Indications And Clinical Uses: The symptomatic relief of respiratory allergic conditions which include acute and chronic allergic rhinitis, pollenosis (hay fever), and vasomotor rhinitis.
Also indicated in the symptomatic relief of such allergic dermatological conditions as acute and chronic urticaria, angioneurotic edema, allergic eczema, contact dermatitis, insect bites, pruritus vulvae and ani, pruritus of nonspecific origin, drug and serum reactions, dermographism; for anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures.
Contra-Indications: Known hypersensitivity to azatadine or its components.
Antihistamines should not be used to treat lower respiratory tract symptoms.
Patients receiving MAO inhibitor therapy or within 10 days of stopping such treatment (see Precautions, Drug Interactions).
Antihistamines should be discontinued approximately 4 days prior to skin testing procedures since these may prevent or diminish otherwise positive reactions to dermal reactivity indicators.
Precautions: Azatadine should be used with caution in patients with narrow angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction, prostatic hypertrophy or bladder neck obstruction, cardiovascular disease, hyperthyroidism or those with increased intraocular pressure.
Because of the atropine-like action of antihistamines, this product should be used with caution in patients with a history of bronchial asthma.
Drug Interactions: MAO inhibitors prolong and intensify the effects of antihistamines. Concomitant use of antihistamines with alcohol, tricyclic antidepressants, barbiturates, or other CNS depressants may have an additive effect. The action of oral anticoagulants may be inhibited by antihistamines.
Occupational Hazards: Patients should be warned about engaging in activities requiring mental alertness, such as driving a car or operating appliances, or machinery.
Antihistamines are more likely to cause dizziness, sedation, hypotension in patients over 60 years of age.
Overdosage of antihistamines, particularly in infants and children may produce convulsions and death.
Pregnancy and Lactation: The safe use of this product during pregnancy and lactation has not been established and therefore the compound should be used only if the potential benefit justifies the potential risk to the fetus or infant.
Adverse Reactions: Adverse effects with antihistamines vary in incidence and severity. Among them are cardiovascular, hematologic (pancytopenia, thrombocytopenia, hemolytic anemia), neurologic (confusion, hallucinations, tremor), gastrointestinal, genitourinary (urinary retention), respiratory adverse reactions and mood changes. The most common include sedation, sleepiness, dizziness, disturbed coordination, epigastric distress, rash, dry mouth and thickening of bronchial secretions.
General side effects such as urticaria, drug rash, anaphylactic shock, photosensitivity, excessive perspiration, chills, dryness of mouth, nose and throat have been reported.
Symptoms And Treatment Of Overdose: Symptoms: Manifestations of overdosage may vary from CNS depression (sedation, apnea, diminished mental alertness, cyanosis, coma, cardiovascular collapse) to stimulation (insomnia, hallucinations, tremors, or convulsions) to death. Other signs and symptoms may be euphoria, excitement, tachycardia, palpitations, thirst, perspiration, nausea, dizziness, tinnitus, ataxia, blurred vision, and hypertension or hypotension. Stimulation is particularly likely in children as are atropine-like signs and symptoms (dry mouth; fixed, dilated pupils; flushing; hyperthermia; and gastrointestinal symptoms).
Treatment: Emergency treatment should be started immediately. The patient should be induced to vomit, even if emesis has occurred spontaneously. Pharmacologically induced vomiting by the administration of ipecac syrup is a preferred method. However, vomiting should not be induced in patients with impaired consciousness. Following emesis, any drug remaining in the stomach may be absorbed by activated charcoal administered as a slurry with water. If vomiting is unsuccessful or contraindicated, gastric lavage should be performed. Dialysis is of little value in antihistamine poisoning. After emergency treatment the patient should continue to be medically monitored.
Treatment of the signs and symptoms of overdosage is symptomatic and supportive. Stimulants (analeptic agents) should not be used. Vasopressors may be used to treat hypotension. Short-acting barbiturates, diazepam, or paraldehyde may be administered to control seizures. Hyperpyrexia, especially in children, may require treatment with tepid water sponge baths or a hypothermic blanket. Apnea is treated with ventilatory support.
Dosage: Adults: 1 mg in the morning and evening. In refractory or more severe cases, 2 mg twice daily may be used. Children 6 to 12 years of age: 0.5 to 1 mg twice daily.
Availability And Storage: Each white, compressed, scored tablet, impressed with the Schering trademark contains: azatadine maleate 1 mg. Nonmedicinal ingredients: cornstarch, lactose, magnesium stearate and povidone. Tartrazine-free. Bottles of 100. Store between 2 and 30°C.
OPTIMINE® Schering Azatadine Maleate Antihistamine
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