Temovate Gel

Pronunciation: kloe-BAY-ta-sol
Generic Name: Clobetasol
Brand Name: Examples include Embeline and Temovate

Temovate Gel is used for:

Treating inflammation and itching due to certain skin conditions. It may also be used for other conditions as determined by your doctor.

Temovate Gel is a topical adrenocortical steroid. It works by reducing skin inflammation (eg, redness, swelling, itching, irritation) in a way that is not clearly understood.

Do NOT use Temovate Gel if:

• you are allergic to any ingredient in Temovate Gel or to other corticosteroids (eg, prednisone)

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

Before using Temovate Gel:

Some medical conditions may interact with Temovate Gel. 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 any kind of skin infection, cuts, scrapes, or lessened blood flow to your skin


• if you have had a recent vaccination; have measles, tuberculosis, chickenpox, or shingles; or have had a positive tuberculosis test


• if you are taking prednisone or similar medicines

Some MEDICINES MAY INTERACT with Temovate Gel. Because little, if any, of Temovate Gel is absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if Temovate Gel 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 Temovate Gel:

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

• Apply a small amount of medicine to the affected area. Gently rub the medicine in until it is evenly distributed. Wash your hands after applying Temovate Gel, unless your hands are part of the treated area.


• Do not bandage or cover the treated skin area unless directed by your doctor.


• If you miss a dose of Temovate Gel, apply 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 apply 2 doses at once.

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

Important safety information:

• Temovate Gel is for external use only. Do not get Temovate Gel in your eyes, nose, or mouth. If contact is made with the eyes, flush them immediately with tap water.


• Do not use Temovate Gel on the face, groin, diaper area, or underarms.


• Do not use Temovate Gel to treat rosacea or conditions around the mouth.


• Do NOT take more than the recommended dose or use for longer than 2 weeks without checking with your doctor.


• If your symptoms do not get better within 2 weeks or if they get worse, check with your doctor.


• Do not use Temovate Gel to treat large areas of your body without first checking with your doctor.


• Tell your doctor or dentist that you take Temovate Gel before you receive any medical or dental care, emergency care, or surgery.


• Check with your doctor before having vaccinations while using Temovate Gel.


• Do not use Temovate Gel for other skin conditions at a later time.


• Temovate Gel has a corticosteroid in it. Before you start any new medicine, check the label to see if it has a corticosteroid (eg, hydrocortisone) in it too. If it does or if you are not sure, check with your doctor or pharmacist.


• Corticosteroids may affect growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they use Temovate Gel.


• Temovate Gel should not be used in CHILDREN younger than 12 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 Temovate Gel while you are pregnant. It is not known if Temovate Gel is found in breast milk. If you are or will be breast-feeding while you use Temovate Gel, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Temovate Gel:

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:

Dryness; itching; mild burning.

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); acne-like rash; burning, cracking, irritation, or peeling not present before you began using Temovate Gel; dark red blotches on the skin; excessive hair growth; inflamed hair follicles; inflammation around the mouth; muscle weakness; numbness of fingers; thinning, softening, or discoloration of the skin; unusual weight gain, especially in the face.

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: Temovate 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 increased thirst or urination; muscle weakness; unusual weight gain, especially in the face.

Proper storage of Temovate Gel:

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

General information:

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


• Temovate Gel 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 Temovate Gel. 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 Temovate resources

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

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Mesalamine

Mesalamine Rectal Suspension Enema 4 grams/unit (60 mL)

Rx Only

Mesalamine Description

The active ingredient in Mesalamine Rectal Suspension Enema, a disposable (60 mL) unit, is Mesalamine, also known as 5-aminosalicylic acid (5-ASA). Chemically, Mesalamine is 5-amino-2-hydroxybenzoic acid.

The empirical formula is C7H7NO3, representing a molecular weight of 153.14.

The structural formula is:

Each rectal suspension enema unit contains 4 grams of Mesalamine. In addition to Mesalamine the preparation contains the inactive ingredients carbomer 934P, edetate disodium, potassium acetate, potassium metabisulfite, purified water and xanthan gum. Sodium benzoate is added as a preservative. The disposable unit consists of an applicator tip protected by a polyethylene cover and lubricated with USP white petrolatum. The unit has a one-way valve to prevent back flow of the dispensed product.

Mesalamine - Clinical Pharmacology

Sulfasalazine is split by bacterial action in the colon into sulfapyridine (SP) and Mesalamine (5-ASA). It is thought that the Mesalamine component is therapeutically active in ulcerative colitis [A.K. Azad Khan et al, Lancet 2:892-895 (1977)]. The usual oral dose of sulfasalazine for active ulcerative colitis in adults is two to four grams per day in divided doses. Four grams of sulfasalazine provide 1.6 g of free Mesalamine to the colon. Each Mesalamine Rectal Suspension Enema delivers up to 4 g of Mesalamine to the left side of the colon.

The mechanism of action of Mesalamine (and sulfasalazine) is unknown, but appears to be topical rather than systemic. Mucosal production of arachidonic acid (AA) metabolites, both through the cyclooxygenase pathways, i.e., prostanoids, and through the lipoxygenase pathways, i.e., leukotrienes (LTs) and hydroxyeicosatetraenoic acids (HETEs) is increased in patients with chronic inflammatory bowel disease, and it is possible that Mesalamine diminishes inflammation by block cyclooxygenase and inhibiting prostaglandin (PG) production in the colon.

Preclinical Toxicology

Preclinical studies have shown the kidney to be the major target organ for Mesalamine toxicity. Adverse renal function changes were observed in rats after a single 600 mg/kg oral dose, but not after 200 mg/kg dose. Gross kidney lesions, including papillary necrosis, were observed after a single oral >900 mg/kg dose, and after I.V. doses of >214 mg/kg. Mice responded similarly. In a 13-week oral (gavage) dose study in rats, the high dose of 640 mg/kg/day Mesalamine caused deaths, probably due to renal failure, and dose-related renal lesions (papillary necrosis and/or multifocal tubular injury) were seen in most rats given the high dose (males and females) as well as in males receiving lower doses 160 mg/kg/day. Renal lesions were not observed in the 160 mg/kg/day female rats. Minimal tubular epithelial damage was seen in the 40 mg/kg/day males and was reversible. In a six-month oral study in dogs, the no-observable dose level of Mesalamine was 40 mg/kg/day and doses of 80 mg/kg/day and higher caused renal pathology similar to that described for the rat. In a combined 52-week toxicity and 127-week carcinogenicity study in rats, degeneration in kidneys was observed doses of 100 mg/kg/day and above admixed with diet for 52 weeks, and at 127 weeks increased incidence of kidney degeneration and hyalinization of basement membranes and Bowman's capsule were seen at 100 mg/kg/day and above. In the 12-month eye toxicity study in dogs, Keratoconjunctivitis Sicca (KCS) occurred at oral doses of 40 mg/kg/day and above. The oral preclinical studies were done with a highly bioavailable suspension where absorption throughout the gastrointestinal tract occurred. The human dose of 4 grams represents approximately 80 mg/kg but when Mesalamine is given rectally as a suspension, absorption is poor and limited to the distal colon (see Pharmacokinetics). Overt renal toxicity has not been observed (see ADVERSE REACTIONS and PRECAUTIONS), but the potential must be considered.

Pharmacokinetics

Mesalamine administered rectally as Mesalamine Rectal Suspension Enema is poorly absorbed from the colon and is excreted principally in the feces during subsequent bowel movements. The extent of absorption is dependent upon the retention time of the drug product, and there is considerable individual variation. At steady state, approximately 10 to 30% of the daily 4-gram dose can be recovered in cumulative 24-hour urine collections. Other than the kidney, the organ distribution and other bioavailability characteristics of absorbed Mesalamine in man are not known. It is known that the compound undergoes acetylation but whether this process takes place at colonic or systemic sites has not been elucidated.

Whatever the metabolic site, most of the absorbed Mesalamine is excreted in the urine as the N-acetyl-5-ASA metabolite. The poor colonic absorption of rectally administered Mesalamine is substantiated by the low serum concentration of 5-ASA and N-acetyl-5-ASA seen in ulcerative colitis patients after dosage with Mesalamine. Under clinical conditions patients demonstrated plasma levels 10 to 12 hours post Mesalamine administration of 2 µg/mL, about two-thirds of which was the N-acetyl metabolite. While the elimination half-life of Mesalamine is short (0.5 to 1.5 h), the acetylated metabolite exhibits a half-life of 5 to 10 hours [U. Klotz, Clin. Pharmacokin. 10:285-302 (1985)]. In addition, steady state plasma levels demonstrated a lack of accumulation of either free or metabolized drug during repeated daily administrations.

Efficacy

In a placebo-controlled, international, multicenter trial of 153 patients with active distal ulcerative colitis, proctosigmoiditis or proctitis, Mesalamine Rectal Suspension Enema reduced the overall disease activity index (DAI) and individual components as follows:

EFFECT OF TREATMENT ON SEVERITY OF DISEASE DATA FROM U.S.-CANADA TRIAL COMBINED RESULTS OF EIGHT CENTERS

Activity Indices, mean
						Change
				Day	End	Baseline to
		N	Baseline	22	Point	End Point*
Each parameter has a 4-point scale with a numerical rating: 0 = normal, 1 = mild, 2 = moderate, 3 = severe. The four parameters are added together to produce a maximum overall DAI of 12.
* Percent change for overall DAI only (calculated by taking the average of the change for each individual patient). † Significant Mesalamine Rectal Suspension Enema/placebo difference. p < 0.01 ‡ Significant Mesalamine Rectal Suspension Enema/placebo difference. p < 0.001 § Significant Mesalamine Rectal Suspension Enema/placebo difference. p < 0.05
Overall DAI	Mesalamine Rectal Suspension Enema	76	7.42	4.05†	3.37‡	-55.07%‡
	Placebo	77	7.40	6.03	5.83	-21.58%
Stool Frequency	Mesalamine Rectal Suspension Enema		1.58	1.11§	1.01†	-0.57§
	Placebo		1.92	1.47	1.50	-0.41
Rectal Bleeding	Mesalamine Rectal Suspension Enema		1.82	0.59‡	0.51‡	-1.30‡
	Placebo		1.73	1.21	1.11	-0.61
Mucosal Inflama- tion	Mesalamine Rectal Suspension Enema		2.17	1.22†	0.96‡	-1.21†
	Placebo		2.18	1.74	1.61	-0.56
Physcian's Assesment of Disease Severity	Mesalamine Rectal Suspension Enema		1.86	1.13‡	0.88‡	-0.97‡
	Placebo		1.87	1.62	1.55	-0.30

Differences between Mesalamine Rectal Suspension Enema and placebo were also statistically different in subgroups of patients on concurrent sulfasalazine and in those having an upper disease boundary between 5 and 20 or 20 and 40 cm. Significant differences between Mesalamine Rectal Suspension Enema and placebo were not achieved in those subgroups of patients on concurrent prednisone or with an upper disease boundary between 40 and 50 cm.

Indications and Usage for Mesalamine

Mesalamine Rectal Suspension Enema is indicated for the treatment of active mild to moderate distal ulcerative colitis, proctosigmoiditis or proctitis.

Contraindications

Mesalamine Rectal Suspension Enema is contraindicated for patients known to have hypersensitivity to the drug or any component of this medication.

Warnings

Mesalamine Rectal Suspension Enema 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 but probably low. Sulfite sensitivity is seen more frequently in asthmatic or in atopic nonasthmatic persons.

Epinephrine is the preferred treatment for serious allergic or emergency situations even though epinephrine injection contains sodium or potassium metabisulfite with the above-mentioned potential liabilities. The alternatives to using epinephrine in a life-threatening situation may not be satisfactory. The presence of a sulfite(s) in epinephrine injection should not deter the administration of the drug for treatment of serious allergic or other emergency situations.

Precautions

Mesalamine has been implicated in the production of an acute intolerance syndrome characterized by cramping, acute abdominal pain and bloody diarrhea, sometimes fever, headache and a rash; in such cases prompt withdrawal is required. The patient's history of sulfasalazine intolerance, if any, should be re-evaluated. If a rechallenge is performed later in order to validate the hypersensitivity it should be carried out under close supervision and only if clearly needed, giving consideration to reduced dosage. In the literature one patient previously sensitive to sulfasalazine was rechallenged with 400 mg oral Mesalamine; within eight hours she experienced headache, fever, intensive abdominal colic, profuse diarrhea and was readmitted as an emergency. She responded poorly to steroid therapy and two weeks later a pancolectomy was required.

Although renal abnormalities were not noted in the clinical trials with Mesalamine Rectal Suspension Enema, the possibility of increased absorption of Mesalamine and concomitant renal tubular damage as noted in the preclinical studies must be kept in mind. Patients on Mesalamine Rectal Suspension Enema, especially those on concurrent oral products which liberate Mesalamine and those with preexisting renal disease, should be carefully monitored with urinalysis, BUN (blood urea nitrogen), and creatinine studies.

In a clinical trial most patients who were hypersensitive to sulfasalazine were able to take Mesalamine enemas without evidence of any allergic reaction. Nevertheless, caution should be exercised when Mesalamine is initally used in patients known to be allergic to sulfasalazine. These patients should be instructed to discontinue therapy if signs of rash or fever become apparent.

While using Mesalamine Rectal Suspension Enema, some patients have developed pancolitis. However, extension of upper disease boundary and/or flare-ups occurred less often in the Mesalamine Rectal Suspension Enema treated group than in the placebo-treated group.

Worsening of colitis or symptoms of inflammatory bowel disease, including melena and hematochezia, may occur after commencing Mesalamine.

Rare instances of pericarditis have been reported with Mesalamine containing products including sulfasalazine. Cases of pericarditis have also been reported as manifestations of inflammatory bowel disease. In the cases reported with Mesalamine Rectal Suspension Enema, there hae been positive rechallenges with Mesalamine or Mesalamine containing products. In one of these cases, however, a second rechallenge with sulfasalazine was negative throughout a 2-month follow-up. Chest pain or dyspnea in patients treated with Mesalamine Rectal Suspension Enema should be investigated with this information in mind. Discontinuation of Mesalamine Rectal Suspension Enema may be warranted in some cases, but rechallenge with Mesalamine can be performed under careful clinical observation should the continued therapeutic need for Mesalamine be present.

Carcinogenesis, Mutagenesis, Impairment Of Fertility

Mesalamine caused no increase in the incidence of neoplastic lesions over controls in a 2-year study of Wistar rats fed up to 320 mg/kg/day of Mesalamine admixed with diet. Mesalamine is not mutagenic to Salmonella typhimurium tester strains TA98, TA100,TA1535, TA1537, TA1538. There were no reverse mutations in an assay using E. coli strain WP2UVRA. There were no effects in an in vivo mouse micronucleus assay at 600 mg/kg and in an in vivo sister chromatid exchange at doses up to 610 mg/kg. No effects on fertility were observed in rats receiving up to 320 mg/kg/day. The oligospermia and infertility in men associated with sulfasalazine has very rarely been reported among patients treated with Mesalamine.

Pregnancy (Caregory B)

Teratologic studies have been performed in rats and rabbits at oral doses up to five and eight times respectively, the maximum recommended human dose, and have revealed no evidence of harm to the embryo or the fetus. There are, however, no adequate and well-controlled studies in pregnant women for either sulfasalazine or 5-ASA. Because animal reproduction studies are not always predictive of human response, 5-ASA should be used during pregnancy only if clearly needed.

Nursing Mothers

It is not known whether Mesalamine or its metabolite(s) are excreted in human milk. As a general rule, nursing should not be undertaken while a patient is on a drug since many drugs are excreted in human milk.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Adverse Reactions

Clinical Adverse Experience

Mesalamine Rectal Suspension Enema is usually well tolerated. Most adverse effects have been mild and transient.

ADVERSE REACTIONS OCCURING IN MORE THAN 0.1% OF Mesalamine RECTAL SUSPENSION ENEMA TREATED PATIENTS (COMPARISON TO PLACEBO)

	Mesalamine Rectal Suspension Enema		Placebo
	N = 815		N = 128
SYMPTOM	N	%	N	%
Abdominal Pain/Cramps/Discomfort	66	8.10	10	7.81
Headache	53	6.50	16	12.50
Gas/Flatulence	50	6.13	5	3.91
Nausea	47	5.77	12	9.38
Flu	43	5.28	1	0.78
Tired/Weak/Malaise/Fatigue	28	3.44	8	6.25
Fever	26	3.19	0	0.00
Rash/Spots	23	2.82	4	3.12
Cold/Sore Throat	19	2.33	9	7.03
Diarrhea	17	2.09	5	3.91
Leg/Joint Pain	17	2.09	1	0.78
Dizziness	15	1.84	3	2.34
Bloating	12	1.47	2	1.56
Back Pain	11	1.35	1	0.78
Pain on Insertion of Enema Tip	11	1.35	1	0.78
Hemorrhoids	11	1.35	0	0.00
Itching	10	1.23	1	0.78
Rectal Pain	10	1.23	0	0.00
Constipation	8	0.98	4	3.12
Hair Loss	7	0.86	0	0.00
Peripheral Edema	5	0.61	11	8.59
UTI/Urinary Burning	5	0.61	4	3.12
Rectal Pain/Soreness/Burning	5	0.61	3	2.34
Asthenia	1	0.12	4	3.12
Insomnia	1	0.12	3	2.34

In addition, the following adverse events have been identified during post-approval use of products which contain (or are metabolized to) Mesalamine in clinical practice; nephrotoxicity, pancreatitis, fibrosing alveolitis and elevated liver enzymes. Cases of pancreatitis and fibrosing alveolitis have been reported as manifestations of inflammatory bowel disease as well. Published case reports and/or spontaneous post marketing surveillance have described rare instances of aplastic anemia, agranulocytosis, thrombocytopenia, eosinophilia, pancytopenia, neutropenia, oligospermia, and infertility in men. Anemia, leukocytosis, and thrombocytosis can be part of the clinical presentation of inflammatory bowel disease.

Hair Loss

Mild hair loss characterized by "more hair in the comb" but no withdrawal from clinical trials has been observed in 7 of 815 Mesalamine patients but none of the placebo-treated patients. In the literature there are at least six additional patients with mild hair loss who received either Mesalamine of sulfasalazine. Retreatment is not always associated with repeated hair loss.

Overdosage

There have been no documented reports of serious toxicity in man resulting from massive overdosing with Mesalamine. Under ordinary circumstances, Mesalamine absorption from the colon is limited.

Mesalamine Dosage and Administration

The usual dosage of Mesalamine Rectal Suspension Enema in 60 mL units is one rectal instillation (4 grams) once a day, preferably at bedtime, and retained for approximately eight hours. While the effect of Mesalamine Rectal Suspension Enema may be seen within 3 to 21 days, the usual course of therapy would be from 3 to 6 weeks depending on symptoms and sigmoidoscopic findings. Studies available to date have not assessed if Mesalamine Rectal Suspension Enema will modify relapse rates after the 6-week, short-term treatment. Mesalamine Rectal Suspension Enema is for rectal use only.

Patients should be instructed to shake the bottle well to make sure the suspension is homogeneous. The patient should remove the protective sheath from the applicator tip. Holding the bottle at the neck will not cause any of the medication to be discharged. The position most often used is obtained by lying on the left side (to facilitate migration into the sigmoid colon); with the lower leg extended and the upper right leg flexed forward for balance. An alternative is the knee-chest position. The applicator tip should be gently inserted in the rectum pointing toward the umbilicus. A steady squeezing of the bottle will discharge most of the preparation. The preparation should be taken at bedtime with the objective of retaining it all night. Patient instructions are included with every seven units.

How is Mesalamine Supplied

Mesalamine Rectal Suspension Enema for rectal administration is an off-white to tan colored suspension. Each disposable enema bottle contains 4 grams of Mesalamine in 60 mL aqueous suspension. Enema bottles are supplied in boxed, foil-wrapped trays as follows:

NDC 50532 - 066 - 05                     Carton of 7 Bottles

Mesalamine Rectal Suspension Enemas are for rectal use only.

KEEP OUT OF REACH OF CHILDREN

Patient instructions are included.

Storage

Store at controlled room temperature 20° to 25°C (68° to 77°F); excusions permitted, please refer to current USP. Once the foil-wrapped unit of seven bottles is opened, all enemas should be used promptly as directed by your physician. Contents of enemas removed from the foil pouch may darken with time. Slight darkening will not affect potency, however, enemas with dark brown contents should be discarded.

NOTE: Mesalamine Rectal Suspension Enema will cause staining of direct contact surfaces, including but not limited to fabrics, flooring, painted surfaces, marble, granite, vinyl, and enamel. Take care in choosing a suitable location for administration of this product.

Ref CL5-066-00-0110

5-066-00-0110

Rev. 01/10

Franklin Pharmaceutical LLC

200 North Cobb Parkway, Bldg., 400, Suite 428

Marietta, GA 30062

For Medical Inquiries, Call Toll–Free: 1– 800–333–7343

www.FranklinPharm.com

PATIENT INSTRUCTIONS

How to Use this Medication.

Best results are achieved if the bowel is emptied immediately before the medication is given.

NOTE: Mesalamine Rectal Suspension Enema will cause staining of direct contact surfaces, including but not limited to fabrics, flooring, painted surfaces, marble, granite, vinyl, and enamel. Take care in choosing a suitable location for administration of this product.

1.

Remove the Bottles

1. Remove the bottles from the protective foil pouch by tearing or by using scissors as shown, being careful not to squeeze or puncture bottles. Mesalamine Rectal Suspension Enema is an off-white to tan colored suspension. Once the foil-wrapped unit of seven bottles is opened, all enemas should be used promptly as directed by your physician. Contents of enemas removed from the foil pouch may darken with time. Slight darkening will not affect potency, however, enemas with dark brown contents should be discarded.
   
   
   

2.

Prepare the Medication for Administration

1. Shake the bottle well to make sure that the medication is thoroughly mixed.


2. Remove the protective sheath from the applicator tip. Hold the bottle at the neck so as not to cause any of the medication to be discharged.
   
   
   

3.

Assume the Correct Body Position

1. Best results are obtained by lying on the left side with the left leg extended and the right leg flexed forward for balance.
   
   
   


2. An alternative to lying on the left side is the "knee-chest" position as sown here.
   
   
   

4.

Administer the Medication

1. Gently insert the lubricated applicator tip into the rectum to prevent damage to the rectal wall, pointed slightly toward the navel.


2. Grasp the bottle firmly, then tilt slighty so that the nozzle is aimed toward the back, squeeze slowly to instill the medication. Steady hand pressure will discharge most of the medication. After administering, withdraw and discard the bottle.
   
   
   


3. Remain in position for at least 30 minutes to allow thorough distribution of the medication internally. Retain the medication all night, if possible.

Rx only

Ref CL5-066-00-0110         Rev. 01/10

5-066-00-0110

Franklin Pharmaceutical LLC

200 North Cobb Parkway, Bldg., 400, Suite 428

Marietta, GA 30062

For Medical Inquiries, Call Toll-Free:

1-800-333-7343

www.FranklinPharm.com

PRINCIPAL DISPLAY PANEL - Carton of 7 Bottles

60 mL

NDC 50532-066-06

Mesalamine

RECTAL SUSPENSION

ENEMA 4g/60mL

FOR RECTAL USE ONLY

Rx ONLY

Manufactured for:

FRANKLIN™

Pharmaceutical

Marietta, GA 30062

Mesalamine  Mesalamine  suspension

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 50532-066 Route of Administration RECTAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Mesalamine (Mesalamine) Mesalamine 4 g  in 60 mL

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 50532-066-05 7 BOTTLE In 1 CARTON contains a BOTTLE, WITH APPLICATOR (50532-066-06) 1 50532-066-06 60 mL In 1 BOTTLE, WITH APPLICATOR This package is contained within the CARTON (50532-066-05)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA AUTHORIZED GENERIC	NDA019618	04/01/2010

Labeler - Franklin Pharmaceutical LLC (961561581)

Establishment
Name	Address	ID/FEI	Operations
ANIP Acquisition Company		148515737	ANALYSIS, MANUFACTURE

Revised: 03/2010Franklin Pharmaceutical LLC

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Poly-Tussin AC

Generic Name: brompheniramine, codeine, and phenylephrine (BROM fen IR a meen, KOE deen, FEN il EFF rin)

Brand Names: M-End PE, Poly-Tussin AC, TL-Hist CD

What is Poly-Tussin AC (brompheniramine, codeine, and phenylephrine)?

Brompheniramine is an antihistamine that reduces the effects of natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Codeine is a narcotic cough suppressant. It affects the signals in the brain that trigger cough reflex.

Phenylephrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

The combination of brompheniramine, codeine, and phenylephrine is used to treat runny or stuffy nose, sneezing, itching, watery eyes, cough, and sinus congestion caused by allergies, the common cold, or the flu.

Brompheniramine, codeine, and phenylephrine may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Poly-Tussin AC (brompheniramine, codeine, and phenylephrine)?

You should not use this medication if you have severe liver disease, severe constipation, severe colitis or toxic megacolon, if you are unable to urinate, if you have been sick with diarrhea, if you recently drank large amounts of alcohol, or if you have a head injury or brain tumor. Do not use cough and cold medicine if you have untreated or uncontrolled diseases such as glaucoma, asthma or COPD, high blood pressure, heart disease, or overactive thyroid. Do not use a cough or cold medicine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

What should I discuss with my healthcare provider before taking Poly-Tussin AC (brompheniramine, codeine, and phenylephrine)?

Do not use a cough or cold medicine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects. You should not use this medication if you have severe liver disease, severe constipation, severe colitis or toxic megacolon, if you are unable to urinate, if you have been sick with diarrhea, if you recently drank large amounts of alcohol, or if you have a head injury or brain tumor. Do not use cough and cold medicine if you have untreated or uncontrolled diseases such as glaucoma, asthma or COPD, high blood pressure, heart disease, or overactive thyroid.

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

• 
  

  a blockage in your digestive tract (stomach or intestines), a colostomy or ileostomy;

  
  


• 
  

  diabetes;

  
  


• 
  

  liver or kidney disease;

  
  


• 
  

  epilepsy or other seizure disorder;

  
  


• 
  

  gallbladder disease;

  
  


• 
  

  enlarged prostate or urination problems;

  
  


• 
  

  an adrenal gland tumor or disorder (such as Addison's disease); or

  
  


• 
  

  if you take potassium (Cytra, Epiklor, K-Lyte, K-Phos, Kaon, Klor-Con, Polycitra, Urocit-K).

  
  

Codeine may be habit forming and should be used only by the person it was prescribed for. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. FDA pregnancy category C. Codeine may cause addiction or withdrawal symptoms in a newborn if the mother takes the medication during pregnancy. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine. Codeine can pass into breast milk and may harm a nursing baby. The use of codeine by some nursing mothers may lead to life-threatening side effects in the baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take Poly-Tussin AC (brompheniramine, codeine, and phenylephrine)?

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. Cough or cold medicine is usually taken only for a short time until your symptoms clear up.

Do not take for longer than 7 days in a row. Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache or skin rash.

Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. If you need surgery or medical tests, tell the surgeon or doctor ahead of time if you have taken a cough or cold medicine within the past few days. Store at room temperature away from moisture and heat. Do not freeze. Keep track of the amount of medicine used from each new bottle. Codeine is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

What happens if I miss a dose?

Since cough or cold medicine is taken when needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of codeine can be fatal.

Overdose symptoms may include confusion, extreme weakness, pinpoint pupils, cold and clammy skin, weak pulse, slow breathing, fainting, or breathing that stops. Overdose symptoms may also include severe forms of some of the side effects listed in this medication guide.

What should I avoid while taking Poly-Tussin AC (brompheniramine, codeine, and phenylephrine)?

Do not drink alcohol while you are taking medicine that contains codeine. Dangerous side effects or death can occur when alcohol is combined with a narcotic medicine. Check your food and medicine labels to be sure these products do not contain alcohol. Ask a doctor or pharmacist before using any other cold, cough, allergy, or sleep medicine. Antihistamines, decongestants, and cough suppressants are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains an antihistamine, decongestant, or cough suppressant. This medicine may cause blurred vision or impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

Poly-Tussin AC (brompheniramine, codeine, and phenylephrine) 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 taking the medication and call your doctor at once if you have a serious side effect such as:

• 
  

  fast or pounding heartbeats;

  
  


• 
  

  confusion, hallucinations, unusual thoughts or behavior;

  
  


• 
  

  severe dizziness, anxiety, restless feeling, or nervousness;

  
  


• 
  

  urinating less than usual or not at all;

  
  


• 
  

  easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms; or

  
  


• 
  

  dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, chest pain, shortness of breath, uneven heartbeats, seizure).

  
  

Less serious side effects may include:

• 
  

  dizziness, drowsiness, problems with memory or concentration;

  
  


• 
  

  dry mouth, nose, or throat, increased sweating or urination;

  
  


• 
  

  mild stomach pain, diarrhea or constipation;

  
  


• 
  

  sleep problems (insomnia);

  
  


• 
  

  blurred vision; or

  
  


• 
  

  flushing (warmth, redness, or tingly feeling).

  
  

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 Poly-Tussin AC (brompheniramine, codeine, and phenylephrine)?

Before using this medicine, tell your doctor if you regularly use other medicines that make you sleepy (such as other cold or allergy medicines, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by brompheniramine or codeine.

Tell your doctor about all other medications you use, especially:

• 
  

  naloxone (Narcan, Suboxone);

  
  


• 
  

  topiramate (Topamax);

  
  


• 
  

  tramadol (Ultram, Ultracet);

  
  


• 
  

  zonisamide (Zonegran);

  
  


• 
  

  a diuretic (water pill);

  
  


• 
  

  an antidepressant such as amitriptyline (Elavil, Vanatrip, Limbitrol), bupropion (Wellbutrin), doxepin (Sinequan, Silenor), nortriptyline (Pamelor), and others;

  
  


• 
  

  anti-nausea medications such as belladonna (Donnatal), dimenhydrinate (Dramamine), droperidol (Inapsine), methscopolamine (Pamine), or scopolamine (Transderm Scop);

  
  


• 
  

  bladder or urinary medications such as darifenacin (Enablex), flavoxate (Urispas), oxybutynin (Ditropan, Oxytrol), solifenacin (Vesicare), tolterodine (Detrol), or Urogesic Blue;

  
  


• 
  

  bowel cleansing preparations (Half Lytely, Fleet Prep Kit, Evac-Q-Kwik, GoLytely, Supraprep, and others);

  
  


• 
  

  bronchodilators such as ipratropium (Atrovent) or tiotropium (Spiriva);

  
  


• 
  

  irritable bowel medications such as dicyclomine (Bentyl), hyoscyamine (Hyomax), or propantheline (Pro Banthine); or

  
  


• 
  

  ulcer medicine such as glycopyrrolate (Robinul) or mepenzolate (Cantil).

  
  

This list is not complete and other drugs may interact with brompheniramine, codeine, and phenylephrine. 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 Poly-Tussin AC resources

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

• Brompheniramine/Codeine/Phenylephrine Liquid MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Poly-Tussin AC with other medications

• Cold Symptoms
• Cough and Nasal Congestion

Where can I get more information?

• Your pharmacist can provide more information about brompheniramine, codeine, and phenylephrine.

See also: Poly-Tussin AC side effects (in more detail)

Colchicine Tablets BP 0.5mg (Boots Company plc)

1. Name Of The Medicinal Product

Colchicine Tablets BP 0.5mg

2. Qualitative And Quantitative Composition

Active Ingredient
Colchicine	0.5mg

3. Pharmaceutical Form

Tablets

4. Clinical Particulars

4.1 Therapeutic Indications

For the treatment of acute gout and for the prophylaxis of recurrent gout and to prevent acute attacks during the initial treatment with allopurinol or uricosuric drugs.

4.2 Posology And Method Of Administration

For oral administration.

For treatment of acute gout:

1 mg initially then 500 micrograms every 2-3 hours until pain is relieved or diarrhoea or vomiting occurs or until a total dose of 6 mg is reached.

Do not repeat the course of treatment within 3 days.

For prophylaxis:

500 micrograms two to three times daily.

4.3 Contraindications

History of hypersensitivity to colchicine. Blood dyscrasias.

4.4 Special Warnings And Precautions For Use

Colchicine should be given with care to elderly and debilitated patients and to those with cardiac, renal, hepatic or gastrointestinal disease.

Keep all medicines out of the reach of children.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Thiazide diuretics may cause a rise in serum uric acid and this may interfere with the activity of colchicine. Colchicine may impair the absorption of vitamin B12 and may induce muscle disorders when used in combination with ciclosporin.

Concomitant use with clarithromycin may lead to colchicine toxicity. Colchicine is a substrate for both CYP3A and the efflux transporter, P-glycoprotein (Pgp). Clarithromycin and other macrolides are known to inhibit CYP3A and Pgp. When clarithromycin and colchicine are administered together, inhibition of Pgp and/or CYP3A by clarithromycin may lead to increased exposure to colchicine. Patients should be monitored for clinical symptoms of colchicine toxicity.

Concomitant use with erythromycin or tolbutamide may also lead to colchicine toxicity.

4.6 Pregnancy And Lactation

Use of colchicine during pregnancy is not advised.

Chromosomal aberrations have been reported in some patients on prolonged colchicine therapy although a causal relationship is doubtful. Controlled studies in humans have not been performed. The data available do not establish specific teratogenic effects. It is not known whether colchicine is distributed into human milk and it should therefore be used with caution in nursing women.

4.7 Effects On Ability To Drive And Use Machines

None stated.

4.8 Undesirable Effects

Common side effects include nausea, vomiting, diarrhoea and abdominal pain. Larger doses may cause profuse diarrhoea, gastrointestinal haemorrhage, muscle weakness, skin rashes, renal and hepatic damage. Dehydration and hypotension may follow. Alopecia, peripheral neuritis and bone marrow depression with agranulocytosis and aplastic anaemia may occur after prolonged treatment.

4.9 Overdose

Symptoms of poisoning do not appear for at least several hours. Initial symptoms include nausea, vomiting and diarrhoea. The diarrhoea may be severe and blood-stained. Metabolic acidosis, dehydration, hypotension and shock may develop. A burning sensation of the throat, stomach and skin may also occur. Extensive vascular damage and acute renal toxicity with oliguria and haematuria have been reported. The patient may develop convulsions, delirium, muscle weakness, neuropathy and ascending paralysis of the CNS. Death may be due to respiratory depression, cardiovascular collapse or bone marrow depression. The fatal dose varies; 7 mg of colchicine has caused death, yet recovery has occurred after much larger doses.

In acute poisoning the stomach should be emptied by lavage. Treatment is primarily symptomatic and supportive with attention being given to the control of respiration, maintenance of blood pressure and the circulation, and correction of fluid and electrolyte balance. Haemodialysis or peritoneal dialysis may be of value when kidney function is compromised.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Although the precise mode of action of colchicine in the treatment of gout is unknown, it is considered to act against the inflammatory response to urate crystals, by possibly inhibiting the migration of granulocytes into the inflamed area.

5.2 Pharmacokinetic Properties

Colchicine is readily absorbed from the gastrointestinal tract and reaches peak plasma concentration within 2 hours. It is partially deacetylated in the liver and the unchanged drug and its metabolites are excreted in the bile and undergo intestinal reabsorption. Most of the drug is excreted in the faeces but 10-20% is excreted in the urine.

5.3 Preclinical Safety Data

There are no preclinical data of relevance to the prescriber which are additional to that already included.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Lactose

Purified Water

Stearic Acid

6.2 Incompatibilities

None stated.

6.3 Shelf Life

36 months.

6.4 Special Precautions For Storage

Protect from light.

6.5 Nature And Contents Of Container

Amber coloured glass bottle with a tin plate cap fitted with a wax aluminium pulpboard liner.

Pack size: 20, 100.

6.6 Special Precautions For Disposal And Other Handling

None stated.

7. Marketing Authorisation Holder

The Boots Company PLC

1 Thane Road West

Nottingham NG2 3AA

8. Marketing Authorisation Number(S)

PL0014/5043R

9. Date Of First Authorisation/Renewal Of The Authorisation

Date of First Authorisation: 9 February 1979

Date of Last Renewal: 28 April 2000

10. Date Of Revision Of The Text

January 2007

Gamunex

Pronunciation: i-MUNE GLOB-ue-lin
Generic Name: Immune Globulin (Human)
Brand Name: Gamunex

Gamunex may increase the risk of serious and sometimes fatal kidney problems. The risk may be greater if you already have kidney problems. The risk may also be greater if you have diabetes, dehydration or low blood volume, a blood infection, or abnormal proteins in the blood. You may also be at increased risk if you are over 65 years old or if you take another medicine that may harm your kidneys. Contact your doctor right away if you experience decreased urination, lower back or flank pain, swelling or bloating, sudden weight gain, shortness of breath, or weakness.

Gamunex is used for:

Providing antibodies to help prevent infection in certain patients who have a weakened immune system. It is used in patients with a certain blood problem (chronic immune thrombocytopenic purpura; ITP) to raise platelet levels. This helps to prevent bleeding or allows patients with ITP to have surgery. Gamunex is also used in patients with a certain nervous system problem (chronic inflammatory demyelinating polyneuropathy; CIDP). It helps to improve muscle problems and to prevent relapse of muscle problems. It may also be used for other conditions as determined by your doctor.

Gamunex is an immune globulin. It works to prevent infection by providing antibodies that fight infection. Exactly how it works to treat ITP and CIDP is not known.

Do NOT use Gamunex if:

• you are allergic to any ingredient in Gamunex or to immune globulin (human)


• you have had a severe allergic reaction (eg, severe rash, hives, difficulty breathing, dizziness) to blood or products that are produced from blood


• you have immunoglobulin A (IgA) deficiency with antibodies against IgA and a history of allergic reaction to IgA

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

Before using Gamunex:

Some medical conditions may interact with Gamunex. 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 recently received any vaccinations or will be receiving a live vaccine (eg, measles, mumps)


• if you have heart problems, blood vessel problems (eg, narrowed arteries), thick blood, or a history of stroke, heart attack, or blood clots


• if you will be confined to a bed or chair for a long period of time


• if you have kidney problems, diabetes, dehydration or low blood volume, a blood infection, a weakened immune system, abnormal proteins or high protein levels in the blood, or asthma


• if you have a history of migraine headaches

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

• Medicines that may harm the kidney (eg, aminoglycoside antibiotics [eg, gentamicin], amphotericin B, cyclosporine, nonsteroidal anti-inflammatory drugs [NSAIDs] [eg, ibuprofen], tacrolimus, vancomycin) because the risk of kidney side effects may be increased. Ask your doctor if you are unsure if any of your medicines might harm the kidney


• Hydantoins (eg, phenytoin) because unexpected hypersensitivity reactions may occur


• Live vaccines (eg, measles, mumps, rubella) because their effectiveness may be decreased by Gamunex

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

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

• Gamunex is usually given as an injection at your doctor's office, hospital, or clinic.


• Do not use Gamunex if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.


• Do not use Gamunex if it has ever been frozen.


• 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.


• If you miss a dose of Gamunex, contact your doctor right away.

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

Important safety information:

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


• Aseptic meningitis syndrome (AMS) has been reported to occur rarely in association with the use of Gamunex. This usually begins within several hours to 2 days following treatment. Symptoms include severe headache, neck stiffness, unusual drowsiness, fever, painful eye movements, sensitivity to light, nausea, and vomiting.


• You may need to wait for a period of time after you use Gamunex before you receive a live vaccine (eg, measles, mumps). Talk with your doctor before you receive any vaccine.


• Gamunex is made from human plasma. There is an extremely low risk of developing a viral infection (eg, parvovirus, hepatitis A) or Creutzfeldt-Jakob disease (CJD) after using Gamunex. Discuss any questions or concerns with your doctor.


• Gamunex may interfere with certain lab tests. Be sure your doctor and lab personnel know you are using Gamunex.


• Lab tests, including kidney function, blood thickness, and antibody levels, may be performed while you use Gamunex. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Gamunex with caution in the ELDERLY because they may be more sensitive to its effects, especially kidney problems and blood clots.


• Use Gamunex with extreme caution in CHILDREN. Safety and effectiveness of certain products have not been established for certain age groups. Check with your doctor or pharmacist if you have questions about the use of Gamunex in a child.


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

Possible side effects of Gamunex:

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:

Back pain; chills; cough; diarrhea; ear pain; fatigue; flushing; headache; muscle cramps; nausea; pain, swelling, muscle stiffness, or redness at the injection site; sore throat; stuffy nose; weakness.

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

Severe allergic reactions (rash; itching; hives; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, hands, face, lips, eyes, throat, or tongue; unusual hoarseness); calf pain or tenderness; chest pain or tightness; confusion; coughing up blood; eye pain or sensitivity to light; fainting; fast or irregular heartbeat; numbness of an arm or a leg; one-sided weakness; red, swollen, blistered, or peeling skin; seizures; severe headache, dizziness, or stomach pain; shortness of breath or trouble breathing; speech problems; symptoms of kidney problems (eg, decreased urination, lower back or flank pain, swelling or bloating, sudden weight gain); symptoms of liver problems (eg, yellowing of the skin or eyes, dark urine, pale stools, nausea, stomach pain, loss of appetite, unusual tiredness); symptoms of parvovirus infection (eg, fever, drowsiness, chills, runny nose, rash, joint pain); unusual bruising or bleeding; vision problems; wheezing.

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: Gamunex side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Gamunex:

Gamunex is usually handled and stored by a health care provider. If you are using Gamunex at home, store Gamunex as directed by your pharmacist or health care provider. Keep Gamunex out of the reach of children and away from pets.

General information:

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


• Gamunex 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 Gamunex. 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 Gamunex resources

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

Compare Gamunex with other medications

• Chronic Inflammatory Demyelinating Polyradiculoneuropathy
• Evan's Syndrome
• Idiopathic Thrombocytopenic Purpura
• Primary Immunodeficiency Syndrome

Histacol DM Pediatric Syrup

Generic Name: brompheniramine, dextromethorphan, guaifenesin, and pseudoephedrine (brom fen EER a meen, DEX tro me THOR fan, gwye FEN e sin, SOO doe ee FED rin)

Brand Names: Bromhist-DM, Histacol DM Pediatric Syrup, Pediahist DM Syrup

What is Histacol DM Pediatric Syrup (brompheniramine, dextromethorphan, guaifenesin, and pseudoephedrine)?

Brompheniramine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Dextromethorphan is a cough suppressant. It affects the signals in the brain that trigger cough reflex.

Guaifenesin is an expectorant. It helps loosen congestion in your chest and throat, making it easier to cough out through your mouth.

Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

The combination of brompheniramine, dextromethorphan, guaifenesin, and pseudoephedrine is used to treat sneezing, runny or stuffy nose, cough, chest congestion, itchy or watery eyes, hives, skin rash, itching, and other symptoms of allergies and the common cold.

Dextromethorphan will not treat a cough that is caused by smoking, asthma, or emphysema.

Brompheniramine, dextromethorphan, guaifenesin, and pseudoephedrine may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Histacol DM Pediatric Syrup (brompheniramine, dextromethorphan, guaifenesin, and pseudoephedrine)?

Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Ask a doctor or pharmacist before using any other cough, cold, allergy, or sleep medication. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains an antihistamine, decongestant, expectorant, or cough suppressant. This medication impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Do not use a cough or cold medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take cough or cold medicine before the MAO inhibitor has cleared from your body. Drinking alcohol can increase certain side effects of brompheniramine, dextromethorphan, guaifenesin, and pseudoephedrine. Dextromethorphan will not treat a cough that is caused by smoking, asthma, or emphysema.

What should I discuss with my healthcare provider before taking Histacol DM Pediatric Syrup (brompheniramine, dextromethorphan, guaifenesin, and pseudoephedrine)?

Do not use a cough or cold medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take cough or cold medicine before the MAO inhibitor has cleared from your body.

Ask a doctor or pharmacist if it is safe for you to take this medicine if you have:

• kidney disease;


• 
  

  diabetes;

  
  


• 
  

  glaucoma;

  
  


• 
  

  heart disease or high blood pressure;

  
  


• 
  

  diabetes;

  
  


• 
  

  a thyroid disorder;

  
  


• 
  

  emphysema or chronic bronchitis;

  
  


• 
  

  an enlarged prostate; or

  
  


• 
  

  problems with urination.

  
  

This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Brompheniramine, dextromethorphan, guaifenesin, and pseudoephedrine can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Artificially sweetened liquid cough or cold medicine may contain phenylalanine. If you have phenylketonuria (PKU), check the medication label to see if the product contains phenylalanine.

How should I take Histacol DM Pediatric Syrup (brompheniramine, dextromethorphan, guaifenesin, and pseudoephedrine)?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Cold medicine is usually taken only for a short time until your symptoms clear up.

Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Take this medicine with a full glass of water. Do not crush, chew, or break an extended-release tablet. Swallow the pill whole. Breaking or opening the pill would cause too much of the drug to be released at one time.

Measure liquid medicine with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.

If you need surgery, tell the surgeon ahead of time if you have taken a cold medicine within the past few days.

This medication can cause you to have unusual results with allergy skin tests. Tell any doctor who treats you that you are taking an antihistamine.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Since brompheniramine, dextromethorphan, guaifenesin, and pseudoephedrine is taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include feeling restless or nervous, nausea, vomiting, stomach pain, dizziness, drowsiness, dry mouth, warmth or tingly feeling, or seizure (convulsions).

What should I avoid while taking Histacol DM Pediatric Syrup (brompheniramine, dextromethorphan, guaifenesin, and pseudoephedrine)?

Ask a doctor or pharmacist before using any other cough, cold, allergy, or sleep medication. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains an antihistamine, decongestant, expectorant, or cough suppressant. This medication impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Drinking alcohol can increase certain side effects of brompheniramine, dextromethorphan, guaifenesin, and pseudoephedrine.

Avoid taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor's advice. Taking a stimulant together with a decongestant can increase your risk of unpleasant side effects.

Histacol DM Pediatric Syrup (brompheniramine, dextromethorphan, guaifenesin, and pseudoephedrine) 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:

• 
  

  fast, pounding, or uneven heartbeat;

  
  


• 
  

  slow, shallow breathing;

  
  


• 
  

  confusion, hallucinations, unusual thoughts or behavior;

  
  


• 
  

  severe dizziness, anxiety, restless feeling, or nervousness;

  
  


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  increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure);

  
  


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  easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms; or

  
  


• 
  

  urinating less than usual or not at all.

  
  

Less serious side effects may include:

• 
  

  dry mouth;

  
  


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  nausea, stomach pain, constipation, mild loss of appetite, upset stomach;

  
  


• 
  

  blurred vision;

  
  


• 
  

  warmth, tingling, or redness under your skin;

  
  


• 
  

  sleep problems (insomnia);

  
  


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  feeling restless or excited (especially in children);

  
  


• 
  

  skin rash or itching;

  
  


• 
  

  dizziness, drowsiness, or headache;

  
  


• 
  

  problems with memory or concentration; or

  
  


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  ringing in your ears.

  
  

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 Histacol DM Pediatric Syrup (brompheniramine, dextromethorphan, guaifenesin, and pseudoephedrine)?

Before taking this medication, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by brompheniramine, dextromethorphan, or guaifenesin.

Tell your doctor about all other medications you use, especially:

• 
  

  a diuretic (water pill), or blood pressure medicine;

  
  


• 
  

  medication to treat irritable bowel syndrome;

  
  


• 
  

  bladder or urinary medications such as oxybutynin (Ditropan, Oxytrol), darifenacin (Enablex), or tolterodine (Detrol);

  
  


• 
  

  aspirin or salicylates (such as Disalcid, Doan's Pills, Dolobid, Salflex, Tricosal, and others);

  
  


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  a beta-blocker such as atenolol (Tenormin), carteolol (Cartrol), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal), sotalol (Betapace), timolol (Blocadren), and others; or

  
  


• 
  

  antidepressants such as amitriptyline (Elavil), clomipramine (Anafranil), imipramine (Janimine, Tofranil), and others.

  
  

This list is not complete and other drugs may interact with brompheniramine, dextromethorphan, guaifenesin, and pseudoephedrine. 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 Histacol DM Pediatric Syrup resources

• Histacol DM Pediatric Syrup Use in Pregnancy & Breastfeeding
• Histacol DM Pediatric Syrup Drug Interactions
• 0 Reviews for Histacol DM Pediatric - Add your own review/rating

• Bromhist-DM Syrup MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Histacol DM Pediatric Syrup with other medications

• Cold Symptoms

Where can I get more information?

• Your pharmacist can provide more information about brompheniramine, dextromethorphan, guaifenesin, and pseudoephedrine.

Isoproxal

Isoproxal may be available in the countries listed below.

Ingredient matches for Isoproxal

Alprazolam

Alprazolam is reported as an ingredient of Isoproxal in the following countries:

• Argentina

International Drug Name Search

Insulin Glulisine Vials

Pronunciation: IN-su-lin GLOO-lis-een
Generic Name: Insulin Glulisine
Brand Name: Apidra

Insulin Glulisine Vials are used for:

Treating diabetes mellitus. Insulin Glulisine Vials are usually used with a longer-acting insulin or insulin pump therapy.

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

Do NOT use Insulin Glulisine Vials if:

• you are allergic to any ingredient in Insulin Glulisine 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 Glulisine Vials:

Some medical conditions may interact with Insulin Glulisine 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


• if you have had or will be having heart surgery

Some MEDICINES MAY INTERACT with Insulin Glulisine 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, pentoxifylline, 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, diazoxide, diuretics (eg, furosemide, hydrochlorothiazide), estrogen, HIV protease inhibitors (eg, ritonavir), 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 Glulisine 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 Glulisine 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 Glulisine Vials:

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

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


• Use Insulin Glulisine Vials within 15 minutes before a meal or within 20 minutes after starting a meal, unless directed otherwise by your doctor.


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


• You may use Insulin Glulisine Vials in an insulin pump if you are directed to do so by your doctor. If you are using an insulin pump, do NOT dilute Insulin Glulisine Vials or mix it together with any other type of insulin.


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


• If you are mixing Insulin Glulisine Vials with NPH insulin, draw Insulin Glulisine Vials into the syringe first. Inject the dose immediately after mixing, as directed by your doctor. Do not mix Insulin Glulisine Vials with any other type of insulin except NPH.


• 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, 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.


• Insulin Glulisine Vials begins lowering blood sugar within minutes after an injection. The peak effect occurs between 30 and 90 minutes after a dose. The effect usually lasts from 1 to 2½ 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 Glulisine Vials.

Important safety information:

• Drowsiness, dizziness, lightheadedness, or blurred vision may occur while you are using Insulin Glulisine Vials. These effects may be worse if you take it with alcohol or certain medicines. Use Insulin Glulisine 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 the risk of developing high or low blood sugar.


• Do NOT take more than the recommended dose, use Insulin Glulisine Vials 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), 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 take Insulin Glulisine Vials before you receive any medical or dental care, emergency care, or surgery.


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


• Carry an ID card at all times that says you have diabetes. Check your blood sugar levels as directed by your doctor. If they are often higher than they should be and you take Insulin Glulisine Vials exactly as prescribed, tell 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 prescribed, 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 Glulisine Vials.


• Lab tests, including fasting blood glucose levels and hemoglobin A_1c, may be performed while you use Insulin Glulisine 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 Glulisine Vials with caution in the ELDERLY; if low blood sugar occurs, it may be more difficult to recognize in these patients.


• Insulin Glulisine Vials should be used with extreme caution in CHILDREN younger than 4 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 Glulisine Vials while you are pregnant. It is not known if Insulin Glulisine Vials are found in breast milk. If you are or will be breast-feeding while you use Insulin Glulisine Vials, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Insulin Glulisine 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; muscle pain); changes in vision; chills; confusion; dizziness; drowsiness; fainting; fast or irregular heartbeat; headache; loss of consciousness; mood changes; 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 Glulisine 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; fast or irregular heartbeat; headache; loss of consciousness; nervousness; seizures; shakiness; sweating; tremor; vision changes; weakness.

Proper storage of Insulin Glulisine Vials:

Store new (unopened) vials in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Store used (opened) vials either in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C), or at room temperature, below 77 degrees F (25 degrees C). Store away from heat and light. If Insulin Glulisine Vials has been frozen or overheated, throw it away. Throw away unrefrigerated or opened vials after 28 days, even if they still contain medicine.

Avoid temperatures above 98.6 degrees F (37 degrees C). Do not leave Insulin Glulisine Vials in a car on a warm or sunny day. Do not use Insulin Glulisine Vials after the expiration date stamped on the label. Keep Insulin Glulisine Vials, as well as syringes and needles, out of the reach of children and away from pets. If you are using Insulin Glulisine Vials in an insulin pump, you may need to store it differently. Ask your doctor, pharmacist, or other health care provider how to store Insulin Glulisine Vials.

General information:

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


• Insulin Glulisine 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 Glulisine 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 Glulisine resources

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

Compare Insulin Glulisine with other medications

• Diabetes, Type 1
• Diabetes, Type 2