Rosuvastatin Calcium + Clopidogrel Capsule (10mg+75mg) Technical Specification:
| Product Name: | Rosuvastatin Calcium + Clopidogrel Capsule |
| Brand Name: | Generics |
| Strength: | (10mg+75mg), (20mg+75mg) |
| Dosage Form: | Capsule (Hard Gelatin) |
| Route of Administration: | Via oral Route |
| Packing: | 30s, 100s, 150s, 200s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet) |
| Regulatory Documents: | COA, MOA, Stability Studies, GMP |
| Therapeutic use: | Anti-Hyperlipidaemic, Antiplatelet |
| Indication: | Rosuvastatin+Clopidogrel Capsule is used for heart attack prevention and high cholesterol. Rosuvastatin + Clopidogrel is a combination of two medicines: Rosuvastatin and Clopidogrel, which prevents heart attack and stroke. |
| Storage: | Protect from moisture at a temperature not exceeding 25˚C. Do not freeze. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Rosuvastatin calcium + Clopidogrel Capsule 10mg+75mg
- Rosuvastatin Calcium + Clopidogrel Capsule 20mg+75mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- a) Rosuvastatin Calcium + Clopidogrel Capsule 10mg+75mg
Each Hard Gelatin capsule contains:
Rosuvastatin Calcium IP
equivalent to Rosuvastatin……………10mg
(As pellets)
Colours: Brilliant Blue FCF
Clopidogrel Bisulphate IP
Equivalent to Clopidogrel………………75mg
(As pellets)
Colours: Sunset Yellow Lake FCF
Excipients………………………………. q.s.
Approved colours are used in hard gelatin capsule shells.
- b) Rosuvastatin Calcium + Clopidogrel Capsule 20mg+75mg
Each Hard Gelatin capsule contains:
Rosuvastatin Calcium IP
equivalent to Rosuvastatin……………20mg
(As pellets)
Colours: Red oxide iron
Clopidogrel Bisulphate IP
Equivalent to Clopidogrel………………75mg
(As pellets)
Colours: Quinoline Yellow
Excipients………………………………. q.s.
Approved colours used in hard gelatin capsule shells.
THERAPEUTIC INDICATIONS:
Rosuvastatin+Clopidogrel is used for heart attack prevention and high cholesterol. Rosuvastatin + Clopidogrel is a combination of two medicines: Rosuvastatin and Clopidogrel, which prevents heart attack and stroke. It prevents the platelets from sticking together and decreases the formation of harmful blood clots.
CAUTION & WARNING:
CAUTION:
- Not be used in children below 12 years of age except under medical advice.
- SWALLOW WHOLE DO NOT CHEW OR CRUSH.
- Do not take this product during the last three months of pregnancy unless directed by a doctor. Aspirin taken near the time of delivery may cause bleeding problems to both mother and child.
SCHEDULE “H” Prescription Drug
Warning: Not to be sold by retail without the prescription of a Registered Medical Prescriber.
STORAGE & DOSAGE:
Storage: Protected from light and moisture at a temperature not exceeding 25˚C.Do not freeze.
Dosage: As directed by the Physician.
GENERIC NAME OF THE MEDICINAL PRODUCT:
Rosuvastatin calcium + Clopidogrel Capsule 10mg+75mg
Rosuvastatin calcium + Clopidogrel Capsule 20mg+75mg
Rosuvastatin calcium + Clopidogrel Capsule 20mg+75mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
a) Rosuvastatin calcium + Clopidogrel Capsule 10mg+75mg
Each Hard Gelatin capsule contains:
Rosuvastatin Calcium IP
equivalent to Rosuvastatin……………10mg
(As pellets)
Colours: Brilliant Blue FCF
Clopidogrel Bisulphate IP
Equivalent to Clopidogrel……………...75mg
(As pellets)
Colours: Sunset Yellow Lake FCF
Excipients………………………………. q.s.
Approved colours used in hard gelatin capsule shells.
b) Rosuvastatin calcium + Clopidogrel Capsule 20mg+75mg
Each Hard Gelatin capsule contains:
Rosuvastatin Calcium IP
equivalent to Rosuvastatin……………20mg
(As pellets)
Colours: Red oxide iron
Clopidogrel Bisulphate IP
Equivalent to Clopidogrel……………...75mg
(As pellets)
Colours: Quinoline Yellow
Excipients………………………………. q.s.
Approved colours used in hard gelatin capsule shells.
Each Hard Gelatin capsule contains:
Rosuvastatin Calcium IP
equivalent to Rosuvastatin……………10mg
(As pellets)
Colours: Brilliant Blue FCF
Clopidogrel Bisulphate IP
Equivalent to Clopidogrel……………...75mg
(As pellets)
Colours: Sunset Yellow Lake FCF
Excipients………………………………. q.s.
Approved colours used in hard gelatin capsule shells.
b) Rosuvastatin calcium + Clopidogrel Capsule 20mg+75mg
Each Hard Gelatin capsule contains:
Rosuvastatin Calcium IP
equivalent to Rosuvastatin……………20mg
(As pellets)
Colours: Red oxide iron
Clopidogrel Bisulphate IP
Equivalent to Clopidogrel……………...75mg
(As pellets)
Colours: Quinoline Yellow
Excipients………………………………. q.s.
Approved colours used in hard gelatin capsule shells.
THERAPEUTIC INDICATIONS:
Rosuvastatin+Clopidogrel Capsule is used for heart attack prevention and high cholesterol. Rosuvastatin + Clopidogrel is a combination of two medicines: Rosuvastatin and Clopidogrel, which prevents heart attack and stroke. It prevents the platelets from sticking together and decreases the formation of harmful blood clots.
CAUTION & WARNING:
CAUTION:
• Not be used in children below 12 years of age expect under medical advice.
• SWALLOW WHOLE DO NOT CHEW OR CRUSH.
• Do not take this product during the last three months of pregnancy unless directed by a doctor.Aspirin taken near the time of delivery may cause bleeding problems to both mother child.
SCHEDULE “H” Prescription Drug Warning: Not to be sold by retail without the prescription of a Registered Medical Prescriber.
• Not be used in children below 12 years of age expect under medical advice.
• SWALLOW WHOLE DO NOT CHEW OR CRUSH.
• Do not take this product during the last three months of pregnancy unless directed by a doctor.Aspirin taken near the time of delivery may cause bleeding problems to both mother child.
SCHEDULE “H” Prescription Drug Warning: Not to be sold by retail without the prescription of a Registered Medical Prescriber.
STORAGE & DOSAGE:
Storage: Protected from light and moisture at a temperature not exceeding 25˚C.Do not freeze.
Dosage: As directed by the Physician.
Dosage: As directed by the Physician.
