Crisa10 gm

Crisa 10 gm is indicated for topical treatment of mild to moderate atopic dermatitis in pediatric patients 3 months of age and older.

Apply a thin layer of Crisa 10 gm twice daily to affected areas. Crisa 10 gm is for topical use only and not for ophthalmic, oral, or intravaginal use.

In vitro studies using human liver microsomes indicated that under the conditions of clinical use, Crisa 10 gm and metabolite 1 are not expected to inhibit cytochrome P450 (CYP) 1A2, 2B6, 2C8, 2C9, 2C19, 2D6, and 3A4. In vitro human liver microsomes studies for metabolite 2 showed that it did not inhibit activities of CYP2C19, 2D6, and 3A4.

Allergic reactions- Crisa 10 gm may cause allergic reactions at or near the application site. These can be serious and may include hives, itching, swelling, and redness. The most common side effect of Crisa 10 gm is application site pain, such as burning or stinging.

Hypersensitivity reactions, including contact urticaria have occurred in patients treated with Crisa 10 gm. If signs and symptoms of hypersensitivity occur, discontinue Crisa 10 gm immediately and initiate appropriate therapy.

Do not store above 30°C temperature. Keep away from light and out of the reach of children.

Topical anti-inflammatory preparations

The active ingredient, Crisa 10 gm, is a phosphodiesterase-4 (PDE-4) inhibitor, mainly acting on phosphodiesterase 4B (PDE4B), which causes inflammation. Chemically, Crisa 10 gm is a phenoxybenzoxaborole. It contains a boron atom that helps penetrate the skin and is essential for its binding activity. Inhibition of PDE4B appears to suppress the release of tumor necrosis factor alpha (TNFα), interleukin-12 (IL-12), IL-23 and other cytokines, proteins believed to be involved in the immune response and inflammation.

Pregnancy: There is no available data with Crisa 10 gm in pregnant women to inform the drug-associated risk for major birth defects and miscarriage. In animal reproduction studies, there were no adverse developmental effects observed with oral administration of Crisa 10 gm in pregnant rats and rabbits during organogenesis at doses up to 3 and 2 times, respectively, the maximum recommended human dose (MRHD).Lactation: There is no information available on the presence of Crisa 10 gm in human milk. Crisa 10 gm is systemically absorbed. The lack of clinical data during lactation precludes a clear determination of the risk of Crisa 10 gm to a breastfed infant.