Accordian Minus Image

Accordian Plus Image

Adchoice Image

Background Image

Brand Hero Image

Contact Hero Image

Who We Are Hero Image

Investors Hero Image

KeyVisual7

Logo

Media Hero Image

All assets

Popup close image

Tick Image

Registered Office

Manufacturing Site

Mask group

image 1

Banner

- It is indicated for steroid responsive dermatosis associated with mixed infection.


Indications - Betamil GM

Indications 

Section container 3 Betamil

Complete protection for mixed skin infections

BetamilBannerImage

Section 2

1.Contradictions 
Do not use Betamil GM if you are allergic (hypersensitive) to betamethasone dipropionate, gentamicin sulphate, miconazole nitrate, chlorocresol, macrogol cetostearyl ether, cetostearyl alcohol, liquid paraffin (heavy), glycerin, propylene glycol, or disodium hydrogen phosphate. Do not use Betamil GM on a child under 2 years old. 

2.Warnings and Precautions
- Keep out of reach of children. 
- Avoid contact with eyes, as cataracts or glaucoma may result if the cream repeatedly enters the eye. 
- This product contains paraffin which is flammable. Do not smoke or go near naked flames due to the risk of severe burns. 
- As with other antibacterial preparations, prolonged use of Betamil may result in overgrowth of non-susceptible organisms, including fungi. Use this medicine exactly as your doctor has told you. Check with your doctor if you are not sure. Do not exceed the prescribed dosage or duration. 
- Caution is advised if you have a certain type of muscle weakness (myasthenia gravis),Parkinson’s disease or other conditions with muscular weakness. Medicines from the group of aminoglycoside antibiotics such as gentamicin may block nerve and muscle function. Caution is advised if you are also using other medicines with an inhibitory effect on muscles and nerves. If any of this applies to you, tell your doctor before using this medicine. 
- Miconazole can enhance the anticoagulant effect of warfarin. Tell your doctor before using this medicine if you are taking oral anticoagulant agents (drugs used to thin the blood), such as warfarin. 
- In children under 12 years of age, long-term continuous topical corticosteroid therapy should be avoided where possible. Children are more likely to develop local and systemic side effects of topical corticosteroids and, in general, require shorter courses and less potent agents than adults. 

3.Pregnancy, Breastfeeding and Fertility 
If you are breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine. Your doctor can discuss with you the risks and benefits involved. 

4.Adverse Drug Instructions 
Betamil® GM is generally well tolerated. However, like all medicines, it can cause side effects, although not everybody gets them. 

Stop using Betamil® GM and get urgent medical help immediately if you notice:
- Severe allergic reaction: sudden swelling of the face/lips/tongue/throat (angioedema), severe allergy (hypersensitivity), or anaphylactic reaction.
- Blurred vision. 

Contact your doctor as soon as possible if you notice: 
- Worsening of psoriasis, including a pus-filled form (rarely reported during treatment or after stopping corticosteroids). 

Rarely, if enough medicine is absorbed through the skin (especially if used in large amounts or for longer than recommended), it may cause side effects in other parts of the body, such as:
- Hormone gland (adrenal) problems or Cushing’s syndrome
- High blood sugar or sugar in the urine
- Kidney problems (changes in urine tests) or passing less urine than usual
- Dizziness, ringing in the ears, or hearing loss
- Nerve problems such as numbness or tingling
- Muscle twitching or fits (convulsions)
- Effects on the brain (encephalopathy) 

Other side effects (usually on the skin where you apply the cream):
- Stinging
- Application-site reactions, including irritation, burning, itching (pruritus), warmth
- Redness (erythema), rash
- Dryness, cracking
- Skin thinning (atrophy)
- Skin inflammation
- Soft/whitish soggy skin (maceration)
- Hives (urticaria)
- Contact dermatitis, including allergic contact dermatitis
- Lightening of the skin (hypopigmentation)
- Inflamed hair follicles (folliculitis)
- Increased hair growth (hypertrichosis)
- Acne-like eruptions
- Rash around the mouth (perioral dermatitis)
- Secondary infection
- Stretch marks (striae)
- Heat rash (miliaria)
- With continuous use without interruption: skin may become thin and fragile with easy bruising, shininess, and small visible surface blood vessels (telangiectasia); striae and superficial vascular dilation (telangiectasia) may occur, especially on the face.
- Possible local effects related to gentamicin: hair loss (alopecia)

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

5.Drug Interactions 
Miconazole: Concomitant administration of miconazole and warfarin may result in the enhancement of the anticoagulant effect of warfarin. Loss of anticoagulant control has been reported following the concomitant use of warfarin and miconazole (including topical preparations). Tell your doctor before using Betamil GM if you are taking oral anticoagulant agents(drugs used to thin the blood) such as warfarin. 

6.Overdose 
In the event of an overdose, or if you think that you or anyone else may have taken too much of this medicine, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms.

Safety Instructions - Betamil

Safety Instructions

- Use this medicine exactly as your doctor has told you. Check with your doctor if you are
not sure. This cream is for use on your skin only. Do not exceed the prescribed dosage or
duration. 
- Do not let the cream get into your eyes. Wash your hands after using the cream. 
- Consult a doctor if your condition worsens or persists. If the condition worsens or does
not improve after 5 days, you should stop using the cream and go back to your doctor. 
- In children, use of potent topical corticosteroids such as this product should be avoided where possible. Use in children should only be on the advice of a doctor. Do not use in children under 2 years old. Children are particularly vulnerable to local and systemic adverse reactions of topical corticosteroids.

Dosage and Administration - Betamil GM

Dosage and Administration

Betamil image

Section 1 Heading

## Complete protection for mixed skin infections

Betamil® GM is a combination of a potent corticosteroid and broad

spectrum anti-bacterial and antifungal agents, for topical administration.

Main section

- Store at or below 2 5°C. Do not Freeze.
- Batch No., Mfg. Date, and Expiry Date see on crimp.
- For M.R.P. see carton.
- Manufactured by: Procter & Gamble Health Ltd.
- At: Medizest Pharmaceuticals Pvt. Ltd., Plot No. L-40,
Verna Industrial Estate, Verna, Goa - 403 722, India.


Storage / Shelf Life / Address - Betamil GM

Storage / Shelf Life / Address

1.Mechanism of action & pharmacodynamic properties: 
a) Betamethasone Dipropionate: 
Topical corticosteroids act as potent anti-inflammatory agents through various mechanisms that effectively inhibit late-phase allergic reactions. They reduce the density of mast cells in tissues, which play a key role in allergic responses. Additionally, these corticosteroids decrease the chemotaxis and activation of eosinophils, which are crucial in the inflammatory process. They also lower the production of cytokines by various immune cells, including lymphocytes, monocytes, mast cells, and eosinophils, which are involved in mediating inflammation. Furthermore, topical corticosteroids inhibit the metabolism of arachidonic acid, a precursor to inflammatory mediators. Their multifaceted actions result in significant anti-inflammatory, antipruritic, and vasoconstrictive effects, making them essential in managing various inflammatory skin conditions. 

b) Gentamicin Sulphate: 
Gentamicin is mixture of antibiotic substances produced by the growth of Micromonospora Purpurea. It is a bactericidal antibiotic which acts by inhibiting protein synthesis. It has greater antibacterial activity than streptomycin, neomycin or kanamycin.
Gentamicin exerts a number of effects on cells of susceptible bacteria. It affects the integrity of the plasma membrane and the metabolism of RNA, but its most important effect is inhibition of protein synthesis at the level of the 30s ribosomal subunit. 

c) Miconazole Nitrate: 
Miconazole nitrate is an imidazole antifungal agent and may act by interfering with the permeability of the fungal cell membrane. It possesses a wide antifungal spectrum and has some antibacterial activity.

2.Pharmacokinetic Properties 
a) Betamethasone Dipropionate: 
Absorption: 
Topical corticosteroids can be systematically absorbed from intact healthy skin. The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the
vehicle and the integrity of the epidermal barrier. Occlusion, inflammation and/or other disease processes in the skin may also increase percutaneous absorption. The use of pharmacodynamic endpoints for assessing the systemic exposure of topical corticosteroids is necessary due to the fact that circulating levels are well below the level of
detection. 
Metabolism: 
Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. They are metabolised, primarily in the liver. 
Elimination: 
Topical corticosteroids are excreted by the kidneys. In addition, some corticosteroids and their metabolites are also excreted in the bile. 

b) Gentamicin sulphate: 
Absorption: 
Topical application of gentamicin has been reported to occur from wounds and inflamed skin. It is poorly absorbed from the gastrointestinal tract when administered orally. 
Distribution: 
Absorbed gentamicin distributes to tissues. Aminoglycosides appear to accumulate in body tissues to some extent, mainly in the kidney. 
Metabolism and Elimination: 
The plasma elimination half-life for gentamicin has been reported to be 2 to 3 hours though it may be considerably longer in neonates and patients with renal impairment. Gentamicin and other aminoglycosides do not appear to be metabolised and are excreted virtually unchanged in the urine by glomerular filtration. 

c) Miconazole nitrate 
Absorption: 
There is little absorption through skin or mucous membranes when miconazole nitrate is applied topically. 
Distribution: 
Absorbed miconazole is bound to plasma proteins (88.2%) and red blood cells (10.6 %). 
Metabolism and Elimination: 
The small amount of miconazole that is absorbed is eliminated predominately in faeces as both unchanged drug and metabolites.

Clinical Pharmacology - Betamil

Clinical Pharmacology

- Betamethasone Dipropionate IP equivalent to Betamethasone 0.05% w/w
- Gentamicin Sulphate IP equivalent to Gentamicin 0.1% w/w
- Miconazole Nitrate IP 2.0% w/w
- Chlorocresol IP 0.1% w/w (as preservative)
- Other ingredients: Macrogol cetostearyl ether, cetostearyl alcohol, liquid paraffin(heavy), glycerin, propylene glycol, disodium hydrogen phosphate, purified water.


Composition - Betamil GM

Composition

BETAMIL