Alkeran IV

Generic Name: melphalan (Intravenous route)

MEL-fa-lan

Intravenous route(Powder for Solution)

Severe bone marrow suppression with resulting infection or bleeding may occur. The IV formulation has shown more myelosuppression than oral melphalan. Hypersensitivity reactions, including anaphylaxis, have occurred in patients who received the IV formulation. Melphalan is leukemogenic in humans and produces chromosomal aberrations in vitro and in vivo and, therefore, should be considered potentially mutagenic in humans .

Commonly used brand name(s)

In the U.S.

• Alkeran IV

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Alkylating Agent

Chemical Class: Nitrogen Mustard

Uses For Alkeran IV

Melphalan is used to treat multiple myeloma, which is a cancer in the bone marrow .

Melphalan belongs to the group of medicines called alkylating agents. It works by interfering with the growth of cancer cells, which are eventually destroyed. Since the growth of normal body cells may also be affected by melphalan, other effects will also occur. Some of these may be serious and must be reported to your doctor. Other effects may not be serious, but may cause concern. Some effects may not occur for months or years after the medicine is used .

Before you begin treatment with melphalan, you and your doctor should talk about the good this medicine will do as well as the risks of using it .

This medicine is available only with your doctor's prescription .

Before Using Alkeran IV

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

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

Geriatric

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

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

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. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Rotavirus Vaccine, Live

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

• Adenovirus Vaccine Type 4, Live


• Adenovirus Vaccine Type 7, Live


• Bacillus of Calmette and Guerin Vaccine, Live


• Influenza Virus Vaccine, Live


• Measles Virus Vaccine, Live


• Mumps Virus Vaccine, Live


• Rotavirus Vaccine, Live


• Rubella Virus Vaccine, Live


• Smallpox Vaccine


• Typhoid Vaccine


• Varicella Virus Vaccine


• Yellow Fever Vaccine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Buthionine Sulfoximine


• Nalidixic Acid

Interactions with Food/Tobacco/Alcohol

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

Other Medical Problems

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

• Bone marrow suppression or


• Leukopenia (low white blood cells in the blood) or


• Thrombocytopenia (low platelets in the blood)—May make these conditions worse .

• Infection—May decrease your body’s ability to fight infections .

• Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body .

Proper Use of Alkeran IV

You will receive this medicine while you are in a hospital or cancer treatment center. A nurse or other trained health professional will give you this medicine. This medicine is given through a needle placed in one of your veins .

Precautions While Using Alkeran IV

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects .

This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have itching; hives; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth while you are using this medicine .

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away. You should not breastfeed during treatment with melphalan .

If you plan to have children, talk with your doctor before using this medicine. Some men and women using this medicine have become infertile (unable to have children) .

While you are being treated with melphalan, and after you stop treatment with it, do not have any immunizations (vaccines) without your doctor's approval. Melphalan may lower your body's resistance, and there is a chance you might get the infection the vaccine is meant to prevent. In addition, other persons living in your household should not receive certain vaccines, since there is a chance they could pass the infection on to you. If you have questions about this, talk to your doctor .

Melphalan can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.


• Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in urine or stools; or pinpoint red spots on your skin.


• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.


• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.


• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.


• Avoid contact sports or other situations where bruising or injury could occur .

Alkeran IV 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 immediately if any of the following side effects occur:

More common

• Chest pain


• chills


• cough or hoarseness


• fever


• lower back or side pain


• painful or difficult urination


• shortness of breath


• sores, ulcers, or white spots on the lips or in the mouth


• swollen glands


• unusual bleeding or bruising


• unusual tiredness or weakness

Incidence not known

• Abdominal or stomach pain


• absent, missed, or irregular menstrual periods


• back or leg pains


• bleeding gums


• bloated abdomen


• blurred vision


• clay-colored stools


• confusion


• dark urine


• difficult or labored breathing


• difficulty swallowing


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


• fast, pounding, or irregular heartbeat or pulse


• general body swelling


• headache


• hives


• indigestion


• itching


• light-colored stools


• loss of appetite


• nausea and vomiting


• noisy breathing


• nosebleeds


• pain and fullness in right upper abdomen


• pale skin


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


• rash


• reddening of the skin, especially around ears swelling of eyes, face, or inside of nose


• skin rash


• sore throat


• sweating


• swelling of face, hands, ankles, feet, or lower legs


• tightness in chest


• unpleasant breath odor


• unusual lumps or masses


• vomiting of blood


• weight gain


• weight loss


• wheezing


• yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Black, tarry stools


• blood in urine


• bloody stools


• change in frequency of urination or amount of urine


• coma


• convulsions


• cracked lips


• decrease in consciousness


• diarrhea


• drowsiness


• flushing of skin or feeling of warmth


• increased salivation or sweating


• increased thirst


• muscle pain or cramps


• no muscle tone or movement


• seizures


• severe nausea and vomiting


• stomach discomfort, cramps, or tenderness


• swelling or inflammation of the mouth


• troubled breathing


• vomiting of material that looks like coffee grounds


• watery or bloody diarrhea


• weakness

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

Less common

• Indigestion


• passing of gas


• stomach fullness

Incidence not known

• Blue-green to black skin discoloration


• hair loss, thinning of hair


• pain, redness, soreness, or sloughing of skin at place of injection


• sores, welting, or blisters

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: Alkeran IV side effects (in more detail)

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More Alkeran IV resources

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

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• Multiple Myeloma
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Aliskiren/Amlodipine

Pronunciation: a-lis-KYE-ren/am-LOE-di-peen
Generic Name: Aliskiren/Amlodipine
Brand Name: Tekamlo

Aliskiren/Amlodipine may cause birth defects, or fetal or newborn death if you take it while you are pregnant. If you think you may be pregnant, contact your doctor right away.

Aliskiren/Amlodipine is used for:

Treating high blood pressure. It may be used alone or with other medicines. It may also be used for other conditions as determined by your doctor.

Aliskiren/Amlodipine is a renin inhibitor and calcium channel blocker combination. It works by relaxing the blood vessels.

Do NOT use Aliskiren/Amlodipine if:

• you are allergic to any ingredient in Aliskiren/Amlodipine


• you have a history of angioedema (swelling of the hands, face, lips, eyes, throat, or tongue; difficulty swallowing or breathing; or hoarseness) caused by treatment with Aliskiren/Amlodipine


• you are pregnant


• you are taking cyclosporine or itraconazole

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

Before using Aliskiren/Amlodipine:

Some medical conditions may interact with Aliskiren/Amlodipine. 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 (including other blood pressure medicines)


• if you are a woman of childbearing age


• you have a history of angioedema (swelling of the hands, face, lips, eyes, throat, or tongue; difficulty swallowing or breathing; or hoarseness), especially when taking an angiotensin-converting enzyme (ACE) inhibitor (eg, lisinopril)


• if you are dehydrated, have low blood volume, have high blood potassium levels or low blood sodium levels, or are on a low-salt (sodium) diet


• if you have a history of gout, gallbladder or liver problems, kidney problems (eg, renal artery stenosis), low blood pressure, blood vessel problems, or heart problems (eg, heart failure, angina, narrowing of heart blood vessels)


• if you have diabetes, especially if you are also taking an ACE inhibitor (eg, lisinopril) or an angiotensin receptor blocker (eg, losartan)


• if you are on dialysis or will be having surgery


• if you are taking another medicine for blood pressure or heart problems

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

• Diuretics (eg, furosemide, hydrochlorothiazide) or sildenafil because the risk of low blood pressure may be increased


• ACE inhibitors (eg, lisinopril, angiotensin receptor blockers (eg, losartan), potassium-sparing diuretics (eg, triamterene), or potassium supplements because the risk of high blood potassium levels may be increased


• Atorvastatin, azole antifungals (eg, itraconazole, ketoconazole), conivaptan, cyclosporine, or HIV protease inhibitors (eg, ritonavir) because they may increase the risk of Aliskiren/Amlodipine's side effects, including low blood pressure


• Simvastatin because the risk of it's side effects may be increased by Aliskiren/Amlodipine

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

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

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


• Take Aliskiren/Amlodipine by mouth with or without food. It is important to take it consistently with regard to meals. If you take it with food, try to always take it with food. If you prefer to take it on an empty stomach, then try to always take it on an empty stomach.


• Be sure to drink enough liquids while you are taking Aliskiren/Amlodipine. If you do not, you may become dehydrated, which may increase your risk of low blood pressure. Discuss any questions or concerns with your doctor.


• Take Aliskiren/Amlodipine on a regular schedule to get the most benefit from it. Taking Aliskiren/Amlodipine at the same time each day will help you remember to take it.


• Continue to take Aliskiren/Amlodipine even if you feel well. Do not miss any doses.


• If you miss a dose of Aliskiren/Amlodipine, 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 Aliskiren/Amlodipine.

Important safety information:

• Aliskiren/Amlodipine may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Aliskiren/Amlodipine with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Aliskiren/Amlodipine may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.


• It may take up to 4 weeks to get the full benefit from Aliskiren/Amlodipine. Do not stop using Aliskiren/Amlodipine without checking with your doctor.


• Aliskiren/Amlodipine may cause a serious side effect called angioedema. Contact your doctor at once if you develop swelling of the hands, face, lips, eyes, throat, or tongue; difficulty swallowing or breathing; or hoarseness.


• Patients who take medicine for high blood pressure often feel tired or run down for a few weeks after starting treatment. Be sure to take your medicine even if you may not feel "normal." Tell your doctor if you develop any new symptoms.


• Check with your doctor before you use a salt substitute or a product that has potassium in it.


• High-fat meals may decrease the amount of Aliskiren/Amlodipine that is absorbed into your body. Be sure you take Aliskiren/Amlodipine consistently with regard to meals. Discuss any questions or concerns with your doctor.


• If vomiting, diarrhea, or excessive sweating occur, you will need to take care not to become dehydrated. This could increase your risk of low blood pressure. Contact your doctor for instructions.


• Tell your doctor or dentist that you take Aliskiren/Amlodipine before you receive any medical or dental care, emergency care, or surgery.


• Talk with your doctor or pharmacist about all of your blood pressure medicines and how to use them. Do not start, stop, or change the dose of any blood pressure medicine unless your doctor tells you to.


• Lab tests, including blood pressure, kidney function, and blood electrolyte levels, may be performed while you use Aliskiren/Amlodipine. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Aliskiren/Amlodipine with caution in the ELDERLY; they may be more sensitive to its effects.


• Aliskiren/Amlodipine should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: Aliskiren/Amlodipine may cause birth defects, or fetal or newborn death if you take it while you are pregnant. If you think you may be pregnant, contact your doctor right away. It is not known if Aliskiren/Amlodipine is found in breast milk. Do not breast-feed while taking Aliskiren/Amlodipine.

Possible side effects of Aliskiren/Amlodipine:

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:

Diarrhea; dizziness.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); change in the amount of urine produced; chest pain (new or worsening); fainting; fast or irregular heartbeat; muscle pain or weakness; numbness of an arm or leg; severe or persistent dizziness or lightheadedness; shortness of breath; sudden, severe headache or vomiting; sudden, unexplained weight gain; sudden vision changes; swelling of the feet, ankles, or hands; yellowing of the eyes or skin.

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: Aliskiren/Amlodipine 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 fainting; fast or slow heartbeat; severe dizziness or lightheadedness.

Proper storage of Aliskiren/Amlodipine:

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

General information:

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


• Aliskiren/Amlodipine 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 Aliskiren/Amlodipine. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Aliskiren/Amlodipine resources

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

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• High Blood Pressure

Apomorphine Hydrochloride

Class: Nonergot-derivative Dopamine Receptor Agonists
VA Class: CN500
Chemical Name: 5,6,6a,7-Tetrahydro-6-methyl-4H-dibenzo[de,g]quinoline-10,11-diol hydrochloride
Molecular Formula: C₁₇H₁₇NO₂•HCl•½H₂O
CAS Number: 41372-20-7
Brands: Apokyn

Introduction

Nonergot-derivative dopamine receptor agonist.^{1 4}

Uses for Apomorphine Hydrochloride

Hypomobility Episodes Associated with Parkinson’s Disease

Acute, intermittent treatment of episodes of hypomobility (i.e., “off” episodes, including end-of-dose “wearing off” and unpredictable “on-off” episodes) associated with advanced Parkinson’s disease (designated an orphan drug by FDA for this use).^{1 2 3 4 6 5 8 9 11 12 13 14}

Used as an adjunct to other antiparkinsonian agents (e.g., levodopa, oral dopamine receptor agonists).^{1 2 5 8 11}

Acute Poisoning

Formerly used to induce vomiting in the early management of acute oral drug overdose and in certain cases of oral poisoning (dose: 5–6 mg sub-Q)†.¹⁵

Apomorphine Hydrochloride Dosage and Administration

General

• 
  

  Administer an antiemetic (i.e., trimethobenzamide hydrochloride 300 mg orally 3 times daily) beginning 3 days prior to initiation of apomorphine; continue for the first 2 months of therapy or until tolerance to nausea and vomiting develops.^{1 11}

  
  


• 
  

  Avoid certain other antiemetic agents (i.e., selective 5-HT₃ receptor antagonists, dopamine-receptor antagonists [metoclopramide, phenothiazines]).^{1 4} (See Contraindications under Cautions and Specific Drugs under Interactions.)

  
  

Administration

Sub-Q Administration

Administer by sub-Q injection using the dosing pen on an as-needed basis to reverse “off” episodes.¹

Administer sub-Q injections in the abdomen, thigh, or upper arm; rotate injection sites.¹

Test dose: Administer all test doses in a medical setting where BP can be closely monitored.¹ Measure supine and standing BP prior to and 20, 40, and 60 minutes after each test dose.¹

Test dose: Determine dose when patient is experiencing an “off” episode.¹ Induction of an “off” state can be facilitated by withholding the patient’s antiparkinsonian agents overnight.¹

Do not administer IV; possibility of serious adverse effects (e.g., thrombosis, pulmonary embolism).¹

Dosage

Available as apomorphine hydrochloride; dosage expressed in terms of the salt.¹

Provide dosing instructions for the patient or their caregiver in mL; dose on the dosing pen device is expressed in terms of mL.¹

Titrate dose according to patient's response and tolerance.¹

Adults

Hypomobility Episodes Associated with Parkinson’s Disease

Sub–Q

Initial test dose is 0.2 mL (2 mg).¹ If the 0.2-mL (2-mg) dose is effective and tolerated, this dose may be used on an as-needed, outpatient basis.¹ If necessary, the dose may be increased in 0.1-mL (1-mg) increments every few days.¹

Patient is not a candidate for apomorphine therapy if clinically significant orthostatic hypotension occurs in response to initial 0.2-mL (2-mg) test dose.¹

For patients who tolerate, but do not respond to the initial 0.2-mL (2-mg) test dose, administer a second test dose of 0.4 mL (4 mg) at the next observed “off” period, no sooner than 2 hours after the initial test dose.¹ If the 0.4-mL (4-mg) dose is effective and tolerated, a 0.3-mL (3-mg) dose may be used on an as-needed, outpatient basis.¹ If necessary, the dose may be increased in 0.1-mL (1-mg) increments every few days.¹

For patients who respond, but do not tolerate the 0.4-mL (4-mg) test dose, administer a third test dose of 0.3 mL (3 mg) at the next observed “off” period, but no sooner than 2 hours after the 0.4-mL (4-mg) test dose.¹ If the 0.3-mL (3-mg) dose is effective and tolerated, a 0.2-mL (2-mg) dose may be used on an as-needed, outpatient basis.¹ If the 0.2-mL (2-mg) dose is tolerated, the dose may be increased, if needed, to 0.3 mL (3 mg) after a few days.¹ The dose should not usually be increased to 0.4 mL (4 mg) on an outpatient basis in these patients.¹

In clinical studies, most patients responded to doses of 0.3–0.6 mL (3–6 mg); average frequency of dosing was 3 times daily.¹

If therapy has been interrupted for >1 week, reinitiate at a dose of 0.2 mL (2 mg) and gradually titrate to effect.¹

Prescribing Limits

Adults

Hypomobility Episodes Associated with Parkinson's Disease

Sub-Q

No more than one dose of apomorphine should be administered for treatment of a single “off” episode.¹ Safety and efficacy of a second dose during the same hypomobility episode in patients not responding to the initial dose have not been established.¹

Doses >0.6 mL (6 mg) not associated with additional therapeutic effect and are not recommended.¹

Limited experience with >5 doses per day or daily dosages >2 mL (20 mg).¹

Special Populations

Hepatic Impairment

No special recommendations for patients with hepatic impairment.¹ (See Hepatic Impairment under Cautions.)

Renal Impairment

In patients with mild or moderate renal impairment, initial test dose and subsequent starting dose is 0.1 mg (1 mg).¹

Cautions for Apomorphine Hydrochloride

Contraindications

• 
  

  Concomitant use with selective 5-HT₃ receptor antagonists.¹ (See Specific Drugs under Interactions.)

  
  


• 
  

  Known hypersensitivity to apomorphine hydrochloride or any ingredient in the formulation (e.g., sodium metabisulfite).¹

  
  

Warnings/Precautions

Warnings

Administration

Thrombus formation and pulmonary embolism reported following IV administration.^{1 14} Do not administer IV.¹

Nausea and Vomiting

Severe nausea and vomiting expected; concomitant use of an antiemetic recommended.¹ Trimethobenzamide was used in clinical studies; other antiemetics are contraindicated (i.e., 5-HT₃ receptor antagonists) or not recommended (i.e., dopamine-receptor antagonists).¹ (See General under Dosage and Administration and Specific Drugs under Interactions.)

Symptomatic Hypotension

Risk of orthostatic hypotension, hypotension, and/or syncope.¹

Whether hypotension contributes to other adverse events (e.g., falls) unknown.¹

Prolongation of QT Interval

Possible prolonged QT interval.¹ Doses of ≤6 mg are associated with minimal increases in QT_c interval.¹

Use with caution in patients with congenital or known QT interval prolongation, in those with clinically important bradycardia, in those with uncorrected electrolyte disorders (e.g., hypokalemia, hypomagnesemia), and in those receiving drugs known to prolong the QT_c interval.¹

Nervous System and Muscular Effects

Risk of falls; may be due to postural and autonomic instability associated with Parkinson’s disease.¹ Risk may be increased due to effect of apomorphine on BP and mobility.¹

Symptom complex resembling neuroleptic malignant syndrome reported in association with abrupt withdrawal, dosage lowering, or changes in antiparkinsonian therapy.¹

Hallucinations

Potential for hallucinations.¹

Sudden Sleep Episodes

Falling asleep while engaged in activities of daily living has been reported in patients receiving apomorphine.¹ While somnolence occurs frequently in patients receiving apomorphine, these patients perceived no warning signs and believed they were alert immediately prior to the event.¹ Many experts believe that falling asleep while engaged in activities of daily living always occurs in a setting of preexisting somnolence, although patients may not give such a history.¹

Continually reassess patients for drowsiness or sleepiness.¹ Patients may not acknowledge drowsiness or sleepiness until directly questioned about such adverse effects during specific activities.¹ Ask patients about any factors that may increase the risk of somnolence (e.g., concomitant sedating drugs, the presence of sleep disorders).¹

Apomorphine generally should be discontinued if a patient develops clinically important daytime sleepiness or episodes of falling asleep during activities that require active participation (e.g., conversations, eating).¹ If the drug is continued, the patients should be advised not to drive and to avoid other potentially dangerous activities.¹ Insufficient information to establish whether dosage reduction will eliminate episodes of falling asleep while engaged in activities of daily living.¹

Cardiovascular Effects

Risk of angina, MI, cardiac arrest, and/or sudden death.¹ Angina and MI occurred in some patients within 2 hours of apomorphine dosing; cardiac arrest and sudden death occurred at times unrelated to dosing.¹

May exacerbate coronary and cerebral ischemia due to effects of apomorphine on BP.¹ Use with caution in patients with cardiovascular and cerebrovascular disease.¹

If signs and symptoms of coronary or cerebral ischemia occur, reevaluate continued use of the drug.¹

Injection Site Reactions

Injection site reactions (bruising, granuloma, pruritus) reported.¹

Abuse and Misuse Potential

Escalation of apomorphine dose beyond the prescribed frequency reported in patients trying to avoid all symptoms of an “off” episode.¹ Hypersexuality and increased erections can occur due to abuse of apomorphine.^{1 11}

Monitor patients for excessive use (e.g., use out of proportion to motor signs).¹

Sensitivity Reactions

Sulfite Sensitivity

The commercially available apomorphine hydrochloride injection contains sodium metabisulfite, which may cause allergic-type reactions (including anaphylaxis and life-threatening or less severe asthmatic episodes) in certain susceptible individuals.¹

General Precautions

Dyskinesia

May cause or exacerbate dyskinesias.¹

Cardiorespiratory Fibrosis and Fibrotic Complications

Retroperitoneal fibrosis, pulmonary infiltrates, pleural effusion, pleural thickening, and cardiac valvulopathy reported in patients receiving ergot-derivative dopamine receptor agonists; presumably related to the ergoline structure of these agents.¹ Possible that nonergot-derived drugs that increase dopaminergic activity (e.g., apomorphine) may induce similar changes.¹

Priapism

Possible prolonged painful erections.¹

Ocular Effects

Retinal degeneration reported in albino rats given dopamine agonists for prolonged periods (usually 2-year carcinogenicity studies); similar changes not observed in albino mice, rats, or monkeys.¹ Clinical importance in humans not established; however, effect cannot be disregarded because the presumed mechanism of action may apply to all vertebrates.¹

Specific Populations

Pregnancy

Category C.¹

Lactation

Not known whether apomorphine is distributed into milk.¹ Discontinue nursing or the drug.¹

Pediatric Use

Safety and efficacy for hypermobility episodes not established.¹

Geriatric Use

Increased incidence of confusion, hallucinations, serious adverse events (life-threatening events or events resulting in hospitalization and/or increased disability), falls, cardiovascular events, respiratory disorders, and GI events in geriatric individuals compared with younger adults.¹

Hepatic Impairment

Systemic exposure increased in patients with mild to moderate hepatic impairment; use with caution.¹ Not studied in patients with severe hepatic impairment.¹ (See Special Populations under Pharmacokinetics.)

Renal Impairment

Dosage adjustment necessary in patients with mild to moderate renal impairment.¹ Not studied in patients with severe renal impairment or those undergoing dialysis.^{1 13} (See Renal Impairment under Dosage and Administration and Special Populations under Pharmacokinetics.)

Common Adverse Effects

Yawning, dyskinesias, nausea and/or vomiting, somnolence, dizziness, rhinorrhea, hallucinations, edema, chest pain, increased sweating, flushing, and pallor.¹

Interactions for Apomorphine Hydrochloride

Drugs That Prolong QT Interval

Potential pharmacologic interaction (additive effect on QT interval prolongation).¹ (See Prolongation of QT Interval under Cautions.)

Drugs Affecting or Metabolized by Hepatic Microsomal Enzymes

Pharmacokinetic interaction unlikely.¹

Specific Drugs

Drug	Interaction	Comments
Antihypertensive agents and vasodilators	Potential pharmacologic interaction (additive hypotensive effects)1 Concomitant use associated with increased incidence of hypotension, MI, pneumonia, serious falls, bone and joint injuries1	Caution1
Catecho-O-methyltransferase (COMT) inhibitors	Pharmacokinetic interaction unlikely1 7
CNS depressants	Alcohol: Potential pharmacologic interaction (additive sedative and hypotensive effects)1 CNS depressants: Potential pharmacologic interaction (additive sedative effects)1
5-HT3 receptor antagonists (dolasetron, granisetron, ondansetron, palonosetron)	Potential pharmacologic interaction (profound hypotension and loss of consciousness)1	Concomitant use contraindicated1
Dopamine-receptor antagonists (e.g., phenothiazines, butyrophenones, thioxanthenes, metoclopramide)	Potential pharmacologic interaction (reduced efficacy of apomorphine)1	Phenothiazines, butyrophenones, thioxanthenes: Weigh benefits and risks of therapy with a dopamine agonist in patients receiving one of these dopamine-receptor antagonists for the treatment of major psychosis1
Levodopa/carbidopa	Potential pharmacologic interaction (additive neurologic effect; used to therapeutic effect)1 Pharmacokinetic interaction unlikely1

Apomorphine Hydrochloride Pharmacokinetics

Absorption

Bioavailability

Bioavailability following sub-Q administration is 100%.¹ Peak plasma concentrations achieved in 10–60 minutes.¹

Onset

Following sub-Q administration, therapeutic response usually achieved in 10–20 minutes.^{1 2 5 8 12}

Duration

Approximately 60 minutes.^{1 2 5 8 12}

Special Populations

In individuals with moderate hepatic impairment receiving a single sub-Q dose of apomorphine, peak plasma concentrations and AUC were increased 25 and 10%, respectively, compared with healthy individuals.¹

In patients with moderate renal impairment receiving a single sub-Q dose of apomorphine, peak plasma concentrations and AUC were increased 50 and 16%, respectively, compared with healthy individuals.¹ Time to peak plasma concentrations was not affected by renal status.¹

Distribution

Extent

Maximum cerebrospinal fluid concentrations are <10% of peak plasma concentrations.¹

Elimination

Metabolism

Routes of metabolism not known.¹ Potential metabolic routes include sulfation, N–demethylation, glucuronidation, and oxidation.¹

Half-life

40 minutes.¹

Special Populations

Half-life not affected by renal status.¹

Stability

Storage

Parenteral

Injection

25°C (may be exposed to 15–30°C).¹

ActionsActions

• 
  

  Exhibits a higher affinity for dopamine D₄ receptors in vitro than for dopamine D₂, D₃, or D₅ receptors.¹

  
  


• 
  

  Appears to act by stimulating postsynaptic dopamine D₂ receptors in the caudate-putamen.¹

  
  

Advice to Patients

• 
  

  Importance of taking apomorphine only as prescribed.¹

  
  


• 
  

  Importance of instructing patient and/or caregiver regarding proper dosage and administration of apomorphine, including detailed instruction in the use of the dosing pen, in patients whose clinician has determined that the drug can safely and effectively be self-administered in the patient’s home by the patient, family member, or other responsible individual.¹

  
  


• 
  

  Advise that hallucinations, hypotension, and other adverse effects (e.g., injection site reactions) may occur.¹

  
  


• 
  

  Risk of orthostatic hypotension with or without dizziness, nausea, syncope, or sweating.¹ Advise not to rise rapidly after prolonged sitting or lying down, especially during the first few weeks of therapy.¹

  
  


• 
  

  Risk of somnolence and the possibility of falling asleep during activities of daily living; avoid driving or operating machinery until effects on the individual are known.¹

  
  


• 
  

  Importance of informing clinicians if increased somnolence or new episodes of falling asleep during activities of daily living (e.g., watching television, riding in a car as a passenger) occur at any time during apomorphine therapy.¹ Patients should not drive or participate in potentially dangerous activities until their clinician has been notified.¹

  
  


• 
  

  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 (especially selective 5-HT₃ receptor antagonists) 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.

Apomorphine Hydrochloride (Hemihydrate)

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	Injection, for sub-Q use only	10 mg/mL	Apokyn (with sodium metabisulfite; benzyl alcohol 0.5% in cartridges)	Mylan

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

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

1. Mylan Bertek Pharmaceuticals Inc. Apokyn (apomorphine hydrochloride) injection prescribing information. Research Triangle Park, NC; 2004 Apr.

2. Stacy M. Apomorphine: North American clinical experience. Neurology. 2004; 62 (Suppl 4):S18-21. [IDIS 516185] [PubMed 15037667]

3. Dewey RB Jr. Management of motor complications in Parkinson's disease. Neurology. 2004; 62 (Suppl 4):S3-7. [IDIS 516182] [PubMed 15037664]

4. Anon. FDA approves Apokyn for the acute treatment of episodes of immobility in Parkinson’s patients. FDA Talk Paper. Rockville, MD: Food and Drug Administration; 2004 Apr 21.

5. Dewey RB Jr, Hutton JT, LeWitt PA, Factor SA. A randomized, double-blind, placebo-controlled trial of subcutaneously injected apomorphine for parkinsonian off-state events. Arch Neurol. 2001; 58:1385-92. [IDIS 518541] [PubMed 11559309]

6. 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. From FDA website (). Accessed 2004 Aug 16.

7. Zijlmans JCM, Debilly B, Rascol O et. al. Safety of entacapone and apomorphine coadministration in levodopa-treated Parkinson's disease patients: pharmacokinetic and pharmacodynamic results of a multicenter, double-blind, placebo-controlled, cross-over study. Mov Disord. 2004; 19:1006-11. [PubMed 15372589]

8. Sherry JH, Guyton PJ, Van Lunen B, Bottini PB. Continued efficacy and safety of subcutaneous injections of apomorphine in the treatment of off episodes in patients with Parkinson's disease. Neurology. 2003; 60 (Suppl 1): A81.

9. Hughes AJ, Bishop S, Kleedorfer B et al. Subcutaneous apomorphine in Parkinson's disease: response to chronic administration for up to five years. Mov Disord. 1993; 8:165-70. [PubMed 8474483]

10. Food and Drug Administration. Sulfiting agents; labeling in drugs for human use: warning statement. [Docket No. 84N-0113] Fed Regist. 1985; 50:47558-63.

11. Anon. Apomorphine (Apokyn) for advanced Parkinson's disease. Med Lett Drugs Ther. 2005; 47:7-8.

12. Factor SA. Literature review: intermittent subcutaneous apomorphine therapy in Parkinson's disease. Neurology. 2004; 62(Suppl 4):S12-7. [IDIS 516184] [PubMed 15037666]

13. Mylan Bertek Pharmaceuticals Inc. Apokyn (apomorphine hydrochloride) monograph. Research Triangle Park, NC; 2004 May 26.

14. Koller W, Stacy M. Other formulations and future considerations for apomorphine for subcutaneous injection therapy. Neurology. 2004; 62(Suppl 4):S22-6. [IDIS 516186] [PubMed 15037668]

15. AHFS Drug Information 1990. McEvoy, GK, ed. Apomorphine hydrochloride. Bethesda, MD: American Society of Health-System Pharmacists; 1990:1652-3.

16. Mylan Bertek Pharmaceuticals, Overland Park, KS: Personal communication.

More Apomorphine Hydrochloride resources

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

• Apokyn Prescribing Information (FDA)


• Apokyn Advanced Consumer (Micromedex) - Includes Dosage Information


• Apokyn MedFacts Consumer Leaflet (Wolters Kluwer)


• Apokyn Consumer Overview

Compare Apomorphine Hydrochloride with other medications

• Parkinson's Disease
• Tardive Dyskinesia

Alacol DM Elixir

Pronunciation: FEN-il-EF-rin/BROME-fen-IR-a-meen/DEX-troe-meth-OR-fan
Generic Name: Phenylephrine/Brompheniramine/Dextromethorphan
Brand Name: Examples include Alahist DM and Dimetapp DM Cough/Cold

Alacol DM Elixir is used for:

Relieving symptoms of sinus congestion, runny nose, sneezing, and cough due to colds, upper respiratory infections, and allergies. It may also be used for other conditions as determined by your doctor.

Alacol DM Elixir is a decongestant, antihistamine, and cough suppressant combination. The decongestant works by constricting blood vessels and reducing swelling in the nasal passages. The antihistamine works by blocking the action of histamine, which helps reduce symptoms such as watery eyes and sneezing. The cough suppressant works in the brain to help decrease the cough reflex to reduce a dry cough.

Do NOT use Alacol DM Elixir if:

• you are allergic to any ingredient in Alacol DM Elixir


• you have severe high blood pressure, severe heart blood vessel disease, rapid heartbeat, or severe heart problems


• you are unable to urinate or are having an asthma attack


• you are taking sodium oxybate (GHB) or have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days

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

Before using Alacol DM Elixir:

Some medical conditions may interact with Alacol DM Elixir. 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 fast, slow, or irregular heartbeat


• if you have a history of adrenal gland problems (eg, adrenal gland tumor); heart problems; high blood pressure; diabetes; heart blood vessel problems; stroke; glaucoma; a blockage of your bladder, stomach, or intestines; ulcers; trouble urinating; an enlarged prostate or other prostate problems; seizures; or an overactive thyroid


• if you have a history of asthma, chronic cough, lung problems (eg, chronic bronchitis, emphysema), or chronic obstructive pulmonary disease (COPD), or if your cough occurs with large amounts of mucus

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

• Digoxin or droxidopa because the risk of irregular heartbeat or heart attack may be increased


• Beta-blockers (eg, propranolol), catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), furazolidone, indomethacin, MAOIs (eg, phenelzine), sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Alacol DM Elixir's side effects


• Bromocriptine or hydantoins (eg, phenytoin) because the risk of their side effects may be increased by Alacol DM Elixir


• Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Alacol DM Elixir

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

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

• Take Alacol DM Elixir by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.


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


• Drink plenty of water while taking Alacol DM Elixir.


• If you miss a dose of Alacol DM Elixir, 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 Alacol DM Elixir.

Important safety information:

• Alacol DM Elixir may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Alacol DM Elixir 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 Alacol DM Elixir; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.


• Do not take diet or appetite control medicines while you are taking Alacol DM Elixir without checking with your doctor.


• Alacol DM Elixir has phenylephrine, brompheniramine, and dextromethorphan in it. Before you start any new medicine, check the label to see if it has phenylephrine, brompheniramine, or dextromethorphan in it too. If it does or if you are not sure, check with your doctor or pharmacist.


• Do not use Alacol DM Elixir for cough with a lot of mucus. Do not use for long-term cough (eg, caused by asthma, emphysema, smoking). However, you may use it for these conditions if your doctor tells you to.


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


• If your symptoms do not get better within 5 to 7 days, if they get worse, or if they occur along with a fever, check with your doctor.


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


• Alacol DM Elixir may interfere with skin allergy tests. If you are scheduled for a skin test, talk to your doctor. You may need to stop taking Alacol DM Elixir for a few days before the tests.


• Tell your doctor or dentist that you take Alacol DM Elixir before you receive any medical or dental care, emergency care, or surgery.


• Use Alacol DM Elixir with caution in the ELDERLY; they may be more sensitive to its effects, especially confusion, dizziness, drowsiness, dry mouth, excitability, low blood pressure, and trouble urinating.


• Caution is advised when using Alacol DM Elixir in CHILDREN; they may be more sensitive to its effects, especially excitability.


• Alacol DM Elixir should not be used in CHILDREN younger than 6 years old without first checking with the child's doctor; 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 Alacol DM Elixir while you are pregnant. Do not take Alacol DM Elixir in the third trimester of pregnancy. It is not known if Alacol DM Elixir is found in breast milk. If you are or will be breast-feeding while you use Alacol DM Elixir, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Alacol DM Elixir:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Blurred vision; constipation; diarrhea; dizziness; drowsiness; dry mouth, nose, or throat; excitability; headache; increased sweating; loss of appetite; nausea; nervousness or anxiety; trouble sleeping; upset stomach; 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 tightness; difficulty urinating or inability to urinate; fast or irregular heartbeat; fever, chills, or sore throat; flushing or redness of the face; hallucinations; mental or mood changes; numbness or tingling; seizures; severe dizziness, drowsiness, lightheadedness, or headache; severe dryness of the mouth, nose, and throat; severe or persistent trouble sleeping; shortness of breath; tremor; unusual bruising or bleeding; vision changes.

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: Alacol DM 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 blurred vision; confusion; hallucinations; muscle spasms; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; unusual eye movements; unusually fast, slow, or irregular heartbeat; vomiting.

Proper storage of Alacol DM Elixir:

Store Alacol DM Elixir 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 Alacol DM Elixir out of the reach of children and away from pets.

General information:

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


• Alacol DM Elixir 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 Alacol DM Elixir. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Alacol DM resources

• Alacol DM Side Effects (in more detail)
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• Alacol DM Drug Interactions
• Alacol DM Support Group
• 0 Reviews for Alacol DM - Add your own review/rating

Compare Alacol DM with other medications

• Cough and Nasal Congestion

Advate

Generic Name: antihemophilic factor (Intravenous route)

an-tee-hee-moe-FIL-ik FAK-tor

Commonly used brand name(s)

In the U.S.

• Advate


• Helixate FS


• Hemofil-M


• Hyate:C


• Koate DVI


• Kogenate FS


• Kogenate FS w/BIO-SET


• Monarc-M


• Monoclate-P


• Recombinate


• Refacto


• Xyntha

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Antihemophilic Agent

Uses For Advate

Antihemophilic factor (AHF) injection is used to treat serious bleeding episodes in patients with a bleeding problem called hemophilia A. The bleeding episode may be related to an injury (trauma) or a surgical procedure. AHF is a protein that is produced naturally in the body. It helps the blood form clots to stop bleeding and prevents bleeding problems from happening as often.

Hemophilia A, also called classical hemophilia, is a condition where the body does not make enough AHF. If you do not have enough AHF and you become injured, your blood will not form clots properly. You might bleed into and damage your muscles and joints. AHF injection is given to increase the levels of AHF in the blood.

There are several different types of AHF. They are made from human blood or artificially by a man-made process (recombinant). AHF made from human blood has been treated and is not likely to contain harmful viruses, such as hepatitis B, hepatitis C, or human immunodeficiency virus (HIV), the virus that causes acquired immunodeficiency syndrome (AIDS). The man-made AHF products do not contain these viruses.

This medicine is available only with your doctor's prescription.

Before Using Advate

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

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of antihemophilic factor injection in children.

No information is available on the relationship of age to the effects of Hemofil® M in the pediatric population. Safety and efficacy have not been established.

Geriatric

Although appropriate studies on the relationship of age to the effects of Advate® have not been performed in the geriatric population, no geriatric-specific problems have been documented to date. However, elderly patients are more likely to have age-related medical problems, which may require caution and an adjustment in the dose for patients receiving Advate®.

No information is available on the relationship of age to the effects of antihemophilic factor injection in geriatric patients.

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

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

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

Interactions with Food/Tobacco/Alcohol

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

Other Medical Problems

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

• Allergy to hamster or mouse proteins, history of or


• von Willebrand disease—Should not be used in patients with these conditions.

Proper Use of antihemophilic factor

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

A doctor or other trained health professional will give you or your child this medicine in a hospital or clinic setting. This medicine is given through a needle placed in one of your veins.

This medicine may also be given at home to patients who do not need to be in a hospital or clinic. If you or your child are using this medicine at home, your doctor will teach you how to prepare and inject the medicine. Make sure you understand all of the instructions before giving yourself an injection. Your dose may change based on where you are bleeding. Do not use more medicine or use it more often than your doctor tells you to.

Use only the brand of this medicine that your doctor prescribed. Not all brands are prepared in the same way and the dose may be different.

Every package of medicine comes with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.

To prepare the medicine using 2 bottles (vials) or containers:

• Take the bottles of powder medicine and liquid (diluent) out of the refrigerator and warm them to room temperature.


• Wipe the rubber surface of the bottles with an alcohol swab and allow them to dry.


• Follow the specific directions for your brand of medicine when you prepare the injection.


• Add the liquid to the powder using the special transfer needle or transfer device that comes with the package.


• When injecting the liquid into the dry medicine, aim the stream of liquid against the wall of the container of dry medicine to prevent foaming.


• Swirl the bottle gently to dissolve the medicine. Do not shake the bottle. Shaking will create foam in the mixture.


• Check the mixture to make sure it is clear. Do not use the medicine if you can see anything solid in the mixture or if the mixture is cloudy.


• Use a plastic disposable syringe to remove the mixture from the bottle. Use a special filter needle if your brand of medicine provides one.


• Give the injection as directed by your doctor.


• If you are using more than one bottle of medicine for your dose, prepare the second bottle the same way. Add the mixture from the second bottle to the same syringe.

To prepare the medicine using a prefilled dual-chamber syringe (Xyntha®):

• Take the prefilled dual-chamber syringe out of the refrigerator and warm it to room temperature.


• The dual-chamber syringe has the powder medicine in one part and the liquid (diluent) in the second part of the syringe.


• Attach the plunger rod to the syringe according to the directions. Keep the syringe pointed up to prevent leaking of the liquid.


• Remove the white seal and the grey rubber tip cap. Put the blue vented cap on the syringe. Do not touch the open ends of the syringe and the blue cap.


• Slowly push the plunger until the 2 stoppers inside the syringe are together. This will push all of the liquid into the chamber with the powder medicine.


• Keep the syringe pointed up and gently swirl the syringe to mix the liquid and powder.


• Check the mixture to make sure it is clear. Do not use the medicine if you can see anything solid in the mixture or if the mixture is cloudy.


• Keep the syringe pointed up and push the plunger until most of the air is removed.


• A special infusion set comes with the package. Remove the blue cap and attach the infusion set to the syringe.


• Give the injection as directed by your doctor.


• If you are using more than one syringe of medicine for your dose, prepare the second dual-chamber syringe the same way. The mixture from each syringe will be combined together in a separate syringe before your injection. Your doctor will show you how to do this.

Use the mixture within 3 hours after it is prepared. It must not be stored and used later. Do not put the mixture in the refrigerator.

Do not reuse syringes and needles. Put used syringes and needles in a puncture-resistant disposable container, or dispose of them as directed by your doctor.

Talk to your doctor before traveling. You should plan to bring enough medicine for your treatment when traveling.

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 injection dosage form (injection):
  
  • For bleeding episodes in patients with hemophilia A:
    
    • Adults and teenagers—Dose is based on body weight and the type of bleeding episode. The dose must be determined by your doctor.
    
    
    • Children—Dose is based on body weight and the type of bleeding episode. The dose must be determined by your child's doctor.
    
    
  
  

Missed Dose

Call your doctor or pharmacist for instructions.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

The AHF products should be stored in the original container in the refrigerator. Do not let the packages freeze. They can also be kept at room temperature for short periods of time, such as 3 to 6 months. Store the medicine as directed by your doctor or by the manufacturer of the brand you are using. Protect the container from heat and direct light.

If you move the medicine from the refrigerator to room temperature, write the date you take it from the refrigerator on the container. The length of time the medicine can remain at room temperature will depend on the brand you use. If you have already stored the medicine at room temperature, do not return it to the refrigerator. If you do not use the medicine within the time recommended by the manufacturer, you must destroy the medicine.

Precautions While Using Advate

It is very important that your doctor check you or your child closely while you are receiving this medicine to make sure it is working properly. Blood tests may be needed.

This medicine may cause serious types of allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Stop using this medicine and check with your doctor right away if you or your child have a rash; itching; hoarseness; trouble breathing; trouble swallowing; lightheadedness or dizziness; or any swelling of your hands, face, or mouth after you receive this medicine.

It is recommended that you carry an identification (ID) card or letter stating that you have hemophilia A and the type of medicine you are using. If you have any questions about what kind of identification to carry, check with your doctor.

Check with your doctor right away if you have any symptoms of parvovirus infection: fever, chills, drowsiness, runny nose, and followed by a rash or joint pain.

Check with your doctor right away if you have pain or tenderness in the upper stomach; pale stools; dark urine; loss of appetite; nausea; unusual tiredness or weakness; or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine is made from donated human blood. Some human blood products have transmitted certain viruses to people who have received them. The risk of getting a virus from medicines made of human blood has been greatly reduced in recent years. This is the result of required testing of human donors for certain viruses, and testing during manufacture of these medicines. Although the risk is low, talk with your doctor if you have any concerns.

The stopper of the bottle (vial) contains dry natural rubber (a derivative of latex), which may cause allergic reactions in people who are sensitive to latex. Tell your doctor if you have a latex allergy before you start using this medicine.

Advate 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 immediately if any of the following side effects occur:

More common

• Fever

Less common or rare

• Changes in facial skin color


• chills


• fast or irregular breathing


• nausea


• puffiness or swelling of the eyelids or around the eyes


• sensation of burning, warmth, heat, numbness, tightness, or tingling


• shortness of breath


• skin rash, hives, or itching


• tightness in the chest


• troubled breathing


• unusual tiredness or weakness


• wheezing

Incidence not known

• Bluish color of the fingernails, lips, skin, palms, or nail beds


• blurred vision


• chest pain or discomfort


• confusion


• cough


• deep or fast breathing with dizziness


• difficult or labored breathing


• difficulty with swallowing


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


• fast, pounding, or irregular heartbeat or pulse


• noisy breathing


• numbness of the feet, hands, and around the mouth


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


• slow or irregular heartbeat


• sweating


• swelling of the face, throat, or tongue


• unusual tiredness or weakness

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

• Headache

Less common

• Burning, stinging, or swelling at the place of injection


• diarrhea


• dizziness or lightheadedness


• dry mouth or bad taste in the mouth


• lack or loss of strength


• nosebleed


• redness of the face


• vomiting

Rare

• Change in taste


• loss of taste

Incidence not known

• Abdominal or stomach pain


• feeling of warmth


• increased sweating


• irritability


• muscle or bone pain


• redness of the eye


• redness of the face, neck, arms, and occasionally, upper chest


• redness of the skin


• trouble seeing

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: Advate 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.

More Advate resources

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

• Advate Consumer Overview


• Advate Prescribing Information (FDA)


• Advate MedFacts Consumer Leaflet (Wolters Kluwer)


• Antihemophilic Factor Professional Patient Advice (Wolters Kluwer)


• Antihemophilic Factor (Human) Monograph (AHFS DI)


• Antihemophilic Factor (Recombinant) Monograph (AHFS DI)


• Helixate FS Prescribing Information (FDA)


• Kogenate Consumer Overview


• Kogenate FS Prescribing Information (FDA)


• Kogenate FS MedFacts Consumer Leaflet (Wolters Kluwer)


• Monoclate-P Prescribing Information (FDA)


• Recombinate Prescribing Information (FDA)


• Xyntha Prescribing Information (FDA)


• Xyntha MedFacts Consumer Leaflet (Wolters Kluwer)


• Xyntha Consumer Overview

Compare Advate with other medications

• Hemophilia A

Aquacalm Powder

Dosage Form: FOR ANIMAL USE ONLY
AquacalmTM (Metomidate hydrochloride) For immersion use in ornamental finfish only. Not for use in fish intended for human or animal consumption. NOT APPROVED BY FDA – Legally marketed as an FDA indexed product under MIF 900-002. Extra-label use is prohibited.

Aquacalm Powder Description

Each gram of AquacalmTM powder contains 1 gm of metomidate hydrochloride. AquacalmTM acts on the central nervous system to induce sedation or anesthesia in fish immersed in water containing the drug.

INDICATIONS

For the sedation and anesthesia of ornamental finfish. AquacalmTM is not for use in fish intended for human or animal consumption. Sedation may be necessary in

situations such as strip spawning for hatchery rearing, transporting fish from supplier to wholesaler or retailer, photographing fish as part of a strategic marketing approach, or removal of fish from exhibit tanks prior to cleaning. Anesthesia may be necessary in situations where detailed fish examination or minor surgical procedures are to be conducted.

DIRECTIONS FOR USE

AquacalmTM is packaged as a dry powder and must be mixed with water to be used. Determine the amount of AquacalmTM powder needed to achieve the desired concentration for the intended use. Dissolve AquacalmTM in a known volume of water, mix well, and aerate water during sedation or anesthesia. Lightly sedated fish may lose their ability to maintain upright position or position in a stream flow. Deeply sedated or anesthetized fish will experience total loss of equilibrium. Before beginning sedation or anesthesia, ensure that AquacalmTM-free water is available for recovery. Always test the dosage on a small group of fish first to make sure no unintended or adverse effects occur.


SPECIES:

AquacalmTM has been tested on representative ornamental finfish species, but has not been tested on all fish species. The effect of AquacalmTM may vary between (and within) species, depending upon age and physical condition of fish, and under different water conditions. Sedate or anesthetize fish in water with temperature and pH close to the temperature and pH of the rearing water.

Caution should be taken when using this product on/for:

1. Larval fish species, which may be more sensitive to sedation than older fish of the same species

2. Fish species such as knifefish and gouramis

3. Any fish species for extended periods (e.g.> 24 hr) used during transportation


DOSAGE:

Dose for sedation: 0.1 to 1.0 mg/L

Dose for anesthesia: 1.0 to 10.0 mg/L

The dose should be individualized, depending upon the fish species and the degree of anesthesia required. Consideration should be taken when sedating or anesthetizing fish at water temperatures substantially different from the species preferred water temperature or at very low pH.


DURATION OF TREATMENT:

At doses suitable for total loss of equilibrium or anesthesia, do not expose fish for more than 60 min. At doses suitable to sedate fish for transportation, do not expose fish for more than 24 hr. To facilitate recovery upon removal from a solution of AquacalmTM, place fish in well oxygenated, high quality water free of AquacalmTM. Fish should recover in 20 to 90 min.


CONTRAINDICATIONS:

Use of AquacalmTM is contraindicated in species of fish that rely upon accessory air breathing organs for oxygen consumption. Sedation or anesthesia of such species may result in unacceptable rates of mortality.


DOSE CALCULATION:

The dose is based on the volume of water in which fish will be placed or held.

For example, if the desired AquacalmTM concentration is 2.0 mg/L and the tank holding the fish contains 10 L of water, use the following calculation:

2 mg/L X 10L = 20 mg = 0.02 g AquacalmTM

For example, if the desired AquacalmTM concentration is 2.0 mg/L and the tank holding the fish contains 5 gal of water, use the following calculation (note that the correction factor is used when volume is reported in gallons):

2 mg/L X 5 gal X 0.00378 = 0.038 g AquacalmTM

CAUTION AND WARNING

CAUTION:

NOT FOR USE IN FISH INTENDED FOR HUMAN OR ANIMAL CONSUMPTION.

Not for use in humans. Keep out of the reach of children. Use in a well-ventilated area. Wear gloves.

WARNING:

INHALATION: May be harmful. Remove immediately from danger zone and provide fresh air. In case of respiratory problems or respiratory arrest, administer artificial respiration. Keep the affected individual warm and still. Contact emergency medical help.

INGESTION: May be harmful. If the person is conscious, wash out mouth with copious amounts of water. Contact emergency medical help.

EYE CONTACT: May be harmful. In case of contact, flush with copious amounts of water for at least 15 minutes. Assure

adequate flushing by separating eyelids with fingers. Contact emergency medical help.

SKIN CONTACT: May be harmful. In case of contact, flush with copious amounts of water for at least 15 minutes. Remove

contaminated clothing and wash before re-using. Contact emergency medical help.

OTHER HEALTH INFORMATION: The toxicological properties of metomidate hydrochloride have not been thoroughly investigated. It is thought to act on the central nervous system as an imidazole based non-barbiturate hypnotic.

To obtain a Material Safety Data Sheet, call WESTERN CHEMICAL INC. at (360) 384-5898, or visit www.wchemical.com

STORAGE AND HANDLING

Store at 10°C to 30°C (50°F to 86°F) and protect from sunlight or sources of heat.

Aquacalm Label

AQUACALM  metomidate  powder

Product Information Product Type OTC ANIMAL DRUG NDC Product Code (Source) 50378-013 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength metomidate (metomidate) metomidate 1000 mg  in 1 g

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 50378-013-02 1 BOTTLE In 1 CARTON contains a BOTTLE, PLASTIC (50378-013-01) 1 50378-013-01 1 g In 1 BOTTLE, PLASTIC This package is contained within the CARTON (50378-013-02) 2 50378-013-06 1 BOTTLE In 1 CARTON contains a BOTTLE, PLASTIC (50378-013-05) 2 50378-013-05 5 g In 1 BOTTLE, PLASTIC This package is contained within the CARTON (50378-013-06) 3 50378-013-11 1 BOTTLE In 1 CARTON contains a BOTTLE, PLASTIC (50378-013-10) 3 50378-013-10 10 g In 1 BOTTLE, PLASTIC This package is contained within the CARTON (50378-013-11) 4 50378-013-50 50 g In 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Legally Marketed Unapproved New Animal Drugs for Minor Species		06/15/2009

Labeler - Western Chemical Inc. (085803500)

Registrant - Western Chemical Inc. (085803500)

Revised: 10/2010Western Chemical Inc.