TYLENOL® MENSTRUAL McNeil Consumer Healthcare Acetaminophen–Pamabrom–Pyrilamine Maleate Analgesic–Diuretic–Antihistaminic
Action and Clinical
The analgesic and antipyretic effects of acetaminophen are believed to be related to the inhibition of prostaglandin synthetase (a mechanism shared by ASA and related drugs). It is postulated that the analgesic effect is produced by elevation of the pain threshold and the antipyretic effect is produced through action on the hypothalamic heat-regulating centre.:
Acetaminophen is considered equipotent to ASA in its analgesic and antipyretic effects and is unlikely to produce many of the side effects associated with ASA and ASA-containing products. Unlike these drugs, however, it has no anti-inflammatory effect at clinically relevant doses in humans.
Acetaminophen is metabolized primarily in the liver. The major pathway involves glucuronyl transferase and the minor pathway involves the cytochrome P450 mixed function oxidase system.
Pyrilamine is an antihistaminic agent of the ethylenediamine group. In addition, pyrilamine possesses local anesthetic activity and exerts a mild analgesic action.
Pamabrom, a xanthine derivative, is a safe and effective diuretic in relieving the water-accumulation symptoms of water-weight gain, bloating, swelling, and/or full feeling associated with the premenstrual and menstrual periods.
Indications And Clinical Uses:
For the temporary relief of premenstrual and menstrual symptoms including backache, breast tenderness, bloating, swelling, cramps, headache, irritability, tension, mild to moderate aches and pains and the temporary water-weight gain frequently associated with the premenstrual period.
Contra-Indications:
Hypersensitivity to pamabrom, theophylline derivatives, pyrilamine, or acetaminophen.
Warnings in Clinical States:
Individuals with continuing severe or debilitating symptoms accompanying premenstrual syndrome should consult their doctor.
Precautions:
As with any other nonprescription analgesic drug, physicians should be cognizant of and supervise the use of acetaminophen in patients with alcoholism, serious kidney or serious liver disease. Chronic heavy alcohol abusers may be at increased risk of liver toxicity from excessive doses of acetaminophen, although reports of this event are rare. Reports usually involve cases of severe chronic alcoholics and the dosages of acetaminophen most often exceed recommended doses and often involve substantial overdose. Physicians should alert their patients who regularly consume large amounts of alcohol not to exceed the recommended doses of acetaminophen.:
Patients should be counselled to consult a physician if premenstrual or menstrual symptoms do not improve with use of this product or if they worsen, or if other unusual symptoms develop.
This product should not be taken for pain for more than 5 days unless directed by a physician.
Do not use with other products containing acetaminophen. Keep out of the reach of children.
Patients with asthma, glaucoma, bladder-neck obstruction, peptic ulcer or pyloroduodenal obstruction, emphysema, chronic pulmonary disease, or shortness of breath should not use this medication unless directed by a physician.
Pregnancy: This product should not be used by pregnant women.
Lactation: As with any drug, patients who are nursing a baby should consult a physician before taking this product.
Children: Not recommended for children under 12 years of age.
Occupational Hazards: May produce additive CNS effects when taken concomitantly with alcohol, hypnotics, anxiolytics, narcotic analgesics, and neuroleptic drugs. Advise caution when driving a motor vehicle or operating machinery or engaging in any activity requiring alertness. Patients taking tranquilizers or sedatives should not take this medication before consulting a physician.
Precautions:
When used as directed, acetaminophen is virtually free of severe toxicity or side effects.
The classic gastrointestinal irritation associated with NSAIDs, including ASA does not occur with acetaminophen. Sensitivity reactions are rare. Cross-reactivity in ASA-sensitive persons has been rarely reported. If sensitivity is suspected, discontinue use of the drug.
Patients who concomitantly medicate with warfarin-type anticoagulants and regular doses of acetaminophen have occasionally been reported to have unforeseen elevations in their INR. Physicians should be cognizant of this potential interaction and monitor the INR in such patients closely while therapy is established.
Other side effects are usually mild but may include drowsiness and listlessness.
Symptoms And Treatment Of Overdose:
Overdose Acetaminophen: Typical Toxidrome: Significant overdoses of acetaminophen may result in potentially fatal hepatotoxicity. The physician should be mindful that there is no early presentation that is pathoneumonic for the overdose. A high degree of clinical suspicion must always be maintained.
Due to the wide availability of acetaminophen, it is commonly involved in single and mixed drug overdose situations and the practitioner should have a low threshold for screening for its presence in a patient’s serum.
Acute toxicity after single dose overdoses of acetaminophen can be anticipated when the overdose exceeds 150 mg/kg. Chronic alcohol abusers, cachectic individuals, and persons taking pharmacologic inducers of the hepatic P450 microsomal enzyme system may be at risk with lower exposures.
There have been rare reports of chronic intoxication in persons consuming in excess of 150 mg/kg of acetaminophen daily for several days.
Specific Antidote: NAC (N-acetylcysteine) administered by either the i.v. or the oral route is known to be a highly effective antidote for acetaminophen poisoning. It is most effective when administered within 8 hours of a significant overdose but reports have indicated benefits to treatment initiated well beyond this time period. It is imperative to administer the antidote as early as possible in the time course of acute intoxication to reap the full benefits of the antidote’s protective effects.
General Management: When the possibility of acetaminophen overdose exists, treatment should begin immediately and include appropriate decontamination of the gastrointestinal tract, proper supportive care, careful assessment of appropriately timed serum acetaminophen estimations evaluated against the Matthew-Rumack nomogram, timely administration of NAC as required and appropriate follow-up care. Physicians unfamiliar with the current management of acetaminophen overdose should consult with a Poison Control Centre immediately. Telephone numbers for local Poison Control Centres are available in the local phone directory. Delays in initiation of appropriate therapy may jeopardize the patient’s chances for full recovery.
Pamabrom: Typical Toxidrome: Xanthine group.
Specific Antidote: None.
General Management: Stabilize the patient (ABCs), undertake appropriate gastrointestinal tract decontamination procedures, initiate supportive care, consult with a Regional Poison Control Centre regarding ongoing management, and arrange for appropriate follow-up care. Additionally, appropriate monitoring for seizures, arrhythmias and fluid and electrolyte imbalance should be employed.
Pyrilamine: Typical Toxidrome: Anticholinergic, CNS depressant (adult), CNS stimulant (child).
Specific Antidote: None.
General Management: Stabilize the patient (ABCs), undertake appropriate gastrointestinal tract decontamination procedures, initiate supportive care, consult with a Regional Poison Control Centre regarding ongoing management, and arrange for appropriate follow-up care.
Dosage And Administration:
Adults and Children Over 12 Years of Age: 2 caplets every 4 hours, as required. It is hazardous to exceed 8 caplets/day.
Tylenol Menstrual caplets are most effective if taken at the first sign of menstrual discomfort.
Availability And Storage:
Each hard, salmon-colored, coated, capsule-shaped tablet, engraved “TYME” one side and “500” the other side contains: acetaminophen 500 mg, pamabrom 25 mg and pyrilamine maleate 15 mg. Nonmedicinal ingredients: cellulose, citric acid, cornstarch, FD&C red no. 40, FD&C yellow no. 6, hydroxypropyl methylcellulose, magnesium stearate, polydextrose, polyethylene glycol, sodium cyclamate, sodium starch glycolate, titanium dioxide and triacetin. Energy: 1 kJ (0.24 kcal). Sodium: 0.018 mmol (0.42 mg). Gluten-, lactose-, sulfite-, tartrazine- and sucrose-free. Plastic bottles of 16 and 32. Store at controlled room temperature (15 to 30°C).
Container provided with a child-resistant closure.
TYLENOL® MENSTRUAL McNeil Consumer Healthcare Acetaminophen–Pamabrom–Pyrilamine Maleate Analgesic–Diuretic–Antihistaminic
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