Paratramol Uses

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• Paratramol indications
• Paratramol description
• Paratramol dosage
• Paratramol interactions
• Paratramol side effects
• Paratramol contraindications

Paratramol indications

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.

Paratramol description

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.

Paratramol dosage

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.

Paratramol interactions

Use with MAO inhibitors and SSRIs: Interaction with MAO inhibitors have been reported for some centrally-acting drugs.

Use with Carbamazepine: Concomitant administration of Tramadol (Paratramol) HCl and carbamazepine causes a significant increase in Tramadol (Paratramol) metabolism. Patients taking carbamazepine may have a significantly reduced analgesic effect from the Tramadol (Paratramol) component of Paratramol.

Use with Quinidine: Tramadol (Paratramol) is metabolized to M1 by CYP2D6. Concomitant administration of quinidine and Tramadol (Paratramol) results in increased concentrations of Tramadol (Paratramol). The clinical consequences of these findings are unknown.

Use with Warfarin-Like Compounds: As medically appropriate, periodic evaluation of prothrombin time should be performed when Paratramol and these agents are administered concurrently due to reports of increased International Normalized Ratio (INR) in some patients.

Use with Inhibitors of CYP2D6: In vitro 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).

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.

Incompatibilities: None known.

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.

Paratramol contraindications

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.

References

1. PubChem. "Tramadol". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
2. DrugBank. "Tramadol". http://www.drugbank.ca/drugs/DB00193 (accessed September 17, 2018).
3. MeSH. "Narcotics". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology