Sacrosidase

sak-ROE-si-dase

Commonly used brand name(s)

In the U.S.

• Sucraid

Available Dosage Forms:

• Solution

Therapeutic Class: Gastrointestinal Agent

Uses For sacrosidase

Sacrosidase is used to replace the sucrase enzyme in your body. This enzyme helps digest and absorb sucrose (sugar). It is used in certain conditions (e.g., congenital sucrase-isomaltase deficiency or CSID) where the body is not making enough sucrase.

sacrosidase is available only with your doctor's prescription.

Before Using sacrosidase

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 sacrosidase, the following should be considered:

Allergies

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

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of sacrosidase in children and infants over 5 months of age.

Geriatric

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

Pregnancy

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

Breast Feeding

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

Interactions with Medicines

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

Interactions with Food/Tobacco/Alcohol

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

Other Medical Problems

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

• Diabetes—Use with caution. May make this condition worse.

• Glycerin (glycerol) allergy or


• Papain allergy or


• Yeast allergy—Should not use in patients with these conditions.

Proper Use of sacrosidase

Take sacrosidase exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

You or your child might take the first and second dose of sacrosidase at your doctor's office. This is done to see if you or your child are allergic to the medicine.

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

Mix each dose of sacrosidase in 2 to 4 ounces (about 1/4 to 1/2 cup) of milk, water, or infant formula. Do not heat the medicine or mix it in warm or hot beverages. Hot liquids could cause it to break down and not work as well. Also, do not mix the medicine with fruit juice because the acid in the juice could cause it to break down.

Measure your dose by using the scoop that comes with the medicine or by counting the correct number of drops from the bottle. Rinse the dosing scoop with water after each use.

Take sacrosidase with meals or snacks. It is best to take about half of the dose at the beginning of the meal or snack and the rest at the end.

Your doctor may tell you or your child to limit the amount of starch that you eat. Carefully follow any special diet that your doctor gives you.

Dosing

The dose of sacrosidase 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 sacrosidase. 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 oral dosage form (solution):
  
  • To help digest sugar:
    
    • Adults, teenagers, and children weighing more than 15 kilograms (kg)—2 milliliters (mL) (56 drops) with each meal or snack during the day.
    
    
    • Children weighing up to 15 kg—1 mL (28 drops) with each meal or snack during the day.
    
    
  
  

Missed Dose

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

Storage

Store in the refrigerator. Do not freeze.

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.

Throw away any unused medicine 4 weeks after opening the bottle. You should write down the date that you opened the medicine on the bottom of the bottle to help you remember.

Precautions While Using sacrosidase

It is very important that your doctor check your progress at regular visits, to see if sacrosidase is working properly and to decide if you should continue to take it.

Sacrosidase may cause serious allergic reactions. Check with your doctor right away if you or your child have a rash; itching; swelling of the face, tongue, and throat; trouble with breathing; or chest pain after you use sacrosidase.

Your doctor may order a skin test before you or your child start using sacrosidase. The skin test is used to see if you have an allergy to sacrosidase. Tell your doctor if you or anyone in your home has ever had a positive skin test reaction to sacrosidase.

sacrosidase will help your body absorb sugar. This might change the level of sugar in your blood and urine. If you or your child have diabetes, you might need to measure your blood or urine sugar more often. Check with your doctor before changing your diet or the dose of your diabetes medicine.

sacrosidase Side Effects

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

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

Incidence not known

• Chest pain


• increase in heart rate


• itching


• nervousness


• rapid breathing


• rash


• swelling of the face, tongue, and throat


• wheezing or troubled breathing

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:

Less common

• Abdominal or stomach pain


• confusion


• constipation


• decreased urination


• diarrhea


• dizziness


• dry mouth


• fainting


• headache


• increased thirst


• lightheadedness


• nausea and vomiting


• sleeplessness


• sunken eyes


• thirst


• trouble with sleeping


• unable to sleep


• unusual tiredness or weakness


• wrinkled skin

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

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

See also: sacrosidase side effects (in more detail)

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

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

More sacrosidase resources

• Sacrosidase Side Effects (in more detail)
• Sacrosidase Use in Pregnancy & Breastfeeding
• Sacrosidase Support Group
• 0 Reviews · Be the first to review/rate this drug

• sacrosidase Concise Consumer Information (Cerner Multum)


• Sacrosidase Monograph (AHFS DI)


• Sacrosidase MedFacts Consumer Leaflet (Wolters Kluwer)


• Sucraid Prescribing Information (FDA)

Sodium Sulfacetamide

Dosage Form: lotion

Rx Only

DESCRIPTION:

Sulfacetamide sodium is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Chemically sulfacetamide sodium is N-[(4-aminophenyl) sulfonyI]-acetamide, monosodium salt, monohydrate. The structural formula is:

Each gram of sulfacetamide sodium USP 10% and sulfur USP 5% contains 100 mg of Sodium Sulfacetamide USP and 50 mg of Sulfur USP in a cream containing: Benzyl Alcohol, Emulsifying Wax, Hamaelis virginiana (Witch Hazel) Distillate, Kaolin, Propanediol, Propylene Glycol, Purified Water, Quillaja (Quillaia) saponaria Extract, Silicon Dioxide, and Sodium Thiosulfate.

CLINICAL PHARMACOLOGY:

The most widely accepted mechanism of action of sulfonamides is the Woods-Fildes theory, which is based on the fact that sulfonamides act as competitive antagonists to para-aminobenzoic acid (PABA), an essential component for bacterial growth. While absorption through intact skin has not been determined, sulfacetamide sodium is readily absorbed from the gastrointestinal tract when taken orally and excreted in the urine, largely unchanged. The biological half-life has variously been reported as 7 to 12.8 hours. The exact mode of action of sulfur in the treatment of acne is unknown, but it has been reported that it inhibits the growth of Propionibacterium acnes and the formation of free fatty acids.

INDICATIONS:

Sulfacetamide sodium and sulfur cleanser is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

CONTRAINDICATIONS:

Sulfacetamide sodium and sulfur cleanser is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. Sulfacetamide sodium and sulfur cleanser is not to be used by patients with kidney disease.

WARNINGS:

Although rare, sensitivity to sulfacetamide sodium may occur. Therefore, caution and careful supervision should be observed when prescribing this drug for patients who may be prone to hypersensitivity to topical sulfonamides. Systemic toxic reactions such as agranulocytosis, acute hemolytic anemia, purpura hemorrhagica, drug fever, jaundice, and contact dermatitis indicate hypersensitivity to sulfonamides. Particular caution should be employed if areas of denuded or abraded skin are involved.

FOR EXTERNAL USE ONLY. Keep away from eyes. Keep out of reach of children. Keep container tightly closed.

PRECAUTIONS:

General - lf irritation develops, use of the product should be discontinued and appropriate therapy instituted. Patients should be carefully observed for possible local irritation or sensitization during long-term therapy. The object of this therapy is to achieve desquamation without irritation, but sulfacetamide sodium and sulfur can cause reddening and scaling of the epidermis. These side effects are not unusual in the treatment of acne vulgaris, but patients should be cautioned about the possibility.

Information for Patients - Avoid contact with eyes, eyelids, lips and mucous membranes. If accidental contact occurs, rinse with water. If excessive irritation develops, discontinue use and consult your physician.

Carcinogenesis, Mutagenesis and Impairment of Fertility - Longterm studies in animals have not been performed to evaluate carcinogenic potential.

Pregnancy: Category C - Animal reproduction studies have not been conducted with sulfacetamide sodium and sulfur lotion. It is also not known whether sulfacetamide sodium and sulfur cleanser can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sulfacetamide sodium and sulfur cleanser should be given to a pregnant woman only if clearly needed.

Nursing Mothers - It is not known whether sulfacetamide sodium is excreted in the human milk following topical use of sulfacetamide sodium and sulfur lotion. However, small amounts of orally administered sulfonamides have been reported to be eliminated in human milk. In view of this and because many drugs are excreted in human milk, caution should be exercised when sulfacetamide sodium and sulfur cleanser is administered to a nursing woman.

Pediatric Use - Safety and effectiveness in children under the age of 12 have not been established.

ADVERSE REACTIONS:

Although rare, sulfacetamide sodium may cause local irritation.

DOSAGE AND ADMINISTRATION:

Use once daily or as directed by your physician. Wet skin. Apply in a film to entire face, avoiding contact with eyes or mucous membranes. Wait 10 minutes or until dry. Rinse thoroughly with water and pat dry.

HOW SUPPLIED:

Sulfacetamide sodium 10% and sulfur 5% cleanser is supplied in

6 oz (170 g) tube      NDC 67877-268-17

12 oz (340 g) bottle  NDC 67877-268-34


Store at 15°-25°C (59°-77°F).


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


KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN


Rx Only


Manufactured for:

Ascend Laboratories, LLC

Montvale, NJ 07645


Manufactured by:

Crown Laboratories, Inc.

Johnson City, TN 37604

PRINTED IN USA                     P1815.01

ASCEND

Laboratories, LLC

NDC 67877-268-34

Sulfacetamide

Sodium

10%

& Sulfur

5%

Cleanser

Rx Only


NET WT 12oz

(340 g)

SULFACETAMIDE SODIUM, SULFUR  sulfacetamide sodium, sulfur  lotion

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 67877-268 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SULFACETAMIDE SODIUM (SULFACETAMIDE) SULFACETAMIDE SODIUM 100 mg  in 1 g SULFUR (SULFUR) SULFUR 50 mg  in 1 g

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 67877-268-17 170.1 g In 1 TUBE None 2 67877-268-34 340.2 g In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		11/08/2011

Labeler - Ascend Laboratories, LLC (141250469)

Establishment
Name	Address	ID/FEI	Operations
Crown Laboratories, Inc.		079035945	manufacture

Revised: 01/2012Ascend Laboratories, LLC

Sular

Generic Name: Nisoldipine
Class: Dihydropyridines
VA Class: CV200
Chemical Name: Methyl 2-methylpropyl ester 1,4-dihydro-2,6-dimethyl-4-(2-nitrophenyl)-3,5-pyridinedicarboxylic acid
Molecular Formula: C₂₀H₂₄N₂O₆
CAS Number: 63675-72-9

Introduction

Calcium-channel blocking agent; dihydropyridine derivative.^{1 2 3 4 5 6 8 9 10 11 12 42 45}

Uses for Sular

Hypertension

Management of hypertension (alone or in combination with other classes of antihypertensive agents).^{1 11 12 50}

One of several preferred initial therapies in hypertensive patients with a high risk of developing CAD, including those with diabetes mellitus.⁷⁵

Can be used as monotherapy for initial management of uncomplicated hypertension; however, thiazide diuretics are preferred by JNC 7.⁷⁵

Should not be used for acute management of hypertensive crises†.^{13 46 50}

Sular Dosage and Administration

Administration

Oral Administration

Administer orally;^{1 2 3 5 6 7 8 11 12 42} avoid concomitant administration with high-fat food.^{1 42}

Extended-release tablets should be swallowed intact and should not be chewed, broken, or crushed.¹

Dosage

Adults

Hypertension

Extended-release Tablets

Oral

Initially, 20 mg once daily.^{1 42}

Increase as tolerated in increments of 10 mg daily at ≥ weekly intervals up to 60 mg once daily.^{1 42 50} Monitor BP carefully during initial titration or subsequent upward adjustment in dosage.^{1 50}

Usual maintenance dosage is 20–40 mg once daily;¹ however, JNC 7 recommends a usual dosage range of 10–40 mg daily.⁷⁵

Prescribing Limits

Adults

Hypertension

Oral

Maximum 60 mg daily.¹

Special Populations

Hepatic Impairment

Initially, 10 mg daily; monitor BP response closely with each dosage adjustment.^{1 42}

Reduce initial and maintenance dosages in patients with cirrhosis.¹

Renal Impairment

Dosage modification not necessary in patients with mild to moderate renal impairment.¹

Geriatric Patients

Initially, 10 mg daily; monitor BP response closely with each dosage adjustment.^{1 42}

Cautions for Sular

Contraindications

• 
  

  Known hypersensitivity to nisoldipine or other dihydropyridine-derivative calcium channel blockers.¹

  
  

Warnings/Precautions

Warnings

Increased Angina and/or AMI

Rarely, increased frequency, duration, and/or severity of angina or AMI, particularly in patients with severe obstructive CAD, upon initiation or dosage increase of calcium channel blockers.¹

General Precautions

Hypotension

Risk of excessive, poorly tolerated hypotension; usually occurs during initial dosage titration or subsequent upward titration.¹ Carefully monitor BP, especially during therapy initiation, titration, or dosage increase; closely observe patients currently receiving drugs known to lower BP.¹

CHF

Use with caution in patients with CHF or compromised ventricular function, especially in those receiving concomitant β-adrenergic blocking agents.¹

Specific Populations

Pregnancy

Category C.¹

Lactation

Not known whether nisoldipine is distributed into milk.¹ Discontinue nursing or the drug.¹

Pediatric Use

Safety and efficacy not established.¹

Geriatric Use

Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults.¹ Select dosage with caution.¹ (See Geriatric Patients under Dosage and Administration.)

Hepatic Impairment

Use with caution in patients with severe hepatic impairment.¹ Dosage reduction required.¹ (See Hepatic Impairment under Dosage and Administration.)

Common Adverse Effects

Peripheral edema, headache, dizziness, pharyngitis, vasodilation, sinusitis, palpitation, chest pain, nausea, rash.¹

Interactions for Sular

Drugs Affecting Hepatic Microsomal Enzymes

Inducers of CYP3A4: Decreased plasma nisoldipine concentrations.^{1 a} Avoid concomitant use.^{1 a}

Specific Drugs and Foods

Drug or Food	Interaction	Comments
β-Adrenergic blocking agents	Increased risk of hypotension and exacerbation of CHF1
Digoxin	Pharmacokinetic interaction unlikely1
Grapefruit juice	Increased nisoldipine bioavailability1	Avoid grapefruit-containing foods and beverages for at least 1 hour before and after administration of a dose1 44 46
Histamine H2-receptor antagonists	Possible increased nisoldipine concentrations with cimetidine; no significant interaction with ranitidine1
Phenytoin	Decreased plasma concentrations of nisoldipine to undetectable levels1	Avoid concomitant use1
Quinidine	Possible decreased AUC of nisoldipine1	Clinical significance unknown1
Warfarin	Pharmacokinetic interaction unlikely1

Sular Pharmacokinetics

Absorption

Bioavailability

Relatively well absorbed from the GI tract following oral administration,^{1 a} with peak plasma concentrations attained within 6–12 hours.¹

Absolute bioavailability is low (about 5%), due to presystemic metabolism in the intestine; presystemic metabolism decreases from proximal to distal parts of intestine.^{1 a b} Bioavailability of extended-release preparation is increased since nisoldipine is released in the colon where presystemic metabolism is reduced.^{1 a b}

Food

A high-fat meal increases peak plasma concentrations by about 300%, but decreases extent of absorption by 25% (since more of the drug is released proximally).¹

Special Populations

In geriatric patients, plasma concentrations increased about 2- to 3-fold.¹

In patients with hepatic cirrhosis, plasma concentrations increased by 4–5 times.¹

Distribution

Extent

Not known whether nisoldipine is distributed into milk.¹

Plasma Protein Binding

>99%.^{1 a}

Elimination

Metabolism

Thought to be metabolized principally by CYP isoenzymes.¹ Precise enzymes responsible for metabolism are unknown, but other dihydropyridine-derivative calcium-channel blocking agents are metabolized by CYP3A4.¹

Elimination Route

Excreted principally in urine (60–80%) as metabolites.¹

Half-life

Approximately 7–12 hours.^{1 a}

Stability

Storage

Oral

Extended-ReleaseTablets

Tight, light-resistant containers at 20–25°C.¹ Protect from light and moisture.¹

ActionsActions

• 
  

  Inhibits transmembrane influx of extracellular calcium ions across the membranes of myocardial cells and vascular smooth muscle cells.¹

  
  


• 
  

  Peripheral arterial vasodilator; acts directly on vascular smooth muscle causing reduction in peripheral vascular resistance (afterload) and BP.¹

  
  

Advice to Patients

• 
  

  Importance of swallowing extended-release tablets whole; do not chew, crush, or break.¹

  
  


• 
  

  Importance of avoiding administration with a high-fat meal.¹

  
  


• 
  

  Importance of avoiding grapefruit-containing foods and beverages for at least 1 hour before and after administration of a dose.^{1 44 46}

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.¹

  
  


• 
  

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

  
  


• 
  

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

  
  

Preparations

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

Nisoldipine

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Tablets, extended-release, film-coated	10 mg	Sular	First Horizon
		20 mg	Sular	First Horizon
		30 mg	Sular	First Horizon
		40 mg	Sular	First Horizon

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Sular 17MG 24-hr Tablets (SHIONOGI PHARMA): 100/$729.94 or 300/$2189.83

Sular 25.5MG 24-hr Tablets (SHIONOGI PHARMA): 100/$789.99 or 300/$2359.87

Sular 30MG 24-hr Tablets (SHIONOGI PHARMA): 30/$86.99 or 90/$239.98

Sular 34MG 24-hr Tablets (SHIONOGI PHARMA): 100/$789.99 or 300/$2359.87

Sular 8.5MG 24-hr Tablets (SHIONOGI PHARMA): 100/$580.02 or 300/$1725.92

Disclaimer

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

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

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions March 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

1. First Horizon.Sular (nisoldipine) extended-release tablets prescribing information. (dated 2004 Mar). In: Physicians' desk reference. From the PDR electronic library website. Accessed 2006 Nov 9.

2. Zannad F. Clinical pharmacology of nisoldipine coat core. Am J Cardiol. 1995; 75:41-5E.

3. Mitchell J, Frishman W, Heiman M. Nisoldipine: a new dihydropyridine calcium-channel blocker. J Clin Pharmacol. 1993; 33:46-52. [IDIS 308542] [PubMed 8429113]

4. Knorr AM. Why is nisoldipine a specific agent in ischemic left ventricular dysfunction? Am J Cardiol. 1995; 75:36-40E.

5. Fujii Y, Hattori S, Nagami K et al. The hypotensive effect of nisoldipine: 24-hour blood pressure profile and serial alterations of renal and hormonal function. Curr Ther Res. 1994; 55:93-101.

6. Ishiguro M, Shimabukuro S, Minagawa T et al. Evaluation of nisoldipine by noninvasive ambulatory blood pressure monitoring in patients with hypertension. Curr Ther Res. 1991; 50:804-11.

7. Nakanishi T, Takahashi H, Yoshimura M et al. Effects of nisoldipine on ambulatory blood pressure in patients with essential hypertension. Curr Ther Res. 1991; 50:417-24.

8. Shionoiri H, Sugiyama K, Takasaki I et al. Antihypertensive effects of nisoldipine in patients with essential hypertension. Curr Ther Res. 1989; 45:253-61.

9. Lewis BS. Efficacy and safety of nisoldipine coat core in the management of angina pectoris, systemic hypertension, and ischemic ventricular dysfunction. Am J Cardiol. 1995; 75:46E-53E. [IDIS 348305] [PubMed 7726125]

10. Glasser SP. Nisoldipine coat core as concomitant therapy in chronic stable angina pectoris. Am J Cardiol. 1995; 75:68-70E.

11. Shaw-Stiffel TA, Walker SE, Ogilvie RI et al. Pharmacokinetic and pharmacodynamic interactions during multiple-dose administration of nisoldipine and propranolol. Clin Pharmacol Ther. 1994; 55:661-9. [IDIS 331942] [PubMed 8004882]

12. Rosenfeld JB, Zabludowski J. The efficacy and tolerability of nifedipine (NIF) and nisoldipine (NIS) both alone and combined with a beta-blocker in patients with essential hypertension: a multicenter, parallel-group study. J Clin Pharmacol. 1989; 29:1013-16. [IDIS 261842] [PubMed 2574728]

13. Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure. The fifth report of the Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure (JNC V). Arch Intern Med. 1993; 153:154-83. [IDIS 309043] [PubMed 8422206]

14. Alderman MH. Which antihypertensive drugs first—and why! JAMA. 1992; 267:2786-7. Editorial.

15. Glasser SP, Clark PI, Lipicky RJ et al. Exposing patients with chronic, stable, exertional angina to placebo periods in drug trials. JAMA. 1991; 265:1550-4. [PubMed 1671885]

16. National Heart, Lung, and Blood Institute. NHLBI panel reviews safety of calcium channel blockers. Rockville, MD; 1995 Aug 31. Press release.

17. National Heart, Lung, and Blood Institute. New analysis regarding the safety of calcium-channel blockers: a statement for health professionals from the National Heart, Lung, and Blood Institute. Rockville, MD; 1995 Sep 1.

18. Anon. NHLBI panel stands by JNC V in response to Circulation CCB article; AIM report supports use of beta blockers for prevention of sudden cardiac death. F-D-C Rep. 1995; 57(Sep 4):3- 4.

19. American Heart Association. Public advisory statement on calcium channel blocker drugs. Dallas, TX; 1995 Aug 28.

20. Psaty BM, Heckbert SR, Koepsell TD et al. The risk of myocardial infarction associated with antihypertensive drug therapies. JAMA. 1995; 274:620-5. [IDIS 352203] [PubMed 7637142]

21. Psaty BM, Heckbert SR, Koepsell TD et al. The risk of incident myocardial infarction associated with anti-hypertensive drug therapies. Circulation. 1995; 91:925.

22. Buring JE, Glynn RJ, Hennekens CH. Calcium channel blockers and myocardial infarction: a hypothesis formulated but not yet tested. JAMA. 1995; 274:654- 5. [IDIS 352205] [PubMed 7637148]

23. Furberg CD, Psaty BM, Meyer JV. Nifedipine: dose-related increase in mortality in patients with coronary heart disease. Circulation. 1995; 92:1326-31. [IDIS 353358] [PubMed 7648682]

24. Opie LH, Messerli FH. Nifedipine and mortality: grave defects in the dossier. Circulation. 1995; 92:1068-73. [IDIS 353353] [PubMed 7648646]

25. Kloner RA. Nifedipine in ischemic heart disease. Circulation. 1995; 92:1074-8. [IDIS 353354] [PubMed 7648647]

26. Yusuf S. Calcium antagonists in coronary artery disease and hypertension: time for reevaluation? Circulation. 1995; 92:1079-82. Editorial.

27. Lenfant C. The calcium channel blocker scare: lessons for the future. Circulation. 1995; 91:2855-6. [PubMed 7796490]

28. Habib GB. Are calcium antagonists harmful in hypertensive patients? Distinguishing hype from reality. Chest. 1995; 108:3-5. [IDIS 351406] [PubMed 7606987]

29. Horton R. Spinning the risks and benefits of calcium antagonists. Lancet. 1995; 346:586- 7. [IDIS 353102] [PubMed 7650997]

30. Yusuf S, Held P, Furberg C. Update of effects of calcium antagonists in myocardial infarction or angina in light of the Second Danish Verapamil Infarction Trial (DAVIT-II) and other recent studies. Am J Cardiol. 1991; 67:1295-7. [IDIS 284079] [PubMed 2035457]

31. Egstrup K, Andersen PE Jr. Transient myocardial ischemia during nifedipine therapy in stable angina pectoris, and its relation to coronary collateral flow and comparison with metoprolol. Am J Cardiol. 1993; 71:177- 83. [IDIS 308552] [PubMed 8421980]

32. Wagenknecht LE, Furberg CD, Hammon JW et al. Surgical bleeding: unexpected effect of a calcium antagonist. BMJ. 1995; 310:776-7. [IDIS 345035] [PubMed 7711582]

33. Miles Inc. American Heart Association, Dr. Psalty and Miles Inc. release statements qualifying possible risks of calcium channel blockers. West Haven, CT; 1995 Mar 15. Press release.

34. Dear healthcare professional letter regarding calcium-channel blockers and increased risk of heart attack. Chicago: Searle. 1995 Mar 17.

35. McClellan K. Unexpected results from MIDAS in atherosclerosis. Inpharma Wkly. 1994; Apr 9:4.

36. Anon. Groups act to dispel concerns about calcium-channel blockers. Am J Health-Syst Pharm. 1995; 52:1154, 1158. [PubMed 7656105]

37. Waters D. Proischemic complications of dihydropyridine calcium channel blockers. Circulation. 1991; 84:2598-600. [IDIS 295953] [PubMed 1959210]

38. Messerli FH. Case-control study, meta-analysis, and bouillabaisse: putting the calcium antagonist scare into context. Ann Intern Med. 1995; 123:888-9. [IDIS 356631] [PubMed 7486476]

39. Reviewers’ comments (personal observations) on Nifedipine 24:28.

40. Held PH, Yusuf S, Furberg CD. Calcium channel blockers in acute myocardial infarction and unstable angina: an overview. BMJ. 1989; 299:1187-92. [IDIS 260789] [PubMed 2513047]

41. Weber MA, Laragh JH. Hypertension: steps forward and steps backward: the Joint National Committee fifth report. Arch Intern Med. 1993; 153:149-52. [PubMed 8422205]

42. Anon. Nisoldipine—a new calcium channel blocker for hypertension. Med Lett Drugs Ther. 1996; 38:13-4. [PubMed 8592476]

43. Anon. grapefruit juice interactions with drugs. Med Lett Drugs Ther. 1995; 37:73-4. [PubMed 7630329]

44. Bailey DG, Arnold JMO, Strong HA et al. Effect of grapefruit juice and naringin on nisoldipine pharmacokinetics. Clin Pharmacol Ther. 1993; 54:589-94. [IDIS 324230] [PubMed 8275614]

45. Kaplan NM, Gifford RW. Choice of initial therapy for hypertension. JAMA. 1996; 275:1577-9. [IDIS 365188] [PubMed 8622249]

46. Zeneca Pharmaceuticals, Wilmington, DE: Personal communication.

47. Chandler MHH, Clifton GD, Lettieri JT et al. Multiple dose pharmacokinetics of four different doses of nisoldipine in hypertensive patients. J Clin Pharmacol. 1992; 32:571-5. [IDIS 298488] [PubMed 1634646]

48. Marazzi P. A study to demonstrate the equivalence in efficacy and safety of once-daily nisoldipine CC and amlodipine in the treatment of mild to moderate hypertension. Acta Ther. 1996; 22:23-35.

49. Lasseter KC, Muller FO, Garrett BN et al. Pharmacokinetics, pharmacodynamics, and clinical utility of nisoldipine coat core in the treatment of essential hypertension. Cardiovasc Rev Rep. 1996; 17:28,31-35,38,44-46.

50. National Heart, Lung, and Blood Institute National High Blood Pressure Education Program. The sixth report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC VI). Bethesda, MD: National Institutes of Health; 1997 Nov. (NIH publication No. 98-4080.)

51. Kaplan NM. Choice of initial therapy for hypertension. JAMA. 1996; 275:1577-80. [IDIS 365188] [PubMed 8622249]

52. Psaty BM, Smith NL, Siscovich DS et al. Health outcomes associated with antihypertensive therapies used as first-line agents: a systematic review and meta-analysis. JAMA. 1997; 277:739-45. [IDIS 380501] [PubMed 9042847]

53. American College of Cardiology and American Heart Association. ACC/AHA guidelines for the management of patients with acute myocardial infarction: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee on Management of Acute Myocardial Infarction). J Am Coll Cardiol. 1996; 28:1328-428. [IDIS 376249] [PubMed 8890834]

54. Staessen JA, Fagard R, Thijs L et al for the Systolic Hypertension-Europe (Syst-Eur) Trial Investigators. Morbidity and mortality in the placebo-controlled European Trial on Isolated Systolic Hypertension in the Elderly. Lancet. 1997; 350:757-64. [IDIS 392056] [PubMed 9297994]

55. Estacio RO, Jeffers BW, Hiatt WR et al. The effect of nisoldipine as compared with enalapril on cardiovascular outcomes in patients with non-insulin-dependent diabetes and hypertension. N Engl J Med. 1998; 338:645-52. [IDIS 400553] [PubMed 9486993]

56. Pahor M, Psaty BM, Furberg CD. Treatment of hypertensive patients with diabetes. Lancet. 1998; 351:689-90. [IDIS 409001] [PubMed 9504510]

57. Tatti P, Pahor M, Byington RP et al. Outcome results of the Fosinopril versus Amlodipine Cardiovascular Events randomized Trial (FACET) in patients with hypertension and NIDDM. Diabetes Care. 1998; 21:597-603. [IDIS 403787] [PubMed 9571349]

58. Byington RP, Craven TE, Furberg CD et al. Isradipine, raised glycosylated haemoglobin, and risk of cardiovascular events. Lancet. 1997; 350:1075-6. [IDIS 393279] [PubMed 10213554]

59. Alderman M, Madhavan S, Cohen H. Calcium antagonists and cardiovascular events in patients with hypertension and diabetes. Lancet. 1998; 351:216-7. [IDIS 398935] [PubMed 9449897]

60. Josefson D. Infarction risk found with calcium channel blocker. BMJ. 1998; 316:797.

61. Cutler JA. Calcium-channel blockers for hypertension—uncertainty continues. N Engl J Med. 1998; 338:679-81. [IDIS 400554] [PubMed 9486999]

62. Bayer, West Haven, CT: Personal communication.

63. Bakris GL, Copley JB, Vicknair N et al. Calcium channel blockers versus other antihypertensive therapies on progression of NIDDM associated nephropathy. Kidney Int. 1996; 50:1641-50. [PubMed 8914031]

64. Velussi M, Brocco E, Frigato F et al. Effects of cilazapril and amlodipine on kidney function in hypertensive NIDDM patients. Diabetes. 1996; 45:216-22. [IDIS 362953] [PubMed 8549868]

65. Reviewers’ comments (personal observations).

66. Ameer B, Weintraub RA. Drug interactions with grapefruit juice. Clin Phramacokinet. 1997; 33:103-21.

67. Roller L. Drugs and grapefruit juice. Clin Pharmacol Ther. 1998; 63:87. [IDIS 398865] [PubMed 9465845]

68. Spence JD. Drugs and grapefruit juice. Clin Pharmacol Ther. 1998; 63:87-8. [IDIS 398865] [PubMed 9465845]

69. Izzo JL, Levy D, Black HR. Importance of systolic blood pressure in older Americans. Hypertension. 2000; 35:1021-4. [PubMed 10818056]

70. Frohlich ED. Recognition of systolic hypertension for hypertension. Hypertension. 2000; 35:1019-20. [PubMed 10818055]

71. Bakris GL, Williams M, Dworkin L et al. Preserving renal function in adults with hypertension and diabetes: a consensus approach. Am J Kidney Dis. 2000; 36:646-61. [IDIS 452007] [PubMed 10977801]

72. Associated Press (American Diabetes Association). Diabetics urged: drop blood pressure. Chicago, IL; 2000 Aug 29. Press Release from web site.

73. Appel LJ. The verdict from ALLHAT—thiazide diuretics are the preferred initial therapy for hypertension. JAMA. 2002; 288:3039-60. [IDIS 490723] [PubMed 12479770]

74. The ALLHAT Officers and Coordinators for the ALLHAT Collaborative Research Group. Major outcomes in high-riskhypertensive patients randomized to angiotensin-converting enzyme inhibitor or calcium channel blocker vs diuretic: the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). JAMA. 2002; 288:2981-97. [IDIS 490721] [PubMed 12479763]

75. National Heart, Lung, and Blood Institute National High Blood Pressure Education Program. The seventh report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC VII) Express. Bethesda, MD: May 14 2003. From NIH website. (Also published in JAMA. 2003; 289.

76. American Diabetes Association. Position statements: treatment of hypertension in adults with diabetes. Diabetes Care. 2003; 26(Suppl 1):S80-S82.

77. American Diabetes Association. Treatment of hypertension in adults with diabetes. Diabetes Care. 2003; 26(Suppl 1):S80-2.

78. Guidelines Committee. 2003 European Society of Hypertension–European Society of Cardiology guidelines for the management of arterial hypertension. J Hypertension. 2003; 21:1011-53.

79. Carter B for the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Personal communication.

80. Wright JT, Dunn JK, Cutler JA et al. Outcomes in hypertensive black and nonblack patients treated with chlorthalidone, amlodipine, and lisinopril. JAMA. 2005; 293:1595-607. [IDIS 531054] [PubMed 15811979]

81. Neaton JD, Kuller LH. Diuretics are color blind. JAMA. 2005; 293:1663-6. [IDIS 531056] [PubMed 15811986]

82. Leenen FHH, Nwachuku CE, Black HR et al. Clinical events in high-risk hypertensive patients randomly assigned to calcium-channel blocker versus angiotensin-converting enzyme inhibitor in the Antihypertensive and Lipid-Lowering treatment to prevent Heart Attack Trial. Hypertension. 2006; 48:374-84. [PubMed 16864749]

83. Messerli FH, Staessen JA. Amlodipine better than lisinopril: how one randomized clinical trial ended fallacies from observational studies? Hypertension. 2006; 48:359-61. Editorial.

a. Heinig R. Clinical pharmacokinetics of nisoldipine coat-core. Clin Pharmacokinet. 1998; 35:191-208. [PubMed 9784933]

b. Heinig R. Ahr G, Hayauchi Y et al. Pharmacokinetics of the controlled-release nisoldipine coat-core tablet formulation. Int J Clin Pharmacol. 1997; 35:341-51.

More Sular resources

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

• Sular Prescribing Information (FDA)


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


• Sular Concise Consumer Information (Cerner Multum)


• Sular Advanced Consumer (Micromedex) - Includes Dosage Information


• Nisoldipine Prescribing Information (FDA)


• Nisoldipine Professional Patient Advice (Wolters Kluwer)

Compare Sular with other medications

• Angina Pectoris Prophylaxis
• High Blood Pressure
• Raynaud's Syndrome

NovaFerrum

Pronunciation: EYE-urn/VYE-ta-min C/FOE-lik AS-id
Generic Name: Iron/Vitamin C/Folic Acid
Brand Name: NovaFerrum

Accidental overdose of products that contain iron is a leading cause of fatal poisoning in children younger than 6 years old. Keep this and all medicines out of the reach of children. In case of accidental ingestion, call the poison control center or a doctor at once.

NovaFerrum is used for:

Preventing and treating anemia caused by low levels of iron in the body (iron deficiency anemia). It may also be used for other conditions as determined by your doctor.

NovaFerrum is a vitamin, iron, and folic acid combination. It works by providing vitamins, iron, and folic acid to the body to help meet nutritional requirements.

Do NOT use NovaFerrum if:

• you are allergic to any ingredient in NovaFerrum


• you have high levels of iron in your body (eg, hemosiderosis, hemochromatosis) or you have a certain type of anemia (hemolytic anemia)

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

Before using NovaFerrum:

Some medical conditions may interact with NovaFerrum. 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 another type of anemia (eg, pernicious anemia, megaloblastic anemia)


• if you have stomach or bowel problems (eg, inflammation, Crohn disease, ulcer), metabolism problems, porphyria, or a blood disease (eg, thalassemia)


• if you have had multiple blood transfusions

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

• Fluorouracil because the risk of its side effects may be increased by NovaFerrum


• Doxycycline, hydantoins (eg, phenytoin), mycophenolate, penicillamine, or thyroid hormones (eg, levothyroxine) because their effectiveness may be decreased by NovaFerrum

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

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

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


• Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.



• Many medicines (eg, used for infection, blood pressure, immune system suppression, low blood platelets, osteoporosis, thyroid problems) should not be taken at the same time as NovaFerrum because their effectiveness may be decreased. Ask your doctor or pharmacist if your dose of NovaFerrum should be separated from your dose of any of your other medicines.


• Taking NovaFerrum at the same time each day will help you remember to take it.


• Take NovaFerrum on a regular schedule to get the most benefit from it.


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

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

Important safety information:

• NovaFerrum has iron in it. Iron overdose is a leading cause of fatal poisoning in children younger than 6 years old. In case of an overdose, call a doctor or poison control center right away.


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


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


• NovaFerrum may cause your stools to darken. This is normal and not a cause for concern.


• NovaFerrum may interfere with certain lab tests, such as tests used to check for blood in the stool. Make sure your doctor and lab personnel know you are using NovaFerrum.


• Lab tests, including complete blood cell counts and iron levels, may be performed while you use NovaFerrum. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• NovaFerrum should be used with extreme caution in CHILDREN; safety and effectiveness in 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 NovaFerrum while you are pregnant. NovaFerrum is found in breast milk. If you are or will be breast-feeding while you use NovaFerrum, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of NovaFerrum:

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:

Constipation; darkened stools; diarrhea; mild stomach pain; nausea; vomiting.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, bloody, or tarry stools; severe or persistent vomiting or stomach pain.

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: NovaFerrum 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 black, tarry stools; chest pain; coma; dizziness; fast heartbeat; fever; increased or decreased urination; increased thirst or hunger; seizures; severe nausea, vomiting, diarrhea, or stomach pain; shortness of breath; sluggishness; trouble breathing; unusual tiredness or drowsiness; unusually pale skin; weak pulse.

Proper storage of NovaFerrum:

Store NovaFerrum in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Store away from heat, moisture, and light. Do not store in the bathroom. Throw away any unused medicine after 30 days. Keep NovaFerrum out of the reach of children and away from pets.

General information:

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


• NovaFerrum 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 NovaFerrum. 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 NovaFerrum resources

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

• NovaFerrum Prescribing Information (FDA)


• multivitamin with iron Concise Consumer Information (Cerner Multum)


• Allbee-C 800 with Iron Concise Consumer Information (Cerner Multum)


• Ferotrin Prescribing Information (FDA)


• Ferralet 90 Prescribing Information (FDA)


• Ferrex 150 Forte Prescribing Information (FDA)


• Ferrex 150 Forte Plus Prescribing Information (FDA)


• Ferrex 28 Prescribing Information (FDA)


• FerroGels Forte Prescribing Information (FDA)


• Hematogen Forte Prescribing Information (FDA)


• Integra F Prescribing Information (FDA)


• Integra Plus Prescribing Information (FDA)


• Irospan 24/6 Prescribing Information (FDA)


• Tricon Prescribing Information (FDA)

Compare NovaFerrum with other medications

• Anemia
• Vitamin/Mineral Supplementation and Deficiency

Terbinafine Tablets and Hydroxypropyl-Chitosan

Pronunciation: TER-bin-a-feen/hye-DROX-ee-PROE-pil/KYE-toe-san
Generic Name: Terbinafine Tablets and Hydroxypropyl-Chitosan
Brand Name: Terbinex

Terbinafine Tablets and Hydroxypropyl-Chitosan is used for:

Treating certain fungal infections of the fingernails or toenails.

Terbinafine Tablets and Hydroxypropyl-Chitosan is an antifungal agent. It works by killing sensitive fungi.

Do NOT use Terbinafine Tablets and Hydroxypropyl-Chitosan if:

• you are allergic to any ingredient in Terbinafine Tablets and Hydroxypropyl-Chitosan


• you have severe kidney problems


• you have liver problems

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

Before using Terbinafine Tablets and Hydroxypropyl-Chitosan:

Some medical conditions may interact with Terbinafine Tablets and Hydroxypropyl-Chitosan. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

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


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have a history of kidney or liver problems, lupus, psoriasis, cirrhosis, or alcohol abuse or dependence


• if you have a weakened immune system

Some MEDICINES MAY INTERACT with Terbinafine Tablets and Hydroxypropyl-Chitosan. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Amiodarone, cimetidine, fluconazole, or ketoconazole because they may increase the risk of Terbinafine Tablets and Hydroxypropyl-Chitosan's side effects


• Rifampin because it may decrease Terbinafine Tablets and Hydroxypropyl-Chitosan's effectiveness


• Certain antiarrhythmics (eg, flecainide, propafenone), beta-blockers (eg, metoprolol), monoamine oxidase type B (MAO-B) inhibitors (eg, selegiline), selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine), or tricyclic antidepressants (eg, amitriptyline, desipramine) because the risk of their side effects may be increased by Terbinafine Tablets and Hydroxypropyl-Chitosan


• Anticoagulants (eg, warfarin) or cyclosporine because their effectiveness may be decreased or the risk of their side effects may be increased by Terbinafine Tablets and Hydroxypropyl-Chitosan

This may not be a complete list of all interactions that may occur. Ask your health care provider if Terbinafine Tablets and Hydroxypropyl-Chitosan 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 Terbinafine Tablets and Hydroxypropyl-Chitosan:

Use Terbinafine Tablets and Hydroxypropyl-Chitosan as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• To use the tablets: Take by mouth with or without food.


• The tablets are usually taken for 6 to 12 weeks, depending on your condition. The full benefit may not be seen for several months after stopping treatment. This includes the time period necessary for healthy nails to grow.


• To use the nail lacquer: Use at bedtime, unless your doctor tells you otherwise. Wash and dry the affected nails, then apply a thin coat of medicine.


• Do not apply the nail lacquer to a wound, or to broken or damaged skin.


• Use the nail lacquer until a new, healthy nail has grown, unless your doctor tells you otherwise. This usually takes 6 to 12 months, depending on your condition.


• To clear up your infection completely, take Terbinafine Tablets and Hydroxypropyl-Chitosan for the full course of treatment. Keep taking it even if you begin to see improvement before the end of your therapy.


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

Ask your health care provider any questions you may have about how to use Terbinafine Tablets and Hydroxypropyl-Chitosan.

Important safety information:

• Terbinafine Tablets and Hydroxypropyl-Chitosan only works against fungal infections; it does not treat bacterial or viral infections (eg, the common cold).


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


• Be sure to use Terbinafine Tablets and Hydroxypropyl-Chitosan for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The fungus could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.


• Avoid large amounts of food or drink that have caffeine (eg, coffee, tea, cocoa, cola, chocolate) while you are taking Terbinafine Tablets and Hydroxypropyl-Chitosan.


• Taste changes (eg, taste loss) have been reported in patients taking Terbinafine Tablets and Hydroxypropyl-Chitosan. These effects may resolve within several weeks after you stop taking Terbinafine Tablets and Hydroxypropyl-Chitosan, but may last for a long time (eg, more than one year). Tell your doctor right away if you experience a taste disturbance.


• Rarely, Terbinafine Tablets and Hydroxypropyl-Chitosan may cause severe or even fatal liver problems. If liver problems occur, they may be more severe in patients who have other active liver problems or a history of long-term liver problems. Discuss any questions or concerns with your doctor.


• The nail lacquer is for external use only. Do not get it in your eyes, nose, or mouth. If you get it in any of these areas, rinse right away with cool water.


• You may apply nail polish on top of the nail lacquer.


• Unless you are washing your hands, use gloves while using water or chemical substances to avoid accidentally washing the nail lacquer off. Wearing cotton under the gloves is preferred.


• The nail lacquer is flammable. Do not store or use near an open flame or while smoking.


• Lab tests, including liver function and complete blood cell counts, may be performed while you use Terbinafine Tablets and Hydroxypropyl-Chitosan. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Terbinafine Tablets and Hydroxypropyl-Chitosan should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: Do not use Terbinafine Tablets and Hydroxypropyl-Chitosan if you are pregnant. If you think you may be pregnant, contact your doctor right away. Terbinafine Tablets and Hydroxypropyl-Chitosan is found in breast milk. Do not breast-feed while taking Terbinafine Tablets and Hydroxypropyl-Chitosan.

Possible side effects of Terbinafine Tablets and Hydroxypropyl-Chitosan:

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:

Diarrhea; headache; indigestion.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); mental or mood changes (eg, depression); mouth sores; new or worsening symptoms of lupus (eg, butterfly-shaped rash on the face, joint pain, seizures, skin color changes, unusual sensitivity to the sun); red, blistered, peeling, or swollen skin; severe muscle pain or tenderness; symptoms of infection (eg, fever, chills, sore throat); symptoms of liver problems (eg, dark urine; loss of appetite; pale stools; stomach pain; unexplained, persistent nausea; unusual tiredness or weakness; vomiting; yellowing of the skin or eyes); taste changes (eg, taste loss); unexpected weight loss; unusual bruising or bleeding; vision changes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include dizziness; frequent urination; nausea; rash; severe or persistent headache; stomach pain; vomiting.

Proper storage of Terbinafine Tablets and Hydroxypropyl-Chitosan:

Store the tablets at room temperature between 68 and 77 degrees F (20 and 25 degrees C) in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Store the nail lacquer at room temperature between 59 and 86 degrees F (15 and 30 degrees C). Do not store near an open flame. Keep Terbinafine Tablets and Hydroxypropyl-Chitosan out of the reach of children and away from pets.

General information:

• If you have any questions about Terbinafine Tablets and Hydroxypropyl-Chitosan, please talk with your doctor, pharmacist, or other health care provider.


• Terbinafine Tablets and Hydroxypropyl-Chitosan 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 Terbinafine Tablets and Hydroxypropyl-Chitosan. 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 Terbinafine Tablets and Hydroxypropyl-Chitosan resources

• Terbinafine Tablets and Hydroxypropyl-Chitosan Use in Pregnancy & Breastfeeding
• Terbinafine Tablets and Hydroxypropyl-Chitosan Drug Interactions
• Terbinafine Tablets and Hydroxypropyl-Chitosan Support Group
• 0 Reviews · Be the first to review/rate this drug

Nexiclon XR

clonidine

Dosage Form: tablet, extended release
FULL PRESCRIBING INFORMATION

INDICATIONS & USAGE

Nexiclon XR is indicated in the treatment of hypertension. Nexiclon XR Tablet may be employed alone or concomitantly with other antihypertensive agents.

DOSAGE & ADMINISTRATION

The dose of Nexiclon XR must be adjusted according to the patient's individual blood pressure response. The following is a general guide to its administration in adults.

Initial Dose

Dosing with Nexiclon XR should be initiated at 0.17 mg once daily. Elderly patients may benefit from a lower initial dose [see Use is Specific Populations (8.4)]. Initial dose is recommended to be administered at bedtime.

Maintenance Dose

Further increments of 0.09 mg once daily may be made at weekly intervals if necessary until the desired response is achieved. The therapeutic doses most commonly employed have ranged from 0.17 mg to 0.52 mg once daily.

Nexiclon XR was studied at doses of 0.17 to 0.52 mg per day. Doses higher than

0.52 mg per day were not evaluated and are not recommended.

Patients Currently Using Clonidine Hydrochloride Immediate Release Tablets

The recommended dose of Nexiclon XR for patients who are currently taking clonidine hydrochloride immediate-release tablets is provide in the table below.

	Nexiclon XR (clonidine) Extended-Release Tablets	Equivalent Dose of Clonidine HCl Immediate-Release Tablets
Initial Dose	0.17 mg once daily	0.1 mg twice daily
Maintenance Dose Titration Increments	0.09 mg once daily	0.05 mg twice daily
Common Doses Used for Blood Pressure Effect	0.17 mg once daily	0.1 mg twice daily
	0.34 mg once daily	0.2 mg twice daily
	0.52 mg once daily	0.3 mg twice daily

Renal Impairment

Adjust dosage according to the degree of impairment. In patients with end stage kidney disease on maintenance dialysis, start at 0.09 mg per day and up-titrate slowly to minimize dose related adverse events.

Monitor patients carefully, especially for bradycardia, sedation and hypotension. Only a minimal amount of clonidine is removed during routine hemodialysis.

In patients with moderate to severe kidney impairment not undergoing dialysis, initiate clonidine at the same dose as for patients without renal impairment. Up-titrate slowly and monitor for dose-related adverse events.

DOSAGE FORMS & STRENGTHS

Extended-Release Tablet 0.17 and 0.26 mg clonidine base

0.17 mg Extended-Release tablet (clonidine base)

0.26 mg Extended-Release tablet (clonidine base)

CONTRAINDICATIONS

Nexiclon XR should not be used in patients with known hypersensitivity to clonidine [see Warnings and Precautions (5.2)].

WARNINGS AND PRECAUTIONS

Withdrawal

Instruct patients not to discontinue therapy without consulting their physician. Sudden cessation of clonidine treatment has resulted in symptoms such as nervousness, agitation, headache, and tremor accompanied or followed by a rapid rise in blood pressure and elevated catecholamine concentrations in the plasma. The likelihood of such reactions to discontinuation of clonidine therapy appears to be greater after administration of higher doses or continuation of concomitant beta-blocker treatment and special caution is therefore advised in these situations. Rare instances of hypertensive encephalopathy, cerebrovascular accidents and death have been reported after clonidine withdrawal. When discontinuing therapy with Nexiclon XR, reduce the dose gradually over 2 to 4 days to avoid withdrawal symptoms.

An excessive rise in blood pressure following discontinuation of Nexiclon XR can be reversed by administration of oral clonidine hydrochloride or by intravenous phentolamine. If therapy is to be discontinued in patients receiving a beta-blocker and clonidine concurrently, the beta-blocker should be withdrawn several days before the gradual discontinuation of Nexiclon XR.

Because children commonly have gastrointestinal illnesses that lead to vomiting, they may be particularly susceptible to hypertensive episodes resulting from abrupt inability to take medication.

General Precautions

In patients who have developed localized contact sensitization to a clonidine transdermal system, substitution of oral clonidine therapy may be associated with the development of a generalized skin rash.

In patients who develop an allergic reaction to a clonidine transdermal system, substitution of oral clonidine may also elicit an allergic reaction (including generalized rash, urticaria, or angioedema).

Monitor carefully and uptitrate slowly in patients with severe coronary insufficiency, conduction disturbances, recent myocardial infarction, cerebrovascular disease, or chronic renal failure.

Patients who engage in potentially hazardous activities, such as operating machinery or driving, should be advised of a possible sedative effect of clonidine. The sedative effect may be increased by concomitant use of alcohol, barbiturates, or other sedating drugs.

Perioperative Use

Nexiclon XR may be administered up to 28 hours prior to surgery and resumed the following day. Blood pressure should be carefully monitored during surgery and additional measures to control blood pressure should be available if required.

ADVERSE REACTIONS

The following serious adverse reactions are discussed in detail elsewhere in the labeling:

• Withdrawal [see Warnings and Precautions (5.1)]


• Allergic reactions [see Warnings and Precautions (5.2)]

Nexiclon XR Clinical Trial Experience

There is very limited experience with Nexiclon XR Tablet in controlled trials.  Based on this limited experience, the adverse event profile appears similar with to the immediate-release clonidine formulation.

Experience with Immediate-Release Clonidine

Most adverse reactions are mild and tend to diminish with continued therapy. The most frequent (which also appear to be dose-related) are dry mouth (approximately 40%); drowsiness (approximately 33%; dizziness (approximately 16%); constipation and sedation (approximately 10% each).

The following less frequent adverse reactions have also been reported in patients receiving immediate-release clonidine, but in many cases patients were receiving concomitant medication and a causal relationship has not been established.

Body as a Whole: Fatigue, fever, headache, pallor, weakness, and withdrawal syndrome.  Also reported were a weakly positive Coombs’ test and increased sensitivity to alcohol.

Cardiovascular: Bradycardia, congestive heart failure, electrocardiographic abnormalities (i.e., sinus node arrest, junctional bradycardia, high degree AV block and arrhythmias), orthostatic symptoms, palpitations, Raynaud’s phenomenon, syncope, and tachycardia. Cases of sinus bradycardia and atrioventricular block have been reported, both with and without the use of concomitant digitalis.

Central Nervous System (CNS): Agitation, anxiety, delirium, delusional perception, hallucinations (including visual and auditory), insomnia, mental depression, nervousness, other behavioral changes, paresthesia, restlessness, sleep disorder, and vivid dreams or nightmares.

Dermatological: Alopecia, angioneurotic edema, hives, pruritus, rash, and urticaria.

Gastrointestinal: Abdominal pain, anorexia, constipation, hepatitis, malaise, mild transient abnormalities in liver function tests, nausea, parotitis, pseudo-obstruction (including colonic pseudo-obstruction), salivary gland pain, and vomiting.

Genitourinary: Decreased sexual activity, difficulty in micturition, erectile dysfunction, loss of libido, nocturia, and urinary retention.

Hematologic: Thrombocytopenia.

Metabolic: Gynecomastia, transient elevation of blood glucose or serum creatine phosphokinase, and weight gain.

Musculoskeletal: Leg cramps and muscle or joint pain.

Oro-otolaryngeal: Dryness of the nasal mucosa.

Ophthalmological: Accommodation disorder, blurred vision, burning of the eyes, decreased lacrimation, and dryness of eyes.

DRUG INTERACTIONS

No drug interaction studies have been conducted with Nexiclon XR Tablet. The following have been reported with other oral formulations of clonidine.

Clonidine may potentiate the CNS-depressive effects of alcohol, barbiturates or other sedating drugs. If a patient receiving clonidine hydrochloride is also taking tricyclic antidepressants, the hypotensive effect of clonidine may be reduced, necessitating an increase in the clonidine dose.

Monitor heart rate in patients receiving clonidine concomitantly with agents known to affect sinus node function or AV nodal conduction, e.g., digitalis, calcium channel blockers, and beta-blockers. Sinus bradycardia resulting in hospitalization and pacemaker insertion has been reported in association with the use of clonidine concomitantly with diltiazem or verapamil.

Amitriptyline in combination with clonidine enhances the manifestation of corneal lesions in rats [see Nonclinical Toxicology (13.2)].

Alcohol: Based on in vitro studies, high concentration of alcohol may increase the rate of release of Nexiclon XR Tablets.

USE IN SPECIFIC POPULATIONS

Pregnancy

Pregnancy Category C. Reproduction studies performed in rabbits at doses up to approximately 3 times the oral maximum recommended daily human dose (MRDHD) of clonidine hydrochloride produced no evidence of a teratogenic or embryotoxic potential in rabbits. In rats, however, doses as low as 1/3 the oral MRDHD (1/15 the MRDHD on a mg/m2 basis) of clonidine were associated with increased resorptions in a study in which dams were treated continuously from 2 months prior to mating. Increased resorptions were not associated with treatment at the same time or at higher dose levels (up to 3 times the oral MRDHD) when the dams were treated on gestation days 6 to 15. Increases in resorption were observed at much higher dose levels (40 times the oral MRDHD on a mg/kg basis; 4 to 8 times the MRDHD on a mg/m2 basis) in mice and rats treated on gestation days 1 to 14 (lowest dose employed in the study was 500 mcg/kg).

No adequate, well-controlled studies have been conducted in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers

Clonidine is secreted in human milk.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

Elderly patients may benefit from a lower initial dose [see Dosage and Administration (2)].

Patients with Renal Impairment

The initial dosage should be based on the degree of impairment. Monitor patients carefully for hypotension and bradycardia, and titrate to higher doses cautiously. Only a minimal amount of clonidine is removed during routine hemodialysis.

OVERDOSAGE

Hypertension may develop early and may be followed by hypotension, bradycardia, respiratory depression, hypothermia, drowsiness, decreased or absent reflexes, weakness, irritability and miosis. The frequency of CNS depression may be higher in children than adults. Large overdoses may result in reversible cardiac conduction defects or dysrhythmias, apnea, coma, and seizures. Signs and symptoms of overdose generally occur within 30 minutes to two hours after exposure. As little as 0.1 mg of clonidine has produced signs of toxicity in children.

There is no specific antidote for clonidine overdosage. Clonidine overdosage may result in the rapid development of CNS depression; therefore, induction of vomiting with ipecac syrup is not recommended. Gastric lavage may be indicated following recent and/or large ingestions. Administration of activated charcoal and/or a cathartic may be beneficial. Supportive care may include atropine sulfate for bradycardia, intravenous fluids and/or vasopressor agents for hypotension and vasodilators for hypertension. Naloxone may be a useful adjunct for the management of clonidine-induced respiratory depression, hypotension and/or coma; blood pressure should be monitored since the administration of naloxone has occasionally resulted in paradoxical hypertension. Tolazoline administration has yielded inconsistent results and is not recommended as first-line therapy. Dialysis is not likely to significantly enhance the elimination of clonidine.

The largest overdose reported to date involved a 28-year old male who ingested 100 mg of clonidine hydrochloride powder. This patient developed hypertension followed by hypotension, bradycardia, apnea, hallucinations, semicoma, and premature ventricular contractions. The patient fully recovered after intensive treatment. Plasma clonidine levels were 60 ng/mL after 1 hour, 190 ng/mL after 1.5 hours, 370 ng/mL after 2 hours, and 120 ng/mL after 5.5 and 6.5 hours. In mice and rats, the oral LD50 of clonidine is 206 and 465 mg/kg, respectively.

DESCRIPTION

Nexiclon XR (clonidine) Extended-Release Tablets are available for oral administration in two dose strengths: 0.17 mg and 0.26 mg. The 0.17 mg and 0.26 mg tablets are equivalent to 0.2 mg and 0.3 mg of immediate-release clonidine hydrochloride, respectively.

Clonidine hydrochloride, a centrally active alpha-adrenergic agonist, is an imidazoline derivative and exists as a mesomeric compound. The chemical name is 2-(2.6-dichlorophenylamino)-2-imidazoline hydrochloride. The following is the structural formula:

[IC]

C9H9Cl2N3·HCl Mol. Wt. 266.56

Clonidine hydrochloride is an odorless, bitter, white crystalline substance soluble in water and alcohol.

The inactive ingredients are: crospovidone, dental-type silica, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyvinyl acetate, povidone, sodium polystyrene sulfonate, triacetin. The 0.17 mg tablet also contains hypromellose 2910, polyethylene glycol, and titanium dioxide. The 0.26 mg tablet also contains D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, fractionated coconut oil, maltodextrin, polydextrose, talc, and titanium dioxide.

CLINICAL PHARMACOLOGY

Mechanism of Action

Clonidine stimulates alpha-adrenoreceptors in the brain stem. This action results in reduced sympathetic outflow from the central nervous system and in decreases in peripheral resistance, renal vascular resistance, heart rate, and blood pressure. The patient’s maximum blood pressure decrease occurred within 6 to 8 hours. Renal blood flow and glomerular filtration rate remain essentially unchanged. Normal postural reflexes are intact; therefore, orthostatic symptoms are mild and infrequent.

Pharmacodynamics

Nexiclon XR was studied in an open-label crossover, force titration, partially randomized trial in patients with mild and moderate essential hypertension who were on two or fewer antihypertensive medications. The trial was designed to compare steady-state exposures between the Nexiclon XR and clonidine immediate-release tablets. There were up- and down-titration phases. There was no washout period between phases or treatments.

Studies with immediate-release clonidine hydrochloride have demonstrated a moderate reduction (15% to 20%) in cardiac output in the supine position with no change in the peripheral resistance. At a 45° tilt, there is a smaller reduction in cardiac output and a decrease of peripheral resistance. During long-term therapy, cardiac output tends to return to control values, while peripheral resistance remains decreased. Slowing of the pulse rate has been observed in most patients given clonidine, but the drug does not alter normal hemodynamic response to exercise.

Tolerance to the antihypertensive effect may develop in some patients, necessitating a re-evaluation of therapy.

Other studies in patients have provided evidence of a reduction in plasma renin activity and in the excretion of aldosterone and catecholamines. The exact relationship of these pharmacologic actions to the antihypertensive effect of clonidine has not been fully elucidated.

Clonidine acutely stimulates growth hormone release in both children and adults, but does not produce a chronic elevation of growth hormone with long-term use.

Pharmacokinetics

Following single doses of Nexiclon XR 0.17 mg, clonidine mean (S.D.) peak plasma concentrations of 0.49 (±0.09) ng/mL occurred at 7.8 (±1.7) hours. The plasma half-life of clonidine was 13.7 (±3.0) hours. There was no effect of food on the pharmacokinetic parameters.

[IC]

A = Nexiclon XR Tablets (0.17 mg QD) Fasted

B = Clonidine IR Tablet (0.1 mg clonidine hydrochloride Q12h) Fasted

C = Nexiclon XR Tablets (017 mg QD) Fed

In the multi-dose study, mild to moderate hypertensive patients were randomized to ER and BID IR clonidine formulations. The following plot shows the sitting blood pressure values for each treatment group at Day 22.

[IC]

The half-life may increase up to 41 hours in patients with severe impairment of renal function. Following oral administration of clonidine about 40 to 60% of the absorbed dose is recovered in the urine as unchanged drug in 24 hours. About 50% of the absorbed dose is metabolized in the liver.

NONCLINICAL TOXICOLOGY

Carcinogenesis, Mutagenesis, Impairment of Fertility

Chronic dietary administration of clonidine was not carcinogenic to rats (132 weeks) or mice (78 weeks) dosed, respectively, at up to 46 or 70 times the maximum recommended daily human dose as mg/kg (9 or 6 times the MRDHD on a mg/m2 basis). There was no evidence of genotoxicity in the Ames test for mutagenicity or mouse micronucleus test for clastogenicity.

Fertility of male or female rats was unaffected by clonidine doses as high as 150 mcg/kg (approximately 3 times MRDHD). In a separate experiment, fertility of female rats appeared to be affected at dose levels of 500 to 2000 mcg/kg (10 to 40 times the oral MRDHD on a mg/kg basis; 2 to 8 times the MRDHD on a mg/m2 basis).

Animal Toxicology and/or Pharmacology

In several studies with oral clonidine hydrochloride, a dose-dependent increase in the incidence and severity of spontaneous retinal degeneration was seen in albino rats treated for six months or longer. Tissue distribution studies in dogs and monkeys showed a concentration of clonidine in the choroid.

In view of the retinal degeneration seen in rats, eye examinations were performed during clinical trials in 908 patients before, and periodically after, the start of clonidine therapy. In 353 of these 908 patients, the eye examinations were carried out over periods of 24 months or longer. Except for some dryness of the eyes, no drug-related abnormal ophthalmological findings were recorded and, according to specialized tests such as electroretinography and macular dazzle, retinal function was unchanged.

In combination with amitriptyline, clonidine hydrochloride administration led to the development of corneal lesions in rats within 5 days.

CLINICAL STUDIES

[see Clinical Pharmacology (12.3)].

HOW SUPPLIED/STORAGE AND HANDLING

Nexiclon XR Tablet is supplied as splitable, scored, capsule-shaped coated tablets containing 0.17 mg or 0.26 mg clonidine base in bottles of 90 tablets.

Strength	Color	Markings	NDC
0.17 mg	White	NP 2	27808-030-01
0.26 mg	Yellow	NP 3	27808-031-01

Store at 25ºC (77ºF); excursions permitted from 15º to 30ºC (59º to 86ºF). [See USP Controlled Room Temperature.]

Dispense in tight, light-resistant container.

Distributed By: NextWave Pharmaceuticals, Inc.

Cupertino, CA 95014

 

www.nextwavepharma.com

 

Manufactured By: Tris Pharma, Inc.

Monmouth Junction, NJ 08852

 

www.trispharma.com

 

LB8155

Rev 00

10/10

PATIENT COUNSELING INFORMATION

Caution patients against interruption of Nexiclon XR therapy without their healthcare provider’s advice.

Advise patients who engage in potentially hazardous activities, such as operating machinery or driving, of a possible sedative effect of clonidine. The sedative effect may be increased by concomitant use of alcohol, barbiturates, or other sedating drugs.

PACKAGE LABEL PRINCIPAL DISPLAY PANEL

Nexiclon XR® (Clonidine Extended-Release) Tablet

0.17 mg

Nexiclon XR® (Clonidine Extended-Release) Tablet

0.26 mg

NEXICLON  clonidine  tablet, extended release

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 27808-030 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLONIDINE (CLONIDINE) CLONIDINE 0.17 mg

Inactive Ingredients Ingredient Name Strength CROSPOVIDONE   SODIUM SILICATE   LACTOSE MONOHYDRATE   MAGNESIUM STEARATE   CELLULOSE, MICROCRYSTALLINE   VINYL ACETATE   POVIDONE   SODIUM POLYSTYRENE SULFONATE   TRIACETIN   POLYETHYLENE GLYCOL   TITANIUM DIOXIDE

Product Characteristics Color WHITE (white to off-white) Score 2 pieces Shape OVAL (capsule shaped) Size 13mm Flavor Imprint Code NP2 Contains

Packaging # NDC Package Description Multilevel Packaging 1 27808-030-01 90 TABLET In 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA022500	12/17/2010

Nexiclon XR  clonidine  tablet, extended release

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 27808-031 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLONIDINE (CLONIDINE) CLONIDINE 0.26 mg

Inactive Ingredients Ingredient Name Strength CROSPOVIDONE   SODIUM SILICATE   LACTOSE MONOHYDRATE   MAGNESIUM STEARATE   CELLULOSE, MICROCRYSTALLINE   VINYL ACETATE   POVIDONE   SODIUM POLYSTYRENE SULFONATE   TRIACETIN   D&C YELLOW NO. 10   FD&C YELLOW NO. 6   COCONUT OIL   MALTODEXTRIN   POLYDEXTROSE   TALC   TITANIUM DIOXIDE

Product Characteristics Color YELLOW Score 2 pieces Shape OVAL (capsule shaped) Size 15mm Flavor Imprint Code NP3 Contains

Packaging # NDC Package Description Multilevel Packaging 1 27808-031-01 90 TABLET In 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA022500	12/17/2010

Labeler - Tris Pharma, Inc. (947472119)

Registrant - Tris Pharma, Inc. (947472119)

Establishment
Name	Address	ID/FEI	Operations
Tris Pharma, Inc.		947472119	MANUFACTURE

Establishment
Name	Address	ID/FEI	Operations
PCAS Finland Oy		369587311	API MANUFACTURE

Establishment
Name	Address	ID/FEI	Operations
Whitehouse Analytical Laboratories, LLC		138628008	ANALYSIS

Establishment
Name	Address	ID/FEI	Operations
Perritt Laboratories Inc.		077106284	ANALYSIS

Revised: 12/2010Tris Pharma, Inc.

More Nexiclon XR resources

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

• Nexiclon XR Advanced Consumer (Micromedex) - Includes Dosage Information


• Nexiclon XR MedFacts Consumer Leaflet (Wolters Kluwer)


• Catapres Consumer Overview


• Catapres MedFacts Consumer Leaflet (Wolters Kluwer)


• Clonidine Monograph (AHFS DI)


• Clonidine MedFacts Consumer Leaflet (Wolters Kluwer)


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


• Kapvay Consumer Overview


• clonidine Epidural Advanced Consumer (Micromedex) - Includes Dosage Information

Compare Nexiclon XR with other medications

• High Blood Pressure