Prescription Treatments for Rosacea

Clindamycin 1% Lotion, Clindagel Gel (cont'd.)

Before using topical Clindamycin:

Tell your doctor and pharmacist if you are allergic to clindamycin, or any other drugs.

Tell your doctor and pharmacist what prescription and nonprescription medications you are taking, including vitamins. Ask your doctor for advice on using other acne medications (e.g., benzoyl peroxide) and cosmetics. Some cosmetics make acne worse and interfere with the effectiveness of this medication.

Tell your doctor if you have or have ever had gastrointestinal, liver, or kidney disease.

Tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using clindamycin, call your doctor.

Do not use topical clindamycin for children less than 12 years old.

The most common side effects of topical clindamycin are listed below. Tell your doctor if any of these symptoms are severe or do not go away.

  • Burning of the skin
  • Itching of the skin
  • Dry skin
  • Redness or irritation of the skin
  • Oily skin
  • Peeling of the skin

If you experience any of the following symptoms while using topical clindamycin or after you have recently stopped using topical clindamycin, call your doctor immediately:

  • Diarrhea
  • Upset stomach
  • Vomiting
  • Gas
  • Severe skin rash

PLEXION Cleanser

Plexion Cleanser combines the proven antimicrobial action of sodium sulfacetamide and sulfur to control rosacea symptoms. Clinical studies have found PLEXION Cleanser to be highly effective in reducing inflammatory lesions and redness associated with rosacea. Although rare, local irritation has been reported with topical sodium sulfacetamide and sulfur therapy. PLEXION Cleanser is contraindicated for use by patients with hypersensitivity to sulfur and sulfonamides, and patients with kidney disease.

Each gram of Plexion™ (Sodium Sulfacetamide 10% and Sulfur 5%) Cleanser contains 100 mg. of Sodium Sulfacetamide and 50 mg. of Sulfur in a cleanser base containing Water, Sodium Methyl Oleyltaurate, Sodium Cocoyl Isethionate, Disodium Oleamido MEA Sulfosuccinate, Cetyl Alcohol NF, Glyceryl Stearate (and) PEG-100 Stearate, Stearyl Alcohol NF, PEG-55 Propylene Glycol Oleate, Magnesium Aluminum Silicate NF, Methylparaben NF, Disodium EDTA, Butylated Hydroxytoluene NF, Sodium Thiosulfate, Fragrance, Xanthan Gum NF, and Propylparaben NF.

Each gram of Plexion™ (Sodium Sulfacetamide 10% and Sulfur 5%) Lotion contains 100 mg. of Sodium Sulfacetamide and 50 mg. of Sulfur in a lotion containing Water, Propylene Glycol, Isopropyl Myristate, Light Mineral Oil, Polysorbate 60, Sorbitan Monostearate, Cetyl Alcohol, Hydrogenated Coco-Glycerides, Stearyl Alcohol, Fragrances, Benzyl Alcohol, Glyceryl Stearate (and) PEG-100 Stearate, Dimethicone, Zinc Ricinoleate, Xanthan Gum, Disodium EDTA, and Sodium Thiosulfate.

PLEXION Cleanser and Lotion are indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

PLEXION Cleanser and Lotion are contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. PLEXION Cleanser and Lotion are not to be used by patients with kidney disease.

FOR EXTERNAL USE ONLY. Keep away from eyes. Keep out of reach of children. Keep tube tightly closed.

If irritation develops, use of the product should be discontinued and appropriate therapy instituted. Patients should be carefully observed for possible local irritation or sensitization during long-term therapy. The object of this therapy is to achieve desquamation without irritation, but sodium sulfacetamide and sulfur can cause reddening and scaling of the epidermis. These side effects are not unusual in the treatment of acne vulgaris, but patients should be cautioned about the possibility.

Safety and effectiveness in children under the age of 12 have not been established.

Tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding.

Although rare, sodium sulfacetamide may cause local irritation.

Accutane

Accutane has been available through prescription as a treatment for severe acne since 1983. It is currently available in about 80 countries.

Accutane has now been linked with a long list of serious side effects which are frequent, varied and at times severe.

According to the manufacturer of Accutane, some patients, while taking the drug or soon after stopping, have become depressed or developed other serious mental problems. Signs of these problems include:

  • feelings of sadness, irritability
  • unusual tiredness
  • trouble concentrating and loss of appetit

Some patients taking Accutane have had thoughts about hurting themselves or putting an end to their own lives (suicidal thoughts). Some people tried to end their own lives and other people have ended their own lives.

Known side effects of Accutane:

  • dryness of the skin, lips, mouth and lining of the nose
  • facial or body rash
  • flaking of the skin
  • itching
  • peeling of the palms and soles
  • increased sensitivity to the sun
  • inflammation of the lips, mild nose bleed
  • bleeding and inflammation of the gums
  • aches and pains in the joints
  • increased fatigue
  • decreased night vision

People on Accutane are also warned:

  • to avoid excessive exposure to the sun
  • not to use vitamin preparations or health food supplements that contain vitamin A.
  • Patients are also advised to avoid waxing for 5-6 months after taking Accutane - because of the risk of scarring.

More than 1,300 psychiatric side effects and as many as 66 suicides have been reported since Accutane arrived on the market. The numbers prompted the Food and Drug Administration to take another look at Accutane.

The FDA has changed its rules regarding the drug so that doctors must now get patients to sign a consent form. The form is produced by Accutane's maker, Roche Pharmaceuticals. It says the patient understands all the risks associated with Accutane, including depression and suicide. Pharmacists must also hand out a detailed warning brochure from the FDA, called a Medguide. Accutane is one of just three drugs in the United States that has ever been required to come with a Medguide.

A brochure put out by Accutane's maker, designed for patients, still makes no mention of the reports of depression or suicide, although it cautions those who feel depressed or suicidal to contact their doctor.

PROTOPIC® (tacrolimus) Ointment

PROTOPIC Ointment, both 0.03% and 0.1% for adults, and only 0.03% for children aged 2 to 15 years, is indicated for short term and intermittent long term therapy in the treatment of patients with moderate to severe atopic dermatitis in whom the use of alternative, conventional therapies are deemed inadvisable because of potential risks, or in the treatment of patients who are not adequately responsive to or are intolerant of alternative, conventional therapies.

PROTOPIC Ointment is contraindicated in patients with a history of hypersensitivity to tacrolimus or any other component of the preparation.

Studies have not evaluated the safety and efficacy of PROTOPIC Ointment in the treatment of clinically infected atopic dermatitis. Before commencing treatment with PROTOPIC Ointment, clinical infections at treatment sites should be cleared.

While, patients with atopic dermatitis are predisposed to superficial skin infections including eczema herpeticum (Kaposi’s varicelliform eruption), treatment with PROTOPIC Ointment may be associated with an increased risk of varicella zoster virus infection (chicken pox or shingles), herpes simplex virus infection, or eczema herpeticum. In the presence of these infections, the balance of risks and benefits associated with PROTOPIC Ointment use should be evaluated.

The use of PROTOPIC Ointment may cause local symptoms such as skin burning (burning sensation, stinging, soreness) or pruritus. Localized symptoms are most common during the first few days of PROTOPIC Ointment application and typically improve as the lesions of atopic dermatitis heal. With PROTOPIC Ointment 0.1%, 90% of the skin burning events had a duration between 2 minutes and 3 hours (median 15 minutes). Ninety percent of the pruritus events had a duration between 3 minutes and 10 hours (median 20 minutes).

The use of PROTOPIC Ointment in patients with Netherton’s Syndrome is not recommended due to the potential for increased systemic absorption of tacrolimus. The safety of PROTOPIC Ointment has not been established in patients with generalized erythroderma.

Formal topical drug interaction studies with PROTOPIC Ointment have not been conducted. Based on its minimal extent of absorption, interactions of PROTOPIC Ointment with systemically administered drugs are unlikely to occur but cannot be ruled out. The concomitant administration of known CYP3A4 inhibitors in patients with widespread and/or erythrodermic disease should be done with caution. Some examples of such drugs are erythromycin, itraconazole, ketoconazole, fluconazole, calcium channel blockers and cimetidine.

PROTOPIC Ointment 0.03% may be used in pediatric patients 2 years of age and older.

Other adverse events which occurred at an incidence greater than or equal to 1% in any clinical study include: alopecia, ALT or AST increased, anaphylactoid reaction, angina pectoris, angioedema, anorexia, anxiety, arrhythmia, arthralgia, arthritis, bilirubinemia, breast pain, cellulitis, cerebrovascular accident, cheilitis, chills, constipation, creatinine increased, dehydration, depression, dizziness, dyspnea, ear pain, ecchymosis, edema, epistaxis, exacerbation of untreated area, eye disorder, eye pain, furunculosis, gastritis, hernia, hyperglycemia, hypertension, hypoglycemia, hypoxia, laryngitis, leukocytosis, leukopenia, liver function tests abnormal, lung disorder, malaise, migraine, neck pain, neuritis, palpitations, paresthesia, peripheral vascular disorder, photosensitivity reaction, procedural complication, routine procedure, skin discoloration, sweating, taste perversion, tooth disorder, unintended pregnancy, vaginal moniliasis, vasodilatation, and vertigo.

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