Leo Pharma Inc.

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Leo Pharma Inc. Drugs

Enstilar

Enstilar

Instruct patients to shake can prior to using Enstilar® Foam and to wash their hands after applying the product.

Apply Enstilar® Foam to affected areas once daily for up to 4 weeks. Rub in Enstilar® Foam gently. Discontinue use when control is achieved.

Instruct patients not to use more than 60 g every 4 days.

Enstilar® Foam should not be used with occlusive dressings unless directed by a physician. Enstilar® Foam is not for oral, ophthalmic, or intravaginal use.

Avoid use on the face, groin, or axillae, or if skin atrophy is present at the treatment site.
Innohep

Innohep

All patients should be evaluated for bleeding disorders before administration of INNOHEP®. Since coagulation parameters are unsuitable for monitoring INNOHEP® activity, routine monitoring of coagulation parameters is not required (see PRECAUTIONS, Laboratory Tests).

Adult Dosage

The recommended dose of INNOHEP® for the treatment of DVT with or without PE is 175 anti-Xa IU/kg of body weight, administered SC once daily for at least 6 days and until the patient is adequately anticoagulated with warfarin (INR at least 2.0 for two consecutive days). Warfarin sodium therapy should be initiated when appropriate (usually within 1-3 days of INNOHEP® initiation). Pregnancy has little or no influence on the pharmacokinetics of INNOHEP® and no dosing adjustment is needed for pregnancy.

As INNOHEP® may theoretically affect the PT/INR, patients receiving both INNOHEP® and warfarin should have blood for PT/INR determination drawn just prior to the next scheduled dose of INNOHEP®.

Table 8 provides INNOHEP® doses for the treatment of DVT with or without PE. It is necessary to calculate the appropriate INNOHEP® dose for patient weights not displayed in Table 8.

An appropriately calibrated syringe should be used to assure withdrawal of the correct volume of drug from INNOHEP® vials.
Table 8 INNOHEP® Weight-based Dosing for Treatment of Deep Vein Thrombosis With or Without Symptomatic Pulmonary Embolism DVT Treatment Patient Body Weight in Pounds 175 IU/kg SC Once Daily 20,000 IU per mL Patient Body Weight inKilograms Dose (IU) Amount (mL) 68-80 6,000 0.3 31-36 81-94 7,000 0.35 37-42 95-107 8,000 0.4 43-48 108-118 9,000 0.45 49-53 119-131 10,000 0.5 54-59 132-144 11,000 0.55 60-65 145-155 12,000 0.6 66-70 156-168 13,000 0.65 71-76 169-182 14,000 0.7 77-82 183-195 15,000 0.75 83-88 196-206 16,000 0.8 89-93 207-219 17,000 0.85 94-99 220-232 18,000 0.9 100-105 233-243 19,000 0.95 106-110 244-256 20,000 1 111-116 257-270 21,000 1.05 117-122 271-283 22,000 1.1 123-128 284-294 23,000 1.15 129-133 295-307 24,000 1.2 134-139 308-320 25,000 1.25 140-145 321-331 26,000 1.3 146-150 332-344 27,000 1.35 151-156 345-358 28,000 1.4 157-162
To calculate the volume (mL) of an INNOHEP® 175 anti-Xa IU per kg SC dose for treatment of deep vein thrombosis:
Patient weight (kg) X 0.00875 mL/kg = volume to be administered (mL) subcutaneously
Administration

INNOHEP® is a clear, colorless to slightly yellow solution, and as with other parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.

INNOHEP® is administered by SC injection. It must not be administered by intramuscular or intravenous injection.

Subcutaneous Injection Technique: Patients should be lying down (supine) or sitting and INNOHEP® administered by deep SC injection. Administration should be alternated between the left and right anterolateral and left and right posterolateral abdominal wall. The injection site should be varied daily. The whole length of the needle should be introduced into a skin fold held between the thumb and forefinger; the skin fold should be held throughout the injection. To minimize bruising, do not rub the injection site after completion of the injection.
Dovonex

Dovonex

Comb the hair to remove scaly debris and after suitably parting, apply Dovonex® Scalp Solution, 0.005%, twice daily, only to the lesions, and rub in gently and completely, taking care to prevent the solution spreading onto the forehead. The safety and efficacy of Dovonex® Scalp Solution, 0.005%, have been demonstrated in patients treated for eight weeks.

Keep Dovonex® Scalp Solution, 0.005%, well away from the eyes. Avoid application of the solution to uninvolved scalp margins. Always wash hands thoroughly after use.
Metformin Hydrochloride...

Metformin Hydrochloride

For topical use only; Picato® gel is not for oral, ophthalmic, or intravaginal use.

Avoid transfer of Picato® gel to periocular area [see Warnings and Precautions (5.1)].

Avoid application near and around the mouth and lips.

For the treatment of actinic keratosis on the face or scalp Picato® gel, 0.015% should be applied to the affected area once daily for 3 consecutive days.

For the treatment of actinic keratosis on the trunk or extremities Picato® gel, 0.05% should be applied to the affected area once daily for 2 consecutive days.

Picato® gel may be applied to the affected area, up to one contiguous skin area of approximately 25 cm2 (e.g., 5 cm x 5 cm) using one unit dose tube. After spreading evenly over the treatment area, the gel should be allowed to dry for 15 minutes. Patients should wash their hands immediately after applying Picato® gel and take care not to transfer the applied drug to other areas, including the eye. Patients should avoid washing and touching the treated area for a period of 6 hours after application of Picato® gel. Following this time, patients may wash the area with a mild soap.
Dovonex

Dovonex

Apply a thin layer of Dovonex® Cream to the affected skin twice daily and rub in gently and completely. The safety and efficacy of Dovonex® Cream have been demonstrated in patients treated for eight weeks.
Taclonex

Taclonex

Apply an adequate layer of Taclonex® Ointment to the affected area(s) once daily for up to 4 weeks. Taclonex® Ointment should be rubbed in gently and completely. Patients should wash their hands after applying Taclonex®Ointment. Therapy should be discontinued when control is achieved.

Patients 18 years and older should not use more than 100 g per week and patients 12 to 17 years should not use more than 60 g per week. Treatment of more than 30% body surface area is not recommended.

Taclonex® Ointment should not be used with occlusive dressings unless directed by a physician. Avoid use on the face, groin, or axillae, or if skin atrophy is present at the treatment site. Taclonex® Ointment is not for oral, ophthalmic, or intravaginal use.
Taclonex

Taclonex

Instruct patients to shake bottle prior to using Taclonex® Topical Suspension and to wash their hands after applying the product.

Apply Taclonex® Topical Suspension to affected areas once daily for up to 8 weeks. Therapy should be discontinued when control is achieved.

Patients 18 years and older should not use more than 100 g per week and patients 12 to 17 years should not use more than 60 g per week.

Taclonex® Topical Suspension should not be used with occlusive dressings unless directed by a physician. Taclonex® Topical Suspension is not for oral, ophthalmic, or intravaginal use. Avoid use on the face, groin, or axillae, or if skin atrophy is present at the treatment site.

Leo Pharma Inc.

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Leo Pharma Inc. Drugs