Top Content Directory Pakistan: August 2012

Friday, August 31, 2012

Chlordiazepoxide Hydrochloride

Class: Benzodiazepines
VA Class: CN302
CAS Number: 58-25-3
Brands: Librax, Librium, Limbitrol

Introduction

Benzodiazepine.^a ^b ^c ^d ^e Anxiolytic, sedative.^a ^b ^c ^d ^e

Uses for Chlordiazepoxide Hydrochloride

Alcohol Withdrawal

Relief of agitation and tremor and prevention or symptomatic relief of delirium tremens and hallucinations associated with acute alcohol withdrawal.^a ^b ^c

Anxiety and Depressive Disorders

Management of anxiety disorders and short-term relief of symptoms of anxiety.^a ^b ^c

Management of moderate to severe anxiety (in fixed-combination with amitriptyline hydrochloride) in patients with moderate to severe depression.^a ^d

Preoperative Anxiolysis

Preoperatively to relieve anxiety.^a ^b ^c

Peptic Ulcer Disease, Irritable Bowel Syndrome, and Acute Enterocolitis

Has been used in fixed combination with clidinium bromide as an adjunct in the treatment of peptic ulcer disease, functional disturbances of GI motility (e.g., irritable bowel syndrome), and acute enterocolitis. ^a ^e Fixed combination is classified by FDA as possibly effective for these indications.^e

Has limited usefulness in the treatment of peptic ulcer disease because of the advent of more effective therapies for this condition.^h

Therapeutic benefits achieved with the combination preparation in the management of functional disturbances of GI motility may be attributed to the anxiolytic and/or sedative properties of chlordiazepoxide.^g

Although the fixed combination has been used in the treatment of acute enterocolitis,^a ^e antimuscarinic-containing preparations should be used with extreme caution in patients with diarrhea or ulcerative colitis.^h

Chlordiazepoxide Hydrochloride Dosage and Administration

General

Use the smallest effective dosage (especially in geriatric and debilitated patients and in those with liver disease or low serum albumin) to avoid oversedation.^a ^b ^c ^e

Consider the long half-life of chlordiazepoxide and its metabolites when making dosage adjustments.^a ^b (See Half-life under Pharmacokinetics.)

In patients who have received prolonged (e.g., several months) therapy, avoid abrupt discontinuance, since manifestations of withdrawal can be precipitated; gradually taper dosage.^a ^b ^c ^d

Fixed-ratio combination preparations generally should not be used as initial therapy.^a Administer each drug separately.^a If the optimum maintenance dosage corresponds to the ratio in a commercial combination preparation, a fixed-combination preparation may be used.^a If dosage adjustment is necessary, administer the drugs separately.^a Although chlordiazepoxide hydrochloride is commercially available as single-entity preparations, clidinium bromide is commercially available in the US only in fixed combination with chlordiazepoxide hydrochloride.^e Fixed-ratio combination preparations do not permit individual titration of dosages.^h

Anxiety

Periodically reassess the usefulness of the drug.^a ^b ^c Efficacy of chlordiazepoxide beyond 4 months not systematically evaluated.^a ^b ^c Administer for the shortest possible period of time; frequent dosage adjustments may be required.^b

Administration

Administer orally.^a ^b ^c ^d ^e

Has been administered parenterally†; however, a parenteral dosage form is no longer commercially available in the US.¹⁰¹

Oral Administration

Initially, administer orally in 3 or 4 doses daily.^a ^b ^c ^d ^e After dosage has been stabilized, may reduce frequency to 1 or 2 doses daily.^a ^b ^d

Dosage

Available as chlordiazepoxide hydrochloride (alone and in fixed combination with clidinium bromide); dosage expressed in terms of the salt.^c ^e

Also available as chlordiazepoxide (in fixed combination with amitriptyline hydrochloride); dosage expressed in terms of the base.^d

On the basis of molecular weight, 89 mg of chlordiazepoxide is equivalent to 100 mg of chlordiazepoxide hydrochloride; however, the manufacturer of chlordiazepoxide base (no longer commercially available in the US as a single-entity preparation) states that chlordiazepoxide and its hydrochloride salt may be used interchangeably on a mg-for-mg basis.^a

Pediatric Patients

Anxiety Disorders

Oral

Children ≥6 years of age: Usual dosage is 5 mg 2–4 times daily.^a ^c Initial dosage should not exceed 10 mg daily.^a If necessary, increase dosage to 10 mg 2 or 3 times daily.^a ^c

Alternatively, some clinicians have recommended a pediatric dosage of 0.5 mg/kg daily or 15 mg/m² daily in 3 or 4 divided doses.^a

Adults

Alcohol Withdrawal

Oral

Initially, 50- to 100-mg dose; repeat dose until agitation is controlled.^a ^c

Manufacturer states that dosage for acute alcohol withdrawal should not exceed 300 mg daily;^a ^c however, some clinicians have used dosages of 600–800 mg daily to control symptoms without adverse effects.^a

Slowly withdraw the drug after agitation is controlled.^a

Anxiety and Depressive Disorders

Monotherapy

Oral

Mild to moderate anxiety: 5–10 mg 3 or 4 times daily.^a ^c

Severe anxiety: 20–25 mg 3 or 4 times daily.^a ^c

Chlordiazepoxide/Amitriptyline Combination Therapy

Oral

Initially, chlordiazepoxide 30 or 40 mg daily (in fixed combination with amitriptyline hydrochloride 75 or 100 mg daily, respectively) in divided doses.^d If needed, increase dosage to chlordiazepoxide 60 mg daily (in fixed combination with amitriptyline hydrochloride 150 mg daily) in divided doses.^d

Alternatively, in patients who do not tolerate larger dosages, initial dosage of chlordiazepoxide 15 or 20 mg daily (in fixed combination with amitriptyline hydrochloride 37.5 or 50 mg daily, respectively) in divided doses.^d

For some patients, chlordiazepoxide 20 mg daily (in fixed combination with amitriptyline hydrochloride 50 mg daily) in divided doses may be adequate.^d

Preoperative Anxiolysis

Oral

5–10 mg 3 or 4 times daily for several days preceding surgery.^a ^c

Peptic Ulcer Disease, Irritable Bowel Syndrome, and Acute Enterocolitis

Oral

Usual maintenance dosage is 5 or 10 mg (in fixed combination with clidinium bromide 2.5 or 5 mg, respectively) 3 or 4 times daily (before meals and at bedtime).^a ^e

Prescribing Limits

Pediatric Patients

Anxiety Disorders

Oral

Children ≥6 years of age: Maximum initial dosage of 10 mg daily.^a

Adults

Alcohol Withdrawal

Oral

Maximum 300 mg daily recommended by manufacturer.^c Some clinicians have used higher dosages (600–800 mg daily) to control symptoms without adverse effects.^a

Special Populations

Hepatic Impairment

Reduce dosage;^b use the smallest effective dosage.^a

Renal Impairment

No specific dosage recommendations.^a ^c ^d ^e

Geriatric or Debilitated Patients

Reduce initial dosage.^c ^e Use the smallest effective dosage to avoid oversedation.^b ^c ^d ^e

Anxiety and Depressive Disorders

5 mg 2–4 times daily; initial dosage should not exceed 10 mg daily.^a ^c

When used in fixed combination with amitriptyline hydrochloride, select initial dosages at the lower end of the usual ranges and gradually increase dosages if needed and tolerated.^d

Peptic Ulcer Disease, Irritable Bowel Syndrome, and Acute Enterocolitis

Initially, 10 mg daily (given in fixed combination with clidinium bromide 5 mg daily); gradually increase dosages if needed and tolerated.^e

Cautions for Chlordiazepoxide Hydrochloride

Contraindications

Known hypersensitivity to chlordiazepoxide, other benzodiazepines, or any ingredient in the formulation.^c ^d ^e

Many manufacturers state that benzodiazepines are contraindicated in patients with acute angle-closure glaucoma but may be administered to patients with open-angle glaucoma who are receiving appropriate therapy; however, clinical rationale for this contraindication has been questioned.^b

Warnings/Precautions

Warnings

CNS Effects

Performance of activities requiring mental alertness and physical coordination may be impaired.^b ^c ^d ^e

Concurrent use of other CNS depressants may cause additive or potentiated CNS depression.^c ^d ^e (See Specific Drugs and Laboratory Tests under Interactions.)

Paradoxical reactions (e.g., excitement, stimulation, acute rage) reported in psychiatric patients and in hyperactive aggressive children.^b ^c ^d ^e

Fetal/Neonatal Morbidity

Some retrospective studies suggest increased risk of congenital malformations in infants of mothers who received chlordiazepoxide during the first trimester of pregnancy. ^b ^c ^d ^e ^f Since use of anxiolytics is rarely urgent, their use during the first trimester almost always should be avoided.^b ^c ^d ^e

Psychiatric Indications

Benzodiazepines should not be used in patients with depressive neuroses or psychotic reactions in which anxiety is not prominent.^b

Abuse Potential

Possible tolerance, psychologic dependence, and physical dependence following prolonged use.^b

Patients with a history of drug or alcohol dependence or abuse are at risk of habituation or dependence; use only with careful surveillance in such patients.^c ^d ^e

Withdrawal Syndrome

Abrupt discontinuance may result in symptoms of withdrawal (similar to barbiturates).^b ^c ^d ^e Symptoms may be relieved by tapering the dosage.^b ^c ^d ^e

General Precautions

Suicide

Use with caution in depressed patients; potential for suicidal tendencies.^c ^d ^e Prescribe and dispense drug in the smallest feasible quantity.^b

Use of Fixed Combinations

When used in fixed combination with clidinium bromide or amitriptyline hydrochloride, consider the cautions, precautions, and contraindications associated with the concomitant agent.^a ^d ^e

Porphyria

Exacerbation of porphyria reported; use with caution in patients with this disease.^c

Laboratory Testing

Monitor blood counts and liver function tests periodically during prolonged therapy.^b ^c ^d Blood dyscrasias (including agranulocytosis), jaundice, and hepatic dysfunction reported occasionally.^c ^d

Specific Populations

Pregnancy

Category D.^f (See Fetal/Neonatal Morbidity under Cautions.)

Lactation

Many benzodiazepines are distributed into milk;^b ^f distribution of chlordiazepoxide into milk should be expected.^f Discontinue nursing or the drug.^b

Pediatric Use

Safety and efficacy of chlordiazepoxide hydrochloride not established in children <6 years of age.^a ^c

Safety and efficacy of the chlordiazepoxide hydrochloride-clidinium bromide and the chlordiazepoxide-amitriptyline hydrochloride fixed combinations not established in pediatric patients.^a ^d ^e

Response of children to CNS drugs may be unpredictable; initiate therapy at low dosage and increase as required.^a ^c (See Dosage under Dosage and Administration.)

Monitor hyperactive, aggressive children for paradoxical reactions (e.g., excitement, stimulation, acute rage).^c

Geriatric Use

Prolonged elimination of chlordiazepoxide and its metabolites.^b

Possible increased risk of drowsiness, ataxia, and confusion; generally preventable by proper dosage adjustment, but occasionally may be observed at reduced dosages.^a ^c ^e

No overall differences in safety and efficacy of chlordiazepoxide in fixed combination with amitriptyline hydrochloride in geriatric patients relative to younger adults; however, increased sensitivity cannot be ruled out.^d

Initiate therapy at low dosages; gradually increase dosage if needed and tolerated.^a ^c ^d ^e (See Geriatric or Debilitated Patients under Dosage and Administration.)

Hepatic Impairment

Prolonged elimination of chlordiazepoxide and its metabolites.^b Use with caution.^b ^c ^d Use smallest effective dosage.^a

Renal Impairment

Use with caution.^b ^c ^d

Common Adverse Effects

Drowsiness,^b ^c ^d ^e ataxia,^b ^c ^e confusion.^b ^c ^e

Interactions for Chlordiazepoxide Hydrochloride

Specific Drugs and Laboratory Tests

Drug or Test	Interaction	Comments
Antacids (aluminum- and magnesium-containing)	Possible decrease in rate, but not extent, of chlordiazepoxide absorption ^b
Anticoagulants, oral	Manufacturers state that variable effects on coagulation have been reported;^b ^c ^e however, several studies found no clinically important effect on hypoprothrombinemia^b
Cimetidine	Possible decreased clearance and increased plasma concentrations of chlordiazepoxide	Use with caution; consider reduction of chlordiazepoxide dosage
CNS depressants (e.g., alcohol, anticonvulsants, psychotropic drugs, sedatives)	Additive CNS effect^b ^c ^d	Use caution to avoid overdosage^b Concomitant use of chlordiazepoxide with other psychotropic agents generally is not recommended^c ^d
Disulfiram	Reduced plasma clearance and increased plasma half-life of chlordiazepoxide	Reduce chlordiazepoxide dosage as necessary
Levodopa	Possible decreased control of parkinsonian symptoms^b	Use with caution^b
Test for pregnancy (Gravindex test)	Possible false-positive reaction ^b
Tests for urinary alkaloids	Possible interference with Frings thin layer chromatography procedure, resulting in falsely elevated readings ^b
Tests for urinary 17-ketosteroids	Possible interference with Zimmerman reaction, resulting in falsely elevated or decreased concentrations^b

Chlordiazepoxide Hydrochloride Pharmacokinetics

Absorption

Bioavailability

Benzodiazepines are well absorbed from the GI tract after oral administration.^b

Distribution

Extent

Benzodiazepines are widely distributed into body tissues and cross the blood-brain barrier.^b

Many benzodiazepines are distributed into milk;^b ^f distribution of chlordiazepoxide into milk should be expected.^f

Chlordiazepoxide crosses the placenta.^f

Plasma Protein Binding

Benzodiazepines are highly bound to plasma proteins.^b

Elimination

Metabolism

Metabolized in the liver.^b Major active metabolites include demoxepam, desmethylchlordiazepoxide, desmethyldiazepam, and oxazepam.^b Hydroxylated metabolites of chlordiazepoxide are conjugated with glucuronic acid.^b ^j ^k

Elimination Route

Inactive conjugates are excreted principally in urine.^b

Half-life

Chlordiazepoxide: 5–30 hours.^b

Metabolites: Demoxepam: 14–95 hours.^b Desmethylchlordiazepoxide: 18 hours.^b Desmethyldiazepam: 30–200 hours.^b Oxazepam: 3–21 hours.^b

Special Populations

In geriatric patients and patients with liver disease, half-lives of chlordiazepoxide and its metabolites are prolonged.^b

Benzodiazepines are not appreciably removed by hemodialysis.^b

Stability

Storage

Oral

Capsules

25°C (may be exposed to 15–30°C).^c

Fixed-combination (with Amitriptyline Hydrochloride) Tablets

Store in a dry place at 25°C (may be exposed to 15–30°C).^d

Fixed-combination (with Clidinium Bromide) Capsules

25°C (may be exposed to 15–30°C).ⁱ

ActionsActions

Effects appear to be mediated through the inhibitory neurotransmitter GABA; the site and mechanism of action within the CNS appear to involve a macromolecular complex (GABA_A-receptor-chloride ionophore complex) that includes GABA_A receptors, high-affinity benzodiazepine receptors, and chloride channels.

Advice to Patients

Potential for drug to impair mental alertness or physical coordination; avoid driving or operating machinery until effects on individual are known.^b ^c ^d ^e

Importance of informing clinicians of any behavioral or mental changes, memory impairment, tolerance, or dependence/withdrawal symptoms.^b ^c ^d ^e

Importance of taking only as prescribed; do not increase dosage or duration of therapy or abruptly discontinue drug unless otherwise instructed by a clinician.^b ^c ^d ^e

Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.^b ^c ^d ^e Importance of not consuming alcoholic beverages.^c ^d

Importance of informing clinicians about any concomitant illnesses, particularly depression.^b ^c ^d ^e

Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.^b ^c ^d ^e

Importance of informing patients of other important precautionary information.^b ^c (See Cautions.)

Preparations

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

Single-entity preparations of chlordiazepoxide and its hydrochloride salt and preparations containing the drug in combination with amitriptyline hydrochloride are subject to control under the Federal Controlled Substances Act of 1970 as schedule IV (C-IV) drugs.^a ^c ^d

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

Chlordiazepoxide Hydrochloride
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Capsules	5 mg*	Chlordiazepoxide Hydrochloride Capsules (C-IV)	Barr, Par
			Librium (C-IV; with parabens)	Valeant
		10 mg*	Chlordiazepoxide Hydrochloride Capsules (C-IV)	Barr, Par
			Librium (C-IV; with parabens)	Valeant
		25 mg*	Chlordiazepoxide Hydrochloride Capsules (C-IV)	Barr, Par
			Librium (C-IV; with parabens)	Valeant

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

Chlordiazepoxide and Amitriptyline Hydrochloride
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Tablets, film-coated	5 mg Chlordiazepoxide and Amitriptyline Hydrochloride 12.5 mg*	Chlordiazepoxide and Amitriptyline Hydrochloride Tablets (C-IV)	Mylan, Par
			Limbitrol (C-IV; with povidone and propylene glycol)	Valeant
		10 mg Chlordiazepoxide and Amitriptyline Hydrochloride 25 mg*	Chlordiazepoxide and Amitriptyline Hydrochloride Tablets (C-IV)	Mylan, Par
			Limbitrol DS (C-IV; with povidone and propylene glycol)	Valeant

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

Chlordiazepoxide Hydrochloride and Clidinium Bromide
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Capsules	5 mg Chlordiazepoxide Hydrochloride and Clidinium Bromide 2.5 mg*	Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules	Actavis
			Librax (with parabens)	Valeant

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.

ChlordiazePOXIDE HCl 10MG Capsules (TEVA PHARMACEUTICALS USA): 60/$18.6 or 120/$25.16

ChlordiazePOXIDE HCl 25MG Capsules (TEVA PHARMACEUTICALS USA): 60/$18.99 or 180/$42.99

ChlordiazePOXIDE HCl 5MG Capsules (TEVA PHARMACEUTICALS USA): 60/$18.88 or 180/$45.32

Chlordiazepoxide-Amitriptyline 10-25MG Tablets (MYLAN): 60/$65.99 or 180/$189.97

Chlordiazepoxide-Amitriptyline 5-12.5MG Tablets (MYLAN): 60/$49.99 or 180/$135.97

Librax 2.5-5MG Capsules (VALEANT): 60/$417 or 180/$1209.98

Librium 25MG Capsules (VALEANT): 30/$65.99 or 90/$179.97

Limbitrol DS 10-25MG Tablets (VALEANT): 60/$115.99 or 180/$305.98

Disclaimer

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

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

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions August 2008. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

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

References

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

101. ICN Pharmaceuticals, Inc. Librium (chlordiazepoxide) injection prescribing information. Costa Mesa, CA; 1997 Aug.

a. AHFS drug information 2008. McEvoy GK, ed. Chlordiazepoxide hydrochloride. Bethesda, MD: American Society of Health-System Pharmacists; 2008:2582-3.

b. AHFS drug information 2008. McEvoy GK, ed. Benzodiazepines general statement. Bethesda, MD: American Society of Health-System Pharmacists; 2008:2571-80.

c. Valeant. Librium (chlordiazepoxide hydrochloride) capsules prescribing information. Costa Mesa, CA; 2005 Jul.

d. Valeant. Limbitrol and Limbitrol DS (chlordiazepoxide and amitriptyline hydrochloride) tablets prescribing information. Aliso Viejo, CA; 2007 May.

e. Valeant. Librax (chlordiazepoxide hydrochloride and clidinium bromide) capsules prescribing information. Costa Mesa, CA; 2005 Jun.

f. Briggs GG, Freeman RK, Yaffe SJ. Drugs in pregnancy and lactation. 7th ed. Baltimore, MD: Williams & Wilkins; 2005:280-2.

g. AHFS drug information 2008. McEvoy GK, ed. Clidinium bromide. Bethesda, MD: American Society of Health-System Pharmacists; 2008:1307.

h. AHFS drug information 2008. McEvoy GK, ed. Antimuscarinics/antispasmodics general statement. Bethesda, MD: American Society of Health-System Pharmacists; 2008:1293-300.

i. Actavis Totowa LLC. Chlordiazepoxide hydrochloride and clidinium bromide capsules prescribing information. Totowa, NJ; 2006 June.

j. Bailey L, Ward M, Musa MN. Clinical pharmacokinetics of benzodiazepines. J Clin Pharmacol. 1994; 34:804-11. [PubMed 7962667]

k. Charney DS, Mihic SJ, Harris RA. Hypnotics and sedatives. In: Brunton LL, Lazo JS, Parker KL, eds. Goodman and Gilman’s the pharmacological basis of therapeutics. 11th ed. New York: McGraw-Hill; 2006:401-28.

More Chlordiazepoxide Hydrochloride resources

Chlordiazepoxide Hydrochloride Side Effects (in more detail)
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Chlordiazepoxide Hydrochloride Support Group
34 Reviews for Chlordiazepoxide Hydrochloride - Add your own review/rating

Chlordiazepoxide MedFacts Consumer Leaflet (Wolters Kluwer)

Chlordiazepoxide Prescribing Information (FDA)

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chlordiazepoxide Concise Consumer Information (Cerner Multum)

chlordiazepoxide Advanced Consumer (Micromedex) - Includes Dosage Information

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Tubersol

Generic Name: tuberculin (Intradermal route)

too-BER-kue-lin

Commonly used brand name(s)

In the U.S.

Aplisol

Tubersol

Available Dosage Forms:

Solution

Therapeutic Class: Diagnostic Agent, Tuberculin

Uses For Tubersol

Tuberculin purified protein derivative (PPD) is used as a test to help diagnose tuberculous infection.

How the test is done: Tuberculin PPD is injected into the surface layers of the skin. If the test is positive, a reaction will be seen at and around the place of injection or puncture. If the test is given using an injection, this reaction is usually a hard, raised area with clear margins. If the test is given using the puncture devices, the reaction is usually a swollen area at the puncture site. Forty-eight to 72 hours after administration of the injection the size of the reaction is measured and recorded and the results of the test are studied.

Tuberculin PPD is to be used only by or under the supervision of a doctor.

Before Using Tubersol

In deciding to use a diagnostic test, any risks of the test must be weighed against the good it will do. This is a decision you and your doctor will make. Also, other things may affect test results. For this test, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Although there is no specific information comparing use of tuberculin PPD in children with use in other age groups, this diagnostic test is not expected to cause different side effects or problems in children than it does in adults.

Geriatric

Reactions to tuberculin PPD in older patients may be more likely to develop slowly and may not reach the peak effect until after 72 hours.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of tuberculin

This section provides information on the proper use of a number of products that contain tuberculin. It may not be specific to Tubersol. Please read with care.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

Tubersol Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Rare

Redness, blistering, peeling, or loosening of the skin

skin rash or itching

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Pain

redness at the site of injection

sores at and around the place of injection

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Tubersol side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Tubersol resources

Tubersol Side Effects (in more detail)
Tubersol Use in Pregnancy & Breastfeeding
Tubersol Drug Interactions
Tubersol Support Group
0 Reviews · Be the first to review/rate this drug

Tubersol MedFacts Consumer Leaflet (Wolters Kluwer)

Aplisol Prescribing Information (FDA)

Thursday, August 30, 2012

NuLYTELY Lemon Lime

Generic Name: polyethylene glycol electrolyte solution (pall ee ETH il een GLYE kol ee LEK troe lyte)

Brand Names: Colyte, Colyte with Flavor Packs, GoLYTELY, MoviPrep, NuLYTELY, NuLYTELY Cherry, NuLYTELY Lemon Lime, NuLYTELY Orange, NuLYTELY with Flavor Packs, PEG-3350 with Electolytes, TriLyte with Flavor Packs

What is NuLYTELY Lemon Lime (polyethylene glycol electrolyte solution)?

Polyethylene glycol electrolyte solution is a laxative solution that increases the amount of water in the intestinal tract to stimulate bowel movements. This medication also contains potassium, sodium, and other minerals to replace electrolytes that are passed from the body in the stool.

Polyethylene glycol electrolyte solution is used to clean the bowel before colonoscopy, a barium x-ray, or other intestinal procedures.

Polyethylene glycol electrolyte solution may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about NuLYTELY Lemon Lime (polyethylene glycol electrolyte solution)?

Do not use this medication if you are allergic to polyethylene glycol or any other electrolyte solutions (such as Pedialyte or Gatorade).

You should also not take polyethylene glycol electrolyte solution if you have a perforated bowel, a bowel obstruction or severe constipation, or colitis or toxic megacolon. If you have any these conditions, you could have dangerous or life-threatening side effects from polyethylene glycol electrolyte solution.

People with eating disorders (such as anorexia or bulimia) should not take polyethylene glycol electrolyte solution without the advice of a doctor.

Talk to your healthcare provider if you are not able to consume all of the solution. Incomplete cleansing of the bowel may affect the scheduled procedure.

What should I discuss with my health care provider before taking NuLYTELY Lemon Lime (polyethylene glycol electrolyte solution)?

Do not use this medication if you are allergic to polyethylene glycol or any other electrolyte solutions (such as Pedialyte or Gatorade), or if you have:

a perforated bowel;

a bowel obstruction or severe constipation; or

colitis or toxic megacolon.

If you have any these conditions, you could have dangerous or life-threatening side effects from polyethylene glycol electrolyte solution.

People with eating disorders (such as anorexia or bulimia) should not use this medication without the advice of a doctor.

Before taking polyethylene glycol electrolyte solution, tell your doctor if you are allergic to any drugs, or if you have:

nausea or vomiting;

trouble swallowing; or

a history of bowel obstruction, diverticulitis, ulcerative colitis, or other chronic bowel disease.

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

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether polyethylene glycol electrolyte solution 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.

Older adults may be more likely to have serious side effects from this medicine.

How should I take NuLYTELY Lemon Lime (polyethylene glycol electrolyte solution)?

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

Do not take polyethylene glycol electrolyte solution if it has been less than 2 hours since you last ate solid food. For best results, take the medicine 3 to 4 hours after you last ate.

Do not add any flavorings to this medicine, such as sugar, honey, artificial sweetener, fruit juices, or other beverages.

Chilling the medicine in a refrigerator may make it taste better. Shake the liquid well just before you measure a dose. Drink this medicine in the exact portions at the exact time intervals prescribed by your doctor.

Polyethylene glycol electrolyte solution will produce watery diarrhea. Keep taking the medicine until your stool is watery and clear. In most cases, at least 3 liters of polyethylene glycol electrolyte solution is needed for the full effect.

The usual dose of the medication is 8 ounces every 10 minutes. Drink each portion as quickly as possible, rather than sipping it slowly. The first watery stool should appear within 1 hour after you start drinking polyethylene glycol electrolyte solution.

You may be instructed not to drink or eat anything before your medical test or procedure. Follow your doctor's instructions about the type and amount of liquids you should drink for at least 24 hours before and after your test or procedure.

Throw away any polyethylene glycol electrolyte solution you have not used within 48 hours after it was mixed.

What happens if I miss a dose?

Talk to your doctor if you cannot drink all of the medication prescribed for you. Your test or procedure may need to be rescheduled if your bowel is not completely cleansed.

What happens if I overdose?

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

An overdose of this medication is not expected to produce life-threatening symptoms.

What should I avoid while taking NuLYTELY Lemon Lime (polyethylene glycol electrolyte solution)?

Avoid taking other medications, vitamins, or mineral supplements within 1 hour before drinking polyethylene glycol electrolyte solution. Any medications you take just before a bowel cleansing will not be properly absorbed into your body.

Do not use other laxatives while using polyethylene glycol electrolyte solution unless your doctor has told you to.

NuLYTELY Lemon Lime (polyethylene glycol electrolyte solution) side effects

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

severe stomach pain or bloating;

no bowel movement within 2 hours after use; or

gagging, choking, or vomiting.

If you have any of these side effects, you may need to drink the medication more slowly, or stop using it for a short time.

Less serious side effects may include:

mild stomach cramps, gas, or bloating;

rectal pain or irritation;

nausea; or

passing gas.

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

What other drugs will affect NuLYTELY Lemon Lime (polyethylene glycol electrolyte solution)?

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

More NuLYTELY Lemon Lime resources

NuLYTELY Lemon Lime Side Effects (in more detail)
NuLYTELY Lemon Lime Use in Pregnancy & Breastfeeding
NuLYTELY Lemon Lime Support Group
1 Review for NuLYTELY Lemon Lime - Add your own review/rating

Colyte Advanced Consumer (Micromedex) - Includes Dosage Information

Colyte Solution MedFacts Consumer Leaflet (Wolters Kluwer)

Colyte Prescribing Information (FDA)

GoLYTELY Solution (Jug) MedFacts Consumer Leaflet (Wolters Kluwer)

MoviPrep Advanced Consumer (Micromedex) - Includes Dosage Information

MoviPrep Prescribing Information (FDA)

MoviPrep Consumer Overview

MoviPrep MedFacts Consumer Leaflet (Wolters Kluwer)

NuLYTELY Prescribing Information (FDA)

NuLYTELY Solution MedFacts Consumer Leaflet (Wolters Kluwer)

Compare NuLYTELY Lemon Lime with other medications

Bowel Preparation
Constipation, Chronic
Gastrointestinal Decontamination

Where can I get more information?

Your pharmacist can provide more information about polyethylene glycol electrolyte solution.

See also: NuLYTELY Lemon Lime side effects (in more detail)

Itraconazole Capsules

Pronunciation: IT-ra-KON-a-zole
Generic Name: Itraconazole
Brand Name: Sporanox

Itraconazole Capsules should not be used to treat a fungal infection of the toenail or fingernail (onychomycosis) in patients with heart problems (eg, history of congestive heart failure). Contact your doctor immediately if you experience symptoms of congestive heart failure such as swelling of the hands, ankles, feet, or abdomen; bloating; shortness of breath; fast or irregular heartbeat; severe or persistent nausea; or confusion.

Use of Itraconazole Capsules along with certain other medicines may increase your risk of serious and sometimes fatal heart problems, including irregular heartbeat. Do not take Itraconazole Capsules if you are also taking cisapride, pimozide, quinidine, dofetilide, or levacetylmethadol (levomethadyl).

Itraconazole Capsules is used for:

Treating fungal infections. It may also be used for other conditions as determined by your doctor.

Itraconazole Capsules is an azole antifungal. It kills sensitive fungi by interfering with the formation of the fungal cell membrane.

Do NOT use Itraconazole Capsules if:

you are allergic to any ingredient in Itraconazole Capsules

you are being treated for a fungal infection of the toenail or fingernail (onychomycosis) and you also have congestive heart failure, a history of congestive heart failure, you are pregnant, or may become pregnant

you are taking an aldosterone blocker (eg, eplerenone), alprazolam, astemizole, cisapride, conivaptan, dofetilide, an ergot alkaloid (eg, ergotamine), certain HMG-CoA reductase inhibitors (eg, lovastatin, simvastatin), levacetylmethadol (levomethadyl), oral midazolam, nevirapine, nisoldipine, pimozide, a quinazoline (eg, alfuzosin), quinidine, rifabutin, rifampin, terfenadine, triazolam, or certain 5-HT receptor agonists (eg, eletriptan)

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

Before using Itraconazole Capsules:

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

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

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

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

if you are allergic to other azole antifungals (eg, ketoconazole)

if you have HIV infection, a weakened immune system, kidney or liver problems, abnormal liver function tests, lung or breathing problems (eg, chronic obstructive pulmonary disease [COPD]), low stomach acid (eg, hypochlorhydria), nerve problems, or problems with swelling or retaining fluid

if you have an irregular heartbeat or other heart problems (eg, congestive heart failure, coronary artery disease, heart valve problems)

if you have had serious liver problems caused by Itraconazole Capsules or other medicines

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

Many prescription and nonprescription medicines (eg, used for infections, HIV, seizures, anxiety, sleep, heartburn, diabetes, high cholesterol, heart problems, high blood pressure, allergies, irregular heartbeat, pain, blood thinning, asthma, migraines, mood or mental problems, cancer, prostate problems, immune system suppression, erectile dysfunction, urinary problems, or birth control [eg, birth control pills]), multivitamin products, and herbal or dietary supplements may interact with Itraconazole Capsules, increasing the risk of serious side effects

Nevirapine, rifabutin, or rifampin because they may decrease Itraconazole Capsules's effectiveness

Astemizole, cisapride, dofetilide, levacetylmethadol (levomethadyl), nisoldipine, pimozide, quinidine, or terfenadine because the risk of severe heart effects may be increased

Alprazolam, midazolam, or triazolam because their actions and the risk of their side effects may be increased by Itraconazole Capsules, resulting in increased risk of sedation and breathing difficulties

Aldosterone blockers (eg, eplerenone), calcium channel blockers (eg, verapamil), conivaptan, ergot alkaloids (eg, ergotamine), certain HMG-CoA reductase inhibitors (eg, lovastatin, simvastatin), 5-HT receptor agonists (eg, eletriptan), or quinazolines (eg, alfuzosin) because the risk of their side effects may be increased by Itraconazole Capsules

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

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

Take Itraconazole Capsules after a full meal. If you have low stomach acid or you take medicine to reduce stomach acid, take Itraconazole Capsules with a cola beverage.

Do not take antacids within 1 hour before or 2 hours after taking Itraconazole Capsules.

Take Itraconazole Capsules at least 2 hours before proton pump inhibitors (eg, omeprazole).

To clear up your infection completely, take Itraconazole Capsules for the full course of treatment. Keep taking it even if you feel better in a few days. Do not miss any doses.

Itraconazole Capsules works best if it is taken at the same time each day.

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

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

Important safety information:

Itraconazole Capsules may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Itraconazole Capsules with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

Rarely, Itraconazole Capsules has been associated with serious, sometimes fatal liver damage. Contact your doctor right away if you notice dark urine, pale stools, a swollen or tender stomach, or yellowing of the skin or eyes.

Itraconazole Capsules only works against fungi; it does not treat viral infections (eg, the common cold).

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

Do not switch between the capsule and oral solution forms of Itraconazole Capsules without checking with your doctor. Effectiveness and side effects of these forms of Itraconazole Capsules may be different even at the same dose.

Diabetes patients - Itraconazole Capsules may increase the risk of low blood sugar from your diabetes medicine. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.

Hormonal birth control (eg, birth control pills) may not work as well while you are using Itraconazole Capsules. To prevent pregnancy, use an extra form of birth control (eg, condoms).

If you are using Itraconazole Capsules to treat a certain type of fungal infection (onychomycosis), you should use an effective form of birth control while you are taking Itraconazole Capsules and for 2 months after you have stopped treatment. Talk with your doctor about effective forms of birth control.

Tell your doctor or dentist that you take Itraconazole Capsules before you receive any medical or dental care, emergency care, or surgery.

Lab tests, including liver function, may be performed while you use Itraconazole Capsules. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

Use Itraconazole Capsules with caution in the ELDERLY; they may be more sensitive to its effects, especially loss of hearing.

Itraconazole Capsules should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.

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

Possible side effects of Itraconazole Capsules:

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:

Diarrhea; dizziness; gas; headache; nausea; runny nose; stomach pain or upset; unpleasant taste; vomiting.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloating; chest pain; confusion; coughing up white or pink mucus; dark urine; decreased sexual ability; depression; fast or irregular heartbeat; fever, chills, or sore throat; hair loss; increased or uncontrolled urination; joint pain; loss of appetite; loss of hearing; muscle pain, weakness, or cramping; numbness, burning, or tingling of the hands, arms, legs, or feet; pale stools; red, swollen, blistered, or peeling skin; ringing in the ears; sensitivity to sunlight; severe or persistent nausea or vomiting; severe stomach or back pain; shortness of breath; sudden weight gain; swelling of the hands, ankles, or feet; swollen or tender stomach; trouble sleeping; unusual bruising or bleeding; unusual tiredness or fatigue; vision problems (eg, blurred vision, double vision); yellowing of the skin or eyes.

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

See also: Itraconazole side effects (in more detail)

If OVERDOSE is suspected:

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

Proper storage of Itraconazole Capsules:

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

General information:

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

Itraconazole Capsules 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 Itraconazole Capsules. 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

More Itraconazole resources

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

Compare Itraconazole with other medications

Aspergillosis, Aspergilloma
Blastomycosis
Candida Infections, Systemic
Candida Urinary Tract Infection
Coccidioidomycosis
Cryptococcosis
Dermatophytosis
Esophageal Candidiasis
Febrile Neutropenia
Histoplasmosis
Onychomycosis, Fingernail
Onychomycosis, Toenail
Oral Thrush
Paracoccidioidomycosis
Sporotrichosis
Tinea Capitis
Tinea Versicolor
Vaginal Yeast Infection

Thursday, August 23, 2012

Nitroquick oral/sublingual

Generic Name: nitroglycerin (oral/sublingual) (NYE troe GLI ser in (OR al/sub LIN gwal))

Brand Names: Nitro-Time, Nitrolingual, Nitrolingual Duo Pack, Nitromist, Nitrostat

What is nitroglycerin?

Nitroglycerin is in a group of drugs called nitrates. Nitroglycerin dilates (widens) blood vessels, making it easier for blood to flow through them and easier for the heart to pump.

Nitroglycerin is used to treat or prevent attacks of chest pain (angina).

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

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

Do not use nitroglycerin if you are taking sildenafil (Viagra, Revatio). Serious, life-threatening side effects can occur if you take nitroglycerin while you are using sildenafil.

Nitroglycerin can cause severe headaches, especially when you first start using it. These headaches may gradually become less severe as you continue to use nitroglycerin. Do not stop taking the medication. Ask your doctor before using any headache pain medication.

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

Do not use nitroglycerin if you are taking sildenafil (Viagra, Revatio). Serious, life-threatening side effects can occur if you take nitroglycerin while you are using sildenafil.

Do not use this medication without the advice of a doctor if you have early signs of a heart attack (chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling). Seek emergency medical attention if you have symptoms of a heart attack.

You should not use this medication if you are allergic to nitroglycerin or other nitrates such as isosorbide dinitrate (Dilatrate, Isordil, Isochron) or isosorbide mononitrate (Imdur, ISMO, Monoket), or if you have:

severe anemia (a lack of red blood cells); or

a brain injury, hemorrhage, or tumor.

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

congestive heart failure;

a history of heart attack, stroke, or head injury;

low blood pressure;

glaucoma;

migraine headaches; or

liver disease.

FDA pregnancy category C. It is not known whether nitroglycerin will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether nitroglycerin 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 should I take nitroglycerin?

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.

If possible, try to rest or stay seated when you use this medication. Nitroglycerin can cause dizziness or fainting.

If you use nitroglycerin sublingual spray to treat an angina attack: At the first sign of an attack, apply the spray directly on or under your tongue. Close your mouth after each spray. Do not inhale the spray. Do not shake the spray before or during use. You may use additional sprays every 5 minutes, but not more than 3 sprays in 15 minutes.

You may use nitroglycerin spray within 5 to 10 minutes before an activity you think might cause chest pain. Follow your doctor's instructions.

The nitroglycerin sublingual tablet should be placed under your tongue and allowed to dissolve slowly. Do not chew or swallow it. You may use additional tablets every 5 minutes, but not more than 3 tablets in 15 minutes.

Seek emergency medical attention if your chest pain gets worse or lasts more than 5 minutes, especially if you have trouble breathing or feel weak, dizzy, or nauseated, or lightheaded. You may feel a slight burning or stinging in your mouth when you use this medication. However, this sensation is not a sign of how well the medication is working. Do not use more medication just because you do not feel a burning or stinging. Do not crush, chew, break, or open an extended-release capsule. Swallow the pill whole. It is specially made to release medicine slowly in the body. Breaking or opening the pill would cause too much of the drug to be released at one time.

This medication can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using nitroglycerin.

Keep this medicine on hand at all times in case of an angina attack. Get your prescription refilled before you run out of medicine completely.

If you take nitroglycerin on a regular schedule to prevent angina, do not stop taking it suddenly or you could have a severe attack of angina. Store the tablets in the glass container at room temperature, away from moisture and heat. Keep the spray away from open flame or high heat, such as in a car on a hot day. The canister may explode if it gets too hot.

What happens if I miss a dose?

Since nitroglycerin is taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if your next dose is less than 2 hours away. 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. An overdose of nitroglycerin can be fatal.

Overdose symptoms may include a severe throbbing headache, confusion, fever, fast or pounding heartbeats, dizziness, vision problems, nausea, vomiting, bloody diarrhea, trouble breathing, cold or clammy skin, feeling light-headed, fainting, and seizures.

What should I avoid while taking nitroglycerin?

Nitroglycerin can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid drinking alcohol. It can increase some of the side effects of nitroglycerin, such as dizziness, drowsiness, feeling light-headed, or fainting.

Nitroglycerin side effects

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

fast, slow, pounding, or uneven heart rate;

blurred vision or dry mouth;

nausea, vomiting, sweating, pale skin, feeling like you might pass out; or

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

Less serious side effects may include:

mild burning or tingling with the tablet in your mouth;

warmth, redness, or tingly feeling under your skin; or

feeling weak or dizzy.

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 nitroglycerin?

Many drugs can interact with nitroglycerin. Below is just a partial list. Tell your doctor if you are using:

alteplase (Activase);

aspirin or heparin;

bladder or urinary medications such as oxybutynin (Ditropan) or tolterodine (Detrol);

blood pressure medication;

bronchodilators such as ipratropium (Atrovent) or tiotropium (Spiriva);

dihydroergotamine (D.H.E. 45, Migranal) or ergotamine (Ergomar, Cafergot, and others);

an erectile dysfunction medication such as tadalafil (Cialis) or vardenafil (Levitra);

an antidepressant such as amitriptyline (Elavil, Etrafon), clomipramine (Anafranil), imipramine (Tofranil), and others;

a beta-blocker such as atenolol (Tenormin), carvedilol (Coreg), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal), sotalol (Betapace), and others;

a calcium channel blocker such as diltiazem (Tiazac, Cardizem), nifedipine (Procardia), nimodipine (Nimotop), verapamil (Calan, Covera, Verelan), and others;

irritable bowel medications such as dicyclomine (Bentyl), hyoscyamine (Anaspaz, Cystospaz, and others), or propantheline (Pro-Banthine);

any medication that causes dry mouth; or

medicines to treat psychiatric disorders, such as chlorpromazine (Thorazine), haloperidol (Haldol), thioridazine (Mellaril), and others.

This list is not complete and there are many other drugs that can interact with nitroglycerin. 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 Nitroquick resources

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

Compare Nitroquick with other medications

Angina
Angina Pectoris Prophylaxis
Heart Attack
Heart Failure
High Blood Pressure

Where can I get more information?

Your pharmacist can provide more information about nitroglycerin.

See also: Nitroquick side effects (in more detail)

Sunday, August 19, 2012

Nora-BE

Generic Name: progestin contraceptives (Oral route, Parenteral route)

Commonly used brand name(s)

In the U.S.

Aygestin

Camila

Errin

Jolivette

Next Choice

Nora-BE

Nor-QD

Ortho Micronor

Ovrette

Plan B

Plan B One-Step

Provera

Available Dosage Forms:

Tablet

Uses For Nora-BE

Progestins are hormones.

The low-dose progestins for contraception are used to prevent pregnancy. Other names for progestin-only oral contraceptives are minipills and progestin-only pills (POPs). Progestins can prevent fertilization by preventing a woman's egg from fully developing.

Also, progestins cause changes at the opening of the uterus, such as thickening of the cervical mucus. This makes it hard for the partner's sperm to reach the egg. The fertilization of the woman's egg with her partner's sperm is less likely to occur while she is taking, receiving, or using a progestin, but it can occur. Even so, the progestins make it harder for the fertilized egg to become attached to the walls of the uterus, making it difficult to become pregnant.

No contraceptive method is 100 percent effective. Studies show that fewer than 1 of each 100 women become pregnant during the first year of use after correctly receiving the injection on time. Fewer than 10 of each 100 women who take progestins correctly by mouth for contraception become pregnant during the first year of use. Methods that do not work as well include condoms, diaphragms, or spermicides. Discuss with your doctor what your options are for birth control.

Progestin contraceptives are available only with your doctor's prescription.

Importance of Diet

Make certain your doctor knows if you are on any special diet, such as a low-sodium or low-sugar diet.

Before Using Nora-BE

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Progestins have been used by teenagers and have not been shown to cause different side effects or problems than they do in adults. You must take progestin-only oral contraceptives every day in order for them to work. Progestins do not protect against sexually transmitted diseases, a risk factor for teenagers. It is not known if Depo-Provera Contraceptive Injection causes problems with bone development and growth in teenagers and young women. It is important that your doctor check you regularly for growth problems, especially if you have been using this medicine for 2 years or longer.

Geriatric

This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Pregnancy

Use of progestin-only contraceptives during pregnancy is not recommended. Doctors should be told if pregnancy is suspected. When accidently used during pregnancy, progestins used for contraception have not caused problems.

Breast Feeding

Although progestins pass into the breast milk, the low doses of progestins used for contraception have not been shown to cause problems in nursing babies. Progestins used for contraception are recommended for nursing mothers when contraception is desired.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking any of these medicines, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using medicines in this class with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Isotretinoin

Theophylline

Tizanidine

Tranexamic Acid

Interactions with Food/Tobacco/Alcohol

Proper Use of progestin contraceptives

This section provides information on the proper use of a number of products that contain progestin contraceptives. It may not be specific to Nora-BE. Please read with care.

To make the use of a progestin as safe and reliable as possible, you should understand how and when to take it and what effects may be expected. Progestins for contraception usually come with patient directions. Read them carefully before taking or using this medicine.

Progestins do not protect a woman from sexually transmitted diseases (STDs), including human immunodeficiency virus (HIV), or acquired immunodeficiency syndrome (AIDS). The use of latex (rubber) condoms or abstinence is recommended for protection from these diseases.

Take this medicine only as directed by your doctor. Do not take more of it and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects. Try to take the medicine at the same time each day to reduce the possibility of side effects and to allow it to work better.

When using levonorgestrel tablet dosage form for emergency contraception:

The tablets may be taken at any time during the menstrual cycle.

When using medroxyprogesterone injection dosage form for contraception:

Your injection is given by a health care professional every 3 months.

To stop using medroxyprogesterone injection for contraception, simply do not have another injection.

Full protection from pregnancy begins immediately if you receive the first injection within the first 5 days of your menstrual period or within 5 days after delivering a baby if you will not be breast-feeding. If you are going to breast-feed, you may have to wait for 6 weeks from your delivery date before receiving your first injection. If you follow this schedule, you do not need to use another form of birth control. Protection from that one injection ends at 3 months. You will need another injection every 3 months to have full protection from becoming pregnant. However, if the injection is given later than 5 days from the first day of your last menstrual period, you will need to use another method of birth control as directed by your doctor.

When using an oral progestin dosage form:

Take a tablet every 24 hours each day of the year. Taking the medicine at the same time each day helps to reduce the possibility of side effects and makes it work as expected. Taking your tablet 3 hours late is the same as missing a dose and can cause the medicine to not work properly.

Keep the tablets in the container in which you received them to help you to keep track of your dosage schedule.

When switching from estrogen and progestin oral contraceptives, you should take the first dose of the progestin-only contraceptive the next day after the last active pill of the estrogen and progestin oral contraceptive has been taken. This means you will not take the last 7 days (placebo or nonactive pills) of a 28-day cycle of the estrogen and progestin oral contraceptive pack. You will begin a new pack of progestin-only birth control pills on the 22nd day.

Also, when switching, full protection from pregnancy begins after 48 hours if the first dose of the progestin-only contraceptive is taken on the first day of the menstrual period. If the birth control is begun on other days, full protection may begin 3 weeks after you begin taking the medicine for the first time. You should use a second method of birth control for at least the first 3 weeks to ensure full protection. You are not fully protected if you miss pills. The chances of your getting pregnant are greater with each pill that is missed.

Follow your doctor's orders to schedule the proper time to receive an injection of progestins for contraception.

Dosing

The dose medicines in this class will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of these medicines. If your dose is different, do not change it unless your doctor tells you to do so.

For levonorgestrel

For oral dosage form (tablets):
- For emergency contraception for preventing pregnancy:
  - Adults and teenagers—The first dose of 0.75 milligram should be taken as soon as possible within 72 hours of intercourse. The second dose must be taken 12 hours later.

For medroxyprogesterone

For muscular injection dosage form
- For preventing pregnancy:
  - Adults and teenagers—150 milligrams injected into a muscle in the upper arm or in the buttocks every three months (13 weeks).

For subcutaneous injection dosage form
- For preventing pregnancy:
  - Adults and teenagers—104 milligrams injected under the skin of the anterior thigh or abdomen every three months (12 to 14 weeks).

For norethindrone

For oral dosage form (tablets):
- For preventing pregnancy:
  - Adults and teenagers—0.35 milligrams every 24 hours, beginning on the first day of your menstrual cycle whether menstrual bleeding begins or not. The first day of your menstrual cycle can be figured out by counting 28 days from the first day of your last menstrual cycle.

For norgestrel

For oral dosage form (tablets):
- For preventing pregnancy:
  - Adults and teenagers—75 micrograms every 24 hours, beginning on the first day of your menstrual cycle whether menstrual bleeding occurs or not. The first day of your menstrual cycle can be figured out by counting 28 days from the first day of your last menstrual cycle.

Missed Dose

Call your doctor or pharmacist for instructions.

For oral dosage form (tablets):

When you miss 1 day's dose of oral tablets or are 3 hours or more late in taking your dose, many doctors recommend that you take the missed dose immediately, continue your normal schedule, and use another method of contraception for 2 days. This is different from what is done after a person misses a dose of birth control tablets that contain more than one hormone.

For injection dosage form:

If you miss having your next injection and it has been longer than 13 weeks since your last injection, your doctor may want you to stop receiving the medicine. Use another method of birth control until your period begins or until your doctor determines that you are not pregnant.

If your doctor has other directions, follow that advice. Any time you miss a menstrual period within 45 days after a missed or delayed dose you will need to be tested for a possible pregnancy.

Storage

Keep out of the reach of children.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Nora-BE

It is very important that your doctor check your progress at regular visits. This will allow your dosage to be adjusted to your changing needs, and will allow any unwanted effects to be detected. These visits are usually every 12 months when you are taking progestins by mouth for birth control.

If you are receiving the medroxyprogesterone injection for contraception, a physical exam is needed only every 12 months, but you need an injection every 3 months. Your doctor will also want to check you for any bone development or growth problems, especially if you are a teenager or young adult.

Progestins may cause dizziness in some people. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert.

It is possible that certain doses of progestins may cause a temporary thinning of the bones by changing your hormone balance. It is important that your doctor know if you have an increased risk of osteoporosis. Some things that can increase your risk for osteoporosis include cigarette smoking, abusing alcohol, taking or drinking large amounts of caffeine, and having a family history of osteoporosis or easily broken bones. Some medicines, such as steroids (cortisone-like medicines) or anticonvulsants (seizure medicines), can also cause thinning of the bones. It is especially important that you tell your doctor about any of these risk factors if you are taking Depo-Provera® Contraceptive Injection or Depo-SubQ Provera® 104. These contraceptives may cause a loss of bone mineral density. Your doctor may replace these contraceptives with a different one.

Vaginal bleeding of various amounts may occur between your regular menstrual periods during the first 3 months of use. This is not unusual and does not mean you should stop the medicine. This is sometimes called spotting when the bleeding is slight, or breakthrough bleeding when it is heavier. If this occurs, continue on your regular dosing schedule. Check with your doctor:

If vaginal bleeding continues for an unusually long time.

If your menstrual period has not started within 45 days of your last period.

Missed menstrual periods may occur. If you suspect a pregnancy, you should call your doctor immediately.

If you are scheduled for any laboratory tests, tell your doctor that you are taking a progestin. Progestins can change certain test results.

The following medicines might reduce the effectiveness of progestins for contraception:

Aminoglutethimide (e.g., Cytadren®)

Carbamazepine (e.g., Tegretol®)

Phenobarbital

Phenytoin (e.g., Dilantin®)

Rifabutin (e.g., Mycobutin®)

Rifampin (e.g., Rifadin®)

Sometimes your doctor may use these medicines with progestins for contraception, but the doctor will give you special directions to follow to make sure your progestin is working properly. In order to prevent pregnancy, use a second method of birth control together with the progestin when you also use a medicine that could reduce the effectiveness of the progestin. If you are using medroxyprogesterone injection for contraception, continue using a back-up method of birth control until you have your next injection, even if the medicine that affects contraceptives is discontinued. If you are using the oral tablets, continue using a back-up method of birth control for a full cycle (or 4 weeks), even if the medicine that affects contraceptives is discontinued.

If you vomit your oral progestin-only contraceptive for any reason within a few hours after taking it, do not take another dose. Return to your regular dosing schedule and use an additional back-up method of birth control for 48 hours.

If you are receiving levonorgestrel tablets for emergency contraception and vomiting occurs within 1 hour after taking either dose of the medicine, contact your physician to discuss whether the dose should be repeated.

Nora-BE Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

More common

Changes in uterine bleeding (increased amounts of menstrual bleeding occurring at regular monthly periods

heavier uterine bleeding between regular monthly periods

lighter uterine bleeding between menstrual periods

or stopping of menstrual periods

Less common

Mental depression

skin rash

unexpected or increased flow of breast milk

Incidence not known - for patients taking Depo-Provera Contraceptive Injection

Cough

decrease in height

difficulty swallowing

fast heartbeat

hives, itching, puffiness, or swelling of the eyelids or around the eyes, face, lips or tongue

pain in back, ribs, arms, or legs

pain or swelling in arms or legs without any injury

shortness of breath

skin rash

tightness in chest

wheezing

More common

Abdominal pain or cramping

diarrhea

dizziness

fatigue

mild headache

mood changes

nausea

nervousness

pain or irritation at the injection site

swelling of face, ankles, or feet

unusual tiredness or weakness

vomiting

weight gain

Less common

Acne

breast pain or tenderness

brown spots on exposed skin, possibly long-lasting

hot flashes

loss or gain of body, facial, or scalp hair

loss of sexual desire

trouble in sleeping

Not all of the side effects listed above have been reported for each of these medicines, but they have been reported for at least one of them. All of the progestins are similar, so any of the above side effects may occur with any of these medicines.

After you stop using this medicine, your body may need time to adjust. The length of time this takes depends on the amount of medicine you were using and how long you used it. During this period of time, check with your doctor if you notice any of the following side effects:

Delayed return to fertility

stopping of menstrual periods

unusual menstrual bleeding (continuing)

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.