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Optimine (Azatadine Maleate)
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Pharmacology
Information not available
Information not available
Indications
Antihistamine
Antihistamine
Contraindications
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 10days of stopping such treatment (see Precautions, Drug Interactions).
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 10days of stopping such treatment (see Precautions, Drug Interactions).
Safety Information / Warning
Information not available
Information not available
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.
Antihistamines should be discontinued approximately 4days prior to skin testing procedures since these may prevent or diminish otherwise positive reactions to dermal reactivity indicators.
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.
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.
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.
Antihistamines should be discontinued approximately 4days prior to skin testing procedures since these may prevent or diminish otherwise positive reactions to dermal reactivity indicators.
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.
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.
Side Effects / Adverse Effects
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.
Antihistamines are more likely to cause dizziness, sedation, hypotension in patients over 60years of age.
Overdosage of antihistamines, particularly in infants and children may produce convulsions and death.
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.
Antihistamines are more likely to cause dizziness, sedation, hypotension in patients over 60years of age.
Overdosage of antihistamines, particularly in infants and children may produce convulsions and death.
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.
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.
Recommended Dosage
Adults: 1mg in the morning and evening. In refractory or more severe cases, 2mg twice daily may be used. Children 6to 12years of age: 0.5to 1mg twice daily.
Adults: 1mg in the morning and evening. In refractory or more severe cases, 2mg twice daily may be used. Children 6to 12years of age: 0.5to 1mg twice daily.
Supplied / Packaging
Each white, compressed, scored tablet, impressed with the Schering trademark contains: azatadine maleate 1mg. Nonmedicinal ingredients: cornstarch, lactose, magnesium stearate and povidone. Tartrazine-free. Bottles of100. Store between 2and30°C.
Each white, compressed, scored tablet, impressed with the Schering trademark contains: azatadine maleate 1mg. Nonmedicinal ingredients: cornstarch, lactose, magnesium stearate and povidone. Tartrazine-free. Bottles of100. Store between 2and30°C.
