Codeine

Codeine is used to manage mild to moderate pain , where treatment with an opioid is appropriate, and when other pain treatments such as non-opioid pain medicines do not treat your pain well enough or you cannot tolerate them. Codeine is an opioid and considered a strong prescription pain medicine . It also has cough-suppressing (anti-tussive) properties. Codeine is available as one of 2 salts: codeine or codeine phosphate: Codeine phosphate is highly water-soluble and used in oral liquids, tablets, and injections Codeine sulfate is less soluble and primarily used in tablet form Codeine sulfate tablets are the only single-ingredient codeine still available in the United States . An opioid pain medicine that can put you at risk for overdose and death . Even if you take your dose correctly as prescribed, you are at risk for opioid addiction, abuse, and misuse that can lead to death. Codeine is available in combination with several other ingredients, including acetaminophen , guaifenesin , promethazine , and pseudoephedrine. In products containing guaifenesin, promethazine, or pseudoephedrine, codeine is included specifically for its cough-suppressing properties. Codeine falls under three different Schedule classifications depending on the product and how much codeine it contains. Single-ingredient codeine sulfate tablets are Schedule II . Combination products that contain less than 90 mg of codeine per dosage unit (such as acetaminophen with codeine ) are Schedule III Combination cough preparations containing not more than 200 milligrams of codeine per 100 milliliters, such as codeine and guaifenesin , are Schedule V (although some states have reclassified these as Schedule III ). Codeine has been used for over 100 years and has been classified as generally recognized as safe (GRAS) since 1950. On July 16, 2009, single-ingredient, prescription-only codeine tablets received FDA approval via a new drug application (NDA).

Codeine is used to manage mild to moderate pain , where treatment with an opioid is appropriate, and when other pain treatments such as non-opioid pain medicines do not treat your pain well enough or you cannot tolerate them. Codeine is an opioid and considered a strong prescription pain medicine . It also has cough-suppressing (anti-tussive) properties. Codeine is available as one of 2 salts: codeine or codeine phosphate: Codeine phosphate is highly water-soluble and used in oral liquids, tablets, and injections Codeine sulfate is less soluble and primarily used in tablet form Codeine sulfate tablets are the only single-ingredient codeine still available in the United States . An opioid pain medicine that can put you at risk for overdose and death . Even if you take your dose correctly as prescribed, you are at risk for opioid addiction, abuse, and misuse that can lead to death. Codeine is available in combination with several other ingredients, including acetaminophen , guaifenesin , promethazine , and pseudoephedrine. In products containing guaifenesin, promethazine, or pseudoephedrine, codeine is included specifically for its cough-suppressing properties. Codeine falls under three different Schedule classifications depending on the product and how much codeine it contains. Single-ingredient codeine sulfate tablets are Schedule II . Combination products that contain less than 90 mg of codeine per dosage unit (such as acetaminophen with codeine ) are Schedule III Combination cough preparations containing not more than 200 milligrams of codeine per 100 milliliters, such as codeine and guaifenesin , are Schedule V (although some states have reclassified these as Schedule III ). Codeine has been used for over 100 years and has been classified as generally recognized as safe (GRAS) since 1950. On July 16, 2009, single-ingredient, prescription-only codeine tablets received FDA approval via a new drug application (NDA).

Do not take codeine if you have: Severe asthma, trouble breathing, or other lung problems. A bowel blockage or a narrowing of the stomach or intestines. An allergy to codeine Tablets or any of the ingredients. Before taking codeine, tell your healthcare provider if you have a history of: Head injury, seizures Problems urinating Abuse of street or prescription drugs, alcohol addiction, opioid overdose, or mental health problems. Liver, kidney, thyroid problems Pancreas or gallbladder problems Have been told by your healthcare provider that you are a “rapid metabolizer” of certain medicines. Tell your healthcare provider if you are: Noticing your pain is getting worse . If your pain gets worse after you take codeine, do not take more codeine without first talking to your healthcare provider. Talk to your healthcare provider if the pain that you have increases, if you feel more sensitive to pain, or if you have new pain after taking codeine. Pregnant or planning to become pregnant. Use of codeine for an extended period of time during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated. Breastfeeding. Not recommended; may harm your baby. Living in a household where there are small children or someone who has abused street or prescription drugs. Taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking codeine with certain other medicines can cause serious side effects that could lead to death.

The possible side effects of codeine are constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, and abdominal pain. Call your healthcare provider if you have any of these symptoms and they are severe. Get emergency medical help or call 911 right away if you have: Trouble breathing, shortness of breath, fast heartbeat, chest pain, swelling of your face, tongue, or throat, extreme drowsiness, light-headedness when changing positions, feeling faint, agitation, high body temperature, trouble walking, stiff muscles, or mental changes such as confusion If you are a nursing mother taking codeine and your breastfeeding baby has increased sleepiness, confusion, difficulty breathing, shallow breathing, limpness, or difficulty breastfeeding. These are not all the possible side effects of codeine. Call your healthcare provider for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Get emergency help or call 911 right away if you take too much codeine (overdose). When you first start taking codeine, when your dose is changed, or if you take too much (overdose), serious or life-threatening breathing problems that can lead to death may occur. Ask your healthcare provider about medicines like naloxone or nalmefene that can be used in an emergency to reverse an opioid overdose. Taking codeine with other opioid medicines, benzodiazepines, gabapentinoids (gabapentin or pregabalin), alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death. Never give anyone else your codeine. They could die from taking it. Selling or giving away codeine is against the law. Store codeine securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home.

Get emergency help or call 911 right away if you take too much codeine (overdose). When you first start taking codeine, when your dose is changed, or if you take too much (overdose), serious or life-threatening breathing problems that can lead to death may occur. Ask your healthcare provider about medicines like naloxone or nalmefene that can be used in an emergency to reverse an opioid overdose. Taking codeine with other opioid medicines, benzodiazepines, gabapentinoids (gabapentin or pregabalin), alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death. Never give anyone else your codeine. They could die from taking it. Selling or giving away codeine is against the law. Store codeine securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home.

10 to 50 mg (30 (30)) 6 hourly PO —

250 ug/kg (250 (250)) 6 hourly Oral — -

No neonatal dosage information is recorded for this medicine yet.

You may have breathing problems or withdrawal symptoms if you start or stop taking certain other medicines. Tell your doctor if you also use an antibiotic, antifungal medication, heart or blood pressure medication, seizure medication, or medicine to treat HIV or hepatitis C. Opioid medication can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use: cold or allergy medicines, bronchodilator asthma/COPD medication, or a diuretic ("water pill"); medicines for motion sickness, irritable bowel syndrome, or overactive bladder; other narcotic medications - opioid pain medicine or prescription cough medicine; a sedative like Valium - diazepam, alprazolam, lorazepam, Xanax, Klonopin, Versed, and others; drugs that make you sleepy or slow your breathing - a sleeping pill, muscle relaxer, medicine to treat mood disorders or mental illness; or drugs that affect serotonin levels in your body - a stimulant, or medicine for depression, Parkinson's disease, migraine headaches, serious infections, or nausea and vomiting. This list is not complete. Other drugs may interact with codeine, including prescription and over-the-counter medicines, vitamins , and herbal products . Not all possible interactions are listed in this medication guide.

Inj Store at room temperature. Do not Freeze. Protect from Sunlight. Tab, Oral Soln Store Below 40°C. Protect from Sunlight and Moisture.