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Sunday, 19 August 2012

Capastat

Generic Name: Capreomycin Sulfate
Class: Antituberculosis Agents
VA Class: AM500
CAS Number: 1405-37-4

Use great caution in patients with renal insufficiency or preexisting auditory impairment; weigh risk of additional eighth-cranial nerve impairment or renal injury against benefits of the drug.¹⁰²

Concomitant use with other parenteral antituberculosis agents (streptomycin, viomycin [not commercially available in the US]) with similar and sometimes irreversible toxic effects, particularly on eighth-cranial nerve and renal function, not recommended.¹⁰² Use concomitantly with other ototoxic or nephrotoxic drugs (e.g., amikacin, colistimethate/colistin, gentamicin, kanamycin, neomycin, polymyxin A sulfate, tobramycin, vancomycin) with great caution.¹⁰² (See Interactions.)

Safe use during pregnancy not established.¹⁰² (See Pregnancy under Cautions.)

Safety and efficacy not established in pediatric patients.¹⁰²

Introduction

Antituberculosis agent;¹⁰⁰ ¹⁰² polypeptide antibiotic complex of 4 microbiologically active components.¹⁰²

Uses for Capastat

Tuberculosis

Treatment of active (clinical) tuberculosis (TB) in conjunction with other antituberculosis agents.¹⁰⁰ ¹⁰¹ ¹⁰²

Second-line agent used in treatment of drug-resistant TB caused by Mycobacterium tuberculosis known or presumed to be susceptible to capreomycin.¹⁰⁰ ¹⁰¹ ¹⁰²

For initial treatment of active TB caused by drug-susceptible M. tuberculosis, recommended multiple-drug regimens consist of an initial intensive phase (2 months) and a continuation phase (4 or 7 months).¹⁰⁰ ¹⁰¹ Although the usual duration of treatment for drug-susceptible pulmonary and extrapulmonary TB (except disseminated infections and TB meningitis) is 6–9 months,¹⁰⁰ ¹⁰¹ ATS, CDC, and IDSA state that completion of treatment is determined more accurately by the total number of doses and should not be based solely on the duration of therapy.¹⁰⁰ A longer duration of treatment (e.g., 12–24 months) usually is necessary for infections caused by drug-resistant M. tuberculosis.¹⁰⁰ ¹⁰¹

Patients with treatment failure or drug-resistant M. tuberculosis, including multidrug-resistant (MDR) TB (resistant to both isoniazid and rifampin) or extensively drug-resistant (XDR) TB (resistant to both isoniazid and rifampin and also resistant to a fluoroquinolone and at least one parenteral second-line antimycobacterial such as capreomycin, kanamycin, or amikacin), should be referred to or managed in consultation with experts in the treatment of TB as identified by local or state health departments or CDC.¹⁰⁰

Capastat Dosage and Administration

Administration

Administer by IV infusion or deep IM injection.¹⁰²

IV Administration

Reconstitution and Dilution

Reconstitute 1-g vial by adding 2 mL of 0.9% sodium chloride injection or sterile water for injection.¹⁰² Alternatively, reconstitute 1-g vial with 2.15, 2.63, 3.3, or 4.3 mL of 0.9% sodium chloride injection or sterile water for injection to provide solutions containing approximately 370, 315, 260, or 210 mg/mL, respectively, taking into account the retention volume.¹⁰² Allow 2–3 minutes for complete dissolution.¹⁰²

For IV infusion, reconstituted solution must be further diluted with 100 mL of 0.9% sodium chloride injection.¹⁰²

Rate of Administration

Administer by IV infusion over 60 minutes.¹⁰²

IM Administration

Administer by deep IM injection into a large muscle mass.¹⁰²

Avoid superficial IM injections since they may be associated with increased pain and development of sterile abscesses.¹⁰²

Reconstitution

Dosage

Available as capreomycin sulfate; dosage expressed in terms of capreomycin.¹⁰²

Should not be used alone for treatment of active (clinical) TB; must be given in conjunction with other antituberculosis agents.¹⁰⁰ ¹⁰¹ ¹⁰²

Can be used in daily or intermittent (2 times weekly) multiple-drug TB regimens.¹⁰⁰

Pediatric Patients

Tuberculosis

Treatment of Active (Clinical) Tuberculosis

IV or IM

Children <15 years of age or weighing ≤40 kg†: 15–30 mg/kg daily (up to 1 g) ¹⁰⁰ ¹⁰¹ given once daily or twice weekly¹⁰⁰ recommended by ATS, CDC, IDSA, and AAP.

Children ≥15 years of age†: 15 mg/kg daily (up to 1 g) given as a single daily dose 5–7 times weekly for the first 2–4 months or until culture conversion recommended by ATS, CDC, and IDSA; dosage can then be reduced to 15 mg/kg daily (up to 1 g) given 2 or 3 times weekly, depending on efficacy of the other drugs in the regimen.¹⁰⁰

Adults

Tuberculosis

Treatment of Active (Clinical) Tuberculosis

IV or IM

15 mg/kg daily (up to 1 g) given as a single daily dose 5–7 times weekly for the first 2–4 months or until culture conversion recommended by ATS, CDC, and IDSA; dosage can then be reduced to 15 mg/kg daily (up to 1 g) given 2 or 3 times weekly, depending on efficacy of the other drugs in the regimen.¹⁰⁰

Manufacturer recommends 1 g (up to 20 mg/kg) daily for 60–120 days, followed by 1 g 2–3 times weekly.¹⁰²

Prescribing Limits

Pediatric Patients

Tuberculosis

Treatment of Active (Clinical) Tuberculosis

IV or IM

Maximum 1 g per dose in once-daily or 2- or 3-times weekly regimens.¹⁰⁰ ¹⁰¹

Adults

Tuberculosis

Treatment of Active (Clinical) Tuberculosis

IV or IM

Maximum 1 g per dose in once-daily or 2- or 3-times weekly regimens.¹⁰⁰ ¹⁰²

Adults >59 years of age: Maximum 750 mg per dose in once-daily or 2- or 3-times weekly regimens.¹⁰⁰

Special Populations

Renal Impairment

Reduce dosage based on the degree of renal impairment.¹⁰⁰ ¹⁰² Use with caution and monitor serum capreomycin concentrations.¹⁰⁰ ¹⁰² (See Ototoxicity and Nephrotoxicity under Cautions.)

Manufacturer recommends that dosage in adults with renal impairment be based on Cl_cr and adjusted to maintain mean steady-state serum capreomycin concentrations of 10 mcg/mL.¹⁰² Consult manufacturer's literature for specific dosage recommendations for these patients.¹⁰²

Some experts suggest a reduced dosage of 12–15 mg/kg given 2 or 3 times weekly.¹⁰⁰

Doses in patients undergoing hemodialysis should be given after dialysis since the drug is removed by this procedure.¹⁰⁰

Geriatric Patients

Manufacturer states no dosage adjustments except those related to renal impairment.¹⁰² Select dosage with caution (usually starting at low end of dosage range).¹⁰² (See Geriatric Use under Cautions.)

Adults >59 years of age: ATS, CDC, and IDSA recommend 10 mg/kg (up to 750 mg) per dose.¹⁰⁰ (See Geriatric Use under Cautions.)

Cautions for Capastat

Contraindications

Hypersensitivity to capreomycin.¹⁰²

Warnings/Precautions

Warnings

Ototoxicity and Nephrotoxicity

Nephrotoxicity and ototoxicity, the most serious adverse effects of capreomycin,^a are most likely to occur in patients with renal impairment, in geriatric patients, and in patients receiving other nephrotoxic and/or ototoxic drugs.¹⁰² ^a (See Interactions.)

Renal toxicity may be manifested by tubular necrosis, increased BUN, increased S_cr, decreased Cl_cr, abnormal urinary sediment, proteinuria, and presence of casts, erythrocytes, and leukocytes in the urine.¹⁰² ^a Usually reversible when the drug is discontinued, but fatal toxic nephritis has occurred rarely.^a Nephrotoxicity is most closely related to AUC of the drug.¹⁰² Electrolyte disturbances resembling Bartter's syndrome reported rarely.¹⁰²

May cause damage to both the auditory and vestibular portions of the eighth-cranial nerve.^a Some audiometric changes have been reversible, but hearing loss that was permanent (but not progressive) has been reported.¹⁰² Injury to the vestibular branch of the eighth-cranial nerve has resulted in headache, tinnitus, and vertigo.^a

Damage to auditory and vestibular divisions of the eighth-cranial nerve generally associated with capreomycin therapy in patients with impaired renal function or dehydration or those receiving other drugs with additive auditory toxicities; these patients often experience dizziness, tinnitus, vertigo, and a loss of high-tone acuity.¹⁰²

Assess renal, auditory, and vestibular function prior to and at regular intervals during capreomycin therapy.¹⁰² Manufacturer recommends that renal function be monitored once weekly.¹⁰² (See Geriatric Use under Cautions.)

BUN concentrations >30 mg/dL or any other evidence of decreasing renal function (with or without an increase in BUN) requires careful evaluation; dosage should be decreased or the drug discontinued.¹⁰² Clinical importance of abnormal urine sediment and slightly increased BUN (or S_cr) during long-term capreomycin therapy not established.¹⁰²

Use with extreme caution in patients with renal insufficiency or auditory impairment; weigh the risk of additional renal impairment or eighth cranial nerve damage against the possible benefits of capreomycin therapy.¹⁰²

Neuromuscular Blockade

Partial neuromuscular blockade, which was enhanced by ether anesthesia and antagonized by neostigmine, has been reported with large IV doses of capreomycin.¹⁰² Neuromuscular blockade or respiratory paralysis may occur following rapid IV infusion.¹⁰²

Sensitivity Reactions

Hypersensitivity Reactions

Hypersensitivity reactions (e.g., urticaria, photosensitivity, maculopapular rash), which may be associated with fever, have occurred.¹⁰² ^a

Use with caution in patients with a history of allergic reaction, especially to drugs.¹⁰²

General Precautions

Precautions Related to Treatment of Tuberculosis

Should not be used alone for treatment of active (clinical) TB; must be given in conjunction with other antituberculosis agents.¹⁰⁰ ¹⁰¹ ¹⁰²

Clinical specimens for microscopic examination and mycobacterial cultures and in vitro susceptibility testing should be obtained prior to initiation of antituberculosis therapy and periodically during treatment to monitor therapeutic response.¹⁰⁰ ¹⁰² The antituberculosis regimen should be modified as needed.¹⁰⁰ Patients with positive cultures after 4 months of treatment should be considered to have failed treatment (usually as the result of noncompliance or drug-resistant TB).¹⁰⁰

If added as a new drug to a regimen in patients experiencing treatment failure who have proven or suspected drug-resistant TB, at least 2 (preferably 3) new drugs known or expected to be active against the resistant strain should be added at the same time.¹⁰⁰

Compliance with the full course of antituberculosis therapy and all drugs included in the multiple-drug regimen is critical.¹⁰⁰ Missed doses increase the risk of treatment failure and increase the risk that M. tuberculosis will develop resistance to the antituberculosis regimen.¹⁰⁰

To ensure compliance, ATS, CDC, IDSA, and AAP recommend that directly observed (supervised) therapy (DOT) be used for treatment of active TB whenever possible, especially when intermittent regimens are used, when the patient is immunocompromised or infected with HIV, or when drug-resistant M. tuberculosis is involved.¹⁰⁰ ¹⁰¹

Laboratory Monitoring

Monitor renal function prior to and once weekly during capreomycin treatment.¹⁰² Monitor hepatic function periodically.¹⁰²

Monitor serum potassium concentrations since hypokalemia may occur.¹⁰² Some experts recommend that serum potassium and magnesium be assessed at baseline and at least once monthly.¹⁰⁰

Specific Populations

Pregnancy

Category C.¹⁰²

ATS, CDC, and IDSA state that use of capreomycin should be avoided during pregnancy because of risk of fetal nephrotoxicity and ototoxicity.¹⁰⁰

Lactation

Not known whether capreomycin is distributed into milk.¹⁰² Use caution in nursing women.¹⁰²

Pediatric Use

Safety and efficacy not established.¹⁰²

Geriatric Use

No evidence that patients ≥65 years of age respond differently than younger adults.¹⁰²

Select dosage with caution (usually starting at low end of dosage range) because of age-related decreases in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy.¹⁰²

Substantially eliminated by kidneys; risk of toxicity may be greater in patients with impaired renal function.¹⁰² Monitor renal function since geriatric patients are more likely to have renal impairment.¹⁰² (See Renal Impairment under Dosage and Administration.)

Because geriatric patients are more likely to have impaired hearing at baseline, perform audiometric measurements and assess vestibular function prior to and at regular intervals during capreomycin therapy.¹⁰²

Renal Impairment

Use with caution because of risk of nephrotoxicity and/or neurotoxicity.¹⁰⁰ ¹⁰² Dosage adjustments required in those with known or suspected renal impairment.¹⁰⁰ ¹⁰²

If BUN concentrations increase to >30 mg/dL or there is any other evidence of decreasing renal function (with or without an increase in BUN), the patient should be carefully evaluated and capreomycin dosage reduced or the drug discontinued.¹⁰²

Common Adverse Effects

Nephrotoxicity, ototoxicity, injection site reactions.¹⁰²

Interactions for Capastat

Ototoxic or Nephrotoxic Drugs

Concomitant or sequential use with other drugs that have ototoxic or nephrotoxic effects may result in additive toxicity and should be avoided, if possible.¹⁰² Use concomitantly only with great caution.¹⁰²

Specific Drugs

Drug	Interaction	Comments
Aminoglycosides	Possible increased risk of ototoxicity or nephrotoxicity¹⁰²	Concomitant use with streptomycin not recommended;¹⁰² use concomitantly with other aminoglycosides (amikacin, gentamicin, kanamycin, neomycin, tobramycin) only with great caution¹⁰²
Colistimethate/Colistin	Possible increased risk of nephrotoxicity and/or neurotoxicity¹⁰²	Use concomitantly only with great caution¹⁰²
Neuromuscular blocking agents	Possible potentiation of neuromuscular blockade¹⁰²
Polymyxin B	Possible increased risk of nephrotoxicity and/or neurotoxicity¹⁰²	Use concomitantly only with great caution¹⁰²
Vancomycin	Possible increased risk of nephrotoxicity and/or neurotoxicity¹⁰²	Use concomitantly only with great caution¹⁰²

Capastat Pharmacokinetics

Absorption

Bioavailability

Not appreciably absorbed from the GI tract; must be given parenterally.¹⁰²

Following IM administration, peak serum concentrations attained within 1–2 hours.¹⁰²

Plasma Concentrations

Peak serum concentrations after IV infusion are 30% higher than those following IM injection;¹⁰² AUC is similar for both routes.¹⁰²

No evidence of accumulation in plasma in patients with normal renal function.¹⁰²

Distribution

Extent

Information not available on distribution of capreomycin into body tissues or fluids.^a

Does not distribute into CSF.¹⁰⁰

Not known if capreomycin crosses the placenta or is distributed into milk.¹⁰² ^a

Elimination

Elimination Route

Eliminated mainly unchanged in urine by glomerular filtration.^a Animal studies suggest small amounts may also be excreted in bile.^a

Approximately 52% of an IM dose is excreted in urine within 12 hours.¹⁰²

Removed by hemodialysis.¹⁰²

Half-life

4–6 hours in patients with normal renal function.^a

Special Populations

Half-life prolonged in patients with impaired renal function.^a

Stability

Storage

Parenteral

Powder for Injection

15–30°C.¹⁰²

Following reconstitution with 0.9% sodium chloride injection or sterile water for injection, solutions may be stored for up to 24 hours in a refrigerator.¹⁰² Capreomycin solutions may develop a pale straw color and darken with time; this is not associated with loss of potency or development of toxicity.¹⁰²

Actions and SpectrumActions

Usually bacteriostatic in action.^a

Mechanism of antibacterial action not known.^a

Spectrum of activity includes many mycobacterium and some gram-positive and -negative bacteria.^a

Mycobacteria: Active against M. tuberculosis, M. bovis, and M. avium complex (MAC).^a M. kansasii generally is resistant.¹⁰⁷ ¹⁰⁸

Natural and acquired resistance to capreomycin demonstrated in vitro and in vivo in strains of M. tuberculosis.¹⁰³ ¹⁰⁴ ^a

Cross-resistance frequently occurs between capreomycin and viomycin (not commercially available in the US);¹⁰² ¹⁰⁴ cross-resistance also can occur between capreomycin and kanamycin or neomycin.¹⁰² ¹⁰⁴ No evidence of cross-resistance between capreomycin and other antituberculosis agents available in the US.¹⁰²

There have been recent reports of extensively drug-resistant (XDR) TB.¹⁰⁵ ¹⁰⁶ XDR TB is caused by M. tuberculosis resistant to rifampin and isoniazid (multiple-drug resistant strains) that also are resistant to a fluoroquinolone and at least one parenteral second-line antimycobacterial (capreomycin, kanamycin, amikacin).¹⁰⁵ ¹⁰⁶

Advice to Patients

Advise patients that poor compliance with antituberculosis regimens can result in treatment failure and development of drug-resistant TB, which can be life-threatening and lead to other serious health risks.¹⁰⁰

Importance of discontinuing therapy and informing clinicians if an allergic reaction occurs.¹⁰²

Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.¹⁰²

Importance of women informing clinician if they are or plan to become pregnant or plan to breast-feed.¹⁰²

Importance of advising patients of other important precautionary information.¹⁰² (See Cautions.)

Preparations

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

Capreomycin Sulfate
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	For injection	1 g (of capreomycin)	Capastat Sulfate	Lilly

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 January 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

100. Centers for Disease Control and Prevention. Treatment of tuberculosis, American Thoracic Society, CDC, and Infectious Diseases Society of America. MMWR Recomm Rep. 2003; 52(RR-11):1-77.

101. American Academy of Pediatrics. 2006 Red Book: Report of the Committee on Infectious Diseases. 27th ed. Elk Grove Village, IL: American Academy of Pediatrics; 2006.

102. Eli Lilly and Company. Capastat sulfate (capreomycin for injection) prescribing information. Indianapolis, IN; 2003 Dec 8.

103. Mause CE, Plikaytis BB, Shinnick TM. Mutation of tlyA confers capreomycin resistance in Mycobacterium tuberculosis. Antimicrob Agents Chemother. 2005; 49:571-7. [PubMed 15673735]

104. Mause CE, Plikaytis BB, Shinnick TM. Molecular analysis of cross-resistance to capreomycin, kanamycin, amikacin, and viomycin in Mycbacterium tuberculosis. Antimicrob Agents Chemother. 2005; 49:3192-7. [PubMed 16048924]

105. World Health Organization. Extensively drug-resistant tuberculosis (XDR-TB): recommendations for prevention and control. Wkly Epidemiol Rec. 2006; 45:430-2.

106. Gandhi NR, Moll A, Sturm AW et al. Extensively drug-resistant tuberculosis as a cause of death in patients co-infected with tuberculosis and HIV in a rural area of South Africa. Lancet. 2006; 368:1575-80. [PubMed 17084757]

107. Griffith DE, Aksamit T, Brown-Elliott BA et al. An official ATS/IDSA statement: diagnosis, treatment, and prevention of nontuberculous mycobacterial diseases. Am J Respir Crit Care Med. 2007; 175:367-416. [PubMed 17277290]

108. Shitrit D, Baum GL, Priess R et al. Pulmonary Mycobacterium kansasii infection in Israel, 1999-2004: clinical features, drug susceptibility, and outcome. Chest. 2006; 129:771-6. [PubMed 16537880]

a. AHFS Drug Information 2007. McEvoy GK, ed. Capreomycin. American Society of Health-System Pharmacists; 2007:546-8.

More Capastat resources

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

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Tuberculosis, Active

Wednesday, 15 August 2012

St. Joseph 81 mg Adult Chewable Tablets

Pronunciation: AS-pir-in
Generic Name: Aspirin
Brand Name: Examples include Bayer Children's and St. Joseph 81 mg Adult

St. Joseph 81 mg Adult Chewable Tablets are used for:

Treatment of aches and pains associated with headache, common cold, and sore throat and for reduction of fever. It may be used to reduce the risk of death and lessen the damaging effects of an acute heart attack. It is also used to reduce the risk of heart attacks and strokes in certain men and women who have already had a heart attack or ischemic stroke. It may also be used for other conditions as determined by your doctor.

St. Joseph 81 mg Adult Chewable Tablets are a nonsteroidal anti-inflammatory drug (NSAID). It works by inhibiting several different chemical processes within the body that cause pain, inflammation, and fever. It also reduces the tendency for blood to clot.

Do NOT use St. Joseph 81 mg Adult Chewable Tablets if:

you are allergic to any ingredient in St. Joseph 81 mg Adult Chewable Tablets

you are a child or teenager with influenza (flu) or chickenpox

you have bleeding problems such as hemophilia, von Willebrand disease, or low blood platelets

you have had a severe allergic reaction (eg, severe rash, hives, breathing difficulties, dizziness), to aspirin, tartrazine, or an NSAID (eg, ibuprofen, naproxen, celecoxib)

you are taking anticoagulants (eg, heparin, warfarin) or methotrexate

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

Before using St. Joseph 81 mg Adult Chewable Tablets:

Some medical conditions may interact with St. Joseph 81 mg Adult Chewable Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, plan 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 or other substances

if you have alcoholism or if you consume 3 or more alcohol containing drinks every day

if you have asthma, bleeding or clotting problems, growths in the nose (nasal polyps), kidney or liver problems, stomach or peptic ulcers (bleeding ulcers), heartburn, upset stomach, stomach pain, influenza (flu) or chicken pox, or vitamin K deficiency

if you are a child with a stroke, a weakened blood vessel (cerebral aneurysm) or bleeding in the brain, or Kawasaki syndrome (a rare inflammation causing heart problems in children)

Some MEDICINES MAY INTERACT with St. Joseph 81 mg Adult Chewable Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

Carbonic anhydrase inhibitors (eg, acetazolamide) because they may decrease St. Joseph 81 mg Adult Chewable Tablets's effectiveness

Anticoagulants (eg, heparin, warfarin) or nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen, celecoxib) because the risk of their side effects, including risk of bleeding, may be increased by St. Joseph 81 mg Adult Chewable Tablets

Insulin and oral antidiabetics (eg, glyburide, nateglinide) because the risk of their side effects, including low blood sugar (eg, hunger, shakiness or weakness, dizziness, headache, sweating), may be increased by St. Joseph 81 mg Adult Chewable Tablets

Methotrexate or valproic acid because the risk of their actions and side effects may be increased by St. Joseph 81 mg Adult Chewable Tablets

Angiotensin-converting enzyme inhibitors (eg, enalapril), probenecid, or sulfinpyrazone because their effectiveness may be decreased by St. Joseph 81 mg Adult Chewable Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if St. Joseph 81 mg Adult Chewable Tablets 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 St. Joseph 81 mg Adult Chewable Tablets:

Use St. Joseph 81 mg Adult Chewable Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take St. Joseph 81 mg Adult Chewable Tablets by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.

St. Joseph 81 mg Adult Chewable Tablets may be swallowed whole, chewed, or crushed and dissolved in a glass of water, milk, or juice before swallowing.

Take St. Joseph 81 mg Adult Chewable Tablets with a full glass of water (8 oz/240 mL).

Use St. Joseph 81 mg Adult Chewable Tablets exactly as directed on the package, unless instructed differently by your doctor. If you are taking St. Joseph 81 mg Adult Chewable Tablets without a prescription, follow any warnings and precautions on the label.

If you miss a dose of St. Joseph 81 mg Adult Chewable Tablets and you are taking it regularly, 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 St. Joseph 81 mg Adult Chewable Tablets.

Important safety information:

Do not take St. Joseph 81 mg Adult Chewable Tablets for more than 10 days for pain or for more than 3 days for fever unless directed to do so by your health care provider.

St. Joseph 81 mg Adult Chewable Tablets has aspirin in it. Before you start any new medicine, check the label to see if it has aspirin in it too. If it does or if you are not sure, check with your doctor or pharmacist.

Talk to your doctor before you take St. Joseph 81 mg Adult Chewable Tablets or other pain relievers/fever reducers if you drink more than 3 drinks with alcohol per day. St. Joseph 81 mg Adult Chewable Tablets may cause stomach bleeding. Your risk may be greater if you drink alcohol while you are using St. Joseph 81 mg Adult Chewable Tablets.

Serious stomach ulcers or bleeding can occur with the use of St. Joseph 81 mg Adult Chewable Tablets. Taking it in high doses or for a long time, smoking, or drinking alcohol increases the risk of these side effects. Taking St. Joseph 81 mg Adult Chewable Tablets with food will NOT reduce the risk of these effects. Contact your doctor or emergency room at once if you develop severe stomach or back pain; black, tarry stools; vomit that looks like blood or coffee grounds; or unusual weight gain or swelling.

St. Joseph 81 mg Adult Chewable Tablets may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.

Aspirin has been linked to a serious illness called Reye syndrome. Do not give St. Joseph 81 mg Adult Chewable Tablets to a child or teenager who has the flu, chickenpox, or a viral infection. Contact your doctor with any questions or concerns.

Tell your doctor or dentist that you take St. Joseph 81 mg Adult Chewable Tablets before you receive any medical or dental care, emergency care, or surgery.

If St. Joseph 81 mg Adult Chewable Tablets has a strong vinegar-like smell upon opening, do not use. It means the medicine is breaking down. Throw the bottle away safely and out of the reach of children; contact your pharmacist and replace.

Use St. Joseph 81 mg Adult Chewable Tablets with caution in the ELDERLY; they may be more sensitive to its effects, especially those with a blood coagulation disorder.

St. Joseph 81 mg Adult Chewable Tablets should not be used in CHILDREN younger than 12 years old; safety and effectiveness in these children have not been confirmed.

PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using St. Joseph 81 mg Adult Chewable Tablets while you are pregnant. St. Joseph 81 mg Adult Chewable Tablets are not recommended during the last 3 months (third trimester) of pregnancy because it may cause harm to the fetus. St. Joseph 81 mg Adult Chewable Tablets are found in breast milk. If you are or will be breast-feeding while you use St. Joseph 81 mg Adult Chewable Tablets, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of St. Joseph 81 mg Adult Chewable Tablets:

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:

Heartburn; nausea; upset stomach.

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); black or bloody stools; confusion; diarrhea; dizziness; drowsiness; hearing loss; ringing in the ears; severe stomach pain; unusual bruising; vomiting.

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

See also: St. Joseph 81 mg Adult 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. Symptoms may include agitation; fever; hearing loss; lethargy; lightheadedness, especially upon standing; nausea; rapid breathing; rapid or irregular heartbeat; ringing in the ears; seizures; shortness of breath; stomach pain; vomiting.

Proper storage of St. Joseph 81 mg Adult Chewable Tablets:

Store St. Joseph 81 mg Adult Chewable Tablets at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep St. Joseph 81 mg Adult Chewable Tablets out of the reach of children and away from pets.

General information:

If you have any questions about St. Joseph 81 mg Adult Chewable Tablets, please talk with your doctor, pharmacist, or other health care provider.

St. Joseph 81 mg Adult Chewable Tablets are 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 St. Joseph 81 mg Adult Chewable Tablets. 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 St. Joseph 81 mg Adult resources

St. Joseph 81 mg Adult Side Effects (in more detail)
St. Joseph 81 mg Adult Use in Pregnancy & Breastfeeding
Drug Images
St. Joseph 81 mg Adult Drug Interactions
St. Joseph 81 mg Adult Support Group
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Angina
Angina Pectoris Prophylaxis
Heart Attack
Ischemic Stroke
Ischemic Stroke, Prophylaxis
Myocardial Infarction, Prophylaxis
Niacin Flush
Prevention of Thromboembolism in Atrial Fibrillation
Prosthetic Heart Valves
Prosthetic Heart Valves, Mechanical Valves
Revascularization Procedures, Prophylaxis
Transient Ischemic Attack

Monday, 13 August 2012

Urea 45% Cream

Urea Cream 45%

(in a cream base)

Rx only

For external use only. Not for ophthalmic use.

Keep away from eyes, lips and mucous membranes.

DESCRIPTION: UREA CREAM 45% is a keratolytic emollient, which is a gentle, yet potent, tissue softener for nails and/or skin. Each gram contains 45% Urea in a cream base of: camphor, edetate disodium, alcohol, eucalyptus oil, hydroxyethyl cellulose, menthol, purified water, titanium dioxide, sodium hydroxide.

CHEMISTRY: Urea is a diamide of carbonic acid with the following chemical structure:

CLINICAL PHARMACOLOGY: Urea gently dissolves the intercellular matrix, which results in loosening the horny layer of skin and shedding scaly skin at regular intervals, thereby softening hyperkeratotic areas. Urea also hydrates and gently dissolves the intercellular matrix of the nail plate, which can result in the softening and eventual removal of devitalized nail plate tissue.

PHARMACOKINETICS: The mechanism of action of topically applied Urea is not yet known.

INDICATIONS AND USES: Urea 45% Cream is indicated for use in the topical treatment for debridement and promotion of normal healing of hyperkeratotic surface lesions, particularly where healing is retarded by local infection, necrotic tissue, fibrinous or purulent debris or eschar. Urea is useful for the treatment of hyperkeratotic conditions such as dry, rough skin, dermatitis, psoriasis, xerosis, ichthyosis, eczema, keratosis, keratoderma, corns and calluses, as well as damaged devitalized and ingrown nails.

CONTRAINDICATIONS: Known hypersensitivity to any of the listed ingredients.

WARNINGS: For external use only. Avoid contact with eyes, lips or mucous membranes. If swallowed seek medical attention or contact a Poison Control Centter immediately.

PRECAUTIONS: Use this medication only as directed by a physician. It should not be used to treat and condition other than that for which it was prescribed. If redness or irritation occurs, discontinue use. After applying this medication, wash hands and unaffected areas thoroughly. KEEP THIS AND ALL MEDICATION OUT OF REACH OF CHILDREN.

PREGNANCY: Pregnancy Category B. Animal reproduction studies have revealed no evidence of harm to the fetus, however, there are no adequate and well-controlled studies in pregnant women. Because animal reproductive studies are not always predictive of human response, Urea Cream 45% should be given to a pregnant woman only if clearly needed.

NURSING MOTHERS: It is not known whether or not this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Urea Cream 45% is administered to a nursing woman.

ADVERSE REACTIONS: Transient stinging, burning itching or irritation may occur and normally disappear on discontinuing medication.

Call your doctor for medical advice about side effects.

DOSAGE AND ADMINSTRATION: Apply Urea Cream 45% to damaged nail tissue or affected skin area(s) twice a day or as directed by a physician.

HOW SUPPLIED: Urea Cream 45% is supplied in 9 oz. (255 g) tubes, NDC 42808-0202-09.

Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F). See USP Controlled Room Temperature. Protect from freezing.

Manufactured in the U.S.A. for Exact-Rx, Inc., Melville, NY 11747

00-0200-99-205-01

Iss:10/11

PRINCIPAL DISPLAY PANEL

For External Use Only

NDC 42808-0202-09 Rx Only

Urea

In a vehicle containing

camphor, eucalyptus oil

and menthol

45%

CREAM

Exact-Rx.

INCORPORATED

Net Wt. 9 oz (255 g)

UREA
urea cream

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	42808-202
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
UREA (UREA)	UREA	450 mg in 1 g

Inactive Ingredients
Ingredient Name	Strength
CAMPHOR (SYNTHETIC)
EDETATE DISODIUM
ALCOHOL
EUCALYPTUS OIL
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)
MENTHOL
WATER
TITANIUM DIOXIDE
SODIUM HYDROXIDE

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	42808-202-09	1 TUBE In 1 CARTON	contains a TUBE
1		255 g In 1 TUBE	This package is contained within the CARTON (42808-202-09)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		08/01/2011

Labeler - Exact-Rx, Inc. (137953498)

Revised: 08/2011Exact-Rx, Inc.

More Urea 45% Cream resources

Urea 45% Cream Use in Pregnancy & Breastfeeding
Urea 45% Cream Support Group
9 Reviews for Urea 45% - Add your own review/rating

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Dermatological Disorders
Dry Skin
Pityriasis rubra pilaris

Wednesday, 8 August 2012

corticorelin ovine triflutate

Generic Name: corticorelin ovine triflutate (KOR ti koe REL in OH vine TRYE floo ate)

Brand Names: Acthrel

What is corticorelin ovine trifluate?

Corticorelin ovine trifluate is a man-made form of a hormone that occurs naturally in the body.

Corticorelin ovine trifluate is used as part of a medical test in people with Cushing's syndrome. Cushing syndrome is an endocrine disorder caused by high levels of cortisol (a steroid hormone produced by the adrenal gland).

This medication is also used to help your doctor determine why your body is producing too much of its own cortisol.

Corticorelin ovine trifluate may also be used for purposes not listed in this medication guide.

What is the most important information I should know about corticorelin ovine trifluate?

Tell your doctor about any allergies or medical conditions you have.

Tell your doctor if you have recently used dexamethasone (Decadron, Dexone, Hexadrol). Dexamethasone can affect the results of your corticorelin test.

During the corticorelin test, your caregivers will need to draw at least 5 blood samples from you. This will help your doctor determine more about your condition.

The timing of your blood tests before and after the injection is important in assuring the most accurate results from a corticorelin test. Plan to stay in the care of your healthcare providers for at least 1 hour after your injection.

Tell your caregivers at once if you feel like you might pass out, or if you have a fast heart rate, a tight feeling in your chest, or if you feel like you need to take deep breaths.

What should I discuss with my health care provider before receiving corticorelin ovine trifluate?

Tell your doctor about any allergies or medical conditions you have.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Before you receive corticorelin ovine trifluate, tell your doctor if you are pregnant. It is not known whether corticorelin ovine trifluate passes into breast milk or if it could harm a nursing baby. Do not receive this medication without telling your doctor if you are breast-feeding a baby.

How is corticorelin ovine trifluate given?

You will receive corticorelin ovine trifluate in a clinic or hospital setting. The medication is given as a single injection through a needle placed into a vein. Your blood will be tested before and after you receive the injection.

During the corticorelin test, your caregivers will need to draw at least 5 blood samples from you. This will help your doctor determine more about your condition.

In most cases, the blood is tested 15 minutes before and then right before you receive the injection. These tests will give your doctor two "baseline" measurements.

After you receive corticorelin ovine trifluate, your blood will be drawn again at 15 minutes, 30 minutes, and 60 minutes after the injection. This will help your doctor determine more about your condition.

What happens if I miss a dose?

Since this medication is usually given as a single dose, you are not likely to be on a dosing schedule.

What happens if I overdose?

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

Overdose symptoms may include chest tightness, fast heart rate, trouble breathing, or severe redness or warmth in your face.

What should I avoid after receiving corticorelin ovine trifluate?

Follow your doctor's instructions about any restrictions on food, beverages, or activity after you receive this medication.

Corticorelin ovine trifluate side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Tell your caregivers at once if you feel like you might pass out, or if you have:

a fast heart rate;

a tight feeling in your chest; or

if you feel like you need to take deep breaths.

Less serious side effects may include warmth, redness, or tingly feeling in your face, neck, or chest.

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.

Corticorelin ovine triflutate Dosing Information

Usual Adult Dose for Cushing's Syndrome:

Corticorelin stimulation test:

1 mcg/kg (actual body weight) intravenously over 30 seconds once

Alternatively, corticorelin may be administered by intravenous bolus; however, signs and symptoms of side effects may be reduced when the drug is administered via 30 second infusion.

Usual Pediatric Dose for Cushing's Syndrome:

What other drugs will affect corticorelin ovine trifluate?

Tell your doctor if you have recently used dexamethasone (Decadron, Dexone, Hexadrol). Dexamethasone can affect the results of your corticorelin test.

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

More corticorelin ovine triflutate resources

Corticorelin ovine triflutate Dosage
Corticorelin ovine triflutate Use in Pregnancy & Breastfeeding
Corticorelin ovine triflutate Drug Interactions
Corticorelin ovine triflutate Support Group
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Cushing's Syndrome

Where can I get more information?

Your doctor or pharmacist can provide more information about corticorelin ovine trifluate.

Tuesday, 7 August 2012

Furosemide Injection BP (hameln)

1. Name Of The Medicinal Product

Furosemide Injection BP.

2. Qualitative And Quantitative Composition

Each ml contains 10mg of Furosemide BP.

3. Pharmaceutical Form

Sterile injection.

4. Clinical Particulars

4.1 Therapeutic Indications

Furosemide is a potent diuretic with a rapid action.

It is used to treat oedema and hypertensive crises; acute or chronic renal failure.

4.2 Posology And Method Of Administration

Furosemide is administered intravenously or intramuscularly.

Intravenous furosemide must be injected or infused slowly; a rate of 4 mg per minute must not be exceeded. In patients with severe impairment of renal function (serum creatinine >5 mg/dl), it is recommended that an infusion rate of 2.5 mg per minute is not exceeded.

Intramuscular administration must be restricted to exceptional cases where neither oral nor intravenous administration are feasible. It must be noted that intramuscular injection is not suitable for the treatment of acute conditions such as pulmonary oedema.

To achieve optimum efficacy and suppress counter-regulation, a continuous furosemide infusion is generally to be preferred to repeated bolus injections. Where continuous furosemide infusion is not feasible for follow-up treatment after one or several acute bolus doses, a follow-up regimen with low doses given at short intervals (approx. 4 hours) is to be preferred to a regimen with higher bolus doses at longer intervals.

Doses of 20 to 50 mg intramuscularly or intravenously may be given initially. If larger doses are required, they should be given increasing by 20 mg increments and not given more often than every two hours. If doses greater than 50 mg are required it is recommended that they be given by slow intravenous infusion. The recommended maximum daily dose of furosemide administration is 1,500 mg.

Elderly:

The dosage recommendations for adults apply, but in the elderly furosemide is generally eliminated more slowly. Dosage should be titrated until the required response is achieved

Children:

Parenteral doses for children range from 0.5 to 1.5 mg/kg body weight daily up to a maximum total daily dose of 20 mg

4.3 Contraindications

• Hypersensitivity to furosemide or any of the excipients. Patients allergic to sulphonamides may show cross-sensitivity to furosemide.

• Hypovolaemia, dehydration, anuria.

• Renal failure with anuria not responding to furosemide.

• Severe hypokalaemia or hyponatraemia.

• Comatose or pre-comatose states associated with hepatic encephalopathy.

• Renal failure due to poisoning by nephrotoxic or hepatotoxic drugs.

• Renal failure associated with hepatic coma.

• Breastfeeding.

4.4 Special Warnings And Precautions For Use

Urinary output must be secured. Patients with partial obstruction of urinary outflow have an increased risk of developing acute retention and require careful monitoring (e.g. in prostatic hypertrophy, impairment of micturition),

Where indicated, steps should be taken to correct hypotension or hypovolaemia before commencing therapy (see section 4.3 Contraindications).

Careful monitoring is required in:

• Patients with hypotension.

• Patients who are at risk from a pronounced fall in blood pressure.

• Patients with latent diabetes or diabetes, as furosemide may cause hyperglycaemia and increased insulin requirement.

• Patients with gout.

• Patients with hepatorenal syndrome.

• Patients with hypoproteinaemia e.g. associated with nephrotic syndrome (the effect of furosemide may be weakened and its ototoxicity potentiated). Cautious dose titration is required.

• Premature infants. Furosemide may cause nephrocalcinosis/ nephrolithiasis; renal function must be monitored and renal ultrasonography performed.

Caution should be observed in patients with fluid and electrolyte imbalance. Regular monitoring of serum sodium, potassium and creatinine is generally recommended during furosemide therapy; particularly close monitoring is required in patients at high risk of developing electrolyte imbalances or in case of significant additional fluid loss. Hypovolaemia or dehydration as well as any significant electrolyte and acid-base disturbances must be corrected. This may require temporary discontinuation of furosemide.

It is important to ensure that infusion rates do not exceed 4mg of Furosemide per minute. Tinnitus and deafness may occur if this rate is exceeded.

In patients who are at high risk of radiocontrast nephropathy, furosemide is not recommended for use as a diuretic as part of the preventative measures against radiocontrast-induced nephropathy.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

The ototoxic and nephrotoxic effects of other medications may be increased by concomitant administration of furosemide.

Some electrolyte disturbances (e.g. hypokalaemia, hypomagnesaemia) may increase the toxicity of certain drugs (e.g. drugs inducing QT interval prolongation syndrome such as amisulpride, atomoxetine, pimozide, sotalol, sertindole).

There is increased risk of hypokalaemia when furosemide is used in combination with beta-2 sympathomimetics in large doses, theophylline, corticosteroids, liquorice, carbenoxolone, prolonged use of laxatives, reboxetine, or amphotericin.

Furosemide may sometimes attentuate the effect of other drugs e.g. the effect of anti-diabetics and of pressor amines.

Probenecid, methotrexate (see Cytotoxic agents) and other drugs which, like furosemide, undergo significant renal tubular secretion may reduce the effect of furosemide. Conversely, furosemide may decrease renal elimination of these drugs. In case of high-dose treatment (in particular, of both furosemide and the other drugs), this may lead to increased serum levels and an increased risk of adverse effects due to furosemide or the concomitant medication.

Cardiac glycosides:

The potassium loss caused by potassium depleting diuretics such as furosemide increases the toxic effects of digoxin and other digitalis glycosides.

Anti-arrhythmic drugs:

Hypokalaemia caused by loop diuretics may increase the cardiac toxicity of anti-arrhythmic drugs such as amiodarone, disopyramide, flecainide, quinidine and sotalol, and may antagonise the effects of lidocaine and mexiletine.

Antihypertensive drugs:

The dosage of concurrently administered diuretics, antihypertensive agents or other drugs with blood pressure lowering potential may require adjustment as a more pronounced fall in blood pressure must be anticipated if given with furosemide. A marked fall in blood pressure and deterioration in renal function may be seen when angiotensin-converting enzyme (ACE) inhibitors or angiotensin II receptor antagonists are added to furosemide therapy, or when the dosage is increased. The dose of furosemide should be reduced for at least three days, or the drug stopped before initiation of ACE-inhibitor or angiotensin II receptor antagonist therapy, or before their dose is increased.

Lithium:

In common with other diuretics, serum lithium levels may be increased when furosemide is given to patients stabilised on this therapy, resulting in increased lithium toxicity (cardiotoxicity, neurotoxicity). It is recommended that lithium levels are carefully monitored and where necessary the lithium dosage adjusted during concurrent use.

Non-steroidal anti-inflammatory drugs:

Certain NSAIDs (including indometacin, ketorolac, acetylsalicylic acid) may decrease the effectiveness of furosemide and may cause acute renal failure in cases of pre-existing hypovolaemia or dehydration. Salicylate toxicity may be increased by furosemide.

Antibiotics:

Furosemide may potentiate the nephrotoxicity and ototoxicity of aminoglycosides and other ototoxic drugs. Since this may lead to irreversible damage, these drugs must only be used with furosemide when there are compelling medical reasons.

There is an increased risk of ototoxicity when loop diuretics are given with vancomycin or polymyxins (colistin).

Impairment of renal function may develop in patients receiving concurrent treatment with furosemide and high doses of certain cephalosporins (e.g. cephaloridine).

Cytotoxic agents:

There is a risk of ototoxicity if cisplatin and furosemide are given concurrently. Low doses of furosemide (e.g. 40 mg in patients with normal renal function) should be used and a positive fluid balance maintained when furosemide is used to achieve forced diuresis during cisplatin treatment to reduce the risk of additional nephrotoxicity.

Methotrexate and other drugs which, like furosemide, undergo significant renal tubular secretion may reduce the effect of furosemide. Conversely, furosemide may decrease renal elimination of methotrexate. This may lead to increased serum levels and increased risk of adverse events, especially with high dose therapy of methotrexate or furosemide.

Ciclosporin:

Concomitant use of ciclosporin and furosemide is associated with an increased risk of gouty arthritis.

Anti-convulsants:

Phenytoin may decrease the effectiveness of furosemide. Concomitant administration of carbamazepine may increase the risk of hyponatraemia.

Corticosteroids:

Concurrent use of corticosteroids may cause sodium retention and increased risk of developing hypokalaemia.

Chloral hydrate/Triclofos:

Bolus doses of intravenous furosemide may induce flushing, sweating, tachycardia and variations in blood pressure in patients receiving chloral hydrate or triclofos.

Neuromuscular blocking agents:

Furosemide may affect the response to neuromuscular blocking agents (increased or decreased effect).

4.6 Pregnancy And Lactation

Pregnancy:

Results of animal work, in general, show no hazardous effect of furosemide in pregnancy. There is clinical evidence of safety of the drug in the third trimester of human pregnancy; however, furosemide crosses the placental barrier. It must not be given during pregnancy unless there are compelling medical reasons. Treatment during pregnancy requires monitoring of foetal growth.

Lactation:

Furosemide passes into breast milk and may inhibit lactation. Women must not breast-feed if they are treated with furosemide.

4.7 Effects On Ability To Drive And Use Machines

Reduced mental alertness may impair ability to drive or operate dangerous machinery.

4.8 Undesirable Effects

The most common undesirable effect is fluid and electrolyte imbalance. Other undesirable effects are relatively uncommon.

Blood and lymphatic system disorders:

Eosinophilia is rare. Occasionally, thrombocytopenia may occur. In rare cases, leucopenia and, in isolated cases, agranulocytosis, aplastic anaemia or haemolytic anaemia may develop.

Bone marrow depression has been reported as a rare complication and necessitates withdrawal of treatment.

Immune system disorders:

Severe anaphylactic or anaphylactoid reactions (e.g. with shock) occur rarely.

The incidence of allergic reactions, such as skin rashes, photosensitivity, vasculitis, fever, interstitial nephritis or shock is very low, but when these occur treatment should be withdrawn.

Metabolism and nutrition disorders:

Electrolyte and water balance may be disturbed as a result of diuresis. Furosemide causes increased excretion of sodium and chloride and consequently water, and hyponatraemia may occur. The diuretic action of furosemide may lead to or contribute towards hypovolaemia and dehydration, especially in elderly patients. Severe fluid depletion may lead to haemoconcentration with a tendency for thromboses to develop.

Excretion of other electrolytes is increased, and hypokalaemia, serum calcium depletion and hypomagnesaemia may occur. Symptomatic electrolyte disturbances and metabolic alkalosis may develop following gradual electrolyte depletion or acute severe electrolyte losses during higher dose therapy. Warning signs of electrolyte disturbances include increased thirst, headache, hypotension, confusion, muscle cramps, tetany, muscle weakness, disorders of cardiac rhythm and gastrointestinal symptoms. Pre-existing metabolic alkalosis (e.g. in decompensated cirrhosis of the liver) may be aggravated by furosemide treatment.

Serum cholesterol and triglyceride levels may rise during furosemide treatment. During long-term therapy they will usually return to normal within six months.

Furosemide may provoke hyperglycaemia and glycosuria but less so than thiazide diuretics. Glucose tolerance may decrease with furosemide. In patients with diabetes mellitus, this may lead to a deterioration of control; latent diabetes mellitus may become manifest.

Furosemide can increase serum uric acid levels and may precipitate attacks of gout in some patients.

Psychiatric/Nervous system disorders:

Rarely paraesthesia may occur. Symptoms of hypotension may include dizziness, light-headedness, sensation of pressure in the head, headache, drowsiness, concentration impairment and slowed reactions. Headache, lethargy or confusion may be warning signs of electrolyte disturbances.

Eye disorders:

Visual disturbances, blurred vision.

Ear and labyrinth disorders:

Hearing disorders, including deafness and tinnitus, may occur in rare cases, particularly in patients with renal failure, hypoproteinaemia (e.g. nephrotic syndrome) and/ or when intravenous furosemide has been given too rapidly. Although symptoms are usually transient, permanent deafness may occur, especially in patients treated with other ototoxic medications (see section 4.4 Special warnings and precautions for use and section 4.5 Interactions)

Cardiac disorders:

Cardiac rhythm disturbances may occur as a consequence of electrolyte imbalance.

If furosemide is administered to premature infants during the first weeks of life, it may increase the risk of persistence of patent ductus arteriosus.

Vascular disorders:

Hypotension and orthostatic hypotension may occur, especially in patients taking other medications which lower blood pressure.

Allergic vasculitis has been reported very rarely.

Gastrointestinal disorders:

Nausea, vomiting, diarrhoea and dry mouth may occur but are not usually severe enough to necessitate withdrawal of treatment.

Hepatobiliary disorders:

Hepatic encephalopathy in patients with hepatocellular insufficiency may occur (see Section 4.3).

In isolated cases, intrahepatic cholestatsis, an increase in liver transaminases or acute pancreatitis may develop.

Skin and subcutaneous tissue disorders:

Skin and mucous membrane reactions may occasionally occur eg pruritis, urticaria, other rashes or bullous lesions, erythema multiforme, exfoliative dermatitis and purpura.

Musculoskeletal disorders:

Serum calcium levels may be reduced, muscle spasms or muscle weakness may indicate electrolyte disturbances. In very rare cases tetany has been observed.

Renal and urinary disorders:

Treatment with furosemide may lead to transient increases in blood creatinine and urea levels. Renal failure may occur as a consequence of fluid and electrolyte depletion, especially during concurrent treatment with NSAIDs or nephrotoxic medications.

Increased production of urine may provoke or aggravate complaints in patients with an obstruction of urinary outflow. Acute retention of urine with possible secondary complications may occur, for example, in patients with bladder emptying disorders, prostatic hyperplasia or narrowing of the urethra (see section 4.4 Special warnings and precautions for use).

Nephrocalcinosis/nephrolithiasis has been reported in premature infants, and in adults, generally after long-term therapy.

There have been very rare reports of interstitial nephritis.

General disorders:

Asthenia, malaise, fever.

Following intramuscular injection, local reactions such as pain may occur.

4.9 Overdose

Symptoms:

Hypovolaemia, dehydration, haemoconcentration, hyponatraemia, and hypokalaemia may occur following overdose of furosemide injection. Severe hypotension, progressing to shock, cardiac arrhythmias, acute renal failure, thrombosis, delirium, flaccid paralysis, apathy and confusion may occur as a result of electrolyte and fluid loss,

Management:

No specific antidote to furosemide injection is known. Furosemide should be withdrawn or the dose reduced. Treatment should be supportive and aimed at fluid replacement, correction of electrolyte imbalance and maintenance of blood pressure.

Together with the prevention and treatment of serious complications resulting from such disturbances and of other effects on the body, this corrective action may necessitate general and specific intensive medical monitoring and therapeutic measures.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Furosemide is a potent diuretic. It is an anthranilic acid derivative and chemically it is 4-chloro-Nfurfuryl-5sulpha-moylanthranilic acid. Furosemide inhibits the reabsorption of sodium and chloride in the loop of Henle as well as in the proximal and distal tubules; its action is independent of any inhibitory effect on carbonic anhydrase. The urinary excretion of potassium, calcium and magnesium is increased by Furosemide. Hyperuricaemia may occur and is presumed to result from a competitive inhibition of urate secretion in the proximal tubules.

Furosemide has a steep dose-response curve and is designated a high-ceiling diuretic. Following intravenous administration, the onset of diuresis is within 5 minutes and the duration of diuretic effect is approximately two hours.

5.2 Pharmacokinetic Properties

Furosemide is extensively bound to plasma proteins and is mainly excreted in the urine, largely unchanged. Significantly more Furosemide is excreted in urine following intravenous injection than after the tablet form. Furosemide glucuronide is the main biotransformation product.

Furosemide has a biphasic half-life in plasma with a terminal elimination phase of approximately 1.5 hours. Although mainly excreted in the urine, variable amounts are also excreted in bile and non-renal elimination may be considerably increased in renal failure.

5.3 Preclinical Safety Data

No further information other than that which is included in the Summary of Product Characteristics.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Sodium Chloride Ph. Eur.

Sodium Hydroxide BP.

Water for Injections Ph. Eur.

6.2 Incompatibilities

Furosemide should not be mixed with any other medication in the same syringe e.g. Furosemide produces a precipitate when mixed with Dobutamine, Diazepam, Doxorubicin, Droperidol, Gentamicin, Glucose, Mannitol, Metoclopramide, Potassium Chloride, Tetracycline, Vincristine and Vitamins.

It should not be given during infusion with Adrenaline, Isoprenaline, Lidocaine or Pethidine.

6.3 Shelf Life

36 Months.

6.4 Special Precautions For Storage

Store below 25° C and protect from light.

6.5 Nature And Contents Of Container

2, 5 and 25ml type I amber glass ampoules, packed in cardboard cartons to contain 10 ampoules.

6.6 Special Precautions For Disposal And Other Handling

Use as directed by the physician.

ADMINISTRATIVE DATA

7. Marketing Authorisation Holder

hameln pharmaceuticals ltd

Gloucester

8. Marketing Authorisation Number(S)

PL 1502/0032

9. Date Of First Authorisation/Renewal Of The Authorisation

23rd September 1997

10. Date Of Revision Of The Text

19/08/08

Thursday, 2 August 2012

Irrigor Plus

Irrigor Plus may be available in the countries listed below.

Ingredient matches for Irrigor Plus

Citicoline

Citicoline is reported as an ingredient of Irrigor Plus in the following countries:

Peru

Nimodipine

Nimodipine is reported as an ingredient of Irrigor Plus in the following countries:

Peru

International Drug Name Search

Wednesday, 1 August 2012

Cyclosporine eent

Class: Anti-inflammatory Agents, Miscellaneous
VA Class: IM600
Chemical Name: Cyclo[[(E) - (2S,3R,4R) - 3 - hydroxy - 4 - methyl - 2 - (methylamino) - 6 - octenoyl] - l - 2 - aminobutyryl - N - methylglycyl - N - methyl - l - leucyl - l - valyl - N - methyl - l - leucyl - l - alanyl - d - alanyl - N - methyl - l - leucyl - N - methyl - l - leucyl - N - methyl - l - valyl]
CAS Number: 59865-13-3
Brands: Restasis

Introduction

Topical immunomodulator; systemic immunosuppressive agent.¹ ² ³ ⁵ ⁶ ⁷ ⁸ ¹⁰

Uses for Cyclosporine

Keratoconjunctivitis Sicca

Used to increase tear production in adults whose tear production presumably is suppressed secondary to ocular inflammation related to keratoconjunctivitis sicca.¹

Increased tear production not observed in patients already receiving topical anti-inflammatory agents or using punctal plugs.¹

Cyclosporine Dosage and Administration

Administration

For ophthalmic use only.¹ Not for injection.¹ Not for subconjunctival injection or introduction directly into the anterior chamber of the eye.¹ ⁴

Ophthalmic Administration

Apply topically to the eye as an ophthalmic emulsion.¹

Avoid contamination of emulsion container.¹

Invert unit-dose vial a few times before use to obtain a uniform, opaque, white emulsion.¹

Preservative-free emulsion is for single use only in one or both eyes; discard any unused portion immediately after administration.¹

Remove contact lenses prior to administration; may reinsert lenses 15 minutes after dose.¹

When used concomitantly with artificial tears, administer ophthalmic preparations at least 15 minutes apart.¹

Dosage

Adults

Keratoconjunctivitis Sicca

Ophthalmic

1 drop of a 0.05% emulsion into each eye twice daily, approximately 12 hours apart.¹

Cautions for Cyclosporine

Contraindications

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

Active ocular infections.¹

Warnings/Precautions

Warnings

Safety and efficacy not established in patients with history of herpes keratitis.¹

Specific Populations

Pregnancy

Category C.¹

Lactation

Distributed into milk after systemic administration; it is not known whether distributed into milk after topical application to the eye.¹ Caution advised if used in nursing women.¹

Pediatric Use

Safety and efficacy not established in children <16 years of age.¹

Geriatric Use

No substantial differences in safety and efficacy relative to younger adults.¹

Common Adverse Effects

Ocular burning, conjunctival hyperemia, discharge, epiphora, ocular pain, foreign body sensation, pruritus, stinging, visual disturbance (e.g., blurring).¹

Interactions for Cyclosporine

No formal drug interaction studies to date.⁹

Cyclosporine Pharmacokinetics

Absorption

Bioavailability

Blood cyclosporin A concentrations were below quantitation limit (0.1 ng/mL) after topical application of cyclosporine 0.05% emulsion to the eye twice daily for up to 12 months.¹ ⁷ No detectable drug accumulation in blood during 12 months of treatment.¹ ⁷

Distribution

Extent

Not known whether distributed into milk after topical application to the eye.¹

Stability

Storage

Ophthalmic

Emulsion

15–25°C.¹

ActionsActions

Exact mechanism of action not fully elucidated, but thought to act as a partial immunomodulator with anti-inflammatory effects when administered topically to the eye.¹ ² ³ ⁵ ⁶ ⁷ ⁸ ¹⁰

Topical application to the eye reduces cell-mediated inflammatory responses associated with inflammatory ocular surface diseases.² ³

Exhibits immunosuppressive activity when administered systemically.¹

Advice to Patients

Importance of learning and adhering to proper administration techniques to avoid contamination of the product.¹

Importance of administering ophthalmic emulsion immediately after opening single-use vial and discarding any unused portion immediately after administration.¹

Importance of not wearing contact lenses in presence of decreased tear production.¹ If contact lenses are worn, importance of removing lenses prior to administration and delaying reinsertion of lenses for 15 minutes after instillation.¹

Importance of women informing clinicians if they are or plan to become pregnant or to breast-feed.¹

Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.¹

If using artificial tears and ophthalmic cyclosporine, importance of allowing at least 15 minutes to elapse between administration.¹

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

Preparations

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

Cyclosporine
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Ophthalmic	Emulsion	0.05%	Restasis (preservative-free)	Allergan

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.

Restasis 0.05% Emulsion (ALLERGAN): 30/$146.62 or 90/$411.8

Disclaimer

References

1. Allergan, Inc. Restasis (cyclosporine) ophthalmic emulsion 0.05% prescribing information. Irvine, CA; 2002 Dec.

2. Sall K, Stevenson OD, Mundorf TK et al. Two multicenter, randomized studies of the efficacy and safety of cyclosporine ophthalmic emulsion in moderate to severe dry eye disease. Ophthalmology. 2000; 107:631-9. [IDIS 453300] [PubMed 10768324]

3. Stevenson D, Tauber J, Reis BL et al. Efficacy and safety of cyclosporin A ophthalmic emulsion in the treatment of moderate-to-severe dry eye disease. A dose-ranging randomized trial. Ophthalmology. 2000; 107:967-74. [IDIS 446941] [PubMed 10811092]

4. Allergan, Inc, Irvine, CA: Personal communication.

5. Laibovitz R, Solch S, Andriano K et al. Pilot trial of cyclosporine 1% ophthalmic ointment in the treatment of keratoconjunctivitis sicca. Cornea. 1993; 12:315-23. [PubMed 8339560]

6. Tauber J, for the Cyclosporine Study Group. A dose-ranging clinical trial to assess the safety and efficacy of cyclosporine ophthalmic emulsion in patients with keratoconjunctivitis sicca. Adv Exp Med Biol. 1998; 438:969-72. [PubMed 9634996]

7. Small DS, Acheampong A, Reis B et al. Blood cyclosporin A during long-term treatment with cyclosporin A ophthalmic emulsions in patients with moderate to severe dry eye disease. J Ocul Pharmacol Ther. 2002; 18:411-8. [PubMed 12419092]

8. Kunert KS, Tisdale AS, Gipson IK. Goblet cell numbers and epithelial proliferation in the conjunctiva of patients with dry eye syndrome treated with cyclosporine. Arch Ophthalmol. 2002; 120:330-7. [IDIS 478231] [PubMed 11879137]

9. Allergan, Inc. Restasis (cyclosporine ophthalmic emulsion) 0.05% formulary kit. Irvine, CA; 2003.

10. Anon. Ophthalmic cyclosporine (Restasis) for dry eye disease. Med Lett Drugs Ther. 2003; 45:42-3. [PubMed 12766701]

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