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Meptin Syrup

15:04
Meptin® syrup
Procaterol Hydrochloride syrup preparation

COMPOSITION AND DESCRIPTION
1.Composition
Each mL of Meptin syrup contains 5 μg of procaterol hydrochloride.
The formulation contains 3% ethyl alcohol used as a solvent.
2.Product Description
Meptin syrup is a colorless. clear and slight viscous liquid. It has an orange odor and a sweet taste.
pH: 3.5 - 4.5

INDICATIONS
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.

CONTRAINDICATIONS
(Meptin syrup is contraindicated in the following patients)
Patients with a history of hypersensitivity to any ingredient of this drug.

DOSAGE AND ADMINISTRATION
The usual adult dosage is 10 mL of Meptin syrup (50 μg of procaterol hydrochloride) once before bed or twice (in the morning and before bed) a day by the oral route.
The dosage in children 6 years of age or older is 5 mL of Meptin syrup (25 μg of procaterol hydrochloride) once before bed or twice (in the morning and before bed) a day by the oral route.
The dosage in children less than 6 years of age is 0.25 mL of Meptin syrup (1.25 μg of procaterol hydrochloride) per kg body weight once before bed or twice (in the morning and before bed) a day by the oral route.
The dosage may be adjusted according to the patient's age and severity of symptoms. The recommended usual doses for children younger than 6 years old are listed below.
Children younger than 1 year old: 2-3 mL of Meptin syrup (10-15 μg of procaterol hydrochloride).
Children 1-3 years of age: 3-4 mL of Meptin syrup (15-20 μg of procaterol hydrochloride).
Children 3-6 years of age: 4-5 mL of Meptin syrup (20-25 μg of procaterol hydrochloride).

PHARMACOLOGY
1.Bronchodilatory Action
The bronchodilatory action of procaterol hydrochloride was comparable to or more potent than that of isoproterenol and more potent than that of salbutamol and orciprenaline, as determined by inhibition of increased pulmonary resistance, in dogs. cats, and guinea pigs.

2.Duration of Bronchodilatory Action
Procaterol hydrochloride had a longer duration of action than isoproterenol, trimetoquinol, orciprenaline, or salbutamol in dogs, cats, and guinea pigs.

3.Selectivity for β2-Adrenergic Receptors (Organ Selectivity)
The selectivity of procaterol hydrochloride for β2-adrenergic receptors in the respiratory system was greater than that for such receptors in the cardiovascular system, as compared to isoproterenol, trimetoquinol, orciprenaline, and salbutamol, in dogs, cats, and guinea pigs.

4.Anti-allergic Action
Procaterol hydrochloride exhibited a definite anti-allergic 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. The drug also inhibited allergen induced delayed-type and immediate-type bronchial responses.

5.Effects on Airway Secretion
Procaterol hydrochloride accelerates ciliary activity in the airways of pigeons.

6.Inhibitory Effect on Exercise-Induced Asthma Episodes
The results of treadmill or ergometer exercise or methacholine loading tests suggest that procaterol hydrochloride suppresses exercise-induced asthma attacks in patients with bronchial asthma.

7.Effect on Accelerated Airway Hypersensitivity
Procaterol hydrochloride inhibited airway hypersensitivity accelerated by the inoculation of influenza virus C in dogs.

8.Inhibitory Effect on Accelerated Vascular Permeability
Procaterol hydrochloride inhibited the acceleration of vascular permeability and edema formation in dorsal subcutaneous air sacs in rats experimentally prepared using various inflammatory chemical agents. Its potency was similar to that of isoproterenol. Procaterol hydrochloride also inhibited pulmonary edema induced by histamine inhalation in guinea pigs. with greater potency than salbutarnol.

9.Effect on Cough
Procaterol hydrochloride inhibited cough in acute bronchitis induced by the inhalation of substance P.

PHARMACOKINETICS
1.Plasma Concentrations
When procaterol hydrochloride was administered orally to 6 healthy male subjects at single doses of 50 and 100 μg/ subject. the following plasma concentration curves and pharmacokinetic parameters were obtained.


Plasma kinetic data
Dose
Tmax
Cmax
Half-life
50 μg
1.1 hr
97 pg/mL
Not determined
100 μg
1.5 hr
226 pg/mL
3.6 hr

2.Urinary Excretion
When procaterol hydrochloride was administered orally as single doses of 50 and 100 μg/subject, 9.93% and 11.65% of the dose were excreted in the urine within 24 hours post-dosing, respectively.

PRECAUTIONS
1.Careful Administration (Meptin syrup should be administered with care in the following patients.)
  1. Patients with hyperthyroidism (The disease may be exacerbated.)
  2. Patients with hypertension (Blood pressure may further increase.)
  3. Patients with heart disease (Palpitation, arrhythmia exacerbation of heart disease, and other symptoms may occur.)
  4. Patients with diabetes mellitus (The disease may be exacerbated.)
  5. Patients during pregnancy or suspected pregnancy (See Use during Pregnancy, Delivery or lactation section.)
2.Important Precautions
  1. If the desired therapeutic effect of Meptin syrup cannot be achieved at the recommended dose, the drug should be discontinued.
  2. Continuous administration of excessive amounts of this drug may cause cardiac arrhythmia and cardiac arrest. Special care should therefore be taken not to exceed the recommended dosage of this drug.
3.Use in the Elderly
Dosage adjustment or other appropriate measures should be considered when prescribing Meptin syrup to elderly patients, because these patients may be physiologically more sensitive to the drug than younger patients.

4.Use during Pregnancy, Delivery, or Lactation
  1. This drug 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 this drug during pregnancy has not been established.)
  2. Nursing should be interrupted before starting treatment with the drug. (Rat studies showed that procaterol hydrochloride is excreted in breast milk.)
5.Pediatric Use
The safety of this drug in premature babies and neonates has not been established. (Clinical experience in premature babies and neonates is insufficient.)

6.Effects on Laboratory Tests
This drug tends to inhibit skin reactions in allergen tests. The drug should be withdrawn 12 hours prior to such tests.

7.Other Precautions
  1. Tissue damage in cardiac muscle was noted at 30 and 10 mg/kg/day or higher in the sub-acute and chronic toxicity studies, respectively, using rats. The damage was also observed in dog studies. However, the damage has been reported for other β2-adrenergic stimulants in both rat and dogs.
  2. Administration of procaterol hydrochloride with diet for 104 weeks was reported to cause mesovarian leiomyoma in SD rats. The tumor, however, is rat species specific and tends to develop during the long-term use of β2-adrenergic stimulants.

ADVERSE REACTIONS
In clinical trials involving 22,757 subjects, a total of 644 patients (2.83%) showed adverse reactions, including abnormal laboratory values. The following summary of data includes adverse reactions reported after marketing without incidence. (Figures are total cases reported from the time to approval up to December 1999)
1.Clinically significant adverse reactions (*incidence unknown)
  1. Shock, anaphylactoid reaction: Shock or anaphylactoid reaction may occur. Patient should therefore be closely monitored. If abnormal findings are observed, the drug should be discontinued and appropriate measures taken.
  2. Significant decreases in serum potassium levels have been reported in patients receiving procaterol hydrochloride. If xanthine derivatives, corticosteroids, or diuretics are co-administered with this drug in patients with severe potassium levels induced by β2-adrenergic agonists. Serum potassium levels should be closely monitored in hypoxic patients, in view of the possible aggravation of cardiac arrhythmias secondary to a decrease in serum potassium levels.
2.Other adverse reactions
5% › ≥ 0.1%
‹ 0.1%
* Incidence unknown
CardiovascularPalpitations and tachycardiaFacial flushing etc.Supraventricular extrasystoles, supraventricular tachycardia, ventricular extrasystoles. etc.,
Psychoneurologic Tremor and headacheDizziness, insomnia, numbness of limbs, etc.Finger spasticity, muscle cramps, muscular spasm, and nervousness
GastroIntestinalNausea and vomitingDry mouth, gastric discomfort, etc.
Hypersensitivity (note) Skin rash,  etcPruritus
HepaticIncreases in GOT, GPT, and LDH levels and other signs of hepatic dysfunction
OtherGeneralized  fatigue, weakness,  nasal obstruction, and tinnitusDecrease in serum potassium levels


Note:
1) If symptoms of hypersensitivity occur, the drug should be discontinued.
* The incidences rate of adverse reactions reported voluntarily after marketing and those reported outside Japan are not known.

DRUG INTERACTIONS
Precautions for co-administration (Meptin syrup should be administered with care when co-administered with the following drugs.)

DrugsSigns, Symptoms, and TreatmentMechanism and Risk Factors
catecholamines (e.g., epinephrine and isoproterenol)The combined use of this drug with catecholamines may cause arrhythmias or cardiac arrestEpinephrine, isoproterenol, and other catecholamines potentiate the adrenoreceptor stimulating action of this drug, possibly resulting in the induction of arrhythmias
Xanthine derivatives (e,g theophylline, aminophylline, and dipropylline)The combined use of this drug with xanthine derivatives may aggravate hypokalemia and cardiovascular adverse reactions (e.g., tachycardia, arrhythmias) due to adrenergic stimulation. If any of these abnormalities are observed, the dose should be reduced or treatment should be discontinued immediatelyXanthine derivatives potentiate the adrenoreceptor stimulating action of this drug, possibly resulting in a decrease in serum potassium levels and causing cardiac or vascular adverse reactions. The mechanism responsible for the induction of hypokalemia is not known
Corticosteroids (e.g. betamethasone, prednisolone, and hydrocortisone sodium succinate) and Diuretics (e.g. furosemide)The combined use of this drug with corticosteroids or diuretics may cause a decrease in serum potassium levels, resulting in arrhythmias. If any
of these abnormalities are observed. the dose should be reduced or treatment should be discontinued immediately
Corticosteroids and diuretics augment the excretion of potassium from the renal tubules, possibly resulting in an excessive decrease in serum potassium levels

PHYSICOCHEMISTRY
Nonproprietary name:
      Procaterol hydrochloride (JAN)
Chemical name:
8-hydroxy-5-[(1 RS,2SR)-1-hydroxy-2-isopropyl-aminobutyl)-2(1 H)quinolinone monohydrochloride hemihydrate.

Structural formula:


Molecular formula: C16H22N2O3 - HCl -1/2H20
Molecular weight: 335.83

STORAGE
Room temperature, protected from light

PACKAGING
Meptin syrup: 60 mL in bottles
Reg. No. : DKL 8618701437A1

HARUS DENGAN RESEP DOKTER

Manufactured by:
PT Otsuka Indonesia
Lawang, East Java
Indonesia

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