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Because of the risk of QTc prolongation at higher citalopram tablet doses, it is recommended that citalopram tablets not be given at doses above 40 mg once daily [see Dosage and Administration 2. Citalopram tablets should be avoided in patients with congenital long QT syndrome, bradycardia, hypokalemia or hypomagnesemia, recent acute myocardial infarction, or uncompensated heart failure unless the benefits outweigh the risks for a particular patient.

Citalopram tablets should also be avoided in patients who are taking other drugs that prolong the QTc interval [see Drug Interactions 7 ]. Such drugs include Class 1A e. The citalopram dose should be limited in certain populations.

The maximum dose should be limited to 20 mg once daily in patients who are CYP2C19 poor metabolizers or those patients receiving concomitant cimetidine or another CYP2C19 inhibitor, since higher Citalopram exposures would be expected.

The maximum dose should also be limited to 20 mg once daily in patients with hepatic impairment and in patients who are greater than 60 years of age because of expected higher exposures [see Dosage and Administration 2. Patients being considered for treatment with citalopram tablets who are at risk for significant electrolyte disturbances should have baseline serum potassium and magnesium measurements with periodic monitoring. ECG monitoring is recommended in patients for whom citalopram use is not recommended unless the benefits clearly outweigh the risks for a particular patient see above.

These include those patients with the cardiac conditions noted above, and those taking other drugs that may prolong the QTc interval. If patients taking citalopram tablets experience symptoms that could indicate the occurrence of cardiac arrhythmias, e. SSRIs, including citalopram tablets, can precipitate serotonin syndrome, a potentially life-threatening condition. The risk is increased with concomitant use of other serotonergic drugs including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, and St.

Serotonin syndrome can also occur when these drugs are used alone. Symptoms of serotonin syndrome were noted in 0. Serotonin syndrome signs and symptoms may include mental status changes e. The concomitant use of citalopram tablets with MAOIs is contraindicated. In addition, do not initiate citalopram tablets in a patient being treated with MAOIs such as linezolid or intravenous methylene blue.

No reports involved the administration of methylene blue by other routes such as oral tablets or local tissue injection. If it is necessary to initiate treatment with an MAOI such as linezolid or intravenous methylene blue in a patient taking citalopram tablets, discontinue citalopram tablets before initiating treatment with the MAOI [see Contraindications 4 , Drug Interactions 7 ]. Monitor all patients taking citalopram tablets for the emergence of serotonin syndrome.

Discontinue treatment with citalopram tablets and any concomitant serotonergic agents immediately if the above symptoms occur, and initiate supportive symptomatic treatment. If concomitant use of citalopram tablets with other serotonergic drugs is clinically warranted, inform patients of the increased risk for serotonin syndrome and monitor for symptoms. Drugs that interfere with serotonin reuptake inhibition, including citalopram tablets, increase the risk of bleeding events.

Concomitant use of aspirin, nonsteroidal anti-inflammatory drugs NSAIDS , other antiplatelet drugs, warfarin, and other anticoagulants may add to this risk. Case reports and epidemiological studies case-control and cohort design have demonstrated an association between use of drugs that interfere with serotonin reuptake and the occurrence of gastrointestinal bleeding.

Bleeding events related to drugs that interfere with serotonin reuptake have ranged from ecchymosis, hematoma, epistaxis, and petechiae to life-threatening hemorrhages. Inform patients about the increased risk of bleeding associated with the concomitant use of citalopram tablets and antiplatelet agents or anticoagulants.

For patients taking warfarin, carefully monitor the international normalized ratio [see Drug Interactions 7 ]. In controlled clinical trials, patients with bipolar disorder were excluded; however, symptoms of mania or hypomania were reported in 0. Prior to initiating treatment with citalopram tablets, screen patients for any personal or family history of bipolar disorder, mania, or hypomania [see Dosage and Administration 2. Adverse reactions after discontinuation of serotonergic antidepressants, particularly after abrupt discontinuation, include: nausea, sweating, dysphoric mood, irritability, agitation, dizziness, sensory disturbances e.

A gradual reduction in dosage rather than abrupt cessation is recommended whenever possible [see Dosage and Administration 2. Citalopram tablets have not been systematically evaluated in patients with seizure disorders. Patients with a history of seizures were excluded from clinical studies. In clinical trials of citalopram tablets, seizures occurred in 0.

Citalopram tablets should be prescribed with caution in patients with a seizure disorder. The pupillary dilation that occurs following use of many antidepressant drugs, including citalopram tablets, may trigger an angle closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy. Avoid use of antidepressants, including citalopram tablets, in patients with untreated anatomically narrow angles.

Hyponatremia may occur as a result of treatment with SSRIs, including citalopram tablets. Signs and symptoms of hyponatremia include headache, difficulty concentrating, memory impairment, confusion, weakness, and unsteadiness, which may lead to falls. In many cases, this hyponatremia appears to be the result of the syndrome of inappropriate antidiuretic hormone secretion SIADH. In patients with symptomatic hyponatremia, discontinue citalopram tablets and institute appropriate medical intervention.

Elderly patients, patients taking diuretics, and those who are volume-depleted may be at greater risk of developing hyponatremia with SSRIs [see Use in Specific Populations 8. In male patients, SSRI use may result in ejaculatory delay or failure, decreased libido, and erectile dysfunction. In female patients, SSRI use may result in decreased libido and delayed or absent orgasm. It is important for prescribers to inquire about sexual function prior to initiation of citalopram tablets and to inquire specifically about changes in sexual function during treatment, because sexual function may not be spontaneously reported.

When evaluating changes in sexual function, obtaining a detailed history including timing of symptom onset is important because sexual symptoms may have other causes, including the underlying psychiatric disorder. Discuss potential management strategies to support patients in making informed decisions about treatment. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in clinical practice.

There were, in addition, over 19, exposures from mostly open-label, European postmarketing studies. The conditions and duration of treatment with citalopram tablets varied greatly and included in overlapping categories open-label and double-blind studies, inpatient and outpatient studies, fixed-dose and dose-titration studies, and short-term and long-term exposure.

The adverse reactions associated with discontinuation i. Table 3 enumerates the incidence of adverse reactions that occurred among 1, patients with MDD who received citalopram tablets at doses ranging from 10 mg to 80 mg once daily in placebo-controlled trials of up to 6 weeks duration.

The potential relationship between the dosage of citalopram and the incidence of adverse reactions was examined in a fixed-dose study in patients with MDD receiving placebo or citalopram tablets 10 mg, 20 mg 40 mg, or 60 mg 1. Although changes in sexual desire, sexual performance, and sexual satisfaction often occur as manifestations of a psychiatric disorder, they may also be a consequence of SSRI treatment.

However, reliable estimates of the incidence and severity of untoward experiences involving sexual desire, performance, and satisfaction are difficult to obtain, in part because patients and healthcare providers may be reluctant to discuss them. Accordingly, estimates of the incidence of untoward sexual experience and performance cited in labeling may underestimate their actual incidence. In female depressed patients receiving citalopram tablets, the reported incidence of decreased libido and anorgasmia was 1.

Patients treated with citalopram tablets in controlled trials experienced a weight loss of about 0. In a thorough QT study, citalopram tablets were found to be associated with a dose-dependent increase in the QTc interval. In the citalopram group 1. The incidence of tachycardic outliers was 0. The incidence of bradycardic outliers was 0. The following list of adverse reactions does not include reactions that are: 1 included in Table 3 or elsewhere in labeling,.

Cardiovascular - Frequent: tachycardia, postural hypotension, hypotension. Infrequent: hypertension, bradycardia, edema extremities , angina pectoris, extrasystoles, cardiac failure, flushing, myocardial infarction, cerebrovascular accident, myocardial ischemia. Rare: transient ischemic attack, phlebitis, atrial fibrillation, cardiac arrest, bundle branch block.

Infrequent: hyperkinesia, vertigo, hypertonia, extrapyramidal disorder, leg cramps, involuntary muscle contractions, hypokinesia, neuralgia, dystonia, abnormal gait, hypoesthesia, ataxia. Rare: abnormal coordination, hyperesthesia, ptosis, stupor.

Endocrine Disorders - Rare: hypothyroidism, goiter, gynecomastia. Gastrointestinal Disorders - Frequent: saliva increased, flatulence. Infrequent: gastritis, gastroenteritis, stomatitis, eructation, hemorrhoids, dysphagia, teeth grinding, gingivitis, esophagitis.

Rare: colitis, gastric ulcer, cholecystitis, cholelithiasis, duodenal ulcer, gastroesophageal reflux, glossitis, jaundice, diverticulitis, rectal hemorrhage, hiccups. General - Infrequent: hot flushes, rigors, alcohol intolerance, syncope, influenza-like symptoms. Rare: hay fever. Hemic and Lymphatic Disorders - Infrequent: purpura, anemia, epistaxis, leukocytosis, leucopenia, lymphadenopathy. Rare: pulmonary embolism, granulocytopenia, lymphocytosis, lymphopenia, hypochromic anemia, coagulation disorder, gingival bleeding.

Metabolic and Nutritional Disorders - Frequent: decreased weight, increased weight. Infrequent: increased hepatic enzymes, thirst, dry eyes, increased alkaline phosphatase, abnormal glucose tolerance. Rare: bilirubinemia, hypokalemia, obesity, hypoglycemia, hepatitis, dehydration. Musculoskeletal System Disorders - Infrequent: arthritis, muscle weakness, skeletal pain. Rare: bursitis, osteoporosis. Psychiatric Disorders - Frequent: impaired concentration, amnesia, apathy, depression, increased appetite, aggravated depression, suicide attempt, confusion.

Infrequent: increased libido, aggressive reaction, paroniria, drug dependence, depersonalization, hallucination, euphoria, psychotic depression, delusion, paranoid reaction, emotional lability, panic reaction, psychosis. Rare: catatonic reaction, melancholia. Infrequent: galactorrhea, breast pain, breast enlargement, vaginal hemorrhage. Respiratory System Disorders - Frequent: coughing. Infrequent: bronchitis, dyspnea, pneumonia.

Rare: asthma, laryngitis, bronchospasm, pneumonitis, sputum increased. Skin and Appendages Disorders - Frequent: rash, pruritus. Infrequent: photosensitivity reaction, urticaria, acne, skin discoloration, eczema, alopecia, dermatitis, skin dry, psoriasis.

Rare: hypertrichosis, decreased sweating, melanosis, keratitis, cellulitis, pruritus ani. Special Senses - Frequent: abnormal accommodation, taste perversion. Infrequent: tinnitus, conjunctivitis, eye pain. Rare: mydriasis, photophobia, diplopia, abnormal lacrimation, cataract, taste loss. Urinary System Disorders - Frequent: polyuria. Infrequent: micturition frequency, urinary incontinence, urinary retention, dysuria. Rare: facial edema, hematuria, oliguria, pyelonephritis, renal calculus, renal pain.

The following adverse reactions have been identified during postapproval use of citalopram, the racemate, or escitalopram, the S-enantiomer of citalopram. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Blood and Lymphatic System Disorders : hemolytic anemia, thrombocytopenia, prothrombin decreased.

Cardiac Disorders : torsade de pointes, ventricular arrhythmia, QT prolonged. Gastrointestinal Disorders : gastrointestinal hemorrhage, pancreatitis. General Disorders and Administrative Site Conditions : withdrawal syndrome. Nervous System Disorders : grand mal convulsion s , myoclonus, choreoathetosis, dyskinesia, akathisia, nystagmus. Pregnancy, Puerperium and Perinatal Conditions : spontaneous abortion.

Skin and Subcutaneous Tissue Disorders : Stevens Johnson Syndrome, epidermal necrolysis, angioedema, erythema multiforme, ecchymosis. Citalopram is contraindicated in patients taking pimozide [see Contraindications 4 , Warnings and Precautions 5. Concomitant use of citalopram with drugs that prolong QT can cause additional QT prolongation compared to the use of citalopram alone [see Clinical Pharmacology Avoid concomitant use of citalopram with drugs that prolong the QT interval citalopram is contraindicated in patients taking pimozide [see Contraindications 4 , Warnings and Precautions 5.

The maximum recommended dosage of citalopram is 20 mg daily when used concomitantly with a CYP2C19 inhibitor [see Dosage and Administration 2. Concomitant use of citalopram and other serotonergic drugs increases the risk of serotonin syndrome. Monitor patients for signs and symptoms of serotonin syndrome, particularly during citalopram initiation and dosage increases. Drugs That Interfere With Hemostasis antiplatelet agents and anticoagulants. Concomitant use of citalopram and an antiplatelet or anticoagulant may potentiate the risk of bleeding.

Inform patients of the increased risk of bleeding associated with the concomitant use of citalopram and antiplatelet agents and anticoagulants. For patients taking warfarin, carefully monitor the international normalized ratio [see Warning and Precautions 5. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy.

Available data from published epidemiologic studies and postmarketing reports with citalopram use in pregnancy have not established an increased risk of major birth defects or miscarriage. Published studies demonstrated that citalopram levels in both cord blood and amniotic fluid are similar to those observed in maternal serum. There also are risks associated with untreated depression in pregnancy see Clinical Considerations.

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U. Women who discontinue antidepressants during pregnancy are more likely to experience a relapse of major depression than women who continue antidepressants.

This finding is from a prospective longitudinal study of pregnant women with a history of major depressive disorder who were euthymic and taking antidepressants at the beginning of pregnancy. Consider the risk of untreated depression when discontinuing or changing treatment with antidepressant medication during pregnancy and postpartum. Neonates exposed to citalopram and other SSRIs late in third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding.

Such complications can arise immediately upon delivery. Reported clinical findings have included respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying.

These findings are consistent with either a direct toxic effect of SSRIs or possibly, a drug discontinuation syndrome. It should be noted that, in some cases, the clinical picture is consistent with serotonin syndrome [see Warnings and Precautions 5. PPHN occurs in 1- 2 per 1, live births in the general population and is associated with substantial neonatal morbidity and mortality.

No maternal or embryofetal toxicity was observed. Citalopram was administered orally to pregnant rats during late gestation and lactation periods at doses of 4. Data from the published literature report the presence of citalopram in human milk at relative infant doses ranging between 0. There are reports of breastfed infants exposed to citalopram experiencing irritability, restlessness, excessive somnolence, decreased feeding, and weight loss see Clinical Considerations.

There is no information about effects of citalopram on milk production. Monitor breastfeeding infants for adverse reactions, such as irritability, restlessness, excessive somnolence, decreased feeding, and weight loss. The safety and effectiveness of citalopram have not been established in pediatric patients.

Two placebo-controlled trials in pediatric patients with MDD have been conducted with citalopram, and the data were not sufficient to support use in pediatric patients. Antidepressants increase the risk of suicidal thoughts and behaviors in pediatric patients [see Boxed Warning, Warnings and Precautions 5.

Decreased appetite and weight loss have been observed in association with the use of SSRIs in pediatric patients. Of 4, patients in clinical studies of citalopram, 1, were 60 and over, 1, were 65 and over, and were 75 and over. Therefore, the maximum recommended dosage in patients 60 years of age and older is lower than younger patients [see Dosage and Administration 2. SSRIs, including citalopram, have been associated with cases of clinically significant hyponatremia in elderly patients, who may be at greater risk for this adverse reaction [see Warnings and Precautions 5.

Increased citalopram exposure occurs in patients with hepatic impairment. The maximum recommended dosage of citalopram is lower in patients with hepatic impairment [see Dosage and Administration 2. Animal studies suggest that the abuse liability of citalopram is low.

Citalopram has not been systematically studied in humans for its potential for abuse, tolerance, or physical dependence. The premarketing clinical experience with citalopram did not reveal any drug-seeking behavior. Consequently, health care providers should carefully evaluate citalopram patients for history of drug abuse and follow such patients closely, observing them for signs of misuse or abuse e.

Prolonged cardiac monitoring is recommended in citalopram overdosage ingestions due to the arrhythmia risk. Gastrointestinal decontamination with activated charcoal should be considered in patients who present early after a citalopram overdose. Citalopram hydrobromide, USP occurs as a fine, white to off-white powder. Citalopram hydrobromide is sparingly soluble in water and soluble in ethanol.

Citalopram, USP 10 mg tablets are film-coated, round shaped tablets containing citalopram hydrobromide in strengths equivalent to 10 mg citalopram base. Citalopram hydrobromide, USP 20 mg and 40 mg tablets are film-coated, oval shaped, scored tablets containing citalopram hydrobromide, in strengths equivalent to 20 mg or 40 mg citalopram base.

The tablets also contain the following inactive ingredients: copovidone, croscarmellose sodium, ferric oxide red, ferric oxide yellow, glycerin, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, starch, and titanium dioxide. The mechanism of action of citalopram is unclear, but is presumed to be related to potentiation of serotonergic activity in the central nervous system CNS resulting from its inhibition of CNS neuronal reuptake of serotonin 5-HT.

In vitro and in vivo studies in animals suggest that citalopram is a selective serotonin reuptake inhibitor SSRI with minimal effects on norepinephrine NE and dopamine DA neuronal reuptake. Individually corrected QT c QT c Ni interval was evaluated in a randomized, placebo and active moxifloxacin mg controlled cross-over, escalating multiple-dose study in healthy subjects.

Biotransformation of citalopram is mainly hepatic, with a mean terminal half-life of about 35 hours. With once daily dosing, steady state plasma concentrations are achieved within approximately one week. At steady state, the extent of accumulation of citalopram in plasma, based on the half-life, is expected to be 2. Absorption Following a single oral dose 40 mg tablet of citalopram, peak blood levels occur at about 4 hours.

In humans, unchanged citalopram is the predominant compound in plasma. At steady state, the concentrations of citalopram's metabolites, DCT and DDCT, in plasma are approximately one-half and one-tenth, respectively, that of the parent drug. In vitro studies show that citalopram is at least 8 times more potent than its metabolites in the inhibition of serotonin reuptake, suggesting that the metabolites evaluated do not likely contribute significantly to the antidepressant actions of citalopram.

No adjustment of dosage for such patients is recommended. Citalopram would be expected to have little inhibitory effect on in vivo metabolism mediated by these enzymes. However, in vivo data to address this question are limited. However, coadministration of citalopram and the potent CYP3A4 inhibitor ketoconazole did not significantly affect the pharmacokinetics of citalopram. Pimozide In a controlled study, a single dose of pimozide 2 mg co-administered with citalopram 40 mg given once daily for 11 days was associated with a mean increase in QTc values of approximately 10 msec compared to pimozide given alone.

Citalopram did not alter the mean AUC or C max of pimozide. The mechanism of this pharmacodynamic interaction is not known [see Contraindications 4 , Warnings and Precautions 5. The effect of theophylline on the pharmacokinetics of citalopram was not evaluated. Although trough citalopram plasma levels were unaffected, given the enzyme-inducing properties of carbamazepine, the possibility that carbamazepine might increase the clearance of citalopram should be considered if the two drugs are coadministered.

Increased metoprolol plasma levels have been associated with decreased cardioselectivity. Coadministration of citalopram and metoprolol had no clinically significant effects on blood pressure or heart rate. The clinical significance of the desipramine change is unknown. A no-effect level NOEL for this finding was not established. Citalopram was mutagenic in the in vitro bacterial reverse mutation assay Ames test in 2 of 5 bacterial strains Salmonella TA98 and TA in the absence of metabolic activation.

It was clastogenic in the in vitro Chinese hamster lung cell assay for chromosomal aberrations in the presence and absence of metabolic activation. It was not clastogenic in the in vitro chromosomal aberration assay in human lymphocytes or in two in vivo mouse micronucleus assays. Additional studies to investigate the mechanism for this pathology have not been performed, and the potential significance of this effect in humans has not been established.

Study 1, a 6-week trial in which patients received fixed citalopram doses of 10 mg, 20 mg, 40 mg, and 60 mg daily, showed that citalopram 40 daily and 60 mg daily 1. Anticonvulsants — Patients on stable doses of phenytoin and carbamazepine have developed elevated plasma anticonvulsant concentrations and clinical anticonvulsant toxicity following initiation of concomitant fluoxetine treatment. Lithium — There have been reports of both increased and decreased lithium levels when lithium was used concomitantly with fluoxetine.

Cases of lithium toxicity and increased serotonergic effects have been reported. Lithium levels should be monitored when these drugs are administered concomitantly. Drugs Tightly Bound to Plasma Proteins — Because fluoxetine is tightly bound to plasma proteins, the administration of fluoxetine to a patient taking another drug that is tightly bound to protein for example, warfarin, digitoxin may cause a shift in plasma concentrations potentially resulting in an adverse effect [see Clinical Pharmacology Drugs Metabolized by CYP3A4 — In an in vivo interaction study involving coadministration of fluoxetine with single doses of terfenadine a CYP3A4 substrate , no increase in plasma terfenadine concentrations occurred with concomitant fluoxetine.

Additionally, in vitro studies have shown ketoconazole, a potent inhibitor of CYP3A4 activity, to be at least times more potent than fluoxetine or norfluoxetine as an inhibitor of the metabolism of several substrates for this enzyme, including astemizole, cisapride, and midazolam. These data indicate that fluoxetine's extent of inhibition of CYP3A4 activity is not likely to be of clinical significance. Fluoxetine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

All pregnancies have a background risk of birth defects, loss, or other adverse outcome regardless of drug exposure. Treatment of Pregnant Women during the First Trimester — There are no adequate and well-controlled clinical studies on the use of fluoxetine in pregnant women.

Results of a number of published epidemiological studies assessing the risk of fluoxetine exposure during the first trimester of pregnancy have demonstrated inconsistent results. More than 10 cohort studies and case-control studies failed to demonstrate an increased risk for congenital malformations overall. There was no specific pattern of cardiovascular malformations. Overall, however, a causal relationship has not been established. Nonteratogenic Effects — Neonates exposed to fluoxetine and other SSRIs or serotonin and norepinephrine reuptake inhibitors SNRIs , late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding.

Such complications can arise immediately upon delivery. Reported clinical findings have included respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying. It should be noted that, in some cases, the clinical picture is consistent with serotonin syndrome [see Warnings and Precautions 5.

PPHN occurs in 1 to 2 per 1, live births in the general population and is associated with substantial neonatal morbidity and mortality. Other studies do not show a significant statistical association. Physicians should also note the results of a prospective longitudinal study of pregnant women with a history of major depression, who were either on antidepressants or had received antidepressants less than 12 weeks prior to their last menstrual period, and were in remission.

Women who discontinued antidepressant medication during pregnancy showed a significant increase in relapse of their major depression compared to those women who remained on antidepressant medication throughout pregnancy. When treating a pregnant woman with fluoxetine, the physician should carefully consider both the potential risks of taking an SSRI, along with the established benefits of treating depression with an antidepressant. The decision can only be made on a case by case basis. Animal Data — In embryo-fetal development studies in rats and rabbits, there was no evidence of teratogenicity following administration of fluoxetine at doses up to The effect of fluoxetine on labor and delivery in humans is unknown.

However, because fluoxetine crosses the placenta and because of the possibility that fluoxetine may have adverse effects on the newborn, fluoxetine should be used during labor and delivery only if the potential benefit justifies the potential risk to the fetus. Because fluoxetine is excreted in human milk, nursing while on fluoxetine tablet is not recommended. In one breast-milk sample, the concentration of fluoxetine plus norfluoxetine was The concentration in the mother's plasma was No adverse effects on the infant were reported.

In another case, an infant nursed by a mother on fluoxetine developed crying, sleep disturbance, vomiting, and watery stools. Safety and effectiveness of fluoxetine tablet in the pediatric population have not been established [ see Boxed Warning and Warnings and Precautions 5. When considering the use of fluoxetine tablet in a child or adolescent, the potential risks must be balanced with the clinical need.

Significant toxicity, including myotoxicity, long-term neurobehavioral and reproductive toxicity, and impaired bone development, has been observed following exposure of juvenile animals to fluoxetine. Some of these effects occurred at clinically relevant exposures. As with other SSRIs, decreased weight gain has been observed in association with the use of fluoxetine in children and adolescent patients. After 19 weeks of treatment in a clinical trial, pediatric subjects treated with fluoxetine gained an average of 1.

In addition, fluoxetine treatment was associated with a decrease in alkaline phosphatase levels. The safety of fluoxetine treatment for pediatric patients has not been systematically assessed for chronic treatment longer than several months in duration. In particular, there are no studies that directly evaluate the longer-term effects of fluoxetine on the growth, development and maturation of children and adolescent patients.

Therefore, height and weight should be monitored periodically in pediatric patients receiving fluoxetine [see Warnings and Precautions 5. At the end of the treatment period, serum levels of creatine kinase marker of muscle damage were increased at the intermediate and high doses, and abnormal muscle and reproductive organ histopathology skeletal muscle degeneration and necrosis, testicular degeneration and necrosis, epididymal vacuolation and hypospermia was observed at the high dose.

When animals were evaluated after a recovery period up to 11 weeks after cessation of dosing , neurobehavioral abnormalities decreased reactivity at all doses and learning deficit at the high dose and reproductive functional impairment decreased mating at all doses and impaired fertility at the high dose were seen; in addition, testicular and epididymal microscopic lesions and decreased sperm concentrations were found in the high dose group, indicating that the reproductive organ effects seen at the end of treatment were irreversible.

The reversibility of fluoxetine-induced muscle damage was not assessed. Adverse effects similar to those observed in rats treated with fluoxetine during the juvenile period have not been reported after administration of fluoxetine to adult animals. Plasma exposures AUC to fluoxetine in juvenile rats receiving the low, intermediate, and high dose in this study were approximately 0.

Rat exposures to the major metabolite, norfluoxetine, were approximately 0. A specific effect of fluoxetine on bone development has been reported in mice treated with fluoxetine during the juvenile period. These doses did not affect overall growth body weight gain or femoral length. The doses administered to juvenile mice in this study are approximately 0. Because of the early dosing period in this study, the significance of these findings to the approved pediatric use in humans is uncertain.

The diagnosis of PMDD is not applicable to postmenopausal women. In subjects with cirrhosis of the liver, the clearances of fluoxetine and its active metabolite, norfluoxetine, were decreased, thus increasing the elimination half-lives of these substances. A lower or less frequent dose of fluoxetine should be used in patients with cirrhosis.

Caution is advised when using fluoxetine tablet in patients with diseases or conditions that could affect its metabolism [see Dosage and Administration 2. Fluoxetine has not been systematically studied, in animals or humans, for its potential for abuse, tolerance, or physical dependence.

Consequently, physicians should carefully evaluate patients for history of drug abuse and follow such patients closely, observing them for signs of misuse or abuse of fluoxetine tablet for example, development of tolerance, incrementation of dose, drug-seeking behavior. Worldwide exposure to fluoxetine hydrochloride is estimated to be over 38 million patients circa Of the cases of overdose involving fluoxetine hydrochloride, alone or with other drugs, reported from this population, there were deaths.

Among adult patients who overdosed on fluoxetine hydrochloride alone, 34 resulted in a fatal outcome, completely recovered, and 15 patients experienced sequelae after overdosage, including abnormal accommodation, abnormal gait, confusion, unresponsiveness, nervousness, pulmonary dysfunction, vertigo, tremor, elevated blood pressure, impotence, movement disorder, and hypomania. The remaining patients had an unknown outcome.

The most common signs and symptoms associated with non-fatal overdosage were seizures, somnolence, nausea, tachycardia, and vomiting. The largest known ingestion of fluoxetine hydrochloride in adult patients was 8 grams in a patient who took fluoxetine alone and who subsequently recovered. However, in an adult patient who took fluoxetine alone, an ingestion as low as mg has been associated with lethal outcome, but causality has not been established.

Among pediatric patients ages 3 months to 17 years , there were cases of overdose involving fluoxetine alone or in combination with other drugs. Six patients died, patients completely recovered, 1 patient experienced renal failure, and 22 patients had an unknown outcome. One of the six fatalities was a 9-year-old boy who had a history of OCD, Tourette's syndrome with tics, attention deficit disorder, and fetal alcohol syndrome.

He had been receiving mg of fluoxetine daily for 6 months in addition to clonidine, methylphenidate, and promethazine. Mixed-drug ingestion or other methods of suicide complicated all 6 overdoses in children that resulted in fatalities.

The largest ingestion in pediatric patients was 3 grams which was nonlethal. Other important adverse reactions reported with fluoxetine overdose single or multiple drugs include coma, delirium, ECG abnormalities such as QT interval prolongation and ventricular tachycardia, including torsades de pointes-type arrhythmias , hypotension, mania, neuroleptic malignant syndrome-like reactions, pyrexia, stupor, and syncope. Studies in animals do not provide precise or necessarily valid information about the treatment of human overdose.

However, animal experiments can provide useful insights into possible treatment strategies. Acute high oral doses produced hyperirritability and convulsions in several animal species. Among 6 dogs purposely overdosed with oral fluoxetine, 5 experienced grand mal seizures. Seizures stopped immediately upon the bolus intravenous administration of a standard veterinary dose of diazepam.

Tachycardia and an increase in blood pressure were observed. Consequently, the value of the ECG in predicting cardiac toxicity is unknown. Nonetheless, the ECG should ordinarily be monitored in cases of human overdose [see Overdosage Treatment should consist of those general measures employed in the management of overdosage with any SSRI. Ensure an adequate airway, oxygenation, and ventilation.

Monitor cardiac rhythm and vital signs. General supportive and symptomatic measures are also recommended. Induction of emesis is not recommended. Gastric lavage with a large-bore orogastric tube with appropriate airway protection, if needed, may be indicated if performed soon after ingestion, or in symptomatic patients.

Activated charcoal should be administered. Due to the large volume of distribution of this drug, forced diuresis, dialysis, hemoperfusion, and exchange transfusion are unlikely to be of benefit. No specific antidotes for fluoxetine are known. A specific caution involves patients who are taking or have recently taken fluoxetine and might ingest excessive quantities of a TCA. Based on experience in animals, which may not be relevant to humans, fluoxetine-induced seizures that fail to remit spontaneously may respond to diazepam.

In managing overdosage, consider the possibility of multiple drug involvement. The physician should consider contacting a poison control center for additional information on the treatment of any overdose. Its molecular weight is The structural formula is:.

Each Fluoxetine tablets, USP contains fluoxetine hydrochloride equivalent to 10 mg or 20 mg of fluoxetine. Although the exact mechanism of fluoxetine hydrochloride is unknown, it is presumed to be linked to its inhibition of CNS neuronal uptake of serotonin. Studies at clinically relevant doses in humans have demonstrated that fluoxetine blocks the uptake of serotonin into human platelets. Studies in animals also suggest that fluoxetine is a much more potent uptake inhibitor of serotonin than of norepinephrine.

Fluoxetine bind. In animal models, both enantiomers are specific and potent serotonin uptake inhibitors with essentially equivalent pharmacologic activity. The S -fluoxetine enantiomer is eliminated more slowly and is the predominant enantiomer present in plasma at steady state. Figure 1. Food does not appear to affect the systemic bioavailability of fluoxetine, although it may delay its absorption by 1 to 2 hours, which is probably not clinically significant.

Thus, fluoxetine may be administered with or without food. The interaction between fluoxetine and other highly protein-bound drugs has not been fully evaluated, but may be important [ see Drug Interactions 7. Metabolism — Fluoxetine is extensively metabolized in the liver to norfluoxetine and a number of other unidentified metabolites. The only identified active metabolite, norfluoxetine, is formed by demethylation of fluoxetine. In animal models, S -norfluoxetine is a potent and selective inhibitor of serotonin uptake and has activity essentially equivalent to R - or S -fluoxetine.

R -norfluoxetine is significantly less potent than the parent drug in the inhibition of serotonin uptake. Such individuals are referred to as "poor metabolizers" of drugs such as debrisoquin, dextromethorphan, and the TCAs. In a study involving labeled and unlabeled enantiomers administered as a racemate, these individuals metabolized S -fluoxetine at a slower rate and thus achieved higher concentrations of S -fluoxetine.

Consequently, concentrations of S -norfluoxetine at steady state were lower. The metabolism of R -fluoxetine in these poor metabolizers appears normal. When compared with normal metabolizers, the total sum at steady state of the plasma concentrations of the 4 active enantiomers was not significantly greater among poor metabolizers. Thus, the net pharmacodynamic activities were essentially the same. Alternative, nonsaturable pathways non-2D6 also contribute to the metabolism of fluoxetine. This explains how fluoxetine achieves a steady-state concentration rather than increasing without limit.

Because fluoxetine's metabolism, like that of a number of other compounds including TCAs and other selective serotonin reuptake inhibitors SSRIs , involves the CYP2D6 system, concomitant therapy with drugs also metabolized by this enzyme system such as the TCAs may lead to drug interactions [see Drug Interactions 7.

Excretion — The primary route of elimination appears to be hepatic metabolism to inactive metabolites excreted by the kidney. Accumulation and Slow Elimination — The relatively slow elimination of fluoxetine elimination half-life of 1 to 3 days after acute administration and 4 to 6 days after chronic administration and its active metabolite, norfluoxetine elimination half-life of 4 to 16 days after acute and chronic administration , leads to significant accumulation of these active species in chronic use and delayed attainment of steady state, even when a fixed dose is used [see Warnings and Precautions 5.

Plasma concentrations of fluoxetine were higher than those predicted by single-dose studies, because fluoxetine's metabolism is not proportional to dose. Norfluoxetine, however, appears to have linear pharmacokinetics. Its mean terminal half-life after a single dose was 8. Steady-state levels after prolonged dosing are similar to levels seen at 4 to 5 weeks. The long elimination half-lives of fluoxetine and norfluoxetine assure that, even when dosing is stopped, active drug substance will persist in the body for weeks primarily depending on individual patient characteristics, previous dosing regimen, and length of previous therapy at discontinuation.

This is of potential consequence when drug discontinuation is required or when drugs are prescribed that might interact with fluoxetine and norfluoxetine following the discontinuation of fluoxetine tablet. Hepatic Impairment — As might be predicted from its primary site of metabolism, liver impairment can affect the elimination of fluoxetine.

The elimination half-life of fluoxetine was prolonged in a study of cirrhotic patients, with a mean of 7. This suggests that the use of fluoxetine in patients with liver disease must be approached with caution. If fluoxetine is administered to patients with liver disease, a lower or less frequent dose should be used [see Dosage and Administration 2.

While the possibility exists that renally excreted metabolites of fluoxetine may accumulate to higher levels in patients with severe renal dysfunction, use of a lower or less frequent dose is not routinely necessary in renally impaired patients. Mutagenicity — Fluoxetine and norfluoxetine have been shown to have no genotoxic effects based on the following assays: bacterial mutation assay, DNA repair assay in cultured rat hepatocytes, mouse lymphoma assay, and in vivo sister chromatid exchange assay in Chinese hamster bone marrow cells.

Impairment of Fertility — Two fertility studies conducted in adult rats at doses of up to 7. However, adverse effects on fertility were seen when juvenile rats were treated with fluoxetine [see Use in Specific Populations 8. Phospholipids are increased in some tissues of mice, rats, and dogs given fluoxetine chronically.

This effect is reversible after cessation of fluoxetine treatment. Phospholipid accumulation in animals has been observed with many cationic amphiphilic drugs, including fenfluramine, imipramine, and ranitidine.

The significance of this effect in humans is unknown. The effectiveness of fluoxetine hydrochloride for the treatment of PMDD was established in 3 placebo-controlled trials 1 intermittent and 2 continuous dosing. Patients on oral contraceptives were excluded from these trials; therefore, the efficacy of fluoxetine in combination with oral contraceptives for the treatment of PMDD is unknown.

Fluoxetine or placebo was started 14 days prior to the anticipated onset of menstruation and was continued through the first full day of menses. The difference between the 20 and 60 mg doses was not statistically significant. The following table shows the percentage of patients meeting criteria for either moderate or marked improvement on the VAS total score:. Fluoxetine was significantly more effective than placebo as measured by within cycle follicular to luteal phase changes in the VAS total score mood, physical, and social impairment symptoms.

The average VAS total score follicular to luteal phase increase was 3. Neither fluoxetine nor bupropion was shown to be superior to placebo on the primary endpoint, that is, response rate [defined as a rating of 1 very much improved or 2 much improved on the CGI], possibly due to sample size. Fluoxetine tablets, USP is available in 10 mg and 20 mg strengths.

Healthcare providers should instruct their patients to read the Medication Guide before starting therapy with fluoxetine tablet and to reread it each time the prescription is renewed. Healthcare providers should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with fluoxetine tablet and should counsel them in its appropriate use. Healthcare providers should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents.

Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have. Patients should be advised of the following issues and asked to alert their healthcare provider if these occur while taking fluoxetine tablet.

Patients, their families, and their caregivers should be encouraged to be alert to the emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia psychomotor restlessness , hypomania, mania, other unusual changes in behavior, worsening of depression, and suicidal ideation, especially early during antidepressant treatment and when the dose is adjusted up or down.

Families and caregivers of patients should be advised to look for the emergence of such symptoms on a day-to-day basis, since changes may be abrupt. Such symptoms should be reported to the patient's prescriber or health professional, especially if they are severe, abrupt in onset, or were not part of the patient's presenting symptoms. Symptoms such as these may be associated with an increased risk for suicidal thinking and behavior and indicate a need for very close monitoring and possibly changes in the medication [see Boxed Warning and Warnings and Precautions 5.

Patients should be cautioned about the risk of serotonin syndrome with the concomitant use of fluoxetine tablet and other serotonergic agents including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, buspirone, amphetamines, tryptophan, and St. John's Wort [see Contraindications 4. Patients should be cautioned to seek medical care immediately if they experience these symptoms. Patients should be advised to notify their physician if they develop a rash or hives [see Warnings and Precautions 5.

Patients should also be advised of the signs and symptoms associated with a severe allergic reaction, including swelling of the face, eyes, or mouth, or trouble breathing. Patients should be cautioned about the concomitant use of fluoxetine and NSAIDs, aspirin, warfarin, or other drugs that affect coagulation since combined use of psychotropic drugs that interfere with serotonin reuptake and these agents have been associated with an increased risk of bleeding [see Warnings and Precautions 5.

Patients should be advised to call their doctor if they experience any increased or unusual bruising or bleeding while taking fluoxetine tablet. Patients should be advised that taking fluoxetine tablet can cause mild pupillary dilation, which in susceptible individuals, can lead to an episode of angle-closure glaucoma. Pre-existing glaucoma is almost always open-angle glaucoma because angle-closure glaucoma, when diagnosed, can be treated definitively with iridectomy.

Open-angle glaucoma is not a risk factor for angle-closure glaucoma. Patients may wish to be examined to determine whether they are susceptible to angle-closure, and have a prophylactic procedure e. Fluoxetine hydrochloride may impair judgment, thinking, or motor skills. Patients should be advised to avoid driving a car or operating hazardous machinery until they are reasonably certain that their performance is not affected [see Warnings and Precautions 5. Patients should be advised to inform their physician if they are taking, or plan to take, any prescription medication, including Symbyax, Prozac, Prozac Weekly, or over-the-counter drugs, including herbal supplements or alcohol.

Patients should also be advised to inform their physicians if they plan to discontinue any medications they are taking while on fluoxetine tablet. Patients should be advised to take fluoxetine tablet exactly as prescribed, and to continue taking fluoxetine tablet as prescribed even after their symptoms improve. Patients should be advised that they should not alter their dosing regimen, or stop taking fluoxetine tablet without consulting their physician [see Warnings and Precautions 5.

Patients should be advised to consult with their healthcare provider if their symptoms do not improve with fluoxetine tablet. Pregnancy — Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during therapy.

Fluoxetine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus [see Use in Specific Populations 8. Nursing Mothers — Patients should be advised to notify their physician if they intend to breastfeed an infant during therapy.

Because fluoxetine is excreted in human milk, nursing while taking fluoxetine tablet is not recommended [see Use in Specific Populations 8. Read the Medication Guide that comes with fluoxetine tablets before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment. Talk with your healthcare provider if there is something you do not understand or you want to learn more about.

Fluoxetine tablet is in a class of drugs called selective serotonin reuptake inhibitors SSRIs , which are often used for the treatment of depression and anxiety disorders. Although fluoxetine tablets are not a treatment for depression, it contains fluoxetine hydrochloride, the same active ingredient in some antidepressants.

What is the most important information I should know about fluoxetine tablets? Keep all follow-up visits with your healthcare provider and call between visits if you are worried about symptoms. Call your healthcare provider right away if you have any of the following symptoms, or call if an emergency, especially if they are new, worse, or worry you:. Call your healthcare provider right away if you have any of the following symptoms, or call if an emergency.

Fluoxetine tablets may be associated with these serious side effects:. Serotonin Syndrome. This condition can be life-threatening and may include:. Changes in appetite or weight. Children and adolescents should have height and weight monitored during treatment. Abnormal bleeding: Fluoxetine tablets and other antidepressant medicines may increase your risk of bleeding or bruising, especially if you take the blood thinner warfarin Coumadin , Jantoven , a non-steroidal anti-inflammatory drug NSAID's, like ibuprofen or naproxen , or aspirin.

Only some people are at risk for these problems. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are. Low salt sodium levels in the blood. Elderly people may be at greater risk for this. Symptoms may include:. Do not stop fluoxetine tablets without first talking to your healthcare provider.

Stopping fluoxetine tablets too quickly may cause serious symptoms including:. Fluoxetine tablets are a prescription medicine used to treat premenstrual dysphoric disorder PMDD. Talk with your healthcare provider if you do not think that your condition is getting better with fluoxetine tablets treatment. Women who take fluoxetine tablets close in time to an MAOI may have serious or even life-threatening side effects. Get medical help right away if you have any of these symptoms:.

What should I tell my healthcare provider before taking fluoxetine tablets? Ask if you are not sure. Tell your healthcare provider about all the medicines that you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Fluoxetine tablets and some medicines may interact with each other, may not work as well, or may cause serious side effects. Your healthcare provider or pharmacist can tell you if it is safe to take fluoxetine tablets with your other medicines.

Do not start or stop any medicine while taking fluoxetine tablets without talking to your healthcare provider first. If you take fluoxetine tablets, you should not take any other medicines that contain fluoxetine hydrochloride:. How should I take fluoxetine tablets? What should I avoid while taking fluoxetine tablets? Fluoxetine tablets can cause sleepiness or may affect your ability to make decisions, think clearly, or react quickly.

You should not drive, operate heavy machinery, or do other dangerous activities until you know how fluoxetine tablets affects you. Do not drink alcohol while using fluoxetine tablets. What are the possible side effects of fluoxetine tablets? Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of fluoxetine tablets. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. Keep fluoxetine tablets and all medicines out of the reach of children. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide.

Do not use fluoxetine tablets for a condition for which it was not prescribed. Do not give fluoxetine tablets to other people, even if they have the same condition. It may harm them. This Medication Guide summarizes the most important information about fluoxetine tablets. If you would like more information, talk with your healthcare provider.

You may ask your healthcare provider or pharmacist for information about fluoxetine tablets that is written for healthcare professionals. For more information about fluoxetine tablets call What are the ingredients in fluoxetine tablets? Drug Details [ pdf ].

Do not use fluoxetine tablet within 14 days of stopping an MAIO intended to treat psychiatric disorders. In addition, do not start fluoxetine tablet in a patient who is being treated with linezolid or intravenous methylene blue 4.

Do not use thioridazine within 5 weeks of discontinuing fluoxetine tablet 4. Use with NSAIDs, aspirin, warfarin, or drugs that affect coagulation may potentiate the risk of gastrointestinal or other bleeding 5. Use caution when operating machinery 5.

At least 5 weeks should be allowed after stopping fluoxetine before starting treatment with an MAOI 4 , 7. Do not use thioridazine within 5 weeks of discontinuing fluoxetine tablet. Fluoxetine should be used during pregnancy only if the potential benefit justifies the potential risks to the fetus 8.

For additional adverse reaction terms referenced in Warnings and Precautions, reporting rates for fluoxetine tablet 20 mg continuous and intermittent were, respectively: anxiety 4. Incidence less than 0.

Table 7. Fluoxetine tablets and other antidepressant medicines may cause serious side effects including: 1. Suicidal thoughts or actions: Fluoxetine tablets and other antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, or young adults within the first few months of treatment or when the dose is changed. Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions.

Watch for these changes and call your healthcare provider right away if you notice: New or sudden changes in mood, behavior, actions, thoughts, or feelings, especially if severe. Pay particular attention to such changes when fluoxetine tablets are started or when the dose is changed.

Call your healthcare provider right away if you have any of the following symptoms, or call if an emergency, especially if they are new, worse, or worry you: attempts to commit suicide acting on dangerous impulses acting aggressive or violent thoughts about suicide or dying new or worse depression new or worse anxiety or panic attacks feeling agitated, restless, angry or irritable trouble sleeping an increase in activity or talking more than what is normal for you other unusual changes in behavior or mood Call your healthcare provider right away if you have any of the following symptoms, or call if an emergency.

Fluoxetine tablets may be associated with these serious side effects: 2. This condition can be life-threatening and may include: agitation, hallucinations, coma or other changes in mental status coordination problems or muscle twitching overactive reflexes racing heartbeat, high or low blood pressure sweating or fever nausea, vomiting, or diarrhea muscle rigidity dizziness flushing tremor seizures 3.

Severe allergic reactions: trouble breathing swelling of the face, tongue, eyes or mouth rash, itchy welts hives or blisters, alone or with fever or joint pain 4.

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The difference between the two is the size of the spots under the skin. The journal BMJ reports that a purpuric rash comprises of red or brown spots caused by bleeding into the skin. The spots are purpuric if they are over 2 or 3 mm in size, whereas smaller petechiae spots are mm in diameter. Larger red or purples spots in the layers of the skin can be called purpura or bruising.

Depending on the cause of petechiae spots under your skin , you may have other symptoms. Knowing the accompanying symptoms with a petechial rash can help doctors diagnose the source of bleeding under the skin. Tiny purple spots on the skin are often connected with small blood vessels and capillaries and often appear on the lower legs, feet, and ankles.

Many of the causes of petechiae can result in a petechial rash on the front or side of the legs or ankles. However petechiae can affect other body parts such as the back, arms, abdomen, chest, face and neck. Any kind of prolonged straining can cause light hemorrhaging of your capillaries, resulting in tiny red or freckle-like spots on your skin. Doctors from the Mayo Clinic report that activities such as weight lifting or giving birth can put a strain on your capillaries.

This can result in bleeding under the skin and can cause petechiae on the face or upper body. You may also notice pinpoint brown spots on your face or neck if you suffer from a viral infection or gastroenteritis. For example, the Indian Dermatology Online Journal reported that forceful vomiting can cause facial petechiae.

In these cases, petechiae only last a few days as the skin heals itself and signs of bleeding in the skin disappear. Also, chronic coughing could cause a petechial rash in your mouth or on your lips. A medical journal from reported that mucosal petechiae were observed in a patient with severe coughing.

Other types of strenuous activity can cause a petechial rash on your feet, especially on your heel. The Journal of the American Academy of Dermatology reported that some marathon runners experience petechiae on their heel.

This type of harmless bleeding under the skin occurs mainly where there is less protection from the thick skin of the heel. Doctors say that petechiae on the feet usually lasts about 2 or 3 weeks. Injury to your skin can cause bleeding in the layers of the skin that may result in petechia on legs, feet, arms as well as other skin areas.

Some types of trauma to the skin that cause tiny blood spots on the skin can be due to skin conditions or physical trauma. For example, the journal Cureus reported that self-massaging with a softball could leave a petechial rash on the upper back and shoulder. The pressure from the ball can cause light hemorrhaging under the skin that looks like clusters of tiny pinpoint brown spots.

Also, the Journal of Clinical Medicine reports that seborrheic dermatitis can result in tiny reddish brown pustules that are characteristic of a petechial rash. More serious reasons for purpuric rashes that are formed by tiny flat spots are usually due to medical conditions. Vitamin deficiencies can result in weakened capillaries and light bleeding under the skin that causes small purple spots. Two common vitamin deficiencies that cause petechial rashes are a lack of vitamin K and vitamin C.

Not getting enough vitamins from your diet can result in poor health and even signs of scurvy. This can result in rashes of tiny red or purple spots on the legs as well as easy bruising and gum disease. A lack of vitamin K from the diet can result in petechiae rashes and bleeding that is difficult to stop.

A low platelet count can result in bleeding under the skin that can cause petechial or purpuric rashes in different areas such as the legs, feet, arms or chest. Platelets are necessary to help clot blood, and not having enough platelets can result in easy bruising. Low platelet counts are often detected in a blood test to check red blood cells.

Celiac disease can cause petechiae rashes on different parts of the body such as the legs, arms or feet. According to the journal Gastroenterology Research and Practice , celiac disease can cause a number of skin conditions. In fact, scientists have found that the celiac disease often causes vasculitis an inflammation of the blood vessels that affects the skin. Inflammation of the small blood vessels can cause them to rupture and cause light bleeding in the skin. Alexandra Villa-Forte, who specializes in rheumatic diseases, says that vasculitis can be caused by a number of conditions.

The result is usually tiny to large blood spots on the lower legs. Infection in your bloodstream is a potentially life-threatening condition that can manifest itself as rashes of small to large purple or red spots. Andre Kalil from the Department of Infectious Diseases at the University of Nebraska reports that sepsis can cause multiple complications. At the onset, sepsis can cause fever, confusion, and difficulty breathing.

As the condition progresses, any part of the body can be affected. Petechiae, purpura, and skin ulcers are dermatological symptoms of sepsis. Sepsis has other signs and symptoms that you should not ignore. Doctors on PubMed Health report that a bacterial infection of the throat can cause a fever, sore throat, nausea, and vomiting. You may also notice a rash of tiny red dots in your mouth.

Other signs of a strep throat are white spots on your tonsils , pain when swallowing, and swollen lymph nodes. You can read more about strep throat in my article about the best natural remedies for strep throat. Strep throat can lead to scarlet fever that can cause a large petechial rash on the upper body and face. As with strep throat, scarlet fever may cause red dots at the back of your throat.

According to dermatologist Dr. Bahman Sotoodian, scarlet fever can cause a petechial rash in the mouth. However, petechiae are often seen in the armpits, back of the elbows, and upper body. Scarlet fever can also cause a sandpaper-like rash on the upper body. Another infectious condition that can result in petechiae in the mucous membranes of your mouth is mononucleosis. Page Contents 1 What are Petechiae?

Petechiae on the low limb. Petechia photo. Meningococcal Petechiae. Oral Petechiae. Petechia of the lower leg. Heinz F. Related Posts. About The Author Shavit Gavish Gavish is an award-winning freelance medical and health writer and editor with 15 years of experience.

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They are commonly found on the arms, legs, stomach, and buttocks. The size of the spots is an important feature of the rash; the spots must be less than 2 millimeters 0. The spots may or may not be palpable able to be felt depending on the underlying cause. The rash-like red dots which occur in petechiae are not a condition, but rather, a symptom of something else, such as a viral or bacterial infection, a trauma, or other causes.

Petechiae could even be a symptom of an allergic reaction. Petechiae occurs as a result of bleeding—from small blood vessels called capillaries that break under the skin—which causes the spots to be a brownish-purple in color. The spots could appear in one area of the body due to some sort of trauma , or they could be widespread such as those which occur as a result of a bleeding disorder.

Petechiae is sometimes a symptom of a serious disorder, one that could potentially require emergency medical attention. The symptoms of petechiae include:. After they initially appear, areas affected by petechiae may spread out and begin to blend together to form larger patches. This could indicate that a bleeding disorder is present.

If fever accompanies petechiae, it could indicate a serious infection. Petechiae is a common rash seen in pediatric emergency departments; this type of non-blanching rash can be of great concern. Healthcare providers must perform a thorough exam to evaluate the underlying cause of petechiae. There are many potential underlying causes of petechiae; some of the most common causes include fungal, viral or bacterial infections such as those that cause:. Sudden strain can result in the small blood vessels called capillaries to burst and leak into the skin; this appears as red dots that comprise petechiae.

Causes of strain that could result in petechiae may include:. Other causative factors of petechiae include:. Some medications that list petechiae as a possible side effect include:. Common medications that are known to cause petechiae include:. Diagnosing the underlying cause of petechiae involves a thorough physical and history examination.

The healthcare provider will gather information such as:. An in-depth patient history is vital to establish any pattern of symptoms that could alert the healthcare provider of the possibility of serious illness. Diagnostic tests that may be ordered when a child is seen for petechiae may include:. More tests may be ordered after the initial exam and lab tests help to narrow down the possible diagnosis.

Treatment for petechiae depends on the underlying cause. Many times, there is no treatment required, such as when the child is well after the observation period with no signs of infection, normal lab test results, and no spreading of the rash.

In this instance, the healthcare provider will usually discharge the child to go home. But when scattered petechiae are noted with a fever, it could be the sign of a very serious infection such as IMD requiring intravenous antibiotic therapy and possibly hospitalization.

Several other conditions that cause petechiae such as a bleeding disorder will require prompt diagnosis and medical attention as well. Petechiae require prompt medical intervention to screen for medical emergencies. A medical consultation will also rule out serious conditions that may require emergency medical intervention. But this does not mean that parents should panic and assume the worst.

The most important thing to keep in mind is that acting quickly to seek professional medical advice can help to improve the prognosis outcome of any serious medical complications if they do occur. Sign up for our Health Tip of the Day newsletter, and receive daily tips that will help you live your healthiest life. Fairview Patient Education Petichiae child. Santistevan, J. An approach to dangerous rashes based on morphology.

EM Docs. Purpuric and petechial rashes in adults and children: initial assessment. In most cases, petechiae are one of many symptoms indicating a serious condition. Contact your doctor immediately if you develop red spots while experiencing:. Seek medical guidance if you notice the spots are turning into purpura. Blood clots or bleeding into the skin can be a concern when red dots appear underneath the eyes.

Sick children who develop petechiae or purpura should also seek immediate medical care. Petechiae in itself is not dangerous. However, when it is accompanied by other symptoms such as fever, vomiting, headache, or stiff neck, it can indicate a serious underlying condition.

See a doctor immediately. Petechiae prevention depends on the cause. If you develop petechiae after vomiting or coughing violently, do what you can to avoid these activities. However, they're not always possible to control if they're related to illness. If you are experiencing something that you know triggers petechiae, apply a cold compress under your eyes for 10 to 15 minutes throughout the day. If a certain medication triggers petechiae, speak to your doctor about alternative options.

Petechiae usually resolve on their own after about two to three days. However, some home remedies prevent spots from forming or help them quickly ease after they form. Applying cold compresses to the affected area helps reduce inflammation and eases the appearance of petechiae. In some cases, doctors prescribe corticosteroids or antibiotics to treat petechiae. These medicines treat infections and reduce inflammation.

Immunosuppressants are also effective in treating petechiae. If petechiae are not linked to an infection or another underlying condition, the best treatment is rest, relaxation, and plenty of water. If you experience discomfort, over-the-counter pain relievers, like acetaminophen and ibuprofen, are helpful. The best way to prevent activity-induced petechiae is to avoid activities that require heavy lifting or straining.

If petechiae is related to illness, or if you're taking medications that cause petechiae, talk to your doctor about it. They may recommend home remedies if it's nothing serious. They may also prescribe antibiotics or corticosteroids to treat the root cause of the problem. The red circles that appear under your eyes after vomiting are petechiae. They are caused by broken blood vessels that cause minor bleeding under the skin. The blood vessels burst because of the strain of vomiting.

This condition is more likely to arise when vomiting is intense. Vomiting-induced petechiae tend to clear up on their own. Red dots tend to develop under your eyes after drinking alcohol because of how alcohol affects the body. The alcohol also enters your bloodstream and travels into your eyes. This puts a strain on the small blood vessels or capillaries in your face.

Petechiae also form if you vomit after drinking, just as they can when you vomit for any other reason. Drinking alcohol also affects the nutrient balance in your body. Yes, most of the time petechiae go away on their own. You can speed things along by applying cold compresses to the affected area for about 15 minutes at a time every few hours. If red dots are caused by skin conditions or an allergic reaction, you might need to see a dermatologist for treatment.

Indirectly, yes, stress can cause petechiae to form under the eyes. This is because so many people cry when they feel stressed. The harder you cry and the puffier your eyes get from crying, the more likely red dots are to form. Elevated blood pressure, which is a symptom of stress, also causes red spots. People with vitamin B12 deficiencies tend to have a higher risk of petechiae forming. If you believe a vitamin deficiency could be the cause of red spots, seek medical advice and discuss possible supplements or treatment options with your doctor.

Petechiae are often nothing to worry about. They eventually go away on their own. However, if you're experiencing other symptoms, like fever, breathlessness, or weakness, consult your doctor immediately. All Vision Center content is medically reviewed and fact-checked by a licensed optometrist to ensure the information is factual and meets industry standards. We have strict sourcing guidelines and only cite from recent scientific research, scholarly articles, textbooks, government agencies, optometry websites, and medical journals.

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