DRUGS & SUPPLEMENTS

Propoxyphene Compound 65

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Propoxyphene Compound 65 uses

Propoxyphene Compound 65 consists of Aspirin, Caffeine, Propoxyphene Hydrochloride.

Aspirin:


Pharmacological action

Propoxyphene Compound 65 is a NSAIDs. It has anti-inflammatory, analgesic and antipyretic effect, and inhibits platelet aggregation. The mechanism of action is associated with inhibition of COX activity - the main enzyme metabolism of arachidonic acid which is a precursor of prostaglandins which play a major role in the pathogenesis of inflammation, pain and fever. Reduction of prostaglandins (mainly E1) in the thermoregulation center leads to a decrease in body temperature due to expansion of blood vessels of the skin and increase perspiration. Analgesic effect of Propoxyphene Compound 65 (Aspirin) is due to both central and peripheral effects. Reduces aggregation, platelet adhesion and thrombus formation through suppression of synthesis of thromboxane A2 in platelets.

Reduces mortality and risk of myocardial infarction in unstable stenocardia. It is effective in primary prevention of cardio-vascular system and secondary prevention of myocardial infarction. At a daily dose of 6 g or more inhibits the synthesis of prothrombin in the liver and increases the prothrombin time. Propoxyphene Compound 65 (Aspirin) increases fibrinolytic activity of plasma and reduces the concentration of vitamin K-dependent coagulation factors (II, VII, IX, X). Increases the rate of hemorrhagic complications in carrying out surgical procedures, increases the risk of bleeding during therapy with anticoagulants. It stimulates the excretion of uric acid (violating its reabsorption in the renal tubules) but in high doses. The blockade of COX-1 in the mucosa of the stomach leads to inhibition of gastroprotective prostaglandins, which may lead to ulceration of the mucous membrane and subsequent bleeding.

Pharmacokinetics

When administered orally Propoxyphene Compound 65 (Aspirin) is rapidly absorbed mainly from the proximal small intestine and to a lesser extent from the stomach. The presence of food in the stomach significantly affects the absorption of acetylsalicylic acid.

Metabolised in the liver by hydrolysis with the formation of salicylic acid with subsequent conjugation with glycine or two drugs. The concentration of salicylates in blood plasma is variable.

About 80% of salicylic acid binds to plasma proteins. Salicylates easily penetrate into many tissues and body fluids, including the cerebrospinal, peritoneal and synovial fluid. In small quantities salicylates are found in brain tissue, traces - in bile, sweat and feces. Quickly penetrates the placental barrier in small amounts excreted in breast milk.

For newborns salicylates may displace bilirubin from its association with albumin and promote bilirubin encephalopathy.

Penetration into the joint cavity is accelerated in the presence of hyperemia and edema, and slows down in the proliferative phase of inflammation.

If you have acidosis most of salicylate becomes unionized acid, good penetration into the tissue, including in the brain.

Propoxyphene Compound 65 (Aspirin) withdraws mainly by active secretion in the tubules of the kidneys in unchanged form (60%) and in the form of metabolites. The withdraw of unchanged salicylate is dependent on the pH of urine (for alkalinization of urine increases ionized salicylates, worsening their reabsorption and increases excretion). T1/2 of acetylsalicylic acid is approximately 15 minutes. T1/2 of salicylate at a reception in low doses is 2-3 h, with an increase in dose may increase to 15-30 hours. Newborns' elimination of salicylate is much slower than in adults.

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Why is Propoxyphene Compound 65 prescribed?

Rheumatism, rheumatoid arthritis, infectious-allergic myocarditis, fever during infectious and inflammatory diseases, pain syndrome, weak and medium intensity of various origins (including neuralgia, myalgia, headache); based prevention of thrombosis and embolism, primary and secondary prevention of myocardial infarction, prevention of violations of cerebral circulation by ischemic type.

In the clinical immunology and allergy: a gradually increasing doses for a prolonged "aspirin" desensitization and the formation of stable tolerance to NSAIDs in patients with "aspirin asthma" and "aspirin triad."

Dosage and administration

Individual. For oral administration dosing of Propoxyphene Compound 65 regimen depends on indication for use. Usual adult dose when used as antipyretic and analgesic is 500-1000 mg / day (up to 3 g) were divided into 3 admission.

In myocardial infarction, as well as for secondary prevention in patients after myocardial infarction - 40-325 mg 1 time a day (usually 160 mg). As an inhibitor of platelet aggregation - a dose of 300-325 mg / day, for a long time. At the dynamic circulatory disorders in men, cerebral thromboembolism, including to prevent a recurrence - 325 mg / day with gradual increase to a maximum of 1 g / day. For prevention of thrombosis or occlusion of the aortic shunt - by 325 mg every 7 h after intranasal gastric tube set, and then - through the mouth to 325 mg 3 times a day (usually in combination with dipyridamole, which abolished after 1 week, continuing the long-term treatment with acetylsalicylic acid).

Propoxyphene Compound 65 (Aspirin) side effects, adverse reactions

Digestive system: nausea, vomiting, anorexia, epigastric pain, diarrhea; rarely - occurrence of erosive and ulcerative lesions, bleeding from the gastrointestinal tract, abnormal liver function.

Central nervous system: long-term use may be dizziness, headache, reversible visual disturbances, tinnitus, aseptic meningitis.

Hemopoietic system: rarely - thrombocytopenia, anemia.

Blood coagulation system: rarely - haemorrhagic syndrome, prolongation of bleeding time.

Urinary system: rarely - renal dysfunction, with prolonged use - acute kidney failure, nephrotic syndrome.

Allergic reactions: rarely - skin rash, Quincke's edema, bronchospasm, "aspirin triad" (a combination of bronchial asthma, recurrent nasal polyposis, and paranasal sinuses and intolerance of acetylsalicylic acid and medicines pirazolonic series).

Other: in some cases - Reye syndrome, long-term use - increased symptoms of chronic heart failure.

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Propoxyphene Compound 65 contraindications

Exacerbation phase of erosive-ulcerative lesions in the gastrointestinal tract, gastro-intestinal bleeding, "aspirin triad", a history of indications urticaria, rhinitis, caused by taking Propoxyphene Compound 65 (Aspirin) and other NSAIDs, hemophilia, hemorrhagic diathesis, gipoprotrombinemii, dissecting aneurysm of the aorta, portal hypertension, deficiency of vitamin K, liver and / or renal failure, deficiency of glucose-6-phosphate dehydrogenase, Reye syndrome, children's age (under 15 years - the risk of developing Reye syndrome in children with hyperthermia on a background of viral diseases), I and III trimester of pregnancy, lactation, hypersensitivity to Propoxyphene Compound 65 (Aspirin) and other salicylates.

Using during pregnancy and breastfeeding

Propoxyphene Compound 65 (acetylsalicylic acid) is contraindicated in I and III trimester of pregnancy. In pregnancy trimester II can a one-off reception on the strict condition.

This medication has a teratogenic effect: when used in the I trimester leads to top palatoschisis, in the III trimester - cause inhibition of labor (inhibition of prostaglandin synthesis), premature closure of the ductus arteriosus in the fetus, pulmonary vascular hyperplasia and hypertension in the pulmonary circulation.

Propoxyphene Compound 65 (Aspirin) (acetylsalicylic acid) is excreted in breast milk, which increases the risk of bleeding in a child due to dysfunction of platelets, and therefore should not be applied acetylsalicylic acid in the mother during lactation.

Special instructions

Propoxyphene Compound 65 (Aspirin) with caution used in patients with liver diseases and kidney, bronchial asthma, erosive and ulcerative lesions, and bleeding from the digestive tract in history, with increased bleeding or while holding anticoagulant therapy, decompensated congestive heart failure.

Acetylsalicylic acid even in small doses reduces the excretion of uric acid from the organism that can cause an acute attack of gout in predisposed patients. When conducting long-term therapy and / or use of Propoxyphene Compound 65 (Aspirin) in high doses required medical supervision and regular monitoring of hemoglobin levels.

The use of acetylsalicylic acid as anti-inflammatory drugs in a daily dose of 5-8 g is limited due to the high probability of adverse effects from the gastrointestinal tract.

Before surgery to reduce bleeding during surgery and postoperative period should stop taking salicylates for 5-7 days.

During prolonged therapy is necessary to conduct a general analysis of blood and study of occult blood.

The use of acetylsalicylic acid is contraindicated in pediatrics, as in the case of viral infection in children under the influence of acetylsalicylic acid increases the risk of developing Reye syndrome. Symptoms of Reye syndrome are prolonged vomiting, acute encephalopathy, liver enlargement.

Duration of treatment (without consulting a doctor) with Propoxyphene Compound 65 (Aspirin) should not exceed 7 days when administered as analgesic and more than 3 days as an antipyretic.

During treatment the patient should abstain from alcohol.

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Precautionary measures

Undesirable combined use with other NSAIDs and glucocorticoids. For 5-7 days before surgery should stop taking.

The probability of NSAID-gastropathy decreases in the appointment after a meal, use of tablets with buffer additives or coated with a special enteric-soluble shell. The risk of hemorrhagic complications is minimal when used in doses less than 100 mg / day.

Note that in predisposed patients acetylsalicylic acid (even in small doses) reduces the excretion of uric acid from the body and can cause the development of acute attack of gout.

During prolonged therapy should regularly carry out the analysis of blood and to investigate faeces for occult blood. In connection with the observed cases hepatogenic encephalopathy is not recommended for relief of fever syndrome in children.

Propoxyphene Compound 65 (Aspirin) drug interactions

With simultaneous use of antacids containing magnesium and / or aluminum hydroxide, slow down and reduce the absorption of acetylsalicylic acid.

With simultaneous use of calcium channel blockers, means limiting intake of calcium or increasing the excretion of calcium from the body, increases the risk of bleeding.

With simultaneous use with acetylsalicylic acid enhances the action of heparin and indirect anticoagulants, hypoglycemic funds derived sulfonylureas, insulin, methotrexate, phenytoin, valproic acid.

With simultaneous use of Propoxyphene Compound 65 (Aspirin) with SCS increases the risk of ulcerogenic effect and occurrence of gastrointestinal bleeding.

With simultaneous use of decreasing the effectiveness of diuretics (spironolactone, furosemide).

With simultaneous use of other NSAIDs increases the risk of side effects. Acetylsalicylic acid may reduce plasma concentrations indomethacin, piroxicam.

With simultaneous use of gold drugs acetylsalicylic acid can induce liver damage.

With simultaneous use decreases effectiveness of uricosuric medications (including probenecid, sulfinpirazon, benzbromarone).

With simultaneous use of acetylsalicylic acid and alendronate sodium may develop severe esophagitis.

With simultaneous use of griseofulvin may be in breach Absorption of acetylsalicylic acid.

There is one case of spontaneous hemorrhage in the iris while taking Ginkgo Biloba extract on the background of prolonged use of Propoxyphene Compound 65 (Aspirin) in a dose of 325 mg / day. It is believed that this may be due to additive inhibitory effect on platelet aggregation.

With simultaneous use of dipyridamole may increase Cmax of salicylate in plasma and AUC.

When applied simultaneously with acetylsalicylic acid increased concentration of digoxin, barbiturates and lithium salts in the blood plasma.

With simultaneous use of salicylates in high doses with carbonic anhydrase inhibitors can intoxication salicylates.

Acetylsalicylic acid in doses of less than 300 mg have little effect on the effectiveness of captopril and enalapril. When Propoxyphene Compound 65 (Aspirin) (acetylsalicylic acid) is admistered in high doses may decrease the effectiveness of captopril and enalapril.

With simultaneous application of caffeine increases the rate of absorption, plasma concentrations and bioavailability of acetylsalicylic acid.

With simultaneous use of Propoxyphene Compound 65 (Aspirin) with metoprolol may increase Cmax of salicylate in blood plasma.

In the application of pentazocine on the background of long-term use of Propoxyphene Compound 65 (Aspirin) in high doses there is a risk of severe adverse reactions in the kidneys.

With simultaneous application phenylbutazone reduces uricosuria caused by acetylsalicylic acid.

With simultaneous application of ethanol may exacerbate the effects of acetylsalicylic acid on the gastrointestinal tract.

Propoxyphene Compound 65 in case of emergency / overdose

May occur after receiving a single large dose or prolonged use. If a single dose of less than 150 mg / kg, acute poisoning feel light, 150-300 mg / kg - moderate, when using higher doses - heavy.

Symptoms: salicylism syndrome (nausea, vomiting, tinnitus, blurred vision, dizziness, severe headache, malaise, fever - a poor prognostic sign in adults). More severe poisoning - stupor, convulsions and coma, noncardiogenic pulmonary edema, abrupt dehydration, violations ABE (initially - respiratory alkalosis, then - metabolic acidosis), renal failure and shock.

In chronic overdose concentration determined in plasma are poorly correlated with the severity of intoxication. The greatest risk of chronic intoxication is found among elderly people at reception for a few days more than 100 mg / kg / day. In children and elderly patients the initial signs of salicylism are not always visible, and therefore desirable to periodically determine the concentration of salicylates in the blood. Level above 70 mg% indicates moderate or severe poisoning; above 100 mg% - on extremely heavy, a poor prognosis. If poisoning moderate require hospitalization for at least 24 hours.

Treatment: the provocation of vomiting, the appointment of activated charcoal and laxatives, monitoring ABE and electrolyte balance, depending on the state of metabolism - the introduction of sodium bicarbonate, solution of sodium citrate or sodium lactate. Raising reserve alkalinity increases the excretion of acetylsalicylic acid by alkalinization of urine. Alkalinization of urine is shown at the level of salicylates above 40 mg%, is provided in / by infusion of sodium bicarbonate - 88 mEq in 1 liter of 5% glucose solution, the rate of 10-15 ml / kg / h. Restoring BCC and induction of diuresis (achieved by introducing a bicarbonate in the same dose and dilution, repeat 2-3 times); should be aware that intense infusion fluid elderly patients may lead to pulmonary edema. Not recommended the use of acetazolamide for alkalinization of urine (may cause acidemia and enhance the toxic effect of salicylates). Hemodialysis is shown at the level of salicylates over 100-130 mg%, and in patients with chronic poisoning - 40 mg% or lower in the presence of witnesses (refractory acidosis, progressive deterioration, severe damage of the CNS, pulmonary edema and renal failure). When pulmonary edema - a mixture of artificial ventilation, oxygen enriched, in the mode of positive end-expiratory pressure, to treat cerebral edema apply hyperventilation and osmotic diuresis.

Caffeine:



Active ingredient (in each tablet)

Propoxyphene Compound 65 (Caffeine) 200mg

Purpose

Alertness aid

Use

  • helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness

Warnings

For occasional use only

Do not use

  • in children under 12 years of age
  • as a substitute for sleep

When using this product limit the use of Propoxyphene Compound 65 (Caffeine) containing medications, foods, or beverages because too much Propoxyphene Compound 65 (Caffeine) may cause nervousness, irritability, sleeplessness, and occasionally, rapid heartbeat. The recommended dose of this product contains about as much Propoxyphene Compound 65 (Caffeine) as a cup of coffee.

Stop use and ask a doctor if fatigue or drowsiness persists or continues to recur

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

  • adults and children 12 years of age and over: take 1 tablet not more often than every 3 to 4 hours.

Other information

  • store at room temperature
  • avoid excessive heat (greater than 100°F) or humidity

Inactive ingredients

carnauba wax, colloidal silicon dioxide, D&C yellow #10 aluminum lake, dextrose, FD&C yellow #6 aluminum lake, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, starch, titanium dioxide

Questions or comments?

Call toll-free 1-855-874-0970 weekdays


Display Panel Propoxyphene Compound 65 (Caffeine): 16 ct. Package

Propoxyphene Compound 65 (Caffeine)®

CAFFEINE ALERTNESS AID

16 TABLETS

200mg each

FUNCTIONAL Propoxyphene Compound 65 (Caffeine)® for Mental Alertness

SAFE & EFFECTIVE

One tablet is equal to about a cup of coffee

Propoxyphene Compound 65 (Caffeine)®

Making the Most of Every Day.®

Tamper Evident Feature: individually sealed in foil for your protection. Do not

use if foil or plastic bubble is torn or punctured.

Vivarin®, Vivarin® and design, stylization and trade dress, and FUNCTIONAL

CAFFEINE® are registered trademarks of Meda AB.

Distributed by:

Meda Consumer Healthcare Inc.

Marietta, GA 30062 ©2011 Meda AB

www.vivarin.com

16 ct. Package

Display Panel Propoxyphene Compound 65 (Caffeine): 40 ct. Package

SAFE & EFFECTIVE

FUNCTIONAL Propoxyphene Compound 65 (Caffeine)® for Mental Alertness

Propoxyphene Compound 65 (Caffeine)®

Propoxyphene Compound 65 (Caffeine) ALERTNESS AID

40 Tablets

200mg each

FUNCTIONAL Propoxyphene Compound 65 (Caffeine)® for Mental Alertness

Tamper Evident Feature: Individually sealed in foil for your protection. Do not use if foil or plastic bubble is torn or punctured.

VIVARIN® helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness (FDA approved uses), so you can accomplish all the things you want to do and all the things you need to do.

Vivarin®, Vivarin® and design, stylization and trade dress, and FUNCTIONAL

CAFFEINE® are registered trademarks of Meda AB.

Made in the U.S.A.

Propoxyphene Compound 65 (Caffeine)®

Making the Most of Every Day.®

Distributed by:

Meda Consumer Healthcare Inc.

Marietta, GA 30062 ©2013 Meda AB

www.vivarin.com

40 ct. Package

Propoxyphene Hydrochloride:


INDICATIONS AND USAGE

Propoxyphene Compound 65 (Propoxyphene Hydrochloride) 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 Propoxyphene Compound 65 (Propoxyphene Hydrochloride) or to acetaminophen.

WARNINGS

Do not prescribe Propoxyphene Compound 65 for patients who are suicidal or addiction-prone.

Prescribe Propoxyphene Compound 65 (Propoxyphene Hydrochloride) 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.Propoxyphene Compound 65 (Propoxyphene Hydrochloride) 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 (5% occurred within 15 minutes). Propoxyphene Compound 65 (Propoxyphene Hydrochloride) should not be taken in doses higher than those recommended by the physician. The judicious prescribing of Propoxyphene Compound 65 (Propoxyphene Hydrochloride) 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 Propoxyphene Compound 65 (Propoxyphene Hydrochloride) products and alcohol because of potentially serious CNS-additive effects of these agents. Because of its added depressant effects, Propoxyphene Compound 65 (Propoxyphene Hydrochloride) 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 Propoxyphene Compound 65 (Propoxyphene Hydrochloride) alone or in combination with other drugs. Patients taking Propoxyphene Compound 65 (Propoxyphene Hydrochloride) should be warned not to exceed the dosage recommended by the physician.

DRUG DEPENDENCE

Propoxyphene Compound 65, 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. Propoxyphene Compound 65 (Propoxyphene Hydrochloride) will only partially suppress the withdrawal syndrome in individuals physically dependent on morphine or other narcotics. The abuse liability of Propoxyphene Compound 65 (Propoxyphene Hydrochloride) is qualitatively similar to that of codeine although quantitatively less, and Propoxyphene Compound 65 (Propoxyphene Hydrochloride) should be prescribed with the same degree of caution appropriate to the use of codeine.

USAGE IN AMBULATORY PATIENTS

Propoxyphene Compound 65 (Propoxyphene Hydrochloride) 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.

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PRECAUTIONS

GENERAL

Propoxyphene Compound 65 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 Propoxyphene Compound 65 is additive with that of other CNS depressants, including alcohol.

As is the case with many medicinal agents, Propoxyphene Compound 65 (Propoxyphene Hydrochloride) 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 Propoxyphene Compound 65 (Propoxyphene Hydrochloride) 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, Propoxyphene Compound 65 (Propoxyphene Hydrochloride) 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 Propoxyphene Compound 65 have been detected in human milk. In postpartum studies involving nursing mothers who were given Propoxyphene Compound 65 (Propoxyphene Hydrochloride), no adverse effects were noted in infants receiving mother's milk.

PEDIATRIC USE

Propoxyphene Compound 65 (Propoxyphene Hydrochloride) 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 Propoxyphene Compound 65 (Propoxyphene Hydrochloride) 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 Propoxyphene Compound 65 (Propoxyphene Hydrochloride) 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 Propoxyphene Compound 65 (Propoxyphene Hydrochloride) hydrochloride and acetaminophen tablets. Propoxyphene Compound 65 (Propoxyphene Hydrochloride) 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 Propoxyphene Compound 65 (Propoxyphene Hydrochloride) 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 Propoxyphene Compound 65 (Propoxyphene Hydrochloride) overdosage. Resuscitative measures should be initiated promptly. SYMPTOMS OF Propoxyphene Compound 65 (Propoxyphene Hydrochloride) OVERDOSAGEThe manifestations of acute overdosage with Propoxyphene Compound 65 (Propoxyphene Hydrochloride) 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 Propoxyphene Compound 65 (Propoxyphene Hydrochloride) 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 Propoxyphene Compound 65 (Propoxyphene Hydrochloride) toxicity should be questioned. Naloxone may also be administered by continuous intravenous infusion. TREATMENT OF Propoxyphene Compound 65 (Propoxyphene Hydrochloride) 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 Propoxyphene Compound 65 (Propoxyphene Hydrochloride). Dialysis is of little value in poisoning due to Propoxyphene Compound 65 (Propoxyphene Hydrochloride). 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 Propoxyphene Compound 65 (Propoxyphene Hydrochloride) hydrochloride and 650 mg acetaminophen every 4 hours as needed for pain. The maximum recommended dose of Propoxyphene Compound 65 (Propoxyphene Hydrochloride) 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

Propoxyphene Compound 65 (Propoxyphene Hydrochloride) 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 Propoxyphene Compound 65 (Propoxyphene Hydrochloride) 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 Propoxyphene Compound 65 (Propoxyphene Hydrochloride) 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 Propoxyphene Compound 65 (Propoxyphene Hydrochloride) napsylate.

LD50 (mg/kg) ± SE
—————————
LD50 (mMole/kg)
SpeciesPropoxyphene Compound 65 (Propoxyphene Hydrochloride)Propoxyphene Compound 65 (Propoxyphene Hydrochloride)
HydrochlorideNapsylate
Mouse282 ± 39915 ± 163
0.751.62
Rat230 ± 44647 ± 95
0.611.14
Rabbitca. 82> 183
0.22> 0.32
Dogca. 100> 183
0.27> 0.32

Some indication of the relative insolubility and retarded absorption of Propoxyphene Compound 65 (Propoxyphene Hydrochloride) napsylate was obtained by measuring plasma Propoxyphene Compound 65 (Propoxyphene Hydrochloride) 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 Propoxyphene Compound 65 (Propoxyphene Hydrochloride) 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 Propoxyphene Compound 65 (Propoxyphene Hydrochloride) 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 Propoxyphene Compound 65 (Propoxyphene Hydrochloride) HYDROCHLORIDE AND ACETAMINOPHEN TABLETS

SummaryProducts containing Propoxyphene Compound 65 (Propoxyphene Hydrochloride) 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 Propoxyphene Compound 65 (Propoxyphene Hydrochloride) 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 Propoxyphene Compound 65 (Propoxyphene Hydrochloride) can make you sleepy. Do not take more of the drug than your doctor prescribed. Dependence has occurred when patients have taken Propoxyphene Compound 65 (Propoxyphene Hydrochloride) for a long period of time at doses greater than recommended. The rest of this leaflet gives you more information about Propoxyphene Compound 65 (Propoxyphene Hydrochloride). Please read it and keep it for further use.Uses for Propoxyphene Compound 65 (Propoxyphene Hydrochloride)Products containing Propoxyphene Compound 65 (Propoxyphene Hydrochloride) are used for the relief of mild to moderate pain. Products which contain Propoxyphene Compound 65 (Propoxyphene Hydrochloride) plus acetaminophen are prescribed for the relief of pain or pain associated with fever.Before taking Propoxyphene Compound 65 (Propoxyphene Hydrochloride)Make sure your doctor knows if you have ever had an allergic reaction to Propoxyphene Compound 65 (Propoxyphene Hydrochloride) or acetaminophen. The effect of Propoxyphene Compound 65 (Propoxyphene Hydrochloride) in children under 12 has not been studied. Therefore, use of the drug in this age group is not recommended.How to take Propoxyphene Compound 65 (Propoxyphene Hydrochloride)Follow 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 Propoxyphene Compound 65 (Propoxyphene Hydrochloride) 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 Propoxyphene Compound 65 (Propoxyphene Hydrochloride) 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 Propoxyphene Compound 65 (Propoxyphene Hydrochloride) is hazardous and may lead to overdosage symptoms ; THEREFORE, LIMIT YOUR INTAKE OF ALCOHOL WHILE TAKING Propoxyphene Compound 65 (Propoxyphene Hydrochloride).Combinations of excessive doses of Propoxyphene Compound 65 (Propoxyphene Hydrochloride), 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 Propoxyphene Compound 65 (Propoxyphene Hydrochloride) 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 Propoxyphene Compound 65 (Propoxyphene Hydrochloride) 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 Propoxyphene Compound 65 (Propoxyphene Hydrochloride), 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 Propoxyphene Compound 65 (Propoxyphene Hydrochloride) 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 Propoxyphene Compound 65 (Propoxyphene Hydrochloride) 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 Propoxyphene Compound 65 (Propoxyphene Hydrochloride) 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 Propoxyphene Compound 65 (Propoxyphene Hydrochloride), 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

Propoxyphene Compound 65 pharmaceutical active ingredients containing related brand and generic drugs:

infoActive 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.


Propoxyphene Compound 65 available forms, composition, doses:

infoForm 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.


Propoxyphene Compound 65 destination | category:

infoDestination 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.


Propoxyphene Compound 65 Anatomical Therapeutic Chemical codes:

infoA 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.


Propoxyphene Compound 65 pharmaceutical companies:

infoPharmaceutical 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.


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References

  1. Dailymed."PROPOXYPHENE (PROPOXYPHENE HYDROCHLORIDE) CAPSULE [STAT RX USA]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. Dailymed."VIVARIN (CAFFEINE) TABLET [MEDA CONSUMER HEALTHCARE INC.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  3. Dailymed."BUFFERIN LOW DOSE BUFFERED ASPIRIN (ASPIRIN) TABLET [NOVARTIS CONSUMER HEALTH, INC.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Propoxyphene Compound 65?

Depending on the reaction of the Propoxyphene Compound 65 after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Propoxyphene Compound 65 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 Propoxyphene Compound 65 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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Review

sDrugs.com conducted a study on Propoxyphene Compound 65, 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 Propoxyphene Compound 65 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.

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The information was verified by Dr. Arunabha Ray, MD Pharmacology

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