Megace

Generic Name: Megestrol Acetate
Class: Antineoplastic Agents
VA Class: AN500
Chemical Name: 17-Hydroxy-6-methylpregna-4,6-diene-3,20-dione acetate
Molecular Formula: C₂₄H₃₂O₄
CAS Number: 595-33-5

Introduction

Synthetic progestin; antineoplastic agent and appetite stimulant.

Uses for Megace

Breast Cancer

Palliative management of recurrent, inoperable, or metastatic breast cancer.^{b c}

Estrogen and/or progesterone receptor-positive breast cancer is more likely to respond to megestrol therapy.^b

Does not replace appropriate methods of treatment of advanced breast cancer (e.g., surgery, radiation, chemotherapy).^{b c}

Not recommended for treatment of other types of neoplastic disease; use only for treatment of breast cancer or endometrial cancer.^b

Endometrial Cancer

Palliative management of recurrent, inoperable, or metastatic endometrial carcinoma.^{b c}

Does not replace appropriate methods of treatment of advanced endometrial carcinoma (e.g., surgery, radiation, chemotherapy).^{b c}

Not recommended for treatment of other types of neoplastic disease; use only for treatment of endometrial cancer or breast cancer.^b

Cachexia

Management of anorexia, cachexia, or an unexplained, substantial weight loss in HIV-infected individuals (designated an orphan drug by FDA for this use).^{102 104 106 107 108 121 122 123 124 125 126 127 128 129 130 131 132 133 134 135 136 138 a}

Also has been used to stimulate appetite and promote weight gain in a limited number of patients with cachexia associated with neoplastic disease†.^{100 101 103 108 116 117 118 119 134 135}

Therapy should be initiated only after treatable causes (e.g., possible malignancies; systemic infections; GI disorders affecting absorption; endocrine, renal, or psychiatric diseases) of the condition have been evaluated.¹²¹

Manufacturer states that megestrol should not be used prophylactically to avoid weight loss.

Megace Dosage and Administration

Administration

Oral Administration

Administer orally.^{138 a b}

Manufacturer makes no specific recommendations regarding administration with meals.^a

Oral suspensions containing 200 mg/5 mL are not bioequivalent or interchangeable on a mg-per-mg basis with the oral suspension containing 625 mg/5 mL (Megace ES).¹³⁸ (See Plasma Concentrations under Pharmacokinetics.)

Dosage

Available as megestrol acetate; dosage expressed in terms of the salt.^{138 a b}

Adults

Breast Cancer

Oral (Tablets)

160 mg daily in 4 equally divided doses (40 mg 4 times daily); continue therapy for at least 2 months to determine antineoplastic effectiveness.^b

Dosages of 480-1600 mg daily in divided doses have been used in clinical trials.^{100 108 110 114}

Endometrial Carcinoma

Oral (Tablets)

40–320 mg daily in divided doses; continue therapy for at least 2 months to determine antineoplastic effectiveness.^b

Cachexia

Treatment in HIV-infected Individuals

Oral (Oral Suspension)

Initially, 800 mg daily (20 mL per day).^{121 122 126 127 128 130 a}

In clinical trials, 400 mg daily also has been used effectively.^a

Oral (Concentrated Oral Suspension [Megace ES])

Initially, 625 mg daily.¹³⁸

Clinically effective dosages are expected to range from 312.5–625 mg daily.¹³⁸

Treatment in Individuals with Neoplastic Disease†

Oral

480–600 mg daily generally have been used.^c However, some patients may exhibit weight gain with dosages as low as 160 mg daily.^c

Special Populations

Hepatic Impairment

No specific dosage recommendations at this time.^{138 a b}

Renal Impairment

No specific dosage recommendations at this time.^{138 a b} (See Renal Impairment under Cautions.)

Geriatric Patients

Treatment of cachexia in HIV-infected individuals: Select dosage with caution because of age-related decreases in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy.¹³⁸

Treatment of breast cancer or endometrial cancer: No specific dosage recommendations at this time.^b

Cautions for Megace

Contraindications

• 
  

  Known hypersensitivity to megestrol or any ingredient in the formulation.^{138 a c}

  
  

Warnings/Precautions

Warnings

Fetal/Neonatal Morbidity

May cause fetal harm; animal studies indicate dose-related feminization of male fetuses.^{138 a c} If used during pregnancy or if patient becomes pregnant, apprise of potential fetal hazard.^{138 a c}

Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression

Asymptomatic pituitary-adrenal suppression occurs frequently in patients receiving chronic therapy; suppression of HPA function may be fatal if not recognized.^{138 a b} Adrenal insufficiency reported in patients receiving or being withdrawn from chronic therapy.^{138 a b}

Laboratory evaluation recommended if signs/symptoms of adrenal insufficiency (e.g., hypotension, nausea, vomiting, dizziness, weakness) occur in patients receiving or being withdrawn from chronic therapy; administration of replacement or stress dosages of a rapidly acting glucocorticoid may be required, especially in patients subjected to stress (e.g., surgery, infection).^{138 a b}

Glucocorticoid activity of megestrol not fully evaluated.^{138 a b}

Endocrine Effects

May increase insulin requirements and aggravate or precipitate diabetes mellitus.^{138 a b}

Administration over a prolonged period may produce hypercorticism (Cushing's syndrome).^{138 a b}

General Precautions

Cardiovascular Effects

Thromboembolic events (e.g., deep-vein thrombophlebitis, pulmonary embolism), sometimes fatal, reported.^b Use with caution in patients with a history of thromboembolic disease.^{138 a b}

HIV Viral Replication

Effect of megestrol therapy on HIV viral replication not evaluated.^{138 a}

Respiratory Effects

Possible increased risk of respiratory infections associated with chronic therapy.^{138 a}

Specific Populations

Pregnancy

Category X (Oral Suspensions);^{138 a} Category D (Tablets).^b (See Fetal/Neonatal Morbidity under Cautions.)

Lactation

Discontinue nursing because of potential risk to nursing infants.^{138 a b}

Pediatric Use

Safety and efficacy not established.^{138 a b}

Geriatric Use

Insufficient experience in patients ≥65 years of age to determine whether geriatric patients with cachexia respond differently than younger adults; select dosage with caution because of age-related decreases in hepatic, renal, and/or cardiac function and potential for concomitant disease and drug therapy.¹³⁸ (See Geriatric Patients under Dosage and Administration.)

Substantially eliminated by kidneys; assess renal function periodically since geriatric patients are more likely to have decreased renal function.¹³⁸

Renal Impairment

Substantially eliminated by kidneys; possible increased risk of toxicity.¹³⁸

Common Adverse Effects

In patients with breast cancer or endometrial cancer: Weight gain,^b nausea,^b vomiting,^b hypertension,^b vaginal bleeding and discharge (including breakthrough bleeding),^{108 b} hyperglycemia,^b asthenia,^b rash.^b

In patients with cachexia: Diarrhea, flatulence, nausea, vomiting, hypertension, impotence, decreased libido, asthenia, rash, insomnia, anemia, fever, hyperglycemia, pain.^{138 a}

Interactions for Megace

Specific Drugs

Drug	Interaction	Comments
Indinavir	Decreased plasma concentrations and AUC of indinavir138 Effect of indinavir on megestrol pharmacokinetics not evaluated138	If used with megestrol, consider increasing indinavir dosage138
Rifabutin	Pharmacokinetics of rifabutin not significantly altered138 Effect of rifabutin on megestrol pharmacokinetics not evaluated138	Dosage adjustments not required138
Zidovudine	Pharmacokinetics of zidovudine not significantly altered138 Effect of zidovudine on megestrol pharmacokinetics not evaluated138	Dosage adjustments not required138

Megace Pharmacokinetics

Absorption

Bioavailability

Well absorbed following oral administration, with peak plasma concentration usually attained within 1–5 hours.^c

Plasma Concentrations

Plasma concentrations achieved with a 625-mg dose of the concentrated oral suspension (Megace ES 625 mg/5 mL) are equivalent to those achieved with an 800-mg dose of the original formulation (200 mg/5 mL) under fed conditions.¹³⁸

Elimination

Metabolism

Completely metabolized in the liver to free steroids and glucuronide conjugates.

Elimination Route

Excreted principally in urine (about 66%) and in feces (about 20%).^{138 a b}

Stability

Storage

Oral

Tablets

25°C (may be exposed to 15-30°C); protect from heat.^b

Suspension

Tight containers at 15–25°C; protect from heat.^{138 a}

ActionsActions

• 
  

  Induces secretory changes in the endometrium, increases basal body temperature, inhibits pituitary function, and produces withdrawal bleeding in the presence of estrogen.^c

  
  


• 
  

  In animals, suppresses ovulation and produces antigonadotropic, antiuterotropic, and antiandrogenic/antimyotropic effects; has slight glucocorticoid activity and a very slight degree of mineralocorticoid activity; and has no estrogenic, androgenic, or anabolic activity.^c

  
  


• 
  

  Antineoplastic effect may result from inhibition of pituitary gonadotropin production which results in decreased estrogen secretion.^b

  
  


• 
  

  Decreases the number of hormone-dependent breast cancer cells and eliminates the stimulatory effect that estrogen has on these cells.^b

  
  


• 
  

  May produce a local effect on cancerous cells by converting the actively growing stroma into decidua.^c

  
  


• 
  

  May directly or indirectly stimulate appetite or may alter metabolic pathways via interference with the production or action of mediators such as cachectin (a hormone that inhibits adipocyte lipogenic enzymes);^{100 101 103 109 110 111} however precise mechanism for weight gain not clearly established.^{100 101 103 108 109 116 121}

  
  

Advice to Patients

• 
  

  Importance of taking megestrol exactly as prescribed.

  
  


• 
  

  Importance of informing patients that the more concentrated oral suspension containing 625 mg/5 mL (Megace ES) does not contain the same amount of megestrol as oral suspensions containing 200 mg/5 mL and therefore are not interchangeable.¹³⁸

  
  


• 
  

  Importance of patients informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs.^{128 135 c}

  
  


• 
  

  Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed; necessity for clinicians to advise women to avoid pregnancy during therapy and advise pregnant women of risk to the fetus.^{138 a b}

  
  


• 
  

  Importance of informing patients of other important precautionary information.^{138 a b} (See Cautions.)

  
  

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Megestrol Acetate

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Suspension	200 mg/5 mL*	Megace (with alcohol 0.06% v/v, polyethylene glycol, polysorbate [Tween] 80, and xanthan gum)	Bristol-Myers Squibb
			Megestrol Acetate Suspension	Barr, Morton Grove, Par, Roxane, Teva
		625 mg/5 mL	Megace ES (with alcohol 0.06% v/v, docusate sodium, and hydroxypropyl methylcellulose)	Par
	Tablets	20 mg*	Megestrol Acetate Tablets	Barr, Par, Roxane, Teva
		40 mg*	Megestrol Acetate Tablets	Barr, Par, Roxane, Teva

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Megace ES 625MG/5ML Suspension (PAR): 150/$639.99 or 450/$1813.9

Megace Oral 40MG/ML Suspension (B-M SQUIBB ONCOLOGY/IMMUNOLOGY): 240/$167.99 or 480/$313.97

Megestrol Acetate 20MG Tablets (PAR): 100/$37.99 or 300/$104.96

Megestrol Acetate 40MG/ML Suspension (MORTON GROVE PHARMACEUTICALS): 240/$131.99 or 480/$257.99

Megestrol Acetate 40MG Tablets (TEVA PHARMACEUTICALS USA): 100/$52.99 or 300/$152.98

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions June 2006. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

Only references cited for selected revisions after 1984 are available electronically.

1. Ref 1 is cited but not in AHFS mono or Word copy of essential.

2. Mead Johnson. Megace (megestrol acetate) prescribing information. Evansville, IN; 1971 Dec.

24. Cooper JM, Kellie AE. The metabolism of megestrol acetate (17α-acetoxy-6-methylpregna-4,6-diene-3,20-dione) in women. Steroids. 1968; 11:133-49. [PubMed 5636707]

100. Tchekmedyian NS, Tait N, Moody M et al. Appetite stimulation with megestrol acetate in cachectic cancer patients. Semin Oncol. 1986; 13(4 Suppl 4):37-43. [PubMed 3798127]

101. Tchekmedyian NS, Tait N, Moody M et al. High-dose megestrol acetate: a possible treatment for cachexia. JAMA. 1987; 257:1195-8. [IDIS 225863] [PubMed 3806918]

102. Von Roenn JH, Murphy RL, Weber KM et al. Megestrol acetate for treatment of cachexia associated with human immunodeficiency virus (HIV) infections. Ann Intern Med. 1988; 109:840-1. [IDIS 248037] [PubMed 3190032]

103. Aisner J, Tchekmedyian NS, Tait N et al. Studies of high-dose megestrol acetate: potential applications in cachexia. Semin Oncol. 1988; 15(2 Suppl 1):68-75. [PubMed 3285486]

104. Furth PA. Megestrol acetate and cachexia associated with human immunodeficiency virus (HIV) infection. Ann Intern Med. 1989; 110:667. [IDIS 253261] [PubMed 2535614]

105. Von Roenn JH, Murphy RL, Weber KM et al. Megestrol acetate and cachexia associated with human immunodeficiency virus (HIV) infection. Ann Intern Med. 1989; 110:667-8. [IDIS 253261] [PubMed 2535614]

106. Food and Drug Administration. Orphan designations pursuant to Section 526 of the Federal Food and Cosmetic Act as amended by the Orphan Drug Act (P.L. 97-414), to June 30, 1993. Rockville, MD; 1993 Aug.

107. Fessel WJ. Megestrol acetate and hyperpnea. Ann Intern Med. 1989; 110:1034-5. [IDIS 255911] [PubMed 2729805]

108. Schacter L, Rozencweig M, Canetta R et al. Megestrol acetate: clinical experience. Cancer Treat Rev. 1989; 16:49-63. [PubMed 2471590]

109. Hamburger AW, Parnes H, Gordon GB et al. Megestrol acetate-induced differentiation of 3T3-L1 adipocytes in vitro. Semin Oncol. 1988; 15(2 Suppl 1):76-8. [PubMed 2453082]

110. Aisner J, Tchekmedyian NS, Moody M et al. High-dose megestrol acetate for the treatment of advanced breast cancer: dose and toxicities. Semin Hematol. 1987; 24(2 Suppl 1):48-55. [PubMed 3589708]

111. Torti FM, Dieckmann B, Beutler B et al. A macrophage factor inhibits adipocyte gene expression: an in vitro model of cachexia. Science. 1985; 229:867-9. [PubMed 3839597]

112. Miksicek R, Heber A, Schmid W et al. Glucocorticoid responsiveness of the transcriptional enhancer of Moloney murine sarcoma virus. Cell. 1989; 46:283-90.

113. Muss HB, Wells HB, Paschold EH et al. Megestrol acetate versus tamoxifen in advanced breast cancer: 5-year analysis—a phase III trial of the Piedmont Oncology Association. J Clin Oncol. 1988; 6:1098-106. [PubMed 3292710]

114. Tchekmedyian NS, Tait N, Abrams J et al. High-dose megestrol acetate in the treatment of advanced breast cancer. Semin Oncol. 1988; 15(2 Suppl 1):44-9. [PubMed 3368800]

115. Reviewer’s comments (personal observations). 1989 Dec 28.

116. Loprinzi CL, Ellison NM, Schaid DS et al. Controlled trial of megestrol acetate for the treatment of cancer anorexia and cachexia. J Natl Cancer Inst. 1990; 82:1127-32. [PubMed 2193166]

117. Heckmayr M, Gatzemeier U. Megestrol acetate in cachectic patients with advanced bronchogenic cancer. Onkologie. 1990; 13:285-7. [PubMed 2172885]

118. Bruera E, Macmillan K, Kuehn N et al. A controlled trial of megestrol acetate on appetite, caloric intake, nutritional status, and other symptoms in patients with advanced cancer. Cancer. 1990; 66:1279-82. [IDIS 273026] [PubMed 2205358]

119. Raub W. Possible antianorexia/cachexia therapy for cancer patients. JAMA. 1990; 264:1086. [PubMed 2117074]

120. Megace prescribing information. In: Barnhart ER, publisher. Physicians’ desk reference. 44th ed. Oradell, NJ: Medical Economics Company Inc; 1990:749.

121. Mead Johnson. Megace oral suspension (megestrol acetate) prescribing information. Princeton, NJ; 1993 Sep.

122. Oster M, Enders S, Samuels S et al. Randomized, double-blind study comparing high-dose megestrol acetate and placebo in cachectic patients with acquired immunodeficiency syndrome (AIDS). Int Conf AIDS. 1993; 9:528.

123. Berman S, Katz K, Ho M et al. Megestrol acetate produces weight gain in HIV+ patients. Int Conf AIDS. 1993; 9:499.

124. Von Roenn JH, Roth EL, Craig R. HIV-related cachexia: potential mechanisms and treatment. Oncology. 1992; 49(Suppl 2):50-4. [PubMed 1461629]

125. Scevola D, Bottari G, Oberto L et al. Changes in caloric intake, anthropometric parameters and TNF levels induced by megestrol acetate in AIDS patients. Int Conf AIDS. 1992; 8:133.

126. Flynn N, Enders S, Oster M etal. Megestrol acetate 800 mg/day vs placebo for treatment of weight loss and anorexia in AIDS patients. Int Conf Aids. 1992; 8:B205.

127. Mahayni H, Minor JR. Megestrol acetate in AIDS-related cachexia. Am J Hosp Pharm. 1991; 48:2479-80. [PubMed 1746586]

128. Von Roenn J, Roth E, Murphy R et al. Controlled trial of megestrol acetate for the treatment of AIDS-related anorexia and cachexia. Int Conf AIDS. 1991; 7:280.

129. Scevola D, Barbarini G, Bottari G et al. Prevalence, etiology and management of AIDS malnutrition. Int Conf AIDS. 1991; 7:224.

130. Tierney A, Cuff P, Kotler DP. The effect of megestrol acetate (Megace) on appetite, nutritional repletion, and quality of life in AIDS cachexia. Int Conf AIDS. 1991; 7:247.

131. Nathwani D, Green ST, Heslop JM et al. Beneficial response to megoestrol acetate in AIDS-related cachexia and a possible megoestrol withdrawal-associated syndrome? Acta Der Venereol (Stockh). 1990; 70:520-1.

132. Von Roenn JH, Murphy RL, Wegener N. Megestrol acetate for treatment of anorexia and cachexia associated with human immunodeficiency virus infection. Semin Oncol. 1990; 17(Suppl 9):13-6. [PubMed 2259923]

133. Von Roenn JH, Murphy RL, Weitzman S. Megestrol acetate and the treatment of HIV-related cachexia. Proc Ann Meet Am Soc Clin Onco. 1988; 7:A17.

134. Nelson JE. “Pilot” studies. Ann Intern Med. 1989; 111:188-9. [PubMed 2742256]

135. Tchekmedyian NS. Clinical approaches to nutritional support in cancer. Curr Opin Oncol. 1993; 5:633-8. [PubMed 8364079]

136. Henry K, Rathgaber S, Sullivan C et al. Diabetes mellitus induced by megestrol acetate in a patient with AIDS and cachexia. Ann Intern Med. 1992; 116:53-4. [IDIS 289403] [PubMed 1727096]

137. Bristol Myers Squibb, Princeton, NJ: personal communication.

138. Bristol Myers Squibb. Megace ES (megestrol acetate) suspension prescribing information. Spring Valley, NY; 2005 May.

a. Bristol Myers Squibb. Megace oral suspension (megestrol acetate) prescribing information. Princeton, NJ; 2002 Jul.

b. Bristol Myers Squibb. Megace tablets (megestrol acetate) prescribing information. Princeton, NJ; 2002 Jul.

c. AHFS drug information 2006. McEvoy GK, ed. Megestrol Acetate. Bethesda, MD: American Society of Health-System Pharmacists; 2006:1129-31.

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• Megace Suspension MedFacts Consumer Leaflet (Wolters Kluwer)


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• Megestrol Prescribing Information (FDA)


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• Megace ES Prescribing Information (FDA)


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• AIDS Related Wasting
• Anorexia
• Breast Cancer, Palliative
• Cachexia
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• Endometrial Hyperplasia
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Medroxyprogesterone

Pronunciation: meh-DROX-ee-pro-JESS-tuh-rone
Generic Name: Medroxyprogesterone
Brand Name: Provera

Medroxyprogesterone is used for:

Treating certain menstrual problems or uterine problems (eg, abnormal bleeding, endometrial hyperplasia). It may also be used for other conditions as determined by your doctor.

Medroxyprogesterone is a progestin hormone. It works by altering the lining of the uterus.

Do NOT use Medroxyprogesterone if:

• you are allergic to any ingredient in Medroxyprogesterone


• you have vaginal bleeding of unknown cause, or if you have a history of blood clots, bleeding in the brain (eg, stroke), liver problems, or breast or genital cancer.


• you are pregnant or may be pregnant.

Contact your doctor or health care provider right away if any of these apply to you.

Before using Medroxyprogesterone:

Some medical conditions may interact with Medroxyprogesterone. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have diabetes, seizures (eg, epilepsy), migraines, asthma, heart problems, kidney problems, or a history of depression.

Some MEDICINES MAY INTERACT with Medroxyprogesterone. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Aminoglutethimide or rifampin because they may decrease Medroxyprogesterone's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if Medroxyprogesterone may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Medroxyprogesterone:

Use Medroxyprogesterone as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Medroxyprogesterone. Talk to your pharmacist if you have questions about this information.


• Take Medroxyprogesterone by mouth with or without food.


• Take Medroxyprogesterone at the same time every day, with doses not more than 24 hours apart.


• If you miss a dose of Medroxyprogesterone, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Medroxyprogesterone.

Important safety information:

• Medroxyprogesterone may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Medroxyprogesterone with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Medroxyprogesterone may cause dark skin patches on your face. Exposure to the sun may make these patches darker. If patches develop, use a sunscreen or protective clothing when exposed to the sun, sunlamps, or tanning booths.


• Diabetes patients - Medroxyprogesterone may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.


• Medroxyprogesterone should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: Do not use Medroxyprogesterone if you are pregnant. If you think you may be pregnant, contact your doctor right away. Medroxyprogesterone is found in breast milk. If you are or will be breast-feeding while you are using Medroxyprogesterone, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Medroxyprogesterone:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Acne; changes in menstrual flow, including breakthrough bleeding, spotting, or missed periods; dizziness; drowsiness; fever; headache; hot flashes; nausea; nervousness; pain; rash; sleeplessness; stomach pain; weakness; weight gain or loss.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; depression; lumps in the breast or under the armpits; partial or complete loss of vision or changes in vision; shortness of breath; slurred speech; sudden loss of coordination; sudden or severe headache; swelling of fingers or ankles; tenderness, pain, or swelling of the calf; weakness, numbness, or pain in the arms or legs; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Medroxyprogesterone side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org ), or emergency room immediately.

Proper storage of Medroxyprogesterone:

Store Medroxyprogesterone in a tightly closed container at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Medroxyprogesterone out of the reach of children and away from pets.

General information:

• If you have any questions about Medroxyprogesterone, please talk with your doctor, pharmacist, or other health care provider.


• Medroxyprogesterone is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Medroxyprogesterone. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

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Mefoxin

Generic Name: Cefoxitin Sodium
Class: Cephamycins
CAS Number: 33564-30-6

Introduction

Antibacterial; β-lactam antibiotic; cephamycin.^c

Uses for Mefoxin

Bone and Joint Infections

Treatment of bone and joint infections caused by susceptible S. aureus (including penicillinase-producing strains).^{149 150 151 156}

Gynecologic Infections

Treatment of gynecologic infections (including endometritis, pelvic cellulitis, pelvic inflammatory disease [PID]) caused by susceptible S. agalactiae (group B streptococci), E. coli, Neisseria gonorrhoeae, Bacteroides (including B. fragilis), Clostridium, Peptococcus niger, or Peptostreptococcus.^{149 150 151 156}

Cefoxitin (or cefotetan) in conjunction with doxycycline considered a regimen of choice by CDC and others when a parenteral regimen is indicated for treatment of PID.^{100 114 155}

When an oral regimen is used for treatment of mild to moderately severe acute PID, CDC recommends a single IM dose of ceftriaxone, cefoxitin (with oral probenecid), or other parenteral third-generation cephalosporin (e.g., cefotaxime) given in conjunction with a 14-day regimen of oral doxycycline.^{100 155}

Because cefoxitin (like cephalosporins) is not active against Chlamydia, concomitant use of a drug active against Chlamydia (e.g., doxycycline) is necessary when these organisms are suspected pathogens.^{100 114}

Intra-abdominal Infections

Treatment of intra-abdominal infections (including peritonitis and intra-abdominal abscess) caused by susceptible E. coli, Klebsiella, Bacteroides (including B. fragilis), or Clostridium.^{149 150 151 156}

Has been effective in mixed aerobic-anaerobic infections.^c However, cefoxitin may no longer provide reliable coverage against B. fragilis, and metronidazole is recommended by many clinicians to provide coverage against B. fragilis in combination anti-infective regimens used for empiric treatment of intra-abdominal infections.¹²³

Respiratory Tract Infections

Treatment of lower respiratory tract infections (including pneumonia and lung abscess) caused by susceptible Staphylococcus aureus (including penicillinase-producing strains), Streptococcus pneumoniae, or other streptococci (except enterococci), Haemophilus influenzae, Escherichia coli, Klebsiella, or Bacteroides.^{149 150 151 156}

Septicemia

Treatment of septicemia caused by susceptible S. aureus (including penicillinase-producing strains), S. pneumoniae, E. coli, Klebsiella, or Bacteroides (including B. fragilis).^{149 150 151 156}

Skin and Skin Structure Infections

Treatment of skin and skin structure infections caused by susceptible S. aureus (including penicillinase-producing strains), S. epidermidis, S. pyogenes (group A β-hemolytic streptococci), or other streptococci (except enterococci), E. coli, Klebsiella, P. mirabilis, Bacteroides (including B. fragilis), Clostridium, P. niger, or Peptostreptococcus.^{149 150 151 156}

Urinary Tract Infections (UTIs)

Treatment of UTIs caused by susceptible E. coli, Klebsiella, Morganella morganii, P. mirabilis, P. vulgaris, or Providencia (including P. rettgeri).^{149 150 151 156}

Gonorrhea and Associated Infections

Treatment of uncomplicated cervical, urethral, or rectal gonorrhea† caused by susceptible Neisseria gonorrhoeae in adults or adolescents.^{100 155} Drug of choice is IM ceftriaxone or oral cefixime.^{100 155} CDC considers IM† cefoxitin an alternative;^{100 155} does not appear to offer any advantage over IM ceftriaxone.¹⁰⁰

Mycobacterial Infections

Treatment of infections caused by Mycobacterium abscessus†¹⁵⁷ or M. fortuitum†;¹⁵⁷ used in conjunction with other antimycobacterial anti-infectives.¹⁵⁷

For serious skin, soft tissue, and bone infections caused by M. abscessus†, ATS and IDSA recommend a multiple-drug regimen of oral clarithromycin (or azithromycin) used in conjunction with parenteral anti-infectives (e.g., amikacin, cefoxitin, imipenem).¹⁵⁷ This multiple-drug regimen also used in treatment of M. abscessus lung disease;¹⁵⁷ however, anti-infectives may help control symptoms and disease progression, but long-term sputum conversion is unlikely.¹⁵⁷ In patients with focal infections and limited lung disease, curative therapy may be possible if surgical resection is used in conjunction with a multiple-drug treatment regimen.¹⁵⁷

Although optimum regimens not identified for treatment of M. fortuitum infections, ATS and IDSA recommend that pulmonary infections be treated with a regimen consisting of at least 2 anti-infectives selected based on results of in vitro susceptibility testing and tolerability (e.g., amikacin, clarithromycin, cefoxitin, ciprofloxacin or ofloxacin, a sulfonamide, imipenem, doxycycline).¹⁵⁷ In serious skin, bone, and soft tissue infections, ≥4 months of treatment with ≥2 anti-infectives active against the clinical isolate is necessary to provide a high likelihood of cure;¹⁵⁷ 6 months of treatment recommended for bone infections.¹⁵⁷ Surgery usually indicated for extensive disease, abscess formation, or when drug therapy is difficult.¹⁵⁷

Perioperative Prophylaxis

Perioperative prophylaxis in women undergoing gynecologic and obstetric surgery (e.g., vaginal, abdominal, or laparoscopic hysterectomy, cesarean section).^{106 115 136 148 149 150 151 156} A preferred agent for vaginal, abdominal, or laparoscopic hysterectomy.¹⁰⁶ Cefazolin generally preferred for perioperative prophylaxis in cesarean section;¹⁰⁶ doxycycline recommended for perioperative prophylaxis in abortion.¹⁰⁶

Perioperative prophylaxis in patients undergoing GI surgery (e.g., colorectal surgery, nonperforated appendectomy).^{106 115 127 148 149 150 151 156} A preferred agent for colorectal surgery and nonperforated appendectomy.^{106 115 127 148}

Mefoxin Dosage and Administration

Administration

Administer by IV injection or infusion.^{149 150 151 156} Also has been given by IM injection†.¹⁰⁰

IV route preferred in patients with bacteremia, septicemia, or other severe or life-threatening infections, or in patients with lowered resistance resulting from debilitating conditions (e.g., malnutrition, trauma, surgery, diabetes, heart failure, malignancy), particularly with shock.^{149 150 151 156}

For solution and drug compatibility information, see Compatibility under Stability.

IV Injection

Reconstitution

Reconstitute vials containing 1 or 2 g of cefoxitin with 10 mL or 10 or 20 mL, respectively, of sterile water for injection to provide solutions containing approximately 95 or 180 or 95 mg/mL, respectively.¹⁵⁰

Rate of Administration

Inject appropriate dose of reconstituted solution directly into a vein over a 3- to 5-minute period or slowly into the tubing of a compatible IV solution.¹⁵⁰

IV Infusion

Other IV solutions flowing through a common administration tubing or site should be discontinued while cefoxitin is infused.^{149 151 156}

Reconstitution

Reconstitute vials containing 1 or 2 g of cefoxitin with 10 mL or 10–20 mL, respectively, of sterile or bacteriostatic water for injection, 0.9% sodium chloride injection, or 5% dextrose injection to provide solutions containing approximately 95 or 95–180 mg/mL, respectively.^{149 150} Further dilute the reconstituted solutions in 50 mL to 1 L of a compatible IV solution.¹⁵⁰

Reconstitute 10-g pharmacy bulk package with 43 or 93 mL of sterile or bacteriostatic water for injection, 0.9% sodium chloride injection, or 5% dextrose injection and then further dilute in 50 mL to 1 L of a compatible IV solution.¹⁵¹

Reconstitute (activate) commercially available Duplex drug delivery system containing 1 or 2 g of lyophilized cefoxitin and 50 mL of dextrose injection in separate chambers according to the manufacturer’s directions.¹⁴⁹

Thaw the commercially available premixed injection (frozen) at room temperature (25°C) or under refrigeration (5°C); do not thaw by immersion in a water bath or by exposure to microwave radiation.¹⁵⁶ A precipitate may have formed in the frozen injection, but should dissolve with little or no agitation after reaching room temperature.¹⁵⁶ Discard thawed injection if an insoluble precipitate is present or if container seals or outlet ports are not intact or leaks are found.¹⁵⁶ Do not use in series connections with other plastic containers, since such use could result in air embolism from residual air being drawn from the primary container before administration of fluid from the secondary container is complete.¹⁵⁶

Rate of Administration

Administer by intermittent or continuous IV infusion.^{149 151 156}

IM Injection†

Administer IM injections deeply into a large muscle, such as the upper outer quadrant of the gluteus maximus.^c Use aspiration to ensure needle is not in a blood vessel.^c

Reconstitution

IM injections are prepared by adding 2 mL of sterile water for injection or 0.5 or 1% lidocaine hydrochloride injection (without epinephrine) to each g of cefoxitin to provide solutions containing approximately 400 mg/mL.^c

Dosage

Available as cefoxitin sodium; dosage expressed in terms of cefoxitin.^{149 150 151 156}

Pediatric Patients

General Pediatric Dosage

IV

Children ≥3 months of age: 80–160 mg/kg daily given in 4–6 equally divided doses.^{149 150 151 156}

AAP recommends 80–100 mg/kg daily given in 3–4 equally divided doses for mild to moderate infections or 80–160 mg/kg daily given in 4–6 equally divided doses for severe infections in children >1 month of age.¹⁴⁷

Perioperative Prophylaxis

IV

Children ≥3 months of age: Manufacturers recommend 30–40 mg/kg given at induction of anesthesia (within 0.5–1 hour prior to incision), followed by 30–40 mg/kg every 6 hours for up to 24 hours.^{149 150 151 156}

Some clinicians recommend 20–40 mg/kg of cefoxitin given prior to induction of anesthesia.^{115 148}

Some clinicians recommend additional doses during the procedure (e.g., every 2–3 hours) if surgery is prolonged >4 hours or major blood loss occurs.^{106 115 121 148} Postoperative doses usually unnecessary and may increase risk of bacterial resistance.^{106 115 121 148}

Adults

General Adult Dosage

Uncomplicated Infections (Bacteremia Absent or Unlikely)

IV

1 g every 6–8 hours.^{149 150 151 156}

Moderately Severe or Severe Infections

IV

1 g every 4 hours or 2 g every 6–8 hours.^{149 150 151 156}

Infections Requiring Higher Dosage (e.g., Gangrene)

IV

2 g every 4 hours or 3 g every 6 hours.^{149 150 151 156}

Gonorrhea and Associated Infections†

Uncomplicated Urethral, Cervical, or Rectal Gonorrhea†

IM†

2 g as a single dose given with oral probenecid (1 g).^{100 155}

Pelvic Inflammatory Disease

IV

2 g every 6 hours;^{100 114 155} used in conjunction with IV or oral doxycycline (100 mg every 12 hours).^{100 114 155} Cefoxitin may be discontinued 24 hours after clinical improvement occurs and oral doxycycline (100 mg every 12 hours) continued to complete 14 days of treatment.¹⁰⁰

IM†

2 g as a single dose given with oral probenecid (1 g);^{100 114 155} followed by a 14-day regimen of oral doxycycline (100 mg twice daily) with or without oral metronidazole (500 mg twice daily).^{100 114 155}

Mycobacterium abscessus Infections†

IV

If used in initial combination regimens for treatment of serious skin, soft tissue, and bone infections (see Mycobacterial Infections under Uses), ATS and IDSA recommend up to 12 g daily given in divided doses for at least 2 weeks until clinical improvement.¹⁵⁷ At least 4 months of antimycobacterial treatment is necessary for treatment of serious skin and soft tissue infections; 6 months of antimycobacterial treatment recommended for bone infections.¹⁵⁷

Perioperative Prophylaxis

Gynecologic and Obstetric Surgery

IV

Hysterectomy (abdominal, vaginal, laparoscopic): Single 1- or 2-g dose given within 30–60 minutes prior to surgery.^{106 149 150 151 156} Although manufacturers also recommend additional 2-g doses every 6 hours (for up to 24 hours), ^{149 150 151 156} postoperative doses usually unnecessary and may increase risk of bacterial resistance.¹⁰⁶

Cesarean section: Single 1- or 2-g dose given within 30–60 minutes prior to surgery.^{106 149 150 151 156} Manufacturers recommend giving the dose as soon as the umbilical cord is clamped,^{149 150 151 156} but there is some evidence that giving the dose prior to skin incision is more effective than after clamping.¹⁰⁶ Although manufacturers state additional 2-g doses can be given at 4 and 8 hours after the initial dose,^{149 150 151 156} postoperative doses usually unnecessary and may increase risk of bacterial resistance.¹⁰⁶

Some clinicians recommend additional doses during the procedure (e.g., every 2–3 hours) if surgery is prolonged >4 hours or major blood loss occurs.^{106 115 121 148}

Colorectal Surgery, Appendectomy (Nonperforated), or Other GI Surgery

IV

Single 1- or 2-g dose given within 0.5–1 hour prior to incision.^{106 115}

Some clinicians recommend additional doses during the procedure (e.g., every 2–3 hours) if surgery is prolonged >4 hours or major blood loss occurs.^{106 115 121 148}

Although manufacturers state 2 g can be given every 6 hours after the procedure for up to 24 hours,^{149 150 151} postoperative doses usually unnecessary and may increase risk of bacterial resistance.^{106 121 148}

Prescribing Limits

Pediatric Patients

Maximum 12 g daily.^{149 150 151 156}

Adults

Maximum 12 g daily.^{149 150 151 156}

Special Populations

Renal Impairment

Dosage adjustments necessary in those with Cl_cr ≤50 mL/minute.^{149 150 151 156}

Adults with Cl_cr ≤50 mL/minute: Give an initial loading dose of 1–2 g followed by maintenance dosage based on Cl_cr (see Table 1).^{149 150 151 156}

Table 1. Maintenance Dosage for Adults with Renal Impairment149150151156

Clcr (mL/min)	Dosage
30–50	1–2 g every 8–12 h
10–29	1–2 g every 12–24 h
5–9	0.5–1 g every 12–24 h
<5	0.5–1 g every 24–48 h

Adults undergoing hemodialysis: Give a loading dose of 1–2 g after each dialysis period followed by maintenance dosage based on Cl_cr (see Table 1).^{149 150 151 156}

Pediatric patients with renal impairment: Make dosage adjustments similar to those recommended for adults.^{149 150 151 156}

Geriatric Patients

Cautious dosage selection because of age-related decreases in renal function.^{149 150 151 156} (See Renal Impairment under Dosage and Administration.)

Cautions for Mefoxin

Contraindications

• 
  

  Known hypersensitivity to cefoxitin or cephalosporins.^{149 150 151 156}

  
  

Warnings/Precautions

Warnings

Superinfection/Clostridium difficile-associated Diarrhea and Colitis (CDAD)

Possible emergence and overgrowth of nonsusceptible organisms with prolonged therapy.^{149 150 151 156} Careful observation of the patient is essential.^{149 150 151 156} Institute appropriate therapy if superinfection occurs.^{149 150 151 156}

Treatment with anti-infectives alters normal colon flora and may permit overgrowth of Clostridium difficile.^{149 150 151 156} C. difficile-associated diarrhea and colitis (CDAD; also known as antibiotic-associated diarrhea and colitis or pseudomembranous colitis) has been reported with nearly all anti-infectives, including cefoxitin, and may range in severity from mild diarrhea to fatal colitis.^{149 150 151 156}

Consider CDAD if diarrhea develops during or after therapy and manage accordingly.^{149 150 151 156} Careful medical history is necessary since CDAD has been reported to occur as late as 2 months or longer after anti-infective therapy is discontinued.^{149 151 156}

If CDAD is suspected or confirmed, anti-infective therapy not directed against C. difficile may need to be discontinued.^{149 150 151 151 156} Some mild cases may respond to discontinuance alone.^{116 117 118 119 120 149 150 151} Manage moderate to severe cases with fluid, electrolyte, and protein supplementation, anti-infective therapy active against C. difficile (e.g., oral metronidazole or vancomycin), and surgical evaluation when clinically indicated.^{116 117 118 119 120 149 150 151 151 156}

Sensitivity Reactions

Hypersensitivity Reactions

Possible hypersensitivity reactions, including rash (maculopapular or erythematous), pruritus, fever, eosinophilia, urticaria, anaphylaxis, erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis.^{149 150 151 a 156}

If an allergic reaction occurs, discontinue cefoxitin and institute appropriate therapy as indicated (e.g., epinephrine, corticosteroids, and maintenance of an adequate airway and oxygen).^{149 150 151 156}

Cross-hypersensitivity

Partial cross-allergenicity among β-lactam antibiotics, including penicillins, cephalosporins, and cephamycins.^{149 150 151 156}

Prior to initiation of therapy, make careful inquiry concerning previous hypersensitivity reactions to cefoxitin, cephalosporins, penicillins, or other drugs.^{149 150 151 156} Cautious use recommended in individuals hypersensitive to penicillins.^{149 150 151 156 a} Avoid use in those who have had an immediate-type (anaphylactic) hypersensitivity reaction and administer with caution in those who have had a delayed-type (e.g., rash, fever, eosinophilia) reaction.^a

General Precautions

History of GI Disease

Use with caution in patients with a history of GI disease, particularly colitis.^{149 150 151 156} (See Superinfection/Clostridium difficile-associated Diarrhea and Colitis [CDAD] under Cautions.)

Laboratory Monitoring

Periodically assess organ system functions, including renal, hepatic, and hematopoietic, during prolonged therapy.^{149 150 151 156}

Patients with Diabetes

The commercially available Duplex delivery system containing 1 or 2 g of lyophilized cefoxitin and 50 mL of dextrose 2.2 or 4% injection should be used with caution in patients with overt or known subclinical diabetes mellitus or in patients with carbohydrate intolerance for any reason.¹⁴⁹

Selection and Use of Anti-infectives

To reduce development of drug-resistant bacteria and maintain effectiveness of cefoxitin and other antibacterials, use only for treatment or prevention of infections proven or strongly suspected to be caused by susceptible bacteria.^{149 150 151 156}

When selecting or modifying anti-infective therapy, use results of culture and in vitro susceptibility testing.^{149 150 151 156} In the absence of such data, consider local epidemiology and susceptibility patterns when selecting anti-infectives for empiric therapy.^{149 150 151 156}

Sodium Content

Contains approximately 53.8 mg (2.3 mEq) of sodium per g of cefoxitin.^{149 150 151 156}

Specific Populations

Pregnancy

Category B.^{149 150 151 156}

Lactation

Distributed into milk in low concentrations; use with caution.^{149 150 151 156}

Pediatric Use

Safety and efficacy in infants <3 months of age have not been established.^{149 150 151 156}

Use of high doses in children ≥3 months of age have been associated with an increased incidence of eosinophilia and elevated serum AST concentration.^{149 150 151 156}

Cefoxitin reconstituted with bacteriostatic water for injection containing benzyl alcohol should not be used in infants.^{150 151} Benzyl alcohol as a preservative has been associated with toxicity in neonates; although these effects have not been demonstrated in infants >3 months of age, small infants in this age range may also be at risk for benzyl alcohol toxicity.^{150 151}

Geriatric Use

No overall differences in safety and efficacy in those ≥65 years of age compared with younger adults, but the possibility of increased sensitivity in some geriatric individuals cannot be ruled out.^{149 150 156}

Substantially eliminated by kidneys; risk of toxicity may be greater in those with impaired renal function.^{149 150 156} Select dosage with caution and consider monitoring renal function because of age-related decreases in renal function.^{149 150 156} (See Renal Impairment under Dosage and Administration.)

Renal Impairment

High and prolonged serum concentrations may occur.^{149 150 151 156}

Reduce dosage in those with Cl_cr ≤50 mL/minute.^{149 150 151 156} See Renal Impairment under Dosage and Administration.

Common Adverse Effects

Local reactions at the IV administration site (including thrombophlebitis), hypersensitivity reactions, diarrhea.^{149 150 151 156}

Interactions for Mefoxin

Specific Drugs and Laboratory Tests

Drug or Test	Interaction	Comments
Aminoglycosides	Possible increased risk of nephrotoxicity149 150 151 Physical incompatibility if solutions directly mixed together149 150 151	Closely monitor renal function if used concomitantly149 150 151 Administer separately; do not admix149 150 151
Probenecid	Decreased renal excretion and higher and more prolonged serum concentrations of cefoxitin149 150 151
Tests for creatinine	High concentrations (>100 mcg/mL) may cause falsely elevated serum or urine creatinine values when the Jaffe reaction is used149 150 151	Avoid using blood samples for creatinine determinations if they were drawn from the patient within 2 hours after a cefoxitin dose149 150 151
Tests for glucose	Possible false-positive reactions in urine glucose tests using Clinitest, Benedict’s solution, or Fehling’s solution149 150 151 a	Use glucose tests based on enzymatic glucose oxidase reactions (e.g., Clinistix, Tes-Tape)149 150 151

Mefoxin Pharmacokinetics

Absorption

Bioavailability

Not appreciably absorbed from the GI tract; must be administered parenterally.^c

Following IM administration in healthy adults, peak serum concentrations attained within 20–30 minutes.^c

Distribution

Extent

Widely distributed into body tissues and fluids, including ascitic, pleural, and synovial fluid.^c

Therapeutic concentrations may be obtained in bile if biliary obstruction is not present.^c

Diffuses poorly into CSF following IM or IV administration, even when meninges are inflamed.^c

Readily crosses the placenta^c and is distributed into milk in low concentrations.^c

Plasma Protein Binding

50–80%.^c

Elimination

Metabolism

≤2% of a dose is metabolized to descarbamylcefoxitin, which is microbiologically inactive.^c

Elimination Route

Rapidly eliminated in urine by glomerular filtration and renal tubular excretion.^c About 85% of a dose excreted unchanged in urine within 6 hours^c

Half-life

Adults with normal renal function: 0.7–1.1 hours.^c

Special Populations

Patients with renal impairment: Serum concentrations higher and serum half-life prolonged.^c Serum half-life averages 6.3 hours or 21.5 hours in adults with Cl_cr about 18 mL/min or 2 mL/min, respectively.^c

Geriatric adults 64–88 years of age with renal function normal for their age: 0.9–1.5 hours.^{149 150 151 156}

Stability

Storage

Parenteral

Powder for Injection or IV Infusion

2–25° C;^{150 151} avoid exposure to temperatures >50° C.^{150 151}

Powder and reconstituted solutions may darken; does not indicate loss of potency.^{150 151 156}

Reconstituted solutions for IV administration prepared using sterile or bacteriostatic water, 0.9% sodium chloride, or 5% dextrose are stable for 6 hours at room temperature or 1 week when refrigerated at <5°C.^{150 151}

Piggyback units containing 1 or 2 g of cefoxitin prepared using 5 or 10% dextrose or 0.9% sodium chloride are stable for 24 hours at room temperature or 1 week when refrigerated at <5°C.^c

Store commercially available Duplex drug delivery system containing 1 or 2 g of lyophilized cefoxitin and 50 mL of dextrose injection at 20–25°C (may be exposed to 15–30°C).¹⁴⁹ Following reconstitution (activation), use these IV infusions within 12 hours if stored at room temperature or within 7 days if stored in a refrigerator; do not freeze.¹⁴⁹

Injection (Frozen) for IV Infusion

-20°C or lower.¹⁵⁶ After thawing, stable for 24 hours at room temperature (25°C) or 21 days under refrigeration (2–8°C).¹⁵⁶

Do not refreeze after thawing.¹⁵⁶

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Parenteral

Solution Compatibility^HID

Compatible
Dextrose 5% in Ringer’s injection, lactated
Dextrose 5% in sodium chloride 0.2, 0.45, or 0.9%
Dextrose 5 or 10% in water
Invert sugar 10% in sodium chloride 0.9%
Invert sugar 5 or 10% in water
Ionosol B with dextrose 5% in water
Mannitol 5 or 10% in water
Normosol M in dextrose 5% in water
Ringer’s injection
Ringer’s injection, lactated
Sodium bicarbonate 5%
Sodium chloride 0.9%
Sodium lactate (1/6) M

Drug Compatibility

Admixture CompatibilityHID

Compatible
Amikacin sulfate
Cimetidine HCl
Clindamycin phosphate
Gentamicin sulfate
Kanamycin sulfate
Metronidazole HCl with sodium bicarbonate
Multivitamins
Sodium bicarbonate (Neut)
Tobramycin sulfate
Verapamil HCl
Vitamin B complex with C
Incompatible
Ranitidine HCl
Variable
Aztreonam
Metronidazole

Y-Site CompatibilityHID

Compatible
Acyclovir sodium
Amifostine
Amphotericin B cholesteryl sulfate complex
Aztreonam
Bivalirudin
Cyclophosphamide
Dexmedetomidine HCl
Diltiazem HCl
Docetaxel
Doxorubicin HCl liposome injection
Etoposide phosphate
Famotidine
Fluconazole
Foscarnet sodium
Gemcitabine HCl
Granisetron HCl
Hetastarch in lactated electrolyte injection (Hextend)
Hydromorphone HCl
Linezolid
Magnesium sulfate
Meperidine HCl
Morphine sulfate
Ondansetron HCl
Perphenazine
Propofol
Ranitidine HCl
Remifentanil HCl
Teniposide
Thiotepa
Incompatible
Fenoldopam mesylate
Filgrastim
Gatifloxacin
Hetastarch in sodium chloride 0.9%
Pentamidine isethionate
Variable
Vancomycin HCl

Actions and SpectrumActions

• 
  

  Cephamycin;^{149 150 151 a} sometimes classified with second generation cephalosporin based on spectrum of activity.^a

  
  


• 
  

  Usually bactericidal.^{149 150 151 a}

  
  


• 
  

  Like other β-lactam antibiotics, antibacterial activity results from inhibition of bacterial cell wall synthesis.^{149 150 151 a}

  
  


• 
  

  Spectrum of activity includes some gram-positive and -negative aerobic bacteria and some anaerobic bacteria; inactive against Chlamydia, fungi, and viruses.^a

  
  


• 
  

  Gram-positive aerobes: Active in vitro and in clinical infections against S. aureus (including penicillinase-producing strains), S. epidermidis, S. pneumoniae, S. pyogenes (group A β-hemolytic streptococci), and S. agalactiae (group B streptococci).^{149 150 151} Oxacillin-resistant staphylococci (methicillin-resistant staphylococci) and most enterococci (e.g., Enterococcus faecalis) are resistant.^{149 150 151}

  
  


• 
  

  Gram-negative aerobes: Active in vitro and in clinical infections against E. coli, H. influenzae, Klebsiella (including K. pneumoniae), M. morganii, N. gonorrhoeae, P. mirabilis, P. vulgaris, and Providencia (including P. rettgeri).^{149 150 151} Also active in vitro against Eikenella corrodens (non-β-lactamase-producing strains),^{149 150 151} K. oxytoca,^{149 150 151} Salmonella,^c and Shigella.^c Many strains of Enterobacter cloacae and most strains of Pseudomonas aeruginosa are resistant.^{149 150 151}

  
  


• 
  

  Anaerobes: Active in vitro and in clinical infections against Bacteroides distasonis, B. fragilis, B. ovatus, B. thetaiotaomicron, Clostridium (including C. perfringens but not C. difficile), Peptococcus niger, and Peptostreptococcus.^{149 150 151 c} Also active in vitro against Fusobacterium, Prevotella bivia,^{149 150 151} Propionibacterium.^c

  
  


• 
  

  Active in vitro against some mycobacteria, including Mycobacterium abscessus,¹⁵⁷ M. fortuitum,¹⁵⁷ and M. mucogenicum.¹⁵⁷ Has variable activity against M. smegmatis;¹⁵⁷ however, M. chelonae¹⁵⁷ and M. immunogenum¹⁵⁷ are resistant.

  
  

Advice to Patients

• 
  

  Advise patients that antibacterials (including cefoxitin) should only be used to treat bacterial infections; they do not treat viral infections (e.g., the common cold).^{149 150 151}

  
  


• 
  

  Importance of completing full co

Megestrol Suspension

Pronunciation: me-JES-trol
Generic Name: Megestrol
Brand Name: Megace

Megestrol Suspension is used for:

Treating loss of appetite and weight loss in certain patients. It is also used to treat unexplained, significant weight loss in patients who have AIDS. It may also be used for other conditions as determined by your doctor.

Megestrol Suspension is a progesterone hormone. Exactly how it works to treat loss of appetite and weight loss is unknown.

Do NOT use Megestrol Suspension if:

• you are allergic to any ingredient in Megestrol Suspension


• you are pregnant or suspect that you could be pregnant


• you have undiagnosed vaginal bleeding or a history of blood clotting problems (eg, blood clots in the lungs or legs) or stroke


• you are taking dofetilide

Contact your doctor or health care provider right away if any of these apply to you.

Before using Megestrol Suspension:

Some medical conditions may interact with Megestrol Suspension. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are planning to become pregnant or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have adrenal gland problems, diabetes, or cancer

Some MEDICINES MAY INTERACT with Megestrol Suspension. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Rifampin because it may decrease Megestrol Suspension's effectiveness


• Dofetilide because the risk of heart problems, including irregular heartbeat, may be increased


• Indinavir because its effectiveness may be decreased by Megestrol Suspension

This may not be a complete list of all interactions that may occur. Ask your health care provider if Megestrol Suspension may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Megestrol Suspension:

Use Megestrol Suspension as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Megestrol Suspension by mouth with or without food.


• Shake well before each use.


• Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.


• If you miss a dose of Megestrol Suspension, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once. If more than one dose is missed, contact your doctor or pharmacist.

Ask your health care provider any questions you may have about how to use Megestrol Suspension.

Important safety information:

• Megestrol Suspension may reduce the amount of natural steroid your body makes. This may occur while you take Megestrol Suspension or after you stop taking it. Tell your doctor right away if you notice symptoms such as unusual weakness, dizziness, nausea, or vomiting. You may need to take a corticosteroid (eg, prednisone), especially if you experience a period of physical stress (eg, major infection, surgery, injury).


• Tell your doctor or dentist that you take Megestrol Suspension before you receive any medical or dental care, emergency care, or surgery.


• Megestrol Suspension is not intended for use in the prevention of weight loss.


• Megestrol Suspension may raise your blood sugar. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away.


• Diabetes patients - Megestrol Suspension may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.


• Megestrol Suspension should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.


• Women who may become pregnant should use a nonhormonal form of birth control (eg, condoms) while they use Megestrol Suspension.


• PREGNANCY and BREAST-FEEDING: Do not use Megestrol Suspension if you are pregnant. It may cause harm to the fetus. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. Megestrol Suspension is found in the breast milk. Do not breast-feed while taking Megestrol Suspension.

Possible side effects of Megestrol Suspension:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Difficulty sleeping; gas; headache; indigestion.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); calf pain or tenderness; chest pain; coughing up blood; decreased sexual desire or ability; depression; dizziness; increased appetite, thirst, or urination; irregular heartbeat; leg pain; menstrual changes; muscle weakness; nausea; seizures; shortness of breath; signs of infection (eg, fever, chills, sore throat); swelling of the ankles or fingers; unexplained vaginal bleeding; unusual thoughts; unusual weight gain in the face; vomiting.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Megestrol side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Megestrol Suspension:

Store at room temperature, between 59 and 77 degrees F (15 and 25 degrees C). Store in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Megestrol Suspension out of the reach of children and away from pets.

General information:

• If you have any questions about Megestrol Suspension, please talk with your doctor, pharmacist, or other health care provider.


• Megestrol Suspension is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Megestrol Suspension. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Megestrol resources

• Megestrol Side Effects (in more detail)
• Megestrol Use in Pregnancy & Breastfeeding
• Drug Images
• Megestrol Drug Interactions
• Megestrol Support Group
• 13 Reviews for Megestrol - Add your own review/rating

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