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Diazepam


Pronunciation

 (dye AZ e pam)


U.S. Brand Names

 Diastat®; Diazepam Intensol®; Valium®


Generic Available

 Yes: Injection, tablet, solution only


Canadian Brand Names

 Apo-Diazepam®; Diastat®; Diazemuls®; Valium®


Use

 Management of anxiety disorders, ethanol withdrawal symptoms; skeletal muscle relaxant; treatment of convulsive disorders

Orphan drug: Viscous solution for rectal administration: Management of selected, refractory epilepsy patients on stable regimens of antiepileptic drugs (AEDs) requiring intermittent use of diazepam to control episodes of increased seizure activity


Use - Dental

 Oral medication for preoperative dental anxiety; sedative component in I.V. conscious sedation in oral surgery patients; skeletal muscle relaxant


Use - Unlabeled/Investigational

 Panic disorders; preoperative sedation, light anesthesia, amnesia


Restrictions

 C-IV


Pregnancy Risk Factor

 D


Pregnancy Implications

 Crosses the placenta. Oral clefts reported, however, more recent data does not support an association between drug and oral clefts; inguinal hernia, cardiac defects, spina bifida, dysmorphic facial features, skeletal defects, multiple other malformations reported; hypotonia and withdrawal symptoms reported following use near time of delivery


Lactation

 Enters breast milk/contraindicated (AAP rates "of concern")


Contraindications

 Hypersensitivity to diazepam or any component of the formulation (cross-sensitivity with other benzodiazepines may exist); narrow-angle glaucoma; not for use in children <6 months of age (oral) or <30 days of age (parenteral); pregnancy


Warnings/Precautions

 Diazepam has been associated with increasing the frequency of grand mal seizures. Withdrawal has also been associated with an increase in the seizure frequency. Use with caution with drugs which may decrease diazepam metabolism. Use with caution in elderly or debilitated patients, patients with hepatic disease (including alcoholics), or renal impairment. Active metabolites with extended half-lives may lead to delayed accumulation and adverse effects. Use with caution in patients with respiratory disease or impaired gag reflex.

Acute hypotension, muscle weakness, apnea, and cardiac arrest have occurred with parenteral administration. Acute effects may be more prevalent in patients receiving concurrent barbiturates, narcotics, or ethanol. Appropriate resuscitative equipment and qualified personnel should be available during administration and monitoring. Avoid use of the injection in patients with shock, coma, or acute ethanol intoxication. Intra-arterial injection or extravasation of the parenteral formulation should be avoided. Parenteral formulation contains propylene glycol, which has been associated with toxicity when administered in high dosages.

Causes CNS depression (dose-related) resulting in sedation, dizziness, confusion, or ataxia which may impair physical and mental capabilities. Patients must be cautioned about performing tasks which require mental alertness (eg, operating machinery or driving). Use with caution in patients receiving other CNS depressants or psychoactive agents. Effects with other sedative drugs or ethanol may be potentiated. The dosage of narcotics should be reduced by approximately 1/3 when diazepam is added. Benzodiazepines have been associated with falls and traumatic injury and should be used with extreme caution in patients who are at risk of these events (especially the elderly).

Use caution in patients with depression, particularly if suicidal risk may be present. Use with caution in patients with a history of drug dependence. Benzodiazepines have been associated with dependence and acute withdrawal symptoms on discontinuation or reduction in dose. Acute withdrawal, including seizures, may be precipitated in patients after administration of flumazenil to patients receiving long-term benzodiazepine therapy.

Diazepam has been associated with anterograde amnesia. Paradoxical reactions, including hyperactive or aggressive behavior, have been reported with benzodiazepines, particularly in adolescent/pediatric or psychiatric patients. Does not have analgesic, antidepressant, or antipsychotic properties.


Adverse Reactions

 Frequency not defined.

Cardiovascular: Hypotension

Central nervous system: Drowsiness, ataxia, amnesia, slurred speech, paradoxical excitement or rage, fatigue, insomnia, memory impairment, headache, anxiety, depression, vertigo, confusion

Dermatologic: Rash

Endocrine & metabolic: Changes in libido

Gastrointestinal: Changes in salivation, constipation, nausea

Genitourinary: Incontinence, urinary retention

Hepatic: Jaundice

Local: Phlebitis, pain with injection

Neuromuscular & skeletal: Dysarthria, tremor

Ocular: Blurred vision, diplopia

Respiratory: Decrease in respiratory rate, apnea


Overdosage/Toxicology

 Symptoms of overdose include somnolence, confusion, coma, hypoactive reflexes, dyspnea, hypotension, slurred speech, or impaired coordination. Treatment for benzodiazepine overdose is supportive. Flumazenil has been shown to selectively block the binding of benzodiazepines to CNS receptors, resulting in a reversal of benzodiazepine-induced CNS depression, but not respiratory depression.


Drug Interactions

 Substrate of CYP1A2 (minor), 2B6 (minor), 2C8/9 (minor), 2C19 (major), 3A4 (major); Inhibits CYP2C19 (weak), 3A4 (weak)

CNS depressants: Sedative effects and/or respiratory depression may be additive with CNS depressants; includes ethanol, barbiturates, narcotic analgesics, and other sedative agents; monitor for increased effect

CYP2C19 inducers: May decrease the levels/effects of diazepam. Example inducers include aminoglutethimide, carbamazepine, phenytoin, and rifampin.

CYP2C19 inhibitors: May increase the levels/effects of diazepam. Example inhibitors include delavirdine, fluconazole, fluvoxamine, gemfibrozil, isoniazid, omeprazole, and ticlopidine.

CYP3A4 inducers: CYP3A4 inducers may decrease the levels/effects of diazepam. Example inducers include aminoglutethimide, carbamazepine, nafcillin, nevirapine, phenobarbital, phenytoin, and rifamycins.

CYP3A4 inhibitors: May increase the levels/effects of diazepam. Example inhibitors include azole antifungals, ciprofloxacin, clarithromycin, diclofenac, doxycycline, erythromycin, imatinib, isoniazid, nefazodone, nicardipine, propofol, protease inhibitors, quinidine, and verapamil.

Levodopa: Therapeutic effects may be diminished in some patients following the addition of a benzodiazepine; limited/inconsistent data

Oral contraceptives: May decrease the clearance of some benzodiazepines (those which undergo oxidative metabolism); monitor for increased benzodiazepine effect

Theophylline: May partially antagonize some of the effects of benzodiazepines; monitor for decreased response; may require higher doses for sedation


Ethanol/Nutrition/Herb Interactions

Ethanol: Avoid ethanol (may increase CNS depression).

Food: Diazepam serum levels may be increased if taken with food. Diazepam effect/toxicity may be increased by grapefruit juice; avoid concurrent use.

Herb/Nutraceutical: St John's wort may decrease diazepam levels. Avoid valerian, St John's wort, kava kava, gotu kola (may increase CNS depression).


Stability

Protect parenteral dosage form from light; potency is retained for up to 3 months when kept at room temperature; most stable at pH 4-8, hydrolysis occurs at pH <3; do not mix I.V. product with other medications

Rectal gel: Store at 25°C (77°F); excursion permitted to 15°C to 30°C (59°F to 86°F).


Compatibility

 Variable stability (consult detailed reference) in D5W, LR, NS

Y-site administration: Compatible: Dobutamine, nafcillin, quinidine gluconate, sufentanil. Incompatible: Amphotericin B cholesteryl sulfate complex, atracurium, cefepime, diltiazem, fluconazole, foscarnet, gatifloxacin, heparin, heparin with hydrocortisone sodium succinate, hydromorphone, linezolid, meropenem, pancuronium, potassium chloride, propofol, vecuronium, vitamin B complex with C. Variable (consult detailed reference): Cisatracurium, remifentanil

Compatibility in syringe: Compatible: Cimetidine. Incompatible: Doxapram, glycopyrrolate, heparin, hydromorphone, nalbuphine, sufentanil. Variable (consult detailed reference): Ketorolac, ranitidine

Compatibility when admixed: Compatible: Verapamil. Incompatible: Bleomycin, buprenorphine, dobutamine, doxorubicin, floxacillin, fluorouracil, furosemide


Mechanism of Action

 Binds to stereospecific benzodiazepine receptors on the postsynaptic GABA neuron at several sites within the central nervous system, including the limbic system, reticular formation. Enhancement of the inhibitory effect of GABA on neuronal excitability results by increased neuronal membrane permeability to chloride ions. This shift in chloride ions results in hyperpolarization (a less excitable state) and stabilization.


Pharmacodynamics/Kinetics

I.V.: Status epilepticus:

Onset of action: Almost immediate

Duration: 20-30 minutes

Absorption: Oral: 85% to 100%, more reliable than I.M.

Protein binding: 98%

Metabolism: Hepatic

Half-life elimination: Parent drug: Adults: 20-50 hours; increased half-life in neonates, elderly, and those with severe hepatic disorders; Active major metabolite (desmethyldiazepam): 50-100 hours; may be prolonged in neonates


Dosage

 Oral absorption is more reliable than I.M.

Children:

Conscious sedation for procedures: Oral: 0.2-0.3 mg/kg (maximum: 10 mg) 45-60 minutes prior to procedure

Sedation/muscle relaxant/anxiety:

Oral: 0.12-0.8 mg/kg/day in divided doses every 6-8 hours

I.M., I.V.: 0.04-0.3 mg/kg/dose every 2-4 hours to a maximum of 0.6 mg/kg within an 8-hour period if needed

Status epilepticus:

Infants 30 days to 5 years: I.V.: 0.05-0.3 mg/kg/dose given over 2-3 minutes, every 15-30 minutes to a maximum total dose of 5 mg; repeat in 2-4 hours as needed or 0.2-0.5 mg/dose every 2-5 minutes to a maximum total dose of 5 mg

>5 years: I.V.: 0.05-0.3 mg/kg/dose given over 2-3 minutes every 15-30 minutes to a maximum total dose of 10 mg; repeat in 2-4 hours as needed or 1 mg/dose given over 2-3 minutes, every 2-5 minutes to a maximum total dose of 10 mg

Rectal: 0.5 mg/kg, then 0.25 mg/kg in 10 minutes if needed

Anticonvulsant (acute treatment): Rectal gel formulation:

Infants <6 months: Not recommended

Children <2 years: Safety and efficacy have not been studied

Children 2-5 years: 0.5 mg/kg

Children 6-11 years: 0.3 mg/kg

Children 12 years and Adults: 0.2 mg/kg

Note: Dosage should be rounded upward to the next available dose, 2.5, 5, 10, 15, and 20 mg/dose; dose may be repeated in 4-12 hours if needed; do not use more than 5 times per month or more than once every 5 days

Adolescents: Conscious sedation for procedures:

Oral: 10 mg

I.V.: 5 mg, may repeat with 1 /2 dose if needed

Adults:

Anxiety/sedation/skeletal muscle relaxant:

Oral: 2-10 mg 2-4 times/day

I.M., I.V.: 2-10 mg, may repeat in 3-4 hours if needed

Sedation in the ICU patient: I.V.: 0.03-0.1 mg/kg every 30 minutes to 6 hours

Status epilepticus: I.V.: 5-10 mg every 10-20 minutes, up to 30 mg in an 8-hour period; may repeat in 2-4 hours if necessary

Rapid tranquilization of agitated patient (administer every 30-60 minutes): Oral: 5-10 mg; average total dose for tranquilization: 20-60 mg

Elderly: Oral: Initial:

Anxiety: 1-2 mg 1-2 times/day; increase gradually as needed, rarely need to use >10 mg/day (watch for hypotension and excessive sedation)

Skeletal muscle relaxant: 2-5 mg 2-4 times/day

Hemodialysis: Not dialyzable (0% to 5%); supplemental dose is not necessary

Dosing adjustment in hepatic impairment: Reduce dose by 50% in cirrhosis and avoid in severe/acute liver disease


Administration

 Intensol® should be diluted before use; diazepam does not have any analgesic effects

In children, do not exceed 1-2 mg/minute IVP; adults 5 mg/minute


Monitoring Parameters

 Respiratory, cardiovascular, and mental status; check for orthostasis


Reference Range

 Therapeutic: Diazepam: 0.2-1.5 mcg/mL (SI: 0.7-5.3 mol/L); N-desmethyldiazepam (nordiazepam): 0.1-0.5 mcg/mL (SI: 0.35-1.8 mol/L)


Test Interactions

 False-negative urinary glucose determinations when using Clinistix® or Diastix®


Patient Education

 Take exactly as directed; do not increase dose or frequency. Drug may cause physical and/or psychological dependence. While using this medication, do not use alcohol and other prescription or OTC medications (especially pain medications, sedatives, antihistamines, or hypnotics) without consulting prescriber. Maintain adequate hydration (2-3 L/day of fluids) unless instructed to restrict fluid intake. You may experience drowsiness, dizziness, or blurred vision (use caution when driving or engaging in tasks requiring alertness until response to drug is known); nausea, vomiting, loss of appetite, or dry mouth (small, frequent meals, frequent mouth care, chewing gum, or sucking lozenges may help); constipation (increased exercise, fluids, fruit, or fiber may help). If medication is used to control seizures, wear identification that you are taking an antiepileptic medication. Report CNS changes (confusion, depression, increased sedation, excitation, headache, agitation, insomnia or nightmares, dizziness, fatigue, or impaired coordination) or changes in cognition; respiratory difficulty or shortness of breath; changes in urinary pattern; changes in sexual activity; muscle cramping, weakness, tremors, or rigidity; ringing in ears or visual disturbances; excessive perspiration; excessive GI symptoms (cramping, constipation, vomiting, anorexia); or worsening of seizure activity or loss of seizure control. Pregnancy/breast-feeding precautions: Do not get pregnant while taking this medication; use appropriate contraceptive measures. Do not breast-feed.


Additional Information

 Intensol® should be diluted before use; diazepam does not have any analgesic effects.


Anesthesia and Critical Care Concerns/Other Considerations

Oral absorption more reliable than intramuscular. Intensol® should be diluted before use. Diazepam does not have any analgesic effects. Chronic use of this agent may increase the perioperative benzodiazepine dose needed to achieve desired effect. Abrupt discontinuation after sustained use (generally >10 days) may cause withdrawal symptoms. Hypotension may result in orthostatic lightheadedness or syncope. Benzodiazepines, as a class, may depress respiration. The 2002 ACCM/SCCM guidelines for the sustained use of sedatives and analgesics in critically-ill adults recommend diazepam or midazolam for rapid sedation of acutely-agitated patients.

Status Epilepticus: A randomized, double-blind trial (Treiman D, 1998) evaluated the efficacy of four treatments in overt status epilepticus. Treatment arms were designed based upon accepted practices of North American neurologists. The treatments were: 1) lorazepam 0.1 mg/kg, 2) diazepam 0.15 mg/kg followed by phenytoin 18 mg/kg, 3) phenytoin 18 mg/kg alone, and 4) phenobarbital 15 mg/kg. Treatment was considered successful if the seizures were terminated (clinically and by EEG) within 20 minutes of start of therapy without seizure recurrence within 60 minutes from the start of therapy. Patients who failed the first treatment received a second and a third, if necessary. Patients did not receive randomized treatments after the first one but the treating physician remained blinded. Treatment success: Lorazepam 64.9%, phenobarbital 58.2%, diazepam/phenytoin 55.8%, and phenytoin alone 43.6%. Using an "intention-to-treat" analysis, there was no statistical difference between the groups. Results of subsequent treatments in patients who failed the first therapy indicated that response rate significantly dropped regardless of treatment. Aggregate response rate to the second treatment was 7.0% and third treatment 2.3%.


Cardiovascular Considerations

 Hypotension may result in orthostatic lightheadedness or syncope. Benzodiazepines, as a class, may depress respiration. These medications may often be prescribed for difficulty in sleeping but may exacerbate sleep-disordered breathing.


Dental Health: Effects on Dental Treatment

 Key adverse event(s) related to dental treatment: Xerostomia and changes in salivation (normal salivary flow resumes upon discontinuation).


Dental Health: Vasoconstrictor/Local Anesthetic Precautions

 No information available to require special precautions


Dosage Forms

Gel, rectal (Diastat®):

Adult rectal tip [6 cm]: 5 mg/mL (15 mg, 20 mg) [contains ethyl alcohol, sodium benzoate, benzyl alcohol; twin pack]

Pediatric rectal tip [4.4 cm]: 5 mg/mL (2.5 mg, 5 mg) [contains ethyl alcohol, sodium benzoate, benzyl alcohol; twin pack]

Universal rectal tip [for pediatric and adult use; 4.4 cm]: 5 mg/mL (10 mg) [contains ethyl alcohol, sodium benzoate, benzyl alcohol; twin pack]

Injection, solution: 5 mg/mL (2 mL, 10 mL) [may contain benzyl alcohol, sodium benzoate, benzoic acid]

Solution, oral: 5 mg/5 mL (5 mL, 500 mL) [wintergreen-spice flavor]

Solution, oral concentrate (Diazepam Intensol®): 5 mg/mL (30 mL)

Tablet (Valium®): 2 mg, 5 mg, 10 mg


References

Allikmets E, et al, "Long-Term Use of Benzodiazepines: Abrupt Withdrawal Versus Withdrawal Under Nifedipine Cover," Pharmacol Toxicol , 1995, 76(Suppl 3):Abstr 8.

"American Academy of Pediatrics Committee on Drugs. The Transfer of Drugs and Other Chemicals Into Human Milk," Pediatrics , 2001, 108(3):776-89.

Bleck TB, Seizures, Stroke, and Other Neurologic Emergencies. In: Zimmerman JL, Roberts PR, eds. Multidisciplinary Critical Care Review , Des Plains, IL: Society of Critical Care Medicine; 2003:325-34.

Jacobi J, Fraser GL, Coursin DB, et al, "Clinical Practice Guidelines for the Sustained Use of Sedatives and Analgesics in the Critically Ill Adult," Crit Care Med , 2002, 30(1):119-41. Available at: http://www.sccm.org/pdf/sedatives.pdf. Accessed August 2, 2003.

Klotz U, Avant GR, Hoyumpa A, et al, "The Effects of Age and Liver Disease on the Disposition and Elimination of Diazepam in Adult Man," J Clin Invest , 1975, 55(2):347-59.

Marshall JD, Farrar HC, and Kearns GL, "Diarrhea Associated With Enteral Benzodiazepine Solutions," J Pediatr , 1995, 126(4):657-9.

Mokhlesi B, Leikin JB, Murray P, et al, "Adult Toxicology in Critical Care: Part II: Specific Poisonings," Chest , 2003, 123(3):897-922.

Pomara N, Stanley B, Block R, et al, "Increased Sensitivity of the Elderly to the Central Depressant Effects of Diazepam," J Clin Psychiatry , 1985, 46(5):185-7.

Reidenberg MM, Levy M, Warner H, et al, "Relationship Between Diazepam Dose, Plasma Level, Age, and Central Nervous System Depression," Clin Pharmacol Ther , 1978, 23(4):371-4.

Rosman NP, Colton T, Labazzo J, et al, "A Controlled Trial of Diazepam Administered During Febrile Illnesses to Prevent Recurrence of Febrile Seizures," N Engl J Med , 1993, 329(2):79-84.

Traeger SM and Haug MT 3d, "Reduction of Diazepam Serum Half-Life and Reversal of Coma by Activated Charcoal in a Patient With Severe Liver Disease," J Toxicol Clin Toxicol , 1986, 24(4):329-37.

Treiman DM, Meyers PD, Walton NY, et al, "A Comparison of Four Treatments for Generalized Convulsive Status Epilepticus. Veterans Affairs Status Epilepticus Cooperative Study Group," N Engl J Med , 1998, 339(12):792-8.

Votey SR, Bosse GM, Bayer MJ, et al, "Flumazenil: A New Benzodiazepine Antagonist," Ann Emerg Med , 1991, 20(2):181-8.

Zeltzer LK, Altman A, Cohen D, et al, "Report of the Subcommittee on the Management of Pain Associated With Procedures in Children With Cancer," Pediatrics , 1990, 86(5 Pt 2):826-31.


International Brand Names

 Alboral® (MX); Aliseum® (IT); Ansilive® (BR); Ansiolin® (IT); Antenex® (AU); Anxicalm® (IE); Apaurin® (CZ, HR, RU, SI); Apo-Diazepam® (CA, CZ, SG); Apozepam® (DK, SE); Assival® (IL); Azepam® (TH); Bensedin® (YU); Benzopin® (ZA); Bialzepam® (EC, PT); Calmociteno® (BR); Calmpose® (IN, RU, ZA); Cercine® (JP); Compaz® (BR); Condition® (JP); Cuadel® (AR); Daiv® (AR); Dezepan® (AR); Dialar® (GB); Dialudon® (BR); Diano® (TH); Diapam® (FI, RU, TH, TR); Diapine® (SG, TH); Diastat® (CA); Diazem® (TR); Diazemuls® (AU, CA, GB, HK, IT, NL, NZ); Diazep AbZ® (DE); Diazepam-Armedica® (RO); Diazepam® (AU, BG, BR, CL, CZ, DE, GB, HR, IT, NZ, PL, RO, RU, YU); Diazepam Biocrom® (AR); Diazepam Bouzen® (AR); Diazepam Dak® (DK); Diazepam DBL® (SG); Diazepam Desitin® (CH, CZ, DE, DK, FI, HR, HU, IL, NO, RO, SE, SG, TR); Diazepam Drawer® (AR); Diazepam Ecar® (CO); Diazepam EG® (BE); Diazepam-Eurogenerics® (LU); Diazepam Fabra® (AR); Diazepam-Feltrex® (DO); Diazepam Injection® (GB); Diazepam Lacefa® (AR); Diazepam Larjan® (AR); Diazepam L.CH.® (CL); Diazepam Leo® (ES); Diazepam-Lipuro® (DE, PL); Diazepam Normon® (ES); Diazepam NQ® (BR); Diazepam Prodes® (ES); Diazepam-ratiopharm® (BE, DE, LU); Diazepam Rectubes® (GB, IL); Diazépam Renaudin® (FR); Diazepam Sandoz® (DE); Diazepam Stada® (DE); Diazepan® (EG); Diazepan Medipharma® (AR); Diazephar® (BE); diazep von ct® (DE); Diazerekt® (PL); Diaz® (IL); Dicam® (RU); Dienpax® (BR); Dipaz® (EC); Dipezona® (AR); Distensar® (CO); Dizan® (TH); Dizepam® (TH); Doval® (ZA); D-Pam® (NZ); Ducene® (AU); Easium® (BD); Evalin® (BD); Fabotranil® (AR); Faustan® (DE); Fizepam® (BD); G-Diazepam® (BD); Gewacalm® (AT); Glutasedan® (AR); Gradual® (AR); Hexalid® (DK); Horizon® (JP); Kiatrium® (BR); Kratium® (HK); Lamra® (DE); Lembrol® (AR); Lizan® (TR); Lovium® (ID); Medipam® (FI); Mentalium® (ID); Micronoan® (IT); Nervium® (TR); Noan® (BR, IT); Normabel® (HR); Ortopsique® (MX); Pacitran® (MX); Placidox-2® (IN); Plidan® (AR); Plidex® (AR); Propam® (NZ); Psicotran® (AR); Psychopax® (AT, CH); Q-Med Diazepam® (ZA); Relanium® (BG, PL); Relsed® (PL); Remedium® (CY); Rimapam® (GB); Rozam® (BD); Rupediz® (AR); Saromet® (AR); Sedabenz® (YU); Sedapen® (BD); Sedex® (BD); Sedil® (BD); Sedium® (BD); Sedulin® (BD); Seduxen® (BD, CZ, HU, RU); Serenzin® (JP); Sico Relax® (ES); Sipam® (TH); Stesolid® (AT, CH, CY, CZ, DE, DK, EG, ES, FI, GB, HU, ID, IE, IL, JO, KW, LB, NL, NO, PT, SE, SG, TH); Stesolid Novum® (SE); Stesolid Rectal Tubes® (GB, TH); Tensium® (GB); Tranquase® (DE); Tranquirit® (IT); Umbrium® (AT); Uniao Diazepam® (BR); Unisedil® (PT); Valaxona® (DK); Valclair® (GB); Valiquid® (DE); Valisanbe® (ID); Valium® (AR, AU, BE, BR, CA, CL, CR, DE, DK, DO, ES, GB, GT, HK, HN, HR, ID, IE, IN, IT, LU, MX, NL, NO, PA, PL, PT, SV, TH, ZA); Valium Roche® (AT, CH, DE, FR, PL, RU); Valix® (BR); Valocordin-Diazepam® (DE); Vatran® (IT); V-Day Zepam® (TH); Vival® (NO); Zopam® (TH)


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