Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP (10mg+160mg+25mg) Technical Specification:
Product Name: | Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP |
Brand Name: | Noforge |
Strength: | (5mg+160mg+12.5mg), (10mg+160mg+12.5mg), (10mg+160mg+25mg), (10mg+320mg+25mg) |
Dosage Form: | Tablets (film-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: | Antihypertensive |
Indication: | Amlodipine, valsartan, and hydrochlorothiazide is a combination of medicines that is used to treat high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries. |
Storage: | Store at 20° to 25°C (68° to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). Store in dry place protected from light and moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP (5mg+160mg+12.5mg)
- Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP (10mg+160mg+12.5mg)
- Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP (10mg+160mg+25mg)
- Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP (10mg+320mg+25mg)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
1.Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP (5mg+160mg+12.5mg)
Each film-coated tablet contains:
Amlodipine Besylate USP
Equivalent to Amlodipine………………..5mg
Valsartan USP………………………………..160mg
Hydrochlorothiazide USP…………………..12.5mg
Excipients………………………………………q.s
Color: Sunset yellow FCF
2.Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP (10mg+160mg+12.5mg)
Each film-coated tablet contains:
Amlodipine Besylate USP
Equivalent to Amlodipine…………………….10mg
Valsartan USP………………………………..160mg
Hydrochlorothiazide USP……………………12.5mg
Excipients………………………………………………q.s
Color: Orange G
3.Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP (10mg+160mg+25mg)
Each film-coated tablet contains:
Amlodipine Besylate USP
Equivalent to Amlodipine…………………….10mg
Valsartan USP………………………………..160mg
Hydrochlorothiazide USP……………………25mg
Excipients………………………………………………q.s
Color: Ponceau 4 R
4.Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP (10mg+320mg+25mg)
Each film-coated tablet contains:
Amlodipine Besylate USP
Equivalent to Amlodipine…………………….10mg
Valsartan USP………………………………..320mg
Hydrochlorothiazide USP……………………25mg
Excipients………………………………………………q.s
Color: Ponceau 2 R
THERAPEUTIC INDICATIONS:
Amlodipine, valsartan, and hydrochlorothiazide is a combination of medicines that is used to treat high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries.
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 container with a child-resistant closure.
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) ; excursions permitted between 15°C to 30°C (59°F to 86°F).
Store in dry place protected from light and moisture.
Dosage: As directed by the Physician
Attach dispensing label as per end county.
GENERIC NAME OF THE MEDICINAL PRODUCT:
A. Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP (5mg+160mg+12.5mg)
B. Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP (10mg+160mg+12.5mg)
C. Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP (10mg+160mg+25mg)
D. Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP (10mg+320mg+25mg)
B. Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP (10mg+160mg+12.5mg)
C. Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP (10mg+160mg+25mg)
D. Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP (10mg+320mg+25mg)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A. Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP (5mg+160mg+12.5mg)
Each film-coated tablet contains:
Amlodipine Besylate USP
Equivalent to Amlodipine………………..5mg
Valsartan USP………………………………..160mg
Hydrochlorothiazide USP…………………..12.5mg
Excipients………………………………………q.s
Color: Sunset yellow FCF
B. Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP (10mg+160mg+12.5mg)
Each film-coated tablet contains:
Amlodipine Besylate USP
Equivalent to Amlodipine…………………….10mg
Valsartan USP………………………………..160mg
Hydrochlorothiazide USP……………………12.5mg
Excipients………………………………………………q.s
Color: Orange G
C. Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP (10mg+160mg+25mg)
Each film-coated tablet contains:
Amlodipine Besylate USP
Equivalent to Amlodipine…………………….10mg
Valsartan USP………………………………..160mg
Hydrochlorothiazide USP……………………25mg
Excipients………………………………………………q.s
Excipients………………………………………………….q.s
Color: Ponceau 4 R
D. Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP (10mg+320mg+25mg)
Each film-coated tablet contains:
Amlodipine Besylate USP
Equivalent to Amlodipine…………………….10mg
Valsartan USP………………………………...320mg
Hydrochlorothiazide USP……………………25mg
Excipients………………………………………………q.s
Color: Ponceau 2 R
Each film-coated tablet contains:
Amlodipine Besylate USP
Equivalent to Amlodipine………………..5mg
Valsartan USP………………………………..160mg
Hydrochlorothiazide USP…………………..12.5mg
Excipients………………………………………q.s
Color: Sunset yellow FCF
B. Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP (10mg+160mg+12.5mg)
Each film-coated tablet contains:
Amlodipine Besylate USP
Equivalent to Amlodipine…………………….10mg
Valsartan USP………………………………..160mg
Hydrochlorothiazide USP……………………12.5mg
Excipients………………………………………………q.s
Color: Orange G
C. Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP (10mg+160mg+25mg)
Each film-coated tablet contains:
Amlodipine Besylate USP
Equivalent to Amlodipine…………………….10mg
Valsartan USP………………………………..160mg
Hydrochlorothiazide USP……………………25mg
Excipients………………………………………………q.s
Excipients………………………………………………….q.s
Color: Ponceau 4 R
D. Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP (10mg+320mg+25mg)
Each film-coated tablet contains:
Amlodipine Besylate USP
Equivalent to Amlodipine…………………….10mg
Valsartan USP………………………………...320mg
Hydrochlorothiazide USP……………………25mg
Excipients………………………………………………q.s
Color: Ponceau 2 R
THERAPEUTIC INDICATIONS:
Amlodipine, valsartan, and hydrochlorothiazide is a combination of medicines that is used to treat high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries.
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 container with a child-resistant closure.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
Dispense in a tight container with a child-resistant closure.
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); excursions permitted between 15°C to 30°C (59°F to 86°F).
Store in dry place protected from light and moisture.
Dosage: As directed by the Physician
Attach dispensing label as per end county.
Store in dry place protected from light and moisture.
Dosage: As directed by the Physician
Attach dispensing label as per end county.