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Intas Pharmaceuticals Ltd

Tretiva 5mg Capsule 10'S

Acne
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    Introduction About TRETIVA 5MG CAPSULE

    TRETIVA 5MG CAPSULE contains Isotretinoin, a retinoid medication specifically designed to manage severe acne in adults and children over 12 years of age. It is particularly effective for nodular acne, conglobate acne, and acne prone to permanent scarring when other anti-acne treatments have failed. Acne is a skin condition characterized by inflammatory spots, oily skin, and painful nodular lesions that commonly affect the face, chest, and back.

    Take TRETIVA 5MG CAPSULE exactly as prescribed by your doctor, following the recommended dose and duration. It is best taken with food, preferably at the same time each day, to reduce the chances of missing a dose. It may take a few weeks before you notice an improvement in your symptoms but continue taking the medication as directed to achieve optimal results. If your condition does not improve after several weeks, consult your doctor for further advice.

    This medication can make your skin more sensitive to sunlight, so limit sun exposure and use sunscreen when outdoors. It may also make your skin more fragile, so avoid waxing or laser treatments during therapy. Dryness of the lips, mouth, and eyes is another potential side effect—stay hydrated and use moisturizers or lubricating eye drops as needed

    Common side effects include dry skin, rashes, and elevated liver enzymes. While these are generally mild and tend to subside as your body adjusts to the medication, inform your doctor if they persist or cause discomfort.

    TRETIVA 5MG CAPSULE is known to cause birth defects, so it should not be used during pregnancy or if you are planning to conceive. Always discuss your treatment plan with your doctor to ensure safety and effectiveness.

    Uses Of TRETIVA 5MG CAPSULE

    • Severe acne in adults and children (older than 12 years of age)

    Benefits of TRETIVA 5MG CAPSULE for Acne:

    TRETIVA 5MG CAPSULE is highly effective in managing severe acne conditions such as nodular acne, conglobate acne, and acne prone to permanent scarring. It works by reducing the production of excess oil (sebum) in the skin, unclogging pores, and decreasing inflammation, which helps to clear up existing acne and prevent new breakouts. This leads to smoother, healthier skin and reduces the risk of long-term scarring. Additionally, it targets the underlying causes of severe acne, making it a reliable choice for those who have not responded to other treatments. Always consult your doctor to ensure it is suitable for your condition.

    How TRETIVA 5MG CAPSULE Works

    TRETIVA 5MG CAPSULE work by targeting the root causes of severe acne. They reduce the production of excess oil (sebum) in the skin, which helps prevent pores from becoming clogged. This, in turn, reduces the growth of acne-causing bacteria and inflammation. Isotretinoin also promotes the turnover of skin cells, preventing the formation of new acne lesions. Together, these actions help clear up existing acne and reduce the chances of scarring, making it an effective treatment for stubborn or severe acne conditions.

    How to use TRETIVA 5MG CAPSULE

    • Take TRETIVA 5MG CAPSULE exactly as prescribed by your doctor.
    • Swallow the capsule whole with a glass of water; do not crush or chew it.
    • It is recommended to take the capsule with food to improve absorption and reduce stomach discomfort.
    • Take it at the same time each day to maintain consistent levels of the medication in your body.
    • Follow the prescribed dosage and duration carefully. Do not stop the medication abruptly without consulting your doctor, even if your symptoms improve.
    • Regular follow-ups and blood tests may be required to monitor your progress and ensure safe usage.
    • Avoid alcohol, excessive sun exposure, and waxing or laser treatments during the treatment period. Use sunscreen and moisturizers as recommended by your doctor.

    What if I Forget to take TRETIVA 5MG CAPSULE:

    If you miss a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose—do not double the dose to make up for it.

    Overdosage of TRETIVA 5MG CAPSULE –

    In case you or anybody else accidently take too much of TRETIVA 5MG CAPSULE, consult your doctor immediately or visit the nearby hospital. Symptoms of TRETIVA 5MG CAPSULE overdose are severe headache, abdominal pain, nausea, dizziness, redness of face, vomiting, somnolence, irritability, and itching.

     

    Side Effects Of TRETIVA 5MG CAPSULE

    Like all medicines TRETIVA 5MG CAPSULE may cause certain side effects, although not everyone gets them

    Common Side Effects of TRETIVA 5MG CAPSULE:

    • dry skin
    • more fragile and red skin than usual, especially of the face
    • back, muscle or joint pain (particularly in children and teenagers)
    • raised liver enzymes
    • changed blood fat and cholesterol levels
    • easy bruising, bleeding or clotting
    • headache
    • protein or blood in the urine
    • becoming more prone to get infections
    • sore or inflamed throat and nose

    Stop taking TRETIVA 5MG CAPSULE and consult your doctor immediately in case you experience any of the following:

    • persistent pain in your lower back or buttocks (signs of sacroiliitis)
    • Severe skin reactions (Ex. erythema multiforme, Stevens-Johnson Syndrome, toxic epidermal necrolysis) (blistering and peeling of skin, severe rashes, fever, multiple lesions especially in mouth, nose, eyes and genitals, conjunctivitis, flu-like symptoms)
    • Feeling depressed with suicidal thoughts
    • serious reactions (trouble breathing or swallowing due to sudden swelling of the throat, face, lips and mouth, sudden swelling of the hands, feet and ankles, hives, bruises, eczema, bruising, red patches on hands and legs)
    • rhabdomyolysis (muscle weakness along with trouble moving arms or legs, painful, swollen, bruised areas of the body, dark urine, reduced or no urination, confusion or dehydration)
    • hepatitis (yellow skin or eyes, tiredness)
    • kidney inflammation (difficulty urinating, swollen and puffy eyelids, excessive tiredness)

    How To Manage Side Effects

    Dry Skin

    1. Hydrate Regularly: Drink plenty of water throughout the day to keep your skin hydrated from within. Aim for at least 8–10 glasses daily.
    2. Use a Gentle Cleanser: Opt for a mild, fragrance-free cleanser to avoid further irritation. Avoid harsh soaps or scrubs that can strip the skin of natural oils.
    3. Moisturize Frequently: Apply a rich, non-comedogenic moisturizer to your face and body at least twice a day, especially after washing. Look for products with hydrating ingredients like hyaluronic acid or ceramides.
    4. Protect Your Lips: Use a moisturizing lip balm, preferably one with SPF, to prevent and treat cracked lips caused by dryness. Reapply as needed throughout the day.
    5. Avoid Long, Hot Showers: Hot water can strip your skin of its natural moisture. Take shorter showers with lukewarm water to minimize dryness.
    6. Humidify Your Environment: Use a humidifier in your home to add moisture to the air, especially during winter or in dry climates.
    7. Apply Sunscreen: Use a broad-spectrum sunscreen with SPF 30 or higher daily to protect your sensitive skin from sun damage and prevent further dryness.
    8. Limit Exfoliation: Avoid physical or chemical exfoliants, as isotretinoin makes your skin more delicate and prone to irritation.
    9. Choose Gentle Fabrics: Wear soft, breathable fabrics like cotton to reduce friction and irritation on your dry skin.
    10. Seek Medical Advice: If dryness becomes severe or persistent despite home remedies, consult your doctor for additional treatment options or product recommendations.

    Warning & Precautions

    Pregnancy

    Contraindicated
    • Human and animal studies have shown that isotretinoin is teratogenic in nature. Birth defects such as abnormalities of the face, eyes, ears, skull, central nervous system, cardiovascular system, and thymus and parathyroid glands or IQ less than score of 85 have been reported in female patients who were pregnant or became pregnant while on therapy with isotretinoin. Therefore, TRETIVA 5MG CAPSULE is considered unsafe for use during pregnancy.
    • Women of childbearing potential must use a reliable contraceptive method to avoid becoming pregnant. If you accidentally became pregnant while taking this medicine, stop taking it and consult your gynaecologist for further evaluation.
    • It is also not recommended for you to get pregnant for one month after stopping isotretinoin tablets because some medicine may still be left in your body. Consult your doctor before taking it.

    Breastfeeding

    Contraindicated

    It is not known whether this medicine is excreted in human milk. Because of the potential for adverse effects, nursing mothers should not receive TRETIVA 5MG CAPSULE

    Driving and Using Machines

    Use with Caution

    Do not drive or operate machinery if you experience dizziness, drowsiness or decreased night vision after taking TRETIVA 5MG CAPSULE.

    Alcohol

    Consult your doctor

    Avoid consuming alcohol while taking TRETIVA 5MG CAPSULE as it may increase side effects. Inform your doctor if you have an habit of chronic alcoholism.

    Kidney

    Use with Caution

    TRETIVA 5MG CAPSULE should be used with caution in patients with kidney problems. Consult your doctor before taking it.

    Liver

    Contraindicated

    TRETIVA 5MG CAPSULE is not recommended for use in patients with liver disease. Consult your doctor before taking it.

    Allergy

    Contraindicated

    Do not take TRETIVA 5MG CAPSULE if you are allergic to Isotretinoin, soya, peanuts or any of the other ingredients of this medicine.

    Lungs

    Use with Caution

    TRETIVA 5MG CAPSULE should be used with caution in patients having asthma. Consult your doctor before taking it.

    Use In Pediatrics

    Consult your doctor

    The use of isotretinoin tablets in pediatric patients less than 12 years of age has not been studied. The use of isotretinoin for severe recalcitrant nodular acne in adolescents ages 12 to 17 years under careful medical supervision. Extreme caution should be taken if the child is suffering from metabolic or structural bone disease.

    Use In Geriatrics

    Consult your doctor

    There is no proper information about the use of TRETIVA 5MG CAPSULE in elderly patients. Consult your doctor before taking it.

    Others

    TRETIVA 5MG CAPSULE is not recommended for use if you have:

    • high blood fat levels
    • high levels of Vitamin A

    Before taking TRETIVA 5MG CAPSULE inform your doctor if you:

    • have or had mental illness or family history of mental illness such as depression, mood disorders, psychosis, aggressive behaviour, or hurting or killing self
    • have diabetes
    • are fructose intolerant
    • are overweight

    Safety Advice

    • Always take isotretinoin with a meal to improve its absorption.
    • Drink plenty of water to prevent dryness in your mouth and throat.
    • Isotretinoin is related to vitamin A, so extra supplementation can cause toxicity.
    • Avoid Excessive Sun Exposure: Wear sunscreen and protective clothing as isotretinoin can make your skin more sensitive to sunlight.
    • Moisturize Regularly: Use lip balms and non-comedogenic moisturizers to manage dryness of lips and skin.
    • Use Effective Birth Control: Isotretinoin can cause severe birth defects. Therefore, women must use reliable contraception as isotretinoin can cause severe birth defects.
    • Do Not Donate Blood: Avoid donating blood while on isotretinoin and for at least a month after stopping it, as it can harm pregnant recipients.
    • Follow Regular Check-Ups: Attend scheduled visits with your doctor for blood tests and monitoring.
    • Avoid Waxing or Laser Treatments: Your skin is fragile during treatment and prone to scarring.
    • Alcohol can increase the risk of liver problems, so limit or avoid it.
    • Notify your doctor about severe dryness, mood changes, or unusual symptoms.

    Interactions

    A. Drug-Drug interactions:

    Before taking TRETIVA 5MG CAPSULE, inform your doctor if you are taking any of the following medicines:

    • Vitamin A supplements
    • medicines used to manage bacterial infections (Ex. minocycline, doxycycline)
    • phenytoin (used to manage fits)
    • medicines used to manage various inflammatory conditions (Ex. betamethasone, prednisolone, dexamethasone)
    • medicines used to manage pregnancy (Ex. Norethindrone, ethinyl Oestradiol)
    • St. John’s wort (herbal medicine used to manage mental disorders)
    • other medicines used to manage acne like keratolytic or exfoliative agents (Ex. salicylic acid, benzoyl peroxide)

    Synopsis

    Drug :   Isotretinoin
    Pharmacological Category :  

    Retinoids 

    Therapeutic Indication :  

    Severe acne

    Dosage Forms :  

    Tablet, Soft gel Capsule, Capsule 

    FAQs About TRETIVA 5MG CAPSULE

    Q: What is TRETIVA 5MG CAPSULE used for?

    A: TRETIVA 5MG CAPSULE is used to manage severe acne (nodular or cystic acne) that does not respond to other treatments like antibiotics. It works by reducing oil production in the skin and preventing clogged pores.

    Q: How should I take TRETIVA 5MG CAPSULE?

    A: Take TRETIVA 5MG CAPSULE as prescribed by your doctor, usually once or twice daily with food. Swallow the capsule whole with water, and avoid breaking or crushing it. Follow your doctor’s instructions carefully for the best results.

    Q: What are the common side effects of TRETIVA 5MG CAPSULE?

    A: Common side effects include dry skin, chapped lips, dry eyes, nosebleeds, and mild stomach discomfort. If you experience severe reactions like mood changes, persistent headaches, or vision problems, consult your doctor immediately.

    Q: Can TRETIVA 5MG CAPSULE be taken during pregnancy?

    A: No, TRETIVA 5MG CAPSULE should not be taken during pregnancy as it can cause severe birth defects. Women of childbearing age must use effective contraception during and at least one month after treatment.

    Q: Is TRETIVA 5MG CAPSULE safe for long-term use?

    A: Isotretinoin is not usually prescribed for long-term use due to its potential side effects. Treatment duration is typically limited to 16–20 weeks. Always follow your doctor’s advice regarding treatment duration.

    Q: Can I use cosmetics while on TRETIVA 5MG CAPSULE?

    A: Yes, you can use non-comedogenic and fragrance-free cosmetics. Avoid abrasive cleansers, harsh exfoliants, or acne products containing benzoyl peroxide or salicylic acid, as these may irritate your skin.

    Q: Does TRETIVA 5MG CAPSULE cause hair loss?

    A: Temporary hair thinning or hair loss can occur in some individuals during treatment. This side effect typically resolves after completing the course. If hair loss persists, consult your doctor.

    Q: Can I drink alcohol while taking TRETIVA 5MG CAPSULE?

    A: It is advised to avoid alcohol while taking TRETIVA 5MG CAPSULE, as it can increase the risk of liver damage and worsen side effects like dizziness or drowsiness.

    Q: How long does it take for TRETIVA 5MG CAPSULE to work?

    A: You may start noticing improvements within 4–8 weeks, but the full effects are usually seen after completing the treatment course. Be patient and continue using the medicine as prescribed.

    Q: What precautions should I take while using TRETIVA 5MG CAPSULE?

    A: Avoid excessive sun exposure and use sunscreen. Do not donate blood during and for one month after treatment. Inform your doctor about any other medications or supplements you are taking. Use a reliable birth control to avoid becoming pregnant while taking TRETIVA 5MG CAPSULE. Do not undergo cosmetic procedures such as skin waxing, dermabrasion, laser, or artificial UV light detanning while taking TRETIVA 5MG CAPSULE without consulting your doctor.

    Q: Can TRETIVA 5MG CAPSULE be used by men?

    A: Yes, TRETIVA 5MG CAPSULE is safe for men to use for severe acne. However, male patients planning to father a child need not take special precautions, as isotretinoin does not affect sperm.

    Can TRETIVA 5MG CAPSULE cause irregular periods?

    According to some studies, menstrual irregularity was observed during management follow-ups. Consult your doctor if you experience irregularity in your periods during management with TRETIVA 5MG CAPSULE.

    Is TRETIVA 5MG CAPSULE safe to take in pregnancy?

    No. TRETIVA 5MG CAPSULE is not recommended for use in pregnant women and women planning a pregnancy. Inform your doctor if you become pregnant during management with TRETIVA 5MG CAPSULE. It is not recommended to get pregnant for one month after stopping TRETIVA 5MG CAPSULE management because some medicine may still be left in your body. Consult your doctor before taking it. Contraception must be used for a month before taking TRETIVA 5MG CAPSULE, during management and for a month afterwards. Discuss with your doctor regarding suitable contraceptive methods.

    Can I play sports during TRETIVA 5MG CAPSULE management?

    Cut down on extreme exercise and physical activity as TRETIVA 5MG CAPSULE can cause muscle and joint pain especially in children and teenagers taking up vigorous physical activity. Consult your doctor if you can play sports during this management.

    Can I go out in the sun during TRETIVA 5MG CAPSULE management?

    Sensitivity to light may increase during management with TRETIVA 5MG CAPSULE so, avoid going too much into the sun and don’t use a sun-lamp or sun-bed. Before you go out in the sun, wear sunglasses and use sunscreen with a high protection factor (SPF 15 or higher).

    Can undergo cosmetic procedures while taking TRETIVA 5MG CAPSULE?

    No. Do not undergo cosmetic procedures such as skin waxing, dermabrasion, laser, or artificial UV light detanning while taking TRETIVA 5MG CAPSULE or at least for 6 months after stopping it as they could cause scarring, skin irritation, or changes in your skin colour. Consult your doctor before undergoing any cosmetic procedure while taking TRETIVA 5MG CAPSULE.

    References

    1. KD Tripathi. Drugs Acting on Skin and Mucous Membranes. Essentials of Medical Pharmacology, 7th edition 2013. Page- 894.

    2. Layton A. The use of isotretinoin in acne. NIH National Library of Medicine, National center for biotechnology information. Pubmed.govMay-June 2009. [Accessed on 8th October 2022] click here

    3. Jellerichs, Bradley. Clinical Use of Isotretinoin. Journal of the Dermatology Nurses’ Association. 2018. [Accessed on 8th October 2022] click here

    4. Ennogen Healthcare Limited. Electronic Medicines Compendium (EMC). [Revised in March 2022]. [Accessed on 8th October 2022] click here

    5. Sun Pharmaceutical Industries. Isotretinoin. [Revised in April 2022]. [Accessed on 8th October 2022] click here

    Author Details

    Written By Srilekha. R - B.Pharm
    Reviewed For Accuracy By Dr. Janet. C - Pharm.D
    Last updated on 06 Dec 2024 | 06:05 PM(IST)
    Lab updated