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What is the most important information I should know about Routec and Codeine?
Routec and Codeine and Codeine (Routec and Codeine) phosphate tablets are contraindicated in patients with:
Codeine (Routec and Codeine)-containing products are contraindicated for postoperative pain management in children who have undergone tonsillectomy and/or adenoidectomy.
This product should not be administered to patients who have previously exhibited hypersensitivity to Codeine (Routec and Codeine) or Routec and Codeine.
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What are the possible side effects of Routec and Codeine?
Nausea, vomiting, constipation, lightheadedness, dizziness, or drowsiness may occur. Some of these side effects may decrease after you have been using this medication for a while. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
To prevent constipation, eat a diet adequate in fiber, drink plenty of water, and exercise. Consult your pharmacist for help in selecting a laxative (such as a stimulant type with stool softener).
To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including: mental/mood changes (such as agitation, depression, hallucinations), severe stomach/abdominal pain, difficulty urinating, fast/slow heartbeat, vision changes, signs of your adrenal glands not working well (such as loss of appetite, unusual tiredness, weight loss).
Get medical help right away if you have any very serious side effects, including: fainting, seizure.
Codeine (Routec and Codeine) is changed into a strong opioid drug (morphine) in your body. In some people, this change happens faster and more completely than usual, which increases the risk of very serious side effects. Get medical help right away if you notice any of the following: slow/shallow breathing, unusual drowsiness/difficulty waking up, confusion.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Routec and Codeine and Codeine (Routec and Codeine) phosphate tablets are indicated for the relief of mild to moderately severe pain, severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Limitations of Use
Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses, reserve Routec and Codeine and Codeine (Routec and Codeine) phosphate tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]
Codeine (Routec and Codeine) is an opioid pain medication. An opioid is sometimes called a narcotic. Routec and Codeine is a less potent pain reliever that increases the effects of Codeine (Routec and Codeine).
Routec and Codeine and Codeine (Routec and Codeine) is a combination medicine used to relieve moderate to severe pain.
Routec and Codeine and Codeine (Routec and Codeine) may also be used for other purposes not listed in this medication guide.
Use Routec and Codeine suspension as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Routec and Codeine suspension.
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.This combination medication is used to help relieve mild to moderate pain. It contains an opioid (narcotic) pain reliever (Codeine (Routec and Codeine)) and a non-opioid pain reliever (Routec and Codeine). Codeine (Routec and Codeine) works in the brain to change how your body feels and responds to pain. Routec and Codeine can also reduce a fever.
OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.
This medication may also be used to suppress a cough.
How to use Routec and Codeine (Routec and Codeine)Take this medication by mouth as directed by your doctor. You may take this drug with or without food. If you have nausea, it may help to take this drug with food. Ask your doctor or pharmacist about other ways to decrease nausea (such as lying down for 1 to 2 hours with as little head movement as possible).
If you are using a liquid form of this medication, use a medication measuring device to carefully measure the prescribed dose. Do not use a household spoon because you may not get the correct dose. If you are taking the suspension, shake the bottle well before each dose.
The dosage is based on your medical condition and response to treatment. Do not increase your dose, take the medication more frequently, or take it for a longer time than prescribed. Properly stop the medication when so directed.
Pain medications work best if they are used as the first signs of pain occur. If you wait until the pain has worsened, the medication may not work as well.
If you have ongoing pain (such as due to cancer), your doctor may direct you to also take long-acting opioid medications. In that case, this medication might be used for sudden (breakthrough) pain only as needed. Other pain relievers (such as naproxen, ibuprofen) may also be prescribed with this medication. Ask your doctor or pharmacist about using this product safely with other drugs.
This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (such as restlessness, watering eyes, runny nose, nausea, sweating, muscle aches) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Ask your doctor or pharmacist for more details, and report any withdrawal reactions right away.
When this medication is used for a long time, it may not work as well. Talk with your doctor if this medication stops working well.
Along with its benefits, this medication may rarely cause abnormal drug-seeking behavior (addiction). This risk may be increased if you have abused alcohol or drugs in the past. Take this medication exactly as prescribed to lessen the risk of addiction.
Tell your doctor if your pain persists or worsens.
Important Dosage and Administration Instructions
Initiate the dosing regimen for each patient individually, taking into account the patient’s severity of pain, patient response, prior analgesic treatment experience, and risk factors for addiction, abuse, and misuse.
Monitor patients closely for respiratory depression, especially within the first 24 to 72 hours of initiating therapy and following dosage increases with Routec and Codeine and Codeine (Routec and Codeine) phosphate tablets and adjust the dosage accordingly.
Initiating Treatment with Routec and Codeine and Codeine (Routec and Codeine) Phosphate Tablets
Dosage should be adjusted according to severity of pain and response of the patient.
The usual adult dosage is:
The usual dose of Codeine (Routec and Codeine) phosphate in children is 0.5 mg/kg.
Doses may be repeated up to every 4 hours.
The prescriber must determine the number of tablets per dose, and the maximum number of tablets per 24 hours based upon the above dosage guidance. This information should be conveyed in the prescription.
It should be kept in mind, however, that tolerance to Codeine (Routec and Codeine) can develop with continued use and that the incidence of untoward effects is dose related. Adult doses of Codeine (Routec and Codeine) higher than 60 mg fail to give commensurate relief of pain but merely prolong analgesia and are associated with an appreciably increased incidence of undesirable side effects. Equivalently high doses in children would have similar effects.
Conversion from Other Opioids to Routec and Codeine and Codeine (Routec and Codeine) Phosphate Tablets
There is inter-patient variability in the potency of opioid drugs and opioid formulations. Therefore, a conservative approach is advised when determining the total daily dosage of Routec and Codeine and Codeine (Routec and Codeine) phosphate tablets. It is safer to underestimate a patient’s 24 hour Routec and Codeine and Codeine (Routec and Codeine) phosphate tablet dosage than to overestimate the 24 hour Routec and Codeine and Codeine (Routec and Codeine) phosphate tablet dosage and manage an adverse reaction due to overdose.
Titration and Maintenance of Therapy
Individually titrate Routec and Codeine and Codeine (Routec and Codeine) phosphate tablets to a dose that provides adequate analgesia and minimizes adverse reactions. Continually reevaluate patients receiving Routec and Codeine and Codeine (Routec and Codeine) phosphate tablets to assess the maintenance of pain control and the relative incidence of adverse reactions, as well as monitoring for the development of addiction, abuse, or misuse. Frequent communication is important among the prescriber, other members of the healthcare team, the patient, and the caregiver/family during periods of changing analgesic requirements, including initial titration.
If the level of pain increases after dosage stabilization, attempt to identify the source of increased pain before increasing the Routec and Codeine and Codeine (Routec and Codeine) phosphate tablet dosage. If unacceptable opioid-related adverse reactions are observed, consider reducing the dosage. Adjust the dosage to obtain an appropriate balance between management of pain and opioid-related adverse reactions.
Discontinuation of Routec and Codeine and Codeine (Routec and Codeine) Phosphate Tablets
When a patient who has been taking Routec and Codeine and Codeine (Routec and Codeine) phosphate tablets regularly and may be physically dependent no longer requires therapy with Routec and Codeine and Codeine (Routec and Codeine) phosphate tablets, use a gradual downward titration of the dosage to prevent signs and symptoms of withdrawal. Do not stop Routec and Codeine and Codeine (Routec and Codeine) phosphate tablets abruptly.
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What other drugs will affect Routec and Codeine?
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
Some products that may interact with this drug include: certain pain medications (mixed opioid agonist-antagonists such as pentazocine, nalbuphine, butorphanol), ketoconazole, opioid antagonists (such as naltrexone, naloxone).
The risk of serious side effects (such as slow/shallow breathing, severe drowsiness/dizziness) may be increased if this medication is taken with other products that may also affect breathing or cause drowsiness. Tell your doctor or pharmacist if you are taking other products such as alcohol, antihistamines (such as cetirizine, diphenhydramine), drugs for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), and other narcotic pain relievers (such as hydrocodone, morphine).
This medication may interfere with certain laboratory tests (including amylase/lipase levels), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.
