MEPTIN 50MCG TABLET (TABLET)

Description: Procaterol hydrochloride occurs as white to pale yellow-white crystals or crystalline powder. It is soluble in water, formic acid and methanol, slightly soluble in ethanol (95) and practically insoluble in diethyl ether. The pH of its aqueous solution (1-100) is 4-5. It gradually changes in color when exposed to light. Its aqueous solution (1-20) shows no optical rotation. Procaterol hydrochloride is 8-Hydroxy-5-[(1RS,2RS)-1-hydroxy-2-isopopylamino-butyl]-quinolin-2(1H)-one monohydrochloride hemihydrate. Its molecular formula is C16H22N2O3·HCl·½H2O and has a molecular weight of 335.83. Melting point: Approximately 195°C (decomposition). Meptin Swinghaler: Meptin Swinghaler is consisting of a white plastic container with a blue push-button and a counter filled with a white powder. Presentation / Packing: Meptin: Tab 25 mcg (white, round, compressed, 5 mm diameter, 2.2 mm thickness, with code of OG22 scored on one side and weight of approximately 57 mg) x 100's. 50 mcg (white, round, compressed, 6 mm diameter, 2.1 mm thickness, with code of OG21, scored on one side and weight of approximately 80 mg) x 100's. Syr 5 mcg/mL (slightly viscous, clear, colorless, orange odor and sweet taste) x 60 mL. Meptin Swinghaler: 10 mcg/puff (dry powd) x 200 puff x 1's. Storage: Store at temperatures not exceeding 30°C. After removal from the aluminum pillow package, keep it stored in the dedicated storage container. Dosage / Direction for Use: Meptin tab/syr Adult 50 mcg or 10 mL once at bedtime or bid. Childn ≥6 yr 25 mcg or 5 mL once at bedtime or bid; <6 yr (1.25 mcg/kg body wt) 0.25 mL/kg body wt bid or tid. Meptin Swinghaler Adult 20 mcg (2 puffs). Max: 8 puffs/day. Childn 10 mcg (1 puff). Max: 4 puffs/days. Overdosage: Meptin: Overdosage with Meptin has been associated with tachycardia, tachycardiac arrhythmia, hypotension, nervousness, tremor, hypokalemia and hyperglycemia. In the event of any overdosage-related abnormalities are observed, Meptin should be discontinued and, if required, gastric lavage should be performed to remove any unabsorbed drug. Emergency treatment and general maintenance therapy should also be provided, if needed. In the event of serious tachycardiac arrhythmia has developed, β-blockers eg, propanolol may be effective, but administration of these drugs to asthma patients should be performed with care because β-blockers may increase airway resistance in these patients. Meptin Swinghaler: Administration of this drug to patients in excess of the recommended dose can cause ventricular arrhythmias (ventricular tachycardia, ventricular fibrillation and other symptoms), cardiac arrest and other severe adverse reactions. Patients should be properly instructed on the dose and method of administration Meptin/Meptin Swinghaler. (See Dosage and Administration and Precautions). Administration: May be taken with or without food. Contraindications: History of hypersensitivity to any of the ingredients of Meptin/Meptin Swinghaler. Special Precautions: Hyperthyroidism, HTN, heart disease, DM (may be exacerbated). Cardiac arrhythmia & arrest in excessive dose. W/draw therapy 12 hr prior to skin allergen test. Low birth wt infants & neonates. Pregnancy & lactation. Childn. Elderly. Meptin Not a substitute for inhaled corticosteroid & other inflammatory agents. Prolonged treatment. Use In Pregnancy & Lactation: Meptin/Meptin Swinghaler should be administered to pregnant or possibly pregnant women only if the expected therapeutic benefit is thought to outweigh any possible risk. (The safety of Meptin/Meptin Swinghaler during pregnancy has not been established.) Nursing should be interrupted before starting treatment with Meptin/Meptin Swinghaler. (Rat studies showed that procaterol hydrochloride is excreted in breast milk.) Interactions: Potentiates adrenoceptor & stimulates action w/ catecholamines eg, epinephrine & isoproterenol. Decrease K level & aggravates CV effects w/ xanthine derivatives eg, theophylline, aminophylline, diprophylline; corticosteroids (eg, betamethasone, prednisolone & hydrocortisone Na succinate) & diuretics (eg, furosemide). Side Effects / Adverse Reactions: Palpitation, tachycardia; tremor, headache; nausea, vomiting & skin rash. Caution for Usage: Precautions for Handling: Meptin/Meptin Swinghaler is supplied in aluminum pillow package to protect it from moisture and the patient should be instructed not to open the aluminum pillow package until immediately before use. Storage and Care: Patients should keep Meptin/Meptin Swinghaler in the dedicated storage container and to cap the container immediately after use. Patients should wipe the mouthpiece (inhalation orifice) or wipe it with a wet cloth. Avoid Meptin/Meptin Swinghaler to be subject to strong impact and not to disassemble the housing. Instructions for Use/Handling: Meptin Swinghaler: To administer a dose, simple follow the instructions as follows. 1. Open the transparent cover by pushing down both sides of the inhaler. 2. Hold the inhaler at the button (keep the dose counter facing upwards) and shake the inhaler up and down vertically for 3-4 times. 3. Push the button of the inhaler towards the mouthpiece once. 4. Breathe out and hold breathing. 5. Place the mouthpiece gently between the teeth and close the lips. Inhale fast and deeply through the mouth as much as possible, then hold breathing for a few seconds as the medication is being inhaled. Exhale slowly. 6. Push the button once more to make the inhaler return to the unloaded condition. (Press once more to end the session and the dose will not be wasted.) 7. Close the cover after use. 8. If >1 dose has been prescribed, repeat steps 2-6. 9. Rinse mouth with water.