Neo-Minophylline

Drugs , Respiratory System / September 22, 2016

Class: Respiratory System
Dosage Form: Syrup
Description: Bronchodilator and expectorant
Stock: Available
Manufacturer: Alexandria Co.

Composition:

Each 100 ml contains:
Theophylline anhydrous…………50 mg
Guaiphenesin………………………..30 mg

Properties:

Pharmacology
Theophylline is a bronchodilaior by relaxing bronchial smooth muscle; opposing the effects of many broncho-constrictor mediators and also relaxes smooth muscle in the urinary & biliary ways. It is also a central stimulant, analeptic respiratory and psychostimulant effect.
Guaiphenesin helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.

Pharmacokinetics
Good absorption after administration. Hepatic metabolism (90 % of the aoministcrod dose). The metabolism of the Theophylline in infant Is more rapid than in adult and there is an important variation in the metabolism of the drug from one patient to the other.
Plasma half-life is as follows:

  • In infants: 1.9-8 hours
  • In adults: 3-8 hours
  • In geriatrics: Comparable to that of adult

The drug passes to the fetus through placenta.

Indications:

Neo-Minophylline syrup is indicated for the sympathomimetic treatment of bronchospasms associated with such conditions as bronchial asthma, chronic bronchitis and pulmonary emphysema.
Guaiphenesin helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.

Contraindicatons:

Hypersensitivity to theophylline.

Drug Interactions:

The following drug interactions have been reported:

  • Cimetidine, allopurinol, corticosteroids, furosemide, isoprenaline, oral contraceptives, thiobendazole, ciprofloxacin, erythromycin or other macrolide antibiotics and the calcium channel blockers, diltiazem and verapamil, nizatidine, norfloxacin, isoniazid, fluconazole, carbimazole, mexiletine, propafenone, oxpentifylline, disulfiram, viloxazine, interferon alfa, and influenza vaccine increase plasma theophylline concentrations. A reduction of theophylline dosage is thus recommended
  • Phenytoin, carbamazepine, barbiturates, rifampicin, sulphinpyrazone, ritonavir, primidone and aminogluthethimide may reduce plasma theophylline concentrations and therefore the theophylline dosage may neen to be increased
  • Theophylline can increase lithium excretion
  • The concomitant use of theophylline and fluvoxamine should usually be avoided. Where this is not possible, patients should have their theophylline dose halved and plasma theophylline should be closely monitored
  • Plasma concentrations of theophylline can be reduced by concomitant use of the herbal remedy St. John’s Wort
  • Other interactions:
    • ß-Blockers: Antagonism of bronchodilatation
    • Ketamine: Reduced convulsive threshold
    • Doxapram: Increased CNS stimulation
  • Not to be used in association with troleandomycin which can provoke a risk of overdosage
  • It is agreed to be used prudently with erythromycin that can increase the blood concentration of the theophylline

Side Effects:

Variable from one subject to the other, essentially: nausea, vomiting, epigastric pain, cephalalgia , excitation, insomnia, tachycardia. The side effects may be the first sign of overdosage. The appearance of the convulsion is the sign of confirmed poisoning, but can be the first sign of it, notably in the child.

Dosage and Administration:

As directed by the physician or as follows:

  • Infants 6-12 months: 1/2 a teaspoonful 3 times daily after meals
  • Children from 2-6 years: 1 teaspoonful 3 times daily after meals
  • Children to 9 years: One and half teaspoonful 3-4 times daily after meals
  • Children to 16 years: One and half to two teaspoonfuls, 3-4 times daily after meals
  • Over 16 years: 2-3 teaspoonful 3-4 times daily after meals

Pregnancy and Lactation:

In case of administration of the drug In the end of pregnancy, possibility of tachycardia and of hyperexcitability in the neonates exists

Warnings:

Neo-Minophylline should be used with caution in the following cases:

  • Active peptic ulcer disease
  • Seizure disorders
  • Cardiac arrhythmias (not including bradyarrhythmias)
  • Patients with migraine headaches may experience an increased frequency of headaches
  • Patients with congestive heart faliure, cor-pulmonale, prolonged fever, hypothyroidism, liver disease, sepsis with multi-organ failure and shock may require reduced theophylline dosage
  • Concomitant medication use which results in reduced theophylline clearance
  • Hypoproteinemia toxic effects may occur at therapeutic total serum theophylline concentrations in patients with hypoalbuminemia because free (unbound) theophylline concentrations are elevated

Packaging:

Pack contains bottle of 120 ml syrup.

Storage:

Store in airtight container away from light, at a temperature not exceeding 25°C.

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