APR Beclorich Ns

INFORMATION FOR THE USER  

Clotrimazole 1% w/w, Neomycin 0.5% w/w and Beclomethasone 0.25% w/w Cream 

Read all of this information carefully before you start taking this medicine because it contains important information for you. 

• Keep this information. You may need to read it again. 
• If you have any further questions, ask your doctor, pharmacist or nurse. 
• This medicine is prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. 

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this information.  

1. COMPOSITION: 

Each container contains: 

Clotrimazole – 1% w/w 

Neomycin – 0.5% w/w 

Beclomethasone – 0.25% w/w 

 For external use only.  

2. DESCRIPTION: 

Clotrimazole is an anti-fungal that belongs to a class of drugs known as triazole antifungals. 

Neomycin is an anti-bacterial and helps to kill bacteria. It belongs to a class of anti-bacterial known as aminoglycosides. 

Beclomethasone is a topical steroid that helps to relieve pain and inflammation on the skin. 

 3.PHARMACOLOGICAL ACTION: 

Clotrimazole acts against fungi by inhibiting ergosterol synthesis. Inhibition of ergosterol synthesis leads to structural & functional impairment of the fungal cytoplasmic membrane. It has a broad antimycotic spectrum of action in vitro & in vivo, which includes dermatophytes, yeasts, moulds, etc. 

Neomycin is an aminoglycoside antibiotic. It acts by binding to polysomes, inhibiting protein synthesis and generating errors in the transcription of the genetic code. 

Beclomethasone is used primarily for its anti-inflammatory and/or immune suppressive effects. Beclomethasone is effective in the treatment of a range of dermatoses because of their anti-inflammatory, anti-pruritic & vasoconstrictive actions.

3.CLINICAL PHARMACOKINETICS: 

Pharmacokinetic investigations after dermal application have shown that it is minimally absorbed from the intact/inflamed skin into the human blood circulation. The resulting peak serum concentrations were below the detection limit of 0.001 μg/ml, suggesting that clotrimazole applied topically is unlikely to lead to measurable systemic effects or side effects.  

The absorption of neomycin from the is poor: Only 3% of a dose is absorbed, neomycin is rapidly excreted by the kidneys in the unchanged form. The plasma half-life in healthy adults is approximately 2-3 hours. Doses of 3g produce peak plasma concentrations of up to 4 μg/ml.  

Beclomethasone is absorbed following topical administration. The degree of absorption is dependent on various factors including skin condition & site of application. It is metabolised largely in the liver but also to a limited extent in the kidneys & the inactive metabolites are excreted with the urine.  

1. INDICATIONS: 

Clotrimazole, neomycin and beclomethasone cream is indicated for: 

• Genital yeast infections 
• Ringworm infections of the skin 
• Athletes foot 
• Jock itch

1. CONTRAINDICATIONS: 

Clotrimazole, neomycin and beclomethasone cream is contraindicated in the following cases: 

 

• Hypersensitivity to the active substance or to any of the excipients.
  * Cut/scraped/exposed skin.
   

1. WARNINGS AND PRECAUTIONS: 

May cause local skin reactions (e.g. contact dermatitis). 

Avoid if sensitive skin type, especially to clotrimazole, beclomethasone and neomycin. 

Avoid applying on the skin surface that is cut, scraped, sunburned or eczema-affected.  

Meant for topical application only. Not for oral, ophthalmic or intravaginal use. 

In case of eye contact, make sure to thoroughly rinse eyes and contact the doctor if the irritation develops. 

Talk to your doctor about your medical conditions, if any, before using this product. Make sure to inform him/her if your skin conditions do not improve or get worsened. 

Not recommended for individuals who are of age 9 years and below. If you are pregnant or nursing, consult your doctor before using this product.
 

1. ADVERSE EFFECTS: 

Common side effects include: 

• Eryhtema 

• Stinging 
• Blistering 
• Peeling of skin 
• Edema 
• Pruritis 

• Urticaria 
• Burning sensation 
• Skin irritation 

1. DRUG INTERACTIONS: 

Not applicable. 

1. DOSAGE: 

Should be applied thinly 2/3 times daily & rubbed in gently.
 

1. ADMINISTRATION: 

To be applied to the skin only. Before applying this product, the affected area must be cleaned and dried. A thin layer of this cream should be applied to the affected area. Wash hands after application with soap and dry properly.
 

1. PRESENTATION: 

1. STORAGE: 

Store below 25°C in a cool & dry pace. Protect from direct sunlight. Keep away from the reach of children. 

 

1. MANUFACTURED BY: 

1. MARKETED BY: 

 

This information was last revised on May 2019.