GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Hydrocortisone Tablets USP 5mg
B) Hydrocortisone Tablets USP 10mg
C) Hydrocortisone Tablets USP 20mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A)Hydrocortisone Tablets USP 5mg
Each uncoated tablet contains:
Hydrocortisone IP………………………….5 mg
Excipients………………………………….q.s.
B) Hydrocortisone Tablets USP 10mg
Each uncoated tablet contains:
Hydrocortisone IP………………………….10mg
Excipients………………………………….q.s.
C) Hydrocortisone Tablets USP 20mg
Each uncoated tablet contains:
Hydrocortisone IP………………………….20mg
Excipients………………………………….q.s.

THERAPEUTIC INDICATIONS:

Hydrocortisone is a steroid (corticosteroid) medicine. It works by calming down your body's immune response to reduce pain, itching and swelling (inflammation). It can also be used as hormone replacement for people who do not have enough of the natural stress hormone, cortisol.

CAUTION & WARNING:

CAUTION:
Most common side effects of Hydrocortisone are: • Burning, itching, irritation, redness
• Acne
• Unwanted hair growth
• Skin colour changes
• Tiny red bumps
• Small white and red bumps
Some of the most serious side effects of Hydrocortisone are: • Skin rash
• Hives
• Breathing problems
• Fever
• Sore throat
• Sneezing
• Cough
• Wounds that won’t heal
• Pain while urinating
• Depression
• Mood swings
• Vomiting
WARNING: TO BE SOLD BY RETAIL ON THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER ONLY.

STORAGE & DOSAGE:

Storage:
Store at a temperature not exceeding 25°C.
Protect from moisture & light
Dosage:
As directed by the physician

Hydrocortisone Tablets USP 20mg Technical Specification:

Product Name:Hydrocortisone Tablets USP
Brand Name:Generic
Strength:5mg, 10mg, 20mg
Dosage Form:uncoated tablet
Route of Administration:Via Oral Route
Packing:10s,20s
Pack Insert/Leaflet:PIL (Patient Information Leaflet)
Documents:COA, MOA, COPP, FSC, CTD DOSSIER, Stability Studies, GMP
Therapeutic use:Corticosteroids
Indication: Hydrocortisone is a steroid (corticosteroid) medicine. It works by calming down your body’s immune response to reduce pain, itching and swelling (inflammation). It can also be used as hormone replacement for people who do not have enough of the natural stress hormone, cortisol.
Storage:Store at a temperature not exceeding 25°C. Protect from moisture & light.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Hydrocortisone Tablets USP 5mg
  • Hydrocortisone Tablets USP 10mg
  • Hydrocortisone Tablets USP 20mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Hydrocortisone Tablets USP 5mg
    Each uncoated tablet contains:
    Hydrocortisone IP………………………….5 mg
    Excipients………………………………….q.s.
  • Hydrocortisone Tablets USP 10mg
    Each uncoated tablet contains:
    Hydrocortisone IP………………………….10mg
    Excipients………………………………….q.s.
  • Hydrocortisone Tablets USP 20mg
    Each uncoated tablet contains:
    Hydrocortisone IP………………………….20mg
    Excipients………………………………….q.s.

THERAPEUTIC INDICATIONS:

Hydrocortisone is a steroid (corticosteroid) medicine. It works by calming down your body’s immune response to reduce pain, itching and swelling (inflammation). It can also be used as hormone replacement for people who do not have enough of the natural stress hormone, cortisol.

CAUTION & WARNING:

CAUTION:Most common side effects of Hydrocortisone are:

  • Burning, itching, irritation, redness
  • Acne
  • Unwanted hair growth
  • Skin color changes
  • Tiny red bumps
  • Small white and red bumps

Some of the most serious side effects of Hydrocortisone are:

  • Skin rash
  • Hives
  • Breathing problems
  • Fever
  • Sore throat
  • Sneezing
  • Cough
  • Wounds that won’t heal
  • Pain while urinating
  • Depression
  • Mood swings
  • Vomiting
    WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

Storage:Store at a temperature not exceeding 25°C.
Protect from moisture & light.
Dosage:As directed by the physician.