GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Phenytoin Sodium Extended-Release Capsule USP 200mg
B) Phenytoin Sodium Extended-Release Capsule USP 300mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Phenytoin Sodium Extended-Release Capsule USP 200mg
Each hard gelatin capsule contains:
Phenytoin Sodium USP……………100mg
Excipients…………………………….….q.s.
Approved colours used in capsule shells.
B) Phenytoin Sodium Extended-Release Capsule USP 300mg
Each hard gelatin capsule contains:
Phenytoin Sodium USP……………300mg
Excipients…………………….………….q.s.
Approved colours used in capsule shells.

THERAPEUTIC INDICATIONS:

Phenytoin is used to control certain type of seizures, and to treat and prevent seizures that may begin during or after surgery to the brain or nervous system. Phenytoin is in a class of medications called anticonvulsants. It works by decreasing abnormal electrical activity in the brain.

CAUTION & SCHEDULE:

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].
Dispense in tight container.
Protect from light and moisture.
Dosage: As directed by the Physician.
Attach dispensing label as per end country.

Phenytoin Sodium Extended-Release Capsule USP 300mg Technical Specification:

Product Name:Phenytoin Sodium Extended-Release Capsule USP
Brand Name:Generics
Strength: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,Stability Studies, GMP,
Therapeutic use:Anticonvulsant, Antiepileptic, Anti-seizures
Indication: Phenytoin is used to control certain type of seizures, and to treat and prevent seizures that may begin during or after surgery to the brain or nervous system. Phenytoin is in a class of medications called anticonvulsants. It works by decreasing abnormal electrical activity in the brain.
Storage:Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Phenytoin Sodium Extended-Release Capsule USP 200mg
  • Phenytoin Sodium Extended-Release Capsule USP 300mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Phenytoin Sodium Extended-Release Capsule USP 200mg
    Each hard gelatin capsule contains:
    Phenytoin Sodium USP……………100mg
    Excipients…………………………….….q.s.
    Approved colours used in capsule shells.
  • Phenytoin Sodium Extended-Release Capsule USP 300mg
    Each hard gelatin capsule contains:
    Phenytoin Sodium USP……………300mg
    Excipients…………………….………….q.s.
    Approved colours used in capsule shells.

THERAPEUTIC INDICATIONS:

Phenytoin is used to control certain type of seizures, and to treat and prevent seizures that may begin during or after surgery to the brain or nervous system. Phenytoin is in a class of medications called anticonvulsants. It works by decreasing abnormal electrical activity in the brain.

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].
Dispense in tight container.
Protect from light and moisture.
Dosage:As directed by the Physician.