A) Pregabalin Capsules USP 25mg
B) Pregabalin Capsules USP 50mg
C) Pregabalin Capsules USP 75mg
D) Pregabalin Capsules USP 100mg
E) Pregabalin Capsules USP 150mg
F) Pregabalin Capsules USP 200mg
G) Pregabalin Capsules USP 300mg
GENERIC NAME OF THE MEDICINAL PRODUCT:
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A) Pregabalin Capsules USP 25mg
Each hard gelatin capsule contains:
Pregabalin USP………………….25mg
Excipients………………………….q.s.
Approved colours used in hard gelatin capsule shells.
B) Pregabalin Capsules USP 50mg
Each hard gelatin capsule contains:
Pregabalin USP………………….50mg
Excipients………………………….q.s.
Approved colours used in hard gelatin capsule shells.
C) Pregabalin Capsules USP 75mg
Each hard gelatin capsule contains:
Pregabalin USP………………….75mg
Excipients………………………….q.s.
Approved colours used in hard gelatin capsule shells.
D) Pregabalin Capsules USP 100mg
Each hard gelatin capsule contains:
Pregabalin USP………………….100mg
Excipients………………………….q.s.
Approved colours used in hard gelatin capsule shells.
E) Pregabalin Capsules USP 150mg
Each hard gelatin capsule contains:
Pregabalin USP………………….150mg
Excipients………………………….q.s.
Approved colours used in hard gelatin capsule shells.
F) Pregabalin Capsules USP 200mg
Each hard gelatin capsule contains:
Pregabalin USP………………….200mg
Excipients………………………….q.s.
Approved colours used in hard gelatin capsule shells.
G) Pregabalin Capsules USP 300mg
Each hard gelatin capsule contains:
Pregabalin USP………………….300mg
Excipients………………………….q.s.
Approved colours used in hard gelatin capsule shells.
Each hard gelatin capsule contains:
Pregabalin USP………………….25mg
Excipients………………………….q.s.
Approved colours used in hard gelatin capsule shells.
B) Pregabalin Capsules USP 50mg
Each hard gelatin capsule contains:
Pregabalin USP………………….50mg
Excipients………………………….q.s.
Approved colours used in hard gelatin capsule shells.
C) Pregabalin Capsules USP 75mg
Each hard gelatin capsule contains:
Pregabalin USP………………….75mg
Excipients………………………….q.s.
Approved colours used in hard gelatin capsule shells.
D) Pregabalin Capsules USP 100mg
Each hard gelatin capsule contains:
Pregabalin USP………………….100mg
Excipients………………………….q.s.
Approved colours used in hard gelatin capsule shells.
E) Pregabalin Capsules USP 150mg
Each hard gelatin capsule contains:
Pregabalin USP………………….150mg
Excipients………………………….q.s.
Approved colours used in hard gelatin capsule shells.
F) Pregabalin Capsules USP 200mg
Each hard gelatin capsule contains:
Pregabalin USP………………….200mg
Excipients………………………….q.s.
Approved colours used in hard gelatin capsule shells.
G) Pregabalin Capsules USP 300mg
Each hard gelatin capsule contains:
Pregabalin USP………………….300mg
Excipients………………………….q.s.
Approved colours used in hard gelatin capsule shells.
THERAPEUTIC INDICATIONS:
Pregabalin is an anticonvulsant, analgesic and anxiolytic medication used to treat epilepsy, neuropathic pain, fibromyalgia, restless leg syndrome, opioid withdrawal and generalized anxiety disorder. Its use in epilepsy is as an add-on therapy for partial seizures.
CAUTION & WARNING:
CAUTION:
Read enclosed leaflet before use.
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.
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: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Dosage: As directed by the Physician.
Attach dispensing label as per end country.
Dosage: As directed by the Physician.
Attach dispensing label as per end country.
Pregabalin Capsules USP 75mg Technical Specification
| Product Name: | Pregabalin Capsules USP |
| Brand Name: | Generic |
| Strength: | 25mg, 50mg, 75mg, 100mg, 150mg, 200mg, 300mg |
| Dosage Form: | Capsules (Hard Gelatin) |
| 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: | Anticonvulsant, Anti-Epileptic, Anti anxiety |
| Indication: | Pregabalin is used to treat epilepsy and anxiety. It’s also taken to treat nerve pain. Nerve pain can be caused by different conditions including diabetes and shingles, or an injury. |
| Storage: | Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Pregabalin Capsules USP 25mg
- Pregabalin Capsules USP 50mg
- Pregabalin Capsules USP 75mg
- Pregabalin Capsules USP 100mg
- Pregabalin Capsules USP 150mg
- Pregabalin Capsules USP 200mg
- Pregabalin Capsules USP 300mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Pregabalin Capsules USP 25mg
Each hard gelatin capsule contains:
Pregabalin USP………………….25mg
Excipients………………………….q.s.
Approved colours used in hard gelatin capsule shells. - Pregabalin Capsules USP 50mg
Each hard gelatin capsule contains:
Pregabalin USP………………….50mg
Excipients………………………….q.s.
Approved colours used in hard gelatin capsule shells. - Pregabalin Capsules USP 75mg
Each hard gelatin capsule contains:
Pregabalin USP………………….75mg
Excipients………………………….q.s.
Approved colours used in hard gelatin capsule shells. - Pregabalin Capsules USP 100mg
Each hard gelatin capsule contains:
Pregabalin USP………………….100mg
Excipients………………………….q.s.
Approved colours used in hard gelatin capsule shells. - Pregabalin Capsules USP 150mg
Each hard gelatin capsule contains:
Pregabalin USP………………….150mg
Excipients………………………….q.s.
Approved colours used in hard gelatin capsule shells. - Pregabalin Capsules USP 200mg
Each hard gelatin capsule contains:
Pregabalin USP………………….200mg
Excipients………………………….q.s.
Approved colours used in hard gelatin capsule shells. - Pregabalin Capsules USP 300mg
Each hard gelatin capsule contains:
Pregabalin USP………………….300mg
Excipients………………………….q.s.
Approved colours used in hard gelatin capsule shells.
THERAPEUTIC INDICATIONS:
Pregabalin is an anticonvulsant, analgesic and anxiolytic medication used to treat epilepsy, neuropathic pain, fibromyalgia, restless leg syndrome, opioid withdrawal and generalized anxiety disorder. Its use in epilepsy is as an add-on therapy for partial seizures.
CAUTION & WARNING:
CAUTION:
Read enclosed leaflet before use.
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: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Dosage: As directed by the Physician.
Attach dispensing label as per end country.
