Sagalon® cream 5% Doxepin hydrochloride
HOW DRUG / PHARMACOLOGY
Doxepin has activity as an antihistamine (HI and H2 receptor) is a histamine receptor blocking agent that binds competitively inhibits histamine and histamine receptor biological activity, so efficacious as an anti-pruritic.
For short-term treatment (8 days) in patients suffering from moderate to severe pruritus with eczematous dermatitis such as atopic dermatitis and lichen simplex chronicus.
Patients who are sensitive to doxepin. Patients who received treatment with preparations containing alcohol, drugs that suppress the central nervous, cimetidine, drugs that are metabolized by cytochrome P450 PIID and monoamine oxidase (MAO) inhibior. Patients with narrow angle glaucoma, patients who have a tendency to urinary retention. Children under 12 years of age.
WARNING AND CAUTION
Only for external use, not used for the eyes, oral or intravaginal. Use as directed, no more than 8 days. Do not use on a wider area than that recommended. Use Sagalon® cream thinly and evenly on the treated area. Do not use pads because it can increase the absorption of doxepin. Consult your doctor if 8 days is not visible progress or getting worse. During the use of cream Sagalon® do not drink alcohol / preparation containing alcohol, not taking drugs other than those recommended by the physician. Do not drive the vehicle, running machines or other jobs that require high concentrations during treatment with Sagalon® cream. Drowsiness may occur, especially in patients with extensive treatment of more than 10% of the body surface. If too severe drowsiness, reduce dosage and discontinue use Sagalon® cream after a doctor. There may be dryness of the mouth. Eat candy, ice. Examine the dentist if dryness of the mouth continues for more than 2 weeks. Not recommended for pregnant and lactating women. Use caution in patients with urinary retention, liver failure, mania.
Side effects may occur when extensive treatment of more than 10% of the body surface.
Drowsiness, dry mouth or lips, thirst, dizziness, fatigue, emotional changes, burning or tense at points of use, skin irritation, stinging, itching stimulate the "rash".
There may be nausea, fever, anxiety, eczema and more severe pruritus, dryness of skin, paresthesias, edema, but very rarely.
With alcohol, cimetidine, drugs that suppress the central nervous drugs metabolized by the cytochrome P450 isoenzyme P450 IID6 as anti-arrhythmia drugs (encainide, flecainide, profafenone), anti-depressant drugs, carbamazepine, debrisoquine, dextromethorphan, phenothiazines , quinidine, drugs monoamine oxidase (MAO) inhibitors.
HOW TO USE
Applied thinly and evenly on the skin to be treated 4 times a day with a 3-4 hour time span. Treatment can be continued up to 8 days.
Children: not to be used on children under 12 years.
Do not use if you are pregnant or breast feeding.
HOW TO STORAGE
Store in a tightly closed container at a temperature below 27ºC.