Metoprolol Succinate Extended-Release Tablet USP 200mg Technical Specification:

Product Name:Metoprolol Succinate Extended-Release Tablet USP 200mg
Brand Name:Metrol XL
Strength:12.5mg, 25mg, 50mg, 100mg, 200mg
Dosage Form:Extended-Release Tablets (film-coated)
Route of Administration:Via Oral Route
Packing:10s, 20s, 30s, 50s, 150s
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-anginal
Indication: Metoprolol Succinate ER is a beta-blocker that affects the heart and circulation (blood flow through arteries and veins). Metoprolol Succinate ER is used to treat angina (chest pain) and hypertension (high blood pressure). It is also used to lower your risk of death or needing to be hospitalized for heart failure.
Storage:Store at 20° to 25°C (68° to 77°F). Protect from light & moisture. Keep in a cool & dry place.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Metoprolol Succinate Extended-Release Tablet USP 200mg (Metrol XL)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Metoprolol Succinate Extended-Release Tablet USP 200mg (Metrol XL)
    Each film -coated Extended-Release tablet contain:
    Metoprolol Succinate
    Eq. to Metoprolol Tartrate USP…………………200mg
    Excipients………………………………………….…………. q.s.
    Colour: Iron oxide Black

THERAPEUTIC INDICATIONS:

Metoprolol Succinate ER is a beta-blocker that affects the heart and circulation (blood flow through arteries and veins). Metoprolol Succinate ER is used to treat angina (chest pain) and hypertension (high blood pressure). It is also used to lower your risk of death or needing to be hospitalized for heart failure.

CAUTION & WARNING:

CAUTION: SWALLOW WHOLE DO NOT CHEW OR CRUSH.

Take whole tablet with water.

Read enclosed leaflet before use.

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

Keep medicine out of reach of children.

STORAGE & DOSAGE:

Storage: Store at 20° to 25°C (68° to 77°F). Protect from light & moisture. Keep in a cool & dry place.

Dosage:  As directed by the Physician

Attach dispensing label here.

GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Metoprolol Succinate Extended-Release Tablet USP 12.5mg
B) Metoprolol Succinate Extended-Release Tablet USP 25mg (Metrol XL)
C) Metoprolol Succinate Extended-Release Tablet USP 50mg (Metrol XL)
D) Metoprolol Succinate Extended-Release Tablet USP 1000mg (Metrol XL)
E) Metoprolol Succinate Extended-Release Tablet USP 200mg (Metrol XL)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Metoprolol Succinate Extended-Release Tablet USP 12.5mg (Metrol XL)
Each film -coated Extended-Release tablet contain:
Metoprolol Succinate
Eq. to Metoprolol Tartrate USP……...............12.5mg
Excipients………………………………………….…………. q.s.
Colour: Sunset yellow FCF

B) Metoprolol Succinate Extended-Release Tablet USP 25mg (Metrol XL)
Each film -coated Extended-Release tablet contain:
Metoprolol Succinate
Eq. to Metoprolol Tartrate USP……...............25mg
Excipients………………………………………….…………. q.s.
Colour: Sunset yellow FCF

C) Metoprolol Succinate Extended-Release Tablet USP 50mg (Metrol XL)
Each film-coated Extended-Release tablet contain:
Metoprolol Succinate
Eq. to Metoprolol Tartrate USP.……..............50mg
Excipients………………………………………….…………. q.s.
Colour: Titanium Dioxide USP

D) Metoprolol Succinate Extended-Release Tablet USP 100mg (Metrol XL)
Each film-coated Extended-Release tablet contain:
Metoprolol Succinate
Eq. to Metoprolol Tartrate USP …..............100mg
Excipients………………………………….…………. q.s.
Colour: Iron oxide Red

E) Metoprolol Succinate Extended-Release Tablet USP 200mg (Metrol XL)
Each film-coated Extended-Release tablet contain:
Metoprolol Succinate
Eq. to Metoprolol Tartrate USP …...........200mg
Excipients………………………………….…………. q.s.
Colour: Iron oxide Black


THERAPEUTIC INDICATIONS:

Metoprolol Succinate ER is a beta-blocker that affects the heart and circulation (blood flow through arteries and veins). Metoprolol Succinate ER is used to treat angina (chest pain) and hypertension (high blood pressure). It is also used to lower your risk of death or needing to be hospitalized for heart failure.

CAUTION & WARNING:

CAUTION: SWALLOW WHOLE DO NOT CHEW OR CRUSH.
Take whole tablet with water.
Read enclosed leaflet before use.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
KEEP MEDICINE OUT OF REACH OF CHILDREN.

STORAGE & DOSAGE:

Storage: Store at 20° to 25°C (68° to 77°F).
Protect from light & moisture.
Keep in a cool & dry place.
Dosage: As directed by the Physician
Attach dispensing label here.