Salicylic Acid Foam

Salicylic Acid

Salicylic Acid Foam Description

Salicylic Acid 6% Emollient Foam is a keratolytic that contains 6% salicylic acid USP incorporated into an aqueous based ammonium lactate vehicle. Each gram of Salicylic Acid 6% Emollient Foam contains 6% w/w salicylic acid USP, aloe, ammonium lactate, ceteth-10 phosphate, ceteth-20 phosphate, cetostearyl alcohol NF, dicetyl phosphate, dl alpha tocopheryl acetate USP, edetate disodium dihydrate USP, glycerin USP, methylparaben NF, propylene glycol USP, propylparaben NF, purified water USP, sodium hydroxide NF, white petrolatum USP.

Also contains: Propellant HFA-134a(1,1,1,2-tetrafluo-roethane).

Salicylic Acid USP is the 2-hydroxy derivative of benzoic acid having the following Structure:

Salicylic Acid Foam - Clinical Pharmacology

Salicylic acid has been shown to produce desquamation of the horny layer of skin while not effecting qualitative or quantitative changes in the structure of the viable epidermis.1,2 The meachanism of action has been attributed to a dissolution of intercellular cement substance.3 In a study of the percutaneous absorption of salicylic acid in a 6% salicylic acid gel in four patients with extensive active psoriasis, Taylor and Halprin4 showed that the peak serum salicylate levels never exceeded 5 mg/100 ml even though more than 60% of the applied salicylic acid was absorbed. Systemic toxic reactions are usually associated with much higher serum levels (30 to 40 mg/100 ml). Peak serum levels occurred within five hours of the topical application under occlusion. The sites were occluded for 10 hours over the entire body surface below the neck. Since salicylates are distributed in the extracellular space, patients with a contracted extracellular space due to dehydration or diuretics have higher salicylate levels than those with a normal extracellular space.5 (See PRECAUTIONS.)

The major metabolites identified in the urine after topical administration are salicyluric acid (52%), salicylate glucuronides (42%) and free salicylic acid (6%).4 The urinary metabolites after percutaneous absorption differ from those after oral salicylate administration; those derived from percutaneous absorption contain more salicylate glucuronides and less salicyluric and salicylic acid. Almost 95% of a single dose of salicylate is excreted within 24 hours of its entrance into the extracellular space.5

Fifty to eighty percent of salicylate is protein bound to albumin. Salicylates compete with the binding of several drugs and can modify the action of these drugs; by similar competitive mechanisms other drugs can influence the serum levels of salicylate.5 (See WARNINGS.) Ammonium lactate, a salt of lactic acid, is a powerful humectant with exfoliating properties.

Indications and Usage for Salicylic Acid Foam

For Dermatologic Use: Salicylic Acid 6% Emollient Foam is a topical aid in the removal of excessive keratin in hyperkeratotic skin disorders, including verrucae, and the various ichthyoses (vulgaris, sex-linked and lamellar), keratosis palmaris and plantaris, keratosis pilaris, pityriasis rubra pilaris, and psoriasis (including body, scalp, palms and soles).

For Podiatric Use: Salicylic Acid 6% Emollient Foam is a topical aid in the removal of excessive keratin on dorsal and plantar hyperkeratotic lesions. Topical preparations of 6% salicylic acid have been reported to be useful adjunctive therapy for verrucae plantares.

Contraindications

Salicylic Acid 6% Emollient Foam should not be used in any patient known to be sensitive to salicylic acid or any other listed ingredient. Salicylic Acid 6% Emollient Foam should not be used in children under 2 years of age.

Warnings

Prolonged and repeated daily use over large areas, especially in children and those patients with significant renal or hepatic impairment, could result in salicylism. Excessive application of the product other than is needed to cover the affected area will not result in a more rapid therapeutic benefit. Concomitant use of others drugs which may contribute to elevated serum salicylate levels should be avoided where the potential for toxicity is present. In children under 12 years of age and those patients with renal or hepatic impairment, the area to be treated should be limited and the patient monitored closely for signs of salicylate toxicity: nausea, vomiting, dizziness, loss of hearing, tinnitus, lethargy, hyperpnea, diarrhea, and psychic disturbances. In the event of salicylic acid toxicity, the use of Salicylic Acid 6% Emollient Foam should be discontinued. Fluids should be administered to promote urinary excretion. Treatment with sodium bicarbonate (oral or intravenous) should be instituted as appropriate. Patients should be cautioned against the use of oral aspirin and other salicylate containing medications, such as sports injury creams, to avoid additional excessive exposure to salicylic acid. Where needed, aspirin  should be replaced by an alternative non-steroidal anti-inflammatory agent that is not salicylate based.

Due to potential risk of developing Reye's syndrome, salicylate products should not be used in children and teenagers with varicella or influenza, unless directed by a physician.

Keep out of the reach of children. Contents under pressure. Do not puncture or incinerate container. Do not expose to temperatures above 120°F (49°C).

FOR DERMATOLOGICAL USE ONLY. NOT FOR OPTHALMIC, ORAL OR INTRAVAGINAL USE.

Precautions

For EXTERNAL USE ONLY. Avoid contact with eyes and other mucous membranes. Mild burning or stinging may occur. Peeling of the skin may increase as the salicylic acid works to loosen excessive keratin. If excessive burning, stinging or peeling occurs, discontinue use and consult your physician. Keep this and all medications out of reach of children.

Drug Interactions

The following interactions are from a published review5 and include reports concerning both oral and topical salicylate administration. The relationship of these interactions to the use of Salicylic Acid 6% Emollient Foam is not known. 

I. Due to the competition of salicylate with other drugs for binding to serum albumin the following drug interactions may occur:

DRUG	DESCRIPTION OF INTERACTION
Tolbutamide; Sulfonylureas	Hypoglycemia potentiated.
Methotrexate	Decreases tubular reabsorption; clinical toxicity from  methotrexate can result.
Oral Anticoagulants	Increased bleeding.

II. Drugs changing salicylate levels by altering renal tubular reabsorption:

DRUG	DESCRIPTION OF INTERACTION
Corticosteroids	Decreases plasma salicylate level; tapering doses of  steroids may promote salicylism.
Acidifying Agents	Increases plasma salicylate level.
Alkanizing Agents	Decreased plasma salicylate levels.

III. Drugs with complicated interactions with salicylates:

DRUG	DESCRIPTION OF INTERACTION
Heparin	Salicylate decreases platelet adhesiveness and interferes  with hemostasis in heparin treated patients.
Pyrazinamide	Inhibits pyrazinamide induced hyperuricemia.
Uricosuric Agents	Effect of probenemide, sulfinpyrazone and phenylbultazone  inhibited.

The following alterations of laboratory tests have been reported during salicylate therapy6: 

LABORATORY TESTS	EFFECT OF SALICYLATES
Thyroid Function	Decreased PBI; increased T3 uptake.
Urinary Sugar	False negative with glucose oxidase; False positive with  Clinitest with high-dose salicylate therapy (2-5g q.d.).
5-Hydroxyindole acetic acid	False negative with fluorometric test.
Acetone ketone bodies	False positive FeCl3 in Gerhardt reaction; red color  persists with boiling.
17-OH corticosteroids	False reduced values with >4.8g q.d. Salicylate.
Vanilmandelic acid	False reduced values.
Uric acid	May increase or decrease depending on dose.
Prothrombin	Decreased levels; slightly increased prothrombin time.

PREGNANCY (Category C)

Salicylic acid has been shown to be teratogenic in rats and monkeys. It is difficult to extrapolate from oral doses of acetylsalicylic acid used in these studies to topical administration as the oral dose to monkeys may represent six times the maximal daily human dose of salicylic acid when applied topically over a large body surface. There are no adequate and well-controlled studies in pregnant women. Salicylic Acid 6% Emollient Foam should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

Because of the potential for serious adverse reactions in nursing infants from the mother's use of Salicylic Acid 6% Emollient Foam, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. If used by nursing mothers, it should not be used on the chest area to avoid the accidental contamination of the child.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No data are available concerning potential carcinogenic or reproductive effects of Salicylic Acid 6% Emollient Foam. Salicylic acid has been shown to lack mutagenic potential in the Ames Salmonella test.

Adverse Reactions

Excessive erythema and scaling conceivably could result from use on open skin lesions.

Overdosage

See Warnings.

Salicylic Acid Foam Dosage and Administration

Important: Prime Can Before Initial Use.

To Prime can: Grasp can in one hand. Shake can vigorously (until product moves inside can). Firmly strike bottom of can onto palm of other hand or a hard surface at least 3 times. Hold can upright and direct initial spray to a non-skin surface, such as into cap of can. DO NOT spray directly on the skin as the initial spray may expel cold, liquid propellant. Press down on actuator for 1 to 3 seconds until foam begins to dispense. If foam does not dispense within 3 seconds, prime can again.

Before Each Use: Shake can vigorously. Firmly strike bottom of can onto palm of other hand or a hard surface at least 3 times.

During Use: Holding can upright, dispense Salicylic Acid 6% Emollient Foam into palm of hand and apply thoroughly to affected area twice per day, or as directed by a physician. Rub in completely. Wipe off any excess foam from actuator after use. The preferable method of use is to apply Salicylic Acid 6% Emollient Foam thoroughly to the affected area and to cover the treated area at night, after washing and before retiring. Preferably, the skin should be hydrated for at least five minutes prior to application. The medication is washed off in the morning and if excessive drying and/or irritation is observed a bland cream or lotion may be applied. Once clearing is apparent, the occasional use of Salicylic Acid 6% Emollient Foam will usually maintain the remission. In those areas where the placement of a protective covering is difficult or impossible, application of Salicylic Acid 6% Emollient Foam may be made more frequently; hydration by wet packs or baths prior to application apparently enhances the effect. (See WARNINGS.) Unless hands are being treated, hands should be rinsed thoroughly after application. Excessive repeated application of Salicylic Acid 6% Emollient Foam will not necessarily increase its therapeutic benefit, but could result in increased local intolerance and systemic adverse effects such as salicylism. 

How is Salicylic Acid Foam Supplied

Salicylic Acid 6% Emollient Foam is supplied in 60g (NDC# 49808-167-60) aluminum cans.

Store at room temperature 59° - 77°F (15° - 25°C).

Protect from freezing.

Store upright.

REFERENCES

1. Davies M, Marks R: Br J Dermatol 95: 187–192, 1976.


2. Marks R, Davies M, Cattel A: J Invest Dermatol 64: 283, 1975.


3. Huber C, Christophers E: Arch Derm Res 257: 293-297, 1977.


4. Taylor JR, Halprin KM: Arch Dermatol 111: 740-743, 1975. 


5. Goldsmith LA: Int J Dermatol 18: 32-36, 1979.


6. Wilson JG, Ritter EJ, Scott WJ, Fradlein R: Tox Appl Pharmacol 41: 67-78, 1977.

Manufactured for :

Metacon Labs

866-777-4633

www.metaconlabs.com

Patent Pending

P/N 2619 Rev. 0

Rx only

Salicylic Acid 6% 

Emollient Foam

In An Ammonium Lactate Vehicle

NDC 49808-167-60

Net Weight 60g

SALICYLIC ACID  salicylic acid  aerosol, foam

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 49808-167 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID 6 g  in 100 g

Inactive Ingredients Ingredient Name Strength PROPYLENE GLYCOL   CETOSTEARYL ALCOHOL   ALPHA-TOCOPHEROL ACETATE   METHYLPARABEN   PROPYLPARABEN   WATER   PETROLATUM   GLYCERIN   EDETATE SODIUM   ALOE   SODIUM HYDROXIDE   AMMONIUM LACTATE

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 49808-167-60 1 CAN In 1 CARTON contains a CAN 1 60 g In 1 CAN This package is contained within the CARTON (49808-167-60)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		08/01/2010	12/31/2011

Labeler - Metacon Labs (793223707)

Registrant - Onset Dermatologics LLC (964275155)

Establishment
Name	Address	ID/FEI	Operations
Metacon Labs		793223707	Manufacture

Revised: 11/2011Metacon Labs

More Salicylic Acid Foam resources

• Salicylic Acid Foam Side Effects (in more detail)
• Salicylic Acid Foam Use in Pregnancy & Breastfeeding
• Salicylic Acid Foam Drug Interactions
• Salicylic Acid Foam Support Group
• 1 Review for Salicylic Acid - Add your own review/rating

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• Acne
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• Warts

SymlinPen

Generic Name: pramlintide (Subcutaneous route)

PRAM-lin-tide

Subcutaneous route(Solution)

Pramlintide acetate is used with insulin and has been associated with an increased risk of insulin-induced severe hypoglycemia. When severe hypoglycemia associated with pramlintide acetate use occurs, it is seen within 3 hours following a pramlintide acetate injection. Appropriate patient selection, careful patient instruction, and insulin dose adjustments are critical elements for reducing this risk .

Commonly used brand name(s)

In the U.S.

• Symlin


• SymlinPen

Available Dosage Forms:

• Solution

Therapeutic Class: Antidiabetic

Uses For SymlinPen

Pramlintide is used to treat high blood sugar in patients with type 1 and type 2 diabetes. This medicine will decrease the time it takes for food to move through the stomach. It also works to prevent the liver from making sugar. Pramlintide is always used together with insulin to lower the high blood sugar that occurs after meals.

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

Before Using SymlinPen

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 have not been performed on the relationship of age to the effects of pramlintide in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of pramlintide in the elderly.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

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

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

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

• Gastroparesis (stomach does not empty food normally) or


• High HbA1c level, greater than 9% (lab test used for diabetics) or


• Hypoglycemia (severe), occurs often and required doctor's help in the past 6 months or


• Hypoglycemia unawareness (not able to recognize low blood sugar symptoms)—Should not be used in patients with these conditions.

• Hypoglycemia from insulin, history of—May increase risk of severe hypoglycemia occurring again.

• Infection or


• Stress (e.g., physical or emotional)—May increase the amount of pramlintide that is needed.

Proper Use of pramlintide

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

When you start using this medicine, it is very important that you check your blood sugar often, especially before and after meals and at bedtime. This will help lower the chance of having very low blood sugar.

This medicine should come with a medication guide and patient information insert. Read and follow these instructions carefully. Ask your doctor if you have any questions.

You will be using pramlintide at home. Your doctor will teach you how the injections are to be given. Be sure you understand exactly how the medicine is to be injected. Tell your doctor if you have dexterity (skill in using the hands) or vision problems.

This medicine is available in 2 forms. You may use a vial or a SymlinPen™ pen-injector. Your doctor will tell you which dosage form is right for you.

You should never mix your insulin and pramlintide injections together. These injections are always given separately. Also, this medicine should not be used in an insulin infusion pump. If you have questions about this, ask your doctor or pharmacist.

This medicine is given as a shot under the skin of your stomach or upper thigh. Inject pramlintide at a site that is more than 2 inches away from your insulin injection. Never inject insulin and pramlintide in the same site.

Allow the medicine to warm at room temperature before you inject it. If the medicine in the vial or pen-injector has changed color, looks cloudy, or if you see particles in it, do not use it.

Use a new needle and syringe each time you inject your medicine.

Throw away used needles and syringes in a hard, closed container that the needles cannot poke through (puncture-resistant). Keep this container away from children and pets.

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

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 injection dosage form:
  
  • For Type 1 diabetes:
    
    • Adults—The dose is based on your blood sugar and how well your body adjusts to the medicine. This must be determined by your doctor. The starting dose is 15 micrograms (mcg) injected under the skin right before major meals. A major meal has at least 250 calories or 30 grams of carbohydrates. Your doctor may adjust your dose as needed.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For Type 2 diabetes:
    
    • Adults—The dose is based on your blood sugar and how well your body adjusts to the medicine. This must be determined by your doctor. The starting dose is 60 micrograms (mcg) injected under the skin right before major meals. A major meal has at least 250 calories or 30 grams of carbohydrates. Your doctor may adjust your dose as needed.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

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.

Store in the refrigerator. Do not freeze.

Store the unopened vial or pen-injector in the refrigerator until you are ready to use it. Protect the vial or pen-injector from bright light.

A vial or pen-injector that has been used may be kept in the refrigerator or at room temperature for up to 30 days. Throw away any medicine that has not been used after 30 days.

Precautions While Using SymlinPen

It is very important that your doctor check your progress at regular visits, especially during the first few weeks you receive this medicine. Blood tests may be needed to see how well you have adjusted to the medicine.

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

• Alcohol—Drinking alcohol (including beer and wine) 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, especially teenagers, may need special counseling about pramlintide dosing changes that might occur because of lifestyle changes, such as changes in exercise and diet. Furthermore, counseling on contraception and pregnancy may be needed because of the problems that can occur in women with diabetes who become pregnant.


• 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, and store pramlintide properly.

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 lists all of your medicines.


• Keep an extra supply of insulin and syringes with needles on hand in case high blood sugar occurs.


• Keep some kind of quick-acting sugar handy to treat low blood sugar.


• Have a glucagon kit available in case severe low blood sugar occurs. Check and replace any expired kits regularly.

When used together with insulin, pramlintide may cause low blood sugar (also called hypoglycemia or insulin reaction), especially in patients with type 1 diabetes. Symptoms of low blood sugar must be treated before they lead to unconsciousness (passing out). Different people may feel different symptoms of low blood sugar. It is important that you learn what symptoms of low blood sugar you usually have so that you can treat it quickly.

• Symptoms of low blood sugar can include: anxious feeling, behavior change similar to being drunk, blurred vision, cold sweats, confusion, cool pale skin, difficulty in concentrating, drowsiness, excessive hunger, fast heartbeat, headache, nausea, nervousness, nightmares, restless sleep, shakiness, slurred speech, and unusual tiredness or weakness.


• The symptoms of low blood sugar may develop quickly and result from:
  
  • delaying or missing a scheduled meal or snack.
  
  
  • exercising more than usual.
  
  
  • drinking a significant amount of alcohol.
  
  
  • taking certain medicines.
  
  
  • using too much insulin.
  
  
  • sickness (especially with vomiting or diarrhea).
  
  


• Know what to do if symptoms of low blood sugar occur. Eating some form of quick-acting sugar when symptoms of low blood sugar first appear will usually prevent them from getting worse. Good sources of sugar include:
  
  • Glucose tablets or gel, fruit juice or nondiet soft drink (4 to 6 ounces [one-half cup]), corn syrup or honey (1 tablespoon), sugar cubes (six one-half inch size), or table sugar (dissolved in water).
    
    • If a snack is not scheduled for an hour or more you should also eat a light snack, such as cheese and crackers, half a sandwich, or drink an 8-ounce glass of milk.
    
    
    • Do not use chocolate because the fat slows down the sugar getting into the blood.
    
    
  
  
  • Glucagon is used in emergency situations such as unconsciousness. Have a glucagon kit available and know how to prepare and use it. Members of your household also should know how and when to use it.
  
  

High blood sugar (hyperglycemia) is another problem related to uncontrolled diabetes. If you have any symptoms of high blood sugar, contact your health care team right away. If high blood sugar is not treated, severe hyperglycemia can occur, leading to ketoacidosis (diabetic coma) and death.

• The symptoms of mild high blood sugar appear more slowly than those of low blood sugar. Symptoms can include: blurred vision; drowsiness; dry mouth; flushed and dry skin; fruit-like breath odor; increased urination (frequency and volume); loss of appetite; stomachache, nausea, or vomiting; tiredness; troubled breathing (rapid and deep); and unusual thirst.


• Symptoms of severe high blood sugar (called ketoacidosis or diabetic coma) that need immediate hospitalization include: flushed and dry skin, fruit-like breath odor, ketones in urine, passing out, and troubled breathing (rapid and deep).


• High blood sugar symptoms may occur if you:
  
  • have diarrhea, a fever, or an infection.
  
  
  • do not take enough insulin or skip a dose of insulin.
  
  
  • do not exercise as much as usual.
  
  
  • overeat or do not follow your meal plan.
  
  


• Know what to do if high blood sugar occurs. Your doctor may recommend changes in your pramlintide and/or insulin dose or meal plan to avoid high blood sugar. Symptoms of high blood sugar must be corrected before they progress to more serious conditions. Check with your doctor often to make sure you are controlling your blood sugar. Your doctor might discuss the following with you:
  
  • Increasing your insulin dose when you plan to eat an unusually large dinner, such as on holidays. This type of increase is called an anticipatory dose.
  
  
  • Decreasing your dose for a short time for special needs, such as when you cannot exercise as you normally do. Changing only one type of insulin dose (usually the first dose) and anticipating how the change may affect other doses during the day. Contacting your doctor if you need a permanent change in dose.
  
  
  • Delaying a meal if your blood glucose is over 200 mg/dL to allow time for your blood sugar to go down. An extra insulin dose may be needed if your blood sugar does not come down shortly.
  
  
  • Not exercising if your blood glucose is over 240 mg/dL and reporting this to your doctor immediately.
  
  
  • Being hospitalized if ketoacidosis or diabetic coma occurs.
  
  

You may have some skin redness, swelling, or itching at the injection site. If this irritation is severe or does not go away, call your doctor.

SymlinPen 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

• Anxiety


• blurred vision


• chills


• cold sweats


• coma


• confusion


• cool pale skin


• cough


• depression


• difficulty swallowing


• dizziness


• fast heartbeat


• headache


• hives


• increased hunger


• itching


• nausea


• nervousness


• nightmares


• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue


• seizures


• shakiness


• shortness of breath


• skin rash


• slurred speech


• tightness in the chest


• unusual tiredness or weakness


• wheezing

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

• Difficulty with moving


• inflicted injury


• loss of appetite


• muscle pain or stiffness


• pain in the joints


• stomach pain


• vomiting


• weight loss

Less common

• Body aches or pain


• congestion


• dryness or soreness of the throat


• fever


• hoarseness


• runny nose


• tender, swollen glands in the neck


• trouble in swallowing


• voice changes

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: SymlinPen side effects (in more detail)

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

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More SymlinPen resources

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

Compare SymlinPen with other medications

• Diabetes, Type 1
• Diabetes, Type 2

Inovelon

Inovelon may be available in the countries listed below.

UK matches:

• Inovelon Tablets
• Inovelon Tablets (SPC)

Ingredient matches for Inovelon

Rufinamide

Rufinamide is reported as an ingredient of Inovelon in the following countries:

• Austria


• Denmark


• Finland


• France


• Germany


• Greece


• Ireland


• Luxembourg


• Norway


• Sweden


• Switzerland


• United Kingdom

International Drug Name Search

Glossary

SPC	Summary of Product Characteristics (UK)

Click for further information on drug naming conventions and International Nonproprietary Names.

hexaminolevulinate Urinary bladder

hex-a-mee-noe-LEV-ue-lin-ate hye-droe-KLOR-ide

Commonly used brand name(s)

In the U.S.

• Cysview

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Diagnostic Agent, Radiopharmaceutical Imaging

Uses For hexaminolevulinate

Hexaminolevulinate is an imaging agent that is used in a procedure for the bladder called cystoscopy. Imaging agents help create an image or picture of body parts, such as the bladder. Hexaminolevulinate is used to check for cancer cells in the bladder.

hexaminolevulinate is to be used only by or under the direct supervision of a doctor.

Before Using hexaminolevulinate

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 hexaminolevulinate, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to hexaminolevulinate 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 have not been performed on the relationship of age to the effects of hexaminolevulinate in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of hexaminolevulinate in the elderly.

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

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

• Bladder cancer that was treated with BCG (Bacillus Calmette-Guerin) solution in the past 90 days or


• Blood in the urine or


• Porphyria (an enzyme problem)—Should not be used in patients with these conditions.

• Bladder pain or


• Bladder spasm—Use with caution. May make these conditions worse.

Proper Use of hexaminolevulinate

A nurse or other trained health professional will give you hexaminolevulinate in a hospital or clinic. hexaminolevulinate is given through a tube (catheter) that is placed in your bladder.

The tube will be taken out and the medicine must be held in the bladder for at least 1 hour. You may stand, sit, or move during this time. If you feel you cannot hold the medicine in the bladder for 1 hour, tell your doctor or nurse right away.

Precautions While Using hexaminolevulinate

hexaminolevulinate may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor or nurse right away if you have a rash; itching; hoarseness; swelling of your hands, face, or mouth; trouble with breathing or swallowing; or chest pain after you receive the medicine.

hexaminolevulinate 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 or nurse immediately if any of the following side effects occur:

More common

• Blood in the urine


• burning while urinating


• difficult or painful urination


• frequent urge to urinate


• lower stomach pain or spasm

Incidence not known

• Bloody or cloudy urine


• cough


• difficulty with breathing or swallowing


• dizziness


• fast heartbeat


• fever


• hives


• itching


• nausea


• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue


• reddening of the skin, especially around the ears


• shortness of breath


• skin rash


• tightness in the chest


• unusual tiredness or weakness


• wheezing

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.

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 hexaminolevulinate Urinary bladder resources

• Hexaminolevulinate Urinary bladder Support Group
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• Diagnosis and Investigation

Infla-Ban

Infla-Ban may be available in the countries listed below.

Ingredient matches for Infla-Ban

Diclofenac

Diclofenac sodium salt (a derivative of Diclofenac) is reported as an ingredient of Infla-Ban in the following countries:

• Bahrain


• Iraq


• Jordan


• Kuwait


• Lebanon


• Libya


• Nigeria


• Oman


• Qatar


• Saudi Arabia


• South Africa


• Sudan


• Syria


• United Arab Emirates


• Yemen

International Drug Name Search

Metamucil Smooth Texture Powder

Pronunciation: SILL-i-um
Generic Name: Psyllium
Brand Name: Examples include Konsyl and Metamucil Smooth Texture

Metamucil Smooth Texture Powder is used for:

Treating occasional constipation and restoring regularity. It may also be used for other conditions as determined by your doctor.

Metamucil Smooth Texture Powder is a fiber laxative. It works by absorbing water and swelling in the intestines. This helps the stool form the bulk necessary to be easily passed.

Do NOT use Metamucil Smooth Texture Powder if:

• you are allergic to any ingredient in Metamucil Smooth Texture Powder


• you have appendicitis, difficulty swallowing, severe constipation, intestinal blockage, or undiagnosed rectal bleeding

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

Before using Metamucil Smooth Texture Powder:

Some medical conditions may interact with Metamucil Smooth Texture Powder. 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 a sudden change in bowel habits persisting for more than 2 weeks


• if you have stomach or intestinal pain, nausea, or vomiting

Some MEDICINES MAY INTERACT with Metamucil Smooth Texture Powder. However, no specific interactions with Metamucil Smooth Texture Powder are known at this time.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Metamucil Smooth Texture Powder 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 Metamucil Smooth Texture Powder:

Use Metamucil Smooth Texture Powder as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Metamucil Smooth Texture Powder may be taken with or without food.


• Empty the contents of 1 packet (unless directed by your doctor to use a different dose) into an empty glass. Mix Metamucil Smooth Texture Powder with a full glass (at least 8 oz or 240 mL) of water or other liquid. Stir briskly and drink immediately. If the mixture thickens, add more liquid and stir.


• Do not take other oral medicines within 2 hours before or 2 hours after taking Metamucil Smooth Texture Powder.


• If you miss a dose of Metamucil Smooth Texture Powder, 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 Metamucil Smooth Texture Powder.

Important safety information:

• If your symptoms do not improve within 7 days or if they become worse, check with your doctor.


• Do not take additional laxatives or stool softeners with Metamucil Smooth Texture Powder unless directed by your doctor.


• Do not use Metamucil Smooth Texture Powder if you experience stomach pain, nausea, vomiting, or rectal bleeding, except under the direction of your doctor.


• If you notice a sudden change in bowel habits that lasts for 2 weeks or more, do not continue using Metamucil Smooth Texture Powder. Instead, check with your doctor.


• Taking this product without enough liquid may cause it to swell and block your throat or esophagus and may cause choking. Do not take this product if you have difficulty swallowing. If you experience chest pain, vomiting, or difficulty swallowing or breathing after taking this product, seek immediate medical attention.


• Do not use Metamucil Smooth Texture Powder in CHILDREN younger than 12 years of age without first checking with your doctor.


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

Possible side effects of Metamucil Smooth Texture Powder:

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:

Abdominal fullness; minor bloating.

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); chest pain; difficulty swallowing; trouble breathing; vomiting.

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: Metamucil Smooth Texture 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 Metamucil Smooth Texture Powder:

Store Metamucil Smooth Texture Powder 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 Metamucil Smooth Texture Powder out of the reach of children and away from pets.

General information:

• If you have any questions about Metamucil Smooth Texture Powder, please talk with your doctor, pharmacist, or other health care provider.


• Metamucil Smooth Texture Powder is to be used only by the patient for whom it is prescribed. Do not share it with other people.


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


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

This information is a summary only. It does not contain all information about Metamucil Smooth Texture Powder. 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 Metamucil Smooth Texture resources

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

Compare Metamucil Smooth Texture with other medications

• Constipation
• Dietary Fiber Supplementation
• Irritable Bowel Syndrome

Idyl

Idyl may be available in the countries listed below.

Ingredient matches for Idyl

Ibuprofen

Ibuprofen is reported as an ingredient of Idyl in the following countries:

• Philippines

International Drug Name Search

Pralidoxime Chloride

FOR USE IN NERVE AGENT POISONING ONLY

A Sterile Solution For Intramuscular Use Only

Rx Only

Pralidoxime Chloride Description

Pralidoxime Chloride Injection (auto-injector) provides Pralidoxime Chloride in a sterile solution for intramuscular injection.

Each prefilled auto-injector provides a dose of the antidote, Pralidoxime Chloride in a self-contained unit, specially designed for automatic self- or buddy- administration by military personnel. Pralidoxime in the auto-injector may also be administered by qualified civilian emergency responders who have had adequate training in the on-site recognition and treatment of nerve agent intoxication in the event of an accidental release of nerve agent. The recommended procedure (see DOSAGE AND ADMINISTRATION) is to inject the contents of the auto-injector into the muscles of an outer thigh.

After an auto-injector has been activated, the empty container should be disposed of properly (see DOSAGE AND ADMINISTRATION), it cannot be refilled nor can the protruding needle be retracted.

When activated, each auto-injector dispenses 600 mg of Pralidoxime Chloride in 2 mL of a sterile solution containing 20 mg/mL benzyl alcohol, 11.26 mg/mL glycine in Water for Injection, USP. The pH is adjusted with hydrochloric acid. The pH range is 2.0-3.0. The product is pyrogen free.

Pralidoxime Chloride is a cholinesterase reactivator.

Chemical Name: 2-formyl-1 methylpyridinium chloride oxime (pyridine-2-aldoxime methochloride). Also referred to as 2-PAM Chloride.

Structural Formula:

Pralidoxime Chloride occurs as an odorless, white, nonhygroscopic, crystalline powder which is soluble in water to the extent of 1 g in less than 1 mL.  Stable in air, it melts between 215°C and 225°C, with decomposition.

The specific activity of the drug resides in the 2-formyl-1 methylpyridinium ion and is independent of the particular salt employed. The chloride is preferred because of physiologic compatibility, excellent water solubility at all temperatures, and high potency per gram, due to its low (173) molecular weight.

Pralidoxime Chloride - Clinical Pharmacology

Pralidoxime Chloride is a cholinesterase reactivator.

The principal action of pralidoxime is to reactivate cholinesterase (mainly outside of the central nervous system) which has been inactivated by phosphorylation due to an organophosphate pesticide or related compound. The destruction of accumulated acetylcholine can then proceed and neuromuscular junctions will again function normally. Pralidoxime also slows the process of "aging" of phosphorylated cholinesterase to a non-reactivatable form, and detoxifies certain organophosphates by direct chemical reaction. The drug has its most critical effect in relieving paralysis of the muscles of respiration. Because pralidoxime is less effective in relieving depression of the respiratory center, atropine is always required concomitantly to block the effect of accumulated acetylcholine at this site. Pralidoxime relieves muscarinic signs and symptoms, salivation, bronchospasm, etc., but this action is relatively unimportant since atropine is adequate for this purpose.

Pralidoxime is distributed throughout the extracellular water, it is not bound to plasma protein. The drug is rapidly excreted in the urine partly unchanged, and partly as a metabolite produced by the liver. Consequently, pralidoxime is relatively short acting and repeated doses may be needed, especially where there is any evidence of continuing absorption of the poison.

The minimum therapeutic concentration of pralidoxime in plasma is 4 μg/mL, this level is reached in about 16 minutes after a single injection of 600 mg Pralidoxime Chloride. The apparent half-life of Pralidoxime Chloride is 74-77 minutes.

It has been reported that the supplemental use of oxime cholinesterase reactivators (such as pralidoxime) reduces the incidence and severity of developmental defects in chick embryos exposed to such known teratogens as parathion, bidrin, carbachol and neostigmine. This protective effect of the oximes was shown to be dose related.

Indications and Usage for Pralidoxime Chloride

This auto-injector for Pralidoxime Chloride is specifically indicated for intramuscular use as an adjunct to atropine in the treatment of poisoning by nerve agents having anticholinesterase activity.

Contraindications

The Pralidoxime Chloride auto-injector is contraindicated in patients who are hypersensitive to any component of the product.

Warnings

Pralidoxime is not effective in the treatment of poisoning due to phosphorus, inorganic phosphates or organophosphates not having anticholinesterase activity.

Precautions

General:

Pralidoxime has been very well tolerated in most cases, but it must be remembered that the desperate condition of the organophosphate-poisoned patient will generally mask such minor signs and symptoms as have been noted in normal subjects.

Because pralidoxime is excreted in the urine, a decrease in renal function will result in increased blood levels of the drug. Thus, the dosage of pralidoxime should be reduced in the presence of renal insufficiency.

Information for Patients:

The Pralidoxime Chloride auto-injector should be self- or buddy- administered by military personnel or administered by qualified civilian emergency responders only after the following events have occurred:

-

individual has donned his mask subsequent to recognizing the existence of a chemical agent hazard in his area

-

some or all of the symptoms of nerve agent poisoning cited below are present:

 

unexplained runny nose

 

tightness of chest with difficulty in breathing

 

pinpointed pupils of the eye resulting in blurred vision

 

drooling, excessive sweating

 

nausea, vomiting, and abdominal cramps

 

involuntary urination and defecation

 

jerking, twitching, and staggering

 

headache, drowsiness, coma, convulsions

 

stoppage of breathing

Appropriate steps must be taken to insure that personnel equipped with auto-injectors understand their indications and use including review of symptoms of poisoning and operation of the auto-injector.

Laboratory Tests:

Treatment of organophosphate poisoning should be instituted without waiting for the results of laboratory tests. Red blood cell, plasma cholinesterase, and urinary paranitrophenol measurements (in the case of parathion exposure) may be helpful in confirming the diagnosis and following the course of the illness. A reduction in red blood cell cholinesterase concentration to below 50% of normal has been seen only with organophosphate ester poisoning.

Drug Interactions:

When atropine and pralidoxime are used together, the signs of atropinization (flushing, mydriasis, tachycardia, dryness of the mouth and nose) may occur earlier than might be expected when atropine is used alone. This is especially true if the total dose of atropine has been large and the administration of pralidoxime has been delayed.2, 3, 4

The following precautions should be kept in mind in the treatment of anticholesterinase poisoning, although they do not bear directly on the use of pralidoxime; since barbiturates are potentiated by the anticholinesterases, they should be used cautiously in the treatment of convulsions; morphine, theophylline, aminophylline, succinylcholine, reser-pine, and phenothiazine-type tranquilizers should be avoided in patients with organophosphate poisoning.

Carcinogenesis, Mutagensis, Impairment of Fertility:

Since the Pralidoxime Chloride auto-injector is indicated for short-term emergency use only, no investigations of its potential for carcinogenesis, mutagenesis, or impairment of fertility have been conducted by the manufacturer, or reported in the literature.

Pregnancy Category C:

Animal reproduction studies have not been conducted with pralidoxime. It is also not known whether pralidoxime can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Pralidoxime should be given to a pregnant woman only if clearly needed.

Nursing Mother:

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when pralidoxime is administered to a nursing woman.

Pediatric Use:

Safety and effectiveness in children have not been established.

Adverse Reactions

Forty to 60 minutes after intramuscular injection, mild to moderate pain may be experienced at the site of injection.

Pralidoxime may cause blurred vision, diplopia and impaired accommodation, dizziness, headache, drowsiness, nausea, tachycardia, increased systolic and diastolic blood pressure, hyperventilation, and muscular weakness when given parenterally to normal volunteers who have not been exposed to anticholinesterase poisons. In patients it is very difficult to differentiate the toxic effects produced by atropine or the organophosphate compounds from those of the drug.

Elevations in SGOT and/or SGPT enzyme levels were observed in 1 of 6 normal volunteers given 1200 mg of Pralidoxime Chloride intramuscularly, and in 4 of 6 volunteers given 1800 mg intramuscularly. Levels returned to normal in about 2 weeks. Transient elevations in creatine phosphokinase were observed in all normal volunteers given the drug. A single intramuscular injection of 330 mg in 1 mL in rabbits caused myonecrosis, inflammation and hemorrhage.

When atropine and pralidoxime are used together, the signs of atropinization may occur earlier than might be expected when atropine is used alone. This is especially true if the total dose of atropine has been large and the administration of pralidoxime has been delayed.2, 3, 4 Excitement and manic behavior immediately following recovery of consciousness have been reported in several cases. However, similar behavior has occurred in cases of organophosphate poisoning that were not treated with pralidoxime.3, 5, 6

Drug Abuse and Dependence

Pralidoxime Chloride is not subject to abuse and possesses no known potential for dependence.

Overdosage

Manifestations of Overdosage:

Observed in normal subjects only: dizziness, blurred vision, diplopia, headache, impaired accommodation, nausea, slight tachycardia. In therapy it has been difficult to differentiate side effects due to the drug from those due to the effects of the poison.

Treatment of Overdosage:

Artificial respiration and other supportive therapy should be administered as needed.

Acute Toxicity:

 

i.v.—man TDLo: 14 mg/kg (toxic effects: CNS)

 

i.v.— rat LD50: 96 mg/kg

 

i.m.—rat LD50: 150 mg/kg

 

oral—mouse LD50: 4100 mg/kg

 

i.p.—mouse LD50: 155 mg/kg

 

i.v.—mouse LD50: 90 mg/kg

 

i.m.—mouse LD50: 180 mg/kg

 

i.v.—rabbit LD50: 95 mg/kg

 

i.m.—guinea pig LD50: 168 mg/kg

Pralidoxime Chloride Dosage and Administration

Exposure to nerve agents possessing anticholinesterase activity (organophosphate type)

MILD CASE—headache, blurred vision, mild muscarinic signs

MODERATELY SEVERE CASE—excessive sweating, lacrimation, salivation, diarrhea, tightness in the chest

For optimal reactivation of organophosphate-inhibited cholinesterase, atropine and pralidoxime should be administered as soon as possible after exposure. Depending on the severity of symptoms, immediately administer one atropine-containing auto-injector, followed by one pralidoxime-containing auto-injector. Atropine must be given first until its effects become apparent and only then should pralidoxime be administered. If nerve agent symptoms are still present after 15 minutes, repeat injections. If symptoms still exist after an additional 15 minutes, repeat injections for a third time. If after the third set of injections, symptoms remain, do not give any more antidotes but seek medical help.

Directions for Use:

When, as described above, auto-injector use is indicated, proceed as follows:

Remove gray safety cap. Place black end against outer thigh and push hard until the injector functions. Hold firmly in place for ten seconds, then remove. Massage the area of injection. Dispose of properly. Push ejected needle through a pocket flap (or other thick and conspicuous part of outer clothing). Bend needle into a hook.

VERY SEVERE CASE — Cyanosis, Respiratory Embarrassment, Coma

Initial measures should include removal of secretions, maintenance of a patent airway and, if necessary, artificial ventilation. Atropine should not be used until cyanosis has been overcome since atropine produces ventricular fibrillations in the presence of hypoxia. Morphine, theophylline, aminophylline, or succincylcholine are contraindicated. Tranquilizers of the reserpine or phenothiazine type are to be avoided.

"Pralidoxime is most effective if administered immediately after poisoning. Generally, little is accomplished if the drug is given more than 36 hours after termination of exposure. When the poison has been ingested, however, exposure may continue for some time due to slow absorption from the lower bowel, and fatal relapses have been reported after initial improvement. Continued administration for several days may be useful in such patients. Close supervision of the patient is indicated for at least 48 to 72 hours. If dermal exposure has occurred, clothing should be removed and the hair and skin washed thoroughly with sodium bicarbonate or alcohol as soon as possible. Diazepam may be given cautiously if convulsions are not controlled by atropine."7

IMPORTANT: PHYSICIANS AND/OR OTHER MEDICAL PERSONNEL ASSISTING EVACUATED VICTIMS OF NERVE AGENTS, SHOULD AVOID EXPOSING THEMSELVES TO CONTAMINATION BY THE VICTIMS' CLOTHING.

How is Pralidoxime Chloride Supplied

Pralidoxime Chloride is supplied in aqueous solution prefilled in the auto-injector (600 mg, 2 mL) for military use and for use by qualified civilian emergency responders. Auto-injectors are supplied through the Directorate of Medical Materiel, Defense Supply Center Philadelphia or other analogous local, state or federal agency.

When activated, each auto-injector dispenses 600 mg of Pralidoxime Chloride in 2 mL of a sterile solution containing 20 mg/mL benzyl alcohol, 11.26 mg/mL glycine in Water for Injection, USP. The pH is adjusted with hydrochloric acid. The pH is 2.0-3.0 The product is pyrogen free.

Store at 25°C (77°F); Excursions permitted to 15-30°C (59-86°F).

[See USP Controlled Room Temperature] Keep from freezing.

Meridian Medical Technologies, Inc.

Columbia, MD 21046

0001002

10/03

Printed in U.S.A.

REFERENCES

1. Landauer, W.: Cholinomimetic tetrogens. V. The effect of oximes and related cholinesterase reactivators, Teratology 15:33 (Feb.) 1977.


2. Moller, K. O., Jenson-Holm, J., and Lausen, H. H.: Ugeskr. Laeg.123:501, 1961.


3. Namba, T., Nolte, C.T., Jackrel, Jr., and Grob, D.: Poisoning due to organophosphate insecticides. Acute and chronic manifestations, Amer. J. Med. 50:475 (Apr.) 1971.


4. Arena, J. M.: Poisoning. Toxicology. Symptoms. Treatments, ed. 4, Springfield, Ill., Charles C.Thomas, 1979, p. 133.


5. Brachfeld, J., and Zavon, M. R.: Organic phosphate (Phosdrin®) intoxication. Report of case and the results of treatment with 2-PAM, Arch. Environ. Health 11:859,1965.


6. Hayes, W. J., Jr.: Toxicology of Pesticides, Baltimore, The Williams & Wilkins Company, 1975, p. 416.


7. AMA Department of Drugs: AMA Drug Evaluations, ed. 4, Chicago, American Medical Association, 1980, p. 1455.

Pralidoxime Chloride  Pralidoxime Chloride  injection

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 11704-251 Route of Administration INTRAMUSCULAR DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength Pralidoxime Chloride (Pralidoxime cation) Active 600 MILLIGRAM  In 2 MILLILITER Benzyl Alcohol Inactive   Glycine Inactive   Water Inactive   Hydrochloric Acid Inactive

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 11704-251-01 2 mL (MILLILITER) In 1 SYRINGE None

Revised: 06/2008Meridian Medical Technologies, Inc.

More Pralidoxime Chloride resources

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

Compare Pralidoxime Chloride with other medications

• Anticholinesterase Overdose
• Nerve Agent Poisoning
• Organophosphate Poisoning

Multivitamin Drops

Pronunciation: muhl-tee-VYE-ta-min/MIN-er-als
Generic Name: Multivitamin
Brand Name: AquADEKs

Multivitamin Drops are used for:

Treating or preventing low levels of vitamins and minerals in the body. It may also be used for other conditions as determined by your doctor.

Multivitamin Drops are a vitamin and mineral supplement. It works by providing extra vitamins and minerals to the body when you do not get enough from your diet.

Do NOT use Multivitamin Drops if:

• you are allergic to any ingredient in Multivitamin Drops

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

Before using Multivitamin Drops:

Some medical conditions may interact with Multivitamin 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

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

• Acitretin because the risk of its side effects may be increased by Multivitamin Drops


• Anticoagulants (eg, warfarin) because their effectiveness may be decreased by Multivitamin Drops

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

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

• Take Multivitamin Drops by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.


• Shake well before each use.


• Use the dropper that comes with Multivitamin Drops to measure your dose. Ask your pharmacist for help if you are unsure of how to measure your dose.


• If you are also taking a quinolone antibiotic (eg, ciprofloxacin), a tetracycline antibiotic (eg, minocycline), or a thrombopoietin mimetic (eg, eltrombopag), ask your doctor or pharmacist how to take them with Multivitamin Drops.


• If you miss a dose of Multivitamin Drops, 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 Multivitamin Drops.

Important safety information:

• Do not take large doses of vitamins while you use Multivitamin Drops unless your doctor tells you to.


• Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Multivitamin Drops while you are pregnant. It is not known if Multivitamin Drops are found in breast milk. If you are or will be breast-feeding while you use Multivitamin Drops, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Multivitamin Drops:

All medicines may cause side effects, but many people have no, or minor, side effects. No COMMON side effects have been reported with this product. Seek medical attention right away if any of these SEVERE side effects occur:

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

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.

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 Multivitamin Drops:

Store Multivitamin 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 Multivitamin Drops out of the reach of children and away from pets.

General information:

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


• Multivitamin 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 Multivitamin 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 Multivitamin resources

• Multivitamin Use in Pregnancy & Breastfeeding
• Multivitamin Drug Interactions
• Multivitamin Support Group
• 4 Reviews for Multivitamin - Add your own review/rating

Compare Multivitamin with other medications

• Vitamin/Mineral Supplementation and Deficiency

Loratadine Oral Solution

Dosage Form: oral solution
Loratadine Oral Solution Drug Facts


Active Ingredients               Purpose

(in each 5 mL)


Loratadine 5 mg                       Antihistamine

Uses

• relieves itching due to hives (urticaria).  This product will not prevent hives or an allergic skin reaction from occurring.

Warnings

Severe Allergy Warning: Get emergency help immediately if you have hives along with any of the following symptoms:

• trouble swallowing


• dizziness or loss of consciousness


• swelling of tongue


• swelling in or around mouth


• trouble speaking


• drooling


• wheezing or problems breathing

These symptoms may be signs of anaphylactic shock. This condition can be life threatening if not treated by a health professional immediately. Symptoms of anaphylactic shock may occur when hives first appear or up to a few hours later.

Not a Substitute for Epinephrine. If your doctor has prescribed an epinephrine injector for “anaphylaxis” or severe allergy symptoms that could occur with your hives, never use this product as a substitute for the epinephrine injector. If you have been prescribed an epinephrine injector, you should carry it with you at all times.

Do not use

• to prevent hives from any known cause such as:

                     - foods

                     - insects stings

                     - medicines

                     - latex or rubber gloves


because this product will not stop hives from occurring. Avoiding the cause of your hives is the only way to prevent them. Hives can sometimes be serious. If you do not know the cause of your hives, see your doctor for a medical exam. Your doctor may be able to help you find a cause.

• if you have ever had an allergic reaction to this product (loratadine) or any of its ingredients

Ask a doctor before use if you have

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


• hives that are an unusual color, look bruised or blistered


• hives that do not itch
  

When using this product do not take more than directed. Taking more than directed may cause drowsiness.

Stop use and ask a doctor if

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


• symptoms don’t improve after 3 days of treatment


• the hives have lasted more than 6 weeks
  

If pregnant or breast-feeding, ask a health professional before use.

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

Directions

adults and children 6 years and over:	2 teaspoonfuls daily; do not take more than 2 teaspoonfuls in 24 hours
children under 6 years of age:	ask a doctor
consumers with liver or kidney disease:	ask a doctor

Other information

• Safety sealed. Do not use if imprinted seal around cap is broken or missing


• Store at room temperature

Inactive ingredients

citric acid, edetate disodium, flavor, glycerin, propylene glycol, sodium benzoate, sugar, water.

Questions?

To report adverse drug events call: 800-6162471

Distributed by:

Major Pharmaceuticals

31778 Enterprise Drive,

Livonia, MI 48150 USA

Patient Leaflet

Once Daily / Non-Drowsy*

Loratadine Oral Solution

Hives Relief

5 mg per 5 mL

Antihistamine

What you should know about:

Non- Drowsy*

Loratadine Oral Solution – Hives Relief

Original Prescription Strength – 24 Hour Product

Relief of Itching Due to Hives

(Please read all of this information before taking Loratadine Oral Solution – Hives Relief Product. Save this leaflet for future reference.)

What is Loratadine Oral Solution - Hives Relief product?

Loratadine Oral Solution - Hives Relief product contain loratadine, a non-drowsy *antihistamine.

Loratadine Oral Solution – Hives Relief Original prescription strength medicine to relieve itching due to hives.

What are hives and what do they look like?

Hives are itchy raised red or pink bumps, blotches or streaky areas of various sizes on the surface of the skin. They can come and go.


Do not use this product if your hives look bruised, have an unusual color, or look blistered. These may be signs of a more serious problem. If you have these signs, ask a Doctor before taking Loratadine Oral Solution -Hives Relief product.


What can cause hives?

Many things, including food, drugs (medicines), insect stings, stress, exercise or temperature can cause hives. A doctor may be able to help you find the cause of your hives. When you know the cause, avoid it.


Do not use this product to prevent hives or allergic skin reactions known to be caused by food, insect stings, medicines, latex or rubber gloves, or any other causes. Many medicines can cause hives.


How long do hives last?

Hives can last from a few hours to a few weeks, and often come and go. See a doctor if your hives have lasted more than 6 weeks.


Are hives very serious?

Hives are very common and they are usually not serious. But in rare cases, they can be the first sign of a life threatening allergic reaction called anaphylaxis. A sign that you have this serious reaction would be that you have hives along with any of the following symptoms:

• Dizziness or feeling faint
  


• Trouble swallowing
  


• Wheezing or problems breathing
  


• Trouble speaking
  


• Hives or swelling in or around the mouth
  


• Drooling

Hives AND any of these symptoms means call 911 or Get Immediate Medical Help


Can I use Loratadine Oral Solution -Hives Relief product instead of an epinephrine injection for my allergic reaction?


Never use Loratadine Oral Solution – Hives Relief product as a substitute for epinephrine.

If your doctor has prescribed an epinephrine injector for your severe allergic reactions, your doctor is concerned that your hives might lead to a severe allergic reaction (anaphylaxis) or to asthma-like symptoms that could occur with your hives. Loratadine Oral Solution – Hives Relief product is not a substitute for epinephrine. If you have been prescribed an epinephrine injector, carry it with you at all times.


Who can take Loratadine Oral Solution – Hives Relief Product?

People who have hives (urticaria) and are 6 years of age or older can take Loratadine Oral Solution – Hives Relief product. (See label Directions for proper dose.)


Who should not take Loratadine Oral Solution – Hives Relief Product?

• People who have ever had an allergic reaction to these products or any of their ingredients.
  


• People who are taking any other products containing loratadine
  


• People with liver or kidney disease unless directed by a doctor
  


• Children under the age of 6 years.

What if I know the cause of my hives and I want to take Loratadine Oral Solution – Hives Relief Product to prevent the hives from occurring?

Loratadine Oral Solution – Hives Relief product should never be used to prevent hives or allergic skin reactions from any known cause. Such causes can include but are not limited to:

• Food
  


• Insect Stings
  


• Medicines
  


• Latex or rubber gloves.

If you have ever had an allergic reaction to any of these causes, you should see a doctor.


When should you contact a doctor?

Contact a doctor before taking Loratadine Oral Solution – Hives Relief product if you have:

• Hives that have an unusual color or that look bruised or blistered
  


• Hives that have lasted longer than 6 weeks

If you are pregnant or breast feeding, you should ask a doctor or health professional before use.


Contact a doctor while taking Loratadine Oral Solution – Hives Relief Product if you (or your child) have:

• A rash or itching that does not get better after taking Loratadine Oral Solution – Hives Relief product for 3 days
  


• Hives that keep coming back.

How long can Loratadine Oral Solution – Hives Relief product be taken to relieve the itching?

Loratadine Oral Solution – Hives Relief product can be taken during the entire time that you have itching due to hives (see Directions). Don’t forget, if the hives last longer than 6 weeks, contact your doctor.


How should Loratadine Oral Solution – Hives Relief product be taken?

• Adults and children 6 years and older should take 2 teaspoonfuls of Loratadine Oral Solution (10 mg) daily.
  


• Do not take more than one dose in 24 hour period.
  


• If you have liver or kidney disease, ask a doctor.

What else can I do to make the itching and rash feel better?

Wear loose clothing to help reduce irritation. Keeping the temperature cool can help with the itching.


Other important information:

• Allergy Alert: Do not use if you are allergic to loratadine, any of its ingredients, or other antihistamines.
  


• If you have been prescribed an epinephrine injector, you should carry it with you at all times.
  


• Keep out of reach of children.
  


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

* When taken as directed. See drug facts panel on carton.


Silarx Pharmaceuticals, Inc.

Spring Valley, NY 10977

USA


Rev. May 2009

LORATADINE  loratadine  solution

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 0904-5727 Route of Administration ORAL DEA Schedule

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

Inactive Ingredients Ingredient Name Strength anhydrous citric acid   edetate disodium   glycerin   propylene glycol   sodium benzoate   raw sugar   water

Product Characteristics Color      Score      Shape Size Flavor FRUIT (Fruit Flavor) Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0904-5727-20 120 mL In 1 BOTTLE, DROPPER None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA077421	06/29/2006

Labeler - Major Pharmaceuticals, Inc (191427277)

Registrant - Silarx Pharmaceuticals, Inc (161630033)

Revised: 06/2010Major Pharmaceuticals, Inc

More Loratadine Oral Solution resources

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

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• Hay Fever
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