Meptin 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 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 (at the time of asthma episodes).
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 β₂-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.
Effects on Laboratory Tests: Meptin tends to inhibit skin reactions in allergen tests. Meptin should be withdrawn 12 hrs prior to such tests.
Other Precautions: Similar to other β₂-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 β₂-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 β₂-adrenergic agonists.
Use in pregnancy & lactation: Meptin 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 during pregnancy has not been established.)
Nursing should be interrupted before starting treatment with Meptin. (Rat studies showed that procaterol hydrochloride is excreted in breast milk.)
Use in children: The safety of Meptin in low birth weight infants and neonates has not been established.
Use in the elderly: Dosage adjustment or other appropriate measures should be considered when prescribing Meptin to elderly patients, because these patients may be physiologically more sensitive to the drug than younger patients.