Etidronic Acid/Glycerol/Maleleuca Alternifolia/Octyldecanol/Palmi

For the treatment of symptomatic Paget's disease of bone and in the prevention and treatment of heterotopic ossification following total hip replacement or due to spinal cord injury. (Paget's disease of bone; heterotropic ossification;)

This medication is used as a moisturizer to treat or prevent dry, rough, scaly, itchy skin and minor skin irritations (e.g., diaper rash, skin burns from radiation therapy). Emollients are substances that soften and moisturize the skin and decrease itching and flaking. Some products (e.g., zinc oxide, white petrolatum) are used mostly to protect the skin against irritation (e.g., from wetness).

Dry skin is caused by a loss of water in the upper layer of the skin. Emollients/moisturizers work by forming an oily layer on the top of the skin that traps water in the skin. Petrolatum, lanolin, mineral oil and dimethicone are common emollients. Humectants, including glycerin, lecithin, and propylene glycol, draw water into the outer layer of skin. Many products also have ingredients that soften the horny substance (keratin) that holds the top layer of skin cells together (e.g., urea, alpha hydroxy acids such as lactic/citric/glycolic acid, and allantoin). This helps the dead skin cells fall off, helps the skin keep in more water, and leaves the skin feeling smoother and softer.

For the treatment of superficial infections of the external auditory canal caused by organisms susceptible to the action of the antimicrobial, complicated by inflammation

It has been employed as a 30% solution as an alternative to glucose in parenteral nutrition but its use is not recommended because of the risk of lactic acidosis.

Sorbitol may be administered by mouth or rectally as an osmotic laxative in the management of constipation doses of 20 to 50 g have been suggested.

Solutions containing about 3% of sorbitol are used as irrigating fluids in transurethral surgical procedures.

Sorbitol also acts as a bulk sweetening agent. It is used in limited quantities as a sweetener in energy-reduced diabetic food products. It is also used as an alternative to sucrose in many sugar-free oral liquid preparations and in sugar-free foods as it is less likely to cause dental caries.

Sorbitol also has humectant and stabilising properties and is used in various pharmaceutical and cosmetic products including toothpaste.

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 occasional constipation or to cleanse the bowel before a rectal exam or other intestinal procedure.

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

There are many brands and forms of ocular lubricant available and not all are listed on this leaflet.

Ocular lubricant is a solution specially formulated to moisten the eyes.

Ocular lubricant is used to relieve burning, irritation, and discomfort caused by dry eyes.

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

Preventing infection during prostate surgery or other urinary tract surgeries. It may also be used for other conditions as determined by your doctor.

Sorbitol is a hexitol irrigant. It works by flushing debris out of the surgical area to help prevent infection.

Glycerol can be used as often as required in the shower or at the hand basin. Wet skin and apply a small amount of Glycerol to the area to be cleansed. Lightly massage onto skin. Rinse and gently pat skin dry.

Adjunct Therapy: QV cream or QV skin lotion can be used to further moisturise the skin after cleansing with Glycerol. For severe conditions or extensive areas of dry skin, soaking in a bath containing QV bath oil gives the best therapeutic effect.

Carefully remove all cerumen and debris to allow VōSoL to contact infected surfaces directly. To promote continuous contact, insert a wick of cotton saturated with VōSoL into the ear canal; the wick may also be saturated after insertion. Instruct the patient to keep the wick in for at least 24 hours and to keep it moist by adding 3 to 5 drops of VōSoL every 4 to 6 hours. The wick may be removed after 24 hours but the patient should continue to instill 5 drops of VōSoL 3 or 4 times daily thereafter, for as long as indicated. In pediatric patients, 3 to 4 drops may be sufficient due to the smaller capacity of the ear canal.

Usual Adult Dose for Constipation

Oral: 30 to 150 mL (70% solution) once.

Rectal: 120 mL (25% to 30% solution) as a rectal enema once.

Usual Pediatric Dose for Constipation

2 to 11 years:

Oral: 2 mL/kg (70% solution) once.

Rectal: 30 to 60 mL (25% to 30% solution) as a rectal enema once.

Greater than or equal to 12 years:

Oral: 30 to 150 mL (70% solution) once.

Rectal: 120 mL (25% to 30% solution) as a rectal enema once.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

The use of sorbitol is contraindicated in patients with anuria. Sorbitol should not be used in patients with suspected or documented fructose intolerance. Sorbitol should not given by injection.

Sudden severe abdominal bloating and diarrhea have been reported in patients ingesting sorbitol.

Solutions for urologic irrigation should be used with caution in patients with severe cardiopulmonary or renal dysfunction.

Irrigating fluids used during transurethral prostatectomy have been demonstrated to enter the systemic circulation in relatively large volumes; thus sorbitol irrigating solution must be regarded as a systemic agent. Absorption of large amounts of fluids containing sorbitol may significantly alter cardiopulmonary and renal dynamics. Appropriate patient monitoring should be conducted due to the possibility of fluid overload. If fluid overload occurs, intensive fluid and electrolyte management should be initiated. Monitoring of fluid and electrolyte levels beyond the acute phase may be necessary due to the possibility of delayed fluid absorption.

Hyperglycemia from metabolism of absorbed sorbitol may be observed in patients with diabetes mellitus.

The cardiovascular status, especially of the patient with cardiac disease, should be carefully monitored before and during transurethral resection of the prostate when using 3% sorbitol urologic irrigating solution, because the quantity of fluid absorbed into the systemic circulation by opened prostatic veins may produce significant expansion of the intravascular fluid and lead to fulminating congestive heart failure.

Shift of sodium free intracellular fluid into the extracellular compartment, following systemic absorption could lower serum concentration and aggravate preexisting hyponatremia.

Excessive loss of water and electrolytes may lead to serious imbalances. With continuous use of solution, loss of water may occur in excess of electrolytes, producing hypernatremia.

Sustained diuresis that results from transurethral irrigation with sorbitol irrigating solutions could obscure and intensify inadequate hydration or hypovolemia.

Dialysis

Data not available

Osteoporosis with hypercalcaemia/hypercalciuria; osteomalacia.

See also:
What is the most important information I should know about Glycerol?

hypersensitivity to any of the ingredients of Glycerol.

See also:
What is the most important information I should know about Propylene Glycol?

Hypersensitivity to Propylene Glycol HC or any of the ingredients; herpes simplex, vaccinia and varicella. Performated tympanic membrane is considered a contraindication to the use of any medication in the external ear canal.

See also:
What is the most important information I should know about Sorbitol?

Sorbitol should not be given to patients with hereditary fructose intolerance. It should be given with caution to patients with impaired kidney function or severe liver damage.

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. Overuse of a laxative may cause damage to the nerves, muscles, or tissues in your intestines.

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

Wash your hands before and after using a rectal enema or suppository.

This medicine comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

To use the suppository:

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

• Use your finger or the applicator provided to insert the suppository.

• Lie on your left side with your lower leg straight and your upper leg bent. Gently insert the suppository pointed tip first into your rectum, about 1/2 inch for a child or 1 inch for an adult.

• For best results, stay lying down for a few minutes. The suppository will melt quickly and you should feel little or no discomfort while holding it in.

To use the enema:

• Remove the protective shield before inserting the enema tip.

• Lie on your left side with your lower leg straight and your upper leg bent. If giving this medicine to a child, have the child kneel on the floor and then lower the chest forward until the side of the child's face is resting on the floor.

• Gently insert the tip of the applicator or bulb syringe into the rectum, pointing it toward your navel (belly button). Do not force the applicator into the rectum or injury could result.

• Slowly squeeze the bottle or bulb until it is nearly empty.

For best results after using glycerin rectal, stay lying down until you feel the urge to have a bowel movement. This medicine should produce a bowel movement within 15 to 60 minutes after using the suppository.

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

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. Keep the bottle tightly closed when not in use.

Store the rectal suppositories at cool room temperature away from moisture and heat. Some suppositories can be refrigerated. Check your medicine label to be sure how to store your medicine.

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.

Do not use this medicine while wearing contact lenses. Ocular lubricant may contain a preservative that can discolor soft contact lenses. Wait at least 15 minutes after using this medicine before putting in your contact lenses.

Wash your hands before using the eye drops.

To apply the eye drops:

• Tilt your head back slightly and pull down your lower eyelid to create a small pocket. Hold the dropper above the eye with the tip down. Look up and away from the dropper and squeeze out a drop.

• Close your eyes for 2 or 3 minutes with your head tipped down, without blinking or squinting. Gently press your finger to the inside corner of the eye for about 1 minute, to keep the liquid from draining into your tear duct.

• Use only the number of drops your doctor has prescribed. If you use more than one drop, wait about 5 minutes between drops.

• Wait at least 10 minutes before using any other eye drops your doctor has prescribed.

Do not use the eye drops if the liquid has changed colors or has particles in it. Call your pharmacist for new medicine.

To apply the ointment:

• Tilt your head back slightly and pull down your lower eyelid to create a small pocket. Hold the ointment tube with the tip pointing toward this pocket. Look up and away from the tip.

• Squeeze out a ribbon of ointment into the lower eyelid pocket without touching the tip of the tube to your eye. Blink your eye gently and then keep it closed for 1 or 2 minutes.

• Use a tissue to wipe excess ointment from your eyelashes.

• After opening your eyes, you may have blurred vision for a short time. Avoid driving or doing anything that requires you to be able to see clearly.

Do not touch the tip of the eye dropper or ointment tube. Do not place the tip directly on your eye. A contaminated dropper or tube tip can infect your eye, which could lead to serious vision problems.

Call your doctor if your symptoms do not improve, or if they get worse while using ocular lubricant.

Store at room temperature away from moisture and heat. Do not freeze. Keep the bottle or tube tightly closed when not in use.

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

• Sorbitol may be taken with or without food.
• Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.
• Do not take additional laxatives or stool softeners while taking Sorbitol unless directed by your doctor.
• If you are using Sorbitol as a rectal enema, follow the directions given with the enema. Ask your doctor or pharmacist any questions you may have about giving an enema.
• Do not exceed the recommended dose or use Sorbitol for longer than 1 week without checking with your doctor.
• If you miss a dose of Sorbitol, 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 Sorbitol.

This product is used to relieve occasional constipation. Glycerin belongs to a class of drugs known as hyperosmotic laxatives. It works by drawing water into the intestines. This effect usually results in a bowel movement within 15 to 60 minutes.

The normal frequency of bowel movements varies from once daily to 1 to 2 times weekly. Constipation is best treated by drinking plenty of fluids (four to six 8-ounce glasses daily), eating foods high in fiber, and exercising regularly.

How to use Glycerol (Infant) rectal

This product is for rectal use only. Read and follow all directions on the product package, or use as directed by your doctor. If you are uncertain about any of the information, consult your doctor or pharmacist. If the suppository is too soft to insert, chill in the refrigerator for 30 minutes or run cold water over it before removing the foil wrapper.

Wash your hands before and after using this product. If the medication is wrapped in foil, remove the foil wrapper. If desired, the suppository may be moistened with lukewarm water. Do not use petroleum jelly or mineral oil. Doing so may cause the product to be less effective. Lie on your left side with the right knee slightly bent. Using your finger, gently insert the suppository well up into the rectum, pointed end first. After insertion, stay in position for 15 to 20 minutes if possible until you feel a strong urge to have a bowel movement. This product does not need to melt completely to produce an effect.

Do not use this product more than once daily unless otherwise directed by your doctor.

If this product is used too frequently, it may cause loss of normal bowel function and an inability to have a bowel movement without using the product (laxative dependence). If you notice symptoms of overuse, such as diarrhea, abdominal pain, decreased weight, or weakness, contact your doctor promptly.

Consult your doctor promptly if you do not have a bowel movement after using this product or if you think you may have a serious medical problem.

Propylene glycol is used as moisturizer in cosmetics and pharmaceuticals.

Sorbitol is used to treat occasional constipation.

Calcium, iron and antacids reduce absorption. May increase prothrombin time when used with warfarin. May increase GI and/or renal side effects when used with NSAIDs.

Food Interaction

Food, milk and dairy products interfere with its absorption.

See also:
What other drugs will affect Glycerol?

*blood thinner such as warfarin (Coumadin);

*a thyroid medication such as levothyroxine (Synthroid);

*insulin or diabetes medicine taken by mouth;

*rifampin (Rifadin, Rifater, Rifamate, Rimactane);

*ketoconazole (Nizoral) or itraconazole (Sporanox);

*seizure medicines such as phenytoin (Dilantin), carbamazepine (Tegretol), felbamate (Felbatol), oxcarbazepine (Trileptal), or primidone (Mysoline);

*a barbiturate such as amobarbital (Amytal), butabarbital (Butisol), mephobarbital (Mebaral), secobarbital (Seconal), or phenobarbital (Luminal, Solfoton); or

*antidepressants such as amitriptyline (Elavil, Etrafon), amoxapine (Asendin), clomipramine (Anafranil), desipramine (Norpramin), doxepin (Sinequan), imipramine (Janimine, Tofranil), nortriptyline (Pamelor), protriptyline (Vivactil), or trimipramine (Surmontil).

See also:
What other drugs will affect Propylene Glycol?

Macrogols can demonstrate oxidising activity leading to incompatibilities. The activity of bacitracin or benzylpenicillin may be reduced in a macrogol base. Some plastics are softened by macrogols.

See also:
What other drugs will affect Sorbitol?

Calcium Polystyrene Sulfonate: Sorbitol may enhance the adverse/toxic effect of Calcium Polystyrene Sulfonate. More specifically, concomitant use of these agents may increase the risk for intestinal necrosis. Avoid combination

LamiVUDine: Sorbitol may decrease the serum concentration of LamiVUDine. Management: When possible, avoid chronic coadministration of sorbitol-containing solutions with lamivudine, but if this combination cannot be avoided, monitor patients more closely for possible therapeutic failure associated with decreased lamivudine exposure. Consider therapy modification

Sodium Polystyrene Sulfonate: Sorbitol may enhance the adverse/toxic effect of Sodium Polystyrene Sulfonate. More specifically, concomitant use of these agents may increase the risk for intestinal necrosis. Avoid combination

GI symptoms like abdominal pain, constipation, diarrhoea and nausea, hypersensitivity reactions including angioedema, urticaria, rash and pruritus, increase or recurrent bone pain at pagetic sites or the onset of pain at previously asymptomatic sites, metallic, altered or loss of taste during or shortly after the treatment. Headache, paraesthesia, leucopenia, agranulocytosis.

See also:
What are the possible side effects of Glycerol?

Applies to glycerin: enema, suppositories

Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Anal irritation; burning sensation; diarrhea; gas; nausea; stomach cramps.

Seek medical attention right away if any of these SEVERE side effects occur while taking glycerin (the active ingredient contained in Glycerol)

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); rectal bleeding.

See also:
What are the possible side effects of Propylene Glycol?

Nausea, abdominal bloating, cramping and flatulence may occur. High doses may produce diarrhea and excessive stool frequency, particularly in elderly nursing home patients. Patients taking other medications containing polyethylene glycol have occasionally developed urticaria suggestive of an allergic reaction.

See also:
What are the possible side effects of Sorbitol?

Life threatening adverse reactions with intravenous Sorbitol infusions have been reported in patients with fructose intolerance.

The literature reports occasional adverse reactions for intravenous Sorbitol infusions. These include disturbances such as acidosis, electrolyte loss, marked diuresis, urinary retention, edema, dryness of mouth and thirst, and dehydration; cardiovascular/pulmonary disorders such as pulmonary congestion, hypotension, tachycardia, angina-like pains, and other general reactions such as blurred vision, convulsions, nausea, vomiting, diarrhea, rhinitis, chills, vertigo, and backache. Allergic reactions reported to occur from Sorbitol include urticaria.

Should adverse reactions occur, discontinue the irrigant and reevaluate the clinical status of the patient.

Post-Marketing Experience

Following off-label use of 3% Sorbitol Urologic Irrigating Solution for hysteroscopic procedures in women, life-threatening adverse events related to fluid overload have been reported.

A diphosphonate which affects calcium metabolism. It inhibits ectopic calcification and slows down bone resorption and bone turnover. [PubChem]

Glycerol contains glycerol 10%; methyl hydroxybenzoate 0.2% and propyl hydroxybenzoate 0.1% as preservatives; N-alkyl betaine and coconut imidazoline betaine, sodium lauryl sulfate as surfactants. Glycerol has a pH of 6 to match the natural protective pH of the skin, which helps prevent the growth of microorganisms. It contains no oils or greases so it is suitable for all skin types and it is soft to use on very tender, sensitive skin for which a liquid may be preferred. It contains no perfume, lanolin or lanolin derivatives.

A polyhydric alcohol with about half the sweetness of sucrose. Sorbitol occurs naturally and is also produced synthetically from glucose. It was formerly used as a diuretic and may still be used as a laxative and in irrigating solutions for some surgical procedures.