What happens if I overdose Uphamol 650?
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include coma; dark urine; decreased urination; excessive sweating; extreme fatigue; nausea and vomiting; pale stools; stomach pain; unusual bruising or bleeding; yellowing of the skin or eyes.
Proper storage of Uphamol 650 injection:
Uphamol 650 injection is usually handled and stored by a health care provider. If you are using Uphamol 650 injection at home, store Uphamol 650 injection as directed by your pharmacist or health care provider. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Uphamol 650 injection out of the reach of children and away from pets.
Overdose of Uphamol 650 in details
Signs and Symptoms
In acute Uphamol 650 overdosage, dose-dependent, potentially fatal hepatic necrosis is the most serious adverse effect. Renal tubular necrosis, hypoglycemic coma, and thrombocytopenia may also occur. Plasma Uphamol 650 levels > 300 mcg/mL at 4 hours after oral ingestion were associated with hepatic damage in 90% of patients; minimal hepatic damage is anticipated if plasma levels at 4 hours are < 150 mcg/mL or < 37.5 mcg/mL at 12 hours after ingestion. 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.
Treatment
If an Uphamol 650 overdose is suspected, obtain a serum Uphamol 650 assay as soon as possible, but no sooner than 4 hours following oral ingestion. Obtain liver function studies initially and repeat at 24-hour intervals. Administer the antidote N-acetylcysteine (NAC) as early as possible. As a guide to treatment of acute ingestion, the Uphamol 650 level can be plotted against time since oral ingestion on a nomogram (Rumack-Matthew). The lower toxic line on the nomogram is equivalent to 150 mcg/mL at 4 hours and 37.5 mcg/mL at 12 hours. If serum level is above the lower line, administer the entire course of NAC treatment. Withhold NAC therapy if the Uphamol 650 level is below the lower line.
For additional information, call a poison control center at 1-800-222-1222.
What should I avoid while taking Uphamol 650?
Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Uphamol 650 (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much Uphamol 650 which can lead to a fatal overdose. Check the label to see if a medicine contains Acetaminophen or APAP.
Avoid drinking alcohol. It may increase your risk of liver damage while taking Uphamol 650.
Uphamol 650 warnings
Keep out of reach of children.
Caution is advised for this formulation with extra strength dosing of Uphamol 650 due to the easily chewable gels and good taste. This is not a candy and the same caution with every medication should be applied to this product.
Hepatotoxicity
This product contains Acetaminophen. Severe liver damage may occur if you take
- more than 4,000 mg of Uphamol 650 in 24 hours
- with other drugs containing Uphamol 650 (prescription or nonprescription). If you are not sure whether a drug contains Acetaminophen, ask a physician or pharmacist.
- 3 or more alcoholic drinks every day while using this product
Uphamol 650 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 Uphamol 650 at doses that exceed 4,000 milligrams per day, and often involve more than one Uphamol 650-containing product. The excessive intake of Uphamol 650 may be intentional to cause self-harm or unintentional as patients attempt to obtain more pain relief or unknowingly take other Uphamol 650-containing products.
The risk of acute liver failure is higher in individuals with underlying liver disease and in individuals who ingest alcohol while taking Uphamol 650.
Instruct patients to look for Uphamol 650 or APAP on package labels and not to use more than one product that contains Acetaminophen. Instruct patients to seek medical attention immediately upon ingestion of more than 4,000 milligrams of Uphamol 650 per day, even if they feel well.
Serious Skin Reactions
Rarely, Uphamol 650 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.
Uphamol 650 may cause severe skin reactions. Symptoms may include
- skin reddening
- blisters
- rash
If a skin reaction occurs, stop use and seek medical help right away. Do not use if you are allergic to Uphamol 650 or any of the inactive ingredients in this product.
Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
What should I discuss with my healthcare provider before taking Uphamol 650?
Some medical conditions may interact with Uphamol 650 injection. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have a history of alcohol abuse or you drink more than 3 alcohol-containing drinks every day
- if you have liver problems (eg, hepatitis), poor nutrition, low blood volume (eg, caused by dehydration or blood loss), or kidney problems
Some MEDICINES MAY INTERACT with Uphamol 650 injection. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Anticoagulants (eg, warfarin) because the risk of their side effects, including bleeding, may be increased by Uphamol 650 injection
- Isoniazid or other medicines that may harm the liver (eg, methotrexate, ketoconazole, certain medicines for HIV infection) because the risk of liver problems may be increased. Ask your doctor if you are unsure if any of your medicines might harm the liver
This may not be a complete list of all interactions that may occur. Ask your health care provider if Uphamol 650 injection may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Uphamol 650 precautions
Hepatic Injury
Administration of Uphamol 650 in doses higher than recommended may result in hepatic injury, including the risk of liver failure and death. Do not exceed the maximum recommended daily dose of Uphamol 650. The maximum recommended daily dose of Uphamol 650 includes all routes of Uphamol 650 administration and all Uphamol 650-containing products administered, including combination products.
Use caution when administering Uphamol 650 in patients with the following conditions: hepatic impairment or active hepatic disease, alcoholism, chronic malnutrition, severe hypovolemia (e.g., due to dehydration or blood loss), or severe renal impairment (creatinine clearance ≤ 30 mL/min).
Serious Skin Reactions
Rarely, Uphamol 650 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.
Risk of Medication Errors
Take care when prescribing, preparing, and administering Uphamol 650 Injection in order to avoid dosing errors which could result in accidental overdose and death. In particular, be careful to ensure that:
- the dose in milligrams (mg) and milliliters (mL) is not confused;
- the dosing is based on weight for patients under 50 kg;
- infusion pumps are properly programmed; and
- the total daily dose of Uphamol 650 from all sources does not exceed maximum daily limits.
Allergy and Hypersensitivity
There have been post-marketing reports of hypersensitivity and anaphylaxis associated with the use of Uphamol 650. Clinical signs included swelling of the face, mouth, and throat, respiratory distress, urticaria, rash, and pruritus. There were infrequent reports of life-threatening anaphylaxis requiring emergent medical attention. Discontinue Uphamol 650 immediately if symptoms associated with allergy or hypersensitivity occur. Do not use Uphamol 650 in patients with Uphamol 650 allergy.
What happens if I miss a dose of Uphamol 650?
Since Uphamol 650 is used as needed, you may not be on a dosing schedule. If you are using the medication regularly, 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.
Do not use Uphamol 650 injection more often than every 4 hours.
References
- 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).
- DrugBank. "acetaminophen". http://www.drugbank.ca/drugs/DB00316 (accessed September 17, 2018).
- MeSH. "Antipyretics". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
