Citrate Salts, Citric Acid, Citric Acid Monohydrate, Potassium Citrate, Potassium Citrate Monohydrate, Sodium Citrate, Sodium Citrate and Citric Acid, Sodium Citrate Dihydrate

Class: Alkalinizing Agents
VA Class: TN400
CAS Number: 77-92-9
Brands: Bicitra, Cytra-2, Cytra-3, Cytra-K, Oracit

Introduction

Alkalinizing agents.^{104 105 106 107 108 109 a}

Uses for Citrate Salts, Citric Acid, Citric Acid Monohydrate, Potassium Citrate, Potassium Citrate Monohydrate, Sodium Citrate, Sodium Citrate and Citric Acid, Sodium Citrate Dihydrate

Preparations containing sodium citrate and citric acid are especially useful when administration of potassium salts is undesirable or contraindicated,^{105 109} while those containing potassium citrate and citric acid are used when administration of sodium salts is undesirable or contraindicated.^{107 108 111}

Alkalinization of Urine

Citrates are used for alkalinization of urine (as alternatives to sodium bicarbonate) in conditions where long-term maintenance of an alkaline urine is desirable (e.g., management of uric acid and cystine calculi of the urinary tract).^{104 106 107 108 109 111 112 a}

Chronic Metabolic Acidosis

Citrates are used for management of chronic metabolic acidosis associated with conditions such as chronic renal insufficiency or renal tubular acidosis.^{104 105 106 107 108 109 111 114 a}

Adjuvant in Gout Therapy

Citrates are used as adjuvants to uricosuric agents in gout therapy.^{108 111 112}

Prevention of Milk Curdling

Sodium citrate has been used to alter cow’s milk so that large hard curds are not formed in the stomach of feeding infants†.^a

Gastric Acid Neutralization

Some citrate salts (e.g., sodium citrate and citric acid) also used for buffering and neutralizing gastric hydrochloric acid.^{105 109}

Compounding Uses

Sodium citrate and citric acid may be used as a buffer to maintain an approximate pH in various extemporaneous formulations.^a (See Compatibility under Stability.)

Citrate Salts, Citric Acid, Citric Acid Monohydrate, Potassium Citrate, Potassium Citrate Monohydrate, Sodium Citrate, Sodium Citrate and Citric Acid, Sodium Citrate Dihydrate Dosage and Administration

General

• 
  

  Selection of a specific preparation may in part be determined by potassium and sodium content.^a

  
  


• 
  

  Unlike sodium bicarbonate solution, citrate solutions generally are considered highly palatable and pleasant tasting, and may be particularly useful as alkalinizing agents in patients who do not tolerate the taste of sodium bicarbonate oral solution.^{105 106 107 108 109 111 112 a}

  
  

Administration

Oral Administration

Dilute oral citrate solutions with adequate amounts of water prior to administration to minimize the risk of GI complications, and follow with additional water after administration;^{104 105 106 108 109 111 112 a} enhance palatability by chilling the solution before administration.^{109 a}

Reconstitute contents of single-dose packets containing potassium citrate and citric acid for oral solution with cool water or juice prior to administration; give additional water or juice after administration.^{100 108}

Administer oral citrate solutions after meals to avoid the saline laxative effect of the drugs as well as upset stomach.^{105 106 107 108 109 111 112 a}

Shake oral solutions well before use, unless otherwise directed.^{105 106 107}

Reconstitution

Reconstitute contents of single-dose packets containing potassium citrate and citric acid for oral solution with at least 180 mL of cool water or juice prior to administration.^{100 108}

Dosage

Pediatric Patients

General Pediatric Dosage

Potassium Citrate and Citric Acid

Oral

Usually, 5–15 mL of solution, diluted with 1/2 glass of water, after meals and at bedtime.^{107 111}

Do not use single-dose packets of potassium citrate and citric acid for oral solution in pediatric patients, since dosage for these patients can be more easily regulated with the commercially available oral solution.¹⁰⁸ Individualize dosage according to the patient’s tolerance and response.^a

Sodium Citrate and Citric Acid

Oral

Children ≥2 years of age: Usually, 5–15 mL of solution, diluted in 30–90 mL of water, after meals and at bedtime;^{105 109} individualize dosage according to patient’s tolerance and response.^a Consult a clinician for use in children <2 years of age.^{105 109}

Tricitrates

Oral

Usually, 5–15 mL 4 times daily, after meals and at bedtime;^{106 112} individualize dosage according to patient’s tolerance and response.^a

Prevention of Milk Curdling

Sodium Citrate

Oral

Prevention of the formation of large curds in the stomach of feeding infants: Add 100 mg of sodium citrate to each 30 mL of cow’s milk.^a

Adults

General Adult Dosage

Potassium Citrate and Citric Acid

Oral

Usually, 15–30 mL of solution, diluted with 1 glass of water, after meals and at bedtime.^{107 111} The usual dosage of potassium citrate and citric acid for oral solution is one single-dose packet (containing 3300 mg of potassium citrate monohydrate and 1002 mg of citric acid monohydrate), reconstituted as directed 4 times daily, after meals and at bedtime.¹⁰⁸ Individualize dosage according to patient’s tolerance and response.^a

Sodium Citrate

Oral

Usually, 1–2 g every 2–4 hours as necessary for alkalinization effect.^a

Sodium Citrate and Citric Acid

Oral

Usually, 10–30 mL of solution,¹⁰⁴ diluted in 30–90 mL of water, after meals and at bedtime.^{104 105} Individualize dosage according to patient’s tolerance and response.^a

Tricitrates

Oral

Usually, 15–30 mL of solution diluted in water 4 times daily, after meals and at bedtime.^{106 112} Individualize dosage according to the patient’s tolerance and response.^a

Gastric Acid Neutralization

Sodium Citrate and Citric Acid

Oral

15 mL of solution, diluted in 15 mL of water, taken as a single dose.¹⁰⁵

Cautions for Citrate Salts, Citric Acid, Citric Acid Monohydrate, Potassium Citrate, Potassium Citrate Monohydrate, Sodium Citrate, Sodium Citrate and Citric Acid, Sodium Citrate Dihydrate

Contraindications

• 
  

  Potassium citrate and citric acid (oral solution and for oral solution [Cytra-K Crystals]): Manufacturer states that preparation is contraindicated in severe renal impairment with oliguria or azotemia, untreated Addison’s disease, adynamia episodica hereditaria, acute dehydration, heat cramps, anuria, severe myocardial damage, or hyperkalemia (from any cause).^{108 111}

  
  


• 
  

  Sodium citrate and citric acid oral solution (Bicitra, Cytra-2): Manufacturers state that preparations are contraindicated in patients requiring sodium-restricted diet and those with severe renal impairment.^{105 109}

  
  


• 
  

  Sodium citrate and citric acid (Oracit): Manufacturer states that preparation is contraindicated in severe renal impairment, oliguria or azotemia, untreated Addison’s disease, adynamia episodica hereditaria, acute dehydration, heat cramp, anuria, severe myocardial damage, and hyperkalemia.¹⁰⁴

  
  


• 
  

  Tricitrates oral solution (e.g., Cytra-3): Manufacturer states that preparation is contraindicated in severe renal impairment with oliguria and azotemia, untreated Addison’s disease, and severe myocardial damage.^{112 a}

  
  

Warnings/Precautions

Warnings

Electrolyte and Acid-Base Disturbances

Potassium-containing formulations: Large doses may cause hyperkalemia and alkalosis, especially in patients with renal impairment.^{108 111} Listlessness, weakness, mental confusion, and tingling of the extremities may be associated with hyperkalemia.^{108 111 112}

Sodium-containing formulations: Excessive doses may cause metabolic alkalosis, especially in patients with hypocalcemia or renal impairment.^{105 109 a} Possible tetany or depression of the heart associated with decreased ionized calcium concentrations may occur with large doses.^a

General Precautions

Concomitant Disease

Sodium-containing formulations: Use with extreme caution in patients with low urine output (unless patient is closely supervised), CHF, hypertension, renal dysfunction, peripheral or pulmonary edema, or toxemia of pregnancy.^{105 109 112}

Potassium-containing formulations: Use with extreme caution in patients in whom excessive potassium may cause deleterious effects.^a

Adequate Patient Evaluation and Monitoring

Evaluate patient’s clinical condition and monitor serum electrolyte concentrations and acid-base balance periodically, especially in patients with renal impairment, to avoid complications.^{104 105 108 109 a}

Laxative Effects

Possible saline laxative effects; dilute citrate solution with water and administer after meals to minimize this effect.^{104 105 108 a}

Specific Populations

Pregnancy

Potassium citrate: Category A.¹¹⁰

Lactation

Not known whether potassium citrate is distributed into milk.¹¹⁰ Because potassium freely distributes into and out of milk, use of potassium citrate by nursing woman with normal plasma potassium concentrations should have no adverse effect on nursing infant; milk potassium concentrations may be increased in hyperkalemic women.¹¹⁰

Renal Impairment

Use citrates with caution in patients with renal impairment.^{105 109 112} Monitor serum electrolyte concentrations and acid-base balance to avoid complications (see Warnings/Precautions under Cautions).^{104 105 108 109 111 112 a} Manufacturers state that citrates are contraindicated in patients with severe renal impairment (see Contraindications under Cautions).^{104 105 108 109 111 112 a}

Common Adverse Effects

Generally well tolerated at recommended dosages in patients with normal renal function and urine output.^{104 105 108 109 a} (See Warnings under Cautions.)

Interactions for Citrate Salts, Citric Acid, Citric Acid Monohydrate, Potassium Citrate, Potassium Citrate Monohydrate, Sodium Citrate, Sodium Citrate and Citric Acid, Sodium Citrate Dihydrate

Specific Drugs

Drug	Interaction	Comments
ACE inhibitors	Potential for hyperkalemia and toxicity with citrate preparations containing potassium108 111 112 116
Amphetamines	Urinary alkalinization may decrease renal elimination of amphetamines116	Avoid concomitant use, especially in amphetamine overdosage116
Antacids (aluminum-containing)	Increased GI absorption of aluminum;113 114 115 risk of aluminum toxicity in patients with chronic kidney disease receiving citrates and aluminum-containing drugs114	Avoid concomitant use in patients with chronic kidney disease;105 109 112 sodium bicarbonate may be an alternative if aluminum-containing phosphate binders required113 115
Cardiac glycosides	Potential for toxicity108 111 112
Chlorpropamide	Urinary alkalinization may increase renal elimination of chlorpropamide116
Diuretics, potassium-sparing	Potential for hyperkalemia and toxicity with citrate preparations containing potassium108 111 112 116
Eplerenone	Potential for hyperkalemia and toxicity with citrate preparations containing potassium116
Lithium	Urinary alkalinization may increase renal lithium clearance116
Potassium-containing drugs	Potential for hyperkalemia and toxicity with citrate preparations containing potassium108 112 116
Pseudoephedrine	Urinary alkalinization may decrease elimination of pseudoephedrine116	Pseudoephedrine dosage reduction may be needed116
Quinidine	Urinary alkalinization may decrease elimination of quinidine116	Monitor ECGs and serum quinidine concentrations if citrate therapy is initiated or discontinued in a patient receiving a stable quinidine dosage116
Salicylates	Urinary alkalinization may increase renal elimination of salicylates; possible decreased therapeutic and toxic effects of salicylates116

Citrate Salts, Citric Acid, Citric Acid Monohydrate, Potassium Citrate, Potassium Citrate Monohydrate, Sodium Citrate, Sodium Citrate and Citric Acid, Sodium Citrate Dihydrate Pharmacokinetics

Distribution

Extent

Not known whether potassium citrate is distributed into milk.¹¹⁰

Elimination

Metabolism

Metabolism of citrates appears to be associated with bicarbonate formation. ^{105 108 109 111 a}

Elimination Route

Citrates are excreted in urine, mainly as metabolites; <5% of an oral dose is excreted in the urine unchanged.^{104 105 108 109 a}

Stability

Storage

Oral

Solution

Potassium citrate and citric acid oral solutions (e.g., Cytra-K): Tight, light-resistant containers at 20–25°C; protect from excessive heat or freezing.^{107 111}

Potassium citrate and citric acid for oral solution (Cytra-K Crystals): Protect from excessive heat or freezing.¹⁰⁸

Sodium citrate and citric acid oral solution (Oracit): Well-closed containers at 15–30°C.¹⁰⁴

Sodium citrate and citric acid oral solution (Cytra-2): Tight, light-resistant containers at 20–25°C; protect from freezing.¹⁰⁵

Sodium citrate and citric acid oral solution (Bicitra): Tight containers; protect from freezing or excessive heat.¹⁰⁹

Tricitrates oral solution (e.g., Cytra-3): Tight, light-resistant containers at 20–25°C; protect from excessive heat or freezing.^{106 112}

Compatibility

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

Oral

Solution

May use sodium citrate and citric acid as a buffer to maintain an approximate pH in various extemporaneous formulations.^a In general, the addition of the following concentration of the drugs should produce a solution buffered to the approximate pH listed:

Adapted from Schumacher GE. Buffer formulations. Am J Hosp Pharm. 1966; 23:628-9.

Citrate Buffer

pH	Citric Acid Monohydrate g/L	Sodium Citrate Dihydrate g/L
2.5	64.4	7.8
3.0	57.4	17.6
3.5	47.6	31.4
4.0	40.6	41.2
4.5	30.8	54.9
5.0	19.6	70.6
5.5	9.8	84.3
6.0	4.2	92.1
6.5	1.8	95.6

ActionsActions

• 
  

  Potassium citrate is absorbed and then appears to be metabolized to potassium bicarbonate, resulting in systemic alkalinization.^{108 111}

  
  


• 
  

  Sodium citrate is absorbed and then appears to be metabolized to sodium bicarbonate, resulting in systemic alkalinization.^{105 109}

  
  


• 
  

  Sodium citrate has anticoagulant activity;^a prevents the clotting of blood by forming an undissociated calcium citrate complex, making calcium unavailable to the clotting mechanism. ^a Anticoagulant sodium citrate solution, when added to blood, prevents the clotting of blood and the crenation or swelling of cells.^a Sterile solution is used as an anticoagulant for banked blood for transfusion and to prepare citrated human plasma and blood for fractionation.^a

  
  


• 
  

  Sodium citrate prevents the curdling of milk by rennin; has been used to alter cow’s milk so that large hard curds are not formed in the stomach of feeding infants.^a

  
  

Advice to Patients

• 
  

  Importance of following instructions for dosage preparation, including reconstitution and/or dilution recommendations.^{104 105 106 107 108 109} (See Oral Administration under Dosage and Administration.)

  
  


• 
  

  Importance of taking drugs only as prescribed, unless otherwise instructed by a clinician.^{105 106 107 109 111}

  
  


• 
  

  Importance of taking doses after meals to avoid saline laxative effect.^{104 105 106 107 108 109 111 112}

  
  


• 
  

  Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.^{104 105 106 107 108 109}

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.^{105 106 107 108 109}

  
  


• 
  

  Importance of informing patients of other important precautionary information.^{104 105 106 107 108 109} (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

Potassium Citrate and Citric Acid

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	For solution	Potassium Citrate Monohydrate 3300 mg and Citric Acid Monohydrate 1002 mg per packet	Cytra-K Crystals	Cypress
	Solution	Potassium Citrate Monohydrate 1100 mg/5 mL and Citric Acid Monohydrate 334 mg/5 mL*	Cytra-K	Cypress
			Potassium Citrate Monohydrate and Citric Acid Monohydrate Solution

Sodium Citrate

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Bulk	Powder

Sodium Citrate and Citric Acid

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Solution (Shohl’s Solution)	Hydrous Sodium Citrate 490 mg/5 mL and Citric Acid 640 mg/5 mL	Oracit	Carolina Medical
		Sodium Citrate Dihydrate 500 mg/5 mL and Citric Acid Monohydrate 334 mg/5 mL	Bicitra	Ortho-McNeil
			Cytra-2	Cypress

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

Tricitrates

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Solution	Citric Acid Monohydrate 334 mg/5 mL, Potassium Citrate Monohydrate 550 mg/5 mL, and Sodium Citrate Dihydrate 500 mg/5 mL*	Cytra-3 Syrup	Cypress
			Citric Acid Monohydrate, Potassium Citrate Monohydrate, and Sodium Citrate Dihydrate Solution

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 April 2009. 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.

100. Alza Pharmaceuticals. Polycitra-K (potassium citrate and citric acid for oral solution) crystals prescribing information. Mountain View, CA; Feb 2000. From the Alza website ()

101. Alza Pharmaceuticals. Polycitra-K (potassium citrate and citric acid) oral solution prescribing information. Mountain View, CA; Apr 1998. From the Alza website ()

102. Alza Pharmaceuticals. Bicitra (potassium citrate and citric acid) oral solution prescribing information. Mountain View, CA; Apr 1998. From the Alza website ()

103. Alza Pharmaceuticals. Polycitra-LC and syrup (tricitrates) oral solution prescribing information. Mountain View, CA; Apr 1998. From the Alza website ()

104. Carolina Medical Products. ORACIT oral citrate (Shohl’s) solution prescribing information. Farmville, NC; 1986 May.

105. Cypress Pharmaceuticals. Cytra-2(sodium citrate and citric acid) oral solution prescribing information.Madison, MS; 2006 Mar.

106. Cypress Pharmaceuticals. Cytra-3 (potassium citrate, sodium citrate, and citric acid) oral syrup prescribing information.Madison, MS; 1998 Jul.

107. Cypress Pharmaceuticals. Cytra-K Oral Solution (potassium citrate and citric acid) prescribing information. Madison, MS; 1998 Jun.

108. Cypress Pharmaceuticals. Cytra-K Crystals (potassium citrate and citric acid for oral solution) prescribing information. Madison, MS; 1997 Dec.

109. Ortho-McNeil Pharmaceutical. Bicitra (sodium citrate and citric acid) oral solution prescribing information. Raritan, NJ; 2005 Mar.

110. Briggs GG, Freeman RK, Yaffe SJ. Drugs in Pregnancy and Lactation. Lippincott Williams & Wilkins: Philadelphia, PA; 2008.

111. Pai Pharmaceutical Associates. Potassium citrate and citric acid oral solution prescribing information. Greenville, SC; 2000 Jun.

112. Pai Pharmaceutical Associates. Potassium citrate, sodium citrate, and citric acid oral solution prescribing information. Greenville, SC; 1999 Dec.

113. Rudy D, Sica DA, Comstock T et al. Aluminum-citrate interaction in end-stage renal disease. Int J Artif Organs. 1991; 14:625-9. [PubMed 1748529]

114. KDOQI, National Kidney Foundation. K/DOQI clinical practice guidelines for bone metabolism and disease in children with chronic kidney disease. Am J Kidney Dis. 2005; 46(4 Suppl 1):S1-21. Available at . Accessed 2008 Jun 13.

115. Walker JA, Sherman RA, Cody RP. The effect of oral bases on enteral aluminum absorption. Arch Intern Med. 1990; 150:2037-9. [PubMed 2171446]

116. Tatro DS, ed. Drug interaction facts. St. Louis: Wolters Kluwer Health; 2008 (Apr):202he, 313b, 470, 579, 580, 608, 620b, 672, 684a.

a. AHFS Drug Information 2008. McEvoy GK, ed. Citrate Salts. Bethesda, MD: American Society of Health-System Pharmacists; 2008: 2710-11.

Idursulfase

In the US, Idursulfase (idursulfase systemic) is a member of the drug class lysosomal enzymes and is used to treat Mucopolysaccharidosis Type II.

US matches:

• Idursulfase


• Idursulfase Intravenous

Scheme

Rec.INN

ATC (Anatomical Therapeutic Chemical Classification)

A16AB09

CAS registry number (Chemical Abstracts Service)

0050936-59-9

Chemical Formula

C2689-H4057-N699-O792-S14

Molecular Weight

59297

Therapeutic Category

Enzyme

Chemical Names

α-L-iduronate sulfate sulfatase (WHO)

Sulfatase, L-idurono- (USAN)

Foreign Names

• Idursulfaseum (Latin)
• Idursulfase (German)
• Idursulfase (French)
• Idursulfasa (Spanish)

Generic Names

• Idursulfase (OS: BAN, USAN)
• EC 3.1.6.13 (IS: TranskaryoticT)
• I2S (IS: Shire)
• I2S CNS (IS)
• Idusulfase (IS)
• Sulfoiduronate sulfohydrolase (IS)

Brand Names

• Elaprase
  Drac, Switzerland; LCA, Belgium; Paladin, Canada; Shire, Austria; Shire, France; Shire, Greece; Shire, Netherlands; Shire, United States; Shire HGT, Germany; Shire Human, Spain; Shire Human, Sweden; Shire Human Genetic, United Kingdom; Shire Human Genetic Therapies, Denmark; Shire Human Genetic Therapies, Finland; Solpharm, Croatia (Hrvatska)

International Drug Name Search

Glossary

BAN	British Approved Name
IS	Inofficial Synonym
OS	Official Synonym
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)
USAN	United States Adopted Name
WHO	World Health Organization

Click for further information on drug naming conventions and International Nonproprietary Names.

Chlordiazepoxide

Dosage Form: capsule
Chlordiazepoxide HYDROCHLORIDE CAPSULES USP CIV

Rx only

Chlordiazepoxide Description

Chlordiazepoxide hydrochloride is the prototype for the benzodiazepine compounds. It is a versatile therapeutic agent of proven value for the relief of anxiety. Chlordiazepoxide hydrochloride is among the safer of the effective psychopharmacologic compounds available, as demonstrated by extensive clinical evidence.

Chlordiazepoxide hydrochloride is 7-chloro-2- (methylamino)-5-phenyl-3H-1, 4-benzodiazepine 4-oxide hydrochloride. A white to practically white crystalline substance, it is soluble in water. It is unstable in solution and the powder must be protected from light. The structural formula is:

C16H14ClN3O • HCl M.W. 336.22

Each capsule, for oral administration, contains either 5 mg, 10 mg or 25 mg of Chlordiazepoxide hydrochloride USP and has the following inactive ingredients: anhydrous lactose, D&C yellow no. 10, FD&C blue no. 1, FD&C blue no. 1 aluminum lake, gelatin, hydrogenated vegetable oil, microcrystalline cellulose, pharmaceutical glaze, and titanium dioxide. The 5 mg and 25 mg also contains D&C yellow no. 10 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C red no. 40 aluminum lake, propylene glycol, and synthetic black iron oxide. In addition, the 5 mg contains D&C red no. 33 and the 10 mg also contains butyl paraben, edetate calcium disodium, dimethyl polysiloxane, ethylene glycol monoethyl ether, FD&C red no. 40, methyl paraben, propyl paraben, sodium, sodium lauryl sulfate, sodium propionate, and soya lecithin.

CLINICAL PHARMACOLOGY

Chlordiazepoxide HCl has antianxiety, sedative, appetite-stimulating and weak analgesic actions. The precise mechanism of action is not known. The drug blocks EEG arousal from stimulation of the brain stem reticular formation. It takes several hours for peak blood levels to be reached and the half-life of the drug is between 24 and 48 hours. After the drug is discontinued plasma levels decline slowly over a period of several days. Chlordiazepoxide is excreted in the urine, with 1% to 2% unchanged and 3% to 6% as conjugate.

Animal Pharmacology

The drug has been studied extensively in many species of animals and these studies are suggestive of action on the limbic system of the brain, which recent evidence indicates is involved in emotional responses.

Hostile monkeys were made tame by oral drug doses which did not cause sedation. Chlordiazepoxide HCl revealed a “taming” action with the elimination of fear and aggression. The taming effect of Chlordiazepoxide HCl was further demonstrated in rats made vicious by lesions in the septal area of the brain. The drug dosage which effectively blocked the vicious reaction was well below the dose which caused sedation in these animals.

The LD50 of parenterally administered Chlordiazepoxide HCl was determined in mice (72 hours) and rats (5 days), and calculated according to the method of Miller and Tainter, with the following results: mice, IV, 123 ± 12 mg/kg; mice, IM, 366 ± 7 mg/kg; rats, IV, 120 ± 7 mg/kg; rats, IM, > 160 mg/kg.

Effects on Reproduction

Reproduction studies in rats fed 10, 20 and 80 mg/kg daily and bred through one or two matings showed no congenital anomalies, nor were there adverse effects on lactation of the dams or growth of the newborn. However, in another study at 100 mg/kg daily there was noted a significant decrease in the fertilization rate and a marked decrease in the viability and body weight of off-spring which may be attributable to sedative activity, thus resulting in lack of interest in mating and lessened maternal nursing and care of the young. One neonate in each of the first and second matings in the rat reproduction study at the 100 mg/kg dose exhibited major skeletal defects. Further studies are in progress to determine the significance of these findings.

Indications and Usage for Chlordiazepoxide

Chlordiazepoxide HCl capsules USP are indicated for the management of anxiety disorders or for the short term relief of symptoms of anxiety, withdrawal symptoms of acute alcoholism, and preoperative apprehension and anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic.

The effectiveness of Chlordiazepoxide HCl capsules USP in long term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.

Contraindications

Chlordiazepoxide HCl capsules are contraindicated in patients with known hypersensitivity to the drug.

Warnings

Chlordiazepoxide HCl may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a vehicle or operating machinery. Similarly, it may impair mental alertness in children. The concomitant use of alcohol or other central nervous system depressants may have an additive effect. PATIENTS SHOULD BE WARNED ACCORDINGLY.

Usage in Pregnancy

An increased risk of congenital malformations associated with the use of minor tranquilizers (Chlordiazepoxide, diazepam and meprobamate) during the first trimester of pregnancy has been suggested in several studies. Because use of these drugs is rarely a matter of urgency, their use during this period should almost always be avoided. The possibility that a woman of childbearing potential may be pregnant at the time of institution of therapy should be considered. Patients should be advised that if they become pregnant during therapy or intend to become pregnant they should communicate with their physicians about the desirability of discontinuing the drug.

Withdrawal symptoms of the barbiturate type have occurred after the discontinuation of benzodiazepines (see DRUG ABUSE AND DEPENDENCE section).

Precautions

In elderly and debilitated patients, it is recommended that the dosage be limited to the smallest effective amount to preclude the development of ataxia or oversedation (10 mg or less per day initially, to be increased gradually as needed and tolerated). In general, the concomitant administration of Chlordiazepoxide HCl and other psychotropic agents is not recommended. If such combination therapy seems indicated, careful consideration should be given to the pharmacology of the agents to be employed — particularly when the known potentiating compounds such as MAO inhibitors and phenothiazines are to be used. The usual precautions in treating patients with impaired renal or hepatic function should be observed.

Paradoxical reactions, e.g., excitement, stimulation and acute rage, have been reported in psychiatric patients and in hyperactive aggressive pediatric patients, and should be watched for during Chlordiazepoxide HCl therapy. The usual precautions are indicated when Chlordiazepoxide HCl is used in the treatment of anxiety states where there is any evidence of impending depression; it should be borne in mind that suicidal tendencies may be present and protective measures may be necessary. Although clinical studies have not established a cause and effect relationship, physicians should be aware that variable effects on blood coagulation have been reported very rarely in patients receiving oral anticoagulants and Chlordiazepoxide HCl. In view of isolated reports associating Chlordiazepoxide with exacerbation of porphyria, caution should be exercised in prescribing Chlordiazepoxide to patients suffering from this disease.

Pediatric Use

Because of the varied response of pediatric patients to CNS-acting drugs, therapy should be initiated with the lowest dose and increased as required (see DOSAGE AND ADMINISTRATION). Since clinical experience with Chlordiazepoxide HCl in pediatric patients under 6 years of age is limited, use in this age group is not recommended. Hyperactive aggressive pediatric patients should be monitored for paradoxical reactions to Chlordiazepoxide HCl (see PRECAUTIONS).

Information for Patients

To assure the safe and effective use of benzodiazepines, patients should be informed that, since benzodiazepines may produce psychological and physical dependence, it is advisable that they consult with their physician before either increasing the dose or abruptly discontinuing this drug.

Adverse Reactions

The necessity of discontinuing therapy because of undesirable effects has been rare. Drowsiness, ataxia and confusion have been reported in some patients — particularly the elderly and debilitated. While these effects can be avoided in almost all instances by proper dosage adjustment, they have occasionally been observed at the lower dosage ranges. In a few instances syncope has been reported.

Other adverse reactions reported during therapy include isolated instances of skin eruptions, edema, minor menstrual irregularities, nausea and constipation, extrapyramidal symptoms, as well as increased and decreased libido. Such side effects have been infrequent, and are generally controlled with reduction of dosage. Changes in EEG patterns (low-voltage fast activity) have been observed in patients during and after Chlordiazepoxide HCl treatment.

Blood dyscrasias (including agranulocytosis), jaundice and hepatic dysfunction have occasionally been reported during therapy. When Chlordiazepoxide HCl treatment is protracted, periodic blood counts and liver function tests are advisable.

Drug Abuse and Dependence

Chlordiazepoxide hydrochloride capsules are classified by the Drug Enforcement Administration as a Schedule IV controlled substance.

Withdrawal symptoms, similar in character to those noted with barbiturates and alcohol (convulsions, tremor, abdominal and muscle cramps, vomiting and sweating), have occurred following abrupt discontinuance of Chlordiazepoxide. The more severe withdrawal symptoms have usually been limited to those patients who had received excessive doses over an extended period of time. Generally milder withdrawal symptoms (e.g., dysphoria and insomnia) have been reported following abrupt discontinuance of benzodiazepines taken continuously at therapeutic levels for several months. Consequently, after extended therapy, abrupt discontinuation should generally be avoided and a gradual dosage tapering schedule followed. Addiction-prone individuals (such as drug addicts or alcoholics) should be under careful surveillance when receiving Chlordiazepoxide or other psychotropic agents because of the predisposition of such patients to habituation and dependence.

Overdosage

Manifestations of Chlordiazepoxide overdosage includes somnolence, confusion, coma and diminished reflexes. Respiration, pulse and blood pressure should be monitored, as in all cases of drug overdosage, although, in general, these effects have been minimal following Chlordiazepoxide HCl overdosage. General supportive measures should be employed, along with immediate gastric lavage. Intravenous fluids should be administered and an adequate airway maintained. Hypotension may be combated by the use of norepinephrine or metaraminol. Dialysis is of limited value. There have been occasional reports of excitation in patients following Chlordiazepoxide HCl overdosage; if this occurs barbiturates should not be used. As with the management of intentional overdosage with any drug, it should be borne in mind that multiple agents may have been ingested.

Flumazenil, a specific benzodiazepine-receptor antagonist, is indicated for the complete or partial reversal of the sedative effects of benzodiazepines and may be used in situations when an overdose with a benzodiazepine is known or suspected. Prior to the administration of flumazenil, necessary measures should be instituted to secure airway, ventilation and intravenous access. Flumazenil is intended as an adjunct to, not as a substitute for, proper management of benzodiazepine overdose. Patients treated with flumazenil should be monitored for resedation, respiratory depression and other residual benzodiazepine effects for an appropriate period after treatment. The prescriber should be aware of a risk of seizure in association with flumazenil treatment, particularly in long term benzodiazepine users and in cyclic antidepressant overdose. The complete flumazenil package insert, including CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS, should be consulted prior to use.

Chlordiazepoxide Dosage and Administration

Because of the wide range of clinical indications for Chlordiazepoxide HCl, the optimum dosage varies with the diagnosis and response of the individual patient. The dosage, therefore, should be individualized for maximum beneficial effects.

ADULTS	USUAL DAILY DOSE
Relief of Mild and Moderate Anxiety Disorders and Symptoms of Anxiety	5 mg or 10 mg, 3 or 4 times daily
Relief of Severe Anxiety Disorders and Symptoms of Anxiety	20 mg or 25 mg, 3 or 4 times daily
Geriatric Patients, or in the presence of debilitating disease.	5 mg, 2 to 4 times daily

Preoperative Apprehension and Anxiety

On days preceding surgery, 5 to 10 mg orally, 3 or 4 times daily. If used as preoperative medication, 50 to 100 mg IM* 1 hour prior to surgery.

PEDIATRIC PATIENTS	USUAL DAILY DOSE
Because of the varied response of pediatric patients to CNS-acting drugs, therapy should be initiated with the lowest dose and increased as required. Since clinical experience in pediatric patients under 6 years of age is limited, the use of the drug in this age group is not recommended.	5 mg, 2 to 4 times daily (may be increased in some pediatric patients to 10 mg, 2 to 3 times daily)

For the relief of withdrawal symptoms of acute alcoholism, the parenteral form* is usually used initially. If the drug is administered orally, the suggested initial dose is 50 to 100 mg, to be followed by repeated doses as needed until agitation is controlled — up to 300 mg per day. Dosage should then be reduced to maintenance levels.

*See package insert for Injectable Chlordiazepoxide HCl.

How is Chlordiazepoxide Supplied

Chlordiazepoxide Hydrochoride Capsules USP, 5 mg are available as a two-piece hard gelatin capsule with an aqua green opaque cap and a yellow opaque body filled with white powder, imprinted in black ink barr 158, packaged in bottles of 100 and 500 capsules.

Chlordiazepoxide Hydrochloride Capsules USP, 10 mg are available as a two-piece hard gelatin capsule with a black opaque cap and a green opaque body filled with white powder, imprinted in white ink barr 033, packaged in bottles of 100 and 1000 capsules.

Chlordiazepoxide Hydrochloride Capsules USP, 25 mg are available as a two-piece hard gelatin capsule with an aqua green opaque cap and a white opaque body filled with white powder, imprinted in black ink barr 159, available in bottles of 100 and 500 capsules.

Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature] in a dry place.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

TEVA PHARMACEUTICALS USA

Sellersville, PA 18960

Rev. A 8/2011

PRINCIPAL DISPLAY PANEL

Chlordiazepoxide Hydrochloride Capsules USP 5 mg 100s Label Text

NDC 0555-0158-02

Chlordiazepoxide

HYDROCHLORIDE

Capsules USP

5 mg

Rx only

100 CAPSULES

TEVA

PRINCIPAL DISPLAY PANEL

Chlordiazepoxide Hydrochloride Capsules USP 10 mg 100s Label Text

NDC 0555-0333-02

Chlordiazepoxide

HYDROCHLORIDE

Capsules USP

10 mg

Rx only

100 CAPSULES

TEVA

PRINCIPAL DISPLAY PANEL

Chlordiazepoxide Hydrochloride Capsules USP 25 mg 100s Label Text

NDC 0555-0159-02

Chlordiazepoxide

HYDROCHLORIDE

Capsules USP

25 mg

Rx only

100 CAPSULES

TEVA

Chlordiazepoxide HYDROCHLORIDE  Chlordiazepoxide hydrochloride  capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0555-0158 Route of Administration ORAL DEA Schedule CIV

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Chlordiazepoxide HYDROCHLORIDE (Chlordiazepoxide) Chlordiazepoxide HYDROCHLORIDE 5 mg

Inactive Ingredients Ingredient Name Strength ALUMINUM OXIDE   ANHYDROUS LACTOSE   CELLULOSE, MICROCRYSTALLINE   D&C RED NO. 33   D&C YELLOW NO. 10   FD&C BLUE NO. 1   FD&C BLUE NO. 2   FD&C RED NO. 40   FERROSOFERRIC OXIDE   GELATIN   PROPYLENE GLYCOL   SHELLAC   TITANIUM DIOXIDE

Product Characteristics Color GREEN (aqua green) , YELLOW Score no score Shape CAPSULE Size 14mm Flavor Imprint Code barr;158 Contains

Packaging # NDC Package Description Multilevel Packaging 1 0555-0158-02 100 CAPSULE In 1 BOTTLE None 2 0555-0158-04 500 CAPSULE In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA084768	12/01/2011

Chlordiazepoxide HYDROCHLORIDE  Chlordiazepoxide hydrochloride  capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0555-0033 Route of Administration ORAL DEA Schedule CIV

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Chlordiazepoxide HYDROCHLORIDE (Chlordiazepoxide) Chlordiazepoxide HYDROCHLORIDE 10 mg

Inactive Ingredients Ingredient Name Strength ALUMINUM OXIDE   ANHYDROUS LACTOSE   BUTYLPARABEN   CELLULOSE, MICROCRYSTALLINE   D&C YELLOW NO. 10   DIMETHICONE   ETHYLENE GLYCOL MONOETHYL ETHER   FD&C BLUE NO. 1   FD&C RED NO. 40   GELATIN   LECITHIN, SOYBEAN   METHYLPARABEN   PROPYLPARABEN   SHELLAC   SODIUM LAURYL SULFATE   SODIUM PROPIONATE   TITANIUM DIOXIDE

Product Characteristics Color BLACK, GREEN Score no score Shape CAPSULE Size 14mm Flavor Imprint Code barr;033 Contains

Packaging # NDC Package Description Multilevel Packaging 1 0555-0033-02 100 CAPSULE In 1 BOTTLE None 2 0555-0033-05 1000 CAPSULE In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA083116	12/01/2011

Chlordiazepoxide HYDROCHLORIDE  Chlordiazepoxide hydrochloride  capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0555-0159 Route of Administration ORAL DEA Schedule CIV

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Chlordiazepoxide HYDROCHLORIDE (Chlordiazepoxide) Chlordiazepoxide HYDROCHLORIDE 25 mg

Inactive Ingredients Ingredient Name Strength ALUMINUM OXIDE   ANHYDROUS LACTOSE   CELLULOSE, MICROCRYSTALLINE   D&C YELLOW NO. 10   FD&C BLUE NO. 1   FD&C BLUE NO. 2   FD&C RED NO. 40   FERROSOFERRIC OXIDE   GELATIN   PROPYLENE GLYCOL   SHELLAC   TITANIUM DIOXIDE

Product Characteristics Color GREEN (aqua green) , WHITE Score no score Shape CAPSULE Size 14mm Flavor Imprint Code barr;159 Contains

Packaging # NDC Package Description Multilevel Packaging 1 0555-0159-02 100 CAPSULE In 1 BOTTLE None 2 0555-0159-04 500 CAPSULE In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA084769	12/01/2011

Labeler - Barr Laboratories Inc. (802716563)

Revised: 12/2011Barr Laboratories Inc.

Halog-E

Generic Name: halcinonide topical (hal SIN oh nide)

Brand Names: Halog, Halog-E

What is Halog-E (halcinonide topical)?

Halcinonide is a topical (for the skin) steroid. It reduces the actions of chemicals in the body that cause inflammation, redness, and swelling.

Halcinonide topical is used to treat the inflammation and itching caused by a number of skin conditions such as allergic reactions, eczema, and psoriasis.

Halcinonide topical may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Halog-E (halcinonide topical)?

Use this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger amounts or for longer than recommended. Topical steroid medicine can be absorbed through the skin, which may cause steroid side effects throughout the body.

Do not cover treated skin areas with a bandage or other covering unless your doctor has told you to. Plastic film covering (such as plastic wrap) is sometimes used when treating psoriasis. Follow your doctor's instructions.

If you are treating the diaper area of a baby, do not use plastic pants or tight-fitting diapers. Covering the skin that is treated with halcinonide topical can increase the amount of medicine your skin absorbs, which may lead to unwanted side effects.

Do not use this medication on a child without a doctor's advice. Children are more likely to absorb large amounts of a topical steroid through the skin. Steroid absorption in children may cause unwanted side effects, or a delay in growth with long-term use. Talk with your doctor if you think your child is not growing at a normal rate while using this medication over a long treatment period. Contact your doctor if your condition does not improve, or if you develop signs of a bacterial, fungal, or viral skin infection.

What should I discuss with my healthcare provider before using Halog-E (halcinonide topical)?

Do not use this medication if you are allergic to halcinonide.

Before using halcinonide topical, tell your doctor if you are allergic to any drugs, or if you have any type of skin infection.

Also tell your doctor if you have diabetes. Topical steroid medicines absorbed through the skin may increase the glucose (sugar) levels in your blood or urine.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether halcinonide topical passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not use this medication on a child without a doctor's advice. Children are more likely to absorb large amounts of a topical steroid through the skin. Steroid absorption in children may cause unwanted side effects, or a delay in growth with long-term use. Talk with your doctor if you think your child is not growing at a normal rate while using this medication over a long treatment period.

How should I use Halog-E (halcinonide topical)?

Use this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger amounts or for longer than recommended. Topical steroid medicine can be absorbed through the skin, which may cause steroid side effects throughout the body.

Wash your hands before and after using halcinonide topical, unless you are using the medication to treat the skin on your hands.

Apply a small amount to the affected area and rub it gently into the skin. Do not use this medication over a large area of skin.

Do not cover treated skin areas with a bandage or other covering unless your doctor has told you to. Plastic film covering (such as plastic wrap, plastic gloves, or a shower cap) is sometimes used to cover areas of psoriasis that are treated with halcinonide topical. Follow your doctor's instructions.

Avoid plastic covering over skin lesions that are oozing or draining pus or any type of fluid.

If you are treating the diaper area of a baby, do not use plastic pants or tight-fitting diapers. Covering the skin that is treated with halcinonide topical can increase the amount of medicine your skin absorbs, which may lead to unwanted side effects.

Contact your doctor if your condition does not improve, or if you develop signs of a bacterial, fungal, or viral skin infection. It is important to use halcinonide topical regularly to get the most benefit.

If you are treating psoriasis, use the medication for at least a few days after the skin clears. Stopping too soon could cause a relapse.

To be sure this medication is not causing harmful effects with long-term use, you may need blood tests. Do not miss any scheduled appointments.

Store halcinonide topical at room temperature away from moisture and heat. Keep from freezing.

What happens if I miss a dose?

Use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and use the medicine at the next regularly scheduled time. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

An overdose of halcinonide is not expected to produce life-threatening symptoms. However, long-term use of high steroid doses can lead to symptoms such as thinning skin, easy bruising, changes in the shape or location of body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.

What should I avoid while using Halog-E (halcinonide topical)?

Halcinonide topical should not be used to treat any skin condition your doctor has not prescribed it for.

Avoid getting this medication in your eyes. If contact does occur, rinse with water. Do not use halcinonide topical on broken or infected skin. Also avoid using this medication in open wounds.

Halog-E (halcinonide topical) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have severe irritation of any treated skin, or if you show signs of absorbing halcinonide topical through your skin, such as:

• 
  

  blurred vision, or seeing halos around lights;

  
  


• 
  

  mood changes;

  
  


• 
  

  sleep problems (insomnia);

  
  


• 
  

  weight gain, puffiness in your face; or

  
  


• 
  

  muscle weakness, feeling tired.

  
  

Less serious side effects may include:

• 
  

  mild skin itching, burning, or dryness;

  
  


• 
  

  thinning or softening of your skin;

  
  


• 
  

  skin rash or irritation around your mouth;

  
  


• 
  

  swollen hair follicles;

  
  


• 
  

  changes in color of treated skin;

  
  


• 
  

  blisters, pimples, or crusting of treated skin; or

  
  


• 
  

  stretch marks.

  
  

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Halog-E (halcinonide topical)?

It is not likely that other drugs you take orally or inject will have an effect on topically applied halcinonide topical. But many drugs can interact with each other. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More Halog-E resources

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

• Halog-E Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• Halog-E Prescribing Information (FDA)


• Halog Advanced Consumer (Micromedex) - Includes Dosage Information

Compare Halog-E with other medications

• Atopic Dermatitis
• Dermatitis
• Eczema
• Psoriasis

Where can I get more information?

• Your pharmacist can provide more information about halcinonide topical.

See also: Halog-E side effects (in more detail)

Cleocin Cream

Pronunciation: KLIN-da-MYE-sin
Generic Name: Clindamycin
Brand Name: Cleocin

Cleocin Cream is used for:

Treating vaginal infections caused by certain bacteria.

Cleocin Cream is a topical lincomycin antibiotic. It works by slowing the growth of certain bacteria.

Do NOT use Cleocin Cream if:

• you are allergic to any ingredient in Cleocin Cream or to lincomycin


• you have Crohn disease, antibiotic-associated colitis, or ulcerative colitis

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

Before using Cleocin Cream:

Some medical conditions may interact with Cleocin Cream. 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 a gastrointestinal (bowel) disease or diarrhea

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

• Nondepolarizing muscle relaxants (eg, vecuronium) or succinylcholine because their actions and the risk of their side effects may be increased by Cleocin Cream


• Erythromycin because it may decrease Cleocin Cream's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if Cleocin Cream 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 Cleocin Cream:

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

• Cleocin Cream is for vaginal use only.


• Wash your hands before and after using Cleocin Cream. To use, remove the cap from the tube. Screw the plastic applicator on the threaded end of the tube. Rolling the tube from the bottom, squeeze gently and force the medicine into the applicator. The applicator is filled when the plunger reaches its predetermined stopping point.


• Unscrew the applicator from the tube and replace the cap. While lying on your back, firmly grasp the applicator barrel and insert into the vagina as far as it will possibly go without causing discomfort. Slowly push the plunger until it stops. Carefully remove the applicator from the vagina and throw the applicator away.


• Use Cleocin Cream at bedtime. This will help keep the medicine in the vagina and reduce leaking.


• Cleocin Cream works best if it is used at the same time each day.


• To clear up your infection completely, use Cleocin Cream for the full course of treatment. Keep using it even if you feel better in a few days.


• If you miss a dose of Cleocin Cream and you are using it regularly, use it as soon as possible. If several hours have passed or if it is nearing time for the next dose, do not double the dose to catch up, unless advised by your health care provider. Do not use 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 Cleocin Cream.

Important safety information:

• Avoid contact with the eyes. Burning and irritation can occur. If contact does occur, rinse the eye with large amounts of cool tap water.


• Do not have sexual intercourse or use other vaginal products, such as tampons or douches, while using Cleocin Cream.


• Use a sanitary napkin rather than a tampon to prevent staining of clothes and bed linens.


• This cream contains mineral oil that may weaken latex products such as condoms and diaphragms. Therefore, do not use these products within 72 hours of using Cleocin Cream.They may not provide adequate birth control and you may become pregnant.


• Be sure to use Cleocin Cream for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.


• Long-term or repeated use of Cleocin Cream may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.


• If severe diarrhea, stomach pain or cramping, or bloody stools develop during treatment or within several months after treatment with Cleocin Cream, check with your doctor or pharmacist right away. Do not treat it without first checking with your doctor.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Cleocin Cream while you are pregnant. It is not known if Cleocin Cream is found in breast milk. If you are or will be breast-feeding while you use Cleocin Cream, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Cleocin Cream:

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:

Fungal infection; genital itching or burning; inflammation or pain; vaginal discharge.

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); blood/mucus in stools; diarrhea; new or worsening vaginal or vulvar itching; painful sex; stomach cramps/pain; white vaginal discharge.

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: Cleocin 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. Cleocin Cream may be harmful if swallowed.

Proper storage of Cleocin Cream:

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

General information:

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


• Cleocin Cream 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 Cleocin Cream. 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 Cleocin resources

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

Compare Cleocin with other medications

• Bacterial Vaginitis

cefadroxil

Generic Name: cefadroxil (SEF a DROX il)

Brand Names: Duricef

What is cefadroxil?

Cefadroxil is in a group of drugs called cephalosporin (SEF a low spor in) antibiotics. It works by fighting bacteria in your body.

Cefadroxil is used to treat many different types of infections caused by bacteria.

Cefadroxil may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about cefadroxil?

Do not take this medication if you are allergic to cefadroxil, or to similar antibiotics, such as Ceftin, Cefzil, Keflex, Omnicef, and others.

Before taking this medication, tell your doctor if you are allergic to any drugs (especially penicillin). Also tell your doctor if you have kidney disease or a history of intestinal problems.

Take this medication for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated. Cefadroxil will not treat a viral infection such as the common cold or flu.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or has blood in it, call your doctor. Do not use any medicine to stop the diarrhea unless your doctor has told you to.

What should I discuss with my healthcare provider before taking cefadroxil?

Do not take this medication if you are allergic to cefadroxil or to other cephalosporin antibiotics, such as:

• 
  

  cefaclor (Raniclor);

  
  


• 
  

  cefazolin (Ancef);

  
  


• 
  

  cefdinir (Omnicef);

  
  


• 
  

  cefditoren (Spectracef);

  
  


• 
  

  cefpodoxime (Vantin);

  
  


• 
  

  cefprozil (Cefzil);

  
  


• 
  

  ceftibuten (Cedax);

  
  


• 
  

  cefuroxime (Ceftin);

  
  


• 
  

  cephalexin (Keflex); or

  
  


• 
  

  cephradine (Velosef); and others.

  
  

Before taking cefadroxil, tell your doctor if you are allergic to any drugs (especially penicillins), or if you have:

• kidney disease; or


• 
  

  a history of intestinal problems, such as colitis.

  
  

If you have any of these conditions, you may need a dose adjustment or special tests to safely take cefadroxil.

The cefadroxil suspension (liquid) contains sucrose. Talk to your doctor before using this form of cefadroxil if you have diabetes.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Cefadroxil may pass into breast milk and could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take cefadroxil?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Take this medicine with a full glass of water. Take this medication for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated. Cefadroxil will not treat a viral infection such as the common cold or flu.

Cefadroxil can be taken on an empty stomach or with food or milk if it causes stomach upset.

Shake the liquid form of cefadroxil well before measuring a dose. To ensure that you get a correct dose, measure the suspension with a dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one.

This medication can cause you to have false results with certain medical tests, including urine glucose (sugar) tests. Tell any doctor who treats you that you are using cefadroxil.

Store the tablets and capsules at room temperature away from moisture and heat. Store cefadroxil oral liquid in the refrigerator. Do not allow it to freeze. Throw away any unused medication that is older than 14 days.

What happens if I miss a dose?

Take the medication as soon as you remember the missed dose. If it is almost time for your next dose, skip the missed dose and use the medicine at your next regularly scheduled time. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Symptoms of a cefadroxil overdose are not known.

What should I avoid while taking cefadroxil?

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or has blood in it, call your doctor. Do not use any medicine to stop the diarrhea unless your doctor has told you to.

Cefadroxil side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:

• 
  

  diarrhea that is watery or bloody;

  
  


• 
  

  fever, chills, body aches, flu symptoms;

  
  


• 
  

  unusual bleeding or bruising;

  
  


• 
  

  seizure (convulsions);

  
  


• 
  

  pale or yellowed skin, dark colored urine, fever, confusion or weakness;

  
  


• 
  

  jaundice (yellowing of the skin or eyes);

  
  


• 
  

  fever, swollen glands, rash or itching, joint pain, or general ill feeling;

  
  


• 
  

  fever, sore throat, and headache with a severe blistering, peeling, and red skin rash; or

  
  


• 
  

  increased thirst, loss of appetite, swelling, weight gain, feeling short of breath, urinating less than usual or not at all.

  
  

Less serious side effects may include:

• 
  

  nausea, vomiting, stomach pain, mild diarrhea;

  
  


• 
  

  stiff or tight muscles;

  
  


• 
  

  joint pain;

  
  


• 
  

  feeling restless or hyperactive;

  
  


• 
  

  unusual or unpleasant taste in your mouth;

  
  


• 
  

  mild itching or skin rash; or

  
  


• 
  

  vaginal itching or discharge.

  
  

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Cefadroxil Dosing Information

Usual Adult Dose for Bacterial Endocarditis Prophylaxis:

2 g orally as a single dose one hour prior to the procedure

Usual Adult Dose for Pyelonephritis:

Uncomplicated: 1 g orally every 12 hours for 14 days

Usual Adult Dose for Skin or Soft Tissue Infection:

1 g/day orally in 1 to 2 divided doses

Usual Adult Dose for Tonsillitis/Pharyngitis:

1 g/day orally in 1 to 2 divided doses for 10 days

Usual Adult Dose for Upper Respiratory Tract Infection:

500 mg orally every 12 hours or 1 g orally every 24 hours for 7 to 10 days

Usual Adult Dose for Urinary Tract Infection:

Uncomplicated: 1 to 2 g/day orally in 1 to 2 divided doses
Complicated: 1 g orally twice a day

Usual Pediatric Dose for Bacterial Endocarditis Prophylaxis:

1 to 18 years and 39 kg or less: 50 mg/kg orally, not to exceed 2 g, administered once 1 hour prior to the procedure
1 to 18 years and 40 kg or more: 2 g orally, administered once 1 hour prior to the procedure

Usual Pediatric Dose for Urinary Tract Infection:

1 month or older: 15 mg/kg orally every 12 hours, not to exceed 2 g per 24 hours

Usual Pediatric Dose for Skin and Structure Infection:

1 month or older: 15 mg/kg orally every 12 hours, not to exceed 2 g per 24 hours

Usual Pediatric Dose for Tonsillitis/Pharyngitis:

1 month or older: 30 mg/kg/day orally in 1 to 2 divided doses, not to exceed 2 g per 24 hours

Usual Pediatric Dose for Impetigo:

1 month or older: 30 mg/kg/day orally in 1 to 2 divided doses, not to exceed 2 g per 24 hours

What other drugs will affect cefadroxil?

There may be other drugs that can interact with cefadroxil. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start taking a new medication without telling your doctor.

More cefadroxil resources

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

• cefadroxil Advanced Consumer (Micromedex) - Includes Dosage Information


• Cefadroxil Prescribing Information (FDA)


• Cefadroxil Professional Patient Advice (Wolters Kluwer)


• Cefadroxil Monograph (AHFS DI)


• Cefadroxil MedFacts Consumer Leaflet (Wolters Kluwer)


• Duricef Prescribing Information (FDA)

Compare cefadroxil with other medications

• Bacterial Endocarditis Prevention
• Impetigo
• Kidney Infections
• Skin and Structure Infection
• Skin Infection
• Tonsillitis/Pharyngitis
• Upper Respiratory Tract Infection
• Urinary Tract Infection

Where can I get more information?

• Your pharmacist can provide more information about cefadroxil.

See also: cefadroxil side effects (in more detail)