ORATANE TABLETS (ISOTRETIOIN) 20mg PACK OF 30 SOFT GELATIN CAPSULES
ORATANE TABLETS (Isotretinoin, soft gelatin capsule, 20mg by crystolite, Each Pack Contains 30 Capsules)
Oratane Soft Gelatin Capsules contain Isotretinoin, providing an effective solution for severe forms of acne
Dosage adjustments may be necessary since Oratane’s therapeutic response and adverse events vary between patients
A cumulative treatment dose of 120-150mg/kg has been shown to increase remission rates and prevent relapse.
Patients with renal impairment should start at lower doses, and Oratane is contraindicated during pregnancy and breastfeeding.
This article covers absorption, distribution, metabolism, elimination, teratogenicity, and more to ensure a thorough understanding of Oratane’s use and effects
ORATANE TABLETS : Your Guide to Acne Treatment with Isotretinoin
Composition:
-
ORATANE TABLETS 10mg Soft
Gelatin Capsules: Each capsule contains Isotretinoin -
ORATANE TABLETS 20mg Soft
Gelatin Capsules: Each capsule contains Isotretinoin
Therapeutic Indications:
Oratane is prescribed for severe acne, including nodular
conglobate acne and cases at risk of permanent scarring that haven't responded
to standard treatments
Dosage and Administration:
- Begin with 0.5mg/kg
daily - Doses typically range
from 0.51.0mg/kg per day - Higher doses (up to
2.0mg/kg) may be needed for severe or truncal acne - Take capsules with
food once or twice daily - A cumulative dose of
120150mg/kg over the treatment period is often effective - Duration varies by
daily dose and individual response but is typically 1624 weeks - Treatment may
continue at lower doses for longer duration in case of intolerance
Special Dosage Instructions:
- Patients with renal
impairment should start with a lower dose and increase gradually - Oratane is
contraindicated in pregnant or breastfeeding women - Pediatric patients
under 12 years old should not use Oratane
Undesirable Effects:
- Dryness of the skin,
lips, and mucous membranes - Skin disorders such
as exanthema, pruritis, and facial erythema - Musculoskeletal
issues like myalgia and arthralgia
Behavioral disorders
and central nervous system effects
- Enhanced skin
sensitivity to sunlight - Hair thinning and
reversible alopecia - Acne flare may occur
at the start but usually subsides within 710 days
Absorption, Distribution, Metabolism, and Elimination:
- Absorption of
Isotretinoin from the gastrointestinal tract varies - Taking Isotretinoin
with food doubles its bioavailability - Concentrations of
Isotretinoin in the epidermis are lower than in serum - Major metabolites
include 4oxoisotretinoin and tretinoin - Elimination halflife
for unaltered drug is about 19 hours
Termination of
Oratane therapy leads to endogenous retinoid concentrations within two weeks
Teratogeicity:
Isotretinoin has
shown teratogenic potential in animal studies
It has therapeutic
implications for women of childbearing age and is contraindicated in pregnant
individuals
Presentation:
Oratane Soft Gelatin Capsules are available in blister packs
of 30 capsules
This comprehensive guide provides crucial information about
Oratane Soft Gelatin Capsules and their use in treating severe acne with
Isotretinoin. Always consult with your healthcare provider for personalized
treatment recommendations
Usage and Benefits of ORATANE Tablets
- Effective Acne Treatment: ORATANE is highly effective for treating severe acne, including nodular and conglobate acne, reducing the appearance of acne lesions and preventing permanent scarring.
- Reduces Sebum Production: Isotretinoin works by decreasing sebum production, which is a primary cause of acne outbreaks.
- Long-Term Relief: After completing the treatment course, many patients experience long-term acne remission.
- Reduces Inflammation: The treatment also reduces inflammation and swelling, which contributes to clearer skin.
- Safe for Adults: ORATANE is suitable for adults with severe acne that has not responded to conventional treatments.
How to Use ORATANE Tablets
Follow these guidelines for proper usage of ORATANE:
- Take ORATANE tablets with food, as this increases bioavailability.
- The recommended starting dose is typically 0.5mg/kg per day, which can be adjusted depending on your response.
- For severe acne, higher doses of up to 2.0mg/kg per day may be required. Consult your healthcare provider for the exact dosage.
- Take the tablet(s) once or twice daily, as instructed by your doctor.
- Ensure that the total cumulative dose over the treatment period reaches 120–150mg/kg for optimal results.
Always follow the specific recommendations of your healthcare provider to ensure the best possible outcome.
1. What is ORATANE used for?
ORATANE (Isotretinoin) is primarily used for the treatment of severe acne, including nodular conglobate acne and cases at risk of permanent scarring that haven’t responded to standard treatments. It is an effective solution for persistent acne that doesn’t improve with other treatments.
2. How should I take ORATANE tablets?
ORATANE should be taken with food, once or twice daily. The typical dosage starts at 0.5mg/kg daily and can range from 0.5 to 1.0mg/kg per day depending on individual needs. Higher doses (up to 2.0mg/kg) may be required for severe acne. The treatment duration typically lasts between 16 to 24 weeks, with some cases continuing at lower doses for longer durations.
3. Are there any side effects of ORATANE?
Common side effects of ORATANE include dryness of the skin, lips, and mucous membranes, skin disorders like rashes, pruritis, and facial erythema. Other side effects include musculoskeletal issues, behavioral disorders, hair thinning, and enhanced skin sensitivity to sunlight. Acne may worsen temporarily at the beginning of treatment but typically resolves within 7–10 days.
4. Who should not use ORATANE?
ORATANE is contraindicated in pregnant women and breastfeeding mothers due to its teratogenic potential. It is also not recommended for pediatric patients under 12 years of age. Individuals with renal impairment should use ORATANE with caution and at a lower starting dose.
5. How does ORATANE work in the body?
ORATANE is absorbed in the gastrointestinal tract and is more bioavailable when taken with food. It is metabolized to form major metabolites like 4-oxo-isotretinoin and tretinoin. The drug works by reducing sebum production, which helps in controlling acne. The elimination half-life of unaltered isotretinoin is about 19 hours, and retinoid concentrations return to normal within two weeks after stopping therapy.