Laronidase

Class: Enzymes
ATC Class: A16AB05
VA Class: RE900
Chemical Name: α-l-[8-Histidine] (human) iduronidase
Molecular Formula: C₃₅₆₇H₅₆₄₅N₉₂₁O₁₂₆₁S₁₂P₄
CAS Number: 210589-09-6
Brands: Aldurazyme

Introduction

Biosynthetic (recombinant DNA origin) replacement form of l-iduronidase.^{1 3 4}

Uses for Laronidase

Mucopolysaccharidosis I

Replacement therapy in patients with Hurler’s or Hurler-Scheie forms of mucopolysaccharidosis I (MPS I),^{2 3} as well as in patients with Scheie’s form of MPS I² who have moderate to severe symptoms¹ (designated an orphan drug by FDA for this use).⁴

Risks and benefits of laronidase therapy in mildly affected patients with Scheie’s syndrome not established.¹

Laronidase Dosage and Administration

General

• 
  

  To minimize the risk of infusion-related reactions, administer antipyretics and/or antihistamines 60 minutes prior to each infusion.¹

  
  


• 
  

  Infusion should be slowed or temporarily discontinued and appropriate supportive treatment initiated if signs or symptoms of an infusion reaction occur. ¹ (See Infusion Reactions under Cautions.)

  
  

Administration

IV Administration

Administer by IV infusion.¹

Laronidase injection concentrate contains no preservative; vials are for single use only.¹

Do not mix with other drugs in the same infusion solution.¹

Laronidase solutions should be prepared using PVC containers and administered with a PVC infusion set equipped with an inline, low-protein-binding filter with a pore diameter of 0.2 mcm.¹

Dilution

Use strict aseptic technique since drug product contains no preservative.^a

Laronidase vials should be allowed to reach room temperature before dilution; do not heat (e.g., in a microwave).¹

Determine appropriate number of vials to be diluted based on patient’s body weight and recommended dosage.¹

Patients weighing ≤20 kg should receive a total infusion volume of 100 mL; patients weighing >20 kg should receive a total infusion volume of 250 mL.¹

Laronidase injection concentrate must be diluted in 0.9% sodium chloride containing 0.1% albumin human prior to administration.¹

Prepare infusion bag of 0.9% sodium chloride containing albumin human 0.1% based on the total infusion volume.¹ Remove and discard the volume of 0.9% sodium chloride equal to the volume of albumin human to be added (see Table 1).¹ Add appropriate volume of albumin human to the infusion bag; gently rotate to ensure proper distribution of the albumin.¹

Table 1. Preparation of 0.9% Sodium Chloride Containing Albumin Human 0.1% Infusion Solution1

Total Infusion Volume	Volume of Albumin Human 5% to be Added to Infusion Bag	Volume of Albumin Human 25% to be Added to Infusion Bag
100 mL	2 mL	0.4 mL
250 mL	5 mL	1 mL

Prior to addition of calculated volume of laronidase injection concentrate to infusion bag, remove and discard an equal volume of 0.9% sodium chloride containing albumin human 0.1%.¹ Slowly withdraw the calculated volume of laronidase injection concentrate from the appropriate number of vials and add slowly to the infusion bag; gently rotate bag.¹ Do not use a filter needle, since it may cause agitation, which may denature laronidase and render the drug biologically inactive.¹

Rate of Administration

Administer total volume of the infusion over 3–4 hours.¹

Initially, infuse at a rate of 10 mcg/kg per hour; rate may be increased incrementally every 15 minutes during the first hour of the infusion, as tolerated, up to a maximum rate of 200 mcg/kg per hour.¹ Maximum rate should be continued for the remainder of the infusion (2–3 hours).¹

Recommended infusion protocols are summarized in Table 2 and Table 3.^a

Monitor patient’s vital signs; if stable at the end of the 15-minute infusion time, increase infusion rate to the next recommended level.

Table 2. Infusion Protocol for Patients Weighing ≤20 kg (Total Volume of Infusion 100 mL)a

Infusion Rate	Duration of Infusion
Initially, 2 mL per hour (10 mcg/kg per hour)	15 minutes
4 mL per hour (20 mcg/kg per hour)	15 minutes
8 mL per hour (50 mcg/kg per hour)	15 minutes
16 mL per hour (100 mcg/kg per hour)	15 minutes
32 mL per hour (200 mcg/kg per hour)	For remainder of inufsion (approximately 3 hours)

Monitor patient’s vital signs; if stable at the end of the 15-minute infusion time, increase infusion rate to the next recommended level.^a

Table 3. Infusion Protocol for Patients Weighing >20 kg (Total Volume of Infusion 250 mL)a

Infusion Rate	Duration of Infusion
Initially, 5 mL per hour (10 mcg/kg per hour)	15 minutes
10 mL per hour (20 mcg/kg per hour)	15 minutes
20 mL per hour (50 mcg/kg per hour)	15 minutes
40 mL per hour (100 mcg/kg per hour)	15 minutes
80 mL per hour (200 mcg/kg per hour)	For remainder of infusion (approximately 3 hours)

Dosage

Dosage of laronidase is expressed in mg.¹ The specific activity of laronidase is 172 units/mg.¹

Pediatric Patients

Mucopolysaccharidosis I

IV

Children ≥5 years of age: 0.58 mg/kg administered once weekly.¹

Adults

Mucopolysaccharidosis I

IV

0.58 mg/kg administered once weekly.¹

Cautions for Laronidase

Contraindications

• 
  

  No known contraindications.¹

  
  

Warnings/Precautions

Sensitivity Reactions

Infusion Reactions

Risk of potentially severe infusion reactions consistent with hypersensitivity reactions.^a

Signs and symptoms include flushing, fever, headache, rash, cough, bronchospasm, dyspnea, urticaria, angioedema, and pruritus.¹ Severe reactions, including anaphylaxis requiring emergency tracheostomy, also reported.¹

Administer antipyretics and/or antihistamines prior to infusion.¹ (See General under Dosage and Administration.) Infusion reactions may be controlled by slowing the infusion rate or administering appropriate treatment (additional antipyretics and/or antihistamines).¹

If severe hypersensitivity or anaphylactic reaction occurs, discontinue immediately and institute appropriate therapy as indicated.¹ Administer subsequent infusions with extreme caution, considering risks and benefits of therapy, and with appropriate resuscitation measures available.^a

Caution advised if epinephrine is considered for use in patients with MPS I because of the increased prevalence of CAD in such patients.¹

General Precautions

MPS I Registry

A registry has been established to monitor the variability and progression of MPS I disease and to monitor and evaluate treatments for the disease.^a Information is available at and 800-745-4447.^a

Immunogenicity

Antibodies to laronidase develop in most patients;¹ clinical importance, including potential for drug neutralization, not known.¹

Development of laronidase-specific IgE binding antibodies and complement activation reported in a patient with an anaphylactic reaction to larondiase.^a (See Infusion Reactions under Cautions.)

Specific Populations

Pregnancy

Category B.¹

Lactation

Not known whether laronidase is distributed into milk.¹ Caution advised if laronidase is used. ¹ Register nursing women at 800-745-4447 or .¹

Pediatric Use

Safety and efficacy not established in children <5 years of age.¹

Geriatric Use

Safety and/or efficacy in those ≥65 years of age not studied specifically to date;¹ it is not known whether geriatric patients respond differently than younger patients.¹

Common Adverse Effects

Rash, upper respiratory tract infection, injection site reactions, infusion-related reactions (flushing, fever, headache, and rash).¹

Interactions for Laronidase

No formal drug interaction studies to date.¹

Laronidase Pharmacokinetics

Distribution

Extent

Not known whether laronidase crosses the blood-brain barrier or distributes into milk.^a

Elimination

Half-life

1.5–3.6 hours.¹

Stability

Storage

Parenteral

Powder for Injection

2–8°C; do not freeze or shake.¹

Following dilution, 2–8°C for up to 36 hours; however, immediate use following dilution is preferred since product contains no preservatives.¹

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Parenteral

Solution Compatibility

Compatible
Sodium Chloride 0.9%

Drug Compatibility

Admixture Compatibility

Compatible
Albumin 0.1%

ActionsActions

• 
  

  Biosynthetic (recombinant DNA origin) replacement form of l-iduronidase, a lysosomal enzyme that catalyzes the hydrolysis of terminal α-l-iduronic acid residues of dermatan sulfate and heparan sulfate.^{1 3 4}

  
  


• 
  

  Provides an exogenous source of l-iduronidase for uptake into lysosomes and catabolism of glycosaminoglycans.¹

  
  

Advice to Patients

• 
  

  Importance of notifying clinician immediately if manifestations of infusion reaction (fever, flushing, headache, rash, cough, difficulty breathing) occur.^b

  
  


• 
  

  Importance of informing patients that a registry has been established to monitor the variability and progression of MPS I and to evaluate treatments for the disease; importance of encouraging patient participation and of advising patients that participation may involve long-term follow-up.¹

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, dietary supplements, and herbal products.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. (See Cautions.)

  
  

Preparations

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

Laronidase (Recombinant DNA Origin)

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	For injection, concentrate, for IV infusion only	0.58 mg/mL (2.9 mg)	Aldurazyme (preservative-free)	Genzyme

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

1. BioMarin Pharmaceutical Inc. Aldurazyme (laronidase) for intravenous infusion prescribing information. Novato, CA. 2003 Apr

2. Kakkis ED, Muenzer J, Tiller GE et al. Enzyme-replacement therapy in mucopolysaccharidosis I. N Engl J Med. 2001; 344:182-8. [IDIS 458270] [PubMed 11172140]

3. Anon. Laronidase. BioDrugs. 2002; 16:316-8. [PubMed 12196045]

4. US Food and Drug Administration. FDA approves first treatment for genetic metabolic disorder including Hurler disorder. Rockville, MD; 2003 Apr 30. FDA Talk Paper. No. T03-32.

5. Kakkis ED, McEntee MF, Schmidtchen A et al. Long-term and high-dose trials of enzyme replacement therapy in the canine model of mucopolysaccharidosis I. Biochem Mol Med . 1996; 58:156-67. [PubMed 8812735]

6. Grabowski GA. Lysosomal storage diseases. In: Braunwald E, Fauci AS, , Kasper DL et al, eds. Harrison’s principles of internal medicine. l5th ed. New York: McGraw Hill Company; 2001: 2276-81.

7. Peters C, Shapiro EG, Anderson J et al. Hurler syndrome: II. Outcome of HLA-genotypically identical sibling and HLA-haploidentical related donor bone marrow transplantation in fifty-four children. Blood. 1998; 91:2601-8. [PubMed 9516162]

8. Grewal SS, Krivit W, Defor TE et al. Outcome of second hematopoietic cell transplantation in Hurler syndrome. Bone Marrow Transplant. 2002; 29:491-6. [IDIS 479500] [PubMed 11960268]

9. Genzyme Corporation. Mucopolysaccharidosis I and Aldurazyme (laronidase). Cambridge, MA; 2003 Apr. Press release from website .

10. Genzyme Corporation, Cambridge, MA: Personal communication.

a. Genzyme Corporation. Aldurazyme (laronidase) solution for intravenous infusion prescribing information. Cambridge, MA. 2005 May.

b. Genzyme Corporation. Aldurazyme (laronidase) solution for intravenous infusion patient information. Cambridge, MA. 2003 May.

More Laronidase resources

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

• Laronidase MedFacts Consumer Leaflet (Wolters Kluwer)


• Laronidase Professional Patient Advice (Wolters Kluwer)


• laronidase Intravenous Advanced Consumer (Micromedex) - Includes Dosage Information


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• Mucopolysaccharidosis Type I

Latanoprost Ophthalmic Solution

Dosage Form: ophthalmic solution
Latanoprost Ophthalmic Solution, 0.005%

125 µg/2.5 mL

Sterile

Latanoprost Ophthalmic Solution Description

Latanoprost is a prostaglandin F2αanalogue. Its chemical name is isopropyl-(Z)-7 [(1R,2R,3R,5S) 3,5-dihydroxy-2-[(3R)-3-hydroxy-5-phenylpentyl]cyclopentyl]-5-heptenoate. Its molecular formula is C26H40O5and its chemical structure is:

Latanoprost is a colorless to slightly yellow oil that is very soluble in acetonitrile and freely soluble in acetone, ethanol, ethyl acetate, isopropanol, methanol and octanol. It is practically insoluble in water.

Latanoprost Ophthalmic Solution, 0.005% is supplied as a sterile, isotonic, buffered aqueous solution of latanoprost with a pH of approximately 6.7 and an osmolality of approximately 267 mOsmol/kg. Each mL of Latanoprost Ophthalmic Solution, 0.005% contains 50 micrograms of latanoprost. Benzalkonium chloride, 0.02% is added as a preservative. The inactive ingredients are: sodium chloride, sodium dihydrogen phosphate monohydrate, disodium hydrogen phosphate anhydrous and water for injection. One drop contains approximately 1.5 µg of latanoprost.

Latanoprost Ophthalmic Solution - Clinical Pharmacology

Mechanism of Action

Latanoprost is a prostanoid selective FP receptor agonist that is believed to reduce the intraocular pressure (IOP) by increasing the outflow of aqueous humor. Studies in animals and man suggest that the main mechanism of action is increased uveoscleral outflow. Elevated IOP represents a major risk factor for glaucomatous field loss. The higher the level of IOP, the greater the likelihood of optic nerve damage and visual field loss.

Pharmacokinetics/Pharmacodynamics

Absorption:

Latanoprost is absorbed through the cornea where the isopropyl ester prodrug is hydrolyzed to the acid form to become biologically active. Studies in man indicate that the peak concentration in the aqueous humor is reached about two hours after topical administration.

Distribution:

The distribution volume in humans is 0.16 ± 0.02 L/kg. The acid of latanoprost can be measured in aqueous humor during the first 4 hours, and in plasma only during the first hour after local administration.

Metabolism:

Latanoprost, an isopropyl ester prodrug, is hydrolyzed by esterases in the cornea to the biologically active acid. The active acid of latanoprost reaching the systemic circulation is primarily metabolized by the liver to the 1,2-dinor and 1,2,3,4-tetranor metabolites via fatty acid β-oxidation.

Excretion:

The elimination of the acid of latanoprost from human plasma is rapid (t1/2=17 min) after both intravenous and topical administration. Systemic clearance is approximately 7 mL/min/kg. Following hepatic β-oxidation, the metabolites are mainly eliminated via the kidneys. Approximately 88% and 98% of the administered dose is recovered in the urine after topical and intravenous dosing, respectively.

Animal Studies

In monkeys, latanoprost has been shown to induce increased pigmentation of the iris. The mechanism of increased pigmentation seems to be stimulation of melanin production in melanocytes of the iris, with no proliferative changes observed. The change in iris color may be permanent.

Ocular administration of latanoprost at a dose of 6 µg/eye/day (4 times the daily human dose) to cynomolgus monkeys has also been shown to induce increased palpebral fissure. This effect was reversible upon discontinuation of the drug.

Indications and Usage for Latanoprost Ophthalmic Solution

Latanoprost Ophthalmic Solution, 0.005% is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

Clinical Studies

Patients with mean baseline intraocular pressure of 24 – 25 mmHg who were treated for 6 months in multi-center, randomized, controlled trials demonstrated 6 – 8 mmHg reductions in intraocular pressure. This IOP reduction with Latanoprost Ophthalmic Solution, 0.005% dosed once daily was equivalent to the effect of timolol 0.5% dosed twice daily.

A 3-year open-label, prospective safety study with a 2-year extension phase was conducted to evaluate the progression of increased iris pigmentation with continuous use of Latanoprost Ophthalmic Solution, 0.005% once-daily as adjunctive therapy in 519 patients with open-angle glaucoma. The analysis was based on observed-cases population of the 380 patients who continued in the extension phase.

Results showed that the onset of noticeable increased iris pigmentation occurred within the first year of treatment for the majority of the patients who developed noticeable increased iris pigmentation. Patients continued to show signs of increasing iris pigmentation throughout the five years of the study. Observation of increased iris pigmentation did not affect the incidence, nature or severity of adverse events (other than increased iris pigmentation) recorded in the study. IOP reduction was similar regardless of the development of increased iris pigmentation during the study.

Contraindications

Known hypersensitivity to latanoprost, benzalkonium chloride or any other ingredients in this product.

Warnings

Latanoprost Ophthalmic Solution, 0.005% has been reported to cause changes to pigmented tissues. The most frequently reported changes have been increased pigmentation of the iris, periorbital tissue (eyelid) and eyelashes, and growth of eyelashes. Pigmentation is expected to increase as long as Latanoprost Ophthalmic Solution, 0.005% is administered. After discontinuation of Latanoprost Ophthalmic Solution, 0.005%, pigmentation of the iris is likely to be permanent while pigmentation of the periorbital tissue and eyelash changes have been reported to be reversible in some patients. Patients who receive treatment should be informed of the possibility of increased pigmentation. The effects of increased pigmentation beyond 5 years are not known.

Precautions

General:

Latanoprost Ophthalmic Solution, 0.005% may gradually increase the pigmentation of the iris. The eye color change is due to increased melanin content in the stromal melanocytes of the iris rather than to an increase in the number of melanocytes. This change may not be noticeable for several months to years (seeWARNINGS). Typically, the brown pigmentation around the pupil spreads concentrically towards the periphery of the iris and the entire iris or parts of the iris become more brownish. Neither nevi nor freckles of the iris appear to be affected by treatment. While treatment with Latanoprost Ophthalmic Solution, 0.005% can be continued in patients who develop noticeably increased iris pigmentation, these patients should be examined regularly.

During clinical trials, the increase in brown iris pigment has not been shown to progress further upon discontinuation of treatment, but the resultant color change may be permanent.

Eyelid skin darkening, which may be reversible, has been reported in association with the use of Latanoprost Ophthalmic Solution, 0.005% (seeWARNINGS).

Latanoprost Ophthalmic Solution, 0.005% may gradually change eyelashes and vellus hair in the treated eye; these changes include increased length, thickness, pigmentation, the number of lashes or hairs, and misdirected growth of eyelashes. Eyelash changes are usually reversible upon discontinuation of treatment.

Latanoprost Ophthalmic Solution, 0.005% should be used with caution in patients with a history of intraocular inflammation (iritis/uveitis) and should generally not be used in patients with active intraocular inflammation.

Macular edema, including cystoid macular edema, has been reported during treatment with Latanoprost Ophthalmic Solution, 0.005%. These reports have mainly occurred in aphakic patients, in pseudophakic patients with a torn posterior lens capsule, or in patients with known risk factors for macular edema. Latanoprost Ophthalmic Solution, 0.005% should be used with caution in patients who do not have an intact posterior capsule or who have known risk factors for macular edema.

There is limited experience with Latanoprost Ophthalmic Solution, 0.005% in the treatment of angle closure, inflammatory or neovascular glaucoma.

There have been reports of bacterial keratitis associated with the use of multiple-dose containers of topical ophthalmic products. These containers had been inadvertently contaminated by patients who, in most cases, had a concurrent corneal disease or a disruption of the ocular epithelial surface (seePRECAUTIONS, Information for Patients).

Contact lenses should be removed prior to the administration of Latanoprost Ophthalmic Solution, 0.005%, and may be reinserted 15 minutes after administration (seePRECAUTIONS, Information for Patients).

Information for Patients

(seeWARNINGSandPRECAUTIONS):

Patients should be advised about the potential for increased brown pigmentation of the iris, which may be permanent. Patients should also be informed about the possibility of eyelid skin darkening, which may be reversible after discontinuation of Latanoprost Ophthalmic Solution, 0.005%.

Patients should also be informed of the possibility of eyelash and vellus hair changes in the treated eye during treatment with Latanoprost Ophthalmic Solution, 0.005%. These changes may result in a disparity between eyes in length, thickness, pigmentation, number of eyelashes or vellus hairs, and/or direction of eyelash growth. Eyelash changes are usually reversible upon discontinuation of treatment.

Patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye or surrounding structures because this could cause the tip to become contaminated by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions.

Patients also should be advised that if they develop an intercurrent ocular condition (e.g., trauma, or infection) or have ocular surgery, they should immediately seek their physician's advice concerning the continued use of the multiple-dose container.

Patients should be advised that if they develop any ocular reactions, particularly conjunctivitis and lid reactions, they should immediately seek their physician's advice.

Patients should also be advised that Latanoprost Ophthalmic Solution, 0.005% contains benzalkonium chloride, which may be absorbed by contact lenses. Contact lenses should be removed prior to administration of the solution. Lenses may be reinserted 15 minutes following administration of Latanoprost Ophthalmic Solution, 0.005%.

If more than one topical ophthalmic drug is being used, the drugs should be administered at least five (5) minutes apart.

Drug Interactions:

In vitrostudies have shown that precipitation occurs when eye drops containing thimerosal are mixed with Latanoprost Ophthalmic Solution, 0.005%. If such drugs are used they should be administered at least five (5) minutes apart.

Carcinogenesis, Mutagenesis, Impairment of Fertility:

Latanoprost was not mutagenic in bacteria, in mouse lymphoma or in mouse micronucleus tests.

Chromosome aberrations were observedin vitrowith human lymphocytes.

Latanoprost was not carcinogenic in either mice or rats when administered by oral gavage at doses of up to 170 µg/kg/day (approximately 2,800 times the recommended maximum human dose) for up to 20 and 24 months, respectively.

Additionalin vitroandin vivostudies on unscheduled DNA synthesis in rats were negative. Latanoprost has not been found to have any effect on male or female fertility in animal studies.

Pregnancy:

Teratogenic Effects:

Pregnancy Category C.

Reproduction studies have been performed in rats and rabbits. In rabbits an incidence of 4 of 16 dams had no viable fetuses at a dose that was approximately 80 times the maximum human dose, and the highest nonembryocidal dose in rabbits was approximately 15 times the maximum human dose. There are no adequate and well-controlled studies in pregnant women. Latanoprost Ophthalmic Solution, 0.005% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers:

It is not known whether this drug or its metabolites are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Latanoprost Ophthalmic Solution, 0.005% is administered to a nursing woman.

Pediatric Use:

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use:

No overall differences in safety or effectiveness have been observed between elderly and younger patients.

Adverse Reactions

Adverse events referred to in other sections of this insert:

Eyelash changes (increased length, thickness, pigmentation, and number of lashes); eyelid skin darkening; intraocular inflammation (iritis/uveitis); iris pigmentation changes; and macular edema, including cystoid macular edema (seeWARNINGSandPRECAUTIONS).

Controlled Clinical Trials:

The ocular adverse events and ocular signs and symptoms reported in 5 to 15% of the patients on Latanoprost Ophthalmic Solution, 0.005% in the three 6-month, multi-center, double-masked, active-controlled trials were blurred vision, burning and stinging, conjunctival hyperemia, foreign body sensation, itching, increased pigmentation of the iris, and punctate epithelial keratopathy.

Local conjunctival hyperemia was observed; however, less than 1% of the patients treated with Latanoprost Ophthalmic Solution, 0.005% required discontinuation of therapy because of intolerance to conjunctival hyperemia.

In addition to the above listed ocular events/signs and symptoms, the following were reported in 1 to 4% of the patients: dry eye, excessive tearing, eye pain, lid crusting, lid discomfort/pain, lid edema, lid erythema, and photophobia.

The following events were reported in less than 1% of the patients: conjunctivitis, diplopia and discharge from the eye.

During clinical studies, there were extremely rare reports of the following: retinal artery embolus, retinal detachment, and vitreous hemorrhage from diabetic retinopathy.

The most common systemic adverse events seen with Latanoprost Ophthalmic Solution, 0.005% were upper respiratory tract infection/cold/flu, which occurred at a rate of approximately 4%. Chest pain/angina pectoris, muscle/joint/back pain, and rash/allergic skin reaction each occurred at a rate of 1 to 2%.

Clinical Practice:

The following events have been identified during postmarketing use of Latanoprost Ophthalmic Solution, 0.005% in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. The events, which have been chosen for inclusion due to either their seriousness, frequency of reporting, possible causal connection to Latanoprost Ophthalmic Solution, 0.005%, or a combination of these factors, include: asthma and exacerbation of asthma; corneal edema and erosions; dyspnea; eyelash and vellus hair changes (increased length, thickness, pigmentation, and number); eyelid skin darkening; herpes keratitis; intraocular inflammation (iritis/uveitis); keratitis; macular edema, including cystoid macular edema; misdirected eyelashes sometimes resulting in eye irritation; dizziness, headache, and toxic epidermal necrolysis.

Overdosage

Apart from ocular irritation and conjunctival or episcleral hyperemia, the ocular effects of latanoprost administered at high doses are not known. Intravenous administration of large doses of latanoprost in monkeys has been associated with transient bronchoconstriction; however, in 11 patients with bronchial asthma treated with latanoprost, bronchoconstriction was not induced. Intravenous infusion of up to 3 µg/kg in healthy volunteers produced mean plasma concentrations 200 times higher than during clinical treatment and no adverse reactions were observed. Intravenous dosages of 5.5 to 10 µg/kg caused abdominal pain, dizziness, fatigue, hot flushes, nausea and sweating.

If overdosage with Latanoprost Ophthalmic Solution, 0.005% occurs, treatment should be symptomatic.

Latanoprost Ophthalmic Solution Dosage and Administration

The recommended dosage is one drop (1.5 µg) in the affected eye(s) once daily in the evening.

The dosage of Latanoprost Ophthalmic Solution, 0.005% should not exceed once daily; the combined use of two or more prostaglandins, or prostaglandin analogs including Latanoprost Ophthalmic Solution, 0.005% is not recommended. It has been shown that administration of these prostaglandin drug products more than once daily may decrease the intraocular pressure lowering effect or cause paradoxical elevations in IOP.

Reduction of the intraocular pressure starts approximately 3 to 4 hours after administration and the maximum effect is reached after 8 to 12 hours.

Latanoprost Ophthalmic Solution, 0.005% may be used concomitantly with other topical ophthalmic drug products to lower intraocular pressure. If more than one topical ophthalmic drug is being used, the drugs should be administered at least five (5) minutes apart.

How is Latanoprost Ophthalmic Solution Supplied

Latanoprost Ophthalmic Solution, 0.005% is a clear, isotonic, buffered, preserved colorless solution of latanoprost 0.005% (125 µg/2.5 mL). It is supplied as a 2.5 mL solution in a 5 mL clear low density polyethylene bottle with a clear low density polyethylene dropper tip, and a white tamper-evident high density polyethylene screw cap.

NDC 0574-4015-25 2.5 mL fill, 0.005% (125 µg/2.5 mL)

Storage:

Protect from light. Store unopened bottle(s) under refrigeration at 2 to 8 C (36 to 46 F). During shipment to the patient, the bottle may be maintained at temperatures up to 40 C (104 F) for a period not exceeding 8 days. Once a bottle is opened for use, it may be stored at room temperature up to 25 C (77 F) for 6 weeks.

Sterile

Manufactured for:	Manufactured by:
Paddock Laboratories, Inc.	Indoco Remedies Ltd.
Minneapolis, MN 55427	Santacruz (East)
(11-10)	Mumbi, 400098
	India

PRINCIPAL DISPLAY PANEL - 2.5 mL Bottle Carton

NDC 0574-4015-25

LATANOPROST

OPHTHALMIC

SOLUTION, 0.005%

125 µg/2.5 mL

Rx ONLY

Sterile

FOR USE IN THE

EYES ONLY.

2.5 mL BOTTLE

Paddock

Laboratories, Inc.

LATANOPROST  latanoprost  solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0574-4015 Route of Administration OPHTHALMIC DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Latanoprost (Latanoprost) Latanoprost 50 ug  in 1 mL

Inactive Ingredients Ingredient Name Strength benzalkonium chloride 0.2 mg  in 1 mL sodium chloride   sodium phosphate, dibasic anhydrous   water

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0574-4015-25 1 BOTTLE In 1 BOX contains a BOTTLE, DROPPER 1 2.5 mL In 1 BOTTLE, DROPPER This package is contained within the BOX (0574-4015-25)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA090887	10/17/2011	10/01/2012

Labeler - Paddock Laboratories, LLC (967694121)

Establishment
Name	Address	ID/FEI	Operations
INDOCO REMEDIES LTD		915851870	MANUFACTURE

Revised: 12/2011Paddock Laboratories, LLC

Lazerformalyde Solution

Pronunciation: for-MAL-de-hyde
Generic Name: Formaldehyde
Brand Name: Examples include Formadon and Lazerformalyde

Lazerformalyde Solution is used for:

Drying skin before or after surgical removal of warts or where dryness is required. It may also be used for treating excessive foot moisture or for other conditions as determined by your doctor.

Lazerformalyde Solution is a drying agent. It works by drying excessive moisture.

Do NOT use Lazerformalyde Solution if:

• you are allergic to any ingredient in Lazerformalyde Solution

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

Before using Lazerformalyde Solution:

Some medical conditions may interact with Lazerformalyde Solution. 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

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

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

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

• Apply with roll-on applicator to affected areas.


• Do not shake bottle with the cap removed.


• Do not bandage or wrap the affected area unless directed otherwise by your doctor.


• Wash your hands immediately after using Lazerformalyde Solution, unless your hands are part of the treated area.


• If you miss a dose of Lazerformalyde Solution, use 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 use 2 doses at once.

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

Important safety information:

• Skin should be checked for sensitivity to formaldehyde prior to application because it may be irritating and sensitizing to the skin of some patients.


• Avoid getting Lazerformalyde Solution in your eyes, nose, or mouth, or on your face.


• PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Lazerformalyde Solution, discuss with your doctor the benefits and risks of using Lazerformalyde Solution during pregnancy. It is unknown if Lazerformalyde Solution is excreted in breast milk. If you are or will be breast-feeding while you are using Lazerformalyde Solution, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Lazerformalyde Solution:

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:

Skin redness or irritation.

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

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); persisting irritation or redness.

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: Lazerformalyde side effects (in more detail)

If OVERDOSE is suspected:

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

Proper storage of Lazerformalyde Solution:

Store Lazerformalyde Solution at room temperature, between 59 and 86 degrees F (15 and 30 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Keep Lazerformalyde Solution out of the reach of children and away from pets.

General information:

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


• Lazerformalyde Solution 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 Lazerformalyde Solution. 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 Lazerformalyde resources

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

Lariam

Generic Name: mefloquine (MEF loe kwin)

Brand Names: Lariam

What is Lariam (mefloquine)?

Mefloquine is a medication to treat malaria, a disease caused by parasites. This medicine works by interfering with the growth of parasites in the red blood cells of the human body.

Parasites that cause malaria typically enter the body through the bite of a mosquito. Malaria is common in areas such as Africa, South America, and Southern Asia.

Mefloquine is used to treat or prevent malaria.

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

What is the most important information I should know about Lariam (mefloquine)?

Do not use this medication if you are allergic to mefloquine or similar medications such as quinine (Qualaquin) or quinidine (Quinaglute, Quinidex, Quin-Release).

You should not use this medication to prevent malaria if you have a recent history of seizures, depression, anxiety, or a psychiatric illness such as schizophrenia. However, your doctor may prescribe mefloquine to treat malaria even if you do have any of these conditions.

Before using this medication, tell your doctor if you have liver or kidney disease, severe complications from infection with malaria, or uncontrolled vomiting or diarrhea.

If you vomit within 1 hour after taking this medication, take another dose. If your vomiting continues, call your doctor.

If you are taking this medicine to prevent malaria, start taking it 1 week before entering an area where malaria is common. Take the medication once per week during your stay and for at least 4 weeks after you leave. If you stop taking the medicine early for any reason, contact a healthcare professional about another form of malaria prevention.

If you are taking this medicine to treat malaria, the usual dose is 5 tablets at one time as a single dose.

Take this medication for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated.

In addition to taking mefloquine, use protective clothing, insect repellents, and mosquito netting around your bed to further prevent mosquito bites that could cause malaria.

Contact your doctor as soon as possible if you have been exposed to malaria, or if you have a fever or other symptoms of illness during or after a stay in an area where malaria is common.

No medication is 100% effective in treating or preventing malaria. For best results, keep using the medication as directed. Talk with your doctor if you have fever, vomiting, or diarrhea during your treatment.

What should I discuss with my healthcare provider before taking Lariam (mefloquine)?

Do not use this medication if you are allergic to mefloquine or similar medications such as quinine (Qualaquin) or quinidine (Quinaglute, Quinidex, Quin-Release).

You also should not use mefloquine to prevent malaria if you have a recent history of:

• 
  

  seizures;

  
  


• 
  

  depression;

  
  


• 
  

  anxiety; or

  
  


• 
  

  schizophrenia or other psychiatric illness.

  
  

However, your doctor may prescribe mefloquine to treat malaria even if you do have any of the conditions listed above.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use this medication:

• 
  

  liver disease;

  
  


• 
  

  a history of depression;

  
  


• 
  

  epilepsy or other seizure disorder;

  
  


• 
  

  kidney disease;

  
  


• 
  

  severe complications from malaria; or

  
  


• 
  

  uncontrolled vomiting or diarrhea.

  
  

FDA pregnancy category C. It is not known whether mefloquine is harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Malaria is more likely to cause death in a pregnant woman. If you are pregnant, talk with your doctor about the risks of traveling to areas where malaria is common. Mefloquine 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. Mefloquine should not be used to treat malaria in a child younger than 6 months old or who weighs less than 11 pounds. Mefloquine should not be used to prevent malaria in a child who weighs less than 99 pounds.

How should I take Lariam (mefloquine)?

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

It is important to use this medication regularly to best prevent malaria. If you stop using the medication early for any reason, talk to your doctor about other forms of malaria prevention.

If you have trouble swallowing the mefloquine tablet, you may crush the tablet and mix it into a small glass of milk, water, or other beverage to make swallowing easier.

If you vomit within 1 hour after taking this medication, take another half dose. If your vomiting continues, call your doctor.

If you are taking this medicine to prevent malaria:

• 
  

  Start taking the medicine 1 week before entering an area where malaria is common. Continue taking the medicine once weekly during your stay and for at least 4 weeks after you leave the area.

  
  


• 
  

  Take your weekly dose on the same day each week.

  
  


• 
  

  If you stop taking the medicine early for any reason, contact a healthcare professional about another form of malaria prevention.

  
  

If you are taking mefloquine to treat malaria:

• 
  

  Take five (5) tablets at one time, unless your doctor tells you otherwise.

  
  


• Do not take mefloquine on an empty stomach.


• Take the medicine with a full glass (8 ounces) of water.

In addition to taking mefloquine, use protective clothing, insect repellents, and mosquito netting around your bed to further prevent mosquito bites that could cause malaria.

To be sure this medication is not causing harmful effects, your liver function may need to be tested with blood tests on a regular basis. You may also need regular eye exams. Do not miss any visits to your doctor.

Contact your doctor as soon as possible if you have been exposed to malaria, or if you have fever or other symptoms of illness during or after a stay in an area where malaria is common.

No medication is 100% effective in treating or preventing malaria. For best results, keep using the medication as directed. Talk with your doctor if you have fever, vomiting, or diarrhea during your treatment.

Store mefloquine at room temperature away from moisture and heat.

See also: Lariam dosage (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include stomach discomfort, vomiting, mouth sores, hair loss, easy bruising or bleeding, and peeling of the skin on your hands or feet.

What should I avoid while taking Lariam (mefloquine)?

Do not take halofantrine (Halfan) while you are taking mefloquine or just after you stop taking it. Serious, life-threatening side effects on your heart can occur if you take halofantrine before the mefloquine has cleared from your body.

Avoid taking chloroquine (Aralen Phosphate), quinine (Qualaquin) or quinidine (Quinaglute, Quinidex, Quin-Release) while you are taking mefloquine.

Mefloquine can cause side effects that may impair your thinking or reactions. Be careful if you drive, operate machinery, pilot an airplane, SCUBA dive, or do anything that requires you to be awake and alert.

Lariam (mefloquine) side effects

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

• 
  

  depressed mood, feeling restless or anxious;

  
  


• 
  

  confusion, extreme fear, hallucinations, unusual thoughts or behavior;

  
  


• 
  

  severe or uncontrolled vomiting or diarrhea;

  
  


• 
  

  fever;

  
  


• 
  

  cough, wheezing, feeling short of breath;

  
  


• 
  

  nausea, stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

  
  


• 
  

  mouth sores;

  
  


• 
  

  unusual aches and pains, tired feeling, weight loss;

  
  


• 
  

  severe skin rash; or

  
  


• 
  

  easy bruising or bleeding.

  
  

Less serious side effects may include:

• 
  

  cough;

  
  


• 
  

  headache;

  
  


• 
  

  weakness;

  
  


• 
  

  dizziness; or

  
  


• 
  

  itching.

  
  

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 Lariam (mefloquine)?

The following drugs can interact with mefloquine. Tell your doctor if you are using any of these:

• 
  

  a blood thinner such as warfarin (Coumadin);

  
  


• 
  

  ketoconazole (Nizoral);

  
  


• 
  

  rifabutin (Mycobutin);

  
  


• 
  

  rifampin (Rifadin, Rifater, Rifamate, Rimactane);

  
  


• 
  

  tetracycline (Brodspec, Panmycin, Sumycin, Tetracap); or

  
  


• 
  

  metoclopramide (Reglan).

  
  

This list is not complete and there may be other drugs that can interact with mefloquine. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More Lariam resources

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

• Lariam Prescribing Information (FDA)


• Lariam MedFacts Consumer Leaflet (Wolters Kluwer)


• Lariam Monograph (AHFS DI)


• Lariam Advanced Consumer (Micromedex) - Includes Dosage Information


• Mefloquine Prescribing Information (FDA)

Compare Lariam with other medications

• Malaria
• Malaria Prevention

Where can I get more information?

• Your pharmacist can provide more information about mefloquine.

See also: Lariam side effects (in more detail)

Laryngesic Lozenges

Pronunciation: BEN-zoe-kane
Generic Name: Benzocaine
Brand Name: Examples include Trocaine Throat and Laryngesic

Laryngesic Lozenges are used for:

Temporarily relieving minor mouth or gum irritation or minor sore throat.

Laryngesic Lozenges are a topical anesthetic. It works by numbing the affected area.

Do NOT use Laryngesic Lozenges if:

• you are allergic to any ingredient in Laryngesic Lozenges or to other similar local anesthetics (eg, lidocaine)

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

Before using Laryngesic Lozenges:

Some medical conditions may interact with Laryngesic Lozenges. 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

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

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

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

• Dissolve Laryngesic Lozenges slowly in your mouth as directed on the package labeling or by your doctor.


• Do not chew Laryngesic Lozenges.


• If you miss a dose of Laryngesic Lozenges and you are taking it regularly, take it as soon as you remember. Continue to take Laryngesic Lozenges as directed. Do not take 2 doses at once.

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

Important safety information:

• Do not exceed the recommended dose or use Laryngesic Lozenges for longer than 2 days without checking with your doctor.


• Severe or persistent sore throat accompanied by high fever, headache, nausea, or vomiting may be serious. Check with your doctor immediately if you experience these symptoms.


• Diabetes patients - Some of these products may contain sugar. Read the labeling carefully. If you are unsure if this product contains sugar, check with your doctor or pharmacist.


• Laryngesic Lozenges are not recommended for use in CHILDREN younger than 5 years of age. Safety and effectiveness in this age group have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Laryngesic Lozenges, discuss with your doctor the benefits and risks of using Laryngesic Lozenges during pregnancy. It is unknown if Laryngesic Lozenges are excreted in breast milk. If you are or will be breast-feeding while you are using Laryngesic Lozenges, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Laryngesic Lozenges:

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:

Numbness of the mouth or throat.

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).

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: Laryngesic 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. Laryngesic Lozenges may be harmful if swallowed.

Proper storage of Laryngesic Lozenges:

Store Laryngesic Lozenges between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Laryngesic Lozenges out of the reach of children and away from pets.

General information:

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


• Laryngesic Lozenges are to be used only by the patient for whom it is prescribed. Do not share it with other people.


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


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

This information is a summary only. It does not contain all information about Laryngesic Lozenges. 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 Laryngesic resources

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

Compare Laryngesic with other medications

• Tonsillitis/Pharyngitis

Laxmar

Generic Name: psyllium (SIL ee um)

Brand Names: Fiberall, Hydrocil, Konsyl, Konsyl Orange Sugar-free, Konsyl-D, Konsyl-Orange, Laxmar, Laxmar Orange, Laxmar Sugar Free, Metamucil, Metamucil Berry Burst Smooth Texture Sugar Free, Metamucil Orange Coarse Milled Original Texture, Metamucil Orange Smooth Texture, Metamucil Orange Smooth Texture Sugar Free, Metamucil Original Texture Regular, Metamucil Pink Lemonade Smooth Texture Sugar-Free, Metamucil Unflavored Coarse Milled Original Texture, Metamucil Unflavored Smooth Texture Sugar Free, Natural Fiber Therapy, Perdiem Fiber Powder, Reguloid

What is Laxmar (psyllium)?

Psyllium is a bulk-forming fiber laxative. Psyllium works by absorbing liquid in the intestines and swelling to create a softer, bulky stool that is easier to pass.

Psyllium is used to treat occasional constipation or bowel irregularity. Psyllium may also be used to treat diarrhea and may help lower cholesterol when used together with a diet low in cholesterol and saturated fat.

Psyllium may also be used for purposes not listed in this product guide.

What is the most important information I should know about Laxmar (psyllium)?

Laxatives may be habit-forming if they are used too often or for too long. This can lead to damage of intestinal nerves or muscle tissues. Do not take psyllium for longer than directed on the label or prescribed by your doctor. You should not take this product if you are allergic to psyllium, or if you have trouble swallowing, a sudden change in bowel habits that lasts longer than 2 weeks, severe nausea, vomiting, or stomach pain, or if you have ever had a skin rash while taking psyllium.

Also talk with your doctor before using psyllium if you have a colostomy or ileostomy, rectal bleeding, or a blockage in your intestines.

Stop using psyllium and call your doctor at once if you have choking or trouble swallowing, severe stomach pain or cramping, nausea or vomiting, constipation that lasts longer than 7 days, rectal bleeding, or itchy skin rash. Do not take psyllium for longer than 7 days in a row unless your doctor has told you to.

What should I discuss with my healthcare provider before taking Laxmar (psyllium)?

Laxatives may be habit-forming if they are used too often or for too long. This can lead to damage of intestinal nerves or muscle tissues. Do not take psyllium for longer than directed on the label or prescribed by your doctor. You should not take this product if you are allergic to psyllium, or if you have:

• 
  

  trouble swallowing;

  
  


• 
  

  a sudden change in bowel habits that lasts longer than 2 weeks;

  
  


• 
  

  severe nausea, vomiting, or stomach pain; or

  
  


• 
  

  if you have ever had a skin rash while taking psyllium.

  
  

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

• 
  

  a colostomy or ileostomy;

  
  


• 
  

  rectal bleeding; or

  
  


• 
  

  a blockage in your intestines.

  
  

Psyllium products may contain sugar, sodium, or artificial sweeteners. This may be of concern to you if you have diabetes, high blood pressure, or phenylketonuria (PKU). Check the product label if you have any of these conditions.

Psyllium is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether psyllium passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take Laxmar (psyllium)?

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.

Take psyllium with a full glass (at least 8 ounces) of water or another liquid. Taking psyllium without enough liquid may cause it to swell in your throat and cause choking. Drinking plenty of fluids each day while you are taking psyllium will also help improve bowel regularity.

The psyllium wafer must be chewed before you swallow it.

Do not swallow psyllium powder dry. It must be mixed with liquid. Place the psyllium powder into an empty glass and add at least 8 ounces of water or other liquid such as fruit juice. Stir this mixture and drink all of it right away.

If the powder and liquid mixture is too thick, add more liquid. After drinking the entire mixture, add a little more liquid to the same glass, swirl gently and drink right away to make sure you get the entire dose of psyllium.

Psyllium may be only part of a complete program of treatment that also includes diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely.

It may take up to 3 days of using this medicine before your symptoms improve. For best results, keep using the medication as directed. Talk with your doctor if your symptoms do not improve after 2 or 3 days of treatment.

Do not take psyllium for longer than 7 days in a row unless your doctor has told you to. Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Since psyllium is used as needed, it does not have a daily dosing schedule. Call your doctor promptly if your symptoms do not improve after using psyllium.

What happens if I overdose?

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

Overdose symptoms may include nausea, vomiting, and stomach pain. Using a laxative too often or for too long may cause severe medical problems involving your intestines.

What should I avoid while taking Laxmar (psyllium)?

Avoid taking other oral (by mouth) medications within 2 hours before or after you take psyllium. Bulk-forming laxatives can make it harder for your body to absorb other medications, possibly making them less effective.

Avoid breathing in the dust from psyllium powder when mixing. Inhaling psyllium dust may cause an allergic reaction.

If you take psyllium as part of a cholesterol-lowering treatment plan, avoid eating foods that are high in fat or cholesterol. Your treatment will not be as effective in lowering your cholesterol if you do not follow a cholesterol-lowering diet plan.

Laxmar (psyllium) side effects

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

• 
  

  choking or trouble swallowing;

  
  


• 
  

  severe stomach pain, cramping, nausea or vomiting;

  
  


• 
  

  constipation that lasts longer than 7 days;

  
  


• 
  

  rectal bleeding; or

  
  


• 
  

  itchy skin rash.

  
  

Less serious side effects may include:

• 
  

  bloating; or

  
  


• 
  

  minor change in your bowel habits.

  
  

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 Laxmar (psyllium)?

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

• 
  

  a blood thinner such as warfarin (Coumadin, Jantoven); or

  
  


• 
  

  demeclocycline (Declomycin), doxycycline (Adoxa, Doryx, Oracea, Vibramycin), minocycline (Dynacin, Minocin, Solodyn, Vectrin), or tetracycline (Brodspec, Panmycin, Sumycin, Tetracap).

  
  

This list is not complete and other drugs may interact with psyllium. 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 Laxmar resources

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

• Konsyl Powder MedFacts Consumer Leaflet (Wolters Kluwer)


• Metamucil MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Laxmar with other medications

• Constipation
• Irritable Bowel Syndrome

Where can I get more information?

• Your pharmacist can provide more information about psyllium.

See also: Laxmar side effects (in more detail)

Legend

Dosage Form: FOR ANIMAL USE ONLY
Legend®

(hyaluronate sodium)

Injectable Solution

For Intravenous or Intra-Articular Use In Horses Only

CAUTION:

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

DESCRIPTION:

Legend® (hyaluronate sodium) Injectable Solution is a clear, colorless solution of low viscosity. Legend Injectable Solution is pyrogen free, sterile and does not contain a preservative. It is administered by intravenous or intra-articular injection. `

Hyaluronic acid, the conjugate acid of hyaluronate sodium, is extracted from the capsule of Streptococcus spp. and purified, resulting in a form which is essentially free of protein and nucleic acids.

Legend Injectable Solution is supplied in 2 mL (20 mg) vials. Each mL contains 10 mg hyaluronate sodium, 8.5 mg sodium chloride, 0.223 mg sodium phosphate dibasic, and 0.04 mg sodium phosphate monobasic. The pH is adjusted to between 6.5 and 8.0 with sodium hydroxide or hydrochloric acid.

CHEMISTRY:

Hyaluronic acid, a glycosaminoglycan, can exist in the following forms depending upon the chemical environment in which it is found: as the acid, hyaluronic acid; as the sodium salt, sodium hyaluronate (hyaluronate sodium); or as the hyaluronate anion. These terms may be used interchangeably but in all cases, reference is made to the glycosaminoglycan composed of repeating subunits of D-glucuronic acid and N-acetyl-D-glucosamine linked together by glycosidic bonds. Since this product originates from a microbial source, there is no potential for contamination with dermatan or chondroitin sulfate or any other glycosaminoglycan.

CLINICAL PHARMACOLOGY:

Hyaluronic acid is a naturally occurring substance present in connective tissue, skin, vitreous humour and the umbilical cord in all mammals. High concentrations of hyaluronic acid are also found in the synovial fluid. It also constitutes the major component of the capsule of certain microorganisms. The hyaluronic acid produced by bacteria is of the same structure and configuration as that found in mammals.

The actual mechanism of action for hyaluronate sodium in the healing of degenerative joint disease is not completely understood. One major function appears to be the regulation of normal cellular constituents. This effect decreases the impact of exudation, enzyme release and subsequent degradation of joint integrity. Additionally, hyaluronate sodium exerts an anti-inflammatory action by inhibiting the movement of granulocytes and macrophages.1

Hyaluronate molecules are long chains which form a filter network interspersed with normal cellular fluids. It is widely accepted that injection directly into the joint pouch enhances the healing of inflamed synovium by restoring lubrication of the joint fluid. This further supplements the visco-elastic properties of normal joint fluid.

INDICATIONS:

Legend® (hyaluronate sodium) Injectable Solution is indicated in the treatment of joint dysfunction of the carpus or fetlock in horses due to non-infectious synovitis associated with equine osteoarthritis.

CONTRAINDICATIONS:

There are no known contraindications for the use of Legend® (hyaluronate sodium) Solution in horses.

RESIDUE WARNING:

Do not use in horses intended for human consumption.

HUMAN WARNINGS:

Not for use in humans. Keep this and all other drugs out of reach of children.

PRECAUTIONS:

Radiographic evaluation should be carried out in cases of acute lameness to ensure that the joint is free from serious fractures. As with any intra-articular treatment, special precautions must be followed as to injection technique and sterility for prevention of possible swelling or infection. Intra-articular injections should not be made through skin that has been recently fired or blistered, or that has excessive scurf and counterirritant on it.

The safety of Legend Injectable Solution has not been evaluated in breeding stallions or in breeding, pregnant or lactating mares.

ADVERSE REACTIONS:

No local or systemic side effects were observed in the clinical field trials with either intravenous or intra-articular injections.

Post-Approval Experience: While all adverse reactions are not reported, the following adverse reactions are based on voluntary post-approval reporting:

Following intravenous use: Occasional depression, lethargy, and fever.

Following intra-articular use: lameness, joint effusion, joint or injection site swelling, and joint pain.

For medical emergencies or to report adverse reactions, call 1-800-422-9874.

EFFECTIVENESS:

Forty-six horses with lameness in either the carpal or fetlock joints were treated intravenously or intra-articularly with Legend Injectable Solution in a well-controlled clinical study conducted at four locations. One, two or three injections were given based on clinical improvement. Overall clinical improvement was judged as excellent or good in 90% of the cases treated intravenously and 96% of those treated intra-articularly with Legend Injectable Solution.

ANIMAL SAFETY:

Legend Injectable Solution was administered to normal horses at one, three and five times the recommended intra-articular dosage of 20 mg and the intravenous dosage of 40 mg. Treatments were given once weekly for nine consecutive weeks (three times the maximum duration). No systemic clinical signs were observed nor were there any adverse effects upon hematology or clinical chemistry parameters. A transient, slight to mild post-injection swelling of the joint capsule occurred in some of the animals treated intra-articularly with Legend Injectable Solution as it did in the saline treated control horses. No gross or histological lesions were observed in the soft tissues or the surface areas of the treated joint.

DOSAGE AND ADMINISTRATION:

Intravenously-4 mL (40 mg), Intra-articular- 2 mL (20 mg) in the carpus or fetlock. Treatment may be repeated at weekly intervals for a total of three treatments.

Strict aseptic technique should be observed when administering by intra-articular injection. As with any intra-articular procedure, proper injection site disinfection and animal restraint are important. Excess joint fluid should be aseptically removed prior to injection. Care should be taken to avoid scratching the cartilage surface with the tip of the injection needle. Diffuse swelling lasting 24 to 48 hours may result from movement of the needle while in the joint space.

For intravenous administration, use aseptic technique and inject slowly into the jugular vein.

Horses should be given stall rest after treatment before gradually resuming normal activity.

Discard any unused portion of the drug and the empty vial after opening.

HOW SUPPLIED:

Legend Injectable Solution is supplied in a carton of six 2 mL (20 mg) bottles.

STORAGE:

Do not store above 40° C (104° F).

REFERENCE:

1Swanstrom, O.G. 1978. Hyaluronate (hyaluronic acid) and its use, Proc. American Assoc. Equine Pract., 24th annual convention, pp. 345-348.

U.S. Patent No. 4,808,576

For customer service or to obtain product information, including a Material Safety Data Sheet, call 1-800-633-3796.

08710980-017599

Made in U.S.A.

September, 2005

08715516-79001750, R.11

NADA 140-883, Approved by FDA

Bayer, the Bayer Cross, Legend and the horse logo are trademarks of Bayer.

© 2005 Bayer HealthCare LLC

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Product Label

Legend® (hyaluronate sodium) Injectable Solution 10mg/mL 2mL

For Intravenous Use in Horses Only

Read Package Insert for Details

Legend  hyaluronate sodium  injection, solution

Product Information Product Type PRESCRIPTION ANIMAL DRUG NDC Product Code (Source) 00859-2272 Route of Administration INTRAVENOUS, INTRA-ARTICULAR DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYALURONATE SODIUM (HYALURONIC ACID) HYALURONATE SODIUM 10 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE 8.5 mg  in 1 mL SODIUM PHOSPHATE, DIBASIC 0.223 mg  in 1 mL SODIUM PHOSPHATE, MONOBASIC 0.04 mg  in 1 mL

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 00859-2272-1 6 BOTTLE In 1 CARTON contains a BOTTLE 1 2 mL In 1 BOTTLE This package is contained within the CARTON (00859-2272-1)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA140883	09/12/1991

Labeler - Bayer HealthCare LLC Animal Health Division (152266193)

Revised: 05/2009Bayer HealthCare LLC Animal Health Division