Diocalm Complete

Oral

As an alkaliniser agent

Adult: As sodium citrate and Citric Acid (Diocalm Complete) solution: 10-30 ml after meals and at bedtime. Dosage should be individualised according to patient's response and tolerance. As sodium citrate: 1-2 g every 2-4 hr when necessary.

Child: As sodium citrate and Citric Acid (Diocalm Complete) solution: 5-15 ml after meals and at bedtime. Dosage should be individualised according to patient's response and tolerance.

Oral

Hypoglycaemia

Adult: 10-20 g as single dose; may repeat in 10 min if needed.

Child: >2 yr: 10-20 g as single dose; may repeat in 10 min if needed.

Intravenous

Hypoglycaemia

Adult: 10-25 g (40-100 ml of 25% solution or 20-50 ml of 50% solution). Doses may be repeated in severe cases.

Child: ≤6 mth: 0.25-0.5 g/kg/dose; >6 mth: 0.5-1 g/kg/dose. Doses may be repeated in severe cases. Max: 25 g/dose.

Intravenous

Hyperkalaemia

Adult: 25-50 g combined with 10 units of regular insulin, administered over 30-60 minutes; may repeat if necessary. Alternatively, 25 g combined with 5-10 units of regular insulin infused over 5 minutes; may repeat if necessary.

Child: and infants: 0.5-1 g/kg (using 25% or 50% solution) combined with regular insulin (1 unit for every 4-5 g Dextrose (Diocalm Complete) given); infuse over 2 hr, may repeat if necessary.

Loperamide (Diocalm Complete)® (Loperamide (Diocalm Complete) hydrochloride) is indicated for the control and symptomatic relief of acute nonspecific diarrhea and of chronic diarrhea associated with inflammatory bowel disease. Loperamide (Diocalm Complete)® (Loperamide (Diocalm Complete) hcl) is also indicated for reducing the volume of discharge from ileostomies.

BECAUSE OF REPORTS OF INTESTINAL AND GASTRIC ULCERATION AND BLEEDING WITH CONTROLLED-RELEASE Potassium Chloride (Diocalm Complete) PREPARATIONS, THESE DRUGS SHOULD BE RESERVED FOR THOSE PATIENTS WHO CANNOT TOLERATE OR REFUSE TO TAKE LIQUID OR EFFERVESCENT POTASSIUM PREPARATIONS OR FOR PATIENTS IN WHOM THERE IS A PROBLEM OF COMPLIANCE WITH THESE PREPARATIONS.

1. For the treatment of patients with hypokalemia with or without metabolic alkalosis, in digitalis intoxications, and in patients with hypokalemic familial periodic paralysis. If hypokalemia is the result of diuretic therapy, consideration should be given to the use of a lower dose of diuretic, which may be sufficient without leading to hypokalemia.
2. For the prevention of hypokalemia in patients who would be at particular risk if hypokalemia were to develop e.g., digitalized patients or patients with significant cardiac arrhythmias, hepatic cirrhosis with ascites, states of aldosterone excess with normal renal function, potassium-losing nephropathy, and certain diarrheal states.

The use of potassium salts in patients receiving diuretics for uncomplicated essential hypertension is often unnecessary when such patients have a normal dietary pattern and when low doses of the diuretic are used. Serum potassium should be checked periodically, however, and if hypokalemia occurs, dietary supplementation with potassium-containing foods may be adequate to control milder cases. In more severe cases, and if dose adjustment of the diuretic is ineffective or unwarranted, supplementation with potassium salts may be indicated.

Airlife Modudose Sodium Chloride (Diocalm Complete) as isotonic solution: the dehydration of various origins. To maintain the volume of blood plasma during and after surgery. As a solvent for various drugs.

Hypertonic solution: violations of water-electrolyte metabolism: lack of sodium and chlorine ions; hypoosmotic dehydration of various origins (due to prolonged vomiting, diarrhea, burns with a gastric fistula, pulmonary hemorrhage, intestinal bleeding).

Eye drops and ointment: irritation of the cornea with inflammatory and allergic diseases (combined therapy).

Prophylaxis & treatment of cystine & uric acid renal calculi. Urinary alkalizer in gout therapy. Treatment of acidosis in renal tubular disorders; chronic metabolic acidosis resulting from chronic renal insufficiency or the syndrome of renal tubular acidosis especially when administration of K salts is contraindicated. Prophylactic agent for acid-aspiration pneumonitis. Used in pre-anaesth medication as a non-particulate acid-neutralizing buffer of gastric acid to lessen the danger from acid-aspiration pneumonitis.

Dextrose (Diocalm Complete) (glucose) is a form of natural sugar that is normally produced by the liver. Glucose is a source of energy, and all the cells and organs in your body need glucose to function properly. Glucose as a medication is given either by mouth (orally) or by injection.

Dextrose (Diocalm Complete) is used to treat very low blood sugar (hypoglycemia), most often in people with diabetes mellitus. Dextrose (Diocalm Complete) is given by injection to treat insulin shock (low blood sugar caused by using insulin and then not eating a meal or eating enough food afterward). This medicine works by quickly increasing the amount of glucose in your blood.

Dextrose (Diocalm Complete) is also used to provide carbohydrate calories to a person who cannot eat because of illness, trauma, or other medical condition. It is sometimes given to people who are sick from drinking too much alcohol.

Dextrose (Diocalm Complete) may also be used to treat hyperkalemia (high levels of potassium in your blood).

Loperamide (Diocalm Complete) slows the rhythm of digestion so that the small intestines have more time to absorb fluid and nutrients from the foods you eat.

Loperamide (Diocalm Complete) is used to treat diarrhea. Loperamide (Diocalm Complete) is also used to reduce the amount of stool in people who have an ileostomy (re-routing of the bowel through a surgical opening in the stomach).

Loperamide (Diocalm Complete) may also be used for purposes not listed in this medication guide.

Potassium Chloride (Diocalm Complete) (Potassium Chloride (Diocalm Complete)) is used to prevent or to treat low blood levels of potassium (hypokalemia). Potassium levels can be low as a result of a disease or from taking certain medicines, or after a prolonged illness with diarrhea or vomiting.

Potassium Chloride (Diocalm Complete) contains Potassium Chloride (Diocalm Complete). Potassium is a mineral that is found in many foods and is needed for several functions of your body, especially the beating of your heart.

Potassium Chloride (Diocalm Complete) may also be used for other purposes not listed here.

Sodium Chloride (Diocalm Complete) is the chemical name for salt. Sodium Chloride (Diocalm Complete) can reduce some types of bacteria in certain body secretions, such as saliva.

Sodium Chloride (Diocalm Complete) inhalation is used to produce sputum (mucus, or phlegm) from the mouth to help improve lung function in people with cystic fibrosis, or to collect sputum for medical testing. This medication may also be used to dilute other medications inhaled through a nebulizer.

Sodium Chloride (Diocalm Complete) inhalation may also be used for other purposes not listed in this medication guide.

Sodium Citrate (Diocalm Complete) and Sodium Citrate (Diocalm Complete) are both alkalinizing agents that make the urine less acidic.

The combination of Sodium Citrate (Diocalm Complete) and Sodium Citrate (Diocalm Complete) is used to prevent gout or kidney stones, or metabolic acidosis in people with kidney problems.

Sodium Citrate (Diocalm Complete) and Sodium Citrate (Diocalm Complete) may also be used for other purposes not listed in this medication guide.

Oral

As an alkaliniser agent

Adult: As sodium citrate and Citric Acid (Diocalm Complete) solution: 10-30 ml after meals and at bedtime. Dosage should be individualised according to patient's response and tolerance. As sodium citrate: 1-2 g every 2-4 hr when necessary.

Child: As sodium citrate and Citric Acid (Diocalm Complete) solution: 5-15 ml after meals and at bedtime. Dosage should be individualised according to patient's response and tolerance.

As directed by a physician. Dosage is dependent upon the age, weight and clinical condition of the patient as well as laboratory determinations.

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

All injections in VIAFLEX plastic containers are intended for intravenous administration using sterile equipment.

Additives may be incompatible. Complete information is not available.

Those additives known to be incompatible should not be used. Consult with pharmacist, if available. If, in the informed judgment of the physician, it is deemed advisable to introduce additives, use aseptic technique. Mix thoroughly when additives have been introduced. Do not store solutions containing additives.

How supplied

Dextrose (Diocalm Complete) (hydrous Dextrose (Diocalm Complete) (hydrous Dextrose (Diocalm Complete)) ) Injection, USP in VIAFLEX plastic container is available as follows:

Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the product be stored at room temperature (25deg;C/ 77deg;F); brief exposure up to 40deg;C/ 104deg;F does not adversely affect the product.

Directions For Use Of Viaflex Plastic Container

Warning: Do not use plastic containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is completed.

To Open

Tear overwrap down side at slit and remove solution container. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. Check for minute leaks by squeezing inner bag firmly. If leaks are found, discard solution as sterility may be impaired. If supplemental medication is desired, follow “ To Add Medication” directions below.

Preparation for Administration

1. Suspend container from eyelet support.
2. Remove plastic protector from outlet port at bottom of container.
3. Attach administration set. Refer to complete directions accompanying set.

To Add Medication

Warning: Additives may be incompatible.

To add medication before solution administration

1. Prepare medication site.
2. Using syringe with 19 to 22 gauge needle, puncture resealable medication port and inject.
3. Mix solution and medication thoroughly. For high density medication such as potassium chloride, squeeze ports while ports are upright and mix thoroughly.

To add medication during solution administration

1. Close clamp on the set.
2. Prepare medication site.
3. Using syringe with 19 to 22 gauge needle, puncture resealable medication port and inject.
4. Remove container from IV pole and/or turn to an upright position.
5. Evacuate both ports by squeezing them while container is in the upright position.
6. Mix solution and medication thoroughly.
7. Return container to in-use position and continue administration.

Baxter Healthcare Corporation, Deerfield, IL 60015 USA. FDA revision date: n/a

(1 capsule = 2 mg)

Patients should receive appropriate fluid and electrolyte replacement as needed.

Acute Diarrhea

Adults: The recommended initial dose is 4mg (two capsules) followed by 2 mg (one capsule) after each unformed stool. Daily dose should not exceed 16mg (eight capsules). Clinical improvement is usually observed within 48 hours.

Children: In children 2 to 5 years of age (20 kg or less), the non-prescription liquid formulation (Loperamide (Diocalm Complete)® (Loperamide (Diocalm Complete) hcl) A-D 1 mg/5 mL) should be used; for ages 6 to 12, either Loperamide (Diocalm Complete)® (Loperamide (Diocalm Complete) hcl) Capsules or Loperamide (Diocalm Complete)® (Loperamide (Diocalm Complete) hcl) A-D Liquid may be used. For children 2 to 12 years of age, the following schedule for capsules or liquid will usually fulfill initial dosage requirements:

Recommended First Day Dosage Schedule

Two to five years: 1 mg t.i.d. (3mg daily dose) (13 to 20 kg) Six to eight years: 2 mg b.i.d. (4mg daily dose) (20 to 30 kg) Eight to twelve years: 2mg t.i.d. (6mg daily dose) (greater than 30 kg)

Recommended Subsequent Daily Dosage

Following the first treatment day, it is recommended that subsequent Loperamide (Diocalm Complete)® (Loperamide (Diocalm Complete) hcl) doses (1 mg/10 kg body weight) be administered only after a loose stool. Total daily dosage should not exceed recommended dosages for the first day.

Chronic Diarrhea

Children: Although Loperamide (Diocalm Complete)® (Loperamide (Diocalm Complete) hcl) has been studied in a limited number of children with chronic diarrhea; the therapeutic dose for the treatment of chronic diarrhea in a pediatric population has not been established.

Adults: The recommended initial dose is 4 mg (two capsules) followed by 2 mg (one capsule) after each unformed stool until diarrhea is controlled, after which the dosage of Loperamide (Diocalm Complete)® (Loperamide (Diocalm Complete) hcl) should be reduced to meet individual requirements. When the optimal daily dosage has been established, this amount may then be administered as a single dose or in divided doses.

The average daily maintenance dosage in clinical trials was 4 to 8 mg (two to four capsules). A dosage of 16 mg (eight capsules) was rarely exceeded. If clinical improvement is not observed after treatment with 16 mg per day for at least 10 days, symptoms are unlikely to be controlled by further administration. Loperamide (Diocalm Complete)® (Loperamide (Diocalm Complete) hcl) administration may be continued if diarrhea cannot be adequately controlled with diet or specific treatment.

Children under 2 Years

The use of Loperamide (Diocalm Complete) (Loperamide (Diocalm Complete) hcl) in children under 2 years is not recommended. There have been rare reports of paralytic ileus associated with abdominal distention. Most of these reports occurred in the setting of acute dysentery, overdose, and with very young children less than two years of age.

Elderly

No formal pharmacokinetic studies were conducted in elderly subjects. However, there were no major differences reported in the drug disposition in elderly patients with diarrhea relative to young patients. No dosage adjustment is required for the elderly.

Renal Impairment

No pharmacokinetic data are available in patients with renal impairment. Since the metabolites and the unchanged drug are mainly excreted in the feces, no dosage adjustment is required for patients with renal impairment.

Hepatic Impairment

Although no pharmacokinetic data are available in patients with hepatic impairment, Loperamide (Diocalm Complete) (Loperamide (Diocalm Complete) hcl) should be used with caution in such patients because of reduced first pass metabolism..

How supplied

Capsules - each capsule contains 2 mg of Loperamide (Diocalm Complete) hydrochloride. The capsules have a light green body and a dark green cap with "JANSSEN" imprinted on one segment and "Loperamide (Diocalm Complete)" on the other segment. Loperamide (Diocalm Complete)® (Loperamide (Diocalm Complete) hcl) capsules are supplied in bottles of 100.

NDC 50458-400-10.........(100 CAPSULES)

Store at 15°-25°C (59°-77°F).

Janssen Pharmaceutica Inc. Revised September 1996, July 1998. FDA Rev date: 10/21/2005

The usual dietary intake of potassium by the average adult is 50 to 100 mEq per day. Potassium depletion sufficient to cause hypokalemia usually requires the loss of 200 or more mEq of potassium from the total body store.

Dosage must be adjusted to the individual needs of each patients. The dose for the prevention of hypokalemia is typically in the range of 20 mEq per day. Doses of 40 to 100 mEq per day or more are used for the treatment of potassium depletion. Dosage should be divided if more than 20 mEq per day is given such that no more than 20 mEq is given in a single dose. Because of the potential for gastric irritation, Potassium Chloride (Diocalm Complete) (Potassium Chloride (Diocalm Complete) extended-release) ® Extencaps® should be taken with meals and with a full glass of water or other liquid.

Patients who have difficulty swallowing capsules may sprinkle the contents of the capsule onto a spoonful of soft food. The soft food, such as applesauce or pudding, should be swallowed immediately without chewing and followed with a glass of cool water or juice to ensure complete swallowing of the microcapsules. The food used should not be hot and should be soft enough to be swallowed without chewing. Any microcapsule/food mixture should be used immediately and not stored for future use.

How supplied

Potassium Chloride (Diocalm Complete) (Potassium Chloride (Diocalm Complete) extended-release) ® Extencaps® are pale orange capsules monogrammed Potassium Chloride (Diocalm Complete) (Potassium Chloride (Diocalm Complete) extended-release) ® and "Ther-Rx"/ "010", each containing 600 mg microencapsulated Potassium Chloride (Diocalm Complete) (equivalent to 8 mEq K) in bottles of 100 (NDC 64011-010-04), 500 (NDC 64011-010-08) and Dis-Co® unit dose packs of 100 (NDC 64011-010-11).

Potassium Chloride (Diocalm Complete) (Potassium Chloride (Diocalm Complete) extended-release) ® 10 Extencaps® are pale orange and opaque white capsules monogrammed Potassium Chloride (Diocalm Complete) (Potassium Chloride (Diocalm Complete) extended-release) ® 10 and "Ther-Rx"/"009", each containing 750 mg microencapsulated Potassium Chloride (Diocalm Complete) (equivalent to 10 mEq K) in bottles of 100 (NDC 64011-009-04), 100 Unit-of-Use (NDC 64011-009-21), bottles of 500 (NDC 64011-009-08), and Dis-Co® unit dose packs of 100 (NDC 64011-009-11).

Store at controlled room temperature, between 20° C and 25° C (68° F and 77° F).

Dispense in tight container.

Manufactured by KV Pharmaceutical

for Ther-Rx Corporation., St. Louis, MO 63045

FDA rev date: 8/20/2003

All injections in VIAFLEX plastic containers are intended for intravenous administration using sterile and nonpyrogenic equipment.

As directed by a physician. Dosage, rate, and duration of administration are to be individualized and depend upon the indication for use, the patient’s age, weight, clinical condition, concomitant treatment, and on the patient’s clinical and laboratory response to treatment.

When other electrolytes or medicines are added to this solution, the dosage and the infusion rate will also be dictated by the dose regimen of the additions.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Use of a final filter is recommended during administration of all parenteral solutions, where possible.

Do not administer unless the solution is clear and seal is intact.

Additives may be incompatible with Sodium Chloride (Diocalm Complete) Injection, USP. As with all parenteral solutions, compatibility of the additives with the solution must be assessed before addition. Before adding a substance or medication, verify that it is soluble and/or stable in water and that the pH range of Sodium Chloride (Diocalm Complete) Injection, USP is appropriate. After addition, check for unexpected color changes and/or the appearance of precipitates, insoluble complexes or crystals.

The instructions for use of the medication to be added and other relevant literature must be consulted. Additives known or determined to be incompatible must not be used. When introducing additives to Sodium Chloride (Diocalm Complete) Injection, USP, aseptic technique must be used. Mix the solution thoroughly when additives have been introduced. Do not store solutions containing additives.

After opening the container, the contents should be used immediately and should not be stored for a subsequent infusion. Do not reconnect any partially used containers. Discard any unused portion.

Adult: Add the contents of 1-2 sachets to a glass of cool water and mix. Sodium Citrate (Diocalm Complete) may be taken up to 4 times daily. Do not take for >5 days unless advised to do so by the physician.

Patients on a sodium-restricted diet. Severe renal impairment. Potassium citrate and Citric Acid (Diocalm Complete) oral solution are contraindicated in patients with adynamia episodica hereditaria, acute dehydration, heat cramps, anuria, severe myocardial damage, or hyperkalaemia.

See also:
What is the most important information I should know about Dextrose (Diocalm Complete)?

Solutions containing Dextrose (Diocalm Complete) may be contraindicated in patients with hypersensitivity to corn products.

Administration of solutions containing hypertonic Dextrose (Diocalm Complete) is contraindicated in patients with intracranial or intraspinal hemorrhage, diabetic coma or delirium tremens, especially if such patients are already dehydrated.

See also:
What is the most important information I should know about Loperamide (Diocalm Complete)?

Loperamide (Diocalm Complete) (Loperamide (Diocalm Complete) hcl) is contraindicated in patients with a known hypersensitivity to Loperamide (Diocalm Complete) hydrochloride or to any of the excipients.

Loperamide (Diocalm Complete) (Loperamide (Diocalm Complete) hcl) is contraindicated in patients with abdominal pain in the absence of diarrhea.

Loperamide (Diocalm Complete) (Loperamide (Diocalm Complete) hcl) is not recommended in infants below 24 months of age.

Loperamide (Diocalm Complete) (Loperamide (Diocalm Complete) hcl) should not be used as the primary therapy:

- in patients with acute dysentery, which is characterized by blood in stools and high fever,

- in patients with acute ulcerative colitis,

- in patients with bacterial enterocolitis caused by invasive organisms including Salmonella, Shigella, and Campylobacter,

- in patients with pseudomembranous colitis associated with the use of broad- spectrum antibiotics.

See also:
What is the most important information I should know about Potassium Chloride (Diocalm Complete)?

Potassium supplements are contraindicated in patients with hyperkalemia since a further increase in serum potassium concentration in such patients can produce cardiac arrest. Hyperkalemia may complicate any of the following conditions: chronic renal failure, systemic acidosis such as diabetic acidosis, acute dehydration, extensive tissue breakdown as in severe burns, adrenal insufficiency, or the administration of a potassium-sparing diuretic, e.g., spironolactone, triamterene, or amiloride.

Potassium Chloride (Diocalm Complete) (Potassium Chloride (Diocalm Complete) extended-release tablets) tablets are contraindicated in patients with known hypersensitivity to any ingredient in this product.

Controlled-release formulations of Potassium Chloride (Diocalm Complete) have produced esophageal ulceration in certain cardiac patients with esophageal compression due to an enlarged left atrium. Potassium supplementation, when indicated in such patients, should be given as a liquid preparation.

All solid oral dosage forms of Potassium Chloride (Diocalm Complete) are contraindicated in any patient in whom there is structural, pathological, e.g., diabetic gastroparesis, or pharmacologic (use of anticholinergic agents or other agents with anticholinergic properties at sufficient doses to exert anticholinergic effects) cause for arrest or delay in tablet passage through the gastrointestinal tract.

See also:
What is the most important information I should know about Sodium Chloride (Diocalm Complete)?

Due to potential toxicity of benzyl alcohol in newborns, Bacteriostatic Sodium Chloride (Diocalm Complete) Injection, USP, 0.9% containing benzyl alcohol must not be used in this patient population.

Bacteriostatic Sodium Chloride (Diocalm Complete) Injection, USP, 0.9% should not be used for fluid or Sodium Chloride (Diocalm Complete) replacement.

See also:
What is the most important information I should know about Sodium Citrate (Diocalm Complete)?

Renal failure or hypernatremia; in conjunction with hexamine mandelate or hexamine hippurate therapy because an acidic urine is needed.

Caution is advised in overt and occult cardiac failure. Concomitant use of urinary alkalinizers and quinolone antibiotics should be avoided. Crystalluria may be more likely to occur in alkaline urine.

Use Dextrose (Diocalm Complete) exactly as directed on the label, or as prescribed by your doctor. Do not use this medicine in larger or smaller amounts or for longer than recommended.

The chewable tablet must be chewed before you swallow it.

If you take Dextrose (Diocalm Complete) gel in a pre-measured tube, be sure to swallow the entire contents of the tube to get a full dose.

Your hypoglycemia symptoms should improve in about 10 minutes after taking oral Dextrose (Diocalm Complete). If not, take another dose. Seek medical attention if you still have hypoglycemia symptoms after taking two doses.

Dextrose (Diocalm Complete) injection is given through an IV into a vein. Do not inject this medicine into a muscle or under the skin. The injection should be given only as an intravenous (IV) injection and should be given slowly. Tell your caregivers if you feel any burning, pain, or swelling around the IV needle when Dextrose (Diocalm Complete) is injected.

You may be shown how to use an IV at home. Do not give yourself Dextrose (Diocalm Complete) injection if you do not understand how to use the injection and properly dispose of needles, IV tubing, and other items used.

Use a disposable needle, syringe, or prefilled syringe only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

Call your doctor if your symptoms do not improve, or if they get worse.

Check the expiration date on your medicine label each time you use this medicine. If the medicine has been stored for a long time, the expiration date may have passed and the Dextrose (Diocalm Complete) may not work as well.

Store at room temperature away from moisture and heat. Keep the medicine container tightly closed when not in use.

Use Loperamide (Diocalm Complete) solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Loperamide (Diocalm Complete) solution by mouth with or without food.
• Use the measuring cup that comes with Loperamide (Diocalm Complete) solution. Ask your pharmacist for help if you are unsure of how to measure your dose.
• Drinking extra fluids is recommended while you have diarrhea. Check with your doctor if you have questions.
• If you miss a dose of Loperamide (Diocalm Complete) solution, take it as soon as you remember. Continue to take it as directed by your doctor or on the package label.

Ask your health care provider any questions you may have about how to use Loperamide (Diocalm Complete) solution.

Use Potassium Chloride (Diocalm Complete) as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Potassium Chloride (Diocalm Complete) is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Potassium Chloride (Diocalm Complete) at home, a health care provider will teach you how to use it. Be sure you understand how to use Potassium Chloride (Diocalm Complete). Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
• Do not use Potassium Chloride (Diocalm Complete) if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
• Potassium Chloride (Diocalm Complete) MUST be diluted before use.
• It is very important to carefully check that the right amount of medicine is drawn into the syringe before injecting the medicine into its diluent solution.
• If this solution is given by way of a pumping device, be sure to stop the pumping action before the container runs dry or air embolism may occur.
• Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
• If you miss a dose of Potassium Chloride (Diocalm Complete), use 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 use 2 doses at once.

Ask your health care provider any questions you may have about how to use Potassium Chloride (Diocalm Complete).

Use Sodium Chloride (Diocalm Complete) as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Sodium Chloride (Diocalm Complete) is for inhalation in a nebulizer only. Do not take Sodium Chloride (Diocalm Complete) by mouth or inject it.
• Sodium Chloride (Diocalm Complete) is used to dilute other medicines. Follow the instructions provided by your doctor.
• Sodium Chloride (Diocalm Complete) may come in a single-dose vial or in a container with multiple doses. Be sure to use the proper amount of Sodium Chloride (Diocalm Complete). If you are using Sodium Chloride (Diocalm Complete) from a multiple-dose container, use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.
• If you are using a vial, use your dose immediately after opening the vial and throw away any unused medicine. Do not save the contents of an opened vial for later use.
• Do not use Sodium Chloride (Diocalm Complete) if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
• This product is intended to dilute other medicines for use in a nebulizer. If you miss a dose of your medicine, follow the missed dose instructions for the medicine that you are mixing with this product.

Ask your health care provider any questions you may have about how to use Sodium Chloride (Diocalm Complete).

Use Sodium Citrate (Diocalm Complete) as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Sodium Citrate (Diocalm Complete) after meals and at bedtime, unless directed otherwise by your health care provider.
• Shake well before using.
• Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.
• Mix Sodium Citrate (Diocalm Complete) with water before swallowing. Follow with additional water, if desired.
• If you miss a dose of Sodium Citrate (Diocalm Complete), 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 Sodium Citrate (Diocalm Complete).

Urinary alkalinization.

Carbohydrate depletion, dehydration, energy source, fluid depletion, hypoglycaemia, water replacement.

This medication is used to treat sudden diarrhea (including traveler's diarrhea). It works by slowing down the movement of the gut. This decreases the number of bowel movements and makes the stool less watery. Loperamide (Diocalm Complete) is also used to reduce the amount of discharge in patients who have had an ileostomy. It is also used to treat ongoing diarrhea in people with inflammatory bowel disease.

Loperamide (Diocalm Complete) treats only the symptoms, not the cause of the diarrhea (e.g., infection). Treatment of other symptoms and the cause of the diarrhea should be determined by your doctor.

Do not use in children younger than 6 years unless directed by your doctor. This medication should not be used in infants younger than 24 months.

How to use Loperamide (Diocalm Complete) (Loperamide (Diocalm Complete))

If you are using the over-the-counter product to self-treat, read all the directions on the product package before taking this medication. If your doctor has prescribed this medication, follow your doctor's directions and the directions on your prescription label.

Take this medication by mouth, usually after each loose stool or as directed by your doctor. Shake the bottle well before each use. Measure each dose carefully using the attached measuring cup. Do not use a household spoon since you may not get the correct dose.

The dosage is based on your condition and response to treatment. In children, dosage is also based on age and weight. Adults should not use more than 8 milligrams in 24 hours if self-treating, or 16 milligrams in 24 hours if under a doctor's direction.

Improper use of this medication (overuse or abuse) - or use with certain other medications - may cause serious harm, such as fast/irregular heartbeat or death. Do not increase your dose, take it more often, or use it for longer than directed. Be sure to tell your doctor or pharmacist about all the products you use (including prescription, nonprescription, and herbal products).

Diarrhea can cause a serious loss of body water (dehydration). Drink plenty of fluids and minerals (electrolytes) to replace what is lost. Tell your doctor right away if you develop signs of dehydration (e.g., extreme thirst, decreased urination, muscle cramps, weakness, fainting). You may also need to change to a bland diet during this time to reduce irritation to your stomach/intestines. Consult your doctor or pharmacist for more information.

Tell your doctor if your diarrhea does not improve after 2 days, if your condition worsens, or if you develop new symptoms. If you develop blood in the stool, fever, or an uncomfortable fullness/swelling of the stomach/abdomen, or if you think you may have a serious medical problem, seek immediate medical attention.

If you are taking this medication under your doctor's direction for ongoing diarrhea, tell your doctor if your diarrhea continues after 10 days of treatment.

This medication is a mineral supplement used to treat or prevent low amounts of potassium in the blood. A normal level of potassium in the blood is important. Potassium helps your cells, kidneys, heart, muscles, and nerves work properly. Most people get enough potassium by eating a well-balanced diet. Some conditions that can lower your body's potassium level include severe prolonged diarrhea and vomiting, hormone problems such as hyperaldosteronism, or treatment with "water pills"/diuretics.

How to use Potassium Chloride (Diocalm Complete)

Take this medication by mouth as directed by your doctor. To prevent stomach upset, take each dose with a meal and a full glass of water (8 ounces/240 milliliters) unless your doctor directs you otherwise. Do not lie down for 10 minutes after taking this medication.

Do not crush, chew, or suck extended-release capsules or tablets. Doing so can release all of the drug at once, increasing the risk of side effects. Also, do not split extended-release tablets unless they have a score line and your doctor or pharmacist tells you to do so. Swallow the whole or split tablet without crushing or chewing.

Swallow the capsules whole. If you have trouble swallowing the capsules, tell your doctor or pharmacist. Some brands may be opened and the contents sprinkled onto a spoonful of cool, soft food such as applesauce or pudding. Immediately swallow the food/medication mixture without chewing. Do not prepare the mixture ahead of time. Drink a glass of cool water after each dose to make sure you swallow all the medication. Ask your pharmacist if you have questions about your brand.

Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time(s) each day. The dosage is based on your medical condition and response to treatment. Do not increase your dose or take it more often than prescribed. Do not take more than 20 milliequivalents per dose.

Tell your doctor if your condition does not improve or if you have symptoms of low potassium in the blood (such as irregular heartbeat, muscle weakness/cramps).

This product is used to treat dryness inside the nose (nasal passages). It helps add moisture inside the nose to dissolve and soften thick or crusty mucus. In babies and young children with stuffy noses who cannot blow their noses, using this product helps to make the mucus easier to remove with a nasal bulb syringe. This helps relieve stuffiness and makes breathing easier.

This product contains a purified gentle salt solution (also called saline or Sodium Chloride (Diocalm Complete) solution). It does not contain any medication.

How to use Sodium Chloride (Diocalm Complete) nasal

Spray this product into each nostril as needed or as directed by your doctor. This product may also be given into the nose as drops or a stream. Follow all directions on the product package. If you are uncertain about any of the information, consult your doctor or pharmacist.

Try not to touch the container tip to the inside of your nose. If this happens, rinse the tip with hot water and dry with a clean tissue before recapping the container.

If your condition persists or worsens, or if you think you may have a serious medical problem, seek immediate medical attention.

Use: Labeled Indications

Anticoagulant:

Concentrate (triCitrasol): Anticoagulant used in granulocytapheresis procedures

Solution: Anticoagulant for use with cytapheresis device only

Off Label Uses

Regional anticoagulation for continuous renal replacement therapy circuit

Data from several small randomized, controlled trials support the use of regional Sodium Citrate (Diocalm Complete) to reduce the risk of clot formation in continuous renal replacement therapy (CRRT) circuits, thus prolonging circuit life and avoiding interruptions in therapy. It should be noted that patients with high bleeding risk, severe coagulopathy, metabolic abnormalities, or liver dysfunction were excluded from these trials.

If the patient is concurrently taking digitalis, the physician should bear in mind that the average daily dose of this medicine (10 g of granules) contains approximately 1.75 g (44 mmol) of potassium.

If a low sodium diet has been prescribed, it should be remembered that the average daily dose of this medicine contains approximately 1 g (44 mmol) of sodium.

See also:
What other drugs will affect Dextrose (Diocalm Complete)?

Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, use aseptic technique, mixthoroughly and do not store.

Some opacity of the plastic due to moisture absorption during sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually.

See also:
What other drugs will affect Loperamide (Diocalm Complete)?

Desmopressin: Loperamide (Diocalm Complete)-Loperamide (Diocalm Complete) Oxide may increase the serum concentration of Desmopressin. Monitor therapy

Eluxadoline: Loperamide (Diocalm Complete)-Loperamide (Diocalm Complete) Oxide may enhance the constipating effect of Eluxadoline. Monitor therapy

Erdafitinib: May increase the serum concentration of P-glycoprotein/ABCB1 Substrates. Monitor therapy

Haloperidol: QT-prolonging Agents (Indeterminate Risk - Avoid) may enhance the QTc-prolonging effect of Haloperidol. Monitor therapy

Lasmiditan: May increase the serum concentration of P-glycoprotein/ABCB1 Substrates. Avoid combination

Lumacaftor and Ivacaftor: May decrease the serum concentration of P-glycoprotein/ABCB1 Substrates. Lumacaftor and Ivacaftor may increase the serum concentration of P-glycoprotein/ABCB1 Substrates. Monitor therapy

P-glycoprotein/ABCB1 Inducers: May decrease the serum concentration of P-glycoprotein/ABCB1 Substrates. P-glycoprotein inducers may also further limit the distribution of p-glycoprotein substrates to specific cells/tissues/organs where p-glycoprotein is present in large amounts (e.g., brain, T-lymphocytes, testes, etc.). Monitor therapy

QT-prolonging Agents (Highest Risk): QT-prolonging Agents (Indeterminate Risk - Avoid) may enhance the QTc-prolonging effect of QT-prolonging Agents (Highest Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Monitor therapy

QuiNIDine: May enhance the CNS depressant effect of Loperamide (Diocalm Complete)-Loperamide (Diocalm Complete) Oxide. Loperamide (Diocalm Complete)-Loperamide (Diocalm Complete) Oxide may enhance the QTc-prolonging effect of QuiNIDine. QuiNIDine may increase the serum concentration of Loperamide (Diocalm Complete)-Loperamide (Diocalm Complete) Oxide. Monitor therapy

Ramosetron: Loperamide (Diocalm Complete)-Loperamide (Diocalm Complete) Oxide may enhance the constipating effect of Ramosetron. Monitor therapy

Ranolazine: May increase the serum concentration of P-glycoprotein/ABCB1 Substrates. Monitor therapy

Sincalide: Drugs that Affect Gallbladder Function may diminish the therapeutic effect of Sincalide. Management: Consider discontinuing drugs that may affect gallbladder motility prior to the use of sincalide to stimulate gallbladder contraction. Consider therapy modification

See also:
What other drugs will affect Potassium Chloride (Diocalm Complete)?

Aliskiren: Potassium Salts may enhance the hyperkalemic effect of Aliskiren. Monitor therapy

Angiotensin II Receptor Blockers: Potassium Salts may enhance the hyperkalemic effect of Angiotensin II Receptor Blockers. Monitor therapy

Angiotensin-Converting Enzyme Inhibitors: Potassium Salts may enhance the hyperkalemic effect of Angiotensin-Converting Enzyme Inhibitors. Monitor therapy

Anticholinergic Agents: May enhance the ulcerogenic effect of Potassium Chloride (Diocalm Complete). Management: Patients on drugs with substantial anticholinergic effects should avoid using any solid oral dosage form of Potassium Chloride (Diocalm Complete). Avoid combination

Drospirenone: Potassium Salts may enhance the hyperkalemic effect of Drospirenone. Monitor therapy

Eplerenone: May enhance the hyperkalemic effect of Potassium Salts. Management: This combination is contraindicated in patients receiving eplerenone for treatment of hypertension. Consider therapy modification

Glycopyrrolate (Systemic): May enhance the adverse/toxic effect of Potassium Chloride (Diocalm Complete). This is specific to solid oral dosage forms of Potassium Chloride (Diocalm Complete). Avoid combination

Heparin: May enhance the hyperkalemic effect of Potassium Salts. Monitor therapy

Heparins (Low Molecular Weight): May enhance the hyperkalemic effect of Potassium Salts. Monitor therapy

Nicorandil: May enhance the hyperkalemic effect of Potassium Salts. Monitor therapy

Potassium-Sparing Diuretics: Potassium Salts may enhance the hyperkalemic effect of Potassium-Sparing Diuretics. Management: Avoid coadministration of a potassium-sparing diuretic and a potassium salt. This combination should only be used in cases of significant hypokalemia, and only if serum potassium can be closely monitored. Consider therapy modification

See also:
What other drugs will affect Sodium Chloride (Diocalm Complete)?

Caution must be exercised in the administration of Sodium Chloride (Diocalm Complete) Injection, USP to patients receiving corticosteroids or corticotropin.

Studies have not been conducted to evaluate additional drug/drug or drug/food interactions with Sodium Chloride (Diocalm Complete) (Sodium Chloride (Diocalm Complete) (Sodium Chloride (Diocalm Complete) injection) injection) Injection, USP.

See also:
What other drugs will affect Sodium Citrate (Diocalm Complete)?

General: Alkalinization of the urine due to the use of Sodium Citrate (Diocalm Complete), theoretically, may result in a decreased therapeutic effect of the following medications: Chlorpropamide, lithium, salicylates and tetracyclines. Alternatively, alkalinization of the urine due to the use of Sodium Citrate (Diocalm Complete), theoretically, may result in an increased therapeutic effect of the following medications: Amphetamines, ephedrine/pseudoephedrine.

Antacids: Concurrent use of antacids with citrates may result in systemic alkalosis. Concomitant administration of antacids with Sodium Citrate (Diocalm Complete) and sodium bicarbonate may promote the development of calcium stones in patients with uric acid stones and may also cause hypernatremia. Concurrent use of aluminum-containing antacids with citrate salts can increase aluminum absorption, possibly resulting in acute aluminum toxicity, especially in patients with renal insufficiency.

Quinolones: Citrates may reduce the solubility of ciprofloxacin, norfloxacin or ofloxacin in the urine. Patients should be observed for signs of crystalluria and nephrotoxicity.

Laxatives: Concurrent administration of citrates with laxatives may have an additive effect.

Frequent administration or intake of large quantities may cause teeth erosion and have a local irritant effect.

See also:
What are the possible side effects of Dextrose (Diocalm Complete)?

Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation and hypervolemia.

Too rapid infusion of hypertonic solutions may cause local pain and venous irritation. Rate of administration should be adjusted according to tolerance. Use of the largest peripheral vein and a small bore needle is recommended.

Dextrose (Diocalm Complete) may be administered at a rate of 0.5 g/kg/hour without producing glycosuria. Hyperglycemia and glycosuria may be a function of rate of administration or metabolic insufficiency. Appropriate therapy may include slowing of the infusion rate and administration of insulin.

Too rapid administration of hypertonic Dextrose (Diocalm Complete) solutions may result in hyperosmolar syndrome with signs of mental confusion and/or loss of consciousness. If undetected and untreated, this can lead to osmotic dehydration, hyperosmolar coma and death.

If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.

See also:
What are the possible side effects of Loperamide (Diocalm Complete)?

Clinical Trial Data

The adverse effects reported during clinical investigations of Loperamide (Diocalm Complete)® (Loperamide (Diocalm Complete) hydrochloride) are difficult to distinguish from symptoms associated with the diarrheal syndrome. Adverse experiences recorded during clinical studies with Loperamide (Diocalm Complete)® (Loperamide (Diocalm Complete) hcl) were generally of a minor and self-limiting nature. They were more commonly observed during the treatment of chronic diarrhea.

The adverse events reported are summarized irrespective of the causality assessment of the investigators.

1) Adverse events from 4 placebo-controlled studies in patients with acute diarrhea The adverse events with an incidence of 1.0% or greater, which were reported at least as often in patients on Loperamide (Diocalm Complete) hydrochloride as on placebo, are presented in the table below.

The adverse events with an incidence of 1.0% or greater, which were more frequently reported in patients on placebo than on Loperamide (Diocalm Complete) hydrochloride, were: dry mouth, flatulence, abdominal cramp and colic.

2) Adverse events from 20 placebo-controlled studies in patients with chronic diarrhea

The adverse events with an incidence of 1.0% or greater, which were reported at least as often in patients on Loperamide (Diocalm Complete) hydrochloride as on placebo, are presented below in the table below.

The adverse events with an incidence of 1.0% or greater, which were more frequently reported in patients on placebo than on Loperamide (Diocalm Complete) hydrochloride were: nausea, vomiting, headache, meteorism, abdominal pain, abdominal cramp and colic.

3) Adverse events from seventy-six controlled and uncontrolled studies in patients with acute or chronic diarrhea

The adverse events with an incidence of 1.0% or greater in patients from all studies are given in the table below.

Post -marketing experience

The following adverse events have been reported:

Skin and subcutaneous tissue disorders

Rash, pruritus, urticaria, angioedema, and extremely rare cases of bullous eruption including erythema multiforme, Stevens-Johnson syndrome and Toxic Epidermal Necrolysis have been reported with use of Loperamide (Diocalm Complete) (Loperamide (Diocalm Complete) hcl).

Immune system disorders

Isolated occurrences of allergic reactions and in some cases severe hypersensitivity reactions including anaphylactic shock and anaphylactoid reactions have been reported with the use of Loperamide (Diocalm Complete) (Loperamide (Diocalm Complete) hcl).

Gastrointestinal disorders

Dry mouth, abdominal pain, distention or discomfort, nausea, vomiting, flatulence, dyspepsia, constipation, paralytic ileus, megacolon, including toxic megacolon.

Renal and urinary disorders

Urinary retention

Nervous system disorders

Drowsiness, dizziness

General disorders and administrative site conditions

Tiredness

A number of the adverse events reported during the clinical investigations and post- marketing experience with Loperamide (Diocalm Complete) are frequent symptoms of the underlying diarrheal syndrome (abdominal pain/discomfort, nausea, vomiting, dry mouth, tiredness, drowsiness, dizziness, constipation, and flatulence). These symptoms are often difficult to distinguish from undesirable drug effects.

Drug Abuse And Dependence

Abuse

A specific clinical study designed to assess the abuse potential of Loperamide (Diocalm Complete) at high doses resulted in a finding of extremely low abuse potential.

Dependence

Studies in morphine-dependent monkeys demonstrated that Loperamide (Diocalm Complete) hydrochloride at doses above those recommended for humans prevented signs of morphine withdrawal. However, in humans, the naloxone challenge pupil test, which when positive indicates opiate-like effects, performed after a single high dose, or after more than two years of therapeutic use of Loperamide (Diocalm Complete)® (Loperamide (Diocalm Complete) hydrochloride), was negative.

Orally administered Loperamide (Diocalm Complete)® (Loperamide (Diocalm Complete) hcl) (Loperamide (Diocalm Complete) formulated with magnesium stearate) is both highly insoluble and penetrates the CNS poorly.

See also:
What are the possible side effects of Potassium Chloride (Diocalm Complete)?

One of the most severe adverse effects is hyperkalemia. Gastrointestinal bleeding and ulceration have been reported in patients treated with Potassium Chloride (Diocalm Complete) (Potassium Chloride (Diocalm Complete) extended-release) ® Extencaps®. In addition to gastrointestinal bleeding and ulceration, perforation and obstruction have been reported in patients treated with other solid KCl dosage forms, and may occur with Potassium Chloride (Diocalm Complete) (Potassium Chloride (Diocalm Complete) extended-release) ® Extencaps®.

The most common adverse reactions to the oral potassium salts are nausea, vomiting, flatulence, abdominal discomfort, and diarrhea. These symptoms are due to irritation of the gastrointestinal tract and are best managed by taking the dose with meals, or reducing the amount taken at one time. Skin rash has been reported rarely with potassium preparations.

See also:
What are the possible side effects of Sodium Chloride (Diocalm Complete)?

Post-Marketing Adverse Reactions

The following adverse reactions have been identified during postapproval use of Sodium Chloride (Diocalm Complete) Injection, USP. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

The following adverse reactions have been reported in the post-marketing experience during use of 0.9% Sodium Chloride (Diocalm Complete) Injection, USP and include the following:

hypersensitivity/infusion reactions, including hypotension, pyrexia, tremor, chills, urticaria, rash, and pruritus.

Also reported are infusion site reactions, such as infusion site erythema, injection site streaking, burning sensation, and infusion site urticaria.

The following adverse reactions have not been reported with 0.9% Sodium Chloride (Diocalm Complete) Injection, USP but may occur: hypernatremia, hyperchloremic metabolic acidosis, and hyponatremia, which may be symptomatic.

Hyponatremia has been reported for 0.45% Sodium Chloride (Diocalm Complete) Injection, USP.

The following adverse reactions have not been reported with 0.45% Sodium Chloride (Diocalm Complete) Injection, USP but may occur: hyperchloremic metabolic acidosis, hypersensitivity/infusion reactions (including hypotension, pyrexia, tremor, chills, urticaria, rash, and pruritus), and infusion site reactions (such as infusion site erythema, injection site streaking, burning sensation, infusion site urticaria).

If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.

See also:
What are the possible side effects of Sodium Citrate (Diocalm Complete)?

The tartrate component of Sodium Citrate (Diocalm Complete) may be incompletely absorbed. Because of this Sodium Citrate (Diocalm Complete) may be exert a mild laxative effect. Prolonged and excessive use may cause a systemic alkolosis and / or hypernatremia.

One of the long-acting synthetic antidiarrheals; it is not significantly absorbed from the gut, and has no effect on the adrenergic system or central nervous system, but may antagonize histamine and interfere with acetylcholine release locally. [PubChem]

A white crystal or crystalline powder used as an electrolyte replenisher, in the treatment of hypokalemia, in buffer solutions, and in fertilizers and explosives.

Sodium Chloride (Diocalm Complete), also known as salt, common salt, table salt or halite, is an ionic compound with the chemical formula NaCl, representing a 1:1 ratio of sodium and chloride ions. Sodium Chloride (Diocalm Complete) is the salt most responsible for the salinity of seawater and of the extracellular fluid of many multicellular organisms. It is listed on the World Health Organization Model List of Essential Medicines.

Each 4 g of Sodium Citrate (Diocalm Complete) contains sodium bicarbonate 1760 mg, anhydrous Sodium Citrate (Diocalm Complete) 630 mg, anhydrous Sodium Citrate (Diocalm Complete) 720 mg and tartaric acid 890 mg.

It also contains the following excipients: Nature identical lemon flavor oil, terpeneless and sodium saccharin.

Sodium Citrate (Diocalm Complete) consists of formulation and pleasantly flavored granules. When added to water, Sodium Citrate (Diocalm Complete) effervesces and dissolves, forming a clear or orange-colored alkaline solution.