Online Articles Directory Barbados: September 2016

Thursday, September 29, 2016

Muchan

Muchan may be available in the countries listed below.

Ingredient matches for Muchan

Ephedrine

Ephedrine sulfate (a derivative of Ephedrine) is reported as an ingredient of Muchan in the following countries:

Argentina

International Drug Name Search

Meganox

Meganox may be available in the countries listed below.

Ingredient matches for Meganox

Lamotrigine

Lamotrigine is reported as an ingredient of Meganox in the following countries:

Chile

International Drug Name Search

Skincure Topical

Generic Name: pyrithione (Topical route)

pir-i-THYE-one

Commonly used brand name(s)

In the U.S.

2 in 1 Dandruff

Beta Med

DermaZinc

DHS Zinc

Skincure

Zincon

Available Dosage Forms:

Shampoo

Spray

Cream

Lotion

Soap

Therapeutic Class: Dermatological Agent

Chemical Class: Pyrethrums

Uses For Skincure

Pyrithione is used to help control the symptoms of dandruff and seborrheic dermatitis of the scalp.

This medicine is available without a prescription.

Before Using Skincure

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 this medicine, 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

Although there is no specific information comparing use of pyrithione in children with use in other age groups, this medicine is not expected to cause different side effects or problems in children than it does in adults.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of pyrithione in the elderly with use in other age groups, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults.

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 pyrithione

This section provides information on the proper use of a number of products that contain pyrithione. It may not be specific to Skincure. Please read with care.

For best results, use this medicine at least 2 times a week or as directed by your doctor.

To use:

Before applying this shampoo, wet the hair and scalp with lukewarm water.

Apply enough shampoo to the scalp to work up a lather and rub in well, then rinse.

Apply the shampoo again and rinse thoroughly.

Keep this medicine away from the eyes. If you should accidentally get some in your eyes, flush them thoroughly with water.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For bar dosage form:
- For dandruff and seborrheic dermatitis:
  - Adults and children—Apply to the affected skin of body, face, or scalp once a day at least two times a week. Lather, massage into affected area, rinse, and repeat.

For cream dosage forms:
- For dandruff or seborrheic dermatitis:
  - Adults and children—Apply one to three times a day to affected skin on the body, face, or scalp or as directed by the doctor.
  - For Brylcreem Antidandruff—Adults: Apply to scalp once a day after shampooing and toweling hair dry. Massage into scalp for one minute.
  - Children—Use and dose must be determined by the doctor.

For lotion dosage form:
- For dandruff and seborrheic dermatitis:
  - For DermaZinc Scalp: Adults—Apply to scalp one to three times a day or as directed by the doctor.
  - For DermaZinc Spray: Adults—Apply one spray to affected skin of body, face, or scalp one to three times a day or as directed by the doctor. Medicine should cover a three-inch-square area. Treatment should continue for one week after symptoms lessen.
  - For DermaZinc Baby: Children—Apply to affected skin of face, body, or scalp one to four times a day or as directed by the doctor.

For lotion shampoo dosage forms:
- For dandruff and seborrheic dermatitis:
  - Adults and children up to 2 years of age—Use once a day as a shampoo on the scalp at least two times a week; however, may be used every day. Apply to wet hair and leave on the scalp for several minutes or massage into scalp vigorously before rinsing.
  - Children up to 2 years of age—Use and dose must be determined by the doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Skincure

If your condition does not get better after regular use of this medicine, or if it gets worse, check with your doctor.

Skincure Side Effects

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

Check with your doctor as soon as possible if any of the following side effects occur:

Less common or rare

Irritation of 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: Skincure Topical side effects (in more detail)

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

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

Compare Skincure Topical with other medications

Dandruff
Seborrheic Dermatitis

Wednesday, September 28, 2016

Cytadren

Pronunciation: ah-MEE-no-glue-TETH-ih-mide
Generic Name: Aminoglutethimide
Brand Name: Cytadren

Cytadren is used for:

Treating Cushing syndrome in certain patients. It may also be used for other conditions as determined by your doctor.

Cytadren is an adrenal steroid inhibitor. It works by blocking the production of a variety of hormones, including glucocorticoids, mineralocorticoids, estrogens, and androgens.

Do NOT use Cytadren if:

you are allergic to any ingredient in Cytadren or to similar medications (eg, glutethimide)

you have shingles or chickenpox

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

Before using Cytadren:

Some medical conditions may interact with Cytadren. 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 an infection or the blood disease porphyria

if you are having surgery or you have been injured

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

Anticoagulants (eg, warfarin), corticosteroids (eg, dexamethasone), or digitoxin because the effectiveness of these medicines may be decreased

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

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

Cytadren may be taken with or without food.

Cytadren will initially be given in a hospital setting by a health care provider who is familiar with its use.

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

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

Important safety information:

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

Cytadren may cause dizziness or weakness. Alcohol, hot weather, exercise, and fever can increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Also, sit or lie down at the first sign of dizziness, lightheadedness, or weakness.

Alcohol may increase the risk of side effects from Cytadren. Talk to your doctor before drinking alcohol while you are taking Cytadren.

Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Cytadren.

Contact your doctor if you experience injury, infection, or illness. Your body may not respond as well to these situations, and you may need to begin taking oral corticosteroids to help your body heal.

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

Use Cytadren with caution in the ELDERLY because they may be more sensitive to its effects.

Use Cytadren with extreme caution in CHILDREN. Safety and effectiveness have not been confirmed.

PREGNANCY and BREAST-FEEDING: Cytadren has been shown to cause harm to the fetus. If you think you may be pregnant, discuss with your doctor the benefits and risks of using Cytadren during pregnancy. It is unknown if Cytadren is excreted in breast milk. Do not breast feed while taking Cytadren.

Possible side effects of Cytadren:

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:

Dizziness; drowsiness; headache; loss of appetite; muscle pain or weakness; nausea; rash; vomiting; weakness.

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; fast heartbeat; fever, chills, or sore throat; severe or prolonged dizziness; unusual tiredness; 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: Cytadren 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 extreme weakness; increase or decrease in breathing rate; loss of consciousness; severe or prolonged drowsiness or dizziness; severe or prolonged nausea or vomiting; unusual tiredness.

Proper storage of Cytadren:

Store Cytadren below 86 degrees F (30 degrees C) in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Cytadren out of the reach of children and away from pets.

General information:

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

Cytadren 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 Cytadren. 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 Cytadren resources

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

Cytadren Prescribing Information (FDA)

Cytadren Concise Consumer Information (Cerner Multum)

Cytadren Advanced Consumer (Micromedex) - Includes Dosage Information

Compare Cytadren with other medications

Breast Cancer
Cushing's Syndrome
Prostate Cancer

Tuesday, September 27, 2016

Naproxen-CT

Naproxen-CT may be available in the countries listed below.

Ingredient matches for Naproxen-CT

Naproxen

Naproxen is reported as an ingredient of Naproxen-CT in the following countries:

Germany

Luxembourg

Naproxen sodium salt (a derivative of Naproxen) is reported as an ingredient of Naproxen-CT in the following countries:

Germany

International Drug Name Search

Co-Bisoprolol Mylan

Co-Bisoprolol Mylan may be available in the countries listed below.

Ingredient matches for Co-Bisoprolol Mylan

Bisoprolol

Bisoprolol fumarate (a derivative of Bisoprolol) is reported as an ingredient of Co-Bisoprolol Mylan in the following countries:

Belgium

Hydrochlorothiazide

Hydrochlorothiazide is reported as an ingredient of Co-Bisoprolol Mylan in the following countries:

Belgium

International Drug Name Search

Remodulin

Generic Name: Treprostinil Sodium
Class: Vasodilating Agents, Miscellaneous
VA Class: CV900

Introduction

Vasodilator; a synthetic analog of prostacyclin.² ³ ¹⁵

Uses for Remodulin

Pulmonary Arterial Hypertension

Used parenterally (as a continuous sub-Q or IV infusion) for treatment of pulmonary arterial hypertension (PAH) in patients with NYHA class II–IV symptoms to reduce symptoms associated with exercise.¹ ² ³ Also used parenterally to reduce rate of clinical deterioration in PAH patients who require conversion from epoprostenol therapy; carefully consider risks and benefits of each drug prior to transition.¹

Used by oral inhalation to improve walk distance in patients with WHO group I PAH and NYHA class III symptoms.¹⁵ ¹⁶ ¹⁷ Controlled clinical experience with orally inhaled treprostinil is based primarily on short-term trials in patients receiving the drug as add-on therapy to bosentan or sildenafil.¹³ ¹⁵ ¹⁶ ¹⁷

Sub-Q or IV treprostinil recommended by the American College of Chest Physicians (ACCP) as one of several options for treatment of PAH in patients with NYHA functional class II, III, or IV disease.¹² ¹³ ²⁵ Choice of PAH therapy should be individualized; consider factors such as disease severity, route of administration, potential adverse effects, and patient preference.¹² ¹³

Designated an orphan drug by FDA for treatment of PAH.³¹

Remodulin Dosage and Administration

Administration

Administer by continuous sub-Q or IV infusion, or by oral inhalation.¹ ¹⁵

When administered parenterally, sub-Q route generally preferred; reserve IV use for patients who cannot tolerate sub-Q therapy (e.g., due to infusion-site pain or reaction) or in whom risks of IV therapy are considered warranted.¹

Sub-Q Administration

Administer undiluted drug solution by continuous sub-Q infusion via a self-inserted sub-Q catheter, using a controlled-infusion device (ambulatory infusion pump).¹ Consult manufacturer's labeling for pump specifications.¹

To avoid potential interruptions in drug delivery, patient must have immediate access to backup infusion pump and sub-Q infusion sets (since abrupt withdrawal or sudden, large dosage reductions may result in worsening of PAH symptoms).¹

For sub-Q use, administer as supplied without further dilution.¹ A single reservoir (syringe) of undiluted treprostinil may be administered for up to 72 hours at 37°C.¹

Rate of Administration

Calculate sub-Q infusion rates using the following formula:¹

sub-Q infusion rate (mL/hr) = [dose (ng/kg per minute) × wt (kg) × 0.00006] ÷ treprostinil dosage strength concentration (mg/mL)

IV Administration

For solution compatibility information, see Compatibility under Stability.

Must be diluted prior to IV administration.¹ ¹⁴ (See Dilution under Dosage and Administration.)

Administer diluted drug solution by continuous IV infusion through a permanent indwelling central venous catheter using a controlled-infusion device (ambulatory infusion pump).¹ Consult manufacturer's labeling for pump specifications.¹

A peripheral IV catheter (preferably placed in a large vein) may be used temporarily until central venous access can be established.¹

To avoid potential interruptions in drug delivery, patient must have immediate access to backup infusion pump and IV infusion sets (since abrupt withdrawal or sudden, large dosage reductions may result in worsening of PAH symptoms).¹

Consult manufacturer's labeling for additional information on administration of IV treprostinil.¹ ¹⁴

Dilution

Must be diluted with sterile water for injection, 0.9% sodium chloride injection, or Flolan sterile diluent for injection prior to IV administration. Diluted solutions are stable at 37°C for ≤48 hours at concentrations as low as 0.004 mg/mL (4000 ng/mL).¹

Add appropriate amount of drug to a sufficient volume of diluent to fill pump reservoir (typical IV infusion system reservoirs have a total capacity of 50 or 100 mL).¹ Select an infusion rate that will allow for an infusion period of ≤48 hours, and calculate concentration and amount of treprostinil required for the dilution according to the following formulas:¹

Diluted IV treprostinil concentration (mg/mL) = [dose (ng/kg per minute) × wt (kg) × 0.00006] ÷ IV infusion rate (mL/hr)

Amount of treprostinil injection (mL) = [diluted IV treprostinil concentration (mg/mL) ÷ treprostinil vial strength (mg/mL)] × total reservoir volume (mL)

Consult manufacturer's labeling for additional information on preparation of IV treprostinil.¹

Oral Inhalation

Treprostinil inhalation solution is for oral inhalation only; do not ingest.¹⁵

Administer using only the Tyvaso Inhalation System (Optineb-ir Model ON-100/7 device and related accessories).¹⁵ Patients should have access to a back-up Optineb-ir device in the event of equipment malfunction.¹⁵ Instruct patients on proper administration (including dosing frequency), use, and maintenance of Optineb-ir device.¹⁵

Administer 4 times daily during waking hours at equally spaced intervals of approximately 4 hours.¹⁵

Prior to first inhalation session, transfer entire contents of a single 2.9-mL ampul of drug into medicine cup supplied by the manufacturer.¹⁵ One ampul should contain enough drug for one day of treatment.¹⁵ ¹⁹ After each inhalation session, cap inhalation device and store upright with remaining drug inside for ≤24 hours.¹⁵ Discard medicine cup and any unused solution at end of each day and clean Optineb-ir device according to manufacturer's instructions.¹⁵

Do not mix with other drugs.¹⁵

Do not allow solution to come into contact with the eyes or skin.¹⁵

Dosage

Adults

PAH

Continuous Sub-Q or IV Infusion

Initially, 1.25 ng/kg per minute.¹ If initial dosage is not tolerated, reduce infusion rate to 0.625 ng/kg per minute.¹

Adjust dosage to achieve symptomatic improvement while minimizing adverse effects.¹ Increase infusion rate based on clinical response in increments of 1.25 ng/kg per minute at weekly intervals for the first 4 weeks and then 2.5 ng/kg per minute at weekly intervals for the remaining duration of the infusion.¹

Several months may be required to identify optimal dosage.² ⁸ ¹⁴

Oral Inhalation

Initially, 18 mcg (3 inhalations) per treatment session 4 times daily.¹⁵ If initial dosage not tolerated, reduce to 1 or 2 inhalations per treatment session, then increase up to 3 inhalations as tolerated.¹⁵ Continue to increase dose by 3 inhalations every 1–2 weeks until target maintenance dosage of 54 mcg (9 inhalations) per treatment session attained.¹⁵ If unable to titrate to target dosage, maintain patient on highest possible tolerated dosage.¹⁵

If a treatment session is missed or interrupted, resume therapy as soon as possible at usual dosage.¹⁵

Conversion from Epoprostenol to Sub-Q or IV Treprostinil Therapy

Sub-Q or IV

Perform transition in a hospital setting where patient can be closely monitored.¹

Initiate treprostinil at a dosage equivalent to 10% of the current epoprostenol dosage; gradually increase treprostinil dosage while simultaneously decreasing dosage of epoprostenol.¹ Manufacturer recommends the following titration protocol:¹

Step	Epoprostenol Dosage	Treprostinil Dosage
1	Unchanged	10% of starting epoprostenol dosage
2	80% of starting epoprostenol dosage	30% of starting epoprostenol dosage
3	60% of starting epoprostenol dosage	50% of starting epoprostenol dosage
4	40% of starting epoprostenol dosage	70% of starting epoprostenol dosage
5	20% of starting epoprostenol dosage	90% of starting epoprostenol dosage
6	5% of starting epoprostenol dosage	110% of starting epoprostenol dosage
7	0	110% of starting epoprostenol dosage + additional 5–10% increments as needed

Individually titrate treprostinil dosage to allow transition from epoprostenol therapy while balancing symptoms of PAH and prostacyclin-related adverse effects.¹ Manage any increase in PAH symptoms (e.g., shortness of breath) by initially increasing dosage of treprostinil; manage symptoms of excess prostacyclin (e.g., facial flushing, headache, jaw pain) by initially decreasing dosage of epoprostenol.¹

Other transition protocols have been used successfully.⁹ ²¹ ²² ²⁵ Limited data indicate that patients whose therapy is transitioned from epoprostenol to IV treprostinil appear to require higher average dosages of treprostinil to maintain the same clinical benefits.¹¹ ¹⁴ ²¹ ²² ²⁴ ²⁵

Prescribing Limits

Adults

PAH

Parenteral

Limited experience with dosages >40 ng/kg per minute.¹

Oral Inhalation

Maximum 54 mcg (9 inhalations) per treatment session 4 times daily.¹⁵

Special Populations

Hepatic Impairment

In patients with mild to moderate hepatic impairment, decrease initial dosage of sub-Q or IV treprostinil to 0.625 ng/kg per minute (based on ideal body weight).¹

Titrate orally inhaled treprostinil slowly in patients with hepatic impairment because of the possibility of increased systemic exposure to the drug.¹⁵

Renal Impairment

Manufacturer makes no specific dosage recommendations for patients with renal impairment;¹ titrate dosage slowly because of the possibility of increased systemic exposure to the drug.¹ ¹⁵

Geriatric Patients

Select dosage with caution because of age-related decreases in hepatic, renal, and/or cardiac function and of concomitant disease and drug therapy.¹ ¹⁵

Cautions for Remodulin

Contraindications

None known.¹

Warnings/Precautions

Warnings

Risk of Infection with IV Administration

Risk of serious and potentially fatal blood stream infections (BSI) and sepsis associated with drug delivery system (chronic indwelling central venous catheter).¹ ¹⁴ ²⁵ ²⁸ Patients must use strict aseptic technique in routine catheter care and in the preparation and administration of treprostinil.¹ Sub-Q route of administration is preferred when the drug is given parenterally.¹

Adequate Patient Evaluation and Monitoring

Use only under the supervision of a qualified clinician experienced in the diagnosis and management of PAH.¹

Initiate therapy in a setting with adequate medical personnel and equipment for providing physiologic monitoring and emergency care.¹

Therapy may be continued for prolonged periods; carefully consider patient's ability to administer the drug and care for an infusion system (when drug is given parenterally).¹

Precautions Related to Inhaled Treprostinil

Safety and efficacy of orally inhaled treprostinil not established in patients with lung disease (i.e., asthma, COPD).¹⁵ Monitor patients who develop acute pulmonary infections for any worsening of lung disease and loss of drug effect.¹⁵

Withdrawal of Therapy

Avoid abrupt withdrawal or sudden, large dosage reductions; may result in worsening of PAH symptoms.¹

Hematologic Effects

Possible increased risk of bleeding, particularly in patients receiving anticoagulant therapy.¹ ¹⁵ (See Specific Drugs under Interactions.)

Hypotensive Effects

Risk of symptomatic hypotension in patients with low systemic arterial pressure receiving orally inhaled treprostinil.¹⁵

Specific Populations

Pregnancy

Category B.¹ ¹⁵

Lactation

Not known whether treprostinil is distributed into milk;¹ ¹⁵ use with caution in nursing women.¹ ¹⁵

Pediatric Use

Parenteral treprostinil: Safety and efficacy not established in children or adolescents <16 years of age.¹ ⁸ Clinical studies did not include sufficient numbers of patients ≤16 years of age to determine whether pediatric patients respond differently than adults.¹ Titrate dosage carefully.⁸

Orally inhaled treprostinil: Safety and efficacy not established in patients <18 years of age.¹⁵

Geriatric Use

Clinical studies did not include sufficient numbers of patients ≥65 years of age to determine whether geriatric patients respond differently than younger patients.¹ ¹⁵

Hepatic Impairment

Adjust dosage of sub-Q or IV treprostinil in patients with mild to moderate hepatic impairment.¹ (See Hepatic Impairment under Dosage and Administration.)

Not studied in patients with severe hepatic impairment.¹ ¹⁵

Renal Impairment

Not studied in patients with renal impairment.¹ ¹⁵ However, possibility of reduced renal clearance of the drug in such patients.¹⁵

Common Adverse Effects

Sub-Q therapy: Infusion site pain and reaction (e.g., erythema, induration, rash).¹

IV therapy: Arm swelling, paresthesias, hematoma, pain.¹

Sub-Q and IV therapy: Headache, diarrhea, nausea, jaw pain, vasodilation, dizziness, edema, pruritus, hypotension.¹

Orally inhaled therapy: Cough and throat irritation; headache; GI effects; muscle, jaw, or bone pain; flushing; syncope.¹⁵ ¹⁶

Interactions for Remodulin

Extensively metabolized in liver, principally by CYP2C8.¹ ²⁹ Does not inhibit CYP1A2, 2A6, 2C8, 2C9, 2C19, 2D6, 2E1, or 3A in vitro.¹ ¹⁵ Does not induce CYP1A2, 2B6, 2C9, 2C19, or 3A in vitro.¹ ¹⁵ Pharmacokinetic interactions with drugs metabolized by the CYP enzyme system are considered unlikely.¹

Specific Drugs

Drug	Interaction	Comments
Acetaminophen	Pharmacokinetics of treprostinil not substantially affected¹ ¹⁵
Anticoagulants	Potential for increased risk of bleeding¹ ¹⁵ Warfarin: No clinically important interaction observed¹ ¹⁵
Antihypertensive agents	Additive hypotensive effect possible¹ ¹⁵
Bosentan	Pharmacokinetic interaction not observed with an oral formulation of treprostinil¹ ¹⁵ ²⁹
Diuretics	Additive hypotensive effect possible¹ ¹⁵
Fluconazole	Pharmacokinetics of treprostinil not substantially affected¹ ¹⁵
Gemfibrozil	Increased systemic exposure to an oral formulation of treprostinil; possible increased risk of adverse effects with treprostinil¹ ¹⁵
Rifampin	Decreased systemic exposure to an oral formulation of treprostinil; possible reduced efficacy of treprostinil¹ ¹⁵
Sildenafil	Pharmacokinetic interaction not observed with an oral formulation of treprostinil¹ ¹⁵
Vasodilating agents	Additive hypotensive effect possible¹ ¹⁵

Remodulin Pharmacokinetics

Absorption

Bioavailability

Rapidly and completely absorbed after sub-Q infusion; absolute bioavailability of 100%.¹

Sub-Q and IV treprostinil are bioequivalent at steady-state dosage of 10 ng/kg per minute.¹ ⁹ ³⁰

Mean absolute systemic bioavailability following oral inhalation is approximately 64 and 72% following doses of 18 and 36 mcg, respectively.¹⁵

Plasma Concentrations

Steady-state concentrations occur in approximately 10 hours following sub-Q administration.¹

Peak plasma concentrations of treprostinil achieved approximately 10–15 minutes after oral inhalation.¹⁸

Special Populations

Peak plasma concentrations increased by twofold or fourfold in patients with portopulmonary hypertension and mild or moderate hepatic impairment, respectively, compared with healthy individuals.¹

Distribution

Plasma Protein Binding

91%.¹ ¹⁵

Elimination

Metabolism

Extensively metabolized in liver, principally by CYP2C8; 5 metabolites described thus far.¹ ¹⁵

Elimination Route

Following sub-Q administration, excreted in urine (79%) and feces (13%).¹ ¹⁵

Half-life

Biphasic; terminal half-life of approximately 4 hours.¹ ¹⁵

Special Populations

In patients with hepatic insufficiency, clearance was reduced by up to 80% compared with healthy adults.¹ ¹⁵

In patients with renal impairment, clearance may be reduced since treprostinil and its metabolites are eliminated principally by the kidneys.¹⁵

Stability

Storage

Parenteral

Injection

25°C (may be exposed to 15–30°C).¹

May use vial for ≤30 days after initial entry.¹

May store undiluted drug in a single reservoir (syringe) for ≤72 hours at 37°C.¹

Diluted solutions of treprostinil are stable at 37°C for ≤48 hours at concentrations as low as 0.004 mg/mL (4000 ng/mL).¹

Oral Inhalation

25°C (may be exposed to 15–30°C) for unopened ampuls in unopened foil pouch.¹⁵

Use ampuls within 7 days after opening foil pouch; store unopened ampuls in pouch until use because drug is light-sensitive.¹⁵

Once drug solution is placed in medicine cup in inhalation device, use within 24 hours.¹⁵ Discard any unused solution at end of day.¹⁵

Compatibility

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

Parenteral

Solution Compatibility

Compatible¹ ^HID
Sodium chloride 0.9%
Variable^HID
Dextrose 5%

Actions

Pharmacologic actions (e.g., vasodilation of pulmonary and systemic arterial vascular beds, inhibition of platelet aggregation) similar to those of epoprostenol.² ³

In animals, vasodilatory effects reduce right and left ventricular afterload and increase cardiac output and stroke volume.¹

Causes dose-related negative inotropic and lusitropic effect.¹

Orally inhaled treprostinil exhibits high pulmonary selectivity and produces sustained pulmonary vasodilation without substantial systemic effects.¹⁸

Modest and temporary effects on QT_c interval observed following single oral inhalation doses; possibly an artifact of the rapidly changing heart rate produced by the drug.¹ ¹⁵ Effects of parenteral treprostinil on QT_c not studied.¹

Advice to Patients

Importance of advising patient that treprostinil is infused continuously through a self-inserted sub-Q or surgically placed indwelling central venous catheter, via an infusion pump, which will require a long-term commitment on the part of the patient.¹

Importance of advising patient to use sterile technique when preparing and administering drug.¹

Importance of advising patients that subsequent management of PAH may require therapy with an alternate IV prostacyclin therapy (e.g., epoprostenol).¹

Importance of understanding potential risks associated with therapy.¹

Importance of patients receiving adequate training in the proper administration and dosing of orally inhaled treprostinil, and on set-up, operation, and maintenance of the Optineb-ir device.¹⁵

Importance of having immediate access to a back-up pump and infusion sets (when administered parenterally) or a back-up Optineb-ir device (when administered via oral inhalation) in order to avoid potential interruptions in drug therapy secondary to drug delivery device failure or equipment malfunction.¹ ¹⁵

Importance of advising patients that if a scheduled treatment session of orally inhaled treprostinil is missed, treatment should be resumed as soon as possible.¹⁵

Importance of advising patients to avoid skin or eye contact with treprostinil oral inhalation solution.¹⁵ If skin or eye contact occurs, instruct patient to immediately rinse the affected area with water.¹⁵

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

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

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

Preparations

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

Treprostinil Sodium
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	Injection, for continuous sub-Q or IV infusion via controlled-infusion device only	1 mg (of treprostinil) per mL	Remodulin	United Therapeutics
		2.5 (of treprostinil) per mL	Remodulin	United Therapeutics
		5 (of treprostinil) per mL	Remodulin	United Therapeutics
		10 (of treprostinil) per mL	Remodulin	United Therapeutics
Oral Inhalation	Solution, for nebulization	0.6 mg/mL (1.74 mg)	Tyvaso (available with Tyvaso Inhalation System)	United Therapeutics

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 August 04, 2011. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

1. United Therapeutics Corp. Remodulin (treprostinil sodium) injection prescribing information. Research Triangle Park, NC; 2010 Jan.

2. Simonneau G, Barst RJ, Galie N et al. Continuous subcutaneous infusion of treprostinil, a prostacyclin analogue, in patients with pulmonary arterial hypertension: a double-blind, randomized, placebo-controlled trial. Am J Respir Crit Care Med. 2002; 165:800-4. [IDIS 480255] [PubMed 11897647]

3. Fleming T, Lindenfeld J, Lipicky R et al. Report from the 93rd Cardiovascular and renal drugs advisory committee meeting, August 9-10, 2001. Circulation. 2001; 104:1742. [PubMed 11591605]

4. Vachiery JL, Hill N, Zwicke D et al. Transitioning from i.v. epoprostenol to subcutaneous treprostinil in pulmonary arterial hypertension. Chest. 2002; 121:1561-5. [IDIS 481609] [PubMed 12006444]

5. United Therapeutics Corporation. Cardiovascular and Renal drugs Advisory Committee presentation. NDA 21-272 Remodulin (treprostinil sodium) injection. Research Triangle Park, NC: 2001 Aug 21.

6. Newman JH. Treatment of primary pulmonary hypertension the next generation. N Engl J Med. 2002; 346:933-5. [IDIS 478527] [PubMed 11907295]

7. Food and Drug Administration. Cardiovascular and Renal Drugs Advisory Committee meeting. Rockville, MD; Aug 2001. From FDA web site.

8. United Therapeutics Corp., Research Triangle Park, NC; Personal communication.

9. Rubenfire M, McLaughlin VV, Allen RP et al. Transition from IV epoprostenol to subcutaneous treprostinil in pulmonary arterial hypertension: a controlled trial. Chest. 2007; 132:757-63. [PubMed 17400684]

10. Tapson VF, Gomberg-Maitland M, McLaughlin VV et al. Safety and efficacy of IV treprostinil for pulmonary arterial hypertension: a prospective, multicenter, open-label, 12-week trial. Chest. 2006; 129:683-8. [PubMed 16537868]

11. Gomberg-Maitland M, Tapson VF, Benza RL et al. Transition from intravenous epoprostenol to intravenous treprostinil in pulmonary hypertension. Am J Respir Crit Care Med. 2005; 172:1586-9. [PubMed 16151039]

12. Badesch DB, Abman SH, Simonneau G et al. Medical therapy for pulmonary arterial hypertension: Updated ACCP evidence-based clinical practice guidelines. Chest. 2007; 131:1917-28.

13. Barst RJ, Gibbs JS, Ghofrani HA et al. Updated evidence-based treatment algorithm in pulmonary arterial hypertension. J Am Coll Cardiol. 2009; 54(1 Suppl):S78-84. [PubMed 19555861]

14. Oudiz RJ, Farber HW. Dosing considerations in the use of intravenous prostanoids in pulmonary arterial hypertension: an experience-based review. Am Heart J. 2009; 157:625-35. [PubMed 19332188]

15. United Therapeutics Corp. Tyvaso (treprostinil) inhalation solution prescribing information. Research Triangle Park, NC; 2009 Jul.

16. McLaughlin VV, Benza RL, Rubin LJ et al. Addition of inhaled treprostinil to oral therapy for pulmonary arterial hypertension: a randomized controlled clinical trial. J Am Coll Cardiol. 2010; 55:1915-22. [PubMed 20430262]

17. Channick RN, Olschewski H, Seeger W et al. Safety and efficacy of inhaled treprostinil as add-on therapy to bosentan in pulmonary arterial hypertension. J Am Coll Cardiol. 2006; 48:1433-7. [PubMed 17010807]

18. Voswinckel R, Enke B, Reichenberger F et al. Favorable effects of inhaled treprostinil in severe pulmonary hypertension: results from randomized controlled pilot studies. J Am Coll Cardiol. 2006; 48:1672-81. [PubMed 17045906]

19. United Therapeutics Corp. Tyvaso inhalation system instructions for use. Research Triangle Park, NC; 2009 Aug.

20. Oudiz RJ, Schilz RJ, Barst RJ et al. Treprostinil, a prostacyclin analogue, in pulmonary arterial hypertension associated with connective tissue disease. Chest. 2004; 126:420-7. [PubMed 15302727]

21. Sitbon O, Manes A, Jais X et al. Rapid switch from intravenous epoprostenol to intravenous treprostinil in patients with pulmonary arterial hypertension. J Cardiovasc Pharmacol. 2007; 49:1-5. [PubMed 17261956]

22. Ivy DD, Claussen L, Doran A. Transition of stable pediatric patients with pulmonary arterial hypertension from intravenous epoprostenol to intravenous treprostinil. Am J Cardiol. 2007; 99:696-8. [PubMed 17317374]

23. Barst RJ, Galie N, Naeije R et al. Long-term outcome in pulmonary arterial hypertension patients treated with subcutaneous treprostinil. Eur Respir J. 2006; 28:1195-203. [PubMed 16899485]

24. Naeije R, Huez S. Expert opinion on available options treating pulmonary arterial hypertension. Expert Opin Pharmacother. 2007; 8:2247-65. [PubMed 17927481]

25. Skoro-Sajer N, Lang I. Treprostinil for the treatment of pulmonary hypertension. Expert Opin Pharmacother. 2008; 9:1415-20. [PubMed 18473715]

26. Feldman JP, Chakinala M, Torres F et al. Treprostinil sodium improves exercise capacity when added to existing oral pulmonary arterial hypertension therapy. Chest. 2007; 132 (suppl). Abstract No. 474b.

27. Gomberg-Maitland M, McLaughlin V, Gulati M et al. Efficacy and safety of sildenafil added to treprostinil in pulmonary hypertension. Am J Cardiol. 2005; 96:1334-6. [PubMed 16253609]

28. Centers for Disease Control and Prevention (CDC). Bloodstream infections among patients treated with intravenous epoprostenol or intravenous treprostinil for pulmonary arterial hypertension--seven sites, United States, 2003-2006. MMWR Morb Mortal Wkly Rep. 2007; 56:170-2. [PubMed 17332729]

29. Gotzkowsky SK, Dingemanse J, Lai A et al. Lack of a pharmacokinetic interaction between oral treprostinil and bosentan in healthy adult volunteers. J Clin Pharmacol. 2010; 50:829-34. [PubMed 20133511]

30. Laliberte K, Arneson C, Jeffs R et al. Pharmacokinetics and steady-state bioequivalence of treprostinil sodium (Remodulin) administered by the intravenous and subcutaneous route to normal volunteers. J Cardiovasc Pharmacol. 2004; 44:209-14. [PubMed 15243302]

31. US Food and Drug Administration. Orphan designations pursuant to Section 526 of the Federal Food and Cosmetic Act as amended by the Orphan Drug Act (P.L. 97-414). Rockville, MD; [August 6, 2010]. From FDA web site.

HID. Trissel LA. Handbook on injectable drugs. 16th ed. Bethesda, MD: American Society of Health-System Pharmacists; 2011:1492-3.

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Midazolam

Midazolam is reported as an ingredient of Midazolam Normon in the following countries:

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Mixobar

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Barium Sulfate

Barium Sulfate is reported as an ingredient of Mixobar in the following countries:

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Malaseb

Malaseb may be available in the countries listed below.

In some countries, this medicine may only be approved for veterinary use.

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Chlorhexidine

Chlorhexidine digluconate (a derivative of Chlorhexidine) is reported as an ingredient of Malaseb in the following countries:

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Miconazole

Miconazole nitrate (a derivative of Miconazole) is reported as an ingredient of Malaseb in the following countries:

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International Drug Name Search

Fotex

Fotex may be available in the countries listed below.

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Tobramycin

Tobramycin is reported as an ingredient of Fotex in the following countries:

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Moxonidine Sandoz

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Moxonidine

Moxonidine is reported as an ingredient of Moxonidine Sandoz in the following countries:

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Monday, September 26, 2016

Morfine HCl PCH

Morfine HCl PCH may be available in the countries listed below.

Ingredient matches for Morfine HCl PCH

Morphine

Morphine hydrochloride (a derivative of Morphine) is reported as an ingredient of Morfine HCl PCH in the following countries:

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International Drug Name Search

Metoserpate

In some countries, this medicine may only be approved for veterinary use.

Scheme

Rec.INN

CAS registry number (Chemical Abstracts Service)

0001178-28-5

Chemical Formula

C24-H32-N2-O5

Molecular Weight

428

Therapeutic Category

Sedative agent

Chemical Name

Yohimban-16-carboxylic acid, 11,17,18-trimethoxy-, methyl ester, (3ß,16ß,17α,18α,20α)-

Foreign Names

Metoserpatum (Latin)
Metoserpat (German)
Métoserpate (French)
Metoserpato (Spanish)

Generic Names

Metoserpate (OS: BAN)
Mepireserpate (IS)
Metoserpate Hydrochloride (OS: BANM, USAN)
Su 9064 (IS)

Brand Name

Pacitran (veterinary use)
Fort Dodge Animale Health, United States

International Drug Name Search

Glossary

BAN	British Approved Name
BANM	British Approved Name (Modified)
IS	Inofficial Synonym
OS	Official Synonym
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)
USAN	United States Adopted Name

Click for further information on drug naming conventions and International Nonproprietary Names.

Medapril

Medapril may be available in the countries listed below.

Ingredient matches for Medapril

Lisinopril

Lisinopril is reported as an ingredient of Medapril in the following countries:

Romania

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Megostat

Megostat may be available in the countries listed below.

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Megestrol

Megestrol 17α-acetate (a derivative of Megestrol) is reported as an ingredient of Megostat in the following countries:

Bosnia & Herzegowina

Croatia (Hrvatska)

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Nardil

Pronunciation: FEN-el-zeen
Generic Name: Phenelzine
Brand Name: Nardil

Antidepressants may increase the risk of suicidal thoughts or actions in children, teenagers, and young adults. However, depression and certain other mental problems may also increase the risk of suicide. Talk with the patient's doctor to be sure that the benefits of using Nardil outweigh the risks.

Family and caregivers must closely watch patients who take Nardil. It is important to keep in close contact with the patient's doctor. Tell the doctor right away if the patient has symptoms like worsened depression, suicidal thoughts, or changes in behavior. Discuss any questions with the patient's doctor.

Nardil is used for:

Treating depression in patients who do not respond well to other medicines. It may also be used for other conditions as determined by your doctor.

Nardil is a monoamine oxidase inhibitor (MAOI). It works by increasing certain chemicals in the brain that help elevate mood.

Do NOT use Nardil if:

you are allergic to any ingredient in Nardil

you have a history of alcohol abuse or stroke

you have heart disease, blood vessel disease in the brain, congestive heart failure, schizophrenia, severe headaches, liver problems, abnormal liver function tests, high blood pressure, severe kidney problems, severely decreased kidney function, or an adrenal gland tumor

you will be having surgery

you eat foods with a high tyramine content (eg, aged cheeses, sour cream, red wines, beer, bologna, pepperoni, salami, summer sausage, pickled herring, liver, meat prepared with tenderizers, canned figs, raisins, bananas, avocados, soy sauce, fava beans, yeast extracts), drink alcohol, or consume large quantities of caffeine (coffee, tea, chocolate, or cola)

you are taking an amphetamine (eg, methylphenidate), an anesthetic, an anorexiant (eg, phentermine), an antihistamine (eg, loratadine), apraclonidine, brimonidine, bupropion, buspirone, carbamazepine, cyclobenzaprine, dextromethorphan, dibenzazepine, a diuretic (eg, hydrochlorothiazide), entacapone, an herbal product, indoramin, levodopa, meperidine, methylphenidate, a narcotic, nefazodone, other medicines for Parkinson disease, papaverine, a sedative, a serotonin-norepinephrine reuptake inhibitor (SNRI) (eg, atomoxetine), sibutramine, a sympathomimetic (eg, pseudoephedrine), a tetracyclic antidepressant (eg, trazodone), tolcapone, tramadol, a tricyclic antidepressant (eg, amitriptyline), or a triptan (eg, sumatriptan)

you have taken linezolid, methylene blue, an MAOI (eg, selegiline), or a selective serotonin reuptake inhibitor (SSRI) (eg, paroxetine) within the last 14 days

you have taken fluoxetine within the past 5 weeks

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

Video: Treatment for Depression

Treatments for depression are getting better everyday and there are things you can start doing right away.

Before using Nardil:

Some medical conditions may interact with Nardil. 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 breastfeeding

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 asthma, bipolar mood disorder, bronchitis, an irregular heartbeat, diabetes, epilepsy, an overactive thyroid, Parkinson disease, the blood disease porphyria, kidney problems, or suicidal thoughts or behaviors

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

Many prescription and nonprescription medicines (eg, used for diabetes, depression, headaches, pain, cold and flu, high blood pressure, seizures) may interact with Nardil and increase the risk of serious, life-threatening side effects.

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

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

Nardil comes with an additional patient information sheet called a Medication Guide. Read it carefully and reread it each time you get Nardil refilled.

Nardil may be taken with or without food.

Continue to take Nardil even if you feel better. Do not miss any doses.

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

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

Important safety information:

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

Avoid drinking alcohol or taking other medicines that cause drowsiness (eg, sedatives, tranquilizers) while taking Nardil. Nardil will add to the effects of alcohol and other depressants. Ask your pharmacist if you have questions about which medicines are depressants.

Nardil may cause dizziness, lightheadedness, or fainting. Alcohol, hot weather, exercise, and fever can increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Also, sit or lie down at the first sign of dizziness, lightheadedness, or weakness.

Children, teenagers, and young adults who take Nardil may be at increased risk for suicidal thoughts or actions. Watch all patients who take Nardil closely. Contact the doctor at once if new, worsened, or sudden symptoms such as depressed mood; anxious, restless, or irritable behavior; panic attacks; or any unusual change in mood or behavior occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur.

Avoid large amounts of food or drink that have caffeine (eg, coffee, tea, cocoa, cola, chocolate).

Nardil may cause serious increases in blood pressure if certain foods are eaten. Avoid eating foods such as aged cheeses, sour cream, red wines, beer, bologna, pepperoni, salami, summer sausage, pickled herring, liver, meat prepared with tenderizers, canned figs, raisins, bananas, avocados, soy sauce, fava beans, or yeast extracts. Obtain a complete list of foods and beverages from your doctor or pharmacist.

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

Diabetes patients - Nardil may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.

Use Nardil with caution in the ELDERLY; they may be more sensitive to its effects.

Nardil should not be used in CHILDREN younger than 16 years old; safety and effectiveness in these children have not been confirmed. CHILDREN taking Nardil may be at increased risk for suicidal thoughts or behaviors.

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

If you stop taking Nardil suddenly, you may have WITHDRAWAL symptoms. These may include nausea, vomiting, and a general feeling of discomfort.

Possible side effects of Nardil:

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:

Changes in sexual function; constipation; dizziness; drowsiness; headache; sleeping problems; tiredness; tremors; twitching; unusual muscle movements; upset stomach; weakness; weight gain.

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); agitation; changes in heartbeat; chest pain; difficulty sleeping; feelings of irritability or hostility; impulsive behavior or other unusual changes in behavior; mental or mood changes; nausea; neck stiffness; panic attacks; severe anxiety or nervousness; severe headache; severe restlessness; suicidal thoughts or behaviors; urination problems; vomiting; worsening feelings of depression.

See also: Nardil 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 confusion; dizziness; drowsiness; excitement; fast heartbeat; flushing; irritability; restlessness; seizures; sweating; weakness.

Proper storage of Nardil:

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

General information:

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

Nardil 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 Nardil. 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

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UK matches:

Tridestra (SPC)

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Glossary

SPC

Summary of Product Characteristics (UK)

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Meglumine Amidotrizoate Injection

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Meglumine Amidotrizoate Injection (JAN) is also known as Diatrizoic acid (USAN)

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Glossary

JAN	Japanese Accepted Name
USAN	United States Adopted Name

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Unitears

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Melphalan

Dosage Form: injection
Melphalan Hydrochloride for Injection

WARNING

Melphalan should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. Severe bone marrow suppression with resulting infection or bleeding may occur. Controlled trials comparing intravenous (IV) to oral Melphalan have shown more myelosuppression with the IV formulation. Hypersensitivity reactions, including anaphylaxis, have occured in approximately 2% of patients who received the IV formulation. Melphalan is leukemogenic in humans. Melphalan produces chromosomal aberrations in vitro and in vivo and, therefore, should be considered potentially mutagenic in humans.

Melphalan Description

Melphalan, also known as L-phenylalanine mustard, phenylalanine mustard, L-PAM, or L-sarcolysin, is a phenylalanine derivative of nitrogen mustard. Melphalan is a bifunctional alkylating agent that is active against selected human neoplastic diseases. It is known chemically as 4-[bis(2-chloroethyl)amino]-L-phenylalanine. The molecular formula is C13H18Cl2N2O2 and the molecular weight is 305.20. The structural formula is:

Melphalan is the active L-isomer of the compound and was first synthesized in 1953 by Bergel and Stock; the D-isomer, known as medphalan, is less active against certain animal tumors, and the dose needed to produce effects on chromosomes is larger than that required with the L-isomer. The racemic (DL-) form is known as merphalan or sarcolysin.

Melphalan is practically insoluble in water and has a pKa1 of~2.5.

Melphalan Hydrochloride for Injection is supplied as a sterile, nonpyrogenic, freeze-dried powder. Each single-use vial contains Melphalan hydrochloride equivalent to 50 mg Melphalan and the inactive ingredient povidone 20 mg. Melphalan Hydrochloride for Injection is reconstituted using the sterile diluent provided. Each vial of sterile diluent contains sodium citrate 0.2 g, propylene glycol 6.0 mL, ethanol (96%) 0.52 mL, and Water for Injection to a total of 10 mL. Melphalan Hydrochloride for Injection is administered intravenously.

Melphalan - Clinical Pharmacology

Melphalan is an alkylating agent of the bischloroethylamine type. As a result, its cytotoxicity appears to be related to the extent of its interstrand cross-linking with DNA, probably by binding at the N7 position of guanine. Like other bifunctional alkylating agents, it is active against both resting and rapidly dividing tumor cells.

Pharmacokinetics

The pharmacokinetics of Melphalan after IV administration has been extensively studied in adult patients. Following injection, drug plasma concentrations declined rapidly in a biexponential manner with distribution phase and terminal elimination phase half-lives of approximately 10 and 75 minutes, respectively. Estimates of average total body clearance varied among studies, but typical values of approximately 7 to 9 mL/min/kg (250 to 325 mL/min/m2) were observed. One study has reported that on repeat dosing of 0.5 mg/kg every 6 weeks, the clearance of Melphalan decreased from 8.1 mL/min/kg after the first course, to 5.5 mL/min/kg after the third course, but did not decrease appreciably after the third course. Mean (±SD) peak Melphalan plasma concentrations in myeloma patients given IV Melphalan at doses of 10 or 20 mg/m2 were 1.2 ± 0.4 and 2.8 ± 1.9 mcg/mL, respectively.

The steady-state volume of distribution of Melphalan is 0.5 L/kg. Penetration into cerebrospinal fluid (CSF) is low. The extent of Melphalan binding to plasma proteins ranges from 60% to 90%. Serum albumin is the major binding protein, while α 1-acid glycoprotein appears to account for about 20% of the plasma protein binding. Approximately 30% of the drug is (covalently) irreversibly bound to plasma proteins. Interactions with immunoglobulins have been found to be negligible.

Melphalan is eliminated from plasma primarily by chemical hydrolysis to monohydroxyMelphalan and dihydroxyMelphalan. Aside from these hydrolysis products, no other Melphalan metabolites have been observed in humans. Although the contribution of renal elimination to Melphalan clearance appears to be low, one study noted an increase in the occurrence of severe leukopenia in patients with elevated BUN after 10 weeks of therapy.

CLINICAL TRIAL

A randomized trial compared prednisone plus IV Melphalan to prednisone plus oral Melphalan in the treatment of myeloma. As discussed below, overall response rates at week 22 were comparable; however, because of changes in trial design, conclusions as to the relative activity of the 2 formulations after week 22 are impossible to make.

Both arms received oral prednisone starting at 0.8 mg/kg/day with doses tapered over 6 weeks. Melphalan doses in each arm were:

Arm 1 Oral Melphalan 0.15 mg/kg/day × 7 followed by 0.05 mg/kg/day when WBC began to rise.

Arm 2 IV Melphalan 16 mg/m2 q 2 weeks × 4 (over 6 weeks) followed by the same dose every 4 weeks.

Doses of Melphalan were adjusted according to the following criteria:

Table 1. Criteria for Dosage Adjustment in a Randomized Clinical Trial
WBC/mm3	Platelets	Percent of Full Dose
≥4,000	≥100,000	100
≥3,000	≥75,000	75
≥2,000	≥50,000	50
<2,000	<50,000	0

One hundred seven patients were randomized to the oral Melphalan arm and 203 patients to the IV Melphalan arm. More patients had a poor-risk classification (58% versus 44%) and high tumor load (51% versus 34%) on the oral compared to the IV arm (P<0.04).

Response rates at week 22 are shown in the following table:

Table 2. Response Rates at Week 22
Initial Arm	Evaluable Patients	Responders n (%)	P
Oral Melphalan	100	44 (44%)	P>0.2
IV Melphalan	195	74 (38%)

Because of changes in protocol design after week 22, other efficacy parameters such as response duration and survival cannot be compared.

Severe myelotoxicity (WBC ≤1,000 and/or platelets ≤25,000) was more common in the IV Melphalan arm (28%) than in the oral Melphalan arm (11%).

An association was noted between poor renal function and myelosuppression; consequently, an amendment to the protocol required a 50% reduction in IV Melphalan dose if the BUN was ≥30 mg/dL. The rate of severe leukopenia in the IV arm in the patients with BUN over 30 mg/dL decreased from 50% (8/16) before protocol amendment to 11% (3/28) (P = 0.01) after the amendment.

Before the dosing amendment, there was a 10% (8/77) incidence of drug-related death in the IV arm. After the dosing amendment, this incidence was 3% (3/108). This compares to an overall 1% (1/100) incidence of drug-related death in the oral arm.

Indications and Usage for Melphalan

Melphalan Hydrochloride for Injection is indicated for the palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate.

Contraindications

Melphalan should not be used in patients whose disease has demonstrated prior resistance to this agent. Patients who have demonstrated hypersensitivity to Melphalan should not be given the drug.

Warnings

Melphalan Hydrochloride for Injection may cause local tissue damage should extravasation occur, and consequently it should not be administered by direct injection into a peripheral vein. It is recommended that Melphalan Hydrochloride for Injection be administered by injecting slowly into a fast-running IV infusion via an injection port, or via a central venous line (see DOSAGE AND ADMINISTRATION: Administration Precautions).

Melphalan should be administered in carefully adjusted dosage by or under the supervision of experienced physicians who are familiar with the drug's actions and the possible complications of its use.

As with other nitrogen mustard drugs, excessive dosage will produce marked bone marrow suppression. Bone marrow suppression is the most significant toxicity associated with Melphalan Hydrochloride for Injection in most patients. Therefore, the following tests should be performed at the start of therapy and prior to each subsequent dose of Melphalan Hydrochloride: platelet count, hemoglobin, white blood cell count, and differential. Thrombocytopenia and/or leukopenia are indications to withhold further therapy until the blood counts have sufficiently recovered. Frequent blood counts are essential to determine optimal dosage and to avoid toxicity. Dose adjustment on the basis of blood counts at the nadir and day of treatment should be considered.

Hypersensitivity reactions including anaphylaxis have occurred in approximately 2% of patients who received the IV formulation (see ADVERSE REACTIONS). These reactions usually occur after multiple courses of treatment. Treatment is symptomatic. The infusion should be terminated immediately, followed by the administration of volume expanders, pressor agents, corticosteroids, or antihistamines at the discretion of the physician. If a hypersensitivity reaction occurs, IV or oral Melphalan should not be readministered since hypersensitivity reactions have also been reported with oral Melphalan.

Carcinogenesis

Secondary malignancies, including acute nonlymphocytic leukemia, myeloproliferative syndrome, and carcinoma, have been reported in patients with cancer treated with alkylating agents (including Melphalan). Some patients also received other chemotherapeutic agents or radiation therapy. Precise quantitation of the risk of acute leukemia, myeloproliferative syndrome, or carcinoma is not possible. Published reports of leukemia in patients who have received Melphalan (and other alkylating agents) suggest that the risk of leukemogenesis increases with chronicity of treatment and with cumulative dose. In one study, the 10-year cumulative risk of developing acute leukemia or myeloproliferative syndrome after oral Melphalan therapy was 19.5% for cumulative doses ranging from 730 to 9,652 mg. In this same study, as well as in an additional study, the 10-year cumulative risk of developing acute leukemia or myeloproliferative syndrome after oral Melphalan therapy was less than 2% for cumulative doses under 600 mg. This does not mean that there is a cumulative dose below which there is no risk of the induction of secondary malignancy. The potential benefits from Melphalan therapy must be weighed on an individual basis against the possible risk of the induction of a second malignancy.

Adequate and well-controlled carcinogenicity studies have not been conducted in animals. However, intraperitoneal (IP) administration of Melphalan in rats (5.4 to 10.8 mg/m2) and in mice (2.25 to 4.5 mg/m2) 3 times per week for 6 months followed by 12 months post-dose observation produced peritoneal sarcoma and lung tumors, respectively.

Mutagenesis

Melphalan has been shown to cause chromatid or chromosome damage in humans. Intramuscular administration of Melphalan at 6 and 60 mg/m2 produced structural aberrations of the chromatid and chromosomes in bone marrow cells of Wistar rats.

Impairment of Fertility

Melphalan causes suppression of ovarian function in premenopausal women, resulting in amenorrhea in a significant number of patients. Reversible and irreversible testicular suppression have also been reported.

Pregnancy

Pregnancy Category D

Melphalan may cause fetal harm when administered to a pregnant woman. While adequate animal studies have not been conducted with IV Melphalan, oral (6 to 18 mg/m2/day for 10 days) and IP (18 mg/m2) administration in rats was embryolethal and teratogenic. Malformations resulting from Melphalan included alterations of the brain (underdevelopment, deformation, meningocele, and encephalocele) and eye (anophthalmia and microphthalmos), reduction of the mandible and tail, as well as hepatocele (exomphaly). There are no adequate and well-controlled studies in pregnant women. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, 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

In all instances where the use of Melphalan Hydrochloride for Injection is considered for chemotherapy, the physician must evaluate the need and usefulness of the drug against the risk of adverse events. Melphalan should be used with extreme caution in patients whose bone marrow reserve may have been compromised by prior irradiation or chemotherapy or whose marrow function is recovering from previous cytotoxic therapy.

Dose reduction should be considered in patients with renal insufficiency receiving IV Melphalan. In one trial, increased bone marrow suppression was observed in patients with BUN levels ≥30 mg/dL. A 50% reduction in the IV Melphalan dose decreased the incidence of severe bone marrow suppression in the latter portion of this study.

Administration of live vaccines to immunocompromised patients should be avoided.

Information for Patients

Patients should be informed that the major acute toxicities of Melphalan are related to bone marrow suppression, hypersensitivity reactions, gastrointestinal toxicity, and pulmonary toxicity. The major long-term toxicities are related to infertility and secondary malignancies. Patients should never be allowed to take the drug without close medical supervision and should be advised to consult their physicians if they experience skin rash, signs or symptoms of vasculitis, bleeding, fever, persistent cough, nausea, vomiting, amenorrhea, weight loss, or unusual lumps/masses. Women of childbearing potential should be advised to avoid becoming pregnant.

Laboratory Tests

Periodic complete blood counts with differentials should be performed during the course of treatment with Melphalan. At least 1 determination should be obtained prior to each dose. Patients should be observed closely for consequences of bone marrow suppression, which include severe infections, bleeding, and symptomatic anemia (see WARNINGS).

Drug Interactions

The development of severe renal failure has been reported in patients treated with a single dose of IV Melphalan followed by standard oral doses of cyclosporine. Cisplatin may affect Melphalan kinetics by inducing renal dysfunction and subsequently altering Melphalan clearance. IV Melphalan may also reduce the threshold for BCNU lung toxicity. When nalidixic acid and IV Melphalan are given simultaneously, the incidence of severe hemorrhagic necrotic enterocolitis has been reported to increase in pediatric patients.

Carcinogenesis, Mutagenesis, Impairment of Fertility

See WARNINGS section.

Pregnancy

Teratogenic Effects

Pregnancy Category D

See WARNINGS section

Nursing Mothers

It is not known whether this drug is excreted in human milk. IV Melphalan should not be given to nursing mothers.

Pediatric Use

The safety and effectiveness in pediatric patients have not been established.

Geriatric Use

Clinical studies of Melphalan Hydrochloride for Injection did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Adverse Reactions

(SEE OVERDOSAGE)

The following information on adverse reactions is based on data from both oral and IV administration of Melphalan as a single agent, using several different dose schedules for treatment of a wide variety of malignancies.

Hematologic

The most common side effect is bone marrow suppression leading to leukopenia, thrombocytopenia, and anemia. White blood cell count and platelet count nadirs usually occur 2 to 3 weeks after treatment, with recovery in 4 to 5 weeks after treatment. Irreversible bone marrow failure has been reported.

Gastrointestinal

Gastrointestinal disturbances such as nausea and vomiting, diarrhea, and oral ulceration occur infrequently. Hepatic disorders ranging from abnormal liver function tests to clinical manifestations such as hepatitis and jaundice have been reported. Hepatic veno-occlusive disease has been reported.

Hypersensitivity

Acute hypersensitivity reactions including anaphylaxis were reported in 2.4% of 425 patients receiving Melphalan Hydrochloride for Injection for myeloma (see WARNINGS). These reactions were characterized by urticaria, pruritus, edema, skin rashes, and in some patients, tachycardia, bronchospasm, dyspnea, and hypotension. These patients appeared to respond to antihistamine and corticosteroid therapy. If a hypersensitivity reaction occurs, IV or oral Melphalan should not be readministered since hypersensitivity reactions have also been reported with oral Melphalan. Cardiac arrest has also been reported rarely in association with such reports.

Miscellaneous

Other reported adverse reactions include skin hypersensitivity, skin ulceration at injection site, skin necrosis rarely requiring skin grafting, maculopapular rashes, vasculitis, alopecia, hemolytic anemia, allergic reaction, pulmonary fibrosis (including fatal outcomes), and interstitial pneumonitis. Temporary significant elevation of the blood urea has been seen in the early stages of therapy in patients with renal damage. Subjective and transient sensation of warmth and/or tingling.

Overdosage

Overdoses resulting in death have been reported. Overdoses, including doses up to 290 mg/m2, have produced the following symptoms: severe nausea and vomiting, decreased consciousness, convulsions, muscular paralysis, and cholinomimetic effects. Severe mucositis, stomatitis, colitis, diarrhea, and hemorrhage of the gastrointestinal tract occur at high doses (>100 mg/m2). Elevations in liver enzymes and veno-occlusive disease occur infrequently. Significant hyponatremia caused by an associated inappropriate secretion of ADH syndrome has been observed. Nephrotoxicity and adult respiratory distress syndrome have been reported rarely. The principal toxic effect is bone marrow suppression. Hematologic parameters should be closely followed for 3 to 6 weeks. An uncontrolled study suggests that administration of autologous bone marrow or hematopoietic growth factors (i.e., sargramostim, filgrastim) may shorten the period of pancytopenia. General supportive measures together with appropriate blood transfusions and antibiotics should be instituted as deemed necessary by the physician. This drug is not removed from plasma to any significant degree by hemodialysis or hemoperfusion. A pediatric patient survived a 254-mg/m2 overdose treated with standard supportive care.

Melphalan Dosage and Administration

The usual IV dose is 16 mg/m2. Dosage reduction of up to 50% should be considered in patients with renal insufficiency (BUN ≥30 mg/dL) (see PRECAUTIONS: General). The drug is administered as a single infusion over 15 to 20 minutes. Melphalan is administered at 2-week intervals for 4 doses, then, after adequate recovery from toxicity, at 4-week intervals. Available evidence suggests about one third to one half of the patients with multiple myeloma show a favorable response to the drug. Experience with oral Melphalan suggests that repeated courses should be given since improvement may continue slowly over many months, and the maximum benefit may be missed if treatment is abandoned prematurely. Dose adjustment on the basis of blood cell counts at the nadir and day of treatment should be considered.

Administration Precautions

As with other toxic compounds, caution should be exercised in handling and preparing the solution of Melphalan Hydrochloride. Skin reactions associated with accidental exposure may occur. The use of gloves is recommended. If the solution of Melphalan Hydrochloride contacts the skin or mucosa, immediately wash the skin or mucosa thoroughly with soap and water.

Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on this subject have been published. 1-8 There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate.

Parenteral drug products should be visually inspected for particulate matter and discoloration prior to administration whenever solution and container permit. If either occurs, do not use this product.

Care should be taken to avoid possible extravasation of Melphalan and in cases of poor peripheral venous access, consideration should be given to use of a central venous line (see WARNINGS).

Preparation for Administration/Stability

Melphalan Hydrochloride for Injection must be reconstituted by rapidly injecting 10 mL of the supplied diluent directly into the vial of lyophilized powder using a sterile needle (20-gauge or larger needle diameter) and syringe. Immediately shake vial vigorously until a clear solution is obtained. This provides a 5-mg/mL solution of Melphalan. Rapid addition of the diluent followed by immediate vigorous shaking is important for proper dissolution.

Immediately dilute the dose to be administered in 0.9% Sodium Chloride Injection, USP, to a concentration not greater than 0.45 mg/mL.

Administer the diluted product over a minimum of 15 minutes.

Complete administration within 60 minutes of reconstitution.

The time between reconstitution/dilution and administration of Melphalan Hydrochloride for Injection should be kept to a minimum because reconstituted and diluted solutions of Melphalan Hydrochloride for Injection are unstable. Over as short a time as 30 minutes, a citrate derivative of Melphalan has been detected in reconstituted material from the reaction of Melphalan Hydrochloride with Sterile Diluent for Melphalan Hydrochloride for Injection. Upon further dilution with saline, nearly 1% label strength of Melphalan hydrolyzes every 10 minutes.

A precipitate forms if the reconstituted solution is stored at 5°C. DO NOT REFRIGERATE THE RECONSTITUTED PRODUCT.

How is Melphalan Supplied

Melphalan Hydrochloride for Injection is supplied in a carton containing one single-use clear glass vial of freeze-dried Melphalan hydrochloride equivalent to 50 mg Melphalan and one 10-mL clear glass vial of sterile diluent.

NDC 67457-195-01

NOVAPLUS® NDC 67457-215-01

Novation, the supply company of VHA and UHC, and NOVAPLUS are trademarks of Novation LLC.

Store between 20° to 25°C (68° - 77°F). [See USP for Controlled Room Temperature]. Protect from light.

REFERENCES

ONS Clinical Practice Committee. Cancer Chemotherapy Guidelines and Recommendations for Practice. Pittsburg, PA: Oncology Nursing Society; 1999:32-41.

Recommendations for the safe handling of parenteral antineoplastic drugs. Washington, DC: Division of Safety, Clinical Center Pharmacy Department and Cancer Nursing Services, National Institutes of Health; 1992. US Dept of Health and Human Services. Public Health Service publication NIH 92-2621.

AMA Council on Scientific Affairs. Guidelines for handling parenteral antineoplastics. JAMA. 1985;253:1590-1591.

National Study Commission on Cytotoxic Exposure. Recommendations for handling cytotoxic agents. 1987. Available from Louis P. Jeffrey, Chairman, National Study Commission on Cytotoxic Exposure. Massachusetts College of Pharmacy and Allied Health Sciences, 179 Longwood Avenue, Boston, MA 02115.

Clinical Oncological Society of Australia. Guidelines and recommendations for safe handling of antineoplastic agents. Med J Australia. 1983;1:426-428.

Jones RB, Frank R, Mass T. Safe handling of chemotherapeutic agents: a report from the Mount Sinai Medical Center. CA-A Cancer J for Clin. 1983;33:258-263.

American Society of Hospital Pharmacists. ASHP technical assistance bulletin on handling cytotoxic and hazardous drugs. Am J Hosp Pharm. 1990;47:1033-1049.

Controlling Occupational Exposure to Hazardous Drugs. (OSHA Work-Practice Guidelines.) Am J Health-Syst Pharm. 1996;53:1669-1685.

Melphalan for Injection manufactured for:

Bioniche Pharma USA LLC,

Lake Forest, IL 60045

Made in Italy

August 2008

P080815

PRINCIPAL DISPLAY PANEL - 50 mg Carton

SINGLE USE

NDC 67457-195-01

Rx Only

Melphalan

Hydrochloride

for Injection

50 mg*

Cytotoxic Agent

*Each vial of Melphalan for injection contains

Melphalan hydrochloride equivalent to 50 mg

Melphalan and 20 mg povidone.

One vial of sterile, nonpyrogenic diluent containing

0.2 g sodium citrate, 6.0 mL propylene glycol,

0.52 mL ethanol (95%), and Water for Injection

to a total of 10 mL.

For intravenous infusion

BIONICHEPHARMA

PRINCIPAL DISPLAY PANEL - 50 mg Carton

NDC 67457-215-01

Melphalan

Hydrochloride

for Injection

50 mg*

For intravenous infusion

Cytotoxic Agent – SINGLE USE

*Each vial of Melphalan for injection contains Melphalan

hydrochloride equivalent to 50 mg Melphalan and 20 mg

povidone.

One vial of sterile, nonpyrogenic diluent containing 0.2 g

sodium citrate, 6.0 mL propylene glycol, 0.52 mL ethanol

(95%), and Water for Injection to a total of 10 mL.

Rx Only

NOVAPLUS®

Melphalan HYDROCHLORIDE
Melphalan hydrochloride kit

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	67457-195

Packaging
#	NDC	Package Description	Multilevel Packaging
1	67457-195-01	1 KIT In 1 CARTON	None

QUANTITY OF PARTS
Part #	Package Quantity	Total Product Quantity
Part 1	1 VIAL, GLASS	10 mL
Part 2	1 VIAL, GLASS	10 mL

Part 1 of 2

Melphalan HYDROCHLORIDE
Melphalan hydrochloride injection, powder, for solution

Product Information
NDC Product Code (Source)	67457-193
Route of Administration	INTRAVENOUS	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Melphalan Hydrochloride (Melphalan)	Melphalan Hydrochloride	50 mg in 10 mL

Inactive Ingredients
Ingredient Name	Strength
povidone	20 mg in 10 mL

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	67457-193-50	10 mL In 1 VIAL, GLASS	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA090270	10/06/2009

Part 2 of 2

STERILE DILUENT
sodium citrate, propylene glycol and water injection, solution

Product Information
NDC Product Code (Source)	67457-194
Route of Administration	INTRAVENOUS	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
No Active Ingredients Found

Inactive Ingredients
Ingredient Name	Strength
Sodium Citrate	0.2 g in 10 mL
propylene glycol	0.52 mL in 10 mL
Water

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	67457-194-10	10 mL In 1 VIAL, GLASS	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA090270	10/06/2009

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA090270	01/21/2011

Melphalan HYDROCHLORIDE
Melphalan hydrochloride kit

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	67457-215

Packaging
#	NDC	Package Description	Multilevel Packaging
1	67457-215-01	1 KIT In 1 CARTON	None

QUANTITY OF PARTS
Part #	Package Quantity	Total Product Quantity
Part 1	1 VIAL, GLASS	10 mL
Part 2	1 VIAL, GLASS	10 mL

Part 1 of 2

Melphalan HYDROCHLORIDE
Melphalan hydrochloride injection, powder, for solution

Product Information
NDC Product Code (Source)	67457-213
Route of Administration	INTRAVENOUS	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Melphalan Hydrochloride (Melphalan)	Melphalan Hydrochloride	50 mg in 10 mL

Inactive Ingredients
Ingredient Name	Strength
povidone	20 mg in 10 mL

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	67457-213-50	10 mL In 1 VIAL, GLASS	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA090270	10/06/2009

Part 2 of 2

STERILE DILUENT
sodium citrate, propylene glycol and water injection, solution

Product Information

Route of Administration	INTRAVENOUS	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
No Active Ingredients Found

Inactive Ingredients
Ingredient Name	Strength
Sodium Citrate	0.2 g in 10 mL
propylene glycol	0.52 mL in 10 mL
Water

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#

Thursday, September 29, 2016

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Wednesday, September 28, 2016

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Tuesday, September 27, 2016

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Introduction

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