Lactic Acid Cream

Pronunciation: LACK-tick ASS-id
Generic Name: Lactic Acid
Brand Name: Examples include AmLactin and Lac-Hydrin

Lactic Acid Cream is used for:

Treating mild to severe forms of dry, scaly skin.

Lactic Acid Cream is a humectant. Exactly how it works is unknown but it increases the amount of water in the skin, making it softer and more pliable.

Do NOT use Lactic Acid Cream if:

• you are allergic to any ingredient in Lactic Acid Cream

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

Before using Lactic Acid Cream:

Some medical conditions may interact with Lactic Acid 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

Some MEDICINES MAY INTERACT with Lactic Acid Cream. Because little, if any, of Lactic Acid Cream is absorbed into the blood, the risk of it interacting with another medicine is low.

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

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

• Apply Lactic Acid Cream to the affected area and rub in thoroughly twice daily or as directed by your health care provider.


• Wash your hands immediately after using Lactic Acid Cream, unless your hands are part of the treated area.


• If you miss a dose of Lactic Acid Cream, use 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 use 2 doses at once.

Ask your health care provider any questions you may have about how to use Lactic Acid Cream.

Important safety information:

• Lactic Acid Cream may cause stinging or burning when applied to cracked or scraped skin (eg, after shaving).


• Lactic Acid Cream is for external use only. Avoid contact with the eyes, lips, or mucous membranes.


• Lactic Acid Cream may be harmful if swallowed. If you or someone you know may have taken Lactic Acid Cream by mouth, contact your local poison control center or emergency room immediately.


• Overuse of topical products may worsen your condition.


• Lactic Acid Cream may cause increased sensitivity to the sun. Avoid exposure to the sun, sunlamps, or tanning booths until you know how you react to Lactic Acid Cream. Use a sunscreen or protective clothing if you must be outside for a prolonged period.


• PREGNANCY and BREAST-FEEDING: If you plan on becoming pregnant, discuss with your doctor the benefits and risks of using Lactic Acid Cream during pregnancy. It is unknown if Lactic Acid Cream is excreted in breast milk. If you are or will be breast-feeding while you are using Lactic Acid Cream, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Lactic Acid 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:

Burning; dry skin; flushing; irritation; itching; rash; stinging.

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

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); worsening of condition.

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: Lactic Acid 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. Lactic Acid Cream may be harmful if swallowed.

Proper storage of Lactic Acid Cream:

Store at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Keep Lactic Acid Cream out of the reach of children and away from pets.

General information:

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


• Lactic Acid 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 Lactic Acid 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 Lactic Acid resources

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

Compare Lactic Acid with other medications

• Dry Skin
• Pityriasis rubra pilaris

Lindane

Class: Scabicides and Pediculicides
CAS Number: 58-98-9

• 
  

  Use only in patients who have not responded to or cannot tolerate other recommended therapies.¹¹⁷

  
  

• CNS Toxicity


• 
  

  Seizures and deaths have been reported following repeated or prolonged topical application; however, rare cases reported after a single application.^{117 118} (See CNS Effects under Cautions.)

  
  


• 
  

  Increased risk of serious neurotoxicity in infants, children, geriatric patients, patients weighing <50 kg, and patients with certain other skin conditions.^{117 118}

  
  

• 
  

  Contraindicated in premature neonates and patients with uncontrollable seizure disorders.^{117 118}

  
  

• Proper Use


• 
  

  Instruct patients or their caregivers on the proper use of shampoo or lotion, including the amount to apply, how soon to wash the drug off, and the importance of avoiding repeated application.^{117 118}

  
  


• 
  

  Inform patients that pruritus may persist after successful treatment and is not an indication for further treatment.^{117 118}

  
  

Introduction

A scabicide and pediculicide.¹²²

Uses for Lindane

Pediculosis

Used as a second-line agent for the topical treatment of pediculosis capitis (head lice infestation) caused by Pediculus humanus var capitis in patients who have not responded to or who cannot tolerate other recommended therapies.^{103 117}

Used as a second-line agent for the topical treatment of pediculosis pubis (pubic lice infestation) caused by Phthirus pubis in patients who have not responded to or cannot tolerate other recommended therapies.¹¹⁷

Not recommended as initial therapy for pediculosis capitis or pediculosis pubis because of reports of resistance and neurotoxicity (e.g., seizures).^{101 103 104 112 117} (See CNS Effects under Cautions.)

Scabies

Used as a second-line agent for the topical treatment of scabies in patients who have not responded to or cannot tolerate other recommended therapies.¹⁰⁴

Not recommended for the treatment of Norwegian scabies because of the risks of neurotoxicity with heavy application and denuded skin.^{104 117 118} (See CNS Effects under Cautions.)

Not effective in the prophylaxis of scabies; does not prevent infestation or reinfestation.¹¹⁸

Used as treatment of individuals (e.g., household, family, and sexual contacts) who have had close personal contact with a patient with scabies within the previous month.^{103 104 109 113}

Has been used for treatment of scabies epidemics in institutional settings (e.g., nursing homes, hospitals, residential facilities and communities).^{104 115} However, permethrin is recommended as a scabicide of choice in institutional outbreaks.¹¹⁴

Lindane Dosage and Administration

General

Measures to Avoid Reinfestation and Transmission

• 
  

  To avoid reinfestation or transmission following treatment, all clothing, bed linens, and towels used within the last 72 hours should be machine-washed in hot water and dried in a hot dryer or dry-cleaned; fumigation of living areas is not necessary.^{117 118 119 120 121}

  
  


• 
  

  For lice infestation, it is recommended that items that cannot be laundered or dry-cleaned be removed from contact and sealed in a plastic bag for 10 days.¹⁰³

  
  


• 
  

  Combs and brushes used by the infected patient may be disinfected by soaking in hot water (temperature exceeding 53°C) for 5 minutes;¹⁰³ alternatively, soaking in a pediculicide for 1 hour may be used.¹⁰² Combs and brushes may be washed with lindane shampoo, but they should be rinsed thoroughly with water to remove the drug.¹²²

  
  

Pediculosis

• 
  

  Pruritus does not indicate treatment failure and is not an indication for further treatment.^{117 118} Oral antihistamines and/or topical corticosteroids may be used to help relieve pruritus.^{103 109 113} (See Dermatologic and Sensitivity Reactions under Cautions.)

  
  

Scabies

• 
  

  Follow-up examinations of patients recommended 2 and 4 weeks after treatment.¹⁰⁹ If patient is not clear of new lesions at either examination, it should be considered a treatment failure (secondary to failure to treat all exposed individuals or failure to apply the drug properly).¹⁰⁹ If patient is clear of new lesions when examined at 2 weeks but has new lesions at 4 weeks, it should be considered a reinfestation rather than a treatment failure.¹⁰⁹

  
  


• 
  

  Pruritus does not indicate treatment failure and is not an indication for further treatment.^{117 118} Oral antihistamines and/or topical corticosteroids may be used to help relieve pruritus.^{103 109 113} (See Dermatologic and Sensitivity Reactions under Cautions.)

  
  


• 
  

  Scabies rarely affects the head of adults but may affect the head of infants and young children.¹²²

  
  

Administration

Topical Administration

Lindane shampoo is indicated only for the treatment of lice.¹¹⁷ Lindane lotion is indicated only for the treatment of scabies.¹¹⁸

Apply topically to the skin.¹²²

Lindane preparations are for external use only and should not be ingested.^{117 120}

Do not apply to patients with extensive dermatitis or to those with acutely inflamed skin or raw, weeping surfaces.¹²² Do not use if open wounds, cuts, or sores are present at the site of application.^{117 118}

Avoid contact with the eyes and mouth.^{117 118 119 120} If contact with the eyes occurs, immediately flush the eyes with water.^{117 118 120}

Not a suitable alternative for infants, young children, pregnant and lactating women, or in those with extensive dermatitis because of the drug’s topical toxicity profile.^{103 104} (See CNS Effects under Cautions.)

Parents or caregivers who apply lindane on an infected individual should wear gloves made of nitrile, latex with neoprene, or sheer vinyl; natural latex gloves should not be used since lindane can diffuse through natural latex gloves.^{117 118 119 120} Hands should be thoroughly cleaned after application is completed.^{119 120}

Shampoo

Apply to hair that is clean and completely dry.^{117 119}

Hair may be washed at least 1 hour before applying lindane shampoo with regular shampoo (without conditioner) and dried completely.¹¹⁹

Avoid use of oil treatments or oil-based hair preparations immediately before or after applying lindane shampoo.^{117 119} (See Oils and Oil-based Preparations under Interactions.)

Apply 30–60 mL of shampoo to hair; use just enough to lightly coat hair and scalp.¹¹⁹ Work shampoo thoroughly into hair and allow to stay in place for 4 minutes.¹¹⁷ Special attention should be given to the fine hairs along the neck and behind the ears.¹¹⁷ After 4 minutes, add small quantities of water to the hair to form a good lather and then immediately and thoroughly rinse hair until all the lather is gone.¹¹⁷ Avoid unnecessary contact of lather with other body parts.¹¹⁷

One treatment usually is effective in eradicating pediculosis capitis and pediculosis pubis.^{117 118}

If symptoms persist, do not retreat with lindane because of concerns about neurotoxicity.^{117 118} (See CNS Effects under Cautions.) Retreatment with an alternative pediculicide may be appropriate at the advice of the clinician if live lice or nits are detected after 1 week.^{117 118}

For further information on application of lindane shampoo, consult manufacturer’s patient information.¹¹⁹

Lotion

Apply a thin layer of lotion to skin that is clean and free of any creams, ointments, or oil.^{118 120 120} Do not apply to the skin immediately after a bath or shower;^{104 118} patients should wait at least 1 hour after bathing or showering and the skin should be completely dry before applying lotion.^{118 120} (See Oils and Oil-based Preparations under Interactions.)

Apply uniformly and gently massage into all skin surfaces (entire trunk and extremities) from the neck to the toes (including the soles of the feet).¹²⁰ Do not apply to the face, eyes, mucous membranes, or urethral meatus.¹²² After 8–12 hours, completely wash lotion off the body using warm (not hot) water.^{118 120} Do not leave lotion on the skin for >12 hours.¹¹⁸

One treatment usually is successful.^{117 118} If symptoms persist, do not retreat with lindane because of concerns about neurotoxicity.^{117 118} Additional treatment with an alternative scabicide generally is warranted only if live mites can be demonstrated.^{117 118}

For further information on application of lindane lotion, consult manufacturer’s patient information.¹²⁰

Dosage

Pediatric Patients

Use with caution in children weighing <50 kg, especially infants.^{117 118} (See Pediatric Use under Cautions.)

Pediculosis

Topical

Children ≥2 years of age: Apply about 30–60 mL of shampoo once to hair; amount of shampoo needed depends on the length of the hair (most patients require only 30 mL).¹¹⁷ After 4 minutes, add small quantities of water to the hair to form a good lather and then immediately and thoroughly rinse hair until all the lather is gone.¹¹⁷

Because of concerns about neurotoxicity, retreatment with lindane is not recommended.^{117 118} (See CNS Effects under Cautions.)

Scabies

Topical

Children ≥2 years of age: Apply lotion once into all skin surfaces (entire trunk and extremities) from the neck to the toes (including the soles of the feet).¹²⁰

After 8–12 hours, lotion must be completely washed off the body using warm (not hot) water.^{118 120} Do not leave on the skin for >12 hours.¹¹⁸

Because of concerns about neurotoxicity, retreatment with lindane is not recommended.^{117 118} (See CNS Effects under Cautions.)

Adults

Pediculosis

Topical

Apply about 30–60 mL of shampoo once to hair; amount of shampoo needed depends on the length of the hair (most patients require only 30 mL).¹¹⁷ After 4 minutes, add small quantities of water to the hair to form a good lather and then immediately and thoroughly rinse hair until all the lather is gone.¹¹⁷

Because of concerns about neurotoxicity, retreatment with lindane is not recommended.^{117 118} (See CNS Effects under Cautions.)

Scabies

Topical

Apply lotion once into all skin surfaces (entire trunk and extremities) from the neck to the toes (including the soles of the feet).

Approximately 30 mL of the lotion is recommended for an average adult.¹¹⁸

After 8–12 hours, lotion must be completely washed off the body using warm (not hot) water.^{118 120} Do not leave on the skin for >12 hours.¹¹⁸

Because of concerns about neurotoxicity, retreatment with lindane is not recommended.^{117 118} (See CNS Effects under Cautions.)

Prescribing Limits

Pediatric Patients

Pediculosis

Topical

Children ≥2 years of age: Do not leave shampoo in the hair for >4 minutes and do not retreat.¹¹⁷

Scabies

Topical

Children ≥2 years of age: Do not leave lotion on the skin for >12 hours and do not retreat.¹¹⁸

Adults

Pediculosis

Topical

Do not leave shampoo in the hair for >4 minutes and do not retreat.¹¹⁷

Scabies

Topical

Do not leave lotion on the skin for >12 hours and do not retreat.¹¹⁸

Special Populations

Hepatic Impairment

No specific dosage recommendations.

Renal Impairment

No specific dosage recommendations.

Geriatric Patients

No specific dosage recommendations.

Cautions for Lindane

Contraindications

Premature neonates.^{117 118}

Uncontrollable seizure disorders.^{117 118}

Norwegian scabies (crusted scabies) and in those with other skin disorders (e.g., atopic dermatitis, psoriasis).^{117 118}

Known sensitivity to lindane or any ingredient in the formulations.^{117 118}

Warnings/Precautions

Sensitivity Reactions

Dermatologic and Sensitivity Reactions

If primary irritation or hypersensitivity occurs, discontinue treatment and remove the drug with soap and water.¹²²

Alopecia,^{117 118} dermatitis,^{117 118} pruritus,^{117 118} and urticaria have been reported.^{117 118}

Pruritus (caused by an acquired sensitivity to the ectoparasites and their products) frequently persists for one to several weeks following treatment, does not indicate treatment failure, and is not an indication for further treatment.^{117 118} Oral antihistamines and/or topical corticosteroids may be used to help relieve pruritus.^{103 109 113}

Major Toxicities

CNS Effects

Neurotoxicity, including seizures and deaths, has occurred following repeated or prolonged topical application; however, rare cases reported after a single application.^{117 118} Serious CNS effects have occurred more frequently with lindane lotion than with lindane shampoo.^{117 118}

Infants, children, geriatric patients, patients weighing <50 kg, and patients with certain other skin conditions may be at greater risk of serious neurotoxicity than other individuals.^{117 118}

Dizziness, headache, pain, and paresthesia have been reported.^{117 118}

Use with caution in patients at increased risk of seizure (e.g., patients with HIV infection, a history of head trauma, seizure history, CNS tumor, severe hepatic cirrhosis, excessive alcohol consumption, or concomitant use of agents that lower the seizure threshold [see Specific Drugs under Interactions], or who are undergoing abrupt discontinuance of alcohol or sedatives).^{117 118}

Specific Populations

Pregnancy

Category C.^{117 118}

Lactation

Distributed into milk.^{117 118} Risk of toxicity if lindane were absorbed through the skin in the course of breast-feeding if the mother has applied lindane to the chest area.^{117 118} Discontinue nursing for at least 24 hours following application of lindane^{117 118} and avoid large areas of skin-to-skin contact with the infant while lindane is applied.¹¹⁸

Pediatric Use

Pediatric patients have a higher surface-to-volume ratio than adults; increased risk of greater systemic absorption and serious neurotoxicity following topical application in infants and small children.^{117 118} In addition, infants and children may be at greater risk than older individuals because of immature organ systems (e.g., skin, liver).^{117 118}

Use not recommended in infants and children <2 years of age.¹⁰⁴

Contraindicated in premature neonates, since their skin might be more permeable than full-term neonates and their liver enzymes not sufficiently developed to metabolize lindane.^{117 118}

If used in children, take care to prevent ingestion of the drug as from thumb-sucking (by covering hands and feet).¹²² Children must not be allowed to apply lindane without adult supervision.¹²²

Geriatric Use

Safety and efficacy not specifically studied in geriatric patients.^{117 118} However, increased risk of serious and potentially fatal neurotoxicity; use with caution.^{117 118}

Immunocompromised Patients

Increased risk of developing Norwegian scabies in immunocompromised individuals, including those with HIV infection; such patients should be managed in consultation with an expert.^{104 108 113}

Common Adverse Effects

Itching and burning skin, dry skin, skin rash.^{117 118}

Interactions for Lindane

Oils and Oil-based Preparations

Possible pharmacokinetic interaction (increased percutaneous absorption of lindane).^{117 118} Avoid use of oil treatments or oil-based hair preparations immediately before or after applying lindane shampoo;^{117 119} lindane lotion should not be applied simultaneously with any other cream (e.g., conditioner), ointment, or oil.^{117 118 120}

Specific Drugs

Drug	Interaction	Comments
Antidepressants	Possible increased risk of seizures117 118	Use concomitantly with caution117 118
Antipsychotics	Possible increased risk of seizures117 118	Use concomitantly with caution117 118
Anticholinesterase agents, centrally active	Possible increased risk of seizures117 118	Use concomitantly with caution117 118
Chloroquine sulfate117 118	Possible increased risk of seizures117 118	Use concomitantly with caution117 118
Cyclosporine	Possible increased risk of seizures117 118	Use concomitantly with caution117 118
Imipenem	Possible increased risk of seizures117 118	Use concomitantly with caution117 118
Isoniazid	Possible increased risk of seizures117 118	Use concomitantly with caution117 118
Meperidine	Possible increased risk of seizures117 118	Use concomitantly with caution117 118
Methocarbamol	Possible increased risk of seizures117 118	Use concomitantly with caution117 118
Mycophenolate mofetil	Possible increased risk of seizures117 118	Use concomitantly with caution117 118
Penicillins	Possible increased risk of seizures117 118	Use concomitantly with caution117 118
Pyrimethamine	Possible increased risk of seizures117 118	Use concomitantly with caution117 118
Quinolones	Possible increased risk of seizures117 118	Use concomitantly with caution117 118
Radiographic contrast agents	Possible increased risk of seizures117 118	Use concomitantly with caution117 118
Tacrolimus	Possible increased risk of seizures117 118	Use concomitantly with caution117 118
Theophylline	Possible increased risk of seizures117 118	Use concomitantly with caution117 118

Lindane Pharmacokinetics

Absorption

Bioavailability

Slowly and incompletely absorbed through intact skin when applied topically, from the GI tract when ingested, and through the mucous membranes when inhaled.¹²²

Following topical application, 5.6–13% (mean 9.3%) of the dose was absorbed systemically.¹²² Percutaneous absorption usually is greater when the drug is applied to the face, scalp, axillae, neck, scrotum, or damaged or occluded skin.¹²²

Total body application of lindane lotion in infants and children with scabies resulted in mean peak blood concentrations of 28 ng/mL 6 hours after application.¹¹⁷

Special Populations

Increased systemic absorption in patients with Norwegian scabies (crusted scabies); in those with other skin disorders (e.g., atopic dermatitis, psoriasis); and in pediatric patients, especially premature infants.^{117 118}

Distribution

Data suggest a rapid distribution phase followed by a longer elimination phase.^{117 118}

Extent

Stored in body fat.^{117 118} Lindane is lipophilic and may accumulate in the placenta.^{117 118}

Elimination

Metabolism

Metabolized by the liver.^{117 118}

Elimination Route

Excreted in urine and feces.^{117 118}

Half-life

Approximately 18 hours.^{117 118}

Stability

Storage

Topical

Shampoo and Lotion

15–30°C.^{117 118}

Actions and SpectrumActions

• 
  

  Toxic to the parasitic arthropod Sarcoptes scabiei (the causative organism of scabies) and their eggs; also toxic to Pediculus humanus var capitis (head louse), Pediculus humanus var corporis (body louse), and Phthirus pubis (pubic or crab louse), and possibly their nits.¹²²

  
  


• 
  

  Resistance to lindane may develop in strains of Pediculus humanus var capitis. Although resistance of Sarcoptes scabiei to the drug has been reported, it has not been conclusively demonstrated.¹²²

  
  


• 
  

  A CNS stimulant when absorbed systemically.¹²²

  
  


• 
  

  Following absorption through the chitinous exoskeleton of arthropods, presumably stimulates the nervous system, resulting in seizures and death.¹²²

  
  

Advice to Patients

• 
  

  Importance of using only as directed.^{117 118}

  
  


• 
  

  Importance of giving a medication guide for lindane lotion or shampoo to the patient each time the product is dispensed as required by law. The medication guides are important parts of the risk management program for the patient.^{117 118}

  
  


• 
  

  Importance of instructing patients or their caregivers on the proper use of lindane shampoo or lotion, including the amount to apply, how soon to wash the drug off, and the importance of avoiding repeated application of lindane.^{117 118}

  
  


• 
  

  Importance of advising patients that pruritus may persist after successful treatment of pediculosis or scabies and is not an indication for further treatment.^{117 118}

  
  


• 
  

  Risk of potentially fatal seizures.¹²² Importance of following recommended application procedures and not exceeding recommended dosages.¹²²

  
  


• 
  

  Importance of informing patients that seizures have been reported in patients receiving lindane following a bath; therefore, patients should wait at least 1 hour after bathing or showering before applying lindane lotion.^{118 120} Patients should wait at least 1 hour after washing their hair before applying lindane shampoo.^{117 119}

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.¹²²

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed;¹²² necessity of advising women who are breast-feeding of the potential risks and advising them that they should interrupt breast-feeding and express and discard breast milk for at least 24 hours following application of lindane and avoid large areas of skin-to-skin contact with the infant while lindane is applied.¹¹⁸

  
  


• 
  

  Importance of informing patients of other important precautionary information. (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

Lindane

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Topical	Lotion	1%*	Lindane Lotion	Alliant
	Shampoo	1%*	Lindane Shampoo	Alliant

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.

Lindane 1% Lotion (MORTON GROVE PHARMACEUTICALS): 60/$129.99 or 180/$369.97

Lindane 1% Shampoo (MORTON GROVE PHARMACEUTICALS): 60/$125.99 or 180/$359.96

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 September 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

101. Brown S, Becher J, Brady W. Treatment of ectoparasitic infections: review of the English-language literature, 1982-1992. Clin Infect Dis. 1995; 20:S104-9. [IDIS 345865] [PubMed 7540875]

102. Mathieu ME, Wilson BB. Lice (pediculosis). In: Mandell GL, Bennett JE, Dolin R, eds. Mandell, Douglas, and Bennett’s principles and practices of infectious diseases. 5th ed. New York: Churchill Livingstone; 2000:2972-3.

103. Committee on Infectious Diseases, American Academy of Pediatrics. 2000 Red book: report of the Committee on Infectious Diseases. 25th ed. Elk Grove Village, IL: American Academy of Pediatrics; 2000:427-31,506-8.

104. Centers for Disease Control and Prevention. Sexually transmitted diseases treatment guidelines 2002. MMWR Morb Mortal Wkly Rep. 2002; 51(No. RR-6):1-78.

105. Anon. Permethrin for scabies. Med Lett Drugs Ther. 1990; 32:21-2. [PubMed 2179695]

106. Wendel K, Rompalo A. Scabies and pediculosis pubis: an update of treatment regimens and general review. Clin Infect Dis. 2002; 35(Suppl 2):S146-51.

107. Anon. Drugs for parasitic infections. Med Lett Drugs Ther. Apr 2002. From the Medical Letter website ( ).

108. Rico MJ, Myers SA, Sanchez MR et al. Guidelines of care for dermatologic conditions in patients infected with HIV. J Am Acad Dermatol. 1997; 37:450-72. [IDIS 392270] [PubMed 9308562]

109. Peterson CM, Eichenfield LF. Scabies. Ped Annals. 1996; 25:97-100.

110. Kerl H, Ackerman AB. Inflammatory diseases that simulate lymphomas: cutaneous pseudolymphomas. In: Fitzpatrick TB, Eisen AZ, Wolff K et al, eds. Dermatology in general medicine. 4th ed. New York: McGraw Hill Inc. 1993:1315-27.

111. Wilson DC, Leyva WH, King LE. Arthropod bites and stings. In: Fitzpatrick TB, Eisen AZ, Wolff K et al, eds. Dermatology in general medicine. 4th ed. New York: McGraw Hill Inc. 1993:2810-26.

112. Anon. Drugs for head lice. Med Lett Drugs Ther. 1997; 39:6-7. [PubMed 9008683]

113. Kolar KA, Rapini RP. Crusted (Norwegian) scabies. Am Fam Physician. 1991; 44:1317-21. [PubMed 1718155]

114. Degelau J. Scabies in long-term care facilities. Infect Control Hosp Epidemiol. 1992; 13:421-5. [PubMed 1640101]

115. Estes SA, Estes J. Therapy of scabies: nursing homes, hospitals, and the homeless. Semin Dermatol. 1993; 12:26-33. [PubMed 7682834]

116. Reviewers’ comments (personal observations) on permethrin 84:04.12.

117. Lindane Shampoo USP, 1% prescribing information. From the FDA web site ( ). Accessed 2003 Apr 4.

118. Lindane Lotion USP, 1% prescribing information. From the FDA web site ( ). Accessed 2003 Apr 4.

119. Medication guide: Lindane shampoo USP, 1%. From the FDA Web site ( ). Accessed 2003 Apr 4.

120. Medication guide: Lindane lotion USP, 1%. From the FDA web site ( ). Accessed 2003 Apr 4.

121. Mathieu ME, Wilson BB. Scabies. In: Mandell GL, Bennett JE, Dolin R, eds. Mandell, Douglas, and Bennett’s principles and practices of infectious diseases. 5th ed. New York: Churchill Livingstone; 2000:2974-6.

122. AHFS Drug Information 2005. McEvoy, GK, ed. Lindane. Bethesda, MD: American Society of Health-System Pharmacists; 2005: 3400-3.

More Lindane resources

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

• lindane topical Concise Consumer Information (Cerner Multum)

Compare Lindane with other medications

• Head Lice
• Lice
• Scabies

Levsinex SR

Generic Name: hyoscyamine (hye oh SYE a meen)

Brand Names: Anaspaz, Cystospaz, Ed Spaz, HyoMax, HyoMax DT, HyoMax FT, HyoMax SL, HyoMax SR, Hyospaz, Hyosyne, IB-Stat, Levbid, Levsin, Levsin SL, Levsinex SR, NuLev, Nulev, Symax Duotab, Symax FasTab, Symax SL, Symax SR

What is Levsinex SR (hyoscyamine)?

Hyoscyamine produces many effects in the body, including relief from muscle spasms.

Hyoscyamine also reduces the fluid secretions of many organs and glands in the body, such as the stomach, pancreas, lungs, saliva glands, sweat glands, and nasal passages.

Hyoscyamine is used to treat many different stomach and intestinal disorders, including peptic ulcer and irritable bowel syndrome. It is also used to control muscle spasms in the bladder, kidneys, or digestive tract, and to reduce stomach acid. Hyoscyamine is sometimes used to reduce tremors and rigid muscles in people with symptoms of Parkinson's disease.

Hyoscyamine is also used as a drying agent to control excessive salivation, runny nose, or excessive sweating.

Hyoscyamine may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Levsinex SR (hyoscyamine)?

Do not take hyoscyamine if you are allergic to it, or if you have kidney disease, a bladder or intestinal obstruction, severe ulcerative colitis, toxic megacolon, glaucoma, or myasthenia gravis.

Before taking hyoscyamine, tell your doctor if you have heart disease, congestive heart failure, a heart rhythm disorder, high blood pressure, overactive thyroid, or hiatal hernia with gastroesophageal reflux disease.

Avoid taking antacids at the same time you take hyoscyamine. Antacids can make it harder for your body to absorb hyoscyamine. If you use an antacid, take it after you have taken hyoscyamine and eaten a meal.

Hyoscyamine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Drinking alcohol can increase drowsiness and dizziness while you are taking hyoscyamine.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Hyoscyamine can decrease sweating and you may be more prone to heat stroke.

What should I discuss with my healthcare provider before taking Levsinex SR (hyoscyamine)?

Do not take hyoscyamine if you are allergic to it, or if you have:

• kidney disease;


• 
  

  an enlarged prostate or problems with urination;

  
  


• 
  

  intestinal blockage;

  
  


• 
  

  severe ulcerative colitis, or toxic megacolon;

  
  


• 
  

  glaucoma; or

  
  


• 
  

  myasthenia gravis.

  
  

To make sure you can safely take hyoscyamine, tell your doctor if you have any of these other conditions:

• 
  

  heart disease, congestive heart failure;

  
  


• 
  

  a heart rhythm disorder;

  
  


• 
  

  high blood pressure;

  
  


• 
  

  overactive thyroid; or

  
  


• 
  

  hiatal hernia with GERD (gastroesophageal reflux disease).

  
  

FDA pregnancy category C. It is not known whether hyoscyamine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Hyoscyamine can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take Levsinex SR (hyoscyamine)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Your medication may come with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Hyoscyamine is usually taken before a meal. Follow your doctor's instructions.

Do not crush, chew, or open an extended-release tablet or capsule. It is specially made to release medicine slowly in the body. Breaking or crushing the pill would cause too much of the drug to be released at one time. Your doctor may want you to break an extended-release tablet and take only half of it. Follow your doctor's instructions.

Measure the oral liquid form of hyoscyamine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

The sublingual tablet form of this medication must be placed under the tongue, where it will dissolve. Do not swallow the sublingual tablet whole or wash it down with water. You may drink water after the pill has completely dissolved in your mouth.

Before using hyoscyamine oral spray for the first time, you must prime the spray pump. To do this, spray 3 test sprays into the air and away from your face. Prime the spray pump at least 1 test spray any time you have not used the oral spray for longer than 2 days. Spray until a fine mist appears.

After using the oral spray, try not to swallow right away. Do not rinse your mouth or spit for 5 to 10 minutes after using the oral spray.

Store this medication at room temperature away from moisture and heat.

Do not use hyoscyamine oral spray for more than 30 sprays, even if there is medicine still left in the bottle.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include headache, dizziness, dry mouth, trouble swallowing, nausea, vomiting, blurred vision, hot dry skin, and feeling restless or nervous.

What should I avoid while taking Levsinex SR (hyoscyamine)?

Avoid taking antacids at the same time you take hyoscyamine. Antacids can make it harder for your body to absorb hyoscyamine. If you use an antacid, take it after you have taken hyoscyamine and eaten a meal.

Hyoscyamine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Drinking alcohol can increase drowsiness and dizziness while you are taking hyoscyamine.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Hyoscyamine can decrease sweating and you may be more prone to heat stroke.

Levsinex SR (hyoscyamine) 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 hyoscyamine and call your doctor at once if you have any of these serious side effects:

• 
  

  diarrhea;

  
  


• 
  

  confusion, hallucinations;

  
  


• 
  

  unusual thoughts or behavior;

  
  


• 
  

  fast, pounding, or uneven heart rate;

  
  


• 
  

  rash or flushing (warmth, redness, or tingly feeling); or

  
  


• 
  

  eye pain.

  
  

Less serious side effects may include:

• 
  

  dizziness, drowsiness, feeling nervous;

  
  


• 
  

  blurred vision, headache;

  
  


• 
  

  sleep problems (insomnia);

  
  


• 
  

  nausea, vomiting, bloating, heartburn, or constipation;

  
  


• 
  

  changes in taste;

  
  


• 
  

  problems with urination;

  
  


• 
  

  decreased sweating;

  
  


• 
  

  dry mouth; or

  
  


• 
  

  impotence, loss of interest in sex, or trouble having an orgasm.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Levsinex SR (hyoscyamine)?

Tell your doctor about all other medicines you use, especially:

• 
  

  amantadine (Symmetrel);

  
  


• 
  

  haloperidol (Haldol);

  
  


• 
  

  an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate);

  
  


• 
  

  phenothiazines such as chlorpromazine (Thorazine), fluphenazine (Permitil, Prolixin), perphenazine (Trilafon), prochlorperazine (Compazine, Compro), promethazine (Pentazine, Phenergan, Anergan, Antinaus), thioridazine (Mellaril), or trifluoperazine (Stelazine); or

  
  


• 
  

  an antidepressant such as amitriptyline (Elavil, Vanatrip), doxepin (Sinequan), desipramine (Norpramin), imipramine (Janimine, Tofranil), nortriptyline (Pamelor), and others.

  
  

This list is not complete and other drugs may interact with hyoscyamine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Levsinex SR resources

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

• Hyoscyamine Monograph (AHFS DI)


• Hyoscyamine MedFacts Consumer Leaflet (Wolters Kluwer)


• Anaspaz MedFacts Consumer Leaflet (Wolters Kluwer)


• HyoMax Prescribing Information (FDA)


• Hyosyne Drops MedFacts Consumer Leaflet (Wolters Kluwer)


• Hyosyne Prescribing Information (FDA)


• IB-Stat Spray MedFacts Consumer Leaflet (Wolters Kluwer)


• Levbid Extended-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Levsin Prescribing Information (FDA)


• NuLev Orally Disintegrating Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Symax Duotab Controlled-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Levsinex SR with other medications

• Anesthesia
• Crohn's Disease
• Endoscopy or Radiology Premedication
• Irritable Bowel Syndrome
• Urinary Incontinence

Where can I get more information?

• Your pharmacist can provide more information about hyoscyamine.

See also: Levsinex SR side effects (in more detail)

Lexiscan

Generic Name: regadenoson (re ga DEN oh son)

Brand Names: Lexiscan

What is regadenoson?

Regadenoson is a stress agent that works by increasing blood flow in the arteries of the heart.

Regadenoson is given in preparation for a radiologic (x-ray) examination of blood flow through the heart to test for coronary artery disease.

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

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

You should not use this medication if you are allergic to regadenoson, or if you have a serious heart condition such as AV block or "sick sinus syndrome" (unless you have a pacemaker).

Before you receive regadenoson, tell your doctor if you have asthma or COPD, a history of heart disease or high blood pressure, or if you have had an illness causing vomiting or diarrhea.

Avoid drinking coffee or other beverages with caffeine for at least 12 hours before your stress test. Tell your caregivers if you have a serious side effect such as chest pain or heavy feeling, pain spreading to the arm or shoulder, sweating, general ill feeling, wheezing or trouble breathing, slow heart rate, severe headache, seizure (convulsions), weak pulse, slow breathing, or fainting.

What should I discuss with my health care provider before receiving regadenoson?

You should not use this medication if you are allergic to regadenoson, or if you have a serious heart condition such as AV block or "sick sinus syndrome" (unless you have a pacemaker).

If you have any of these other conditions, you may need a dose adjustment or special tests:

• 
  

  asthma or COPD (chronic obstructive pulmonary disease);

  
  


• 
  

  a history of heart disease or high blood pressure; or

  
  


• 
  

  if you have had a prolonged illness that caused vomiting or diarrhea.

  
  

FDA pregnancy category C. It is not known whether regadenoson is harmful to an unborn baby. Before you receive this medication, tell your doctor if you are pregnant. It is not known whether regadenoson 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.

How is regadenoson given?

Regadenoson is injected into a vein through an IV. You will receive this injection in a clinic or hospital setting.

After regadenoson is injected, you will be given other intravenous (IV) medications that allow blood vessels to be seen more clearly on the radiologic examination.

Your breathing, blood pressure, oxygen levels, and other vital signs will be watched closely during your stress test.

What happens if I miss a dose?

Since regadenoson is given by a healthcare professional in preparation for medical testing, you are not likely to be on a dosing schedule.

What happens if I overdose?

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

Overdose symptoms may include severe dizziness, increased heart rate, and warmth or tingly feeling.

What should I avoid while receiving regadenoson?

Avoid drinking coffee or other beverages with caffeine for at least 12 hours before your stress test.

Regadenoson 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. Tell your caregivers at once if you have a serious side effect such as:

• 
  

  chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;

  
  


• 
  

  slow heart rate, weak pulse, fainting, slow breathing (breathing may stop);

  
  


• 
  

  dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, shortness of breath, uneven heart rate);

  
  


• 
  

  seizure (convulsions);

  
  


• 
  

  wheezing, trouble breathing; or

  
  


• 
  

  feeling like you might pass out.

  
  

Less serious side effects may include:

• 
  

  headache;

  
  


• 
  

  dizziness;

  
  


• 
  

  nausea, stomach discomfort, decreased sense of taste;

  
  


• 
  

  mild chest discomfort; or

  
  


• 
  

  warmth, redness, or tingly feeling under your skin.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1 800 FDA 1088.

What other drugs will affect regadenoson?

Tell your doctor about all other medications you use, especially:

• 
  

  dipyridamole (Persantine); or

  
  


• 
  

  theophylline (Elixophyllin, Theo-24, Uniphyl).

  
  

This list is not complete and other drugs may interact with regadenoson. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Lexiscan resources

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

• Lexiscan Prescribing Information (FDA)


• Lexiscan Advanced Consumer (Micromedex) - Includes Dosage Information


• Lexiscan Consumer Overview


• Regadenoson Professional Patient Advice (Wolters Kluwer)

Compare Lexiscan with other medications

• Diagnosis and Investigation
• Radionuclide Myocardial Perfusion Study

Where can I get more information?

• Your doctor or pharmacist can provide more information about regadenoson.

See also: Lexiscan side effects (in more detail)

Levitra

Generic Name: Vardenafil Hydrochloride
Class: Phosphodiesterase Inhibitors
VA Class: GU900
Chemical Name: 1 - [[3 - (3,4 - Dihydro - 5 - methyl - 4 - oxo - 7 - propylimidazo[5,1 - f] - as - triazin - 2 - yl) - 4 - ethoxyphenyl]sulfonyl] - 4 - ethylpiperazine
Molecular Formula: C₂₃H₃₂N₆O₄S
CAS Number: 224785-90-4

Special Alerts:

[Posted 10/18/2007] FDA informed healthcare professionals of reports of sudden decreases or loss of hearing following the use of PDE5 inhibitors sildenafil (Viagra), tadalafil (Levitra), vardenafil (Cialis) for the treatment of erectile dysfunction, and sildenafil (Revatio) for the treatment of pulmonary arterial hypertension. In some cases, the sudden hearing loss was accompanied by tinnitus and dizziness. Medical follow-up on these reports was often limited which makes it difficult to determine if the loss of hearing was related to the use of one of the drugs, an underlying medical condition or other risk factors for hearing loss, a combination of these factors or other factors. The PRECAUTIONS and ADVERSE REACTIONS sections of the approved product labeling for sildenafil (Viagra), tadalafil, and vardenafil were revised. FDA is working with the manufacturer to revise the labeling for sildenafil (Revatio). For more information visit the FDA website at: , and .

Introduction

Vasodilating agent; a selective phosphodiesterase (PDE) inhibitor.¹

Uses for Levitra

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Erectile Dysfunction

To facilitate attainment of a sexually functional erection in males with erectile dysfunction (ED, impotence).¹

Levitra Dosage and Administration

General

• 
  

  Dosage must be individualized carefully according to the patient’s tolerance and erectile response.¹

  
  


• 
  

  Sexual stimulation is required for response to therapy.¹

  
  

Administration

Oral Administration

Administer orally, no more than once daily, without regard to meals.^{1 3}

Administer approximately 1 hour before anticipated sexual activity.¹

Dosage

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Available as vardenafil hydrochloride; dosage expressed in terms of vardenafil.¹

Adults

Erectile Dysfunction

Oral

Initially, 10 mg.¹ Depending on effectiveness and tolerance, increase dosage to a maximum of 20 mg or decrease to 5 mg. Administer no more frequently than once daily.¹

Prescribing Limits

Adults

Erectile Dysfunction

Oral

Maximum 20 mg daily.¹

Special Populations

Hepatic Impairment

In patients with moderate hepatic impairment (Child-Pugh class B), decrease initial dosage to 5 mg; maximum dosage is 10 mg once daily.¹ Not studied in patients with severe hepatic impairment (Child-Pugh class C).¹

Renal Impairment

Dosage adjustments not required in patients with patients with mild (Cl_cr of 50–80 mL/minute) to severe (Cl_cr <30 mL/minute) renal impairment.¹ Not studied in patients requiring renal dialysis.¹

Geriatric Patients

Reduce initial dose to 5 mg given no more frequently than once daily in men ≥65 years of age.^{1 26}

Cautions for Levitra

Contraindications

• 
  

  Known hypersensitivity to vardenafil or any ingredient in the formulation.¹

  
  


• 
  

  Concomitant use of nitrates, nitrites, or nitric oxide donors, either regularly or intermittently, or α-adrenergic blocking agents.^{1 28}

  
  


• 
  

  Should not be used in men for whom sexual activity is inadvisable because of their underlying cardiovascular status.^{1 5}

  
  

Warnings/Precautions

Warnings

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Cardiovascular Effects

Serious, potentially fatal cardiovascular events reported rarely.^{1 5 6}

Use not recommended in patients with a recent (within 6 months) MI, stroke, or life-threatening arrhythmia; resting hypotension (<90 mm Hg resting SBP) or hypertension (170/110 mm Hg SBP/DBP); or severe heart failure or unstable angina.^{1 4 7 8 26}

Possible hypotension; consider whether patients with underlying cardiovascular disease could be affected adversely by vardenafil’s vasodilatory activity.¹ Risk of an undesired hypotensive or vasodilatory response is of particular concern in patients with left-ventricular outflow obstruction (e.g., aortic stenosis, idiopathic hypertrophic subaortic stenosis).^{1 6}

Potentiation of hypotensive effect with organic nitrates may result in life-threatening hypotension and/or hemodynamic compromise.¹ Possible significant hypotension when given concurrently with α-adrenergic blocking agents.¹ Manufacturers state that concomitant use of nitrates or α-adrenergic blocking agents with vardenafil is contraindicated.¹ (See Specific Drugs under Interactions.)

Possible prolonged QT interval.¹ Use not recommended in patients with known prolongation of the QT interval and those receiving class IA (e.g., quinidine, procainamide) or class III (e.g., amiodarone, sotalol) antiarrhythmic agents.¹

Concomitant Use with Potent CYP3A4 Inhibitors

Safety not established with long-term use of vardenafil concomitantly with potent CYP3A4 inhibitors (e.g., ritonavir, indinavir, ketoconazole, itraconazole).¹ Increased plasma vardenafil concentrations with concomitant use; dosage reduction of vardenafil recommended.¹ (See Specific Drugs under Interactions.)

Priapism

Possible prolonged erections (>4 hours in duration) and priapism (painful erection >6 hours).¹

May result in penile tissue damage and permanent loss of potency if priapism is not treated immediately.¹ Use with caution in patients with conditions that may predispose them to priapism (e.g., sickle cell anemia, multiple myeloma, leukemia).¹

Ocular Effects

Possible visual disturbances (e.g., abnormal, dim, or blurred vision; changes in color vision [e.g., chromatopsia]).^{1 4}

Not studied in patients with hereditary degenerative retinal disorders, including those with retinitis pigmentosa.¹ Use not recommended until further information is available.¹

Sensitivity Reactions

Anaphylactic reaction, including laryngeal edema, reported.¹

General Precautions

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Patient Assessment

Thorough medical history and physical examination recommended to diagnose erectile dysfunction, determine potential underlying causes, and identify appropriate treatment.^{1 5}

Review of the patient’s current drug regimens recommended to detect possible drug-induced erectile dysfunction.⁵

Hematologic Effects

No prolongation of bleeding time with vardenafil dosages ≤20 mg.¹

However, not studied in patients with bleeding disorders or active peptic ulcers;^{1 4 8} therefore, careful risk/benefit assessment is necessary before use in such patients.^{1 4 8}

GU Effects

Use with caution in patients with anatomical deformation of the penis (e.g., angulation, cavernosal fibrosis, Peyronie’s disease).¹

Specific Populations

Pregnancy

Category B.¹ Not indicated for use in women.¹

Lactation

Not indicated for use in women.¹

Pediatric Use

Not indicated for use in neonates or children.¹

Geriatric Use

Safety and efficacy in males ≥65 years of age similar to that in younger males.¹ Increased plasma vardenafil concentrations in men ≥65 years of age compared to that in younger males; therefore consider lower initial dosage.¹ (See Geriatric Patients under Dosage and Administration.)

Hepatic Impairment

Decreased clearance in patients with mild (Child-Pugh class A) or moderate (Child-Pugh class B) hepatic impairment.¹ (See Hepatic Impairment under Dosage and Administration.) Not studied in patients with severe hepatic impairment (Child-Pugh class C), and use of the drug in such patients is not recommended.^{1 26}

Renal Impairment

Clearance decreased in patients with moderate (Cl_cr 30–50 mL/minute) to severe (Cl_cr <30 mL/minute) renal impairment.¹ (See Renal Impairment under Dosage and Administration.) Not studied in patients with end-stage renal disease requiring dialysis.¹

Common Adverse Effects

Headache,^{1 2 7 8} flushing, ^{1 2 7 8} rhinitis,^{1 2 8} dyspepsia.^{1 2 7}

Interactions for Levitra

Metabolized principally by CYP3A4; CYP2C and CYP3A5 appear to play a minor role.¹

Drugs Affecting Hepatic Microsomal Enzymes

Inhibitors of CYP3A4: Potential pharmacokinetic interaction (increased plasma vardenafil concentrations).¹

Specific Drugs

Drug	Interaction	Comments
α-Adrenergic blocking agents	Possible symptomatic hypotension 1	Concurrent use is contraindicated1
Alcohol	No potentiation of hypotensive effect reported1
Antacids (aluminum hydroxide and magnesium hydroxide)	Pharmacokinetic interaction unlikely1
Antiarrhythmic agents (amiodarone, procainamide, quinidine, sotalol)	Possible prolongation of the QTc interval1	Avoid concomitant use1
Antihypertensive agents	Possible additive hypotensive effects
Antiretroviral agents, HIV protease inhibitors	Possible increased vardenafil concentrations and increased risk of vardenafil-associated adverse effects (e.g., hypotension, visual changes, prolonged erection)1 29 31 33 Decreased indinavir and ritonavir concentrations1 29 31 33	Ritonavir or lopinavir: Do not exceed a single vardenafil dose of 2.5 mg in 72 hours;1 29 no change in ritonavir dosage needed29 Ritonavir in combination with indinavir, atazanavir, saquinavir, fosamprenavir, or nelfinavir: Do not exceed a vardenafil dosage of 2.5 mg in 72 hours29 33 Nelfinavir, indinavir, amprenavir, saquinavir, fosamprenavir, or atazanavir: Use initial vardenafil dosage of 2.5 mg and do not exceed a single dose of 2.5 mg in 24 hours1 29 30 31 33 Monitor closely 29 31 32 33 34
Antiretroviral agents, nonnucleoside reverse transcriptase inhibitors	Possible increased vardenafil concentrations and increased risk of vardenafil-associated adverse effects (e.g., hypotension, visual changes, prolonged erection)29	Delavirdine: Use initial vardenafil dosage of 2.5 mg; do not exceed 2.5 mg once in 24 hours29
Aspirin	No increase in bleeding time reported1
Cimetidine	Pharmacokinetic interaction unlikely1
Digoxin	Pharmacokinetic interaction unlikely1
Erythromycin	Increased AUC and peak plasma concentrations of vardenafil1	Reduce initial vardenafil dosage to 5 mg in patients receiving erythromycin1
Glyburide	Pharmacokinetic interaction unlikely1
Inhaled nitrites (e.g., amyl or butyl nitrite)	Potentiation of hypotensive effect28	Concomitant use is contraindicated28 (see Cautions)
Itraconazole	Possible increased vardenafil concentrations1	Reduce initial vardenafil dosage to 2.5 mg in patients receiving itraconazole 400 mg daily1 Reduce initial vardenafil dosage to 5 mg in patients receiving itraconazole 200 mg daily1
Ketoconazole	Increased vardenafil concentrations 1	Reduce initial vardenafil dosage to 2.5 mg in patients in patients receiving ketoconazole 400 mg daily1 Reduce initial vardenafil dosage to 5 mg in patients receiving ketoconazole 200 mg daily1
Nifedipine	Possible additive hypotensive effect1
Nitrates and nitric acid donors	Potentiation of vasodilatory effects; potentially life-threatening hypotension and/or hemodynamic compromise can result1	Concomitant use is contraindicated1 28
Ranitidine	Pharmacokinetic interaction unlikely
Warfarin	Pharmacokinetic and pharmacodynamic interaction unlikely1

Levitra Pharmacokinetics

Absorption

Bioavailability

Rapidly absorbed following oral administration; peak concentrations usually attained within 0.5–2 hours.¹

Absolute bioavailability is approximately 15%.¹

Food

Administration with a high-fat meal reduces the peak plasma concentrations by 18–50%.^{1 3}

Distribution

Extent

Extensively distributed into tissues.¹

Plasma Protein Binding

Approximately 95% for the drug and major metabolite.¹

Elimination

Metabolism

Metabolized in the liver to active metabolite(s) principally via CYP3A4, with minor contributions from CYP3A5 and CYP2C.¹

Elimination Route

Excreted as metabolites principally in the feces (91–95%) and to a lesser extent in urine (2–6%).¹

Half-life

Terminal half-life 4–5 hours for drug and major metabolite.¹

Special Populations

Clearance reduced in men ≥65 years of age, resulting in an increase in AUC and peak plasma concentrations compared with younger males.¹

Clearance reduced in patients with moderate (Cl_cr of 30–50 mL/minute) or severe (Cl_cr <30 ml/minute) renal impairment, resulting in an increase in AUC compared with patients with normal renal function.¹

Clearance reduced in patients with mild (Child-Pugh class A) or moderate (Child-Pugh class B) hepatic impairment, resulting in an increase in AUC and peak plasma concentrations compared with healthy adults.¹

Stability

Storage

Oral

Tablets

25°C (may be exposed to 15–30°C).¹

ActionsActions

• 
  

  Selective inhibitor of phosphodiesterases (PDEs) with the greatest selectivity for PDE type 5, the principal isoenzyme involved in the metabolism of cGMP to GMP in the corpora cavernosa of the penis.¹

  
  


• 
  

  Enhances the effect of nitric oxide by inhibiting PDE type 5-mediated hydrolysis of cGMP.^{1 2}

  
  


• 
  

  Potentiates accumulation of cGMP only when cGMP production in the penis is increased by sexual arousal.¹ No effect on erectile function in the absence of sexual stimulation.¹

  
  


• 
  

  Modest peripheral vasodilation accompanied by a small increase in heart rate at usual dosages.^{1 6 27}

  
  


• 
  

  Although less affinity than sildenafil for PDE type 6 receptor in the retina, some transient visual abnormalities observed.^{1 27}

  
  

Advice to Patients

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

• 
  

  Importance of informing clinician of risk factors for cardiovascular disease prior to initiating any treatment for erectile dysfunction.^{1 5}

  
  


• 
  

  Importance of informing clinician of stroke history.¹

  
  


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  Importance of informing clinician of low or high BP.¹

  
  


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  Importance of informing clinician of the presence of retinitis pigmentosa.²

  
  


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  Importance of informing patients of the potential for life-threatening hypotension and/or hemodynamic compromise with concurrent use of organic nitrates and nitrites (e.g., nitroglycerin, isosorbide dinitrate) or nitric oxide donors (e.g., sodium nitroprusside) in any form, including the recreational use of inhaled nitrites (“poppers”), because of the potential for hypotension and associated dizziness, syncope, or even MI or stroke.^{1 26}

  
  


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  Importance of avoiding concurrent use of α-adrenergic blocking agents because of the potential for hypotension, dizziness, or fainting.¹

  
  


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  Importance of seeking immediate medical attention if an erection persists >4 hours or is painful.¹

  
  


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  Importance of advising patient that vardenafil does not protect against sexually transmitted diseases (e.g., HIV) and about measures to protect against such transmission.¹

  
  


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  Importance of contacting a clinician for assessment of therapeutic benefit, the need for possible dosage adjustment, and potential adverse effects.¹

  
  


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  Importance of informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.¹

  
  


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  Importance of informing patients of other important precautionary information.¹ (See Cautions.)

  
  

Preparations

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

Vardenafil Hydrochloride

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Tablets, film-coated	2.5 mg (of vardenafil)	Levitra	Schering-Plough
		5 mg (of vardenafil)	Levitra	Schering-Plough
		10 mg (of vardenafil)	Levitra	Schering-Plough
		20 mg (of vardenafil)	Levitra	Schering-Plough

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.

Levitra 10MG Tablets (SCHERING): 10/$163.99 or 30/$469.97

Levitra 20MG Tablets (SCHERING): 10/$163.99 or 30/$469.97

Levitra 5MG Tablets (SCHERING): 10/$163.99 or 30/$469.97

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 November 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

1. Schering-Plough. Levitra (vardenafil hydrochloride) tablets prescribing information. West Haven, CT; 2004 Oct.

2. Coleman CI, Carabino JM, Vergara CM. Vardenafil: an oral selective phosphodiesterase 5 inhibitor for the treatment of erectile dysfunction. Formulary. 2003; 38:131-148.

3. Rajagopalan P, Mazzu A, Xia C et al. Effect of high-fat breakfast and moderate-fat evening meal on the pharmacokinetics of vardenafil, an oral phosphodiesterase-5 inhibitor for the treatment of erectile dysfunction. J Clin Pharmacol. 2003; 43(3):260-7. [IDIS 495567] [PubMed 12638394]

4. Brock G, Nehra A, Lipshultz LI et al. Safety and efficacy of vardenafil for the treatment of men with erectile dysfunction after radical retropubic prostatectomy. J Urol. 2003; 170(4 Pt 1):1278-83. [IDIS 504241] [PubMed 14501741]

5. Jackson G, Betteridge J, Dean J et al. A systematic approach to erectile dysfunction in the cardiovascular patient: a Consensus Statement--update 2002. Int J Clin Pract. 2002; 56(9):663-71. [IDIS 491098] [PubMed 12469980]

6. Cheitkin MD, Hutter AM, Brindis RG for the American College or Cardiology and American Heart Association. Technology and Practice Executive Committee [duplicate publication of Cheitkin MD, Hutter AM, Brindis RG for the American College or Cardiology and American Heart Association. ACC/AHA expert consensus document: use of sildenafil (viagra) in patients with cardiovascular disease. American College of Cardiology/American Heart Association. J Am Coll Cardiol. 1999; 33:273-82. [IDIS 426556] [PubMed 9935041]

7. Hellstrom WJ, Gittelman M, Karlin G et al. Sustained efficacy and tolerability of vardenafil, a highly potent selective phosphodiesterase type 5 inhibitor, in men with erectile dysfunction: results of a randomized, double-blind, 26-week placebo-controlled pivotal trial. Urology. 2003; 61(4 Suppl 1):8-14. [PubMed 12657355]

8. Goldstein I, Young JM, Fischer J et al. Vardenafil, a new phosphodiesterase type 5 inhibitor, in the treatment of erectile dysfunction in men with diabetes: a multicenter double-blind placebo-controlled fixed-dose study. Diabetes Care. 2003; 26(3):777-83. [IDIS 517794] [PubMed 12610037]

9. National Institutes of Health Office of Medical Applications of Research. Consensus Conference: impotence. JAMA. 1993; 270:83-90. [IDIS 316686] [PubMed 8510302]

10. Pfizer Inc, New York, NY: Personal communication on sildenafil.

11. Reviewers’ comments on sildenafil (personal observations).

12. The Process of Care Consensus Panel. Position paper: the process of care model for evaluation and treatment of erectile dysfunction. Int J Impotence Res. 1999; 11:59-70.

13. Palmer BF. Sexual dysfunction in uremia. J Am Soc Nephrol. 1999; 10:1381-8. [PubMed 10361878]

14. Guay AT, Nankin AR et al. AACE clinical practice guidelines for the evaluation and treatment of male sexual dysfunction. From American Association of Clinical Endocrinologists web site. ()

15. Whitehead ED, Klyde BJ, Zussman S et al. Treatment alternatives for impotence. Postgrad Med. 1990; 88:139-52. [IDIS 269901] [PubMed 2199954]

16. Gerber GS, Levine LA. Pharmacological erection program using prostaglandin E1. J Urol. 1991; 146:786-9. [IDIS 287641] [PubMed 1875494]

17. Porst H. Editorial comments on the process of care model for evaluation and treatment of erectile dysfunction. Int J Impotence Res. 1999; 11: 72-3.

18. Sarramon JP. Editorial comments on the process of care model for evaluation and treatment of erectile dysfunction. Int J Impotence Res. 1999; 11:73.

19. Vermeuler A. Editorial comments on the process of care model for evaluation and treatment of erectile dysfunction. Int J Impotence Res. 1999; 11:74.

20. Sohn MHH. Editorial comments on the process of care model for evaluation and treatment of erectile dysfunction. Int J Impotence Res. 1999; 11:72.

21. Sefetl AD. Phosphodiesterase type 5 inhibitor differentiation based on selectivity, pharmacokinetic, and efficacy profiles. Clin Cardiol. 2004; 27(Suppl. 1):I-14-9.

22. Padma-Nathan H. A new era in the treatment of erectile dysfunction. Am J Cardiol. 1999; 84:18-23N. [PubMed 10404845]

23. Wespes E, Amar E, Hatzichtistou D et al. Guidelines on reactile dysfunction. Arnhem: European Association of Urology, 2004 Mar. Available at . Accessed 2004 Aug.

24. Pfizer Inc. Viagra (sildenafil citrate) prescribing information. New York, NY; 2002 Sep.

25. Lilly ICOS. Cialis (tadalafil) tablets prescribing information. Indianapolis, IN; 2003 Nov.

26. Schering-Plough, Kenilowrth, NJ. Personal communication.

27. Crowe SM, Streetman DS. Vardenafil treatment for erectile dysfunction. Ann Pharmacother. 2004; 38:77-85. [IDIS 514325] [PubMed 14742800]

28. Schering-Plough. Levitra (vardenafil hydrochloride) tablets patient information. From Levitra website: (). Accessed 2005 May16.

29. Panel on Clinical Practices for Treatment of HIV infection of the Department of Health and Human Services (DHHS). Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents (Apr 7, 2005). From the US Department of Health and Human Services HIV/AIDS Information Services (AIDSinfo) website ().

30. Merck & Company Inc. Crixivan (indinavir sulfate) capsules prescribing information. West Point, PA; 2004 May.

31. Bristol-Myers Squibb. Reyataz (atazanavir sulfate) prescribing information. Princeton, NJ; 2004 Jul.

32. Roche Pharmaceuticals. Fortovase (saquinavir) soft gelatin capsules prescribing information. Nutley, NJ; 2003 Dec.

33. GlaxoSmithKline. Lexiva (fosamprenavir calcium) tablets prescribing information. Research Triangle Park, NC; 2004 May.

34. Roche Laboratories. Invirase (saquinavir mesylate) capsules prescribing information. Nutley, NJ; 2004 Dec.

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