Calcichew D3 Forte Chewable Tablets

1. Name Of The Medicinal Product

Calcichew-D₃ Forte Chewable Tablets

2. Qualitative And Quantitative Composition

Per tablet: Calcium carbonate 1250 mg

(equivalent to 500 mg of elemental calcium)

Colecalciferol 400 IU

(equivalent to 10 micrograms vitamin D₃)

Contains sorbitol, 390mg; isomalt, 49.90mg; aspartame, 1mg; sucrose, 1.52mg; and soya bean oil, hydrogenated, 0.30mg. For a full list of excipients, see Section 6.1.

3. Pharmaceutical Form

Chewable tablet.

Round, white, uncoated and convex tablets. May have small specks.

4. Clinical Particulars

4.1 Therapeutic Indications

The treatment and prevention of vitamin D/calcium deficiency (characterised by raised serum alkaline phosphatase levels associated with increased bone loss, raised levels of serum PTH and lowered 25-hydroxyvitamin D) particularly in the housebound and institutionalised elderly subjects.

The supplementation of vitamin D and calcium as an adjunct to specific therapy for osteoporosis, in pregnancy, in established vitamin D dependent osteomalacia, and in other situations requiring therapeutic supplementation of malnutrition.

4.2 Posology And Method Of Administration

Oral.

Adults and elderly:

2 chewable tablets per day, preferably one tablet morning and evening.

The tablet may be chewed or sucked.

Dosage in hepatic impairment:

No dose adjustment is required.

Dosage in renal impairment:

Calcichew-D₃ Forte Chewable Tablets should not be used in patients with severe renal impairment.

4.3 Contraindications

• Diseases and/or conditions resulting in hypercalcaemia and/or hypercalciuria

• Nephrolithiasis

• Hypervitaminosis D

• Hypersensitivity to soya or peanut

• Hypersensitivity to the active substances or to any of the excipients

4.4 Special Warnings And Precautions For Use

During long-term treatment, serum calcium levels should be followed and renal function should be monitored through measurements of serum creatinine. Monitoring is especially important in patients on concomitant treatment with cardiac glycosides or diuretics (see section 4.5) and in patients with a high tendency to calculus formation. In case of hypercalcaemia or signs of impaired renal function the dose should be reduced or the treatment discontinued.

Vitamin D should be used with caution in patients with impairment of renal function and the effect on calcium and phosphate levels should be monitored. The risk of soft tissue calcification should be taken into account. In patients with severe renal insufficiency, vitamin D in the form of colecalciferol is not metabolised normally and other forms of vitamin D should be used (see section 4.3, contraindications).

Calcichew-D₃ Forte Chewable Tablets should be prescribed with caution to patients suffering from sarcoidosis because of the risk of increased metabolism of vitamin D to its active form. These patients should be monitored with regard to the calcium content in serum and urine.

Calcichew-D₃ Forte Chewable Tablets should be used with caution in immobilised patients with osteoporosis due to the increased risk of hypercalcaemia.

The content of colecalciferol (400 IU) in Calcichew-D₃ Forte Chewable Tablets should be considered when prescribing other medicinal products containing vitamin D and/or medications or nutrients (such as milk) containing calcium, Additional doses of calcium or vitamin D increase the risk of hypercalcaemia with subsequent kidney function impairment and milk-alkali syndrome; therefore they should be taken under close medical supervision. In such cases it is necessary to monitor serum calcium levels and urinary calcium excretion frequently.

Calcichew-D₃ Forte Chewable Tablets contain aspartame (a source of phenylalanine) which may be harmful for people with phenylketonuria.

Calcichew-D₃ Forte Chewable Tablets contain sorbitol (E420), isomalt and sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

Calcichew-D₃ Forte Chewable Tablets are not intended for use in children.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Thiazide diuretics reduce the urinary excretion of calcium. Due to increased risk of hypercalcaemia, serum calcium should be regularly monitored during concomitant use of thiazide diuretics.

Systemic corticosteroids reduce calcium absorption. During concomitant use, it may be necessary to increase the dose of Calcichew-D₃ Forte Chewable Tablets.

Simultaneous treatment with ion exchange resins such as cholestyramine or laxatives such as paraffin oil may reduce the gastrointestinal absorption of vitamin D.

Calcium carbonate may interfere with the absorption of concomitantly administered tetracycline preparations. For this reason, tetracycline preparations should be administered at least two hours before, or four to six hours after, oral intake of calcium.

Hypercalcaemia may increase the toxicity of cardiac glycosides during treatment with calcium and vitamin D. Patients should be monitored with regard to electrocardiogram (ECG) and serum calcium levels.

The efficacy of levothyroxine can be reduced by the concurrent use of calcium, due to decreased levothyroxine absorption. Administration of calcium and levothyroxine should be separated by at least four hours.

The absorption of quinolone antibiotics may be impaired if administered concomitantly with calcium. Quinolone antibiotics should be taken two hours before or after intake of calcium.

If a bisphosphonate or sodium fluoride is used concomitantly, this preparation should be administered at least three hours before the intake of Calcichew-D₃ Forte Chewable Tablets since gastrointestinal absorption may be reduced.

Oxalic acid (found in spinach and rhubarb) and phytic acid (found in whole cereals) may inhibit calcium absorption through formation of insoluble calcium salts. The patient should not take calcium products within two hours of eating foods high in oxalic acid and phytic acid.

4.6 Pregnancy And Lactation

Pregnancy

During pregnancy the daily intake should not exceed 1500 mg calcium and 600 IU colecalciferol (15μg vitamin D). Studies in animals have shown reproductive toxicity with high doses of vitamin D. In pregnant women, overdoses of calcium and vitamin D should be avoided as permanent hypercalcaemia has been related to adverse effects on the developing foetus. There are no indications that vitamin D at therapeutic doses is teratogenic in humans. Calcichew-D₃ Forte Chewable Tablets can be used during pregnancy, in case of a calcium and vitamin D deficiency.

Lactation

Calcichew-D₃ Forte Chewable Tablets can be used during breast-feeding. Calcium and vitamin D₃ pass into breast milk. This should be considered when giving additional vitamin D to the child.

4.7 Effects On Ability To Drive And Use Machines

There are no data about the effect of this product on driving capacity. An effect is, however, unlikely.

4.8 Undesirable Effects

Adverse reactions are listed below, by system organ class and frequency. Frequencies are defined as: uncommon (

Metabolism and nutrition disorders

Uncommon: Hypercalcaemia and hypercalciuria.

Very rare: Seen usually only in overdose, see 4.9: Milk-alkali syndrome

Gastrointestinal disorders

Rare: Constipation, dyspepsia, flatulence, nausea, abdominal pain and diarrhoea.

Skin and subcutaneous disorders

Rare: Pruritus, rash and urticaria.

4.9 Overdose

Overdose can lead to hypercalcaemia. Symptoms of hypercalcaemia may include anorexia, thirst, nausea, vomiting, constipation, abdominal pain, muscle weakness, fatigue, mental disturbances, polydipsia, polyuria, bone pain, nephrocalcinosis, nephrolithiasis and in severe cases, cardiac arrhythmias. Extreme hypercalcaemia may result in coma and death. Persistently high calcium levels may lead to irreversible renal damage and soft tissue calcification.

Milk-alkali syndrome (frequent urge to urinate; continuing headache; continuing loss of appetite; nausea or vomiting; unusual tiredness or weakness; hypercalcaemia, alkalosis and renal impairment). The milk-alkali syndrome of hypercalcaemia, alkalosis and renal impairment still occur in patients who ingest large amounts of calcium and absorbable alkali; it is not uncommon as a cause of hypercalcaemia requiring hospitalisation. The syndrome has also been reported in a patient taking recommended doses of antacids containing calcium carbonate for chronic epigastric discomfort, and in a pregnant woman taking high, but not grossly excessive, doses of calcium (about 3 g of elemental calcium daily). Metastatic calcification can develop.

Treatment of hypercalcaemia: The treatment with calcium must be discontinued. Treatment with thiazide diuretics, lithium, vitamin A, vitamin D and cardiac glycosides must also be discontinued. Treatment: rehydration, and, according to severity of hypercalcaemia, isolated or combined treatment with loop diuretics, bisphosphonates, calcitonin and corticosteroids should be considered. Serum electrolytes, renal function and diuresis must be monitored. In severe cases, ECG and CVP should be followed.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Mineral supplements

ATC code: A12AX

Vitamin D increases the intestinal absorption of calcium.

Administration of calcium and vitamin D₃ counteracts the increase of parathyroid hormone (PTH), which is caused by calcium deficiency and which causes increased bone resorption.

A clinical study of institutionalised patients suffering from vitamin D deficiency indicated that a daily intake of two tablets of Calcichew-D₃ Forte chewable tablets for six months normalised the value of the 25-hydroxylated metabolite of vitamin D₃ and reduced secondary hyperparathyroidism and alkaline phosphatases.

An 18 month double-blind, placebo controlled study including 3270 institutionalised women aged 84+/- 6 years who received supplementation of vitamin D (800 IU/day) and calcium phosphate (corresponding to 1200 mg/day of elemental calcium), showed a significant decrease of PTH secretion. After 18 months, an "intent-to treat" analysis showed 80 hip fractures in the calcium-vitamin D group and 110 hip fractures in the placebo group (p=0.004). A follow-up study after 36 months showed 137 women with at least one hip fracture in the calcium-vitamin D group (n=1176) and 178 in the placebo group (n=1127) (p

5.2 Pharmacokinetic Properties

Calcium

Absorption: The amount of calcium absorbed through the gastrointestinal tract is approximately 30% of the swallowed dose.

Distribution and metabolism: 99% of the calcium in the body is concentrated in the hard structure of bones and teeth. The remaining 1% is present in the intra- and extracellular fluids. About 50% of the total blood-calcium content is in the physiologically active ionised form with approximately 10% being complexed to citrate, phosphate or other anions, the remaining 40% being bound to proteins, principally albumin.

Elimination: Calcium is eliminated through faeces, urine and sweat. Renal excretion depends on glomerular filtration and calcium tubular reabsorption.

Vitamin D

Absorption: Vitamin D is easily absorbed in the small intestine.

Distribution and metabolism: Colecalciferol and its metabolites circulate in the blood bound to a specific globulin. Colecalciferol is converted in the liver by hydroxylation to the active form 25-hydroxycholecalciferol. It is then further converted in the kidneys to 1,25-hydroxycholecalciferol; 1,25-hydroxycholecalciferol is the metabolite responsible for increasing calcium absorption. Vitamin D, which is not metabolised, is stored in adipose and muscle tissues.

Elimination: Vitamin D is excreted in faeces and urine.

5.3 Preclinical Safety Data

At doses far higher than the human therapeutic range teratogenicity has been observed in animal studies. There is no further information of relevance to the safety assessment in addition to what is stated in other parts of the SmPC.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Sorbitol E420

Povidone

Isomalt (E953)

Flavouring (lemon)

Fatty acid mono- and diglycerides

Aspartame (E951)

Magnesium stearate

Sucrose

Gelatin

Soya bean oil, hydrogenated

Tocopherol

Maize starch

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

3 years.

6.4 Special Precautions For Storage

Do not store above 30°C. Keep the container tightly closed to protect from moisture.

6.5 Nature And Contents Of Container

White, high density polyethylene bottles containing 20, 30, 60, 90 or 100 tablets with tamper-evident seal.

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

No special requirements.

7. Marketing Authorisation Holder

Shire Pharmaceuticals Limited

Hampshire International Business Park

Chineham

Basingstoke

Hampshire RG24 8EP

United Kingdom

8. Marketing Authorisation Number(S)

PL 08557/0029

9. Date Of First Authorisation/Renewal Of The Authorisation

26 March 1996

10. Date Of Revision Of The Text

09-Jun-2010

Statrol

Dosage Form: ophthalmic ointment

DESCRIPTION

Statrol® (Neomycin and Polymyxin B Sulfates Ophthalmic Ointment, USP) is a sterile ophthalmic drug combining two antibacterials in ointment form.

Each gram of ointment contains: Active: Neomycin Sulfate equivalent to 3.5 mg Neomycin base, Polymyxin B Sulfate equal to 10,000 polymyxin B units.

Preservatives: Methylparaben 0.05%, Propylparaben 0.01%. Inactive: White Petrolatum, Anhydrous Liquid Lanolin. DM-01

CLINICAL PHARMACOLOGY

The anti-infective components in Statrol Ophthalmic Ointment provide action against specific organisms susceptible to them. Polymyxin B Sulfate and Neomycin Sulfate are active in vitro against Staphylococcus aureus, Escherichia coli, Klebsiella/Enterobacter species, Neisseria species, Pseudomonas aeruginosa. This product does not provide adequate coverage against: Serratia marcescens, Streptococci, including Streptococcus pneumoniae.

INDICATIONS AND USAGE

STRATOL Ophthalmic Ointment is indicated in the topical treatment of infections of the external eye and its adnexa caused by susceptible bacteria. Such infections encompass conjunctivitis, keratitis, and keratoconjunctivitis, blepharitis and blepharoconjunctivitis, acute meibomianitis and dacryocystitis.

CONTRAINDICATIONS

Epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, and many other viral diseases of the cornea and conjunctiva. Mycobacterial infection of the eye. Fungal diseases of ocular structures. Hypersensitivity to a component of the medication.

WARNINGS

NOT FOR INJECTION INTO THE EYE. Should a sensitivity reaction occur, discontinue use. Ophthalmic ointments may retard corneal wound healing. Neomycin Sulfate may cause cutaneous sensitization. Remove contact lenses before using.

PRECAUTIONS

General

As with other antibiotic preparations, prolonged use may result in overgrowth of nonsusceptible organisms including fungi. If superinfection occurs, appropriate measures should be initiated. Whenever clinical judgment dictates; the patient should be examined with the aid of magnification, such as slit lamp biomicroscopy, and, where appropriate, corneal staining.

Information for Patients

This product is sterile when packaged. To prevent contamination, care should be taken to avoid touching the tube tip to eyelids or to any other surface. The use of this tube by more than one person may spread infection. Keep tube tightly closed when not in use. Keep out of the reach of children.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies in animals to evaluate carcinogenic or mutagenic potential have not been conducted with Polymyxin B Sulfate. Treatment of cultured human lymphocytes in-vitro with neomycin increased the frequency of chromosome aberrations at the highest concentrations (80 µg/mL) tested; however, the effects of neomycin on carcinogenesis and mutagenesis in humans are unknown.

Polymyxin B Sulfate has been reported to impair the motility of equine sperm, but its effects on male or female fertility are unknown.

Pregnancy

Teratogenic Enects

Pregnancy Category C.

Animal reproduction studies have not been conducted with Statrol® (Neomycin and Polymyxin B Sulfates Ophthalmic Ointment, USP). It is also not known whether Neomycin Sulfate and/or Polymyxin B Sulfate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Statrol Ophthalmic Ointment should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether these drugs are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Statrol Ophthalmic Ointment is administered to a nursing mother.

ADVERSE REACTIONS

Adverse reactions have occurred with the anti-infective components. Exact incidence figures are not available since no denominator of treated patients is available.

Reactions occurring most often from the presence of the anti-infective ingredients are allergic sensitizations. (SEE WARNINGS.)

DOSAGE AND ADMINISTRATION

Instill about a half-inch ribbon into the conjunctival sac(s) up to three or four times daily, or may be used adjunctively with the solution at bedtime.

HOW SUPPLIED

Statrol (Neomycin and Polymyxin B Sulfates Ophthalmic Ointment, USP) in 3.5 g ophthalmic tube: NDC 0065-0624-36.

STORAGE: Store at 46° - 80°F (8° - 27°C).

Federal (USA) law prohibits dispensing without prescription.

Alcon®

OPHTHALMIC

ALCON LABORATORIES, INC.

Fort Worth, Texas; 76134; USA

Revised: June 1995

Printed in USA

298392

Statrol  neomycin sulfate and polymyxin b sulfate  ointment

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0065-0624 Route of Administration OPHTHALMIC DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength neomycin sulfate (neomycin) Active 3.5 MILLIGRAM  In 1 GRAM polymyxin B sulfate (polymyxin B) Active 10000 UNITS  In 1 GRAM methylparaben Inactive   propylparaben Inactive   white petrolatum Inactive   anhydrous liquid lanolin Inactive

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0065-0624-36 3.5 g (GRAM) In 1 TUBE None

Revised: 05/2006ALCON LABORATORIES, INC.

More Statrol resources

• Statrol Side Effects (in more detail)
• Statrol Dosage
• Statrol Support Group
• 0 Reviews · Be the first to review/rate this drug

Zincate

Generic Name: zinc sulfate (ZINK SUL fate)

Brand Names: Orazinc 110, Orazinc 220, Verazinc, Zinc-220, Zincate

What is Zincate (zinc sulfate)?

Zinc is a naturally occurring mineral. Zinc is important for growth and for the development and health of body tissues.

Zinc sulfate is used to treat and to prevent zinc deficiency.

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

What is the most important information I should know about Zincate (zinc sulfate)?

Before using zinc sulfate, talk to your doctor, pharmacist, herbalist, or other healthcare provider. You may not be able to use zinc sulfate if you have certain medical conditions.

Avoid taking this medication with foods that are high in calcium or phosphorus, which can make it harder for your body to absorb zinc sulfate. Foods high in calcium or phosphorus include milk, cheese, yogurt, ice cream, dried beans or peas, lentils, nuts, peanut butter, beer, cola soft drinks, and hot cocoa.

Zinc sulfate can make certain antibiotics less effective. Tell your doctor about all other medications you are using before you start taking zinc sulfate.

What should I discuss with my healthcare provider before taking Zincate (zinc sulfate)?

Before using zinc sulfate, talk to your doctor, pharmacist, herbalist, or other healthcare provider. You may not be able to use zinc sulfate if you have certain medical conditions.

It is not known whether zinc sulfate will harm an unborn baby. Do not take zinc sulfate without telling your doctor if you are pregnant or could become pregnant during treatment. It is not known whether zinc sulfate passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take Zincate (zinc sulfate)?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Take zinc sulfate with a full glass of water. Take zinc sulfate with food if it upsets your stomach.

Your healthcare provider may occasionally change your dose to make sure you get the best results from zinc sulfate. The recommended dietary allowance of zinc sulfate increases with age. Follow your healthcare provider's instructions. You may also consult the National Academy of Sciences "Dietary Reference Intake" or the U.S. Department of Agriculture's "Dietary Reference Intake" (formerly "Recommended Daily Allowances" or RDA) listings for more information.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

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

Overdose symptoms may include nausea, severe vomiting, dehydration, and restlessness.

What should I avoid while taking Zincate (zinc sulfate)?

Avoid taking this medication with foods that are high in calcium or phosphorus, which can make it harder for your body to absorb zinc sulfate. Foods high in calcium or phosphorus include milk, cheese, yogurt, ice cream, dried beans or peas, lentils, nuts, peanut butter, beer, cola soft drinks, and hot cocoa.

Zincate (zinc sulfate) 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.

Less serious side effects may include:

• 
  

  nausea; or

  
  


• 
  

  upset stomach.

  
  

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

What other drugs will affect Zincate (zinc sulfate)?

The following drugs can interact with or be made less effective by zinc sulfate. Tell your doctor if you are using any of these:

• 
  

  a blood thinner such as warfarin (Coumadin);

  
  


• 
  

  methyltestosterone (Android, Methitest, Oreton);

  
  


• 
  

  penicillamine (Cuprimine, Depen);

  
  


• 
  

  risedronate (Actonel);

  
  


• 
  

  a tetracycline antibiotic such as demeclocycline (Declomycin), doxycycline (Adoxa, Doryx, Oracea, Vibramycin), minocycline (Dynacin, Minocin, Solodyn, Vectrin), or tetracycline (Brodspec, Panmycin, Sumycin, Tetracap); or

  
  


• 
  

  an antibiotic such as ciprofloxacin (Cipro), ofloxacin (Floxin), norfloxacin (Noroxin), levofloxacin (Levaquin), and others.

  
  

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

More Zincate resources

• Zincate Side Effects (in more detail)
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• Drug Images
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• Zincate Support Group
• 0 Reviews for Zincate - Add your own review/rating

• Zincate MedFacts Consumer Leaflet (Wolters Kluwer)


• Zinc Sulfate Professional Patient Advice (Wolters Kluwer)


• Orazinc 110 Advanced Consumer (Micromedex) - Includes Dosage Information

Compare Zincate with other medications

• Vitamin/Mineral Supplementation and Deficiency

Where can I get more information?

• Your pharmacist can provide more information about zinc sulfate.

See also: Zincate side effects (in more detail)

Candesartan/Hydrochlorothiazide

Pronunciation: KAN-de-SAR-tan/HYE-droe-KLOR-oh-THYE-a-zide
Generic Name: Candesartan/Hydrochlorothiazide
Brand Name: Atacand HCT

Candesartan/Hydrochlorothiazide can cause injury or even death to a fetus when used after the third month of pregnancy. Contact your doctor immediately if you suspect that you are pregnant.

Candesartan/Hydrochlorothiazide is used for:

Treating high blood pressure. It may also be used for other conditions as determined by your doctor.

Candesartan/Hydrochlorothiazide is a combination angiotensin II receptor blocker and diuretic. The angiotensin II receptor blocker works by relaxing the blood vessels. Exactly how the diuretic works to decrease blood pressure is not known, but it helps the kidneys to eliminate fluid and sodium from the body.

Do NOT use Candesartan/Hydrochlorothiazide if:

• you are allergic to any ingredient in Candesartan/Hydrochlorothiazide or to any other sulfonamide medicine (eg, sulfamethoxazole)


• you are pregnant


• you have severe kidney problems or are unable to urinate


• you are taking dofetilide or ketanserin

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

Before using Candesartan/Hydrochlorothiazide:

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

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


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


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


• if you are a woman of childbearing age


• if you have ever had a severe allergic reaction (eg, swelling of the hands, face, lips, eyes, throat, or tongue; trouble swallowing or breathing; hoarseness) after taking any other angiotensin II receptor blocker or an angiotensin-converting enzyme (ACE) inhibitor (eg, captopril)


• if you have low blood sodium, chloride, potassium, or magnesium levels; low blood volume; or high blood calcium levels; or you are dehydrated


• if you have asthma; gout; heart problems (eg, congestive heart failure); liver, gall bladder, or kidney problems; high blood cholesterol or lipid levels; or systemic lupus erythematosus


• if you have diabetes, especially if you are also taking aliskiren


• if you have recently had nerve surgery


• if you have never taken another medicine for high blood pressure

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

• Aliskiren, potassium supplements, or potassium-sparing diuretics (eg, spironolactone) because the risk of high blood potassium levels may be increased


• ACE inhibitors (eg, lisinopril) because the risk of kidney problems and high blood potassium levels may be increased


• Dofetilide or ketanserin because the risk of irregular heartbeat may be increased


• Adrenocorticotropic hormone (ACTH), barbiturates (eg, phenobarbital), corticosteroids (eg, prednisone), diuretics (eg, furosemide), narcotic pain medicines (eg, morphine), or other medicines for high blood pressure because they may increase the risk of Candesartan/Hydrochlorothiazide's side effects


• Nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, celecoxib, ibuprofen) because they may decrease Candesartan/Hydrochlorothiazide's effectiveness and the risk of serious kidney problems may be increased


• Cholestyramine or colestipol because they may decrease Candesartan/Hydrochlorothiazide's effectiveness


• Diazoxide, digoxin, or lithium because risk of their side effects and toxic effects may be increased by Candesartan/Hydrochlorothiazide


• Diabetes medicine (eg, glipizide, metformin) or insulin because their effectiveness may be decreased by Candesartan/Hydrochlorothiazide

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

Use Candesartan/Hydrochlorothiazide as directed by your doctor. Check the label on the medicine for exact dosing instructions. Check the label on the medicine for exact dosing instructions.

• Take Candesartan/Hydrochlorothiazide by mouth with or without food.


• Drinking extra fluids while you are taking Candesartan/Hydrochlorothiazide is recommended. Check with your doctor for instructions.


• Candesartan/Hydrochlorothiazide may increase the amount of urine or cause you to urinate more often when you first start taking it. To keep this from disturbing your sleep, try to take your dose before 6 pm.


• If you take cholestyramine or colestipol, ask your doctor or pharmacist how to take it with Candesartan/Hydrochlorothiazide.


• Continue to take Candesartan/Hydrochlorothiazide even if you feel well. Do not miss any doses.


• If you miss a dose of Candesartan/Hydrochlorothiazide, 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 Candesartan/Hydrochlorothiazide.

Important safety information:

• Candesartan/Hydrochlorothiazide may cause drowsiness, dizziness, or light-headedness. These effects may be worse if you take it with alcohol or certain medicines. Take Candesartan/Hydrochlorothiazide with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Candesartan/Hydrochlorothiazide may cause dizziness, light-headedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.


• Report any light-headedness or fainting to your doctor immediately. Your risk of light-headedness or fainting may be increased if you experience diarrhea, vomiting, or excessive sweating; if you do not drink enough fluids; or if you are on a low-salt (sodium) diet.


• Patients who take medicine for high blood pressure often feel tired or run down for a few weeks after starting treatment. Be sure to take your medicine even if you may not feel "normal." Tell your doctor if you develop any new symptoms.


• Candesartan/Hydrochlorothiazide may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Candesartan/Hydrochlorothiazide. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.


• Candesartan/Hydrochlorothiazide has a sulfonamide called hydrochlorothiazide in it. Hydrochlorothiazide can cause certain eye problems (myopia, angle-closure glaucoma). Your risk may be increased if you are allergic to sulfonamide medicines (eg, sulfamethoxazole) or to penicillin antibiotics (eg, amoxicillin). Untreated angle-closure glaucoma can lead to permanent vision loss. If these eye problems occur, symptoms usually occur within hours to weeks of starting Candesartan/Hydrochlorothiazide. Contact your doctor right away if you experience symptoms such as vision changes (eg, decreased vision clearness) or eye pain.


• Tell your doctor or dentist that you take Candesartan/Hydrochlorothiazide before you receive any medical or dental care, emergency care, or surgery.


• If you have high blood pressure, do not use nonprescription products that contain stimulants. These products may include diet pills or cold medicines. Contact your doctor if you have any questions or concerns.


• Your doctor may have also prescribed a potassium supplement for you. If so, follow the dosing carefully. Do not start taking additional potassium on your own or change your diet to include more potassium without first checking with your doctor.


• Check with your doctor before you use a salt substitute or a product that has potassium in it.


• Diabetes patients - Candesartan/Hydrochlorothiazide may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.


• Candesartan/Hydrochlorothiazide may raise your blood sugar. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away.


• Candesartan/Hydrochlorothiazide may interfere with certain lab tests, including parathyroid function tests. Be sure your doctor and lab personnel know you are taking Candesartan/Hydrochlorothiazide.


• Lab tests, including kidney function, blood pressure, and blood electrolytes, may be performed while you use Candesartan/Hydrochlorothiazide. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Candesartan/Hydrochlorothiazide with caution in the ELDERLY; they may be more sensitive to its effects.


• Candesartan/Hydrochlorothiazide should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: Candesartan/Hydrochlorothiazide may cause birth defects or fetal death if you take it while you are pregnant. If you think you may be pregnant, contact your doctor right away. Candesartan/Hydrochlorothiazide is found in breast milk. Do not breast-feed while taking Candesartan/Hydrochlorothiazide.

Possible side effects of Candesartan/Hydrochlorothiazide:

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:

Back pain; diarrhea; dizziness; tiredness.

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; unusual hoarseness); burning, numbness, or tingling of the skin; chest pain; confusion; dark urine; decrease in sexual ability; decreased, difficult, or painful urination; eye pain; fainting; fast, slow, or irregular heartbeat; fever, chills, or persistent sore throat; light-headedness; mental or mood changes (eg, depression); muscle pain, weakness, tenderness, or cramps; numbness of an arm or leg; red, swollen, blistered, or peeling skin; restlessness; seizures; severe or persistent dizziness or drowsiness; severe or persistent dry mouth or nausea; severe stomach pain; shortness of breath; sluggishness; swelling of the arms or legs; unusual bruising or bleeding; unusual thirst, tiredness, or weakness; vision changes (eg, decreased vision clearness); vomiting; yellowing of the skin or eyes.

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

See also: Candesartan/Hydrochlorothiazide 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 confusion; fainting; fast, slow, or irregular heartbeat; severe or unusual dizziness.

Proper storage of Candesartan/Hydrochlorothiazide:

Store Candesartan/Hydrochlorothiazide at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Candesartan/Hydrochlorothiazide out of the reach of children and away from pets.

General information:

• If you have any questions about Candesartan/Hydrochlorothiazide, please talk with your doctor, pharmacist, or other health care provider.


• Candesartan/Hydrochlorothiazide is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Candesartan/Hydrochlorothiazide. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Candesartan/Hydrochlorothiazide resources

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

Compare Candesartan/Hydrochlorothiazide with other medications

• High Blood Pressure

Enlon

edrophonium chloride

Dosage Form: injection, solution

Enlon Description

Enlon is a short and rapid-acting cholinergic drug. Chemically, edrophonium chloride is ethyl(m-hydroxyphenyl) dimethylammonium chloride and its structural formula is:

Each mL contains, in a sterile solution, 10 mg edrophonium chloride compounded with 0.45%phenol as a preservative, and 0.2% sodium sulfite as an antioxidant, buffered with sodium citrate and citric acid, and pH adjusted to approximately 5.4.

Enlon is intended for IV and IM use.

Enlon - Clinical Pharmacology

Enlon is an anticholinesterase drug. Its pharmacologic action is due primarily to the inhibition or inactivation of acetylcholinesterase at sites of cholinergic transmission. Its effect is manifest within 30 to 60 seconds after injection and lasts an average of 10 minutes.

Pediatric Pharmacology

The pharmacology of edrophonium chloride was studied in 14 infants (between 3 weeks and 11 months old) and 12 children (between 1 year and 6 years old) during a steady-state infusion of d-tubocurarine during N2O-halothane anesthesia and controlled ventilation for elective surgery.1 The ED50 dose (dose producing 50% antagonism of 90% neuromuscular depression) for edrophonium chloride was 145 mcg/kg in infants and 233 mcg/kg in children not significantly different from that observed in adult patients; however, there was greater variability among infants and children than adults. Time to peak antagonism and duration of antagonism were similar between the two pediatric age groups and adult patients. Edrophonium chloride pharmacokinetics were studied in four infants (3 months through 7 months of age) and four children (1 through 4 years of age). Total clearance was 17.8 mL/kg•min in infants and 14.2 mL/kg•min in children. Total clearance was significantly greater in infants than in adults (8.3 + 2.9 mL/kg•min) p<0.05. Elimination half-life was 73 ± 30 minutes in infants and 99 ± 31 minutes in children compared with 126 ± 59 minutes in adult patients. Volume of distribution in infants and children was 1.18 ± 0.20 L/kg and 1.22 ± 0.74 L/kg, respectively, compared with 0.90 ± 0.13 L/kg in adults.

Indications and Usage for Enlon

Enlon is recommended for the differential diagnosis of myasthenia gravis and as an adjunct in the evaluation of treatment requirements in this disease. It may also be used for evaluating emergency treatment in myasthenic crises. Because of its brief duration of action, it is not recommended for maintenance therapy in myasthenia gravis.

Enlon is also useful whenever a curare antagonist is needed to reverse the neuromuscular block produced by curare, tubocurarine, gallamine triethiodide or dimethyl-tubocurarine. It is not effective against decamethonium bromide and succinylcholine chloride. It may be used adjunctively in the treatment of respiratory depression caused by curare overdosage.

Contraindications

Known hypersensitivity to anticholinesterase agents; intestinal and urinary obstructions of mechanical type.

Warnings

Whenever anticholinesterase drugs are used for testing, a syringe containing 1 mg of atropine sulfate should be immediately available to be given in aliquots intravenously to counteract severe cholinergic reactions which may occur in the hypersensitive individual, whether he is normal or myasthenic. Enlon should be used with caution in patients with bronchial asthma or cardiac dysrhythmias. The transient bradycardia which sometimes occurs can be relieved by atropine sulfate. Isolated instances of cardiac and respiratory arrest following administration of Enlon have been reported. It is postulated that these are vagotonic effects.

Enlon contains sodium sulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.

Usage in Pregnancy

The safety of Enlon during pregnancy or lactation in humans has not been established. Therefore, use of Enlon in women who may become pregnant requires weighing the drug’s potential benefits against its possible hazards to mother and child.

Precautions

Patients may develop “anticholinesterase insensitivity” for brief or prolonged periods. During these periods the patients should be carefully monitored and may need respiratory assistance. Dosages of anticholinesterase drugs should be reduced or withheld until patients again become sensitive to them.

Pediatric Use

The safety and effectiveness of edrophonium chloride in the differential diagnosis of myasthenia gravis have been established in pediatric patients. (See DOSAGE AND ADMINISTRATION: Enlon Test in the Differential Diagnosis of Myasthenia Gravis: Dosage in Pediatric Patients). The safety and effectiveness of edrophonium chloride in reversing neuromuscular blockade in pediatric patients have not been fully determined, although doses ranging from 0.1 mg/kg to 1.43 mg/kg have been described.2-6 Antagonism of nondepolarizing neuromuscular blocking drugs in pediatric patients is more rapid than in adults. Limited pharmacodynamic and pharmacokinetic data in pediatric patients have been published. (See CLINICAL PHARMACOLOGY: Pediatric Pharmacology.)

Adverse Reactions

Careful observation should be made for severe cholinergic reactions in the hyperreactive individual. The myasthenic patient in crisis who is being tested with Enlon should be observed for bradycardia or cardiac standstill and cholinergic reactions if an overdose is given.

The following reactions common to anticholinesterase agents may occur, although not all of these reactions have been reported with the administration of Enlon, probably because of its short duration of action and limited indications:

Eye:	Increased lacrimation, pupillary constriction, spasm of accommodation, diplopia, conjunctival hyperemia.
CNS:	Convulsions, dysarthria, dysphonia, dysphagia.
Respiratory:	Increased tracheobronchial secretions, laryngospasm, bronchiolar constriction, paralysis of muscles of respiration, central respiratory paralysis.
Cardiac:	Arrhythmias (especially bradycardia), fall in cardiac output leading to hypotension.
G.I.:	Increased salivary, gastric and intestinal secretion, nausea, vomiting, increased peristalsis, diarrhea, abdominal cramps.
Skeletal Muscle:	Weakness, fasciculations.
Miscellaneous:	Increased urinary frequency and incontinence, diaphoresis.

Drug Interactions

Care should be given when administering this drug to patients with symptoms of myasthenic weakness who are also on anticholinesterase drugs. Since symptoms of anticholinesterase overdose (cholinergic crisis) may mimic underdosage (myasthenic weakness), their condition may be worsened by the use of this drug. (See OVERDOSAGE section for treatment.)

Overdosage

With drugs of this type, muscarine-like symptoms (nausea, vomiting, diarrhea, sweating, increased bronchial and salivary secretions and bradycardia) often appear with overdosage (cholinergic crisis). An important complication that can arise is obstruction of the airway by bronchial secretions. These may be managed with suction (especially if tracheostomy has been performed) and by the use of atropine. Many experts have advocated a wide range of dosages of atropine (for Enlon, see atropine dosage below), but if there are copious secretions, up to 1.2 mg intravenously may be given initially and repeated every 20 minutes until secretions are controlled. Signs of atropine overdosage such as dry mouth, flush and tachycardia should be avoided as tenacious secretions and bronchial plugs may form. A total dose of atropine of 5 to 10 mg or even more may be required. The following steps should be taken in the management of overdosage of Enlon:

1. Adequate respiratory exchange should be maintained by assuring an open airway and the use of assisted respiration augmented by oxygen.


2. Cardiac function should be monitored until complete stabilization has been achieved.


3. Atropine sulfate in doses of 0.4 to 0.5 mg should be administered intravenously. This may be repeated every 3 to 10 minutes. Because of the short duration of action of Enlon the total dose required will seldom exceed 2 mg.


4. If convulsions occur or shock is present, appropriate measures should be instituted.

Enlon Dosage and Administration

Enlon Test in the Differential Diagnosis of Myasthenia Gravis7-14

Intravenous Dosage (Adults)

A tuberculin syringe containing 1 mL (10 mg) of Enlon is prepared with an intravenous needle, and 0.2 mL (2 mg) is injected intravenously within 15 to 30 seconds. The needle is left in situ. Only if no reaction occurs after 45 seconds is the remaining 0.8 mL (8 mg) injected. If a cholinergic reaction (muscarinic side effects, skeletal muscle fasciculations and increased muscle weakness) occurs after injection of 0.2 mL (2 mg), the test is discontinued and atropine sulfate, 0.4 mg to 0.5 mg, is administered intravenously. After one-half hour the test may be repeated.

Intramuscular Dosage (Adults)

In adults with inaccessible veins, dosage for intramuscular injection is 1 mL (10 mg) of Enlon. Subjects who demonstrate hyperreactivity to this injection (cholinergic reaction), should be retested after one-half hour with 0.2 mL (2 mg) of Enlon intramuscularly to rule out false-negative reactions.

Dosage in Pediatric Patients

The intravenous testing dose of Enlon in pediatric patients weighing up to 75 lbs is 0.1 mL (1 mg); above this weight, the dose is 0.2 mL (2 mg). If there is no response after 45 seconds, it may be titrated up to 0.5 mL (5 mg) in pediatric patients under 75 lbs, given in increments of 0.1 mL (1 mg) every 30 to 45 seconds and up to 1 mL (10 mg) in heavier patients. In infants, the recommended dose is 0.05 mL (0.5 mg). Because of technical difficulty with intravenous injection in pediatric patients, the intramuscular route may be used. In pediatric patients weighing up to 75 lbs, 0.2 mL (2 mg) is injected intramuscularly. In pediatric patients weighing more than 75 lbs, 0.5 mL (5 mg) is injected intramuscularly. All signs which would appear with the intravenous test appear with the intramuscular test except that there is a delay of 2 to 10 minutes before a reaction is noted.

Enlon Test for Evaluation of Treatment Requirements in Myasthenia Gravis

The recommended dose is 0.1 mL to 0.2 mL (1 mg to 2 mg) of Enlon, administered intravenously 1 hour after oral intake of the drug being used in treatment.7-11 Response will be myasthenic in the undertreated patient, adequate in the controlled patient, and cholinergic in the overtreated patient. Responses to Enlon in myasthenic and nonmyasthenic individuals are summarized in the following chart.8

* Myasthenic Response - occurs in untreated myasthenics and may serve to establish diagnosis; in patients under treatment, indicates that therapy is inadequate. † Adequate Response - observed in treated patients when therapy is stabilized: a typical response in normal individuals. In addition to this response in non-myasthenics, the phenomenon of forced lid closure is often observed in psychoneurotics. ‡ Cholinergic Response - seen in myasthenics who have been overtreated with anticholinesterase drugs.
	Myasthenic*	Adequate†	Cholinergic‡
Muscle Strength (ptosis, diplopia dysphonia, dysphagia, dysarthria, respiration, limb strength)	Increased	No change	Decreased
Fasciculations (orbicularis oculi, facial muscles, limb muscles)	Absent	Present or absent	Present or absent
Side reactions (lacrimation diaphoresis, salivation, abdominal cramps, nausea, vomiting, diarrhea)	Absent	Minimal	Severe

Enlon Test in Crisis

The term crisis is applied to the myasthenic whenever severe respiratory distress with objective ventilatory inadequacy occurs and the response to medication is not predictable. This state may be secondary to a sudden increase in severity of myasthenia gravis (myasthenic crisis), or to overtreatment with anticholinesterase drugs (cholinergic crisis).

When a patient is apneic, controlled ventilation must be secured immediately in order to avoid cardiac arrest and irreversible central nervous system damage. No attempt is made to test with Enlon until respiratory exchange is adequate.

Dosage used at this time is most important

If the patient is cholinergic, Enlon will cause increased oropharyngeal secretions and further weakness in the muscles of respiration. If the crisis is myasthenic, the test clearly improves respiration and the patient can be treated with longer-acting intravenous anticholinesterase medication. When the test is performed, there should not be more than 0.2 mL (2 mg) Enlon in the syringe. An intravenous dose of 0.1 mL (1 mg) is given initially. The patient’s heart action is carefully observed. If, after an interval of 1 minute, this dose does not further impair the patient, the remaining 0.1 mL (1 mg) can be injected. If no clear improvement of respiration occurs after 0.2 mL (2 mg) dose, it is usually wisest to discontinue all anticholinesterase drug therapy and secure controlled ventilation by tracheostomy with assisted respiration.5

For Use as a Curare Antagonist

Enlon should be administered by intravenous injection in 1 mL (10 mg) doses given slowly over a period of 30 to 45 seconds so that the onset of cholinergic reaction can be detected. This dosage may be repeated whenever necessary. The maximal dose for any one patient should be 4 mL (40 mg). Because of its brief effect, Enlon should not be given prior to the administration of curare, tubocurarine, gallamine triethiodide or dimethyl-tubocurarine: it should be used at the time when its effect is needed. When given to counteract curare overdosage, the effect of each dose on the respiration should be carefully observed before it is repeated, and assisted ventilation should always be employed.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

How is Enlon Supplied

Enlon (edrophonium chloride injection, USP):

NDC 67457-190-15 15 mL Multiple Dose Vial

Enlon (edrophonium chloride injection, USP) Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

REFERENCES

1. Fisher DM, Cronnelly R, Sharma M, Miller RD. Anesthesiology. 1984; 428-433.


2. Meakin G, Sweet PT, Bevan JC, Bevan DR. Neostigmine and edrophonium as antagonists of pancuronium in infants and children. Anesthesiology. 1983; 59:316-321.


3. Abdulatif M, Al-Ghamdi A, Al-Sanabary M, Abdel-Gaffar ME. Br. J. Anesth. 1996; 76:239-244.


4. Bevan JC, Tousignant C, Stephenson C, et al. Dose responses for neostigmine and edrophonium as antagonists of mivacurium in adults and children. Anesthesiology. 1996; 84:354-361.


5. Kirkegaard-Nielsen H, Meretoja OA, Wirtavuori K. Reversal of atracurium-induced neuromuscular block in paediatric patients. Acta Anesthesiol. Scand. 1995; 39:906-911.


6. Gwinnutt CL, Walker WM, Meakin G. Antagonism of intense atracurium-induced neuromuscular block in children. Br. J. Anesth. 1991; 67:13-16.


7. Osserman KE, Kaplan LI. JAMA. 1952; 150:265.


8. Osserman KE, Kaplan LI, Besson G. J Mt Sinai Hosp. 1953; 20:165.


9. Osserman KE, Kaplan LI. Arch Neurol & Psychiat. 1953; 70:385.


10. Osserman KE, Teng P. JAMA. 1956; 160:153.


11. Osserman KE, Genkins G. Ann NY Acad Sci. 1966; 135:312.


12. Tether JE. Second International Symposium Proceedings, Myasthenia Gravis. 1961:444.


13. Tether JE. In: HF Conn. Current Therapy. Philadelphia: WB Saunders Company; 1960:551.


14. Tether JE. In: HF Conn. Current Therapy. Philadelphia: WB Saunders Company; 1965:556.

Enlon is a registered trademark of Bioniche Teo.

Manufactured for:

Bioniche Pharma USA LLC,

Lake Forest, IL 60045

Manufactured by: Akorn Inc.

Made in USA

BED00N      Rev. 03/10

 

PRINCIPAL DISPLAY PANEL - 150 mg/15 mL

15 mL

NDC 67457-190-15

Enlon®

(edrophonium chloride injection, USP)

150 mg/15 mL

(10 mg/mL)     Rx only

FOR IV OR IM USE

Multiple Dose Vial

Bioniche Pharma USA LLC,

Lake Forest, IL 60045

Each mL contains: edrophonium

chloride 10 mg; 0.45% phenol as a

preservative; 0.2% sodium sulfite

as an antioxidant; buffered with

sodium citrate and citric acid. Its

pH is adjusted to approximately 5.4.

Store at 20° to 25° C (68° to 77° F) [see

USP Controlled Room Temperature].

Manufactured by: Akorn, Inc. USA

BEDABL     Rev. 03/10

Enlon  edrophonium chloride  injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 67457-190 Route of Administration INTRAVENOUS, INTRAMUSCULAR DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength EDROPHONIUM CHLORIDE (EDROPHONIUM) EDROPHONIUM CHLORIDE 10 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL 4.5 mg  in 1 mL SODIUM SULFATE 2 mg  in 1 mL SODIUM CITRATE   CITRIC ACID MONOHYDRATE

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 67457-190-15 1 VIAL In 1 CARTON contains a VIAL, GLASS 1 15 mL In 1 VIAL, GLASS This package is contained within the CARTON (67457-190-15)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA088873	03/31/2011

Labeler - Bioniche Pharma USA LLC (790384503)

Revised: 03/2010Bioniche Pharma USA LLC

More Enlon resources

• Enlon Side Effects (in more detail)
• Enlon Drug Interactions
• Enlon Support Group
• 0 Reviews for Enlon - Add your own review/rating

• Enlon Concise Consumer Information (Cerner Multum)

Compare Enlon with other medications

• Reversal of Nondepolarizing Muscle Relaxants

Colace Glycerin Suppositories rectal

Generic Name: glycerin (rectal) (GLISS er in)

Brand Names: Colace Glycerin Suppositories, Fleet Babylax, Fleet Glycerin Suppositories Adult, Fleet Glycerin Suppositories Pediatric, Glycerin Suppositories Maximum Strength, Pedia-Lax Liquid, Sani-Supp

What is Colace Glycerin Suppositories (glycerin (rectal))?

Glycerin rectal is used as a laxative. It works by causing the intestines to hold more water, which softens the stool.

Glycerin rectal is used to treat constipation or to cleanse the bowel before a rectal exam or other intestinal procedure.

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

What is the most important information I should know about Colace Glycerin Suppositories (glycerin (rectal))?

Before using glycerin rectal, tell your doctor if you have nausea, vomiting, stomach pain, rectal bleeding, a change in bowel habits that has lasted for 2 weeks or longer, toxic megacolon, or if you have used another laxative for longer than 1 week.

Do not take glycerin rectal by mouth. It is for use only in your rectum. Call your doctor if this medication does not cause you to have a bowel movement within 1 hour after use. Do not use glycerin rectal more than once in a 24-hour period. Do not use other laxatives in combination with glycerin rectal unless your doctor has told you to. Stop using glycerin rectal and call your doctor at once if you have severe stomach pain or cramping, bloody diarrhea, or severe rectal pain, bleeding, or irritation.

What should I discuss with my health care provider before using Colace Glycerin Suppositories (glycerin (rectal))?

You should not use this medication if you are allergic to glycerin.

If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before using glycerin rectal, tell your doctor if you have:

• 
  

  nausea, vomiting, and stomach pain;

  
  


• 
  

  rectal bleeding;

  
  


• 
  

  a change in bowel habits that has lasted for 2 weeks or longer;

  
  


• 
  

  intestinal blockage;

  
  


• 
  

  ulcerative colitis, toxic megacolon; or

  
  


• 
  

  if you have used another laxative for longer than 1 week.

  
  

It is not known whether glycerin rectal is harmful to an unborn baby when used during pregnancy. Before using this medication, tell your doctor if you are pregnant. Do not use this medication in a child younger than 2 years old. Seek your doctor's advice when using glycerin rectal in a child who is 2 to 5 years old.

How should I use Colace Glycerin Suppositories (glycerin (rectal))?

Do not take glycerin rectal by mouth. It is for use only in your rectum.

Use this medication exactly as directed on the label, or as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended.

Do not use glycerin rectal more than once in a 24-hour period.

This medication comes with patient instructions for using either the rectal suppository or the rectal enema. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Try to empty your bowel and bladder just before using the glycerin suppository or enema.

Remove the outer wrapper from the rectal suppository before inserting it. Avoid handling the suppository too long or it will melt in your hands.

You may wet the suppository first with a small amount of water to make it easier to insert. Gently insert the suppository into the rectum, pointed tip first. The suppository will begin to melt once inserted and you should feel little or no discomfort while holding it in.

You should have a bowel movement within 15 to 60 minutes after using the suppository.

To use the rectal enema or liquid suppository, remove the protective cap and gently insert the tip of the applicator or bulb syringe into the rectum. Do not force the applicator into the rectum or injury could result. Slowly squeeze the bottle to place the medicine into the rectum. You do not need to empty the bottle completely and there may be a small amount of liquid left in the bottle after use.

For best results after using glycerin rectal, stay lying down until you feel the urge to have a bowel movement.

Call your doctor if this medication does not cause you to have a bowel movement within 1 hour after use. Store the rectal enema at room temperature away from moisture and heat. Store the rectal suppositories at cool room temperature away from moisture and heat. Do not refrigerate them unless directed on the medicine label.

What happens if I miss a dose?

Since this medication is usually given only once as needed, you will not be on a dosing schedule. Do not use glycerin rectal more than once in a 24-hour period.

What happens if I overdose?

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

If you use glycerin rectal as directed on the medicine label, an overdose is not likely to occur.

What should I avoid while using Colace Glycerin Suppositories (glycerin (rectal))?

Avoid using other laxatives in combination with glycerin rectal unless your doctor has told you to.

Colace Glycerin Suppositories (glycerin (rectal)) side effects

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

• 
  

  severe stomach pain or cramping

  
  


• 
  

  bloody diarrhea; or

  
  


• 
  

  severe rectal pain, bleeding, or irritation.

  
  

Less serious side effects may include:

• 
  

  diarrhea;

  
  


• 
  

  nausea or stomach discomfort; or

  
  


• 
  

  mild rectal pain or burning.

  
  

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

What other drugs will affect Colace Glycerin Suppositories (glycerin (rectal))?

There may be other drugs that can interact with glycerin rectal. 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 Colace Glycerin Suppositories resources

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

Compare Colace Glycerin Suppositories with other medications

• Constipation
• Cough

Where can I get more information?

• Your pharmacist can provide more information about glycerin rectal.

See also: Colace Glycerin side effects (in more detail)

Tri-K

Generic Name: potassium supplement (Oral route, Parenteral route)

Commonly used brand name(s)

In the U.S.

• Effer-K


• Glu-K


• K+Care ET


• K-Lyte


• K-Lyte Cl


• K-Tab


• Potassimin


• Tri-K


• Urocit-K 10

In Canada

• K-10 Solution


• Kaochlor 10


• Kaochlor 20


• Kaon


• K-Lor


• K-Lyte/Ci


• Potassium Chloride


• Potassium-Rougier


• Roychlor

Available Dosage Forms:

• Tablet, Effervescent


• Solution


• Capsule


• Tablet, Extended Release


• Powder for Suspension, Extended Release


• Tablet


• Powder for Suspension


• Liquid


• Elixir


• Granule


• Capsule, Extended Release


• Powder for Solution

Uses For Tri-K

Potassium is needed to maintain good health. Although a balanced diet usually supplies all the potassium a person needs, potassium supplements may be needed by patients who do not have enough potassium in their regular diet or have lost too much potassium because of illness or treatment with certain medicines.

There is no evidence that potassium supplements are useful in the treatment of high blood pressure.

Lack of potassium may cause muscle weakness, irregular heartbeat, mood changes, or nausea and vomiting.

Injectable potassium is administered only by or under the supervision of your doctor. Some forms of oral potassium may be available in stores without a prescription. Since too much potassium may cause health problems, you should take potassium supplements only if directed by your doctor.

Importance of Diet

For good health, it is important that you eat a balanced and varied diet. Follow carefully any diet program your health care professional may recommend. For your specific dietary vitamin and/or mineral needs, ask your health care professional for a list of appropriate foods.

The following table includes some potassium-rich foods.

Food (amount)	Milligrams of potassium	Milliequivalents of potassium
Acorn squash, cooked (1 cup)	896	23
Potato with skin, baked (1 long)	844	22
Spinach, cooked (1 cup)	838	21
Lentils, cooked (1 cup)	731	19
Kidney beans, cooked (1 cup)	713	18
Split peas, cooked (1 cup)	710	18
White navy beans, cooked (1 cup)	669	17
Butternut squash, cooked (1 cup)	583	15
Watermelon (1/16)	560	14
Raisins (½ cup)	553	14
Yogurt, low-fat, plain (1 cup)	531	14
Orange juice, frozen (1 cup)	503	13
Brussel sprouts, cooked (1 cup)	494	13
Zucchini, cooked, sliced (1 cup)	456	12
Banana (medium)	451	12
Collards, frozen, cooked (1 cup)	427	11
Cantaloupe (¼)	412	11
Milk, low-fat 1% (1 cup)	348	9
Broccoli, frozen, cooked (1 cup)	332	9

The daily amount of potassium needed is defined in several different ways.

• For U.S.—


• Recommended Dietary Allowances (RDAs) are the amount of vitamins and minerals needed to provide for adequate nutrition in most healthy persons. RDAs for a given nutrient may vary depending on a person's age, sex, and physical condition (e.g., pregnancy).


• Daily Values (DVs) are used on food and dietary supplement labels to indicate the percent of the recommended daily amount of each nutrient that a serving provides. DV replaces the previous designation of United States Recommended Daily Allowances (USRDAs).

• For Canada—


• Recommended Nutrient Intakes (RNIs) are used to determine the amounts of vitamins, minerals, and protein needed to provide adequate nutrition and lessen the risk of chronic disease.

Because lack of potassium is rare, there is no RDA or RNI for this mineral. However, it is thought that 1600 to 2000 mg (40 to 50 milliequivalents [mEq]) per day for adults is adequate.

Remember:

• The total amount of potassium that you get every day includes what you get from food and what you may take as a supplement. Read the labels of processed foods. Many foods now have added potassium.


• Your total intake of potassium should not be greater than the recommended amounts, unless ordered by your doctor. In some cases, too much potassium may cause muscle weakness, confusion, irregular heartbeat, or difficult breathing.

Before Using Tri-K

If you are taking a dietary supplement without a prescription, carefully read and follow any precautions on the label. For these supplements, the following should be considered:

Allergies

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

Pediatric

Although there is no specific information comparing use of potassium supplements in children with use in other age groups, they are not expected to cause different side effects or problems in children than they do in adults.

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. Although there is no specific information comparing use of potassium supplements in the elderly with use in other age groups, they are not expected to cause different side effects or problems in older people than they do in younger adults.

Older adults may be at a greater risk of developing high blood levels of potassium (hyperkalemia).

Pregnancy

Potassium supplements have not been shown to cause problems in humans.

Breast Feeding

Potassium supplements pass into breast milk. However, this medicine has not been reported to cause problems in nursing babies.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking any of these dietary supplements, 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 dietary supplements in this class with any of the following medicines is not recommended. Your doctor may decide not to treat you with dietary supplements in this class or change some of the other medicines you take.

• Amantadine


• Atropine


• Belladonna


• Belladonna Alkaloids


• Benztropine


• Biperiden


• Clidinium


• Darifenacin


• Dicyclomine


• Eplerenone


• Glycopyrrolate


• Hyoscyamine


• Methscopolamine


• Oxybutynin


• Procyclidine


• Scopolamine


• Solifenacin


• Tolterodine


• Trihexyphenidyl

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

• Alacepril


• Amiloride


• Benazepril


• Canrenoate


• Captopril


• Cilazapril


• Delapril


• Enalaprilat


• Enalapril Maleate


• Fosinopril


• Imidapril


• Indomethacin


• Lisinopril


• Moexipril


• Pentopril


• Perindopril


• Quinapril


• Ramipril


• Spirapril


• Spironolactone


• Temocapril


• Trandolapril


• Triamterene


• Zofenopril

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 dietary supplements in this class. Make sure you tell your doctor if you have any other medical problems, especially:

• Addison's disease (underactive adrenal glands) or


• Dehydration (excessive loss of body water, continuing or severe)


• Type 2 diabetes mellitus or


• Kidney disease—Potassium supplements may increase the risk of hyperkalemia (high blood levels of potassium), which may worsen or cause heart problems in patients with these conditions.

• Diarrhea (continuing or severe)—The loss of fluid in combination with potassium supplements may cause kidney problems, which may increase the risk of hyperkalemia (high blood levels of potassium).

• Heart disease—Potassium supplements may make this condition worse.

• Intestinal or esophageal blockage—Potassium supplements may damage the intestines.

• Stomach ulcer—Potassium supplements may make this condition worse.

Proper Use of potassium supplement

This section provides information on the proper use of a number of products that contain potassium supplement. It may not be specific to Tri-K. Please read with care.

For patients taking the liquid form of this medicine:

• This medicine must be diluted in at least one-half glass (4 ounces) of cold water or juice to reduce its possible stomach-irritating or laxative effect.


• If you are on a salt (sodium)-restricted diet, check with your doctor before using tomato juice to dilute your medicine. Tomato juice has a high salt content.

For patients taking the soluble granule, soluble powder, or soluble tablet form of this medicine:

• This medicine must be completely dissolved in at least one-half glass (4 ounces) of cold water or juice to reduce its possible stomach-irritating or laxative effect.


• Allow any "fizzing" to stop before taking the dissolved medicine.


• If you are on a salt (sodium)-restricted diet, check with your doctor before using tomato juice to dilute your medicine. Tomato juice has a high salt content.

For patients taking the extended-release tablet form of this medicine:

• Swallow the tablets whole with a full (8-ounce) glass of water. Do not chew or suck on the tablet.


• Some tablets may be broken or crushed and sprinkled on applesauce or other soft food. However, check with your doctor or pharmacist first, since this should not be done for most tablets.


• If you have trouble swallowing tablets or if they seem to stick in your throat, check with your doctor. When this medicine is not properly released, it can cause irritation that may lead to ulcers.

For patients taking the extended-release capsule form of this medicine:

• Do not crush or chew the capsule. Swallow the capsule whole with a full (8-ounce) glass of water.


• Some capsules may be opened and the contents sprinkled on applesauce or other soft food. However, check with your doctor or pharmacist first, since this should not be done for most capsules.

Take this medicine immediately after meals or with food to lessen possible stomach upset or laxative action.

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. This is especially important if you are also taking both diuretics (water pills) and digitalis medicines for your heart.

Dosing

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

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 potassium bicarbonate


• For oral dosage forms (tablets for solution):
  
  • To prevent potassium loss or replace potassium lost by the body:
    
    • Adults and teenagers—25 to 50 milliequivalents (mEq) dissolved in one-half to one glass of cold water, taken one or two times a day. Your doctor may change the dose if needed. However, most people will not take more than 100 mEq a day.
    
    
    • Children—Dose must be determined by your doctor.
    
    
  
  

• For potassium bicarbonate and potassium chloride


• For oral dosage form (granules for solution):
  
  • To prevent potassium loss or replace potassium lost by the body:
    
    • Adults and teenagers—20 milliequivalents (mEq) dissolved in one-half to one glass of cold water, taken one or two times a day. Your doctor may change the dose if needed. However, most people will not take more than 100 mEq a day.
    
    
    • Children—Dose must be determined by your doctor.
    
    
  
  


• For oral dosage form (tablets for solution):
  
  • To prevent potassium loss or replace potassium lost by the body:
    
    • Adults and teenagers—20, 25, or 50 mEq dissolved in one-half to one glass of cold water, taken one or two times a day. Your doctor may change the dose if needed. However, most people will not take more than 100 mEq a day.
    
    
    • Children—Dose must be determined by your doctor.
    
    
  
  

• For potassium bicarbonate and potassium citrate


• For oral dosage form (tablets for solution):
  
  • To prevent potassium loss or replace potassium lost by the body:
    
    • Adults and teenagers—25 or 50 milliequivalents (mEq) dissolved in one-half to one glass of cold water, taken one or two times a day. Your doctor may change the dose if needed. However, most people will not take more than 100 mEq a day.
    
    
    • Children—Dose must be determined by your doctor.
    
    
  
  

• For potassium chloride


• For long-acting oral dosage form (extended-release capsules):
  
  • To replace potassium lost by the body:
    
    • Adults and teenagers—40 to 100 milliequivalents (mEq) a day, divided into two or three smaller doses during the day. Your doctor may change the dose if needed. However, most people will not take more than 100 mEq a day.
    
    
  
  
  • To prevent potassium loss:
    
    • Adults and teenagers—16 to 24 mEq a day, divided into two or three smaller doses during the day. Your doctor may change the dose if needed. However, most people will not take more than 100 mEq a day.
    
    
    • Children—Dose must be determined by your doctor.
    
    
  
  


• For long-acting oral dosage forms (liquid for solution):
  
  • To prevent potassium loss or replace potassium lost by the body:
    
    • Adults and teenagers—20 mEq mixed into one-half glass of cold water or juice, taken one to four times a day. Your doctor may change the dose if needed. However, most people will not take more than 100 mEq a day.
    
    
    • Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 1 to 3 mEq of potassium per kilogram (kg) (0.45 to 1.36 mEq per pound) of body weight taken in smaller doses during the day. The solution should be well mixed in water or juice.
    
    
  
  


• For oral dosage form (powder for solution):
  
  • To prevent potassium loss or replace potassium lost by the body:
    
    • Adults and teenagers—15 to 25 mEq dissolved in four to six ounces of cold water, taken two or four times a day. Your doctor may change the dose if needed. However, most people will not take more than 100 mEq a day.
    
    
    • Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 1 to 3 mEq per kg (0.45 to 1.36 mEq per pound) of body weight taken in smaller doses during the day. The solution should be mixed into water or juice.
    
    
  
  


• For oral dosage form (powder for suspension):
  
  • To prevent potassium loss or replace potassium lost by the body:
    
    • Adults and teenagers—20 mEq dissolved in two to six ounces of cold water, taken one to five times a day. Your doctor may change the dose if needed. However, most people will not take more than 100 mEq a day.
    
    
    • Children—Dose must be determined by your doctor.
    
    
  
  


• For long-acting oral dosage form (extended-release tablets):
  
  • To prevent potassium loss or replace potassium lost by the body:
    
    • Adults and teenagers—6.7 to 20 mEq taken three times a day. However, most people will not take more than 100 mEq a day.
    
    
    • Children—Dose must be determined by your doctor.
    
    
  
  


• For oral dosage form (liquid for solution):
  
  • To prevent potassium loss or replace potassium lost by the body:
    
    • Adults and teenagers—20 milliequivalents (mEq) mixed into one-half glass of cold water or juice, taken two to four times a day. Your doctor may change the dose if needed. However, most people will not take more than 100 mEq a day.
    
    
    • Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 2 to 3 mEq per kilogram (kg) (0.9 to 1.36 mEq per pound) of body weight a day, taken in smaller doses during the day. The solution should be completely mixed into water or juice.
    
    
  
  


• For oral dosage form (tablets):
  
  • To prevent potassium loss or replace potassium lost by the body:
    
    • Adults and teenagers—5 to 10 mEq taken two to four times a day. However, most people will not take more than 100 mEq a day.
    
    
    • Children—Dose must be determined by your doctor.
    
    
  
  

• For potassium gluconate and potassium chloride


• For oral dosage form (liquid for solution):
  
  • To prevent potassium loss or replace potassium lost by the body:
    
    • Adults and teenagers—20 milliequivalents (mEq) diluted in 2 tablespoonfuls or more of cold water or juice, taken two to four times a day. Your doctor may change the dose if needed. However, most people will not take more than 100 mEq a day.
    
    
    • Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 2 to 3 mEq per kilogram (kg) (0.9 to 1.36 mEq per pound) of body weight taken in smaller doses during the day. The solution should be well mixed into water or juice.
    
    
  
  


• For oral dosage form (powder for solution):
  
  • To prevent potassium loss or replace potassium lost by the body:
    
    • Adults and teenagers—20 mEq mixed in 2 tablespoonfuls or more of cold water or juice taken two to four times a day. Your doctor may change the dose if needed. However, most people will not take more than 100 mEq a day.
    
    
    • Children—Dose is base on body weight and must be determined by your doctor. The usual dose is 2 to 3 mEq per kg (0.9 to 1.36 mEq per pound) of body weight taken in smaller doses during the day. The solution should be well mixed into water or juice.
    
    
  
  

• For potassium gluconate and potassium citrate


• For oral dosage form (liquid for solution):
  
  • To prevent potassium loss or replace potassium lost by the body:
    
    • Adults and teenagers—20 milliequivalents (mEq) mixed into one-half glass of cold water or juice, taken two to four times a day. Your doctor may change the dose if needed. However, most people will not take more than 100 mEq a day.
    
    
    • Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 2 to 3 mEq per kg (0.9 to 1.36 mEq per pound) of body weight taken in smaller doses during the day. The solution should be well mixed into water or juice.
    
    
  
  

• For trikates


• For oral dosage form (liquid for solution):
  
  • To prevent potassium loss or replace potassium lost by the body:
    
    • Adults and teenagers—15 milliequivalents (mEq) mixed into one-half glass of cold water or juice, taken three or four times a day. Your doctor may change the dose if needed. However, most people will not take more than 100 mEq a day.
    
    
    • Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 2 to 3 mEq per kilogram (kg) (0.9 to 1.36 mEq per pound) of body weight taken in smaller doses during the day. The solution should be well mixed into water or juice.
    
    
  
  

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

Keep out of the reach of children.

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

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Tri-K

Your doctor should check your progress at regular visits to make sure the medicine is working properly and that possible side effects are avoided. Laboratory tests may be necessary.

Do not use salt substitutes, eat low-sodium foods, especially some breads and canned foods, or drink low-sodium milk unless you are told to do so by your doctor, since these products may contain potassium. It is important to read the labels carefully on all low-sodium food products.

Check with your doctor before starting any physical exercise program, especially if you are out of condition and are taking any other medicine. Exercise and certain medicines may increase the amount of potassium in the blood.

Check with your doctor at once if you notice blackish stools or other signs of stomach or intestinal bleeding. This medicine may cause such a condition to become worse, especially when taken in tablet form.

Tri-K 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.

Stop taking this medicine and check with your doctor immediately if any of the following side effects occur:

Less common

• Confusion


• irregular or slow heartbeat


• numbness or tingling in hands, feet, or lips


• shortness of breath or difficult breathing


• unexplained anxiety


• unusual tiredness or weakness


• weakness or heaviness of legs

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

Rare

• Abdominal or stomach pain, cramping, or soreness (continuing)


• chest or throat pain, especially when swallowing


• stools with signs of blood (red or black color)

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

• Diarrhea


• nausea


• stomach pain, discomfort, or gas (mild)


• vomiting

Sometimes you may see what appears to be a whole tablet in the stool after taking certain extended-release potassium chloride tablets. This is to be expected. Your body has absorbed the potassium from the tablet and the shell is then expelled.

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.

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