Lulisafe
Lulisafe Uses, Dosage, Side Effects, Food Interaction and all others data.
Lulisafe is a topical antifungal agent. It is a broad-spectrum antifungal agent that belongs to the azole group. It acts against fungus by inhibiting the enzyme lanosterol demethylase and blocks ergosterol synthesis which is an important constituent of fungal cell membrane. Thus it exerts strong fungicidal activity both in-vitro and in-vivo against dermatophytes, Candida albicans, Malassezia spp, Trichophyton and Epidermophyton spp.
Lulisafe kills the organisms Trichophyton rubrum and Epidermophyton floccosum, most likely by altering their fungal cell membranes.
Trade Name | Lulisafe |
Generic | Luliconazole |
Luliconazole Other Names | Luliconazole |
Type | Cream |
Formula | C14H9Cl2N3S2 |
Weight | Average: 354.27 Monoisotopic: 352.961495 |
Protein binding | Plasma protein binding of luliconazole is >99%. |
Groups | Approved |
Therapeutic Class | Miscellaneous topical agents |
Manufacturer | Dal Pharma |
Available Country | India |
Last Updated: | September 19, 2023 at 7:00 am |
Uses
Lulisafe is used for the topical treatment of interdigital
- Tinea pedis (athelet's foot),
- Tinea cruris, and
- Tinea corporis.
Lulisafe is also used to associated treatment for these conditions: Tinea Corporis, Tinea Cruris, Tinea Pedis
How Lulisafe works
The exact mechanism of action for luliconazole's anti-fungal activity is still not known, but luliconazole is thought to inhibit the enzyme lanosterol demethylase. Lanosterol demethylase is needed for the synthesis of ergosterol, which is a major component of the fungus cell membranes.
Dosage
Lulisafe dosage
Adult:
- Interdigital tinea pedis: Lulisafe cream should be applied to the affected area and approximately 1 inch of the immediate surrounding area(s) once daily for two weeks.
- Tinea cruris and Tinea corporis: Lulisafe cream should be applied to the affected area and approximately 1 inch of the immediate surrounding area(s) once daily for one week.
Pediatric: Safety and effectiveness have not been established.
Side Effects
Contact dermatitis and cellulitis may occur. Application site reactions were observed in iess than 1% of subjects in clinical trial.
Toxicity
In clinical trials, no serious toxicity was reported, only local irritation (mild contact dermatitis and cellulitis) at the site of application was found.
Precaution
If there is any unusual allergic reaction with the use of Lulisafe, then treatment should be discontinued and appropriate therapy should be instituted. Lulisafe is recommended for topical use only. It is not intended for ophthalmic, oral or intravaginal use.
Food Interaction
No interactions found.Volume of Distribution
The volume of distribution was not quantified.
Elimination Route
Although luliconazole is administered topically, clinical studies have shown that after the first dose in patients with tina pedis, a maximum plasma concentration of 0.40 ± 0.76 ng/mL (mean ± SD) occurred in 16.9 ± 9.39 hours (mean ± SD).
Half Life
The half life of luliconazole has yet to be determined.
Clearance
The clearance of luliconazole has yet to be determined.
Elimination Route
The route of elimination of luliconazole has yet to be determined.
Pregnancy & Breastfeeding use
Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Lulisafe should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether luliconazole is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Lulisafe cream is applied to women who are breastfeeding.
Contraindication
None
Storage Condition
Do not store above 30°C. Keep away from light and out of the reach of children.
Innovators Monograph
You find simplified version here Lulisafe
Lulisafe contains Luliconazole see full prescribing information from innovator Lulisafe Monograph, Lulisafe MSDS, Lulisafe FDA label
FAQ
What is Lulisafe used for?
Lulisafe is indicated for the treatment of athlete's foot, jock itch, and ringworm caused by dermatophytes such as Trichophyton rubrum, Microsporum gypseum and Epidermophyton floccosum. Lulisafe cream is used to treat: Ringworm of the body ; Ringworm of the foot between the toes; and Ringworm of the groin.
How safe is Lulisafe?
Lulisafe when applied once daily to all 10 fungus-infected toenails for 29 days, is generally safe and well tolerated and results in significant accumulation of drug in the nail.
How does Lulisafe work?
Lulisafe works by slowing the growth of fungi that cause infection.
What are the common side effects of Lulisafe?
Common side effects may include mild skin irritation where the medicine was applied.
Is Lulisafe safe during pregnancy?
There are no adequate and well-controlled studies of Lulisafe in pregnant women. Lulisafe should be used during pregnancy only if the potential benefit justifies the potential risk to the unborn baby.
Is Lulisafe safe during breastfeeding?
Lulisafe has not been studied during breastfeeding; low risk to the nursing infant expected as this drug is poorly absorbed after topical use and is highly plasma protein bound. Application to the nipple area should be avoided.
Can I drink alcohol with Lulisafe?
You can drink alcohol while taking Lulisafe.
Can I drive after taking Lulisafe ?
Lulisafe may occasionally cause dizziness which may affect your ability to drive or operate machinery.
How long does Lulisafe take to work?
Lulisafe is usually applied once a day for 1 week. To treat athlete's foot, Lulisafe is usually applied once a day for 2 weeks.
Can I take Lulisafe for a long time?
You usually take Lulisafe for a short time to clear an infection. If you have a serious infection, you may need to take Lulisafe long term. It is safe to take for a long time if your doctor has advised you to.
Who should not take Lulisafe?
Tell your doctor about all your current medicines and any you start or stop using. Many drugs can interact, and some drugs should not be used together.
What happens if I overdose of Lulisafe?
Seek emergency medical attention. Overdose symptoms may include confusion or unusual thoughts or behavior.
What happens if I miss a dose?
Use the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not use two doses at one time.
What happen If I stop taking Lulisafe?
If you stop taking the drug suddenly or don't take it at all your infection may not get better or may get worse.
Can I take Lulisafe every other day?
You'll usually take Lulisafe once a day.
Can Lulisafe damage the liver?
The severity of liver injury from Lulisafe ranges from mild and transient enzyme elevations to clinically apparent hepatitis to acute liver failure and death.
Is Lulisafe bad for kidneys?
Increased side effects can include kidney damage. Your doctor will check your blood for signs of kidney damage while you're taking Lulisafe. If you show signs of kidney damage, your doctor may lower your doses of these drugs or stop them completely until your treatment with Lulisafe is done.
Can Lulisafe affect my fertility?
An experimental animal study did not find Lulisafe to affect fertility.