Aminosyn 10%

Dosage Form: injection, solution
Aminosyn® 10% (pH 6)

Sulfite-Free

AN AMINO ACID INJECTION

Flexible Plastic Container

Rx only

Aminosyn 10% Description

Aminosyn® 10% (pH 6), Sulfite-Free, (an amino acid injection) is a sterile, nonpyrogenic solution for intravenous infusion. Aminosyn 10% (pH 6) is oxygen sensitive.

Essential Amino Acids (mg/100 mL)

Aminosyn (pH 6)	10%
Isoleucine	720
Leucine	940
Lysine (acetate)*	720
Methionine	400
Phenylalanine	440
Threonine	520
Tryptophan	160
Valine	800
*Amount cited is for L-lysine alone and does not include the acetate salt.

Nonessential Amino Acids (mg/100 mL)

Aminosyn (pH 6)	10%
Alanine	1280
Arginine	980
Histidine	300
Proline	860
Serine	420
Tyrosine	44
Glycine	1280

Electrolytes (mEq/Liter)

Aminosyn (pH 6)	10%
Potassium (K+)	None
Chloride (Cl-)	None
Acetate (C2H3O2-)b	111a
a Includes acetate from acetic acid used in processing and from L-lysine acetate. b Adjusted with acetic acid.

Product Characteristics

Aminosyn (pH 6)	10%
Protein Equivalent     (approx. grams/liter)	100
Total Nitrogen     (grams/liter)	15.7
Osmolarity     (mOsmol/liter)	938
pH	6.0 (5.5 − 6.5)b
b Adjusted with acetic acid.

The formulas for the individual amino acids present in Aminosyn 10% (pH 6) are as follows:

Essential Amino Acids

Isoleucine, USP	C6H13NO2
Leucine, USP	C6H13NO2
Lysine Acetate, USP	C6H14N2O2 • CH3COOH
Methionine, USP	C5H11NO2S
Phenylalanine, USP	C9H11NO2
Threonine, USP	C4H9NO3
Tryptophan, USP	C11H12N2O2
Valine, USP	C5H11NO2

Nonessential Amino Acids

Alanine, USP	C3H7NO2
Arginine, USP	C6H14N4O2
Histidine, USP	C6H9N3O2
Proline, USP	C5H9NO2
Serine, USP	C3H7NO3
Tyrosine, USP	C9H11NO3
Glycine, USP	C2H5NO2

The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly.

Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials.

Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period.

Aminosyn 10% - Clinical Pharmacology

Aminosyn 10% (pH 6), Sulfite-Free, (an amino acid injection) provides amino acids to promote protein synthesis and wound healing, and to reduce the rate of endogenous protein catabolism. Aminosyn 10% (pH 6), given by central venous infusion in combination with concentrated dextrose, electrolytes, vitamins, trace metals, and ancillary fat supplements, constitutes total parenteral nutrition (TPN). Aminosyn 10% (pH 6) can also be administered by peripheral vein with dextrose and maintenance electrolytes. Intravenous fat emulsion may be substituted for part of the carbohydrate calories during either TPN or peripheral vein administration of Aminosyn 10% (pH 6).

Indications and Usage for Aminosyn 10%

Aminosyn 10% (pH 6), Sulfite-Free, (an amino acid injection) infused with dextrose by peripheral vein infusion is indicated as a source of nitrogen in the nutritional support of patients with adequate stores of body fat, in whom, for short periods of time, oral nutrition cannot be tolerated, is undesirable, or inadequate.

SUPPLEMENTAL ELECTROLYTES, IN ACCORDANCE WITH THE PRESCRIPTION OF THE ATTENDING PHYSICIAN, MUST BE ADDED TO AMINOSYN SOLUTIONS WITHOUT ELECTROLYTES.

Aminosyn 10% (pH 6) can be administered peripherally with dilute (5% to 10%) dextrose solution and I.V. fat emulsion as a source of nutritional support in patients who, while not hypermetabolic, cannot be satisfactorily maintained on peripheral intravenous nutrition. This form of nutritional support can help to preserve protein and reduce catabolism in stress conditions where oral intake is inadequate.

When administered with concentrated dextrose solutions with or without fat emulsions, Aminosyn 10% (pH 6) is also indicated for central vein infusion to prevent or reverse negative nitrogen balance in patients where: (a) the alimentary tract, by the oral, gastrostomy or jejunostomy route cannot or should not be used; (b) gastrointestinal absorption of protein is impaired; (c) metabolic requirements for protein are substantially increased as with extensive burns and (d) morbidity and mortality may be reduced by replacing amino acids lost from tissue breakdown, thereby preserving tissue reserves, as in acute renal failure.

Contraindications

This preparation should not be used in patients with hepatic coma or metabolic disorders involving impaired nitrogen utilization.

Warnings

Intravenous infusion of amino acids may induce a rise in blood urea nitrogen (BUN), especially in patients with impaired hepatic or renal function. Appropriate laboratory tests should be performed periodically and infusion discontinued if BUN levels exceed normal postprandial limits and continue to rise. It should be noted that a modest rise in BUN normally occurs as a result of increased protein intake.

Administration of amino acid solutions to a patient with hepatic insufficiency may result in serum amino acid imbalances, metabolic alkalosis, prerenal azotemia, hyperammonemia, stupor and coma.

Administration of amino acid solutions in the presence of impaired renal function may augment an increasing BUN, as does any protein dietary component.

Solutions containing sodium ion should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency and in clinical states in which there exists edema with sodium retention.

Solutions which contain potassium ion should be used with great care, if at all, in patients with hyperkalemia, severe renal failure and in conditions in which potassium retention is present.

Solutions containing acetate ion should be used with great care in patients with metabolic or respiratory alkalosis. Acetate should be administered with great care in those conditions in which there is an increased level or an impaired utilization of this ion, such as severe hepatic insufficiency.

Hyperammonemia is of special significance in infants, as it can result in mental retardation. Therefore, it is essential that blood ammonia levels be measured frequently in infants.

Instances of asymptomatic hyperammonemia have been reported in patients without overt liver dysfunction. The mechanisms of this reaction are not clearly defined, but may involve genetic defects and immature or subclinically impaired liver function.

Aminosyn 10% (pH 6), Sulfite-Free, (an amino acid injection) can be infused simultaneously with fat emulsion by means of a Y-connector located near the infusion site using separate flow rate controls for each solution.

WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.

Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.

Precautions

Special care must be taken when administering glucose to provide calories in diabetic or prediabetic patients.

Do not withdraw venous blood for blood chemistries through the peripheral infusion site, as interference with estimations of nitrogen containing substances may occur.

Intravenous feeding regimens which include amino acids should be used with caution in patients with history of renal disease, pulmonary disease, or with cardiac insufficiency so as to avoid excessive fluid accumulation.

The effect of infusion of amino acids, without dextrose, upon carbohydrate metabolism of children is not known at this time.

Nitrogen intake should be carefully monitored in patients with impaired renal function. For long-term total nutrition, or if a patient has inadequate fat stores, it is essential to provide adequate exogenous calories concurrently with the amino acids. Concentrated dextrose solutions are an effective source of such calories. Such strongly hypertonic nutrient solutions should be administered through an indwelling intravenous catheter with the tip located in the superior vena cava.

SPECIAL PRECAUTIONS FOR CENTRAL VENOUS INFUSIONS ADMINISTRATION BY CENTRAL VENOUS CATHETER SHOULD BE USED ONLY BY THOSE FAMILIAR WITH THIS TECHNIQUE AND ITS COMPLICATIONS.

 

Central vein infusion (with added concentrated carbohydrate solutions) of amino acid solutions requires a knowledge of nutrition as well as clinical expertise in recognition and treatment of complications. Attention must be given to solution preparation, administration and patient monitoring. IT IS ESSENTIAL THAT A CAREFULLY PREPARED PROTOCOL BASED ON CURRENT MEDICAL PRACTICES BE FOLLOWED, PREFERABLY BY AN EXPERIENCED TEAM.

SUMMARY HIGHLIGHTS OF COMPLICATIONS (consult current medical literature.)

1. Technical

The placement of a central venous catheter should be regarded as a surgical procedure. One should be fully acquainted with various techniques of catheter insertion. For details of technique and placement sites, consult the medical literature. X-ray is the best means of verifying catheter placement. Complications known to occur from the placement of central venous catheters are pneumothorax, hemothorax, hydrothorax, artery puncture and transection, injury to the brachial plexus, malposition of the catheter, formation of arteriovenous fistula, phlebitis, thrombosis and air and catheter emboli.

2. Septic

The constant risk of sepsis is present during administration of total parenteral nutrition. It is imperative that the preparation of the solution and the placement and care of catheters be accomplished under strict aseptic conditions.

Solutions should ideally be prepared in the hospital pharmacy in a laminar flow hood using careful aseptic technique to avoid inadvertent touch contamination. Solutions should be used promptly after mixing. Storage should be under refrigeration and limited to a brief period of time, preferably less than 24 hours.

Administration time for a single container and set should never exceed 24 hours.

3. Metabolic

The following metabolic complications have been reported with TPN administration: metabolic acidosis and alkalosis, hypophosphatemia, hypocalcemia, osteoporosis, glycosuria, hyperglycemia, hyperosmolar nonketotic states and dehydration, rebound hypoglycemia, osmotic diuresis and dehydration, elevated liver enzymes, hypo- and hypervitaminosis, electrolyte imbalances and hyperammonemia in children. Frequent evaluations are necessary especially during the first few days of therapy to prevent or minimize these complications.

Administration of glucose at a rate exceeding the patient’s utilization rate may lead to hyperglycemia, coma and death.

Pregnancy Category C

Animal reproduction studies have not been conducted with Aminosyn 10% (pH 6), Sulfite-Free, (an amino acid injection). It is not known whether Aminosyn 10% (pH 6) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Aminosyn 10% (pH 6) should be given to a pregnant woman only if clearly needed.

Geriatric Use

Clinical studies of Aminosyn 10% (pH 6) have not been performed to determine whether patients over 65 years respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients. In general, dose selection for elderly patients should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal functions.

CLINICAL EVALUATION AND LABORATORY DETERMINATIONS, AT THE DISCRETION OF THE ATTENDING PHYSICIAN, ARE NECESSARY FOR PROPER MONITORING DURING ADMINISTRATION. Blood studies should include glucose, urea nitrogen, serum electrolytes, ammonia, cholesterol, acid-base balance, serum proteins, kidney and liver function tests, osmolarity and hemogram. White blood count and blood cultures are to be determined if indicated. Urinary osmolality and glucose should be determined as necessary.

Aminosyn 10% (pH 6) contains no more than 25 mcg/L of aluminum.

Drug Interactions

Because of its antianabolic activity, concurrent administration of tetracycline may reduce the potential anabolic effects of amino acids infused with dextrose as part of a parenteral feeding regimen.

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

Adverse Reactions

Peripheral Infusions

Aminosyn 10% (pH 6), Sulfite-Free, (an amino acid injection) is hypertonic and must be diluted prior to administration by peripheral vein. Local reactions consisting of a warm sensation, erythema, phlebitis and thrombosis at the infusion site have occurred with peripheral intravenous infusion of amino acids particularly if other substances, such as antibiotics, are also administered through the same site. In such cases the infusion site should be changed promptly to another vein. Use of large peripheral veins, inline filters, and slowing the rate of infusion may reduce the incidence of local venous irritation. Simultaneous administration of Aminosyn/dextrose admixtures with intravenous lipid emulsion may reduce the likelihood of peripheral vein irritation. Electrolyte additives should be spread throughout the day. Irritating additive medications may need to be injected at another venous site.

Generalized flushing, fever and nausea also have been reported during peripheral infusions of amino acid solutions.

Overdosage

In the event of overhydration or solute overload, re-evaluate the patient and institute appropriate corrective measures. See WARNINGS and PRECAUTIONS.

Aminosyn 10% Dosage and Administration

The total daily dose of the solution depends on the daily protein requirements and on the patient’s metabolic and clinical response. In many patients, provision of adequate calories in the form of hypertonic dextrose may require the administration of exogenous insulin to prevent hyperglycemia and glycosuria. To prevent rebound hypoglycemia, a solution containing 5% dextrose should be administered when hypertonic dextrose infusions are abruptly discontinued.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. COLOR VARIATION FROM PALE YELLOW TO YELLOW IS NORMAL AND DOES NOT ALTER EFFICACY.

1. Peripheral Vein Nutritional Maintenance

Aminosyn 10% (pH 6), Sulfite-Free, (an amino acid injection) may be diluted with 5% to 10% Dextrose Injection to achieve a final amino acid concentration of 3.5, 4.25 or 5% for peripheral administration.

For peripheral intravenous infusion, 1.0 to 1.5 g/kg/day of total amino acids will achieve optimal fat mobilization and reduce protein catabolism. Infusion or ingestion of carbohydrate or lipid will not reduce the nitrogen sparing effect of intravenous amino acid infusions at this dose.

As with all intravenous fluid therapy, the primary aim is to provide sufficient water to compensate for insensible, urinary and other (nasogastric suction, fistula drainage, diarrhea) fluid losses. Total fluid requirements, as well as electrolyte and acid-base needs, should be estimated and appropriately administered.

For an amino acid solution of specified total concentration, the volume required to meet amino acid requirements per 24 hours can be calculated. After making an estimate of the total daily fluid (water) requirement, the balance of fluid needed beyond the volume of amino acid solution required can be provided either as a noncarbohydrate or a carbohydrate-containing electrolyte solution. I.V. lipid emulsion may be substituted for part of the carbohydrate containing solution. Vitamins and additional electrolytes as needed for maintenance or to correct imbalances may be added to the amino acid solution.

If desired, only one-half of an estimated daily amino acid requirement of 1.5 g/kg can be given on the first day. Amino acids together with dextrose in concentrations of 5% to 10%, infused into a peripheral vein can be continued while oral nutrition is impaired. However, if a patient is unable to take oral nourishment for a prolonged period of time, institution of total parenteral nutrition with exogenous calories should be considered.

2. Central Vein Total Parenteral Nutrition

For central vein infusion with concentrated dextrose solution, alone or with I.V. lipid, the total daily dose of the amino acid solution depends upon daily protein requirements and the patient’s metabolic and clinical response. The determination of nitrogen balance and accurate daily body weights, corrected for fluid balance, are probably the best means of assessing individual protein requirements.

Adults

Diluted solutions containing 3.5 to 5% amino acids with 5 to 10% glucose may be coinfused with a fat emulsion by peripheral vein to provide approximately 1400 to 2000 kcal/day.

Aminosyn 10% (pH 6) solution should only be infused via a central vein when admixed with sufficient dextrose to provide full caloric requirements in patients who require prolonged total parenteral nutrition. I.V. lipid may be administered separately to provide part of the calories, if desired.

Total parenteral nutrition (TPN) may be started with 10% dextrose added to the calculated daily requirement of amino acids (1.5 g/kg for a metabolically stable patient). Dextrose content is gradually increased over the next few days to the estimated daily caloric need as the patient adapts to the increasing amounts of dextrose. Each gram of dextrose provides approximately 3.4 kcal. Each gram of fat provides 9 kcal.

The average depleted major surgical patient with complications requires between 2500 and 4000 kcal and between 12 and 24 grams of nitrogen per day. An adult patient in an acceptable weight range with restricted activity who is not hypermetabolic, requires about 30 kcal/kg of body weight/day. Average daily adult fluid requirements are between 2500 and 3000 mL and may be much higher with losses from fistula drainage or severe burns. Typically, a hospitalized patient may lose 12 to 18 grams of nitrogen a day, and in severe trauma the daily loss may be 20 to 25 grams or more.

Aminosyn solutions without electrolytes are intended for patients requiring individualized electrolyte therapy. Sodium, chloride, potassium, phosphate, calcium and magnesium are major electrolytes which should be added to Aminosyn as required.

SERUM ELECTROLYTES SHOULD BE MONITORED AS INDICATED. Electrolytes may be added to the nutrient solution as indicated by the patient’s clinical condition and laboratory determinations of plasma values. Major electrolytes are sodium, chloride, potassium, phosphate, magnesium and calcium. Vitamins, including folic acid and vitamin K are required additives. The trace element supplements should be given when long-term parenteral nutrition is undertaken.

Calcium and phosphorus are added to the solution as indicated. The usual dose of phosphate added to a liter of TPN solution (containing 25% dextrose) is 12mM. This requirement is related to the carbohydrate calories delivered. Iron is added to the solution or given intramuscularly in depot form as indicated. Vitamin B12, vitamin K and folic acid are given intramuscularly or added to the solution as desired.

Calcium and phosphate additives are potentially incompatible when added to the TPN admixture. However, if one additive is added to the amino acid container, and the other to the container of concentrated dextrose, and if the contents of both containers are swirled before they are combined, then the likelihood of physical incompatibility is reduced.

In patients with hyperchloremic or other metabolic acidosis, sodium and potassium may be added as the acetate or lactate salts to provide bicarbonate alternates.

In adults, hypertonic mixtures of amino acids and dextrose may be safely administered by continuous infusion through a central venous catheter with the tip located in the vena cava. Typically, the 10% solution is used in equal volume with 50% dextrose to provide an admixture containing 5% amino acids and 25% dextrose.

The rate of intravenous infusion initially should be 2 mL/min and may be increased gradually. If administration should fall behind schedule, no attempt to “catch up” to planned intake should be made. In addition to meeting protein needs, the rate of administration is governed by the patient’s glucose tolerance estimated by glucose levels in blood and urine.

Aminosyn 10% (pH 6) solution, when mixed with an appropriate volume of concentrated dextrose, offers a higher concentration of calories and nitrogen per unit volume. This solution is indicated for patients requiring larger amounts of nitrogen than could otherwise be provided or where total fluid load must be kept to a minimum, for example, patients with renal failure.

Provision of adequate calories in the form of hypertonic dextrose may require exogenous insulin to prevent hyperglycemia and glycosuria. To prevent rebound hypoglycemia, do not abruptly discontinue administration of nutritional solutions.

Pediatric

Pediatric requirements for parenteral nutrition are constrained by the greater relative fluid requirements of the infant and greater caloric requirements per kilogram. Amino acids are probably best administered in a 2.5% concentration. For most pediatric patients on intravenous nutrition, 2.5 grams amino acids/kg/day with dextrose alone or with I.V. lipid calories of 100 to 130 kcal/kg/day is recommended. In cases of malnutrition or stress, these requirements may be increased. It is acceptable in pediatrics to start with a nutritional solution of half strength at a rate of about 60 to 70 mL/kg/day. Within 24 to 48 hours the volume and concentration of the solution can be increased until the full strength pediatric solution (amino acids and dextrose) is given at a rate of 125 to 150 mL/kg/day.

Supplemental electrolytes and vitamin additives should be administered as deemed necessary by careful monitoring of blood chemistries and nutritional status. Addition of iron is more critical in the infant than the adult because of the increasing red cell mass required for the growing infant. Serum lipids should be monitored for evidence of essential fatty acid deficiency in patients maintained on fat-free TPN. Bicarbonate should not be administered during infusion of the nutritional solution unless deemed absolutely necessary.

To ensure the precise delivery of the small volumes of fluid necessary for total parenteral nutrition in infants, accurately calibrated and reliable infusion systems should be used.

A basic solution for pediatric use should contain 25 grams of amino acids and 200 to 250 grams of glucose per 1000 mL, administered from containers containing 500 mL or less. Such a solution given at the rate of 145 mL/kg/day provides 130 kcal/kg/day.

WARNING: Do not use flexible container in series connections.

How is Aminosyn 10% Supplied

NDC No.	Concentration	Container (mL)
0409-4192-05	Aminosyn 10% (pH 6), Sulfite-Free, (an amino acid injection)	1000

Store at 20 to 25ºC (68 to 77ºF). [See USP Controlled Room Temperature.] Protect from freezing. Avoid exposure to light until use.

Revised: June, 2008

Printed in USA                            EN - 1818

Hospira, Inc., Lake Forest, IL 60045 USA

IM-0298

AMINOSYN SULFITE FREE  isoleucine, leucine, lysine acetate, methionine, phenylalanine, threonine, tryptophan, valine, alanine, arginine, histidine, proline, serine, tyrosine, and glycine  injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0409-4192 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ISOLEUCINE (ISOLEUCINE) ISOLEUCINE 720 mg  in 100 mL LEUCINE (LEUCINE) LEUCINE 940 mg  in 100 mL LYSINE ACETATE (LYSINE) LYSINE 720 mg  in 100 mL METHIONINE (METHIONINE) METHIONINE 400 mg  in 100 mL PHENYLALANINE (PHENYLALANINE) PHENYLALANINE 440 mg  in 100 mL THREONINE (THREONINE) THREONINE 520 mg  in 100 mL TRYPTOPHAN (TRYPTOPHAN) TRYPTOPHAN 160 mg  in 100 mL VALINE (VALINE) VALINE 800 mg  in 100 mL ALANINE (ALANINE) ALANINE 1280 mg  in 100 mL ARGININE (ARGININE) ARGININE 980 mg  in 100 mL HISTIDINE (HISTIDINE) HISTIDINE 300 mg  in 100 mL PROLINE (PROLINE) PROLINE 860 mg  in 100 mL SERINE (SERINE) SERINE 420 mg  in 100 mL TYROSINE (TYROSINE) TYROSINE 44 mg  in 100 mL GLYCINE (GLYCINE) GLYCINE 1280 mg  in 100 mL

Inactive Ingredients Ingredient Name Strength ACETIC ACID

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0409-4192-05 6 POUCH In 1 CASE contains a POUCH 1 1 BAG In 1 POUCH This package is contained within the CASE (0409-4192-05) and contains a BAG 1 1000 mL In 1 BAG This package is contained within a POUCH and a CASE (0409-4192-05)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA017673	10/27/2011

Labeler - Hospira, Inc. (141588017)

Revised: 10/2011Hospira, Inc.

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Clarinex Reditabs Orally Disintegrating Tablets

Pronunciation: DES-lor-A-ta-deen
Generic Name: Desloratadine
Brand Name: Clarinex Reditabs

Clarinex Reditabs Orally Disintegrating Tablets are used for:

Treating allergy symptoms and chronic hives. It may also be used for other conditions as determined by your doctor.

Clarinex Reditabs Orally Disintegrating Tablets are an antihistamine. It works by blocking the action of histamine to relieve allergy symptoms, such as sneezing, runny nose, and itchy or watery eyes, and to relieve itching and rash due to chronic hives.

Do NOT use Clarinex Reditabs Orally Disintegrating Tablets if:

• you are allergic to any ingredient in Clarinex Reditabs Orally Disintegrating Tablets or to loratadine

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

Before using Clarinex Reditabs Orally Disintegrating Tablets:

Some medical conditions may interact with Clarinex Reditabs Orally Disintegrating Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, 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 have kidney or liver problems


• if you have phenylketonuria (PKU)

Some MEDICINES MAY INTERACT with Clarinex Reditabs Orally Disintegrating Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Amiodarone because the risk of fast or irregular heartbeat may be increased


• Other antihistamines (eg, diphenhydramine), azithromycin, cimetidine, erythromycin, fluoxetine, or ketoconazole because they may increase the risk of Clarinex Reditabs Orally Disintegrating Tablets's side effects

This may not be a complete list of all interactions that may occur. Ask your health care provider if Clarinex Reditabs Orally Disintegrating Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Clarinex Reditabs Orally Disintegrating Tablets:

Use Clarinex Reditabs Orally Disintegrating Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Clarinex Reditabs Orally Disintegrating Tablets. Talk to your pharmacist if you have questions about this information.


• Take Clarinex Reditabs Orally Disintegrating Tablets by mouth with or without food.


• Do not remove the blister from the outer pouch until you are ready to take Clarinex Reditabs Orally Disintegrating Tablets. Make sure that your hands are dry when you open the blister pack. Do not push the tablet through the foil. Peel back the foil on the blister pack and place the tablet on your tongue. The tablet dissolves quickly and can be swallowed with saliva. Clarinex Reditabs Orally Disintegrating Tablets may be taken with or without water. Take the tablet immediately after opening the blister pack. Do not store the removed tablet for future use.


• If you miss a dose of Clarinex Reditabs Orally Disintegrating Tablets and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Clarinex Reditabs Orally Disintegrating Tablets.

Important safety information:

• Clarinex Reditabs Orally Disintegrating Tablets may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Clarinex Reditabs Orally Disintegrating Tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Do not change your dose or take Clarinex Reditabs Orally Disintegrating Tablets more often than prescribed without checking with your doctor. Drowsiness may occur if you take more of Clarinex Reditabs Orally Disintegrating Tablets than prescribed.


• Some of these products contain phenylalanine. If you must have a diet that is low in phenylalanine, ask your pharmacist if it is in your product.


• Clarinex Reditabs Orally Disintegrating Tablets may interfere with skin allergy tests. If you are scheduled for a skin test, talk to your doctor. You may need to stop taking Clarinex Reditabs Orally Disintegrating Tablets for a few days before the tests.


• Clarinex Reditabs Orally Disintegrating Tablets should be used with extreme caution in CHILDREN younger than 6 years old; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Clarinex Reditabs Orally Disintegrating Tablets while you are pregnant. Clarinex Reditabs Orally Disintegrating Tablets are found in breast milk. Do not breast-feed while taking Clarinex Reditabs Orally Disintegrating Tablets.

Possible side effects of Clarinex Reditabs Orally Disintegrating Tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dizziness; drowsiness; dry mouth; menstrual pain; muscle pain; nausea; sore throat; tiredness; upset stomach.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue); dark urine; fast or irregular heartbeat; pale stools; seizures; 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: Clarinex Reditabs 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 drowsiness; fast or irregular heartbeat.

Proper storage of Clarinex Reditabs Orally Disintegrating Tablets:

Store Clarinex Reditabs Orally Disintegrating Tablets 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 Clarinex Reditabs Orally Disintegrating Tablets out of the reach of children and away from pets.

General information:

• If you have any questions about Clarinex Reditabs Orally Disintegrating Tablets, please talk with your doctor, pharmacist, or other health care provider.


• Clarinex Reditabs Orally Disintegrating Tablets are to be used only by the patient for whom it is prescribed. Do not share it with other people.


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


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

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

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Clarinex Reditabs resources

• Clarinex Reditabs Side Effects (in more detail)
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• Hay Fever
• Urticaria

Aczone topical

Generic Name: Dapsone topical
Class: Skin and Mucous Membrane Agents, Miscellaneous
ATC Class: D10AX05
Chemical Name: Diaminodiphenylsulfone
Molecular Formula: C₁₂H₁₂N₂O₂S
CAS Number: 80-08-0

Introduction

Synthetic sulfone^{1 2 3 5 18} with anti-infective and anti-inflammatory effects.^{2 3 5 18}

Uses for Aczone

Acne Vulgaris

Topical treatment of acne vulgaris.^{1 2 3 4 11}

Effective against inflammatory acne lesions and, to a lesser extent, noninflammatory acne lesions.^{2 3}

Aczone Dosage and Administration

Administration

Topical Administration

Administer topically to the skin as a 5% gel.¹

For external use only.¹ Do not use orally or intravaginally; avoid contact with the mouth and eyes.¹

Gently cleanse and dry the acne-affected area prior to application.¹ Apply a pea-sized amount of dapsone 5% gel in a thin layer; rub in gently and completely.¹

The gel is gritty with visible drug substance particles.¹ Wash hands after applying the gel.¹

Dosage

Pediatric Patients

Acne Vulgaris

Topical

Children ≥12 years of age: Apply a thin layer of dapsone 5% gel to cleansed affected area twice daily.¹

Reassess use of the drug if improvement does not occur after 12 weeks of treatment.¹

Has been used for up to 12 months in clinical studies.³

Adults

Acne Vulgaris

Topical

Apply a thin layer of dapsone 5% gel to the cleansed affected area twice daily.¹

Reassess use of the drug if improvement does not occur after 12 weeks of treatment.¹

Has been used for up to 12 months in clinical studies.³

Cautions for Aczone

Contraindications

• 
  

  Manufacturer states none known.¹

  
  

Warnings/Precautions

Sensitivity Reactions

Moderate erythema has been reported when topical dapsone 5% gel was evaluated in combined contact sensitization/irritation studies.¹ Pruritus,^{2 3 6} rash,³ and contact dermatitis⁶ were reported in some patients receiving the topical gel for treatment of acne vulgaris.

Oral dapsone has been associated with hypersensitivity reactions that include severe dermatologic reactions.^{1 7 16} (See Dermatologic Reactions under Cautions.) Hypersensitivity reactions reported with oral dapsone have also included fever, malaise, hepatitis, and hemolysis.¹⁰

Topical dapsone did not induce phototoxicity or photoallergy in human dermal safety studies.¹

Hematologic Effects

Oral dapsone has been associated with dose-related hemolysis and hemolytic anemia.^{1 14} Agranulocytosis also reported in patients receiving oral dapsone.^{1 9} Individuals with glucose-6-phosphate dehydrogenase (G6PD) deficiency are more prone to hemolysis when receiving certain drugs.¹ G6PD deficiency is most prevalent in populations of African, South Asian, Middle Eastern, and Mediterranean ancestry.¹

There were no reports of clinically relevant hemolysis or hemolytic anemia in clinical studies evaluating topical dapsone 5% gel in individuals with acne vulgaris, including individuals with G6PD deficiency.^{1 2 3 6} However, laboratory changes suggestive of hemolysis (slight decreases in hemoglobin) occurred in some individuals with G6PD deficiency using the topical gel.^{1 2 6}

If signs and symptoms suggestive of hemolytic anemia occur, discontinue topical dapsone therapy.¹

Because of the potential for hemolytic reactions, do not use topical dapsone 5% gel in individuals receiving oral dapsone or antimalarial agents.¹ (See Specific Drugs under Interactions.)

Concomitant use of topical dapsone 5% gel and co-trimoxazole may increase the risk of hemolysis in patients with G6PD deficiency.¹ (See Specific Drugs under Interactions.)

Peripheral Neuropathy

Oral dapsone has been associated with peripheral neuropathy (motor loss and muscle weakness).¹

Peripheral neuropathy was not reported in clinical studies evaluating topical dapsone 5% gel for the treatment of acne vulgaris.¹

Dermatologic Reactions

Oral dapsone has been associated with serious skin reactions, including toxic epidermal necrolysis, erythema multiforme, morbilliform and scarlatiniform reactions, bullous and exfoliative dermatitis, erythema nodosum, and urticaria.^{1 7}

Although erythema,¹ pruritus,^{2 3} and rash³ were reported in clinical studies evaluating topical dapsone 5% gel for the treatment of acne vulgaris, more severe dermatologic reactions were not reported.¹

Specific Populations

Pregnancy

Category C.¹

Oral dapsone has been associated with embryocidal effects in rats and rabbits when used in dosages approximately 800 and 500 times, respectively, the systemic exposure (based on AUC) observed in human females receiving the maximum recommended dosage of topical dapsone 5% gel.¹ These effects were probably secondary to maternal toxicity.¹

Use during pregnancy only if potential benefits outweigh potential risks to the fetus.¹

Lactation

Distributed into milk following oral administration.¹ Systemic absorption is low following topical application of dapsone 5% gel; however, because of the potential to cause adverse reactions in nursing infants, discontinue nursing or discontinue topical dapsone therapy.¹

Pediatric Use

Safety and efficacy not established in children <12 years of age.¹

Geriatric Use

Insufficient experience with topical dapsone 5% gel in geriatric patients ≥65 years of age to determine whether such individuals respond differently than younger individuals.¹

Common Adverse Effects

Local reactions at the application site (oiliness/peeling, dryness, erythema).^{1 2}

Interactions for Aczone

Although only small amounts of dapsone are absorbed systemically following topical application to skin, the possibility that drug interactions could occur should be considered.¹ Concomitant use of oral dapsone and certain drugs (e.g., rifampin, anticonvulsants, St. John's wort) may increase the formation of dapsone hydroxylamine, a dapsone metabolite associated with hemolysis.¹ In addition, concomitant use of oral dapsone and folic acid antagonists (e.g., pyrimethamine) may increase the likelihood of adverse hematologic effects.¹

Specific Drugs

Drug	Interaction	Comments
Antimalarial agents	Increased risk of hemolytic reactions if topical dapsone used concomitantly with antimalarial agents1	Do not use topical dapsone in patients receiving antimalarial agents1
Benzoyl peroxide	In vitro, combinations of topical dapsone 5% gel and topical benzoyl peroxide resulted in an orange discoloration17 Concomitant use of topical dapsone 5% gel and topical benzoyl peroxide in individuals with acne vulgaris may result in temporary local yellow or orange discoloration of the skin and facial hair;1 usually resolves in 4–57 days1
Co-trimoxazole	Concomitant use of topical dapsone 5% gel and oral co-trimoxazole results in increased systemic exposure to dapsone and dapsone metabolites; pharmacokinetics of co-trimoxazole not affected1 5 Possible increased risk of hemolysis in patients with G6PD deficiency1
Dapsone, oral	Increased risk of hemolytic reactions if oral and topical dapsone used concomitantly1	Do not use topical dapsone in patients receiving oral dapsone1

Aczone Pharmacokinetics

Absorption

Bioavailability

Absorbed systemically following topical application to skin.^{1 5}

In patients with acne vulgaris skin lesions, plasma concentrations of dapsone are detectable within 2 hours after the first dose of topical dapsone 5% gel.⁵

After topical application of dapsone 5% gel to acne vulgaris skin lesions on the face, upper back, shoulders, and/or upper chest (up to approximately 22.5% of total body surface area) twice daily for 14 days, mean peak plasma concentrations of the drug were 19.4 ng/mL and the median time to peak concentrations after a dose was 9 hours.⁵

In a long-term safety study of dapsone 5% gel, there was no evidence that systemic exposure increases over time.¹

Systemic exposure (AUC) following a 14-day regimen of dapsone 5% gel is 126 times lower than systemic exposure (AUC) following a single 100-mg dose of oral dapsone.⁵

Special Populations

Systemic dapsone exposure following topical application of dapsone 5% gel in children 12–15 years of age is similar to that reported in those ≥16 years of age.¹

Stability

Storage

Topical

Gel

20–25°C (may be exposed to 15–30°C).¹ Do not freeze.¹

ActionsActions

• 
  

  Synthetic sulfone^{1 2 3 5 18} with anti-infective and anti-inflammatory effects.^{3 5 18}

  
  


• 
  

  For dermatologic use, dapsone is commercially available in an aqueous gel base.¹

  
  


• 
  

  Mechanism of action in the treatment of acne vulgaris not known, but may result from a combination of both anti-inflammatory and anti-infective effects.^{1 2 3 18}

  
  


• 
  

  Dapsone exerts a variety of anti-inflammatory effects.^{2 3 18} The drug may inhibit myeloperoxidase- and hydrogen peroxide-based cytotoxic systems in neutrophils or may act as a scavenger of reactive oxygen species, thereby minimizing inflammation associated with generation of these reactive species.¹⁸

  
  


• 
  

  The anti-infective effects of dapsone involve inhibition of folic acid synthesis in susceptible organisms.¹⁸

  
  


• 
  

  In vitro, dapsone has some antibacterial activity against Propionibacterium acnes.¹⁸ It is not known whether topical dapsone therapy results in decreased susceptibility of P. acnes to other drugs used to treat acne.¹

  
  

Advice to Patients

• 
  

  Importance of using as directed by the clinician and only for condition prescribed.¹

  
  


• 
  

  Advise patient that topical dapsone is for external use only and should not be used orally or intravaginally; importance of avoiding contact with the mouth and eyes.¹

  
  


• 
  

  Importance of storing at room temperature and protecting the drug from freezing.¹

  
  


• 
  

  Importance of informing clinician of glucose-6-phosphate dehydrogenase (G6PD) deficiency.¹

  
  


• 
  

  Importance of reporting any signs of adverse reactions to a clinician.¹

  
  


• 
  

  Importance of informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs, especially topical agents applied to the skin (e.g., preparations containing benzoyl peroxide).¹

  
  


• 
  

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

  
  


• 
  

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

  
  

Preparations

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

Dapsone

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Topical	Gel	5%	Aczone	Allergan

Disclaimer

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

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

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions July 2010. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

1. Allergan. Aczone (dapsone) gel 5% prescribing information. Irvine, CA. 2009 Mar.

2. Draelos ZD, Carter E, Maloney JM et al. Two randomized studies demonstrate the efficacy and safety of dapsone gel, 5% for the treatment of acne vulgaris. J Am Acad Dermatol. 2007; 56:439.e1-10.

3. Lucky AW, Maloney JM, Roberts J et al. Dapsone gel 5% for the treatment of acne vulgaris: safety and efficacy of long-term (1 year) treatment. J Drugs Dermatol. 2007; 6:981-7. [PubMed 17966175]

4. Raimer S, Maloney JM, Bourcier M et al. Efficacy and safety of dapsone gel 5% for the treatment of acne vulgaris in adolescents. Cutis. 2008; 81:171-8. [PubMed 18441772]

5. Thiboutot DM, Willmer J, Sharata H et al. Pharmacokinetics of dapsone gel, 5% for the treatment of acne vulgaris. Clin Pharmacokinet. 2007; 46:697-712. [PubMed 17655376]

6. Piette WW, Taylor S, Pariser D et al. Hematologic safety of dapsone gel, 5%, for topical treatment of acne vulgaris. Arch Dermatol. 2008; 144:1564-70. [PubMed 19075138]

7. Agrawal S, Agarwalla A. Dapsone hypersensitivity syndrome: a clinico-epidemiological review. J Dermatol. 2005; 32:883-9. [PubMed 16361748]

9. Coleman MD. Dapsone-mediated agranulocytosis: risks, possible mechanisms and prevention. Toxicology. 2001; 162:53-60. [PubMed 11311458]

10. Corp CC, Ghishan FK. The sulfone syndrome complicated by pancreatitis and pleural effusion in an adolescent receiving dapsone for treatment of acne vulgaris. J Pediatr Gastroenterol Nutr. 1998; 26:103-5. [PubMed 9443128]

11. Del Rosso JQ. Newer topical therapies for the treatment of acne vulgaris. Cutis. 2007; 80:400-10. [PubMed 18189027]

14. Ismail R. Acne fulminans with dapsone induced haemolysis: a case report. Med J Malaysia. 1987; 42:124-6. [PubMed 2971861]

16. Tomecki KJ, Catalano CJ. Dapsone hypersensitivity. The sulfone syndrome revisited. Arch Dermatol. 1981; 117:38-9. [PubMed 6450569]

17. Dubina MI, Fleischer AB. Interaction of topical sulfacetamide and topical dapsone with benzoyl peroxide. Arch Dermatol. 2009; 145:1027-9. [PubMed 19770443]

18. Center for Drug Evaluation and Research. Microbiology review of NDA application 21-794. 2005 Jun 20.

More Aczone topical resources

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

Compare Aczone topical with other medications

• Acne

Glucophage XR

Generic Name: metformin (Oral route)

met-FOR-min hye-droe-KLOR-ide

Oral route(Tablet;Tablet, Extended Release;Solution)

Fortamet(R), Glucophage(R), Glucophage XR(R), Riomet(R): Lactic acidosis is a rare, but serious, metabolic complication that can occur due to metformin accumulation during treatment with metformin hydrochloride; when it occurs, it is fatal in approximately 50% of cases. Lactic acidosis may also occur in association with pathophysiologic conditions, including diabetes mellitus, characterized by significant tissue hypoperfusion and hypoxemia. The risk of lactic acidosis increases with renal impairment, increased age, congestive heart failure, and hepatic insufficiency. Treatment with metformin should not be initiated in patients 80 years old or older, unless measurement of creatinine clearance demonstrates that renal function is normal. Therapy should temporarily be discontinued prior to any intravascular radiocontrast study or surgical procedure. Excessive alcohol use should be avoided, because alcohol potentiates the effects of metformin on lactate metabolism. Discontinue therapy immediately and institute supportive measures promptly for suspected lactic acidosis .

Oral route(Tablet, Extended Release)

Glumetza(R): Lactic acidosis is a rare, but serious, complication that can occur due to metformin accumulation. The risk of lactic acidosis increases with renal or hepatic impairment, acute congestive heart failure, sepsis, dehydration, and excess alcohol intake. Onset may be subtle and include nonspecific symptoms such as malaise, myalgia, respiratory distress, somnolence, and abdominal distress; laboratory abnormalities include low pH, increased anion gap and elevated blood lactate. If lactic acidosis is suspected, Glumetza(R) should be discontinued and the patient immediately hospitalized .

Commonly used brand name(s)

In the U.S.

• Fortamet


• Glucophage


• Glucophage XR


• Glumetza


• Riomet

Available Dosage Forms:

• Tablet


• Tablet, Extended Release


• Solution

Therapeutic Class: Hypoglycemic

Chemical Class: Metformin

Uses For Glucophage XR

Metformin is used to treat high blood sugar levels that are caused by a type of diabetes mellitus or sugar diabetes called type 2 diabetes. With this type of diabetes, insulin produced by the pancreas is not able to get sugar into the cells of the body where it can work properly. Using metformin alone, with a type of oral antidiabetic medicine called a sulfonylurea, or with insulin, will help to lower blood sugar when it is too high and help restore the way you use food to make energy.

Many people can control type 2 diabetes with diet and exercise. Following a specially planned diet and exercise will always be important when you have diabetes, even when you are taking medicines. To work properly, the amount of metformin you take must be balanced against the amount and type of food you eat and the amount of exercise you do. If you change your diet or exercise, you will want to test your blood sugar to find out if it is too low. Your doctor will teach you what to do if this happens.

Metformin does not help patients does not help patients who have insulin-dependent or type 1 diabetes because they cannot produce insulin from their pancreas gland. Their blood glucose is best controlled by insulin injections.

This medicine is available only with your doctor's prescription.

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

• Polycystic ovary syndrome.

Before Using Glucophage XR

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

Allergies

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

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of metformin oral solution and tablets in children 10 to 16 years of age. However, safety and efficacy of metformin extended-release tablets in the pediatric population have not been established.

Geriatric

Although appropriate studies on the relationship of age to the effects of metformin have not been performed in the geriatric population, geriatric-specific problems are not expected to limit the usefulness of metformin in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution in patients receiving metformin. This medicine is not recommended in patients 80 years of age and older who have kidney problems.

Pregnancy

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

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Acetrizoic Acid


• Diatrizoate


• Ethiodized Oil


• Iobenzamic Acid


• Iobitridol


• Iocarmic Acid


• Iocetamic Acid


• Iodamide


• Iodipamide


• Iodixanol


• Iodohippuric Acid


• Iodopyracet


• Iodoxamic Acid


• Ioglicic Acid


• Ioglycamic Acid


• Iohexol


• Iomeprol


• Iopamidol


• Iopanoic Acid


• Iopentol


• Iophendylate


• Iopromide


• Iopronic Acid


• Ioseric Acid


• Iosimide


• Iotasul


• Iothalamate


• Iotrolan


• Iotroxic Acid


• Ioversol


• Ioxaglate


• Ioxitalamic Acid


• Ipodate


• Metrizamide


• Metrizoic Acid


• Tyropanoate Sodium

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

• Acetazolamide


• Alatrofloxacin


• Balofloxacin


• Cimetidine


• Ciprofloxacin


• Clinafloxacin


• Dichlorphenamide


• Dofetilide


• Enoxacin


• Fleroxacin


• Flumequine


• Gatifloxacin


• Gemifloxacin


• Grepafloxacin


• Levofloxacin


• Lomefloxacin


• Moxifloxacin


• Norfloxacin


• Ofloxacin


• Pefloxacin


• Prulifloxacin


• Rufloxacin


• Sparfloxacin


• Temafloxacin


• Topiramate


• Tosufloxacin


• Trovafloxacin Mesylate


• Zonisamide

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

• Acebutolol


• Alprenolol


• Atenolol


• Betaxolol


• Bevantolol


• Bisoprolol


• Bitter Melon


• Bucindolol


• Carteolol


• Carvedilol


• Celiprolol


• Cephalexin


• Clorgyline


• Dilevalol


• Enalaprilat


• Enalapril Maleate


• Esmolol


• Fenugreek


• Glucomannan


• Guar Gum


• Iproniazid


• Isocarboxazid


• Labetalol


• Levobunolol


• Mepindolol


• Metipranolol


• Metoprolol


• Moclobemide


• Nadolol


• Nebivolol


• Nialamide


• Oxprenolol


• Pargyline


• Penbutolol


• Phenelzine


• Pindolol


• Procarbazine


• Propranolol


• Psyllium


• Rifampin


• Selegiline


• Sotalol


• Talinolol


• Tertatolol


• Timolol


• Toloxatone


• Tranylcypromine


• Trospium

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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other Medical Problems

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

• Alcohol, excessive use or


• Underactive adrenal glands or


• Underactive pituitary gland or


• Undernourished condition or


• Weakened physical condition or


• Any other condition that causes low blood sugar—Patients with these conditions may be more likely to develop low blood sugar while taking metformin.

• Anemia (low levels of red blood cells) or


• Vitamin B12 deficiency—Use with caution. May make these conditions worse.

• Congestive heart failure, acute or unstable or


• Dehydration or


• Heart attack, acute or


• Hypoxemia (decreased oxygen in the blood) or


• Kidney disease or


• Liver disease or


• Sepsis (blood poisoning) or


• Shock (low blood pressure, blood circulation is poor)—A rare condition called lactic acidosis can occur. Talk with your doctor if you have concerns about this.

• Diabetic ketoacidosis (ketones in the blood) or


• Kidney disease, severe or


• Metabolic acidosis (extra acids in the blood) or


• Type 1 diabetes—Should not be used in patients with these conditions.

• Fever or


• Infection or


• Surgery or


• Trauma—These conditions may cause temporary problems with blood sugar control and your doctor may want to treat you with insulin.

Proper Use of metformin

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

This medicine usually comes with a patient information insert. Read the information carefully and make sure you understand it before taking this medicine. If you have any questions, ask your doctor.

Carefully follow the special meal plan your doctor gave you. This is a very important part of controlling your condition, and is necessary if the medicine is to work properly. Also, exercise regularly and test for sugar in your blood or urine as directed.

Metformin should be taken with meals to help reduce stomach or bowel side effects that may occur during the first few weeks of treatment.

Swallow the extended-release tablet whole with a full glass of water. Do not crush, break, or chew it.

While taking the extended-release tablet, part of the tablet may pass into your stool after your body has absorbed the medicine. This is normal and nothing to worry about.

Measure the oral liquid with a marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid.

Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way.

You may notice improvement in your blood glucose control in 1 to 2 weeks, but the full effect of blood glucose control may take up to 2 to 3 months. Ask your doctor if you have any questions about this.

Dosing

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

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For type 2 diabetes:
  
  • For oral dosage form (extended-release tablets):
    
    • Adults—
      
      • Metformin alone (Fortamet®): At first, 1000 milligrams (mg) once a day taken with the evening meal. Your doctor may increase your dose if needed until your blood sugar is controlled. However, the dose is usually not more than 2500 mg per day.
      
      
      • Metformin alone (Glucophage® XR): At first, 500 mg once daily with the evening meal. Your doctor may increase your dose if needed until your blood sugar is controlled. However, the dose is usually not more than 2000 mg per day.
      
      
      • Metformin alone (Glumetza®): At first, 500 mg once a day taken with the evening meal. Then, your doctor may increase your dose if needed until your blood sugar is controlled. However, the dose is usually not more than 2000 mg per day.
      
      
      • Metformin with a sulfonylurea: Your doctor will determine the dose of each medicine.
      
      
      • Metformin with insulin: At first, 500 mg once a day. Then, your doctor may increase your dose by 500 mg every week if needed until your blood sugar is controlled. However, the dose is usually not more than 2500 mg per day.
      
      
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For oral dosage form (solution):
    
    • Adults—
      
      • Metformin alone: At first, 5 milliliters (mL) two times a day, or 8.5 mL once a day with meals. Your doctor may increase your dose if needed until your blood sugar is controlled. However, the dose is usually not more than 25.5 mL per day.
      
      
      • Metformin with a sulfonylurea: Your doctor will determine the dose of each medicine.
      
      
      • Metformin with insulin: At first, 5 mL once a day. Your doctor may increase your dose if needed until your blood sugar is controlled. However, the dose is usually not more than 25 mL per day.
      
      
    
    
    • Children 10 to 16 years of age—At first, 5 mL two times a day with meals. Your doctor may increase your dose if needed until your blood sugar is controlled. However, the dose is usually not more than 20 mL per day.
    
    
    • Children younger than 10 years of age—Use and dose must be determined by your doctor.
    
    
  
  
  • For oral dosage form (tablets):
    
    • Adults—
      
      • Metformin alone: At first, 500 milligrams (mg) two times a day taken with the morning and evening meals, or 850 mg a day taken with the morning meal. Your doctor may increase your dose if needed until your blood sugar is controlled. Later, your doctor may want you to take 500 or 850 mg two to three times a day with meals. However, the dose is usually not more than 2550 mg per day.
      
      
      • Metformin with a sulfonylurea: Your doctor will determine the dose of each medicine.
      
      
      • Metformin with insulin: At first, 500 mg a day. Your doctor may increase your dose by 500 mg every week if needed until your blood sugar is controlled. However, the dose is usually not more than 2500 mg per day.
      
      
    
    
    • Children 10 to 16 years of age—At first, 500 mg two times a day taken with the morning and evening meals. Your doctor may increase your dose if needed until your blood sugar is controlled. However, the dose is usually not more than 2000 mg per day.
    
    
    • Children younger than 10 years of age—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

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

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Glucophage XR

It is very important that your doctor check your progress at regular visits, especially during the first few weeks that you take this medicine. Blood and urine tests may be needed to check for unwanted effects.

This medicine may interact with the dye used for an X-ray or CT scan. Your doctor should advise you to stop taking it before you have any medical exams or diagnostic tests that might cause less urine output than usual. You may be advised to start taking the medicine again 48 hours after the exams or tests if your kidney function is tested and found to be normal.

Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several days before having surgery or medical tests.

It is very important to carefully follow any instructions from your health care team about:

• Alcohol—Drinking alcohol may cause severe low blood sugar. Discuss this with your health care team.


• Other medicines—Do not take other medicines unless they have been discussed with your doctor. This especially includes nonprescription medicines such as aspirin, and medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems.


• Counseling—Other family members need to learn how to prevent side effects or help with side effects if they occur. Also, patients with diabetes may need special counseling about diabetes medicine dosing changes that might occur with lifestyle changes, such as changes in exercise or diet. Counseling on birth control and pregnancy may be needed because of the problems that can occur in pregnancy for patients with diabetes.


• Travel—Keep a recent prescription and your medical history with you. Be prepared for an emergency as you would normally. Make allowances for changing time zones and keep your meal times as close as possible to your usual meal times.


• In case of emergency—There may be a time when you need emergency help for a problem caused by your diabetes. You need to be prepared for these emergencies. It is a good idea to wear a medical identification (ID) bracelet or neck chain at all times. Also, carry an ID card in your wallet or purse that says that you have diabetes and a list of all of your medicines.

Under certain conditions, too much metformin can cause lactic acidosis. The symptoms of lactic acidosis are severe and quick to appear, and usually occur when other health problems not related to the medicine are present and are very severe, such as a heart attack or kidney failure. Symptoms of lactic acidosis include abdominal or stomach discomfort, decreased appetite; diarrhea; fast or shallow breathing; a general feeling of discomfort; severe muscle pain or cramping; and unusual sleepiness, tiredness, or weakness.

If symptoms of lactic acidosis occur, you should get immediate emergency medical help.

Metformin can cause low blood sugar (hypoglycemia). However, this can also occur if you delay or miss a meal or snack, drink alcohol, exercise more than usual, cannot eat because of nausea or vomiting, take certain medicines, or take metformin with another type of diabetes medicine. The symptoms of low blood sugar must be treated before they lead to unconsciousness (passing out). Different people feel different symptoms of low blood sugar. It is important that you learn which symptoms of low blood sugar you usually have so that you can treat it quickly.

Symptoms of hypoglycemia (low blood sugar) include anxiety; behavior change similar to being drunk; blurred vision; cold sweats; confusion; cool, pale skin; difficulty with thinking; drowsiness; excessive hunger; fast heartbeat; headache (continuing); nausea; nervousness; nightmares; restless sleep; shakiness; slurred speech; or unusual tiredness or weakness.

If symptoms of low blood sugar occur, eat glucose tablets or gel, corn syrup, honey, or sugar cubes; or drink fruit juice, non-diet soft drink, or sugar dissolved in water. Also, check your blood for low blood sugar. Glucagon is used in emergency situations when severe symptoms such as seizures (convulsions) or unconsciousness occur. Have a glucagon kit available, along with a syringe or needle, and know how to use it. The members of your household also should know how to use it.

High blood sugar (hyperglycemia) is another problem related to uncontrolled diabetes. Symptoms of mild high blood sugar appear more slowly than those of low blood sugar. These may include blurred vision; drowsiness; dry mouth; flushed, dry skin; fruit-like breath odor; increased urination (frequency and volume); ketones in the urine; loss of appetite; sleepiness; stomachache, nausea or vomiting; tiredness; troubled breathing (rapid and deep); unconsciousness; or unusual thirst.

High blood sugar may occur if you do not exercise as much as usual, have a fever or infection, do not take enough or skip a dose of your diabetes medicine, or overeat or do not follow your meal plan.

If symptoms of high blood sugar occur, check your blood sugar level and then call your doctor for instructions.

This medicine is only part of a complete program for controlling diabetes. It is important that you always eat a healthy diet, watch your weight, and get regular exercise.

Glucophage XR Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Abdominal or stomach discomfort


• cough or hoarseness


• decreased appetite


• diarrhea


• fast or shallow breathing


• fever or chills


• general feeling of discomfort


• lower back or side pain


• muscle pain or cramping


• painful or difficult urination


• sleepiness

Less common

• Anxiety


• blurred vision


• chest discomfort


• cold sweats


• coma


• confusion


• cool, pale skin


• depression


• difficult or labored breathing


• dizziness


• fast, irregular, pounding, or racing heartbeat or pulse


• feeling of warmth


• headache


• increased hunger


• increased sweating


• nausea


• nervousness


• nightmares


• redness of the face, neck, arms, and occasionally, upper chest


• seizures


• shakiness


• shortness of breath


• slurred speech


• tightness in the chest


• unusual tiredness or weakness


• wheezing

Rare

• Behavior change similar to being drunk


• difficulty with concentrating


• drowsiness


• lack or loss of strength


• restless sleep


• unusual sleepiness

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

• Acid or sour stomach


• belching


• bloated


• excess air or gas in the stomach or intestines


• full feeling


• heartburn


• indigestion


• loss of appetite


• metallic taste in the mouth


• passing of gas


• stomachache


• stomach upset or pain


• vomiting


• weight loss

Less common

• Abnormal stools


• bad, unusual, or unpleasant (after) taste


• change in taste


• difficulty with moving


• discoloration of the fingernails or toenails


• flu-like symptoms


• joint pain


• rash


• runny nose


• sneezing


• stuffy nose


• swollen joints

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Glucophage XR side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Glucophage XR resources

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

• Glucophage XR Prescribing Information (FDA)


• Glucophage XR Extended-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Fortamet Prescribing Information (FDA)


• Glucophage Consumer Overview


• Glucophage Prescribing Information (FDA)


• Glucophage MedFacts Consumer Leaflet (Wolters Kluwer)


• Glumetza Prescribing Information (FDA)


• Metformin Prescribing Information (FDA)


• Metformin Hydrochloride Monograph (AHFS DI)


• Riomet Prescribing Information (FDA)


• Riomet Consumer Overview


• Riomet Solution MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Glucophage XR with other medications

• Diabetes, Type 2
• Insulin Resistance Syndrome

Altafrin Drops

Pronunciation: fen-il-EF-rin
Generic Name: Phenylephrine
Brand Name: Generic only. No brands available.

Altafrin Drops are used for:

Relieving eye redness and dryness due to minor eye irritation. It may also be used for other conditions as determined by your doctor.

Altafrin Drops are a decongestant. It works by constricting blood vessels in the eye, which helps relieve redness.

Do NOT use Altafrin Drops if:

• you are allergic to any ingredient in Altafrin Drops


• you are taking droxidopa or you have taken furazolidone or a monoamine oxidase (MAO) inhibitor (eg, phenelzine) in the last 14 days

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

Before using Altafrin Drops:

Some medical conditions may interact with Altafrin Drops. 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 have heart disease, glaucoma, high blood pressure, or an overactive thyroid

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

• Droxidopa, furazolidone, or MAO inhibitors (eg, phenelzine) because the risk of serious side effects, such as high blood pressure and irregular heartbeat, may be increased

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

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

• Altafrin Drops are for use in the eye only. Avoid contact with other mucous membranes.


• To use Altafrin Drops, first, wash your hands. Tilt your head back. Using your index finger, pull the lower eyelid away from the eye to form a pouch. Drop the medicine into the pouch and gently close your eyes. Immediately use your finger to apply pressure to the inside corner of the eye for 1 to 2 minutes. Do not blink. Remove excess medicine around your eye with a clean tissue, being careful not to touch your eye. Wash your hands to remove any medicine that may be on them.


• To prevent germs from contaminating your medicine, do not touch the applicator tip to any surface, including your eye. Keep the container tightly closed.


• Contact your doctor for instructions on using your contact lenses while using Altafrin Drops.


• If you miss a dose of Altafrin Drops, 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 take 2 doses at once.

Ask your health care provider any questions you may have about how to use Altafrin Drops.

Important safety information:

• Do not use Altafrin Drops for more than 3 days unless instructed otherwise by your doctor.


• Do not use Altafrin Drops if it is brown or contains particles.


• Altafrin Drops are not recommended for use in CHILDREN younger than 6 years of age. Safety and effectiveness in this age group have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Altafrin Drops during pregnancy. It is unknown if Altafrin Drops are excreted in breast milk. If you are or will be breast-feeding while you are using Altafrin Drops, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Altafrin Drops:

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:

Burning or stinging of the eye.

Seek medical attention right away if any of these SEVERE side effects occur:

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

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: Altafrin 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.

Proper storage of Altafrin Drops:

Store Altafrin Drops at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Altafrin Drops out of the reach of children and away from pets.

General information:

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


• Altafrin Drops are to be used only by the patient for whom it is prescribed. Do not share it with other people.


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


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

This information is a summary only. It does not contain all information about Altafrin Drops. 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 Altafrin resources

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

Compare Altafrin with other medications

• Eye Dryness/Redness
• Eye Redness/Itching
• Pupillary Dilation