Ginger

Pronunciation: Not applicable.
Generic Name: Ginger
Brand Name: Generics only. No brands available.

Ginger is used for:

Upset stomach, motion sickness, and nausea. It may also have other uses. Check with your pharmacist for more details regarding the particular brand you use.

Ginger is an herbal product. It works by neutralizing stomach acid. It also has anti-inflammatory properties.

Do NOT use Ginger if:

• you are allergic to any ingredient in Ginger


• you are bleeding

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

Before using Ginger:

Some medical conditions may interact with Ginger. 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 diabetes, heart conditions, or gallstones

Some MEDICINES MAY INTERACT with Ginger. However, no specific interactions are known at this time.

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

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

• Dosing depends on the use and the source of the product.


• Use as directed on the package, unless instructed otherwise by your doctor.


• If you miss taking a dose of Ginger for 1 or more days, there is no cause for concern. If your doctor recommended that you take it, try to remember your dose every day.

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

Important safety information:

• This product has not been approved by the Food and Drug Administration (FDA) as safe and effective for any medical condition. The long-term safety of herbal products is not known. Before using any alternative medicine, talk with your doctor or pharmacist.


• This product may contain aristolochic acid, which can cause serious kidney/urinary system disease (eg, renal fibrosis, urinary tract cancer). Symptoms include an unusual change in the amount of urine or blood in the urine. Consult your pharmacist for more details regarding the contents of this ginger product.


• PREGNANCY and BREAST-FEEDING: If you plan on becoming pregnant, discuss with your doctor the benefits and risks of using Ginger during pregnancy. If you are or will be breast-feeding while using this product, check with your doctor to discuss the risks to your baby.

Possible side effects of Ginger:

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:

Heartburn; stomach upset.

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); change in the amount of urine; drowsiness; irregular heartbeat.

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: Ginger 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 coma or unconsciousness; severe drowsiness.

Proper storage of Ginger:

Store at room temperature away from heat, moisture, and light unless otherwise directed on the package label. Do not store in the bathroom. Most herbal products are not in childproof containers. Keep Ginger out of the reach of children and away from pets.

General information:

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


• Ginger 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 Ginger. 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 Ginger resources

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

• Ginger Natural MedFacts for Professionals (Wolters Kluwer)


• Ginger Natural MedFacts for Consumers (Wolters Kluwer)


• ginger Concise Consumer Information (Cerner Multum)

Compare Ginger with other medications

• Herbal Supplementation
• Motion Sickness
• Nausea/Vomiting

Glofil-125

Dosage Form: Injection

Glofil-125 Description

General

GLOFIL®-125 (Sodium Iothalamate I-125 Injection) is a sterile, nonpyrogenic aqueous injection containing approximately 1 mg sodium iothalamate per mL, and 0.9 percent benzyl alcohol as a preservative. The radioactive concentration of the material is 250-300 μCi/mL as of the calibration date. Sodium bicarbonate and hydrochloric acid are present for pH adjustment.

Physical Characteristics

Iodine-125 decays by electron capture with a physical half-life of 60.14 days. Photons that are useful for detection are listed in Table 1.

Table 1. Principal Radiation Emission Data*

* ICRP Publication 38: Radionuclide Transformations - Energy and Intensity of Emissions. Published for the International Commission on Radiological Protection by Pergamon Press, New York, 1983, p. 446.
Radiation	Mean Number Per Disintegration	Mean Energy (keV)
Gamma-1	0.067	35.5
Kα1 X-ray	0.741	27.5
Kα2 X-ray	0.398	27.2
Kß1 X-ray	0.140	31.0
Kß2 X-ray	0.043	31.7
Kß3 X-ray	0.072	30.9

The specific gamma ray constant for I-125 is 1.43 R/mCi-hr at 1 cm. The first half value thickness of lead (Pb) for I-125 is 0.017 mm. A range of values for the relative attenuation of the radiation emitted by this radionuclide resulting from interposition of various thicknesses of Pb is shown in Table 2. For example, the use of 0.28 mm of Pb will decrease the external radiation exposure by a factor of 10,000.

Table 2. Radiation Attenuation by Lead Shielding*

* Data supplied by Oak Ridge Associated Universities, Radiopharmaceutical Internal Dose Information Center, Oak Ridge, TN 1989.
Shield Thickness (Pb), mm	Coefficient of Attenuation
0.017	0.5
0.058	0.1
0.12	0.01
0.2	0.001
0.28	0.0001

To correct for physical decay of this radionuclide, the fractions that remain at selected time intervals after the date of calibration are shown in Table 3.

Table 3. Physical Decay Chart; I-125, half-life 60.14 days

* Calibration Date
Days	Fraction Remaining	Days	Fraction Remaining	Days	Fraction Remaining
0*	1.000	15	0.841	30	0.707
1	0.989	16	0.831	31	0.699
2	0.977	17	0.822	32	0.691
3	0.966	18	0.812	33	0.683
4	0.955	19	0.803	34	0.675
5	0.944	20	0.794	35	0.667
6	0.933	21	0.785	36	0.660
7	0.922	22	0.776	37	0.652
8	0.912	23	0.767	38	0.645
9	0.901	24	0.758	39	0.637
10	0.891	25	0.749	40	0.630
11	0.881	26	0.740	41	0.623
12	0.871	27	0.732	42	0.616
13	0.861	28	0.724	43	0.608
14	0.851	29	0.715	44	0.601
				45	0.595

Glofil-125 - Clinical Pharmacology

The renal clearance of sodium iothalamate in man closely approximates that of inulin. The compound is cleared by glomerular filtration without tubular secretion or reabsorption. Following infusion administration of I-125 iothalamate, the effective half-life is about 0.07 days.

Indications and Usage for Glofil-125

GLOFIL®-125 (Sodium Iothalamate I-125 Injection) is indicated for evaluation of glomerular filtration in the diagnosis or monitoring of patients with renal disease.

Contraindications

GLOFIL®-125 should not be administered via a central venous line.

Warnings

None known.

Precautions

General

As in the use of any radioactive material, care should be taken to minimize radiation exposure to the patient, consistent with proper patient management, and to insure minimum radiation exposure to occupational workers.

Radiopharmaceuticals should be used only by physicians who are qualified by training and experience in the safe use and handling of radionuclides.

Rapid or bolus-like injections should be avoided.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No long-term animal studies have been performed to evaluate carcinogenic potential, mutagenic potential, or whether this drug affects fertility in males or females.

Pregnancy Category C

Animal reproduction studies have not been conducted with GLOFIL®-125. It is also not known whether GLOFIL®-125 can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. GLOFIL®-125 should be given to a pregnant woman only if clearly needed.

Nursing Mothers

Radioiodine is excreted in human milk during lactation. It is not known whether GLOFIL®-125 is excreted in human milk. Therefore, formula feedings should be substituted for breast feedings.

Pediatric Use

Safety and effectiveness in children have not been established.

Adverse Reactions

None reported.

Glofil-125 Dosage and Administration

Dosage

The suggested dose range employed in the average patient (70 kg) is as follows:

    Continuous intravenous infusion: 20 to 100 μCi (0.74-3.7 megabecquerels) (Sigman, et al (1) method).

    Single intravenous injection: 10 to 30 μCi (0.37-1.11 megabecquerels) (Cohen, et al (2) method).

    The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration.

Technique

Continuous intravenous infusion

Sigman (1) method

I. Preparation:

1. Adequate diuresis (a urine flow exceeding 3 mL/min.) is established, preferably by an oral water load of 1,500 mL two hours prior to the beginning of the clearance study.


2. It is not necessary to withhold breakfast or admit the patient the night before.

II. Procedure:

1. After the establishment of adequate diuresis, a number 14 or 16 French Foley catheter is aseptically inserted into the bladder.


2. An intravenous infusion of Lactated Ringer’s (Hartmann’s) solution is started in each arm, one to maintain a site for injection of the GLOFIL®-125, the other to serve as a site for serial withdrawal of blood. A two-way stopcock connects the needle and intravenous tubing of each arm.


3. The dose is equally divided into (1) an intravenous priming dose to be injected as is and (2) a sustaining dose to be diluted in 30 to 60 mL of isotonic sodium chloride, depending on how many collection periods are anticipated.


4. The priming dose is slowly injected into one arm. This is immediately followed by infusion of the sustaining solution through the same site, usually at the rate of 0.5 mL/min., by means of an automatic pump. During this infusion, the Lactated Ringer’s solution in the same arm is discontinued, and 40 to 45 minutes are allowed for equilibration in order to reach a state of constant plasma concentration of radioactivity.


5. After attaining equilibrium, consecutive 15 minute collection periods are started. From the arm opposite the injection site, 5 mL of blood (allowing duplicate plasma counting volumes) is drawn six minutes prior to the midpoint of each collection period, placed in heparinized tubes, mixed, and centrifuged. The blood samples may be obtained through the two-way stopcock after discarding the first 30 mL aspirated into the syringe. This 30 mL contains the contents of the tubing, including infusion fluid, and must be cleared in order to obtain an undiluted blood sample. If desired, this step may be eliminated and blood samples obtained by direct venipuncture.


6. During each collection period, total urine must be accurately collected and the volume accurately measured. Three such consecutive collection periods are sufficient for most clinical studies.

III. Clearance Calculations:

1. Aliquots (1 mL each) of plasma and urine from each collection period are counted in a standard gamma-ray scintillation well detector.


2. All counts are corrected for background activity.


3. Glomerular filtration rate is calculated by the formula C=UV/P, in which:
   
         C = glomerular filtration rate in mL/min
   
         U= urinary concentration of radioactivity in net counts/min/mL
   
         V= urinary flow rate in mL/min
   
         P = plasma concentration of radioactivity in net counts/min/mL


4. Average glomerular filtration rate (GFR) is calculated from the rates for the individual collection periods. GFR can be expressed in terms of body weight (mL/min/kg) or body surface area (mL/min/m2).


5. Unilateral glomerular filtration rates can be determined by the same technique by utilizing ureteral catheterization.

Single intravenous injection

Cohen (2) method:

The method of Cohen, et al (2) requires little preparation, few and small blood samples, no bladder catheterization, and no constant intravenous infusion. It is simple to perform, rapid, and utilizes equipment which is readily available in most modern laboratories.

I. Preparation:

1. Lugol's solution, 3 drops orally, three times a day, is administered for one or two days prior to the test.
   

   No diet or water restriction is necessary.

   
   


2. Oral water load is begun one hour before starting the test. Start with 20 mL/kg and force any clear liquids (unless contraindicated) until the test is complete.

II. Procedure: Record actual times for the collection of the blood and urine samples.

1. Empty the bladder and label the urine Urine control.


2. Inject 10-30 μCi GLOFIL®-125 intravenously; wait 30 to 60 minutes.


3. Collect the entire urine and label Urine discard.


4. Draw 4 to 5 mL of blood into a heparinized syringe. Label Plasma #1.


5. After another 30 to 60 minutes, collect the entire urine and label Urine #1.


6. Immediately draw another blood specimen. Label Plasma #2.


7. After final 30 to 60 minute wait, collect the urine. Label Urine #2.


8. Draw the last blood specimen immediately. Label Plasma #3.

III. Clearance Calculations:

1. Radioactivity of one mL aliquots of both urine and plasma are determined using a well-scintillation detector with a single channel pulse-height analyzer. Sufficiently reproducible counts are usually obtained with time settings of 2 minutes for urine samples and 20 minutes for the plasma samples. Calculations of the clearance rates are made by using the formula:(1)

       C = UV/P + 1.73/SA    where

C = glomerular filtration rate in mL/min/1.73 m2

U = urine radioactivity in counts/min/mL

V = urine flow rate in mL/min

P= mean plasma radioactivity in counts/min/mL

SA= body surface area in m2

Radiation Dosimetry

The estimated absorbed radiation doses to an average (70 kg) patient from an intravenous dose of 100 μCi (3.7 megabecquerels) of GLOFIL®-125 are shown in Table 4. Calculations assume that there is 1% free iodide in the preparation and that the thyroid uptake of the iodine is 25%.

Table 4. Absorbed Radiation Doses*

* Data supplied by Oak Ridge Associated Universities, Radiopharmaceutical Internal Dose Information Center, Oak Ridge, TN, 1988.
	Absorbed radiation doses for 100 µCi (3.7 megabecquerels)
	2 hour bladder voiding interval		4.8 hour bladder voiding interval
Organ	rads	mGy	rads	mGy
Lower Large Intestine Wall	0.00065	0.0065	0.0012	0.012
Small Intestine	0.00044	0.0044	0.00050	0.0050
Stomach	0.00047	0.0047	0.00047	0.0047
Upper Large Intestine Wall	0.00040	0.0040	0.00044	0.0044
Kidneys	0.0064	0.064	0.0064	0.064
Liver	0.0018	0.018	0.0018	0.018
Ovaries	0.00054	0.0054	0.00085	0.0085
Testes	0.0019	0.019	0.0021	0.021
Urinary Bladder Wall	0.022	0.22	0.06	0.6
Red Marrow	0.00033	0.0033	0.00034	0.0034
Thyroid	0.78	7.8	0.78	7.8
Total Body	0.00096	0.0096	0.0011	0.011

Visual Inspection

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

How is Glofil-125 Supplied

Identity

No. 1000, GLOFIL®-125 is a clear, colorless, sterile, and nonpyrogenic solution available as a 4 mL vial. It is supplied in a concentration of approximately 1 mg/mL sodium iothalamate (range is 0.5–2.0 mg sodium iothalamate per mL), with a radioactivity concentration of 250 to 300 μCi/mL at the time of calibration. Benzyl alcohol 0.9%, is added as a preservative. Sodium bicarbonate and hydrochloric acid are added for pH adjustment. The calibration and expiration dates are shown on the label.

Storage

Refrigerate the product upon receipt at 2°C to 8°C.

Dose Volume Calculation

Table 3 provides the required factors for the determination of activity per mL post calibration date for GLOFIL®-125 sterile solution.

To determine the dose volume, locate the decay factor (fraction remaining) which corresponds to the day that the dose is to be administered. The following equation is then utilized to determine the dose volume:

(activity of desired dose) /[(decay factor) x (amount of activity/mL on calibration day)] = dose volume (mL)                                                                                          (information on label)

REFERENCES

1. Sigman EM, Elwood CM, Reagan ME, Morris AM, Catanzaro A. The renal clearance of 131I labeled sodium iothalamate in man. Invest Urol 1965; 2:432.


2. Cohen ML, Smith FG Jr., Mindell RS, Vernier RL. A simple reliable method of measuring glomerular filtration rate using single low dose sodium iothalamate 131I.Pediatrics 1969; 43:407.

ADDITIONAL REFERENCES

3.

Maher FT, Nolan NG, Elveback LR. Comparisons of simultaneous clearances of 125I-labeled sodium iothalamate (Glofil) and of Inulin. Mayo Clin Proc 1971; 46: 690-691.

4.

Skov PE. Glomerular filtration rate in patients with severe and very severe renal insufficiency. Acta Med Scand 1970; 187: 419-428.

Manufactured by Iso-Tex Diagnostics, Inc. for QOL Medical

QOL Medical

Kirkland, WA 98033

Phone 1-866-469-3773

Revised April 2006

No. 1000

NDC 67871-772-92

Glofil-125  iothalamate sodium, i-125  injection

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 67871-772 Route of Administration INTRAVENOUS DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength Iothalamate sodium, I-125 (Iothalamate sodium, I-125) Active 1 MILLIGRAM  In 1 MILLILITER benzyl alcohol Inactive   sodium bicarbonate Inactive   hydrochloric acid Inactive

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 67871-772-92 4 mL (MILLILITER) In 1 VIAL None

Revised: 06/2007QOL Medical

More Glofil-125 resources

• Glofil-125 Drug Interactions
• Glofil-125 Support Group
• 0 Reviews · Be the first to review/rate this drug

Gladase

Generic Name: papain-urea topical (PA pane yoo REE ah)

Brand Names: Accuzyme, AllanEnzyme, Ethezyme 650, Ethezyme 830, Gladase, Kovia, Pap-Urea

The U.S. Food and Drug Administration (FDA) has ordered companies to stop marketing unapproved drug products that contain papain in a topical dosage form. Firms marketing any unapproved topical papain products must stop manufacturing these products by November 24, 2008. Issued 23rd September 2008

What is Gladase (papain-urea topical)?

Papain is a substance from the papaya fruit. Papain breaks down certain proteins.

Urea also breaks down protein.

Papain-urea topical is used to break down dead skin or tissues in wounds such as bed sores, ulcers, burns, surgical wounds, cysts, and carbuncles. This process is sometimes called debridement (de-BREED-ment). The broken-down tissues can then be more easily removed.

Papain-urea topical may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Gladase (papain-urea topical)?

Wash your hands before and after applying papain-urea topical.

Clean the wound as directed by your doctor. Use only the type of cleanser your doctor has recommended.

Apply papain-urea topical directly to the wound. Then cover the treated area with bandaging or other dressing recommended by your doctor. Keep the wound covered at all times, because this medication will cause the dead tissues to slough and peel off.

Avoid using hydrogen peroxide to clean your wound before applying papain-urea topical. Hydrogen peroxide can make the papain-urea less effective in breaking down the tissues of your wound.

Do not use other medicated skin products unless your doctor has told you to.

What should I discuss with my healthcare provider before using Gladase (papain-urea topical)?

Do not use this medication if you are allergic to papain or urea.

Before using papain-urea topical, tell your doctor if you are allergic to any drugs, or if you have other medical conditions. You may not be able to papain-urea topical, or you may need a dosage adjustment or special tests during treatment.

It is not known whether papain-urea will be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether papain-urea passes into breast milk. Do not use papain-urea topical without telling your doctor if you are breast-feeding a baby.

How should I use Gladase (papain-urea topical)?

Use this medication exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor. Follow the instructions on your prescription label.

Wash your hands before and after applying papain-urea topical.

Clean the wound as directed by your doctor. Use only the type of cleanser your doctor has recommended.

Apply papain-urea topical directly to the wound. Then cover the treated area with bandaging or other dressing recommended by your doctor. Keep the wound covered at all times, because this medication will cause the dead tissues to slough and peel off.

Papain-urea topical is usually applied two times each day. Clean the wound and apply a fresh bandage dressing each time you use the medication.

It is important to use papain-urea regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Store papain-urea topical at room temperature away from moisture and heat.

What happens if I miss a dose?

Use the medication as soon as you remember the missed dose. If it is almost time for your next dose, skip the missed dose and use the medicine at your 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 an overdose of papain-urea is suspected or if the medication has been ingested.

Symptoms of an overdose of papain-urea topical are not known.

What should I avoid while using Gladase (papain-urea topical)?

Avoid using hydrogen peroxide to clean your wound before applying papain-urea topical. Hydrogen peroxide can make the papain-urea less effective in breaking down the tissues of your wound.

Do not use other medicated skin products unless your doctor has told you to.

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.

Gladase (papain-urea 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.

Less serious side effects may be more likely to occur, such as mild stinging or burning of the skin where the medicine is applied.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect Gladase (papain-urea topical)?

There may be other drugs that can affect papain-urea topical. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More Gladase resources

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

• Accuzyme Ointment MedFacts Consumer Leaflet (Wolters Kluwer)


• Accuzyme SE Spray Emulsion MedFacts Consumer Leaflet (Wolters Kluwer)


• AllanEnzyme Spray MedFacts Consumer Leaflet (Wolters Kluwer)


• Paptase Foam MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Gladase with other medications

• Burns, External
• Dermatologic Lesion
• Wound Cleansing

Where can I get more information?

• Your pharmacist has information about papain-urea topical written for health professionals that you may read.

See also: Gladase side effects (in more detail)

Gingimed

Dosage Form: oral liquid

ACTIVE INGREDIENT

STANNOUS FLUORIDE

INACTIVE INGREDIENTS

GLYCERIN, FLAVOR,XYLITOL

USE

APPROVED USES:  RELIEF OF DENTINAL HYPERSENSITIVITY.  CONTROL OF PERIO INFECTION.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

DIRECTIONS FOR USE

ADULTS AND CHILDREN 6 YEARS AND OLDER: RINSE EACH DAY AFTER USUAL BRUSHING AND FLOSSING OR MORE OFTEN IF YOUR DENTIST RECOMMENDS ADDITIONAL THERAPY BASED ON THE DIAGNOSIS.  PUSH DOWN ON PUMP TWICE OR POUR THE CONCENTRATED RINSE TO THE 1/8 FL. OX. MARK ON THE MIXING VIAL.  ADD WATER TO THE 1 OZ. LINE.  CLOSE TIGHTLY WITH SNAP-ON CAP AND SHAKE WELL.  THIS PREPARES A 0.1% STANNOUS FLUORIDE RINSE.  RINSE WITH ONE HALF OF THE SOLUTION FOR ONE MINUTE, EXPECTORATE (SPIT) AND REPEAT THE PROCEDURE WITH THE REMAINING HALF OF THE MIXTURE.  DO NOT SWALLOW AND DO NOT RINSE MOUTH.  RINSE MIXING VIAL WITH WATER AFTER EACH USE.

CHILDREN 6-12 YEARS: INSTRUCT AND SUPERVISE IN GOOD RINSING HABITS. (HELP TO MINIMIZE SWALLOWING)

CHILDREN UNDER 6: CONSULT A DENTIST.

FOR HOME IRRIGATION: PREPARE 1 OZ. OF Gingimed RINSE AS DESCRIBED ABOVE.  POUR INTO IRRIGATOR RESIVOIR AND ADD 4 OZ. OF WATER.  MIX THOROUGHLY.  USE IRRIGATOR AS DESCRIBED

OTHER INFORMATION

THIS PRODUCT MAY CAUSE MINIMAL SURFACE DISCOLORATION ON THE TEETH, MAY BE PREVENTED BY ADEQUATE BRUSHING.

Warnings

IF MORE THAN AMOUNT DIRECTED FOR RINSING IS ACCIDENTALLY SWALLOWED, SEEK MEDICAL HELP FROM A POISON CONTROL CENTER.  DO NOT USE BEFORE MIXING WITH WATER.  USE AS DIRECTED BY A DENTAL PROFESSIONAL.  THIS IS A FLUORIDE TREATMENT RINSE, NOT A MOUTHWASH.

PACKAGE LABEL

ALCOHOL FREE PERIO TREATMENT.  Gingimed  0.63% STANNOUS FLUORIDE  READ DIRECTIONS THOROUGHLY.  MIX WITH WATER BEFORE USE. NOW CONTAINING XYLITOL

MANUFACTURED BY MASSCO DENTAL A DIVISION OF DUNAGIN PHARMACEUTICALS, GRAVETTE, AR (479) 787-5168  WWW.MASSCODENTAL.NET

Gingimed  stannous fluoride  liquid

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 63783-210 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength STANNOUS FLUORIDE (FLUORIDE ION) STANNOUS FLUORIDE .71034 g  in 120 g

Inactive Ingredients Ingredient Name Strength GLYCERIN   XYLITOL

Product Characteristics Color      Score      Shape Size Flavor SPEARMINT (MINT) Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 63783-210-06 120 g In 1 BOTTLE, WITH APPLICATOR None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	01/01/1989

Gingimed  stannous fluoride  liquid

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 63783-211 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength STANNOUS FLUORIDE (FLUORIDE ION) STANNOUS FLUORIDE .71034 g  in 120 g

Inactive Ingredients Ingredient Name Strength GLYCERIN   XYLITOL

Product Characteristics Color      Score      Shape Size Flavor GRAPE (CARIBBEAN ICE) Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 63783-211-06 120 g In 1 BOTTLE, WITH APPLICATOR None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	01/01/1989

Gingimed  stannous fluoride  liquid

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 63783-212 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength STANNOUS FLUORIDE (FLUORIDE ION) STANNOUS FLUORIDE .71034 g  in 120 g

Inactive Ingredients Ingredient Name Strength GLYCERIN   XYLITOL

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

Packaging # NDC Package Description Multilevel Packaging 1 63783-212-06 120 g In 1 BOTTLE, WITH APPLICATOR None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	01/01/1989

Labeler - Massco Dental A Division of Dunacin Pharmaceuticals (008081858)

Registrant - Massco Dental A Division of Dunacin Pharmaceuticals (008081858)

Establishment
Name	Address	ID/FEI	Operations
Massco Dental A Division of Dunacin Pharmaceuticals		008081858	manufacture

Revised: 10/2011Massco Dental A Division of Dunacin Pharmaceuticals

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• Gingimed Use in Pregnancy & Breastfeeding
• Gingimed Support Group
• 3 Reviews for Gingimed - Add your own review/rating

Compare Gingimed with other medications

• Prevention of Dental Caries

Gildess FE 1.5/0.03

Generic Name: ethinyl estradiol and norethindrone (ETH in il ess tra DYE ole and nor ETH in drone)

Brand Names: Aranelle, Balziva, Brevicon, Briellyn, Cyclafem 1/35, Cyclafem 7/7/7, Estrostep Fe, Femcon FE, Generess Fe, Gildess FE 1.5/0.03, Gildess FE 1/0.2, Junel 1.5/30, Junel 1/20, Junel Fe 1.5/30, Junel Fe 1/20, Leena, Lo Loestrin Fe, Loestrin 21 1.5/30, Loestrin 21 1/20, Loestrin 24 Fe, Loestrin Fe 1.5/30, Loestrin Fe 1/20, Microgestin 1.5/30, Microgestin 1/20, Microgestin FE 1.5/30, Microgestin FE 1/20, Modicon, Necon 0.5/35, Necon 1/35, Necon 10/11, Necon 7/7/7, Norinyl 1+35, Nortrel 0.5/35, Nortrel 1/35, Nortrel 7/7/7, Ortho-Novum 1/35, Ortho-Novum 7/7/7, Ovcon 35, Ovcon 35 Fe, Ovcon 50, Tilia Fe, Tri-Legest Fe, Tri-Norinyl, Zenchent Fe, Zeosa

What is Gildess FE 1.5/0.03 (ethinyl estradiol and norethindrone)?

Ethinyl estradiol and norethindrone contains a combination of female hormones that prevent ovulation (the release of an egg from an ovary). This medication also causes changes in your cervical mucus and uterine lining, making it harder for sperm to reach the uterus and harder for a fertilized egg to attach to the uterus.

Ethinyl estradiol and norethindrone are used as contraception to prevent pregnancy. It is also used to treat severe acne.

Ethinyl estradiol and norethindrone may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Gildess FE 1.5/0.03 (ethinyl estradiol and norethindrone)?

Do not use birth control pills if you are pregnant or if you have recently had a baby. Do not use this medication if you have any of the following conditions: a history of stroke or blood clot, circulation problems, a hormone-related cancer such as breast or uterine cancer, abnormal vaginal bleeding, liver disease or liver cancer, or a history of jaundice caused by birth control pills.

You may need to use back-up birth control, such as condoms or a spermicide, when you first start using this medication. Follow your doctor's instructions.

Taking hormones can increase your risk of blood clots, stroke, or heart attack, especially if you smoke and are older than 35.

Some drugs can make birth control pills less effective, which may result in pregnancy. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

What should I discuss with my healthcare provider before taking Gildess FE 1.5/0.03 (ethinyl estradiol and norethindrone)?

This medication can cause birth defects. Do not use if you are pregnant. Tell your doctor right away if you become pregnant, or if you miss two menstrual periods in a row. If you have recently had a baby, wait at least 4 weeks before taking birth control pills (6 weeks if you are breast-feeding). You should not take birth control pills if you have:

• 
  

  coronary artery disease, a severe or uncontrolled heart valve disorder, untreated or uncontrolled high blood pressure;

  
  


• 
  

  a history of a stroke, blood clot, or circulation problems;

  
  


• 
  

  a hormone-related cancer such as breast or uterine cancer;

  
  


• 
  

  unusual vaginal bleeding that has not been checked by a doctor;

  
  


• 
  

  liver disease or liver cancer;

  
  


• 
  

  severe migraine headaches; or

  
  


• 
  

  a history of jaundice caused by pregnancy or birth control pills.

  
  

To make sure you can safely take this medication, tell your doctor if you have any of these other conditions:

• 
  

  high blood pressure or a history of heart disease;

  
  


• 
  

  high cholesterol, gallbladder disease, or diabetes;

  
  


• 
  

  migraine headaches or a history of depression; or

  
  


• 
  

  a history of breast cancer or an abnormal mammogram.

  
  

The hormones in birth control pills can pass into breast milk and may harm a nursing baby. This medication may also slow breast milk production. Do not use if you are breast-feeding a baby.

How should I take Gildess FE 1.5/0.03 (ethinyl estradiol and norethindrone)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Take your first pill on the first day of your period or on the first Sunday after your period begins (follow your doctor's instructions).

You may need to use back-up birth control, such as condoms or a spermicide, when you first start using this medication. Follow your doctor's instructions.

The 28-day birth control pack contains seven "reminder" pills to keep you on your regular cycle. Your period will usually begin while you are using these reminder pills.

You may have breakthrough bleeding, especially during the first 3 months. Tell your doctor if this bleeding continues or is very heavy.

Take one pill every day, no more than 24 hours apart. When the pills run out, start a new pack the following day. You may get pregnant if you do not use this medication regularly. Get your prescription refilled before you run out of pills completely.

The chewable tablet may be chewed or swallowed whole. If chewed, drink a full glass of water just after you swallow the pill.

If you need surgery or medical tests or if you will be on bed rest, you may need to stop using this medication for a short time. Any doctor or surgeon who treats you should know that you are using birth control pills.

Your doctor will need to check your progress on a regular basis. Do not miss any scheduled appointments.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Missing a pill increases your risk of becoming pregnant. If you miss one "active" pill, take two pills on the day that you remember. Then take one pill per day for the rest of the pack.

If you miss two "active" pills in a row in week one or two, take two pills per day for two days in a row. Then take one pill per day for the rest of the pack. Use back-up birth control for at least 7 days following the missed pills.

If you miss two "active" pills in a row in week three, or if you miss three pills in a row during any of the first 3 weeks, throw out the rest of the pack and start a new one the same day if you are a Day 1 starter. If you are a Sunday starter, keep taking a pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new one that day.

If you miss two or more pills, you may not have a period during the month. If you miss a period for two months in a row, call your doctor because you might be pregnant.

If you miss any reminder pills, throw them away and keep taking one pill per day until the pack is empty. You do not need back-up birth control if you miss a reminder pill.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include nausea, vomiting, and vaginal bleeding.

What should I avoid while taking Gildess FE 1.5/0.03 (ethinyl estradiol and norethindrone)?

Do not smoke while using birth control pills, especially if you are older than 35. Smoking can increase your risk of blood clots, stroke, or heart attack caused by birth control pills.

Birth control pills will not protect you from sexually transmitted diseases--including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.

Gildess FE 1.5/0.03 (ethinyl estradiol and norethindrone) 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 this medication and call your doctor at once if you have any of these serious side effects:

• 
  

  sudden numbness or weakness, especially on one side of the body;

  
  


• 
  

  sudden severe headache, confusion, problems with vision, speech, or balance;

  
  


• 
  

  sudden cough, wheezing, rapid breathing, coughing up blood;

  
  


• 
  

  pain, swelling, warmth, or redness in one or both legs;

  
  


• 
  

  chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;

  
  


• 
  

  a change in the pattern or severity of migraine headaches;

  
  


• 
  

  pain in your upper stomach, jaundice (yellowing of the skin or eyes);

  
  


• 
  

  a lump in your breast;

  
  


• 
  

  swelling in your hands, ankles, or feet; or

  
  


• 
  

  symptoms of depression (sleep problems, weakness, mood changes).

  
  

Less serious side effects may include:

• 
  

  mild nausea or vomiting, appetite or weight changes;

  
  


• 
  

  breast swelling or tenderness;

  
  


• 
  

  headache, nervousness, dizziness;

  
  


• 
  

  problems with contact lenses;

  
  


• 
  

  freckles or darkening of facial skin, loss of scalp hair; or

  
  


• 
  

  vaginal itching or discharge.

  
  

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 Gildess FE 1.5/0.03 (ethinyl estradiol and norethindrone)?

Some drugs can make ethinyl estradiol and norethindrone less effective, which may result in pregnancy. Before using ethinyl estradiol and norethindrone, tell your doctor if you are using any of the following drugs:

• 
  

  acetaminophen (Tylenol) or ascorbic acid (vitamin C);

  
  


• 
  

  bosentan (Tracleer);

  
  


• 
  

  prednisolone (Orapred);

  
  


• 
  

  St. John's wort;

  
  


• 
  

  theophylline (Elixophyllin, Theo-24, Uniphyl);

  
  


• 
  

  an antibiotic;

  
  


• 
  

  HIV or AIDS medications;

  
  


• 
  

  phenobarbital (Solfoton) and other barbiturates; or

  
  


• 
  

  seizure medication.

  
  

This list is not complete and other drugs may interact with birth control pills. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Gildess FE 1.5/0.03 resources

• Gildess FE 1.5/0.03 Side Effects (in more detail)
• Gildess FE 1.5/0.03 Use in Pregnancy & Breastfeeding
• Gildess FE 1.5/0.03 Drug Interactions
• 1 Review for Gildess FE.5/0.03 - Add your own review/rating

• Aranelle Prescribing Information (FDA)


• Balziva Prescribing Information (FDA)


• Brevicon Prescribing Information (FDA)


• Briellyn Prescribing Information (FDA)


• Cyclafem 1/35 Prescribing Information (FDA)


• Cyclafem 7/7/7 Prescribing Information (FDA)


• Estrostep Fe Prescribing Information (FDA)


• Femcon FE Prescribing Information (FDA)


• Femcon Fe Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Femhrt Consumer Overview


• Femhrt Prescribing Information (FDA)


• Femhrt MedFacts Consumer Leaflet (Wolters Kluwer)


• Jevantique Prescribing Information (FDA)


• Jinteli Prescribing Information (FDA)


• Leena Prescribing Information (FDA)


• Lo Loestrin Fe MedFacts Consumer Leaflet (Wolters Kluwer)


• Lo Loestrin Fe Consumer Overview


• Lo Loestrin Fe Advanced Consumer (Micromedex) - Includes Dosage Information


• Lo Loestrin Fe Prescribing Information (FDA)


• Loestrin 24 FE Prescribing Information (FDA)


• Loestrin 24 Fe Consumer Overview


• Loestrin Fe 1/20 MedFacts Consumer Leaflet (Wolters Kluwer)


• Ovcon 35 MedFacts Consumer Leaflet (Wolters Kluwer)


• Tilia FE Prescribing Information (FDA)


• Tri-Norinyl Prescribing Information (FDA)


• Zenchent FE Prescribing Information (FDA)


• Zeosa Prescribing Information (FDA)

Compare Gildess FE 1.5/0.03 with other medications

• Abnormal Uterine Bleeding
• Acne
• Birth Control
• Endometriosis
• Gonadotropin Inhibition
• Menstrual Disorders
• Polycystic Ovary Syndrome
• Postmenopausal Symptoms

Where can I get more information?

• Your pharmacist can provide more information about ethinyl estradiol and norethindrone.

See also: Gildess FE.5/0.03 side effects (in more detail)

Glucotrol

Generic Name: glipizide (Oral route)

GLIP-i-zide

Commonly used brand name(s)

In the U.S.

• Glucotrol


• Glucotrol XL

Available Dosage Forms:

• Tablet, Extended Release


• Tablet

Therapeutic Class: Hypoglycemic

Chemical Class: 2nd Generation Sulfonylurea

Uses For Glucotrol

Glipizide is used to treat high blood sugar levels caused by a type of diabetes mellitus (sugar diabetes) called type 2 diabetes. In type 2 diabetes, your body does not work properly to store excess sugar and the sugar remains in your bloodstream. Chronic high blood sugar can lead to serious health problems in the future.

Proper diet is the first step in managing type 2 diabetes, but often medicines are needed to help your body. Glipizide belongs to a class of drugs called sulfonylureas. It stimulates the release of insulin from the pancreas, directing your body to store blood sugar. This helps lower blood sugar and restore the way you use food to make energy.

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

Before Using Glucotrol

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 glipizide 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 glipizide in the elderly. However, elderly patients are more likely to have age-related heart, liver, or kidney problems which may require caution in patients receiving glipizide.

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. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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

• Acarbose


• Alatrofloxacin


• Balofloxacin


• Ciprofloxacin


• Clinafloxacin


• Disopyramide


• Enoxacin


• Fleroxacin


• Flumequine


• Gatifloxacin


• Gemifloxacin


• Grepafloxacin


• Levofloxacin


• Lomefloxacin


• Moxifloxacin


• Norfloxacin


• Ofloxacin


• Pefloxacin


• Prulifloxacin


• Rufloxacin


• Sparfloxacin


• Temafloxacin


• Tosufloxacin


• Trovafloxacin Mesylate

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

• Acebutolol


• Aceclofenac


• Acemetacin


• Alclofenac


• Alprenolol


• Apazone


• Atenolol


• Benoxaprofen


• Betaxolol


• Bevantolol


• Bisoprolol


• Bitter Melon


• Bromfenac


• Bucindolol


• Bufexamac


• Carprofen


• Carteolol


• Carvedilol


• Celiprolol


• Cimetidine


• Clarithromycin


• Clometacin


• Clonixin


• Clorgyline


• Cyclosporine


• Dexketoprofen


• Diazoxide


• Diclofenac


• Diflunisal


• Dilevalol


• Dipyrone


• Droxicam


• Esmolol


• Etodolac


• Etofenamate


• Felbinac


• Fenbufen


• Fenoprofen


• Fentiazac


• Fenugreek


• Floctafenine


• Flufenamic Acid


• Flurbiprofen


• Glucomannan


• Hydrochlorothiazide


• Ibuprofen


• Indomethacin


• Indoprofen


• Iproniazid


• Isocarboxazid


• Isoxicam


• Ketoprofen


• Ketorolac


• Labetalol


• Levobunolol


• Lornoxicam


• Meclofenamate


• Mefenamic Acid


• Meloxicam


• Mepindolol


• Metipranolol


• Metoprolol


• Moclobemide


• Nabumetone


• Nadolol


• Naproxen


• Nebivolol


• Nialamide


• Niflumic Acid


• Nimesulide


• Oxaprozin


• Oxprenolol


• Oxyphenbutazone


• Pargyline


• Penbutolol


• Phenelzine


• Phenylbutazone


• Pindolol


• Pirazolac


• Piroxicam


• Pirprofen


• Procarbazine


• Propranolol


• Propyphenazone


• Proquazone


• Psyllium


• Ranitidine


• Selegiline


• Sotalol


• Sulfadiazine


• Sulfamethoxazole


• Sulindac


• Suprofen


• Talinolol


• Tenidap


• Tenoxicam


• Tertatolol


• Tiaprofenic Acid


• Timolol


• Tolmetin


• Toloxatone


• Tranylcypromine


• Voriconazole


• Zomepirac

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

Other Medical Problems

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

• Alcohol intoxication or


• Underactive adrenal glands or


• Underactive pituitary gland or


• Undernourished condition or


• Weakened physical condition or


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

• Diabetic ketoacidosis (ketones in the blood) or


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

• Fever or


• Infection or


• Surgery or


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

• Glucose 6-phosphate dehydrogenase (G6PD) deficiency (an enzyme problem)—May cause hemolytic anemia (blood disorder) in patients with this condition.

• Heart or blood vessel disease—Use with caution. May make this condition worse.

• Kidney disease or


• Liver disease—Higher blood levels of this medicine may occur, which may cause serious problems.

• Narrowed or blocked food passages (e.g., esophagus, stomach, or intestines), severe—Use with caution. The extended-release tablet may cause obstruction in patients with this condition.

Proper Use of glipizide

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

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

This medicine comes with a patient information insert. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.

Swallow the extended release tablet whole. Do not split, crush, or chew it.

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

Dosing

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

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

• For type 2 diabetes:
  
  • For oral dosage form (extended-release tablets):
    
    • Adults—At first, 5 milligrams (mg) once a day taken with breakfast. Your doctor may adjust your dose if needed. The dose is usually not more than 20 mg per day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For oral dosage form (tablets):
    
    • Adults—At first, 5 milligrams (mg) once a day taken at least 30 minutes before breakfast. Your doctor may adjust your dose if needed. The dose is usually not more than 40 mg per day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

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

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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

Precautions While Using Glucotrol

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

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

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


• Counseling—Other family members need to learn how to prevent side effects or help with side effects if they occur. Also, patients with diabetes may need special counseling about diabetes medicine dosing changes that might occur 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 patients with diabetes during pregnancy.


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


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

Check with your doctor right away if you start having chest pain or discomfort; nausea; pain or discomfort in the arms, jaw, back, or neck; shortness of breath; sweating; or vomiting while you are using this medicine. These may be symptoms of a serious heart problem, including a heart attack.

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

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

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

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Glucotrol 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:

Less common

• Anxiety


• blurred vision


• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings


• chills


• cold sweats


• coma


• confusion


• cool, pale skin


• depression


• difficulty with moving


• dizziness


• fainting


• fast heartbeat


• headache


• increased hunger


• joint pain


• leg cramps


• muscle aching or cramping


• muscle pain or stiffness


• nausea


• nervousness


• nightmares


• pain in the joints


• problems in urination or increase in the amount of urine


• seizures


• shakiness


• slurred speech


• sweating


• swollen joints


• unusual tiredness or weakness

Rare

• Abdominal or stomach pain


• bloating


• bloody or black, tarry stools


• body aches or pain


• burning, dry, or itching eyes


• clay-colored stools


• congestion


• constipation


• cough


• dark urine


• decreased vision or other changes in vision


• diarrhea


• difficult or labored breathing


• difficult or painful urination


• dryness or soreness of the throat


• excessive tearing


• fainting


• fast, slow, or irregular heartbeat


• feeling of warmth


• fever


• heartburn


• hoarseness


• indigestion


• itching


• loss of appetite


• pain in the eye


• pounding in the ears


• rash


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


• redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid


• runny nose


• severe stomach pain


• shortness of breath


• tender, swollen glands in the neck


• tightness in the chest


• trouble in swallowing


• unpleasant breath odor


• voice changes


• vomiting of blood or material that looks like coffee grounds


• wheezing


• yellow eyes or skin

Incidence not known

• Agitation


• back or leg pains


• bleeding gums


• blood in the urine or stools


• chest pain


• convulsions


• decreased urine output


• fluid-filled skin blisters


• general body swelling


• general feeling of tiredness or weakness


• high fever


• hostility


• increased thirst


• irritability


• lethargy


• light-colored stools


• lower back or side pain


• muscle twitching


• nosebleeds


• pinpoint red pots on the skin


• rapid weight gain


• sensitivity to the sun


• skin thinness


• sores, ulcers, or white spots on the lips or in the mouth


• stupor


• swelling of the face, ankles, or hands


• unusual bleeding or bruising

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

• Indigestion


• passing of gas

Less common

• Acid or sour stomach


• belching


• excess air or gas in the stomach or intestines


• full feeling


• pain


• sleeplessness


• sneezing


• stuffy nose


• trouble sleeping


• unable to sleep

Rare

• Decreased interest in sexual intercourse


• dizziness or lightheadedness


• excessive muscle tone


• feeling of constant movement of self or surroundings


• flushing or redness of the skin


• headache, severe and throbbing


• hives or welts


• inability to have or keep an erection


• loss in sexual ability, desire, drive, or performance


• mood or mental changes


• muscle stiffness


• muscle tension or tightness


• sensation of spinning


• skin rash, encrusted, scaly, and oozing


• sleepiness or unusual drowsiness


• unusually warm skin


• walking in unusual manner


• weight loss

Incidence not known

• Increased sensitivity of the skin to sunlight


• severe sunburn

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: Glucotrol side effects (in more detail)

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More Glucotrol resources

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

• Glucotrol Prescribing Information (FDA)


• Glucotrol MedFacts Consumer Leaflet (Wolters Kluwer)


• Glucotrol Consumer Overview


• Glipizide Prescribing Information (FDA)


• Glipizide Professional Patient Advice (Wolters Kluwer)


• Glipizide Monograph (AHFS DI)


• Glipizide XL Prescribing Information (FDA)


• Glucotrol XL Prescribing Information (FDA)


• Glucotrol XL Extended-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

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