Instacort-10

Generic Name: hydrocortisone (Topical application route)

hye-droe-KOR-ti-sone

Commonly used brand name(s)

In the U.S.

• Ala-Cort


• Ala-Scalp HP


• Anusol HC


• Aquanil HC


• Beta HC


• Caldecort


• Cetacort


• Corta-Cap


• Cortagel Extra Strength


• Cortaid


• CortAlo With Aloe


• Corticaine


• Corticool Maximum Strength


• Cortizone-10


• Cortizone-5


• Cotacort


• Delacort


• Dermarest


• Dermtex-HC


• Foille Cort


• Gly-Cort


• Hydrozone Plus


• Hytone


• Instacort-10


• Ivy Soothe


• IvyStat


• Keratol HC


• Kericort 10


• Lacticare-HC


• Locoid


• Locoid Lipocream


• Medi-Cortisone Maximum Strength


• Microcort


• Mycin Scalp


• Neutrogena T/Scalp


• NuCort


• Nupercainal HC


• Nutracort


• Pandel


• Pediaderm HC Kit


• Preparation H Hydrocortisone


• Proctocream-HC


• Recort Plus


• Sarnol-HC Maximum Strength


• Scalacort


• Scalpcort


• Summer's Eve Specialcare


• Texacort


• Therasoft Anti-Itch & Dermatitis


• U-Cort


• Westcort

In Canada

• Barriere-Hc


• Cortate


• Cort-Eze


• Cortoderm Mild Ointment


• Cortoderm Regular Ointment


• Emo-Cort


• Emo-Cort Scalp Solution


• Hydrocortisone Cream


• Novo-Hydrocort


• Novo-Hydrocort Cream


• Prevex Hc


• Sarna Hc

Available Dosage Forms:

• Solution


• Cream


• Spray


• Lotion


• Ointment


• Pad


• Liquid


• Gel/Jelly


• Kit


• Foam


• Stick


• Paste

Therapeutic Class: Corticosteroid, Weak

Pharmacologic Class: Adrenal Glucocorticoid

Uses For Instacort-10

Hydrocortisone topical is used to help relieve redness, itching, swelling, or other discomfort caused by skin conditions. This medicine is a corticosteroid (cortisone-like medicine or steroid).

This medicine is available both over-the-counter (OTC) and with your doctor's prescription.

Before Using Instacort-10

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 hydrocortisone topical in the pediatric population. However, because of this medicine's toxicity, it should be used with caution. Children may absorb large amounts through the skin, which can cause serious side effects. If your child is using this medicine, follow your doctor's instructions very carefully.

Geriatric

No information is available on the relationship of age to the effects of hydrocortisone topical in geriatric patients.

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:

• Cushing's syndrome (adrenal gland disorder) or


• Diabetes or


• Hyperglycemia (high blood sugar) or


• Intracranial hypertension (increased pressure in the head)—Use with caution. May make these conditions worse.

• Infection of the skin at or near the place of application or


• Large sores, broken skin, or severe skin injury at the place of application—The chance of side effects may be increased.

Proper Use of hydrocortisone

This section provides information on the proper use of a number of products that contain hydrocortisone. It may not be specific to Instacort-10. Please read with care.

It is very important that you use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may cause unwanted side effects or skin irritation.

This medicine is for use on the skin only. Do not get it in your eyes. Do not use it on skin areas that have cuts, scrapes, or burns. If it does get on these areas, rinse it off right away with water.

This medicine should only be used for skin conditions that your doctor is treating. Check with your doctor before using it for other conditions, especially if you think that a skin infection may be present. This medicine should not be used to treat certain kinds of skin infections or conditions, such as severe burns.

To use:

• Wash your hands with soap and water before and after using this medicine.


• Apply a thin layer of this medicine to the affected area of the skin. Rub it in gently.


• With the lotion, shake it well before using.


• Do not bandage or otherwise wrap the skin being treated unless directed to do so by your doctor.


• If the medicine is applied to the diaper area of an infant, do not use tight-fitting diapers or plastic pants unless directed to do so by your doctor.


• If your doctor ordered an occlusive dressing or airtight covering to be applied over the medicine, make sure you know how to apply it. Occlusive dressings increase the amount of medicine absorbed through your skin, so use them only as directed. If you have any questions about this, check with your doctor.

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 redness, itching, and swelling of the skin:
  
  • For topical dosage form (cream):
    
    • Adults—Apply to the affected area of the skin two or three times per day.
    
    
    • Children—Apply to the affected area of the skin two or three times per day.
    
    
  
  
  • For topical dosage form (lotion):
    
    • Adults—Apply to the affected area of the skin two to four times per day.
    
    
    • Children—Apply to the affected area of the skin two to four times per day.
    
    
  
  
  • For topical dosage form (ointment):
    
    • Adults—Apply to the affected area of the skin three or four times per day.
    
    
    • Children—Apply to the affected area of the skin three or four times per day.
    
    
  
  
  • For topical dosage form (solution):
    
    • Adults—Apply to the affected area of the skin three or four times per day.
    
    
    • Children—Apply to the affected area of the skin three or four times per day.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, apply 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.

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 Instacort-10

It is very important that your doctor check your or your child's progress at regular visits for any unwanted effects that may be caused by this medicine.

If your or your child's symptoms do not improve within a few days, or if they become worse, check with your doctor.

Using too much of this medicine or using it for a long time may increase your risk of having adrenal gland problems. The risk is greater for children and patients who use large amounts for a long time. Talk to your doctor right away if you or your child have more than one of these symptoms while you are using this medicine: blurred vision; dizziness or fainting; a fast, irregular, or pounding heartbeat; increased thirst or urination; irritability; or unusual tiredness or weakness.

Stop using this medicine and check with your doctor right away if you or your child have a skin rash, burning, stinging, swelling, or irritation on the skin.

Do not use cosmetics or other skin care products on the treated areas.

Instacort-10 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:

Incidence not known

• Blistering, burning, crusting, dryness, or flaking of the skin


• irritation


• itching, scaling, severe redness, soreness, or swelling of the skin


• redness and scaling around the mouth


• thinning of the skin with easy bruising, especially when used on the face or where the skin folds together (e.g. between the fingers)


• thinning, weakness, or wasting away of the skin

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:

Incidence not known

• Acne or pimples


• burning and itching of the skin with pinhead-sized red blisters


• burning, itching, and pain in hairy areas, or pus at the root of the hair


• increased hair growth on the forehead, back, arms, and legs


• lightening of normal skin color


• lightening of treated areas of dark skin


• reddish purple lines on the arms, face, legs, trunk, or groin


• softening of the skin

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 Instacort-10 resources

• Instacort-10 Use in Pregnancy & Breastfeeding
• Instacort-10 Drug Interactions
• Instacort-10 Support Group
• 15 Reviews for Instacort-10 - Add your own review/rating

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Isocaine

mepivacaine hydrochloride

Dosage Form: injection, solution
Mepivacaine HCl 3%

(Mepivacaine Hydrochloride Injection, USP)


Mepivacaine HCl 2%

(with Levonordefrin 1:20,000)

(Mepivacaine Hydrochloride and Levonordefrin Injection, USP)

Rx Only

THESE SOLUTIONS ARE INTENDED FOR DENTAL USE ONLY.

Isocaine Description

Mepivacaine Hydrochloride, a tertiary amine used as a local anesthetic, is 1-methyl-2', 6' - pipecoloxylidide monohydrochloride with the following structural formula:

It is a white, crystalline, odorless powder soluble in water, but very resistant to both acid and alkaline hydrolysis.

Levonordefrin, a sympathomimetic amine used as a vasoconstrictor in local anesthetic solution, is (-)-

It is a white or buff-colored crystalline solid, freely soluble in aqueous solutions of mineral acids, but practically insoluble in water;

DENTAL CARTRIDGES MAY NOT BE AUTOCLAVED.

Mepivacaine hydrochloride injection 3% and Mepivacaine hydrochloride 2% with levonordefrin 1:20,000 injection are sterile solutions for injection.

COMPOSITION

	CARTRIDGE
Each mL contains:	2%	3%
Mepivacaine Hydrochloride	20 mg	30 mg
Levonordefrin	0.05 mg	-
Sodium Chloride	4 mg	6 mg
Potassium metabisulfite	1.2 mg	-
Edetate disodium	0.25 mg	-
Sodium Hydroxide q.s. ad pH; Hydrochloric Acid	0.5 mg	-
Water For Injection, qs. ad.	1 mL	1 mL
The pH of the 2% cartridge solution is adjusted between 3.3 and 5.5 with NaOH.
The pH of the 3% cartridge solution is adjusted between 4.5 and 6.8 with NaOH.

Isocaine - Clinical Pharmacology

Mepivacaine stabilizes the neuronal membrane and prevents the initiation and transmission of nerve impulses, thereby effecting local anesthesia.

Mepivacaine is rapidly metabolized, with only a small percentage of the anesthetic (5 to 10 percent) being excreted unchanged in the urine. Mepivacaine because of its amide structure, is not detoxified by the circulating plasma esterases. The liver is the principal site of metabolism, with over 50 percent of the administered dose being excreted into the bile as metabolites. Most of the metabolized Mepivacaine is probably resorbed in the intestine and then excreted into the urine since only a small percentage is found in the feces. The principal route of excretion is via the kidney. Most of the anesthetic and its metabolites are eliminated within 30 hours. It has been shown that hydroxylation and N-demethylation, which are detoxification reactions, play important roles in the metabolism of the anesthetic. Three metabolites of Mepivacaine have been identified from adult humans: two phenols, which are excreted almost exclusively as their glucuronide conjugates, and the N-demethylated compound (2', 6' - pipecoloxylidide).

The onset of action is rapid (30 to 120 seconds in the upper jaw; 1 to 4 minutes in the lower jaw) and Mepivacaine HCl 3% will ordinarily provide operating anesthesia of 20 minutes in the upper jaw and 40 minutes in the lower jaw.

Mepivacaine HCl 2% with Levonordefrin 1:20,000 provides anesthesia of longer duration for more prolonged procedures, 1 hour to 2.5 hours in the upper jaw and 2.5 hours to 5.5 hours in the lower jaw.

Mepivacaine does not ordinarily produce irritation or tissue damage.

Levonordefrin is a sympathomimetic amine used as a vasoconstrictor in local anesthetic solutions. It has pharmacologic activity similar to that of Epinephrine but it is more stable than Epinephrine. In equal concentrations, Levonordefrin is less potent than Epinephrine in raising blood pressure, and as a vasoconstrictor.

Indications and Usage for Isocaine

Mepivacaine is indicated for production of local anesthesia for dental procedures by infiltration or nerve block in adults and pediatric patients.

Contraindications

Mepivacaine is contraindicated in patients with a known hypersensitivity to amide-type local anesthetics.

Warnings

RESUSCITATIVE EQUIPMENT AND DRUGS SHOULD BE IMMEDIATELY AVAILABLE. (See ADVERSE REACTIONS).

Reactions resulting in fatality have occurred on rare occasions with the use of local anesthetics, even in the absence of a history of hypersensitivity.

Fatalities may occur with use of local anesthetics in the head and neck region as the result of retrograde arterial flow to vital CNS areas even when maximum recommended doses are observed. The practitioner should be alert to early evidence of alteration in sensorium or vital signs.

The solution which contains a vasoconstrictor (Mepivacaine HCl 2%) should be used with extreme caution for patients whose medical history and physical evaluation suggest the existence of hypertension, arteriosclerotic heart disease, cerebral vascular insufficiency, heart block, thyrotoxicosis and diabetes, etc.

The solution which contains a vasoconstrictor (Mepivacaine HCl 2%) also contains potassium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people. Mepivacaine HCl 3% is SULFITE FREE.

Mepivacaine, along with other local anesthetics, is capable of producing methemoglobinemia. The clinical signs of methemoglobinemia are cyanosis of the nail beds and lips, fatigue and weakness. If methemoglobinemia does not respond to administration of oxygen, administration of methylene blue intravenously 1-2 mg/kg body weight over a 5 minute period is recommended.

The American Heart Association has made the following recommendations regarding the use of local anesthetics with vasoconstrictors in patients with ischemic heart disease: "Vasoconstrictor agents should be used in local anesthesia solutions during dental practice only when it is clear that the procedure will be shortened or the analgesia rendered more profound. When a vasoconstrictor is indicated, extreme care should be taken to avoid intravascular injection. The minimum possible amount of vasoconstrictor should be used." (Kaplan, EL, editor: Cardiovascular disease in dental practice, Dallas 1986, American Heart Association.)

Precautions

The safety and effectiveness of Mepivacaine depend upon proper dosage, correct technique, adequate precautions, and readiness for emergencies.

The lowest dose that results in effective anesthesia should be used to avoid high plasma levels and possible adverse effects. Injection of repeated doses of Mepivacaine may cause significant increases in blood levels with each repeated dose due to slow accumulation of the drug or its metabolites, or due to slower metabolic degradation than normal.

Tolerance varies with the status of the patient. Debilitated, elderly patients, acutely ill patients, and children should be given reduced doses commensurate with their weight and physical status.

Mepivacaine should be used with caution in patients with a history of severe disturbances of cardiac rhythm or heart block.

INJECTIONS SHOULD ALWAYS BE MADE SLOWLY WITH ASPIRATION TO AVOID INTRAVASCULAR INJECTION AND THEREFORE SYSTEMIC REACTION TO BOTH LOCAL ANESTHETIC AND VASOCONSTRICTOR.

If sedatives are employed to reduce patient apprehension, use reduced doses, since local anesthetic agents, like sedatives, are central nervous system depressants which in combination may have an additive effect. Young children should be given minimal doses of each agent.

Changes in sensorium such as excitation, disorientation or drowsiness may be early indications of a high blood level of the drug and may occur following inadvertent intravascular administration or rapid absorption of Mepivacaine.

Local anesthetic procedures should be used with caution when there is inflammation and/or sepsis in the region of the proposed injection.

Information for Patients

The patient should be cautioned against loss of sensation and possibility of biting trauma should the patient attempt to eat or chew gum prior to return of sensation.

Clinically Significant Drug Interactions

The administration of local anesthetic solutions containing vasopressors, such as Levonordefrin, Epinephrine or Norepinephrine, to patients receiving tricyclic antidepressants or monoamine oxidase inhibitors may produce severe, prolonged hypertension. Concurrent use of these agents should generally be avoided. In situations when concurrent therapy is necessary, careful patient monitoring is essential. Concurrent administration of vasopressor drugs and of ergot-type oxytocic drugs may cause severe, persistent hypertension or cerebrovascular accidents.

Phenothiazines and butyrophenones may reduce or reverse the pressor effect of Epinephrine.

Solutions containing a vasoconstrictor should be used cautiously in the presence of disease which may adversely affect the patient's cardiovascular system. Serious cardiac arrhythmias may occur if preparations containing a vasoconstrictor are employed in patients during or following the administration of potent inhalation anesthetics.

MEPIVACAINE SHOULD BE USED WITH CAUTION IN PATIENTS WITH KNOWN DRUG ALLERGIES AND SENSITIVITIES. A thorough history of the patient's prior experience with Mepivacaine or other local anesthetics as well as concomitant or recent drug use should be taken (see CONTRAINDICATIONS). Patients allergic to methylparaben or para-aminobenzoic acid derivatives (procaine, tetracaine, benzocaine, etc.) have not shown cross-sensitivity to agents of the amide type such as Mepivacaine. Since Mepivacaine is metabolized in the liver and excreted by the kidneys, it should be used cautiously in patients with liver and renal disease.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Studies of Mepivacaine HCl in animals to evaluate the carcinogenic and mutagenic potential or the effect on fertility have not been conducted.

Pregnancy

Teratogenic Effects

Pregnancy Category C

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

Nursing Mothers

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 this solution is administered to a nursing woman.

Pediatric Use

Great care must be exercised in adhering to safe concentrations and dosages for pedodontic administration (see DOSAGE AND ADMINISTRATION).

Adverse Reactions

Reactions to MEPIVACAINE are characteristic of those associated with other amide-type local anesthetics. Systemic adverse reactions involving the central nervous system and the cardiovascular system usually result from high plasma levels (which may be due to excessive dosage, rapid absorption, inadvertent intravascular injection, or slow metabolic degradation), injection technique, or volume of injection.

A small number of reactions may result from hypersensitivity, idiosyncrasy or diminished tolerance to normal dosage on the part of the patient.

Persistent paresthesias of the lips, tongue, and oral tissues have been reported with the use of mepivacaine, with slow, incomplete, or no recovery. These post-marketing events have been reported chiefly following nerve blocks in the mandible and have involved the trigeminal nerve and its branches.

Reactions involving the central nervous system are characterized by excitation and/or depression. Nervousness, dizziness, blurred vision, or tremors may occur followed by drowsiness, convulsions, unconsciousness, and possible respiratory arrest. Since excitement may be transient or absent, the first manifestations may be drowsiness merging into unconsciousness and respiratory arrest.

Cardiovascular reactions are depressant. They may be the result of direct drug effect or more commonly in dental practice, the result of vasovagal reaction, particularly if the patient is in the sitting position. Failure to recognize premonitory signs such as sweating, feeling of faintness, changes in pulse or sensorium may result in progressive cerebral hypoxia and seizure or serious cardiovascular catastrophe. Management consists of placing the patient in the recumbent position and administration of oxygen. Vasoactive drugs such as Ephedrine or Methoxamine may be administered intravenously.

Allergic reactions are rare and may occur as a result of sensitivity to the local anesthetic and are characterized by cutaneous lesions of delayed onset or urticaria, edema and other manifestations of allergy. The detection of sensitivity by skin testing is of limited value. As with other local anesthetics, anaphylactoid reactions to Mepivacaine have occurred rarely. The reaction may be abrupt and severe and is not usually dose related. Localized puffiness and swelling may occur.

Overdosage

Treatment of a patient with toxic manifestations consists of assuring and maintaining a patient airway and supporting ventilation (respiration) as required. This usually will be sufficient in the management of most reactions. Should a convulsion persist despite ventilatory therapy, small increments of anticonvulsive agents may be given intravenously, such as benzodiazephine (e.g., diazepam) or ultrashort-acting barbiturates (e.g., thiopental or thiamylal) or short-acting barbiturates (e.g., pentobarbital or secobarbital). Cardiovascular depression may require circulatory assistance with intravenous fluids and/or vasopressor (e.g., Ephedrine) as dictated by the clinical situation. Allergic reactions should be managed by conventional means.

IV and SC LD50's in mice for Mepivacaine Hydrochloride 3% are 33 and 258 mg/kg, respectively. The acute IV and SC LD50's in mice for Mepivacaine Hydrochloride 2% with Levonordefrin 1:20,000 are 30 and 184 mg/kg, respectively.

Isocaine Dosage and Administration

As with all local anesthetics, the dose varies and depends upon the area to be anesthetized, the vascularity of the tissues, individual tolerance and the technique of anesthesia. The lowest dose needed to provide effective anesthesia should be administered. For specific techniques and procedures refer to standard dental manuals and textbooks.

For infiltration and block injections in the upper or lower jaw, the average dose of 1 cartridge will usually suffice.

Each cartridge contains 1.7 mL (34 mg of 2% or 51 mg of 3%).

5.3 cartridges (180 mg of the 2% solution or 270 mg of the 3% solution) are usually adequate to effect anesthesia of the entire oral cavity. Whenever a larger dose seems to be necessary for an extensive procedure, the maximum dose should be calculated according to the patient's weight. A dose of up to 3 mg per pound of body weight may be administered. At any single dental sitting the total dose for all injected sites should not exceed 400 mg in adults.

The maximum pediatric dose should be carefully calculated.

Maximum dose for pediatric population =

Child's Weight (lbs.) 150

×

Maximum Recommended Dose for Adults (400 mg)

The following table, approximating these calculations, may also be used as a guide. This table is based upon a recommended maximum for larger pediatric population of 5.3 cartridges (the maximum recommended adult dose) during any single dental sitting, regardless of the pediatric patient's weight or (for 2% mepivacaine) calulated maximum amount of drug:

Maximum Allowable Dosage*
	3% Mepivacaine		2% Mepivacaine
			1:20,000 Levonordefrin
	3 mg/lb		3mg/lb
	(270 mg max.)		(180 mg max.)
Weight (lb.)	mg	Number of Cartridges	mg	Number of Cartridges
* Adapted from Malamed, Stanley F: Handbook of medical emergencies in the dental office, ed. 2, St. Louis, 1982. The C.V. Mosby Co.
20	60	1.2	60	1.8
30	90	1.8	90	2.6
40	120	2.3	120	3.5
50	150	2.9	150	4.4
60	180	3.5	180	5.3
80	240	4.7	180	5.3
100	270	5.3	180	5.3
120	270	5.3	180	5.3

When using Mepivacaine HCl injection USP for infiltration or regional block anesthesia, injection should always be made slowly and with frequent aspiration.

Any unused portion of a cartridge should be discarded.

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

DISINFECTION OF CARTRIDGES

As in the case of any cartridge, the diaphragm should be disinfected before needle puncture. The diaphragm should be thoroughly swabbed with either pure 91% isopropyl alcohol or 70% ethyl alcohol, USP, just prior to use. Many commercially available alcohol solutions contain ingredients which are injurious to container components, and therefore, should not be used. Cartridges should not be immersed in any solution.

How is Isocaine Supplied

Mepivacaine HCl 3%; (Mepivacaine Hydrocholoride Injection USP) is available in cardboard boxes containing 5 blisters of 10 × 1.7 mL dental cartridges, 50 per carton. Mepivacaine HCl 2% (Mepivacaine Hydrochloride and Levonordefrin Injection; USP) is available in cardboard boxes containing 5 blisters of 10 × 1.7 mL dental cartridges, 50 per carton.

Both solutions should be stored at controlled room temperature, below 25° C (77° F). Protect from light. Do not permit to freeze. BOXES: For protection from light, retain in box until time of use. Once opened, the box should be reclosed by closing the top flap. The Mepivacaine 2% solution should not be used if its color is pinkish or darker than slightly yellow or it contains a precipitate. Cartridge warmers should not be used with Mepivacaine HCl injection USP products.

Manufactured and Distributed by

Novocol Pharmaceutical of Canada, Inc.

Cambridge Ontario Canada N1R 5S9

Rev 07/07 (2780-1)

PRINCIPAL DISPLAY PANEL - 1.7 mL Cartridge Carton

NRG

Distributed by IQ Dental

NDC 51004-2020-5

MEPIVACAINE HCl 3%

INJECTION

without VASOCONSTRICTOR

(MEPIVACAINE HCl INJECTION, USP)

50 Cartridges • 1.7 mL Minimum

Rx Only

iQDental™

Isocaine  mepivacaine hydrochloride  injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 51004-2020 Route of Administration SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Mepivacaine Hydrochloride (Mepivacaine) Mepivacaine Hydrochloride 30 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength Sodium Chloride 6 mg  in 1 mL Water

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 51004-2020-5 50 CARTRIDGE In 1 CARTON contains a CARTRIDGE 1 1.7 mL In 1 CARTRIDGE This package is contained within the CARTON (51004-2020-5)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA088387	08/20/2010

Labeler - Novocol Pharmaceutical of Canada, Inc. (201719960)

Registrant - IQ Dental (800349763)

Establishment
Name	Address	ID/FEI	Operations
Novocol		201719960	MANUFACTURE

Revised: 07/2010Novocol Pharmaceutical of Canada, Inc.

More Isocaine resources

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

Compare Isocaine with other medications

• Local Anesthesia

Insulin Detemir Vials

Pronunciation: IN-su-lin DE-te-mir
Generic Name: Insulin Detemir
Brand Name: Levemir

Insulin Detemir Vials are used for:

Treating diabetes mellitus.

Insulin Detemir Vials are a long-acting form of the hormone insulin. It works by helping your body to use sugar properly. This lowers the amount of glucose in the blood, which helps to treat diabetes.

Do NOT use Insulin Detemir Vials if:

• you are allergic to any ingredient in Insulin Detemir Vials


• you are having an episode of low blood sugar

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

Before using Insulin Detemir Vials:

Some medical conditions may interact with Insulin Detemir Vials. 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 drink alcoholic beverages or smoke


• if you have kidney or liver problems; nerve problems; adrenal, pituitary, or thyroid problems; or diabetic ketoacidosis


• if you use 3 or more insulin injections per day


• if you are fasting, have high blood sodium levels, or are on a low-salt diet

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

• Beta-blockers (eg, propranolol), clonidine, guanethidine, lithium, or reserpine because they may increase the risk of high or low blood sugar or may hide the signs and symptoms of low blood sugar, if it occurs


• Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril), disopyramide, fenfluramine, fibrates (eg, clofibrate, gemfibrozil), fluoxetine, monoamine oxidase inhibitors (MAOIs) (eg, phenelzine), oral medicines for diabetes (eg, glipizide, metformin, nateglinide), pentamidine, propoxyphene, salicylates (eg, aspirin), somatostatin analogs (eg, octreotide), or sulfonamide antibiotics (eg, sulfamethoxazole) because the risk of low blood sugar may be increased


• Corticosteroids (eg, prednisone), danazol, diuretics (eg, furosemide, hydrochlorothiazide), estrogen, hormonal contraceptives (eg, birth control pills), isoniazid, niacin, phenothiazines (eg, chlorpromazine), progesterones (eg, medroxyprogesterone), somatropin, sympathomimetics (eg, albuterol, epinephrine, terbutaline), or thyroid hormones (eg, levothyroxine) because they may decrease Insulin Detemir Vials's effectiveness, resulting in high blood sugar

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

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

• An extra patient leaflet is available with Insulin Detemir Vials. Talk to your pharmacist if you have questions about this information.


• Use Insulin Detemir Vials at the same time each day, as directed by your doctor.


• If you will be using Insulin Detemir Vials at home, a health care provider will teach you how to use it. Be sure you understand how to use Insulin Detemir Vials. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.


• Insulin Detemir Vials should be clear and colorless. Do not use Insulin Detemir Vials if it contains particles, is cloudy, discolored, or thickened, or if the vial is cracked or damaged.


• Do NOT dilute Insulin Detemir Vials or mix it with other insulin. Do NOT use it in an insulin pump.


• Use the proper technique taught to you by your doctor. Inject deep under the skin, NOT into a vein or muscle.


• Injection sites within an injection area (eg, abdomen, thigh, upper arm) must be rotated from one injection to the next. Do not inject insulin into skin that is red, swollen, or itchy.


• Be sure you have purchased the correct insulin. Insulin comes in a variety of containers, including vials, cartridges, and pens. Make sure that you understand how to properly measure and prepare your dose. If you have any questions about measuring and preparing your dose, contact your doctor or pharmacist for information.


• The effect of Insulin Detemir Vials may last for up to 24 hours.


• Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.


• It is very important to follow your insulin regimen exactly. Do NOT miss any doses. Ask your doctor for specific instructions to follow in case you ever miss a dose of insulin.

Ask your health care provider any questions you may have about how to use Insulin Detemir Vials.

Important safety information:

• Drowsiness, dizziness, lightheadedness, or blurred vision may occur while you use Insulin Detemir Vials. These effects may be worse if you take it with alcohol or certain medicines. Use Insulin Detemir Vials with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Do not drink alcohol without discussing it with your doctor. Drinking alcohol may increase your risk of developing high or low blood sugar.


• Do NOT use more than the recommended dose, use more often than prescribed, or change the type or dose of insulin you are using without checking with your doctor.


• Any change of insulin should be made cautiously and only under medical supervision. Changes in purity, strength, brand (manufacturer), type (regular, NPH, lente), or species (beef, pork, beef-pork, human), and/or method of manufacture may require a change in dose.


• Illness, especially with nausea and vomiting, may cause your insulin requirements to change. Even if you are not eating, you still require insulin. You and your doctor should establish a sick day plan to use in case of illness. When you are sick, test your blood/urine frequently and call your doctor as instructed.


• Tell your doctor or dentist that you use Insulin Detemir Vials before you receive any medical or dental care, emergency care, or surgery.


• If you will be traveling across time zones, ask your doctor about adjustments to your insulin schedule.


• Carry an ID card at all times that says you have diabetes.


• Proper diet, regular exercise, and regular testing of blood sugar are important for best results when using Insulin Detemir Vials. Follow your doctor's instructions carefully. If your blood sugar level is often higher than it should be and you are taking Insulin Detemir Vials according to the directions, check with your doctor.


• An insulin reaction resulting from low blood sugar levels (hypoglycemia) may occur if you take too much insulin, skip a meal, or exercise too much. Low blood sugar may make you anxious, sweaty, weak, dizzy, drowsy, or faint. It may also make your heart beat faster; make your vision change; give you a headache, chills, or tremors; or make you more hungry. It is a good idea to carry a reliable source of glucose (eg, tablets or gel) to treat low blood sugar. If this is not available, you should eat or drink a quick source of sugar like table sugar, honey, candy, orange juice, or non-diet soda. This will raise your blood sugar level quickly. Tell your doctor right away if this happens. To prevent low blood sugar, eat meals at the same time each day and do not skip meals.


• Developing a fever or infection, eating significantly more than usual, or missing your dose of insulin may cause high blood sugar (hyperglycemia). High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away.


• Check with your doctor if you notice a depression in the skin or skin thickening at the injection site. You may need to change your injection technique.


• Proper diet, regular exercise, and regular testing of blood sugar are important for best results when using Insulin Detemir Vials. Tell your doctor is you have had a recent change in diet or physical activity.


• Lab tests, including fasting blood glucose levels or hemoglobin A_1c, may be performed while you use Insulin Detemir Vials. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Insulin Detemir Vials with caution in the ELDERLY; if low blood sugar occurs, it may be more difficult to recognize in these patients.


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

Possible side effects of Insulin Detemir Vials:

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:

Redness, swelling, itching, or mild pain at the injection site.

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; wheezing); changes in vision; chills; confusion; dizziness; drowsiness; fainting; fast or irregular heartbeat; headache; loss of consciousness; mental or mood changes; muscle pain, weakness, or cramping; seizures; slurred speech; swelling; tremor; trouble breathing; trouble concentrating; unusual hunger; unusual sweating; weakness.

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: Insulin Detemir 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 chills; dizziness; drowsiness; fainting; headache; increased heartbeat; increased hunger; loss of consciousness; nervousness; seizures; shakiness; sweating; tremor; vision changes; weakness.

Proper storage of Insulin Detemir Vials:

Store new (unopened) vials in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Store used (open) vials in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). If refrigeration is not possible, store at room temperature, below 86 degrees F (30 degrees C). Store away from heat and light. Throw away unrefrigerated or opened vials after 42 days, even if they still contain medicine.

Do not leave Insulin Detemir Vials in a car on a warm or sunny day. Do not use Insulin Detemir Vials after the expiration date stamped on the label. Keep Insulin Detemir Vials, as well as syringes and needles, out of the reach of children and away from pets.

General information:

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


• Insulin Detemir Vials 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 Insulin Detemir Vials. 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 Insulin Detemir resources

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

Compare Insulin Detemir with other medications

• Diabetes, Type 1
• Diabetes, Type 2

Instacort

Generic Name: hydrocortisone topical (hye droe KOR ti sone)

Brand Names: Ala-Cort, Ala-Scalp HP, Aquanil HC, Beta HC, Caldecort, Cortaid, Cortaid Intensive Therapy, Cortaid Maximum Strength, Cortaid with Aloe, Cortalo with Aloe, Corticaine, Cortizone for Kids, Cortizone-10, Cortizone-10 Intensive Healing Formula, Cortizone-10 Plus, Cortizone-5, Dermarest Dricort, Dermarest Eczema Medicated, Dermarest Plus Anti-Itch, Dermtex HC, Genasone/Aloe, Gly-Cort, Gynecort Maximum Strength, Hycort, Hydrocortisone 1% In Absorbase, Hydrocortisone with Aloe, Hydrocortisone-Aloe, Hytone, Instacort, Itch-X Lotion, Locoid, Locoid Lipocream, Locoid Lotion, Massengill Medicated Soft Cloth, MD Hydrocortisone, Neutrogena T-Scalp, NuCort with Aloe, NuZon, Pandel, Recort Plus, Rederm, Sarnol-HC, Scalacort, Texacort, U-Cort, Westcort

What is Instacort (hydrocortisone topical)?

Hydrocortisone is a topical steroid. It reduces the actions of chemicals in the body that cause inflammation, redness, and swelling.

Hydrocortisone topical is used to treat inflammation of the skin caused by a number of conditions such as allergic reactions, eczema, or psoriasis.

Hydrocortisone topical may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Instacort (hydrocortisone topical)?

There are many brands and forms of hydrocortisone topical available and not all brands are listed on this leaflet.

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

Do not cover treated skin areas with a bandage or other covering unless your doctor has told you to. If you are treating the diaper area of a baby, do not use plastic pants or tight-fitting diapers. Covering the skin that is treated with hydrocortisone topical can increase the amount of the drug your skin absorbs, which may lead to unwanted side effects. Follow your doctor's instructions.

Avoid using this medication on your face, near your eyes, or on body areas where you have skin folds or thin skin.

Do not use this medication on a child without a doctor's advice. Children are more sensitive to the effects of hydrocortisone topical.

Hydrocortisone topical will not treat a bacterial, fungal, or viral skin infection.

Contact your doctor if your condition does not improve or if it gets worse after using this medication for several days.

What should I discuss with my healthcare provider before using Instacort (hydrocortisone topical)?

Do not use this medication if you are allergic to hydrocortisone.

Hydrocortisone topical will not treat a bacterial, fungal, or viral skin infection.

FDA pregnancy category C. It is not known whether hydrocortisone topical is harmful to an unborn baby. Before using this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether hydrocortisone topical passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not use this medication on a child without a doctor's advice. Children are more sensitive to the effects of hydrocortisone topical.

How should I use Instacort (hydrocortisone topical)?

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

Hydrocortisone topical will not treat a bacterial, fungal, or viral skin infection.

Wash your hands before and after each application, unless you are using hydrocortisone topical to treat a hand condition.

Apply a small amount to the affected area and rub it gently into the skin.

Avoid using this medication on your face, near your eyes or mouth, or on body areas where you have skin folds or thin skin.

Do not cover treated skin areas with a bandage or other covering unless your doctor has told you to. If you are treating the diaper area of a baby, do not use plastic pants or tight-fitting diapers. Covering the skin that is treated with hydrocortisone topical can increase the amount of the drug your skin absorbs, which may lead to unwanted side effects. Follow your doctor's instructions. Contact your doctor if your condition does not improve or if it gets worse after using this medication for several days. It is important to use hydrocortisone topical regularly to get the most benefit. Store hydrocortisone topical at room temperature away from moisture and heat.

What happens if I miss a dose?

Use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and use the medicine at the next regularly scheduled time. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine, or if anyone has accidentally swallowed it. An overdose of hydrocortisone topical applied to the skin is not expected to produce life-threatening symptoms.

What should I avoid while using Instacort (hydrocortisone topical)?

Avoid getting this medication in your eyes, mouth, and nose, or on your lips. If it does get into any of these areas, wash with water. Do not use hydrocortisone topical on sunburned, windburned, irritated, or broken skin. Also avoid using this medication in open wounds.

Avoid using skin products that can cause irritation, such as harsh soaps or shampoos or skin cleansers, hair coloring or permanent chemicals, hair removers or waxes, or skin products with alcohol, spices, astringents, or lime. Do not use other medicated skin products unless your doctor has told you to.

Instacort (hydrocortisone topical) side effects

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

• 
  

  blurred vision, or seeing halos around lights;

  
  


• 
  

  uneven heartbeats;

  
  


• 
  

  sleep problems (insomnia);

  
  


• 
  

  weight gain, puffiness in your face; or

  
  


• 
  

  feeling tired.

  
  

Less serious side effects may include:

• 
  

  skin redness, burning, itching, or peeling;

  
  


• 
  

  thinning of your skin;

  
  


• 
  

  blistering skin; or

  
  


• 
  

  stretch marks.

  
  

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

What other drugs will affect Instacort (hydrocortisone topical)?

It is not likely that other drugs you take orally or inject will have an effect on topically applied hydrocortisone. But many drugs can interact with each other. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More Instacort resources

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

• Instacort Gel MedFacts Consumer Leaflet (Wolters Kluwer)


• Ala-Cort Advanced Consumer (Micromedex) - Includes Dosage Information


• Anusol-HC Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• Carmol HC MedFacts Consumer Leaflet (Wolters Kluwer)


• Carmol HC Prescribing Information (FDA)


• Cortizone-10 Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• Hydrocortisone Acetate Monograph (AHFS DI)


• Hydrocortisone with Aloe Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• Hytone Prescribing Information (FDA)


• Locoid Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• Locoid Lipocream Prescribing Information (FDA)


• Locoid Lotion Prescribing Information (FDA)


• Nutracort Lotion MedFacts Consumer Leaflet (Wolters Kluwer)


• Pandel Prescribing Information (FDA)


• Pediaderm HC Lotion MedFacts Consumer Leaflet (Wolters Kluwer)


• ProctoCream-HC Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• Proctocort Prescribing Information (FDA)


• Texacort Prescribing Information (FDA)


• U-cort Prescribing Information (FDA)


• Westcort Prescribing Information (FDA)

Compare Instacort with other medications

• Anal Itching
• Aphthous Stomatitis, Recurrent
• Atopic Dermatitis
• Dermatitis
• Eczema
• Gingivitis
• Proctitis
• Pruritus
• Psoriasis
• Seborrheic Dermatitis
• Skin Rash
• Ulcerative Colitis, Active

Where can I get more information?

• Your pharmacist can provide more information about hydrocortisone topical.

See also: Instacort side effects (in more detail)

Insulin Glargine Vials

Pronunciation: IN-su-lin GLAR-jeen
Generic Name: Insulin Glargine
Brand Name: Lantus

Insulin Glargine Vials are used for:

Treating diabetes mellitus.

Insulin Glargine Vials are a long-acting form of the hormone insulin. It works by helping your body to use sugar properly. This lowers the amount of glucose in the blood, which helps to treat diabetes.

Do NOT use Insulin Glargine Vials if:

• you are allergic to any ingredient in Insulin Glargine Vials

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

Before using Insulin Glargine Vials:

Some medical conditions may interact with Insulin Glargine Vials. 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 drink alcoholic beverages


• if you have liver or kidney problems, diabetic ketoacidosis, or nerve problems


• if you have high blood sodium levels or are on a low salt diet

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

• Beta-blockers (eg, propranolol), clonidine, guanethidine, lithium, or reserpine because they may increase the risk of high or low blood sugar or may hide the signs and symptoms of low blood sugar, if it occurs


• Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril), disopyramide, fenfluramine, fibrates (eg, clofibrate, gemfibrozil), fluoxetine, monoamine oxidase inhibitors (MAOIs) (eg, phenelzine), oral medicine for diabetes (eg, glipizide, metformin, nateglinide), pentamidine, propoxyphene, salicylates (eg, aspirin), somatostatin analogs (eg, octreotide), or sulfonamide antibiotics (eg, sulfamethoxazole) because the risk of low blood sugar may be increased


• Atypical antipsychotics (eg, olanzapine), corticosteroids (eg, prednisone), danazol, diuretics (eg, furosemide, hydrochlorothiazide), estrogen, hormonal contraceptives (eg, birth control pills), isoniazid, phenothiazines (eg, chlorpromazine), progesterones (eg, medroxyprogesterone), protease inhibitors (eg, ritonavir), somatropin, sympathomimetics (eg, albuterol, epinephrine, terbutaline), or thyroid hormones (eg, levothyroxine) because they may decrease Insulin Glargine Vials's effectiveness, resulting in high blood sugar

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

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

• Extra patient leaflets are available with Insulin Glargine Vials. Talk to your pharmacist if you have questions about this information.


• Use Insulin Glargine Vials at the same time each day, as directed by your doctor.


• A health care provider will teach you how to use Insulin Glargine Vials. Be sure you understand how to use it. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.


• Wash your hands before you use Insulin Glargine Vials.


• Always check before each use to be sure you are injecting the correct dose of insulin. Using too much or too little insulin may result in serious side effects.


• Insulin Glargine Vials should be clear and colorless. Do not use Insulin Glargine Vials if it contains particles or is discolored, or if the container is cracked or damaged.


• Do NOT dilute Insulin Glargine Vials or mix it with other insulin. Do NOT use it in an insulin pump.


• Use the proper technique taught to you by your doctor. Inject deep under the skin, NOT into a vein or muscle.


• Injection sites within an injection area (abdomen, thigh, or upper arm) must be rotated from one injection to the next.


• Be sure you have purchased the correct insulin. Insulin comes in a variety of containers, including vials, cartridges, and pens. Make sure that you understand how to properly measure and prepare your dose. If you have any questions about measuring and preparing your dose, contact your doctor or pharmacist for information.


• The effect of Insulin Glargine Vials lasts for up to 24 hours.


• Insulin Glargine Vials begins lowering blood sugar about 1 to 2 hours after an injection. There is no peak effect. The effect lasts for up to 24 hours.


• Do not mix this insulin together with any other type of insulin or any other medicine in the same syringe.


• Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.


• It is very important to follow your insulin regimen exactly. Do NOT miss any doses. Ask your doctor for specific instructions to follow in case you ever miss a dose of insulin.

Ask your health care provider any questions you may have about how to use Insulin Glargine Vials.

Important safety information:

• Insulin Glargine Vials may cause drowsiness, dizziness, blurred vision, or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Insulin Glargine Vials with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Do not drink alcohol without discussing it with your doctor. Drinking alcohol may increase your risk of developing high or low blood sugar.


• Do not exceed the recommended dose, use Insulin Glargine Vials more often than prescribed, or change the type or dose of insulin you are taking without checking with your doctor.


• Proper diet, regular exercise, and regular testing of the blood sugar are important for best results when using Insulin Glargine Vials.


• Illness, especially with nausea and vomiting, emotional problems, stress, or changes in diet or activity level, may cause your insulin requirements to change. Even if you are not eating, you still require insulin. You and your doctor should establish a sick day plan to use in case of illness. When you are sick, test your blood/urine frequently and call your doctor as instructed.


• If you will be traveling across time zones, consult your doctor concerning adjustments in your insulin schedule.


• An insulin reaction resulting from low blood sugar levels (hypoglycemia) may occur if you take too much insulin, skip a meal, or exercise too much. Low blood sugar may make you anxious, sweaty, weak, dizzy, drowsy, or faint. It may also make your heart beat faster; make your vision change; give you a headache, chills, or tremors; or make you more hungry. It is a good idea to carry a reliable source of glucose (eg, tablets or gel) to treat low blood sugar. If this is not available, you should eat or drink a quick source of sugar like table sugar, honey, candy, orange juice, or non-diet soda. This will raise your blood sugar level quickly. Tell your doctor right away if this happens. To prevent low blood sugar, eat meals at the same time each day and do not skip meals.


• Developing a fever or infection, eating significantly more than usual, or missing your dose of insulin may cause high blood sugar (hyperglycemia). High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away. If not treated, loss of consciousness, coma, or death may occur.


• Carry an ID card at all times that says you have diabetes.


• Lab tests, including fasting blood glucose levels or glycosylated hemoglobin levels, may be performed while you use Insulin Glargine Vials. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Insulin Glargine Vials with caution in the ELDERLY; they may be more sensitive to its effects, especially low blood sugar.


• Insulin Glargine Vials 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 using Insulin Glargine Vials while you are pregnant. Insulin Glargine Vials are found in breast milk. If you are or will be breast-feeding while you use Insulin Glargine Vials, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Insulin Glargine Vials:

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:

Redness, swelling, itching, or mild pain at the injection site.

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); changes in vision; chills; confusion; dizziness; drowsiness; fainting; fast heartbeat; fast, shallow breathing; headache; hoarseness; increased hunger, thirst, or urination; loss of consciousness; nervousness; seizures; slurred speech; stomach pain; sweating; sweet or fruity breath odor; swelling of the arms or legs; tremor; weakness.

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: Insulin Glargine 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 chills; dizziness; drowsiness; fainting; headache; increased heartbeat; increased hunger; loss of consciousness; nervousness; seizures; shakiness; sweating; tremor; vision changes; weakness.

Proper storage of Insulin Glargine Vials:

Store new (unopened) vials in a refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze Insulin Glargine Vials. Store used (open) vials either in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C), or at room temperature, below 86 degrees F (30 degrees C). Store away from heat and light. If Insulin Glargine Vials has been frozen or overheated, throw it away. Throw away unrefrigerated or used vials after 28 days, even if they still contain medicine.

Do not leave Insulin Glargine Vials in a car on a warm or sunny day. Do not use Insulin Glargine Vials after the expiration date stamped on the label. Keep Insulin Glargine Vials, as well as syringes and needles, out of the reach of children and away from pets.

General information:

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


• Insulin Glargine Vials 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 Insulin Glargine Vials. 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 Insulin Glargine resources

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

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Irbesartan/Hydrochlorothiazide

Pronunciation: IR-be-SAR-tan/HYE-droe-KLOR-oh-THYE-a-zide
Generic Name: Irbesartan/Hydrochlorothiazide
Brand Name: Avalide

Irbesartan/Hydrochlorothiazide can cause injury or even death to a developing fetus when used during pregnancy. Contact your doctor immediately if you suspect that you are pregnant.

Irbesartan/Hydrochlorothiazide is used for:

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

Irbesartan/Hydrochlorothiazide is a combination angiotensin II receptor blocker and diuretic. The angiotensin II receptor blocker works by relaxing the blood vessels. The diuretic works by helping the kidneys remove fluid from the body, which lowers blood pressure and helps the heart to pump blood more easily.

Do NOT use Irbesartan/Hydrochlorothiazide if:

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


• you are pregnant


• you have severe kidney problems or are unable to urinate


• you are taking dofetilide or ketanserin

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

Before using Irbesartan/Hydrochlorothiazide:

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

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


• if you are able to become pregnant


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


• if you are dehydrated, have low blood volume, or are on a low-salt (sodium) diet


• if you have blood electrolyte problems (eg, sodium, chloride, potassium, magnesium levels, calcium)


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


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


• if you have recently had a certain type of nerve surgery (sympathectomy)

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

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


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


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


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


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


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


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


• Insulin or other diabetes medicine (eg, glipizide, metformin) because their effectiveness may be decreased by Irbesartan/Hydrochlorothiazide

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

How to use Irbesartan/Hydrochlorothiazide:

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

• Irbesartan/Hydrochlorothiazide may be taken with or without food.


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


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


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


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


• If you miss a dose of Irbesartan/Hydrochlorothiazide, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Irbesartan/Hydrochlorothiazide.

Important safety information:

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


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


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


• It may take up to 2 to 4 weeks to get the full benefit from Irbesartan/Hydrochlorothiazide. Do not stop using Irbesartan/Hydrochlorothiazide or change your dose of Irbesartan/Hydrochlorothiazide without checking with your doctor.


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


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


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


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


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


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


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


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


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


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


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


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


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


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

Possible side effects of Irbesartan/Hydrochlorothiazide:

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

Dizziness; nausea; tiredness; vomiting.

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

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 fainting; fast or slow heartbeat; light-headedness; severe or unusual dizziness; symptoms of blood electrolyte problems (eg, confusion; irregular heartbeat; mental or mood changes; muscle pain, weakness, or cramping; seizures; sluggishness); symptoms of dehydration (eg, dry mouth or eyes; decreased urination; fast heartbeat; unusual thirst, tiredness, or weakness).

Proper storage of Irbesartan/Hydrochlorothiazide:

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

General information:

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


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


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


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

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

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Irbesartan/Hydrochlorothiazide resources

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

Compare Irbesartan/Hydrochlorothiazide with other medications

• High Blood Pressure