Uphamol 650 Side effects

• Side effects of Uphamol 650 in details
• Uphamol 650 contraindications
• Uphamol 650 reviews

What are the possible side effects of Uphamol 650?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

In rare cases, Uphamol 650 may cause a severe skin reaction that can be fatal. This could occur even if you have taken Uphamol 650 in the past and had no reaction. Stop using this medicine and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling. If you have this type of reaction, you should never again take any medicine that contains Acetaminophen.

Stop using Uphamol 650 and call your doctor at once if you have:

• chest pain, trouble breathing; or

• liver problems--nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects may include:

• vomiting;

• constipation;

• feeling agitated;

• headache; or

• sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Side effects of Uphamol 650 in details

The following serious adverse reactions are discussed elsewhere in the labeling:

• Hepatic Injury
• Serious Skin Reactions
• Allergy and Hypersensitivity

Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed cannot be directly compared to rates in other clinical trials and may not reflect the rates observed in practice.

Adult Population

A total of 1,020 adult patients have received Uphamol 650 in clinical trials, including 37.3% (n=380) who received 5 or more doses, and 17.0% (n=173) who received more than 10 doses. Most patients were treated with Uphamol 650 1,000 mg every 6 hours. A total of 13.1% (n=134) received Uphamol 650 650 mg every 4 hours.

All adverse reactions that occurred in adult patients treated with either Uphamol 650 or placebo in repeated dose, placebo-controlled clinical trials at an incidence ≥ 3% and at a greater frequency than placebo are listed in Table 4. The most common adverse events in adult patients treated with Uphamol 650 (incidence ≥ 5% and greater than placebo) were nausea, vomiting, headache, and insomnia.

Other Adverse Reactions Observed During Clinical Studies of Uphamol 650 in Adults

The following additional treatment-emergent adverse reactions were reported by adult subjects treated with Uphamol 650 in all clinical trials (n=1,020) that occurred with an incidence of at least 1% and at a frequency greater than placebo (n=525).

Blood and lymphatic system disorders: anemia

General disorders and administration site conditions: fatigue, infusion site pain, edema peripheral

Investigations: aspartate aminotransferase increased, breath sounds abnormal

Metabolism and nutrition disorders: hypokalemia

Musculoskeletal and connective tissue disorders: muscle spasms, trismus

Psychiatric disorders: anxiety

Respiratory, thoracic and mediastinal disorders: dyspnea

Vascular disorders: hypertension, hypotension

Pediatric Population

A total of 483 pediatric patients (72 neonates, 167 infants, 171 children, and 73 adolescents) have received Uphamol 650 in active-controlled (n=250) and open-label clinical trials (n=225), including 43.9% (n=212) who received 5 or more doses and 31.2% (n=153) who received more than 10 doses. Pediatric patients received Uphamol 650 doses up to 15 mg/kg on an every 4 hours, every 6 hours, or every 8 hours schedule. The maximum exposure was 7.7, 6.4, 6.8, and 7.1 days in neonates, infants, children, and adolescents, respectively.

The most common adverse events (incidence ≥ 5%) in pediatric patients treated with Uphamol 650 were nausea, vomiting, constipation, and pruritus.

Other Adverse Reactions Observed During Clinical Studies of Uphamol 650 in Pediatrics

The following additional treatment-emergent adverse reactions were reported by pediatric subjects treated with Uphamol 650 (n=483) that occurred with an incidence of at least 1%.

Blood and lymphatic system disorders: anemia

Gastrointestinal disorders: diarrhea

General disorders and administration site conditions: pyrexia, injection site pain

Metabolism and nutrition disorders: hypokalemia, hypomagnesemia, hypoalbuminemia, hypophosphatemia

Musculoskeletal and connective tissue disorders: muscle spasm

Nervous system disorders: headache

Psychiatric disorders: agitation

Renal and urinary disorders: oliguria

Respiratory, thoracic and mediastinal disorders: atelectasis, pleural effusion, pulmonary edema, stridor, wheezing

Vascular disorders: hypotension, hypertension

What is the most important information I should know about Uphamol 650?

• Uphamol 650 injection has Uphamol 650 in it. Before you start any new medicine, check the label to see if it has Uphamol 650 in it too. If it does or if you are not sure, check with your doctor or pharmacist.
• Uphamol 650 injection may harm your liver. Your risk may be greater if you drink alcohol while you are using Uphamol 650 injection or if you use Uphamol 650 injection in high doses. Talk to your doctor before you use Uphamol 650 injection or other fever reducers if you drink more than 3 drinks with alcohol per day. Do NOT use more than the recommended dose without checking with your doctor.
• A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
• Uphamol 650 injection should be used with extreme caution in CHILDREN younger than 2 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Uphamol 650 injection while you are pregnant. Uphamol 650 injection is found in breast milk. If you are or will be breast-feeding while you use Uphamol 650 injection, check with your doctor. Discuss any possible risks to your baby.

Uphamol 650 contraindications

There are many brands and forms of Uphamol 650 available and not all brands are listed on this leaflet.

Do not take more of this medication than is recommended. An overdose of Uphamol 650 can damage your liver or cause death.

Know the amount of Uphamol 650 in the specific product you are taking.

Do not take this medication without a doctor's advice if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You may not be able to take Uphamol 650.

Avoid drinking alcohol. It may increase your risk of liver damage while taking Uphamol 650.

Ask a doctor or pharmacist if it is safe for you to take this medicine if you have liver disease or a history of alcoholism.

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.

References

1. 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).
2. DTP/NCI. "acetaminophen: The NCI Development Therapeutics Program (DTP) provides services and resources to the academic and private-sector research communities worldwide to facilitate the discovery and development of new cancer therapeutic agents.". https://dtp.cancer.gov/dtpstandard/s... (accessed September 17, 2018).
3. European Chemicals Agency - ECHA. "Paracetamol: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology