A Pharmacist's Guide to OTC Therapy

Author: Yvette C. Terrie, BSPharm, RPh


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 both therapies.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 menstrual pain.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 should ensure that patients understand the proper use and selection of OTC menstrual products and the adverse effects associated with them and also remind women about the importance of routine gynecologic examinations.

Patients with preexisting medical conditions should always seek advice from their primary health care provider before taking any of these products. Pharmacists can help to identify possible drug interactions and contraindications, such as an allergy to aspirin and other NSAIDs. Those taking anticoagulants or lithium should avoid the use of nonsalicylate NSAIDs.

It is important to refer women whose symptoms do not improve after the use of OTC products or those with more severe symptoms to their primary health care provider for further advice and treatment. Women with secondary dysmenorrhea and those who experience severe pain or changes in the level of pain or abdominal pain that is experienced at times other than menstruation also should be referred to their primary health care provider for further medical evaluation.

In addition, pharmacists can make recommendations about nondrug measures, such as using topical heat products, relaxation techniques, 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

  1. 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.
  2. Beers MH. Dysmenorrhea. In: The Merck Manual of Diagnosis and Therapy. 18th ed. Whitehouse Station, NJ: Merck Research Laboratories; 2006:2078-2079.
  3. 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 essential source of information for women interested in selecting a multivitamin supplement that is formulated to meet their nutritional needs and appropriate for the various stages of life. It is important, however, for pharmacists to remind patients that OTC multivitamin supplements are intended to be used in conjunction with, not as a substitute for, a balanced diet.

Nutrients to Promote Overall Health

Multivitamin supplements formulated for women contain essential nutrients that promote overall health, as well as support reproductive health. Calcium, magnesium, and vitamin D enhance and support bone health, and vitamins A, C, and E provide extra antioxidant protection. In addition, folic acid, vitamins B6 and B12, magnesium, and zinc have been shown to be beneficial for women experiencing premenstrual syndrome, using oral contraceptives, and experiencing menopause.1 Iron is frequently found in multivitamin supplements for women, because iron supplementation is often warranted in many females due to blood loss from menstrual cycles.

In March 2007, McNeil Nutritionals, widely known for its calcium supplement Viactiv, introduced Viactiv Multi-Vitamin Flavor Glides, which contain 24 essential vitamins and minerals.2 Viactiv Multivitamin Chews, another McNeil Nutritionals product, contain 12 essential vitamins and calcium and are available in chocolate and chocolate cherry flavors.

As women age, their nutritional needs change, and in recent years various multivitamin supplements have been formulated to target women older than 50. These multivitamin supplements may include increased levels of calcium, folic acid, vitamin D, vitamin E, vitamin B6, and other nutrients, but not iron, because individuals 50 and older require less iron and generally meet their iron needs through diet alone.

Examples of these products include One A Day Women's 50+ Advantage (Bayer HealthCare, LLC) and Centrum Silver (Wyeth Consumer Healthcare). In addition to essential vitamins and minerals, One A Day Women's 50+ Advantage tablets contain ginkgo for memory and concentration. Centrum Silver is available in a chewable tablet form for individuals who may have difficulty swallowing.

Prenatal Supplements

Prenatal multivitamins contain nutrients that are crucial for a woman during various stages, such as preconception, pregnancy, and lactation, as well as for fetal development.

Various clinical studies have demonstrated that folic acid, particularly just before conception and in the early stages of pregnancy, decreases the incidence of neural tube defects (NTDs) in infants.3 According to the Centers for Disease Control and Prevention, daily consumption of 400 µg of folic acid by women of childbearing age can prevent 50% to 70% of all cases of NTDs.3 The US Public Health Service recommends that women of childbearing age obtain a minimum of 400 µg of folic acid daily through food sources and/or nutritional supplements.4 Most OTC prenatal vitamins 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 multivitamin supplements to a patient, pharmacists should always assess the patient's allergy history, medical history, and complete medication profile, to determine if a potential exists for any drug–micronutrient or micronutrient–micronutrient interactions or possible contraindications for use. When assisting patients in the selection of a multivitamin supplement, pharmacists also should remind women about the importance of adequate calcium intake, to decrease their risk of developing osteoporosis.

Patients with preexisting medical conditions and pregnant or lactating women should always be advised to consult with their primary health care provider prior to using any of these supplements to ensure appropriateness. It also is important for pharmacists to remind patients to use these products as directed and to administer only the recommended daily dosage.

Pharmacists should stress the importance of adhering to a balanced diet and incorporating various lifestyle modifications, such as establishing a routine exercise regimen, giving up smoking, and eliminating or limiting alcohol use when warranted. The various multivitamin supplements available enable women to use the multivitamin supplement that best suits their individual needs, thus enabling them to take a proactive role in the overall quality of their health. For more information on 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

  1. One A Day Vitamin Web site. Bayer Healthcare, LLC. www.oneaday.com.
  2. Viactiv Product Information. McNeil Nutritionals Web site. www.viactiv.com.
  3. Folic Acid: CDC Assistance. Centers for Disease Control and Prevention Web site. www.cdc.gov/ncbddd/folicacid/health_cdcassist.htm.
  4. 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