To prevent coughing or to treat chronic diarrhoea Not suitable for children. Codeine Phosphate Tablets should not be taken by children below the age of 12 years, due to the risk of severe breathing problems. This medicine should not be taken for more than 3 days. If the pain does not improve after 3 days, talk to your doctor for advice. Do not stop taking your medicines suddenly. Ask your doctor how to reduce the dose gradually.

If you take more tablets than you should If you accidentally take too much of your medicine, tell your doctor at once or contact your nearest hospital casualty department. Take your medicine with you. If you forget to take your medicine If you forget to take a dose, just take the next dose at the usual time. Raritan, New Jersey These effects seem to be more prominent in ambulatory than in non-ambulatory patients, and some of these adverse reactions may be alleviated if the patient lies down.

Other adverse reactions include allergic reactions, euphoria , dysphoria , constipation, abdominal pain , pruritus , rash , thrombocytopenia , and agranulocytosis. At higher doses, codeine has most of the disadvantages of morphine including respiratory depression. Abuse and Dependence Codeine can produce drug dependence of the morphine type and, therefore, has the potential for being abused. Psychological dependence, physical dependence, and tolerance may develop upon repeated administration and it should be prescribed and administered with the same degree of caution appropriate to the use of other oral narcotic medications.

Acetaminophen may produce false-positive test results for urinary 5-hydroxyindoleacetic acid. Narcotics also produce other CNS depressant effects, such as drowsiness, that may further obscure the clinical course of the patients with head injuries. Codeine or other narcotics may obscure signs on which to judge the diagnosis or clinical course of patients with acute abdominal conditions.

Codeine is habit forming and potentially abusable. Consequently, the extended use of this product is not recommended. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.

These individuals convert codeine into its active metabolite, morphine , more rapidly and completely than other people. This rapid conversion results in higher than expected serum morphine levels. Unit dose, 25 tablets per blister card NDC Bottles of Tablets 60 mg Tablet: Protect from moisture and light. Blisters are not child-resistant. Use child-resistant closure if dispensing to outpatient. All opioids are liable to diversion and misuse both by the general public and healthcare workers and should be handled accordingly.

The most frequently observed adverse reactions with codeine administration include drowsiness, lightheadedness , dizziness, sedation, shortness of breath, nausea, vomiting, sweating, and constipation.

Other adverse reactions include allergic reactions, euphoria , dysphoria , abdominal pain, and pruritis. Other less frequently observed adverse reactions expected from opioid analgesics, including codeine sulfate, include: Use codeine sulfate with caution and in reduced dosages in patients taking these agents.

Antidepressants Use of MAO inhibitors or tricyclic antidepressants with codeine sulfate may increase the effect of either the antidepressant or codeine. MAOIs markedly potentiate the action of morphine sulfate, the major metabolite of codeine. Codeine should not be used in patients taking MAOIs or within 14 days of stopping such treatment. Metabolic Enzymes Patients taking cytochrome P enzyme inducers or inhibitors may demonstrate an altered response to codeine, therefore analgesic activity should be monitored.

The concurrent use of drugs that preferentially induce codeine Ndemethylation cytochrome P 3A4 may increase the plasma concentrations of codeine's inactive metabolite norcodeine. Drugs that are strong inhibitors of codeine O-demethylation cytochrome P 2D6 may decrease the plasma concentrations of codeine's active metabolites, morphine and morphineglucuronide.

The contribution of these active metabolites to the overall analgesic effect of codeine is not fully understood, but should be considered. Drug-Laboratory Test Interaction Codeine sulfate tablets may cause an elevation of plasma amylase and lipase due to the potential of codeine to produce spasm of the sphincter of Oddi.

Determination of these enzyme levels may be unreliable for some time after an opiate agonist has been given. Codeine sulfate can be abused and is subject to criminal diversion. Abuse Drug addiction is characterized by compulsive use, use for non-medical purposes, and continued use despite harm or risk of harm. Drug addiction is a treatable disease, utilizing a multi-disciplinary approach, but relapse is common. Abuse and addiction are separate and distinct from physical dependence and tolerance.

Physicians should be aware that addiction may not be accompanied by concurrent tolerance and symptoms of physical dependence. The converse is also true. In addition, abuse of opioids can occur in the absence of true addiction and is characterized by misuse for nonmedical purposes, often in combination with other psychoactive substances. Careful record-keeping of prescribing information, including quantity, frequency, and renewal requests is strongly advised.

Codeine is intended for oral use only. Abuse of codeine poses a risk of overdose and death. The risk is increased with concurrent abuse of alcohol and other substances. Parenteral drug abuse is commonly associated with transmission of infectious diseases such as hepatitis and HIV.

Proper assessment of the patient, proper prescribing practices, periodic re-evaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs. Dependence Tolerance is the need for increasing doses of opioids to maintain a defined effect such as analgesia in the absence of disease progression or other external factors.

Codeine may impair your thinking or reactions. Avoid driving or operating machinery until you know how codeine will affect you.

What other drugs will affect codeine? Do not take codeine with any other narcotic pain medications , sedatives, tranquilizers, sleeping pills, muscle relaxers, or other medicines that can make you sleepy or slow your breathing. Dangerous side effects may result. Before taking codeine, tell your doctor if you are using pentazocine Talwin , nalbuphine Nubain , butorphanol Stadol , or buprenorphine Buprenex, Subutex. If you are using any of these drugs, you may not be able to use codeine, or you may need dosage adjustments or special tests during treatment.

No studies have been carried out to look at whether there is an increased risk of learning and behavioural problems in children who were exposed to codeine while in the womb. Can taking codeine in pregnancy cause other health problems in the child? Breathing problems at birth Codeine affects breathing in some people. Only one small study has investigated this. Although this study did not show that babies exposed to codeine during pregnancy are at increased risk of having breathing problems around the time of birth, information on more pregnant women is needed to be sure.

If you are likely to be taking codeine towards the end of pregnancy it is advisable to plan, with your health care provider, where you are going to have your baby so that, if necessary, arrangements for your baby to be monitored are already in place. Studies have shown that some babies who have been exposed to morphine in the womb experience withdrawal symptoms after birth as a result of no longer getting morphine through the placenta.

Taking codeine near to the end of pregnancy may also cause neonatal withdrawal. Unless instructed differently, take your tablet s with a glass of water. If you have been given a blister pack, to obtain a tablet, press on the tablet from the blister or bubble pushing it through the foil.

Do not remove the tablet from the blister until you are ready to take it. This medicine should not be taken for more than 3 days.

If the pain does not improve after 3 days, talk to your doctor for advice. If you miss a dose of Codeine Phosphate Tablets You should continue to take your medicine for as long as your doctor tells you to. If you forget a dose, take another as soon as you remember.

If it is almost time for your next dose, then do not take the missed dose at all. NEVER double the next dose to make up for the one missed. Do not stop taking the medicine without telling your doctor first. If treatment with Codeine Phosphate Tablets is stopped You should always check with your doctor before the treatment is stopped.

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