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THEOLINE SR 200

Quick Overview

The pedigree of SAVA Medica Ltd stands tall as our Nasal spray and Dry powder inhaler technology and expertise.


Our aim is to reach out to the globewithinshortest possible time frame. 


To promote this objective, not only we distribute and market our respiratory range of products globally through our distribution channels but we also undertake ‘contract manufacturing’& ‘formulation development ’of our wide range of generic products such as  Theolin SR 200 which contains Theophylline (Anhydrous) BP 200 mg. 


 


 

TheoLin SR 200

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Details

Each uncoated Sustained Release Tablet contains:

Theophylline (Anhydrous) BP... 200 mg

Excipients        q.s.

Mode of Action:

Theophylline is a bronchodilator which directly relaxes the smooth muscle of the bronchial airways and pulmonary and coronary blood vessels. These actions may be mediated through inhibition of phosphodiesterase and a resultant increase in intracellular cyclic AMP.

Indications And Clinical Uses:

For the symptomatic treatment of reversible bronchospasm associated with asthma, chronic bronchitis, emphysema and related bronchospastic disorders.

Contra-Indications:

In patients with hypersensitivity to theophylline or xanthine derivatives; peptic ulcer; coronary artery disease (when, in the physician's judgment, myocardial stimulation might prove harmful).

Warnings in Clinical States:

Children: The margin of safety above the therapeutic dose is small. The use of theophylline sustained release tablets in children under the age of 12 years is not recommended as a dose schedule in this age group has not been established.

Drug Interactions :

Cimetidine, erythromycin, influenza vaccine and propranolol may increase the effect of theophylline by decreasing theophylline clearance.

Smoking may decrease theophylline effect by

increasing clearance.

Acidifying agents, by increasing urinary excretion of weak bases such as xanthines, may inhibit theophylline action. Alkalinizing agents, by decreasing urinary excretion, may potentiate the action of theophylline.

The actions of thiazide diuretics and digitalis glycosides may be potentiated by xanthine derivatives such as theophylline.

The effects of coumarin anticoagulants may be antagonized by methylxanthine-induced increases of prothrombin and fibrinogen.

Theophylline has been shown to increase the ratio of clearance of lithium/creatinine and may thus decrease serum lithium to ineffective levels. Xanthines may antagonize the antihyperuricemic action of allopurinol; the uricosuric action of probenecid may also be antagonized.

Xanthines have been shown to be nephrotoxic with prolonged use at high dosage. Coincident toxicity should therefore be borne in mind when other potentially nephrotoxic drugs are administered concurrently. Combined use of several xanthines, or the concurrent use of sympathomimetics, may cause excessive CNS stimulation.

Adverse Reactions:

The most common adverse reactions are nausea, vomiting, epigastric pain, headache and tremor. These are usually early signs of toxicity; however, with high doses, ventricular arrhythmias or seizures may be the first signs to appear. Adverse reactions reported with theophylline preparations include:

Gastrointestinal: nausea, vomiting, epigastric pain, hematemesis, diarrhoea, anorexia, reactivation of peptic ulcer, intestinal bleeding.

CNS: headaches, irritability, restlessness, insomnia, hyperactivity, reflex hyperexcitability, muscle twitching, clonic and tonic generalized convulsions.

Car failure, life-threatening ventricular arrhythmias. Respiratory: tachypnea.

Renal: albuminuria, diuresis and hematuria. Others: hyperglycemia and inappropriate ADH syndrome.

Symptoms And Treatment Of Overdose : Symptoms: Insomnia, restlessness, mild excitement or irritability, and rapid pulse, are early symptoms which may progress to mild delirium. Sensory disturbances such as tinnitus or flashes of light are common. Anorexia, nausea and vomiting are frequently early observations of theophylline overdosage.

Fever, diuresis, dehydration and extreme thirst may be seen. Severe poisoning results in bloody, syrup-like "coffee-ground" vomitus, tremors, tonic extensor spasm interrupted by clonic convulsions, extrasystoles, quickened respiration, stupor and finally coma. Cardiovascular disorders and respiratory collapse, leading to shock, cyanosis and death follow gross overdosages.

Treatment: If potential oral overdose is established and seizure has not occurred, induce vomiting. Administer a cathartic (this is particularly important when a sustained release preparation has been taken). Administer activated charcoal.

Dosage and Administration :

Theo-Lin SR 200/300 tablets should be swallowed whole. It should not be crushed or chewed. Adults:

The average starting dose for adults is 16 mg/kg or 400 mg (whichever is less) in two divided doses and then gradually increased up to 800 mg per day to obtain maximum benefit.

Pharmacokinetics:

Theophylline sustained release tablets produce peak blood levels of theophylline between 5 and 8 hours following dosing in adults. Once a steady state level has been reached, the therapeutic blood levels of theophylline persist for 12 hours in most adult patients.

diovascular: palpitation, tachycardia, extrasystoles, flushing, hypotension, circulatory

Theophylline is usually well absorbed following oral administration. In the therapeutic blood range of between 5 and 20 pg/mL (28 to 111 pmol/L), about 55 to 65% of theophylline is found bound to plasma protein. The half-life of theophylline is influenced by a number of known variables. In adult nonsmokers with uncomplicated asthma the half- life ranges from 3 to 9 hours. In older adults (over 55 years of age), patients with chronic obstructive lung disease, impaired hepatic or renal function, or chronic alcoholism, the half-life is usually longer, sometimes exceeding 24 hours. The half-life of theophylline in smokers and young children is, on the other hand, shorter. Between 3 months and 2 years may be necessary to reverse the effect of smoking on theophylline pharmacokinetics. The time required to reach steady state varies between subjects but is related to the half-life for theophylline in that subject. Steady state is generally reached within 5 half-lives.

Theophylline is metabolized by the liver to 3-methyl-xanthine, 1-methyl-uric acid and 1,3-dimethyluric acid. About 10% of a dose is excreted unchanged in the urine.

Biliary excretion, with subsequent reabsorption, may occur but has not been demonstrated in man.

Packing:

Blister of 10 Tablets

 

 

 
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