Cebeta

 6 mg+200 mg+50 mg Tablet
Amulet Pharmaceuticals Ltd.

Unit Price: ৳ 2.50 (30's pack: ৳ 75.00)

Indications

Approved Indications:

  • Dietary supplementation to prevent or treat vitamin deficiencies, especially antioxidants deficiency.
  • Adjunct therapy to support immune function and reduce oxidative stress.
  • Supportive care in conditions associated with increased oxidative damage, such as aging, chronic inflammatory diseases, and certain dermatologic conditions.

Clinically Accepted Off-Label Uses:

  • Supplementation to promote skin health and reduce signs of photoaging.
  • Potential use in the prevention of chronic diseases associated with oxidative stress (e.g., cardiovascular diseases).
  • Adjunct in eye health maintenance to reduce risk of age-related macular degeneration progression.
Dosage & Administration

Formulation and Route:

  • Oral tablets or capsules.

Adults:

  • Typical daily doses vary by formulation, commonly:
    • Betacarotene: 3 to 15 mg daily
    • Vitamin C: 60 to 1000 mg daily
    • Vitamin E: 15 to 400 IU daily

Pediatrics:

  • Dosage not routinely established; use under medical supervision if needed.

Elderly:

  • No specific dosage adjustment; consider nutritional status and comorbidities.

Special Populations:

  • Renal or hepatic impairment: No specific dose adjustments recommended, but use with caution in severe organ dysfunction.

Administration Notes:

  • Take with food to improve absorption, especially for fat-soluble vitamins like betacarotene and vitamin E.
  • Avoid high-dose vitamin supplements without medical advice due to potential toxicity.
Mechanism of Action (MOA)

Betacarotene is a provitamin A carotenoid that converts to retinol (active vitamin A) in the body, playing a crucial role in vision, immune function, and cellular growth. Vitamin C (ascorbic acid) is a water-soluble antioxidant that scavenges free radicals, regenerates other antioxidants, and supports collagen synthesis. Vitamin E (tocopherol) is a fat-soluble antioxidant protecting cell membranes from oxidative damage by neutralizing lipid peroxyl radicals. Together, this combination provides synergistic antioxidant effects that reduce oxidative stress, support immune defense, and promote tissue repair.

Pharmacokinetics
  • Absorption:
    • Betacarotene is absorbed in the intestine and converted to vitamin A. Absorption is enhanced by dietary fats.
    • Vitamin C is absorbed actively in the small intestine via sodium-dependent transporters.
    • Vitamin E is absorbed with dietary fats via micelle formation in the intestine.
  • Distribution:
    • Betacarotene and vitamin E are distributed to liver, adipose tissue, and plasma lipoproteins.
    • Vitamin C is widely distributed in aqueous compartments throughout the body.
  • Metabolism:
    • Betacarotene is enzymatically converted to retinol in the intestinal mucosa and liver.
    • Vitamin C undergoes limited metabolism and is mostly excreted unchanged.
    • Vitamin E is metabolized in the liver via cytochrome P450 enzymes.
  • Elimination:
    • Betacarotene metabolites and vitamin E are excreted mainly via bile and feces.
    • Vitamin C is excreted primarily by the kidneys in urine.
  • Half-Life:
    • Betacarotene: Approximately 12–33 days due to storage in tissues.
    • Vitamin C: Approximately 10–20 days depending on body stores.
    • Vitamin E: Approximately 48–72 hours depending on form and dose.
Pregnancy Category & Lactation
  • Pregnancy:
    • Vitamins at recommended dietary levels are generally considered safe.
    • High doses of vitamin A derivatives (from betacarotene) should be avoided due to teratogenic risk; betacarotene itself is considered safer than preformed vitamin A.
  • Lactation:
    • Generally safe at recommended doses. Vitamins are excreted into breast milk in small amounts beneficial to the infant.
Therapeutic Class
  • Nutritional supplement combining:
    • Provitamin A (Carotenoid)
    • Antioxidant vitamins (Vitamin C and Vitamin E)
Contraindications
  • Known hypersensitivity to any component of the formulation.
  • Patients with hypervitaminosis A or excessive vitamin A intake.
  • Avoid in smokers or those at risk for lung cancer with high-dose betacarotene supplementation.
Warnings & Precautions
  • High doses of betacarotene linked with increased lung cancer risk in smokers.
  • Excessive vitamin E supplementation may increase bleeding risk, especially with anticoagulants.
  • Vitamin C in high doses can cause gastrointestinal upset or kidney stones in predisposed individuals.
  • Monitor patients with renal impairment for vitamin C accumulation.
  • Use caution in patients on blood thinners or with bleeding disorders.
Side Effects

Common:

  • Mild gastrointestinal disturbances (nausea, abdominal discomfort).
  • Skin yellowing (carotenemia) with high betacarotene intake, reversible and harmless.

Less Common:

  • Headache.
  • Diarrhea or loose stools with high vitamin C doses.

Rare / Serious:

  • Allergic reactions (rash, itching).
  • Increased bleeding risk with high vitamin E doses.
  • Hypervitaminosis A symptoms (headache, dizziness) with excessive intake.
Drug Interactions
  • Vitamin E may potentiate anticoagulants (e.g., warfarin), increasing bleeding risk.
  • Vitamin C can increase iron absorption and may affect certain chemotherapeutic agents.
  • High doses of antioxidants may reduce the efficacy of some chemotherapy or radiotherapy treatments.
  • Avoid concurrent high-dose vitamin A supplements.
Recent Updates or Guidelines
  • Current guidelines recommend antioxidant supplementation at dietary levels for general health benefits.
  • High-dose betacarotene supplementation is discouraged in smokers due to cancer risk.
  • Emerging evidence supports the role of combined antioxidant therapy in skin health and age-related disease prevention, but high-dose supplementation remains controversial.
Storage Conditions
  • Store at 20°C to 25°C (68°F to 77°F).
  • Protect from moisture and light to prevent degradation.
  • Keep container tightly closed.
  • Keep out of reach of children.
Available Brand Names