Generic Name: primidone (PRIM i done)
Brand Names: Mysoline

What is primidone?

Primidone is an anti-epileptic drug, also called an anticonvulsant.

Primidone is used to control seizures.

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

What is the most important information I should know about primidone?

You should not use this medication if you are allergic to primidone or phenobarbital (Luminal, Solfoton), or if you have porphyria.

Before taking this medication, tell your doctor if you are allergic to any drugs, or if you are pregnant or breast-feeding.

You may have thoughts about suicide while taking this medication. Your doctor will need to check you at regular visits. Do not miss any scheduled appointments.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, depression, anxiety, or if you feel agitated, hostile, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself. If you are taking primidone to prevent seizures, keep taking the medication even if you feel fine. You may have an increase in seizures if you stop taking primidone. Follow your doctor’s instructions.

To be sure this medication is helping your condition, your blood may need to be tested on a regular basis. Do not miss any scheduled appointments.

Do not change your dose of primidone without your doctor’s advice. Tell your doctor if the medication does not seem to work as well in treating your condition.

Carry an ID card or wear a medical alert bracelet stating that you are taking primidone, in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you are taking a seizure medication.

What should I discuss with my healthcare provider before taking primidone?

You should not use this medication if you are allergic to primidone or phenobarbital (Luminal, Solfoton), or if you have porphyria.

You may have thoughts about suicide while taking this medication. Tell your doctor if you have new or worsening depression or suicidal thoughts during the first several months of treatment, or whenever your dose is changed.

Your family or other caregivers should also be alert to changes in your mood or symptoms. Your doctor will need to check you at regular visits. Do not miss any scheduled appointments.

Before taking this medication, tell your doctor if you are allergic to any drugs, or if you are pregnant or breast-feeding.

Primidone may cause harm to an unborn baby, but having a seizure during pregnancy could harm both the mother and the baby. Do not start taking primidone during pregnancy without your doctor’s advice.

If you become pregnant while taking primidone, do not stop taking it without telling your doctor. Seizure control is very important during pregnancy and the benefits of preventing seizures may outweigh any risks posed by taking primidone.

If you have taken primidone during pregnancy, be sure to tell the doctor who delivers your baby about your primidone use. Both you and the baby may need to receive medications to prevent excessive bleeding during delivery and just after birth.

Primidone can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take primidone?

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

Primidone is usually taken 2 to 4 times daily. If you are switching to primidone from another seizure medication, you may need to start taking primidone only at bedtime. Follow your doctor’s instructions.

If you are taking primidone to treat seizures, keep taking the medication even if you feel fine. You may have an increase in seizures if you stop taking primidone. Follow your doctor’s instructions.

To be sure this medication is helping your condition, your blood may need to be tested on a regular basis. Do not miss any scheduled appointments.

Do not change your dose of primidone without your doctor’s advice. Tell your doctor if the medication does not seem to work as well in treating your condition.

Carry an ID card or wear a medical alert bracelet stating that you are taking primidone, in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you are taking a seizure medication. Store primidone at room temperature away from moisture, light, and heat.

See also: Primidone dosage in more detail

What happens if I miss a dose?

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

What happens if I overdose?

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

Symptoms of a primidone overdose are not known.

What should I avoid while taking primidone?

Follow your doctor’s instructions about any restrictions on food, beverages, or activity while you are using primidone.

Primidone side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, depression, anxiety, or if you feel agitated, hostile, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have any of these serious side effects:

• slurred speech;

• loss of balance or coordination;

• easy bruising or bleeding; or

• unusual weakness.

Less serious side effects may include:

• dizziness, drowsiness, spinning sensation;

• nausea, vomiting, loss of appetite;

• feeling irritable;

• blurred vision;

• mild skin rash; or

• impotence, loss of interest in sex.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Primidone Dosing Information

Usual Adult Dose for Seizures:

Days 1 to 3: 100 to 125 mg orally at bedtime

Days 4 to 6: 100 to 125 mg orally twice a day

Days 7 to 9: 100 to 125 mg orally three times a day

Day 10 onward: 250 mg orally three to four times a day, increasing up to five or six times a day if necessary, not to exceed 500 mg four times a day (2 g/day).

Usual Pediatric Dose for Seizures:

< 8 years:
Days 1 to 3: 50 mg orally at bedtime

Days 4 to 6: 50 mg orally twice a day

Days 7 to 9: 100 mg orally twice a day

Day 10 onward: 125 to 250 mg orally three times a day or 10 to 25 mg/kg/day in divided doses.

> 8 years:

Days 1 to 3: 100 to 125 mg orally at bedtime

Days 4 to 6: 100 to 125 mg orally twice a day

Days 7 to 9: 100 to 125 mg orally three times a day

Day 10 onward: 250 mg orally three to four times a day, increasing up to five or six times a day if necessary.

What other drugs will affect primidone?

There may be other drugs that can interact with primidone. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

• Your pharmacist can provide more information about primidone.

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 3.02. Revision Date: 4/12/2009 4:37:09 PM.

PRIM-i-done

Commonly used brand name(s):

In the U.S.

• Mysoline

Available Dosage Forms:

• Tablet
• Suspension

Therapeutic Class: Anticonvulsant

Pharmacologic Class: Barbiturate, Intermediate Acting

Uses For primidone

Primidone is used alone or in combination with other medicines, to control seizures (convulsions) in the treatment of epilepsy. primidone is an anticonvulsant that works in the brain tissue to stop seizures.

primidone is available only with your doctor’s prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in product labeling, primidone is used in certain patients with the following medical conditions:

• Essential tremor.

Before Using primidone

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 primidone, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to primidone 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 primidone in children.

Geriatric

No information is available on the relationship of age to the effects of primidone in geriatric patients.

Unusual excitement or restlessness may occur in elderly patients, who are usually more sensitive than younger adults to these effects of primidone.

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

Using primidone 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.

• Adinazolam
• Alprazolam
• Amobarbital
• Anisindione
• Aprobarbital
• Bromazepam
• Brotizolam
• Butabarbital
• Butalbital
• Carisoprodol
• Chloral Hydrate
• Chlordiazepoxide
• Chlorzoxazone
• Clobazam
• Clonazepam
• Clorazepate
• Dantrolene
• Diazepam
• Dicumarol
• Estazolam
• Ethchlorvynol
• Flunitrazepam
• Flurazepam
• Halazepam
• Ketazolam
• Lorazepam
• Lormetazepam
• Medazepam
• Mephenesin
• Mephobarbital
• Meprobamate
• Metaxalone
• Methocarbamol
• Methohexital
• Midazolam
• Nitrazepam
• Nordazepam
• Oxazepam
• Pentobarbital
• Phenindione
• Phenobarbital
• Phenprocoumon
• Prazepam
• Primidone
• Quazepam
• Quetiapine
• Secobarbital
• Sodium Oxybate
• Temazepam
• Thiopental
• Triazolam
• Valproic Acid

Using primidone 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.

• Betamethasone
• Cannabis
• Carbamazepine
• Cortisone
• Dexamethasone
• Ethinyl Estradiol
• Etonogestrel
• Ginkgo
• Hydrocortisone
• Lamotrigine
• Leucovorin
• Levonorgestrel
• Mestranol
• Methylprednisolone
• Norelgestromin
• Norethindrone
• Norgestrel
• Prednisolone
• Prednisone
• Rufinamide
• Tiagabine
• Triamcinolone
• Warfarin

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.

Using primidone with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use primidone, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

Other Medical Problems

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

• Asthma, emphysema, or chronic lung disease—Primidone may cause serious problems in breathing.

• Depression, history of or
• Hyperactivity (in children) or
• Kidney disease or
• Liver disease—Primidone may make these conditions worse.

• Porphyria (an enzyme problem)—Should not be used in patients with this condition.

Proper Use of primidone

Take primidone only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

primidone may be used with other seizure medicines. Keep using all of your seizure medicines unless your doctor tells you to stop.

Take primidone everyday in regularly spaced doses as ordered by your doctor. This will provide the proper amount of medicine needed to prevent seizures.

Dosing

The dose of primidone 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 primidone. 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 oral dosage forms (chewable tablets, suspension, or tablets):
  • For seizures:
    • Adults, teenagers, and children 8 years of age or older—At first, 100 or 125 milligrams (mg) once a day at bedtime. Your doctor may increase your dose if needed. However, the dose is usually not more than 2000 mg a day.
    • Children up to 8 years of age—At first, 50 mg once a day at bedtime. Your doctor may increase your dose if needed.

Missed Dose

If you miss a dose of primidone, 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.

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

Precautions While Using primidone

It is very important that your doctor check your progress at regular visits while you are using primidone to see if it is working properly and to allow for a change in the dose. Blood tests may be needed to check for any unwanted effects.

Using primidone 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. Your doctor may want you to join a pregnancy registry for patients taking a seizure medicine.

If you have been taking primidone regularly for several weeks, you should not suddenly stop taking it without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are taking before stopping completely.

primidone may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you, your child, or your caregiver notice any of these side effects, tell your doctor or your child’s doctor right away.

Before you have any medical tests, tell the medical doctor in charge that you are taking primidone. The results of some tests (such as the metyrapone and phentolamine tests) may be affected by primidone.

Before having any kind of surgery, dental treatment, or emergency treatment, tell the medical doctor or dentist in charge that you are using primidone.

primidone will add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; medicine for seizures or barbiturates; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using primidone.

Primidone may cause some people to become dizzy, lightheaded, drowsy, or less alert than they are normally. Even if taken at bedtime, it may cause some people to feel drowsy or less alert on arising. Make sure you know how you react to primidone before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.

Oral contraceptives (birth control pills) containing estrogen may not work properly if you take them while you are taking primidone. Unplanned pregnancies may occur. You should use a different or additional means of birth control while you are taking primidone. If you have any questions about this, check with your doctor.

primidone 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

• Shakiness and unsteady walk
• unsteadiness, trembling, or other problems with muscle control or coordination

Less common

• Unusual excitement or restlessness (especially in children and in the elderly)

Rare

• Chills
• cough or hoarseness
• fainting spells
• fever and sore throat
• fever with or without chills
• general feeling of tiredness or weakness
• irregular heartbeat
• lower back or side pain
• painful or difficult urination
• pale skin
• shortness of breath
• skin rash
• sores, ulcers, or white spots on the lips or in the mouth
• unusual bleeding or bruising
• unusual tiredness or weakness

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

Symptoms of overdose

• Confusion
• continuous, uncontrolled rolling eye movements
• double vision
• troubled breathing

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

• Clumsiness or unsteadiness
• dizziness or lightheadedness
• feeling of constant movement of self or surroundings
• sensation of spinning

Less common

• Decreased sexual ability
• drowsiness
• loss of appetite
• mood or mental changes
• nausea or vomiting

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.

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Generic Name: Ephedrine/Guaifenesin (eh-FED-rin/gwye-FEN-ah-sin)
Brand Name: Primatene Asthma

Primatene Asthma is used for:

Relieving congestion, cough, and throat and airway irritation due to colds, flu, or hay fever. It may also be used for other conditions as determined by your doctor.

Primatene Asthma is a decongestant and expectorant combination. It works by constricting blood vessels, reducing swelling in the nasal passages, and thinning and loosening mucus in the airway. This allows you to breathe more easily and makes coughs more productive.

Do NOT use Primatene Asthma if:

• you are allergic to any ingredient in Primatene Asthma
• you have severe high blood pressure, rapid heartbeat, or other severe heart problems (eg, heart blood vessel disease)
• you have taken furazolidone or a monoamine oxidase (MAO) inhibitor (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 Primatene Asthma:

Some medical conditions may interact with Primatene Asthma. 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, tumor), heart problems, high blood pressure, diabetes, heart blood vessel problems, stroke, glaucoma, an enlarged prostate or other prostate problems, seizures, or an overactive thyroid
• if you have chronic cough

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

• Beta-blockers (eg, propranolol), catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), furazolidone, indomethacin, MAO inhibitors (eg, phenelzine), or tricyclic antidepressants (eg, amitriptyline) because the risk of side effects from Primatene Asthma may be increased
• Digoxin or droxidopa because the risk of irregular heartbeat or heart attack may be increased
• Bromocriptine because the risk of side effects may be increased by Primatene Asthma
• Guanethidine, guanadrel, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Primatene Asthma

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

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

• Primatene Asthma may be taken with or without food.
• Take Primatene Asthma with a full glass of water unless otherwise directed by your doctor.
• If you miss a dose of Primatene Asthma, 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 Primatene Asthma.

Important safety information:

• Primatene Asthma may cause dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Primatene Asthma. Using Primatene Asthma alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
• Do not take appetite suppressants while you are taking Primatene Asthma without checking with your doctor.
• Primatene Asthma contains ephedrine. Before you begin taking any new prescription or nonprescription medicine, read the ingredients to see if it also contains ephedrine. If it does or if you are uncertain, contact your doctor or pharmacist.
• Do NOT exceed the recommended dose or take Primatene Asthma for longer than prescribed without checking with your doctor.
• If your symptoms do not improve within 5 to 7 days or if they become worse, check with your doctor.
• Primatene Asthma may interfere with certain lab test results. Make sure that all of your doctors and laboratory personnel know that you are taking Primatene Asthma.
• Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Primatene Asthma.
• Use Primatene Asthma with caution in the ELDERLY because they may be more sensitive to its effects.
• Caution is advised when using Primatene Asthma in CHILDREN because they may be more sensitive to its effects.
• PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Primatene Asthma, discuss with your doctor the benefits and risks of using Primatene Asthma during pregnancy. It is unknown if Primatene Asthma is excreted in breast milk. Do not breast-feed while taking Primatene Asthma.

Possible side effects of Primatene Asthma:

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; excitability; headache; nausea; nervousness or anxiety; trouble sleeping; weakness.

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

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty urinating; fast or irregular heartbeat; hallucinations; seizures; severe dizziness, lightheadedness, or headache; tremor.

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. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include blurred vision; confusion; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; unusually fast, slow, or irregular heartbeat; vomiting.

Proper storage of Primatene Asthma:

Store Primatene Asthma 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 Primatene Asthma out of the reach of children and away from pets.

General information:

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

This information is a summary only. It does not contain all information about Primatene Asthma. 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.

Generic Name: Epinephrine (ep-i-NEF-rin)
Brand Name: Examples include Asthmahaler and Primatene Mist

Primatene Mist Aerosol is used for:

Treating shortness of breath, chest tightness, and wheezing associated with asthma, emphysema, and other breathing problems. It may also be used for other conditions as determined by your doctor.

Primatene Mist Aerosol is an alpha- and beta-receptor stimulant. It works by widening the airway, which makes it easier to breathe.

Do NOT use Primatene Mist Aerosol if:

• you are allergic to any ingredient in Primatene Mist Aerosol
• you have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the past 14 days

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

Before using Primatene Mist Aerosol:

Some medical conditions may interact with Primatene Mist Aerosol. 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 overactive thyroid, urinary problems, an enlarged prostate, diabetes, high blood pressure, ischemic heart disease, irregular heartbeat, or other heart problems

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

• Beta-blockers (eg, propranolol), droxidopa, or phenothiazines (eg, chlorpromazine) because the risk of high or low blood pressure and fast or slow heartbeat may be increased
• Bromocriptine, furazolidone, MAOIs (eg, phenelzine), or tricyclic antidepressants (eg, amitriptyline) because the risk of side effects, such as headache, high temperature, and high blood pressure, may be increased
• Catechol-O-methyltransferase (COMT) inhibitors (eg, entacapone), digoxin, or medicines for irregular heartbeat (eg, quinidine) because they may increase the risk of Primatene Mist Aerosol’s side effects
• Guanethidine because its effectiveness may be decreased by Primatene Mist Aerosol

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

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

• An extra patient leaflet is available with Primatene Mist Aerosol. Talk to your pharmacist if you have questions about this information.
• Before using Primatene Mist Aerosol, be sure that the canister is properly placed in the inhaler unit. Shake well. Breathe out slowly and completely. Place the mouthpiece between your lips and try to rest your tongue flat, unless your doctor has told you otherwise. Your doctor may have told you to hold the inhaler 1 or 2 inches (2 or 3 centimeters) away from the open mouth or to use a special spacing device. As you start to take a slow deep breath, press the canister and mouthpiece together at exactly the same time. This will release a dose of Primatene Mist Aerosol. Continue breathing in slowly and deeply and hold for as long as comfortable, then breathe out slowly through pursed lips or your nose. If more than 1 inhalation is to be used, wait a few minutes and repeat the above steps. Keep the spray away from your eyes.
• If you miss a dose of Primatene Mist Aerosol, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Primatene Mist Aerosol.

Important safety information:

• 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 or if they get worse, check with your doctor.
• Primatene Mist Aerosol may cause dry mouth or an unpleasant taste in your mouth. Rinsing your mouth with water after each dose may help relieve these effects.
• Primatene Mist Aerosol should not be used in CHILDREN younger than 4 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Primatene Mist Aerosol while you are pregnant. Primatene Mist Aerosol is found in breast milk. If you are or will be breast-feeding while you use Primatene Mist Aerosol, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Primatene Mist Aerosol:

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:

Difficulty sleeping; fast heartbeat; headache; loss of appetite; nausea; nervousness; tremors.

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); wheezing.

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. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include headache; irregular heartbeat; nausea; tremor; vomiting; weakness.

Proper storage of Primatene Mist Aerosol:

Store Primatene Mist Aerosol at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not puncture, break, or burn the canister even if it appears to be empty. Keep Primatene Mist Aerosol out of the reach of children and away from pets.

General information:

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

This information is a summary only. It does not contain all information about Primatene Mist Aerosol. 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.

Generic Name: imipenem and cilastatin (IM i PEN em and SYE la STAT in)
Brand Names: Primaxin IM, Primaxin IV

What is Primaxin IM (imipenem and cilastatin)?

Imipenem is an antibiotic that fights serious infections caused by bacteria.

Cilastatin helps imipenem work more effectively by preventing the breakdown of the antibiotic in the kidneys.

Imipenem and cilastatin is used to treat severe infections of the lower respiratory tract, skin, stomach, female reproductive organs, and other body systems.

Imipenem and cilastatin may also be used for other purposes not listed here.

What is the most important information I should know about Primaxin IM (imipenem and cilastatin)?

Do not use imipenem and cilastatin if you are allergic to it, if you have heart block, or if you are allergic to lidocaine or other local anesthetics (numbing medicine).

Before using imipenem and cilastatin, tell your doctor if you have kidney disease (or if you are on dialysis), or a seizure disorder.

Also tell your doctor if you are either allergic to or are currently taking a penicillin or cephalosporin antibiotic such as Amoxil, Augmentin, Bactocill, Beepen-VK, Ceclor, Ceftin, Duricef, Dycill, Dynapen, Keflex, Ledercillin VK, Omnipen, Pen-V, Pfizerpen, Principen, Veetids, and others.

Primaxin IM (for the muscle) and Primaxin IV (for the vein) are different forms of this medicine and should be used only for their specific type of injection. Do not inject Primaxin IM into a vein and do not inject Primaxin IV into a muscle.

Call your doctor at once if you have serious side effects such as pounding heartbeats, confusion, hallucinations, seizure (convulsions), feeling light-headed, fainting, flu symptoms, nausea, stomach pain, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes), or a severe blistering, peeling, and red skin rash.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or has blood in it, call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.

What should I discuss with my healthcare provider before use Primaxin IM (imipenem and cilastatin)?

Do not use imipenem and cilastatin if you are allergic to it, if you have heart block, or if you are allergic to lidocaine or other local anesthetics (numbing medicine).

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

• kidney disease (or if you are on dialysis);

• epilepsy or other seizure disorder;

• a history of allergy to penicillin antibiotics such as Amoxil, Augmentin, Omnipen, Principen, Dycill, Dynapen, Bactocill, Beepen-VK, Ledercillin VK, Pen-V, Pfizerpen, Veetids, and others; or

• a history of allergy to cephalosporin antibiotics such as Ceclor, Ceftin, Duricef, Keflex, and others.

FDA pregnancy category C. It is not known whether imipenem and cilastatin will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.. It is not known whether imipenem and cilastatin passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use Primaxin IM (imipenem and cilastatin)?

Imipenem and cilastatin is injected into a vein (IV) or into a muscle (IM).

Imipenem and cilastatin is usually given in a clinic or hospital setting. The IV medicine must be given as a slow infusion and can take up to an hour to complete. Tell your caregiver if you feel nauseated during the infusion. You may need to receive the medicine at a slower rate.

The IM form of imipenem and cilastatin is given as a rapid injection into a muscle. You may be shown how to use injections at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.

Primaxin IM (for the muscle) and Primaxin IV (for the vein) are different forms of this medicine and should be used only for their specific type of injection. Do not inject Primaxin IM into a vein and do not inject Primaxin IV into a muscle.

Imipenem and cilastatin is usually given as long as needed until your infection has cleared or you have been symptom-free for at least 48 hours.

Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Imipenem and cilastatin will not treat a viral infection such as the common cold or flu.

Do not give this medication to another person, even if they have the same symptoms you do.

Imipenem and cilastatin is a powder that must be mixed with a liquid (diluent). Primaxin IM and Primaxin IV are each mixed with different types of diluent.

Prepare your dose in a syringe only when you are ready to give yourself an injection.

After mixing Primaxin IV, you may keep it in a refrigerator and use it within 24 hours. You may also store the mixed IV medicine at room temperature if you use it within 4 hours. Store unmixed imipenem and cilastatin powder at room temperature away from moisture and heat.

What happens if I miss a dose?

If imipenem and cilastatin is given in a hospital setting, it is not likely that you will miss a dose. If you are using the medication at home and you miss a dose, give the injection as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

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

Overdose symptoms may include weakness, drooping eyelid, tremors, trouble breathing, or seizure (black-out or convulsions).

What should I avoid while using Primaxin IM (imipenem and cilastatin)?

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or has blood in it, call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.

Primaxin IM (imipenem and cilastatin) side effects

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

• fast or pounding heartbeats;

• diarrhea that is watery or bloody;

• confusion, tremors, hallucinations, seizure (convulsions);

• feeling light-headed, fainting;

• fever, chills, body aches, flu symptoms;

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

• fever, sore throat, and headache with a severe blistering, peeling, and red skin rash.

Less serious side effects may include:

• pain, swelling, or redness where the medicine was injected;

• mild nausea, vomiting, heartburn, or stomach pain;

• sore throat;

• vaginal itching or discharge;

• mild skin rash or itching;

• dizziness or tired feeling;

• numbness or tingling; or

• ringing in your ears.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Primaxin IM (imipenem and cilastatin)?

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

• valproic acid (Depakene, Stavzor);

• ganciclovir (Cytovene);

• probenecid (Benemid);

• a penicillin antibiotic such as amoxicillin (Amoxil, Augmentin), ampicillin (Omnipen, Principen), dicloxacillin (Dycill, Dynapen), oxacillin (Bactocill), or penicillin (Beepen-VK, Ledercillin VK, Pen-V, Pen-Vee K, Pfizerpen, V-Cillin K, Veetids, and others); or

• a cephalosporin antibiotic such as cefaclor (Ceclor), cefuroxime (Ceftin), cefadroxil (Duricef), cephalexin (Keflex), and others.

This list is not complete and other drugs may interact with imipenem and cilastatin. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

• Your doctor or pharmacist can provide more information about imipenem and cilastatin.

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medicine only for the indication prescribed.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 2.01. Revision Date: 02/17/2010 10:20:11 AM.

Generic Name: imipenem and cilastatin (IM i PEN em and SYE la STAT in)
Brand Names: Primaxin IM, Primaxin IV

What is Primaxin IV (imipenem and cilastatin)?

Imipenem is an antibiotic that fights serious infections caused by bacteria.

Cilastatin helps imipenem work more effectively by preventing the breakdown of the antibiotic in the kidneys.

Imipenem and cilastatin is used to treat severe infections of the lower respiratory tract, skin, stomach, female reproductive organs, and other body systems.

Imipenem and cilastatin may also be used for other purposes not listed here.

What is the most important information I should know about Primaxin IV (imipenem and cilastatin)?

Do not use imipenem and cilastatin if you are allergic to it, if you have heart block, or if you are allergic to lidocaine or other local anesthetics (numbing medicine).

Before using imipenem and cilastatin, tell your doctor if you have kidney disease (or if you are on dialysis), or a seizure disorder.

Also tell your doctor if you are either allergic to or are currently taking a penicillin or cephalosporin antibiotic such as Amoxil, Augmentin, Bactocill, Beepen-VK, Ceclor, Ceftin, Duricef, Dycill, Dynapen, Keflex, Ledercillin VK, Omnipen, Pen-V, Pfizerpen, Principen, Veetids, and others.

Primaxin IM (for the muscle) and Primaxin IV (for the vein) are different forms of this medicine and should be used only for their specific type of injection. Do not inject Primaxin IM into a vein and do not inject Primaxin IV into a muscle.

Call your doctor at once if you have serious side effects such as pounding heartbeats, confusion, hallucinations, seizure (convulsions), feeling light-headed, fainting, flu symptoms, nausea, stomach pain, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes), or a severe blistering, peeling, and red skin rash.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or has blood in it, call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.

What should I discuss with my healthcare provider before use Primaxin IV (imipenem and cilastatin)?

Do not use imipenem and cilastatin if you are allergic to it, if you have heart block, or if you are allergic to lidocaine or other local anesthetics (numbing medicine).

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

• kidney disease (or if you are on dialysis);

• epilepsy or other seizure disorder;

• a history of allergy to penicillin antibiotics such as Amoxil, Augmentin, Omnipen, Principen, Dycill, Dynapen, Bactocill, Beepen-VK, Ledercillin VK, Pen-V, Pfizerpen, Veetids, and others; or

• a history of allergy to cephalosporin antibiotics such as Ceclor, Ceftin, Duricef, Keflex, and others.

FDA pregnancy category C. It is not known whether imipenem and cilastatin will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.. It is not known whether imipenem and cilastatin passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use Primaxin IV (imipenem and cilastatin)?

Imipenem and cilastatin is injected into a vein (IV) or into a muscle (IM).

Imipenem and cilastatin is usually given in a clinic or hospital setting. The IV medicine must be given as a slow infusion and can take up to an hour to complete. Tell your caregiver if you feel nauseated during the infusion. You may need to receive the medicine at a slower rate.

The IM form of imipenem and cilastatin is given as a rapid injection into a muscle. You may be shown how to use injections at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.

Primaxin IM (for the muscle) and Primaxin IV (for the vein) are different forms of this medicine and should be used only for their specific type of injection. Do not inject Primaxin IM into a vein and do not inject Primaxin IV into a muscle.

Imipenem and cilastatin is usually given as long as needed until your infection has cleared or you have been symptom-free for at least 48 hours.

Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Imipenem and cilastatin will not treat a viral infection such as the common cold or flu.

Do not give this medication to another person, even if they have the same symptoms you do.

Imipenem and cilastatin is a powder that must be mixed with a liquid (diluent). Primaxin IM and Primaxin IV are each mixed with different types of diluent.

Prepare your dose in a syringe only when you are ready to give yourself an injection.

After mixing Primaxin IV, you may keep it in a refrigerator and use it within 24 hours. You may also store the mixed IV medicine at room temperature if you use it within 4 hours. Store unmixed imipenem and cilastatin powder at room temperature away from moisture and heat.

What happens if I miss a dose?

If imipenem and cilastatin is given in a hospital setting, it is not likely that you will miss a dose. If you are using the medication at home and you miss a dose, give the injection as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

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

Overdose symptoms may include weakness, drooping eyelid, tremors, trouble breathing, or seizure (black-out or convulsions).

What should I avoid while using Primaxin IV (imipenem and cilastatin)?

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or has blood in it, call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.

Primaxin IV (imipenem and cilastatin) side effects

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

• fast or pounding heartbeats;

• diarrhea that is watery or bloody;

• confusion, tremors, hallucinations, seizure (convulsions);

• feeling light-headed, fainting;

• fever, chills, body aches, flu symptoms;

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

• fever, sore throat, and headache with a severe blistering, peeling, and red skin rash.

Less serious side effects may include:

• pain, swelling, or redness where the medicine was injected;

• mild nausea, vomiting, heartburn, or stomach pain;

• sore throat;

• vaginal itching or discharge;

• mild skin rash or itching;

• dizziness or tired feeling;

• numbness or tingling; or

• ringing in your ears.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Primaxin IV (imipenem and cilastatin)?

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

• valproic acid (Depakene, Stavzor);

• ganciclovir (Cytovene);

• probenecid (Benemid);

• a penicillin antibiotic such as amoxicillin (Amoxil, Augmentin), ampicillin (Omnipen, Principen), dicloxacillin (Dycill, Dynapen), oxacillin (Bactocill), or penicillin (Beepen-VK, Ledercillin VK, Pen-V, Pen-Vee K, Pfizerpen, V-Cillin K, Veetids, and others); or

• a cephalosporin antibiotic such as cefaclor (Ceclor), cefuroxime (Ceftin), cefadroxil (Duricef), cephalexin (Keflex), and others.

This list is not complete and other drugs may interact with imipenem and cilastatin. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

• Your doctor or pharmacist can provide more information about imipenem and cilastatin.

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medicine only for the indication prescribed.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 2.01. Revision Date: 02/17/2010 10:20:11 AM.

Generic Name: primaquine (PRIM a kwin)
Brand Names:

What is primaquine?

Primaquine is an antimalarial drug. The exact way that primaquine works is unknown.

Primaquine is used to treat and prevent malaria.

Primaquine may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about primaquine?

Notify your doctor if your urine turns dark.

Use caution when driving or performing other hazardous activities until you know how this medication affects you. Primaquine may cause visual disturbances such as blurred vision, misty vision, and difficulty focusing. Report any vision or hearing changes to your doctor.

Who should not take primaquine?

Before taking this medication, tell your doctor if you have

• a history of an allergic reaction to previous primaquine therapy,

• glucose-6-phosphate dehydrogenase (G-6-PD) deficiency,

• rheumatoid arthritis,

• lupus erythematosus, or

• quinacrine (Atabrine) therapy.

You may not be able to take primaquine, or you may require a lower dose or special monitoring during your therapy if you have any of the conditions listed above.

It is not known whether primaquine will harm an unborn baby. Do not take primaquine without first talking to your doctor if you are pregnant. It is not known how primaquine will affect a nursing baby. Do not take primaquine without first talking to your doctor if you are breast-feeding a baby.

How should I take primaquine?

Take primaquine exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each dose with a full glass of water. Take primaquine with food to lessen stomach upset. Store primaquine at room temperature away from moisture and heat.

See also: Primaquine dosage in more detail

What happens if I miss a dose?

Take the missed dose as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and only take your next regularly scheduled dose. Do not take a double dose of this medication.

What happens if I overdose?

Seek emergency medical attention.

Symptoms of a primaquine overdose include nausea, vomiting, stomach upset, and stomach cramps.

What should I avoid while taking primaquine?

Use caution when driving or performing other hazardous activities until you know how this medication affects you. Primaquine may cause visual disturbances such as blurred vision, misty vision, and difficulty focusing. Report any vision or hearing changes to your doctor.

Primaquine side effects

Stop taking primaquine and seek emergency medical attention if you experience an allergic reaction (flushing; swelling of your lips, tongue, or face, difficulty breathing; closing of your throat; vision problems; a rash; or itching).

Notify your doctor if you experience darkening of your urine.

Nausea, stomach pain or upset, vomiting, and loss of appetite may also occur during therapy.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Primaquine Dosing Information

Usual Adult Dose for Malaria:

26.3 mg (15 mg base) orally once a day for 14 days

Alternatively, the Centers for Disease Control and Prevention (CDC) recommend 52.6 mg (30 mg base) orally once a day for 14 days. For patients with borderline glucose-6-phosphate dehydrogenase (G6PD) deficiency or as an alternative regimen, 78.9 mg (45 mg base) orally once a week for 8 weeks has been recommended.

Usual Adult Dose for Malaria Prophylaxis:

26.3 mg (15 mg base) orally once a day

Alternatively, the CDC recommend 52.6 mg (30 mg base) orally once a day.

Usual Adult Dose for Pneumocystis Pneumonia:

26.3 mg (15 mg base) to 52.6 mg (30 mg base) orally once a day for 21 days; effective in combination with clindamycin
Seriously ill patients should receive IV trimethoprim-sulfamethoxazole or pentamidine therapy.

Usual Pediatric Dose for Malaria:

0.526 mg/kg (0.3 mg/kg base) orally once a day for 14 days (not to exceed 15 mg base/day)

Alternatively, the CDC recommend 1.052 mg/kg (0.6 mg/kg base) orally once a day for 14 days (not to exceed 30 mg base/day). For patients with borderline G6PD deficiency or as an alternative regimen, 1.578 mg/kg (0.9 mg/kg base) orally once a week for 8 weeks (not to exceed 45 mg base/week) has been recommended.

Usual Pediatric Dose for Malaria Prophylaxis:

0.526 mg/kg (0.3 mg/kg base) orally once a day (not to exceed 15 mg base/day)

Alternatively, the CDC recommend 1.052 mg/kg (0.6 mg/kg base) orally once a day (not to exceed 30 mg base/day).

What other drugs will affect primaquine?

Do not take primaquine if you have recently taken quinacrine (Atabrine). These two drugs are similar and can cause dangerous side effects if they are taken together.

Drugs other than those listed here may also interact with primaquine. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.

Where can I get more information?

• Your pharmacist can provide more information about primaquine.

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 4.01. Revision Date: 04/02/2009 2:41:37 PM.

PRIM-a-kwin

Available Dosage Forms:

• Tablet

Therapeutic Class: Antimalarial

Chemical Class: Aminoquinoline

Uses For primaquine

Primaquine belongs to the group of medicines called antiprotozoals. It is used in the treatment of malaria, a red blood cell infection transmitted by the bite of a mosquito.

Malaria transmission occurs in large areas of Central and South America, Hispaniola, sub-Saharan Africa, the Indian subcontinent, Southeast Asia, the Middle East, and Oceania. Country-specific information on malaria can be obtained from the Centers for Disease Control and Prevention (CDC), or from the CDC’s web site at http://www.cdc.gov/travel/yellowbk.

Primaquine is available only with your doctor’s prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in product labeling, primaquine is used in certain patients with the following medical condition:

• Pneumocystis carinii pneumonia (PCP)

Before Using primaquine

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 primaquine, the following should be considered:

Allergies

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

Children should avoid traveling to areas where there is a chance of getting malaria, unless they can take effective antimalarial medicines such as primaquine.

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 or if they cause different side effects or problems in older people. There is no specific information comparing use of primaquine in the elderly with use in other age groups.

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

Using primaquine 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.

• Aurothioglucose
• Levomethadyl

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 primaquine. Make sure you tell your doctor if you have any other medical problems, especially:

• Family or personal history of favism or hemolytic anemia or
• Glucose-6-phosphate dehydrogenase (G6PD) deficiency or
• Nicotinamide adenine dinucleotide (NADH) methemoglobin reductase deficiency—Patients with any of these medical problems who take primaquine may have an increased chance of side effects affecting the blood.

Proper Use of primaquine

If primaquine upsets your stomach, it may be taken with meals or with antacids. If stomach upset (nausea, vomiting, or stomach pain) continues, check with your doctor.

If you are taking primaquine for malaria, keep taking it for the full time of treatment to help prevent or completely clear up the infection. Do not miss any doses.

Dosing

The dose of primaquine 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 primaquine. 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 malaria:
  • For oral dosage form (tablets):
    • Adults and older children: 15 milligrams (mg) once a day for 14 days.
    • Younger children: Dose is based on body weight and must be determined by your doctor.

Missed Dose

If you miss a dose of primaquine, 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 primaquine

Your doctor should check your progress at regular visits to make sure that primaquine is not causing blood problems.

primaquine 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

• Back, leg, or stomach pains
• dark urine
• fever
• loss of appetite
• pale skin
• unusual tiredness or weakness

Less common

• Bluish fingernails, lips, or skin
• difficulty breathing
• dizziness or lightheadedness

Rare

• Sore throat and fever

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

• Cramps
• nausea or vomiting

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.

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Pronunciation: (PRIM-uh-kween FOSS-fate)
Class: Antimalarial

Trade Names:
Primaquine Phosphate
- Tablets 26.3 mg (equiv. to 15 mg base)

Pharmacology

Disrupts metabolic processes of parasitic organism, eliminating tissue (exoerythrocytic) infection and preventing development of blood (erythrocytic) forms of parasite responsible for relapses of vivax malaria.

Pharmacokinetics

Absorption

Rapid. Bioavailability is approximately 96%. T _max is approximately 2 to 3 h (primaquine), approximately 7 h (metabolite carboxyprimaquine). C _max is 50 to 66 ng/mL (15 mg); 104 ng/mL (30 mg).

Distribution

Extensively distributed. Vd is 248 L. C _max is 291 to 736 ng/mL (metabolite) and 432 to 1240 ng/mL (metabolite).

Metabolism

Rapidly converted to carboxyprimaquine. Undetermined if the main plasma metabolite has activity.

Elimination

Urine (less than 2% of dose). The t _½ is 5.8 h (primaquine); 22 to 30 h (metabolite carboxyprimaquine).

Indications and Usage

Radical cure or prevention of relapse in vivax malaria; after termination of chloroquine phosphate suppressive therapy in areas where vivax malaria is endemic.

Unlabeled Uses

With clindamycin, treatment of Pneumocystis carinii pneumonia associated with AIDS.

Contraindications

Concomitant administration of quinacrine and primaquine; acutely ill patient with systemic disease manifested by granulocytopenia (eg, rheumatoid arthritis, lupus erythematosus); concurrent administration of other potentially hemolytic or bone marrow depressant medications.

Dosage and Administration

Begin therapy during last 2 wk of or after course of suppression with chloroquine or comparable drug.

Adults

PO 26.3 mg (15 mg base) for 14 days.

Children

PO 0.5 mg/kg/day (0.3 mg/kg/day of base) for 14 days (max, 15 mg/day of base).

General Advice

Administer without regard to meals. Administer with food if GI upset occurs.

Storage/Stability

Store at room temperature in tightly closed, light-resistant container.

Drug Interactions

Quinacrine

May potentiate toxicity of antimalarial compounds that are structurally related to primaquine.

Laboratory Test Interactions

None well documented.

Adverse Reactions

GI

Nausea; vomiting; epigastric distress; abdominal cramps.

Hematologic

Leukopenia; hemolytic anemia in G-6-PD deficiency; methemoglobinemia in NADH methemoglobin reductase deficiency.

Precautions

Pregnancy

Pregnancy category undetermined.

Lactation

Undetermined. To avoid adverse reactions in the infant, do not give to lactating women.

Hemolytic anemia

May occur in patients with following conditions: G-6-PD deficiency, NADH methemoglobin reductase deficiency; idiosyncratic reactions (leukopenia, methemoglobinemia; hemolytic anemia). Discontinue drug if marked darkening of urine or sudden decrease in Hgb or leukocyte count occurs.

Max dose

Hemolytic reactions may occur with doses of drug exceeding recommended dose.

Overdosage

Symptoms

Anemia, methemoglobinemia, leukopenia, acute abdominal cramps, vomiting, epigastric distress, CNS and cardiovascular disturbances, granulocytopenia, hemolytic anemia.

Patient Information

• Tell patient that medicine may be taken with food if stomach upset (eg, nausea, vomiting, abdominal cramps) occurs, and advise patient to contact health care provider if upset persists.
• Emphasize importance of compliance with drug regimen.
• Advise patient to report marked darkening of urine to health care provider.

Copyright © 2009 Wolters Kluwer Health.