DRUGS & SUPPLEMENTS
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Pethidine hydrochloride tablets are indicated for the relief of moderate to severe pain.
Pethidine hydrochloride tablets are contraindicated in patients with hypersensitivity to Pethidine or to any of its ingredients.
Pethidine is contraindicated in patients who are receiving monoamine oxidase (MAO) inhibitors or those who have recently received such agents. Therapeutic doses of Pethidine have occasionally precipitated unpredictable, severe, and occasionally fatal reactions in patients who have received such agents within 14 days. The mechanism of these reactions is unclear, but may be related to a preexisting hyperphenylalaninemia. Some have been characterized by coma, severe respiratory depression, cyanosis, and hypotension, and have resembled the syndrome of acute narcotic overdose. Serotonin syndrome with agitation, hyperthermia, diarrhea, tachycardia, sweating, tremors and impaired consciousness may also occur. In other reactions the predominant manifestations have been hyperexcitability, convulsions, tachycardia, hyperpyrexia, and hypertension. Although it is not known that other narcotics are free of the risk of such reactions, virtually all of the reported reactions have occurred with Pethidine. If a narcotic is needed in such patients, a sensitivity test should be performed in which repeated, small, incremental doses of morphine are administered over the course of several hours while the patient's condition and vital signs are under careful observation. (Intravenous hydrocortisone or prednisolone have been used to treat severe reactions, with the addition of intravenous chlorpromazine in those cases exhibiting hypertension and hyperpyrexia. The usefulness and safety of narcotic antagonists in the treatment of these reactions is unknown.)
Pethidine hydrochloride tablets are contraindicated in patients with severe respiratory insufficiency (see WARNINGS: Respiratory Conditions ).
Pethidine should not be used for treatment of chronic pain. Pethidine should only be used in the treatment of acute episodes of moderate to severe pain. Prolonged Pethidine use may increase the risk of toxicity from the accumulation of the Pethidine metabolite, normeperidine.
Pethidine hydrochloride tablets are opioid agonists and a Schedule II controlled substance with an abuse liability similar to morphine.
Pethidine hydrochloride tablets can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing Pethidine hydrochloride tablets in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion.
Pethidine is an opioid agonist of the morphine-type. Such drugs are sought by drug abusers and people with addiction disorders and are subject to criminal diversion.
Pethidine can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing Pethidine hydrochloride tablets in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion.
Pethidine hydrochloride tablets have been reported as being abused by crushing, chewing, snorting, or injecting the dissolved product. These practices will result in the uncontrolled delivery of the opioid and pose a significant risk to the abuser that could result in overdose or death (see WARNINGS and DRUG ABUSE AND ADDICTION ).
Concerns about abuse, addiction, and diversion should not prevent the proper management of pain.
Healthcare professionals should contact their State Professional Licensing Board or State Controlled Substances Authority for information on how to prevent and detect abuse or diversion of this product.
Pethidine may be expected to have additive effects when used in conjunction with alcohol, other opioids, or illicit drugs that cause central nervous system depression.
The respiratory depressant effects of Pethidine and its capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, other intracranial lesions, or a preexisting increase in intracranial pressure. Furthermore, narcotics produce adverse reactions which may obscure the clinical course of patients with head injuries. In such patients, Pethidine must be used with extreme caution and only if its use is deemed essential.
Pethidine should be used with extreme caution in patients having an acute asthmatic attack, patients with chronic obstructive pulmonary disease or cor pulmonale, patients having a substantially decreased respiratory reserve, and patients with preexisting respiratory depression, hypoxia, or hypercapnia. In such patients, even usual therapeutic doses of narcotics may decrease respiratory drive while simultaneously increasing airway resistance to the point of apnea.
The administration of Pethidine may result in severe hypotension in the postoperative patient or any individual whose ability to maintain blood pressure has been compromised by a depleted blood volume or the administration of drugs such as the phenothiazines or certain anesthetics.
Pethidine may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. The patient should be cautioned accordingly.
Pethidine, like other narcotics, may produce orthostatic hypotension in ambulatory patients.
Pethidine should not be used in pregnant women prior to the labor period, unless in the judgment of the physician the potential benefits outweigh the possible risks, because safe use in pregnancy prior to labor has not been established relative to possible adverse effects on fetal development.
Pethidine crosses the placental barrier and can produce depression of respiration and psychophysiologic functions in the newborn. Resuscitation may be required. Therefore Pethidine is not recommended during labor.
Pethidine appears in the milk of nursing mothers receiving the drug. Due to the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the potential benefits of the drug to the nursing woman.
Opioid analgesics can have a narrow therapeutic index in certain patient populations, particularly when combined with CNS depressant drugs. The use of these products should be reserved for cases where the benefits of opioid analgesia outweigh the known risks of respiratory depression, altered mental state, and postural hypotension.
Use of Pethidine hydrochloride tablets may be associated with increased potential risks and should be used with caution in the following conditions: sickle cell anemia, pheochromocytoma, acute alcoholism; adrenocortical insufficiency ; CNS depression or coma; delirium tremens; debilitated patients; kyphoscoliosis associated with respiratory depression; myxedema or hypothyroidism; prostatic hypertrophy or urethral stricture; severe impairment of hepatic, pulmonary, or renal function; and toxic psychosis (see PRECAUTIONS: Special Risk Patients ).
The administration of Pethidine may obscure the diagnosis or clinical course in patients with acute abdominal conditions. All opioids may induce or aggravate seizures in some clinical settings.
Pethidine hydrochloride tablets should be used with caution and consideration should be given to starting with a reduced dosage in patients who are concurrently receiving other central nervous system depressants including sedatives or hypnotics, general anesthetics, phenothiazines, other tranquilizers, and alcohol. Drug-drug interactions may result in respiratory depression, hypotension, profound sedation, coma, or death if these drugs are taken in combination with the usual doses of Pethidine hydrochloride tablets.
Agonist/antagonist analgesics should be administered with caution to a patient who has received or is receiving a course of therapy with a pure opioid agonist analgesic such as Pethidine. In this situation, mixed agonist/antagonist analgesics may reduce the analgesic effect of Pethidine and/or may precipitate withdrawal symptoms in these patients due to competitive blocking of receptors.
Pethidine should be used with caution in patients with atrial flutter and other supraventricular tachycardias because of a possible vagolytic action which may produce a significant increase in the ventricular response rate.
Pethidine may aggravate preexisting convulsions in patients with convulsive disorders. If dosage is escalated substantially above recommended levels because of tolerance development, convulsions may occur in individuals without a history of convulsive disorders.
The administration of Pethidine or other narcotics may obscure the diagnosis or clinical course in patients with acute abdominal conditions.
Pethidine has the potential to produce tolerance and drug dependence. Tolerance is the need for increasing doses of opioids to maintain a defined effect such as analgesia. Physical dependence is manifested by withdrawal symptoms after abrupt discontinuation of a drug or upon administration of an antagonist. Physical dependence and tolerance are not unusual during chronic opioid therapy.
The opioid abstinence or withdrawal syndrome is characterized by some or all of the following: restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, myalgia, 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.
In general, opioids used regularly should not be abruptly discontinued.
Pethidine hydrochloride tablets are opioids with no approved use in the management of addictive disorders. Its proper usage in individuals with drug or alcohol dependence, either active or in remission, is for the management of pain requiring opioid analgesia. Pethidine hydrochloride tablets should be used with caution in patients with alcoholism and other drug dependencies due to the increased frequency of narcotic tolerance, dependence, and the risk of addiction observed in these patient populations. Abuse of Pethidine hydrochloride tablets in combination with other CNS depressant drugs can result in serious risk to the patient.
If clinically advisable, patients receiving Pethidine hydrochloride tablets or their caregivers should be given the following information by the physician, nurse, pharmacist, or caregiver:
Also see WARNINGS .
Plasma concentrations of Pethidine and its metabolite, normeperidine, may be increased by acyclovir, thus caution should be used with concomitant administration.
Cimetidine reduced the clearance and volume of distribution of Pethidine and also the formation of the metabolite, normeperidine, in healthy subjects and thus, caution should be used with concomitant administration.
Concomitant use of CNS depressants with usual doses of meperidine may result in respiratory depression, hypotension, profound sedation, coma or death.
The hepatic metabolism of Pethidine may be enhanced by phenytoin. Concomitant administration resulted in reduced half-life and bioavailability with increased clearance of Pethidine in healthy subjects, however, blood concentrations of normeperidine were increased, thus exercise caution when phenytoin is used concomitantly with Pethidine.
Plasma concentrations of the active metabolite normeperidine may be increased by ritonavir, thus concomitant administration should be avoided.
Opioid analgesics, including Pethidine hydrochloride tablets, may enhance the neuromuscular blocking action of skeletal muscle relaxants and produce an increased degree of respiratory depression.
Pethidine should be given with caution and the initial dose should be reduced in certain patients such as the elderly or debilitated, and those with severe impairment of hepatic or renal function, Sickle Cell Anemia, hypothyroidism, Addison's disease, Pheochromocytoma and prostatic hypertrophy or urethral stricture. In patients with pheochromocytoma, Pethidine has been reported to provoke hypertension.
Accumulation of Pethidine and/or its active metabolite, normeperidine, can occur in patients with hepatic impairment. Pethidine should therefore be used with caution in patients with hepatic impairment.
Accumulation of Pethidine and/or its active metabolite, normeperidine, can also occur in patients with renal impairment. Pethidine should therefore be used with caution in patients with renal impairment.
Studies to assess the carcinogenic or mutagenic potential of Pethidine have not been conducted. Studies to determine the effect of Pethidine on fertility have not been conducted.
Animal reproduction studies have not been conducted with Pethidine. It is also not known whether Pethidine hydrochloride tablets can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Pethidine hydrochloride tablets should be given to a pregnant woman only if clearly needed.
See WARNINGS .
See WARNINGS .
The safety and effectiveness of Pethidine in pediatric patients has not been established. Literature reports indicate that Pethidine has a slower elimination rate in neonates and young infants compared to older children and adults. Neonates and young infants may also be more susceptible to the effects, especially the respiratory depressant effects. If Pethidine use is contemplated in neonates or young infants, any potential benefits of the drug need to be weighed against the relative risk of the patient.
Clinical studies of Pethidine hydrochloride tablets during product development did not include sufficient numbers of subjects aged 65 and over to evaluate age-related differences in safety or efficacy. Literature reports indicate that geriatric patients have a slower elimination rate compared to young patients and they may be more susceptible to the effects of Pethidine. Reducing the total daily dose of meperidine is recommended in elderly patients and the potential benefits of the drug should be weighed against the relative risk to a geriatric patient.
The major hazards of Pethidine, as with other narcotic analgesics, are respiratory depression and, to a lesser degree, circulatory depression; respiratory arrest, shock, and cardiac arrest have occurred.
The most frequently observed adverse reactions include lightheadedness, dizziness, sedation, nausea, vomiting, and sweating. These effects seem to be more prominent in ambulatory patients and in those who are not experiencing severe pain. In such individuals, lower doses are advisable. Some adverse reactions in ambulatory patients may be alleviated if the patient lies down.
Other adverse reactions include:
Nervous System: Mood changes (e.g., euphoria, dysphoria), weakness, headache, agitation, tremor, involuntary muscle movements (e.g., muscle twitches, myoclonus), severe convulsions, transient hallucinations and disorientation, confusion, delirium, visual disturbances.
Gastrointestinal: Dry mouth, constipation, biliary tract spasm.
Cardiovascular: Flushing of the face, tachycardia, bradycardia, palpitation, hypotension (see WARNINGS ), syncope.
Genitourinary: Urinary retention.
Allergic: Pruritus, urticaria, other skin rashes, wheal and flare over the vein with intravenous injection. Hypersensitivity reactions, anaphylaxis.
Histamine release leading to hypotension and/or tachycardia, flushing, sweating, and pruritus.
Pethidine hydrochloride tablets contain Pethidine, a mu-agonist opioid with an abuse liability similar to morphine and is a Schedule II controlled substance. Pethidine, like morphine and other opioids used in analgesia, can be abused and is subject to criminal diversion.
Drug addiction is characterized by compulsive use, use for non-medical purposes, and continued use despite harm or risk of harm. Drug addiction is a treatable disease, utilizing a multi-disciplinary 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 hours, 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 opioids can occur in the absence of true addiction and is characterized by misuse for non-medical purposes, often in combination with other psychoactive substances. Pethidine hydrochloride tablets, like other opioids, have been diverted for non-medical use. Careful record-keeping of prescribing information, including quantity, frequency, and renewal requests is strongly advised.
Abuse of Pethidine hydrochloride tablets poses a risk of overdose and death. This risk is increased with concurrent abuse of Pethidine hydrochloride tablets with alcohol and other substances. Due to the presence of talc as one of the excipients in tablets, parenteral abuse of crushed tablets can be expected to result in local tissue necrosis, infection, pulmonary granulomas, and increased risk of endocarditis and valvular heart disease. In addition, parenteral drug abuse is commonly associated with transmission of infectious diseases such as hepatitis and HIV.
Proper assessment of the patient, proper prescribing practices, periodic re-evaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs.
Serious overdosage with Pethidine is characterized by respiratory depression, extreme somnolence progressing to stupor or coma, skeletal muscle flaccidity, hypothermia, cold and clammy skin, and sometimes bradycardia and hypotension. In severe overdosage, particularly by the intravenous route, apnea, circulatory collapse, cardiac arrest, and death may occur.
Primary attention should be given to the reestablishment of adequate respiratory exchange through provision of a patent airway and institution of assisted or controlled ventilation. The narcotic antagonist, naloxone hydrochloride, is a specific antidote against respiratory depression which may result from overdosage or unusual sensitivity to narcotics, including Pethidine. Therefore, an appropriate dose of this antagonist should be administered as necessary, preferably by the intravenous route, simultaneously with efforts at respiratory resuscitation.
An antagonist should not be administered in the absence of clinically significant respiratory or cardiovascular depression.
Oxygen, intravenous fluids, vasopressors, and other supportive measures should be employed as indicated.
In cases of overdosage with Pethidine hydrochloride tablets, the stomach should be evacuated by emesis or gastric lavage.
NOTE: In an individual physically dependent on narcotics, the administration of the usual dose of a narcotic antagonist will precipitate an acute withdrawal syndrome. The severity of this syndrome will depend on the degree of physical dependence and the dose of antagonist administered. The use of narcotic antagonists in such individuals should be avoided if possible. If a narcotic antagonist must be used to treat serious respiratory depression in the physically dependent patient, the antagonist should be administered with extreme care and only one-fifth to one-tenth the usual initial dose administered.
Dosage should be adjusted according to the severity of the pain and the response of the patient. Pethidine is less effective orally than on parenteral administration. The dose of Pethidine hydrochloride tablets should be proportionately reduced when administered concomitantly with phenothiazines and many other tranquilizers since they potentiate the action of Pethidine hydrochloride tablets.
The usual dosage is 50 mg to 150 mg orally, every 3 or 4 hours as necessary.
The usual dosage is 1.1 mg/kg to 1.8 mg/kg orally, up to the adult dose, every 3 or 4 hours as necessary (see PRECAUTIONS: Pediatric Use ).
Pethidine hydrochloride tablets are a dosage form that contains Pethidine hydrochloride which is a controlled substance. Like morphine, Pethidine is controlled under Schedule II of the Controlled Substances Act. Pethidine, like all opioids, is liable to diversion and misuse and should be handled accordingly. Patients and their families should be instructed to flush any Pethidine hydrochloride tablets that are no longer needed.
Pethidine hydrochloride tablets have been targeted for theft and diversion by criminals. Healthcare professionals should contact their State Professional Licensing Board or State Controlled Substance Authority for information on how to prevent and detect abuse or diversion of this product.
NDC: 63629-4549-1 30 TABLET in a BOTTLE
NDC: 63629-4549-2 50 TABLET in a BOTTLE
NDC: 63629-4549-3 60 TABLET in a BOTTLE
NDC: 63629-4549-4 90 TABLET in a BOTTLE
NDC: 63629-4549-5 120 TABLET in a BOTTLE
Huntsville, AL 35811
Depending on the reaction of the Pethidine after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Pethidine not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.Is Pethidine addictive or habit forming?
Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.
Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.
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The information was verified by Dr. Rachana Salvi, MD Pharmacology