hydromorphone

hye-droe-MOR-fone

Oral route(Tablet;Liquid)

Hydromorphone is a potent Schedule II opioid agonist, which has the highest potential for abuse and risk of producing respiratory depression. Alcohol, other opioids and central nervous system depressants (sedative-hypnotics) potentiate the respiratory depressant effects of hydromorphone, increasing the risk of respiratory depression that might result in death .

Oral route(Tablet, Extended Release)

Exalgo(R) is a potent Schedule II opioid agonist, which has the highest potential for abuse and risk of respiratory depression. Hydromorphone extended-release tablets (Exalgo(R)) are for use in opioid-tolerant patients only with moderate to severe chronic pain. Use in non-opioid-tolerant patients may lead to fatal respiratory depression. Exalgo(R) is for continuous analgesia only and is not intended for use on an as needed basis (ie, PRN). Exalgo(R) should be swallowed whole; not broken, chewed, opened, dissolved, or crushed .

Commonly used brand name(s)

In the U.S.

• Dilaudid


• Dilaudid-5


• Exalgo


• Palladone

Available Dosage Forms:

• Liquid


• Tablet, Extended Release


• Capsule, Extended Release


• Tablet


• Solution

Therapeutic Class: Analgesic

Chemical Class: Opioid

Uses For hydromorphone

Hydromorphone oral liquid and tablets are used to relieve pain. The hydromorphone extended-release tablets are used to relieve moderate to severe pain in opioid-tolerant patients.

Hydromorphone belongs to the group of medicines called narcotic analgesics (pain medicines). It acts on the central nervous system (CNS) to relieve pain.

When a narcotic medicine is used for a long time, it may become habit-forming, causing mental or physical dependence. However, people who have continuing pain should not let the fear of dependence keep them from using narcotics to relieve their pain. Mental dependence (addiction) is not likely to occur when narcotics are used for this purpose. Physical dependence may lead to withdrawal side effects if treatment is stopped suddenly. However, severe withdrawal side effects can usually be prevented by gradually reducing the dose over a period of time before treatment is stopped. completely.

hydromorphone is available only with your doctor's prescription.

Before Using hydromorphone

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 hydromorphone, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to hydromorphone or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

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

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of hydromorphone in the elderly. However, elderly patients may be more sensitive to the effects of hydromorphone than younger adults, and are more likely to have age-related lung, liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving hydromorphone.

Pregnancy

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

Breast Feeding

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

Interactions with Medicines

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

• Naltrexone

Using hydromorphone 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


• Alfentanil


• Alprazolam


• Amobarbital


• Anileridine


• Aprobarbital


• Aripiprazole


• Brofaromine


• Bromazepam


• Brotizolam


• Buprenorphine


• Buspirone


• Butabarbital


• Butalbital


• Butorphanol


• Carisoprodol


• Chloral Hydrate


• Chlordiazepoxide


• Chlorpromazine


• Chlorzoxazone


• Clobazam


• Clonazepam


• Clorazepate


• Clorgyline


• Clozapine


• Codeine


• Dantrolene


• Desflurane


• Dexmedetomidine


• Dezocine


• Diazepam


• Diphenhydramine


• Doxylamine


• Enflurane


• Estazolam


• Eszopiclone


• Ethchlorvynol


• Fentanyl


• Flumazenil


• Flunitrazepam


• Fluphenazine


• Flurazepam


• Fospropofol


• Furazolidone


• Halazepam


• Haloperidol


• Halothane


• Hydrocodone


• Hydromorphone


• Hydroxyzine


• Iproniazid


• Isocarboxazid


• Isoflurane


• Ketamine


• Ketazolam


• Lazabemide


• Levorphanol


• Linezolid


• Lorazepam


• Lormetazepam


• Loxapine


• Medazepam


• Meperidine


• Mephenesin


• Mephobarbital


• Meprobamate


• Mesoridazine


• Metaxalone


• Methocarbamol


• Methohexital


• Midazolam


• Moclobemide


• Molindone


• Morphine


• Morphine Sulfate Liposome


• Nalbuphine


• Nialamide


• Nitrazepam


• Nitrous Oxide


• Nordazepam


• Olanzapine


• Opium


• Oxazepam


• Oxycodone


• Oxymorphone


• Paliperidone


• Pargyline


• Pentazocine


• Pentobarbital


• Perphenazine


• Phenelzine


• Phenobarbital


• Pimozide


• Prazepam


• Procarbazine


• Promazine


• Promethazine


• Propofol


• Propoxyphene


• Quazepam


• Quetiapine


• Ramelteon


• Rasagiline


• Remifentanil


• Risperidone


• Secobarbital


• Selegiline


• Sevoflurane


• Sodium Oxybate


• Sufentanil


• Tapentadol


• Temazepam


• Thiopental


• Thioridazine


• Thiothixene


• Toloxatone


• Tranylcypromine


• Triazolam


• Trifluoperazine


• Zaleplon


• Ziprasidone


• Zolpidem

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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using hydromorphone with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use hydromorphone, 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 hydromorphone. Make sure you tell your doctor if you have any other medical problems, especially:

• Addison's disease (adrenal gland problem) or


• Alcohol abuse, or history of or


• Breathing or lung problems (e.g., chronic obstructive pulmonary disease [COPD], cor pulmonale, hypercapnia, hypoxia, sleep apnea) or


• CNS depression, history of or


• Drug dependence, especially narcotic abuse or dependence, history of or


• Enlarged prostate (BPH, prostatic hypertrophy) or


• Gallbladder disease or


• Hypothyroidism (an underactive thyroid) or


• Kyphoscoliosis (curvature of spine that can cause breathing problems) or


• Mental illness, or history of or


• Obesity, severe or


• Problems with passing urine—Use with caution. May increase risk for more serious side effects.

• Brain tumor or


• Head injuries or


• Increased pressure in your head—Some of the side effects of hydromorphone can cause serious problems in people who have these medical problems.

• Breathing problems (e.g., asthma, hypercapnia), severe or


• Respiratory depression (hypoventilation or slow breathing)—Should not be used in patients with these conditions.

• Gallbladder surgery or


• Hypotension (low blood pressure) or


• Pancreatitis (inflammation of the pancreas) or


• Seizures, history of—Use with caution. May make these conditions worse.

• Kidney disease or


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

• Not opioid-tolerant (if you are not already taking a certain amount of morphine, oxycodone, or other opioid medicine) or


• Paralytic ileus (intestinal blockage) or


• Stomach or bowel problems (e.g., narrowing of the intestines, Meckel's diverticulum, peritonitis, "short gut" syndrome), history of or


• Surgery (e.g., stomach, intestinal), history of or


• Trouble with swallowing—Exalgo® extended-release tablets should not be given in patients with these conditions.

• Stomach or digestion problems—hydromorphone may mask the diagnosis of these conditions.

Proper Use of hydromorphone

Take hydromorphone 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. This is especially important for elderly patients, who may be more sensitive to the effects of pain medicines. If too much of hydromorphone is taken for a long time, it may become habit-forming (causing mental or physical dependence).

Measure the oral liquid with a marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid.

If you are using the extended-release tablets:

• Hydromorphone extended-release tablets are for use in opioid-tolerant patients only. If you are uncertain whether or not you are opioid-tolerant, check with your doctor before using hydromorphone.


• hydromorphone comes with a medication guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.


• Swallow the tablets whole. Do not break, crush, or chew it.


• While taking hydromorphone, part of the tablet may pass into your stools. This is normal and is nothing to worry about.

Exalgo® tablets works differently than hydromorphone tablets, even at the same dose (number of milligrams). Do not switch from the extended-release tablets to the immediate-release tablets unless your doctor tells you to.

Be careful not to handle crushed or broken tablets. If you have contact with broken or crushed tablets or spilled oral liquid, wash your skin or the affected areas with soap and water right away.

Dosing

The dose of hydromorphone 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 hydromorphone. 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 (extended-release tablets):
  
  • For moderate to severe pain:
    
    • For patients switching from other oral hydromorphone to Exalgo®:
      
      • Adults—The once daily starting dose is the same as the total hydromorphone dose that you are taking daily. Your doctor may increase the dose every 3 to 4 days as needed.
      
      
      • Children—Use and dose must be determined by your doctor.
      
      
    
    
    • For patients switching from oral opioids to Exalgo®:
      
      • Adults—At first, the dose is half of the total opioid dose that you are taking every 24 hours. Your doctor may increase the dose as needed.
      
      
      • Children—Use and dose must be determined by your doctor.
      
      
    
    
    • For patients switching from fentanyl transdermal to Exalgo®:
      
      • Adults—The medicine should be started at least 18 hours after the removal of the fentanyl patch. At first, the dose is 12 mg every 24 hours for each 25 microgram per hour (mcg/hr) of the transdermal fentanyl. Your doctor may increase the dose as needed.
      
      
      • Children—Use and dose must be determined by your doctor.
      
      
    
    
  
  


• For oral dosage form (liquid):
  
  • For pain:
    
    • Adults—At first, 2.5 to 10 milliliters (mL) or one-half to two teaspoonfuls every 3 to 6 hours as needed . Your doctor may increase your dose as needed.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  


• For oral dosage form (tablets):
  
  • For pain:
    
    • Adults—At first, 2 to 4 milligrams (mg) every 4 to 6 hours. Your doctor may increase your dose as needed.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of hydromorphone, 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.

Flush the unused medicine down the toilet.

Precautions While Using hydromorphone

It is very important that your doctor check your progress while you are using hydromorphone. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.

hydromorphone will add to the effects of alcohol and other CNS depressants (medicines that can make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds; sedatives, tranquilizers, or sleeping medicine; other 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 other medicines listed above while you are using hydromorphone.

hydromorphone may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.

Dizziness, lightheadedness, or fainting may occur when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen this problem. Also, lying down for a while may relieve dizziness or lightheadedness.

Using narcotics for a long time can cause severe constipation. To prevent this, your doctor may direct you to take laxatives, drink a lot of fluids, or increase the amount of fiber in your diet. Be sure to follow the directions carefully, because continuing constipation can lead to more serious problems.

hydromorphone may make you dizzy, drowsy, or lightheaded. Make sure you know how you react to hydromorphone before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.

hydromorphone may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash; itching; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth while you are using hydromorphone.

If you have been using hydromorphone regularly for several weeks or more, do not change your dose or suddenly stop using it without first checking with your doctor. You may be directed to gradually reduce the amount you are using before stopping treatment completely, or to take another narcotic for a while, to lessen the chance of withdrawal side effects (such as abdominal or stomach cramps, anxiety, fever, nausea, runny nose, sweating, tremors, or trouble with sleeping).

Using hydromorphone while you are pregnant may cause neonatal withdrawal syndrome in your newborn babies. Tell your doctor right away if your child has the following symptoms: abnormal sleep pattern, diarrhea, high-pitched cry, irritability, shakiness or tremor, weight loss, vomiting, or failure to gain weight.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

hydromorphone 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:

Less common or rare

• Agitation


• bloody, black, or tarry stools


• blurred vision


• changes in behavior


• chest pain or discomfort


• convulsions


• decreased urination


• dry mouth


• fast, pounding, or irregular heartbeat or pulse


• lightheadedness, dizziness, or fainting


• mood or mental changes


• rapid breathing


• severe stomach pain, cramping, or burning


• severe vomiting


• shortness of breath


• slow or irregular heartbeat


• stiff neck


• sunken eyes


• thoughts of killing oneself


• trouble breathing


• unusual tiredness


• vomiting of material that looks like coffee grounds, severe and continuing


• wrinkled skin

Incidence not known

• Bluish lips or skin


• change in the ability to see colors, especially blue or yellow


• cold, clammy skin


• confusion


• cough


• decrease in the frequency of urination


• decrease in urine volume


• difficulty in passing urine (dribbling)


• difficult or troubled breathing


• dizziness


• fast, weak pulse


• headache


• heart stops


• irregular, fast or slow, or shallow breathing


• loss of appetite


• no pulse or blood pressure


• noisy breathing


• not breathing


• painful urination


• pale or blue lips, fingernails, or skin


• sleeplessness


• sweating


• tightness in the chest


• trouble sleeping


• unable to sleep


• unconscious


• wheezing

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

Symptoms of overdose

• Decreased awareness or responsiveness


• increased sensitivity of the eyes to light


• no muscle tone or movement


• sleepiness or unusual drowsiness

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

• Difficulty having a bowel movement (stool)


• difficulty with moving


• muscle pain or stiffness


• nausea


• pain in the joints

Less common

• Acid or sour stomach


• back pain


• belching


• bloating or swelling of the face, arms, hands, lower legs, or feet


• diarrhea


• discouragement


• feeling sad or empty


• heartburn


• indigestion


• irritability


• loss of interest or pleasure


• muscle spasms


• pain in the arms or legs


• rapid weight gain


• stomach discomfort, upset, or pain


• tingling of the hands or feet


• trouble concentrating


• unusual weight gain or loss


• weight loss

Less common or rare

• Being forgetful


• bleeding after defecation


• change in taste


• changes in the patterns and rhythms of speech


• clumsiness


• continuing ringing or buzzing or other unexplained noise in the ears


• crying


• decreased interest in sexual intercourse


• delusions of persecution, mistrust, suspiciousness, or combativeness


• difficulty with swallowing


• difficulty with walking


• double vision


• excess air or gas in the stomach or intestines


• extra heartbeats


• feeling of constant movement of self or surroundings


• full feeling


• hearing loss


• inability to have or keep an erection


• increased appetite


• joint pain, stiffness, or swelling


• loss in sexual ability, desire, drive, or performance


• loss of balance


• loss of taste


• low body temperature


• muscle aches


• muscle twitching or jerking


• overactive reflexes


• passing gas


• rhythmic movement of muscles


• runny nose


• seeing double


• seeing, hearing, or feeling things that are not there


• sensation of spinning


• shivering


• slurred speech


• sneezing


• swelling of the feet or lower legs


• trouble with speaking


• uncomfortable swelling around the anus


• weak or feeble pulse

Incidence not known

• Bad, unusual or unpleasant (after)taste


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


• chills


• constricted, pinpoint, or small pupils (black part of the eye)


• deep or fast breathing with dizziness


• drowsiness


• dry mouth


• false or unusual sense of well-being


• fear or nervousness


• feeling of warmth


• hives or welts


• muscle stiffness or tightness


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


• redness of the skin


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


• relaxed and calm


• shaking


• skin itching


• uncontrolled eye movements


• upper abdominal or stomach pain


• weight loss

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: hydromorphone side effects (in more detail)

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More hydromorphone resources

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

• Dilaudid Prescribing Information (FDA)


• Dilaudid Consumer Overview


• Dilaudid-HP MedFacts Consumer Leaflet (Wolters Kluwer)


• Dilaudid-HP Prescribing Information (FDA)


• Exalgo MedFacts Consumer Leaflet (Wolters Kluwer)


• Exalgo Prescribing Information (FDA)


• Exalgo Consumer Overview


• Hydromorphone Prescribing Information (FDA)


• Hydromorphone MedFacts Consumer Leaflet (Wolters Kluwer)


• Hydromorphone Hydrochloride Monograph (AHFS DI)


• Palladone Prescribing Information (FDA)


• Palladone Extended-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)

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Panadol Ultra

1. Name Of The Medicinal Product

Panadol Ultra

2. Qualitative And Quantitative Composition

Each tablet contains Paracetamol Ph Eur 500 mg, Codeine phosphate hemihydrate Ph Eur 12.8 mg

3. Pharmaceutical Form

Tablet

4. Clinical Particulars

4.1 Therapeutic Indications

For the short term treatment of acute moderate pain which is not relieved by paracetamol, ibuprofen or aspirin alone.

Panadol Ultra are recommended for the relief of migraine, headache, dental pain, period pain, backache, arthritic & rheumatic pain, strains & sprains and sciatica.

4.2 Posology And Method Of Administration

Adults (including the elderly)

Two tablets up to 4 times a day. This dose should not be repeated at more than 4 hour intervals, and not more than 4 doses should be given in any 24 hour period. Do not take for more than 3 days without consulting a doctor.

Children

Not recommended for children under 12 years of age.

For oral adminstration only.

4.3 Contraindications

Hypersensitivity to paracetamol, codeine, opioid analgesics or any of the other constituents.

Use of codeine containing products is contraindicated in mothers who are breast feeding unless prescribed by a doctor.

4.4 Special Warnings And Precautions For Use

Care is advised in the administration of paracetamol to patients with renal or hepatic impairment. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease.

Do not exceed the stated dose.

Patients should be advised to consult their doctor if their headaches become persistent.

Patients should be advised not to take other paracetamol or codeine-containing products concurrently.

If symptoms persist consult your doctor.

Keep out of the reach and sight of children.

Patients with obstructive bowel disorders or acute abdominal conditions should consult a doctor before using this product.

Patients with a history of cholecystectomy should consult a doctor before using this product as it may cause acute pancreatitis in some patients.

The label will state:

Front of pack

• Can cause addiction

• Use for 3 days only

Back of pack

• Panadol Ultra tablets are for the short term treatment of acute moderate pain when other painkillers have not worked. Wait at least four hours after taking any other painkiller before you take this medicine. For: migraine, headache, dental pain, period pain, backache, arthritic & rheumatic pain, strains & sprains and sciatica.

• If you need to take this medicine continuously for more than 3 days you should see your doctor or pharmacist

• This medicine contains codeine which can cause addiction if you take continuously for more than 3 days. If you take this medicine for headaches for more than 3 days it can make them worse.

The leaflet will state:

Headlines section (to be prominently displayed)

• This medicine is for the short term treatment of acute moderate pain when other painkillers have not worked.

• You should only take this product for a maximum of 3 days at a time. If you need to take it for longer than 3 days you should see your doctor or pharmacist for advice.

• This medicine contains codeine which can cause addiction if you take it continuously for more than 3 days. This can give you withdrawal symptoms from the medicine when you stop taking it.

• If you take this medicine for headaches for more than 3 days it can make them worse.

Section 1: What the medicine is for:

• Panadol Ultra tablets are for the short term treatment of acute moderate pain which is not relieved by paracetamol, ibuprofen or aspirin alone. They can be used for migraine, headache, dental pain, period pain, strains & sprains, backache, arthritic & rheumatic pain and sciatica.

Section 2: Before taking

• This medicine contains codeine which can cause addiction if you take it continuously for more than 3 days. This can give you withdrawal symptoms from the medicine when you stop taking it

• If you take a painkiller for headaches for more than 3 days it can make them worse.

• .

Section 3: Dosage

• Do not take for more than 3 days. If you need to use this medicine for more than 3 days you must speak to your doctor or pharmacist

• Possible withdrawal effects

This medicine contains codeine and can cause addiction if you take it continuously for more than 3 days. When you stop taking it you may get withdrawal symptoms. You should talk to your doctor or pharmacist if you think you are suffering from withdrawal symptoms.

Section 4: Side effects

• Some people may have side-effects when taking this medicine. If you have any unwanted side-effects you should seek advice from your doctor, pharmacist or other healthcare professional. Also you can help to make sure that medicines remain as safe as possible by reporting any unwanted side-effects via the internet at www.yellowcard.gov.uk; alternatively you can call Freephone 0808 100 3352 (available between 10am-2pm Monday – Friday) or fill in a paper form available from your local pharmacy.

• How do I know if I am addicted?

If you take the medicine according to the instructions on the pack it is unlikely that you will become addicted to the medicine. However, if the following apply to you it is important that you talk to your doctor:

• You need to take the medicine for longer periods of time

• You need to take more than the recommended dose

• When you stop taking the medicine you feel very unwell but you feel better if you start taking the medicine again

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Paracetamol

The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by colestyramine. The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular daily use of paracetamol with increased risk of bleeding; occasional doses have no significant effect.

Opioid analgesics should be given with care to patients receiving monoamine oxidase inhibitors. The effect of CNS depressants (including alcohol) may be potentiated by codeine; these interactions are unlikely to be significant at the dosage involved.

Codeine

Codeine may antagonize the effects of metoclopramide and domperidone on gastrointestinal motility.

Codeine potentiates the central depressive effects of central nervous system depressants including alcohol, anaesthetics, hypnotics, sedatives, tricyclic antidepressants and phenothiazines.

Opiate analgesics may interact with monoamine oxidase inhibitors (MAOIs) and result in serotonin syndrome.

4.6 Pregnancy And Lactation

Pregnancy

Use during pregnancy should be avoided, unless advised by a physician. This includes maternal use during labour because of the potential for respiratory depression in the neonate.

The safety of paracetamol-codeine during pregnancy has not been established relative to the possible adverse effects of foetal development.

Lactation

At normal therapeutic doses codeine and its active metabolites may be present in breast milk at very low doses and is unlikely to adversely affect the breast fed infant.

However, if the patient is an ultra-rapid metaboliser of CYP2D6, higher levels of the active metabolites may be present in breast milk and on very rare occasions may result in symptoms of opioid toxicity in the infant.

If symptoms of opioid toxicity develop in either the mother or the infant, then all codeine containing medicines should be stopped and alternative non-opioid analgesics prescribed. In severe cases consideration should be given to prescribing naloxone to reverse these effects.

Although significant caffeine toxicity has not been observed in breastfed infants, caffeine may have a stimulating effect on the infant.

Due to the caffeine content of this product it should not be used if you are pregnant or breastfeeding.

4.7 Effects On Ability To Drive And Use Machines

Patients should be advised not to drive or operate machinery if affected by dizziness or sedation.

4.8 Undesirable Effects

Adverse events from historical clinical trial data are both infrequent and from small patient exposure. Accordingly, events reported from extensive post-marketing experience at therapeutic/labelled dose and considered attributable are tabulated below by system. The frequency of these adverse events is not known (cannot be estimated from available data).

Paracetamol

Body System	Undesirable effect
Blood and lymphatic system disorders	Thrombocytopenia Agranulocytosis
Immune system disorders	Anaphylaxis Cutaneous hypersensitivity reactions including skin rashes, angiodema and Stevens Johnson syndrome/toxic epidermal necrolysis
Respiratory, thoracic and mediastinal disorders	Bronchospasm*
Hepatobiliary disorders	Hepatic dysfunction

* There have been cases of bronchospasm with paracetamol, but these are more likely in asthmatics sensitive to aspirin or other NSAIDs.

Codeine

Adverse reactions identified during post-marketing use are listed below by MedDRA system organ class. The frequency of these reactions is not known.

Body System	Undesirable effect
Psychiatric disorders	Drug dependency can occur after prolonged use of codeine at higher doses
Gastrointestinal disorder	Constipation, nausea, vomiting, dry mouth, acute pancreatitis in patients with a history of cholecystectomy
Nervous system disorder	Dizziness, worsening of headache with prolonged use, drowsiness.
Skin and subcutaneous tissue disorder	Pruritus, sweating

4.9 Overdose

Overuse of this product, defined as consumption of quantities in excess of the recommended dose, or consumption for a prolonged period of time may lead to physical or psychological dependency. Symptoms of restlessness and irritability may result when treatment is stopped.

Codeine

The effects in overdosage will be potentiated by simultaneous ingestion of alcohol and psychotropic drugs.

Symptoms

Central nervous system depression, including respiratory depression, may develop but is unlikely to be severe unless other sedative agents have been co-ingested, including alcohol, or the overdose is very large. The pupils may be pin-point in size; nausea and vomiting are common. Hypotension and tachycardia are possible but unlikely.

Management

This should include general symptomatic and supportive measures including a clear airway and monitoring of vital signs until stable. Consider activated charcoal if an adult presents within one hour of ingestion of more than 350 mg or a child more than 5 mg/kg.

Give naloxone if coma or respiratory depression is present. Naloxone is a competitive antagonist and has a short half-life, so large and repeated doses may be required in a seriously poisoned patient. Observe for at least four hours after ingestion, or eight hours if a sustained release preparation has been taken.

Paracetamol

Liver damage is possible in adults who have taken 10 g or more of paracetamol. Ingestion of 5 g or more of paracetamol may lead to liver damage if the patient has risk factors (see below).

Risk Factors:

If the patient

• Is on long term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St John's Wort or other drugs that induce liver enzymes.

Or

• Regularly consumes ethanol in excess of recommended amounts.

Or

• Is likely to be glutathione deplete e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia.

Symptoms

Symptoms of paracetamol overdose in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, haemorrhage, hypoglycaemia, cerebral oedema and death. Acute renal failure with acute tubular necrosis, strongly suggested by loin pain, haematuria and proteinuria, may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported.

Management

Immediate treatment is essential in the management of paracetamol overdose. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention. Symptoms may be limited to nausea or vomiting and may not reflect the severity of overdose or the risk of organ damage. Management should be in accordance with established treatment guidelines, see BNF overdose section.

Treatment with activated charcoal should be considered if the overdose has been taken within 1 hour. Plasma paracetamol concentration should be measured at 4 hours or later after ingestion (earlier concentrations are unreliable). Treatment with N-acetylcysteine may be used up to 24 hours after ingestion of paracetamol, however, the maximum protective effect is obtained up to 8 hours post-ingestion. The effectiveness of the antidote declines sharply after this time. If required the patient should be given intravenous N-acetylcysteine, in line with the established dosage schedule. If vomiting is not a problem, oral methionine may be a suitable alternative for remote areas, outside hospital. Management of patients who present with serious hepatic dysfunction beyond 24h from ingestion should be discussed with the NPIS or a liver unit.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Paracetamol is an analgesic and antipyretic. Codeine phosphate is a moderate analgesic and has weak cough suppressant activity.

5.2 Pharmacokinetic Properties

Paracetamol is rapidly and almost completely absorbed from the gastro-intestinal tract. Concentration in plasma reaches a peak in 30-60 minutes. Plasma half-life is 1-4 hours. Paracetamol is relatively uniformly distributed throughout most body fluids. Plasma protein binding is variable.

Codeine phosphate is well absorbed after oral administration and is widely distributed. About 86% is excreted in the urine in 24 hours, 40-70% is free or conjugated codeine, 5-15% is free or conjugated morphine and 10-20% is free or conjugated norcodeine.

5.3 Preclinical Safety Data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6. Pharmaceutical Particulars

6.1 List Of Excipients

starch, pre-gelatinised

povidone

potassium sorbate

maize starch

talc

magnesium stearate

stearic acid

microcrystalline cellulose

croscarmellose sodium

lactose monohydrate

hypromellose

macrogol

quinoline yellow (E104)

erthyrosine (E127)

titanium dioxide (E171)

6.2 Incompatibilities

None.

6.3 Shelf Life

48 months.

6.4 Special Precautions For Storage

None.

6.5 Nature And Contents Of Container

PVC 250 µm / aluminium foil 30 µm blisters in outer cartons, containing 6, 10, 12, 16, 20, 24, 30 or 32 tablets.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

SmithKline Beecham (SWG) Limited

980 Great West Road

Brentford

Middlesex

TW8 9GS

United Kingdom

Trading as GlaxoSmithKline Consumer Healthcare, Brentford, TW8 9GS, UK.

8. Marketing Authorisation Number(S)

PL 00071/0233

9. Date Of First Authorisation/Renewal Of The Authorisation

18.04.84

10. Date Of Revision Of The Text

21.06.11

nifedipine

nye-FED-i-peen

Commonly used brand name(s)

In the U.S.

• Adalat CC


• Afeditab CR


• Nifediac CC


• Nifedical XL


• Procardia


• Procardia XL

Available Dosage Forms:

• Capsule, Liquid Filled


• Tablet, Extended Release


• Tablet


• Capsule

Therapeutic Class: Cardiovascular Agent

Pharmacologic Class: Calcium Channel Blocker

Chemical Class: Dihydropyridine

Uses For nifedipine

Nifedipine is used alone or together with other medicines to treat severe chest pain (angina) or high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. High blood pressure may also increase the risk of heart attacks. These problems may be less likely to occur if blood pressure is controlled.

Nifedipine is a calcium channel blocker. It works by affecting the movement of calcium into the cells of the heart and blood vessels. As a result, nifedipine relaxes blood vessels and increases the supply of blood and oxygen to the heart while reducing its workload.

nifedipine is available only with your doctor's prescription.

Before Using nifedipine

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 nifedipine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to nifedipine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

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

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of nifedipine in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems which may require caution and an adjustment in the dose for patients receiving nifedipine.

Pregnancy

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

Breast Feeding

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

Interactions with Medicines

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

• Carbamazepine


• Phenobarbital


• Phenytoin


• Rifabutin


• Rifampin

Using nifedipine 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.

• Amiodarone


• Atazanavir


• Clarithromycin


• Dantrolene


• Fentanyl


• Mibefradil

Using nifedipine 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.

• Acebutolol


• Alprenolol


• Atenolol


• Betaxolol


• Bevantolol


• Bisoprolol


• Bucindolol


• Carteolol


• Carvedilol


• Celiprolol


• Cimetidine


• Clopidogrel


• Dalfopristin


• Dilevalol


• Diltiazem


• Doxazosin


• Esmolol


• Fluconazole


• Ginkgo


• Ginseng


• Indinavir


• Itraconazole


• Ketoconazole


• Labetalol


• Levobunolol


• Magnesium


• Mepindolol


• Metipranolol


• Metoprolol


• Micafungin


• Nadolol


• Nafcillin


• Nebivolol


• Oxprenolol


• Penbutolol


• Pindolol


• Propranolol


• Quinidine


• Quinupristin


• Rifapentine


• Sotalol


• St John's Wort


• Tacrolimus


• Talinolol


• Tertatolol


• Timolol


• Vincristine


• Vincristine Liposome

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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using nifedipine 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 nifedipine, or give you special instructions about the use of food, alcohol, or tobacco.

• Grapefruit Juice

Other Medical Problems

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

• Aortic stenosis (narrowing of a valve in your heart) or


• Bowel blockage, severe or


• Congestive heart failure or


• Coronary artery disease or


• Heart attack or


• Hypotension (low blood pressure)—Use with caution. May increase risk of serious side effects.

• Cardiogenic shock (shock caused by heart attack)—Should not be used in patients with these conditions.

• Galactose intolerance (rare hereditary problem) or


• Glucose-galactose malabsorption (rare hereditary problem) or


• Lapp lactase deficiency (rare hereditary problem)—The extended release tablet form of nifedipine contains lactose (milk sugar), and should not be given to patients with these conditions.

• Kidney problems or


• Liver problems (including cirrhosis)—Use with caution. The effects of nifedipine may be increased because of the slower removal of the medicine from the body.

Proper Use of nifedipine

In addition to the use of nifedipine, treatment for your high blood pressure may include weight control and changes in the types of foods you eat, especially foods high in sodium (salt). Your doctor will tell you which of these are most important for you. You should check with your doctor before changing your diet.

Many patients who have high blood pressure will not notice any signs of the problem. In fact, many may feel normal. It is very important that you take your medicine exactly as directed and that you keep your appointments with your doctor even if you feel well.

Remember that nifedipine will not cure your high blood pressure, but it does help control it. You must continue to take it as directed if you expect to lower your blood pressure and keep it down. You may have to take high blood pressure medicine for the rest of your life. If high blood pressure is not treated, it can cause serious problems such as heart failure, blood vessel disease, stroke, or kidney disease.

Swallow the extended release tablet whole. Do not break, crush, or chew it. It is best to take this tablet on an empty stomach.

If you are taking the extended-release tablets, part of the tablet may pass into your stool after your body has absorbed the medicine. This is normal and nothing to worry about.

Dosing

The dose of nifedipine 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 nifedipine. 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 treatment of chest pain or high blood pressure:
  
  • For oral dosage form (capsules):
    
    • Adults—At first, 10 milligrams (mg) three times a day. Your doctor may increase your dose as needed.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For oral dosage form (extended-release tablets):
    
    • Adults—At first, 30 or 60 milligrams (mg) once a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 90 mg once a day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of nifedipine, 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 nifedipine

It is very important that your doctor check your progress at regular visits to make sure that nifedipine is working properly and to check for unwanted effects.

You should not use nifedipine if you are also taking certain other medications such as carbamazepine (Tegretol®), phenobarbital (Luminal®), phenytoin (Dilantin®), rifabutin (Mycobutin®), rifampin (Rifadin®, Rimactane®), or St. John's Wort. Using these medicines together can cause serious problems. Make sure your doctor knows all of the medications you are taking.

Dizziness, lightheadedness, or fainting may occur, especially when you get up suddenly from a lying or sitting position. These symptoms are more likely to occur when you begin taking nifedipine, or when the dose is increased.

nifedipine may cause fluid retention (edema) in some patients. Tell your doctor right away if you have bloating or swelling of the face, arms, hands, lower legs, or feet; tingling of the hands or feet; or unusual weight gain or loss.

Do not stop taking nifedipine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping completely.

Make sure any doctor or dentist who treats you knows that you are using nifedipine. You may need to stop using nifedipine several days before having surgery or medical tests. nifedipine may affect the results of certain medical tests.

Grapefruits and grapefruit juice may increase the effects of nifedipine by increasing the amount of nifedipine in your body. You should not eat grapefruit or drink grapefruit juice while you taking nifedipine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

nifedipine 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

• Bloating or swelling of the face, arms, hands, lower legs, or feet


• cough


• difficult or labored breathing


• dizziness or lightheadedness


• fast, irregular, pounding, or racing heartbeat or pulse


• feeling of warmth


• headache


• muscle cramps


• rapid weight gain


• shakiness in the legs, arms, hands, or feet


• shortness of breath


• tightness in the chest


• tingling of the hands or feet


• trembling or shaking of the hands or feet


• unusual weight gain or loss


• weakness


• wheezing

Less common

• Blue lips and fingernails


• chest congestion


• chest pain


• chills


• coughing that sometimes produces a pink frothy sputum


• decreased urine output


• difficult, fast, or noisy breathing, sometimes with wheezing


• dilated neck veins


• extreme fatigue


• fever


• increased sweating


• irregular breathing


• nausea


• pain or discomfort in the arms, jaw, back, or neck


• pale skin


• severe unusual tiredness or weakness


• sweating


• troubled breathing


• vomiting

Rare

• Black, tarry stools


• bleeding gums


• blood in the eyes


• blood in the urine or stools


• bloody stools


• bluish color


• blurred vision


• body aches or pain


• changes in skin color


• cold sweats


• dark urine


• difficulty with swallowing


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


• dry mouth


• dryness or soreness of throat


• ear congestion or pain


• extra heartbeats


• eye pain


• feeling unusually cold


• general tiredness and weakness


• headache, severe and throbbing


• hoarseness


• increased urge to urinate during the night


• irritation in the mouth


• itching


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


• light-colored stools


• nasal congestion


• neck pain


• nervousness


• no blood pressure or pulse


• noisy breathing


• pain


• pain in the groin or genitals


• pain or burning while urinating


• painful or difficult urination


• pinpoint red spots on the skin


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


• redness and swelling of the gums


• redness in the whites of the eyes


• runny nose


• shakiness and unsteady walk


• sharp back pain just below ribs


• shivering


• skin rash


• small clicking, bubbling, or rattling sounds in the lung when listening with a stethoscope


• sneezing


• sore throat


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


• stopping of heart


• swelling around the eyes


• swollen glands


• tenderness


• tender, swollen glands in the neck


• troubled breathing with exertion


• unconsciousness


• unsteadiness, trembling, or other problems with muscle control or coordination


• unusual bleeding or bruising


• upper right abdominal or stomach pain


• vision changes


• voice changes


• vomiting of blood or material that looks like coffee grounds


• waking to urinate at night


• yellow eyes and skin

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

• Belching


• feeling of indigestion


• mood changes


• pain in the chest below the breastbone


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

Less common

• Abnormal ejaculation


• bloody nose


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


• decreased interest in sexual intercourse


• decreased sexual performance or desire


• diarrhea


• difficulty having a bowel movement (stool)


• excess air or gas in stomach or intestines


• feeling of constant movement of self or surroundings


• full feeling


• general feeling of discomfort or illness


• inability to have or keep an erection


• increased need to urinate


• joint stiffness


• leg cramps or pain


• loss in sexual ability, desire, drive, or performance


• nervousness


• passing gas


• passing urine more often


• sneezing


• stuffy nose


• trouble sleeping

Rare

• Acid or sour stomach


• ankle, knee, or great toe joint pain


• cracks in the skin


• difficulty with moving


• discouragement


• excessive muscle tone


• fear or nervousness


• feeling sad or empty


• hair loss or thinning of the hair


• heartburn


• increased sensitivity of the skin to sunlight


• irritability


• itching, pain, redness, swelling, tenderness, or warmth on the skin


• lack of appetite


• lack or loss of strength


• loss of heat from the body


• loss of interest or pleasure


• loss of strength or energy


• loss in sexual ability, desire, drive, or performance


• lower back or side pain


• muscle pain or weakness


• muscle stiffness


• muscle tension or tightness


• pain or burning in the throat


• red, swollen skin


• redness or other discoloration of the skin


• scaly skin


• severe sunburn


• sleepiness or unusual drowsiness


• sleeplessness


• stomach discomfort, upset, or pain


• swelling of the breasts or breast soreness in both females and males


• tiredness


• trouble concentrating


• unable to sleep

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: nifedipine 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 nifedipine resources

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

• Adalat Consumer Overview


• Adalat CC Prescribing Information (FDA)


• Adalat CC Sustained-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Afeditab CR Prescribing Information (FDA)


• Nifediac CC Prescribing Information (FDA)


• Nifedical XL Prescribing Information (FDA)


• Nifedipine Monograph (AHFS DI)


• Nifedipine Professional Patient Advice (Wolters Kluwer)


• Nifedipine MedFacts Consumer Leaflet (Wolters Kluwer)


• Procardia Prescribing Information (FDA)


• Procardia XL Prescribing Information (FDA)

Compare nifedipine with other medications

• Angina Pectoris Prophylaxis
• Heart Failure
• High Blood Pressure
• Hypertensive Emergency
• Hypertrophic Cardiomyopathy
• Migraine Prevention
• Premature Labor
• Raynaud's Syndrome

Flebogamma IGIV

Generic Name: immune globulin (intravenous) (IGIV) (im MYOON GLOB yoo lin)

Brand Names: Carimune, Flebogamma, Gammagard (obsolete), Gammagard S/D, Gammaplex, Gammar-P I.V., Gamunex, Octagam, Polygam S/D, Privigen, Sandoglobulin

What is immune globulin intravenous (IVIG)?

Immune globulin intravenous is a sterilized solution made from human plasma. It contains the antibodies to help your body protect itself against infection from various diseases.

Immune globulin is used to treat primary immune deficiency, and to reduce the risk of infection in individuals with poorly functioning immune systems such as those with chronic lymphocytic leukemia (CLL). IGIV is also used to increase platelets (blood clotting cells) in people with idiopathic thrombocytopenic purpura (ITP) and to prevent aneurysm caused by a weakening of the main artery in the heart associated with Kawasaki syndrome.

Immune globulin is also used to treat chronic inflammatory demyelinating polyneuropathy (CIDP), a debilitating nerve disorder that causes muscle weakness and can affect daily activities.

Immune globulin may also be used for purposes not listed in this medication guide.

What is the most important information I should know about immune globulin?

Immune globulin can harm your kidneys, and this effect is increased when you also use certain other medicines harmful to the kidneys. Before using immune globulin, tell your doctor about all other medications you use. Many other drugs (including some over-the-counter medicines) can be harmful to the kidneys.

Before using immune globulin intravenous, tell your doctor if you have kidney disease, diabetes (especially if you use insulin), a history of stroke or blood clot, heart disease, high blood pressure, a condition called paraproteinemia, or if you are over 65 years old.

To be sure this medicine is helping your condition and is not causing harmful effects, your blood will need to be tested often. Your kidney function may also need to be tested. Visit your doctor regularly.

This medication can cause unusual results with certain blood glucose tests. Tell any doctor who treats you that you are using immune globulin.

Immune globulin is made from human plasma (part of the blood) which may contain viruses and other infectious agents. Donated plasma is tested and treated to reduce the risk of it containing infectious agents, but there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

What should I discuss with my health care provider before using immune globulin?

You should not use this medication if you have ever had an allergic reaction to an immune globulin or if you have immune globulin A (IgA) deficiency with antibody to IgA.

To make sure you can safely use immune globulin, tell your doctor if you have any of these other conditions:

• 
  

  kidney disease;

  
  


• 
  

  diabetes (especially if you use insulin);

  
  


• 
  

  a history of stroke or blood clot;

  
  


• 
  

  heart disease or high blood pressure;

  
  


• 
  

  a condition called paraproteinemia; or

  
  


• 
  

  if you are over 65 years old.

  
  

FDA pregnancy category C. It is not known whether immune globulin 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 if immune globulin 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.

Immune globulin is made from human plasma (part of the blood) which may contain viruses and other infectious agents. Donated plasma is tested and treated to reduce the risk of it containing infectious agents, but there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

How is immune globulin intravenous given?

Immune globulin intravenous is injected into a vein through an IV. You may be shown how to use an IV 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, IV tubing, and other items used to inject the medicine.

IVIG should not be injected into a muscle or under the skin.

Do not use the medication if it has changed colors or has particles in it. Call your doctor for a new prescription. Throw away any unused medicine that is left over after injecting your dose.

Use each disposable needle only one time. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

IVIG is usually given every 3 to 4 weeks. Your dosing schedule may be different. Follow your doctor's instructions.

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

To be sure this medicine is helping your condition and is not causing harmful effects, your blood will need to be tested often. Your kidney function may also need to be tested. Visit your doctor regularly.

This medication can cause unusual results with certain blood glucose tests. Tell any doctor who treats you that you are using immune globulin.

Some brands of immune globulin should be stored in a refrigerator, while others can be kept at room temperature. Follow the directions on your prescription label or ask your pharmacist if you have questions about how to store the medication. Do not allow the medicine to freeze.

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose of this medication.

What happens if I overdose?

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

What should I avoid while using immune globulin?

Do not receive a "live" vaccine while using IVIG. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), oral polio, typhoid, chickenpox (varicella), BCG (Bacillus Calmette and Guérin), and nasal flu vaccine.

Immune globulin 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:

• 
  

  urinating less than usual or not at all;

  
  


• 
  

  drowsiness, confusion, mood changes, increased thirst, loss of appetite, nausea and vomiting;

  
  


• 
  

  swelling, weight gain, feeling short of breath;

  
  


• 
  

  wheezing, chest tightness;

  
  


• 
  

  feeling like you might pass out;

  
  


• 
  

  fever with headache, neck stiffness, chills, increased sensitivity to light, purple spots on the skin, and/or seizure (convulsions); or

  
  


• 
  

  pale or yellowed skin, dark colored urine, fever, confusion or weakness.

  
  

Less serious side effects may include:

• 
  

  mild headache;

  
  


• 
  

  dizziness;

  
  


• 
  

  tired feeling;

  
  


• 
  

  back pain, muscle cramps;

  
  


• 
  

  minor chest pain; or

  
  


• 
  

  flushing (warmth, redness, or tingly feeling).

  
  

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 immune globulin?

Immune globulin can harm your kidneys. This effect is increased when you also use other medicines harmful to the kidneys. You may need dose adjustments or special tests if you have recently used:

• 
  

  lithium (Lithobid);

  
  


• 
  

  methotrexate (Rheumatrex, Trexall);

  
  


• 
  

  pain or arthritis medicines such as aspirin (Anacin, Excedrin), acetaminophen (Tylenol), diclofenac (Cataflam, Voltaren), etodolac (Lodine), ibuprofen (Advil, Motrin), indomethacin (Indocin), meloxicam (Mobic), nabumetone (Relafen), naproxen (Aleve, Naprosyn), piroxicam (Feldene), and others;

  
  


• 
  

  medicines used to treat ulcerative colitis, such as mesalamine (Pentasa) or sulfasalazine (Azulfidine);

  
  


• 
  

  medicines used to prevent organ transplant rejection, such as cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune) or tacrolimus (Prograf);

  
  


• 
  

  IV antibiotics such as amphotericin B (Fungizone, AmBisome, Amphotec, Abelcet), amikacin (Amikin), bacitracin (Baci-IM), capreomycin (Capastat), gentamicin (Garamycin), kanamycin (Kantrex), streptomycin, or vancomycin (Vancocin, Vancoled);

  
  


• 
  

  antiviral medicines such as adefovir (Hepsera), cidofovir (Vistide), or foscarnet (Foscavir); or

  
  


• 
  

  cancer medicine such as aldesleukin (Proleukin), carmustine (BiCNU, Gliadel), cisplatin (Platinol), ifosfamide (Ifex), oxaliplatin (Eloxatin), streptozocin (Zanosar), or tretinoin (Vesanoid).

  
  

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

More Flebogamma resources

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

Compare Flebogamma with other medications

• Autoimmune Neutropenia
• Bone Marrow Transplantation
• Chronic Lymphocytic Leukemia
• Evan's Syndrome
• HIV Infection
• Idiopathic Thrombocytopenic Purpura
• Kawasaki Disease
• Polymyositis/Dermatomyositis
• Primary Immunodeficiency Syndrome

Where can I get more information?

• Your pharmacist can provide more information about immune globulin intravenous.

See also: Flebogamma side effects (in more detail)

Eskalith

Generic Name: lithium (Oral route)

LITH-ee-um

Oral route(Tablet;Tablet, Extended Release;Capsule)

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 .

Oral route(Solution)

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 .

Commonly used brand name(s)

In the U.S.

• Eskalith


• Eskalith-CR


• Lithobid

Available Dosage Forms:

• Capsule


• Solution


• Tablet, Extended Release


• Tablet


• Syrup

Therapeutic Class: Antimanic

Uses For Eskalith

Lithium is used to treat mania that is part of bipolar disorder (manic-depressive illness). It is also used on a daily basis to reduce the frequency and severity of manic episodes. Manic-depressive patients experience severe mood changes, ranging from an excited or manic state (e.g., unusual anger or irritability or a false sense of well-being) to depression or sadness.

It is not known how lithium works to stabilize a person's mood. However, it does act on the central nervous system. It helps you to have more control over your emotions and helps you cope better with the problems of living.

It is important that you and your family understand all the effects of this medicine. These effects depend on your individual condition and response and the amount of lithium you use. You also must know when to contact your doctor if there are problems with using the medicine.

This medicine 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 these uses are not included in product labeling, lithium is used in certain patients with the following medical conditions:

• Cluster headaches.


• Mental depression.


• Neutropenia (a blood condition where there is a decreased number of a certain type of white blood cells).

Before Using Eskalith

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

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of lithium extended-release tablets in children younger than 12 years of age. Safety and efficacy have not been established.

No information is available on the relationship of age to the effects of lithium capsules, solution, and tablets in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies on the relationship of age to the effects of lithium have not been performed in the geriatric population. However, elderly patients are more likely to have age-related heart and kidney problems, which may require caution and an adjustment in the dose for patients receiving lithium.

Pregnancy

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

Breast Feeding

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

Interactions with Medicines

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

• Acetophenazine


• Azosemide


• Bemetizide


• Bendroflumethiazide


• Benzthiazide


• Bromperidol


• Bumetanide


• Buthiazide


• Candesartan Cilexetil


• Canrenoate


• Chlorothiazide


• Chlorpromazine


• Chlorprothixene


• Chlorthalidone


• Clozapine


• Cyclothiazide


• Domperidone


• Droperidol


• Duloxetine


• Ethacrynic Acid


• Ethopropazine


• Flupenthixol


• Fluphenazine


• Furosemide


• Haloperidol


• Hydrochlorothiazide


• Hydroflumethiazide


• Indapamide


• Linezolid


• Losartan


• Loxapine


• Melperone


• Mesoridazine


• Methotrimeprazine


• Methyclothiazide


• Metolazone


• Milnacipran


• Molindone


• Olanzapine


• Penfluridol


• Periciazine


• Perphenazine


• Phenelzine


• Pimozide


• Pipamperone


• Pipotiazine


• Piretanide


• Polythiazide


• Prochlorperazine


• Promazine


• Promethazine


• Quinethazone


• Remoxipride


• Risperidone


• Sertindole


• Sibutramine


• Spironolactone


• Sulpiride


• Thiopropazate


• Thioproperazine


• Thioridazine


• Thiothixene


• Tiapride


• Torsemide


• Trichlormethiazide


• Trifluoperazine


• Triflupromazine


• Trimeprazine


• Valsartan


• Xipamide


• Zotepine


• Zuclopenthixol

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.

• Alacepril


• Benazepril


• Bromfenac


• Calcitonin


• Carbamazepine


• Celecoxib


• Cilazapril


• Citalopram


• Clometacin


• Clovoxamine


• Diclofenac


• Diltiazem


• Dipyrone


• Escitalopram


• Femoxetine


• Fluoxetine


• Fluvoxamine


• Fosinopril


• Ibuprofen


• Indomethacin


• Ketoprofen


• Ketorolac


• Lisinopril


• Lurasidone


• Mazindol


• Mefenamic Acid


• Meloxicam


• Metronidazole


• Naproxen


• Paroxetine


• Perindopril


• Piroxicam


• Quinapril


• Rofecoxib


• Sertraline


• Spirapril


• Succinylcholine


• Sulindac


• Telmisartan


• Tenidap


• Tenoxicam


• Tiaprofenic Acid


• Tolmetin


• Trandolapril


• Valdecoxib


• Verapamil


• Yohimbine


• Zimeldine


• Zofenopril

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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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:

• Brugada syndrome (heart disorder), or family history of or


• Decreased urination or


• Diarrhea, prolonged or


• Infection, severe with fever or


• Kidney disease or


• Sweating, prolonged or


• Vomiting, prolonged—May increase risk for serious side effects.

• Dehydration, severe or


• Heart or blood vessel disease or


• Hyponatremia (low sodium in the blood) or


• Kidney disease, severe or


• Muscle weakness, severe or


• Weakened physical condition—Should not be used in patients with these conditions.

• Encephalopathic syndrome (brain disease) or


• Goiter or other thyroid problems or


• Nervous system problems—Use with caution. May make these conditions worse.

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

Proper Use of lithium

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

Take this medicine exactly as directed by your doctor. Do not take more or less of it, do not take it more or less often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

You might have to take this medicine for several weeks before you begin to feel better. Talk to your doctor if you have any questions.

Make sure that your doctor knows if you are on a low-sodium or low-salt diet. Too little salt in your diet could lead to serious side effects.

Talk to your doctor about the correct amount of fluid to take with this medicine. Some people need to drink extra fluid every day with the lithium.

Swallow the extended-release tablet whole. Do not break, crush, or chew it.

Measure the oral solution with a marked measuring spoon, oral syringe, or medicine cup. A regular teaspoon may not measure the correct amount of medicine.

There are several different forms of lithium. The dose for each is different and they are used at different times of the day. Do not change the type of medicine you take without talking to your doctor first.

In order for lithium to work properly, it must be taken every day in regularly spaced doses as ordered by your doctor. This is necessary to keep a constant amount of lithium in your blood. To help keep the amount constant, do not miss any doses and do not stop taking the medicine even if you feel better.

Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way.

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 forms (capsules, solution, and tablets):
  
  • For acute mania:
    
    • Adults—600 milligrams (mg) or 10 milliliters (mL) three times a day. Your doctor may adjust your dose if needed.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For long-term treatment of mania:
    
    • Adults—300 milligrams (mg) or 5 milliliters (mL) three or four times a day. Your doctor may adjust your dose if needed.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

• For oral dosage form (extended-release tablets):
  
  • For acute mania:
    
    • Adults—900 milligrams (mg) two times a day, or 600 mg three times a day.
    
    
    • Teenagers and children 12 years of age—Use and dose must be determined by your doctor.
    
    
    • Children younger than 12 years of age—Use is not recommended.
    
    
  
  
  • For long-term treatment of mania:
    
    • Adults—600 milligrams (mg) two times a day, or three times a day up to 1200 mg per day.
    
    
    • Teenagers and children 12 years of age—Use and dose must be determined by your doctor.
    
    
    • Children younger than 12 years of age—Use is not recommended.
    
    
  
  

Missed Dose

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

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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

Precautions While Using Eskalith

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

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

Stop using this medicine and call your doctor right away if you have diarrhea, vomiting, drowsiness, muscle weakness, tremors, unsteadiness, or other problems with muscle control or coordination.

Make sure your doctor knows if you have a heart disorder called Brugada syndrome. Brugada syndrome can be life-threatening and requires immediate medical attention. Call your doctor or the emergency department right away if you have a fast, pounding, or uneven heartbeat; unexplained fainting; lightheadedness; shortness of breath; or troubled breathing after taking this medicine.

Encephalopathic syndrome (brain problem) may occur in patients taking this medicine together with haloperidol (Haldol®). Check with your doctor right away if you have the following symptoms while taking this medicine: a fever, confusion, drowsiness, difficulty with speaking, uncontrolled body movements, and unusual tiredness or weakness.

This medicine may cause some people to become dizzy, drowsy, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert.

Use extra care in hot weather and during activities that cause you to sweat heavily, such as hot baths, saunas, or exercising. If you have an infection or illness that causes heavy sweating, vomiting, diarrhea, shakiness, or muscle weakness, check with your doctor right away. The loss of too much water and salt from your body could lead to serious side effects from this medicine.

Do not go on a diet to lose weight and do not make a major change in your diet without first checking with your doctor. Improper dieting could cause the loss of too much water and salt from your body and could lead to serious side effects from this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Eskalith 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:

Less common

• Confusion, poor memory, or lack of awareness


• fainting


• fast or slow heartbeat


• frequent urination


• increased thirst


• irregular pulse


• stiffness of the arms or legs


• troubled breathing (especially during hard work or exercise)


• unusual tiredness or weakness


• weight gain

Rare

• Blue color and pain in the fingers and toes


• coldness of the arms and legs


• dizziness


• eye pain


• headache


• noise in the ears


• vision problems

Incidence not known

• Dry, rough skin


• fast, irregular, pounding, or racing heartbeat or pulse


• hair loss


• hoarseness


• lightheadedness


• mental depression


• sensitivity to cold


• shortness of breath


• swelling of the feet or lower legs


• swelling of the neck


• unusual excitement

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

Symptoms of overdose

• Blurred vision


• clumsiness or unsteadiness


• convulsions (seizures)


• diarrhea


• drowsiness


• increase in the amount of urine


• lack of coordination


• loss of appetite


• muscle weakness


• nausea or vomiting


• ringing in the ears


• slurred speech


• trembling (severe)

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

• Acne or skin rash


• bloated feeling or pressure in the stomach


• muscle twitching (slight)

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: Eskalith side effects (in more detail)

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More Eskalith resources

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

• Eskalith Prescribing Information (FDA)


• Eskalith MedFacts Consumer Leaflet (Wolters Kluwer)


• Eskalith Concise Consumer Information (Cerner Multum)


• Lithium Prescribing Information (FDA)


• Lithium Professional Patient Advice (Wolters Kluwer)


• Lithium Salts Monograph (AHFS DI)


• Lithobid Prescribing Information (FDA)


• Lithobid Controlled-Release and Extended-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Eskalith with other medications

• Bipolar Disorder
• Cluster Headaches
• Mania
• Schizoaffective Disorder