Human Health Division (HHD) Products

Product List by Generic Name
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Roflumilast INN 0.3%

Composition:
Lumilast Cream: Each gram cream contains Roflumilast INN 3 mg.

Indication:
Lumilast cream is indicated for topical treatment of plaque psoriasis, including intertriginous areas, in patients 12 years of age and older.

Dosage & Administration:
Lumilast cream should be applied on affected areas once daily and rubbed in completely. Hands should be washed after application, unless the cream is for treatment of the hands. Lumilast cream is for topical use only and not for ophthalmic, oral, or intravaginal use or as directed by the physician.

Rosuvatatin

Composition
Nestor™ 5 Tablet: Each film coated tablet contains Rosuvastatin Calcium BP equivalent to Rosuvastatin 5 mg.
Nestor™ 10 Tablet: Each film coated tablet contains Rosuvastatin Calcium BP equivalent to Rosuvastatin 10 mg.

Indication
Heterozygous Hypercholesterolemia (Familial and Nonfamilial) Homozygous Hypercholesterolemia (Familial) Mixed Dyslipidemia (Fredrickson Type lla and lib)

Dosage & Administration
For asian people, initial starting dose of Rosuvastatin is 5 mg once daily. The dose range of Rosuvastatin is 5-40 mg once daily. Heterozygous Hypercholesterolemia (Familial and Nonfamilial) and Mixed Dyslipidemia (Fredrickson Type lla and lib) The usual recommended starting dose of rosuvastatin is 10 mg once daily. Initiation of therapy with 5 mg  once daily may be considered for patients requiring less aggressive LDL-C reductions or who have predisposing factors for myopathy. For patients with marked hypercholesterolemia (LDLC > 190 mg/dL) and aggressive lipid targets, a 20-mg starting dose may be considered. The 40-mg dose of rosuvastatin should be reserved for those patients who have not achieved goal LDL-C at 20 mg. After initiation and/or upon titration of rosuvastatin, lipid levels should be analyzed within 2 to 4 weeks and dosage adjusted accordingly.

Homozygous Hypercholesterolemia (Familial):
The recommended starting dose of rosuvastatin is 20 mg once daily in patients with homozygous FH. The maximum recommended daily dose is 40 mg. Rosuvastatin should be used in these patients as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable. Patients with renal insufficiency: No modification of dosage is necessary for patients with mild to moderate renal insufficiency. For patients with severe renal impairment (CLcr <30 mL/min/1.73 m2) not on hemodialysis, dosing of rosuvastatin should be started at 5 mg once daily and should not be exceeded 10 mg once daily or as directed by the physician.