CLOP G – IS IT SAFE? USES, SIDE EFFECTS, DOSAGE

WHAT IS CLOP G?

Clop g is a medicated cream whose contents are Clobetasol and Gentamicin which is mainly indicated for bacterial skin infections.

It is available in the pharmacy as a tube of 25 gm.
The manufacturer of Clop g is Zydus Cadila.
It should be stored at 15-30°c and should not be refrigerated.

CLOP G – IS IT SAFE? USES, SIDE EFFECTS, DOSAGE

What is the Generic name(s)?
What is its composition?
How does it work?
What are its uses?
How effective is this medicine?
Is it addictive?
What is the dosage?
What if I miss a dose?
What to do in case of overdosage?
What to do in case of allergic reactions?
ARE THERE ANY DRUG INTERACTIONS?
PRECAUTION
WHAT ARE THE SIDE EFFECTS?
CAN I USE IT IF I AM PREGNANT?
CAN I USE IT IF I AM BREASTFEEDING?
CAN IT BE USED FOR CHILDREN AND INFANT
IS IT AVAILABLE AS OTC (Over The Counter) PRODUCT?
FREQUENTLY ASKED QUESTIONS (FAQs)
Reference

WHAT IS THE GENERIC NAME(S)?

Clop g cream is a combination of two agents. They are:

1. CLOBETASOL[1] in a measure of 0.05%w/w
2. GENTAMICIN[2] in a measure of 0.1%w/w

Clobetasol is a corticosteroid and Gentamicin is an antibiotic.
Various other brands are available in this combination in the market as listed below:

1. MONOSOL-G
2. ZINCODERM-G
3. ETAN-G
4. COSVATE-G
5. TOPISONE-G
6. CLOPINATE-G
7. OCOVATE-G
8. EXCEL-G
9. CLOBETAMIL-G
10. CLOSOL-G
11. CLO-G

WHAT IS IT’S COMPOSITION?

Clop g contains 0.05% w/w of Clobetasol and 0.1% w/w of Gentamicin.

Clobetasol is a synthetic fluorinated corticosteroid.
It is mainly indicated for the short-term relief from:

• Pruritus[3]
• Dermatoses[4]
• Plaque Psoriatic etc

Gentamicin is an aminoglycoside antibiotic[5]. It is mainly indicated for

• Dermatological infection
• Gram-negative bacteria-induced infections
• Superficial Skin Infection
• Infection prophylaxis
• Aid to healing

HOW DOES IT WORK?

CLOBETASOL

Clobetasol is a topical corticosteroid[6]. They act by its anti-inflammatory, immunosuppressive and antiproliferative action. The action intensity depends on how much drug has been absorbed from the skin. Thus it is the lipophilicity of the drug which will determine the intensity of the action. Fluorinated compounds and lipid esters[7] are said to highly potent.

Steroids under this are:

• CLOBETASOL
• BECLOMETHASONE[8]
• BETAMETHASONE[9]
• HALCINONIDE[10]
• DEXAMETHASONE[11]
• TRIAMCINOLONE ACETONIDE[12]

GENTAMICIN

Gentamicin is an aminoglycoside antibiotic. It acts by binding to the 30S ribosome subunit of bacteria and inhibiting the protein synthesis. The mechanism could be generalized in two steps as:

• Transport of the antibiotic through the bacterial cell wall and then the cytoplasm.
• Binding to the Ribosome will inhibit the protein synthesis.

The transport of the antibiotic through the cell wall itself is too dramatic to explain. They first diffuse to the gram-negative bacteria’s outer coat (other than the cell wall) through porin channels. Its entry from this peri-plasmic space to the cytoplasm is channel-mediated. i.e., its mediated by electron transport chain. Once inside the bacterial cell, it binds to the ribosomal subunit. This step freezes the initiation step of protein synthesis, prevents poly-some formation and promotes their disintegration as monosomes.

This antibiotic has got -cidal action which is based on secondary changes to the integrity of the bacterial cell wall.
Once the bacteria are exposed to gentamicin, it becomes sensitized and turns out to be more permeable; which is due to the incorporation of defective protein into the cell membranes.

WHAT ARE IT’S USES?

The main indications of Clop g are:

• Inflammation[13]
• Redness[14]
• Itching
• Eczema[15]
• Vitiligo
• Alopecia areata
• Allergic contact dermatitis
• Lichen simplex
• Psoriasis
• Lichen planus
• Minor Bacterial skin infection
• Keloids
• Allergic Contact Dermatitis
• Primary irritant dermatitis
• Varicose eczema
• Seborrheic Dermatitis
• Nail disorders
• Scalp psoriasis

HOW EFFECTIVE IS Clop G?

This cream is applied as a thin film onto the affected area.
It is done preferably at day and night time.
It is not indicated to be applied to the face or other intertriginous areas like axilla and groin.

The kinetics of the drug is as follows:

ABSORPTION: Percutaneous absorption of the drug (Clobetasol) will depend upon the delivery system and can be varied on each individual dependent.
Clinical studies state that absorption of the gel is higher than that of the cream formulation.
The drug penetration can be improved by using occlusive dressings.
For gentamicin systemic absorption following the local application has been reported

DISTRIBUTION: Following the drug application only small amount reaches the dermis.
For systemic distribution either the skin has to be inflamed or to be of higher doses.
The peak concentration is 0.63 ng/ml occurs within 8 hours of application of the second dose (With an interval 0f 13 hours)

METABOLISM: They follow the same metabolic mechanism as that of other corticosteroids as that of systemic drugs.

ELIMINATION: The drug is excreted through bile and urine itself.

The bactericidal action is directly dependent on the concentration of the cream or the antibiotic concentration specifically. Resistance also occurs to the aminoglycoside antibiotic.

They are through the following mechanism:

• Acquisition of cell membrane-bound inactivating enzyme which will phosphorylate the antibiotic.
• A mutation which decreases the affinity of the ribosomal subunit to the antibiotic.
• Decreased efficiency of the aminoglycoside transporting mechanism.

The cream is active against mainly:

1. E.Coli
2. Klebsiella pneumoniae
3. Enterobacter
4. H. influenzae
5. Proteus
6. Serratia
7. Pseudomonas aeruginosa
8. Strains of Brucella
9. Staph. aureus
10. Strep. faecalis

Apply 1-4 times daily on the affected area.

IS IT ADDICTIVE?

The cream usage is not linked to addiction.

But continuous use may lead to:

1. SUPER-INFECTION – Prolonged usage will lead to bacterial or fungal super-infection. Super-infection is the phenomenon by which he already colonized or affected skin/cells are being attacked again by different strains of organism than the previous ones at a later point in time.
2. TOLERANCE – The microorganism no longer reacts to the normal dose of the drug and requires larger doses which can lead to drug toxicity if exceeds the normal dose as per the regimen.
3. RESISTANCE – Super-infection ultimately leads to bacterial resistance, as mentioned earlier with mechanisms

WHAT IS THE DOSAGE?

• The cream should be applied twice daily.
• More than two applications a day do not afford any additional benefits.
• The twice-daily application itself is satisfactory.
• Clean and dry the area before the medicine application and it is indicated for external use only.
• Apply a pea-sized cream to the affected area with a clean index finger.
• Occlusive will enhance the drug absorption from the site of topical administration.

NOTE: Take care not to apply in face, armpits or groin unless indicated and advised by the physician.

WHAT IF I MISS A DOSE?

There is nothing to panic if you miss an application of Clop g topical preparation.

• Apply the medicine right when you remember about it.
• If you have reached the timing for next administration time, Its OK!; just skip the last one and apply the present dose.
• You are never instructed to apply the double the amount of cream to overcome the missed dose.
• Be aware that your skin can uptake only a certain amount of drug from its skin, and you are not going to get an extra benefit if you are to apply double the amount of the cream usually prescribed.
• As said previously, the drug action is concentration dependent and never the quantity dependent.

WHAT TO DO IN CASE OF AN OVER-DOSAGE?

Generally, there occurs no over-dosage with topical administration.
There are only chances of:

• Sensitization – Local sensitization with the skin will cause itching and redness of the skin. Discontinue the drug if this happens.
• Super-infection – Long term use of the medicine will lead to infection which can be either bacterial or viral in origin.
• Resistance – The resistance will be due to; the cell membrane-bound inactivating enzyme phosphorylates the antibiotic and conjugates them, which in turn doesn’t allow them to bind to the ribosome and thus are incapable of enhancing the active transport like that of the drug. Mutation to the genes of the bacteria will decrease the ribosome affinity towards the antibiotic, which offers the highest degree of resistance. A decreased efficiency of an antibiotic transporting mechanism is also a reason for resistance.
• Tolerance – Normal dose of the medicine becomes ineffective and thus exceeding the normal dose will also cause toxicity out of tolerance.

WHAT TO DO IN CASE OF AN ALLERGIC REACTION?

In case you encounter any allergic reaction:

1. Stop the medicine immediately.
2. Wash off the medicine.
3. Consult the physician

NOTE: DO NOT PANIC

ADVICE:

1. Before taking the cream, do a hypersensitivity test from the clinic.
2. Inform your doctor on prior if you are sensitive to any content.
3. If your doctor fails to ask you about allergy, take initiative to ask him/her.

ARE THERE ANY DRUG INTERACTIONS?

Avoid the usage of following with Clop g:

1. NSAIDs
2. Amphotericin B
3. Vancomycin
4. Cyclosporine
5. Cisplatin
6. Minocycline

These are generally the systemic interactions.

PRECAUTION

1. Kindly do a hyper-sensitive reaction test before you are starting the medication.
2. Inform your doctor if you have any other skin infections or co-morbid conditions or if you are pregnant before the drug administration.
3. Take care to avoid any other nephrotoxic drug along with this.
4. Keep the cream away from children and store in a cool and dry place.
5. Do not apply the medicine to the face or near eyes.
6. Do not swallow the medicine.
7. This medicine is not indicated for open wounds or chapped skin.
8. Apply the cream as a thin film and do not rub harshly. Do not wash it off completely and allow them to remain there for few hours to get it sufficient time to be absorbed.
9. Use a pea-sized amount of medicine only. Excess amount will lead to pilling of the drug.
10. The medication is not indicated for anyone who is allergic and to children below 12years of age.

WHAT ARE THE SIDE EFFECTS?

The local adverse effects are:

1. Thinning of epidermis
2. Dermal changes
3. Atrophy
4. Striae
5. Easy bruising
6. Hypo-pigmentation
7. Delayed wound healing
8. Fungal and bacterial infection

Systemic adverse effects include:

1. Adrenal pituitary suppression
2. Cushing’s syndrome

CAN I USE IT IF I AM PREGNANT?

The teratogenic effect of topical clobetasone is not studied.
A study which carried out a subcutaneous administration of the drug resulted in fetal toxicity. And thus the drug is used cautiously in pregnancy

Gentamicin belongs to category C of teratogenicity. There is a lack of relevant data to label it as a potent teratogen. So far gentamicin is administered when benefit outweighs the risk in a patient.

CAN I USE IT IF I AM BREASTFEEDING?

• There are chances of systemic absorption of the drug which may eventually reach the baby.
• We advise the patients to feed your child before you apply the medication and never soon after you have applied it.
• There are little studies done on this combination about teratogenicity and for nursing mother.

CAN IT BE USED FOR CHILDREN AND INFANT

• Children below 12 years of age should not be prescribed with Clop g.
• Children show higher absorption than adults and milder dose should be administered to them.
• Make sure that the medicine is applied under adult supervision only and is always kept out of reach of the children at home.
• If they say any burning sensation in their skin after application, immediately remove the applied cream by washing the applied area under running water and soap.
• Seek physician advise to change to any other alternative medicine instead of clop g.

IS IT AVAILABLE AS OTC (Over The Counter) PRODUCT?

Yes, the medicine is available as Over The Counter medicine from the pharmacy.

• Make sure that you follow the right instruction and use it if and only if you have an indication for its use.
• Do not suddenly discontinue the medicine, instead consult a physician before you do so.
• Take care to purchase the right dose of the medicine when getting it directly from the pharmacy.

FREQUENTLY ASKED QUESTIONS (FAQs)

1. CAN I USE THE MEDICINE FOR MY ACNE ON FACE?
   No. Acne is not an indication of Clop g. Do not use it. Clobetasone is a potent steroid and is not a first-line therapy for acne vulgaris. Neither gentamicin is a specific drug for acne-causing bacteria.
2. CAN I GO OUTDOOR AFTER APPLYING THE CREAM?
   It is advised that you do not get exposed to sunlight after medicine application.  You can go out after 2-4 hours of application.
3. THE CREAM BOUGHT FROM THE PHARMACY IS EXPIRED. WHAT CAN BE DONE?
   Medicine does not get toxic when expired, it’s just that their action gets compromised and there is nothing to worry if you have applied an expired medicine one. Return the medicine to the pharmacy from where you bought the medicine and consumer rights have given you the basic right to get an alternative pack.
4. WHAT ARE THE DIFFERENT PACKS AND STRENGTHS OF THIS COMBINATION AVAILABLE?
   Tubes of 11gm, 12gm and 25gm are available with the combination of 0.05% Clobetasone and 0.1% gentamicin.
5. IS THE MEDICINE SAFE TO BE APPLIED TO ANY OPEN WOUNDS?
   No, it should not be applied to any kind of open wounds. It decreases the wound healing time. And there are chances of super-infection as well.

Reference

Wikipedia page on Bacteria

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