acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine

Generic Name: acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine (a SEET a MIN o fen, DEX troe meth OR fan, dox IL a meen, SOO doe e FED rin)

Brand names: Alka-Seltzer Plus Night Time Cold Liquigel, All-Nite Multi-Symptom Cold/Flu Relief, Multi-Symptom Nighttime, NyCair, Nyquil Cold Medicine, NyQuil D, Nyquil Liquicap, Robitussin Night Cold, Theraflu Nighttime Severe Cold (pseudoephedrine), Nyquil Hot Therapy, All-Nite Cold, Tylenol Flu Night Time, Tylenol Severe Cold & Flu Night Time, Night Time

What is acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine?

Acetaminophen is a pain reliever and fever reducer.

Doxylamine is an antihistamine that reduces the effects of the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Dextromethorphan is a cough suppressant. It affects the cough reflex in the brain that triggers coughing.

Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

The combination of acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine is used to treat headache, fever, body aches, cough, runny nose, sneezing, itching, and watery eyes caused by allergies, the common cold, or the flu.

This medicine will not treat a cough that is caused by smoking, asthma, or emphysema.

Acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine may also be used for purposes not listed in this medication guide.

What is the most important information I should know about this medicine?

Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death. Do not take this medication without a doctor's advice if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You should not use this medicine if you have severe constipation, a blockage in your stomach or intestines, or if you are unable to urinate. Do not use this medicine if you have untreated or uncontrolled diseases such as glaucoma, asthma or COPD, high blood pressure, heart disease, coronary artery disease, or overactive thyroid. Do not use this medicine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects. Avoid drinking alcohol. It may increase your risk of liver damage while you are taking acetaminophen, and can increase certain side effects of doxylamine. Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP.

What should I discuss with my healthcare provider before taking this medicine?

You should not use this medicine if you have severe constipation, a blockage in your stomach or intestines, or if you are unable to urinate. Do not use this medicine if you have untreated or uncontrolled diseases such as glaucoma, asthma or COPD, high blood pressure, heart disease, coronary artery disease, or overactive thyroid. Do not use this medicine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Ask a doctor or pharmacist if it is safe for you to take this medicine if you have:

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  liver disease, cirrhosis, a history of alcoholism, or if you drink more than 3 alcoholic beverages per day;

  
  


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  a blockage in your digestive tract (stomach or intestines);

  
  


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  kidney disease;

  
  


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  cough with mucus, or cough caused by emphysema or chronic bronchitis;

  
  


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  enlarged prostate or urination problems; or

  
  


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  if you take potassium (Cytra, Epiklor, K-Lyte, K-Phos, Kaon, Klor-Con, Polycitra, Urocit-K).

  
  

It is not known whether acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine will harm an unborn baby. Do not use this medicine without a doctor's advice if you are pregnant. Acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine may pass into breast milk and may harm a nursing baby. Antihistamines and decongestans may also slow breast milk production. Do not use this medicine without a doctor's advice if you are breast-feeding a baby.

How should I take this medicine?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. This medicine is usually taken only for a short time until your symptoms clear up.

Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death. Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

Measure liquid medicine with a special dose measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose measuring device, ask your pharmacist for one.

Do not take for longer than 7 days in a row. Stop taking the medicine and call your doctor if you still have a fever after 3 days of use, you still have pain after 7 days (or 5 days if treating a child), if your symptoms get worse, or if you have a skin rash, ongoing headache, or any redness or swelling.

If you need surgery or medical tests, tell the surgeon or doctor ahead of time if you have taken this medicine within the past few days. Store at room temperature away from moisture and heat. Do not allow liquid medicine to freeze.

See also: Acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine dosage (in more detail)

What happens if I miss a dose?

Since this medicine is taken when needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of acetaminophen can be fatal.

The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.

Overdose symptoms may also include severe forms of some of the side effects listed in this medication guide.

What should I avoid while taking this medicine?

Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP. Avoid drinking alcohol. It may increase your risk of liver damage while you are taking acetaminophen, and can increase certain side effects of doxylamine. This medicine may cause blurred vision or impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

This medicine side effects

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

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  chest pain, rapid pulse;

  
  


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  fast, slow, or uneven heart rate;

  
  


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  severe dizziness or anxiety, feeling like you might pass out;

  
  


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  severe headache;

  
  


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  mood changes, confusion, hallucinations, severe nervousness;

  
  


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  tremor, seizure (convulsions);

  
  


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  fever, easy bruising or bleeding, unusual weakness;

  
  


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  urinating less than usual or not at all;

  
  


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  nausea, pain in your upper stomach, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of your skin or eyes); or

  
  


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  dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, chest pain, uneven heartbeats, seizure).

  
  

Less serious side effects may include:

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  dizziness, drowsiness, mild headache;

  
  


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  dry mouth, nose, or throat;

  
  


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  constipation, diarrhea, mild nausea, upset stomach;

  
  


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  blurred vision;

  
  


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  feeling restless or irritable; or

  
  


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  sleep problems (insomnia).

  
  

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

Acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine Dosing Information

Usual Adult Dose for Cold Symptoms:

acetaminophen/dextromethorphan/doxylamine/PSE 325 mg-15 mg-6.25 mg-30 mg oral capsule: 1 to 2 capsules orally every 6 hours not to exceed 8 capsules daily.

Usual Pediatric Dose for Cold Symptoms:

acetaminophen/dextromethorphan/doxylamine/PSE 325 mg-15 mg-6.25 mg-30 mg oral capsule:
12 yrs and older: 1 to 2 capsules orally every 6 hours not to exceed 8 capsules daily.

What other drugs will affect this medicine?

Ask a doctor or pharmacist before using this medicine if you regularly use other medicines that make you sleepy (such as narcotic pain medication, sedatives, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety). They can add to sleepiness caused by doxylamine.

Ask a doctor or pharmacist if it is safe for you to use acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine if you are also using any of the following drugs:

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  leflunomide (Arava);

  
  


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  topiramate (Topamax);

  
  


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  zonisamide (Zonegran);

  
  


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  an antibiotic, antifungal medicine, sulfa drug, or tuberculosis medicine;

  
  


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  an antidepressant;

  
  


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  birth control pills or hormone replacement therapy;

  
  


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  bladder or urinary medications;

  
  


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  blood pressure medication;

  
  


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  a bronchodilator;

  
  


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  cancer medicine;

  
  


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  cholesterol-lowering medications such as Lipitor, Niaspan, Zocor, Vytorin, and others;

  
  


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  gout or arthritis medications (including gold injections);

  
  


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  HIV/AIDS medication;

  
  


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  medication for nausea and vomiting, stomach ulcers, or irritable bowel syndrome;

  
  


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  medicines to treat psychiatric disorders;

  
  


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  an NSAID such as Advil, Aleve, Arthrotec, Cataflam, Celebrex, Indocin, Motrin, Naprosyn, Treximet, Voltaren, others; or

  
  


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  seizure medication.

  
  

This list is not complete and there may be other drugs that can affect acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine . 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.

More acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine resources

• Acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine Side Effects (in more detail)
• Acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine Dosage
• Acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine Use in Pregnancy & Breastfeeding
• Acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine Drug Interactions
• Acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine Support Group
• 3 Reviews for Acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine - Add your own review/rating

Compare acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine with other medications

• Cold Symptoms

Where can I get more information?

• Your pharmacist can provide more information about acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine .

See also: acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine side effects (in more detail)

Antihemophilic Factor (Recombinant) Plasma/Albumin Free

Pronunciation: AN-tye-HEE-moe-FIL-ik
Generic Name: Antihemophilic Factor (Recombinant) (Plasma/Albumin Free)
Brand Name: Advate

Antihemophilic Factor (Recombinant) (Plasma/Albumin Free) is used for:

Preventing and controlling bleeding in patients with hemophilia A (factor VIII deficiency), including in surgical settings.

Antihemophilic Factor (Recombinant) (Plasma/Albumin Free) is a manmade clotting factor. It works by increasing the amount of clotting factor VIII in the body, which helps the blood clot normally.

Do NOT use Antihemophilic Factor (Recombinant) (Plasma/Albumin Free) if:

• you are allergic to any ingredient in Antihemophilic Factor (Recombinant) (Plasma/Albumin Free), including mouse or hamster proteins

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

Before using Antihemophilic Factor (Recombinant) (Plasma/Albumin Free):

Some medical conditions may interact with Antihemophilic Factor (Recombinant) (Plasma/Albumin Free). 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 von Willebrand disease


• if you have been told that you have inhibitors to factor VIII

Some MEDICINES MAY INTERACT with Antihemophilic Factor (Recombinant) (Plasma/Albumin Free). However, no specific interactions with Antihemophilic Factor (Recombinant) (Plasma/Albumin Free) are known at this time.

Ask your health care provider if Antihemophilic Factor (Recombinant) (Plasma/Albumin Free) 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 Antihemophilic Factor (Recombinant) (Plasma/Albumin Free):

Use Antihemophilic Factor (Recombinant) (Plasma/Albumin Free) as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An additional patient leaflet is available with Antihemophilic Factor (Recombinant) (Plasma/Albumin Free). Talk to your pharmacist if you have questions about this information.


• Antihemophilic Factor (Recombinant) (Plasma/Albumin Free) is usually administered as an injection at your doctor's office, hospital, or clinic. If you are using Antihemophilic Factor (Recombinant) (Plasma/Albumin Free) at home, carefully follow the injection procedures taught to you by your health care provider.


• Your doctor or other health care provider will give you detailed instructions on how to mix and administer Antihemophilic Factor (Recombinant) (Plasma/Albumin Free) if you will be using it at home. Instructions are also included in the patient leaflet that is available with Antihemophilic Factor (Recombinant) (Plasma/Albumin Free). Be sure you understand how to give Antihemophilic Factor (Recombinant) (Plasma/Albumin Free) before you administer a dose. If you have any questions or concerns, contact your doctor or other health care provider.


• If Antihemophilic Factor (Recombinant) (Plasma/Albumin Free) contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.


• When drawing a dose into a syringe, be sure to follow the procedure demonstrated to you by your doctor to prevent contamination of the vial, syringe, or medicine. Never touch the rubber stopper of the vial or the needle of the syringe with your fingers.


• Carefully check that you have drawn the correct dose before administration.


• Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor or pharmacist to explain local regulations for proper disposal.


• If you miss a dose of Antihemophilic Factor (Recombinant) (Plasma/Albumin Free), contact your doctor immediately.

Ask your health care provider any questions you may have about how to use Antihemophilic Factor (Recombinant) (Plasma/Albumin Free).

Important safety information:

• Tell your doctor right away if bleeding is not controlled after using Antihemophilic Factor (Recombinant) (Plasma/Albumin Free).


• Antihemophilic Factor (Recombinant) (Plasma/Albumin Free) may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Antihemophilic Factor (Recombinant) (Plasma/Albumin Free) with caution. Do not drive or perform any other possibly unsafe tasks until you know how you react to it.


• Patients receiving clotting factors sometimes develop antibodies or inhibitors to the medicine. This makes it less effective. If Antihemophilic Factor (Recombinant) (Plasma/Albumin Free) stops working or does not work as well as it has before, contact your doctor immediately for instructions.


• Tell your doctor or dentist that you take Antihemophilic Factor (Recombinant) (Plasma/Albumin Free) before you receive any medical or dental care, emergency care, or surgery.


• Talk with your doctor before you travel while you are using Antihemophilic Factor (Recombinant) (Plasma/Albumin Free). Be sure to take along enough of Antihemophilic Factor (Recombinant) (Plasma/Albumin Free) for your treatment while you are traveling


• Lab tests, including factor VIII levels, may be performed while you take Antihemophilic Factor (Recombinant) (Plasma/Albumin Free). These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• PREGNANCY and BREAST-FEEDING: It is not known if Antihemophilic Factor (Recombinant) (Plasma/Albumin Free) can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Antihemophilic Factor (Recombinant) (Plasma/Albumin Free) while you are pregnant. It is not known if Antihemophilic Factor (Recombinant) (Plasma/Albumin Free) is found in breast milk. If you are or will be breast-feeding while you are using Antihemophilic Factor (Recombinant) (Plasma/Albumin Free), check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Antihemophilic Factor (Recombinant) (Plasma/Albumin Free):

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:

Cough; diarrhea; headache; joint pain; sore throat; stuffy or runny nose; vomiting.

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 or throat; swelling of the mouth, face, lips, or tongue; unusual hoarseness); burning numbness, or tingling; chest pain; dizziness; fainting; fever or chills; hot flashes; light-headedness; nausea; pain, swelling, or redness at the injection site; severe headache; shortness of breath; swelling of the legs; unusual bruising.

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: Antihemophilic Factor (Recombinant) (Plasma/Albumin Free) side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Antihemophilic Factor (Recombinant) (Plasma/Albumin Free):

Store Antihemophilic Factor (Recombinant) (Plasma/Albumin Free) in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. You may also store Antihemophilic Factor (Recombinant) (Plasma/Albumin Free) at room temperature, below 86 degrees F (30 degrees C), for up to 6 months. Once Antihemophilic Factor (Recombinant) (Plasma/Albumin Free) has been kept at room temperature, do not return it to the refrigerator. Do not use Antihemophilic Factor (Recombinant) (Plasma/Albumin Free) if the expiration date on the product has passed. Once Antihemophilic Factor (Recombinant) (Plasma/Albumin Free) has been mixed, it must be used within 3 hours. Do not refrigerate after mixing. Discard any medicine remaining in the vial after you use it. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Antihemophilic Factor (Recombinant) (Plasma/Albumin Free) out of the reach of children and away from pets.

General information:

• If you have any questions about Antihemophilic Factor (Recombinant) (Plasma/Albumin Free), please talk with your doctor, pharmacist, or other health care provider.


• Antihemophilic Factor (Recombinant) (Plasma/Albumin Free) 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 Antihemophilic Factor (Recombinant) (Plasma/Albumin Free). 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 Antihemophilic Factor (Recombinant) (Plasma/Albumin Free) resources

• Antihemophilic Factor (Recombinant) (Plasma/Albumin Free) Side Effects (in more detail)
• Antihemophilic Factor (Recombinant) (Plasma/Albumin Free) Use in Pregnancy & Breastfeeding
• Antihemophilic Factor (Recombinant) (Plasma/Albumin Free) Support Group
• 0 Reviews for Antihemophilic Factor (Recombinant) (Plasma/Albumin Free) - Add your own review/rating

Compare Antihemophilic Factor (Recombinant) (Plasma/Albumin Free) with other medications

• Hemophilia A

Lithium Citrate Syrup

Dosage Form: oral syrup
Lithium Citrate Syrup, USP

Sugar-Free

For Oral Administration Only

Rx Only

8 mEq/5 mL

WARNING

Lithium toxicity is closely related to serum lithium levels, and can occur at doses close to therapeutic levels. Facilities for prompt and accurate serum lithium determinations should be available before initiating therapy (see DOSAGE AND ADMINISTRATION).

Lithium Citrate Syrup Description

Lithium Citrate Syrup, USP is a palatable oral dosage form of lithium ion, with a raspberry flavor. Lithium citrate is prepared in solution from lithium hydroxide and citric acid in a ratio approximately dilithium citrate.

Each 5 mL of Lithium Citrate Syrup, USP contains 8 mEq of lithium ion (Li+), equivalent to the amount of lithium in 300 mg of lithium carbonate and alcohol 0.3% v/v. Lithium is an element of the alkali-metal group with atomic number 3, atomic weight 6.94, and an emission line at 671 nm on the flame photometer.

Lithium Citrate is a white, granular or crystalline powder which is soluble in water and slightly soluble in alcohol. Its molecular formula is C6H5Li3O7•4H2O. Its chemical name is 1,2,3-Propanetri-carboxylic acid, 2-hydroxy-trilithium salt tetrahydrate and its molecular weight is 282.0. Lithium acts as an antimanic.

Inactive Ingredients: artificial raspberry flavor; citric acid anhydrous, glycerin, methylparaben, propylene glycol, propylparaben, purified water, and sorbitol solution. It may also contain hydrochloric acid, and sodium hydroxide.

Lithium Citrate Syrup - Clinical Pharmacology

Preclinical studies have shown that lithium alters sodium transport in nerve and muscle cells and effects a shift toward intraneuronal metabolism of catecholamines, but the specific biochemical mechanism of lithium action in mania is unknown.

Indications and Usage for Lithium Citrate Syrup

Lithium citrate is indicated in the treatment of manic episodes of Bipolar Disorder. Bipolar Disorder, Manic (DSM-III) is equivalent to Manic Depressive Illness, Manic, in the older DSM-II terminology.

Lithium is also indicated as a maintenance treatment for individuals with a diagnosis of Bipolar Disorder. Maintenance therapy reduces the frequency of manic episodes and diminishes the intensity of those episodes which may occur.

Typical symptoms of mania include pressure of speech, motor hyperactivity, reduced need for sleep, flight of ideas, grandiosity, elation, poor judgement, aggressiveness, and possibly hostility. When given to a patient experiencing a manic episode, lithium may produce a normalization of symptomatology within 1 to 3 weeks.

Contraindications

Lithium should generally not be given to patients with significant renal or cardiovascular disease, severe debilitation or dehydration, or sodium depletion, and to patients receiving diuretics, since the risk of lithium toxicity is very high in such patients. If the psychiatric indication is life-threatening, and if such a patient fails to respond to other measures, lithium treatment may be undertaken with extreme caution, including daily serum lithium determinations and adjustment to the usually low doses ordinarily tolerated by these individuals. In such instances, hospitalization is a necessity.

Warnings

Lithium may cause fetal harm when administered to a pregnant woman. There have been reports of lithium having adverse effects on nidations in rats, embryo viability in mice, and metabolism in vitro of rat testis and human spermatozoa have been attributed to lithium, as have teratogenicity in submammalian species and cleft palates in mice. Studies in rats, rabbits and monkeys have shown no evidence of lithium-induced teratology. Data from lithium birth registries suggest an increase in cardiac and other anomalies, especially Ebstein's anomaly. If the patient becomes pregnant while taking lithium, she should be apprised of the potential risk to the fetus. If possible, lithium should be withdrawn for at least the first trimester unless it is determined that this would seriously endanger the mother.

Chronic lithium therapy may be associated with diminution of renal concentrating ability, occasionally presenting as nephrogenic diabetes insipidus, with polyuria and polydipsia. Such patients should be carefully managed to avoid dehydration with resulting lithium retention and toxicity. This condition is usually reversible when lithium is discontinued.

Morphologic changes with glomerular and interstitial fibrosis and nephronatrophy have been reported in patients on chronic lithium therapy. Morphologic changes have also been seen in bipolar patients never exposed to lithium. The relationship between renal functional and morphologic changes and their association with lithium therapy has not been established.

When kidney function is assessed, for baseline data prior to starting lithium therapy or thereafter, routine urinalysis and other tests may be used to evaluate tubular function (e.g., urine specific gravity or osmolality following a period of water deprivation, or 24-hour urine volume) and glomerular function (e.g., serum creatinine or creatinine clearance). During lithium therapy, progressive or sudden changes in renal function, even within the normal range, indicate the need for reevaluation of treatment.

Lithium toxicity is closely related to serum lithium levels, and can occur at doses close to therapeutic levels (See DOSAGE AND ADMINISTRATION).

Precautions

General

The ability to tolerate lithium is greater during the acute manic phase and decreases when manic symptoms subside (See DOSAGE AND ADMINISTRATION).

The distribution space of lithium approximates that of total body water. Lithium is primarily excreted in urine with insignificant excretion in feces. Renal excretion of lithium is proportional to its plasma concentration. The half-life of elimination of lithium is approximately 24 hours. Lithium decreases sodium reabsorption by the renal tubules which could lead to sodium depletion. Therefore, it is essential for the patient to maintain a normal diet, including salt, and an adequate fluid intake (2500–3000 mL) at least during the initial stabilization period. Decreased tolerance to lithium has been reported to ensue from protracted sweating or diarrhea and, if such occur, supplemental fluid and salt should be administered.

In addition to sweating and diarrhea, concomitant infection with elevated temperatures may also necessitate a temporary reduction or cessation of medication.

Previously existing underlying thyroid disorders do not necessarily constitute a contraindication to lithium treatment; where hypothyroidism exists, careful monitoring of thyroid function during lithium stabilization and maintenance allows for correction of changing thyroid parameters, if any. Where hypothyroidism occurs during lithium stabilization and maintenance, supplemental thyroid treatment may be used.

Information for the Patients

Outpatients and their families should be warned that the patient must discontinue lithium therapy and contact his physician if such clinical signs of lithium toxicity as diarrhea, vomiting, tremor, mild ataxia, drowsiness, or muscular weakness occur.

Lithium may impair mental and/or physical abilities. Caution patients about activities requiring alertness (e.g., operating vehicles or machinery).

Drug Interactions

Combined Use of Haloperidol and Lithium

An encephalopathic syndrome (characterized by weakness, lethargy, fever, tremulousness and confusion, extrapyramidal symptoms, leukocytosis, elevated serum enzymes, BUN and FBS) followed by irreversible brain damage has occurred in a few patients treated with lithium plus haloperidol. A causal relationship between these events and the concomitant administration of lithium and haloperidol has not been established; however, patients receiving such combined therapy should be monitored closely for early evidence of neurological toxicity and treatment discontinued promptly if such signs appear.

The possibility of similar adverse interactions with other antipsychotic medication exists.

Lithium may prolong the effects of neuromuscular blocking agents. Therefore, neuromuscular blocking agents should be given with caution to patients receiving lithium.

Caution should be used when lithium and diuretics or angiotensin converting enzyme (ACE) inhibitors are used concomitantly because sodium loss may reduce the renal clearance of lithium and increase serum lithium levels with risk of lithium toxicity. When such combinations are used, the lithium dosage may need to be decreased, and more frequent monitoring of lithium plasma levels is recommended.

Non-steroidal anti-inflammatory drugs (NSAIDS)

Lithium levels should be closely monitored when patients initiate or discontinue NSAID use. In some cases, lithium toxicity has resulted from interactions between an NSAID and lithium. Indomethacin and piroxicam have been reported to increase significantly steady-state plasma lithium concentrations. There is also evidence that other nonsteroidal anti-inflammatory agents, including the selective cyclooxygenase-2 (COX-2) inhibitors, have the same effect. In a study conducted in healthy subjects, mean steady-state lithium plasma levels increased approximately 17% in subjects receiving lithium 450 mg BID with celecoxib 200 mg BID as compared to subjects receiving lithium alone.

Pregnancy

Teratogenic Effects

Pregnancy Category D

See "WARNINGS" Section.

Nursing Mothers

Lithium is excreted in human milk. Nursing should not be undertaken during lithium therapy except in rare and unusual circumstances where, in the view of the physician, the potential benefits to the mother outweigh possible hazards to the child.

Pediatric Use

Since information regarding the safety and effectiveness of lithium in children under 12 years of age is not available, its use in such patients is not recommended at this time. There has been a report of a transient syndrome of acute dystonia and hyperreflexia occurring in a 15 kg child who ingested 300 mg of lithium carbonate.

Adverse Reactions

Lithium Toxicity

The likelihood of toxicity increases with increasing serum lithium levels. Serum lithium levels greater than 1.5 mEq/L carry a greater risk than lower levels. However, patients sensitive to lithium may exhibit toxic signs at serum levels below 1.5 mEq/L.

Diarrhea, vomiting, drowsiness, muscular weakness and lack of coordination may be early signs of lithium toxicity, and can occur at lithium levels below 2.0 mEq/L. At higher levels, giddiness, ataxia, blurred vision, tinnitus and a large output of dilute urine may be seen. Serum lithium levels above 3.0 mEq/L may produce a complex clinical picture involving multiple organs and organ systems. Serum lithium levels should not be permitted to exceed 2.0 mEq/L during the acute treatment phase.

Fine hand tremor, polyuria and mild thirst may occur during initial therapy for the acute manic phase, and may persist throughout treatment. Transient and mild nausea and general discomfort may also appear during the first few days of lithium administration.

These side effects are an inconvenience rather than a disabling condition, and usually subside with continued treatment or a temporary reduction or cessation of dosage. If persistent, a cessation of dosage is indicated.

The following adverse reactions have been reported and do not appear to be directly related to serum lithium levels.

Neuromuscular: Tremor, muscle hyperirritability (fasciculations, twitching, clonic movements of whole limbs), ataxia, choreoathetotic movements, hyperactive deep tendon reflexes.

Central Nervous System: Blackout spells, epileptiform seizures, slurred speech, dizziness, vertigo, incontinence of urine or feces, somnolence, psychomotor retardation, restlessness, confusion, stupor, coma, acute dystonia, downbeat nystagmus.

Cardiovascular: Cardiac arrhythmia, hypotension, peripheral circulatory collapse, sinus node dysfunction with severe bradycardia (which may result in syncope).

Neurological: Cases of pseudotumor cerebri (increased intracranial pressure and papilledema) have been reported with lithium use. If undetected, this condition may result in enlargement of the blind spot, constriction of visual fields and eventual blindness due to optic atrophy. Lithium should be discontinued, if clinically possible, if this syndrome occurs.

Gastrointestinal: Anorexia, nausea, vomiting, diarrhea.

Genitourinary: Albuminuria, oliguria, polyuria, glycosuria.

Dermatologic: Drying and thinning of hair, anesthesia of skin, chronic folliculitis, xerosis cutis, alopecia and exacerbation of psoriasis.

Autonomic Nervous System: Blurred vision, dry mouth.

Thyroid Abnormalities: Euthyroid goiter and/or hypothyroidism (including myxedema) accompanied by lower T3 and T4. Iodine 131 uptake may be elevated. (See PRECAUTIONS). Paradoxically, rare cases of hyperthyroidism have been reported.

EEG Changes: Diffuse slowing, widening of frequency spectrum, potentiation and disorganization of background rhythm.

EKG Changes: Reversible flattening, isoelectricity or inversion of T-waves.

Miscellaneous: Fatigue, lethargy, transient scotomata, dehydration, weight loss, tendency to sleep.

Miscellaneous reactions unrelated to dosage are: Transient electroencephalographic and electrocardiographic changes, leukocytosis, headache, diffuse nontoxic goiter with or without hypothyroidism, transient hyperglycemia, generalized pruritis with or without rash, cutaneous ulcers, albuminuria, worsening of or-ganic brain syndromes, excessive weight gain, edematous swelling of ankles or wrists, and thirst or polyuria, sometimes resembling diabetes insipidus, and metallic taste.

A single report has been received of the development of painful discoloration of fingers and toes and coldness of the extremities within one day of the starting of treatment of lithium. The mechanism through which these symptoms (resembling Raynaud's Syndrome) developed is not known. Recovery followed discontinuance.

Overdosage

The toxic levels for lithium are close to the therapeutic levels. It is therefore important that patients and their families be cautioned to watch for early symptoms and to discontinue the drug and inform the physician should they occur. Toxic symptoms are listed in detail under ADVERSE REACTIONS.

Treatment

No specific antidote for lithium poisoning is known. Early symptoms of lithium toxicity can usually be treated by reduction or cessation of dosage of the drug and resumption of the treatment at a lower dose after 24 to 48 hours. In severe cases of lithium poisoning, the first and foremost goal of treatment consists of elimination of this ion from the patient.

Treatment is essentially the same as that used in barbiturate poisoning: 1) gastric lavage, 2) correction of fluid and electrolyte imbalance and 3) regulation of kidney functioning. Urea, mannitol, and aminophylline all produce significant increases in lithium excretion. Hemodialysis is an effective and rapid means of removing the ion from the severely toxic patient. Infection prophylaxis, regular chest X-rays, and preservation of adequate respiration are essential.

Lithium Citrate Syrup Dosage and Administration

Acute Mania

Optimal patient response to Lithium Citrate usually can be established and maintained with 600 mg t.i.d. [10 mL (2 teaspoonfuls) (16 mEq of lithium) t.i.d.]. Such doses will normally produce an effective serum lithium level ranging between 1.0 and 1.5 mEq/L. Dosage must be individualized according to serum levels and clinical response. Regular monitoring of the patient's clinical state and of serum lithium levels is necessary. Serum levels should be determined twice per week during the acute phase, and until the serum level and clinical condition of the patient have been stabilized.

Long-Term Control

The desirable serum lithium levels are 0.6 to 1.2 mEq/L. Dosage will vary from one individual to another, but usually 300 mg t.i.d. or q.i.d. [5 mL (1 teaspoonful) (8 mEq of lithium) t.i.d. or q.i.d.] will maintain this level. Serum lithium levels in uncomplicated cases receiving maintenance therapy during remission should be monitored at least every two months.

Patients abnormally sensitive to lithium may exhibit toxic signs at serum levels of 1.0 to 1.5 mEq/L.

Elderly patients often respond to reduced dosage, and may exhibit signs of toxicity at serum levels ordinarily tolerated by other patients.

N.B.

Blood samples for serum lithium determination should be drawn immediately prior to the next dose when lithium concentrations are relatively stable (i.e., 8–12 hours after the previous dose). Total reliance must not be placed on serum levels alone. Accurate patient evaluation requires both clinical and laboratory analysis.

How is Lithium Citrate Syrup Supplied

Lithium Citrate Syrup, USP 8 mEq/5 mL (equivalent to the amount of lithium in 300 mg of lithium carbonate) is a clear, colorless solution, with a raspberry flavor.

NDC 68094-767-62

5 mL per unit dose cup

Thirty (30) cups per shipper

RECOMMENDED STORAGE

Store at 25°C (77°F); excursions permitted to 15°–30°C (59°– 86°F) [see USP Controlled Room Temperature].

Dispense in a tight container as defined in the USP.

Rx Only

Manufactured By:

Morton Grove Pharmaceuticals, Inc.

Morton Grove, IL 60053

Packaged By:

Precision Dose, Inc.

S. Beloit, IL 61080

LI769

Rev. 07/09

PRINCIPAL DISPLAY PANEL - 5 mL Cup Label

NDC 68094-767-59

PrecisionDose™

LITHIUM

Citrate Syrup, USP

8 mEq/5 mL

Pkg: Precision Dose, Inc., S. Beloit, IL 61080

LITHIUM CITRATE  lithium citrate  syrup

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 68094-767 (60432-616) Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Lithium Citrate (Lithium) Lithium Citrate 8 meq  in 5 mL

Inactive Ingredients Ingredient Name Strength anhydrous citric acid   glycerin   methylparaben   propylene glycol   propylparaben   water   sorbitol   hydrochloric acid   sodium hydroxide

Product Characteristics Color      Score      Shape Size Flavor RASPBERRY Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 68094-767-62 3 TRAY In 1 CASE contains a TRAY 1 10 CUP In 1 TRAY This package is contained within the CASE (68094-767-62) and contains a CUP, UNIT-DOSE (68094-767-59) 1 68094-767-59 5 mL In 1 CUP, UNIT-DOSE This package is contained within a TRAY and a CASE (68094-767-62)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA070755	09/29/2009

Labeler - Precision Dose Inc. (035886746)

Revised: 01/2011Precision Dose Inc.

More Lithium Citrate Syrup resources

• Lithium Citrate Syrup Side Effects (in more detail)
• Lithium Citrate Syrup Dosage
• Lithium Citrate Syrup Use in Pregnancy & Breastfeeding
• Drug Images
• Lithium Citrate Syrup Drug Interactions
• Lithium Citrate Syrup Support Group
• 88 Reviews for Lithium Citrate - Add your own review/rating

Compare Lithium Citrate Syrup with other medications

• Bipolar Disorder
• Cluster Headaches
• Mania
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Cytovene

Generic Name: ganciclovir (Oral route, Intravenous route)

gan-SYE-kloe-vir

Oral route(Capsule)

The clinical toxicity of ganciclovir includes granulocytopenia, anemia, and thrombocytopenia. In animal studies ganciclovir was carcinogenic, teratogenic, and caused aspermatogenesis. Ganciclovir is indicated only for prevention of CMV disease in patients with advanced HIV infection at risk for CMV disease, for maintenance treatment of CMV retinitis in immunocompromised patients, and for prevention of CMV disease in solid organ transplant recipients. Because ganciclovir is associated with a risk of more rapid rate of CMV retinitis progression, it should be used as maintenance treatment only in those patients for whom this risk is balanced by the benefit associated with avoiding daily intravenous infusions .

Intravenous route(Powder for Solution)

The clinical toxicity of ganciclovir sodium for injection includes granulocytopenia, anemia, and thrombocytopenia. In animal studies ganciclovir was carcinogenic, teratogenic, and caused aspermatogenesis. Ganciclovir sodium for injection is indicated for use only in the treatment of cytomegalovirus (CMV) retinitis in immunocompromised patients and for the prevention of CMV disease in transplant patients at risk for CMV disease .

Commonly used brand name(s)

In the U.S.

• Cytovene


• Cytovene IV

Available Dosage Forms:

• Capsule


• Powder for Solution

Therapeutic Class: Antiviral

Pharmacologic Class: Viral DNA Polymerase Inhibitor

Chemical Class: Guanosine Nucleoside Analog

Uses For Cytovene

Ganciclovir is an antiviral. It is used to treat infections caused by viruses.

Ganciclovir is used to treat the symptoms of cytomegalovirus (CMV) infection of the eyes in people whose immune system is not working fully. This includes patients with acquired immune deficiency syndrome (AIDS). Ganciclovir will not cure this eye infection, but it may help to keep the symptoms from becoming worse. It is also used to help prevent CMV infection in patients who receive organ or bone marrow transplants, as well as in patients with advanced human immunodeficiency virus (HIV) infection. Ganciclovir may be used for other serious CMV infections as determined by your doctor. However, it does not work in treating certain viruses, such as the common cold or the flu.

This medicine may cause some serious side effects, including anemia and other blood problems. Before you begin treatment with ganciclovir, you and your doctor should talk about the good this medicine will do as well as the risks of using it.

Ganciclovir is to be administered only by or under the supervision of your doctor.

Before Using Cytovene

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

Ganciclovir can cause serious side effects in any patient. Therefore, it is especially important that you discuss with the child's doctor the good that this medicine may do as well as the risks of using it.

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 ganciclovir in the elderly with use in other age groups.

Pregnancy

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

Breast Feeding

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

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. 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 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.

• Imipenem


• Zidovudine

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.

• Didanosine

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:

• Kidney disease—Ganciclovir may build up in the blood in patients with kidney disease, increasing the chance of side effects

• Low platelet count or


• Low white blood cell count—Ganciclovir may make these blood diseases worse

Proper Use of ganciclovir

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

It is important that you take ganciclovir capsules with food. This is to make sure the medicine is fully absorbed into the body and will work properly.

To get the best results, ganciclovir must be given for the full time of treatment. Also, this medicine works best when there is a constant amount in the blood. To help keep the amount constant, ganciclovir must be given on a regular schedule.

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 oral dosage form (capsules):
  
  • For treatment of CMV retinitis after you have received ganciclovir injection for at least fourteen to twenty-one days:
    
    • Adults and teenagers—1000 milligrams (mg) three times a day with food; or 500 mg six times a day, every three hours with food, during waking hours.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For prevention of CMV disease in transplant patients and patients with advanced HIV infection:
    
    • Adults and teenagers—1000 mg three times a day with food.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  


• For injection dosage form:
  
  • For treatment of CMV retinitis:
    
    • Adults and teenagers—Dose is based on body weight and must be determined by your doctor. At first, 5 mg per kilogram (2.3 mg per pound) of body weight is injected into a vein every twelve hours for fourteen to twenty-one days. Then, 5 mg per kilogram (2.3 mg per pound) of body weight is injected into a vein once a day for seven days of the week; or 6 mg per kilogram (2.7 mg per pound) of body weight is injected into a vein once a day for five days of the week.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For prevention of CMV in transplant patients:
    
    • Adults and teenagers—Dose is based on body weight and must be determined by your doctor. At first, 5 mg per kilogram (2.3 mg per pound) of body weight is injected into a vein every twelve hours for seven to fourteen days. Then the dose is reduced to 5 mg per kilogram (2.3 mg per pound) of body weight once a day for seven days of the week; or 6 mg per kilogram (2.7 mg per pound) of body weight is injected into a vein once a day for five days of the week.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Precautions While Using Cytovene

Ganciclovir can 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 to reduce the risk of infection or bleeding:

• Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills.


• 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.


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

The use of birth control is recommended for both men and women. Women should use effective birth control methods while receiving this medicine. Men should use a condom during treatment with this medicine and for at least 90 days after treatment has been completed.

It is very important that your doctor check you at regular visits for any blood problems that may be caused by this medicine.

If you have CMV retinitis: It is also very important that your ophthalmologist (eye doctor) check your eyes at regular visits since it is still possible that you may have some loss of eyesight during ganciclovir treatment.

Cytovene 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.

Medicines like ganciclovir can sometimes cause serious side effects such as blood problems; these are described below. Discuss these possible effects with your doctor.

Check with your doctor immediately if any of the following side effects occur:

More commonFor oral capsules and injection into the vein only

• Sore throat and fever


• unusual bleeding or bruising

Less commonFor oral capsules and injection into the vein only

• Mood or other mental changes


• nervousness


• pain at place of injection


• skin rash


• tremor


• unusual tiredness and weakness

For injection into the eye only

• Decreased vision or any change in vision

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

• Abdominal or stomach pain


• loss of appetite


• nausea and 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.

See also: Cytovene 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 Cytovene resources

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

• Cytovene oral and injectable Concise Consumer Information (Cerner Multum)


• Cytovene Monograph (AHFS DI)


• Cytovene MedFacts Consumer Leaflet (Wolters Kluwer)


• Ganciclovir Prescribing Information (FDA)

Compare Cytovene with other medications

• CMV Retinitis
• Cytomegalovirus Infection

Ketotifen Drops

Pronunciation: KEY-toe-TIE-fen
Generic Name: Ketotifen
Brand Name: Zaditor

Ketotifen Drops are used for:

Temporary prevention of itching of the eye due to allergies.

Ketotifen Drops are an antihistamine and mast cell stabilizer. It works by blocking the release of chemicals from cells involved in allergic reactions.

Do NOT use Ketotifen Drops if:

• you are allergic to any ingredient in Ketotifen Drops

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

Before using Ketotifen Drops:

Some medical conditions may interact with Ketotifen Drops. 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

Some MEDICINES MAY INTERACT with Ketotifen Drops. However, no specific interactions with Ketotifen Drops are known at this time.

Ask your health care provider if Ketotifen Drops 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 Ketotifen Drops:

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

• To use Ketotifen Drops in the eye, first, wash your hands. Tilt your head back. Using your index finger, pull the lower eyelid away from the eye to form a pouch. Drop the medicine into the pouch and gently close your eyes. Immediately use your finger to apply pressure to the inside corner of the eyelid for 1 to 2 minutes. Do not blink. Remove excess medicine around your eye with a clean, dry tissue, being careful not to touch your eye. Wash your hands to remove any medicine that may be on them.


• To prevent germs from contaminating your medicine, do not touch the applicator tip to any surface, including the eye. Keep the container tightly closed.


• Ketotifen Drops are only for the eye. Do not get it in your nose or mouth.


• Do not wear contact lenses if your eye is red.


• Do not use Ketotifen Drops to treat irritation caused by contact lenses.


• Remove contact lenses before you use Ketotifen Drops; soft contact lenses may be placed back in the eyes 10 minutes after use of Ketotifen Drops if your eyes are not red.


• If you miss a dose of Ketotifen Drops, 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 Ketotifen Drops.

Important safety information:

• Ketotifen Drops may cause mild stinging when you first put it in your eye. Contact your doctor if the stinging continues.


• Do not use Ketotifen Drops for future eye problems without first checking with your doctor.


• Ketotifen Drops may cause harm if it is swallowed. If you may have taken it by mouth, contact your poison control center or emergency room right away.


• Ketotifen Drops should not be used in CHILDREN younger than 3 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 Ketotifen Drops while you are pregnant. It is not known if Ketotifen Drops are found in breast milk. If you are or will be breast-feeding while you use Ketotifen Drops, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Ketotifen Drops:

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:

Burning; dry eyes; eye discharge; eyelid disorder; flu-like syndrome; headache; infection of the mucous membrane around the eye; inflammation of the cornea; itching; nasal congestion; red eyes; runny nose; sensitivity to light; sore throat; stinging; tearing.

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); eye pain or swelling; trouble breathing.

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: Ketotifen side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Ketotifen Drops:

Store Ketotifen Drops at 77 degrees F (25 degrees C). Store in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Ketotifen Drops out of the reach of children and away from pets.

General information:

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


• Ketotifen Drops are 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 Ketotifen Drops. 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 Ketotifen resources

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

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• Conjunctivitis, Allergic

minocycline hydrochloride Subgingival

min-oh-SYE-kleen

Chemical Class: Tetracycline (class)

Uses For minocycline hydrochloride

Minocycline is used to help treat periodontal disease (a disease of your gums). Periodontal disease is caused by bacteria growing beneath the gum line. Minocycline works by keeping the number of bacteria from growing. Lowering the amount of bacteria helps to reduce inflammation and swelling in your mouth, and the amount of bleeding around the teeth. Minocycline is placed in deep gum pockets next to your teeth in order to reduce the depth of the pockets.

minocycline hydrochloride will be applied by your dentist or other oral health care professional.

Before Using minocycline hydrochloride

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 minocycline hydrochloride, the following should be considered:

Allergies

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

Use is not recommended in infants and children up to 8 years of age. Tetracyclines, such as minocycline, may cause permanent discoloration of teeth and slow down the growth of bones. The safety and effectiveness of minocycline have not been determined in children 8 years of age or older.

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 minocycline in the elderly with use in other age groups.

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

Studies suggest that this medication may alter milk production or composition. If an alternative to this medication is not prescribed, you should monitor the infant for side effects and adequate milk intake.

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 minocycline hydrochloride, 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 minocycline hydrochloride 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.

• Acitretin

Using minocycline hydrochloride 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.

• Atazanavir


• Digoxin


• Isotretinoin

Using minocycline hydrochloride 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.

• Iron


• Penicillin G


• Penicillin G Procaine


• Penicillin V


• Vitamin A

Interactions with Food/Tobacco/Alcohol

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

Proper Use of minocycline hydrochloride

The amount of medicine that is put into your gum pockets will be determined by your dentist. The number of teeth that need treatment and the depth of the pockets will determine the amount of medicine that is used.

After the medicine is placed in your mouth, try to avoid any actions that may cause the medicine to come out. For example:

• Do not chew hard, crunchy, or sticky foods for 1 week after treatment.


• Do not brush near any treated areas. Wait 12 hours after the procedure before brushing the other teeth.


• Do not use dental floss or any other cleaning tools that go between the teeth for 10 days after treatment.


• Do not probe or pick at the treated areas with your tongue, toothpicks, or fingers.

Precautions While Using minocycline hydrochloride

Check with your dentist as soon as possible if you have pain or swelling or other problems in the treated areas.

It is very important that your dentist check your progress. Do not miss any dental appointments.

Tetracyclines, such as minocycline, may cause your skin to be more sensitive to sunlight than normal. Exposure to sunlight, even for brief periods of time, may cause a skin rash, itching, redness or other discoloration of the skin, or a severe sunburn. After receiving minocycline:

• Stay out of direct sunlight, especially between the hours of 10:00 a.m. and 3:00 p.m., if possible.


• Wear protective clothing, including a hat. Also, wear sunglasses.


• Apply a sun block product that has a skin protection factor (SPF) of at least 15. Some patients may require a product with a higher SPF number, especially if they have a fair complexion. If you have any questions about this, check with your health care professional.


• Apply a sun block lip balm or lipstick that has an SPF of at least 15 to protect your lips.


• Do not use a sunlamp or tanning bed or booth.

If you have a severe reaction from the sun, check with your dentist or doctor.

minocycline hydrochloride 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

• Bleeding from the gums


• chills


• dental pain


• fever


• pain, redness, and swelling in the mouth


• problems with teeth


• redness or swelling of the gums


• toothache

Less common

• Bad taste in the mouth


• discharge from the gums


• foul breath odor


• painful sores in the mouth


• problems in the lining of the mouth

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

• Acid or sour stomach


• belching


• cough


• heartburn


• increased sensitivity to sunlight


• indigestion


• pain


• pain in the joints or muscles


• runny nose


• sneezing


• sore throat


• stomach discomfort, upset, or pain

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.

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 minocycline hydrochloride Subgingival resources

• Minocycline hydrochloride Subgingival Use in Pregnancy & Breastfeeding
• Minocycline hydrochloride Subgingival Support Group
• 0 Reviews for Minocycline hydrochloride Subgingival - Add your own review/rating

Compare minocycline hydrochloride Subgingival with other medications

• Periodontitis

Humulin U

Generic Name: insulin zinc extended (IN suh lin ZINK)

Brand Names: Humulin U

What is Humulin U (insulin zinc extended)?

Insulin is a hormone naturally produced by the pancreas. Insulin enables the body to use the sugar in food as a source of energy. When the body does not produce enough insulin, or when the insulin produced by the body is not effective enough, the condition is called diabetes mellitus. This condition allows sugar levels in the blood to become very high. Diabetics must use man-made insulin or insulin that comes from pigs (which is very similar to human insulin) to lower these high blood sugar levels.

Insulin zinc extended is used in the treatment of diabetes mellitus.

Insulin zinc extended may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Humulin U (insulin zinc extended)?

Know the signs and symptoms of low blood sugar (hypoglycemia), which include shaking; nausea; headache; drowsiness; weakness; dizziness; fast heartbeat; sweating; pale, cool skin; anxiety; and difficulty concentrating. Carry a piece of candy or glucose tablets with you to treat episodes of low blood sugar.

Follow any diet and exercise plan that you have developed with your doctor or nurse. Changes in what you eat or how much you exercise can change the amount of insulin that you need to control your blood sugar levels.

Ask your doctor or nurse what to do if you are sick with a cold, flu, or fever. These illnesses may change your insulin requirements.

Do not change the brand of insulin zinc extended or syringe that you are using without first talking to your doctor or pharmacist. Some brands of insulin zinc extended and syringes are interchangeable, while others are not. Your doctor and/or pharmacist know which brands can be substituted for one another.

What should I discuss with my healthcare provider before using Humulin U (insulin zinc extended)?

Do not use insulin zinc extended if you are allergic to insulin or if you have intolerance to a certain insulin zinc extended product.

Before using insulin, tell your doctor if you have any other medical conditions or if you take other prescription or over-the-counter medications, including vitamins, minerals, and herbal supplements.

Before using insulin zinc extended, tell your doctor if you have kidney or liver disease. You may require a dosage adjustment or special monitoring during treatment.

Most insulins can be used during pregnancy and breast-feeding. They are not expected to be harmful to an unborn baby. It is very important to control blood sugar levels during pregnancy and breast-feeding and insulin is often chosen as the treatment. Some types of insulin may be better than others for use during pregnancy and breast-feeding. Talk to your doctor about the use of insulin during pregnancy and breast-feeding.

How should I use Humulin U (insulin zinc extended)?

Use insulin zinc extended exactly as directed by your doctor. If you do not understand these instructions, ask your doctor, nurse, or pharmacist to explain them to you.

If the insulin has been stored in the refrigerator, it can be warmed to room temperature before use. Also, roll it gently between your hands to be sure that it is mixed. Never shake insulin vigorously.

If you are mixing different types of insulins in the same syringe, follow your doctor's directions and always draw up the different insulins in the same order (usually the clear insulin first). This may help prevent a dosage error. Do not mix different insulins in the same syringe unless specifically directed to do so by your doctor. Some types of insulins should not be mixed.

Do not use any insulin that is discolored, looks thick, has particles in it, or looks different from previous bottles, cartridges, or pens of zinc extended.

Change injection sites exactly as directed by your doctor. Usually, you should not inject within 1 inch of the same site within 1 month.

Never reuse a needle or syringe. Dispose of all needles and syringes in an appropriate, puncture-resistant disposal container.

Do not change the insulin strength (e.g., U-100) or insulin type (e.g., zinc extended, lispro, glargine, etc.) unless your doctor recommends a change for you.

Do not change the brand of insulin zinc extended or syringe that you are using without first talking to your doctor or pharmacist. Some brands of insulin zinc extended and syringes are interchangeable, while others are not. Your doctor and/or pharmacist know which brands can be substituted for one another.

Follow any diet and exercise plan that you have developed with your doctor or nurse. Changes in what you eat or how much you exercise can change the amount of insulin that you need to control your blood sugar levels.

Ask your doctor or nurse what to do if you are sick with a cold, flu, or fever. These illnesses may change your insulin requirements.

Your healthcare provider may recommend regular monitoring of blood sugar levels with blood or urine tests.

Wear some type of medical identification bracelet, necklace, or other alert tag to inform others that you have diabetes and that you require insulin in the case of an emergency.

Proper foot care, eye care, dental care, and overall proper health care are important for people with diabetes. Visit your doctor, dentist, eye doctor, and other heath care practitioners as recommended by your doctor.

Store unopened vials of insulin zinc extended the refrigerator between 36 and 46 degrees Fahrenheit (2 and 8 degrees Celsius), in the original carton. Do not store insulin zinc extended in the freezer and do not allow it to freeze. Do not use insulin zinc extended if it has been frozen. Throw away any expired insulin zinc extended. Vials of insulin zinc extended can be kept unrefrigerated for up to 28 days, but should not be exposed to excessive heat or sunlight.

Once punctured, the insulin vial in use, whether stored in the refrigerator or at room temperature, must be used within 28 days. Throw away any unused insulin 28 days after the vial is first punctured.

What happens if I miss a dose?

Follow your doctor's directions if you miss a dose of insulin. To prevent missed doses, be sure to always have enough insulin on hand, especially if you are going on vacation.

What happens if I overdose?

Seek emergency medical attention if an overdose is suspected.

Symptoms of an insulin overdose reflect very low blood sugar levels and include headache, irregular heartbeat, increased heart rate or pulse, sweating, tremor, nausea, increased hunger, and anxiety.

What should I avoid while using Humulin U (insulin zinc extended)?

Do not use alcohol without first talking to your doctor. It lowers blood sugar, and you may experience dangerously low blood sugar levels.

Follow any diet and exercise plan that you have developed with your doctor or nurse. Changes in what you eat or how much you exercise can change the amount of insulin you need to control your blood sugar levels.

Humulin U (insulin zinc extended) side effects

Rarely, people have allergic reactions to insulin. Seek emergency medical attention if you experience an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives).

The side effects of insulin therapy result mostly from blood sugar levels that are either too high or too low. You should be familiar with the symptoms of both high and low blood sugar levels and know how to treat both conditions. Also, be sure your family and close friends know how to help you in an emergency.

Low blood sugar may occur when too much insulin is used; when meals are missed or delayed; if you exercise more than usual; during illness, especially with vomiting or diarrhea; if you take other medications; after drinking alcohol; and in other situations.

Hypoglycemia, or low blood sugar, has the following symptoms: shaking; nausea; headache; drowsiness; weakness; dizziness; fast heartbeat; sweating; pale, cool skin; anxiety; and difficulty concentrating.

Keep sugary candy, fruit juice, or glucose tablets on hand to treat episodes of low blood sugar.

Increased blood sugar may occur if not enough insulin is used, if you eat significantly more food then usual, if you exercise less than usual, if you take other medications, if you have a fever or other illness, and in other situations.

Hyperglycemia, or high blood sugar, has the following symptoms: increased thirst, increased hunger, and increased urination.

Monitor your blood sugar levels and ask your doctor how to adjust your insulin doses if your blood sugar levels are too high.

Side effects may also occur at the site of injection. If the area becomes thickened, hard, or pitted, talk to your doctor before injecting at that site again.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect Humulin U (insulin zinc extended)?

Many drugs can interact with insulin or affect blood sugar levels. Do not take any other prescription or over-the-counter medicines, including vitamins, minerals, and herbal products, without first talking to your doctor or pharmacist during treatment with insulin.

More Humulin U resources

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

• Humulin U Prescribing Information (FDA)


• Humulin U MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Humulin U with other medications

• Diabetes, Type 1
• Diabetes, Type 2
• Gestational Diabetes

Where can I get more information?

• Your pharmacist has additional information about insulin zinc extended written for health professionals that you may read.

What does my medication look like?

Insulin zinc extended is available under the brand name Humulin U. The insulin should be a clear, colorless or evenly colored liquid after it is gently rolled or shaken. Do not use it if it appears to be thick, looks sticky, has particles in it, or looks different from previous bottles of insulin that you have had. Always use the same brand unless your doctor approves a change. Ask your pharmacist, nurse, or doctor any questions you have about this medication.

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  Humulin U-10 mL vials

  
  

See also: Humulin U side effects (in more detail)