DRUGS & SUPPLEMENTS
INDICATIONS AND USAGE
Dolestine hydrochloride tablets are indicated for the relief of moderate to severe pain.
Dolestine hydrochloride tablets are contraindicated in patients with hypersensitivity to Dolestine or to any of its ingredients.
Dolestine is contraindicated in patients who are receiving monoamine oxidase (MAO) inhibitors or those who have recently received such agents. Therapeutic doses of Dolestine 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 Dolestine. 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.)
Dolestine hydrochloride tablets are contraindicated in patients with severe respiratory insufficiency (see WARNINGS: Respiratory Conditions ).
Dolestine should not be used for treatment of chronic pain. Dolestine should only be used in the treatment of acute episodes of moderate to severe pain. Prolonged Dolestine use may increase the risk of toxicity from the accumulation of the Dolestine metabolite, normeperidine.
Dolestine hydrochloride tablets are opioid agonists and a Schedule II controlled substance with an abuse liability similar to morphine.
Dolestine hydrochloride tablets can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing Dolestine hydrochloride tablets in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion.
Misuse, Abuse, and Diversion of Opioids
Dolestine 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.
Dolestine can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing Dolestine hydrochloride tablets in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion.
Dolestine 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.
Interactions with Alcohol and Drugs of Abuse
Dolestine may be expected to have additive effects when used in conjunction with alcohol, other opioids, or illicit drugs that cause central nervous system depression.
Head Injury and Increased Intracranial Pressure
The respiratory depressant effects of Dolestine 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, Dolestine must be used with extreme caution and only if its use is deemed essential.
Dolestine 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 Dolestine 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.
Usage in Ambulatory Patients
Dolestine 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.
Dolestine, like other narcotics, may produce orthostatic hypotension in ambulatory patients.
Usage in Pregnancy
Dolestine 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.
Labor and Delivery
Dolestine crosses the placental barrier and can produce depression of respiration and psychophysiologic functions in the newborn. Resuscitation may be required. Therefore Dolestine is not recommended during labor.
Dolestine 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 Dolestine 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 Dolestine may obscure the diagnosis or clinical course in patients with acute abdominal conditions. All opioids may induce or aggravate seizures in some clinical settings.
Interactions with Other CNS Depressants
Dolestine 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 Dolestine hydrochloride tablets.
Interactions with Mixed Agonist/Antagonist Opioid Analgesics
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 Dolestine. In this situation, mixed agonist/antagonist analgesics may reduce the analgesic effect of Dolestine and/or may precipitate withdrawal symptoms in these patients due to competitive blocking of receptors.
Dolestine 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.
Dolestine 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.
Acute Abdominal Conditions
The administration of Dolestine or other narcotics may obscure the diagnosis or clinical course in patients with acute abdominal conditions.
Tolerance and Physical Dependence
Dolestine 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.
Use in Drug and Alcohol Addiction
Dolestine 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. Dolestine 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 Dolestine hydrochloride tablets in combination with other CNS depressant drugs can result in serious risk to the patient.
Information for Patients/Caregivers
If clinically advisable, patients receiving Dolestine hydrochloride tablets or their caregivers should be given the following information by the physician, nurse, pharmacist, or caregiver:
Also see WARNINGS .
Plasma concentrations of Dolestine 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 Dolestine 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 Dolestine may be enhanced by phenytoin. Concomitant administration resulted in reduced half-life and bioavailability with increased clearance of Dolestine in healthy subjects, however, blood concentrations of normeperidine were increased, thus exercise caution when phenytoin is used concomitantly with Dolestine.
Plasma concentrations of the active metabolite normeperidine may be increased by ritonavir, thus concomitant administration should be avoided.
Opioid analgesics, including Dolestine hydrochloride tablets, may enhance the neuromuscular blocking action of skeletal muscle relaxants and produce an increased degree of respiratory depression.
Special Risk Patients
Dolestine 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, Dolestine has been reported to provoke hypertension.
Usage in Hepatically Impaired Patients
Accumulation of Dolestine and/or its active metabolite, normeperidine, can occur in patients with hepatic impairment. Dolestine should therefore be used with caution in patients with hepatic impairment.
Usage in Renally Impaired Patients
Accumulation of Dolestine and/or its active metabolite, normeperidine, can also occur in patients with renal impairment. Dolestine should therefore be used with caution in patients with renal impairment.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Studies to assess the carcinogenic or mutagenic potential of Dolestine have not been conducted. Studies to determine the effect of Dolestine on fertility have not been conducted.
Pregnancy Category C:
Animal reproduction studies have not been conducted with Dolestine. It is also not known whether Dolestine hydrochloride tablets can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Dolestine hydrochloride tablets should be given to a pregnant woman only if clearly needed.
Labor and Delivery
See WARNINGS .
See WARNINGS .
The safety and effectiveness of Dolestine in pediatric patients has not been established. Literature reports indicate that Dolestine 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 Dolestine 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 Dolestine 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 Dolestine. 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 Dolestine, 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.
DRUG ABUSE AND ADDICTION
Dolestine hydrochloride tablets contain Dolestine, a mu-agonist opioid with an abuse liability similar to morphine and is a Schedule II controlled substance. Dolestine, 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. Dolestine 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 Dolestine hydrochloride tablets poses a risk of overdose and death. This risk is increased with concurrent abuse of Dolestine 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 Dolestine 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 Dolestine. 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 Dolestine 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 AND ADMINISTRATION
For Relief of Pain
Dosage should be adjusted according to the severity of the pain and the response of the patient. Dolestine is less effective orally than on parenteral administration. The dose of Dolestine hydrochloride tablets should be proportionately reduced when administered concomitantly with phenothiazines and many other tranquilizers since they potentiate the action of Dolestine 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 ).
SAFETY AND HANDLING
Dolestine hydrochloride tablets are a dosage form that contains Dolestine hydrochloride which is a controlled substance. Like morphine, Dolestine is controlled under Schedule II of the Controlled Substances Act. Dolestine, like all opioids, is liable to diversion and misuse and should be handled accordingly. Patients and their families should be instructed to flush any Dolestine hydrochloride tablets that are no longer needed.
Dolestine 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
Dolestine HCL 50mg Tablet
Dolestine pharmaceutical active ingredients containing related brand and generic drugs:
Active ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.
Dolestine available forms, composition, doses:
Form of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.
Dolestine destination | category:
Destination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.
Dolestine Anatomical Therapeutic Chemical codes:
A medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.
Dolestine pharmaceutical companies:
Pharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.
Frequently asked QuestionsCan i drive or operate heavy machine after consuming Dolestine?
Depending on the reaction of the Dolestine after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Dolestine 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 Dolestine 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.
ReviewsDrugs.com conducted a study on Dolestine, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Dolestine consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.
One visitor reported side effectsDid you get side effects while taking the Dolestine drug, or were there no side effects?
According to the survey conducted by website sDrugs.com users, the below-mentioned percentages indicate the number of people experiencing the side effects and the number of people not experiencing the side effects when taking Dolestine medicine. Every drug produces minimal side effects, and they are negligible most times, when compared to the desired effect [use] of the medicine. Side effects depend on the dose you are taking, any drug interactions that happen when you are on other medications, if the patient is sensitive, and other associated conditions. If you cannot tolerate the side effects, consult your doctor immediately, so he can either adjust the dose or change the medication.
Five visitors reported dosesWhat is the dose of Dolestine drug you are taking?
According to the survey conducted among sDrugs.com website users, the maximum number of people are using the following dose 201-500mg. Few medications come in only one or two doses. Few are specific for adult dose and child dose. The dose of the medicine given to the patient depends on the severity of the symptom/disease. There can be dose adjustments made by the doctor, based on the progression of the disease. Follow-up is important.
One visitor reported time for resultsWhat is the time duration Dolestine drug must be taken for it to be effective or for it to reduce the symptoms?
Most chronic conditions need at least some time so the dose and the drug action gets adjusted to the body to get the desired effect. The stastistics say sDrugs.com website users needed 1 week to notice the result from using Dolestine drug. The time needed to show improvement in health condition after using the medicine Dolestine need not be same for all the users. It varies based on other factors.
One visitor reported administrationThe drugs are administered in various routes, like oral or injection form. They are administered before food or after food. How are you taking Dolestine drug, before food or after food?
Click here to find out how other users of our website are taking it. For any doubts or queries on how and when the medicine is administered, contact your health care provider immediately.
Three visitors reported age
The information was verified by Dr. Arunabha Ray, MD Pharmacology