, Side Effects, Food Interaction and all others data.
Clobetasol Propionate Cream is a multiple combination cream which exhibits anti-bacterial, anti-protozoal, anti-fungal and steroid properties to control inflammation. Ofloxacin is a broad-spectrum antibiotic that acts against many gram-positive and gram-negative bacteria. Ornidazole belongs
to the nitroimidazole group of antibiotics and is used to treat amoeba and trichomonas infections. Terbinafine is a topical antifungal and antiparasitic drug. Clobetasol is a potent corticosteroid which exhibits anti-inflammatory, anti-pruritic and vasoconstrictive properties.
Corticosteroids bind to the glucocorticoid receptor, inhibiting pro-inflammatory signals, and promoting anti-inflammatory signals. Clobetasol propionate is generally applied twice daily so the duration of action is long. Corticosteroids have a wide therapeutic window as patients may require doses that are multiples of what the body naturally produces. Patients taking corticosteroids should be counselled regarding the risk of hypothalamic-pituitary-adrenal axis suppression and increased susceptibility to infections.
Fusidic acid is an antimicrobial agent that inhibits bacterial protein synthesis. Fusidic acid interferes with amino acid transfer from aminoacyl-tRNA to protein on the ribosomes. Fusidic acid is active against a wide range of gram-positive organisms. The sustained release formulation ensures prolonged contact with the conjunctival sac. Fusidic acid penetrates well into the aqueous humor.
Fusidic acid is a bacteriostatic antibiotic and helps prevent bacterial growth while the immune system clears the infection.
Trade Name | Clotrol F Tube |
Generic | Clobetasol Propionate + Fusidic Acid |
Weight | 0.05%w/w |
Type | Cream |
Therapeutic Class | |
Manufacturer | Innovative Pharmaceuticals |
Available Country | India |
Last Updated: | September 19, 2023 at 7:00 am |
Uses
Clobetasol Propionate is used for:
- Initial control of all forms of hyperacute eczema in all age groups
- Chronic hyperkeratotic eczema of the hands and feet and patches of chronic lichen simplex
- Chronic hyperkeratotic psoriasis of any area of the body
- Severe acute photosensitivity
- Hypertrophic lichen planus
- Localized bullous disorders
- Keloid scarring
- Pretibial myxoedema
- Vitiligo
- Suppression of reaction after cryotherapy
- Scalp Solution is used for the topical therapy of recalcitrant corticosteroid-responsive dermatoses of the scalp, including recalcitrant cases of psoriasis and seborrheic dermatitis.
Fusidic Acid is used for the topical treatment of superficial bacterial infections of the eye and its adnexa. These may include - bacterial conjunctivitis, blepharoconjunctivitis, blepharitis, sty and keratitis. It may also be used for the management of corneal and conjunctival abrasions and foreign body injuries.
Clotrol F Tube is also used to associated treatment for these conditions: Alopecia, Severe Plaque psoriasis, Corticosteroid responsive, Inflammatory Dermatosis, Corticosteroid responsive, pruritic Dermatosis, Moderate Plaque psoriasis, Moderate Scalp Psoriasis, Severe Scalp PsoriasisBacterial Conjunctivitis, Eye and eyelid infections, Fungal skin infection, Skin Infections caused by Corynebacterium minutissimum infection, Skin Infections caused by Staphylococcus Aureus, Skin Infections caused by Streptococcus Infection, Skin Infections, Bacterial, Stye, Cutaneous dermatophyte infection, Eczematous rash, Mild Atopic dermatitis, Mild Dermatitis caused by Staphylococcus aureusis, Moderate Atopic dermatitis, Moderate Dermatitis caused by Staphylococcus aureusis, Ocular bacterial infections, Susceptible Bacterial Infections
How Clotrol F Tube works
The short term effects of corticosteroids are decreased vasodilation and permeability of capillaries, as well as decreased leukocyte migration to sites of inflammation. Corticosteroids binding to the glucocorticoid receptor mediates changes in gene expression that lead to multiple downstream effects over hours to days.
Glucocorticoids inhibit neutrophil apoptosis and demargination; they inhibit phospholipase A2, which decreases the formation of arachidonic acid derivatives; they inhibit NF-Kappa B and other inflammatory transcription factors; they promote anti-inflammatory genes like interleukin-10.
Lower doses of corticosteroids provide an anti-inflammatory effect, while higher doses are immunosuppressive. High doses of glucocorticoids for an extended period bind to the mineralocorticoid receptor, raising sodium levels and decreasing potassium levels.
Fusidic acid works by interfering with bacterial protein synthesis, specifically by preventing the translocation of the elongation factor G (EF-G) from the ribosome. It also can inhibit chloramphenicol acetyltransferase enzymes.
Dosage
Clotrol F Tube dosage
Nyclobate Cream & Ointment
Adults and children over 1 year:
• Apply sparingly to cover the affected area, and gently rub into the skin. Frequency of application is 2 to 3 times daily according to the severity of the condition. The total dose applied should not exceed 50 g weekly.
• Treatment should not be continued for more than 7 days without medical supervision. If a longer course is necessary, it is recommended that treatment should not be continued for more than 4 weeks without the patient\\\'s condition being reviewed.
• Repeated short courses of Clobetasol may be used to control exacerbations
Children below 1 year: Under 1 year this preparation is not recommended
Nyclobate Scalp Application
• It should be applied to the affected scalp areas twice daily, once in morning and once at night.
• Total dosage should not exceed 50 ml per week.
• As with other highly active topical steroid preparations, therapy should be discontinued when control is achieved
Children: Under 1 year this preparation is not recommended.
Nyclobate Shampoo
• It should be applied to the dry (not wet) scalp once a day to the affected areas only.
• It should be massaged gently into the lesions and left in place for 15 minutes before lathering and rinsing.
• Treatment should be limited to 4 consecutive weeks.
• Total dosage of shampoo should not exceed 50 g per week.
• Under 18 years this preparation is not recommended.
Adults and children (≥ 2 years): Instill one drop in the affected eye(s) twice daily for 7 days. Treatment should be continued for at least 48 hours after the eye returns to normal.
Side Effects
Generally Clobetasol Propionate is well tolerated. However, few side effects after prolonged and intensive treatment may cause local atrophic changes in the skin such as Burning, itching, irritation, dry skin eczema.
Fusidic acid is generally associated with very few adverse effects. The most frequently reported treatment-related side-effect is slight stinging or irritation.
Toxicity
Data regarding acute overdoses of glucocorticoids are rare. Overdoses of clobetasol propionate can lead to reversible HPA axis suppression and glucocorticoid insufficiency. Chronic high doses of glucocorticoids can lead to the development of cataract, glaucoma, hypertension, water retention, hyperlipidemia, peptic ulcer, pancreatitis, myopathy, osteoporosis, mood changes, psychosis, dermal atrophy, allergy, acne, hypertrichosis, immune suppression, decreased resistance to infection, moon face, hyperglycemia, hypocalcemia, hypophosphatemia, metabolic acidosis, growth suppression, and secondary adrenal insufficiency.[A188405] Overdose may be treated by adjusting the dose or stopping the corticosteroid as well as initiating symptomatic and supportive treatment.[A188405]
Precaution
Do not swallow. For external use only.
- For ophthalmic use only
- To avoid possible contamination of the drops, do not touch the tube nozzle or to any surface
- Do not wear contact lenses during the treatment
- If more than one topical eye drug is being used, the drugs should be administered at least five (5) minutes interval between applications
Interaction
No hazardous interactions have been reported with use of Clobetasol Propionate.
Synergistic action with antistaphylococcal penicillin. Antagonism with ciprofloxacin.
Volume of Distribution
Data regarding the volume of distribution of clobetasole propionate are not readily available.
Elimination Route
Twice daily application of clobetasol foam leads to a Cmax of 59±36pg/mL with a Tmax of 5 hours. Clobetasol cream showed an increase in clobetasol concentrations from 50.7±96.0pg/mL to 56.3±104.7pg/mL.
Sodium fusidic acid tablets have a 91% oral bioavailability. Absorption of the film-coated tablets is complete when compared to a solution, however oral absorption is variable. Oral fusidic acid hemihydrate (suspension) achieved a 22.5% bioavailability in pediatric patients following a 20 milligram/kilogram dose.
Half Life
Data regarding the half life of clobetasol propionate are not readily available.
Approximately 5 to 6 hours in adults.
Clearance
Data regarding the clearance of clobetasol propionate are not readily available.
Elimination Route
Corticosteroids are eliminated predominantly in the urine.
Pregnancy & Breastfeeding use
The safe use of Clobetasol Propionate during pregnancy & lactation has not been established.
Use in pregnancy: There are no adequate and well-controlled studies in pregnant women. Fusidic acid should be used during pregnancy unless the potential benefit justifies the potential risk to the fetus.
Use in lactation: It is not clear if enough medication from the eye drop would pass into breast milk. Caution should be exercised while giving this eye drops to a nursing mother
Contraindication
Contraindicated in Cutaneous infections such as impetigo, tinea corporis and herpes simplex, Infestations such as scabies, Acne vulgaris, Hypersensitivity, Rosacea, Gravitational ulceration, Perioral dermatitis, Children under 1 year
Fusidic acid viscous eye drops is contraindicated in patients who are hypersensitive to any component of Fusidic Acid (Eye Drops).
Special Warning
Use in Paediatrics: The drug may be used in paediatrics patients in appropriate dosage, but large quantities for prolonged period should be avoided. It is contraindicated in children less than one year.
Use in children: Safety & effectiveness in children below the age of 2 years have not been established.
Acute Overdose
Acute overdosage is very unlikely to occur. However, in the case of chronic overdose or misuse the features of hypercortisolism may appear.
Storage Condition
Do not store above 30 0 C. Keep away from light and out of the reach of children. Do not freeze.
Store between 2-25°C. Discard 1 mth after opening.
Innovators Monograph
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