Trelstar

Generic Name: Triptorelin Pamoate
Class: Antineoplastic Agents
VA Class: AN500
Chemical Name: 6-d-Tryptophan luteinizing hormone-releasing factor (pig)
Molecular Formula: C₆₄H₈₂N₁₈O₁₃
CAS Number: 57773-63-4

Special Alerts:

[Posted 10/20/2010] ISSUE: Gonadotropin-Releasing Hormone (GnRH) agonists will have new safety information added to the Warnings and Precautions section of the drug labels. This new information warns about increased risk of diabetes and certain cardiovascular diseases (heart attack, sudden cardiac death, stroke) in men receiving these medications for the treatment of prostate cancer.

BACKGROUND: GnRH agonists are approved to treat the symptoms (palliative treatment) of advanced prostate cancer. The benefits of GnRH agonist use for earlier stages of prostate cancer that have not spread (non-metastatic prostate cancer) have not been established. FDA’s notification to manufacturers of GnRH agonists to add this safety information is based on the Agency’s review of several published studies. Most of the studies reviewed by FDA reported small but statistically significant increased risks of diabetes and/or cardiovascular events in patients receiving GnRH agonists.

RECOMMENDATIONS: Healthcare professionals should evaluate patients for risk factors for these diseases and carefully weigh the benefits and risks of using GnRH agonists before determining appropriate treatment for prostate cancer. Patients who are receiving treatment with GnRH agonists should undergo periodic monitoring of blood glucose and/or glycosylated hemoglobin (HbA1c). Healthcare professionals should also monitor patients for signs and symptoms suggestive of development of cardiovascular disease and manage according to current clinical practice. For more information visit the FDA website at: and .

[Posted 05/03/2010] FDA notified healthcare professionals and patients of FDA’s preliminary and ongoing review which suggests an increase in the risk of diabetes and certain cardiovascular diseases in men treated with GnRH agonists, drugs that suppress the production of testosterone, a hormone that is involved in the growth of prostate cancer.

Most of the studies reviewed by FDA reported small, but statistically significant increased risks of diabetes and/or cardiovascular events in patients receiving GnRH agonists. FDA’s review is ongoing and the agency has not made any conclusions about GnRH agonists and whether they increase the risk of diabetes and cardiovascular disease in patients receiving these medications for prostate cancer.

Healthcare professionals and patients should be aware of these potential safety issues and carefully weigh the benefits and risks of GnRH agonists when determining treatment choices. FDA recommends that patients receiving GnRH agonists should be monitored for development of diabetes and cardiovascular disease. Patients should not stop their treatment with GnRH agonists unless told to do so by their healthcare professional.

Some GnRH agonists are also used in women and in children for other indications than those above. There are no known comparable studies that have evaluated the risk of diabetes and heart disease in women and children taking GnRH agonists. For more information visit the FDA website at: and .

Introduction

Antineoplastic agent; synthetic decapeptide analog of gonadotropin-releasing hormone (GnRH, luteinizing hormone-releasing hormone, gonadorelin);^{1 7} structurally related to leuprolide and goserelin.^{1 2 3 4 6 7}

Uses for Trelstar

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Prostate Cancer

Palliative treatment of advanced prostate cancer; considered alternative therapy when orchiectomy or estrogen therapy is not appropriate or is unacceptable to the patient.^{1 7}

Trelstar Dosage and Administration

Administration

IM Administration

Administer by IM injection once monthly (every 28 days) as a depot 1-month formulation or every 84 days (12 weeks) as a long-acting 3-month formulation.^{1 7}

Inject IM into buttock; rotate injection sites periodically.^{1 7}

Administer under the supervision of a qualified clinician.^{1 7}

Reconstitution

Reconstitute powder just prior to administration.^{1 7} Discard suspension if not used immediately after reconstitution.^{1 7}

Using a syringe with 20-gauge needle, add 2 mL of sterile water for injection to vial containing the powder (1- or 3-month formulation); do not reconstitute with other diluents.^{1 7} Shake well to disperse particles and obtain a uniform, milky suspension.^{1 7}

If using the single-dose delivery system, add contents of the prefilled syringe (2 mL of sterile water for injection) to vial containing the powder according to the manufacturer’s instructions.^{1 7} Mix well.^{1 7}

Withdraw entire contents of vial and use immediately.^{1 7}

Dosage

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Available as triptorelin pamoate; dosage is expressed in terms of triptorelin.^{1 7}

Adults

Prostate Cancer

IM

3.75 mg every 28 days (monthly) as the 1-month formulation or 11.25 mg every 84 days (12 weeks) as the 3-month formulation.^{1 7}

Special Populations

Hepatic Impairment

Potential need for dosage adjustment not determined.¹

Renal Impairment

Potential need for dosage adjustment not determined.¹

Cautions for Trelstar

Contraindications

• 
  

  Known hypersensitivity to triptorelin or any other ingredient in the formulation, other GnRH agonists, or GnRH.^{1 7}

  
  


• 
  

  Known or suspected pregnancy.^{1 7}

  
  

Warnings/Precautions

Warnings

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Endocrine Effects

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Possible worsening of signs and/or symptoms of prostate cancer and/or development of new manifestations (e.g., bone pain, neuropathy, hematuria, urethral or bladder outlet obstruction) due to increases in serum testosterone concentrations during initial weeks of therapy.^{1 2 3 5 7}

Possible spinal cord compression contributing to paralysis; possibly fatal.^{1 2 5 7}

Increased risk of neurologic and/or genitourinary complications during initial therapy in patients with prostate cancer and metastatic vertebral lesions and/or urinary tract obstruction.^{1 7} Observe such patients closely during initial weeks of therapy.^{1 5 7}

If spinal cord compression or renal impairment develops, institute standard treatment of these complications; consider immediate orchiectomy in extreme cases.^{1 7}

Sensitivity Reactions

Hypersensitivity Reactions

Anaphylactic shock and angioedema reported rarely.^{1 7} If such reactions occur, discontinue immediately and provide supportive and symptomatic care.^{1 7}

Major Toxicities

Pituitary Apoplexy

Pituitary apoplexy, a clinical syndrome resulting from infarction of the pituitary gland, reported rarely.^{1 7} Most cases occur within 2 weeks of the first dose, sometimes within the first hour.^{1 7} If manifestations occur (e.g., sudden headache, vomiting, visual changes, ophthalmoplegia, altered mental status, sometimes cardiovascular collapse), immediate medical attention required.^{1 7} In most cases, pituitary adenoma diagnosed.¹

General Precautions

Laboratory Monitoring

Periodically determine serum testosterone and prostate-specific antigen concentrations to monitor therapeutic response.^{1 7}

Specific Populations

Pregnancy

Category X.^{1 7} (See Contraindications under Cautions.)

Lactation

Not known whether distributed into milk; not recommended for use in nursing women.^{1 7}

Pediatric Use

Safety and efficacy not established in children.^{1 7}

Geriatric Use

Studies conducted principally in patients ≥65 years of age, since prostate cancer occurs mainly in an older patient population.^{1 7}

Common Adverse Effects

Temporary worsening of disease manifestations, hot flushes (flashes), skeletal pain, impotence, headache, pain at injection site, leg pain and edema, dysuria, hypertension.^{1 7}

Also observed with 3-month formulation: decreased hemoglobin and erythrocyte counts, increased BUN, increased serum concentrations of glucose, AST, ALT, and alkaline phosphatase.⁷

Interactions for Trelstar

Metabolism unlikely to involve CYP enzymes; effect of triptorelin on other drug-metabolizing enzymes unknown.⁷

Drugs That Induce Hyperprolactinemia

Potential pharmacologic interaction (possible decrease in triptorelin efficacy due to decreased number of GnRH receptors) with drugs such as antipsychotic agents, methyldopa, metoclopramide, and reserpine.^{1 6 7}

Trelstar Pharmacokinetics

Absorption

Bioavailability

Not active when administered orally.^{1 7}

Following IM administration as Trelstar Depot or Trelstar LA, peak plasma concentrations usually are attained within 1 or 3 hours, respectively.^{1 7}

Duration

Following IM injection of Trelstar Depot or Trelstar LA in males, therapeutic plasma concentrations persist for 1 or 3 months, respectively.^{1 7}

Distribution

Extent

Not known whether triptorelin is distributed into milk.^{1 7}

Plasma Protein Binding

No evidence that triptorelin binds to plasma proteins.^{1 7}

Elimination

Metabolism

Metabolism is unknown; involvement of CYP enzymes is unlikely.^{1 7} No metabolites identified to date.^{1 7}

Elimination Route

Hepatic and renal elimination.^{1 7}

Half-life

Approximately 3 hours.^{1 7}

Special Populations

In males with hepatic impairment or moderate or severe renal impairment, AUC increased 2- to 4-fold compared with healthy males.^{1 7}

Stability

Storage

Parenteral

Powder for Injection

20–25°C (may be exposed to 15–30°C).^{1 7} Do not freeze.⁷

Discard suspension if not used immediately after reconstitution.^{1 7}

ActionsActions

• 
  

  Potent inhibitor of gonadotropin secretion when given continuously in therapeutic doses; greater activity than naturally occurring GnRH.^{1 7}

  
  


• 
  

  Transient surge in circulating levels of LH, FSH, testosterone, and estradiol observed after initial administration.^{1 7} Sustained decreases in LH and FSH secretion and reduced testicular and ovarian steroidogenesis observed following chronic, continuous administration (generally 2–4 weeks after initiation of therapy).^{1 4 7}

  
  


• 
  

  Reduction of serum testosterone in males comparable to effects achieved after surgical castration; results in inactivation of physiologic functions and tissues dependent on testosterone.^{1 2 4 7} These effects usually are reversible after cessation of therapy.^{1 7}

  
  

Advice to Patients

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

• 
  

  Risk of worsening manifestations of prostate cancer during initial weeks of therapy.^{1 7}

  
  


• 
  

  Importance of promptly reporting weakness or paresthesia of lower limbs and/or worsening of urinary signs and symptoms to clinicians.⁶

  
  


• 
  

  Importance of promptly reporting sudden onset of headache, vomiting, or visual changes to clinicians.^{1 7}

  
  


• 
  

  Risk of anaphylactoid and other sensitivity reactions.^{1 7}

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.^{1 7}

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.^{1 7} If used during pregnancy, apprise of potential fetal hazard.⁷

  
  


• 
  

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

  
  

Preparations

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

Triptorelin Pamoate

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	For injection, for IM use only	3.75 mg (of triptorelin)	Trelstar Depot	Watson
			Trelstar Depot Clip’n’Ject	Watson
		11.25 mg (of triptorelin)	Trelstar LA	Watson
			Trelstar LA Clip’n’Ject	Watson

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 November 2010. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

1. Watson Pharma. Trelstar Depot 3.75 mg (triptorelin pamoate for injectable suspension) prescribing information. Corona, CA; 2006 Aug.

2. Parmar H, Phillips RH, Lightman SL et al. Randomised controlled study of orchidectomy vs long-acting D-Trp-6-LHRH microcapsules in advanced prostatic carcinoma. Lancet. 1985; 2:1201-5. [PubMed 2866289]

3. Mahler C. Is disease flare a problem? Cancer. 1993; 72:3799-802.

4. Rolandi E, Martorana G, Franceschini R et al. Treatment of prostatic cancer with a depot preparation of an LHRH analogue: endocrine effects. Curr Ther Res. 1985; 38:670-5.

5. Kahan A, Delrieu F, Amor B et al. Disease flare induced by D-Trp⁶-LHRH analogue in patients with metastatic prostatic cancer. Lancet. 1984; 1:971-2. [IDIS 184509] [PubMed 6143912]

6. Pharmacia & Upjohn, Kalomazoo, MI: Personal communication.

7. Watson Pharma. Trelstar LA 11.25 mg (triptorelin pamoate for injectable suspension) prescribing information. Corona, CA: 2006 Aug.

8. Anon. Drugs of choice for cancer. Treat Guidel Med Lett. 2003; 1:41-52.

More Trelstar resources

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

Compare Trelstar with other medications

• Prostate Cancer

Zeflopto

Zeflopto may be available in the countries listed below.

Ingredient matches for Zeflopto

Limaprost

Limaprost alfadex (a derivative of Limaprost) is reported as an ingredient of Zeflopto in the following countries:

• Japan

International Drug Name Search

gadofosveset Injection

gad-oh-FOS-ve-set

Injection route(Solution)

Gadolinium-based contrast agents (GBCAs) increase the risk for nephrogenic systemic fibrosis (NSF) in patients with impaired elimination of the drugs (ie, chronic, severe renal insufficiency (GFR less than 30 mL/min/1.73 m(2)), or acute kidney injury. Avoid use of GBCAs unless the diagnostic information is essential and not available with non-contrast enhanced MRI. NSF may result in fatal or debilitating systemic fibrosis affecting the skin, muscle, and internal organs. Screen all patients for acute kidney injury and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (eg, age greater than 60 years, hypertension, or diabetes), perform lab testing to estimate the GFR. For patients with the highest NSF risk, do not exceed recommended dose and allow a sufficient time period for elimination prior to readministration .

Commonly used brand name(s)

In the U.S.

• Ablavar

Available Dosage Forms:

• Solution

Uses For gadofosveset

Gadofosveset is a contrast agent. It is used in magnetic resonance angiography (MRA) to help create a clear picture of the blood vessels (arteries). The MRA scan is a special kind of diagnostic procedure. It uses magnets and computers to create images or “pictures” of the blood vessels in certain areas of the body. Gadofosveset is a gadolinium-based contrast agent (GBCA).

Gadofosveset is given by injection before MRA to help diagnose problems in the blood vessels (e.g., blockage of the arteries).

gadofosveset is to be used only by or under the direct supervision of a doctor.

Before Using gadofosveset

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For gadofosveset, the following should be considered:

Allergies

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

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of gadofosveset in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of gadofosveset in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving gadofosveset.

Pregnancy

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

Breast Feeding

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

Interactions with Medicines

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

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. 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 gadofosveset. Make sure you tell your doctor if you have any other medical problems, especially:

• Asthma or allergies, history of or


• Heart disease, history of or


• Heart rhythm problems (e.g., QT prolongation) or


• Kidney problems, severe (recent or long-term)—Use with caution. May cause side effects to become worse.

• Diabetes or


• Hypertension (high blood pressure)—Use with caution. May increase risk for kidney problems.

Proper Use of gadofosveset

A doctor or other trained health professional will give you gadofosveset. gadofosveset is given through a needle placed in one of your veins just before you have an MRA scan.

Precautions While Using gadofosveset

Check with your doctor right away if you have burning or itching of the skin; red or dark patches on the skin; skin swelling, hardening, or tightening; joint stiffness; limited range of motion in the arms and legs; pain that is deep in the hip bone or ribs; or muscle weakness. These may be symptoms of a very serious disease called nephrogenic systemic fibrosis (NSF).

gadofosveset may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor or nurse right away if you have cold, clammy skin; confusion; dizziness; lightheadedness; a skin rash; itching; sweating; swelling of the face, tongue, and throat; trouble with breathing; or chest pain after you receive the medicine.

gadofosveset can cause changes in the heart rhythm, such as a condition called QT prolongation. It may change the way your heart beats and cause fainting or serious side effects in some patients. Contact your doctor right away if you have any symptoms of heart rhythm problems, such as fast, pounding, or irregular heartbeats.

Tell your doctor right away if you have mild, burning pain; feeling of warmth or coldness; or redness at the injection site.

gadofosveset 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 or nurse immediately if any of the following side effects occur:

More common

• Cough


• difficulty with swallowing


• dizziness


• fast heartbeat


• hives


• itching


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


• shortness of breath


• skin rash


• tightness in the chest


• unusual tiredness or weakness


• wheezing

Less common

• Blurred vision


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


• feeling faint, dizzy, or lightheaded


• feeling of warmth or heat


• flushing or redness of the skin, especially on the face and neck


• headache


• nervousness


• pounding in the ears


• slow or fast heartbeat


• sweating

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

Less common

• Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site


• change in taste


• feeling cold


• loss of taste


• nausea

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

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

See also: gadofosveset Injection side effects (in more detail)

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

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More gadofosveset Injection resources

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

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• Magnetic Resonance Angiography

Floxil

Floxil may be available in the countries listed below.

Ingredient matches for Floxil

Ofloxacin

Ofloxacin is reported as an ingredient of Floxil in the following countries:

• Argentina


• Mexico


• Peru

International Drug Name Search

Viroptic

trifluridine

Dosage Form: ophthalmic solution
Viroptic® Ophthalmic Solution, 1% Sterile

(trifluridine ophthalmic solution)

Viroptic Description

Viroptic is the brand name for trifluridine (also known as trifluorothymidine, F3TdR,F3T), an antiviral drug for topical treatment of epithelial keratitis caused by herpes simplex virus. The chemical name of trifluridine is α,α,α -trifluorothymidine; it has the following structural formula:

Viroptic sterile ophthalmic solution contains 1% trifluridine in an aqueous solution with acetic acid and sodium acetate (buffers), sodium chloride, and thimerosal 0.001% (added as a preservative). The pH range is 5.5 to 6.0 and osmolality is approximately 283 mOsm.

Viroptic - Clinical Pharmacology

Trifluridine is a fluorinated pyrimidine nucleoside with in vitro and in vivo activity against herpes simplex virus, types 1 and 2 and vacciniavirus. Some strains of adenovirus are also inhibited in vitro.

Viroptic is also effective in the treatment of epithelial keratitis that has not responded clinically to the topical administration of idoxuridine or when ocular toxicity or hypersensitivity to idoxuridine has occurred. In a smaller number of patients found to be resistant to topical vidarabine, Viroptic was also effective.

Trifluridine interferes with DNA synthesis in cultured mammalian cells. However, its antiviral mechanism of action is not completely known.

In vitro perfusion studies on excised rabbit corneas have shown that trifluridine penetrates the intact cornea as evidenced by recovery of parental drug and its major metabolite, 5-carboxy-2'-deoxyuridine, on the endothelial side of the cornea. Absence of the corneal epithelium enhances the penetration of trifluridine approximately two-fold.

Intraocular penetration of trifluridine occurs after topical instillation of Viroptic into human eyes. Decreased corneal integrity or stromal or uveal inflammation may enhance the penetration of trifluridine into the aqueous humor. Unlike the results of ocular penetration of trifluridine in vitro, 5-carboxy-2'-deoxyuridine was not found in detectable concentrations within the aqueous humor of the human eye.

Systemic absorption of trifluridine following therapeutic dosing with Viroptic appears to be negligible. No detectable concentrations of trifluridine or 5-carboxy-2'-deoxyuridine were found in the sera of adult healthy normal subjects who had Viroptic instilled into their eyes seven times daily for 14 consecutive days.

Clinical Studies

During a controlled multicenter clinical trial, 92 of 97 (95%) patients (78 of 81 with dendritic and 14 of 16 with geographic ulcers) responded to therapy with Viroptic as evidenced by complete corneal re-epithelialization within the 14-day therapy period. Fifty-six of 75 (75%) patients (49 of 58 with dendritic and 7 of 17 with geographic ulcers) responded to idoxuridine therapy. The mean time to corneal re-epithelialization for dendritic ulcers (6 days) and geographic ulcers (7 days) was similar for both therapies.

In other clinical studies, Viroptic was evaluated in the treatment of herpes simplex virus keratitis in patients who were unresponsive or intolerant to the topical administration of idoxuridine or vidarabine. Viroptic was effective in 138 of 150 (92%) patients (109 of 114 with dendritic and 29 of 36 with geographic ulcers) as evidenced by corneal re-epithelialization. The mean time to corneal re-epithelialization was 6 days for patients with dendritic ulcers and 12 days for patients with geographic ulcers.

The clinical efficacy of Viroptic in the treatment of stromal keratitis and uveitis due to herpes simplex virus or ophthalmic infections caused by vacciniavirus and adenovirus has not been established by well-controlled clinical trials. Viroptic has not been shown to be effective in the prophylaxis of herpes simplex virus keratoconjunctivitis and epithelial keratitis by well-controlled clinical trials. Viroptic is not effective against bacterial, fungal, or chlamydial infections of the cornea or nonviral trophic lesions.

Indications and Usage for Viroptic

Viroptic Ophthalmic Solution, 1% (trifluridine ophthalmic solution) is indicated for the treatment of primary keratoconjunctivitis and recurrent epithelial keratitis due to herpes simplex virus, types 1 and 2.

Contraindications

Viroptic Ophthalmic Solution, 1% is contraindicated for patients who develop hypersensitivity reactions or chemical intolerance to trifluridine.

Warnings

The recommended dosage and frequency of administration should not be exceeded (see DOSAGE AND ADMINISTRATION).

Precautions

General

Viroptic Ophthalmic Solution, 1% should be prescribed only for patients who have a clinical diagnosis of herpetic keratitis.

Viroptic may cause mild local irritation of the conjunctiva and cornea when instilled, but these effects are usually transient.

Although documented in vitro viral resistance to trifluridine has not been reported following multiple exposures to Viroptic, the possibility of the development of viral resistance exists.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Mutagenic Potential

Trifluridine has been shown to exert mutagenic, DNA-damaging and cell-transforming activities in various standard in vitro test systems, and clastogenic activity in Vicia faba cells. It did not induce chromosome aberrations in bone marrow cells of male or female rats following a single subcutaneous dose of 100 mg/kg, but was weakly positive in female, but not in male, rats following daily subcutaneous administration at 700 mg/kg/day for 5 days.

Although the significance of these test results is not clear or fully understood, there exists the possibility that mutagenic agents may cause genetic damage in humans.

Oncogenic Potential

Lifetime carcinogenicity bioassays in rats and mice given daily subcutaneous doses of trifluridine have been performed. Rats tested at 1.5, 7.5, and 15 mg/kg/day had increased incidences of adenocarcinomas of the intestinal tract and mammary glands, hemangiosarcomas of the spleen and liver, carcinosarcomas of the prostate gland, and granulosa-thecal cell tumors of the ovary. Mice were tested at 1, 5, and 10 mg/kg/day; those given 10 mg/kg/day trifluridine had significantly increased incidences of adenocarcinomas of the intestinal tract and uterus. Those given 10 mg/kg/day also had a significantly increased incidence of testicular atrophy as compared to vehicle control mice.

Pregnancy

Teratogenic Effects

Pregnancy Category C. Trifluridine was not teratogenic at doses up to 5 mg/kg/day (23 times the estimated human exposure) when given subcutaneously to rats and rabbits. However, fetal toxicity consisting of delayed ossification of portions of the skeleton occurred at dose levels of 2.5 and 5 mg/kg/day in rats and at 2.5 mg/kg/day in rabbits. In addition, both 2.5 and 5 mg/kg/day produced fetal death and resorption in rabbits. In both rats and rabbits, 1 mg/kg/day (5 times the estimated human exposure) was a no-effect level. There were no teratogenic or fetotoxic effects after topical application of Viroptic Ophthalmic Solution, 1% (approximately 5 times the estimated human exposure) to the eyes of rabbits on the 6th through the 18th days of pregnancy. In a non-standard test, trifluridine solution has been shown to be teratogenic when injected directly into the yolk sac of chicken eggs. There are no adequate and well-controlled studies in pregnant women. Viroptic Ophthalmic Solution, 1% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

It is unlikely that trifluridine is excreted in human milk after ophthalmic instillation of Viroptic because of the relatively small dosage (≤5 mg/day), its dilution in body fluids and its extremely short half-life (approximately 12 minutes). The drug should not be prescribed for nursing mothers unless the potential benefits outweigh the potential risks.

Pediatric Use

Safety and effectiveness in pediatric patients below six years of age have not been established.

Geriatric Use

No overall clinical differences in safety or effectiveness have been observed between elderly and other adult patients.

Adverse Reactions

The most frequent adverse reactions reported during controlled clinical trials were mild, transient burning or stinging upon instillation (4.6%) and palpebral edema (2.8%). Other adverse reactions in decreasing order of reported frequency were superficial punctate keratopathy, epithelial keratopathy, hypersensitivity reaction, stromal edema, irritation, keratitis sicca, hyperemia, and increased intraocular pressure.

Overdosage

Overdosage by ocular instillation is unlikely because any excess solution should be quickly expelled from the conjunctival sac.

Acute overdosage by accidental oral ingestion of Viroptic has not occurred. However, should such ingestion occur, the 75 mg dosage of trifluridine in a 7.5 mL bottle of Viroptic is not likely to produce adverse effects. Single intravenous doses of 1.5 to 30 mg/kg/day in children and adults with neoplastic disease produce reversible bone marrow depression as the only potentially serious toxic effect and only after three to five courses of therapy. The acute oral LD50 in the mouse and rat was 4379 mg/kg or higher.

Viroptic Dosage and Administration

Instill one drop of Viroptic Ophthalmic Solution, 1% onto the cornea of the affected eye every 2 hours while awake for a maximum daily dosage of nine drops until the corneal ulcer has completely re-epithelialized. Following re-epithelialization, treatment for an additional 7 days of one drop every 4 hours while awake for a minimum daily dosage of five drops is recommended.

If there are no signs of improvement after 7 days of therapy or complete re-epithelialization has not occurred after 14 days of therapy, other forms of therapy should be considered. Continuous administration of Viroptic for periods exceeding 21 days should be avoided because of potential ocular toxicity.

How is Viroptic Supplied

Viroptic Ophthalmic Solution, 1% is supplied as a sterile ophthalmic solution in a plastic Drop Dose® dispenser bottle of 7.5 mL (NDC 61570-037-75).

Store under refrigeration 2° to 8°C (36° to 46°F).

ANIMAL PHARMACOLOGY AND ANIMAL TOXICOLOGY

Corneal wound healing studies in rabbits showed that Viroptic did not significantly retard closure of epithelial wounds. However, mild toxic changes such as intracellular edema of the basal cell layer, mild thinning of the overlying epithelium and reduced strength of stromal wounds were observed.

Whereas instillation of Viroptic into rabbit eyes during a subchronic toxicity study produced some degree of corneal epithelial thinning, a 12-month chronic toxicity study in rabbits in which Viroptic was instilled into eyes in intermittent, multiple, full-therapy courses showed no drug-related changes in the cornea.

Rx Only.

Prescribing Information as of April 2007.

Distributed by: Monarch Pharmaceuticals, Inc., Bristol, TN 37620

Manufactured by: DSM Pharmaceuticals, Inc., Greenville, NC 27834

LabelGraphic1

LabelGraphic2

Viroptic  trifluridine  solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 61570-037 Route of Administration OPHTHALMIC DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRIFLURIDINE (TRIFLURIDINE) TRIFLURIDINE 1 g  in 100 mL

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 61570-037-75 1 BOTTLE In 1 CARTON contains a BOTTLE, DROPPER 1 7.5 mL In 1 BOTTLE, DROPPER This package is contained within the CARTON (61570-037-75)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA018299	04/10/1980

Labeler - Monarch Pharmaceuticals, Inc (809587413)

Revised: 07/2011Monarch Pharmaceuticals, Inc

More Viroptic resources

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

• Viroptic Concise Consumer Information (Cerner Multum)


• Viroptic Monograph (AHFS DI)


• Viroptic Advanced Consumer (Micromedex) - Includes Dosage Information


• Viroptic Drops MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Viroptic with other medications

• Herpetic Keratitis

Avonex Prefilled Syringe

Generic Name: interferon beta-1a (in ter FEAR on BAY ta)

Brand Names: Avonex, Avonex Prefilled Syringe, Rebif

What is Avonex Prefilled Syringe (interferon beta-1a)?

Interferon beta-1a is made from human proteins. Interferons help the body fight viral infections.

Interferon beta-1a is used to treat relapsing multiple sclerosis (MS). This medication will not cure MS, it will only decrease the frequency of relapse symptoms.

Interferon beta-1a may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Avonex Prefilled Syringe (interferon beta-1a)?

This medication may be harmful to an unborn baby, or may cause a miscarriage. Do not use interferon beta-1a if you are pregnant. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

Before using interferon beta-1a, tell your doctor if you are allergic to any drugs, or if you have liver disease, a thyroid disorder, epilepsy or other seizure disorder, heart disease, chest pain (angina), congestive heart failure, a heart rhythm disorder, or a history of depression or suicidal behavior.

Some patients using interferon medications have become very depressed or had thoughts of suicide. Stop using interferon beta-1a if you have symptoms of depression (sadness, crying, loss of interest in things you once liked) or if you have any thoughts of hurting yourself. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.

To be sure this medication is not causing harmful effects, your blood may need to be tested often. Your liver or thyroid function may also need to be tested. Visit your doctor regularly.

What should I discuss with my healthcare provider before using Avonex Prefilled Syringe (interferon beta-1a)?

Do not use this medication if you are allergic to interferons or human albumin. Some patients using interferon medications have become very depressed or had thoughts of suicide. Stop using interferon beta-1a if you have symptoms of depression (sadness, crying, loss of interest in things you once liked) or if you have any thoughts of hurting yourself.

If you have any of these other conditions, you may need a dose adjustment or special tests:

• 
  

  liver disease;

  
  


• 
  

  epilepsy or other seizure disorder;

  
  


• 
  

  heart disease, chest pain (angina), congestive heart failure, or a heart rhythm disorder;

  
  


• 
  

  a thyroid disorder; or

  
  


• 
  

  a history of depression or suicidal behavior.

  
  

FDA pregnancy category C. This medication may be harmful to an unborn baby, or may cause a miscarriage. Do not use interferon beta-1a if you are pregnant. Tell your doctor if you become pregnant during treatment. It is not known whether interferon beta-1a 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.

Avonex powder contains albumin, but the Avonex prefilled syringe does not. Albumin comes from human plasma (part of the blood) and may contain viruses and other infectious agents that can cause disease. Although donated human plasma is screened, tested, and treated to reduce the risk of it containing anything that could cause disease, there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

How should I use Avonex Prefilled Syringe (interferon beta-1a)?

Avonex is injected into a muscle. It is usually given once weekly at bedtime, on the same day each week (such as every Monday). Follow your doctor's instructions.

Rebif is injected under the skin. It is usually given 3 times per week (such as Monday, Wednesday, and Friday) at the same time on each dosing day. Follow your doctor's instructions.

You may be shown how to use injections at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Use a different place on your body each time you give the injection. Your care provider will show you the best places on your body to inject the medication. Do not inject into the same place two times in a row.

The powder form of Avonex must be mixed with a liquid (diluent) in the medicine vial. Gently swirl but do not shake the vial after mixing the medicine. The mixture should be clear or light yellow. Do not use the mixture if it has changed colors or has any particles in it. Mix a new dose or call your doctor for a new prescription.

Do not draw your dose into a syringe until you are ready to give yourself an injection.

Each prefilled syringe or single use vial (bottle) of this medicine is for one use only. Throw away after one use, even if there is still some medicine left after injecting your dose.

Use each disposable needle only one time. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

Interferon beta-1 can lower blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. Your blood may need to be tested often. Your liver or thyroid function may also need to be tested. Visit your doctor regularly.

Store interferon beta-1a in a refrigerator. Do not freeze. You may take the Avonex prefilled syringe out of the refrigerator and allow it to reach room temperature before giving the injection. Do not heat the medicine before using. Interferon beta-1a may be kept at room temperature for short periods if protected from light. Avonex powder or Rebif prefilled syringes can be stored at room temperature for up to 30 days. Avonex prefilled syringes can be stored at room temperature for only 7 days. After mixing Avonex powder with a diluent, store in the refrigerator and use it within 6 hours.

Throw away any interferon beta-1a that has become frozen or has been exposed to light or high heat.

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose of this medication. Your injections should be at least 48 hours apart. Do not use interferon beta-1a injections 2 days in a row.

What happens if I overdose?

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

What should I avoid while using Avonex Prefilled Syringe (interferon beta-1a)?

Avoid drinking alcohol. It may increase your risk of liver damage.

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Avonex Prefilled Syringe (interferon beta-1a) 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. Call your doctor at once if you have a serious side effect such as:

• 
  

  depressed mood, anxiety, trouble sleeping, restlessness, or thoughts of suicide or hurting yourself;

  
  


• 
  

  easy bruising or bleeding, weakness;

  
  


• 
  

  seizure (convulsions);

  
  


• 
  

  numbness or tingling in your hands or feet;

  
  


• 
  

  pain or burning when you urinate;

  
  


• 
  

  pain, swelling, or skin changes where the injection was given;

  
  


• 
  

  fever, chills, body aches, flu symptoms; or

  
  


• 
  

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

  
  

Less serious side effects may include:

• 
  

  headache, dizziness;

  
  


• 
  

  stomach pain; or

  
  


• 
  

  runny or stuffy nose.

  
  

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 Avonex Prefilled Syringe (interferon beta-1a)?

Interferon beta-1a can harm your liver. This effect is increased when you also use other medicines harmful to the liver. Many other drugs (including some over-the-counter medicines) can be harmful to the liver, such as:

• 
  

  acetaminophen (Tylenol);

  
  


• 
  

  cancer medications;

  
  


• 
  

  tuberculosis medications;

  
  


• 
  

  birth control pills or hormone replacement therapy;

  
  


• 
  

  methotrexate (Rheumatrex, Trexall);

  
  


• 
  

  arthritis medications such as auranofin (Ridaura);

  
  


• 
  

  an antibiotic;

  
  


• 
  

  HIV/AIDS medications;

  
  


• 
  

  cholesterol medications such atorvastatin (Lipitor), simvastatin (Zocor), and others;

  
  


• 
  

  an ACE inhibitor such as benazepril (Lotensin), captopril (Capoten), lisinopril (Prinivil, Zestril), and others;

  
  


• 
  

  an NSAID (non-steroidal anti-inflammatory drug) such as ibuprofen (Motrin, Advil), naproxen (Aleve, Naprosyn), indomethacin (Indocin), and others; or

  
  


• 
  

  seizure medications such as carbamazepine (Carbatrol, Tegretol), phenytoin (Dilantin), or valproic acid (Depakene).

  
  

This list is not complete and other drugs may interact with interferon beta-1a. 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 Avonex Prefilled Syringe resources

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

• Interferon Beta-1a Professional Patient Advice (Wolters Kluwer)


• Interferon Beta-1a MedFacts Consumer Leaflet (Wolters Kluwer)


• Avonex Prescribing Information (FDA)


• Avonex Prefilled Syringes MedFacts Consumer Leaflet (Wolters Kluwer)


• Avonex Advanced Consumer (Micromedex) - Includes Dosage Information


• Avonex Consumer Overview


• Rebif Prescribing Information (FDA)


• Rebif Consumer Overview

Compare Avonex Prefilled Syringe with other medications

• Multiple Sclerosis
• Neuritis

Where can I get more information?

• Your doctor or pharmacist can provide more information about interferon beta-1a.

See also: Avonex Prefilled Syringe side effects (in more detail)

Vitaphil Aide

Generic Name: prenatal multivitamins (PRE nay tal VYE ta mins)

Brand Names: Advance Care Plus, Bright Beginnings, Cavan Folate, Cavan One, Cavan-Heme OB, Cenogen Ultra, CitraNatal Rx, Co Natal FA, Complete Natal DHA, Complete-RF, CompleteNate, Concept OB, Docosavit, Dualvit OB, Duet, Edge OB, Elite OB 400, Femecal OB, Folbecal, Folcaps Care One, Folivan-OB, Foltabs, Gesticare, Icar Prenatal, Icare Prenatal Rx, Inatal Advance, Infanate DHA, Kolnatal DHA, Lactocal-F, Marnatal-F, Maternity, Maxinate, Mission Prenatal, Multi-Nate 30, Multinatal Plus, Nata 29 Prenatal, Natachew, Natafort, Natelle, Neevo, Nestabs, Nexa Select with DHA, Novanatal, NovaStart, O-Cal Prenatal, OB Complete, OB Natal One, Ob-20, Obtrex DHA, OptiNate, Paire OB Plus DHA, PNV Select, PNV-Total, PR Natal 400, Pre-H-Cal, Precare, PreferaOB, Premesis Rx, PrenaCare, PrenaFirst, PrenaPlus, Prenatabs OBN, Prenatabs Rx, Prenatal 1 Plus 1, Prenatal Elite, Prenatal Multivitamins, Prenatal Plus, Prenatal S, Prenatal-U, Prenate Advanced Formula, Prenate DHA, Prenate Elite, Prenavite FC, PreNexa, PreQue 10, Previte Rx, PrimaCare, Pruet DHA, RE OB Plus DHA, Renate, RightStep, Rovin-NV, Se-Care, Se-Natal One, Se-Plete DHA, Se-Tan DHA, Select-OB, Seton ET, Strongstart, Stuart Prenatal with Beta Carotene, Tandem OB, Taron-BC, Tri Rx, TriAdvance, TriCare, Trimesis Rx, Trinate, Triveen-PRx RNF, UltimateCare Advance, Ultra-Natal, Vemavite PRX 2, VeNatal FA, Verotin-BY, Verotin-GR, Vinacal OR, Vinatal Forte, Vinate Advanced (New Formula), Vinate AZ, Vinate Care, Vinate Good Start, Vinate II (New Formula), Vinate III, Vinate One, Vitafol-OB, VitaNatal OB plus DHA, Vitaphil, Vitaphil Aide, Vitaphil Plus DHA, Vitaspire, Viva DHA, Vol-Nate, Vol-Plus, Vol-Tab Rx, Vynatal F.A., Zatean-CH, Zatean-PN

What are Vitaphil Aide (prenatal multivitamins)?

There are many brands and forms of prenatal vitamin available and not all brands are listed on this leaflet.

Prenatal vitamins are a combination of many different vitamins that are normally found in foods and other natural sources.

Prenatal vitamins are used to provide the additional vitamins needed during pregnancy. Minerals may also be contained in prenatal multivitamins.

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

What is the most important information I should know about prenatal vitamins?

There are many brands and forms of prenatal vitamin available and not all brands are listed on this leaflet.

Never take more than the recommended dose of a multivitamin. Avoid taking any other multivitamin product within 2 hours before or after you take your prenatal vitamins. Taking similar vitamin products together at the same time can result in a vitamin overdose or serious side effects.

Many multivitamin products also contain minerals such as calcium, iron, magnesium, potassium, and zinc. Minerals (especially taken in large doses) can cause side effects such as tooth staining, increased urination, stomach bleeding, uneven heart rate, confusion, and muscle weakness or limp feeling. Read the label of any multivitamin product you take to make sure you are aware of what it contains.

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of vitamins A, D, E, or K can cause serious or life-threatening side effects and can also harm your unborn baby. Certain minerals contained in a prenatal multivitamin may also cause serious overdose symptoms or harm to the baby if you take too much.

Overdose symptoms may include stomach pain, vomiting, diarrhea, constipation, loss of appetite, hair loss, peeling skin, tingly feeling in or around your mouth, changes in menstrual periods, weight loss, severe headache, muscle or joint pain, severe back pain, blood in your urine, pale skin, and easy bruising or bleeding.

Do not take this medication with milk, other dairy products, calcium supplements, or antacids that contain calcium. Calcium may make it harder for your body to absorb certain ingredients of the multivitamin.

What should I discuss with my healthcare provider before taking prenatal vitamins?

Many vitamins can cause serious or life-threatening side effects if taken in large doses. Do not take more of this medication than directed on the label or prescribed by your doctor.

Before taking prenatal vitamins, tell your doctor about all of your medical conditions.

You may need to continue taking prenatal vitamins if you breast-feed your baby. Ask your doctor about taking this medication while breast-feeding.

How should I take prenatal vitamins?

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.

Never take more than the recommended dose of prenatal vitamins.

Many multivitamin products also contain minerals such as calcium, iron, magnesium, potassium, and zinc. Minerals (especially taken in large doses) can cause side effects such as tooth staining, increased urination, stomach bleeding, uneven heart rate, confusion, and muscle weakness or limp feeling. Read the label of any multivitamin product you take to make sure you are aware of what it contains.

Take your prenatal vitamin with a full glass of water.

Swallow the regular tablet or capsule whole. Do not break, chew, crush, or open it.

The chewable tablet must be chewed or allowed to dissolve in your mouth before swallowing. You may also allow the chewable tablet to dissolve in drinking water, fruit juice, or infant formula (but not milk or other dairy products). Drink this mixture right away.

Use prenatal vitamins regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Store at room temperature away from moisture and heat. Keep prenatal vitamins in their original container. Storing vitamins in a glass container can ruin the medication.

What happens if I miss a dose?

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 if you think you have used too much of this medicine. An overdose of vitamins A, D, E, or K can cause serious or life-threatening side effects and can also harm your unborn baby. Certain minerals contained in a prenatal multivitamin may also cause serious overdose symptoms or harm to the baby if you take too much.

Overdose symptoms may include stomach pain, vomiting, diarrhea, constipation, loss of appetite, hair loss, peeling skin, tingly feeling in or around your mouth, changes in menstrual periods, weight loss, severe headache, muscle or joint pain, severe back pain, blood in your urine, pale skin, and easy bruising or bleeding.

What should I avoid while taking prenatal vitamins?

Avoid taking any other multivitamin product within 2 hours before or after you take your prenatal vitamins. Taking similar vitamin products together at the same time can result in a vitamin overdose or serious side effects.

Avoid the regular use of salt substitutes in your diet if your multivitamin contains potassium. If you are on a low-salt diet, ask your doctor before taking a vitamin or mineral supplement.

Do not take this medication with milk, other dairy products, calcium supplements, or antacids that contain calcium. Calcium may make it harder for your body to absorb certain ingredients of the prenatal vitamin.

Prenatal vitamins 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.

When taken as directed, prenatal vitamins are not expected to cause serious side effects. Less serious side effects may include:

• 
  

  upset stomach;

  
  


• 
  

  headache; or

  
  


• 
  

  unusual or unpleasant taste in your mouth.

  
  

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 prenatal vitamins?

Vitamin and mineral supplements can interact with certain medications, or affect how medications work in your body. Before taking a prenatal vitamin, tell your doctor if you also use:

• 
  

  diuretics (water pills);

  
  


• 
  

  heart or blood pressure medications;

  
  


• 
  

  tretinoin (Vesanoid);

  
  


• 
  

  isotretinoin (Accutane, Amnesteen, Clavaris, Sotret);

  
  


• 
  

  trimethoprim and sulfamethoxazole (Cotrim, Bactrim, Gantanol, Gantrisin, Septra, TMP/SMX); or

  
  


• 
  

  an NSAID (non-steroidal anti-inflammatory drug) such as ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Cataflam, Voltaren), indomethacin (Indocin), meloxicam (Mobic), and others.

  
  

This list is not complete and other drugs may interact with prenatal vitamins. 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 Vitaphil Aide resources

• Vitaphil Aide Use in Pregnancy & Breastfeeding
• Vitaphil Aide Drug Interactions
• Vitaphil Aide Support Group
• 0 Reviews for Vitaphil Aide - Add your own review/rating

• Cal-Nate MedFacts Consumer Leaflet (Wolters Kluwer)


• CareNatal DHA MedFacts Consumer Leaflet (Wolters Kluwer)


• CitraNatal 90 DHA MedFacts Consumer Leaflet (Wolters Kluwer)


• CitraNatal Assure Prescribing Information (FDA)


• CitraNatal Harmony Prescribing Information (FDA)


• Concept DHA Prescribing Information (FDA)


• Docosavit Prescribing Information (FDA)


• Duet DHA with Ferrazone MedFacts Consumer Leaflet (Wolters Kluwer)


• Folbecal MedFacts Consumer Leaflet (Wolters Kluwer)


• Folcal DHA Prescribing Information (FDA)


• Folcaps Care One Prescribing Information (FDA)


• Gesticare DHA Prescribing Information (FDA)


• Gesticare DHA MedFacts Consumer Leaflet (Wolters Kluwer)


• Inatal Advance Prescribing Information (FDA)


• Inatal Ultra Prescribing Information (FDA)


• Multi-Nate DHA Prescribing Information (FDA)


• Multi-Nate DHA Extra Prescribing Information (FDA)


• MultiNatal Plus MedFacts Consumer Leaflet (Wolters Kluwer)


• Natelle One Prescribing Information (FDA)


• Neevo Caplets MedFacts Consumer Leaflet (Wolters Kluwer)


• Neevo DHA MedFacts Consumer Leaflet (Wolters Kluwer)


• OB Complete 400 MedFacts Consumer Leaflet (Wolters Kluwer)


• Paire OB Plus DHA Prescribing Information (FDA)


• PreNexa MedFacts Consumer Leaflet (Wolters Kluwer)


• PreNexa Prescribing Information (FDA)


• PreferaOB Prescribing Information (FDA)


• Prenatal Plus Prescribing Information (FDA)


• Prenatal Plus Iron Prescribing Information (FDA)


• Prenate Elite Prescribing Information (FDA)


• Prenate Elite MedFacts Consumer Leaflet (Wolters Kluwer)


• Prenate Elite tablets


• Prenate Essential Prescribing Information (FDA)


• PrimaCare Advantage MedFacts Consumer Leaflet (Wolters Kluwer)


• PrimaCare ONE capsules


• PrimaCare One MedFacts Consumer Leaflet (Wolters Kluwer)


• Renate DHA Prescribing Information (FDA)


• Se-Natal 19 Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Se-Natal 19 Prescribing Information (FDA)


• Tandem DHA Prescribing Information (FDA)


• Tandem OB Prescribing Information (FDA)


• TriAdvance Prescribing Information (FDA)


• Triveen-One MedFacts Consumer Leaflet (Wolters Kluwer)


• Triveen-PRx RNF Prescribing Information (FDA)


• UltimateCare ONE NF Prescribing Information (FDA)


• Ultra NatalCare MedFacts Consumer Leaflet (Wolters Kluwer)


• Vinate AZ Prescribing Information (FDA)


• Vitafol-One MedFacts Consumer Leaflet (Wolters Kluwer)


• Zatean-CH Prescribing Information (FDA)

Compare Vitaphil Aide with other medications

• Vitamin/Mineral Supplementation during Pregnancy/Lactation

Where can I get more information?

• Your pharmacist can provide more information about prenatal vitamins.

Vfend Suspension

Pronunciation: VOR-i-KON-a-zole
Generic Name: Voriconazole
Brand Name: Vfend

Vfend Suspension is used for:

Treating certain fungal infections.

Vfend Suspension is an azole antifungal. It works by blocking fungal cell wall growth, which results in the death of the fungus.

Do NOT use Vfend Suspension if:

• you are allergic to any ingredient in Vfend Suspension


• you have certain rare hereditary problems (glucose-galactose malabsorption, fructose intolerance, sucrase-isomaltase deficiency)


• you have untreated low blood calcium, magnesium, or potassium levels


• you are taking astemizole, a barbiturate (eg, phenobarbital), cabazitaxel, carbamazepine, cisapride, crizotinib, dronedarone, an ergot alkaloid (eg, ergotamine), erythromycin, everolimus, fluconazole, lurasidone, pimozide, quinidine, rifabutin, rifampin, rivaroxaban, sirolimus, St. John's wort, terfenadine, or ticagrelor

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

Before using Vfend Suspension:

Some medical conditions may interact with Vfend Suspension. 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 are allergic to other azole antifungals (eg, fluconazole, itraconazole)


• if you have a history of heart problems (eg, cardiomyopathy, irregular heartbeat); an abnormal electrocardiogram (ECG) (a type of heart test); or low blood calcium, magnesium, or potassium levels


• if you have liver problems (eg, cirrhosis), kidney problems, pancreas problems, a weakened immune system, or a blood disease (eg, blood or bone marrow cancer)


• if you have diabetes or trouble digesting table sugar


• if you have ever been on chemotherapy or have had a stem cell transplant


• if you have taken fluconazole within the last 24 hours


• if you are taking ritonavir. Vfend Suspension should not be taken with certain doses of ritonavir

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

• Medicines that may harm the kidney because the risk of kidney side effects may be increased. Ask your doctor or pharmacist if you are unsure if any of your medicines might affect the kidney


• Medicines that may increase the risk of a certain type of irregular heartbeat (prolonged QT interval). Check with your doctor or pharmacist if you are unsure if any of your medicines may increase the risk of this type of irregular heartbeat


• Many other prescription and nonprescription medicines (eg, used for aches and pains, anxiety, birth control, blood flow problems, blood thinning, cancer, diabetes, drug dependence, heartburn or reflux, high blood pressure, high cholesterol, HIV, immune system suppression, infections, irregular heartbeat or other heart problems, mental or mood problems, pain, seizures, stomach or bowel problems), multivitamin products, or herbal or dietary supplements (eg, herbal teas, coenzyme Q10, garlic, ginseng, ginkgo, St. John's wort) may interact with Vfend Suspension. Ask your doctor or pharmacist if you are unsure if any of your medicines might interact with Vfend Suspension

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

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

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


• Take Vfend Suspension by mouth on an empty stomach at least 1 hour before or 1 hour after eating.


• Shake well before each use.


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


• Do not mix Vfend Suspension with any other medicine or flavoring.


• To clear up your infection completely, take Vfend Suspension for the full course of treatment. Keep taking it even if you feel better in a few days.


• If you miss a dose of Vfend Suspension, take it as soon as possible. If it is more than 6 hours after the missed dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

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

Important safety information:

• Vfend Suspension may cause blurred vision or sensitivity to light. These effects may be worse if you take it with alcohol or certain medicines. Use Vfend Suspension with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Avoid driving at night while you are using Vfend Suspension.


• Vfend Suspension may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Vfend Suspension. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.


• Certain types of skin cancers (eg, melanoma, squamous cell) have been reported in patients who became sensitive to sunlight while taking Vfend Suspension for a long period of time. Contact your doctor if you notice a change in the appearance of a mole or other unusual skin change or growth. Discuss any questions or concerns with your doctor.


• Vfend Suspension may make your eyes more sensitive to sunlight. It may help to wear sunglasses. Avoid strong, direct sunlight.


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


• If your symptoms do not get better within a few days or if they get worse, check with your doctor.


• Women who may become pregnant should use effective birth control (eg, birth control pills) while taking Vfend Suspension. Talk with your doctor if you have questions about effective birth control.


• Lab tests, including eye exams, liver and kidney function, and pancreas function, may be performed while you use Vfend Suspension. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Vfend Suspension should be used with extreme caution in CHILDREN younger than 12 years old; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: Vfend Suspension may cause harm to the fetus. Do not become pregnant while you are using it. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Vfend Suspension while you are pregnant. It is not known if Vfend Suspension is found in breast milk. Do not breast-feed while taking Vfend Suspension.

Possible side effects of Vfend Suspension:

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:

Blurred vision; headache; nausea; sensitivity to light; sensitivity to the sun; vomiting.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); abnormal thoughts; black, tarry stools; bone pain; calf or leg pain, redness, swelling, or tenderness; change in the appearance of a mole; chest, jaw, or arm pain; confusion; decreased urination; fainting; fast, slow, or irregular heartbeat; fever, chills, or persistent sore throat; flushing; hallucinations; mental or mood changes (eg, depression); mouth sores; one-sided weakness; red, swollen, peeling, or blistered skin; seizures; severe or persistent dizziness or headache; shortness of breath; speech changes; sudden, severe nausea or vomiting; suicidal thoughts or actions; swelling of the arms or legs; symptoms of liver problems (eg, yellowing of the skin or eyes; dark urine; pale stools; severe or persistent nausea, vomiting, or stomach pain; loss of appetite; itching); symptoms of pancreatitis (eg, severe stomach or back pain, with or without nausea or vomiting); unusual bruising or bleeding; unusual skin change or skin growth; unusual sweating or weakness; unusual tiredness; unusual vaginal bleeding; vision changes (eg, color vision change, persistent or severe blurred vision or sensitivity to light).

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: Vfend 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 Vfend Suspension:

Store Vfend Suspension at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Do not refrigerate or freeze. Store away from heat, moisture, and light. Do not store in the bathroom. Discard any unused medicine after 14 days. Keep Vfend Suspension out of the reach of children and away from pets.

General information:

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


• Vfend Suspension 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 Vfend Suspension. 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 Vfend resources

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

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