A Pharmacist's Guide to OTC Therapy

Ms. Terrie is a clinical pharmacy writer based in Haymarket, Virginia.

Menstrual Pain

Dysmenorrhea, commonly known as difficult or painful menstruation, is considered to be one of the most prevalent gynecologic problems in the United States.¹ Dysmenorrhea falls into 2 classifications: primary or secondary. Although the exact cause of primary dysmenorrhea is not fully understood, the cramping and lower abdominal pain are thought to be related to levels of the hormone prostaglandin that is released during menstruation.^1-3 Levels of the inflammatory mediators (leukotrienes), which cause vasoconstriction and uterine contractions, have been found to be elevated in women who experience dysmenorrhea.¹

Primary dysmenorrhea is suspected if the symptoms start soon after menarche or during adolescence,² when the condition is most common, affecting as many as 90% of women in this patient population.¹ Severe dysmenorrhea is reported by an estimated 15% of young women.¹

Secondary dysmenorrhea is suspected if symptoms start after adolescence and if pelvic pain occurs at times other than menses.^1,2 The causes of secondary dysmenorrhea are typically related to pelvic disorders, such as endometriosis, uterine fibroids, pelvic inflammatory disease,polycystic ovary syndrome, and uterine adenomyosis or a structural abnormality within or outside the uterus.^1-3

Treatment for Primary Dysmenorrhea

An estimated 80% to 90% of women affected by dysmenorrhea may be treated successfully with nonsteroidal antiinflammatory drugs (NSAIDs), oral contraceptives, or a combination of boththerapies.¹ Nonpharmacologic therapies include the use of topical heat applications,regular exercise, and discontinuation of smoking.¹

Table

Recommended Doses of OTC Analgesics for Treatment of Dysmenorrhea

Drug

Dosage

Acetaminophen

650-1000 mg q 4-6h (maximum daily dosage: 4000 mg)

Aspirin

650-1000 mg q 4-6h (maximum daily dosage: 4000 mg)

Ibuprofen

200-400 mg q 4-6h (maximum daily dosage: 1200 mg)

Naproxen sodium

220-440 mg initially, then 220 mg q 8-12h (maximum daily dosage: 660 mg)

Adapted from reference 1.

Various OTC products are marketed for the management of menstrual pain. Many of these are combination products that contain analgesics, diuretics such as pamabrom and caffeine, and the antihistamine pyrilamine maleate to address both premenstrual syndrome symptoms and menstrualpain.¹ Single-entity products containing analgesics also are available for menstrual pain. Patients should be advised to check the active ingredients prior to taking any of these products to avoid possible therapeutic duplications.

Acetaminophen, aspirin, and ibuprofen are the 3 most common OTC analgesics used for treating primary dysmenorrhea (Table).¹ The use of acetaminophen and aspirin is considered to be effective for treating only mild cases of dysmenorrhea.¹ Patients should be informed that the use of aspirin may increase menstrual flow, and, due to the potential for Reye's syndrome, aspirin should not be used in adolescent women.¹

Nonsalicylate NSAIDs (ibuprofen and naproxen sodium) are the most widely used agents for treating primary dysmenorrhea and also are considered the preferred agents of choice if not contraindicated.¹ These agents inhibit the production and action of prostaglandins.¹ Therapy can be initiated at the start of menses or pain or 2 to 3 days before expected onset.¹

Patients should be advised that these agents should be taken on a scheduled basis rather than on an as-needed basis to achieve satisfactory pain relief, but they should not take more than the recommended dosage or use the agents more frequently than recommended.¹ In general, patients should experience pain relief within 30 to 60 minutes after administration and should be advised to take these agents with food to minimize the incidence of gastric upset.¹

Table

Examples of Topical Products

Topical Heat Products

Manufacturer

ThermaCare Air-Activated Heatwraps, Menstrual Cramp Relief

Procter & Gamble

Heat Treat Personal Heating Pads, Menstrual Cramps

Grabber Performance Group

Cura-Heat, Air-Activated Therapeutic Heat Packs forMenstrual Pain

Kobayashi HealthCare Inc

Conclusion

During counseling, pharmacists shouldensure that patients understand theproper use and selection of OTC menstrualproducts and the adverse effectsassociated with them and also remindwomen about the importance of routinegynecologic examinations.

Patients with preexisting medical conditionsshould always seek advice fromtheir primary health care provider beforetaking any of these products. Pharmacistscan help to identify possible drug interactionsand contraindications, such as anallergy to aspirin and other NSAIDs. Thosetaking anticoagulants or lithium shouldavoid the use of nonsalicylate NSAIDs.

It is important to refer women whosesymptoms do not improve after the use ofOTC products or those with more severesymptoms to their primary health careprovider for further advice and treatment.Women with secondary dysmenorrheaand those who experience severe pain orchanges in the level of pain or abdominalpain that is experienced at times otherthan menstruation also should be referredto their primary health care provider forfurther medical evaluation.

In addition, pharmacists can make recommendationsabout nondrug measures,such as using topical heat products, relaxationtechniques, and avoiding stress.

Table

Examples of OTC Menstrual Products

Brand Name (Manufacturer)

Active Ingredients

Midol Maximum Strength Menstrual Complete (Bayer HealthCare LLC)

Acetaminophen (500 mg), caffeine (60 mg), pyrilamine maleate (15 mg)

Midol Teen Formula (Bayer HealthCare LLC)

Acetaminophen (500 mg), pamabrom (25 mg)

Midol Cramps & Body Aches (Bayer HealthCare LLC)

Ibuprofen (200 mg)

Midol Extended Relief (Bayer HealthCare LLC)

Naproxen sodium (220 mg)

Midol Menstrual Headache (Bayer HealthCare LLC)

Acetaminophen (500 mg), caffeine (65 mg)

Pamprin Multi-Symptom Caplets (Chattem Inc)

Acetaminophen (500 mg), pamabrom (25 mg), pyrilamine maleate (15 mg)

Pamprin Cramp (Chattem Inc)

Acetaminophen (250 mg), magnesium salicylate (250 mg), pamabrom (25 mg)

Pamprin All Day (Chattem Inc)

Naproxen sodium (220 mg)

Pamprin Maximum Strength Advanced Pain Relief, Max (Chattem Inc)

Acetaminophen (250 mg), aspirin (250 mg), caffeine (65 mg)

Premsyn PMS Maximum Strength Premenstrual Syndrome Relief (Chattem Inc)

Acetaminophen (500 mg), pamabrom (25 mg), pyrilamine maleate (15 mg)

Diurex PMS Tablet (Alva)

Acetaminophen (500 mg), pamabrom (25 mg), pyrilamine maleate (15 mg)

Boiron Cyclease Cramp, Menstrual Cramp Relief Quick Dissolving Tablets (Boiron)

Cimicifuga Racemosa 6C HPUS*, Colocynthis 6C HPUS, Magnesia Phosphorica 6C HPUS

*The letters HPUS indicate that these ingredients are officially included in the Homeopathic Pharmacopoeia of the United States.

References

• Shimp LA. Disorders Related to Menstruation. In: Berardi RR, Kroon LA, McDermott JH, et al, eds. Handbook of Nonprescription Drugs. 15th ed. Washington, DC: American Pharmacists Association; 2006:156-162.
• Beers MH. Dysmenorrhea. In: The Merck Manual of Diagnosis and Therapy. 18th ed. Whitehouse Station, NJ: Merck Research Laboratories; 2006:2078-2079.
• Painful Menstrual Periods. United States National Library of Medicine and the National Institutes of Health's Medline Plus Web site. www.nlm.nih.gov/medlineplus/ency/article/003150.htm.

Women's Multivitamin Supplements

Pharmacists can be an essentialsource of information for women interestedin selecting a multivitamin supplementthat is formulated to meet theirnutritional needs and appropriate for thevarious stages of life. It is important, however,for pharmacists to remind patientsthat OTC multivitamin supplements areintended to be used in conjunction with,not as a substitute for, a balanced diet.

Nutrients to Promote Overall Health

Multivitamin supplements formulatedfor women contain essential nutrientsthat promote overall health, as well assupport reproductive health. Calcium,magnesium, and vitamin D enhance andsupport bone health, and vitamins A, C,and E provide extra antioxidant protection.In addition, folic acid, vitamins B₆and B₁₂, magnesium, and zinc have beenshown to be beneficial for women experiencingpremenstrual syndrome, usingoral contraceptives, and experiencingmenopause.¹ Iron is frequently found inmultivitamin supplements for women,because iron supplementation is oftenwarranted in many females due to bloodloss from menstrual cycles.

In March 2007, McNeil Nutritionals,widely known for its calcium supplementViactiv, introduced Viactiv Multi-VitaminFlavor Glides, which contain 24 essentialvitamins and minerals.² Viactiv MultivitaminChews, another McNeil Nutritionalsproduct, contain 12 essential vitaminsand calcium and are available inchocolate and chocolate cherry flavors.

As women age, their nutritional needschange, and in recent years various multivitaminsupplements have been formulatedto target women older than 50.These multivitamin supplements mayinclude increased levels of calcium, folicacid, vitamin D, vitamin E, vitamin B₆, andother nutrients, but not iron, becauseindividuals 50 and older require less ironand generally meet their iron needsthrough diet alone.

Examples of these products includeOne A Day Women's 50+ Advantage(Bayer HealthCare, LLC) and CentrumSilver (Wyeth Consumer Healthcare). Inaddition to essential vitamins and minerals,One A Day Women's 50+ Advantagetablets contain ginkgo for memory andconcentration. Centrum Silver is availablein a chewable tablet form for individualswho may have difficulty swallowing.

Prenatal Supplements

Prenatal multivitamins contain nutrientsthat are crucial for a woman duringvarious stages, such as preconception,pregnancy, and lactation, as well as forfetal development.

Various clinical studies have demonstratedthat folic acid, particularly just beforeconception and in the early stages of pregnancy,decreases the incidence of neuraltube defects (NTDs) in infants.³ Accordingto the Centers for Disease Control andPrevention, daily consumption of 400 µg offolic acid by women of childbearing agecan prevent 50% to 70% of all cases ofNTDs.³ The US Public Health Service recommendsthat women of childbearing ageobtain a minimum of 400 µg of folic aciddaily through food sources and/or nutritionalsupplements.⁴ Most OTC prenatalvitamins contain 800 µg of folic acid.

Table

Examples of OTC Prenatal Vitamins

Brand

Manufacturer

Nature's Bounty Prenatal Vitamins

Nature's Bounty

Nature's Way Completia Prenatal Multivitamin

Nature's Way Products Inc

Nature Made Prenatal Vitamins

Pharmavite LLC

New Chapter Organics Perfect Prenatal Vitamins

New Chapter Inc

Rainbow Light Prenatal Vitamins

Rainbow Light Nutritional Systems

Stuart Prenatal Vitamins

Xanodyne Pharmaceuticals Inc

Conclusion

Prior to recommending any multivitaminsupplements to a patient, pharmacistsshould always assess the patient'sallergy history, medical history, and completemedication profile, to determine if apotential exists for any drug–micronutrientor micronutrient–micronutrientinteractions or possible contraindicationsfor use. When assisting patients in theselection of a multivitamin supplement,pharmacists also should remind womenabout the importance of adequate calciumintake, to decrease their risk of developingosteoporosis.

Patients with preexisting medical conditionsand pregnant or lactating womenshould always be advised to consult withtheir primary health care provider prior tousing any of these supplements to ensureappropriateness. It also is important forpharmacists to remind patients to usethese products as directed and to administeronly the recommended daily dosage.

Pharmacists should stress the importanceof adhering to a balanced diet andincorporating various lifestyle modifications,such as establishing a routine exerciseregimen, giving up smoking, and eliminatingor limiting alcohol use whenwarranted. The various multivitamin supplementsavailable enable women to usethe multivitamin supplement that bestsuits their individual needs, thus enablingthem to take a proactive role in the overallquality of their health. For more informationon these nutritional supplements,please visit the manufacturer Web sites.

Table

Examples of OTC Multivitamin Supplements for Women

Brand

Manufacturer

One A Day Women's Multivitamin/Multimineral Supplement with More Calcium, Tablets

One A Day Women's 50+ Advantage

Bayer Healthcare LLC

Nature Made Multi For Her Multi Vitamin/Mineral Supplement with Calcium and Iron, Premium Tablets

Nature Made Multi For Her 50+ Multi Vitamin/Mineral Supplement, Premium Tablets

Nature Made Women's Vitamin Pack

Pharmavite LLC

Nature's Bounty Prescriptive Formulas Women's Optimal Vitamin Packs

Nature's Bounty

Natrol My Favorite Multiple For Women

Natrol Inc

Prevention Age-Defying Multivitamin & Mineral for Women 50 Plus

Windmill Vitamins LLC

Viactiv Soft Multi-Vitamin Chews

Viactiv Multi-Vitamin Flavor Glides

McNeil Nutritionals

Centrum Silver Tablets

Wyeth Consumer Healthcare

References

• One A Day Vitamin Web site. Bayer Healthcare, LLC. www.oneaday.com.
• Viactiv Product Information. McNeil Nutritionals Web site. www.viactiv.com.
• Folic Acid: CDC Assistance. Centers for Disease Control and Prevention Web site. www.cdc.gov/ncbddd/folicacid/health_cdcassist.htm.
• Care Before and During Pregnancy—Prenatal Care. National Institutes of Health, National Institute of Child Health and Human Development Web site. www.nichd.nih.gov/womenshealth/research/pregbirth/prenatal_care.cfm