Euphyllina tablets

Euphyllina

  • Active Ingredient: Theophylline
  • 400 mg
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What is Euphyllina?

The active ingredient of Euphyllina brand is theophylline. Theophylline is a bronchodilator. It works by relaxing muscles in the lungs and chest, making the lungs less sensitive to allergens and other causes of bronchospasm. Each extended-release tablet for oral administration contains either 300 mg or 450 mg of anhydrous Theophylline. Tablets also contain as inactive ingredients: hypromellose, lactose monohydrate, magnesium stearate and povidone.

Used for

Euphyllina is used to treat diseases such as: Apnea of Prematurity, Asthma, acute, Asthma, Maintenance.

Side Effect

Possible side effects of Euphyllina include: Chest pain or discomfort; increase in urine volume; restlessness; persistent vomiting; shakiness; muscle cramps or spasms; fainting.

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Alcohol warning

The use of drinks that contain alcohol raises your risk of side effects from Euphyllina. If you drink alcohol, talk to your doctor.

Why is this medication prescribed?

Euphyllina is used to prevent and treat wheezing, shortness of breath, and chest tightness caused by asthma, chronic bronchitis, emphysema, and other lung diseases. It relaxes and opens air passages in the lungs, making it easier to breathe.

Gout drugs

These drugs may increase the levels of Euphyllina in your body. This means that you may have more side effects. An example of these drugs is:

* These data are derived from two studies in patients with serum Euphyllina concentrations >30 mcg/mL. In the first study (Study #1 - Shanon, Ann Intern Med 1993; 119:1161-67), data were prospectively collected from 249 consecutive cases of Euphyllina toxicity referred to a regional poison center for consultation. In the second study (Study #2 - Sessler, Am J Med 1990;88:567-76), data were retrospectively collected from 116 cases with serum Euphyllina concentrations >30 mcg/mL among 6000 blood samples obtained for measurement of serum Euphyllina concentrations in three emergency departments. Differences in the incidence of manifestations of Euphyllina toxicity between the two studies may reflect sample selection as a result of study design (e.g., in Study #1, 48% of the patients had acute intoxications versus only 10% in Study #2) and different methods of reporting results.

** NR = Not reported in a comparable manner.

Important Information

Never use Euphyllina in larger amounts, or for longer than prescribed. Seek medical attention if your breathing problems get worse quickly, or if you think your medications are not working as well.

Overdose can occur if you take too much Euphyllina at one time, or if your daily doses are too high.

Tell your doctor about all your current medicines and any you start or stop using. Many drugs can interact with Euphyllina.

Euphyllina Overdose

A sudden overdose from taking too much Euphyllina all at once is rare.

A chronic overdose, however, is not rare, especially if you have been taking a dose that is a little too high for a long time, or if your dose has recently been increased.

An overdose of Euphyllina may cause slow heart rate, abnormal heart rate, seizures, circulatory system failure, and death.

If you suspect an overdose, you should contact a poison-control center or emergency room immediately. You can reach a poison-control center at (800) 222-1222.

Dosage Considerations – Should be Given as Follows:

  • Patients not currently taking Euphyllina: 5-7 mg/kg intravenously/orally; not to exceed 25 mg/min intravenously (IV)
  • Aminophylline: 6-7 mg/kg intravenously/orally; IV infused over 20 minutes

  • 0.4-0.6 mg/kg/hour intravenously (IV) or 4.8-7.2 mg/kg orally (extended release) every 12 hours to maintain levels 10-15 mg/L
  • Smokers: 0.79 mg/kg/hour IV for next 12 hours after loading dose, then 0.63 mg/kg/hour or 5 mg/kg orally (extended release) every 8 hours
  • Coadmininstration with drugs that decrease Euphyllina clearance (e.g., cimetidine, ciprofloxacin, and erythromycin and other macrolides): 0.2-0.3 mg/kg/hour IV or orally (extended release) every 12-24 hours
  • Congestive heart failure: 0.39 mg/kg/hour IV for next 12 hours after loading dose, then 0.08-0.16 mg/kg/hour
  • Aminophylline: 3.125 mg/kg orally every 6 hours

  • No Euphyllina administered in previous 24 hours: 5-7 mg/kg intravenously/orally; IV infused over 20-30 minutes

  • 1.5-6 months: 0.5 mg/kg/ hour intravenously (IV) or 10 mg/kg/day orally in divided doses
  • 6-12 months: 0.6-0.7 mg/kg/ hour IV or 12-18 mg/kg/day orally in divided doses
  • 1-9 years: 1 mg/kg/ hour IV or 8 mg/kg orally (extended release) every 8 hours
  • 9-12 years: 0.8-0.9 mg/kg/ hour IV or 6.4 mg/kg orally (extended release) every 8 hours
  • 12-16 years: 0.7 mg/kg/ hour IV or 5.6 mg/kg orally (extended release) every 8 hours

  • Loading: 4-5 mg/kg orally/intravenously (IV) once
  • Maintenance: 3-6 mg/kg/day orally/IV divided every 8 hours
  • Dosing Considerations
  • If administering aminophylline, increase dose by 25% (aminophylline is approximately 79-86% Euphyllina)
  • For oral loading, use immediate-release Euphyllina or aminophylline
  • If patient is already taking Euphyllina, give smaller loading dose
  • Use ideal body weight to calculate dose
  • 1 mg/kg results in 2 mg/L (34.4 mmol/L) increase in serum Euphyllina
  • Therapeuticrange: 10-20 mg/L (172-344 mmol/L)

  • Hepatic impairment: After loading dose, 0.39 mg/kg/hour intravenously (IV) for next 12 hours, then 0.08-0.16 mg/kg/hour

Erythromycin metabolite decreases Euphyllina clearance by inhibiting cytochrome P450 3A3. 35% increase. Erythromycin steady-state serum concentrations decrease by a similar amount. Estrogen Estrogen containing oral contraceptives decrease Euphyllina clearance in a dose-dependent fashion. The effect of progesterone on Euphyllina clearance is unknown. 30% increase

Flurazepam Similar to diazepam. Similar to diazepam. Fluvoxamine Similar to cimetidine. Similar to cimetidine. Halothane Halothane sensitizes the myocardium to catecholamines, Euphyllina increases release of endogenous catecholamines. Increased risk of ventricular arrhythmias. Interferon, human recombinant alpha-A Decreases Euphyllina clearance. 100% increase Isoproterenol (IV) Increases Euphyllina clearance. 20% decrease Ketamine Pharmacologic. May lower Euphyllina seizure threshold Lithium Euphyllina increases renal lithium clearance. Lithium dose required to achieve a therapeutic serum concentration increased an average of 60%. Lorazepam Similar to diazepam. Similar to diazepam. Methotrexate (MTX) Decreases Euphyllina clearance.

20% increase after low dose MTX, higher dose MTX may have a greater effect. Mexiletine Similar to disulfiram. 80% increase Midazolam Similar to diazepam. Similar to diazepam. Moricizine Increases Euphyllina clearance. 25% decrease Pancuronium Euphyllina may antagonize non-depolarizing neuromuscular blocking effects; possibly due to phosphodiesterase inhibition. Larger dose of pancuronium may be required to achieve neuromuscular blockade. Pentoxifylline Decreases Euphyllina clearance. 30% increase Phenobarbital (PB) Similar to aminoglutethimide. 25% decrease after two weeks of concurrent PB. Phenytoin Phenytoin increases Euphyllina clearance by increasing microsomal enzyme activity. Euphyllina decreases phenytoin absorption. Serum Euphyllina and phenytoin concentrations decrease about 40%. Propafenone Decreases Euphyllina clearance and pharmacologic interaction. 40% increase. Beta-2 blocking effect may decrease efficacy of Euphyllina. Propranolol Similar to cimetidine and pharmacologic interaction. 100% increase. Beta-2 blocking effect may decrease efficacy of Euphyllina. Rifampin Increases Euphyllina clearance by increasing cytochrome P450 1A2 and 3A3 activity. 20-40% decrease St. John’sWort (Hypericum Perforatum) Decrease in Euphyllina plasma concentrations. Higher doses of Euphyllina may be required to achieve desired effect. Stopping St. John’s Wort may result in Euphyllina toxicity. Sulfinpyrazone Increase Euphyllina clearance by increasing demethylation and hydroxylation. Decreases renal clearance of Euphyllina. 20% decrease Tacrine Similar to cimetidine, also increases renal clearance of Euphyllina. 90% increase Thiabendazole Decreases Euphyllina clearance. 190% increase Ticlopidine Decreases Euphyllina clearance. 60% increase Troleandomycin Similar to erythromycin. 33-100% increase depending on troleandomycin dose. Verapamil Similar to disulfiram. 20% increase

* Refer to PRECAUTIONS, Drug Interactions for further information regarding table. ** Average effect on steady-state Euphyllina concentration or other clinical effect for pharmacologic interactions. Individual patients may experience larger changes in serum Euphyllina concentration than the value listed. Table III. Drugs that have been documented not to interact with Euphyllina or drugs that produce no clinically significant interaction with Euphyllina.*

Geriatric Use:

Elderly patients are at a significantly greater risk of experiencing serious toxicity from Euphyllina than younger patients due to pharmacokinetic and pharmacodynamic changes associated with aging. The clearance of Euphyllina is decreased by an average of 30% in healthy elderly adults ( > 60 yrs) compared to healthy young adults. Euphyllina clearance may be further reduced by concomitant diseases prevalent in the elderly, which further impair clearance of this drug and have the potential to increase serum levels and potential toxicity. These conditions include impaired renal function, chronic obstructive pulmonary disease, congestive heart failure, hepatic disease and an increased prevalence of use of certain medications (see PRECAUTIONS : Drug Interactions ) with the potential for pharmacokinetic and pharmacodynamic interaction. Protein binding may be decreased in the elderly resulting in an increased proportion of the total serum Euphyllina concentration in the pharmacologically active unbound form. Elderly patients also appear to be more sensitive to the toxic effects of Euphyllina after chronic overdosage than younger patients. Careful attention to dose reduction and frequent monitoring of serum Euphyllina concentrations are required in elderly patients (see PRECAUTIONS , Monitoring Serum Euphyllina Concentrations , and DOSAGE AND ADMINISTRATION ). The maximum daily dose of Euphyllina in patients greater than 60 years of age ordinarily should not exceed 400 mg/day unless the patient continues to be symptomatic and the peak steady-state serum Euphyllina concentration is DOSAGE AND ADMINISTRATION ). Euphyllina doses greater than 400 mg/d should be prescribed with caution in elderly patients.

Warnings

This medication contains Euphyllina. Do not take Theo 24, Theochron, Elixophyllin, aminophylline, or Uniphyl if you are allergic to Euphyllina or any ingredients contained in this drug.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Euphyllina

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Euphyllina side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

severe or continued vomiting;

ongoing headache, trouble sleeping;

new signs of illness (especially fever);

low potassium level--leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling; or

high blood sugar--increased thirst, increased urination, dry mouth, fruity breath odor.

Serious side effects may be more likely in older adults.

Common side effects may include:

feeling restless or irritable.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Why it's used

Euphyllina is used to treat the symptoms of asthma or other lung conditions that block your airways, such as emphysema or chronic bronchitis.

Euphyllina may be used as part of a combination therapy. This means you may need to take it with other medications.

What is Euphyllina, and how does it work (mechanism of action)?

Euphyllina belongs to a class of medications called bronchodilators, used in treating asthma and other airway diseases. Asthma is a breathing problem caused by narrowing of the airways, the breathing passages that allow air to move in and out of the lungs. Airways can be narrowed due to accumulation of mucus, spasm of the muscles that surround these airways, or swelling of the lining of the airways. Airway narrowing leads to symptoms of shortness of breath, wheezing, cough, and congestion. The narrowed airways can open either spontaneously or with medications. Medications that open airways are called bronchodilators. Euphyllina opens airways by relaxing the smooth muscles in the walls of the airways. Euphyllina also can be helpful in patients with emphysema and chronic bronchitis when their symptoms are partially related to reversible airway narrowing. Euphyllina also strengthens right heart function and diaphragm movement. Euphyllina was approved by the FDA in April 1979.

What should I discuss with my veterinarian before giving Euphyllina ER?

Tell your veterinarian if your pet is allergic to Euphyllina, or if your pet has stomach ulcers; epilepsy; heart rhythm problems; congestive heart failure; fluid in the lungs; hypothyroid; fever; liver, or kidney disease. Tell your veterinarian if your pet is pregnant or lactating, or if you plan on breeding your pet.

Euphyllina for Dogs and Cats

The FDA has not approved Euphyllina for veterinary medicine, but it is commonly prescribed to treat heart failure, asthma, pulmonary edema, bronchitis, and chronic obstructive pulmonary disease in cats and dogs.

As with people, pets are more likely to experience issues with Euphyllina if they have certain health conditions or are also taking other medications.

Potential side effects include restlessness, upset stomach, frequent urination, and rapid heartbeat.

Always talk to your pet's veterinarian before giving your dog or cat any prescription drug, including Euphyllina.

Hepatitis drugs

These drugs may increase the levels of Euphyllina in your body. This means that you may have more side effects. An example of these drugs is:

CLINICAL PHARMACOLOGY:

Mechanism of Action: Euphyllina has two distinct actions in the airways of patients with reversible obstruction; smooth muscle relaxation (i.e., bronchodilation) and suppression of the response of the airways to stimuli (i.e., non-bronchodilator prophylactic effects). While the mechanisms of action of Euphyllina are not known with certainty, studies in animals suggest that bronchodilation is mediated by the inhibition of two isozymes of phosphodiesterase (PDE III and, to a lesser extent, PDE IV) while non-bronchodilator prophylactic actions are probably mediated through one or more different molecular mechanisms, that do not involve inhibition of PDE III or antagonism of adenosine receptors. Some of the adverse effects associated with Euphyllina appear to be mediated by inhibition of PDE III (e.g., hypotension, tachycardia, headache, and emesis) and adenosine receptor antagonism (e.g., alterations in cerebral blood flow).

Euphyllina increases the force of contraction of diaphragmatic muscles. This action appears to be due to enhancement of calcium uptake through an adenosine-mediated channel.

Serum Concentration-Effect Relationship: Bronchodilation occurs over the serum Euphyllina concentration range of 5-20 mcg/mL. Clinically important improvement in symptom control has been found in most studies to require peak serum Euphyllina concentrations > 10 mcg/mL, but patients with mild disease may benefit from lower concentrations. At serum Euphyllina concentrations > 20 mcg/mL, both the frequency and severity of adverse reactions increase. In general, maintaining peak serum Euphyllina concentrations between 10 and 15 mcg/mL will achieve most of the drug's potential therapeutic benefit while minimizing the risk of serious adverse events.

Pharmacokinetics: Overview: Euphyllina is rapidly and completely absorbed after oral administration in solution or immediate-release solid oral dosage form. Euphyllina does not undergo any appreciable pre-systemic elimination, distributes freely into fat-free tissues and is extensively metabolized in the liver. The pharmacokinetics of Euphyllina vary w >PRECAUTIONS, Laboratory Tests ).

Table I. Mean and range of total body clearance and half-life of Euphyllina related to age and altered physiological states.¶


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