Roter Paracetamol
Roter Paracetamol Uses, Dosage, Side Effects, Food Interaction and all others data.
Roter Paracetamol exhibits analgesic action by peripheral blockage of pain impulse generation. It produces antipyresis by inhibiting the hypothalamic heat-regulating centre. Its weak anti-inflammatory activity is related to inhibition of prostaglandin synthesis in the CNS.
Roter Paracetamol (Acetaminophen) is thought to act primarily in the CNS, increasing the pain threshold by inhibiting both isoforms of cyclooxygenase, COX-1, COX-2, and COX-3 enzymes involved in prostaglandin (PG) synthesis. Unlike NSAIDs, acetaminophen does not inhibit cyclooxygenase in peripheral tissues and, thus, has no peripheral anti-inflammatory affects. While aspirin acts as an irreversible inhibitor of COX and directly blocks the enzyme's active site, studies have found that acetaminophen indirectly blocks COX, and that this blockade is ineffective in the presence of peroxides. This might explain why acetaminophen is effective in the central nervous system and in endothelial cells but not in platelets and immune cells which have high levels of peroxides. Studies also report data suggesting that acetaminophen selectively blocks a variant of the COX enzyme that is different from the known variants COX-1 and COX-2. This enzyme is now referred to as COX-3. Its exact mechanism of action is still poorly understood, but future research may provide further insight into how it works. The antipyretic properties of acetaminophen are likely due to direct effects on the heat-regulating centres of the hypothalamus resulting in peripheral vasodilation, sweating and hence heat dissipation.
| Trade Name | Roter Paracetamol |
| Generic | Paracetamol |
| Paracetamol Other Names | Acenol, Acetaminofén, Acetaminophen, Acétaminophène, APAP, Paracetamol, Paracétamol, Paracetamolum |
| Type | |
| Formula | C8H9NO2 |
| Weight | Average: 151.1626 Monoisotopic: 151.063328537 |
| Protein binding | The binding of acetaminophen to plasma proteins is low (ranging from 10% to 25%), when given at therapeutic doses. |
| Therapeutic Class | Non opioid analgesics |
| Manufacturer | |
| Available Country | Netherlands |
| Last Updated: | September 19, 2023 at 7:00 am |
Uses
Roter Paracetamol IV is used for the management of mild to moderate pain, the management of moderate to severe pain with adjunctive opioid analgesics, the reduction of fever.
Roter Paracetamol is a non-salicylate antipyretic and non-opioid analgesic agent. Roter Paracetamol IV injection is a sterile, clear, colorless, non pyrogenic, isotonic formulation of Roter Paracetamol intended for intravenous infusion.
Roter Paracetamol is also used to associated treatment for these conditions: Acute Gouty Arthritis, Acute Musculoskeletal Pain, Allergies, Ankylosing Spondylitis (AS), Arthritis, Chills, Cold, Cold Symptoms, Common Cold, Common Cold/Flu, Cough, Cough caused by Common Cold, Coughing caused by Flu caused by Influenza, Dyskinesia of the Biliary Tract, Dyskinesia of the Urinary Tract, Febrile Convulsions, Febrile Illness Acute, Fever, Fibromyalgia Syndrome, Flu caused by Influenza, Headache, Joint dislocations, Menstrual Distress (Dysmenorrhea), Mild pain, Muscle Inflammation, Muscle Injuries, Muscle Spasms, Musculoskeletal Pain, Nasal Congestion, Neuralgia, Osteoarthritis (OA), Pain, Pollen Allergy, Postoperative pain, Premenstrual cramps, Rheumatoid Arthritis, Rhinopharyngitis, Rhinorrhoea, Severe Pain, Sinusitis, Soreness, Muscle, Spasms, Spastic Pain of the Gastrointestinal Tract, Sprains, Tension Headache, Toothache, Upper Respiratory Tract Infection, Whiplash Syndrome, Acute Torticollis, Mild to moderate pain, Minor aches and pains, Minor pain, Moderate Pain, Airway secretion clearance therapy, Antispasmodic, Bronchodilation
Dosage
Roter Paracetamol dosage
Adults and adolescents weighing 50 kg and over: the recommended dosage of Roter Paracetamol IV is 1000 mg every 6 hours or 650 mg every 4 hours, with a maximum single dose of Roter Paracetamol IV of 1000 mg, a minimum dosing interval of 4 hours, and a maximum daily dose of Roter Paracetamol of 4000 mg per day.
Adults and adolescents weighing under 50 kg: the recommended dosage of Roter Paracetamol IV is 15 mg/kg every 6 hours or 12.5 mg/kg every 4 hours, with a maximum single dose of Roter Paracetamol IV of 15 mg/kg, a minimum dosing interval of 4 hours, and a maximum daily dose of Roter Paracetamol of 75 mg/kg per day.
Children >2 to 12 years of age: the recommended dosage of Roter Paracetamol IV is 15 mg/kg every 6 hours or 12.5 mg/kg every 4 hours, with a maximum single dose of Roter Paracetamol IV of 15 mg/kg, a minimum dosing interval of 4 hours, and a maximum daily dose of Roter Paracetamol of 75 mg/kg per day.
Side Effects
As all paracetamol products, adverse drug reactions are rare (>1/10000, <1/1000) or very rare (<1/10000). Frequent adverse reactions at injection site have been reported during clinical trials (pain and burning sensation). Very rare cases of hypersensitivity reactions ranging from simple skin rash or urticaria to anaphylactic shock have been reported and require discontinuation of treatment. Cases of erythema, flushing, pruritus and tachycardia have been reported.
Precaution
Administration of Roter Paracetamol in doses higher than recommended may result in hepatic injury, including the risk of severe hepatotoxicity and death. Do not exceed the maximum recommended daily dose of Roter Paracetamol. Use caution when administering Roter Paracetamol 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). There were infrequent reports of life-threatening anaphylaxis requiring emergent medical attention. Discontinue Roter Paracetamol IV immediately if symptoms associated with allergy or hypersensitivity occurs. Do not use Roter Paracetamol IV in patients with Roter Paracetamol allergy.
Food Interaction
- Avoid alcohol. Alcohol may increase the risk of hepatotoxicity.
Volume of Distribution
Volume of distribution is about 0.9L/kg. 10 to 20% of the drug is bound to red blood cells. Acetaminophen appears to be widely distributed throughout most body tissues except in fat.
Half Life
The half-life for adults is 2.5 h after an intravenous dose of 15 mg/kg. After an overdose, the half-life can range from 4 to 8 hours depending on the severity of injury to the liver, as it heavily metabolizes acetaminophen.
Clearance
Adults: 0.27 L/h/kg following a 15 mg/kg intravenous (IV) dose. Children: 0.34 L/h/kg following a 15 mg/kg intravenous (IV dose).
Pregnancy & Breastfeeding use
Pregnancy Category C. There are no studies of intravenous Roter Paracetamol in pregnant women; however, epidemiological data on oral Roter Paracetamol use in pregnant women show no increased risk of major congenital malformations. Animal reproduction studies have not been conducted with IV Roter Paracetamol and it is not known whether Roter Paracetamol IV can cause fetal harm when administered to a pregnant woman. Roter Paracetamol IV should be given to a pregnant woman only if clearly needed. There are no adequate and well-controlled studies with Roter Paracetamol IV during labor and delivery; therefore, it should be used in such settings only after a careful benefit-risk assessment. While studies with Roter Paracetamol IV have not been conducted, Roter Paracetamol is secreted in human milk in small quantities after oral administration.
Contraindication
Roter Paracetamol is contraindicated in patients with known hypersensitivity to its active ingredient or to any of the excipients in the intravenous formulation. Also contraindicated in patients with severe hepatic impairment or severe active liver disease
Special Warning
Pediatric Use: The safety and effectiveness of Roter Paracetamol IV for the treatment of acute pain and fever in pediatric patients ages 2 years and older is supported by evidence from adequate and well-controlled studies of Roter Paracetamol IV in adults.
Geriatric use: No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients.
Patients with Hepatic Impairment: Roter Paracetamol is contraindicated in patients with severe hepatic impairment or severe active liver disease and should be used with caution in patients with hepatic impairment or active liver disease. A reduced total daily dose of Roter Paracetamol may be warranted.
Patients with Renal Impairment: In cases of severe renal impairment (creatinine clearance < 30 ml/min), longer dosing intervals and a reduced total daily dose of Roter Paracetamol may be warranted.
Storage Condition
Store in a cool & dry place & away from children. For single use only. The product should be used within 6 hours after opening. Do not refrigerate or freeze.
Innovators Monograph
You find simplified version here Roter Paracetamol
FAQ
What is Roter Paracetamol?
Roter Paracetamol is a common painkiller used to treat aches and pain. It can also be used to reduce a high temperature. It's available combined with other painkillers and anti-sickness medicines. It's also an ingredient in a wide range of cold and flu remedies.
What are side effects of Roter Paracetamol?
- Skin rash that may include itchy, red, swollen, blistered or peeling skin.
- Wheezing.
- Tightness in the chest or throat.
- Trouble breathing or talking.
- Mouth, face, lips, tongue or throat start swelling.
How safe is Roter Paracetamol?
Roter Paracetamol is known to cause liver failure in overdose, but it also causes liver failure in people taking standard doses for pain relief. The risk is only about one in a million, but it is a risk. All these different risks stack up.
What are the types of Roter Paracetamol?
Types of Roter Paracetamol
- tablets or caplets.
- capsules.
- liquid – usually for children.
- soluble tablets (tablets that dissolve in water to make a drink)
- suppositories (capsules inserted into the back passage)
- an injection given into a vein – normally only used in hospital.
What happens if I take Roter Paracetamol without any reason?
Even taking one or two more tablets than recommended can cause serious liver damage and possibly death. Roter Paracetamol overdose is one of the leading causes of liver failure.
Why is Roter Paracetamol bad for our liver?
Roter Paracetamol itself is not toxic, but in large amounts it overwhelms the body's ability to process it safely. This can lead to build up of a toxic metabolite (or break-down product), which binds to liver cells, causing these cells to die.
What are the indications of Roter Paracetamol?
This Roter Paracetamol is used to treat mild to moderate pain (from headaches, menstrual periods, toothaches, backaches, osteoarthritis, or cold/flu aches and pains) and to reduce fever.
What happens if I take Roter Paracetamol on an empty stomach?
Ibuprofen, aspirin and other NSAIDs (non-steroidal anti-inflammatory drugs) can irritate the stomach lining, so it is best to take them with food, or a glass of milk. Roter Paracetamol doesn't irritate the stomach lining so it won't matter if you haven't eaten.
Can Roter Paracetamol help I sleep?
A successful result is one where the pain is reduced by half or more, or where they have no or only mild pain. That result delivers not just on pain, but also improves sleep, depression, quality of life, work, and the ability to get on with life.
How is Roter Paracetamol eliminated from the body?
Roter Paracetamol is readily absorbed from the gastrointestinal tract with peak plasma concentrations occurring about 30 minutes to 2 hours after ingestion. It is metabolised in the liver (90-95%) and excreted in the urine mainly as the glucuronide and sulphate conjugates. Less than 5% is excreted as unchanged Roter Paracetamol.
Is Roter Paracetamol is safe during pregnancy?
Roter Paracetamol is the first choice of painkiller if you're pregnant. Roter Paracetamol been taken by many pregnant women with no harmful effects in the mother or baby.
Is Roter Paracetamol safe during breastfeeding?
Roter Paracetamol is the first choice of painkiller if you're breastfeeding women. It's been taken by many breastfeeding women with no harmful effects in the mother or baby.
How does Roter Paracetamol work?
Roter Paracetamol seems to work by blocking chemical messengers in the brain that tell us we have pain. It also reduces fever by affecting the chemical messengers in an area of the brain that regulates body temperature.
When will I feel better after taking Roter Paracetamol?
Roter Paracetamol takes up to an hour to work. It keeps on working for about 5 hours.
Can I take Roter Paracetamol for a long time?
It's safe to take Roter Paracetamol regularly for many years as long as you don't take more than the recommended dosage.
Will Roter Paracetamol affect my fertility?
There's no firm evidence to suggest that taking Roter Paracetamol will reduce fertility in either men or women.
Will Roter Paracetamol affect my contraception?
Roter Paracetamol doesn't affect any type of contraception including the contraceptive pill or emergency contraception.
Can I drink alcohol with Roter Paracetamol?
Drinking a small amount of alcohol while taking Roter Paracetamol is usually safe. Try to keep to the recommended guidelines of no more than 14 units of alcohol a week. A standard glass of wine (175ml) is 2 units. A pint of lager or beer is usually 2 to 3 units of alcohol.
Is there any food or drink I need to avoid when taking Roter Paracetamol?
You can eat and drink normally while taking Roter Paracetamol. You can safely take Roter Paracetamol (but not ibuprofen) on an empty stomach.
