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Theophylline Sustained-release Tablets for bronchial asthma
Theophylline Sustained-release Tablets for bronchial asthma
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Chajian Huanshi Pian
Cha Jian Huan Shi Tablets
茶碱缓释片
FUNCTION and INDICATIONS
Applicable to bronchial asthma, wheezing bronchitis, obstructive emphysema and other relief of wheezing symptoms; can also be used for asthma due to cardiogenic pulmonary edema.
INGREDIENTS
The main ingredient is anhydrous theophylline.
DESCPRIPTION
This product is white film tablet.
SPECIFICATION AND PACKAGE
0.1g*24 tablets/box.
USAGE AND DOSAGE
For oral use after meals,this product should not be crushed or chewed. Adults or children over 12 years old, the initial dose is 0.1g-0.2g (1-2 tablets), 2 times a day,morning and evening take it with 100ml warm water, the dose is adjusted according to the condition and efficacy, but the daily dose does not exceed 0.9 g (9 tablets), taken in 2 divided doses.
REFERENCES
ADVERSE REACTION
The toxicity of theophylline often occurs in the serum concentration of 15-20g / ml, especially at the beginning of treatment, early nausea, vomiting, irritability, insomnia, etc., when the serum concentration exceeds 20g / ml, can be There are tachycardia, arrhythmia, and the serum theophylline exceeds 40g/ml, which can cause fever, water loss, convulsions, etc., and even death, heartbeat and death.
CONTRAINDICATIONS
Patients with allergies to this product should not ues it, active peptic ulcers and patients with uncontrolled convulsive diseases are banned to use.
Warning
1.Like other theophylline sustained-release preparations, this product is not suitable for patients with persistent asthma or acute bronchitis.
2.Serum theophylline concentration should be monitored regularly to ensure maximum efficacy without the risk of excessive blood levels.
3.Patients with renal function or hepatic insufficiency, patients over 55 years of age, especially men and patients with chronic lung disease, patients with heart failure caused by any cause, persistent fever patients. Patients who used certain drugs and those who had reduced theophylline clearance rate often had a significant prolongation of serum theophylline concentration after discontinuation of the combination drug. The dosage should be adjusted or the interval between medications should be extended as appropriate.
4.Theophylline preparation can cause arrhythmia and/or worsen the original arrhythmia; any changes in the patient's heart rate and/or rhythm should be monitored and studied.
5.Patients with a history of hypoxemia, hypertension or digestive ulcers should use this product with caution.
6. Please keep out of reach of children.
Pregnant women and lactating women:
This product can pass through the placental barrier and can also be discharged into the milk. Pregnant women and lactating women should use it with caution.
Children's medication
Neonatal plasma clearance can be reduced, serum concentration increases, should be used with caution. The safety and efficacy of this product for children under 12 years of age is uncertain. Please follow the doctor's advice when using children over 12 years old.
Medication in elderly patients
The elderly have decreased plasma clearance and increased potential toxicity. Patients over 55 years of age should be used with caution.
DRUG INTERACTION
(1) Diltiazem and verapamil can interfere with the metabolism of theophylline in the liver, and can be combined with this product to increase the blood concentration and toxicity of the product.
(2) Cimetidine can reduce the liver clearance rate of this product, and increase the serum concentration and/or toxicity of theophylline when used together.
(3) Certain antibacterial drugs, such as macrolides of erythromycin, roxithromycin, clarithromycin, quinolones, enoxacin, ciprofloxacin, ofloxacin, levofloxacin, clin Magnesium, lincomycin, etc. can reduce the rate of theophylline clearance, increase its blood concentration, especially erythromycin and enoxacin, when theophylline and the above drugs should be appropriate.
(4) phenobarbital, phenytoin, rifampicin can induce liver drug enzymes, accelerate the hepatic clearance rate of theophylline; theophylline also interferes with the absorption of phenytoin, both plasma concentrations are decreased, the dose should be adjusted when used.
(5) In combination with lithium salt, the renal excretion of lithium can be increased, which affects the action of lithium salt.
(6) In combination with mexiletine, the rate of theophylline can be reduced, the concentration of theophylline in the plasma can be increased, and the dose needs to be adjusted.
(7) Combined with caffeine or other xanthine drugs, it can increase its action and toxicity.
PHARMACOLOGIC ACTION
This product has a direct relaxation effect on the smooth muscle of the respiratory tract, and its mechanism of action is relatively complicated. It was thought that the inhibition of phosphodiesterase caused the increase of intracellular CAMP content. Recent experiments have suggested that the bronchodilating effect of theophylline is partly due to the release of endogenous adrenaline and norepinephrine. In addition, theophylline is a sputum receptor blocker, which can counteract the contractile effect of adenine on the respiratory tract. Theophylline can enhance the contractile force of the diaphragm, especially when the diaphragm is contracted, and it is beneficial to improve respiratory function.
[Pharmacokinetics]
Oral is easy to be absorbed, blood concentration peak time is 4-7 hours, once a day orally, the body's theophylline blood concentration can be maintained within the treatment range (5-20g/ml) for 12 hours. The blood drug concentration is relatively stable. Protein binding rate is about 60%, t1/2 newborn (within 6 months) >24 hours, children (over 6 months) (3.7 & plusmn; 1.1) hours, adults (no smoking and no asthma) (8.7 & plusmn; 2.2 ) hours, smokers (1-2 packs a day) 4-5 hours. This product is mainly metabolized in the liver and excreted by the urine. About 10% of it is a prototype.
[Indications] Applicable to bronchial asthma, wheezing bronchitis, obstructive emphysema and other relief of wheezing symptoms; can also be used for asthma caused by cardiogenic pulmonary edema.
STORAGE
Hermetically sealed,keep in cool and dry places.
PERIOD OF VALIDITY
24 months.
CERTIFICATE NO
Stage Food and Drug Administration Approval number:H44023791.
Manufactured
GUANGZHOU MAITE XINGHUA PHARMACEUTICAL CO.,LTD
Tips: Please read the directions for use in retail or directed by physician.
Part of the goods frequent replacement of packaging, such as goods and pictures are not exactly the same, please refer to the goods you receive.
General Cautions
Keep away from animals and children.This product has not been evaluated by the FDA. It is not intended to diagnose, treat, cure, or prevent any disease.We highly recommend that you consult with a Traditional Chinese Medical practitioner or physician before taking any products or if you have any questions regarding your health.