Xalatan

Generic Name: Latanoprost
Class: Prostaglandin Analogs
VA Class: OP109
Molecular Formula: C₂₆H₄₀O₅
CAS Number: 130209-82-4

Introduction

Ocular hypotensive agent; a synthetic analog of prostaglandin F_2α (PGF_2α).^{1 2 3 32 33}

Uses for Xalatan

Ocular Hypertension and Glaucoma

Reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.^{1 3 10 11 12 13 15 30 31 32 33 48 55 60} One of several first-line agents to reduce elevated IOP.⁷⁵

Safety and efficacy not established for the treatment of angle-closure, inflammatory, or neovascular glaucoma.¹

Appears to be more effective than unoprostone, as effective as travoprost, and slightly less effective than bimatoprost in reducing IOP in patients with open-angle glaucoma or ocular hypertension.^{76 77 78 79 80 81}

May be more effective or at least as effective as twice daily administration of timolol 0.5% in reducing IOP in patients with open-angle glaucoma or ocular hypertension.^{1 3 10 11 12 30 31 32 33} Appears to be more effective than thrice-daily administration of dorzolamide 2%.^{86 87}

May be used in conjunction with a topical β-adrenergic blocking agent (e.g., betaxolol, carteolol, levobunolol, metipranolol, timolol),^{3 28 29 32 33 36} topical dipivefrin,^{33 59} topical epinephrine, an oral carbonic anhydrase inhibitor (e.g., acetazolamide), ³³ or a topical carbonic anhydrase inhibitor (e.g., dorzolamide).^{1 44 56}

Tolerance does not occur, and reduction in mean IOP is maintained for up to at least 24 months of therapy after initial stabilization.^{1 3 10 11 12 15 36 44 48}

Xalatan Dosage and Administration

Administration

Ophthalmic Administration

Apply topically to the affected eye(s).^{1 10 11 12 32 33 36}

Avoid contamination of the solution container.¹

If more than one topical ophthalmic drug is used, administer the drugs at least 5 minutes apart.¹ (See Interactions.)

Dosage

Adults

Ocular Hypertension and Glaucoma

Ophthalmic

One drop of a 0.005% solution (1.5 mcg) in the affected eye(s) once daily in the evening.^{1 10 11 12 32 33 36} More frequent dosing may paradoxically diminish the IOP-lowering effect of the drug.^{1 15 29 39} If a dose is missed, omit the dose and apply the next dose the following evening.¹⁵

Cautions for Xalatan

Contraindications

• 
  

  Known hypersensitivity to latanoprost, benzalkonium chloride, or any ingredient in the formulation.¹

  
  

Warnings/Precautions

Warnings

Ocular Effects

Increases in brown pigmentation of the iris and periorbital tissue (eyelid) or increases in length, thickness, and pigmentation of eyelashes or vellus hair in the treated eye reported;^{1 3 10 11 12 15 31 32 33 36} misdirected growth of eyelashes also may occur.¹ Pigmentation is expected to increase throughout the treatment period.¹ Increased pigmentation of the iris may be permanent, while pigmentation of the periorbital tissue and eyelash changes reportedly are reversible in some patients.¹ Long-term effects (i.e., beyond 5 years) of increased pigmentation are unknown.¹

Increased pigmentation of iris develops slowly; may not be evident until after several months to years of latanoprost therapy.¹ In clinical studies, noticeable increased pigmentation of the iris generally occurred within the first year of therapy.¹ Therapy generally may be continued in the presence of increased iris pigmentation;¹ patients should be examined regularly.^{1 33 36}

General Precautions

Ocular Precautions

Macular edema, including cystoid macular edema, reported in aphakic patients, in pseudophakic patients with a torn posterior lens capsule, or in patients with known risk factors for macular edema; use with caution in such patients.^{1 51 52 53 54 58 61 62 63 64 65}

Use with caution in patients with a history of intraocular inflammation (e.g., iritis, uveitis); use generally not recommended in patients with active intraocular inflammation.¹

Specific Populations

Pregnancy

Category C.¹

Lactation

Not known if distributed into milk; use with caution.¹

Pediatric Use

Safety and efficacy not established in pediatric patients.^{1 15}

Geriatric Use

No substantial differences in safety and efficacy relative to younger adults.^{1 10 11 12}

Common Adverse Effects

Blurred vision, burning and stinging, conjunctival hyperemia, foreign body sensation, pruritus, increased pigmentation of the iris, punctate epithelial keratopathy.¹

Interactions for Xalatan

Ocular Hypotensive Agents

Potential for additive IOP-lowering effects when used concomitantly with another ocular hypotensive agent (e.g., topical β-adrenergic blocking agent, oral or topical carbonic anhydrase inhibitor).^{1 3 19 28 29 32 33 36 56 59} Additive effect may be used to therapeutic advantage.^{1 3 19 28 29 32 33 36}

Thimerosal

Precipitation occurs when ophthalmic solutions containing thimerosal are admixed with latanoprost ophthalmic solution.¹ If more than one topical ophthalmic drug is used, administer the drugs at least 5 minutes apart.¹

Xalatan Pharmacokinetics

Absorption

Bioavailability

Approximately 1% of a topically applied dose penetrates the human eye;¹⁵ remaining portion is absorbed into systemic circulation through blood vessels in the conjunctiva and mucous membranes of the nose, pharynx, esophagus, and GI tract.^{6 15}

Prodrug; absorbed through the cornea following ocular instillation and rapidly hydrolyzed to active form (latanoprost acid).^{1 6 14 15 16 18} Peak plasma concentrations of latanoprost acid occur within 2 hours.^{1 15}

Onset

Reduction in IOP generally occurs within 3–4 hours after topical application and peaks within 8–12 hours.

Duration

Effects on IOP generally persist for up to 24 hours or longer.^{1 10 11 12 13 15 17}

Following long-term therapy (i.e., 6 months), pharmacologic effects may persist for at least 14 days after the drug is discontinued.¹⁵

Distribution

Extent

The volume of distribution of latanoprost acid in humans following ocular or IV administration is 0.36 or 0.16 L/kg, respectively.^{1 15} Latanoprost acid can be measured in aqueous humor during the first 4 hours, and in plasma only during the first hour after ocular instillation.¹

Not known whether the drug or its metabolites distribute into milk in humans.¹

Elimination

Metabolism

Rapidly hydrolyzed by esterases in the cornea and plasma to biologically active form (latanoprost acid).^{1 15 16 33}

Systemically absorbed latanoprost acid is metabolized in the liver.^{1 15}

Elimination Route

Metabolites are excreted principally in urine; however, biliary excretion also may occur.^{1 6 15} Unchanged latanoprost or latanoprost acid generally are not recovered in urine or feces.¹⁵ Following topical administration of radiolabeled latanoprost to the eye, 88% of the dose was eliminated in urine.¹⁵

Half-life

The elimination half-life of latanoprost acid from aqueous humor is approximately 3 hours.¹⁵

Following topical application to the eye, the plasma elimination half-life of latanoprost acid is approximately 17 minutes.¹⁵

Stability

Storage

Ophthalmic

Solution

Unopened bottles: refrigerate at 2–8°C and protect from light.^{1 15}

Opened bottles: room temperature (not exceeding 25°C) for up to 6 weeks.¹

ActionsActions

• 
  

  Selective prostanoid agonist.^{1 2 3 5 6 7 8 9 33 40}

  
  


• 
  

  Appears to reduce IOP by increasing uveoscleral outflow of aqueous humor.^{1 2 3 5 6 7 9 31 32 33}

  
  

Advice to Patients

• 
  

  Risk of changes in eyelashes and permanent darkening of iris, eyelashes, or skin around the eyes associated with therapy.¹ Potential for disparity between eyes if only one eye is treated.^{1 36}

  
  


• 
  

  Importance of learning and adhering to proper administration techniques to avoid contamination of the solution with common bacteria that can cause ocular infections.¹ Serious damage to the eye and subsequent loss of vision may result from using contaminated ophthalmic solutions.¹

  
  


• 
  

  Importance of informing clinicians if intercurrent ocular condition (e.g., trauma, infection) develops or ocular surgery is planned.¹ Importance of immediately reporting ocular reactions, particularly conjunctivitis and eyelid reactions.¹

  
  


• 
  

  Importance of delaying insertion of contact lenses for at least 15 minutes after latanoprost instillation, since benzalkonium chloride preservative may be absorbed by soft lenses.¹

  
  


• 
  

  Importance of administering different topical ophthalmic preparations at least 5 minutes apart.¹

  
  


• 
  

  Importance of informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs.¹

  
  


• 
  

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

  
  


• 
  

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

  
  

Preparations

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

Latanoprost

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Ophthalmic	Solution	0.005%	Xalatan (with benzalkonium chloride)	Pharmacia

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.

Xalatan 0.005% Solution (PFIZER U.S.): 2/$104.99 or 7/$295.97

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 July 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

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82. Jampel HD, Bacharach J, Sheu WP et al. Randomized clinical trial of latanoprost and unoprostone in patients with elevated intraocular pressure. Am J Ophthalmol. 2002; 134:863-71. [IDIS 491312] [PubMed 12470755]

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85. Susanna R Jr, Giampani J Jr, Borges AS et al. A double-masked, randomized clinical trial comparing latanoprost with unoprostone in patients with open-angle glaucoma or ocular hypertension. Ophthalmology. 2001; 108:259-63. [IDIS 459094] [PubMed 11158796]

86. Niazi MK and Raja N. Comparison of latanoprost and dorzolamide in the treatment of patients with open angle glaucoma. J Ayub Med Coll Abbottabad. 2004; 16:50-3.

87. O’Donoghue EP for the Ireland Latanoprost Study Group. A comparison of latanoprost and dorzolamide in patients with glaucoma and ocular hypertension: a 3 month, randomised study. Br J Ophthalmol. 2000; 84:579-82. [PubMed 10837379]

88. Shin DH, McCracken MS, Bendel RE et al. The additive effect of latanoprost to maximum-tolerated medications with low-dose, high-dose, or no pilocarpine therapy. Ophthalmology. 1999; 106:386-90. [IDIS 422864] [PubMed 9951495]

89. Toris CB, Zhan GL, Zhao J et al. Potential mechanism for the additivity of pilocarpine and latanoprost. Am J Ophthalmol. 2001; 131:722-8. [IDIS 464258] [PubMed 11384567]

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• Glaucoma, Open Angle
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Nor-QD

Generic Name: progestin contraceptives (Oral route, Parenteral route)

Commonly used brand name(s)

In the U.S.

• Aygestin


• Camila


• Errin


• Jolivette


• Next Choice


• Nora-BE


• Nor-QD


• Ortho Micronor


• Ovrette


• Plan B


• Plan B One-Step


• Provera

Available Dosage Forms:

• Tablet

Uses For Nor-QD

Progestins are hormones.

The low-dose progestins for contraception are used to prevent pregnancy. Other names for progestin-only oral contraceptives are minipills and progestin-only pills (POPs). Progestins can prevent fertilization by preventing a woman's egg from fully developing.

Also, progestins cause changes at the opening of the uterus, such as thickening of the cervical mucus. This makes it hard for the partner's sperm to reach the egg. The fertilization of the woman's egg with her partner's sperm is less likely to occur while she is taking, receiving, or using a progestin, but it can occur. Even so, the progestins make it harder for the fertilized egg to become attached to the walls of the uterus, making it difficult to become pregnant.

No contraceptive method is 100 percent effective. Studies show that fewer than 1 of each 100 women become pregnant during the first year of use after correctly receiving the injection on time. Fewer than 10 of each 100 women who take progestins correctly by mouth for contraception become pregnant during the first year of use. Methods that do not work as well include condoms, diaphragms, or spermicides. Discuss with your doctor what your options are for birth control.

Progestin contraceptives are available only with your doctor's prescription.

Importance of Diet

Make certain your doctor knows if you are on any special diet, such as a low-sodium or low-sugar diet.

Before Using Nor-QD

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group 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

Progestins have been used by teenagers and have not been shown to cause different side effects or problems than they do in adults. You must take progestin-only oral contraceptives every day in order for them to work. Progestins do not protect against sexually transmitted diseases, a risk factor for teenagers. It is not known if Depo-Provera Contraceptive Injection causes problems with bone development and growth in teenagers and young women. It is important that your doctor check you regularly for growth problems, especially if you have been using this medicine for 2 years or longer.

Geriatric

This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Pregnancy

Use of progestin-only contraceptives during pregnancy is not recommended. Doctors should be told if pregnancy is suspected. When accidently used during pregnancy, progestins used for contraception have not caused problems.

Breast Feeding

Although progestins pass into the breast milk, the low doses of progestins used for contraception have not been shown to cause problems in nursing babies. Progestins used for contraception are recommended for nursing mothers when contraception is desired.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking any of these medicines, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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

• Isotretinoin


• Theophylline


• Tizanidine


• Tranexamic Acid

Interactions with Food/Tobacco/Alcohol

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

Other Medical Problems

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

• Asthma or


• Epilepsy, or history of or


• Heart or circulation problems or


• Kidney disease, severe or


• Migraine headaches—May cause fluid buildup and make these conditions worse.

• Bleeding problems, undiagnosed, such as blood in the urine or changes in vaginal bleeding—May make diagnosis of these problems more difficult.

• Breast disease (e.g., breast lumps or cysts), history of—May make this condition worse in certain types of diseases that do not react to progestins in a positive way.

• Central nervous system (CNS) disorders (e.g., depression), or history of or


• High blood cholesterol or


• Osteoporosis (brittle bones), or a family history of—May cause these conditions to occur or make these conditions worse.

• Diabetes mellitus—May cause a mild increase in blood sugar and a need to monitor blood sugar more often.

• Liver disease—The effects of some progestins may be increased. May make this condition worse.

Proper Use of progestin contraceptives

This section provides information on the proper use of a number of products that contain progestin contraceptives. It may not be specific to Nor-QD. Please read with care.

To make the use of a progestin as safe and reliable as possible, you should understand how and when to take it and what effects may be expected. Progestins for contraception usually come with patient directions. Read them carefully before taking or using this medicine.

Progestins do not protect a woman from sexually transmitted diseases (STDs), including human immunodeficiency virus (HIV), or acquired immunodeficiency syndrome (AIDS). The use of latex (rubber) condoms or abstinence is recommended for protection from these diseases.

Take this medicine only as directed by your doctor. Do not take more of it and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects. Try to take the medicine at the same time each day to reduce the possibility of side effects and to allow it to work better.

When using levonorgestrel tablet dosage form for emergency contraception:

• The tablets may be taken at any time during the menstrual cycle.

When using medroxyprogesterone injection dosage form for contraception:

• Your injection is given by a health care professional every 3 months.


• To stop using medroxyprogesterone injection for contraception, simply do not have another injection.


• Full protection from pregnancy begins immediately if you receive the first injection within the first 5 days of your menstrual period or within 5 days after delivering a baby if you will not be breast-feeding. If you are going to breast-feed, you may have to wait for 6 weeks from your delivery date before receiving your first injection. If you follow this schedule, you do not need to use another form of birth control. Protection from that one injection ends at 3 months. You will need another injection every 3 months to have full protection from becoming pregnant. However, if the injection is given later than 5 days from the first day of your last menstrual period, you will need to use another method of birth control as directed by your doctor.

When using an oral progestin dosage form:

• Take a tablet every 24 hours each day of the year. Taking the medicine at the same time each day helps to reduce the possibility of side effects and makes it work as expected. Taking your tablet 3 hours late is the same as missing a dose and can cause the medicine to not work properly.


• Keep the tablets in the container in which you received them to help you to keep track of your dosage schedule.


• When switching from estrogen and progestin oral contraceptives, you should take the first dose of the progestin-only contraceptive the next day after the last active pill of the estrogen and progestin oral contraceptive has been taken. This means you will not take the last 7 days (placebo or nonactive pills) of a 28-day cycle of the estrogen and progestin oral contraceptive pack. You will begin a new pack of progestin-only birth control pills on the 22nd day.


• Also, when switching, full protection from pregnancy begins after 48 hours if the first dose of the progestin-only contraceptive is taken on the first day of the menstrual period. If the birth control is begun on other days, full protection may begin 3 weeks after you begin taking the medicine for the first time. You should use a second method of birth control for at least the first 3 weeks to ensure full protection. You are not fully protected if you miss pills. The chances of your getting pregnant are greater with each pill that is missed.

Follow your doctor's orders to schedule the proper time to receive an injection of progestins for contraception.

Dosing

The dose medicines in this class 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 these medicines. 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 levonorgestrel


• For oral dosage form (tablets):
  
  • For emergency contraception for preventing pregnancy:
    
    • Adults and teenagers—The first dose of 0.75 milligram should be taken as soon as possible within 72 hours of intercourse. The second dose must be taken 12 hours later.
    
    
  
  

• For medroxyprogesterone


• For muscular injection dosage form
  
  • For preventing pregnancy:
    
    • Adults and teenagers—150 milligrams injected into a muscle in the upper arm or in the buttocks every three months (13 weeks).
    
    
  
  


• For subcutaneous injection dosage form
  
  • For preventing pregnancy:
    
    • Adults and teenagers—104 milligrams injected under the skin of the anterior thigh or abdomen every three months (12 to 14 weeks).
    
    
  
  

• For norethindrone


• For oral dosage form (tablets):
  
  • For preventing pregnancy:
    
    • Adults and teenagers—0.35 milligrams every 24 hours, beginning on the first day of your menstrual cycle whether menstrual bleeding begins or not. The first day of your menstrual cycle can be figured out by counting 28 days from the first day of your last menstrual cycle.
    
    
  
  

• For norgestrel


• For oral dosage form (tablets):
  
  • For preventing pregnancy:
    
    • Adults and teenagers—75 micrograms every 24 hours, beginning on the first day of your menstrual cycle whether menstrual bleeding occurs or not. The first day of your menstrual cycle can be figured out by counting 28 days from the first day of your last menstrual cycle.
    
    
  
  

Missed Dose

Call your doctor or pharmacist for instructions.

For oral dosage form (tablets):

• When you miss 1 day's dose of oral tablets or are 3 hours or more late in taking your dose, many doctors recommend that you take the missed dose immediately, continue your normal schedule, and use another method of contraception for 2 days. This is different from what is done after a person misses a dose of birth control tablets that contain more than one hormone.

For injection dosage form:

• If you miss having your next injection and it has been longer than 13 weeks since your last injection, your doctor may want you to stop receiving the medicine. Use another method of birth control until your period begins or until your doctor determines that you are not pregnant.


• If your doctor has other directions, follow that advice. Any time you miss a menstrual period within 45 days after a missed or delayed dose you will need to be tested for a possible pregnancy.

Storage

Keep out of the reach of children.

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

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Nor-QD

It is very important that your doctor check your progress at regular visits. This will allow your dosage to be adjusted to your changing needs, and will allow any unwanted effects to be detected. These visits are usually every 12 months when you are taking progestins by mouth for birth control.

• If you are receiving the medroxyprogesterone injection for contraception, a physical exam is needed only every 12 months, but you need an injection every 3 months. Your doctor will also want to check you for any bone development or growth problems, especially if you are a teenager or young adult.

Progestins may cause dizziness in some people. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert.

It is possible that certain doses of progestins may cause a temporary thinning of the bones by changing your hormone balance. It is important that your doctor know if you have an increased risk of osteoporosis. Some things that can increase your risk for osteoporosis include cigarette smoking, abusing alcohol, taking or drinking large amounts of caffeine, and having a family history of osteoporosis or easily broken bones. Some medicines, such as steroids (cortisone-like medicines) or anticonvulsants (seizure medicines), can also cause thinning of the bones. It is especially important that you tell your doctor about any of these risk factors if you are taking Depo-Provera® Contraceptive Injection or Depo-SubQ Provera® 104. These contraceptives may cause a loss of bone mineral density. Your doctor may replace these contraceptives with a different one.

Vaginal bleeding of various amounts may occur between your regular menstrual periods during the first 3 months of use. This is not unusual and does not mean you should stop the medicine. This is sometimes called spotting when the bleeding is slight, or breakthrough bleeding when it is heavier. If this occurs, continue on your regular dosing schedule. Check with your doctor:

• If vaginal bleeding continues for an unusually long time.


• If your menstrual period has not started within 45 days of your last period.

Missed menstrual periods may occur. If you suspect a pregnancy, you should call your doctor immediately.

If you are scheduled for any laboratory tests, tell your doctor that you are taking a progestin. Progestins can change certain test results.

The following medicines might reduce the effectiveness of progestins for contraception:

• Aminoglutethimide (e.g., Cytadren®)


• Carbamazepine (e.g., Tegretol®)


• Phenobarbital


• Phenytoin (e.g., Dilantin®)


• Rifabutin (e.g., Mycobutin®)


• Rifampin (e.g., Rifadin®)

Sometimes your doctor may use these medicines with progestins for contraception, but the doctor will give you special directions to follow to make sure your progestin is working properly. In order to prevent pregnancy, use a second method of birth control together with the progestin when you also use a medicine that could reduce the effectiveness of the progestin. If you are using medroxyprogesterone injection for contraception, continue using a back-up method of birth control until you have your next injection, even if the medicine that affects contraceptives is discontinued. If you are using the oral tablets, continue using a back-up method of birth control for a full cycle (or 4 weeks), even if the medicine that affects contraceptives is discontinued.

If you vomit your oral progestin-only contraceptive for any reason within a few hours after taking it, do not take another dose. Return to your regular dosing schedule and use an additional back-up method of birth control for 48 hours.

If you are receiving levonorgestrel tablets for emergency contraception and vomiting occurs within 1 hour after taking either dose of the medicine, contact your physician to discuss whether the dose should be repeated.

Nor-QD 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 as soon as possible if any of the following side effects occur:

More common

• Changes in uterine bleeding (increased amounts of menstrual bleeding occurring at regular monthly periods


• heavier uterine bleeding between regular monthly periods


• lighter uterine bleeding between menstrual periods


• or stopping of menstrual periods

Less common

• Mental depression


• skin rash


• unexpected or increased flow of breast milk

Incidence not known - for patients taking Depo-Provera Contraceptive Injection

• Cough


• decrease in height


• difficulty swallowing


• fast heartbeat


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


• pain in back, ribs, arms, or legs


• pain or swelling in arms or legs without any injury


• shortness of breath


• skin rash


• tightness in chest


• wheezing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Abdominal pain or cramping


• diarrhea


• dizziness


• fatigue


• mild headache


• mood changes


• nausea


• nervousness


• pain or irritation at the injection site


• swelling of face, ankles, or feet


• unusual tiredness or weakness


• vomiting


• weight gain

Less common

• Acne


• breast pain or tenderness


• brown spots on exposed skin, possibly long-lasting


• hot flashes


• loss or gain of body, facial, or scalp hair


• loss of sexual desire


• trouble in sleeping

Not all of the side effects listed above have been reported for each of these medicines, but they have been reported for at least one of them. All of the progestins are similar, so any of the above side effects may occur with any of these medicines.

After you stop using this medicine, your body may need time to adjust. The length of time this takes depends on the amount of medicine you were using and how long you used it. During this period of time, check with your doctor if you notice any of the following side effects:

• Delayed return to fertility


• stopping of menstrual periods


• unusual menstrual bleeding (continuing)

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

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

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

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

Ponstel

Pronunciation: me-fe-NAM-ik
Generic Name: Mefenamic Acid
Brand Name: Ponstel

Ponstel is a nonsteroidal anti-inflammatory drug (NSAID). It may cause an increased risk of serious and sometimes fatal heart and blood vessel problems (eg, heart attack, stroke). The risk may be greater if you already have heart problems or if you take Ponstel for a long time. Do not use Ponstel right before or after bypass heart surgery.

Ponstel may cause an increased risk of serious and sometimes fatal stomach ulcers and bleeding. Elderly patients may be at greater risk. This may occur without warning signs.

Ponstel is used for:

Treating menstrual pain. It may be used for short term (not more than 7 days) treatment of mild to moderate pain. It may also be used for other conditions as determined by your doctor.

Ponstel is an NSAID. Exactly how it works is not known. It may block certain substances in the body that are linked to inflammation. NSAIDs treat the symptoms of pain and inflammation. They do not treat the disease that causes those symptoms.

Do NOT use Ponstel if:

• you are allergic to any ingredient in Ponstel


• you have had a severe allergic reaction (eg, severe rash, hives, trouble breathing, growths in the nose, dizziness) to aspirin or a nonsteroidal anti-inflammatory drug (NSAID) (eg, ibuprofen, celecoxib)


• you have recently had or will be having bypass heart surgery


• you have kidney problems, ulcers, or inflammation of the stomach or bowel


• you are in the last 3 months of pregnancy

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

Before using Ponstel:

Some medical conditions may interact with Ponstel. 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 liver disease, diabetes, or stomach or bowel problems (eg, bleeding, perforation, ulcers)


• if you have a history of swelling or fluid buildup, asthma, growths in the nose (nasal polyps), or mouth inflammation


• if you have high blood pressure, blood disorders (eg, porphyria), bleeding or clotting problems, heart problems (eg, heart failure), or blood vessel disease, or if you are at risk for any of these diseases


• if you have poor health, dehydration or low fluid volume, or low blood sodium levels, you drink alcohol, or you have a history of alcohol abuse

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

• Anticoagulants (eg, warfarin), aspirin, corticosteroids (eg, prednisone), heparin, or selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine) because the risk of stomach bleeding may be increased


• Magnesium hydroxide (eg, antacids) or probenecid because they may increase the risk of Ponstel's side effects


• Cyclosporine, lithium, methotrexate, quinolones (eg, ciprofloxacin), or sulfonylureas (eg, glipizide) because the risk of their side effects may be increased by Ponstel


• Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril) or diuretics (eg, furosemide, hydrochlorothiazide) because their effectiveness may be decreased by Ponstel

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

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

• Ponstel comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Ponstel refilled.


• Take Ponstel by mouth. It may be taken with food if it upsets your stomach. Taking it with food may not lower the risk of stomach or bowel problems (eg, bleeding, ulcers). Talk with your doctor or pharmacist if you have persistent stomach upset.


• Take Ponstel with a full glass of water (8 oz/240 mL) as directed by your doctor.


• If you miss a dose of Ponstel and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose. 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 Ponstel.

Important safety information:

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


• Serious stomach ulcers or bleeding can occur with the use of Ponstel. Taking it in high doses or for a long time, smoking, or drinking alcohol increases the risk of these side effects. Taking Ponstel with food will NOT reduce the risk of these effects. Contact your doctor or emergency room at once if you develop severe stomach or back pain; black, tarry stools; vomit that looks like blood or coffee grounds; or unusual weight gain or swelling.


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


• Ponstel is an NSAID. Before you start any new medicine, check the label to see if it has an NSAID (eg, ibuprofen) in it too. If it does or if you are not sure, check with your doctor or pharmacist.


• Do not take aspirin while you are using Ponstel unless your doctor tells you to.


• Ponstel may interfere with certain lab tests. Be sure your doctor and lab personnel know that you take Ponstel.


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


• Use Ponstel with caution in the ELDERLY; they may be more sensitive to its effects, especially stomach bleeding and kidney problems.


• Ponstel should be used with extreme caution in CHILDREN younger than 14 years old; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: Ponstel may cause harm to the fetus. Do not use it during the last 3 months of pregnancy. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Ponstel while you are pregnant. Ponstel is found in breast milk. Do not breast-feed while taking Ponstel.

Possible side effects of Ponstel:

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; diarrhea; dizziness; gas; headache; heartburn; nausea; stomach upset.

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

Severe allergic reactions (rash; hives; itching; trouble breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody or black, tarry stools; change in the amount of urine produced; chest pain; confusion; dark urine; depression; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; mental or mood changes; numbness of an arm or leg; one-sided weakness; red, swollen, blistered, or peeling skin; ringing in the ears; seizures; severe headache or dizziness; severe or persistent stomach pain or nausea; severe vomiting; shortness of breath; sudden or unexplained weight gain; swelling of hands, legs, or feet; unusual bruising or bleeding; unusual joint or muscle pain; unusual tiredness or weakness; vision or speech changes; vomit that looks like coffee grounds; yellowing of the skin or eyes.

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

See also: Ponstel 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 decreased urination; loss of consciousness; seizures; severe dizziness or drowsiness; severe nausea or stomach pain; slow or troubled breathing; unusual bleeding or bruising; vomit that looks like coffee grounds.

Proper storage of Ponstel:

Store Ponstel at 68 to 77 degrees F (20 to 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Ponstel out of the reach of children and away from pets.

General information:

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


• Ponstel 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 summary only. It does not contain all information about Ponstel. 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 Ponstel resources

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

• Ponstel Prescribing Information (FDA)


• Ponstel Advanced Consumer (Micromedex) - Includes Dosage Information


• Ponstel Concise Consumer Information (Cerner Multum)


• Ponstel Monograph (AHFS DI)


• Mefenamic Acid Prescribing Information (FDA)


• Mefenamic Acid Professional Patient Advice (Wolters Kluwer)

Compare Ponstel with other medications

• Pain
• Period Pain

Arthrix Joint Relief

Generic Name: toxicodendron pubescens leaf tablet

Dosage Form: FOR ANIMAL USE ONLY
Arthrix Joint Relief

ACTIVE INGREDIENTS:  Rhus toxicodendron 6X.

INDICATIONS:  For temporary relief of joint pain.

WARNINGS:  For pets.  Keep out of the reach of children.  If symptoms persist consult your veterinarian.  If animal is pregnant or nursing, ask a veterinarian before use.

Do not use if tamper evident seal around the neck of the bottle is broken or missing.

INACTIVE INGREDIENTS:  Lactose, Magnesium stearate, Microcrystalline cellulose.

Distributed by:

ZHOLISTICS, Iowa City, IA 52245

888-558-1783

www.zholistics.com

Arthrix Joint Relief

FOR PETS

HOMEOPATHIC

125 TABLETS

Arthrix Joint Relief  thus toxicodendron,  tablet

Product Information Product Type OTC ANIMAL DRUG NDC Product Code (Source) 57520-0240 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TOXICODENDRON PUBESCENS LEAF (TOXICODENDRON PUBESCENS LEAF) TOXICODENDRON PUBESCENS LEAF 6 [hp_X]  in 1 mg

Inactive Ingredients Ingredient Name Strength LACTOSE   MAGNESIUM STEARATE   CELLULOSE, MICROCRYSTALLINE

Product Characteristics Color white (white) Score no score Shape ROUND (round convex) Size 6mm Flavor Imprint Code diamond Contains

Packaging # NDC Package Description Multilevel Packaging 1 57520-0240-1 15000 mg In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		11/03/2010

Labeler - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Operations
Apotheca Company		844330915	manufacture

Revised: 11/2010Apotheca Company

Chlorphen

Generic Name: chlorpheniramine (KLOR fen IR a meen)

Brand Names: AHist, Aller-Chlor, Allergy Relief, C.P.M., Chlo-Amine, Chlor-Mal, Chlor-Trimeton, Chlor-Trimeton Allergy SR, Chlorphen, ChlorTan, Ed Chlor-Tan, Ed ChlorPed, PediaTan, TanaHist-PD, Triaminic Allergy, Wal-finate

What is Chlorphen (chlorpheniramine)?

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

Chlorpheniramine is used to treat sneezing, itching, watery eyes, and runny nose caused by allergies or the common cold.

Chlorpheniramine may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Chlorphen (chlorpheniramine)?

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. Do not take chlorpheniramine if you are allergic to it.

Ask a doctor or pharmacist before taking chlorpheniramine if you have glaucoma, a stomach ulcer, severe constipation, kidney disease, urination problems, an enlarged prostate, or a thyroid disorder.

Ask a doctor or pharmacist before using any other cold, cough, or allergy medicine. Chlorpheniramine is 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.

Chlorpheniramine may 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 chlorpheniramine.

What should I discuss with my healthcare provider before taking Chlorphen (chlorpheniramine)?

Do not take this medication if you are allergic to chlorpheniramine. Do not use chlorpheniramine 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.

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

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  glaucoma;

  
  


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  a stomach ulcer;

  
  


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  severe constipation;

  
  


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  kidney disease;

  
  


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  urination problems or an enlarged prostate; or

  
  


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  a thyroid disorder.

  
  

FDA pregnancy category B. Chlorpheniramine is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Chlorpheniramine 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. Older adults may be more likely to have side effects from this medication.

How should I take Chlorphen (chlorpheniramine)?

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

Take this medication with a full glass of water. Take chlorpheniramine with food or milk if it upsets your stomach. Do not crush, chew, break, or open an extended-release tablet or capsule. Swallow it whole. Breaking or opening the pill may cause too much of the drug to be released at one time.

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

This medication can cause 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 cold or allergy 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.

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 Chlorphen (chlorpheniramine)?

Ask a doctor or pharmacist before using any other cold, cough, or allergy medicine. Chlorpheniramine is 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.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Chlorpheniramine can decrease perspiration and you may be more prone to heat stroke.

This medication may 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 chlorpheniramine.

Chlorphen (chlorpheniramine) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Stop taking chlorpheniramine and call your doctor at once if you have a serious side effect such as:

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  urinating less than usual or not at all;

  
  


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  confusion, extreme drowsiness;

  
  


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  severe dizziness, anxiety, restless feeling, nervousness; or

  
  


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  weak or shallow breathing.

  
  

Less serious side effects may include:

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  mild dizziness, drowsiness;

  
  


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  blurred vision;

  
  


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  dry mouth;

  
  


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  nausea, stomach pain, constipation;

  
  


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  problems with memory or concentration; or

  
  


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  feeling restless or excited (especially in children).

  
  

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 Chlorphen (chlorpheniramine)?

Other cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can add to sleepiness caused by chlorpheniramine. Tell your doctor if you regularly use any of these medicines.

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

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  glycopyrrolate (Robinul);

  
  


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  mepenzolate (Cantil);

  
  


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  probenecid (Benemid, Probalan);

  
  


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  rifampin (Rifadin, Rifater, Rifamate, Rimactane);

  
  


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  zidovudine (Retrovir, AZT);

  
  


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  a diuretic (water pill);

  
  


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  atropine (Atreza, Sal-Tropine), belladonna (Donnatal, and others), benztropine (Cogentin), dimenhydrinate (Dramamine), methscopolamine (Pamine), or scopolamine (Transderm-Scop);

  
  


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

  
  


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

  
  


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

  
  


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  salicylates such as aspirin, Backache Relief Extra Strength, Novasal, Nuprin Backache Caplet, Doan's Pills Extra Strength, Pepto-Bismol, Tricosal, and others;

  
  

This list is not complete and other drugs may interact with chlorpheniramine. 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 Chlorphen resources

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

• Ahist MedFacts Consumer Leaflet (Wolters Kluwer)


• Aller-Chlor Syrup MedFacts Consumer Leaflet (Wolters Kluwer)


• Chlorpheniramine Maleate/Tannate, Dexchlorpheniramine Maleate Monograph (AHFS DI)


• Ed ChlorPed Suspension Drops MedFacts Consumer Leaflet (Wolters Kluwer)


• Pediox-S Suspension MedFacts Consumer Leaflet (Wolters Kluwer)


• QDALL AR Sustained-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Chlorphen with other medications

• Allergic Reactions
• Cold Symptoms
• Hay Fever
• Urticaria

Where can I get more information?

• Your pharmacist can provide more information about chlorpheniramine.

See also: Chlorphen side effects (in more detail)

FerraPlus 90

Dosage Form: tablet, film coated
FerraPlus 90

Tablets with 90 mg Carbonyl Iron

Rx Only

FerraPlus 90 Description

FerraPlus 90 is a dark grey, oval, film-coated tablet, debossed "TL012".

Each dark grey film-coated tablet for oral administration contains:

Docusate Sodium	50 mg
Folic Acid	1 mg
Iron (Carbonyl iron)	90 mg
Vitamin B12 (Cyanocobalamin)	12 mcg
Vitamin C (Ascorbic acid)	120 mg

Inactive Ingredients

Microcrystalline Cellulose, Di Calcium Phosphate, TriPotassium Citrate, Sodium Carboxymethyl Cellulose, Acacia, Povidone K30, Croscarmellose Sodium, Fumed Silica, Stearic Acid, Magnesium Stearate, Citric Acid, Dextrin, Dextrose, Lecithin, and Sodium Citrate.

FerraPlus 90 - Clinical Pharmacology

Oral iron is absorbed most efficiently when administered between meals. Iron is critical for normal hemoglobin synthesis to maintain oxygen transport, energy production and proper function of cells. Adequate amounts of iron are necessary for effective erythropoiesis. Iron also serves as a cofactor of several essential enzymes, including cytochromes, which are involved in electron transport. Folic acid is required for nucleoprotein synthesis and the maintenance of normal erythropoiesis. Folic acid is the precursor of tetrahydrofolic acid, which is involved as a cofactor for transformylation reactions in the biosynthesis of purines and thymidylates of nucleic acids. Deficiency of folic acid may account for the defective deoxyribonucleic acid (DNA) synthesis that leads to megaloblast formation and megaloblastic macrocytic anemias. Vitamin B12 is essential to growth, cell reproduction, hematopoiesis, nucleic acid, and myelin synthesis. Deficiency may result in megaloblastic anemia or pernicious anemia.

Indications and Usage for FerraPlus 90

FerraPlus 90 is indicated for the treatment of all anemias that are responsive to oral iron therapy. These include: hypochromic anemia associated with pregnancy, chronic and/or acute blood loss, metabolic disease, post-surgical convalescence, and dietary needs.

Contraindications

Hypersensitivity to any of the ingredients. Hemolytic anemia, hemochromatosis, and hemosiderosis are contraindications to iron therapy.

Warning

Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient.

Warning

Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. KEEP THIS PRODUCT OUT OF REACH OF CHILDREN. In case of accidental overdose, call a doctor or poison control center immediately.

Precautions

General

Take 2 hours after meals. Do not exceed recommended dose. Discontinue use if symptoms of intolerance appear. The type of anemia and underlying cause or causes should be determined before starting therapy with FerraPlus 90 tablets. Ensure Hgb, Hct, reticulocyte count are determined before starting therapy and periodically thereafter during prolonged treatment. Periodically review therapy to determine if it needs to be continued without change or if a dose change is indicated.

Folic Acid

Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive. Pernicious anemia should be excluded before using these products since folic acid may mask the symptoms of pernicious anemia.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

Dosing for elderly patients should be cautious. Due to the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy, dosing should start at the lower end of the dosing range.

Adverse Reactions

Adverse reactions with iron therapy may include GI irritation, constipation, diarrhea, nausea, vomiting, and dark stools. Adverse reactions with iron therapy are usually transient. Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

Drug Interactions

Prescriber should be aware of a number of iron/drug interactions, including antacids, tetracyclines, or fluoroquinolones.

Overdosage

Symptoms

abdominal pain, metabolic acidosis, anuria, CNS damage, coma, convulsions, death, dehydration, diffuse vascular congestion, hepatic cirrhosis, hypotension, hypothermia, lethargy, nausea, vomiting, diarrhea, tarry stools, melena, hematemesis, tachycardia, hyperglycemia, drowsiness, pallor, cyanosis, lassitude, seizures, and shock.

FerraPlus 90 Dosage and Administration

One tablet daily or as directed by a physician.

NOTICE

Contact with moisture can discolor or erode the tablet. Do not chew tablet.

How is FerraPlus 90 Supplied

FerraPlus 90 is packaged in bottles of 90 tablets.

NDC 13811-012-90

Dispense in a tight container with a child-resistant closure.

STORAGE

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP controlled room temperature].

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

Rx Only

Call your doctor about side effects. You may report side effects by calling 888 9 TRIGEN (888-987-4436).

All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product. There are no implied or explicit claims on therapeutic equivalence.

Manufactured For:

TRIGEN Laboratories, Inc.

Sayreville, NJ 08872

www.trigenlab.com

Rev. 07/11

PRINCIPAL DISPLAY PANEL - 90 mg Tablet Bottle

NDC 13811-012-90

Rx Only

FerraPlus 90

Tablets

WITH 90 MG CARBONYL IRON

90 COATED TABLETS

TRIGEN

LABORATORIES

FerraPlus 90  docusate sodium, folic acid, iron, cyanocobalamin, and ascorbic acid  tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 13811-012 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Docusate Sodium (Docusate) Docusate Sodium 50 mg Folic Acid (Folic Acid) Folic Acid 1 mg Iron (Iron) Iron 90 mg Cyanocobalamin (Cyanocobalamin) Cyanocobalamin 12 ug Ascorbic acid (Ascorbic acid) Ascorbic acid 120 mg

Inactive Ingredients Ingredient Name Strength Cellulose, Microcrystalline   Anhydrous Dibasic Calcium Phosphate   Potassium Citrate Anhydrous   Carboxymethylcellulose Sodium   Acacia   Povidone K30   Croscarmellose Sodium   Silicon Dioxide   Stearic Acid   Magnesium Stearate   Citric Acid Monohydrate   Icodextrin   Dextrose   Sodium Citrate

Product Characteristics Color GRAY (dark grey) Score no score Shape OVAL Size 15mm Flavor Imprint Code TL012 Contains

Packaging # NDC Package Description Multilevel Packaging 1 13811-012-90 90 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		09/01/2011

Labeler - TRIGEN Laboratories, Inc. (830479668)

Revised: 09/2011TRIGEN Laboratories, Inc.

More FerraPlus 90 resources

• FerraPlus 90 Use in Pregnancy & Breastfeeding
• Drug Images
• FerraPlus 90 Drug Interactions
• FerraPlus 90 Support Group
• 11 Reviews for FerraPlus 90 - Add your own review/rating

Compare FerraPlus 90 with other medications

• Anemia
• Vitamin/Mineral Supplementation and Deficiency