Meptin 50 Mcg Tablet
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??H2O 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.
Indications / Uses :
Relief of dyspnea and other symptoms caused by respiratory obstructive disturbance in the following diseases: Bronchial asthma, chronic bronchitis and pulmonary emphysema. Meptin: Treatment of acute bronchitis. Meptin Swinghaler: For symptomatic relief of respiratory conditions only and therefore, the drug should be used only at the onset of asthmatic attacks.
May be taken with or without food.
History of hypersensitivity to any of the ingredients of Meptin/Meptin Swinghaler.
Special Precautions :
Patients with hyperthyroidism (the disease may be exacerbated), hypertension (blood pressure may further increase), heat disease (palpitation, arrhythmia, exacerbation of heart disease and other symptoms may occur), diabetes mellitus (the disease may be exacerbated). Patients who are pregnant or suspected of being pregnant which requires careful administration; an additional important precaution with regards to its use for the long-term management of bronchial asthma. It should be initiated when symptoms are not adequately controlled by inhaled corticosteroids or other asthma medications, the development of acute asthma episodes during its use.
Important: If the desired therapeutic effect of Meptin/Meptin Swinghaler cannot be achieved at the recommended dose, it should be discontinued.
Continuous administration of excessive amounts of the drug may cause cardiac arrhythmia and cardiac arrest. Special care should therefore be taken not to exceed the recommended dosage of Meptin and Meptin Swinghaler (at the time of asthma episodes).
Meptin: The mainstay of long-term management of bronchial asthma is inflammatory agents eg, inhaled corticosteroids. Meptin should therefore be used only as additional therapy for patients whose symptoms are not adequately controlled by inhaled corticosteroid or other asthma medications, or whose disease severity clearly warrants initiation of treatment with Meptin.
As Meptin is not a substitute for inhaled corticosteroids and other anti-inflammatory agents, the patients or their guardian or other legally authorized person should be instructed not to reduce the dosage of inhaled corticosteroids or to stop use of inhaled corticosteroids and switch to monotherapy with Meptin unless specifically instructed to do so by their physician, even if they have felt symptomatic improvement with the use of Meptin.
During the long-term management of bronchial asthma with Meptin, the patient may develop acute asthma episodes. The patient or their guardian or other legally authorized person should therefore be instructed to use adequate drugs other than Meptin eg, short-acting inhaled ?2-stimulants, if acute asthma episodes occur during treatment with Meptin. In addition, if the use of such drugs becomes more frequent or sufficient therapeutic effect is not observed with the initial dose of the drugs, the patient’s asthma my not be adequately controlled. The patient or the guardian or other legally authorized person should be instructed to consult a physician as soon as possible and receive adequate medication in such cases. In addition, as such conditions may be life-threatening, anti-inflammatory therapy should be consolidated by adequate measures eg, increasing the dosage of inhaled corticosteroids.
Meptin Swinghaler: Patients and parents should be cautioned about the possible risk of serious adverse reactions, including arrhythmia and cardiac arrest, that may result from excessive use of Meptin Swinghaler.
Patients should be properly instructed on the method of use of Meptin Swinghaler and adequately observed for any effects. If the desired therapeutic effect has not been achieved at the recommended dose, Meptin Swinghaler should be discontinued and replaced with other medication to prevent excessive use, since airway inflammation may possibly be exacerbated.
Patients and their families should be instructed to consult a physician for emergency treatment and re-assessment of therapy if the recommended dosing schedule is not effective in relieving severe episodes of asthma.
Effects on Laboratory Tests: Meptin/Meptin Swinghaler tends to inhibit skin reactions in allergen tests. Meptin/Meptin Swinghaler should be withdrawn 12 hrs prior to such tests.
Other Precautions: Similar to other ?2-adrenergic agonists, tissue damage in cardiac muscle was noted in oral toxicity studies at Meptin 30 and 10 mg/kg/day, or higher in the subacute and chronic toxicity studies, respectively, using rats. The damage was also observed in dog studies. However, the damage has been reported with other ?2-adrenergic agonists in both rats and dogs.
Dietary administration of procaterol hydrochloride for 104 weeks was reported to cause mesovarian leiomyoma in SD rats. The tumor, however, is rat-specific and tends to develop during long-term administration of ?2-adrenergic agonists.
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.)
Use in children: The safety of Meptin/Meptin Swinghaler in low birth weight infants and neonates has not been established.
Meptin Swinghaler: Pediatric patients should be properly instructed on the dose and administration and adequate observation should be performed during the course of treatment.
Use in the elderly: Dosage adjustment or other appropriate measures should be considered when prescribing Meptin/Meptin Swinghaler to elderly patients, because these patients may be physiologically more sensitive to the drug than younger patients.
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.