| Product Name: | Tetrabenazine Hydrochloride Tablets 12.5mg |
| Brand Name: | Generics |
| Strength: | (12.5mg), (25mg) |
| Dosage Form: | Tablets (Un-Coated) |
| Route of Administration: | Via oral Route |
| Packing: | 30s, 90s, 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: | Antipsychotic drug, Central Nervous System |
| Indication: | Tetrabenazine is used to treat chorea (sudden movements that you cannot control) caused by Huntington’s disease (an inherited disease that causes the progressive breakdown of nerve cells in the brain). Tetrabenazine is in a class of medications called vesicular monoamine transporter 2 (VMAT2) inhibitors. |
| Storage: | Controlled room temperature medications must be stored between 68°F and 77°F (20°C and 25°C), with some allowances for temporary excursions. Keep the container tightly closed in order to protect from moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Tetrabenazine Hydrochloride Tablet 12.5mg
- Tetrabenazine Hydrochloride Tablet 25mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Tetrabenazine Hydrochloride Tablet 12.5mg
Each Uncoated tablet contains:
Tetrabenazine Hydrochloride ……………12.5mg
Excipients……………………………q.s.
Colours: Yellow Iron Oxide
- Tetrabenazine Hydrochloride Tablet 25mg
Each Uncoated tablet contains:
Tetrabenazine Hydrochloride ……………25mg
Excipients……………………………q.s.
Colours: Iron oxide red
THERAPEUTIC INDICATIONS:
Tetrabenazine is used to treat chorea (sudden movements that you cannot control) caused by Huntington’s disease (an inherited disease that causes the progressive breakdown of nerve cells in the brain). Tetrabenazine is in a class of medications called vesicular monoamine transporter 2 (VMAT2) inhibitors.
CAUTION & WARNING:
CAUTION:
Read enclosed leaflet before use.
Do not accept if seal over bottle opening is missing or broken.
Keep medicine out of reach of children.
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: Controlled room temperature medications must be stored between 68°F and 77°F (20°C and 25°C), with some allowances for temporary excursions. Keep the container tightly closed in order to protect from moisture.
Dispense in tight, light-resistant and child-resistant container (USP).
Dosage: As directed by the Physician.
GENERIC NAME OF THE MEDICINAL PRODUCT:
A. Tetrabenazine Hydrochloride Tablet 12.5mg
B. Tetrabenazine Hydrochloride Tablet 25mg
B. Tetrabenazine Hydrochloride Tablet 25mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
a) Tetrabenazine Hydrochloride Tablet 12.5mg
Each Uncoated tablet contains:
Tetrabenazine Hydrochloride …………...12.5mg
Excipients……………………………q.s.
Colours: Yellow Iron Oxide
b) Tetrabenazine Hydrochloride Tablet 25mg
Each Uncoated tablet contains:
Tetrabenazine Hydrochloride …………...25mg
Excipients……………………………q.s.
Colours: Iron oxide red
Each Uncoated tablet contains:
Tetrabenazine Hydrochloride …………...12.5mg
Excipients……………………………q.s.
Colours: Yellow Iron Oxide
b) Tetrabenazine Hydrochloride Tablet 25mg
Each Uncoated tablet contains:
Tetrabenazine Hydrochloride …………...25mg
Excipients……………………………q.s.
Colours: Iron oxide red
THERAPEUTIC INDICATIONS:
Tetrabenazine is used to treat chorea (sudden movements that you cannot control) caused by Huntington's disease (an inherited disease that causes the progressive breakdown of nerve cells in the brain). Tetrabenazine is in a class of medications called vesicular monoamine transporter 2 (VMAT2) inhibitors.
CAUTION & WARNING:
CAUTION:
Read enclosed leaflet before use.
DO NOT ACCEPT IF SEAL OVER BOTTLE OPENING IS MISSING OR BROKEN.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
Read enclosed leaflet before use.
DO NOT ACCEPT IF SEAL OVER BOTTLE OPENING IS MISSING OR BROKEN.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
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: Controlled room temperature medications must be stored between 68°F and 77°F (20°C and 25°C), with some allowances for temporary excursions. Keep the container tightly closed in order to protect from moisture.
Dispense in tight, light resistant and child resistant container (USP).
Dosage: As directed by the Physician.
Dispense in tight, light resistant and child resistant container (USP).
Dosage: As directed by the Physician.
