Lithobid

lithium carbonate

Dosage Form: tablet, film coated, extended release
Lithobid® (Lithium Carbonate, USP)

Extended-Release Tablets 300 mg

Rev 10/2011

Rx only

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).

Lithobid Description

Lithobid® tablets contain lithium carbonate, a white odorless alkaline powder with molecular formula Li2CO3 and molecular weight 73.89. 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. Each peach-colored, film-coated, extended-release tablet contains 300 mg of lithium carbonate. This slowly dissolving film-coated tablet is designed to give lower serum lithium peak concentrations than obtained with conventional oral lithium dosage forms. Inactive ingredients consist of calcium stearate, carnauba wax, cellulose compounds, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, povidone, propylene glycol, sodium chloride, sodium lauryl sulfate, sodium starch glycolate, sorbitol, and titanium dioxide. Product meets USP Drug Release Test 1.

ACTIONS

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

Lithobid® (lithium carbonate) is indicated in the treatment of manic episodes of Bipolar Disorder. Bipolar Disorder, Manic (DSM-IV) is equivalent to Manic Depressive illness, Manic, in the older DSM-II terminology. Lithobid® 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 judgment, 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.

Warnings

Lithium Toxicity


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


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 should generally not be given to patients with significant renal or cardiovascular disease, severe debilitation, dehydration, sodium depletion, and to patients receiving diuretics, or angiotensin converting enzyme (ACE) inhibitors, 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.

Unmasking of Brugada Syndrome

There have been postmarketing reports of a possible association between treatment with lithium and the unmasking of Brugada Syndrome.  Brugada Syndrome is a disorder characterized by abnormal electrocardiographic (ECG) findings and a risk of sudden death. Lithium should generally be avoided in patients with Brugada Syndrome or those suspected of having Brugada Syndrome.  Consultation with a cardiologist is recommended if: (1) treatment with lithium is under consideration for patients suspected of having Brugada Syndrome or patients who have risk factors for Brugada Syndrome, e.g., unexplained syncope, a family history of Brugada Syndrome, or a family history of sudden unexplained death before the age of 45 years, (2) patients who develop unexplained syncope or palpitations after starting lithium therapy.


Renal Effects


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 nephron atrophy have been reported in patients on chronic lithium therapy. Morphologic changes have also been seen in manic-depressive patients never exposed to lithium. The relationship between renal function and morphologic changes and their association with lithium therapy have not been established.


Kidney function should be assessed prior to and during lithium therapy. 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.


Encephalopathic Syndrome


An encephalopathic syndrome (characterized by weakness, lethargy, fever, tremulousness and confusion, extrapyramidal symptoms, leukocytosis, elevated serum enzymes, BUN, and FBS) has occurred in a few patients treated with lithium plus a neuroleptic, most notably haloperidol. In some instances, the syndrome was followed by irreversible brain damage. Because of possible causal relationship between these events and the concomitant administration of lithium and neuroleptic drugs, patients receiving such combined therapy or patients with organic brain syndrome or other CNS impairment should be monitored closely for early evidence of neurologic toxicity and treatment discontinued promptly if such signs appear. This encephalopathic syndrome may be similar to or the same as Neuroleptic Malignant Syndrome (NMS).


Concomitant Use with Neuromuscular Blocking Agents


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

Usage in Pregnancy

Adverse effects on nidationin 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 palate in mice.


In humans, lithium may cause fetal harm when administered to a pregnant woman. Data from lithium birth registries suggest an increase in cardiac and other anomalies, especially Ebstein's anomaly. If this drug is used in women of childbearing potential, or during pregnancy, or if a patient becomes pregnant while taking this drug, the patient should be apprised by their physician of the potential hazard to the fetus.

Usage in 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 hazard to the infant or neonate. Signs and symptoms of lithium toxicity such as hypertonia, hypothermia, cyanosis, and ECG changes have been reported in some infants and neonates.

Pediatric Use

Safety and effectiveness in pediatric patients under 12 years of age have not been determined; its use in these patients is not recommended.

There has been a report of transient syndrome of acute dystonia and hyperreflexia occurring in a 15 kg pediatric patient who ingested 300 mg of lithium carbonate.

Precautions

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 elimination half-life 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 (2500-3500 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 under careful medical supervision and lithium intake reduced or suspended until the condition is resolved.


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


Previously existing thyroid disorders do not necessarily constitute a contraindication to lithium treatment. Where hypothyroidism preexists, careful monitoring of thyroid function during lithium stabilization and maintenance allows for correction of changing thyroid parameters and/or adjustment of lithium doses, if any. If hypothyroidism occurs during lithium stabilization and maintenance, supplemental thyroid treatment may be used. In general, the concomitant use of diuretics or angiotensin converting enzyme (ACE) inhibitors with lithium carbonate should be avoided. In those cases where concomitant use is necessary, extreme caution is advised since sodium loss from these drugs may reduce the renal clearance of lithium resulting in increased serum lithium concentrations with the risk of lithium toxicity. When such combinations are used, the lithium dosage may need to be decreased, and more frequent monitoring of lithium serum concentrations is recommended. See WARNINGS for additional caution information.


Concomitant administration of carbamazepine and lithium may increase the risk of neurotoxic side effects.


The following drugs can lower serum lithium concentrations by increasing urinary lithium excretion: acetazolamide, urea, xanthine preparations, and alkalinizing agents such as sodium bicarbonate.


Concomitant extended use of iodide preparations, especially potassium iodide, with lithium may produce hypothyroidism.


Concurrent use of calcium channel blocking agents with lithium may increase the risk of neurotoxicity in the form of ataxia, tremors, nausea, vomiting, diarrhea, and/or tinnitus.


Concurrent use of metronidazole with lithium may provoke lithium toxicity due to reduced renal clearance. Patients receiving such combined therapy should be monitored closely.


Concurrent use of fluoxetine with lithium has resulted in both increased and decreased serum lithium concentrations. Patients receiving such combined therapy should be monitored closely.


Nonsteroidal 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 a 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.


Lithium may impair mental and/or physical abilities. Patients should be cautioned about activities requiring alertness (e.g., operating vehicles or machinery).

Usage in Pregnancy

Pregnancy Category D. (See WARNINGS).

Usage in Nursing Mothers

Because of the potential for serious adverse reactions in nursing infants and neonates from lithium, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother (see WARNINGS).

Pediatric Use

Safety and effectiveness in pediatric patients below the age of 12 have not been established (see WARNINGS).

Geriatric Use

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


This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

Adverse Reactions

The occurrence and severity of adverse reactions are generally directly related to serum lithium concentrations and to individual patient sensitivity to lithium. They generally occur more frequently and with greater severity at higher concentrations.


Adverse reactions may be encountered at serum lithium concentrations below 1.5 mEq/L. Mild to moderate adverse reactions may occur at concentrations from 1.5-2.5 mEq/L, and moderate to severe reactions may be seen at concentrations from 2.0 mEq/L and above.


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 usually subside with continued treatment or with a temporary reduction or cessation of dosage. If persistent, a cessation of lithium therapy may be required. Diarrhea, vomiting, drowsiness, muscular weakness, and lack of coordination may be early signs of lithium intoxication, and can occur at lithium concentrations below 2.0 mEq/L. At higher concentrations, giddiness, ataxia, blurred vision, tinnitus, and a large output of dilute urine may be seen. Serum lithium concentrations above 3.0 mEq/L may produce a complex clinical picture involving multiple organs and organ systems. Serum lithium concentrations should not be permitted to exceed 2.0 mEq/L during the acute treatment phase.


The following reactions have been reported and appear to be related to serum lithium concentrations, including concentrations within the therapeutic range:


Central Nervous System: tremor, muscle hyperirritability (fasciculations, twitching, clonic movements of whole limbs), hypertonicity, ataxia, choreoathetotic movements, hyperactive deep tendon reflex, extrapyramidal symptoms including acute dystonia, cogwheel rigidity, blackout spells, epileptiform seizures, slurred speech, dizziness, vertigo, downbeat nystagmus, incontinence of urine or feces, somnolence, psychomotor retardation, restlessness, confusion, stupor, coma, tongue movements, tics, tinnitus, hallucinations, poor memory, slowed intellectual functioning, startled response, worsening of organic brain syndromes. 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. Cardiovascular: cardiac arrhythmia, hypotension, peripheral circulatory collapse, bradycardia, sinus node dysfunction with severe bradycardia (which may result in syncope), Unmasking of Brugada Syndrome (See WARNINGS and PATIENT COUNSELING INFORMATION). Gastrointestinal: anorexia, nausea, vomiting, diarrhea, gastritis, salivary gland swelling, abdominal pain, excessive salivation, flatulence, indigestion. Genitourinary: glycosuria, decreased creatinine clearance, albuminuria, oliguria, and symptoms of nephrogenic diabetes insipidus including polyuria, thirst and polydipsia. Dermatologic: drying and thinning of hair, alopecia, anesthesia of skin, acne, chronic folliculitis, xerosis cutis, psoriasis or its exacerbation, generalized pruritus with or without rash, cutaneous ulcers, angioedema. Autonomic Nervous System: blurred vision, dry mouth, impotence/ sexual dysfunction. Thyroid Abnormalities: euthyroid goiter and/or hypothyroidism (including myxedema) accompanied by lower T3 and T4. 131Iodine 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, exophthalmos, dehydration, weight loss, leucocytosis, headache, transient-hyperglycemia, hypercalcemia, hyperparathyroidism, albuminuria, excessive weight gain, edematous swelling of ankles or wrists, metallic taste, dysgeusia/taste distortion, salty taste, thirst, swollen lips, tightness in chest, swollen and/or painful joints, fever, polyarthralgia, and dental caries.


Some reports of nephrogenic diabetes insipidus, hyperparathyroidism, and hypothyroidism which persist after lithium discontinuation have been received.


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

DOSAGE AND ADMINISTRATION

Acute Mania

Optimal patient response can usually be established with 1800 mg/day in the following dosages:

Acute Mania

1Can also be administered on 600 mg TID recommended dosing interval.
	Morning	Afternoon	Nighttime
Lithobid®	3 tabs		3 tabs
Extended-Release Tablets1	(900 mg)		(900 mg)

Such doses will normally produce an effective serum lithium concentration ranging between 1.0 and 1.5 mEq/L. Dosage must be individualized according to serum concentrations and clinical response. Regular monitoring of the patient's clinical state and of serum lithium concentrations is necessary. Serum concentrations should be determined twice per week during the acute phase, and until the serum concentrations and clinical condition of the patient have been stabilized.

Long-Term Control

Desirable serum lithium concentrations are 0.6 to 1.2 mEq/L which can usually be achieved with 900-1200 mg/day. Dosage will vary from one individual to another, but generally the following dosages will maintain this concentration:

Long-Term Control

1Can be administered on TID recommended dosing interval up to 1200 mg/day.
	Morning	Afternoon	Nighttime
Lithobid®	2 tabs		2 tabs
Extended-Release Tablets1	(600 mg)		(600 mg)

Serum lithium concentrations 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 concentrations of 1.0 to 1.5 mEq/L. Geriatric patients often respond to reduced dosage, and may exhibit signs of toxicity at serum concentrations ordinarily tolerated by other patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Important Considerations

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


• Lithobid® Extended-Release Tablets must be swallowed whole and never chewed or crushed.

Overdosage

The toxic concentrations for lithium (1.5 mEq/ L) are close to the therapeutic concentrations (0.6-1.2 mEq/L). It is therefore important that patients and their families be cautioned to watch for early toxic 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.  Treatment is supportive. 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. However, patient recovery may be slow.


Infection prophylaxis, regular chest X-rays, and preservation of adequate respiration are essential.

Patient Counseling Information

Information for Patients: A condition known as Brugada Syndrome may pre-exist and be unmasked by lithium therapy.  Brugada Syndrome is a heart disorder characterized by abnormal electrocardiographic (ECG) findings and risk of sudden death.  Patients should be advised to seek immediate emergency assistance if they experience fainting, lightheadedness, abnormal heart beats, or shortness of breath because they may have a potentially life-threatening heart disorder known as Brugada Syndrome.

How is Lithobid Supplied

Lithobid® (Lithium Carbonate, USP)

Extended-Release Tablets, 300 mg, peach-colored imprinted “Lithobid 300”

NDC 68968-4492-1

(Bottle of 100)

Storage Conditions

Store between 59°-86°F (15°-30°C). Protect from moisture. Dispense in tight, child-resistant container (USP).


Lithobid®

(Lithium Carbonate, USP)

Extended-Release Tablets, 300 mg


Manufactured By:

ANI Pharmaceuticals, Inc.

Baltimore, Maryland 21244


For:

Noven Therapeutics, LLC

Miami, FL 33186

Print Date: MM/YYYY

© 2011 Noven Therapeutics, LLC

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 300 MG LABEL

NDC 68968-4492-1

100 TABLETS

Lithobid®

(lithium carbonate)

TABLET, FILM COATED, EXTENDED RELEASE

300 mg

Rx ONLY

NOVEN THERAPEUTICS, LLC

Lithobid  lithium carbonate  tablet, film coated, extended release

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 68968-4492 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength lithium carbonate (Lithium cation) lithium carbonate 300 mg

Inactive Ingredients Ingredient Name Strength calcium stearate   carnauba wax   Hypromellose 2910 (50 MPA.S)   FD&C Blue No. 2   FD&C Red No. 40   FD&C Yellow No. 6   povidone   propylene glycol   sodium chloride   sodium lauryl sulfate   sodium starch glycolate type a potato   sorbitol   titanium dioxide

Product Characteristics Color pink (PINK) Score no score Shape ROUND (ROUND) Size 10mm Flavor Imprint Code Lithobid;300 Contains

Packaging # NDC Package Description Multilevel Packaging 1 68968-4492-1 100 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA018027	04/27/1979

Labeler - NOVEN THERAPEUTICS, LLC (166888268)

Establishment
Name	Address	ID/FEI	Operations
ANI Pharmaceuticals, Inc.		148515737	MANUFACTURE, ANALYSIS

Revised: 10/2011NOVEN THERAPEUTICS, LLC

More Lithobid resources

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

• Lithobid Concise Consumer Information (Cerner Multum)


• Lithobid Advanced Consumer (Micromedex) - Includes Dosage Information


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


• Lithium Professional Patient Advice (Wolters Kluwer)


• Eskalith MedFacts Consumer Leaflet (Wolters Kluwer)


• Lithium Salts Monograph (AHFS DI)

Compare Lithobid with other medications

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pregabalin

Generic Name: pregabalin (pre GAB a lin)

Brand Names: Lyrica

What is pregabalin?

Pregabalin is an anti-epileptic drug, also called an anticonvulsant. It works by slowing down impulses in the brain that cause seizures. Pregabalin also affects chemicals in the brain that send pain signals across the nervous system.

Pregabalin is used to control seizures and to treat fibromyalgia. It is also used to treat pain caused by nerve damage in people with diabetes (diabetic neuropathy) or herpes zoster (post-herpetic neuralgia).

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

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

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

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

If you are taking pregabalin to prevent seizures, keep taking the medication even if you feel fine. Do not stop using pregabalin without first talking to your doctor, even if you feel fine. You may have increased seizures or withdrawal symptoms such as headache, sleep problems, nausea, and diarrhea. Ask your doctor how to avoid withdrawal symptoms when you stop using pregabalin.

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

Wear a medical alert tag or carry an ID card stating that you take pregabalin. Any medical care provider who treats you should know that you take seizure medication.

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

You should not use this medication if you are allergic to pregabalin.

To make sure you can safely take pregabalin, tell your doctor if you have any of these other conditions:

• 
  

  congestive heart failure;

  
  


• 
  

  diabetes (unless you are taking pregabalin to treat diabetic neuropathy);

  
  


• 
  

  kidney disease (or if you are on dialysis);

  
  


• 
  

  a bleeding disorder;

  
  


• 
  

  low levels of platelets in your blood;

  
  


• 
  

  a history of depression or suicidal thoughts;

  
  


• 
  

  a history of drug or alcohol addiction; or

  
  


• 
  

  if you have ever had a severe allergic reaction.

  
  

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

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

FDA pregnancy category C. It is not known whether pregabalin will harm an unborn baby, but having a seizure during pregnancy could harm both mother and baby. Tell your doctor right away if you become pregnant while taking pregabalin for seizures. Do not start or stop taking pregabalin during pregnancy without your doctor's advice.

If you become pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of pregabalin on the baby.

It is not known whether pregabalin passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using pregabalin.

If a man fathers a child while using this medication, the baby may have birth defects. Use a condom to prevent pregnancy during your treatment.

Do not give this medication to a child younger than 18 years old.

How should I take pregabalin?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

You may take pregabalin with or without food.

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

Call your doctor if you have any problems with your vision while taking pregabalin. If you are taking pregabalin to prevent seizures, keep taking it even if you feel fine. You may have an increase in seizures if you stop taking pregabalin. Follow your doctor's instructions. Do not stop using pregabalin without first talking to your doctor, even if you feel fine. You may have increased seizures or withdrawal symptoms such as headache, sleep problems, nausea, and diarrhea. Ask your doctor how to avoid withdrawal symptoms when you stop using pregabalin. Wear a medical alert tag or carry an ID card stating that you take pregabalin. Any medical care provider who treats you should know that you take seizure medication. Store at room temperature away from moisture, light, and heat.

See also: Pregabalin dosage (in more detail)

What happens if I miss a dose?

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.

What should I avoid while taking pregabalin?

Drinking alcohol can increase certain side effects of pregabalin. Pregabalin may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Pregabalin 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.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

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

• 
  

  muscle pain, weakness, or tenderness (especially if you also have a fever and feel tired);

  
  


• 
  

  vision problems;

  
  


• 
  

  easy bruising or bleeding; or

  
  


• 
  

  swelling in your hands or feet, rapid weight gain.

  
  

Less serious side effects may include:

• 
  

  dizziness, drowsiness;

  
  


• 
  

  loss of balance or coordination;

  
  


• 
  

  problems with memory or concentration;

  
  


• 
  

  breast swelling;

  
  


• 
  

  tremors; or

  
  


• 
  

  dry mouth, constipation.

  
  

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.

Pregabalin Dosing Information

Usual Adult Dose for Diabetic Neuropathy:

Initial dose: 50 mg 3 times a day

The maximum recommended dose is 100 mg 3 times a day in patients with a creatinine clearance of at least 60 mL/min.

The dose may be increased to 100 mg 3 times a day within 1 week based on efficacy and tolerability.

Usual Adult Dose for Postherpetic Neuralgia:

Initial dose: 75 mg 2 times a day or 50 mg 3 times a day in patients with a creatinine clearance of at least 60 mL/min

The dose may be increased to 100 mg 3 times a day within 1 week based on efficacy and tolerability.

Maximum dose: Patients who do not experience sufficient pain relief following 2 to 4 weeks of treatment with 300 mg/day and who are able to tolerate pregabalin, may be treated with up to 300 mg 2 times a day or 200 mg 3 times a day. Due to the dose-dependent adverse effects and the higher rate of treatment discontinuation due to adverse events, dosing above 300 mg/day should be reserved only for those patients who have ongoing pain and are tolerating 300 mg daily.

Usual Adult Dose for Epilepsy:

Initial dose: 75 mg 2 times a day or 50 mg 3 times a day

Doses of 150 mg to 600 mg/day have been shown to be effective as adjunctive therapy in the treatment of partial onset seizures. The total daily dose should be divided and given either 2 or 3 times a day.

Maximum dose: Based on individual patient response and tolerability, the dose may be increased to a maximum of 600 mg/day.

The efficacy of add-on pregabalin in patients taking gabapentin has not been evaluated in controlled trials. Therefore, dosing recommendations for the use of pregabalin with gabapentin cannot be offered.

Usual Adult Dose for Fibromyalgia:

Initial dose: 75 mg two times a day (150 mg/day)
The dose may be increased to 150 mg two times a day (300 mg/day) within one week based on efficacy and tolerability.

Patients who do not experience sufficient benefit with 300 mg/day may be further increased to 225 mg two times a day (450 mg/day).

Recommended dose: 300 to 450 mg/day

Although pregabalin was also studied at 600 mg/day, there is no evidence that this dose confers additional benefit and this dose was less well tolerated. In view of the dose-dependent adverse reactions, treatment with doses above 450 mg/day is not recommended.

What other drugs will affect pregabalin?

Cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for depression or anxiety can add to dizziness or sleepiness caused by pregabalin. Tell your doctor if you regularly use any of these medicines, or any other seizure medication.

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

• 
  

  rosiglitazone (Avandia, Avandamet, Avandaryl); or

  
  


• 
  

  heart or blood pressure medication such as benazepril (Lotensin), enalapril (Vasotec), lisinopril (Prinivil, Zestril), quinapril (Accupril), ramipril (Altace), and others.

  
  

This list is not complete and other drugs may interact with pregabalin. 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 pregabalin resources

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

• pregabalin Advanced Consumer (Micromedex) - Includes Dosage Information


• Pregabalin Professional Patient Advice (Wolters Kluwer)


• Pregabalin MedFacts Consumer Leaflet (Wolters Kluwer)


• Pregabalin Monograph (AHFS DI)


• Lyrica Prescribing Information (FDA)


• Lyrica Consumer Overview

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See also: pregabalin side effects (in more detail)

Neo-Terramycin 100/50

Dosage Form: FOR ANIMAL USE ONLY
Neo-Terramycin® 100/50

(neomycin-oxytetracycline)

(Antibiotic Premix)

Active Drug Ingredients:

Oxytetracycline (from oxytetracycline quaternary salt) equivalent to

oxytetracycline hydrochloride (Terramycin®) . . . . . . . . . . . . . . . . . . . . . . . . .50 g/lb

Neomycin sulfate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .100 g/lb

(providing 70 g neomycin base per lb)

CAUTION:

For use in manufacturing medicated animal feeds only.

CAUTION: Certain components of animal feeds, including medicated premixes, possess properties that may be a potential health hazard or a source of personal discomfort to certain individuals who are exposed to them. Human exposure should, therefore, be minimized by observing the general industry standards for occupational health and safety.

Precautions such as the following should be considered: dust masks or respirators and protective clothing should be worn; dust-arresting equipment and adequate ventilation should be utilized; personal hygiene should be observed; wash before eating or leaving a work site; be alert for signs of allergic reactions—seek prompt medical treatment if such reactions are suspected.

STORE IN A DRY, COOL PLACE

Mixing Directions

Thoroughly mix the amount of this premix according to the tables in the DIRECTIONS FOR USE with nonmedicated feed.

Directions for Use

Indications for use	g/ton Terramycin	g/ton Neomycin Base	lb of Neo-Terramycin 100/50/ton
CHICKENS
Prevention of diseases from oxytetracycline-susceptible organisms during periods of stress As an aid in the prevention of bacterial enteritis and in the control of neomycin-sensitive organisms associated with bluecomb (mud fever or transmissible enteritis)	50	70	1
Prevention of early chick mortality due to oxytetracycline-susceptible organisms As an aid in the prevention of bacterial enteritis and in the control of neomycin-sensitive organisms associated with bluecomb (mud fever or transmissible enteritis)	50–100 (first 2 weeks)	70–140	1–2
To extend period of high egg production, to improve feed efficiency, to improve fertility, to improve egg production and feed efficiency in presence of disease and at times of stress; as an aid in maintaining and improving hatchability where birds are suffering stress from moving, vaccination, culling, extreme temperature changes and worming; to improve livability of progeny when losses are due to oxytetracycline-susceptible organisms, to improve egg shell quality, prevention of bluecomb (mud fever or transmissible enteritis) As an aid in the prevention of bacterial enteritis and in the control of neomycin-sensitive organisms associated with bluecomb (mud fever or transmissible enteritis)	50–100	70–140	1–2
Prevention of complicated chronic respiratory disease (air-sac infection) and control of complicated CRD by lowering mortality and severity during outbreaks As an aid in the prevention of bacterial enteritis and in the control of neomycin-sensitive organisms associated with bluecomb (mud fever or transmissible enteritis)	100	140	2
SPECIAL CONSIDERATIONS: Oxytetracycline in low calcium feeds (0.18–0.55% dietary calcium) should not be fed for more than five days and should not be fed to laying hens.
WARNING: This combination requires withdrawal from feed 5 days before slaughter of broilers and 14 days before slaughter of laying hens.
TURKEYS
As an aid in the prevention of disease from oxytetracycline-susceptible organisms during periods of stress As an aid in the prevention of bacterial enteritis and in the control of neomycin-sensitive organisms associated with bluecomb (mud fever or transmissible enteritis)	50	70	1
To extend period of high egg production, to improve egg production, to improve feed efficiency, to improve fertility, to improve egg production and feed efficiency in presence of disease and at time of stress; as an aid in maintaining and improving hatchability where birds are suffering from stress from exposure, moving, vaccination, culling, extreme losses due to oxytetracycline-susceptible organisms, and to improve egg shell quality; prevention of hexamitiasis As an aid in the prevention of bacterial enteritis and in the control of neomycin-sensitive organisms associated with bluecomb (mud fever or transmissible enteritis)	50–100	70–140	1–2
As an aid in the prevention of early poultry mortality due to oxytetracycline-susceptible organisms As an aid in the prevention of bacterial enteritis and in the control of neomycin-sensitive organisms associated with bluecomb (mud fever or transmissible enteritis)	50–100 (first 4 weeks)	70–140	1–2
Control of bluecomb (mud fever or transmissible enteritis), infectious sinusitis and hexamitiasis; prevention of infectious synovitis As an aid in the prevention of bacterial enteritis and in the control of neomycin-sensitive organisms associated with bluecomb (mud fever or transmissible enteritis)	100	140	2
SWINE (baby pigs, growing-finishing pigs and sows)
As an aid in the prevention of bacterial enteritis (scours), baby pig diarrhea (in baby pigs only), vibrionic dysentery, bloody dysentery and salmonellosis (necro or necrotic enteritis)	50	70	1
As an aid in the treatment of bacterial enteritis (scours), baby pig diarrhea (in baby pigs only), vibrionic dysentery, bloody dysentery and salmonellosis (necro or necrotic enteritis)	50–100	70–140	1–2
(When used in sows: to be fed during the gestation and lactation periods) As an aid in the maintenance of weight gains and feed consumption in the presence of atrophic rhinitis As an aid in the treatment of bacterial enteritis	50–100	70–140	1–2
WARNING: Withdraw from feed 10 days before slaughter when neomycin base level is 140 g/ton and 5 days before slaughter when the neomycin base level is below 140g/ton.
CALVES (starter feeds)
Aid in the prevention of bacterial enteritis (scours)	50	70	1
Aid in the treatment of bacterial enteritis (scours)	100	140	2
WARNING: This combination, when fed at the level of 1.4 grams neomycin base plus 2 grams oxytetracycline per head daily, requires withdrawal from feed 7 days before slaughter. No withdrawal is required at lower levels. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.

FOR USE IN DRY FEEDS ONLY. NOT FOR USE IN LIQUID FEED SUPPLEMENTS.

Neo-Terramycin is a registered trademark of Pfizer, Inc., licensed to

Phibro Animal Health, for Neomycin-Oxytetracycline combination products.

SEE BACK PANEL FOR COMPLETE MIXING DIRECTIONS

USE DIRECTIONS AND WARNINGS

Net Weight 50 lb (22.6 kg)

NADA #94-975, Approved by FDA

7931000

101-9014-02

Neo-Terramycin 100/50  neomycin-oxytetracycline  powder

Product Information Product Type OTC TYPE A MEDICATED ARTICLE ANIMAL DRUG NDC Product Code (Source) 66104-8850 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYTETRACYCLINE HYDROCHLORIDE (OXYTETRACYCLINE) OXYTETRACYCLINE HYDROCHLORIDE 50 g  in 0.45 kg NEOMYCIN SULFATE (NEOMYCIN) NEOMYCIN SULFATE 100 g  in 0.45 kg

Inactive Ingredients Ingredient Name Strength MINERAL OIL   SODIUM ALUMINIUM SILICATE   RICE BRAN

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 66104-8850-1 22.6 kg In 1 BAG None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA94975	01/11/1999

Labeler - Phibro Animal Health (006989008)

Revised: 04/2010Phibro Animal Health

Vivelle 100 Mcg

Generic Name: estrogen (Oral route, Parenteral route, Topical application route, Transdermal route)

Commonly used brand name(s)

In the U.S.

• Alora


• Cenestin


• Climara


• Divigel


• Elestrin


• Emcyt


• Enjuvia


• Esclim


• Estinyl


• EstroGel


• Evamist


• Femtrace


• Gynodiol


• Menest


• Menostar


• Ogen .625


• Ogen 1.25


• Ogen 2.5


• Premarin


• Vivelle


• Vivelle-Dot

In Canada

• Estraderm


• Estradot Transdermal


• Estradot Transdermal Therapeutic System


• Estradot Transdermal Therapeutic System


• Estrogel


• Oesclim


• Rhoxal-Estradiol Derm 50


• Rhoxal-Estradiol Derm 75


• Roxal-Estradiol Derm 100


• Vivelle 100 Mcg


• Vivelle 25 Mcg

Available Dosage Forms:

• Tablet


• Patch, Extended Release


• Gel/Jelly


• Spray


• Emulsion


• Tablet, Enteric Coated


• Capsule

Uses For Vivelle 100 Mcg

Estrogens are female hormones. They are produced by the body and are necessary for the normal sexual development of the female and for the regulation of the menstrual cycle during the childbearing years.

The ovaries begin to produce less estrogen after menopause (the change of life). This medicine is prescribed to make up for the lower amount of estrogen. Estrogens help relieve signs of menopause, such as hot flashes and unusual sweating, chills, faintness, or dizziness.

Estrogens are prescribed for several reasons:

• To provide additional hormone when the body does not produce enough of its own, such as during menopause or when female puberty (development of female sexual organs) does not occur on time. Other conditions include a genital skin condition (vulvar atrophy), inflammation of the vagina (atrophic vaginitis), or ovary problems (female hypogonadism or failure or removal of both ovaries).


• To help prevent weakening of bones (osteoporosis) in women past menopause.


• In the treatment of selected cases of breast cancer in men and women.


• In the treatment of cancer of the prostate in men.

Estrogens may also be used for other conditions as determined by your doctor.

There is no medical evidence to support the belief that the use of estrogens will keep the patient feeling young, keep the skin soft, or delay the appearance of wrinkles. Nor has it been proven that the use of estrogens during menopause will relieve emotional and nervous symptoms, unless these symptoms are caused by other menopausal symptoms, such as hot flashes or hot flushes.

Estrogens are 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, estrogen is used in certain patients with the following medical conditions:

• Gender identity disorder, male-to-female transsexualism (person who is born as a man but adapts to a woman's lifestyle, sees himself as a woman, and feels like a woman instead of a man.


• Osteoporosis caused by lack of estrogen before menopause.


• Turner's syndrome (a genetic disorder).

Before Using Vivelle 100 Mcg

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group 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 of this medicine before puberty is not recommended. Growth of bones can be stopped early. Girls and boys may develop growth of breasts. Girls may have vaginal changes, including vaginal bleeding.

This medicine may be used to start puberty in teenagers with some types of delayed puberty.

Geriatric

Elderly people are especially sensitive to the effects of estrogens. This may increase the chance of side effects during treatment, especially stroke, invasive breast cancer, and memory problems.

Pregnancy

Estrogens are not recommended for use during pregnancy or right after giving birth. Becoming pregnant or maintaining a pregnancy is not likely to occur around the time of menopause.

Certain estrogens have been shown to cause serious birth defects in humans and animals. Some daughters of women who took diethylstilbestrol (DES) during pregnancy have developed reproductive (genital) tract problems and, rarely, cancer of the vagina or cervix (opening to the uterus) when they reached childbearing age. Some sons of women who took DES during pregnancy have developed urinary-genital tract problems.

Breast Feeding

Use of this medicine is not recommended in nursing mothers. Estrogens pass into the breast milk and their possible effect on the baby is not known.

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 any of these medicines, 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 medicines in this class with any of the following medicines is not recommended. Your doctor may decide not to treat you with a medication in this class or change some of the other medicines you take.

• Rotavirus Vaccine, Live

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

• Adenovirus Vaccine Type 4, Live


• Adenovirus Vaccine Type 7, Live


• Bacillus of Calmette and Guerin Vaccine, Live


• Boceprevir


• Felbamate


• Influenza Virus Vaccine, Live


• Isotretinoin


• Measles Virus Vaccine, Live


• Mumps Virus Vaccine, Live


• Paclitaxel


• Paclitaxel Protein-Bound


• Rotavirus Vaccine, Live


• Rubella Virus Vaccine, Live


• Smallpox Vaccine


• St John's Wort


• Theophylline


• Tizanidine


• Tranexamic Acid


• Typhoid Vaccine


• Varicella Virus Vaccine


• Yellow Fever Vaccine

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 medicines in this class. Make sure you tell your doctor if you have any other medical problems, especially:

For all patients

• Asthma or


• Calcium, too much or too little in blood or


• Diabetes or


• Epilepsy or seizures or


• Heart problems or


• Kidney problems or


• Liver tumors, benign or


• Lupus erythematosus, systemic or


• Migraine headaches—Estrogens may worsen these conditions.

• Blood clotting problems, or history of during previous estrogen therapy—Estrogens usually are not used until blood clotting problems stop; using estrogens is not a problem for most patients without a history of blood clotting problems due to estrogen use.

• Breast cancer or


• Bone cancer or


• Cancer of the uterus or


• Fibroid tumors of the uterus—Estrogens may interfere with the treatment of breast or bone cancer or worsen cancer of the uterus when these conditions are present.

• Bulging eyes or


• Double vision or


• Migraine headache or


• Vision changes, sudden onset including or


• Vision loss, partial or complete—Estrogens may cause these problems. Tell your doctor if you have had any of these problems, especially while taking estrogen or oral contraceptives (“birth control pills”).

• Changes in genital or vaginal bleeding of unknown causes—Use of estrogens may delay diagnosis or worsen condition. The reason for the bleeding should be determined before estrogens are used.

• Endometriosis or


• Gallbladder disease or gallstones, or history of or


• High cholesterol or triglycerides, or history of or


• Liver disease, or history of or


• Pancreatitis (inflammation of pancreas) or


• Porphyria—Estrogens may worsen these conditions. Although estrogens can improve blood cholesterol, they can worsen blood triglycerides for some people.

• Hypothyroid (too little thyroid hormone)—Dose of thyroid medicine may need to be increased.

For males treated for breast or prostate cancer:

• Blood clots or


• Heart or circulation disease or


• Stroke—Males with these medical problems may be more likely to have clotting problems while taking estrogens; the high doses of estrogens used to treat male breast or prostate cancer have been shown to increase the chances of heart attack, phlebitis (inflamed veins) caused by a blood clot, or blood clots in the lungs.

Proper Use of estrogen

This section provides information on the proper use of a number of products that contain estrogen. It may not be specific to Vivelle 100 Mcg. Please read with care.

Take this medicine only as directed by your doctor. Do not take more of it and do not take or use it for a longer time than your doctor ordered. For patients taking any of the estrogens by mouth, try to take the medicine at the same time each day to reduce the possibility of side effects and to allow it to work better.

This medicine usually comes with patient information or directions. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.

For patients taking any of the estrogens by mouth or by injection:

• Nausea may occur during the first few weeks after you start taking estrogens. This effect usually disappears with continued use. If the nausea is bothersome, it can usually be prevented or reduced by taking each dose with food or immediately after food.

For patients using the transdermal (skin patch):

• Wash and dry your hands thoroughly before and after handling the patch.


• Apply the patch to a clean, dry, non-oily skin area of your lower abdomen, hips below the waist, or buttocks that has little or no hair and is free of cuts or irritation. The manufacturer of the 0.025-mg patch recommends that its patch be applied to the buttocks only. Furthermore, each new patch should be applied to a new site of application. For instance, if the old patch is taken off the left buttock, then apply the new patch to the right buttock.


• Do not apply to the breasts. Also, do not apply to the waistline or anywhere else where tight clothes may rub the patch loose.


• Press the patch firmly in place with the palm of your hand for about 10 seconds. Make sure there is good contact, especially around the edges.


• If a patch becomes loose or falls off, you may reapply it or discard it and apply a new patch.


• Each dose is best applied to a different area of skin on your lower abdomen, hips below the waist, or buttocks so that at least 1 week goes by before the same area is used again. This will help prevent skin irritation.

For patients using the topical emulsion (skin lotion):

• Washing and drying hands thoroughly before each application.


• Apply while you are sitting comfortably. Apply one pouch to each leg every morning.


• Apply the entire contents of one pouch to clean, dry skin on the left thigh. Rub the emulsion into the entire thigh and calf for 3 minutes until thoroughly absorbed.


• Apply entire contents of the second pouch to clean, dry skin on the right thigh. Rub the emulsion into the entire thigh and calf for 3 minutes until thoroughly absorbed.


• Rub any remaining emulsion on both hands on the buttocks.


• Washing and drying hands thoroughly after application.


• To avoid transfer to other individuals, allow the application areas to dry completely before covering with clothing.

If you are using the Evamist® transdermal spray:

• Spray the medicine on your skin on the inside of your forearm, between the elbow and the wrist.


• Do not allow your child to touch the area of the arm where the medicine was sprayed. If you cannot avoid to come nearer with your child, wear clothes with long sleeves to cover the application site.


• If your child comes in direct contact with the arm where the medicine was sprayed, wash your child's skin right away with soap and water.


• Do not allow your pets to lick or touch the arm where the medicine was sprayed.

Dosing

The dose medicines in this class 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 these medicines. 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 conjugated estrogens


• For oral dosage form (tablets):
  
  • For treating breast cancer in women after menopause and in men:
    
    • Adults—10 milligrams (mg) three times a day for at least 3 months.
    
    
  
  
  • For treating a genital skin condition (vulvar atrophy), inflammation of the vagina (atrophic vaginitis), or symptoms of menopause:
    
    • Adults—0.3 milligram (mg) a day. Your doctor may want you to take the medicine each day or only on certain days of the month. Your doctor may change the dose based on how your body responds to the medication.
    
    
  
  
  • To prevent loss of bone (osteoporosis):
    
    • Adults—0.3 milligram (mg) a day. Your doctor may want you to take the medicine each day or only on certain days of the month. Your doctor may change the dose based on how your body responds to the medication.
    
    
  
  
  • For treating ovary problems (female hypogonadism or for starting puberty):
    
    • Adults and teenagers—0.3 to 0.625 milligram (mg) a day. Your doctor may want you to take the medicine only on certain days of the month.
    
    
  
  
  • For treating ovary problems (failure or removal of both ovaries):
    
    • Adults—1.25 milligram (mg) a day. Your doctor may want you to take the medicine each day or only on certain days of the month.
    
    
  
  
  • For treating prostate cancer:
    
    • Adults—1.25 to 2.5 milligram (mg) three times a day.
    
    
  
  


• For injection dosage form:
  
  • For controlling abnormal bleeding of the uterus:
    
    • Adults—25 milligrams (mg) injected into a muscle or vein. This may be repeated in six to twelve hours if needed.
    
    
  
  

• For esterified estrogens


• For oral dosage form (tablets):
  
  • For treating breast cancer in women after menopause and in men:
    
    • Adults—10 milligrams (mg) three times a day for at least three months.
    
    
  
  
  • For treating a genital skin condition (vulvar atrophy) or inflammation of the vagina (atrophic vaginitis), or to prevent loss of bone (osteoporosis):
    
    • Adults—0.3 to 1.25 mg a day. Your doctor may want you to take the medicine each day or only on certain days of the month.
    
    
  
  
  • For treating ovary problems (failure or removal of both ovaries):
    
    • Adults—1.25 mg a day. Your doctor may want you to take the medicine each day or only on certain days of the month.
    
    
  
  
  • For treating ovary problems (female hypogonadism):
    
    • Adults—2.5 to 7.5 mg a day. This dose may be divided up and taken in smaller doses. Your doctor may want you to take the medicine each day or only on certain days of the month.
    
    
  
  
  • For treating symptoms of menopause:
    
    • Adults—0.625 to 1.25 mg a day. Your doctor may want you to take the medicine each day or only on certain days of the month.
    
    
  
  
  • For treating prostate cancer:
    
    • Adults—1.25 to 2.5 mg three times a day.
    
    
  
  

• For estradiol


• For oral dosage form:
  
  • For treating breast cancer in women after menopause and in men:
    
    • Adults—10 milligrams (mg) three times a day for at least 3 months.
    
    
  
  
  • For treating a genital skin condition (vulvar atrophy), inflammation of the vagina (atrophic vaginitis), ovary problems (female hypogonadism or failure or removal of both ovaries), or symptoms of menopause:
    
    • Adults—At first, 1 to 2 milligrams (mg) one time per day for at least 3 months. Your doctor may want you to take the medicine each day or only on certain days of the month. Your doctor may also need to change the dose based on how your body responds to the medication.
    
    
  
  
  • For treating prostate cancer:
    
    • Adults—1 to 2 milligrams (mg) three times a day.
    
    
  
  
  • To prevent loss of bone (osteoporosis):
    
    • Adults—0.5 milligram (mg) a day. Your doctor may want you to take the medicine each day or only on certain days of the month.
    
    
  
  


• For topical emulsion dosage form (skin lotion):
  
  • For treating symptoms of menopause:
    
    • Adults—1.74 grams (one pouch) applied to the skin of each leg (thigh and calf) once a day in the morning.
    
    
  
  


• For transdermal dosage form (skin patches):
  
  • For treating a genital skin condition (vulvar atrophy), inflammation of the vagina (atrophic vaginitis), symptoms of menopause, ovary problems (female hypogonadism or failure or removal of both ovaries), or to prevent loss of bone (osteoporosis):
    
    • For the Climara patches
    
    
    • Adults—0.025 to 0.1 milligram (mg) (one patch) applied to the skin and worn for one week. Then, remove that patch and apply a new one. A new patch should be applied once a week for three weeks. During the fourth week, you may or may not wear a patch. Your health care professional will tell you what you should do for this fourth week. After the fourth week, you will repeat the cycle.
    
    
    • For the Alora, Estraderm, Estradot, Vivelle, or Vivelle-Dot patches
    
    
    • Adults—0.025 to 0.1 mg (one patch) applied to the skin and worn for one half of a week. Then, remove that patch and apply and wear a new patch for the rest of the week. A new patch should be applied two times a week for three weeks. During the fourth week, you may or may not apply new patches. Your health care professional will tell you what you should do for this fourth week. After the fourth week, you will repeat the cycle.
    
    
  
  

• For estradiol cypionate


• For injection dosage form:
  
  • For treating ovary problems (female hypogonadism):
    
    • Adults—1.5 to 2 milligrams (mg) injected into a muscle once a month.
    
    
  
  
  • For treating symptoms of menopause:
    
    • Adults—1 to 5 milligrams (mg) injected into a muscle every 3 to 4 weeks.
    
    
  
  

• For estradiol valerate


• For injection dosage form:
  
  • For treating a genital skin condition (vulvar atrophy), inflammation of the vagina (atrophic vaginitis), symptoms of menopause, or ovary problems (female hypogonadism or failure or removal of both ovaries):
    
    • Adults—10 to 20 milligrams (mg) injected into a muscle every 4 weeks as needed.
    
    
  
  
  • For treating prostate cancer:
    
    • Adults—30 milligrams (mg) injected into a muscle every 1 or 2 weeks.
    
    
  
  

• For estrone


• For injection dosage form:
  
  • For controlling abnormal bleeding of the uterus:
    
    • Adults—2 to 5 milligrams (mg) a day, injected into a muscle for several days.
    
    
  
  
  • For treating a genital skin condition (vulvar atrophy), inflammation of the vagina (atrophic vaginitis), or symptoms of menopause:
    
    • Adults—0.1 to 0.5 milligram (mg) injected into a muscle 2 or 3 times a week. Your doctor may want you to receive the medicine each week or only during certain weeks of the month.
    
    
  
  
  • For treating ovary problems (female hypogonadism or failure or removal of both ovaries):
    
    • Adults—0.1 to 1 milligram (mg) a week. This is injected into a muscle as a single dose or divided into more than one dose. Your doctor may want you to receive the medicine each week or only during certain weeks of the month.
    
    
  
  
  • For treating prostate cancer:
    
    • Adults—2 to 4 milligrams (mg) injected into a muscle 2 or 3 times a week.
    
    
  
  

• For estropipate


• For oral dosage form (tablets):
  
  • For treating a genital skin condition (vulvar atrophy), inflammation of the vagina (atrophic vaginitis), or symptoms of menopause:
    
    • Adults—0.75 to 6 milligrams (mg) a day. Your doctor may want you to take the medicine each day or only on certain days of the month.
    
    
  
  
  • For treating ovary problems (female hypogonadism or failure or removal of both ovaries):
    
    • Adults—1.5 to 9 milligrams (mg) a day. Your doctor may want you to take the medicine each day or only on certain days of the month.
    
    
  
  
  • To prevent loss of bone (osteoporosis):
    
    • Adults—0.75 milligram (mg) a day. Your doctor may want you to take the medicine each day for twenty-five days of a thirty-one–day cycle.
    
    
  
  

• For ethinyl estradiol


• For oral dosage form (tablets):
  
  • For treating breast cancer in women after menopause and in men:
    
    • Adults—1 milligram (mg) three times a day.
    
    
  
  
  • For treating ovary problems (female hypogonadism or failure or removal of both ovaries):
    
    • Adults—0.05 milligram (mg) one to three times a day for 3 to 6 months. Your doctor may want you to take the medicine each day or only on certain days of the month.
    
    
  
  
  • For treating prostate cancer:
    
    • Adults—0.15 to 3 milligrams (mg) a day.
    
    
  
  
  • For treating symptoms of menopause:
    
    • Adults—0.02 to 0.05 milligram (mg) a day. Your doctor may want you to take the medicine each day or only on certain days of the month.
    
    
  
  

• For ethinyl estradiol and norethindrone


• For oral dosage form (tablets):
  
  • For treating symptoms of menopause:
    
    • Adults—1 tablet (5 mcg ethinyl estradiol and 1 mg of norethindrone) each day.
    
    
  
  
  • To prevent loss of bone (osteoporosis):
    
    • Adults—1 tablet (5 mcg ethinyl estradiol and 1 mg of norethindrone) each day.
    
    
  
  

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.

If you miss a dose of this medicine, apply 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.

If you forget to wear or change a patch, put one on as soon as you can. If it is almost time to put on your next patch, wait until then to apply a new patch and skip the one you missed. Do not apply extra patches to make up for a missed dose.

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 Vivelle 100 Mcg

It is very important that your doctor check your progress at regular visits to make sure this medicine does not cause unwanted effects. These visits will usually be every year, but some doctors require them more often.

In some patients using estrogens, tenderness, swelling, or bleeding of the gums may occur. Brushing and flossing your teeth carefully and regularly and massaging your gums may help prevent this. See your dentist regularly to have your teeth cleaned. Check with your medical doctor or dentist if you have any questions about how to take care of your teeth and gums, or if you notice any tenderness, swelling, or bleeding of your gums.

Although the incidence is low, the use of estrogens may increase you chance of getting cancer of the breast, ovaries, or uterus (womb). Therefore, it is very important that you regularly check your breasts for any unusual lumps or discharge. Report any problems to your doctor. You should also have a mammogram (x-ray pictures of the breasts) done if your doctor recommends it. Because breast cancer has occurred in men taking estrogens, regular breast self-exams and exams by your doctor for any unusual lumps or discharge should be done.

If your menstrual periods have stopped, they may start again. This effect will continue for as long as the medicine is taken. However, if taking the continuous treatment (0.625 mg conjugated estrogens and 2.5 mg medroxyprogesterone once a day), monthly bleeding usually stops within 10 months.

Also, vaginal bleeding between your regular menstrual periods may occur during the first 3 months of use. Do not stop taking your medicine. Check with your doctor if bleeding continues for an unusually long time, if your period has not started within 45 days of your last period, or if you think you are pregnant.

Tell the doctor in charge that you are using this medicine before having any laboratory test because some results may be affected.

Check with your child's doctor right away if your child starts to have the following symptoms: nipple or breast swelling or tenderness in females, or enlargement of the breasts in males. Your child may have been exposed to Evamist® transdermal spray.

Do not allow your pets to lick or touch the arm where Evamist® transdermal spray was applied. Small pets may be sensitive to this medicine. Call your pet's veterinarian if your pet starts to have the following symptoms: nipple or breast enlargement, swelling of the vulva, or any signs of illness.

Vivelle 100 Mcg Side Effects

Women rarely have severe side effects from taking estrogens to replace estrogen. Discuss these possible effects with your doctor:

The prolonged use of estrogens has been reported to increase the risk of endometrial cancer (cancer of the lining of the uterus) in women after menopause. This risk seems to increase as the dose and the length of use increase. When estrogens are used in low doses for less than 1 year, there is less risk. The risk is also reduced if a progestin (another female hormone) is added to, or replaces part of, your estrogen dose. If the uterus has been removed by surgery (total hysterectomy), there is no risk of endometrial cancer.

Although the incidence is low, the use of estrogens may increase you chance of getting cancer of the breast. Breast cancer has been reported in men taking estrogens.

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.

The following side effects may be caused by blood clots, which could lead to stroke, heart attack, or death. These side effects occur rarely, and, when they do occur, they occur in men treated for cancer using high doses of estrogens.

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

More common

• Breast pain (in females and males)


• fast heartbeat


• fever


• hives


• hoarseness


• increased breast size (in females and males)


• irritation of the skin


• itching of the skin


• joint pain, stiffness, or swelling


• rash


• redness of the skin


• shortness of breath


• swelling of the eyelids, face, lips, hands, or feet


• swelling of the feet and lower legs


• tightness in the chest


• troubled breathing or swallowing


• weight gain (rapid)


• wheezing

Less common or rare

• Changes in vaginal bleeding (spotting, breakthrough bleeding, prolonged or heavier bleeding, or complete stoppage of bleeding)


• chest pain


• chills


• cough


• heavy non-menstrual vaginal bleeding


• lumps in, or discharge from, breast (in females and males)


• pains in the stomach, side, or abdomen


• yellow eyes or skin

Rare - for males being treated for breast or prostate cancer only

• Headache (sudden or severe)


• loss of coordination (sudden)


• loss of vision or change of vision (sudden)


• pains in the chest, groin, or leg, especially in the calf of leg


• shortness of breath (sudden and unexplained)


• slurring of speech (sudden)


• weakness or numbness in the arm or leg

Incidence not known

• Abdominal or stomach bloating


• abdominal or stomach cramps


• acid or sour stomach


• anxiety


• backache


• belching


• blindness


• blistering, peeling, or loosening of the skin


• blue-yellow color blindness


• blurred vision


• change in vaginal discharge


• changes in skin color


• changes in vision


• chest discomfort


• clay-colored stools


• clear or bloody discharge from nipple


• confusion


• constipation


• convulsions


• dark urine


• decrease in the amount of urine


• decreased vision


• depression


• diarrhea


• difficulty with breathing


• difficulty with speaking


• dimpling of the breast skin


• dizziness


• double vision


• dry mouth


• eye pain


• fainting


• fluid-filled skin blisters


• full feeling in upper abdomen or stomach


• full or bloated feeling or pressure in the stomach


• headache


• heartburn


• inability to move the arms, legs, or facial muscles


• inability to speak


• incoherent speech


• increased urination


• indigestion


• inverted nipple


• irregular heartbeats


• light-colored stools


• lightheadedness


• loss of appetite


• loss of bladder control


• lump under the arm


• metallic taste


• migraine headache


• mood or mental changes


• muscle cramps in the hands, arms, feet, legs, or face


• muscle pain


• muscle spasm or jerking of all extremities


• muscle weakness


• nausea


• noisy breathing


• numbness or tingling of the hands, feet, or face


• pain in the ankles or knees


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


• pain or feeling of pressure in the pelvis


• pain, tenderness, swelling of the foot or leg


• painful or tender cysts in the breasts


• painful, red lumps under the skin, mostly on the legs


• pains in the chest, groin, or legs, especially calves of the legs


• partial or complete loss of vision in the eye


• pelvic pain


• persistent crusting or scaling of nipple


• pinpoint red or purple spots on the skin


• prominent superficial veins over affected area


• red, irritated eyes


• redness or swelling of the breast


• sensitivity to the sun


• severe headaches of sudden onset


• skin thinness


• skin warmth


• slow speech


• sore on the skin of the breast that does not heal


• sore throat


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


• stomach discomfort, upset, or pain


• sudden loss of consciousness


• sudden loss of coordination


• sudden onset of shortness of breath for no apparent reason


• sudden onset of slurred speech


• sudden vision changes


• swelling of the abdominal or stomach area


• swelling of the fingers or hands


• thirst


• tremor


• unpleasant breath odor


• unusual tiredness or weakness


• vomiting


• vomiting of blood


• weight loss

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

• Abnormal growth filled with fluid or semisolid material


• accidental injury


• bladder pain


• bloated full feeling


• bloody or cloudy urine


• body aches or pain


• coating or white patches on tongue


• congestion


• cough producing mucus


• decrease in amount of urine


• difficult, burning, or painful urination


• discouragement


• dryness of the throat


• ear congestion or pain


• excess air or gas in the stomach or intestines


• fear


• feeling of warmth


• feeling sad or empty


• frequent urge to urinate


• general feeling of discomfort or illness


• headache, severe and throbbing


• increased clear or white vaginal discharge


• irritability


• itching of the vaginal, rectal or genital areas


• lack of appetite


• lack or loss of strength


• loss of interest or pleasure


• mild dizziness


• neck pain


• nervousness


• pain


• pain during sexual intercourse


• painful or difficult urination


• pain or tenderness around the eyes and cheekbones


• passing gas


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


• runny nose


• skin irritation or redness where skin patch was worn


• shivering


• sleeplessness


• sneezing


• sore mouth or tongue


• stuffy nose


• sudden sweating


• tender, swollen glands in the neck


• thick, white vaginal discharge with no odor or with a mild odor


• tiredness


• trouble concentrating


• trouble sleeping


• unable to sleep


• voice changes

Less common

• Blemishes on the skin


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


• burning or stinging of the skin


• diarrhea (mild)


• difficulty with moving


• dizziness (mild)


• increased hair growth, especially on the face


• lower abdominal or stomach pain or pressure


• mood or mental changes


• muscle stiffness


• painful cold sores or blisters on the lips, nose, eyes, or genitals


• pimples


• pounding in the ears


• problems in wearing contact lenses


• slow heartbeat


• tooth or gum pain


• unusual decrease in sexual desire (in males)


• unusual increase in sexual desire (in females)


• white or brownish vaginal discharge

Incidence not known

• Abnormal turning out of cervix


• changes in appetite


• dull ache or feeling of pressure or heaviness in the legs


• flushed, dry skin


• fruit-like breath odor


• increased hunger


• irritability


• large amount of triglyceride in the blood


• leg cramps


• patchy brown or dark brown discoloration of the skin


• poor insight and judgment


• problems with memory or speech


• trouble recognizing objects


• trouble thinking and planning


• trouble walking


• twitching, uncontrolled movements of the tongue, lips, face, arms, or legs


• unexpected or excess milk flow from the breasts

Also, many women who are taking estrogens with a progestin (another female hormone) will start having monthly vaginal bleeding, similar to menstrual periods, again. This effect will continue for as long as the medicine is taken. However, monthly bleeding will not occur in women who have had the uterus removed by surgery (total hysterectomy).

This medicine may cause loss or thinning of the scalp hair in some people.

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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