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Tuesday, October 25, 2016

Alferon N

Generic Name: interferon alfa-n3 (IN ter FEER on AL fa)

Brand Names: Alferon N

What is Alferon N (interferon alfa-n3)?

Interferon alfa-n3 is made from human proteins. Interferons help the body fight viral infections.

Interferon alfa-n3 is used to treat genital warts that occur on the outside of the body. This medication is for use only in people who are at least 18 years old.

Interferon alfa-n3 is usually given after other medications have been tried without successful treatment of genital warts.

Interferon alfa-n3 may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Alferon N (interferon alfa-n3)?

You should not use this medication if you are allergic to interferons, or if you are allergic to eggs or mouse proteins.

Before receiving interferon alfa-n3, tell your doctor if you have heart disease, congestive heart failure, angina (chest pain), severe lung disease (such as COPD), diabetes, bone marrow suppression, a bleeding or blood clotting disorder, or a seizure disorder.

Call your doctor if you have flu symptoms (fever, chills, and body aches), or if your genital warts do not completely clear up within 3 months after your last injection of interferon alfa-n3.

What should I discuss with my healthcare provider before receiving Alferon N (interferon alfa-n3)?

You should not use this medication if you are allergic to interferons, or if you are allergic to eggs or mouse proteins.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use interferon alfa-n3:

heart disease, congestive heart failure, angina (chest pain);

severe lung disease such as COPD (chronic obstructive pulmonary disease);

diabetes;

bone marrow suppression;

a seizure disorder; or

a bleeding or blood clotting disorder such as hemophilia.

FDA pregnancy category C. It is not known whether interferon alfa-n3 is harmful to an unborn baby. Before using this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether interferon alfa-n3 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.

Interferon alfa-n3 is made 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 is interferon alfa-n3 given?

Interferon alfa-n3 is injected directly into each genital wart lesion. You will receive this injection in a clinic setting.

Interferon alfa-n3 injections are usually given 2 times per week for up to 8 weeks.

Your lesions may only partially clear up by the end of your 8-week treatment. However, you may continue to notice improvement even after your treatment ends.

Tell your doctor if your warts do not completely clear up within 3 months after your last injection of interferon alfa-n3.

To reduce or prevent certain side effects, your doctor may recommend you take acetaminophen (Tylenol) at the time of your interferon alfa-n3 injections. Follow your doctor's instructions about the correct dose.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your interferon alfa-n3 injection.

What happens if I overdose?

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

Symptoms of an interferon alfa-n3 overdose are not known.

What should I avoid while receiving Alferon N (interferon alfa-n3)?

Avoid drinking alcohol if you are also taking acetaminophen (Tylenol) while being treated with interferon alfa-n3.

Alferon N (interferon alfa-n3) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; chest tightness, wheezing, feeling like you might pass out; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have flu symptoms such as fever, chills, and body aches.

Less serious side effects may include:

headache, tired feeling;

dizziness;

joint or muscle pain, back pain;

mild nausea; or

sleep problems (insomnia).

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 Alferon N (interferon alfa-n3)?

There may be other drugs that can interact with interferon alfa-n3. 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 Alferon N resources

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

Alferon N Solution MedFacts Consumer Leaflet (Wolters Kluwer)

Interferon Alfa-n3 Professional Patient Advice (Wolters Kluwer)

Compare Alferon N with other medications

Condylomata Acuminata

Where can I get more information?

Your doctor or pharmacist can provide more information about interferon alfa-n3.

See also: Alferon N side effects (in more detail)

Alimta

Generic Name: Pemetrexed Disodium
Class: Antineoplastic Agents
VA Class: AN900
Chemical Name: N-[4-2-(2-Amino-4,7-dihydro-4-oxo-1H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl]-l-glutamic acid disodium salt.
Molecular Formula: C₂₀H₁₉N₅Na₂O₆
CAS Number: 150399-23-8

Introduction

Antineoplastic agent; a folic acid antagonist.¹ ³ ⁴ ⁵

Uses for Alimta

Malignant Pleural Mesothelioma

Used in combination with cisplatin for the treatment of malignant pleural mesothelioma in adults whose disease is unresectable or who otherwise are not candidates for potentially curative surgery (designated an orphan drug by FDA for this indication).¹ ³ ⁵ ⁶

Non-small Cell Lung Cancer

Monotherapy for the treatment of locally advanced or metastatic non-small cell lung cancer in adults who have received prior chemotherapy.¹ ⁴ Efficacy based on surrogate end points of tumor response rate; improvement in disease-related symptoms or increased survival not demonstrated in clinical studies.¹

Alimta Dosage and Administration

General

Consult specialized references for procedures for proper handling and disposal of antineoplastics.

Premedication

Consider pretreatment with a corticosteroid to reduce the incidence and severity of cutaneous reactions.¹ Oral dexamethasone 4 mg twice daily for 3 days, starting 1 day before pemetrexed, used in clinical studies.¹ (See Dermatologic Effects under Cautions.)

Vitamin Supplementation

To reduce toxicity, all patients should take low-dose oral folic acid (0.4 mg daily) or a multivitamin preparation containing folic acid for at least 5 daily doses during the 7-day period before the first dose of pemetrexed; continue folic acid during therapy and for 21 days after the last dose of pemetrexed.¹

Administer one IM injection of vitamin B₁₂ during the week before the first dose of pemetrexed and then once every 3 cycles; subsequent injections may be given the same day as pemetrexed.¹ ³ IM vitamin B₁₂ 1 mg used in clinical studies.¹ (See Folate and Vitamin B₁₂ Supplementation under Cautions.)

Administration

IV Administration

For solution compatibility information, see Compatibility under Stability.

Administer by IV infusion.¹

Prepare and handle cautiously; use protective gloves.¹ If skin contact occurs, immediately wash affected area(s) thoroughly with soap and water.¹ If mucosa contact occurs, immediately flush thoroughly with water.¹

Not a vesicant.¹ Manage extravasation according to local practice standards.¹

Reconstitution

Reconstitute vial containing 500 mg of pemetrexed with 20 mL of 0.9% sodium chloride injection (without preservatives) to provide a solution containing 25 mg/mL.¹

Gently swirl vial until powder is completely dissolved.¹ Must be diluted further before IV administration.¹

Dilution

Following reconstitution, add the appropriate volume to 100 mL of 0.9% sodium chloride injection (without preservatives).¹

Rate of Administration

Administer by IV infusion over 10 minutes.¹

Dosage

Available as pemetrexed disodium heptahydrate; dosage expressed in terms of anhydrous pemetrexed.¹

Adults

Malignant Pleural Mesothelioma

IV

500 mg/m² on day 1 of a 21-day cycle.¹ Used in conjunction with cisplatin 75 mg/m² on day 1 of a 21-day cycle; initiate cisplatin infusion 30 minutes after completion of pemetrexed infusion.¹

Consult published protocols for information on administration of cisplatin.¹

Adjust subsequent dosages of pemetrexed and cisplatin based on nadir blood counts (i.e., ANCs, platelet counts) and maximum nonhematologic toxicity from preceding dose.¹ (See Dose Modification for Toxicity under Dosage and Administration.)

Do not administer repeat course until ANCs ≥1500/mm³, platelet count ≥100,000/mm³, and Cl_cr ≥45 mL/minute.¹

Non-small Cell Lung Cancer

IV

500 mg/m² on day 1 of a 21-day cycle.¹

Adjust subsequent dosages based on nadir blood counts (i.e., ANCs, platelet counts) and maximum nonhematologic toxicity from preceding dose.¹ (See Dose Modification for Toxicity under Dosage and Administration.)

Do not administer repeat course until ANCs ≥1500/mm³, platelet count ≥100,000/mm³, and Cl_cr ≥45 mL/minute.¹

Dosage Modification for Toxicity

Delay treatment to allow time for recovery from toxicity.¹

Hematologic Toxicity

Reduce dose according to nadir ANC and platelet count.¹ (See Table 1.)

Discontinue therapy if patient experiences grade 3 or 4 hematologic toxicity after 2 dose reductions.¹

Table 1. Recommended Dosage Modification for Hematologic Toxicity of Pemetrexed Monotherapy or Pemetrexed and Cisplatin Combination Therapy
Toxicity	Dose of Pemetrexed	Dose of Cisplatin
Nadir ANC <500/mm³ and nadir platelets ≥50,000/mm³	75% of previous dose	75% of previous dose
Nadir platelets <50,000/mm³, regardless of nadir ANC	50% of previous dose	50% of previous dose

Nonhematologic Toxicity (Except Neurotoxicity)

Reduce dose based on toxicity type and severity. (See Table 2.)¹

Interrupt therapy for grade 3 (except grade 3 elevation in serum transaminase values) or 4 nonhematologic toxicity until resolution to at least pretreatment values.¹

Dosage modification not required for grade 3 elevation in serum transaminase values.¹ ⁷

Discontinue if patient experiences grade 3 or 4 nonhematologic toxicity (except grade 3 elevation in serum transaminase values) after 2 dose reductions.¹

Table 2. Recommended Dosage Modification for Nonhematologic Toxicity (Except Neurotoxicity) of Pemetrexed Monotherapy or Pemetrexed and Cisplatin Combination Therapy
Toxicity and National Cancer Institute (NCI) Common Toxicity Criteria Grade	Dose of Pemetrexed	Dose of Cisplatin
Any grade 3 or 4 nonhematologic toxicity (except neurotoxicity), excluding grade 3 or 4 mucositis or grade 3 elevation in serum transaminase values	75% of previous dose	75% of previous dose
Any diarrhea requiring hospitalization (regardless of grade) or grade 3 or 4 diarrhea	75% of previous dose	75% of previous dose
Grade 3 or 4 mucositis	50% of previous dose	100% of previous dose

Neurotoxicity

Reduce cisplatin dose for grade 2 neurotoxicity; no change in pemetrexed dose needed.¹ (See Table 3.)

Discontinue immediately for grade 3 or 4 neurotoxicity.¹

Table 3. Recommended Dosage Modifications for Neurotoxicity of Pemetrexed Monotherapy or Pemetrexed and Cisplatin Combination Therapy
NCI Common Toxicity Criteria Grade	Dose of Pemetrexed	Dose of Cisplatin
0–1	100% of previous dose	100% of previous dose
2	100% of previous dose	50% of previous dose

Special Populations

Renal Impairment

Cl_cr≥45 mL/minute: Routine dosage adjustment not required.¹

Cl_cr<45 mL/minute: Insufficient information to make dosage recommendation; use not recommended.¹ (See Renal Impairment under Cautions.)

Geriatric Patients

No dosage adjustments except those recommended for all patients.¹

Cautions for Alimta

Contraindications

Known hypersensitivity to pemetrexed or any ingredient in the formulation.¹

Warnings/Precautions

Warnings

Hematologic Toxicity

Dose-limiting bone marrow suppression (neutropenia, thrombocytopenia, and/or anemia).¹ ANC nadir at day 8–10, with return to baseline 4–8 days after nadir.¹

Folate and Vitamin B₁₂ Supplementation

Folic acid and vitamin B₁₂ needed to prevent treatment-related hematologic and GI toxicity.¹ Use of these supplements associated with overall reduction in toxicity and reduction in grade 3/4 hematologic and nonhematologic toxicities (i.e., neutropenia, febrile neutropenia, infection with grade 3/4 neutropenia).¹

Fetal/Neonatal Morbidity and Mortality

May cause fetal harm; teratogenicity and embryolethality demonstrated in animals.¹ Avoid pregnancy during therapy.¹ If used during pregnancy or patient becomes pregnant, apprise of potential fetal hazard.¹

Sensitivity Reactions

Dermatologic Effects

Rash reported.¹ Premedicate patients with corticosteroids to reduce incidence and severity of cutaneous reactions.¹

General Precautions

Adequate Patient Evaluation and Monitoring

Administer only under the supervision of qualified clinicians experienced in the use of cytotoxic therapy.¹

Prior to and during therapy, assess CBC and platelet counts.¹ Monitor renal and hepatic function periodically.¹

Other Considerations

Not known whether pemetrexed accumulates in fluid collections such as pleural effusions or ascites; such accumulations could increase toxicity.¹ ⁵ Some clinicians suggest large effusions be drained before therapy.⁵

Specific Populations

Pregnancy

Category D.¹ (See Fetal/Neonatal Morbidity and Mortality under Cautions.)

Lactation

Not known whether premetrexed is distributed into milk.¹ Discontinue nursing prior to therapy because of potential risk to nursing infants.¹

Pediatric Use

Safety and efficacy not established.¹

Hepatic Impairment

Patients with hepatic impairment excluded from clinical trials except those with liver metastases and transaminase concentrations 3–5 times the ULN.¹

Dosage adjustment based on hepatic impairment (i.e., grade 4 elevations in serum transaminase values) experienced during therapy required.¹ (See Nonhematologic Toxicity (except Neurotoxicity) under Dosage and Administration.)

Renal Impairment

Clearance may be decreased; dosage adjustment not needed in patients with Cl_cr≥45 mL/minute.¹

Use not recommended in patients with Cl_cr<45 mL/minute.¹

Withhold repeat cycles until Cl_cr≥45 mL/minute.¹

Use of pemetrexed with cisplatin not evaluated in patients with moderate renal impairment.¹

Caution advised if NSAIAs used in pemetrexed-treated patients with renal impairment.¹ (See Specific Drugs under Interactions.)

Common Adverse Effects

Hematologic effects, fever and infection, stomatitis/pharyngitis, rash/desquamation, nausea, fatigue, dyspnea, vomiting, constipation, chest pain, anorexia.¹ ⁷

Interactions for Alimta

Drugs Metabolized by Hepatic Microsomal Enzymes

Pharmacokinetic interaction unlikely with drugs metabolized by CYP1A2, 2C9, 2D6, or 3A.¹

Nephrotoxic Drugs

Possible delayed clearance of pemetrexed.¹

Specific Drugs

Drug	Interaction	Comments
Cisplatin	Pharmacokinetic interaction unlikely¹
NSAIAs	Aspirin (325 mg every 6 hours) does not affect pemetrexed pharmacokinetics; effect of higher aspirin dosage not known¹ Ibuprofen may increase pemetrexed AUC¹ Effect of NSAIAs with longer half-life on pemetrexed pharmacokinetics not evaluated¹	Caution if used concomitantly with ibuprofen in patients with mild to moderate renal impairment (Cl_cr 45–79 mL/minute)¹ Patients with mild to moderate renal impairment should not take NSAIAs with short half-lives for 2 days before, the day of, and for 2 days after pemetrexed administration¹ ³ ⁷ Patients with mild to moderate renal impairment should not take NSAIAs with longer half-lives for 5 days before, the day of, and for 2 days after pemetrexed administration¹ Monitor for toxicity (e.g., myelosuppression and renal and GI toxicity) if concomitant use is necessary¹

Probenecid	Possible delayed clearance of pemetrexed¹	Similar interaction possible with other substances secreted at the renal tubule¹
Vitamins	Decreased pemetrexed toxicity with concomitant oral folic acid and vitamin B₁₂¹ Pharmacokinetic interaction unlikely with oral folic acid or vitamin B₁₂¹

Alimta Pharmacokinetics

Absorption

Special Populations

In patients with renal impairment (Cl_cr 45–80 mL/minute), increased AUC.¹

Distribution

Plasma Protein Binding

81%.¹

Special Populations

Degree of renal impairment does not affect protein binding.¹

Elimination

Metabolism

Not metabolized to an appreciable extent.¹

Elimination Route

Principally eliminated in urine as unchanged drug.¹

Half-life

3.5 hours.¹

Special Populations

Clearance of pemetrexed decreases as renal function decreases.¹

Age-related differences in pharmacokinetics not observed in adults 26–80 years of age.¹

Stability

Storage

Parenteral

Powder for Injection

25°C (may be exposed to 15–30°C).¹

Store reconstituted solution and infusion solutions at 25°C (may be exposed to 15–30°C) or refrigerate at 2–8°C; use solution within 24 hours of reconstitution; discard unused solution.¹

Compatibility

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

Parenteral

Use 0.9% sodium chloride injection (without preservatives) to reconstitute and dilute pemetrexed.¹

Pemetrexed is not compatible with diluents containing calcium (e.g., Ringer’s injection; Ringer’s injection, lactated).¹

Manufacturer recommends that pemetrexed not be administered with other drugs or diluents other than 0.9% sodium chloride injection.¹

ActionsActions

Disrupts folate-dependent metabolic processes that are essential for cell replication.¹ ³

Inhibits the in vitro growth of mesothelioma cell lines (MSTO-211H, NCI-H2052).¹ Synergistic inhibitory effects with cisplatin in the MSTO-211H mesothelioma cell line.¹

Advice to Patients

Importance of taking folic acid and vitamin B₁₂ to reduce the risk of adverse effects.¹ ² Importance of taking a corticosteroid for 3 days during each treatment cycle to reduce the risk of a skin reaction.¹ ²

Importance of recognizing and reporting adverse effects of pemetrexed, including myelosuppressive effects, infectious complications, and GI symptoms (i.e., diarrhea, mucositis).¹ ² Necessity of monitoring blood cell counts and serum creatinine.¹ ² Necessity of dosage adjustment or delay in treatment if toxicity occurs.¹ ²

Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.¹ Apprise patient of potential hazard to the fetus if used during pregnancy; women of childbearing potential should avoid becoming pregnant.¹ ²

Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs (e.g., NSAIAs) as well as concomitant illnesses.¹ ²

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.

Pemetrexed Disodium
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	For injection, for IV infusion only	500 mg (of pemetrexed)	Alimta	Lilly

Comparative Pricing

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

Alimta 500MG Solution (LILLY): 1/$2932.99 or 3/$8024.98

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 September 2005. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

1. Eli Lilly and Company. Alimta (pemetrexed) for injection prescribing information. Indianapolis, IN; 2004 Aug 19.

2. Eli Lilly and Company. Information for patients and caregivers: Alimta (pemetrexed for injection). Indianapolis, IN; 2004 Aug 19.

3. Vogelzang NJ, Rusthoven JJ, Symanowski J et al. Phase III study of pemetrexed in combination with cisplatin versus cisplatin alone in patients with malignant pleural mesothelioma. J Clin Oncol. 2003; 21:2636-44. [IDIS 503150] [PubMed 12860938]

4. Hanna N, Shepherd FA, Fossella FV et al. Randomized phase III trial of pemetrexed versus docetaxel in patients with non-small-cell lung cancer previously treated with chemotherapy. J Clin Oncol. 2004; 22:1589-97. [IDIS 518149] [PubMed 15117980]

5. Anon. Pemetrexed (Alimta) for mesothelioma. Med Lett Drugs Ther. 2004; 46:31-2. [PubMed 15079145]

6. Food and Drug Administration. Orphan designation pursuant to Section 526 of the Federal Food and Cosmetic Act as amended by the Orphan Drug Act. (P.L. 97-414). Rockville, MD; From FDA website (); accessed 2004 Sep 7.

7. Eli Lilly and Company, Indianapolis, IN: Personal communication.

More Alimta resources

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

Alimta Prescribing Information (FDA)

Alimta Consumer Overview

Alimta Advanced Consumer (Micromedex) - Includes Dosage Information

Alimta MedFacts Consumer Leaflet (Wolters Kluwer)

Pemetrexed Professional Patient Advice (Wolters Kluwer)

Compare Alimta with other medications

Malignant Pleural Mesothelioma
Non-Small Cell Lung Cancer

Calciodie

Calciodie may be available in the countries listed below.

Ingredient matches for Calciodie

Calcium Carbonate

Calcium Carbonate is reported as an ingredient of Calciodie in the following countries:

Italy

International Drug Name Search

Monday, October 24, 2016

Menstrual PMS

Pronunciation: a-SEET-a-MIN-oh-fen/PAM-a-brom/pir-IL-a-meen
Generic Name: Acetaminophen/Pamabrom/Pyrilamine
Brand Name: Examples include Menstrual PMS and Midol PMS

Menstrual PMS is used for:

Treating symptoms associated with menstrual periods, such as muscle aches, cramps, bloating, headache, fatigue, breast tenderness, and water weight gain.

Menstrual PMS is an analgesic, antihistamine, and mild diuretic combination. The analgesic and antihistamine work in the brain to help reduce aches, pain, and discomfort associated with the menstrual period. The diuretic helps you to get rid of excess water to help relieve bloating and water weight gain.

Do NOT use Menstrual PMS if:

you are allergic to any ingredient in Menstrual PMS

you are taking sodium oxybate (GHB)

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

Before using Menstrual PMS:

Some medical conditions may interact with Menstrual PMS. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

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

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

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

if you have a history of alcohol abuse or you drink more than 3 alcohol-containing drinks every day

if you have hepatitis, liver or kidney problems, lung or breathing problems (eg, asthma, emphysema or chronic bronchitis), increased pressure in the eye, glaucoma, a blockage of your bladder, prostate problems, or trouble urinating

if you are taking a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) or medicines that may damage the liver; ask your doctor or pharmacist if you are unsure if you take these types of medicines

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

Sodium oxybate (GHB) because severe drowsiness and prolonged sleep duration may occur

Anticoagulants (eg, warfarin) because the risk of their side effects, including bleeding, may be increased by Menstrual PMS

Isoniazid because the risk of liver problems may be increased

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

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

Take Menstrual PMS by mouth with or without food.

If you miss a dose of Menstrual PMS and you are taking it regularly, take it as soon as possible. If several hours have passed or if it is nearing time for the next dose, do not double the dose to catch up, unless advised by your health care provider. Do not take 2 doses at once.

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

Important safety information:

Menstrual PMS may cause drowsiness. This effect may be worse if you take it with alcohol or certain medicines. Use Menstrual PMS with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Menstrual PMS; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.

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

Check with your doctor if your pain symptoms do not get better within 10 days, if they get worse, or if new symptoms occur.

Menstrual PMS has acetaminophen in it. Before you start any new medicine, check the label to see if it has acetaminophen in it too. If it does or if you are not sure, check with your doctor or pharmacist.

Menstrual PMS may harm your liver. Your risk may be greater if you drink alcohol while you are using Menstrual PMS. Talk to your doctor before you take Menstrual PMS or other fever reducers if you drink more than 3 drinks with alcohol per day.

Caution is advised when using Menstrual PMS in CHILDREN; they may be more sensitive to its effects, especially excitability.

Check with your child's doctor before giving Menstrual PMS to a CHILD younger than 12 years old; safety and effectiveness in these children have not been confirmed.

PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Menstrual PMS while you are pregnant. It is not known if Menstrual PMS is found in breast milk. If you are or will be breast-feeding while you use Menstrual PMS, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Menstrual PMS:

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:

Drowsiness.

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); dark urine or pale stools; severe or persistent stomach pain; unusual fatigue; yellowing of the skin or eyes.

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

See also: Menstrual PMS side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include dark urine; excessive sweating; extreme fatigue; nausea and vomiting; stomach pain.

Proper storage of Menstrual PMS:

Store Menstrual PMS at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Menstrual PMS out of the reach of children and away from pets.

General information:

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

Menstrual PMS 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 Menstrual PMS. 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

More Menstrual PMS resources

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

Compare Menstrual PMS with other medications

Premenstrual Dysphoric Disorder
Premenstrual Syndrome

Exforge HCT

Generic Name: amlodipine, hydrochlorothiazide, and valsartan (am LOE di peen, HYE droe klor oh THYE a zide, val SAR tan)

Brand Names: Exforge HCT

What is amlodipine, hydrochlorothiazide, and valsartan?

Amlodipine is a calcium channel blocker. Amlodipine relaxes (widens) blood vessels and improves blood flow.

Hydrochlorothiazide is a thiazide diuretic (water pill) that helps prevent your body from absorbing too much salt, which can cause fluid retention.

Valsartan is an angiotensin II receptor antagonists. Valsartan keeps blood vessels from narrowing, which lowers blood pressure and improves blood flow.

The combination of amlodipine, hydrochlorothiazide, and valsartan is used to treat high blood pressure (hypertension).

This medication is usually given after other blood pressure medications have been tried without successful treatment of symptoms.

Amlodipine, hydrochlorothiazide, and valsartan may also be used for purposes not listed in this medication guide.

What is the most important information I should know about amlodipine, hydrochlorothiazide, and valsartan?

Your chest pain may become worse when you first start taking this medication or when your dose is increased. Call your doctor if your chest pain is severe or ongoing. You should not take this medication if you are allergic to amlodipine (Norvasc), hydrochlorothiazide (HCTZ, HydroDiuril, Hyzaar, Vaseretic, Zestoretic and others), valsartan (Diovan), or sulfa drugs, or if you are unable to urinate.

Before taking amlodipine, hydrochlorothiazide, and valsartan, tell your doctor if you have kidney or liver disease, congestive heart failure, glaucoma, asthma or allergies, low or high blood levels of potassium, gout, lupus, diabetes, or a pencillin allergy.

Do not use this medication without telling your doctor if you are pregnant. Amlodipine, hydrochlorothiazide, and valsartan may cause injury and even death to the unborn baby if you take it during the second and third trimesters of pregnancy. Use an effective form of birth control. Stop using this medication and tell your doctor right away if you become pregnant during treatment. Drinking alcohol can further lower your blood pressure and may increase certain side effects of amlodipine, hydrochlorothiazide, and valsartan. Do not use potassium supplements or salt substitutes while you are taking amlodipine, hydrochlorothiazide, and valsartan, unless your doctor has told you to.

What should I discuss with my healthcare provider before taking amlodipine, hydrochlorothiazide, and valsartan?

You should not take this medication if you are allergic to amlodipine (Norvasc), hydrochlorothiazide (HCTZ, HydroDiuril, Hyzaar, Vaseretic, Zestoretic and others), valsartan (Diovan), or sulfa drugs, or if you are unable to urinate.

To make sure you can safely take amlodipine, hydrochlorothiazide, and valsartan, tell your doctor if you have any of these other conditions:

kidney disease;

liver disease;

congestive heart failure;

glaucoma;

asthma or allergies;

low or high levels of magnesium or potassium in your blood;

gout;

lupus;

diabetes; or

a penicillin allergy.

FDA pregnancy category D. Do not use this medication if you are pregnant. Stop using this medication and tell your doctor right away if you become pregnant. Amlodipine, hydrochlorothiazide, and valsartan can cause injury or death to the unborn baby if you take the medicine during your second or third trimester. Use effective birth control while taking amlodipine, hydrochlorothiazide, and valsartan. Amlodipine, hydrochlorothiazide, and valsartan can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are using amlodipine, hydrochlorothiazide, and valsartan.

How should I take amlodipine, hydrochlorothiazide, and valsartan?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Your doctor may occasionally change your dose to make sure you get the best results.

Take this medication with a full glass (8 ounces) of water. Call your doctor if you have ongoing vomiting or diarrhea, or if you are sweating more than usual. You can easily become dehydrated while taking this medication, which can lead to severely low blood pressure or a serious electrolyte imbalance. Your chest pain may become worse when you first start taking this medication or when your dose is increased. Call your doctor if your chest pain is severe or ongoing.

Your blood pressure will need to be checked often. Visit your doctor regularly.

It may take up to 2 weeks of using this medicine before your blood pressure improves. For best results, keep using the medication as directed.

Hydrochlorothiazide can interfere with the results of a thyroid test. Tell any doctor who treats you that you are using this medication.

Keep using this medicine as directed, even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.

Store at room temperature away from moisture and heat.

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 or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include fast or slow heartbeat, confusion, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling; feeling light-headed, and fainting.

What should I avoid while taking amlodipine, hydrochlorothiazide, and valsartan?

Drinking alcohol can further lower your blood pressure and may increase certain side effects of amlodipine, hydrochlorothiazide, and valsartan. Do not use potassium supplements or salt substitutes while you are taking amlodipine, hydrochlorothiazide, and valsartan, unless your doctor has told you to.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Amlodipine, hydrochlorothiazide, and valsartan 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:

eye pain, vision problems;

feeling like you might pass out;

swelling, rapid weight gain;

chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;

slow, fast, or pounding heartbeats;

urinating less than usual, or not at all;

easy bruising or bleeding, unusual weakness;

numbness, tingling, or burning pain;

jaundice (yellowing of the skin or eyes); or

dry mouth, increased thirst, drowsiness, restless feeling, confusion, increased urination, fast heart rate, fainting, or seizure (convulsions).

Less serious side effects may include:

dizziness;

headache, tired feeling;

nausea, upset stomach;

muscle spasms, back pain; or

stuffy nose, sore throat.

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 amlodipine, hydrochlorothiazide, and valsartan?

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

any other blood pressure medications;

steroids (prednisone and others);

carbamazepine (Carbatrol, Equetro, Tegretol);

lithium (Eskalith, Lithobid);

cholestyramine (Prevalite, Questran) or colestipol (Colestid);

insulin or oral diabetes medication;

simvastatin (Zocor, Simcor, Vytorin);

a barbiturate such as amobarbital (Amytal), butabarbital (Butisol), mephobarbital (Mebaral), secobarbital (Seconal), or phenobarbital (Luminal, Solfoton);

any other diuretics (water pills);

aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs) such as ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Arthrotec, Cambia, Cataflam, Voltaren, Flector Patch, Pennsaid, Solareze), indomethacin (Indocin), meloxicam (Mobic), and others;

a muscle relaxer such as baclofen (Lioresal), carisoprodol (Soma), cyclobenzaprine (Flexeril), dantrolene (Dantrium), metaxalone (Skelaxin), or methocarbamol (Robaxin), orphenadrine (Norflex), or tizanidine (Zanaflex);

a narcotic medication such as hydrocodone (Lortab, Vicodin), meperidine (Demerol), methadone (Methadose), morphine (Kadian, MS Contin), oxycodone (OxyContin), and others.

This list is not complete and other drugs may interact with amlodipine, hydrochlorothiazide, and valsartan. 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 Exforge HCT resources

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

Exforge HCT Prescribing Information (FDA)

Exforge HCT Advanced Consumer (Micromedex) - Includes Dosage Information

Exforge HCT MedFacts Consumer Leaflet (Wolters Kluwer)

Exforge HCT Consumer Overview

Compare Exforge HCT with other medications

High Blood Pressure

Where can I get more information?

Your pharmacist can provide more information about amlodipine, hydrochlorothiazide, and valsartan.

See also: Exforge HCT side effects (in more detail)

Amphotericin B

Pronunciation: am-foe-TER-ih-sin B
Generic Name: Amphotericin B
Brand Name: Amphocin and Fungizone

Amphotericin B should be used to treat only serious fungal infections. Do not use Amphotericin B for less severe infections such as oral thrush (white spots in the mouth), vaginal yeast infections, or throat (esophageal) infections, or for localized (not spread throughout the body) fungal infections in people with normal white blood cell levels.

Amphotericin B is used for:

Treating progressive and potentially life-threatening fungal infections. It may be used to treat certain protozoal infections (American mucocutaneous leishmaniasis) or other conditions as determined by your doctor.

Amphotericin B is an antifungal antibiotic. It works by killing the fungus and preventing its reproduction.

Do NOT use Amphotericin B if:

you are allergic to any ingredient in Amphotericin B

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

Before using Amphotericin B:

Some medical conditions may interact with Amphotericin B. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

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

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

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

if you have kidney problems

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

Azole antifungals (eg, ketoconazole) because the effectiveness of Amphotericin B may be decreased

Aminoglycoside antibiotics (eg, gentamicin), antineoplastic medicines (eg, nitrogen mustard), cyclosporine, or pentamidine because side effects, such as kidney problems, may occur

Leukocyte transfusions because side effects, such as lung problems, may occur

Corticosteroids (eg, prednisone) or corticotropin (ACTH) because side effects, such as heart problems, may occur

Digoxin, flucytosine, or skeletal muscle relaxants (eg, tubocurarine) because side effects and toxic effects may be increased

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

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

Amphotericin B is usually administered as an injection at your doctor's office, hospital, or clinic. If you are using Amphotericin B at home, carefully follow the injection procedures taught to you by your health care provider.

If the medicine contains particles or is discolored, or if the vial/container is cracked or damaged in any way, do not use it.

Amphotericin B works best if it is taken at the same time each day.

To clear up your infection completely, continue using Amphotericin B for the full course of treatment even if you feel better in a few days. Do not miss any doses.

Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor, nurse, or pharmacist to explain local regulations for selecting an appropriate container and properly disposing of the container when full.

If you miss a dose of Amphotericin B, contact your doctor for advice on when to schedule the next dose.

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

Important safety information:

Amphotericin B may cause dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Amphotericin B. Using Amphotericin B alone, with certain other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks.

To reduce side effects, your doctor may prescribe other medicines before administration of Amphotericin B. Take these other medicines as directed.

It is important to use Amphotericin B for the full course of treatment. Failure to do so may decrease the effectiveness of Amphotericin B and may increase the risk that the fungus will no longer be sensitive to Amphotericin B and will not be able to be treated by this or certain other antifungals in the future.

LAB TESTS, including kidney function, liver function, blood cell counts, and blood electrolytes, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.

Amphotericin B is not recommended for use in NEWBORNS. Safety and effectiveness in this age group have not been confirmed.

Use Amphotericin B with extreme caution in CHILDREN; safety and effectiveness have not been confirmed.

PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Amphotericin B during pregnancy. It is unknown if Amphotericin B is excreted in breast milk. Do not breast-feed while taking Amphotericin B.

Possible side effects of Amphotericin B:

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:

Chills; fever; headache; loss of appetite; muscle or joint pain; nausea; stomach pain; weight loss.

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); chest pain; convulsions; dark, bloody stools; decreased urination; diarrhea; dizziness; fast breathing; hearing loss; irregular heartbeat; pain or redness at the injection site; unusual tiredness or weakness; vomiting; yellowing of the skin or eyes.

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 Amphotericin B:

Store Amphotericin B as directed on the prescription label. Store away from heat and light. Do not store in the bathroom. Keep Amphotericin B, as well as needles and syringes, out of the reach of children and away from pets.

General information:

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

Amphotericin B 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 Amphotericin B. 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

More Amphotericin B resources

Amphotericin B Dosage
Amphotericin B Use in Pregnancy & Breastfeeding
Amphotericin B Drug Interactions
Amphotericin B Support Group
0 Reviews for Amphotericin B - Add your own review/rating

Amphotericin B Professional Patient Advice (Wolters Kluwer)

Amphotericin B Monograph (AHFS DI)

Amphotericin B Prescribing Information (FDA)

Fungizone Prescribing Information (FDA)

amphotericin B Concise Consumer Information (Cerner Multum)

amphotericin b Intravenous, Injection Advanced Consumer (Micromedex) - Includes Dosage Information

Compare Amphotericin B with other medications

Aspergillosis, Aspergilloma
Aspergillosis, Invasive
Blastomycosis
Candida Infections, Systemic
Candida Urinary Tract Infection
Coccidioidomycosis
Coccidioidomycosis, Meningitis
Cryptococcal Meningitis, Immunocompetent Host
Cryptococcal Meningitis, Immunosuppressed Host
Cryptococcosis
Esophageal Candidiasis
Fungal Endocarditis
Fungal Infection Prophylaxis
Histoplasmosis, Immunocompenent Host
Histoplasmosis, Meningitis
Leishmaniasis
Oral Thrush
Paracoccidioidomycosis
Sporotrichosis

Friday, October 21, 2016

Dipirona La Santé

Dipirona La Santé may be available in the countries listed below.

Ingredient matches for Dipirona La Santé

Metamizole

Metamizole is reported as an ingredient of Dipirona La Santé in the following countries:

Colombia

International Drug Name Search

Adacel

Generic Name: diphtheria, tetanus, and acellular pertussis booster vaccine (Intramuscular route)

ree-DOOST dif-THEER-ee-a TOX-oyd, TET-n-us TOX-oyd, per-TUS-iss VAX-een, a-SELL-yoo-lar

Commonly used brand name(s)

In the U.S.

Adacel

Boostrix

Available Dosage Forms:

Suspension

Therapeutic Class: Vaccine

Uses For Adacel

Diphtheria, tetanus, and acellular pertussis booster vaccine (also known as Tdap) is a combination immunizing agent given by injection to protect against infections caused by diphtheria, tetanus (lockjaw), and pertussis (whooping cough). This vaccine is given to children 10 years of age and older, and to adults who have already been given this vaccine in the past. The vaccine will "boost" or increase the protection that the child or adult had from an earlier dose.

Diphtheria is a serious illness that can cause breathing difficulties, heart problems, nerve damage, pneumonia, and possibly death. The risk of serious complications and death is greater in very young children and in the elderly.

Tetanus (also known as lockjaw) is a serious illness that causes convulsions (seizures) and severe muscle spasms that can be strong enough to cause bone fractures of the spine. Tetanus causes death in 30 to 40 percent of cases.

Pertussis (also known as whooping cough) is a serious disease that causes severe spells of coughing that can interfere with breathing. Pertussis also can cause pneumonia, long-lasting bronchitis, seizures, brain damage, and death.

Children 10 years of age and older, and adults, may need an additional immunization called a booster against diphtheria, tetanus, and pertussis. Adults and teenagers should receive Tdap instead of the tetanus-diphtheria (Td) injection if it has been 10 years or more since their last tetanus-diphtheria vaccine. Tdap vaccine is recommended for adults who are in close contact with a baby who is less than a year old and for adults who work in the healthcare field.

Diphtheria, tetanus, and pertussis are serious diseases that can cause life-threatening illnesses. Although some serious side effects can occur after a dose of Tdap (usually from the pertussis vaccine part), this rarely happens. The chance of your child catching one of these diseases, and being permanently injured or dying as a result, is much greater than the chance of your child getting a serious side effect from the Tdap vaccine.

This vaccine is to be administered only by or under the direct supervision of your doctor.

Before Using Adacel

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

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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

Boostrix® is not used in children younger than 10 years of age. Adacel® is not used in children younger than 11 years of age.

The Advisory Committee on Immunization Practices (ACIP) has recommended that teenagers be given a Tdap vaccine instead of the tetanus-diphtheria (Td) vaccine. The committee is also encouraging all teenagers, even those who have already received Td, to get a Tdap booster to help protect against pertussis (e.g., whooping cough). If you have questions about whether your teenager should receive Tdap, contact your doctor.

Geriatric

Adacel® is not used in adults 65 years of age and older.

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of Boostrix® in the elderly.

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.

Proper Use of diphtheria, tetanus, and acellular pertussis booster vaccine

This section provides information on the proper use of a number of products that contain diphtheria, tetanus, and acellular pertussis booster vaccine. It may not be specific to Adacel. Please read with care.

A nurse or other trained health professional will give you or your child this vaccine. This vaccine is given as a shot into one of your muscles, usually in the upper arm.

This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or nurse if you have any questions.

You or your child may receive other vaccines at the same time as this one, but in a different body area. You should receive patient instructions for all of the vaccines. Make sure you understand all of the information and talk to your doctor or nurse if you have questions.

Precautions While Using Adacel

It is very important that you call the doctor right away if you or your child have any unwanted effects after receiving the vaccine. This may include fainting, seizures, a high fever, crying that will not stop, or severe redness or swelling where the shot was given.

Tell the doctor right away if you or your child are allergic to latex rubber. The syringe tips of the Adacel® and Boostrix® vaccines contain dry natural latex rubber. This may cause an allergic reaction in patients who are sensitive to latex.

It is important to tell your doctor if you become pregnant. Your doctor may want you to join a pregnancy registry for patients receiving Boostrix® vaccine.

This vaccine will not treat an active infection. If you or your child have a diphtheria, tetanus, or pertussis infection, you will need medicine to treat the infection.

Adacel 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:

Less common

Crying for 3 or more hours

fainting

Rare

Confusion

convulsions (seizures)

difficulty with breathing or swallowing

fever of 102.2 degrees F or more

headache (severe or continuing)

hives

itching, especially of the feet or hands

low blood pressure

reddening of the skin, especially around the ears

shock-like state

sleepiness (unusual and continuing)

swelling of the eyes, face, or inside of the nose

unusual tiredness or weakness (sudden and severe)

vomiting (severe or continuing)

Incidence not known

Blood in the urine

bloody or black, tarry stools

blurred vision

chest pain or discomfort

chills

cough

dizziness

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

dry mouth

fast heartbeat

flushed, dry skin

fruit-like breath odor

inability to move the arms and legs

increased hunger

increased thirst

increased urination

large, flat, blue, or purplish patches on the skin

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

loss of consciousness

muscle pain or spasm

nausea

painful knees and ankles

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

redness and swelling on the skin, buttocks, legs, or ankles

shortness of breath

skin rash

stiff neck

stomach pain

sudden numbness and weakness in the arms and legs

sweating

tightness in the chest

trouble breathing

unexplained weight loss

unusual tiredness or weakness

wheezing

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

More common

Body aches

diarrhea

fever of 99.5 degrees F or more

headache

redness, swelling, tenderness, pain, or a lump at the place of injection

tiredness

Incidence not known

Back pain

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

injection site bruising

muscle or joint pain

swollen, painful, or tender lymph glands in the neck, armpit, or groin

weakness of the muscles in the face

welts on the skin

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

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

See also: Adacel side effects (in more detail)

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

More Adacel resources

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

Compare Adacel with other medications

Diphtheria Prophylaxis
Pertussis Prophylaxis
Tetanus Prophylaxis

Uvadex

methoxsalen

Dosage Form: injection, solution
Uvadex™

(Methoxsalen)

STERILE SOLUTION, 20 mcg/mL

Rx ONLY.

CAUTION: READ THE UVAR™ XTS™ or THERAKOS™ CELLEX™ PHOTOPHERESIS SYSTEM OPERATOR'S MANUAL PRIOR TO PRESCRIBING OR DISPENSING THIS MEDICATION.

Uvadex™ (methoxsalen) Sterile Solution should be used only by physicians who have special competence in the diagnosis and treatment of cutaneous T-cell lymphoma and who have special training and experience in the UVAR™ XTS™ or THERAKOS™ CELLEX™ Photopheresis System. Please consult the appropriate Operator's Manual before using this product.

Uvadex Description

Methoxsalen is a naturally occurring photoactive substance found in the seeds of the Ammi majus (Umbelliferae) plant. It belongs to a group of compounds known as psoralens or furocoumarins. The chemical name of methoxsalen is 9-methoxy-7H-furo[3,2-g][1]-benzopyran-7-one; it has the following structure:

Each mL of Uvadex™ (methoxsalen, 8-methoxypsoralen) Sterile Solution contains methoxsalen 20 mcg, propylene glycol 50 mg, sodium chloride 8 mg, sodium acetate 1.75 mg, ethanol 0.05 mL, glacial acetic acid 0.0012 mL, and Water for Injection q.s. to 1.0 mL.

Uvadex™ is used in combination with the UVAR™ XTS™ Photopheresis System to extracorporeally treat leukocyte enriched buffy coat.

Uvadex - Clinical Pharmacology

Mechanism of action

The exact mechanism of action of methoxsalen is not known. The best-known biochemical reaction of methoxsalen is with DNA. Methoxsalen, upon photoactivation, conjugates and forms covalent bonds with DNA which leads to the formation of both monofunctional (addition to a single strand of DNA) and bifunctional adducts (crosslinking of psoralen to both strands of DNA). Reactions with proteins have also been described.

For the palliative treatment of Cutaneous T-Cell Lymphoma, Photopheresis consists of removing a portion of the patient's blood and separating the red blood cells from the white cell layer (buffy coat) by centrifugation. The red cells are returned to the patient and the Uvadex™ Sterile Solution is then injected into the instrument and mixed with the buffy coat. The instrument then irradiates this drug-cell mixture with ultraviolet light (UVA light, 320-400 nm) and returns the treated cells to the patient. See the appropriate Operator's Manual for details of this process. Although extracorporeal phototherapy exposes less than 10% of the total body burden of malignant cells to methoxsalen plus light, some patients achieve a complete response. Animal studies suggest that the photopheresis may activate an immune-mediated response against the malignant T-cells.

Use of the UVAR™ and UVAR™ XTS™ Systems after oral administration of methoxsalen were previously approved for the treatment of Cutaneous T-Cell Lymphoma. Interpatient variability in peak plasma concentration after an oral dose of methoxsalen ranges from 6 to 15 fold. Uvadex™ is injected directly into the separated buffy coat in the instrument in an attempt to diminish this interpatient variability and to improve the exposure of the cells to the drug.

Methoxsalen is reversibly bound to serum albumin and is also preferentially taken up by epidermal cells. Methoxsalen is rapidly metabolized in humans, with approximately 95% of the drug excreted as metabolites in the urine within 24 hours.

Systemic administration of methoxsalen followed by UVA exposure leads to cell injury. The most obvious manifestation of this injury after skin exposure is delayed erythema, which may not begin for several hours and peaks at 48-72 hours. The inflammation is followed over several days to weeks, by repair which is manifested by increased melanization of the epidermis and thickening of the stratum corneum.

The total dose of methoxsalen delivered in Uvadex™ is substantially lower (approximately 200 times) than that used with oral administration.

Clinical Studies

Three single-arm studies were performed to evaluate the effectiveness of photopheresis in the treatment of the skin manifestations of Cutaneous T-Cell Lymphoma (CTCL). In the first study (CTCL 1), 39 patients were treated with the oral formulation of methoxsalen in conjunction with the UVAR™ Photopheresis System. The second study (CTCL 2) was a 5-year post approval follow-up of 57 CTCL patients that was conducted to evaluate long-term safety. This study also used the oral dosage formulation of methoxsalen. In the third study (CTCL 3), 51 patients were treated with the Uvadex™ formulation of methoxsalen in conjunction with the UVAR™ Photopheresis System. In study CTCL 3, 86% of the patients were Caucasian, the median age was 62 years, and the average number of prior therapies was 4.3

In study CTCL 1, prednisone up to 10 mg/day was permitted in addition to topical steroids. In CTCL 2, there was no concomitant medication restriction. In CTCL 3, topical steroids were permitted only for the treatment of fissures on the soles of the feet and the palms of hands. All other steroids, topical or systemic, were prohibited.

In all three studies, patients were initially treated on two consecutive days every four to five weeks. If the patient did not respond after four cycles, treatment was accelerated to two consecutive days every other week. If the patient did not respond after four cycles at the accelerated schedule, the patient was treated on two consecutive days every week. If the patient still did not respond after four cycles of weekly treatments, the schedule was increased to three consecutive days every week for three cycles. In study CTCL 3, 15 of the 17 responses were seen within six months of treatment. Only two patients responded to treatment after six months. Clinical experience does not extend beyond this treatment frequency and there is no evidence to show that treatment with Uvadex™ beyond six months or using a different schedule provided additional benefit.

Overall skin scores were used in the clinical studies of photopheresis to assess the patient's response to treatment. The patient's baseline skin score was used for comparison with subsequent scores. A 25% reduction in skin score maintained for four consecutive weeks was considered a successful response to photopheresis therapy. Table 1 indicates the percent of successful responses within six months of beginning therapy for all patients who received at least one course of photopheresis. Only patients with patch plaque, extensive plaque and erythrodermic disease were enrolled in these studies. No patients with disease in the tumor phase were treated. There are no data available regarding the efficacy of Uvadex™ in patients with disease in the tumor phase.

Table 1: Percentage of Successful Responses Within Six Months of Beginning Therapy
Study Response % Within Six Months
CTCL 3 (Uvadex™)
17/51 (33)
CTCL 2 (oral methoxsalen)
16/57 (28)
CTCL 1 (oral methoxsalen)
21/39 (54)

Although the response rate with Uvadex™ in CTCL 3 was similar to with oral methoxsalen in CTCL 2, the possibility that Uvadex™ is inferior in efficacy to oral methoxsalen cannot be excluded due to the design and size of the clinical trials. The higher response rate with oral methoxsalen in CTCL 1 may be partly due to patients receiving more treatments (mean of 64 in CTCL 1, 31 in CTCL 2, and 20 in CTCL 3), and to the administration of systemic steroids in CTCL 1.

Retrospective analyses of three clinical benefit parameters from the Body Area Severity Scores in CTCL 3 suggested a correlation between skin score response and improvement in edema, scaling and resolution of fissures.

Indications and Usage for Uvadex

Uvadex™ (methoxsalen) Sterile Solution is indicated for extracorporeal administration with the UVAR™ XTS™ or THERAKOS™ CELLEX™ Photopheresis System in the palliative treatment of the skin manifestations of Cutaneous T-Cell Lymphoma (CTCL) that is unresponsive to other forms of treatment.

Contraindications

PHOTOSENSITIVITY

Uvadex™ (methoxsalen) Sterile Solution is contraindicated in patients exhibiting idiosyncratic reactions to psoralen compounds. Patients possessing a specific history of a light sensitive disease state should not initiate methoxsalen therapy. Diseases associated with photosensitivity include lupus erythematosus, porphyria cutanea tarda, erythropoietic protoporphyria, variegate porphyria, xeroderma pigmentosum and albinism.

Uvadex™ Sterile Solution is contraindicated in patients with aphakia, because of the significantly increased risk of retinal damage due to the absence of lenses.

Warnings

Concomitant Therapy

Special care should be exercised in treating patients who are receiving concomitant therapy (either topically or systemically) with known photosensitizing agents such as anthralin, coal tar or coal tar derivatives, griseofulvin, phenothiazines, nalidixic acid, halogenated salicylanilides (bacteriostatic soaps), sulfonamides, tetracyclines, thiazides, and certain organic staining dyes such as methylene blue, toluidine blue, rose bengal and methyl orange.

Carcinogenicity, Mutagenesis, Impairment of Fertility

Oral administration of methoxsalen followed by cutaneous UVA exposure (PUVA therapy) is carcinogenic. In a prospective study of 1380 patients given PUVA therapy for psoriasis, 237 patients developed 1422 cutaneous squamous cell cancers. This observed incidence of cutaneous carcinoma is 17.6 times that expected for the general population. Previous cutaneous exposure to tar and UVB treatment, ionizing radiation or arsenic increased the risk of developing skin carcinomas after PUVA therapy. Because the dose of methoxsalen with Uvadex™ therapy is about 200 times less than with PUVA and the skin is not exposed to high cumulative doses of UVA light, the risk of developing skin cancer following Uvadex™ therapy may be lower.

Methoxsalen was carcinogenic in male rats that were given the drug by oral gavage five days per week for 103 weeks at doses of 37.5 and 75 mg/kg. The 37.5 mg/kg dose is about 1900 times greater than a single human methoxsalen dose during extracorporeal photopheresis treatment on a body surface area basis. The neoplastic lesions in rats included adenomas and adenocarcinomas of the tubular epithelium of the kidneys, carcinoma or squamous cell carcinoma of the Zymbal gland and alveolar or bronchiolar adenomas. Topical or intraperitoneal methoxsalen is a potent photo-carcinogen in albino mice and hairless mice.

With S9 activation, methoxsalen is mutagenic in the Ames test. In the absence of S9 activation and UV light, methoxsalen is clastogenic in vitro (sister chromatid exchange and chromosome aberrations in Chinese hamster ovary cells). Methoxsalen also causes DNA damage, interstrand cross-links and errors in DNA repair.

Pregnancy

Methoxsalen may cause fetal harm when given to a pregnant woman. Doses of 80 to 160 mg/kg/day given during organogenesis caused significant fetal toxicity in rats. The lowest of these doses, 80 mg/kg/day, is over 4000 times greater than a single dose of Uvadex™ on a mg/m2 basis. Fetal toxicity was associated with significant maternal weight loss, anorexia and increased relative liver weight. Signs of fetal toxicity included increased fetal mortality, increased resorptions, late fetal death, fewer fetuses per litter, and decreased fetal weight. Methoxsalen caused an increase in skeletal malformation and variations at doses of 80 mg/kg/day and above. There are no adequate and well-controlled studies of methoxsalen in pregnant women. If Uvadex™ is used during pregnancy, or if the patient becomes pregnant while receiving Uvadex™, the patient should be apprised of the potential hazard to the fetus. Women of childbearing potential should be advised to avoid becoming pregnant.

Precautions

General

ACTINIC DEGENERATION

After methoxsalen administration, exposure to sunlight and/or ultraviolet radiation may result in "premature aging" of the skin.

BASAL CELL CARCINOMAS

Patients exhibiting multiple basal cell carcinomas or having a history of basal cell carcinomas should be diligently observed and treated.

SKIN BURNING

Serious burns from either UVA or sunlight (even through window glass) can result if the recommended dosage of methoxsalen is exceeded or precautions not followed.

THE FORMATION OF CATARACTS

Exposure to large doses of UVA light causes cataracts in animals. Oral methoxsalen exacerbates this toxicity. The concentration of methoxsalen in the human lens is proportional to the concentration in serum. Serum methoxsalen concentrations are substantially lower after extracorporeal Uvadex™ treatment than after oral methoxsalen treatment. Nevertheless, if the lens is exposed to UVA light while methoxsalen is present, photoactivation of the drug may cause adducts to bind to biomolecules within the lens. If the lens is shielded from UVA light, the methoxsalen will diffuse out of the lens in about 24 hours.

Patients who use proper eye protection after PUVA therapy (oral methoxsalen) appear to have no increased risk of developing cataracts. The incidence of cataracts in these patients five years after their first treatment is about the same as that in the general population. Patients should be told emphatically to wear UVA absorbing, wrap-around sunglasses for twenty-four (24) hours after Uvadex™ treatment. They should wear these glasses any time they are exposed to direct or indirect sunlight, whether they are outdoors or exposed through a window.

Information for Patients

Patients should be told emphatically to wear UVA-absorbing, wrap-around sunglasses and cover exposed skin or use a sunblock (SP 15 or higher) for the twenty-four (24) hour period following treatment with methoxsalen, whether exposed to direct or indirect sunlight in the open or through a window glass.

Drug Interactions

See Warnings Section.

Carcinogenesis, Mutagenesis, and Impairment of Fertility

See Warnings Section.

Pregnancy

Pregnancy Category D

See Warnings Section.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when methoxsalen is administered to a nursing woman.

Pediatric Use

Safety in children has not been established. Potential hazards of long-term therapy include the possibilities of carcinogenicity and cataractogenicity as described in the Warnings Section as well as the probability of actinic degeneration which is also described in the Warnings Section.

Adverse Reactions

Side effects of photopheresis (Uvadex™ used with the THERAKOS™ Photopheresis System) were primarily related to hypotension secondary to changes in extracorporeal volume (>1%). In study CTCL 3 (Uvadex™), six serious cardiovascular adverse experiences were reported in five patients (5/51, 10%). Five of these six events were not related to photopheresis and did not interfere with the scheduled photopheresis treatments. One patient (1/51, 2%) with ischemic heart disease had an arrhythmia after the first day of photopheresis that was resolved the next day. Six infections were also reported in five patients. Two of the six events were Hickman catheter infections in one patient, which did not interrupt the scheduled photopheresis. The other four infections were not related to photopheresis and did not interfere with scheduled treatments.

Overdosage

There are no known reports of overdosage with extracorporeal administration of methoxsalen. However, in the event of overdosage, the patient should be kept in a darkened room for at least 24 hours.

DRUG DOSAGE AND ADMINISTRATION

Each Uvadex™ treatment involves collection of leukocytes, photoactivation, and reinfusion of photoactivated cells. Uvadex™ (methoxsalen) Sterile Solution is supplied in 10 mL vials containing 200 mcg of methoxsalen (concentration of 20 mcg/mL). The UVAR™ XTS™ or THERAKOS™ CELLEX™ Photopheresis System Operator's Manual should be consulted before using this product.

During treatment with the UVAR™ XTS™ or THERAKOS™ CELLEX™ Photopheresis System, the dosage of Uvadex™ for each treatment will be calculated according to the treatment volume.

The prescribed amount of Uvadex™ should be injected into the recirculation bag prior to the Photactivation Phase using the formula:

TREATMENT VOLUME X 0.017 = mL of Uvadex™ for each treatment

Example: Treatment volume of 240 mL X 0.017 = 4.1 mL of Uvadex™

Frequency/Schedule of Treatment

Normal Treatment Schedule

Treatment is given on two consecutive days every four weeks for a minimum of seven treatment cycles (six months).

Accelerated Treatment Schedule

If the assessment of the patient during the fourth treatment cycle (approximately three months) reveals an increased skin score from the baseline score, the frequency of treatment may be increased to two consecutive treatments every two weeks. If a 25% improvement in the skin score is attained after four consecutive weeks, the regular treatment schedule may resume. Patients who are maintained in the accelerated treatment schedule may receive a maximum of 20 cycles. There is no clinical evidence to show that treatment with Uvadex™ beyond six months or using a different schedule provides additional benefit. In study CTCL 3, 15 of the 17 responses were seen within six months of treatment and only two patients responded to treatment after six months.

How is Uvadex Supplied

Uvadex™ (methoxsalen) Sterile Solution 20 mcg/mL in 10 mL vials (NDC 64067-216-01), and cartons of 12 vials (NDC 64067-216-01). The drug product must be stored between 59°F (15°C) and 86°F (30°C).

REFERENCES

1.: Recommendations for the Safe Handling of Parenteral Antineoplastic Drugs, NIH Publication No. 83-2621. For sale by the Superintendent of Documents, U.S. Government Printing Office, Washington, DC 20402.
2.: AMA Council Report, Guidelines for Handling of Parenteral Antineoplastics. JAMA, 1985; 2.53 (11): 1590-1592.
3.: National Study Commission on Cytotoxic Exposure- Recommendations for Handling Cytotoxic Agents. Available from Louis P. Jeffrey, ScD., Chairman, National Study Commission on Cytotoxic Exposure, Massachusetts College of Pharmacy and Allied Health Sciences, 179 Longwood Avenue, Boston, Massachusetts 02115.
4.: Clinical Oncological Society of Australia, Guidelines and Recommendations for Safe Handling of Antineoplastic Agents. Med J Australia, 1983; 1:426-428.
5.: Jones, RB, et al. Safe Handling of Chemotherapeutic Agents: A Report from The Mount Sinai Medical Center. CA- A Cancer Journal for Clinicians, 1983;(Sept/Oct) 258-263.
6.: American Society of Hospital Pharmacists Technical Assistance Bulletin of Handling Cytotoxic and Hazardous Drugs. Am J. Hosp Pharm, 1990;47:1033-1049.
7.: Controlling Occupational Exposure to Hazardous Drugs. (OSHA Work-Practice Guidelines), AM J. Health-Syst Pharm, 1996; 53: 1669-1685.

December 2009

NDA 20-969

1460290D

Manufactured by Ben Venue Laboratories, Bedford, OH 44146-0568

For Therakos, Inc., 1001 US Highway 202, Raritan, NJ 08869-0606

PRINCIPAL DISPLAY PANEL -10 ml Carton

NDC 64067-216-01

Uvadex™

(Methoxsalen) Sterile Solution 10 ml

Exp:

Lot No:

1460287F

Uvadex
methoxsalen injection, solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	64067-216
Route of Administration	EXTRACORPOREAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Methoxsalen (Methoxsalen)	Methoxsalen	20 ug in 1 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	64067-216-01	12 VIAL In 1 CARTON	contains a VIAL, GLASS
1		10 mL In 1 VIAL, GLASS	This package is contained within the CARTON (64067-216-01)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA020969	02/25/1999

Labeler - Therakos, Inc. (180680365)

Revised: 01/2010Therakos, Inc.

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Introduction

Uses for Alimta

Malignant Pleural Mesothelioma

Non-small Cell Lung Cancer

Alimta Dosage and Administration

General

Premedication

Vitamin Supplementation

Administration

IV Administration

Reconstitution

Dilution

Rate of Administration

Dosage

Adults

Malignant Pleural Mesothelioma

IV

Non-small Cell Lung Cancer

IV

Dosage Modification for Toxicity

Hematologic Toxicity

Nonhematologic Toxicity (Except Neurotoxicity)

Neurotoxicity

Special Populations

Renal Impairment

Geriatric Patients

Cautions for Alimta

Contraindications

Warnings/Precautions

Warnings

Hematologic Toxicity

Folate and Vitamin B12 Supplementation

Fetal/Neonatal Morbidity and Mortality

Sensitivity Reactions

Dermatologic Effects

General Precautions

Adequate Patient Evaluation and Monitoring

Other Considerations

Specific Populations

Pregnancy

Lactation

Pediatric Use

Hepatic Impairment

Renal Impairment

Common Adverse Effects

Interactions for Alimta

Drugs Metabolized by Hepatic Microsomal Enzymes

Nephrotoxic Drugs

Specific Drugs

Alimta Pharmacokinetics

Absorption

Special Populations

Distribution

Plasma Protein Binding

Special Populations

Elimination

Metabolism

Elimination Route

Half-life

Special Populations

Stability

Storage

Parenteral

Powder for Injection

Compatibility

Parenteral

ActionsActions

Folate and Vitamin B₁₂ Supplementation