How old is patient?
An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or Paracetamol (Paratramol) is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of Paracetamol (Paratramol). A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
Adjunct for surgical analgesia; induction of primary anesthesia for major surgical procedures requiring favorable myocardial or cerebral oxygen balance or when extended postoperative ventilation is anticipated; epidural analgesia with bupivacaine during labor and vaginal delivery.
Each film-coated tablet contains 2 analgesics, Paracetamol (Paratramol) 325 mg and Tramadol (Paratramol) HCl 37.5 mg. It also contains the following excipients: Corn starch, povidone K30, sodium starch glycolate, microcrystalline cellulose PH 101, magnesium stearate, opadry II yellow, purified water.
Tramadol (Paratramol) HCl is a white, bitter, crystalline and odorless powder. Its chemical name is (±)cis-2-[(dimethylamino)methyl]-1-(3-methoxy phenyl) cyclohexanol HCl and has a molecular weight of 299.84.
Paracetamol (Paratramol) is an analgesic and antipyretic agent which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Its chemical name is N-acetyl-p-aminophenol and has a molecular weight of 151.17.
Unless otherwise prescribed, Paratramol should be administered as follows:
Adults and Children >16 years: Maximum Single Dose: 1-2 tabs every 4-6 hrs as needed for pain relief up to a maximum of 8 tabs/day.
Children <16 years: The safety and effectiveness of Paratramol has not been established in the pediatric population.
Elderly: No overall differences with regard to safety or pharmacokinetics were noted between subjects ≥65 years of age and younger subjects.
Paratramol can be administered without regard to food.
CYP2D6 and CYP3A4 Inhibitors: Concomitant administration of CYP2D6 and/or CYP3A4 inhibitors eg, quinidine, fluoxetine, paroxetine and amitriptyline (CYP2D6 inhibitors) and ketoconazole and erythromycin (CYP3A4 inhibitors), may reduce metabolic clearance of Tramadol (Paratramol) increasing the risk for serious adverse events, including seizures and serotonin syndrome.
Serotonergic Drugs: There have been post-marketing reports of serotonin syndrome with use of Tramadol (Paratramol) and SSRIs/SNRIs or MAOIs and α2-adrenergic blockers. Caution is advised when Paratramol are co-administered with other drugs that may affect the serotonergic neurotransmitter systems eg, SSRIs, MAOIs, triptans, linezolid (an antibiotic which is a reversible nonselective MAOI), lithium or St. John’s Wort. If concomitant treatment of Paratramol with a drug affecting the serotonergic neurotransmitter system is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases.
Triptans: Based on the mechanism of action of Tramadol (Paratramol) and the potential for serotonin syndrome, caution is advised when Paratramol are co-administered with a triptan. If concomitant treatment of Tramadol (Paratramol) HCl and Paracetamol (Paratramol) tablets with a triptan is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases.
Use With Carbamazepine: Patients taking carbamazepine may have a significantly reduced analgesic effect of Tramadol (Paratramol). Because carbamazepine increases Tramadol (Paratramol) metabolism and because of the seizure risk associated with Tramadol (Paratramol), concomitant administration of Paratramol and carbamazepine is not recommended.
Use With Quinidine: Tramadol (Paratramol) is metabolized to M1 by CYP2D6. Quinidine is a selective inhibitor of that isoenzyme, so that concomitant administration of quinidine and Tramadol (Paratramol) results in increased concentrations of Tramadol (Paratramol) and reduced concentrations of M1. The clinical consequences of these findings are unknown. In vitro drug interaction studies in human liver microsomes indicate that Tramadol (Paratramol) has no effect on quinidine metabolism.
Potential for Other Drugs to Affect Tramadol (Paratramol): In vitro drug interaction studies in human liver microsomes indicate that concomitant administration with inhibitors of CYP2D6 eg, fluoxetine, paroxetine and amitriptyline could result in some inhibition of the metabolism of Tramadol (Paratramol). Administration of CYP3A4 inhibitors eg, ketoconazole and erythromycin or inducers eg, rifampin and St. John’s Wort, with Paratramol, may affect the metabolism of Tramadol (Paratramol) leading to altered Tramadol (Paratramol) exposure.
Potential for Tramadol (Paratramol) to Affect Other Drugs: In vitro studies indicate that Tramadol (Paratramol) is unlikely to inhibit the CYP3A4-mediated metabolism of other drugs when Tramadol (Paratramol) is administered concomitantly at therapeutic doses. Tramadol (Paratramol) does not appear to induce its own metabolism in humans, since observed maximal plasma concentrations after multiple oral doses are higher than expected based on single-dose data. Tramadol (Paratramol) is a mild inducer of selected drug metabolism pathways measured in animals.
Use With Cimetidine: Concomitant administration of Paratramol and cimetidine has not been studied. Concomitant administration of Tramadol (Paratramol) and cimetidine does not result in clinically significant changes in Tramadol (Paratramol) pharmacokinetics. Therefore, no alteration of the Paratramol dosage regimen is recommended.
Use With Digoxin: Tramadol (Paratramol) has revealed rare reports of digoxin toxicity.
Use With Warfarin-Like Compounds: Both Tramadol (Paratramol) and Paracetamol (Paratramol) individual products have revealed rare alterations of warfarin effect, including elevation of prothrombin times.
While such changes have been generally of limited clinical significance for the individual products, periodic evaluation of prothrombin time should be performed when Paratramol and warfarin-like compounds are administered concurrently.
Paratramol side effects
Common adverse reactions reported in clinical trials are constipation, nausea, diarrhea, dry mouth, psychiatric disorders, somnolence, anorexia, insomnia, dizziness, increased sweating, pruritus, prostatic disorder.
Drug Abuse and Dependence: Abuse: Tramadol (Paratramol) has mu-opioid agonist activity. Paratramol, a Tramadol (Paratramol)-containing product, can be abused and may be subject to criminal diversion.
Addiction is a primary, chronic, neurobiologic disease, with genetic, psychosocial and environmental factors influencing its development and manifestations. Drug addiction is characterized by behaviors that include 1 or more of the following: Impaired control over drug use, compulsive use, use for non-medical purposes, continued use despite harm or risk of harm and craving. Drug addiction is a treatable disease, utilizing a multidisciplinary approach, but relapse is common.
“Drug-seeking” behavior is very common in addicts and drug abusers. Drug-seeking tactics, include emergency calls or visits near the end of office hrs, refusal to undergo appropriate examination, testing or referral, repeated “loss” of prescriptions, tampering with prescriptions and reluctance to provide prior medical records or contact information for other treating physician(s). “Doctor shopping” to obtain additional prescriptions is common among drug abusers and people suffering from untreated addiction.
Abuse and addiction are separate and distinct from physical dependence and tolerance. Physicians should be aware that addiction may not be accompanied by concurrent tolerance and symptoms of physical dependence in all addicts. In addition, abuse of Tramadol (Paratramol) HCl and acetaminophen tablets can occur in the absence of true addiction and is characterized by misuse for non-medical purposes, often in combination with other psychoactive substances.
Concerns about abuse and addiction should not prevent the proper management of pain. However, all patients treated with opioids require careful monitoring for signs of abuse and addiction, because use of opioid analgesic products carries the risk of addiction even under appropriate medical use.
Proper assessment of the patient and periodic re-evaluation of therapy are appropriate measures that help to limit the potential abuse of Paratramol.
Paratramol are intended for oral use only.
Dependence: Tolerance is the need for increasing doses of drugs to maintain a defined effect eg, analgesia (in the absence of disease progression or other external factors). Physical dependence is manifested by withdrawal symptoms after abrupt discontinuation of a drug or upon administration of an antagonist.
The opioid abstinence or withdrawal syndrome is characterized by some or all of the following: Restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, myalgia and mydriasis. Other symptoms also may develop, including irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea or increased blood pressure, respiratory rate or heart rate.
Generally, tolerance and/or withdrawal are more likely to occur the longer a patient is on continuous therapy with Paratramol.
Paracetamol (Paratramol) + Tramadol (Paratramol) HCl (Paratramol) should not be given to patients who have previously demonstrated hypersensitivity reactions to Tramadol (Paratramol), Paracetamol (Paratramol) and any other components of the drug.
Other contraindications include: Patients who are addicted to drugs affecting the CNS such as alcohol, hypnotics, centrally-acting analgesics and anti-psychotic drugs; Patients with epilepsy not controlled by treatment; Patients at risk of mental fog caused by head injury or brain lesion; Patients with severe respiratory depression, and those with a history of aspirin-sensitive asthma; Patients with hematological abnormality and patients with peptic ulcer disease. Paracetamol (Paratramol) + Tramadol (Paratramol) HCl should be avoided if renal impairment is severe.
Active ingredient matches for Paratramol:
Paracetamol/Tramadol in Bulgaria.
ReviewsThe results of a survey conducted on ndrugs.com for Paratramol are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Paratramol. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.
1 consumer reported usefulWas the Paratramol drug useful in terms of decreasing the symptom or the disease?
According to the reports released by ndrugs.com website users, the below mentioned percentages of users say the drug is useful / not useful to them in decreasing their symptoms/disease. The usefulness of the drug depends on many factors, like severity of the disease, perception of symptom, or disease by the patient, brand name used [matters only to a certain extent], other associated conditions of the patient. If the drug is not effective or useful in your case, you need to meet the doctor to get re-evaluated about your symptoms/disease, and he will prescribe an alternative drug.
2 consumers reported price estimatesWas the price you paid to purchase the drug reasonable? Did you feel it was expensive?
The below mentioned numbers have been reported by ndrugs.com website users about whether the Paratramol drug is expensive or inexpensive. There is a mixed opinion among users. The rating about the cost of the drug depends on factors like which brand drug the patient purchased, how effective it was for the price paid, the country or place the drug is marketed, and the economic condition of the patient. The users who feel the drug is expensive can look for an alternative brand drug or a generic drug to save the cost.
1 consumer reported time for resultsTo what extent do I have to use Paratramol before I begin to see changes in my health conditions?
As part of the reports released by ndrugs.com website users, it takes 3 month and a few days before you notice an improvement in your health conditions.
Please note, it doesn't mean you will start to notice such health improvement in the same time frame as other users. There are many factors to consider, and we implore you to visit your doctor to know how long before you can see improvements in your health while taking Paratramol. To get the time effectiveness of using Paratramol drug by other patients, please click here.
7 consumers reported age
Information checked by Dr. Sachin Kumar, MD Pharmacology