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Pamprin PMS (Pamabrom Pyrilamine Maleate Acetaminophen)

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Pharmacology
Information not available

Indications
Diuretic Antihistamine Analgesic

Contraindications
 Hypersensitivity to pamabrom, theophylline derivatives, pyrilamine maleate, or acetaminophen, and in those with the following conditions: asthmatic attacks, narrow-angle glaucoma, bladder-neck obstruction, peptic ulcer or pyloroduodenal obstruction.

Safety Information / Warning
Individuals with continuing severe or debilitating symptoms accompanying premenstrual syndrome should consult their physician.

Pregnancy  and Lactation:  Should not be given to women who are pregnant or who are nursing.

Children: Not recommended for children less than 12years old.

Keep safely out of reach of children. This package contains sufficient medication to seriously harm a child.

Precautions
 Occupational Hazards: May produce additive CNS effects when taken concomitantly with alcohol, hypnotics, anxiolytics, narcotic analgesics, and neuroleptic drugs. If drowsiness occurs, avoid driving a motor vehicle or operating machinery while taking this product.

Side Effects / Adverse Effects
 Side effects are usually mild and may include drowsiness and listlessness. Hypersensitivity reactions are rare but may include urticaria, skin eruptions, pruritus or anaphylaxis.

Overdose
Symptoms:  In mild overdosage, symptoms may be manifest as an exaggeration of the adverse effects listed above, but may be more severe, particularly in children. Severe cases may include hallucinations, excitement, ataxia, incoordination, convulsions and cardiovascular depression.

Acetaminophen poisoning can result in severe hepatic damage. The minimum dose of acetaminophen that may cause hepatotoxicity in adults is generally considered to be 10g, and a dose of 16g is potentially lethal. However, there have been rare instances of hepatotoxicity and death reported from lower doses, and survival after much larger doses (up to 31g) is common.

Phenobarbital increases the activity of microsomal enzymes which produce a toxic metabolite which may enhance acetaminophen's hepatotoxicity. Concomitant ingestion of phenobarbital may increase the likelihood of liver necrosis in acetaminophen overdose. The chronic ingestion of alcohol may also increase the potential for hepatic toxicity in acetaminophen overdose.

Early symptoms (nausea, vomiting, weakness) usually occur after ingestion of an acetaminophen overdose large enough to cause hepatic toxicity. However, since some patients may exhibit few or none of these early signs, in cases of suspected acetaminophen overdose, antidotal therapy should begin as soon as possible. A latent period of 24to 36hours exists between ingestion and onset of hepatic symptoms. Laboratory evidence usually appears within 24to 48hours if severe hepatotoxicity is to occur. In mild cases, clinical evidence of hepatotoxicity may be delayed for as long as 5days. Patients should be monitored by liver function tests for several days following an overdose. Following the latent period, vomiting, pain in the right hypochondrium and manifestations of hepatic failure may occur. Maximum hepatic necrosis appears 2to 6days following overdose. The primary changes in serum chemistries are a gross elevation of hepatic enzymes, an elevation of serum bilirubin, a prolongation of prothrombin time and possible hypoglycemia.



Treatment:  Should be supportive and symptomatic. If the product has been taken recently by mouth, gastric lavage or induction of vomiting with ipecac syrup USP is recommended. If activated charcoal is administered, lavage before treatment with oral antidote (acetylcysteine) to prevent absorption of the latter. Plasma levels of acetaminophen should be monitored.

The patient should be kept quiet to minimize excitement. Convulsions and marked CNS stimulation should be treated. Treatment should include correction of hypoxia fluid and electrolyte imbalance. Assisted respiration may be necessary and cooling, if hyperpyrexia occurs. Dialysis has been employed to treat xanthine overdosage.

Recommended Dosage
Pamprin PMS: 2caplets and repeat every 3to 4hours as needed. Do not exceed 8caplets in 24hours. Do not use for more than 5consecutive days. Use only as directed by a physician.

Supplied / Packaging
Pamprin PMS:  Each white, capsule-shaped tablet, with Pamprin PMS embossed on one side, contains: pamabrom 25mg, pyrilamine maleate 15mg and acetaminophen 500mg. Gluten-, lactose-, sodium- and tartrazine-free. Child-resistant bottles of16 and32.

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