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INTRODUCTION
AZOBRIL FORTE CREAM contains Azelaic acid which belongs to the group of medicines called Dicarboxylic acids. It is used to treat common acne (acne vulgaris). It is also used for the treatment of mild to moderate papulopustular rosacea.
Acne is a skin condition that occurs when the hair follicles become plugged with oil and dead skin cells. It causes whiteheads, blackheads or pimples. Rosacea is a skin condition that causes blushing or redness, pus-filled bumps and small visible blood vessels in the face.
AZOBRIL FORTE CREAM should be applied with caution in patients with lung problems such as asthma. Consult your doctor before applying it.
Inform your doctor if you are pregnant or breastfeeding before applying this medicine. Your doctor will decide whether you can use this medicine.
AZOBRIL FORTE CREAM is generally not recommended for use in children under 12 years of age for the treatment of acne and also not recommended for use in children under 18 years of age for the treatment of rosacea. Consult your doctor before applying it.
The most common side effects of applying AZOBRIL FORTE CREAM are burning, itching or redness of the skin (erythema) at the application site, scaling, pain, dryness, skin discolouration or irritation at the application site. Contact your doctor if any of the symptoms worsen.
USES OF AZOBRIL FORTE CREAM
- Common acne (acne vulgaris)
- Mild to moderate papulopustular rosacea
HOW AZOBRIL FORTE CREAM WORKS
AZOBRIL FORTE CREAM attacks the bacteria called propionibacterium acnes, which plays an essential part in causing acne. It also reduces growth of the harder outermost skin cells (keratin surface cells) that block the pores of the skin to cause blackheads and whiteheads.
DIRECTIONS FOR USE
Apply AZOBRIL FORTE CREAM as directed by your physician. It is for external use only. Wash your hands with soap and water before and after using AZOBRIL FORTE CREAM. Apply a thin layer of this medicine on the affected area and rub it gently into the skin.
Avoid applying this medicine around your eyes, mouth and other mucous membranes or open wounds. If it does, wash the eyes, mouth or other mucous membranes immediately with large amounts of cool water.
SIDE EFFECTS OF AZOBRIL FORTE CREAM
COMMON
- burning, itching or redness of the skin (erythema) at the application site
- scaling, pain, dryness, skin discolouration or irritation at the application site
UNCOMMON
- greasy skin
- acne or loss of skin colour
- tingling
- dermatitis
- discomfort or swelling at the application site
RARE
- cracking of the lips, small blisters
- eczema, ulceration
- warmth at the site of application
- allergic reaction such as urticaria or hives, rash at the site of application
- worsening of asthma
Stop applying AZOBRIL FORTE CREAM and contact your doctor immediately if you experience any of the following side effects:
- allergic reaction such as rash, angioedema (swelling under the skin), swelling of face, eyes and dyspnoea (shortness of breath)
HOW TO MANAGE SIDE EFFECTS
Skin rash:
Avoid hot bath because hot water can irritate your skin further. Do not scratch the affected area. Use sunscreen and wear protective clothing while going outside. Use unscented moisturizers to soothe and hydrate the affected area. Contact your doctor if the rashes worsen.
WARNING & PRECAUTIONS
PREGNANCY
Inform your doctor if you are pregnant or are planning to have a baby before applying this medicine. Your doctor will decide whether you can use AZOBRIL FORTE CREAM.
BREASTFEEDING
AZOBRIL FORTE CREAM should be used with caution in breastfeeding women. Consult your doctor before applying it. Infants must not come into contact with treated skin or breasts.
DRIVING AND USING MACHINES
AZOBRIL FORTE CREAM has no influence on the ability to drive and use machines.
ALLERGY
Do not apply AZOBRIL FORTE CREAM if you are allergic to Azelaic acid or any of the other ingredients of this medicine.
LUNGS
AZOBRIL FORTE CREAM should be applied with caution in patients with lung problems such as asthma. Consult your doctor before applying it.
OTHERS
Use in pediatrics:
AZOBRIL FORTE CREAM is generally not recommended for use in children under 12 years of age for the treatment of acne. It is also not recommended for use in children under 18 years of age for the treatment of rosacea due to a lack of data on safety and efficacy. Consult your doctor before applying it.
Use in geriatrics:
There is limited information available on the use of AZOBRIL FORTE CREAM in elderly patients. Consult your doctor before applying it.
INTERACTIONS
A. Drug - Drug interactions:
Tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, vitamin supplement or herbal products.
Overdosage:
If you or anyone else accidentally used too much of AZOBRIL FORTE CREAM or if you or a child accidentally swallow the medicine, consult your doctor immediately or visit the nearby hospital.
SYNOPSIS
| Drug | : | Azelaic acid |
| Pharmacological Category | : | Dicarboxylic acids |
| Therapeutic Indication | : | Common acne, Papulopustular rosacea |
| Dosage Forms | : | Cream, Gel, Gel (Topical) |
MORE INFORMATION
- Keep AZOBRIL FORTE CREAM out of the sight and reach of children
- Store AZOBRIL FORTE CREAM below 30°C
FAQs ABOUT AZOBRIL FORTE CREAM
How long can I use AZOBRIL FORTE CREAM?
How long AZOBRIL FORTE CREAM has to be used varies from person to person. It depends upon how bad your acne is when you start treatment. In general, you may notice a distinct improvement after 4 weeks. In case of no improvement after 1 month or if the acne or rosacea becomes worse, you should discontinue AZOBRIL FORTE CREAM and consult your doctor.
How long does it take AZOBRIL FORTE CREAM to lighten skin?
AZOBRIL FORTE CREAM when applied twice daily for several (up to 8 months), skin lightening starts after 1 to 2 months of using it. But when AZOBRIL FORTE CREAM is used in combination with a medicine called tretinoin causes more skin lightening after 3 months than AZOBRIL FORTE CREAM alone. Consult your doctor for advice.
Can I use AZOBRIL FORTE CREAM for hair growth?
Yes. AZOBRIL FORTE CREAM may promote hair growth via induction of proteins in hair follicles, when used in combination with minoxidil. Contact your doctor before applying it.
Does AZOBRIL FORTE CREAM cause redness of skin?
Yes. AZOBRIL FORTE CREAM may cause burning, itching or redness of the skin (erythema) at the application site. Contact your doctor if any of the symptoms worsen.
Is AZOBRIL FORTE CREAM safe in pregnancy?
Inform your doctor if you are pregnant or are planning to have a baby before applying this medicine. Your doctor will decide whether you can use AZOBRIL FORTE CREAM.
Can I apply face creams while using AZOBRIL FORTE CREAM?
Yes, you may apply cosmetics after the AZOBRIL FORTE CREAM has dried. Do not wrap or bandage the skin unless your doctor has instructed to do so. Talk to your doctor for advice before using this medicine.
REFERENCES
1. Linda Skidmore-Roth. Azelaic acid. Mosby’s 2021 Nursing drug Reference. 34th edition. 2021. Page- 129.
2. Schulte BC, Wu W, Rosen T. Azelaic Acid: Evidence-based Update on Mechanism of Action and Clinical Application. National Institute of Health NLM, National Centre for Biotechnology Information. PubMed.gov. September 2015. [Accessed on May 2nd 2022] https://pubmed.ncbi.nlm.nih.gov/26355614/
3. Rivero AL, Whitfeld M. An update on the treatment of rosacea. National Institute of Health NLM, National Centre for Biotechnology Information. PubMed Central. 2018 February. [Accessed on May 2nd 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5828925/
4. LEO Pharma Manufacturing Italy S.r.l. Electronic Medicines Compendium (EMC). [Revised in February 2022] [Accessed on May 2nd 2022] https://www.medicines.org.uk/emc/files/pil.285.pdf
5. LEO Pharma Manufacturing Italy S.r.l. Electronic Medicines Compendium (EMC). [Revised in October 2020] [Accessed on May 2nd 2022] https://www.medicines.org.uk/emc/files/pil.240.pdf
6. Azelaic acid gel. DailyMed: National Library of Medicine: National Institute of Health. [Revised in November 2021] [Accessed on May 2nd 2022] https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=ed69bd06-9eae-4354-9250-dc92e16480ac
7. Aziderm cream (Azelaic acid). Micro labs Ltd. [Accessed on May 2nd 2022] https://www.microlabsltd.com/elibrary/node/1620
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