Consists of Acetaminophen, Paracetamol-Pseudoephedrine-Cetirizine
What happens if I overdose Acetaminophen (Sinoclear)?
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 Acetaminophen (Sinoclear):
Acetaminophen (Sinoclear) is usually handled and stored by a health care provider. If you are using Acetaminophen (Sinoclear) at home, store Acetaminophen (Sinoclear) as directed by your pharmacist or health care provider. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Acetaminophen (Sinoclear) out of the reach of children and away from pets.
Overdose of Acetaminophen (Sinoclear) in details
Signs and Symptoms
In acute Acetaminophen (Sinoclear) overdosage, dose-dependent, potentially fatal hepatic necrosis is the most serious adverse effect. Renal tubular necrosis, hypoglycemic coma, and thrombocytopenia may also occur. Plasma Acetaminophen (Sinoclear) 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 Acetaminophen (Sinoclear) overdose is suspected, obtain a serum Acetaminophen (Sinoclear) 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 Acetaminophen (Sinoclear) 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 Acetaminophen (Sinoclear) 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 Acetaminophen (Sinoclear)?
Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (Sinoclear) (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much Acetaminophen (Sinoclear) which can lead to a fatal overdose. Check the label to see if a medicine contains Acetaminophen (Sinoclear) or APAP.
Avoid drinking alcohol. It may increase your risk of liver damage while taking Acetaminophen (Sinoclear).
Acetaminophen (Sinoclear) warnings
Keep out of reach of children.
Caution is advised for this formulation with extra strength dosing of Acetaminophen (Sinoclear) 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 (Sinoclear). Severe liver damage may occur if you take
- more than 4,000 mg of Acetaminophen (Sinoclear) in 24 hours
- with other drugs containing Acetaminophen (Sinoclear) (prescription or nonprescription). If you are not sure whether a drug contains Acetaminophen (Sinoclear), ask a physician or pharmacist.
- 3 or more alcoholic drinks every day while using this product
Acetaminophen (Sinoclear) 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 (Sinoclear) at doses that exceed 4,000 milligrams per day, and often involve more than one Acetaminophen (Sinoclear)-containing product. The excessive intake of Acetaminophen (Sinoclear) may be intentional to cause self-harm or unintentional as patients attempt to obtain more pain relief or unknowingly take other Acetaminophen (Sinoclear)-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 (Sinoclear).
Instruct patients to look for Acetaminophen (Sinoclear) or APAP on package labels and not to use more than one product that contains Acetaminophen (Sinoclear). Instruct patients to seek medical attention immediately upon ingestion of more than 4,000 milligrams of Acetaminophen (Sinoclear) per day, even if they feel well.
Serious Skin Reactions
Rarely, Acetaminophen (Sinoclear) 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.
Acetaminophen (Sinoclear) 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 Acetaminophen (Sinoclear) 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 Acetaminophen (Sinoclear)?
Some medical conditions may interact with Acetaminophen (Sinoclear). 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 Acetaminophen (Sinoclear). 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 Acetaminophen (Sinoclear)
- 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 Acetaminophen (Sinoclear) 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.
Acetaminophen (Sinoclear) precautions
Hepatic Injury
Administration of Acetaminophen (Sinoclear) 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 Acetaminophen (Sinoclear). The maximum recommended daily dose of Acetaminophen (Sinoclear) includes all routes of Acetaminophen (Sinoclear) administration and all Acetaminophen (Sinoclear)-containing products administered, including combination products.
Use caution when administering Acetaminophen (Sinoclear) 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, Acetaminophen (Sinoclear) 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 Acetaminophen (Sinoclear) 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 Acetaminophen (Sinoclear) 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 Acetaminophen (Sinoclear). 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 Acetaminophen (Sinoclear) immediately if symptoms associated with allergy or hypersensitivity occur. Do not use Acetaminophen (Sinoclear) in patients with Acetaminophen (Sinoclear) allergy.
What happens if I miss a dose of Acetaminophen (Sinoclear)?
Since Acetaminophen (Sinoclear) 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 Acetaminophen (Sinoclear) more often than every 4 hours.
References
- DailyMed. "PSEUDOEPHEDRINE SULFATE: 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. "CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE: 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
