DIANA C

Description

DIANA C Capsule (Isotretinoin)

Overview: DIANA C Capsule contains Isotretinoin, a synthetic retinoid primarily used for severe forms of acne. It works by reducing the size and activity of oil-producing glands in the skin and by regulating cell growth and differentiation.

Indications: DIANA C Capsule is indicated for the treatment of:

• Severe, Recalcitrant Nodular Acne: This refers to severe forms of acne with large, painful cysts (nodules) that have not responded to other conventional treatments, including systemic antibiotics.

Dosage and Administration

Adults:

• Oral (PO) – Severe, Recalcitrant Nodular Acne:
  • The usual starting dose is 0.5-1 mg/kg/day, divided into two doses (BID), taken for 15-20 weeks.
  • If the acne is very severe, causes scarring, or is primarily on the trunk, the dose can be increased up to 2 mg/kg/day, as tolerated.

Children:

• Severe, Recalcitrant Nodular Acne:
  • Under 12 years: The safety and effectiveness of Isotretinoin have not been established.
  • Over 12 years: The dosage is the same as for adults: 0.5-1 mg/kg/day, divided into two doses (BID), for 15-20 weeks.
  • For very severe acne with scarring or primarily on the trunk, the dose can be increased up to 2 mg/kg/day, as tolerated.

Renal Dose (Kidney Impairment):

• Severe Renal Impairment: The initial dose should be reduced (e.g., to 10 mg daily), then gradually increased as necessary up to 1 mg/kg/day.

Administration Guidelines:

• DIANA C Capsule must be taken with food to ensure proper absorption.

Important Considerations

Contraindications:

• Pregnancy: Absolutely contraindicated due to a very high risk of severe birth defects.
• Lactation (Breastfeeding): Contraindicated.

Precautions: Use with extreme caution in patients with:

• Hypertriglyceridemia (High Triglycerides): Pre-existing high triglyceride levels or conditions that predispose to them (e.g., diabetes, obesity, high alcohol intake). Triglyceride levels must be monitored regularly.
• Diabetes Mellitus (DM): Monitor blood glucose levels in patients with known or suspected DM.
• Bone Health Issues: Patients with a genetic predisposition for age-related osteoporosis, a history of childhood osteoporosis, osteomalacia, or other bone metabolism disorders.
• Anorexia Nervosa.
• History of Psychiatric Disorder: Isotretinoin has been linked to mood changes, including depression and suicidal thoughts.
• Vision Impairment: May impair night vision.
• Skin Procedures: Avoid wax epilation and skin resurfacing procedures (e.g., dermabrasion, laser) for at least 6 months after stopping treatment due to increased skin fragility.
• Sun Exposure: Avoid prolonged exposure to UV light or sunlight.
• Discontinue if: Hearing impairment, severe abdominal pain, rectal bleeding, severe diarrhea, or adverse ocular (eye) effects occur.
• Blood Donation: Patients should not donate blood during therapy and for at least 1 month after discontinuing the drug, due to the risk to pregnant recipients.
• Lactation: It is unknown if Isotretinoin is distributed into breast milk. Due to the potential for serious adverse reactions in nursing infants, it should not be administered to breastfeeding women.

Drug Interactions:

• Vitamin A or Derivatives: Additive toxicity when taken concurrently.
• Microdosed Progesterone: Decreases the effectiveness of microdosed progesterone-only birth control pills; use two forms of contraception.
• Phenytoin: May increase the risk of bone loss.
• Systemic Corticosteroids: May increase the risk of osteoporosis.
• Carbamazepine: Reduces plasma levels of carbamazepine.
• Potentially Fatal Interaction:
  • Tetracyclines: Greatly increased risk of pseudotumor cerebri (a condition mimicking a brain tumor with increased pressure around the brain). Concurrent use is contraindicated.

Adverse Effects (Side Effects):

• Very Common (>10%):
  • Skin/Mucous Membranes: Cheilitis (inflammation/dryness of lips, 90%), xerosis (dry skin), xerostomia (dry mouth), dry nose, epistaxis (nosebleeds), pruritus (itching), conjunctivitis (inflammation of eye lining, 40%), irritation, thinning of hair (can be persistent), palmoplantar desquamation (peeling of palms/soles), skin fragility, skin infections (e.g., paronychial infections), rash (erythema, seborrhea, eczema), photosensitivity.
  • Laboratory/Metabolic: Hypertriglyceridemia (high triglycerides, 25%), decreased HDLs (15%), increased LFTs (liver function tests, 15%), increased CPK (creatine phosphokinase, 12-24%), decreased hemoglobin/hematocrit, decreased erythrocyte/leukocyte counts, increased platelet count.
  • Musculoskeletal: Bone or joint pain, generalized muscle aches, arthralgia (joint pain).
• Common (1-10%):
  • Decreased bone mineral density (8.8%), premature epiphyseal closure (3%, affecting bone growth in children/adolescents).
• Frequency Not Defined (may occur):
  • Lethargy, fatigue, headache, anorexia (loss of appetite), nausea, vomiting, increased appetite, thirst.
• Potentially Fatal:
  • Anaphylaxis (severe allergic reaction).
  • Hemorrhagic pancreatitis (inflammation of the pancreas with bleeding).

Mechanism of Action: Isotretinoin is a synthetic retinoid. Its primary actions include significantly reducing the size of sebaceous glands and decreasing sebum (oil) production. It also plays a role in regulating cell proliferation and differentiation, which helps normalize skin cell turnover in acne.

Note: DIANA C 20mg Capsule is manufactured by Micro Labs Ltd. Its generic name is Isotretinoin. DIANA C is available in Nepal. This information is a general drug summary and is not intended for diagnosis, medical advice, or treatment. It is not a substitute for the exercise of professional judgment. Always consult a healthcare professional for specific medical advice.