Co-Gesic

Physicians prescribe Co-Gesic to relieve moderate to moderately severe pain.

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Other, off label uses for this medicine

Co-Gesic may relieve symptoms of the common cold, as hydrocodone soothes cough and acetaminophen reduces fever. Acetaminophen also reduces inflammation.

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Administration/Dosage

Co-Gesic contains 5 mg of the opioid pain reliever, hydrocodone bitartrate, and 500 mg of acetaminophen, a non-narcotic analgesic. Kremers Urban Pharmaceuticals Inc., packages Co-Gesic in a tablet form, bottled with a child-resistant cap. Co-Gesic is intended for oral use.

Hydrocodone is a semi-synthetic opioid pain reliever. Pharmacologists created hydrocodone from thebaine and codeine extracted from the opium poppy plant, Papaver somniferum.

Doctors usually prescribe one or two Co-Gesic tablets every four to six hours as needed for pain, but will adjust the dosage according to the severity of pain and the patient's response to treatment. A patient will develop tolerance to Co-Gesic, growing less sensitive to the effects of Co-Gesic. Dosage adjusted for severity of pain and patient response. Side effects are dose-dependent, meaning a person taking high doses of Co-Gesic is more likely to develop side effects and experience more severe side effects than someone taking a lower dose.

Physicians typically prescribed Co-Gesic on an as-needed basis, rather than on a regular schedule, so most Co-Gesic consumers do not have to worry about missed doses.

Scientists have not yet established the safety and efficacy of Co-Gesic use in children.

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Action

Hydrocodone is semi-synthetic opioid that works mainly on the central nervous system, or CNS, to change the way the brain perceives pain. This interaction with the CNS also causes sedation, soothes anxiety and produces a pleasant euphoria.

Hydrocodone acts directly on the area of the brain stem responsible for breathing. This opioid also works on part of the brain that controls respiratory rhythm.

Hydrocodone also works on smooth muscles, like those in the gastrointestinal system. Co-Gesic use slows down digestion in a way that may cause constipation.

Acetaminophen reduces fever by acting on the brain's temperature regulating center, the hypothalamus.
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Warnings

Acetaminophen overdose is the leading cause of acute liver failure, or ALF, in the United States, sometimes resulting in liver transplant and death. Most of these cases of ALF involve high doses of acetaminophen, exceeding 4000 mg per day. Many times, these cases involve the use of multiple acetaminophen-containing products, as acetaminophen is a common ingredient in prescription and non-prescription medications.

The risk for ALF is higher in individuals with underlying liver disease and in people who consume alcohol while taking acetaminophen.

Respiratory Depression

Because of the way hydrocodone interacts with the brain's respiratory centers, Co-Gesic may produce dose-related respiratory depression, irregular breathing rhythms and periodic breathing. Respiratory depression is a serious breathing problem where the lungs do not perform well. Symptoms of respiratory depression include slow or shallow breathing, difficulty breathing and a bluish tint around the eyes, lips and fingertips.

Respiratory depression may increase cerebrospinal fluid pressure; head injury, intracranial lesions or pre-existing high cerebrospinal fluid pressure can markedly exaggerate these effects.

The side effects associated with Co-Gesic may obscure the progress of head injury patients, making it more difficult for physicians to assess the patient's condition. These adverse reactions may also obscure the diagnosis or progress of patients with acute abdominal problems.

Contraindications

Patients who are hypersensitive to the effects of hydrocodone should not take Co-Gesic. A person hypersensitive to opioids other than hydrocodone may experience cross-over hypersensitivity to Co-Gesic.

Pregnancy and breastfeeding warnings 

FDA Co-Gesic is a pregnancy category C, meaning studies performed on animals have shown an adverse effect on the fetus and there are no adequate or well-controlled studies in humans, but the potential benefits may outweigh the risks for the use of Co-Gesic by pregnant women.

Taking Co-Gesic late in the pregnancy may cause the infant to experience withdrawal symptoms after birth. Neonatal withdrawal symptoms include irritability and excessive crying, tremors, hyperactive reflexes, increased respiratory rate, increased stools, sneezing, yawning, vomiting and fever.

Administered to the mother shortly before delivery, Co-Gesic may cause respiratory depression after birth, especially if the mother received high doses.

Mothers who use Co-Gesic may pass small amounts of acetaminophen into breast milk, although scientists have not yet determined whether its presence is significant. Researchers have not yet established whether hydrocodone passes into breast milk.

Sudden cessation

Using Co-Gesic continually for several weeks or more may cause physical dependence to hydrocodone. An opioid-dependent person experiences uncomfortable, flu-like symptoms when he stops using Co-Gesic suddenly. Anyone can become physically dependent on the hydrocodone in Co-Gesic.

Someone using Co-Gesic should not stop using it suddenly unless directed to do so by a physician. Instead, Co-Gesic consumers should taper use by taking successively smaller doses further apart.

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Precautions

Co-Gesic may cause dizziness, drowsiness or impair decision-making. Hydrocodone may affect physical or mental abilities. The consumer should not drive a car or operate heavy machinery until he knows how Co-Gesic will affect him.

The consumption of alcohol and other CNS depressants will add to CNS depression, a slowing of the body's central nervous system. CNS depression may result in staggering, blurred vision and slowed breathing and heart rates. CNS depressant drugs include sedatives, sleeping pills, anti-anxiety tranquilizers, anesthetics and seizure medications.

Special Risk Patients

Special risk patients, include elderly or debilitated individuals, should use Co-Gesic with care. People with severe kidney or liver problems, hypothyroidism, Addison's disease or those with prostate or urinary problems should exercise caution.

Individuals who are susceptible to respiratory depression should use caution when taking Co-Gesic. The hydrocodone in Co-Gesic suppresses the cough reflex. Physicians should prescribe Co-Gesic with care to post-operative patients or to those with breathing problems.

Geriatric Use

Scientific studies have not yet determined whether patients over the age of 65 respond to Co-Gesic differently than younger consumers. Physicians should start an older patient at a low dose to reflect an aging person's decreased liver, kidney or heart function or the presence of other illness and treatments for those illnesses.

The human kidneys excrete most of the hydrocodone and acetaminophen from the body; these substances may accumulate in the blood of those whose kidneys are not functioning properly. As the result, patients with impaired kidney function face a greater risk for toxic reactions.

Older patients are more likely to have decreased kidney function and are therefore at increased risk for toxic reactions. Lower doses of Co-Gesic and regular laboratory blood tests reduce this risk.

Hydrocodone may cause confusion and over-sedation in older patients. Reduced doses and close observation reduce the risk for these side effects and the harm they may cause in elderly patients.

Allergies

Someone who is allergic to hydrocodone, acetaminophen or any other component of Co-Gesic should not take this drug. Those with allergies to other opioids, including morphine or codeine, should not use Co-Gesic.

An allergic reaction is a medical emergency. Discontinue Co-Gesic immediately and seek medical care. Symptoms of an allergic reaction include swelling of the face, mouth and throat, respiratory distress, hives, itching, rash and vomiting.

Medical History

Co-Gesic may not be appropriate for those with a history of certain medical conditions. Co-Gesic may worsen this condition or interfere with treatment.

Lab tests
Physicians should monitor the effects of Co-Gesic therapy in patients with severe kidney or liver conditions with a series of liver or renal function tests.

The acetaminophen in Co-Gesic may produce false-positive test results for urinary 5-hydroxyindoleacetic acid.

Co-Gesic may be habit-forming. Using Co-Gesic at high doses, for a long time or for non-medical reasons increases this risk. Non-medical use includes using Co-Gesic to get high or to treat a condition other than the one for which it was prescribed.

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Drug Interactions

Co-Gesic may interact with other medications in unexpected or unsafe ways. To reduce the risk of drug interactions, Co-Gesic consumers should supply doctors and pharmacists with lists of all medications, including prescriptions, non-prescription drugs, supplements and herbal remedies.

Patients using Co-Gesic along with other opioids, antihistamines, anti-psychotic drugs, anti-anxiety medications or other CNS depressants, including alcohol, may experience additional CNS depression. Using MAO inhibitors or certain types of anti-depressants alongside Co-Gesic may increase the effect of either the anti-depressant or the hydrocodone.

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Side effects

All medications, including Co-Gesic, may cause side effects in some consumers. Most side effects are not serious and disappear with continued use at therapeutic doses.

The most frequently reported adverse reactions include lightheadedness, dizziness, sedation, nausea and vomiting. These effects seem more prominent in ambulatory patients when compared with those confined to a bed or wheelchair. The consumer may alleviate some of these side effects by lying down.

Because of the way hydrocodone acts on the nervous system to cause analgesia, sedation, relaxation and euphoria, Co-Gesic use may cause adverse reactions affecting the CNS. Consumers have reported drowsiness, mental clouding, lethargy, impairment of mental and physical performance. Co-Gesic may cause psychological CNS side effects including anxiety, fear, psychological dependence, mood changes and the emotional opposite of euphoria, dysphoria.

Hydrocodone acts on the breathing center in the brain stem to soothe cough, but may produce dose-related respiratory depression.

Other common side effects include skin rash or itching. Some Co-Gesic consumers have reported hearing impairment or permanent loss, predominately in cases of chronic overdose.

Acetaminophen use may cause allergic reactions, rash, blood disorders that could lead to clotting problems and low white blood cell counts.

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Overdose

Co-Gesic overdose is a serious medical emergency that requires immediate, professional care. Nearly 15,000 Americans die every year from overdose of prescription pain relievers including Co-Gesic. Acetaminophen overdose is one of the most common poisonings worldwide. Acetaminophen overdose frequently causes acute liver failure.

Someone may suffer from an overdose of the hydrocodone component of Co-Gesic, the acetaminophen in this product, or both. Hydrocodone overdose symptoms include respiratory depression, extreme sleepiness that progresses to stupor or coma, flaccid muscles and cold, clammy skin. Sometimes hydrocodone overdose victims suffer from slow heartbeat and low blood pressure. In cases of severe hydrocodone overdose, apnea, collapse of the circulatory system, heart attack and death may occur.

Acetaminophen causes serious liver damage. Early symptoms of an acetaminophen overdose that endangers the liver include nausea, vomiting, excessive sweating and general malaise. Laboratory tests and other clinical signs of liver damage may not appear for 48 to 72 hours after ingestion of Co-Gesic.

Transport suspected overdose victims to the nearest medical facility or call for an ambulance, whichever gets the patient to the hospital sooner. If transportation is not readily available, call poison control center at 1-800-222-1222.

Emergency department physicians will administer naloxone to reduce hydrocodone to safe levels quickly. Since the effects of hydrocodone often outlast naloxone, repeated doses of naloxone may be necessary.

Nurses will establish an airway to help the patient breathe and induce vomiting, pump the stomach or introduce charcoal to remove excess hydrocodone from the system.

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Abuse

Physicians in the United States prescribe more products containing hydrocodone than any other type of drug. In 2010, American pharmacists filled more than 139 million prescriptions for products containing hydrocodone. Because of the euphoric feeling it provides, coupled with widespread availability, hydrocodone is also the most widely abused drugs in the U.S.

The U.S. Drug Enforcement Agency, or DEA, ranks drugs according to their relative potential for non-medical abuse. Schedule I drugs, such as heroin, pose a significant risk for abuse while schedule V narcotics like Robitussin AC are associated with very little abuse. The DEA classifies Co-Gesic is a schedule III narcotic, meaning it carries the same risk as anabolic steroids. To reduce this risk, Co-Gesic is available by prescription only.

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Detoxification and Withdrawal

The body adjusts to the long-term presence of some substances by adjusting itself to maintain chemical balance; continuous use causes the body to depend on a certain level of hydrocodone to feel "normal." When hydrocodone levels fall drastically, the body struggles to maintain chemical stability - a process known as detoxification. The opioid-dependent person experiences the detoxification process through unpleasant withdrawal symptoms. Detoxification causes withdrawal symptoms in an opioid-dependent person.

Some opioid-dependent people can avoid withdrawal symptoms by weaning themselves from Co-Gesic use, taking smaller doses further apart. Breakthrough withdrawal symptoms prevent some people from tapering Co-Gesic use slowly; these individuals must engage in some form of detoxification to overcome physical dependence.

Missing a dose or taking an insufficient dose initiates the detoxification process. Some medications, including naloxone, reduce hydrocodone levels rapidly to start detoxification.

Detoxification from Co-Gesic produces physical and psychological withdrawal symptoms that appear in two sets, with the first wave starting a few hours after the last dose of Co-Gesic. Symptoms last five or more days, with the worst symptoms appearing on or about the fourth day.

Left untreated, withdrawal symptoms subside and do not return unless the individual becomes opioid-dependent again.

An opioid-dependent person can ease the variety of physical symptoms of withdrawal by taking multiple medications, such as Imodium for diarrhea and vitamins for muscle aches. Certain medications, including methadone and buprenorphine, stop withdrawal symptoms by mimicking the effects of Co-Gesic. Taking another dose of Co-Gesic halts the detoxification process and ends withdrawal symptoms.

Early symptoms of withdrawal include:

  • Agitation
  • Anxiety
  • Muscle aches
  • Increased tearing
  • Insomnia
  • Runny nose
  • Sweating
  • Yawning

Late symptoms of withdrawal include:

  • Abdominal cramping
  • Diarrhea
  • Dilated pupils
  • Goose bumps
  • Nausea
  • Vomiting

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Detox and Treatment

Someone may try to overcome physical dependence on hydrocodone by quitting Co-Gesic alone. Doctors call this self-detoxification; it is commonly known as "going cold turkey" as a reference to the skin's appearance during the detoxification process - pale, cold, clammy with goose bumps, resembling a plucked bird.

Without medicine to relieve physical withdrawal symptoms or professional guidance to overcome the demoralizing psychological aspects of the detoxification process, self-detoxification often results in relapse. Some people address symptoms by concocting a homemade treatment plan that includes medicines such as Imodium and vitamins. One such remedy is The Thomas Recipe.
Many health institutions now offer inpatient detoxification where physicians administer medicine to lower hydrocodone levels and drugs to relieve the ensuing withdrawal symptoms. While medications reduce the severity of physical symptoms somewhat, the individual is still left to battle the psychological aspects of detoxification that can make her feel incapable or unworthy of recovery.

Rapid detox is the most humane and efficient form of detoxification available today. During rapid detox, board-certified anesthesiologists administer sedatives and anesthesia alongside the standard detoxification and anti-withdrawal medications. The patient rests in a comfortable "twilight sleep," unaware of the grueling detoxification process.

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Storage

Co-Gesic is best stored at 77 degrees Fahrenheit, can tolerate temperature variances from 59 to 86 degrees. Keep Co-Gesic away from light.

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Miscellaneous information

Co-Gesic is an oval, white pill, about 19 mm in size. It is scored to be easily split into two pieces.

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