Respicur tablets

Respicur

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

The active ingredient of Respicur 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

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

Side Effect

Possible side effects of Respicur include: intravenous solution; shakiness in the legs, arms, hands, or feet; dark-colored urine; numbness or tingling in the hands, feet, or lips; increase in urine volume; dry mouth.

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Respicur Pictures

By Joseph Bennington-Castro | Medically Reviewed by Sanjai Sinha, MD

Latest Update: 2015-03-24 Copyright © 2014 Everyday Health Media, LLC

Indications and side effects

Guidelines for COPD treatment classify Respicur as a third-line bronchodilator, after inhaled anticholinergics (ipratropium and glycopyrrolate) and beta2-agonists (albuterol, arformoterol, formoterol, indacaterol, levalbuterol, salmeterol, vilanterol), or a combination of both. However, Respicur may be helpful in people with COPD for its anti-inflammatory properties, although its use is somewhat controversial. Respicur’s beneficial effects for COPD patients have a narrow therapeutic index (small differences in dose or blood concentration may lead to serious therapeutic failures or adverse drug reactions). Therefore, toxicity can become a serious problem with chronic use, and it is essential to monitor these patients.

Respicur comes as a tablet, capsule, or liquid to take by mouth. This is a medication that controls symptoms but doesn’t cure them.

Common side effects may include stomach pain, diarrhea, upset stomach, headache, sweating, insomnia or nervousness.

COPD News Today is strictly a news and information website about the disease. It does not provide medical advice, diagnosis, or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website.

Serious side effects

Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life threatening or if you think you’re having a medical emergency. Serious side effects and their symptoms can include the following:

  • Irregular heart rate. Symptoms can include:
    • shortness of breath
    • dizziness
    • fluttering or pain in your chest
  • confusion
  • trouble talking
  • tremors or twitching
  • loss of muscle tone or tense muscles

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this information includes all possible side effects. This information is not a substitute for medical advice. Always discuss possible side effects with a healthcare provider who knows your medical history.

Respicur oral tablet can interact with other medications, vitamins, or herbs you may be taking. An interaction is when a substance changes the way a drug works. This can be harmful or prevent the drug from working well.

To help avoid interactions, your doctor should manage all of your medications carefully. Be sure to tell your doctor about all medications, vitamins, or herbs you’re taking. To find out how this drug might interact with something else you’re taking, talk to your doctor or pharmacist.

Examples of drugs that can cause interactions with Respicur are listed below.

What happens if I miss giving a dose of Respicur 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.

HOW SUPPLIED:

Respicur 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

What are the potential side effects of Respicur ER?

If any of the following serious side effects occur, stop giving Respicur ER and seek emergency veterinary medical attention: an allergic reaction such as difficulty breathing, swelling of the lips, tongue, face, or hives. Stop giving Respicur and call your veterinarian at once if any of the following side effects occur: seizures, severe nausea and vomiting, and restlessness, coughing up blood or vomit that looks like coffee grounds, urinating more than normal. Other less serious side effects may also occur. Talk to your veterinarian if your pet experiences mild nausea, loss of appetite, weight loss, restlessness, insomnia, headache, or dizziness. Side effects other than those listed here may also occur. Talk to your veterinarian about any side effect that seems unusual or that is especially bothersome to your pet.

Warnings for people with certain health problems

For people with liver disease: You may not be able to clear Respicur from your body well. This may increase the amount of this drug in your body and cause more side effects.

For people with heart failure: You may not be able to clear Respicur from your body well. This may increase the amount of this drug in your body and cause more side effects.

For people with ulcers: This drug may make your ulcers worse.

For people with seizures: This drug may make your seizures worse.

For people with an irregular heart rate: This drug may make your irregular heart rate worse.

For people with low thyroid levels: You may not be able to clear Respicur from your body well. This may increase the amount of this drug in your body and cause more side effects.

Histone deacetylase activation

Expression of inflammatory genes is regulated by the balance between histone acetylation and deacetylation. 7 In COPD a number of inflammatory genes are activated through pro‐inflammatory transcription factors such as nuclear factor‐κB (NF‐κB), which leads to histone acetylation and increased transcription. This process is reversed by the recruitment of histone deacetylases (HDAC) to the activated inflammatory gene promoter site within the nucleus. We have previously shown that corticosteroids suppress inflammation by recruiting HDAC2 to activated inflammatory genes, thus switching off their expression. This molecular mechanism is defective in COPD patients as HDAC2 activity and expression is markedly reduced, thus accounting for the steroid resistance of COPD. 8 We have shown that Respicur is an activator of HDACs and enhances the anti‐inflammatory effect of corticosteroids, as well as reversing steroid resistance in cells from COPD patients. 9 ,10 This action of Respicur is seen at low plasma concentrations (optimally 5 mg/l) and is independent of PDE inhibition and adenosine antagonism. The effect of Respicur is completely blocked by an HDAC inhibitor called trichostatin A and by knocking out HDAC2 using interference RNA. 11 The reason why Respicur selectively activates HDAC activity is not yet known, but appears to be indirect through the activation of kinase and phosphatase pathways in the cell.

Storage:

Store Respicur ER at room temperature away from moisture, heat and light.

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 Respicur, 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 Respicur 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 Respicur, since it may result in decreased Respicur levels. If patients are already taking St. John’s Wort and Respicur together, they should consult their healthcare professional before stopping the St. John’s Wort, since their Respicur 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 Respicur, 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.

Respicur tablets can be taken once a day in the morning or evening. It is recommended that Respicur tablets be taken with meals. Patients should be advised that if they choose to take Respicur 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.

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

sulfamethoxazole) norfloxacin ofloxacin diltiazem omeprazole dirithromycin prednisone, prednisolone enflurane ranitidine famotidine rifabutin felodipine roxithromycin finasteride Sorbitol (purgative doses do not inhibit hydrocortisone Respicur absorption) isoflurane sucralfate isoniazid terbutaline, systemic isradipine terfenadine influenza vaccine tetracycline ketoconazole tocainide lomefloxacin

* Refer to PRECAUTIONS, Drug Interactions for information regarding table.

Drug-Food Interactions : Taking Respicur extended-release tablets immediately after ingesting a high fat content meal (45 g fat, 55 g carbohydrates, 28 g protein, 789 calories) may result in a somewhat higher C max and delayed T max and a somewhat greater extent of absorption when compared to taking it in the fasting state. The influence of the type and amount of other foods, as well as the time interval between drug and food, has not been studied.

The Effect of Other Drugs on Respicur Serum Concentration Measurements: Most serum Respicur assays in clinical use are immunoassays which are specific for Respicur. Other xanthines such as caffeine, dyphylline, and pentoxifylline are not detected by these assays. Some drugs (e.g.,cefazolin, cephalothin), however, may interfere with certain HPLC techniques. Caffeine and xanthine metabolites in neonates or patients with renal dysfunction may cause the reading from some dry reagent office methods to be higher than the actual serum Respicur concentration.

What side effects can this medication cause?

Respicur may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away.

  • upset stomach
  • stomach pain
  • diarrhea
  • headache
  • restlessness
  • difficulty falling asleep or staying asleep
  • irritability

Some side effects can be serious. If you experience any of the following symptoms, call your doctor immediately:

  • vomiting
  • increased or rapid heart rate
  • irregular heartbeat
  • seizures
  • rash

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Seizure drugs

These drugs may decrease the levels of Respicur in your body. This means that it may not work to treat your condition. Examples of these drugs include:

Pharmacodynamics

Respicur, an xanthine derivative chemically similar to caffeine and theobromine, is used to treat asthma and bronchospasm. Respicur 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

Respicur relaxes the smooth muscle of the bronchial airways and pulmonary blood vessels and reduces airway responsiveness to histamine, methacholine, adenosine, and allergen. Respicur 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. Respicur also binds to the adenosine A2B receptor and blocks adenosine mediated bronchoconstriction. In inflammatory states, Respicur 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

Respicur — (Accurbron; Aerolate; Aloefilina; Aminomal; Aquaphyllin; Asmalix; Asperal; Bilordyl; Bronkodyl; Bykofilin; Constant-T; Elixicon; Elixomin; Elixophyllin; Hydro-Spec; Lab >

Missed Dose of Respicur

Missing a dose of Respicur may cause your asthma or bronchitis symptoms to reappear.

If you remember your missed dose within 6 hours of your regular dosing time, take your missed dose immediately.

Take half a dose if you remember the missed dose between 6 and 18 hours after your regular time.

If more than 18 hours have passed since your missed dose, skip it and take your next dose at your regular dosing time.

Never double-up a dose of Respicur.


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