What happens if I overdose Medigesic Plus?
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local, or emergency room immediately. Symptoms may include cold or clammy skin; confusion; decreased urination; delirium; fainting; fast or irregular heartbeat; loss of consciousness; restlessness; severe dizziness, drowsiness, or light-headedness; severe or persistent nausea or vomiting; slow, shallow, or difficult breathing; symptoms of liver problems (eg, dark urine, loss of appetite, pale stools, severe stomach pain, yellowing of the skin or eyes); tremors; trouble sleeping; unusual bruising or bleeding; unusual sweating; unusual tiredness.
Proper storage of Medigesic Plus:
Store Medigesic Plus at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Medigesic Plus out of the reach of children and away from pets.
Overdose of Medigesic Plus in details
Following an acute overdosage of Medigesic Plus, toxicity may result from the barbiturate or the Acetaminophen (Medigesic Plus). Toxicity due to Medigesic Plus is less likely, due to the relatively small amounts in this formulation.
Signs and Symptoms
Toxicity from barbiturate poisoning include drowsiness, confusion, and coma; respiratory depression; hypotension; and hypovolemic shock.
In Acetaminophen (Medigesic Plus) overdosage: dose-dependent, potentially fatal hepatic necrosis is the most serious adverse effect. Renal tubular necroses, 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.
Acute Medigesic Plus poisoning may cause insomnia, restlessness, tremor, and delirium, tachycardia and extrasystoles.
Treatment
A single or multiple drug overdose with this combination product 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.
Oxygen, intravenous fluids, vasopressors, and other supportive measures should be employed as indicated. Assisted or controlled ventilation should also be considered.
Gastric decontamination with activated charcoal should be administered just prior to N-acetylcysteine (NAC) to decrease systemic absorption if Acetaminophen (Medigesic Plus) ingestion is known or suspected to have occurred within a few hours of presentation. Serum Acetaminophen (Medigesic Plus) levels should be obtained immediately if the patient presents 4 hours or more after ingestion to assess potential risk of hepatotoxicity; Acetaminophen (Medigesic Plus) levels drawn less than 4 hours post-ingestion may be misleading. To obtain the best possible outcome, NAC should be administered as soon as possible where impending or evolving liver injury is suspected.
Intravenous NAC may be administered when circumstances preclude oral administration.
Vigorous supportive therapy is required in severe intoxication. Procedures to limit the continuing absorption of the drug must be readily performed since the hepatic injury is dose dependent and occurs early in the course of intoxication.
What should I avoid while taking Medigesic Plus?
This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.
Avoid drinking alcohol. It may increase your risk of liver damage while taking Acetaminophen (Medigesic Plus).
Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (Medigesic Plus) (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much Acetaminophen (Medigesic Plus) which can lead to a fatal overdose. Check the label to see if a medicine contains Acetaminophen (Medigesic Plus) or APAP.
While you are taking this medication, avoid taking diet pills, Medigesic Plus pills, or other stimulants (such as ADHD medications) without your doctor's advice.
Medigesic Plus warnings
Butalbital (Medigesic Plus) is habit-forming and potentially abusable. Consequently, the extended use of Medigesic Plus is not recommended.
Hepatotoxicity
Acetaminophen (Medigesic Plus) has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of Acetaminophen (Medigesic Plus) at doses that exceed 4000 milligrams per day, and often involve more than one Acetaminophen (Medigesic Plus)-containing product. The excessive intake of Acetaminophen (Medigesic Plus) may be intentional to cause self-harm or unintentional as patients attempt to obtain more pain relief or unknowingly take other Acetaminophen (Medigesic Plus)-containing products.
The risk of acute liver failure is higher in individuals with underlying liver disease and in individuals who ingest alcohol while taking Acetaminophen (Medigesic Plus).
Instruct patients to look for Acetaminophen (Medigesic Plus) or APAP on package labels and not to use more than one product that contains Acetaminophen (Medigesic Plus). Instruct patients to seek medical attention immediately upon ingestion of more than 4000 milligrams of Acetaminophen (Medigesic Plus) per day, even if they feel well.
Serious skin reactions
Rarely, Acetaminophen (Medigesic Plus) may cause serious skin reactions such as acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. Patients should be informed about the signs of serious skin reactions, and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.
Hypersensitivity/Anaphylaxis
There have been post-marketing reports of hypersensitivity and anaphylaxis associated with use of Acetaminophen (Medigesic Plus). Clinical signs included swelling of the face, mouth, and throat, respiratory distress, urticaria, rash, pruritus, and vomiting. There were infrequent reports of life-threatening anaphylaxis requiring emergency medical attention. Instruct patients to discontinue Medigesic Plus immediately and seek medical care if they experience these symptoms. Do not prescribe Medigesic Plus for patients with Acetaminophen (Medigesic Plus) allergy.
What should I discuss with my healthcare provider before taking Medigesic Plus?
Do not use Medigesic Plus if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine.
You should not use Medigesic Plus if you are allergic to Acetaminophen (Medigesic Plus), Butalbital (Medigesic Plus), or Medigesic Plus, if you have porphyria, or if you have recently used alcohol, sedatives, tranquilizers, or other narcotic medications.
To make sure Medigesic Plus is safe for you, tell your doctor if you have:
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liver disease, cirrhosis, a history of alcoholism or drug addiction, or if you drink more than 3 alcoholic beverages per day;
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kidney disease;
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asthma, sleep apnea, or other breathing disorder;
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stomach ulcer or bleeding;
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a history of skin rash caused by any medication;
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a history of mental illness or suicidal thoughts; or
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if you use medicine to prevent blood clots.
It is not known whether Medigesic Plus will harm an unborn baby. If you use Butalbital (Medigesic Plus) while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on habit-forming medicine may need medical treatment for several weeks. Tell your doctor if you are pregnant or plan to become pregnant.
This medicine can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby.
Medigesic Plus precautions
General
Butalbital (Medigesic Plus), Acetaminophen (Medigesic Plus), and Medigesic Plus tablets should be prescribed with caution in certain special-risk patients, such as the elderly or debilitated, and those with severe impairment of renal or hepatic function, or acute abdominal conditions.
Information for Patients/Caregivers
- Do not take Medigesic Plus if you are allergic to any of its ingredients.
- If you develop signs of allergy such as a rash or difficulty breathing, stop taking Medigesic Plus and contact your healthcare provider immediately.
- Do not take more than 4000 milligrams of Acetaminophen (Medigesic Plus) per day. Call your doctor if you took more than the recommended dose.
- Medigesic Plus may impair mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. Such tasks should be avoided while taking this product.
- Alcohol and other CNS depressants may produce an additive CNS depression when taken with Medigesic Plus, and should be avoided.
- Butalbital (Medigesic Plus) may be habit-forming. Patients should take the drug only for as long as it is prescribed, in the amounts prescribed, and no more frequently than prescribed.
- For information on use in geriatric patients, see PRECAUTIONS/Geriatric Use.
Laboratory Tests
In patients with severe hepatic or renal disease, effects of therapy should be monitored with serial liver and/or renal function tests.
Drug Interactions
The CNS effects of Butalbital (Medigesic Plus) may be enhanced by monoamine oxidase (MAO) inhibitors.
Butalbital (Medigesic Plus), Acetaminophen (Medigesic Plus), and Medigesic Plus 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.
Drug/Laboratory Test Interactions
Acetaminophen (Medigesic Plus) may produce false-positive test results for urinary 5-hydroxyindoleacetic acid.
Carcinogenesis, Mutagenesis, Impairment of Fertility
No adequate studies have been conducted in animals to determine whether Acetaminophen (Medigesic Plus) or Butalbital (Medigesic Plus) have a potential for carcinogenesis, mutagenesis or impairment of fertility.
Pregnancy
Teratogenic EffectsPregnancy Category C: Animal reproduction studies have not been conducted with Medigesic Plus. It is also not known whether Butalbital (Medigesic Plus), Acetaminophen (Medigesic Plus), and Medigesic Plus can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. This product should be given to a pregnant woman only when clearly needed.
Nonteratogenic Effects
Withdrawal seizures were reported in a two-day-old male infant whose mother had taken a Butalbital (Medigesic Plus)-containing drug during the last two months of pregnancy. Butalbital (Medigesic Plus) was found in the infant’s serum. The infant was given phenobarbital 5 mg/kg, which was tapered without further seizure or other withdrawal symptoms.
Nursing Mothers
Medigesic Plus, barbiturates, and Acetaminophen (Medigesic Plus) are excreted in breast milk in small amounts, but the significance of their effects on nursing infants is not known. Because of potential for serious adverse reactions in nursing infants from Butalbital (Medigesic Plus), Acetaminophen (Medigesic Plus), and Medigesic Plus, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Pediatric Use
Safety and effectiveness in pediatric patients below the age of 12 have not been established.
Geriatric Use
Clinical studies of Medigesic Plus did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Butalbital (Medigesic Plus) is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
What happens if I miss a dose of Medigesic Plus?
Since this medicine is used when needed, you may not be on a dosing schedule. If you are on a schedule, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.
References
- DailyMed. "CAFFEINE; ERGOTAMINE TARTRATE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- DailyMed. "ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- DailyMed. "ACETAMINOPHEN; ASPIRIN; CAFFEINE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
