Theophylline (Theophylline)

Trade Name : THEOPHYLLINE

Pharmaceutical Associates, Inc.

SOLUTION

Strength 80 mg/15mL

THEOPHYLLINE Methylxanthine [EPC],Xanthines [CS]

Delivery Process

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Wholesalers Suppliers Exporters Doctors MOH Tender Supplies Hospitals Brand CROs Comparator Supplies Generic Cooperate Sourcing Individual Patients Indian Institutional Buyers

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Theophylline (Theophylline) which is also known as THEOPHYLLINE and Manufactured by Pharmaceutical Associates, Inc.. It is available in strength of 80 mg/15mL per ml. Read more

Theophylline (Theophylline) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Rx Only
  • Theophylline is structurally classified as a methylxanthine. It occurs as a white, odorless, crystalline powder with a bitter taste. Anhydrous theophylline has the chemical name 1H-Purine- 2,6-dione, 3,7-dihydro-1,3 -dimethyl-, and is represented by the following structural formula:
  • The molecular formula of anhydrous theophylline is Cn n n Hn n n Nn n n On n n with a molecular weight of 180.17.n nn
  • Theophylline Oral Solution USP is available as a liquid intended for oral administration, containing 80 mg of theophylline anhydrous and 20% alcohol in each 15 mL (tablespoonful).
  • Theophylline Oral Solution USP also contains the following inactive ingredients: citric acid, FD&C Red No. 40, FD&C Yellow No. 6, fruit flavor, purified water and saccharin sodium. May contain sodium citrate for pH adjustment. Theophylline Oral Solution USP has a pH of 3.0 - 4.7.
  • No data
  • Theophylline is indicated for the treatment of the symptoms and reversible airflow obstruction associated with chronic asthma and other chronic lung diseases, e.g., emphysema and chronic bronchitis.
  • Theophylline Oral Solution USP is contraindicated in patients with a history of hypersensitivity to theophylline or other components in the product.
  • No data
  • No data
  • Adverse reactions associated with theophylline are generally mild when peak serum theophylline concentrations are <20 mcg/mL and mainly consist of transient caffeine-like adverse effects such as nausea, vomiting, headache, and insomnia. When peak serum theophylline concentrations exceed 20 mcg/mL, however, theophylline produces a wide range of adverse reactions including persistent vomiting, cardiac arrhythmias, and intractable seizures which can be lethal (seen n n ). The transient caffeine-like adverse reactions occur in about 50% of patients when theophylline therapy is initiated at doses higher than recommended initial doses (e.g., >300 mg/day in adults and >12 mg/kg/day in children beyond >1 year of age). During the initiation of theophylline therapy, caffeine-like adverse effects may transiently alter patient behavior, especially in school age children, but this response rarely persists. Initiation of theophylline therapy at a low dose with subsequent slow titration to a predetermined age-related maximum dose will significantly reduce the frequency of these transient adverse effects (seen n n ). In a small percentage of patients (<3% of children and <10% of adults) the caffeine-like adverse effects persist during maintenance therapy, even at peak serum theophylline concentrations within the therapeutic range (i.e., 10-20 mcg/mL). Dosage reduction may alleviate the caffeine-like adverse effects in these patients, however, persistent adverse effects should result in a re-evaluation of the need for continued theophylline therapy and the potential therapeutic benefit of alternative treatment.n nn
  • Other adverse reactions that have been reported at serum theophylline concentrations <20 mcg/mL include diarrhea, irritability, restlessness, fine skeletal muscle tremors, and transient diuresis. In patients with hypoxia secondary to COPD, multifocal atrial tachycardia and flutter have been reported at serum theophylline concentrations u226515 mcg/mL. There have been a few isolated reports of seizures at serum theophylline concentrations <20 mcg/mL in patients with an underlying neurological disease or in elderly patients. The occurrence of seizures in elderly patients with serum theophylline concentrations <20 mcg/mL may be secondary to decreased protein binding resulting in a larger proportion of the total serum theophylline concentration in the pharmacologically active unbound form. The clinical characteristics of the seizures reported in patients with serum theophylline concentrations <20 mcg/mL have generally been milder than seizures associated with excessive serum theophylline concentrations resulting from an overdose (i.e., they have generally been transient, often stopped without anticonvulsant therapy, and did not result in neurological residua).
  • No data
  • The steady-state peak serum theophylline concentration is a function of the dose, the dosing interval, and the rate of theophylline absorption and clearance in the individual patient. Because of marked individual differences in the rate of theophylline clearance, the dose required to achieve a peak serum theophylline concentration in the 10-20 mcg/mL range varies fourfold among otherwise similar patients in the absence of factors known to alter theophylline clearance (e.g., 400-1600 mg/day in adults <60 years old and 10-36 mg/kg/day in children 1-9 years old). For a given population there is no single theophylline dose that will provide both safe and effective serum concentrations for all patients. Administration of the median theophylline dose required to achieve a therapeutic serum theophylline concentration in a given population may result in either sub-therapeutic or potentially toxic serum theophylline concentrations in individual patients. For example, at a dose of 900 mg/d in adults <60 years or 22 mg/kg/d in children 1-9 years, the steady state peak serum theophylline concentration will be <10 mcg/mL in about 30% of patients, 10-20 mcg/mL in about 50% and 20-30 mcg/mL in about 20% of patients. n n n n
  • Transient caffeine-like adverse effects and excessive serum concentrations in slow metabolizers can be avoided in most patients by starting with a sufficiently low dose and slowly increasing the dose, n n n in small increments (Seen n n ). Dose increases should only be made if the previous dosage is well tolerated and at intervals of no less than 3 days to allow serum theophylline concentrations to reach the new steady state. Dosage adjustment should be guided by serum theophylline concentration measurement (seen n n andn n n ). Health care providers should instruct patients and care givers to discontinue any dosage that causes adverse effects, to withhold the medication until these symptoms are gone and to then resume therapy at a lower, previously tolerated dosage (seen n n ).n nn
  • If the patient's symptoms are well controlled, there are no apparent adverse effects, and no intervening factors that might alter dosage requirements (seen n n andn n n ), serum theophylline concentrations should be monitored at 6 month intervals for rapidly growing children and at yearly intervals for all others. In acutely ill patients, serum theophylline concentrations should be monitored at frequent intervals, e.g., every 24 hours.n nn
  • Theophylline distributes poorly into body fat, therefore, mg/kg dose should be calculated on the basis of ideal body weight.
  • Table V contains theophylline dosing titration schema recommended for patients in various age groups and clinical circumstances. Table VI contains recommendations for theophylline dosage adjustment based upon serum theophylline concentrations. n n n n
  • Theophylline Oral Solution USP is a clear red solution with a berry flavor. u00a0Each tablespoonful (15 mL) contains 80 mg theophylline anhydrous.
  • Theophylline Oral Solution USP is available in the following oral dosage forms:
  • NDC 0121-0820-04:u00a0 4 fl oz (118 mL) bottle
  • NDC 0121-0820-16:u00a0 16 fl oz (473 mL) bottle
  • NDC 0121-4820-15:u00a0 15 mL unit dose cup
  • NDC 0121-4820-40:u00a0 Case contains 40 unit dose cups of 15 mL (0121-4820-15) packaged in 4 trays of 10 unit dose cups each.
  • NDC 0121-0820-16
  • Theophyllinen n n Oral Solution USPn n n
  • 80 mg/15 mL
  • Alcohol 20%
  • Dosage: Should be individualized.n n n See Package Insert.n n n
  • Rx ONLY
  • 16 fl oz (473 mL)
  • Arrayn- Array
  • Each 15 mL (tablespoonful)n n n contains 80 mg theophyllinen n n anhydrous.n nn
  • Pharmacist:
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F).n n n [See USP Controlled Roomn n n Temperature].n nn
  • R04/15n n n L08201600u00a0n nn
  • NDC 0121-0820-04
  • Theophyllinen n n Oral Solution USPn n n
  • 80 mg/15 mL
  • Alcohol 20%
  • Dosage: Should be individualized.n n n See Package Insert.n n n
  • Rx ONLY
  • 4 fl oz (118 mL)
  • Arrayn- Array
  • Each 15 mL (tablespoonful)n n n contains 80 mg theophyllinen n n anhydrous.n nn
  • Pharmacist
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F).[See USP Controlled RoomTemperature].
  • R04/15n n n L08200400n nn
  • Deliversn n n n NDC 0121-4820-15n nn
  • Arrayn- Arrayn- Array
  • 80 mg/15 mL
  • Alcohol 20%
  • FOR INSTITUTIONAL USE ONLYn n n Rx ONLYn n n
  • Pharmaceutical Associates, Inc.n n n Greenville, SC 29605n nn
  • SEE INSERT
  • A48201500

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