Amisol

Indication

Amisol Propionate Spray, 0.05% is a super-high potent topical corticosteroid formulation indicated for the treatment of moderate to severe plaque psoriasis affecting up to 20% body surface area (BSA) in patients 18 years of age or older. The total dosage should not exceed 50 g (59 mL or 2 fl. oz.) per week. Do not use more than 26 sprays per application or 52 sprays per day. Treatment should be limited to 4 consecutive weeks. Patients should be instructed to use Amisol Propionate Spray, 0.05% for the minimum amount of time necessary to achieve the desired results. Use in patients under 18 years of age is not recommended because safety has not been established and because numerically high rates of HPA axis suppression were seen with other Amisol propionate topical formulations.

Limitations of Use

Amisol Propionate Spray, 0.05% should not be used on the face, axillae, or groin. Amisol Propionate Spray, 0.05% should not be used if there is atrophy at the treatment site. Amisol Propionate Spray, 0.05% should not be used in the treatment of rosacea or perioral dermatitis.

Amisol topical is used to help relieve redness, itching, swelling, or other discomfort caused by skin conditions. The solution are used for scalp problems, the foam is used for mild to moderate plaque psoriasis, the cream, lotion, and spray are used for moderate to severe plaque psoriasis, and the foam and shampoo are used for moderate to severe scalp psoriasis. Amisol is a corticosteroid (cortisone-like medicine or steroid).

Amisol is available only with your doctor's prescription.

Apply a thin layer of Amisol (Amisol propionate gel) to the affected areas twice daily and rub in gently and completely.

Amisol (Amisol propionate gel) is a super-high potency topical corticosteroid; therefore, treatment should be limited to 2 consecutive weeks, and amounts greater than 50 g per week should not be used.

As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary.

Amisol (Amisol propionate gel) should not be used with occlusive dressings.

How supplied

Amisol® (Amisol Propionate Gel) 0.05% is supplied in 45-g (NDC 0145-2790-04) tubes.

Store between 15° and 30°C (59° and 86°F). Amisol (Amisol propionate gel) should not be refrigerated.

Stiefel Laboratories, Inc. Coral Gables, FL 33134. Rev. 0804

See also:
What is the most important information I should know about Amisol?

Use this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger amounts or for longer than recommended.

Topical steroid medicine can be absorbed through the skin, which may cause steroid side effects throughout the body.

Do not cover treated skin areas with a bandage or other covering unless your doctor has told you to. If you are treating the diaper area of a baby, do not use plastic pants or tight-fitting diapers. Covering the skin that is treated with Amisol topical can increase the amount of medicine your skin absorbs, which may lead to unwanted side effects. Follow your doctor's instructions.

Do not use this medication on a child without medical advice. Children are more likely to absorb large amounts of a topical steroid through the skin. Steroid absorption in children may cause unwanted side effects, or a delay in growth with long-term use. Talk with your doctor if you think your child is not growing at a normal rate while using this medication over a long treatment period.

Contact your doctor if your condition does not improve within 2 weeks of using this medicine, or if you develop signs of a bacterial, fungal, or viral skin infection.

Use Amisol foam as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Wash your hands before using Amisol foam. If your fingers are warm, rinse them in cold water and dry before you apply Amisol foam.
• Use the smallest amount of medicine necessary to cover the affected area.
• If you are using the emollient foam, shake well before each use.
• Turn the can upside down and squirt a small amount of foam (up to the size of a golf ball) into the cap of the can, onto a clean saucer, or onto another cool, clean surface. You may also squirt it directly onto the affected area. Do not squirt the medicine directly into the hand because it will start to melt immediately upon touching warm skin.
• If you are applying the regular foam to the scalp, move the hair away from the affected area and gently rub the medicine into the affected area until the foam disappears. Repeat until the entire affected area of the scalp is treated.
• If you are applying Amisol foam to other areas, gently rub the medicine into the skin until it disappears.
• Throw away any unused medicine that has been squirted out of the can.
• Wash your hands immediately after using Amisol foam, unless your hands are a part of the treated area.
• Do not use Amisol foam on your face, groin, or underarms unless your doctor tells you otherwise.
• Do not use Amisol foam over large areas of the body without first checking with your doctor.
• Do not bandage or wrap the affected area unless directed to do so by your doctor.
• If the can seems warm or the foam seems runny, rinse the can with cool water.
• If you miss a dose of Amisol foam, apply it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Amisol foam.

Amisol is used to treat itching, redness, dryness, swelling, and discomfort of various scalp and skin conditions, including immune-mediated skin disease with red scaly patches (psoriasis).

See also:
What other drugs will affect Amisol?

Due to the potential for additive effects, caution and careful titration are warranted in patients receiving diltiazem hydrochloride concomitantly with other agents known to affect cardiac contractility and/or conduction. Pharmacologic studies indicate that there may be additive effects in prolonging AV conduction when using beta-blockers or digitalis concomitantly with Tiazac. As with all drugs, care should be exercised when treating patients with multiple medications. Amisol is both a substrate and an inhibitor of the cytochrome P-450 3A4 enzyme system. Other drugs that are specific substrates, inhibitors, or inducers of the enzyme system may have a significant impact on the efficacy and side effect profile of diltiazem. Patients taking other drugs that are substrates of CYP450 3A4, especially patients with renal and/or hepatic impairment, may require dosage adjustment when starting or stopping concomitantly administered diltiazem in order to maintain optimum therapeutic blood levels

Beta Blocker

Controlled and uncontrolled domestic studies suggest that concomitant use of diltiazem hydrochloride and beta-blockers is usually well tolerated, but available data are not sufficient to predict the effects of concomitant treatment in patients with left ventricular dysfunction or cardiac conduction abnormalities. Administration of diltiazem hydrochloride concomitantly with propranolol in five normal volunteers resulted in increased propranolol levels in all subjects and bioavailability of propranolol was increased approximately 50%. In vitro, propranolol appears to be displaced from its binding sites by diltiazem. If combination therapy is initiated or withdrawn in conjunction with propranolol, an adjustment in the propranolol dose may be warranted.

Cimetidin

A study in six healthy volunteers has shown a significant increase in peak diltiazem plasma levels (58%) and AUC (53%) after a 1-week course of cimetidine 1200 mg/day and a single dose of diltiazem 60mg. Ranitidine produced smaller, nonsignificant increases. The effect may be mediated by cimetidines known inhibition of hepatic cytochrome P-450, the enzyme system responsible for the first-pass metabolism of diltiazem. Patients currently receiving diltiazem therapy should be carefully monitored for a change in pharmacological effect when initiating and discontinuing therapy with cimetidine. An adjustment in the diltiazem dose may be warranted

Digitali

Administration of diltiazem hydrochloride with digoxin in 24 healthy male subjects increased plasma digoxin concentrations approximately 20%. Another investigator found no increase in digoxin levels in 12 patients with coronary artery disease. Since there have been conflicting results regarding the effect of digoxin levels, it is recommended that digoxin levels be monitored when initiating, adjusting, and discontinuing diltiazem hydrochloride therapy to avoid possible over- or under-digitalization

Anesthetic

The depression of cardiac contractility, conductivity, and automaticity as well as the vascular dilation associated with anesthetics may be potentiated by calcium channel blockers. When used concomitantly, anesthetics and calcium channel blockers should be titrated carefully

Cyclosporin

A pharmacokinetic interaction between diltiazem and cyclosporine has been observed during studies involving renal and cardiac transplant patients. In renal and cardiac transplant recipients, a reduction of cyclosporine dose ranging from 15% to 48% was necessary to maintain cyclosporine trough concentrations similar to those seen prior to the addition of diltiazem. If these agents are to be administered concurrently, cyclosporine concentrations should be monitored, especially when diltiazem therapy is initiated, adjusted, or discontinued

The effect of cyclosporine on diltiazem plasma concentrations has not been evaluated

Carbamazepin

Concomitant administration of diltiazem with carbamazepine has been reported to result in elevated serum levels of carbamazepine (40% to 72% increase), resulting in toxicity in some cases. Patients receiving these drugs concurrently should be monitored for a potential drug interaction

Benzodiazepine

Studies showed that diltiazem increased the AUC of midazolam and triazolam by 3-4 fold and the Cmax by 2-fold, compared to placebo. The elimination half life of midazolam and triazolam also increased (1.5-2.5 fold) during coadministration with diltiazem. These pharmacokinetic effects seen during diltiazem coadministration can result in increased clinical effects (e.g., prolonged sodation)of both midazolam and triazolam

Lovastati

In a ten-subject study, coadministration of diltiazem (120 mg bid) with lovastatin resulted in a 3-4 times increase in mean lovastatin AUC and Cmax vs. lovastatin alone; no change in pravastatin AUC and Cmax was observed during diltiazem coadministration. Amisol plasma levels were not significantly affected by lovastatin or pravastatin

Rifampi

Coadministration of rifampin with diltiazem lowered the diltiazem plasma concentrations to undetectable levels. Coadministration of diltiazem with rifampin or any known CYP3A4 inducer should be avoided when possible, and alternative therapy considered.

See also:
What are the possible side effects of Amisol?

Applies to Amisol topical: topical application cream, topical application emollient cream, topical application foam, topical application gel/jelly, topical application lotion, topical application ointment, topical application shampoo, topical application solution, topical application spray

In addition to its needed effects, some unwanted effects may be caused by Amisol topical (the active ingredient contained in Amisol). In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when taking Amisol topical:

More common:

• Burning or stinging at the application site

• Burning sensation of the skin
• dry skin
• flushing or redness of the skin
• itching, scaling, severe redness, soreness, or swelling of the skin
• skin irritation
• skin rash, encrusted, scaly and oozing
• thinning of the skin with easy bruising, especially when used on the face or where the skin folds together (eg, between the fingers)

• Burning, itching, and pain in hairy areas, or pus at the root of the hair
• hair loss
• redness and scaling around the mouth
• thinning of the hair
• thinning, weakness, or wasting away of the skin

Minor Side Effects

Some of the side effects that can occur with Amisol topical may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common:

• Cough
• sore throat

• Body aches or pain
• changes in skin coloring
• congestion or cough
• dryness or soreness of the throat
• headache
• raised, dark red, wart-like spots on the skin, especially when used on the face
• skin discomfort
• stuffy or runny nose
• tender, swollen glands in the neck
• trouble swallowing
• unusual tiredness or weakness
• voice changes

• Acne or pimples
• burning and itching of the skin with pinhead-sized red blisters
• increased hair growth on the forehead, back, arms, and legs
• lightening of normal skin color
• lightening of treated areas of dark skin
• reddish purple lines on the arms, face, legs, trunk, or groin
• softening of the skin

Amisol is a post-ganglionic parasympathetic inhibitor. It decreases gastric acid and pepsin secretion and suppresses spontaneous contractions of the colon. Amisol diminishes gastric acid and pepsin secretion. Amisol also suppresses spontaneous contractions of the colon. Pharmacologically, it is a post-ganglionic parasympathetic inhibitor. It has not been shown to be effective in contributing to the healing of peptic ulcer, decreasing the rate of recurrence, or preventing complications.