Sina Ampholeish / سینا آمفولیش

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SinaAmpholeish®

Topical Nanoliposomal Gel 0.4% Amphotericin B

 

This medication is prescribed for your current conditions so please do not recommend it to other people.

If you have any further questions, ask your doctor or pharmacist.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, tell your doctor.

Category:

Antileishmanial and antifungal agent

Indications:

Treatment of cutaneous leishmaniasis caused by different species of leishmania parasites

Treatment of recurrent and chronic topical fungal infections including dermatophytes

Pharmacology:

Amphotericin B is the most effective drug for the treatment of fungal and protozoan infections such as leishmaniasis.

Amphotericin B acts by binding to the sterol component of a cell membrane, forms pores or channels in sterol-containing membranes, which changes permeability of cell membrane and causes leakage of protons, monovalent cations and other cell constituents leading to cell death. The affinity of Amphotericin B for ergosterol (the primary sterol of fungal and leishmanial membrane) is almost 10-fold higher than cholesterol (the primary sterol of mammalian membrane). Therefore, in the therapeutic doses that Amphotericin B kills fungal and leishmanial microorganism has minimal effects on mammalian cells.

In cutaneous leishmaniasis the leishmania parasites lives and multiply within the phagolysosome of the infected macrophages in the dermal layer of skin. The formidable barrier nature of stratum corneum (SC) of skin does not allow the penetration of drugs like Amphotericin B (a big, amphipathic, water insoluble molecule) in conventional dosage form like ointment and cream. SinaAmpholeish is a very flexible nanoliposomal (100 nm diameter) formulation of Amphotericin B. After topical application some of the nanoliposomal vesicles pass through SC of intact skin and reach epidermis and dermis. In the dermis the infected macrophages phagocyte liposomes, and then encapsulated drug is released in the phagolysosome of the macrophage by acidic lysosomal enzymes where Leishmania parasite lives and multiply. Then Amphotericin B would be in contact of leishmania parasites and kill them very effectively.

Before Using This Medicine:

Tell your doctor or pharmacist if you have ever had any unusual or allergic reaction to amphotericin B.

Tell your health care professional if you are using any other topical prescription or nonprescription (over-the-counter [OTC]) medicine that is to be applied to the same area of the skin.

Proper Use of This Medicine:

Apply enough SinaAmpholeish to cover the affected areas, and rub in gently, twice a day.

Do not wash the affected areas up to 2 hours after the application of SinaAmpholeish.

Do not apply an occlusive dressing (airtight covering such as kitchen plastic wrap) over this medicine since it may cause irritation of the skin.

To help clear up your infection completely, it is very important that you keep using this medicine for the full time of treatment, even if your symptoms begin to clear up after a few days. If you stop using this medicine too soon, your symptoms may return.

Do not use this product in your eyes.

Precautions While Using This Medicine:

If your skin problem does not improve within 3 to 4 weeks, or if it becomes worse, check with your doctor.

Side Effects:

Mild skin reaction including erythema, edema with burning and pruritus may occur.

Drug Interactions:

SinaAmpholeish topical gel can be used as part of a topical or general combination therapy, but the form of topical medication should not be used concurrently.

Contraindications:

SinaAmpholeish topical gel shouldn’t be used in patients who have severe allergic reactions to amphotericin B as shown in previous applications or in cases where a person is allergic to a component of this medication.

Pregnancy & Lactation:

Certain adverse reactions have not been reported during pregnancy and lactation period.

Storage:

Keep out of the reach of children.

Store away from heat and direct light.

Keep the medicine from freezing.

Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.