Clofazimine Capsules BP 100mg Technical Specification:

Product Name:Clofazimine Capsules BP 100mg
Brand Name:Clofataj
Strength:100mg, 50mg
Dosage Form:Soft Gelatin Capsules
Route of Administration:Via Oral Route
Packing:10s, 100s
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Anti-leprosy
Indication: Clofazimine is a drug used to treat leprosy. It can slow down the growth and weakly kill Mycobacterium leprae, the bacterium that causes leprosy.
Storage:Store at 20° to 25°C (68° to 77°F). Protect from Light.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Clofazimine Capsules BP 100mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Clofazimine Capsules BP 100mg
    Each soft gelatin capsule contains:
    Clofazimine BP………………….100mg
    Excipients……………………………q. s
    Approved colors are used in empty capsule shells.

THERAPEUTIC INDICATIONS:

Clofazimine is a drug used to treat leprosy. It can slow down the growth and weakly kill Mycobacterium leprae, the bacterium that causes leprosy. It is used in combination with rifampicin and dapsone for the treatment of the many forms of leprosy.

It is specifically used for multibacillary (MB) leprosy and erythema nodosum leprosum. Evidence is insufficient to support its use in other conditions.

It is taken by mouth.

CAUTION & WARNING:

CAUTION:  SWALLOW WHOLE DO NOT CHEW OR CRUSH

Warning:  To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

Storage: Store at room temperature between 15°C to 30°C. Protect from Light & heat.

Read enclosed leaflet before use.

Keep medicine out of reach of children.

Dosage:  For-Sensitive Lepromatous (multibacillary) Leprosy. Administer 100mg Clofazimine daily with meals in combination with two other anti-leprosy drugs for at least 2 years and if possible, until negative skin smears are obtained, followed by monotherapy with an appropriate anti leprosy drug.

Note: *Not suitable for children under 5 years.

GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Clofazimine Capsules BP 100mg
B. Clofazimine Capsules BP 50mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Clofazimine Capsules BP 100mg
Each soft gelatin capsule contains:
Clofazimine BP………………….100mg
Excipients…………………………...q. s
Approved colors are used in empty capsule shells.


B. Clofazimine Capsules BP 50mg
Each soft gelatin capsule contains:
Clofazimine BP………………………50mg
Excipients………………………………q. s
Approved colors are used in empty capsule shells.

THERAPEUTIC INDICATIONS:

Clofazimine is a drug used to treat leprosy. It can slow down the growth and weakly kill Mycobacterium leprae, the bacterium that causes leprosy. It is used in combination with rifampicin and dapsone for the treatment of the many forms of leprosy.
It is specifically used for multibacillary (MB) leprosy and erythema nodosum leprosum. Evidence is insufficient to support its use in other conditions.
It is taken by mouth.

CAUTION & WARNING:

CAUTION: SWALLOW WHOLE DO NOT CHEW OR CRUSH
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

Storage: Store at room temperature between 15°C to 30°C.
Protect from Light & heat.
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
Dosage: For-Sensitive Lepromatous (multibacillary) Leprosy. Administer 100mg Clofazimine daily with meals in combination with two other anti-leprosy drugs for at least 2 years and if possible, until negative skin smears are obtained, followed by monotherapy with an appropriate anti-leprosy drug.
Note: *Not suitable for children under 5 years.