Drug ID: 1d00000015
Drug Name: Acetaminophen and Codein
Generic Names: Narcogin Forte | Capital | Codix | Empracet | Papa-deine | Phenaphen | Prova | Pyregesic-C
Legal Status: Opioid Prescription only drug
Indication for Mother: Category C
Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
Recommended Dose: Per tab contains paracetamol 500 mg and codeine phosphate 8 mg: 1-2 tabs 4-6 hourly. Max: 4-doses/24 hr.
Recommended In: This combination medication contains nonopiate, non-salicylate analgesic, antipyretic and opium alkaloid, prescribed for mild to moderately severe pain, fever and cough.
Directions For Use: It comes as a tablet,capsule and liquid to take by mouth, with food.
Storage: Store tablets and solutions at room temperature (15°-30°C). Keep this medication out of reach of children.
Dosage Forms: Tablet | Capsule |Syrup
Side Effects: Most Common - Drowsiness, lightheadedness, dizziness, slow heartbeat, sedation, shortness of breath, unusual thoughts or behavior, nausea, vomiting, flushing, vision changes, easy bruising or bleeding, stomach pain, loss of appetite, constipation, itching, decrease in platelets in blood, dark urine, clay-colored stools and difficulty in urinating.
In Case of Overdose: Codeine
Toxicity from codeine poisoning includes the opioid triad of: pinpoint pupils, depression of respiration, and loss of consciousness. Convulsions may occur.
In acetaminophen overdosage, dose-dependent, potentially fatal hepatic necrosis is the most serious adverse effect. Renal tubular necrosis, hypoglycemic coma and thrombocytopenia may also occur.
Early symptoms following a potentially hepatotoxic overdose may include: nausea, vomiting, diaphoresis and general malaise. Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48 to 72 hours post-ingestion.
In adults, hepatic toxicity has rarely been reported with acute overdoses of less than 10 grams or fatalities with less than 15 grams.
A single or multiple overdose with acetaminophen and codeine is a potentially lethal polydrug overdose and consultation with a regional poison control center is recommended.
Immediate treatment includes support of cardiorespiratory function and measures to reduce drug absorption. Vomiting should be induced mechanically, or with syrup of ipecac, if the patient is alert (adequate pharyngeal and laryngeal reflexes). Oral activated charcoal (1g/kg) should follow gastric emptying. The first dose should be accompanied by an appropriate cathartic. If repeated doses are used, the cathartic might be included with alternate doses as required. Hypotension is usually hypovolemic and should respond to fluids. Vasopressors and other supportive measures should be employed as indicated. A cuffed endo-tracheal tube should be inserted before gastric lavage of the unconscious patient and, when necessary, to provide assisted respiration.
Meticulous attention should be given to maintaining adequate pulmonary ventilation. In severe cases of intoxication, peritoneal dialysis, or preferably hemodialysis, may be considered. If hypoprothrombinemia occurs due to acetaminophen overdose, vitamin K should be administered intravenously.
Naloxone, a narcotic antagonist, can reverse respiratory depression and coma associated with opioid overdose. Naloxone hydrochloride 0.4 mg to 2 mg is given parenterally. Since the duration of action of codeine may exceed that of the naloxone, the patient should be kept under continuous surveillance and repeated doses of the antagonist should be administered as needed to maintain adequate respiration. A narcotic antagonist should not be administered in the absence of clinically significant respiratory or cardiovascular depression.
If the dose of acetaminophen may have exceeded 140 mg/kg, acetylcysteine should be administered as early as possible. Serum acetaminophen levels should be obtained, since levels four or more hours following ingestion help predict acetaminophen toxicity. Do not await acetaminophen assay results before initiating treatment. Hepatic enzymes should be obtained initially, and repeated at 24-hour intervals.
Methemoglobinemia over 30% should be treated with methylene blue by slow intravenous administration.
Toxic Doses (for adults)
Acetaminophen: toxic dose 10 g
Codeine: toxic dose 240 mg
Avoid If: Caution should be exercised in patients with history of allergy to narcotic pain medication,or to sulfites, depression, respiratory problems, diarrhea, irregular heart rate, low blood pressure, asthma, epilepsy, thyroid disease, liver or kidney impairment, during pregnancy, alcohol dependency and breastfeeding.
Avoid alcohol consumption.
Avoid long-term use of this medication; otherwise it may lead to restlessness and irritability.
It may cause dizziness or lightheadedness, do not drive a car or operate machinery, and get up slowly from bed while taking this medication.
Avoid excess dosage it causes (possibly fatal) liver damage.
It may cause severe allergic reactions; if it so consult with your doctor.
Drug Interaction: This drug may enhance the effects of other narcotic analgesics, alcohol, general anesthetics, tranquilizers such as chlordiazepoxide, sedative-hypnotics, or other CNS depressants, causing increased CNS depression.