GENERIC NAME OF THE MEDICINAL PRODUCT:

Suvorexant Tablet 5mg
Suvorexant Tablet 10mg
Suvorexant Tablet 15mg
Suvorexant Tablet 20mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) Suvorexant Tablet 5mg
Each Film coated tablet contains:
Suvorexant …………….5mg
Excipients……………….… q.s.
Colour: Red Oxide iron

b) Suvorexant Tablet 10mg
Each Film coated tablet contains:
Suvorexant …………….10mg
Excipients………………….… q.s.
Colour: Quinoline Yellow

c) Suvorexant Tablet 15mg
Each Film coated tablet contains:
Suvorexant …………….15mg
Excipients………………….… q.s.
Colour: Indigo Carmine

d) Suvorexant Tablet 20mg
Each Film coated tablet contains:
Suvorexant …………….20mg
Excipients………………….… q.s.
Colour: Iron Oxide Yellow

THERAPEUTIC INDICATIONS:

Suvorexant is used treat insomnia (difficulty falling asleep or staying asleep). Suvorexant is in a class of medications called orexin receptor antagonists. It works by blocking the action of a certain natural substance in the brain that causes wakefulness.

CAUTION & WARNING:

CAUTION:
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
SCHEDULE “H” Prescription Drug -Warning: Not to be sold by retail without the prescription of a Registered Medical Prescriber.

STORAGE & DOSAGE:

Storage: Protect form moisture at a temperature not exceeding 30˚C.Do not freeze. Keep the container tightly closed in order to protect from moisture.
Dosage: As directed by the physician.

Suvorexant Tablet 15mg Technical Specification:

Product Name:                            Suvorexant Tablet
Brand Name: Generics
Strength: (5mg), (10mg), (15mg), (20mg)
Dosage Form: Tablet (Film-coated)
Route of Administration: Via oral Route
Packing: 30s, 90s, 100s, 500s
Pack Insert/Leaflet: PIL (Patient Information Leaflet)
Regulatory Documents: COA, MOA, Stability Studies, GMP
Therapeutic use: CNS Depressant, benzodiazepines
Indication: Suvorexant is used treat insomnia (difficulty falling asleep or staying asleep). Suvorexant is in a class of medications called orexin receptor antagonists. It works by blocking the action of a certain natural substance in the brain that causes wakefulness.
Storage: Protect form moisture at a temperature not exceeding 30˚C.Do not freeze. Keep the container tightly closed in order to protect from moisture.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Suvorexant Tablet 5mg
  • Suvorexant Tablet 10mg
  • Suvorexant Tablet 15mg
  • Suvorexant Tablet 20mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • a) Suvorexant Tablet 5mg
    Each Film coated tablet contains:
    Suvorexant …………….5mg
    Excipients……………….… q.s.
    Colour: Red Oxide iron
  • b) Suvorexant Tablet 10mg
    Each Film coated tablet contains:
    Suvorexant …………….10mg
    Excipients………………….… q.s.
    Colour: Quinoline Yellow
  • c) Suvorexant Tablet 15mg
    Each Film coated tablet contains:
    Suvorexant …………….15mg
    Excipients………………….… q.s.
    Colour: Indigo Carmine
  • d) Suvorexant Tablet 20mg
    Each Film coated tablet contains:
    Suvorexant …………….20mg
    Excipients………………….… q.s.
    Colour: Iron Oxide Yellow

THERAPEUTIC INDICATIONS:

  • Suvorexant is used treat insomnia (difficulty falling asleep or staying asleep). Suvorexant is in a class of medications called orexin receptor antagonists. It works by blocking the action of a certain natural substance in the brain that causes wakefulness.

CAUTION & WARNING:

  • CAUTION:
    Keep medicine out of reach of CHILDREN.
    SWALLOW WHOLE DO NOT CHEW OR CRUSH
  • SCHEDULE “H” Prescription Drug -Warning: Not to be sold by retail without the prescription of a Registered Medical Prescriber.

STORAGE & DOSAGE:

  • Storage: Protect form moisture at a temperature not exceeding 30˚C.Do not freeze. Keep the container tightly closed in order to protect from moisture.
  • Dosage:  As directed by the physician.