Sofradex Cream, is it safe? Uses, side-effects, dosage

What is Sofradex Cream?

Sofradex is a branded skin cream, which is a antibacterial, antifungal and corticosteroid responsive dermatoses. It is manufactured by Abbott India Ltd. It is available in the packaging of 2.5 grams cream per tube.

  1. What is the generic name(s)?
  2. How does it work ?
  3. What are it’s uses ?
  4. How effective is this medicine ?
  5. What are the Side Effects ?
  6. Is this medicine addictive?
  7. What happens if it over-applied and how to manage? ?
  8. What to do in case there is an allergic reaction with it? ?
  9. What is the Dosage ?
  10. What are the precautions I need to take ?
  11. Is it safe to take if I am pregnant ?
  12. Is it safe to take if I am breast feeding ?
  13. Can this medicine be given to children and infants ?
  14. Is sofradex Cream available as an over the counter (OTC) product?
  15. Frequently asked questions
  16. Reference
sofradex cream

sofradex cream- uses, side-effects, dosage


What is the generic name (s)?

The generic components of Sofradex along with their composition in % w/w is being described below:

  • Framycetin Sulphate (1%)
  • Dexamethasone (0.1%)

How does it work ?

The working of Sofradex cream can be understood as that of a combination of its generic components. Below given is a brief description of the same:

Framycetin is a aminoglycoside antibiotic. and it is usually antibiotic.Mechanism of action has not  yet been completely elucidated or known . Although framycetin appears to inhibit protein synthesis in susceptible bacteria by binding to ribosomal subunits.Framycetin and this is not active against the fungi, most of anaerobic bacteria and viruses

Dexamethasone is a powerful corticosteroid hormone, which stimulate the adrenal gland and affect many metabolic functions. This reaction triggers the immune system to fight against inflammation, allergies and many other diseases. It achieves such anti-inflammatory benefits by decreasing the inflammatory chemicals released which are released by our immune system in order to fight the disease.

What are it’s uses ?

Sofradex cream is administered in the management of the following medical conditions:

  • Skin Inflammation,
  • Bacterial Infections Of Skin
  • Treat Itching,
  • Lupus Vulgaris Or Lupus Erythematosus
  • Psoriasis (immune-mediated Skin Disease With Red Scaly Patches)
  • Eczematous Dermatitis
  • Inflammation of skin (atopic dermatitis)
  • Jock itch (fungal infection of the groin area)
  • Athlete’s foot (ringworm infection, a fungal infection of the foot)
  • Vaginal yeast infection,
  • Fungal infection in scalp, foot and arms,
  • Inflammation or infection of the external ear (otitis externa),
  • Napkin rash,
  • Psoriasis,
  • Itchy skin (eczema)

How effective is this medicine ?

Sofradex is a very effective cream in the management of all the skin related disorders as mentioned above. One should use it after discussing the condition and other symptoms with a dermatologist.

What are the Side Effects ?

This cream has the following commonly reported side-effects:

  • Stinging
  • Sensitization
  • Local Irritation
  • Damage To Inner Ear
  • Skin Rash
  • Allergy Due To Contact With The Ointment
  • Headache
  • Increased Redness
  • Scaling Of Skin Sores
  • Perioral dermatitis,
  • steroid purpura
  • Striae esp in flexures
  • Softening And Tearing Of The Skin
  • Burning
  • Dermal and epidermal atrophy esp on the face
  • Unwanted hair growth
  • Rashes
  • Abnormal blood count
  • Swelling
  • Bone Degradation
  • Itching
  • Shortened breath and breathlessness
  • Redness of skin
  • Cushing’s syndrome
  • Acne
  • Nausea, anxiety, convulsions
  • Fainting
  • Easy bruising of skin
  • Headache
  • Peeling
  • High blood pressure
  • Blisters
  • Muscle pain
  • Skin irritation
  • Sleeplessness
  • Skin dryness

Is Sofradex Cream  addictive?

Habit forming tendencies for this medicine has not been reported. Most medicines don’t come with a potential for addiction. Government  also categorizes medicines that can be addictive as controlled substances. Finally,  do not self-medicate and increase your body’s dependence to medicines without taking the advice of a doctor.

What happens if Sofradex Cream over-applied and how to manage?

It is not recommended to use more than the prescribed dose. Taking more than the prescribed dose will not improve your symptoms,  it may cause serious side-effects. If you suspect that you or anyone else who may have overdose, please go to the emergency department of the closest hospital. Do not give your used medicines to others. Please consult your physician or pharmacist or product package for more information.

 What to do in case there is an allergic reaction with Sofradex Cream ?

Some of the side effects of this medicine are skin irritation, rashes, and Inflammation.If you observe any of the above side effects, gently clean the affected area with cold  water and  have a cold compress on the affected area.  Consult your doctor as soon as possible and take necessary remedies.

What is the Dosage ?

The quantity of Sofradex cream to be applied for the particular skin condition and also the frequency of application per day has to be as per Dermatologist’s prescription. Also, one must not exceed the duration (in terms of number of days) of the use of this cream.

Cream - Dosage

Cream – Dosage

What are the precautions I need to take ?

While using Sofradex cream precaution should be exercised:

Heart failure, recent myocardial infarction, hypertension; diabetes mellitus; epilepsy; glaucoma; hypothyroidism; hepatic failure, renal impairment; psychoses; children and elderly. Should not enter eyes. If infection exists, treat with specific anti-infectives. Pregnancy, lactation

  • Avoid excessive dose in children
  • This is cream for external use only
  • Do not use the cream on open wounds
  • Avoid inhaling and swallowing
  • Avoid if patient in pregnant
  • Avoid if you are breastfeeding a baby
  • Avoid contact with mouth and eyes
  • Be sure that the patient is not allergic to any of the component of this cream
  • Avoid covering the affected area with bandage etc. to prevent internal absorption in the skin
  • Monitor actively if being used for long-term
  • Avoid if the patient has acute and/or systemic fungal infection
  • Usage has to be withdrawn slowly
  • Use with caution if the patient is an elderly person
  • Use with caution with patients (especially women), who have recently undergone a thyroid test

Is it safe to take if I am pregnant ?

No, it is not safe to use when you are pregnant. Please consult with your gynecologist along with your dermatologist if a need arises to use this cream.

This medicine is classified by FDA as pregnancy category ‘C’ Risk not ruled out: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Please do not self-medicate with this cream.

Is it safe to take if I am breast feeding ?

Yes , it is safe to use if you are breast feeding but do not apply in the region of breast where baby gets into contact with drug. Please consult with your dermatologist if a need arises to use this cream.

Consult a doctor to know if this cream is safe for you.

Can this medicine be given to children and infants ?

Yes, if prescribed by a qualified dermatologist, this medicine can be used for children of age more than 2 years only. Please consult with the dermatologist regarding the quantity , frequency and duration of application of this cream.

But, it is strictly not to be used for children below the age of 2 years and infants.


Is sofradex Cream available as an over the counter (OTC) product?

No, this cream is not available as an over the counter product. It is prescription medicine and has to be prescribed by a qualified dermatologist. Please consult a dermatologist regarding of the sofradex cream is suitable for you and correct dosage.

sofradex

sofradex

Frequently asked questions

Is dexamethasone topical safe for toddlers?
No, dexamethasone topical is not safe for toddlers

Can I use this cream on my open wounds ?
No, you should not apply this medicinal cream on open wounds. This cream is only for external use. Applying this cream on open wounds can worsen the wound and generate infections.

Can I apply it as many times I want in a day?
No, that will be harmful for the skin. Generally it is advised to be used twice or thrice in a day. Please follow your dermatologist’s instructions on this.

Can Sofradex cream be used on face?
Yes this cream can be used on face. But it is advised that the continuous usage should not be more than 5 days.

How one should store sofradex cream ?
This cream should be stored in an air-tight container at room temperature, protected from heat. Please keep it away from the reach of children and pets. Also, discard the remaining medicine after its expiry date has passed.

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