Cilostazol Tablets USP 100mg
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Cilostazol Tablets USP 100mg Technical Specification:

Product Name: Cilostazol Tablets USP 100mg
Brand Name: Generic
Strength: (50mg) , (100mg)
Dosage Form: Tablets (Un-coated)
Route of Administration: Via Oral Route
Packing: 10s, 30s, 100s, 500s
Pack Insert/Leaflet: PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents: COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use: Anticoagulant
Indication: Cilostazol improves the flow of blood through the blood vessels. It is used to reduce leg pain caused by poor circulation (intermittent claudication). Cilostazol makes it possible to walk farther before having to rest because of leg pain. It works by improving blood flow to the legs.
Storage: Store at 20° to 25°C (68° to 77°F). Store in dry place protected from light and moisture.

 

GENERIC NAME OF THE MEDICINAL PRODUCT:

 

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Cilostazol Tablets USP 50mg
    Each Un-coated tablet contains:
    Cilostazol USP………………..……………50mg
    Excipients………………………………..q.s
    Colour: Sunset Yellow FCF

 

  • Cilostazol Tablets USP 100mg
    Each Un-coated tablet contains:
    Cilostazol USP………………..……………100mg
    Excipients………………………………..q.s
    Colour: Sunset Yellow

 

THERAPEUTIC INDICATIONS: 

Cilostazol improves the flow of blood through the blood vessels. It is used to reduce leg pain caused by poor circulation (intermittent claudication). Cilostazol makes it possible to walk farther before having to rest because of leg pain. Cilostazol is also indicated for secondary prevention in patients with a history of transient ischemic attacks or non-cardioembolic ischemic stroke. It works by improving blood flow to the legs.

 

CAUTION & WARNING:


CAUTION:

Read enclosed leaflet before use.

Keep medicine out of reach of children.

SWALLOW WHOLE DO NOT CHEW OR CRUSH.

DISPENSE IN A TIGHT, LIGHT-RESISTANT, CHILD-RESISTANT CONTAINER AS DEFINES IN THE USP.

WARNING: TO BE SOLD BY RETAIL ON THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER ONLY.

 

STORAGE & DOSAGE:


STORAGE: Store at 20° to 25°C (68° to 77°F)

Store in dry place protected from light and moisture.

DOSAGE: As directed by the Physician.

Attach dispensing label as per end country.

 

GENERIC NAME OF THE MEDICINAL PRODUCT:

a)Cilostazol Tablets USP 50mg
b)Cilostazol Tablets USP 100mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a)Cilostazol Tablets USP 50mg
Each Un-coated tablet contains:
Cilostazol USP………………..……………50mg
Excipients………………………………..q.s
Colour: Sunset yellow FCF

b)Cilostazol Tablets USP 100mg
Each Un-coated tablet contains:
Cilostazol USP………………..……………100mg
Excipients………………………………..q.s
Colour: Sunset yellow

THERAPEUTIC INDICATIONS:

Cilostazol improves the flow of blood through the blood vessels. It is used to reduce leg pain caused by poor circulation (intermittent claudication). Cilostazol makes it possible to walk farther before having to rest because of leg pain. Cilostazol is also indicated for secondary prevention in patients with a history of transient ischemic attacks or non-cardioembolic ischemic stroke. It works by improving blood flow to the legs.

CAUTION & WARNING:

CAUTION:
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
DISPENSE IN A TIGHT, LIGHT-RESISTANT, CHILD-RESISTANT CONTAINER AS DEFINES IN THE USP.

WARNING: TO BE SOLD BY RETAIL ON THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER ONLY.

STORAGE & DOSAGE:

STORAGE: Store at 20° to 25°C (68° to 77°F)
Store in dry place protected from light and moisture.

DOSAGE: As directed by the Physician.
Attach dispensing label as per end country.