OTCs Today
Mary Warner
Almost all women experience uncomfortable mild symptoms before the onset of menses. These include breast tenderness, joint or muscle pain, headache, fatigue, and bloating. These are normal signs of the ovulatory cycle. Many women also experience emotional changes, such as irritability.
Premenstrual symptoms typically begin about a week before the onset of menses and generally disappear within 4 days after the start of the menstrual period. Fortunately, nonpharmacological therapy, OTC medications, and various supplements can help alleviate PMS symptoms.
PMS is distinguished from normal premenstrual symptoms by its negative effect on daily functioning and distress it causes to patients. The causes of PMS are not fully understood, though genetic predisposition and cyclic hormonal fluctuations are likely to contribute to its development. In addition, insufficient amounts of serotonin in the brain may contribute to premenstrual depression, fatigue, food cravings, and sleep problems.
Preventing PMS
For many women, lifestyle changes can prevent or minimize PMS symptoms by increasing endorphin and serotonin levels. Modifying the diet by eating smaller, more frequent meals; limiting salty foods to reduce bloating and fluid retention; choosing foods high in complex carbohydrates, such as fruits, vegetables, and whole grains; choosing foods rich in calcium; and avoiding caffeine and alcohol can be helpful.
Other lifestyle changes, such as incorporating at least 30 minutes exercise most days, getting plenty of sleep, and trying breathing exercises or yoga can relieve the stress that can cause PMS symptoms.
Nonprescription medications
Depending on the severity of symptoms, lifestyle changes may not be enough to lessen the effects of PMS, and a nonprescription medication may be helpful. But because PMS causes multiple symptoms, a single medication may not address all of them, and treatment should focus on the symptoms most distressing to the patient. A log or tracking app may be useful for documenting such symptoms and evaluating the efficacy of treatment.
Medications commonly used to alleviate PMS symptoms include NSAIDs, diuretics, and hormonal contraceptives. NSAIDs taken before or at the onset of menses can ease the physical symptoms of PMS, such as headache, muscle/joint pain, cramping, and breast discomfort.
One of the most annoying PMS symptoms for many women is the sensation of abdominal bloating. Interestingly, however, most women don’t actually experience true water retention but rather shifting of fluids to the abdomen. As a result, diuretics that are indicated for relieving fluid retention are unlikely to be helpful for most women with PMS. In addition, abdominal distention may be a result of muscle relaxation caused by progesterone.
Some women do have true water retention and resultant weight gain, and for these patients, a diuretic may be useful. FDA has approved three nonprescription diuretics for relieving water retention, weight gain, bloating, swelling, and the feeling of fullness: ammonium chloride, caffeine, and pamabrom. Because of its significant adverse effects on the GI and central nervous systems, ammonium chloride is no longer available as a nonprescription drug but can be obtained as a dietary supplement.
Caffeine promotes diuresis by inhibiting renal reabsorption of sodium and water. It is safe and effective, though patients may develop tolerance to its diuretic effect. It may cause anxiety, restlessness, or insomnia, and it may worsen PMS by causing irritability, especially when taken with other caffeine-containing medications, foods, or beverages. Patients taking MAOIs or theophylline should avoid diuretics that contain caffeine.
Pamabrom, a derivative of theophylline, is found in combination products along with analgesics and antihistamines marketed for the treatment of PMS. Pamabrom is also available as a stand-alone agent in products such as Durex Max. It can be taken in dosages of up to 50 mg four times daily.
Combination products containing NSAIDs, a diuretic, and sometimes an antihistamine are also available.
Alternative medicine and supplements
Various vitamins and herbal supplements have been reported to soothe PMS symptoms, but evidence on their effectiveness is limited or lacking.
Magnesium deficiency may lead to premenstrual irritability. However, trial results vary, with some magnesium supplements reducing PMS symptoms and others showing no effect. Similarly, vitamin E deficiency has not been established in women experiencing PMS symptoms, limited evidence suggests that supplementation may improve symptoms in some patients at a dose of 100 mg daily for three cycles. Finally, pyridoxine (vitamin B6) has also been suggested for treating PMS symptoms, but trials have reported mixed results with no dose–response relationship shown. Pyridoxine should be limited to 100 mg daily because of the risk for peripheral neuropathy with higher dosages.
High dietary intake of calcium, on the other hand, may prevent the development of PMS symptoms. Several randomized trials evaluating the effect of calcium supplementation on PMS symptoms have shown a decrease in symptoms by the third month of consistent supplementation.
Anecdotal evidence supports multiple complementary therapies, including chasteberry, St. John’s wort, ginkgo, evening primrose oil, and saffron. Again, results are mixed, and few scientific studies have found that any herbal supplements are effective for relief of PMS symptoms. And because these supplements are not regulated by FDA, there are no records of product safety or effectiveness.
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Combination nonprescription menstrual products
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Trade name
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Diuretic
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Analgesic and/or antihistamine
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Aqua-Ban Tablets; Diurex Max; Diurex Aquagels
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Pamabrom 50 mg
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Diurex Ultra; Diurex Ultimate; Diurex XPL
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Caffeine 100 mg
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Diurex Water Pills + Pain Relief
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Caffeine 50 mg
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Magnesium salicylate 162.5 mg
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Pamprin Multi-symptom; Premsyn PMS
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Pamabrom 25 mg
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Acetaminophen 500 mg; pyrilamine maleate 15 mg
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Pamprin Max
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Caffeine 65 mg
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Acetaminophen 250 mg; aspirin 250 mg
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Midol
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Pamabrom 25 mg
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Acetaminophen 500 mg
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Midol Complete
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Caffeine 60 mg
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Acetaminophen 500 mg; pyrilamine maleate 15 mg
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Midol Long Lasting Relief
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Acetaminophen (extended-release) 650 mg
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What to tell your patients
Ensure that patients understand that several medications may be needed for optimal symptom control. Nonprescription medications and lifestyle modifications may not improve symptoms for all women, and it may take several months to determine whether they are working. Also ensure that women who are taking St. John’s wort understand that it may have a negative effect on the efficacy of birth control pills.
For more information, see the section on “Disorders Related to Menstruation” in APhA’s Handbook of Nonprescription Drugs, available in print in the bookstore on pharmacist.com or online in the APhA OTC module in PharmacyLibrary (pharmacylibrary.com). ■