iodoquinol

Generic Name: iodoquinol (eye oh DOE quih nol)

Brand Names: Diquinol, Yodoxin

What is iodoquinol?

Iodoquinol is an amebicidal drug. The exact way that iodoquinol works is not known.

Iodoquinol is used to treat intestinal infections caused by amoebae.

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

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

Use caution when driving or performing other hazardous activities until you know how this medication affects you. Iodoquinol may cause dizziness or visual disturbances. Report any vision changes to your doctor.

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

Do not take iodoquinol without first talking to your doctor if you have

• liver disease;


• 
  

  optic neuritis (inflammation of the optic nerve) or other vision problems;

  
  


• 
  

  nerve problems (peripheral neuropathy, numbness or tingling); or

  
  


• 
  

  thyroid disease.

  
  

You may not be able to take iodoquinol, or you may require a dosage adjustment or special monitoring during your therapy if you have any of the conditions listed above.

It is not known whether iodoquinol will be harmful to an unborn baby. Do not take iodoquinol without first talking to your doctor if you are pregnant or could become pregnant during treatment. It is not known if iodoquinol will affect a nursing infant. Do not take iodoquinol without first talking to your doctor if you are breast-feeding a baby.

How should I take iodoquinol?

Take iodoquinol exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each dose with a full glass of water. Take iodoquinol after a meal.

It is important to take iodoquinol regularly to get the most benefit.

Store iodoquinol at room temperature away from moisture and heat.

See also: Iodoquinol dosage (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and only take the next regularly scheduled dose. Do not take a double dose of this medication.

What happens if I overdose?

Seek emergency medical attention if an overdose is suspected.

Symptoms of an iodoquinol overdose have not been reported.

What should I avoid while taking iodoquinol?

Use caution when driving or performing other hazardous activities until you know how this medication affects you. Iodoquinol may cause dizziness or visual disturbances. Report any vision changes to your doctor.

Iodoquinol side effects

Seek emergency medical attention or contact your doctor immediately if you experience any of the following uncommon but serious side effects:

• 
  

  an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);

  
  


• 
  

  vision problems;

  
  


• 
  

  numbness or tingling; or

  
  


• 
  

  skin rash.

  
  

Other, less serious side effects may be more likely to occur. Continue to take iodoquinol and talk to your doctor if you experience

• 
  

  nausea, vomiting, or abdominal cramps;

  
  


• 
  

  diarrhea;

  
  


• 
  

  headache;

  
  


• 
  

  dizziness;

  
  


• 
  

  fever or chills;

  
  


• 
  

  itching; or

  
  


• 
  

  enlargement of the thyroid gland.

  
  

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

Iodoquinol Dosing Information

Usual Adult Dose for Amebiasis:

650 mg orally 3 times a day for 20 days. In moderate or severe cases of intestinal amebiasis or extraintestinal amebiasis, iodoquinol should follow therapy with metronidazole.

Usual Adult Dose for Dientamoeba fragilis:

650 mg orally 3 times a day for 20 days. Follow-up stool examinations should be done 4 weeks after the start of therapy.

Usual Adult Dose for Balantidium coli:

650 mg orally 3 times a day for 20 days. Iodoquinol is considered an alternative to tetracycline in the treatment of Balantidium coli infections.

Usual Adult Dose for Blastocystis hominis:

650 mg orally 3 times a day for 20 days. Metronidazole, trimethoprim-sulfamethoxazole, and iodoquinol have been suggested as possible therapeutic choices in treating Blastocystis hominis.

What other drugs will affect iodoquinol?

Before taking iodoquinol, talk to your doctor if you are taking any of the following drugs:

• 
  

  bortezomib (Velcade);

  
  


• 
  

  didanosine (Videx);

  
  


• 
  

  lamivudine (Epivir, Epivir-HBV, Trizivir);

  
  


• 
  

  stavudine (Zerit, Zerit XR); or

  
  


• 
  

  zalcitibine (Hivid).

  
  

You may not be able to take iodoquinol, or you may require a dosage adjustment or special monitoring during treatment.

Drugs other than those listed here may also interact with iodoquinol. Do not take any other prescription or over-the-counter medicines, including vitamins, minerals, and herbal products, without first talking to your doctor.

More iodoquinol resources

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

• iodoquinol Advanced Consumer (Micromedex) - Includes Dosage Information


• Iodoquinol Monograph (AHFS DI)


• Iodoquinol MedFacts Consumer Leaflet (Wolters Kluwer)

Compare iodoquinol with other medications

• Amebiasis
• Balantidium coli
• Blastocystis Infection
• Dientamoeba fragilis

Where can I get more information?

• Your pharmacist has more information about iodoquinol written for health professionals that you may read.

See also: iodoquinol side effects (in more detail)

Solaraze topical

Generic Name: Diclofenac Sodium topical
Class: Skin and Mucous Membrane Agents, Miscellaneous
VA Class: DE900
Chemical Name: 2-[(2,6-dichlorophenyl)amino]-benzeneacetic acid monosodium salt
Molecular Formula: C₁₄H₁₀C_l2NNaO₂
CAS Number: 15307-79-6

Special Alerts:

[Posted 12/04/2009] Endo, Novartis and FDA notified healthcare professionals of revisions to the Hepatic Effects section of the prescribing information to add new warnings and precautions about the potential for elevation in liver function tests during treatment with all products containing diclofenac sodium.

In postmarketing reports, cases of drug-induced hepatotoxicity have been reported in the first month but can occur at any time during treatment with diclofenac. Postmarketing surveillance has reported cases of severe hepatic reactions, including liver necrosis, jaundice, fulminant hepatitis with and without jaundice, and liver failure. Some of these reported cases resulted in fatalities or liver transplantation.

Physicians should measure transaminases periodically in patients receiving long-term therapy with diclofenac. The optimum times for making the first and subsequent transaminase measurement are not known. Based on clinical trial data and postmarketing experiences, transaminases should be monitored within 4 to 8 weeks after initiating treatment with diclofenac. For more information visit the FDA website at: and .

REMS:

FDA approved a REMS for diclofenac (topical) to ensure that the benefits of a drug outweigh the risks. However, FDA later rescinded REMS requirements. See the FDA REMS page () or the ASHP REMS Resource Center ().

Introduction

Prototypical NSAIA; phenylacetic acid derivative.^{1 2 3 4 5}

Uses for Solaraze

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

Actinic Keratoses

Treatment of actinic keratoses.^{1 2 3 4}

Solaraze Dosage and Administration

General

Complete healing of the lesions or optimal therapeutic response may not occur until 30 days after cessation of therapy.¹

Administration

Topical Administration

Apply to actinic keratosis lesions as a 3% gel.¹

Dosage

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

Adults

Actinic Keratoses

Topical

Apply a sufficient amount (usually 0.5 g for each 5 cm × 5 cm lesion) and rub gently onto the lesions twice daily for 60–90 days.¹

Cautions for Solaraze

Contraindications

• 
  

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

  
  

Warnings/Precautions

Warnings

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

Sensitivity Reactions

Sensitivity reactions, including anaphylaxis, possible in patients without prior exposure to diclofenac.¹ Avoid in patients with aspirin triad (aspirin sensitivity, asthma, nasal polyps).¹

General Precautions

GI Effects

Use with caution in patients with active GI ulceration or bleeding.¹

Topical Use

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

For external use only; avoid contact with eyes.¹ Do not apply to open skin wounds, infected lesions, or exfoliative dermatitis.¹

Safety and efficacy of concomitant use with other topical products (e.g., sunscreens, cosmetics, other topical medications) unknown.¹

Specific Populations

Pregnancy

Category B.¹ Avoid use in third trimester (possible premature closure of ductus arteriosus) or in late pregnancy (possible delay in labor or parturition).¹

Lactation

Discontinue nursing or the drug because of potential risk to nursing infants.¹

Pediatric Use

Safety and efficacy not established in children.¹ Actinic keratoses generally are not seen in the pediatric population; diclofenac sodium gel should not be used by children.¹

Geriatric Use

Actinic keratoses occur frequently in an older patient population.¹ No substantial differences in safety and efficacy relative to younger adults, but increased sensitivity cannot be ruled out.¹

Hepatic Impairment

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

Use with caution in patients with severe hepatic impairment.¹

Renal Impairment

Use with caution in patients with severe renal impairment.¹

Common Adverse Effects

Contact dermatitis, rash, dry skin, exfoliation (scaling).¹

Interactions for Solaraze

NSAIAs

Potential pharmacologic interaction with oral NSAIAs including analgesic/anti-inflammatory dosages of aspirin.¹

Solaraze Pharmacokinetics

Absorption

Bioavailability

Absorbed into epidermis after topical application to the skin.^{1 2}

Minimal systemic absorption following topical application (serum diclofenac concentrations averaged 20 ng/mL following topical application twice daily for up to 105 days versus 1417 ng/mL following a single 50-mg oral dose of diclofenac sodium).^{1 6}

Distribution

Plasma Protein Binding

Bound to albumin.¹

Elimination

Metabolism

Metabolized in the liver via hydroxylation and conjugation following oral administration; metabolism following topical administration is expected to be similar to that following oral administration.¹

Elimination Route

Mainly excreted in urine following oral administration.¹

Half-life

1–2 hours following oral administration.¹

Stability

Storage

Topical

Gel

20–25°C (may be exposed to 15–30°C).^a Protect from heat; do not freeze.^a

Actions

• 
  

  Prototypical NSAIA.^{1 2 3 4 5}

  
  


• 
  

  While the mechanism(s) of the topical effects has not been established,^{1 2 3} diclofenac has inhibited angiogenesis and induced neovascular regression in inflammatory tissue in animal models.^{2 3}

  
  


• 
  

  NSAIAs, including diclofenac, may inhibit angiogenesis through inhibition of substance P or by blocking the angiogenic effects of prostaglandin E₂ (PGE₂).²

  
  


• 
  

  For topical use in the treatment of actinic keratoses, diclofenac sodium is commercially available as a 3% gel with benzyl alcohol, hyaluronate sodium, polyethylene glycol monomethyl ether, and purified water.¹ The contribution of individual vehicle components to the efficacy of diclofenac sodium gel remains to be established.¹

  
  

Advice to Patients

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

• 
  

  Risk of adverse effects, including irritant or allergic contact dermatitis.¹ Importance of reporting signs and symptoms of adverse dermal reactions.¹ Necessity of interrupting therapy if severe dermal reactions occur.¹

  
  


• 
  

  Avoid exposure to sunlight and use of sunlamps.¹

  
  


• 
  

  Importance of monitoring and follow-up evaluation.¹

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription, OTC, or herbal products, as well as any concomitant illness.¹ Safety and efficacy of use with other topical products (e.g., sunscreens, cosmetics, other topical medications) is unknown.¹

  
  


• 
  

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

  
  


• 
  

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

  
  

Preparations

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

Diclofenac

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Topical	Gel	3%	Solaraze (with benzyl alcohol)	Bioglan

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 10/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Flector 1.3% Patches (KING PHARMA): 30/$199.50 or 90/$577.50

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 October 27, 2011. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

1. Bioglan Pharma Inc. Solaraze (diclofenac sodium 3%) topical gel prescribing information. Malvern, PA: 2001 Jun 1.

2. Rivers JK, McLean DI. An open study to assess the efficacy and safety of topical 3% diclofenac in a 2.5% hyaluronic acid gel for the treatment of actinic keratoses. Arch Dermatol. 1997; 133:1239-42. [IDIS 392849] [PubMed 9382562]

3. Peters DC, Foster RH. Diclofenac/Hyaluronic acid. Drugs Aging. 1999; 14:313-9. [PubMed 10319244]

4. McEwan LE, Smith JG. Topical diclofenac/hyaluronic acid gel in the treatment of solar keratoses. Australas J Dermatol. 1997; 38:187-9. [PubMed 9431711]

5. Hamor GH. Nonsteroidal anti-inflammatory drugs. In: Foye WO, ed. Principles of medicinal chemistry. 3rd ed. Philadelphia: Lea & Febiger; 1989:503-30.

6. Novartis Pharmaceuticals. Cataflam diclofenac potassium (immediate- release tablets), Voltaren diclofenac sodium (delayed-release tablets), Voltaren-XR diclofenac sodium (extended-release tablets) prescribing information (dated 2000 May). In Physicians’ desk reference. 55th ed. Montvale, NJ: Medical Economics Company; 2001:2151-5.

7. Bioglan Pharma, Malvern, PA: Personal communication.

a. Bioglan Pharma Inc. Solaraze (diclofenac sodium 3%) topical gel prescribing information. Malvern, PA: 2003 May.

More Solaraze topical resources

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

Compare Solaraze topical with other medications

• Actinic Keratosis

Effervescent Calcium Gluconate Tablets BP 1g

1. Name Of The Medicinal Product

EFFERVESCENT CALCIUM GLUCONATE TABLETS BP 1g

2. Qualitative And Quantitative Composition

Each tablet contains 1g Calcium Gluconate BP equivalent to 2.23mmol of calcium (Ca²⁺)

3. Pharmaceutical Form

White uncoated tablets.

White, circular, flat bevelled-edge uncoated tablets impressed “C” and the identifying letters “CN” on one face.

4. Clinical Particulars

4.1 Therapeutic Indications

1) As an adjunct to conventional therapy in the arrest or slowing down of bone demineralisation in osteoporosis where other effective treatment is contraindicated.

2) In the arrest or slowing down of bone demineralisation in osteoporosis where other effective treatment is contraindicated.

3) Therapeutic supplementation in osteomalacia, rickets, post-gastrectomy malabsorption, pregnancy, lactation, malnutrition or dietary deficiency.

4.2 Posology And Method Of Administration

Posology

The tablets must be dissolved in one third to one half a tumblerful of water.

In health the concentration of calcium in serum is maintained close to 2.5mmol/l (normal range 2.25-2.75mmol or 4.5-5.5mEq/l).

Treatment or therapeutic supplementation should aim to restore or maintain this level.

Adults (including elderly):

Osteoporosis: A daily supplement of 800mg (20mmol) calcium or 8-9 tablets may reduce the rate of bone loss, but larger doses have not been shown to be more effective.

Indication:	Daily dosage:
Osteoporosis
Post-gastrectomy malabsorption	12-20 tablets
Osteomalacia and rickets
Lactation
Pregnancy supplement	1-10 tablets
Pregnancy cramps

Children: Children require approximately half the adult dosage.

Infants: A more suitable dosage form should be used for this age group.

Method of Administration

To be dissolved in water for oral administration.

4.3 Contraindications

Severe hypercalcaemia and hypercalciuria (eg in hypervitaminosis D, hyperparathyroidism, severe renal failure and renal calculi, osteoporosis due to immobility and decalcifying tumours such as plasmocytoma and skeletal metastases).

4.4 Special Warnings And Precautions For Use

Calcium salts should be given cautiously to patients with cardiac disease or sarcoidosis.

Careful monitoring of blood levels and urinary calcium excretion is necessary, particularly when high dose or parenteral calcium therapy has been used, especially in children.

In mild hypercalciuria (exceeding 300mg (7.5mmol)/24 hours) as well as in mild to moderate renal failure, or where there is evidence of stone formation in the urinary tract, adequate checks must be kept on urinary calcium excretion; if necessary the dosage should be reduced or calcium therapy discontinued. High vitamin D intake should be avoided during calcium therapy, unless especially indicated.

Effervescent Calcium Gluconate Tablets BP must be used with care in patients receiving alternative compound vitamin or mineral preparations, which often contain sources of additional calcium.

Treatment should be suspended if blood calcium levels exceed 2.625-2.75mmol/litre (105-110mg/litre) or if urinary calcium excretion exceeds 5mg/kg.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Thiazide diuretics reduce urinary calcium excretion so the risk of hypercalcaemia should be considered. Patients receiving therapy with cardiac glycosides such as digoxin must not be given calcium supplements.

Oral calcium administration may reduce the absorption of oral tetracycline or fluoride preparations. An interval of three hours should be observed if the two are to be given.

4.6 Pregnancy And Lactation

The likelihood of hypercalcaemia is increased in pregnant women in whom calcium and vitamin D are co-administered. Epidemiological studies with calcium have shown no increase in the teratogenic hazard to the foetus if used in the doses recommended. Although supplemental calcium may be excreted in breast milk, the concentration is unlikely to be sufficient to produce any adverse effect on the neonate.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Mild gastrointestinal disturbances have occurred rarely (eg constipation, diarrhoea). Cardiac arrhythmias and bradycardia may also occur.

4.9 Overdose

Deliberate overdosage is unlikely due to the large size of the tablets and the necessity to dissolve the tablets in water. The symptoms of overdosage with calcium include anorexia, lassitude, nausea, vomiting, headache, extreme thirst, vertigo, and raised blood urea; calcium may be deposited in many tissues including the kidney and arteries and the plasma cholesterol level may become elevated.

Calcium intake should be reduced to a minimum and any dehydration and electrolyte imbalance corrected immediately. A loop diuretic such as furosemide may be given to increase urinary calcium excretion. Drugs (such as thiazides and vitamin D compounds) which promote hypercalcaemia should be discontinued and dietary calcium should be restricted.

If severe hypercalcaemia persists, drugs which inhibit mobilisation of calcium from the skeleton may be required. The biophosphonates are useful and disodium pamidronate is probably the most effective. Plicamycin is probably the most rapidly effective drug but cannot be given continuously for more than a few days because of marrow toxicity; the duration of its hypocalcaemic effect is unpredictable but can last several days. Corticosteroids may only be useful where hypercalcaemia is due to sarcoidosis or vitamin D intoxication; they often take several days to achieve the desired effect. Calcitonin is relatively non-toxic but its effect can wear off after a few days despite continuous use; it is rarely effective where biophosphonates have failed to reduce serum calcium adequately. In severe cases, significant amounts of calcium may be removed by peritoneal dialysis.

Patients with symptoms of overdosage should avoid exposure to direct sunlight.

Special care must be exercised when treating overdosage in patients with impaired renal or hepatic function.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Calcium gluconate is used in calcium deficiency.

5.2 Pharmacokinetic Properties

Calcium is absorbed from the small intestine; about one third of ingested calcium is absorbed. Absorption decreases with age and may be more efficient when the body is deficient in calcium or from diets deficient in calcium. It is excreted in sweat, bile, pancreatic juice, saliva, urine, faeces and milk.

5.3 Preclinical Safety Data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Also contains: citric acid, magnesium stearate, povidone, saccharin sodium, sodium bicarbonate, stearic acid, tartaric acid.

6.2 Incompatibilities

None known.

6.3 Shelf Life

Shelf-life

Three years from the date of manufacture.

Shelf-life after dilution/reconstitution

Not applicable.

Shelf-life after first opening

Not applicable.

6.4 Special Precautions For Storage

Store below 25°C in a dry place.

6.5 Nature And Contents Of Container

The product containers are rigid injection moulded polypropylene or injection blow-moulded polyethylene containers and snap-on polyethylene lids; in case any supply difficulties should arise the alternative is amber glass containers with screw caps. An alternative closure for polyethylene containers is a polypropylene, twist on, push down and twist off child-resistant, tamper-evident lid.

Also included in each pack is a 2g silica gel capsule.

Pack sizes: 7s, 10s, 14s, 21s, 28s, 30s, 56s, 60s, 84s, 90s, 100s, 112s.

Product may also be supplied in bulk packs, for reassembly purposes only, in polybags contained in tins, skillets or polybuckets filled with suitable cushioning material. Also included are 5 x 50g silica gel bags.

Maximum size of bulk packs: 5,000.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

Administrative Data

7. Marketing Authorisation Holder

Name or style and permanent address of registered place of business of the holder of the Marketing Authorisation:

Actavis UK Limited

(Trading style: Actavis)

Whiddon Valley

BARNSTAPLE

N Devon EX32 8NS

8. Marketing Authorisation Number(S)

PL 0142/5579 R

9. Date Of First Authorisation/Renewal Of The Authorisation

11.7.86 (Product Licence of Right: 26.4.73)

19.10.97 (19.10.92)

10. Date Of Revision Of The Text

March 2007

Tobrex Ophthalmic Ointment

Generic Name: tobramycin

Dosage Form: ophthalmic ointment
Tobrex® (tobramycin ophthalmic ointment) 0.3%

DESCRIPTION

TOBREX® (tobramycin ophthalmic ointment) 0.3% is a sterile topical ophthalmic antibiotic formulation prepared specifically for topical therapy of external ophthalmic infections.

Each gram of TOBREX® (tobramycin ophthalmic ointment) 0.3% contains: Active: tobramycin 0.3% (3 mg). Preservative: chlorobutanol 0.5%. Inactives: mineral oil, white petrolatum.

Tobramycin is a water-soluble aminoglycoside antibiotic active against a wide variety of gram-negative and gram-positive ophthalmic pathogens.

The chemical structure of tobramycin is :

Molecular formula:

C18H37N5O9

Molecular weight:

467.52

Chemical name:

0-{3-amino-3-deoxy-α-D-gluco-pyranosyl-(1→4) }-0-{2,6-diamino-2,3,6-trideoxy-α-D-ribohexo-pyranosyl-(1→6) }-2-deoxystreptamine.

CLINICAL PHARMACOLOGY

In Vitro Data : In vitro studies have demonstrated tobramycin is active against susceptible strains of the following microorganisms: Staphylococci, including S. aureus and S. epidermidis (coagulase-positive and coagulase-negative), including penicillin-resistant strains.

Streptococci, including some of the Group A-beta-hemolytic species, some nonhemolytic species, and some Streptococcus pneumoniae.

Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Enterobacter aerogenes, Proteus mirabilis, Morganella morganii, most Proteus vulgaris strains, Haemophilus influenzae and H. aegyptius, Moraxella lacunata, Acinetobacter calcoaceticus and some Neisseria species. Bacterial susceptibility studies demonstrate that in some cases, microorganisms resistant to gentamicin retain susceptibility to tobramycin.

INDICATIONS AND USAGE

TOBREX® (tobramycin ophthalmic ointment) 0.3 % is a topical antibiotic indicated in the treatment of external infections of the eye and its adnexa caused by susceptible bacteria. Appropriate monitoring of bacterial response to topical antibiotic therapy should accompany the use of TOBREX® (tobramycin ophthalmic ointment) 0.3%. Clinical studies have shown tobramycin to be safe and effective for use in children.

CONTRAINDICATIONS

TOBREX® (tobramycin ophthalmic ointment) 0.3 % is contraindicated in patients with known hypersensitivity to any of its components.

WARNINGS

NOT FOR INJECTION INTO THE EYE. Sensitivity to topically applied aminoglycosides may occur in some patients. If a sensitivity reaction to TOBREX® (tobramycin ophthalmic ointment) 0.3% occurs, discontinue use.

PRECAUTIONS

General. As with other antibiotic preparations, prolonged use may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, appropriate therapy should be initiated. Ophthalmic ointments may retard corneal wound healing.

Cross-sensitivity to other aminoglycoside antibiotics may occur; if hypersensitivity develops with this product, discontinue use and institute appropriate therapy.

Patients should be advised not to wear contact lenses if they have signs and symptoms of ocular infections.

Information For Patients

Do not touch tube tip to any surface, as this may contaminate the ointment.

Do not use the product if the imprinted carton seals have been damaged, or removed.

Pregnancy Category B

Reproduction studies in three types of animals at doses up to thirty-three times the normal human systemic dose have revealed no evidence of impaired fertility or harm to the fetus due to tobramycin. There are, however, no adequate and well-controlled studies in pregnant women. Because animal studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers

Because of the potential for adverse reactions in nursing infants from TOBREX® (tobramycin ophthalmic ointment) 0.3%, a decision should be made whether to discontinue nursing the infant or discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness in pediatric patients below the age of 2 months has not been established.

Geriatric Use

No overall clinical differences in safety or effectiveness have been observed between the elderly and other adult patients.

ADVERSE REACTIONS

The most frequent adverse reactions to TOBREX® (tobramycin ophthalmic ointment) 0.3% are hypersensitivity and localized ocular toxicity, including lid itching and swelling, and conjunctival erythema. These reactions occur in less than three of 100 patients treated with TOBREX® (tobramycin ophthalmic ointment) 0.3%. Similar reactions may occur with the topical use of other aminoglycoside antibiotics. Other adverse reactions have not been reported from TOBREX® (tobramycin ophthalmic ointment) 0.3% therapy; however, if topical ocular tobramycin is administered concomitantly with systemic aminoglycoside antibiotics, care should be taken to monitor the total serum concentration. In clinical trials, TOBREX® (tobramycin ophthalmic ointment) 0.3 % produced significantly fewer adverse reactions (3.7%) than did GARAMYCIN® Ophthalmic Ointment (10.6%).

OVERDOSAGE

Clinically apparent signs and symptoms of an overdose of TOBREX® (tobramycin ophthalmic ointment) 0.3% (punctate keratitis, erythema, increased lacrimation, edema and lid itching) may be similar to adverse reaction effects seen in some patients.

DOSAGE AND ADMINISTRATION

In mild to moderate disease, apply a half-inch ribbon into the affected eye(s) two or three times per day. In severe infections, instill a half-inch ribbon into the affected eye(s) every three to four hours until improvement, following which treatment should be reduced prior to discontinuation.

How to Apply TOBREX® (tobramycin ophthalmic ointment) 0.3%:

1. Tilt your head back.

2. Place a finger on your cheek just under your eye and gently pull down until a ''V'' pocket is formed between your eyeball and your lower lid.

3. Place a small amount (about 1/2 inch) of TOBREX® (tobramycin ophthalmic ointment) 0.3% in the ''V'' pocket. Do not let the tip of the tube touch your eye.

4. Look downward before closing your eye.

HOW SUPPLIED

3.5 g STERILE ointment supplied in an aluminum tube with a white polyethylene tip and white polyethylene cap (NDC 0065-0644-35), containing tobramycin 0.3% (3 mg/g).

Storage: Store at 2°- 25°C (36°- 77°F).

Rx Only

© 2002, 2008 Alcon, Inc.

Revised: July 2008

Manufactured for:

ALCON LABORATORIES, INC.

Fort Worth, Texas 76134 USA

Manufactured by:

S.A. ALCON-COUVREUR N.V.

Puurs, Belgium

44280-1

PRINCIPAL DISPLAY PANEL

NDC 0065-0644-35  Alcon®

Tobrex®

(tobramycin ophthalmic

ointment) 0.3%

Sterile 3.5 g Net Wt.

  

  

TOBREX  tobramycin  ointment

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0065-0644 Route of Administration OPHTHALMIC DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TOBRAMYCIN (TOBRAMYCIN) TOBRAMYCIN 3 mg  in 1 g

Inactive Ingredients Ingredient Name Strength CHLOROBUTANOL   MINERAL OIL   PETROLATUM

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0065-0644-35 3.5 g In 1 TUBE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA050555	06/28/1981

Labeler - Alcon Laboratories, Inc. (008018525)

Registrant - Alcon Laboratories, Inc. (008018525)

Establishment
Name	Address	ID/FEI	Operations
S.A. ALCON-COUVREUR N.V.		370205429	MANUFACTURE

Revised: 07/2011Alcon Laboratories, Inc.

More Tobrex Ophthalmic Ointment resources

• Tobrex Ophthalmic Ointment Use in Pregnancy & Breastfeeding
• Tobrex Ophthalmic Ointment Support Group
• 3 Reviews for Tobrex Ophthalmic - Add your own review/rating

Compare Tobrex Ophthalmic Ointment with other medications

• Conjunctivitis, Bacterial

Children's Allergy Drug Facts

Dosage Form: liquid
Publix Super Markets, Inc. Children's Allergy Drug Facts

Active ingredient (in each 5 mL teaspoonful)

Cetirizine HCl 5 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

• runny nose


• sneezing


• itchy, watery eyes


• itching of the nose or throat

Warnings

Do not use

if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.

Ask a doctor before use if you have

liver or kidney disease. Your doctor should determine if you need a different dose.

Ask a doctor or pharmacist before use if you are

taking tranquilizers or sedatives.

When using this product

• drowsiness may occur avoid alcoholic drinks


• alcohol, sedatives, and tranquilizers may increase drowsiness


• be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

an allergic reaction to this product occurs. Seek medical help right away.

If pregnant or breast-feeding:

• if breast-feeding: not recommended


• if pregnant: ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

• use only with enclosed dosing cup

adults and children 6 years and over	1 teaspoonful (5 mL) or 2 teaspoonfuls (10 mL) once daily depending upon severity of symptoms; do not take more than 2 teaspoonfuls (10 mL) in 24 hours.
adults 65 years and over	1 teaspoonful (5 mL) once daily; do not take more than 1 teaspoonful (5 mL) in 24 hours.
children 2 to under 6 years of age	1/2 teaspoonful (2.5 mL) once daily. If needed, dose can be increased to a maximum of 1 teaspoonful (5 mL) once daily or 1/2 teaspoonful (2.5 mL) every 12 hours. Do not give more than 1 teaspoonful (5 mL) in 24 hours.
children under 2 years of age	ask a doctor
consumers with liver or kidney disease	ask a doctor

Other information

• do not use if carton is opened, or if printed neckband is broken or missing


• store between 20° to 25°C (68° to 77°F)

Inactive ingredients

acetic acid, artificial grape flavor, glycerin, methylparaben, natural banana flavor, propylene glycol, propylparaben, sodium acetate, sucrose, water

Principal Display Panel

Indoor & Outdoor Allergies

Children's Allergy

Cetirizine Hydrochloride Oral Solution, 1 mg/mL

Antihistamine

24 Hour Relief of:

Sneezing

Itchy, Watery Eyes

Runny Nose

Itchy Throat or Nose

Grape Flavored Syrup

2 yrs. and older

Dosing Cup Included

Original Prescription Strength

Compare to active ingredient in Children's Zyrtec®

Children's Allergy Carton

CHILDRENS ALLERGY  cetirizine hydrochloride  liquid

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 56062-974 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CETIRIZINE HYDROCHLORIDE (CETIRIZINE) CETIRIZINE HYDROCHLORIDE 5 mg  in 5 mL

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color YELLOW (Pale Yellow) Score      Shape Size Flavor GRAPE Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 56062-974-26 1 BOTTLE In 1 CARTON contains a BOTTLE 1 120 mL In 1 BOTTLE This package is contained within the CARTON (56062-974-26)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA090254	01/15/2009

Labeler - Publix Super Markets Inc (006922009)

Revised: 05/2009Publix Super Markets Inc

More Children's Allergy Drug Facts resources

• Children's Allergy Drug Facts Side Effects (in more detail)
• Children's Allergy Drug Facts Use in Pregnancy & Breastfeeding
• Drug Images
• Children's Allergy Drug Facts Drug Interactions
• Children's Allergy Drug Facts Support Group
• 73 Reviews for Children's Allergy Drug Facts - Add your own review/rating

Compare Children's Allergy Drug Facts with other medications

• Hay Fever
• Urticaria

Torsemide

Class: Loop Diuretics
VA Class: CV702
Chemical Name: N-[[(1-Methylethyl)amino]carbonyl]-4-[(3-methylphenyl) amino]-3-pyridinesulfonamide
Molecular Formula: C₁₆H₂₀N₄O₃S
CAS Number: 56211-40-6
Brands: Demadex

Introduction

A sulfonamide, loop-type diuretic and antihypertensive agent.^{1 a}

Uses for Torsemide

Edema

Management of edema associated with CHF^{1 4} or hepatic¹ or renal¹ disease (including chronic renal failure).^a

Hypertension

Management of hypertension (alone or in combination with other classes of antihypertensive agents).^{1 2 3}

One of several preferred initial therapies in hypertensive patients with CHF, acute pulmonary edema, or renal disease.^{2 3}

Can be used as monotherapy for initial management of uncomplicated hypertension;^{1 2 3 a} however, thiazide diuretics are preferred by JNC 7.¹¹

Torsemide Dosage and Administration

General

• 
  

  The manufacturer states that since oral and IV doses of torsemide are therapeutically equivalent, torsemide dosage is identical for oral or IV administration.¹

  
  

Edema

• 
  

  Most experts state that all patients with symptomatic CHF who have evidence for, or a prior history of, fluid retention generally should receive diuretic therapy in conjunction with moderate sodium restriction (≤3 g of sodium daily), an ACE inhibitor, and usually a β-blocker, with or without a cardiac glycoside.⁴

  
  


• 
  

  Hospitalization of the patient during initiation of therapy is advisable for patients with hepatic cirrhosis and ascites or chronic renal failure.^{1 a b}

  
  


• 
  

  Chronic use of any diuretic in hepatic disease has not been adequately studied.^{1 a}

  
  

Administration

Administer orally, by direct IV injection, or by continuous IV infusion.¹

Oral Administration

Administer orally without regard to meals.¹

IV Administration

For solution and drug compatibility information, see Compatibility under Stability.

IV administration may be used when a rapid onset of diuresis is desired or when oral therapy is not practical.¹

If torsemide is administered through an IV line, flush the IV line with 0.9% sodium chloride before and after administration.^a

Dilution

For IV infusion, dilute in 5% dextrose, 0.9% sodium chloride, or 0.45% sodium chloride injection.^a

Rate of Administration

For direct IV injection, administer slowly over a period of 2 minutes.¹

Dosage

Adults

Edema

CHF

Oral

Initially, 10–20 mg, given as a single dose.¹ Increase as necessary by approximately doubling daily dosage until desired diuresis is attained.¹ Single doses exceeding 200 mg not adequately studied.¹

IV

Initially, 10–20 mg, given as a single dose.¹ Increase as necessary by approximately doubling dosage until desired diuresis is attained.¹ Single doses exceeding 200 mg not adequately studied.¹

Hypertension

Oral

Initially, 5 mg once daily.¹ If adequate hypotensive response not attained in 4–6 weeks, may increase dosage to 10 mg once daily.¹ If adequate response not observed with 10 mg once daily, an additional antihypertensive agent should be added to antihypertensive therapy.¹

IV

Initially, 5 mg once daily.¹ If adequate hypotensive response not attained in 4–6 weeks, may increase dosage to 10 mg once daily.¹ If adequate response not observed with 10 mg once daily, an additional antihypertensive agent should be added to antihypertensive therapy.¹

Prescribing Limits

Adults

Edema

CHF

Oral

Maximum of 200 mg as a single dose (daily).¹

IV

Maximum of 200 mg as a single dose (daily).¹

Hypertension

Oral

Maximum of 10 mg once daily.¹

IV

Maximum of 10 mg once daily.¹

Special Populations

Renal Impairment

Edema

Edema Associated with Chronic Renal Failure

Oral or IV

In adults, initially, 20 mg once daily.¹ Increase as necessary by approximately doubling dosage until desired diuresis is attained.¹ Single doses exceeding 200 mg not adequately studied.^{1 a}

Hepatic Impairment

Chronic use in hepatic disease not adequately studied.¹

Edema

Edema Associated with Hepatic Cirrhosis

Oral or IV

In adults, initially, 5–10 mg once daily, given concomitantly with an aldosterone antagonist or a potassium-sparing diuretic.^a Increase as necessary by approximately doubling dosage until desired diuresis is attained.^a Single doses exceeding 40 mg not adequately studied.¹

Cautions for Torsemide

Contraindications

• 
  

  Anuria.¹

  
  


• 
  

  Known hypersensitivity to torsemide or to sulfonylureas.¹

  
  

Warnings/Precautions

Warnings

Hepatic Effects

Sudden alterations of electrolyte balance in patients with cirrhosis may precipitate hepatic coma; use with caution in patients with hepatic cirrhosis and ascites.¹

Therapy in such patients is best initiated in the hospital.¹ Use an aldosterone antagonist or potassium-sparing agent concomitantly with torsemide to prevent hypokalemia and metabolic alkalosis in such patients.¹

Ototoxicity

Tinnitus and hearing loss, usually reversible, have been observed following rapid IV injection of other loop diuretics and following oral torsemide administration.¹ Administer IV slowly (over 2 minutes); do not exceed 200 mg as a single dose.¹

Fluid, Electrolyte, and Cardiovascular Effects

Observe carefully for manifestations of fluid and electrolyte depletion (e.g., dryness of mouth, thirst, weakness, lethargy, drowsiness, restlessness, muscle pains or cramps, muscular fatigue, hypotension, oliguria, tachycardia, nausea, vomiting).^{1 a}

Excessive diuresis may cause dehydration and blood volume reduction with circulatory collapse and possibly vascular thrombosis and embolism, particularly in geriatric patients.^{1 a}

Laboratory changes may include altered serum concentrations of sodium, chloride, and potassium; acid-base abnormalities; and increased BUN.^{1 a} If electrolyte imbalance, hypovolemia, or prerenal azotemia develops, torsemide should be discontinued until the abnormality is corrected; treatment then may be restarted at a reduced dosage.^{1 a}

Risk of hypokalemia, especially with brisk diuresis, with inadequate oral electrolyte intake, in those with cirrhosis, or during concomitant use of corticosteroids or ACTH.^{1 a} Risk of arrhythmias secondary to hypokalemia in patients with cardiovascular disease, especially those receiving concomitant therapy with a cardiac glycoside.^{1 a}

Periodically monitor serum potassium and other electrolyte concentrations.^{1 a}

General Precautions

Endocrine Effects

Possible increased blood glucose concentrations; hyperglycemia occurred rarely. ^{1 a}

Renal and Electrolyte Effects

Small, dose-related, reversible increases in BUN, serum creatinine, and uric acid concentrations reported.^{1 a} Symptomatic gout reported at an incidence similar to placebo.¹

Slight alterations in calcium and magnesium concentrations.^{1 a}

Other Effects

Increases in total plasma cholesterol concentrations may occur; usually subside during chronic therapy.^{1 a}

Increases in plasma triglyceride concentrations reported.^{1 a}

In long-term studies, no clinically important differences in lipid profiles compared to baseline.^{1 a}

No clinically important effects on hemoglobin; hematocrit; WBC, erythrocyte, or platelet counts; or serum alkaline phosphatase concentrations.^{1 a}

Specific Populations

Pregnancy

Category B.¹

Lactation

Not known whether torsemide is distributed into milk.¹ Caution if used in nursing women.¹

Pediatric Use

Safety and efficacy not established.¹

Renal calcifications reported in severely premature infants with edema secondary to patent ductus arteriosus and hyaline membrane disease receiving another loop diuretic.^{1 a} Increased risk of persistent patent ductus arteriosus in premature neonates with hyaline membrane disease receiving another loop diuretic also has been reported.^{1 a}

Geriatric Use

No substantial differences in safety and efficacy relative to younger adults.^{1 a}

Renal Impairment

Seizures reported in patients with acute renal failure receiving higher than recommended dosages of torsemide.^{1 a}

Common Adverse Effects

Headache, excessive urination, dizziness, rhinitis, asthenia, diarrhea, ECG abnormality, increased cough.^{1 a}

Interactions for Torsemide

Specific Drugs

Drug	Interaction	Comments
Cholestyramine	Decreased absorption of torsemide in animals1 a	Avoid simultaneous administration when used concomitantly1 a
Digoxin	Increased torsemide AUC1 a	Torsemide dosage adjustment not necessary1 a
Lithium	Reduced renal clearance of lithium and increased risk of lithium toxicity reported with other diuretics 1 a	Avoid concomitant use or use great caution1 a
Ototoxic drugs (e.g., aminoglycoside antibiotics, ethacrynic acid)	Possible additive ototoxic effect when ototoxic drugs used concomitantly with other diuretics, especially in those with impaired renal function1 a
Probenecid	Reduced secretion of torsemide into proximal tubule and decreased diuretic activity1 a
Salicylates (e.g., aspirin, NSAIAs)	Concomitant use of NSAIAs with another loop diuretic (furosemide) occasionally associated with renal dysfunction.1 a Indomethacin may partially inhibit natriuretic effect of torsemide in those with dietary sodium restriction (50 mEq daily) 1 a Concomitant use with high dosages of salicylates may result in salicylate toxicity1 a
Spironolactone	Reduced renal clearance of spironolactone1 a	Adjustment of spironolactone or torsemide dosage not necessary1 a

Torsemide Pharmacokinetics

Absorption

Bioavailability

Bioavailability is approximately 80%.¹

Onset

Following oral administration, onset of diuresis occurs within 1 hour; maximal effect during the first or second hour.^{1 a}

Following IV administration, onset of diuresis occurs within 10 minutes; maximal effect within 1 hour.^{1 a}

Duration

Diuretic effect persists 6–8 hours following oral or IV administration.^{1 a}

Food

Food delays the time to peak plasma concentration following oral dosing but does not affect extent of absorption or diuretic activity.^{1 a}

Plasma Concentrations

Following oral administration, peak plasma concentrations achieved within 1 hour.¹

Distribution

Extent

Not known whether torsemide is distributed into milk.^{1 a}

Plasma Protein Binding

>99%.^{1 a}

Elimination

Metabolism

Hepatic metabolism accounts for approximately 80% of total clearance.^{1 a} Carboxylic acid derivative, the major metabolite, is inactive.^{1 a}

Elimination Route

Urinary excretion accounts for approximately 20% of total clearance in patients with normal renal function.^{1 a} Most renal clearance occurs via active secretion of the drug by the proximal tubules into tubular urine.^{1 a}

Half-life

Approximately 3.5 hours.^{1 a}

Special Populations

In patients with decompensated CHF, hepatic and renal clearance are reduced, resulting in delivery of less drug to the intraluminal site of action and decreased natriuretic effect.^{1 a} Total clearance is about half of that of healthy individuals; half-life and AUC increased.^{1 a}

In patients with renal failure, renal clearance (but not total clearance) is reduced, resulting in delivery of less drug to the intraluminal site of action and decreased natriuretic effect.^{1 a}

In patients with hepatic cirrhosis, renal clearance (but not total clearance) and half-life are increased.¹

In geriatric patients, decreased renal clearance.^{1 a}

Stability

Storage

Oral

Tablets

15–30°C.¹ Do not freeze.^{1 a}

Parenteral

Injection

15–30°C.^{1 a} Do not freeze.^{1 a}

Compatibility

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

Parenteral

Solution Compatibility^HID

Compatible
Dextrose 5% in water
Sodium chloride 0.45 or 0.9%

Y-Site CompatibilityHID

Compatible
Milrinone lactate

ActionsActions

• 
  

  Acts from within the lumen of the thick ascending portion of the loop of Henle, where it inhibits the sodium/potassium/chloride carrier system.¹

  
  


• 
  

  Increases urinary excretion of sodium, chloride, and water without having an important effect on glomerular filtration rate, renal plasma flow, or acid-base balance.¹

  
  

Advice to Patients

• 
  

  Risks associated with excessive fluid loss or electrolyte imbalance.^{1 a}

  
  


• 
  

  Potential for postural hypotension; importance of rising slowly from a seated position.¹

  
  


• 
  

  Importance of informing patients with diabetes mellitus that blood glucose concentrations may increase.¹

  
  


• 
  

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

  
  


• 
  

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

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

Torsemide

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Tablets	5 mg*	Demadex (with povidone; scored)	Roche
			Torsemide Tablets	Apotex, Par, Pliva, Roxane, Teva
		10 mg*	Demadex (with povidone; scored)	Roche
			Torsemide Tablets	Apotex, Par, Pliva, Roxane, Teva, UDL,
		20 mg*	Demadex (with povidone; scored)	Roche
			Torsemide Tablets	Apotex, Par, Pliva, Roxane, Teva, UDL
		100 mg*	Demadex (with povidone; scored)	Roche
			Torsemide Tablets	Apotex, Par, Pliva, Teva
Parenteral	Injection, for IV use	10 mg/mL	Demadex	Roche

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.

Demadex 10MG Tablets (MEDA PHARMACEUTICALS): 30/$43.69 or 90/$110.37

Demadex 100MG Tablets (MEDA PHARMACEUTICALS): 30/$160.99 or 90/$455.97

Demadex 20MG Tablets (MEDA PHARMACEUTICALS): 30/$55.99 or 90/$139.97

Torsemide 10MG Tablets (TEVA PHARMACEUTICALS USA): 30/$29.99 or 90/$79.97

Torsemide 100MG Tablets (TEVA PHARMACEUTICALS USA): 30/$89.99 or 90/$249.96

Torsemide 20MG Tablets (TEVA PHARMACEUTICALS USA): 30/$22.99 or 90/$59.98

Torsemide 5MG Tablets (CAMBER PHARMACEUTICALS): 30/$18.99 or 90/$56.97

Disclaimer

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

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

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions August 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

1. Boehringer Mannheim. Demadex (torsemide) tablets and injection prescribing information. Rockville, MD: 1993 Oct.

2. National Heart, Lung, and Blood Institute National High Blood Pressure Education Program. The sixth report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC VI). Bethesda, MD: National Institutes of Health. (NIH publication No. 98-4080.)

3. Kaplan NM. Choice of initial therapy for hypertension. JAMA. 1996; 275:1577-80. [IDIS 365188] [PubMed 8622249]

4. Anon. Consensus recommendations for the management of chronic heart failure. On behalf of the membership of the advisory council to improve outcomes nationwide in heart failure. Part II. Management of heart failure: approaches to the prevention of heart failure. Am J Cardiol. 1999; 83:9-38A.

5. Izzo JL, Levy D, Black HR. Importance of systolic blood pressure in older Americans. Hypertension. 2000; 35:1021-4. [PubMed 10818056]

6. Frohlich ED. Recognition of systolic hypertension for hypertension. Hypertension. 2000; 35:1019-20. [PubMed 10818055]

7. Bakris GL, Williams M, Dworkin L et al. Preserving renal function in adults with hypertension and diabetes: a consensus approach. Am J Kidney Dis. 2000; 36:646-61. [IDIS 452007] [PubMed 10977801]

8. Associated Press (American Diabetes Association). Diabetics urged: drop blood pressure. Chicago, IL; 2000 Aug 29. Press Release from web site.

9. Appel LJ. The verdict from ALLHAT—thiazide diuretics are the preferred initial therapy for hypertension. JAMA. 2002; 288:3039-42. [IDIS 490723] [PubMed 12479770]

10. The ALLHAT Officers and Coordinators for the ALLHAT Collaborative Research Group. Major outcomes in high-risk hypertensive patients randomized to angiotensin-converting enzyme inhibitor or calcium channel blocker vs diuretic: the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). JAMA. 2002; 288:2981-97. [IDIS 490721] [PubMed 12479763]

11. National Heart, Lung, and Blood Institute National High Blood Pressure Education Program. The seventh report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 7) Express. Bethesda, MD: May 14 2003. From NIH website. (http://www.nhlbi.nih.gov/guidelines/hypertension/jncintro.htm). (Also published in JAMA. 2003; 289:2560-72.

a. Roche Pharmaceuticals. Demadex (torsemide) tablets and injection prescribing information. Nutley, NJ: 2003 Apr.

b. AHFS Drug Information 2007. McEvoy GK, ed. Furosemide. American Society of Health-System Pharmacists; 2007: 2690-4.

HID. Trissel LA. Handbook on injectable drugs. 14th ed. Bethesda, MD: American Society of Health-System Pharmacists; 2007:1581.

More Torsemide resources

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

• Torsemide MedFacts Consumer Leaflet (Wolters Kluwer)


• Torsemide Prescribing Information (FDA)


• Torsemide Professional Patient Advice (Wolters Kluwer)


• torsemide Concise Consumer Information (Cerner Multum)


• torsemide Advanced Consumer (Micromedex) - Includes Dosage Information


• Demadex Prescribing Information (FDA)

Compare Torsemide with other medications

• Ascites
• Edema
• Heart Failure
• High Blood Pressure
• Nonobstructive Oliguria
• Renal Failure

Mesasal Rectal

Generic Name: mesalamine (Rectal route)

me-SAL-a-meen

Commonly used brand name(s)

In the U.S.

• Canasa


• Rowasa


• sfRowasa

In Canada

• Mesasal


• Pentasa


• Salofalk

Available Dosage Forms:

• Suppository


• Enema

Therapeutic Class: Gastrointestinal Agent

Chemical Class: Salicylate, Non-Aspirin

Uses For Mesasal

Mesalamine is used to treat inflammatory bowel disease, such as ulcerative colitis. This medicine works inside the bowel by helping to reduce inflammation and other symptoms.

Mesalamine is available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in product labeling, mesalamine is used in certain patients with the following medical condition:

• Ulcerative colitis, history of—prevent it from occurring again

Before Using Mesasal

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, 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

Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of mesalamine in children with use in other age groups.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of mesalamine in the elderly with use in other age groups.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while 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. When you are taking this medicine, 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 this medicine 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.

• Varicella Virus Vaccine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Ardeparin


• Certoparin


• Dalteparin


• Danaparoid


• Enoxaparin


• Nadroparin


• Parnaparin


• Reviparin


• Tamarind


• Tinzaparin


• Warfarin

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.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Kidney disease—The use of mesalamine may make this condition worse.

Proper Use of mesalamine

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

For best results, empty your bowel just before using the rectal enema or suppository.

Keep using this medicine for the full time of treatment even if you begin to feel better after a few days. Do not miss any doses.

For patients using the enema form of this medicine:

• This medicine usually comes with patient directions. Read them carefully before using this medicine.


• Remove the bottles from the protective foil pouch, being careful not to squeeze or puncture them. The enema is an off-white to tan color. Contents of the enemas removed from the foil pouch may darken with time. Slight darkening will not affect the potency of the contents. However, enemas with dark brown contents should be discarded.


• Shake the bottle well to make sure that the medication is thoroughly mixed. Remove the protective cover from the applicator tip. Hold bottle at the neck so that no medicine spills out.


• Lie on your left side with your left leg straight and your right knee bent in front of you for balance. You can also lie in the knee-chest position, on your knees with your chest touching the bed.


• Gently insert the rectal tip of the enema applicator pointed slightly toward your naval to prevent damage to the rectal wall. Tilt the nozzle slightly toward the back and squeeze slowly to cause the enema to flow into your rectum. Steady pressure will discharge most of the medicine. After administering, withdraw and discard the bottle.


• Remain in position for at least 30 minutes to allow the medicine to distribute thoroughly. Retain the medicine all night if possible.

For patients using the suppository form of this medicine:

• This medicine usually comes with patient directions. Read them carefully before using this medicine.


• Detach one suppository from strip of suppositories. Hold suppository upright and carefully remove the foil wrapper.


• Avoid excessive handling of the suppository, which is designed to melt at body temperature.


• Insert suppository (pointed end first) completely into rectum with gentle pressure. Retain the suppository for 3 hours or longer, if possible, to achieve the best result.

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.

• For inflammatory bowel disease:
  
  • For enema dosage form:
    
    • Adults and teenagers—4 grams (1 unit), used as directed, every night for three to six weeks.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For suppository dosage form:
    
    • Adults and teenagers—500 milligrams (mg), inserted into your rectum, two or three times a day for three to six weeks or 1000 mg, inserted into your rectum, one time a day at bedtime for three to six weeks.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Mesasal

It is important that your doctor check your progress at regular visits.

Contact your doctor if you develop cramping, acute abdominal pain, bloody diarrhea, fever, headache or rash. These may be symptoms of a serious condition.

Tell your doctor right away if you experience chest pain or shortness of breath.

Check with your doctor if you notice rectal bleeding, blistering, pain, burning, itching, or other sign of irritation not present before you started using this medicine.

Mesalamine rectal enema may stain clothing, fabrics, painted surfaces, marble, granite, vinyl, or other surfaces it touches.

Mesasal 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:

Less common or rare

• Abdominal or stomach cramps or pain (severe)


• anxiety


• back pain (severe)


• bloody, black, or tarry stools


• blue or pale skin


• bright red blood in the stool


• chest pain, possibly moving to the left arm, neck, or shoulder


• chills


• diarrhea (severe)


• fast heartbeat


• fever


• headache (severe)


• nausea or vomiting


• shortness of breath


• skin rash


• stomach cramps, tenderness, pain


• swelling of the stomach


• unusual tiredness or weakness


• watery or bloody diarrhea


• yellow eyes or skin

Incidence not known

• Blood in urine


• change in frequency of urination or amount of urine


• cough


• difficulty in breathing


• drowsiness


• high fever


• increased thirst


• loss of appetite


• lower back or side pain


• painful or difficult urination


• pale skin


• sore throat


• sores, ulcers, or white spots on lips or in mouth


• swelling of feet or lower legs


• swollen glands


• troubled breathing


• unexplained or unusual bleeding or bruising


• weakness

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:

More common

• Abdominal or stomach cramps or pain (mild)


• gas or flatulence


• headache (mild)


• nausea

Less common or rare

• Acne


• diarrhea


• dizziness


• leg or joint pain


• loss of hair


• rectal pain or irritation

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: Mesasal Rectal 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.

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More Mesasal Rectal resources

• Mesasal Rectal Side Effects (in more detail)
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• Mesasal Rectal Drug Interactions
• Mesasal Rectal Support Group
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