Meptin

Meptin

procaterol

Manufacturer:

Otsuka
Full Prescribing Info
Contents
Procaterol HCl hemihydrate.
Action
Bronchodilator.
Pharmacology: Bronchodilator Action: Bronchodilator action of procaterol HCl was determined to be equipotent or more potent than that of isoproterenol and more potent than salbutamol and orciprenaline in terms of its inhibitory activity on an increase in pulmonary resistance in dogs, cats and guinea pigs.
Duration of Action: The duration of action of procaterol HCl was longer than that of isoproterenol, trimetoquinol, orciprenaline and salbutamol in dogs, cats and guinea pigs.
Selectivity for β2-Adrenergic Receptors: Procaterol HCl showed a greater selective action for β2-receptors in the respiratory system than on those in the cardiovascular system in comparison to isoproterenol, trimetoquinol, orciprenaline and salbutamol in dog, cat and guinea pig studies.
Antiallergic Action: Procaterol HCl exhibited a definite antiallergic action by inhibiting antibody-induced increases in airway resistance, the PCA reaction and histamine release from sensitized lung tissues in guinea pigs and rats, as well as allergen-induced skin reactions, and increases in asthmatic responses to antibody inhalation in bronchial asthma patients, as compared to isoproterenol, trimetoquinol, orciprenaline and salbutamol. Procaterol HCl also inhibited allergen-induced delayed-type and immediate-type bronchial responses.
Effect on Accelerated Airway Hypersensitivity: Procaterol HCl inhibited airway hypersensitivity accelerated by the inoculation of influenza virus C in dogs.
Inhibitory Effect on Exercise-Induced Asthma Episodes: The results of treadmill or ergometer exercise or methacoline loading tests suggest that procaterol HCl suppresses exercise-induced asthma attacks in patients with bronchial asthma.
Pharmacokinetics: Plasma Concentrations: When procaterol HCl was administered orally to 6 healthy male subjects at single doses of 50 and 100 mcg/subject, the following plasma concentration curves and pharmacokinetic parameters were obtained. (See table and figure.)


Click on icon to see table/diagram/image




Click on icon to see table/diagram/image


Urinary Excretion: When procaterol HCl was administered orally as single doses of 50 and 100 mcg/subject, 9.93% and 11.65% of the dose were excreted in the urine within 24 hrs post-dosing, respectively.
Indications/Uses
Remission of various symptoms caused by respiratory obstructive disturbance in the following diseases: Bronchial asthma, chronic bronchitis, pulmonary emphysema, acute bronchitis and asthma-like bronchitis.
Dosage/Direction for Use
Mini Tablet: Usual Dose: Adults: 2 tabs (equivalent to 50 mcg procaterol HCl) to be taken twice daily (in the morning and at bedtime). Children ≥6 years: 1 tab (25 mcg) twice daily (in the morning and at bedtime). The dose may be adjusted according to the patient's age and severity of symptoms.
Tablet: Usual Dose: Adults: 1 tab (equivalent to 50 mcg procaterol HCl) twice daily (in the morning and at bedtime). The dose may be adjusted according to the patient's age and severity of symptoms.
Syrup: Usual Dose: Adults: 10 mL (equivalent to 50 mcg procaterol HCl) twice daily (in the morning and at bedtime). Children ≥6 years: 5 mL (equivalent to 25 mcg of procaterol HCl) twice daily (in the morning and at bedtime) by the oral route.
Infants <6 years: 0.25 mL/kg/body weight (equivalent to 1.25 mcg/kg of procaterol HCl) twice daily (in the morning and at bedtime) or 3 times daily (in the morning, noon and at bedtime).
The dose may be adjusted according to the patient's age and severity of symptoms.
Special Precautions
Meptin tablets should be discontinued if the use as directed under Dosage & Administration gives no valuable therapeutic effect. The continuation of its excessive use may possibly cause arrhythmia and cardiac arrest. Care should, therefore, be taken not to overdose the drug.
Careful Administration: Patients with hyperthyroidism, hypertension, cardiac diseases and diabetes mellitus.
Use in pregnancy & lactation: Safety during pregnancy has not been established; therefore, Meptin tablets should be administered to patients who are or who may become pregnant only if the expected therapeutic benefit is thought to outweigh any possible risk.
Use In Pregnancy & Lactation
Safety during pregnancy has not been established; therefore, Meptin tablets should be administered to patients who are or who may become pregnant only if the expected therapeutic benefit is thought to outweigh any possible risk.
Adverse Reactions
Cardiovascular: Palpitation and occasional flush and sense of fever have been reported.
Neuropsychic: Tremor and occasional headache, dizziness, sleeplessness and ringing in the ear have been reported.
Gastrointestinal: Occasional nausea and discomfort have been reported.
Hypersensitivity: Occasional eruption has been reported.
Others: Occasional nasal congestion and thirst and rarely, general fatigue have been reported.
Drug Interactions
Meptin tablets should not be used concomitantly with catecholamines like epinephrine and isoproterenol since their combination may induce arrhythmia or cardiac arrest in the extreme case.
Effect on Clinical Laboratory Test: The use of Meptin tablets results in the inhibition of skin reactions to allergens. Hence, it is recommended that skin tests be performed >12 hrs after the withdrawal of the drug.
Storage
Mini Tablet/Tablet: Protect from moisture and light.
Syrup: Store at room temperature, away from light.
ATC Classification
R03CC08 - procaterol ; Belongs to the class of adrenergics for systemic use, selective beta-2-adrenoreceptor agonists. Used in the treatment of obstructive airway diseases.
Presentation/Packing
Tab 50 mcg x 100's. Mini tab 25 mcg x 100's. Syr 25 mcg/5 mL (clear, colorless liqd, orange-flavor) x 60 mL.
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