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Dolene

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Published: 2021-11-11T10:10:10+00:00

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Dolene uses

Indications and usage
Contraindications
Warnings
Precautions
Adverse reactions
Overdosage
Dosage and administration
How supplied
Animal toxicology
Patient information sheet
Dolene reviews

INDICATIONS AND USAGE

Dolene hydrochloride and acetaminophen tablets are indicated for the relief of mild-to-moderate pain, either when pain is present alone or when it is accompanied by fever.

CONTRAINDICATIONS

Hypersensitivity to Dolene or to acetaminophen.

WARNINGS

Do not prescribe Dolene for patients who are suicidal or addiction-prone.

Prescribe Dolene with caution for patients taking tranquilizers or antidepressant drugs and patients who use alcohol in excess.

Tell your patients not to exceed the recommended dose and to limit their intake of alcohol.Dolene products in excessive doses, either alone or in combination with other CNS depressants, including alcohol, are a major cause of drug-related deaths. Fatalities within the first hour of overdosage are not uncommon. In a survey of deaths due to overdosage conducted in 1975, in approximately 20% of the fatal cases, death occurred within the first hour. Dolene should not be taken in doses higher than those recommended by the physician. The judicious prescribing of Dolene is essential to the safe use of this drug. With patients who are depressed or suicidal, consideration should be given to the use of non-narcotic analgesics. Patients should be cautioned about the concomitant use of Dolene products and alcohol because of potentially serious CNS-additive effects of these agents. Because of its added depressant effects, Dolene should be prescribed with caution for those patients whose medical condition requires the concomitant administration of sedatives, tranquilizers, muscle relaxants, antidepressants or other CNS-depressant drugs. Patients should be advised of the additive depressant effects of these combinations. Many of the propoxyphene-related deaths have occurred in patients with previous histories of emotional disturbances or suicidal ideation or attempts, as well as histories of misuse of tranquilizers, alcohol, and other CNS-active drugs. Some deaths have occurred as a consequence of the accidental ingestion of excessive quantities of Dolene alone or in combination with other drugs. Patients taking Dolene should be warned not to exceed the dosage recommended by the physician.

DRUG DEPENDENCE

Dolene, when taken in higher-than-recommended doses over long periods of time, can produce drug dependence characterized by psychic dependence and, less frequently, physical dependence and tolerance. Dolene will only partially suppress the withdrawal syndrome in individuals physically dependent on morphine or other narcotics. The abuse liability of Dolene is qualitatively similar to that of codeine although quantitatively less, and Dolene should be prescribed with the same degree of caution appropriate to the use of codeine.

USAGE IN AMBULATORY PATIENTS

Dolene 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.

PRECAUTIONS

GENERAL

Dolene should be administered with caution to patients with hepatic or renal impairment since higher serum concentrations or delayed elimination may occur.

INFORMATION FOR PATIENTS

A Patient Information Sheet is available for the product. See text following ANIMAL TOXICOLOGY section below.

DRUG INTERACTIONS

The CNS-depressant effect of Dolene is additive with that of other CNS depressants, including alcohol.

As is the case with many medicinal agents, Dolene may slow the metabolism of a concomitantly administered drug. Should this occur, the higher serum concentrations of that drug may result in increased pharmacologic or adverse effects of that drug. Such occurrences have been reported when Dolene was administered to patients on antidepressants, anticonvulsants, or warfarin-like drugs. Severe neurologic signs, including coma, have occurred with concurrent use of carbamazepine.

PREGNANCY

Safe use in pregnancy has not been established relative to possible adverse effects on fetal development. Instances of withdrawal symptoms in the neonate have been reported following usage during pregnancy. Therefore, Dolene should not be used in pregnant women unless, in the judgement of the physician, the potential benefits outweigh the possible hazards.

NURSING MOTHERS

Low levels of Dolene have been detected in human milk. In postpartum studies involving nursing mothers who were given Dolene, no adverse effects were noted in infants receiving mother's milk.

PEDIATRIC USE

Dolene is not recommended for use in pediatric patients because documented clinical experience has been insufficient to establish safety and a suitable dosage regimen in the pediatric age group.

USAGE IN THE ELDERLY

The rate of Dolene metabolism may be reduced in some patients. Increased dosing interval should be considered.

ADVERSE REACTIONS

In a survey conducted in hospitalized patients, less than 1% of patients taking Dolene hydrochloride at recommended doses experienced side effects. The most frequently reported were dizziness, sedation, nausea, and vomiting. Some of these adverse reactions may be alleviated if the patient lies down.

Other adverse reactions include constipation, abdominal pain, skin rashes, light-headedness, headache, weakness, euphoria, dysphoria, hallucinations and minor visual disturbances. Liver dysfunction has been reported in association with both active components of Dolene hydrochloride and acetaminophen tablets. Dolene therapy has been associated with abnormal liver-function tests and, more rarely, with instances of reversible jaundice (including cholestatic jaundice). Hepatic necrosis may result from acute overdose of acetaminophen. In chronic ethanol abusers, this has been reported rarely with short-term use of acetaminophen dosages of 2.5 to 10 g/day. Fatalities have occurred. Renal papillary necrosis may result from chronic acetaminophen use, particularly when the dosage is greater than recommended and when combined with aspirin. Subacute painful myopathy has occurred following chronic Dolene overdosage.

OVERDOSAGE

In all cases of suspected overdosage, call your regional Poison Control Center to obtain the most up-to-date information about the treatment of overdosage. This recommendation is made because, in general, information regarding the treatment of overdosage may change more rapidly than do package inserts.

Initial consideration should be given to the management of the CNS effects of Dolene overdosage. Resuscitative measures should be initiated promptly. SYMPTOMS OF Dolene OVERDOSAGEThe manifestations of acute overdosage with Dolene are those of narcotic overdosage. The patient is usually somnolent, but may be stuporous or comatose and convulsing. Respiratory depression is characteristic. The ventilatory rate and/or tidal volume is decreased, which results in cyanosis and hypoxia. Pupils, initially pinpoint, may become dilated as hypoxia increases. Cheyne-Stokes respiration and apnea may occur. Blood pressure and heart rate are usually normal initially, but blood pressure falls and cardiac performance deteriorates, which ultimately results in pulmonary edema and circulatory collapse unless the respiratory depression is corrected and adequate ventilation is restored promptly. Cardiac arrhythmias and conduction delay may be present. A combined respiratory-metabolic acidosis occurs owing to retained CO₂ (hypercapnia) and to lactic acid formed during anaerobic glycolysis. Acidosis may be severe if large amounts of salicylates have also been ingested. Death may occur. TREATMENT OF Dolene OVERDOSAGEAttention should be directed first to establishing a patent airway and to restoring ventilation. Mechanically assisted ventilation, with or without oxygen, may be required, and positive-pressure respiration may be desirable if pulmonary edema is present. The narcotic antagonist naloxone will markedly reduce the degree of respiratory depression, and 0.4 to 2 mg should be administered promptly, preferably intravenously. If the desired degree of counteraction with improvement in respiratory functions is not obtained, naloxone should be repeated at 2-to-3-minute intervals. The duration of action of the antagonist may be brief. If no response is observed after 10 mg of naloxone have been administered, the diagnosis of Dolene toxicity should be questioned. Naloxone may also be administered by continuous intravenous infusion. TREATMENT OF Dolene OVERDOSAGE IN CHILDRENThe usual initial dose of naloxone in children is 0.01 mg/kg body weight given intravenously. If the dose does not result in the desired degree of clinical improvement, a subsequent increased dose of 0.1 mg/kg body weight may be administered. If an IV route of administration is not available, naloxone may be administered IM or subcutaneously in divided doses. If necessary, naloxone can be diluted with Sterile Water for Injection. Blood gases, pH, and electrolytes should be monitored in order that acidosis and any electrolyte disturbance present may be corrected promptly. Acidosis, hypoxia, and generalized CNS depression predispose to the development of cardiac arrhythmias. Ventricular fibrillation or cardiac arrest may occur and necessitate the full complement of cardiopulmonary resuscitation (CPR) measures. Respiratory acidosis rapidly subsides as ventilation is restored and hypercapnia eliminated, but lactic acidosis may require intravenous bicarbonate for prompt correction. Electrocardiographic monitoring is essential. Prompt correction of hypoxia, acidosis, and electrolyte disturbance (when present) will help prevent these cardiac complications and will increase the effectiveness of agents administered to restore normal cardiac function. In addition to the use of narcotic antagonist, the patient may require careful titration with an anticonvulsant to control convulsions. Analeptic drugs (for example, caffeine or amphetamine) should not be used because of tendency to precipitate convulsions. General supportive measures, in addition to oxygen, include, when necessary, intravenous fluids, vasopressor-inotropic compounds, and when infection is likely, anti-infective agents. Gastric lavage may be useful, and activated charcoal can adsorb a significant amount of ingested Dolene. Dialysis is of little value in poisoning due to Dolene. Efforts should be made to determine whether other agents such as alcohol, barbiturates, tranquilizers, or other CNS depressants, were also ingested, since these increase CNS depression as well as cause specific toxic effects. SYMPTOMS OF ACETAMINOPHEN OVERDOSAGEShortly after oral ingestion of an overdosage of acetaminophen and for the next 24 hours, anorexia, nausea, vomiting, diaphoresis, general malaise and abdominal pain have been noted. The patient may then present no symptoms, but evidence of liver dysfunction may become apparent up to 72 hours after ingestion, with elevated serum transaminase and lactic dehydrogenase levels, an increase in serum bilirubin concentrations, and a prolonged prothrombin time. Death from hepatic failure may result 3 to 7 days after overdosage. Acute renal failure may accompany the hepatic dysfunction and has been noted in patients who do not exhibit signs of fulminant hepatic failure. Typically, renal impairment is more apparent 6 to 9 days after ingestion of the overdose. TREATMENT OF ACETAMINOPHEN OVERDOSAGEAcetaminophen in massive overdosage may cause hepatic toxicity in some patients. In all cases of suspected overdose, immediately call your regional poison control center for assistance in diagnosis and for directions in the use of N-acetylcysteine as an antidote. In adults, hepatic toxicity has rarely been reported with acute overdoses of less than 10 g and fatalities with less than 15 g. Importantly, young children seem to be more resistant than adults to the hepatotoxic effect of an acetaminophen overdose. Despite this, the measures outlined below should be initiated in any adult or child suspected of having ingested an acetaminophen overdose. Because clinical and laboratory evidence of hepatic toxicity may not be apparent until 48 to 72 hours postingestion, liver function studies should be obtained initially and repeated at 24-hour intervals. Consider emptying the stomach promptly by lavage or by induction of emesis with syrup of ipecac. Patients’ estimates of the quantity of a drug ingested are notoriously unreliable. Therefore, if an acetaminophen overdose is suspected, a serum acetaminophen assay should be obtained as early as possible, but no sooner than four hours following ingestion. The antidote, N-acetylcysteine, should be administered as early as possible, and within 16 hours of the overdose ingestion for optimal results. Following recovery, there are no residual, structural or functional hepatic abnormalities.

DOSAGE AND ADMINISTRATION

The product is given orally. The usual dose is 65 mg Dolene hydrochloride and 650 mg acetaminophen every 4 hours as needed for pain. The maximum recommended dose of Dolene hydrochloride is 390 mg per day.

Consideration should be given to a reduced total daily dosage in patients with hepatic or renal impairment.

HOW SUPPLIED

Dolene Hydrochloride and Acetaminophen Tablets 65 mg/650 mg are orange, oblong, unscored tablets, marked 714, and 65 over 650 on one side of the tablet and WATSON on the other side, containing 65 mg of Dolene hydrochloride and 650 mg of acetaminophen available in bottles of 100 and 500.

Keep tightly closed. Protect from light. Store at controlled room temperature 15°-30°C (59°-86°F). Dispense in a tight, light-resistant container as defined in the USP.

ANIMAL TOXICOLOGY

The acute lethal doses of the hydrochloride and napsylate salts of Dolene were determined in 4 species. The results shown in Figure 2 indicate that on a molar basis, the napsylate salt is less toxic than the hydrochloride. This may be due to the relative insolubility and retarded absorption of Dolene napsylate.

LD₅₀ (mg/kg) ± SE
—————————
LD₅₀ (mMole/kg)
Species	Dolene	Dolene
	Hydrochloride	Napsylate
Mouse	282 ± 39	915 ± 163
	0.75	1.62
Rat	230 ± 44	647 ± 95
	0.61	1.14
Rabbit	ca. 82	> 183
	0.22	> 0.32
Dog	ca. 100	> 183
	0.27	> 0.32

Some indication of the relative insolubility and retarded absorption of Dolene napsylate was obtained by measuring plasma Dolene levels in 2 groups of 4 dogs following oral administration of equimolar doses of the 2 salts. As shown in Figure 3, the peak plasma concentration observed with Dolene hydrochloride was much higher than that obtained after administration of the napsylate salt.

Although none of the animals in this experiment died, 3 of the 4 dogs given Dolene hydrochloride exhibited convulsive seizures during the time interval corresponding to the peak plasma levels. The 4 animals receiving the napsylate salt were mildly ataxic but not acutely ill.

PATIENT INFORMATION SHEET

YOUR PRESCRIPTION FOR Dolene HYDROCHLORIDE AND ACETAMINOPHEN TABLETS

SummaryProducts containing Dolene are used to relieve pain. LIMIT YOUR INTAKE OF ALCOHOL WHILE TAKING THIS DRUG. Make sure your doctor knows if you are taking tranquilizers, sleep aids, antidepressants, antihistamines, or any other drugs that make you sleepy. Combining Dolene with alcohol or these drugs in excessive doses is dangerous. Use care while driving a car or using machines until you see how the drug affects you, because Dolene can make you sleepy. Do not take more of the drug than your doctor prescribed. Dependence has occurred when patients have taken Dolene for a long period of time at doses greater than recommended. The rest of this leaflet gives you more information about Dolene. Please read it and keep it for further use.Uses for DoleneProducts containing Dolene are used for the relief of mild to moderate pain. Products which contain Dolene plus acetaminophen are prescribed for the relief of pain or pain associated with fever.Before taking DoleneMake sure your doctor knows if you have ever had an allergic reaction to Dolene or acetaminophen. The effect of Dolene in children under 12 has not been studied. Therefore, use of the drug in this age group is not recommended.How to take DoleneFollow your doctor’s directions exactly. Do not increase the amount you take without your doctor’s approval. If you miss a dose of the drug, do not take twice as much the next time.PregnancyDo not take Dolene during pregnancy unless your doctor knows you are pregnant and specifically recommends its use. Cases of temporary dependence in the newborn have occurred when the mother has taken Dolene consistently in the weeks before delivery. As a general principle, no drug should be taken during pregnancy unless it is clearly necessary.General CautionsHeavy use of alcohol with Dolene is hazardous and may lead to overdosage symptoms ; THEREFORE, LIMIT YOUR INTAKE OF ALCOHOL WHILE TAKING Dolene. Combinations of excessive doses of Dolene, alcohol, and tranquilizers are dangerous. Make sure your doctor knows if you are taking tranquilizers, sleep aids, antidepressant drugs, antihistamines, or any other drugs that make you sleepy. The use of these drugs with Dolene increases their sedative effects and may lead to overdosage symptoms, including death. Propoxyphene may cause drowsiness or impair your mental and/or physical abilities; therefore, use caution when driving a vehicle or operating dangerous machinery. DO NOT perform any hazardous task until you have seen your response to this drug. Propoxyphene may increase the concentration in the body of medications such as anticoagulants (“blood thinners”), antidepressants, or drugs used for epilepsy. The result may be excessive or adverse effects of these medications. Make sure your doctor knows if you are taking any of these medications.DependenceYou can become dependent on Dolene if you take it in higher than recommended doses over a long period of time. Dependence is a feeling of need for the drug and a feeling that you cannot perform normally without it.OverdosageAn overdose of Dolene, alone or in combination with other drugs, including alcohol, may cause weakness, difficulty in breathing, confusion, anxiety, and more severe drowsiness and dizziness. Extreme overdosage may lead to unconsciousness and death. If the Dolene product contains acetaminophen, the overdosage symptoms include nausea, vomiting, lack of appetite, and abdominal pain. Liver damage may occur even after symptoms disappear. Death can occur days later. In any suspected overdosage situation, contact your doctor or nearest hospital emergency room. GET EMERGENCY HELP IMMEDIATELY.KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.Possible Side EffectsWhen Dolene is taken as directed, side effects are infrequent. Among those reported are drowsiness, dizziness, nausea, and vomiting. If these effects occur, it may help if you lie down and rest. Less frequently reported side effects are constipation, abdominal pain, skin rashes, light-headedness, headache, weakness, minor visual disturbances, and feelings of elation or discomfort. If side effects occur and concern you, contact your doctor.Other informationThe safe and effective use of Dolene depends on your taking it exactly as directed. This drug has been prescribed specifically for you and your present condition. Do not give this drug to others who may have similar symptoms. Do not use it for any other reason. If you would like more information about Dolene, ask your doctor or pharmacist. They have a more technical leaflet (professional labeling) you may read.Watson Laboratories, Inc.

Corona, CA 92880 USA30163-3

Rev: September 2003

Dolene pharmaceutical active ingredients containing related brand and generic drugs:

Propoxyphene Hydrochloride

Dolene available forms, composition, doses:

Capsules; Oral; Propoxyphene Hydrochloride 65 mg

Dolene destination | category:

Human:
Analgesics (opioid)

Dolene Anatomical Therapeutic Chemical codes:

N02AX - Other opioids

Dolene pharmaceutical companies:

References

Dailymed."PROPOXYPHENE (PROPOXYPHENE HYDROCHLORIDE) CAPSULE [STAT RX USA]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Dolene?

Depending on the reaction of the Dolene after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Dolene 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 Dolene 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.

Review

sdrugs.com conducted a study on Dolene, 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 Dolene 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.