Sofradex – Side Effects, Dosage And Why it is Prescribed?

What is Sofradex

Sofradex is a skin cream used for the treatment of Bacterial infection, Fungal Infection, Ophthalmic disease, Gastro-intestinal infection, Skin inflammation, Dermatologic disease, Rheumatic disorder, Allergy and other medical conditions. It is manufactured by Aventis Pharma Ltd. (Sanofi-aventis) and is available in the package of 20 grams cream per tube.

  1. Generic Medicine in The Cream?
  2. Dosage of This Cream
  3. Working Mechanism of This Medicine
  4. Why is This Cream Prescribed?
  5. Possible Side Effects of This Medicine
  6. Precautions While Using This Cream
  7. Using The Cream During Pregnancy and Breastfeeding
  8. Dosage for Children and Infants
  9. Where to Buy This Cream?
  10. Patient’s Queries About The Cream?
  11. Reference

sofradex cream

Generic Medicine in The Cream?

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

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

Dosage of This Cream

The usual dosage of sofradex cream is to be applied twice or thrice daily. The quantity and frequency of cream to be applied depend on particular skin condition. Always consult your Dermatologist before using this medicine. Do not self-medicate or overdose the cream for fast results.

sofradex drops

Working Mechanism of This Medicine

Framycetin is an antibiotic used for the treatment of bacterial eye infection. It is not active against virus and other types of anaerobic bacterias. Framycetin is primarily useful in infections involving aerobic bacteria.

Dexamethasone is a powerful corticosteroid hormone, which prevents the release of substances in the body causing inflammation. It is used to treat skin conditions, arthritis, allergic disorder, breathing disorder and other medical conditions.

Why is This Cream Prescribed?

Sofradex cream is used for the treatment/control of following medical conditions:

  • Skin Inflammation, Treat Itching, Bacterial Infections of skin and skin lesions
  • Burns and Scalds, Psoriasis, Melasma
  • Surgical Infection, Surgical Lesions
  • Fungal infection in scalp, foot, and arms
  • Napkin rash
  • Gastro-Intestinal Infection
  • Eye Infection, ENT Infection, Otic Infection
  • Allergy
  • Arthritis
  • Leukemia
  • Bladder Infection
  • Traumatic Injury
  • Lupus Vulgaris
  • Eczematous Dermatitis
  • Jock itch (fungal infection of the groin area)
  • Athlete’s foot
  • Vaginal yeast infection

Sofradex cream may also be used for the purpose not listed here.

Contraindications of Sofradex

  • Hypersensitivity
  • Tuberculosis
  • Glaucoma
  • Viral eye infection

Possible Side Effects of This Medicine

This cream has the following commonly reported side-effects:

  • Depression, Headache, Fainting, GI Symptoms
  • Nausea, anxiety, convulsions
  • Sensitization
  • Damage To Inner Ear
  • Scaling Of Skin Sores, Skin Rash, Easy bruising of skin, Peeling of skin, Skin irritation, skin dryness, Itching, Redness of Skin, Stinging, Burning, Blisters, Softening And Tearing Of The Skin, Perioral dermatitis
  • Reduced visual function, Raised IOP, Posterior subcapsular cataract
  • Allergy Due To Contact With The Ointment
  • Increased Redness
  • Steroid purpura
  • Dermal atrophy
  • Hyperglycaemia
  • Growth retardation
  • Unwanted hair growth
  • Abnormal blood count
  • High blood pressure
  • Swelling
  • Delayed wound healing
  • Suppression of pituitary-adrenocortical system
  • Osteoporosis, Bone Degradation, Potassium and Calcium depletion
  • Shortened breath and breathlessness
  • Cushing’s syndrome
  • Menstrual irregularity
  • Foetal abnormalities
  • Acne
  • Muscle pain
  • Sleeplessness

Sofradex cream may also cause side effects not listed here.

Precautions While Using This Cream

One should take following precautionary steps while using the Cream:

  • This is cream for external use only. Avoid swallowing or inhaling the cream.
  • Use with precaution while applying the cream to the skin near eyes, nose, and mouth.
  • Avoid the contact with Eyes; also wash your hands after using this cream.
  • Patients with the history of a Liver disease, Kidney disease, Intestinal disease and Heart disease should take medical advice before using this cream.
  • Sofradex cream should be used with caution during medical conditions such as diabetes, high blood pressure, damaged ear, underactive thyroid, Eye Infection, ulcer, mental Illness, tuberculosis and other health conditions
  • Be sure that the patient is not allergic to any of the component of this cream
  • Avoid usage of this cream during pregnancy and breastfeeding
  • Inform your doctor if you have any wound on the skin due to sunburn, dryness, chapping, or irritation, or on an open wound. Do not apply to any open wound or severely damaged skin.
  • Do not use the cream for acute or systemic fungal infections.
  • Avoid excessive dosage of this cream in children and Use with precaution while administering the cream to elderly patients
  • Avoid covering the affected area with bandage etc. to prevent internal absorption in the skin
  • Monitor actively if being used for long-term and withdraw the usage of this cream slowly.

Using The Cream During Pregnancy and Breastfeeding

This medicine is classified in the pregnancy category ‘C’ by FDA. It is not safe to use this cream during pregnancy. Animal studies have shown adverse effects on the fetus and there are no appropriate studies in pregnant women. Please do not self-medicate. Consult your Gynecologist and Dermatologist both, before the usage of this cream

It is safe to use this cream during breastfeeding but should not be applied anywhere near breasts, as it may harm the baby. Please contact your Doctor before using this cream and discuss the risks and benefits that may occur.

Dosage for Children and Infants

Sofradex cream is approved to be used for children above 2 years of age, but only after prescribed by a qualified doctor.  But this cream is strictly not to be used for infants and children below 2 years. Please consult your doctor regarding usage of this cream. Do not self-medicate.

Where to Buy This Cream?

It is prescription only medicine. This cream is not available as an over the counter or OTC product. A prescription from a qualified doctor is required in order to purchase this medicine. Please consult your doctor regarding dosage and frequency of this medicine.

Patient’s Queries About The Cream

Can I use this cream on open wounds?
This cream is for external use only, hence should not be applied to open wounds. As it may generate infection and worsen your condition

Can I apply this cream as many times I want in a single day?
The usual dosage of this cream is to be applied twice or thrice daily. Overdose will not improve your skin, rather it may harm your skin. Never use more than the prescribed dose. Please follow your doctor’s instruction.

Can Sofradex cream be used on the face?
Yes, this cream can be used on the face. But use with precaution while using the cream near your eyes, nose, and mouth. Also, avoid direct contact with eyes.

How should I store Sofradex Cream?
Sofradex cream should be kept in airtight container. Avoid direct contact with sunlight and keep it in a cool dry place. Always discard the remaining medicine after the expiry date printed on the pack has passed. Always follow the instructions written on your medicine label regarding storage of the medicine.

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