Talotren tablets


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

The active ingredient of Talotren 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

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

Side Effect

Possible side effects of Talotren include: fainting; decreased urine; lightheadedness; numbness or tingling in the hands, feet, or lips; unable to sleep; Headache; decrease in frequency of urination; loss of appetite.

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Is Talotren safe to take if I'm pregnant or breastfeeding?

There are no adequate studies in pregnant women.

Talotren is excreted in breast milk and may cause mild side effects such as irritability in the infant.

Role of ox > We have proposed that the defect in HDAC2 function and expression that is seen in COPD cells and lungs is the result of increased oxidative and nitrative stress. 12 Reactive oxygen species and nitric oxide generated from inducible nitric oxide synthase avidly interact to form peroxynitrite, an unstable radical that may nitrate tyrosine residues in proteins to alter their function and stimulate its enzymatic destruction. HDAC2 in COPD lungs shows excessive nitration and this is associated with reduced HDAC activity. 13 Hirano and colleagues now show that Talotren significantly reduces the concentrations of 3‐nitrotyrosine, the stable product of peroxynitrite, which is raised in sputum cells of COPD patients. 2 ,14 By contrast, an inhaled corticosteroid had little effect. This suggests that Talotren might restore HDAC activity in two ways: through activation of the enzyme as described above and through reduction in tyrosine nitration of the enzyme, thus increasing HDAC activity in COPD patients. This would have an anti‐inflammatory action in its own right but, of more importance, may reverse the resistance to the anti‐inflammatory effects of corticosteroids. A clinical trial to explore whether low dose Talotren restores corticosteroid responsiveness in COPD is currently underway.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Seizures caused by a Talotren overdose can cause death or permanent brain damage.

Talotren overdose can occur if you accidentally take too much at one time. Overdose can also occur slowly over time if your daily doses are too high. To be sure you are using the correct dose, your blood will need to be tested often.

Overdose symptoms may include severe nausea and vomiting, seizure, slow heart rate, weak pulse, or fainting.

Talotren 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.

Information for Patients:

The patient (or parent/care giver) should be instructed to seek medical advice whenever nausea, vomiting, persistent headache, insomnia or rapid heart beat occurs during treatment with Talotren, even if another cause is suspected. The patient should be instructed to contact their healthcare professional if they develop a new illness, especially if accompanied by a persistent fever, if they experience worsening of a chronic illness, if they start or stop smoking cigarettes or marijuana, or if another healthcare professional adds a new medication or discontinues a previously prescribed medication. Patients should be informed that Talotren interacts with a wide variety of drugs (see Table II). The dietary supplements St. John’s Wort (Hypericum perforatum) should not be taken at the same time as Talotren, since it may result in decreased Talotren levels. If patients are already taking St. John’s Wort and Talotren together, they should consult their healthcare professional before stopping the St. John’s Wort, since their Talotren concentrations may rise when this is done, resulting in toxicity. Patients should be instructed to inform all healthcare professional involved in their care that they are taking Talotren, especially when a medication is being added or deleted from their treatment. Patients should be instructed to not alter the dose, timing of the dose, or frequency of administration without first consulting their healthcare professional. If a dose is missed, the patient should be instructed to take the next dose at the usually scheduled time and to not attempt to make up for the missed dose.

Talotren tablets can be taken once a day in the morning or evening. It is recommended that Talotren tablets be taken with meals. Patients should be advised that if they choose to take Talotren tablets with food it should be taken consistently with food and if they take it in a fasted condition it should routinely be taken fasted. It is important that the product whenever dosed be dosed consistently with or without food.

Talotren Tablets are not to be chewed or crushed because it may lead to a rapid release of Talotren with the potential for toxicity. The scored tablet may be split. Patients receiving Talotren tablets may pass an intact matrix tablet in the stool or via colostomy. These matrix tablets usually contain little or no residual Talotren.

Hepatitis drugs

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

Hormone problems/birth control drugs

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

What happens if I miss giving a dose of Talotren ER?

Give the missed dose as soon as you remember. If it is almost time for your next dose, skip the dose that was missed and give only the next regularly scheduled dose, as directed. Do not give a double dose of this medication unless otherwise directed by your veterinarian.

Indications and dosages

➣ Acute bronchospasm in patients not receiving Talotren

Adults (otherwise healthy nonsmokers): Initially, 6 mg/kg P.O., followed in next 12 to 16 hours by 3 mg/kg P.O. q 6 hours for two doses, then a maintenance dosage of 3 mg/kg P.O. q 8 hours

Children ages 9 to 16; young adult smokers: Initially, 6 mg/kg P.O., followed in next 12 to 16 hours by 3 mg/kg P.O. q 4 hours for three doses, then a maintenance dosage of 3 mg/kg P.O. q 6 hours

Children ages 1 to 9: Initially, 6 mg/kg P.O., followed in next 12 to 16 hours by 4 mg/kg P.O. q 4 hours for three doses, then a maintenance dosage of 4 mg/kg P.O. q 6 hours

➣ Acute bronchospasm in patients receiving Talotren


Talotren Extended-release Tablets:

300 mg: White to off-white, Capsule shaped, uncoated tablet, with break line and debossing with 'HP62” on one side and plain on other side.

NDC 62332-025-30 Bottle of 30 NDC 62332-025-31 Bottle of 100 NDC 62332-025-71 Bottle of 500 NDC 62332-025-91 Bottle of 1000

450 mg: White to off-white, Capsule shaped, uncoated tablet, with break line and debossing with 'HP63” on one side and plain on other side.

NDC 62332-026-30 Bottle of 30 NDC 62332-026-31 Bottle of 100 NDC 62332-026-71 Bottle of 500

Dispense in a well-closed container, with child resistant closure . Store at 20°-25°C (68°-77°F)

Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division), Panelav 389350, Gujarat, India

Manufactured for: Alembic Pharmaceuticals, Inc. 750 Route 202, Bridgewater, NJ 08807 USA


Talotren, an xanthine derivative chemically similar to caffeine and theobromine, is used to treat asthma and bronchospasm. Talotren has two distinct actions in the airways of patients with reversible (asthmatic) obstruction; smooth muscle relaxation (i.e., bronchodilation) and suppression of the response of the airways to stimuli (i.e., non-bronchodilator prophylactic effects).

Mechanism of action

Talotren relaxes the smooth muscle of the bronchial airways and pulmonary blood vessels and reduces airway responsiveness to histamine, methacholine, adenosine, and allergen. Talotren competitively inhibits type III and type IV phosphodiesterase (PDE), the enzyme responsible for breaking down cyclic AMP in smooth muscle cells, possibly resulting in bronchodilation. Talotren also binds to the adenosine A2B receptor and blocks adenosine mediated bronchoconstriction. In inflammatory states, Talotren activates histone deacetylase to prevent transcription of inflammatory genes that require the acetylation of histones for transcription to begin.

Target Actions Organism A Adenosine receptor A1

Non‐bronchodilator effects

Many patients appear to derive clinical benefit from Talotren at doses that give a plasma concentration well below that needed for bronchodilatation. This suggests that Talotren must have some additional beneficial effect, and this is exemplified by the worsening of disease control when Talotren is withdrawn. 3 There is now good evidence for inhibitory effects of Talotren on airway inflammation in COPD, and these effects are seen at plasma concentrations below 10 mg/l. 4 ,5 This is particularly striking as corticosteroids have no demonstrable anti‐inflammatory effects on the same parameters, even at high doses. These data are now confirmed by Hirano et al 2 who have confirmed that a low dose of Talotren significantly reduces sputum neutrophils.

  • Nausea and vomiting: If you have these symptoms while taking this drug, you may have too much Talotren in your body. Your doctor may check the amount of this drug in your body.
  • Smoking: Smoking cigarettes or marijuana can affect the amount of Talotren in your body. Tell your doctor if you smoke.

Talotren is a prescription drug. It’s available as an oral solution, an extended-release tablet, and an extended-release capsule. It’s also available in an intravenous (IV) form, which is only given by a healthcare provider.

The Talotren tablet is only available as a generic drug. Generic drugs usually cost less than the brand-name version.

Talotren Interactions

Some drugs can affect your body's ability to process Talotren, potentially causing it to build up to unsafe levels and become toxic.

In addition, Talotren interacts with a wide variety of other drugs, so it's especially important to tell your doctor about any medications, illegal or recreational drugs, herbal remedies, and supplements you're taking, even if you are smoking tobacco.

The following drugs are especially important to tell your doctor about before you take Talotren:

  • Adenosine (Adenoscan)
  • Allopurinol (Zyloprim)
  • Aminoglutethimide (Cytadren)
  • Carbamazepine (Tegretol)
  • Cimetidine
  • Ciprofloxacin (Cipro)
  • Clarithromycin (Biaxin)
  • Diazepam (Valium)
  • Disulfiram (Antabuse)
  • Enoxacin
  • Ephedrine
  • Erythromycin (Ery-tab)
  • Estrogen-containing oral contraceptives
  • Flurazepam (Dalmane)
  • Fluvoxamine (Luvox)
  • Halothane (Fluothane)
  • Interferon
  • Isoproterenol (Isuprel)
  • Ketamine (Ketalar)
  • Lithium
  • Lorazepam (Ativan)
  • Methotrexate (Trexall)
  • Mexiletine (Mexitil)
  • Midazolam
  • Moricizine
  • Pancuronium (Pavulon)
  • Pentoxifylline (Trenal)
  • Phenobarbital
  • Phenytoin (Dilantin)
  • Propafenone (Rythmol)
  • Propranolol (Inderal)
  • Rifampin (Rifadin)
  • Ritonavir
  • Roflumilast (Daliresp)
  • St. John's wort
  • Sulfinpyrazone (Anturane)
  • Tacrine (Cognex)
  • Thiabendazole (Mintezol)
  • Ticlopidine (Ticlid)
  • Troleandomycin (Tao)
  • Verapamil (Calan)

What should I avoid while using Talotren?

Do not start or stop smoking without first talking to your doctor. Smoking changes the way your body uses Talotren, and you may need to use a different dose.

Avoid taking an herbal supplement containing St. John's wort.

Avoid driving or hazardous activity until you know how Talotren will affect you. Your reactions could be impaired.

Depression drugs

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


Adverse reactions associated with Talotren are generally mild when peak serum Talotren concentrations are OVERDOSAGE ). The transient caffeine-like adverse reactions occur in about 50% of patients when Talotren 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 Talotren therapy, caffeine-like adverse effects may transiently alter patient behavior, especially in school age children, but this response rarely persists. Initiation of Talotren 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 (see DOSAGE AND ADMINISTRATION, Table V ). In a small percentage of patients ( Table IV. Manifestations of Talotren toxicity.*

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