Cipralex D.A.C. may be available in the countries listed below.
Escitalopram oxalate (a derivative of Escitalopram) is reported as an ingredient of Cipralex D.A.C. in the following countries:
International Drug Name Search
DEXTROAMPHETAMINE SULFATE
EXTENDED-RELEASE CAPSULES
CII
Rx only
WARNING
AMPHETAMINES HAVE A HIGH POTENTIAL FOR ABUSE. ADMINISTRATION OF AMPHETAMINES FOR PROLONGED PERIODS OF TIME MAY LEAD TO DRUG DEPENDENCE AND MUST BE AVOIDED. PARTICULAR ATTENTION SHOULD BE PAID TO THE POSSIBILITY OF SUBJECTS OBTAINING AMPHETAMINES FOR NON-THERAPEUTIC USE OR DISTRIBUTION TO OTHERS, AND THE DRUGS SHOULD BE PRESCRIBED OR DISPENSED SPARINGLY.
MISUSE OF AMPHETAMINES MAY CAUSE SUDDEN DEATH AND SERIOUS CARDIOVASCULAR ADVERSE EVENTS.
Dextroamphetamine sulfate is the dextro isomer of the compound d,l-amphetamine sulfate, a sympathomimetic amine of the amphetamine group. Chemically, dextroamphetamine is d-alpha-methylphenethylamine, and is present in all forms of dextroamphetamine sulfate extended-release capsules as the neutral sulfate.
Structural formula:
Each dextroamphetamine sulfate extended-release capsule is so prepared that an initial dose is released promptly and the remaining medication is released gradually over a prolonged period.
Active Ingredient: dextroamphetamine sulfate USP
Inactive Ingredients: sugar spheres, titanium dioxide, gelatin, shellac glaze-45%, SD-45 alcohol, iron oxide black, propylene glycol, FD&C Blue #2/Indigo Carmine Lake, FD&C Red #40/Allura Red AC Lake, FD&C Blue #1/Brilliant Blue FCF Lake, D&C Yellow #10 Lake, SD3A alcohol, shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, strong ammonia solution, FD&C Blue #2 Aluminum Lake, D&C Red #7 Calcium Lake, hydroxypropyl methylcellulose/hypromellose, macrogol/polyethylene glycol, purified water, ethylcellulose, ammonium hydroxide 28%, medium chain triglycerides, oleic acid
Amphetamines are noncatecholamine, sympathomimetic amines with CNS stimulant activity. Peripheral actions include elevations of systolic and diastolic blood pressures and weak bronchodilator and respiratory stimulant action.
There is neither specific evidence that clearly establishes the mechanism whereby amphetamines produce mental and behavioral effects in children, nor conclusive evidence regarding how these effects relate to the condition of the central nervous system.
Dextroamphetamine sulfate extended-release capsules are formulated to release the active drug substance in vivo in a more gradual fashion than the standard formulation, as demonstrated by blood levels. The formulation has not been shown superior in effectiveness over the same dosage of the standard, noncontrolled-release formulations given in divided doses.
The pharmacokinetics of the tablet and sustained-release capsule were compared in 12 healthy subjects. The extent of bioavailability of the sustained-release capsule was similar compared to the immediate-release tablet. Following administration of three 5 mg tablets, average maximal dextroamphetamine plasma concentrations (Cmax) of 36.6 ng/mL were achieved at approximately 3 hours. Following administration of one 15 mg sustained-release capsule, maximal dextroamphetamine plasma concentrations were obtained approximately 8 hours after dosing. The average Cmax was 23.5 ng/mL. The average plasma T1/2 was similar for both the tablet and sustained-release capsule and was approximately 12 hours.
In 12 healthy subjects, the rate and extent of dextroamphetamine absorption were similar following administration of the sustained-release capsule formulation in the fed (58 to 75 gm fat) and fasted state.
Dextroamphetamine Sulfate Extended-Release Capsules are indicated in:
Narcolepsy
Attention Deficit Disorder with Hyperactivity – As an integral part of a total treatment program that typically includes other measures (psychological, educational, social) for patients (ages 6 years to 16 years) with this syndrome. A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. The symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in 2 or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. For the Inattentive Type, at least 6 of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful. For the Hyperactive-Impulsive Type, at least 6 of the following symptoms must have persisted for at least 6 months: fidgeting/squirming; leaving seat; inappropriate running/climbing; difficulty with quiet activities; “on the go”; excessive talking; blurting answers; can’t wait turn; intrusive. The Combined Type requires both inattentive and hyperactive-impulsive criteria to be met.
Special Diagnostic Considerations – Specific etiology of this syndrome is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use of medical and special psychological, educational, and social resources. Learning may or may not be impaired. The diagnosis must be based upon a complete history and evaluation of the patient and not solely on the presences of the required number of DSM-IV characteristics.
Need for Comprehensive Treatment Program – Dextroamphetamine sulfate extended-release capsules are indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with this syndrome. Drug treatment may not be indicated for all patients with this syndrome. Stimulants are not intended for use in patients who exhibit symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis. Appropriate educational placement is essential and psychosocial intervention is often helpful. When remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician’s assessment of the chronicity and severity of the patient’s symptoms.
Advanced arteriosclerosis, symptomatic cardiovascular disease, moderate to severe hypertension, hyperthyroidism, known hypersensitivity or idiosyncrasy to the sympathomimetic amines, glaucoma.
Agitated states.
Patients with a history of drug abuse.
During or within 14 days following the administration of monoamine oxidase inhibitors (hypertensive crises may result).
Children and Adolescents – Sudden death has been reported in association with CNS stimulant treatment at usual doses in children and adolescents with structural cardiac abnormalities or other serious heart problems. Although some serious heart problems alone carry an increased risk of sudden death, stimulant products generally should not be used in children or adolescents with known serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, or other serious cardiac problems that may place them at increased vulnerability to the sympathomimetic effects of a stimulant drug.
Adults – Sudden deaths, stroke, and myocardial infarction have been reported in adults taking stimulant drugs at usual doses for ADHD. Although the role of stimulants in these adult cases is also unknown, adults have a greater likelihood than children of having serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems. Adults with such abnormalities should also generally not be treated with stimulant drugs (see CONTRAINDICATIONS).
Stimulant medications cause a modest increase in average blood pressure (about 2 to 4 mmHg) and average heart rate (about 3 to 6 bpm), and individuals may have larger increases. While the mean changes alone would not be expected to have short-term consequences, all patients should be monitored for larger changes in heart rate and blood pressure. Caution is indicated in treating patients whose underlying medical conditions might be compromised by increases in blood pressure or heart rate, e.g., those with pre-existing hypertension, heart failure, recent myocardial infarction, or ventricular arrhythmia (see CONTRAINDICATIONS).
Children, adolescents, or adults who are being considered for treatment with stimulant medications should have a careful history (including assessment for a family history of sudden death or ventricular arrhythmia) and physical exam to assess for the presence of cardiac disease, and should receive further cardiac evaluation if findings suggest such disease (e.g., electrocardiogram and echocardiogram). Patients who develop symptoms such as exertional chest pain, unexplained syncope, or other symptoms suggestive of cardiac disease during stimulant treatment should undergo a prompt cardiac evaluation.
Pre-Existing Psychosis – Administration of stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with a pre-existing psychotic disorder.
Bipolar Illness – Particular care should be taken in using stimulants to treat ADHD in patients with comorbid bipolar disorder because of concern for possible induction of a mixed/manic episode in such patients. Prior to initiating treatment with a stimulant, patients with comorbid depressive symptoms should be adequately screened to determine if they are at risk for bipolar disorder; such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder, and depression.
Emergence of New Psychotic or Manic Symptoms – Treatment emergent psychotic or manic symptoms, e.g., hallucinations, delusional thinking, or mania in children and adolescents without a prior history of psychotic illness or mania can be caused by stimulants at usual doses. If such symptoms occur, consideration should be given to a possible causal role of the stimulant, and discontinuation of treatment may be appropriate. In a pooled analysis of multiple short-term, placebo-controlled studies, such symptoms occurred in about 0.1% (4 patients with events out of 3,482 exposed to methylphenidate or amphetamine for several weeks at usual doses) of stimulant-treated patients compared to 0 in placebo-treated patients.
Aggression – Aggressive behavior or hostility is often observed in children and adolescents with ADHD, and has been reported in clinical trials and the postmarketing experience of some medications indicated for the treatment of ADHD. Although there is no systematic evidence that stimulants cause aggressive behavior or hostility, patients beginning treatment for ADHD should be monitored for the appearance of, or worsening of, aggressive behavior or hostility.
Careful follow-up of weight and height in children ages 7 to 10 years who were randomized to either methylphenidate or non-medication treatment groups over 14 months, as well as in naturalistic subgroups of newly methylphenidate-treated and non-medication treated children over 36 months (to the ages of 10 to 13 years), suggests that consistently medicated children (i.e., treatment for 7 days per week throughout the year) have a temporary slowing in growth rate (on average, a total of about 2 cm less growth in height and 2.7 kg less growth in weight over 3 years), without evidence of growth rebound during this period of development. Published data are inadequate to determine whether chronic use of amphetamines may cause a similar suppression of growth, however, it is anticipated that they likely have this effect as well. Therefore, growth should be monitored during treatment with stimulants, and patients who are not growing or gaining height or weight as expected may need to have their treatment interrupted.
There is some clinical evidence that stimulants may lower the convulsive threshold in patients with prior history of seizures, in patients with prior EEG abnormalities in absence of seizures, and, very rarely, in patients without a history of seizures and no prior EEG evidence of seizures. In the presence of seizures, the drug should be discontinued.
Difficulties with accommodation and blurring of vision have been reported with stimulant treatment.
General – The least amount feasible should be prescribed or dispensed at one time in order to minimize the possibility of overdosage.
Information for Patients – Amphetamines may impair the ability of the patient to engage in potentially hazardous activities such as operating machinery or vehicles; the patient should therefore be cautioned accordingly.
Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with dextroamphetamine and should counsel them in its appropriate use. A patient Medication Guide is available for dextroamphetamine sulfate extended-release capsules. The prescriber or health professional 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. The complete text of the Medication Guide is reprinted at the end of this document.
Acidifying Agents – Gastrointestinal acidifying agents (guanethidine, reserpine, glutamic acid HCl, ascorbic acid, fruit juices, etc.) lower absorption of amphetamines. Urinary acidifying agents (ammonium chloride, sodium acid phosphate, etc.) increase the concentration of the ionized species of the amphetamine molecule, thereby increasing urinary excretion. Both groups of agents lower blood levels and efficacy of amphetamines.
Adrenergic Blockers – Adrenergic blockers are inhibited by amphetamines.
Alkalinizing Agents – Gastrointestinal alkalinizing agents (sodium bicarbonate, etc.) increase absorption of amphetamines. Urinary alkalinizing agents (acetazolamide, some thiazides) increase the concentration of the non-ionized species of the amphetamine molecule, thereby decreasing urinary excretion. Both groups of agents increase blood levels and therefore potentiate the actions of amphetamines.
Antidepressants, Tricyclic – Amphetamines may enhance the activity of tricyclic or sympathomimetic agents; d-amphetamine with desipramine or protriptyline and possibly other tricyclics cause striking and sustained increases in the concentration of d-amphetamine in the brain; cardiovascular effects can be potentiated.
MAO Inhibitors – MAOI antidepressants, as well as a metabolite of furazolidone, slow amphetamine metabolism. This slowing potentiates amphetamines, increasing their effect on the release of norepinephrine and other monoamines from adrenergic nerve endings; this can cause headaches and other signs of hypertensive crisis. A variety of neurological toxic effects and malignant hyperpyrexia can occur, sometimes with fatal results.
Antihistamines – Amphetamines may counteract the sedative effect of antihistamines.
Antihypertensives – Amphetamines may antagonize the hypotensive effects of antihypertensives.
Chlorpromazine – Chlorpromazine blocks dopamine and norepinephrine reuptake, thus inhibiting the central stimulant effects of amphetamines, and can be used to treat amphetamine poisoning.
Ethosuximide – Amphetamines may delay intestinal absorption of ethosuximide.
Haloperidol – Haloperidol blocks dopamine and norepinephrine reuptake, thus inhibiting the central stimulant effects of amphetamines.
Lithium Carbonate – The stimulatory effects of amphetamines may be inhibited by lithium carbonate.
Meperidine – Amphetamines potentiate the analgesic effect of meperidine.
Methenamine Therapy – Urinary excretion of amphetamines is increased, and efficacy is reduced, by acidifying agents used in methenamine therapy.
Norepinephrine – Amphetamines enhance the adrenergic effect of norepinephrine.
Phenobarbital – Amphetamines may delay intestinal absorption of phenobarbital; co-administration of phenobarbital may produce a synergistic anticonvulsant action.
Phenytoin – Amphetamines may delay intestinal absorption of phenytoin; co-administration of phenytoin may produce a synergistic anticonvulsant action.
Propoxyphene – In cases of propoxyphene overdosage, amphetamine CNS stimulation is potentiated and fatal convulsions can occur.
Veratrum Alkaloids – Amphetamines inhibit the hypotensive effect of veratrum alkaloids.
Drug/Laboratory Test Interactions
Amphetamines can cause a significant elevation in plasma corticosteroid levels. This increase is greatest in the evening.
Amphetamines may interfere with urinary steroid determinations.
Carcinogenesis/Mutagenesis – Mutagenicity studies and long-term studies in animals to determine the carcinogenic potential of dextroamphetamine sulfate extended-release capsules have not been performed.
Teratogenic Effects. Pregnancy Category C – Dextroamphetamine sulfate extended-release capsules have been shown to have embryotoxic and teratogenic effects when administered to A/Jax mice and C57BL mice in doses approximately 41 times the maximum human dose. Embryotoxic effects were not seen in New Zealand white rabbits given the drug in doses 7 times the human dose nor in rats given 12.5 times the maximum human dose. While there are no adequate and well-controlled studies in pregnant women, there has been one report of severe congenital bony deformity, tracheoesophageal fistula, and anal atresia (VATER association) in a baby born to a woman who took dextroamphetamine sulfate with lovastatin during the first trimester of pregnancy. Dextroamphetamine sulfate extended-release capsules should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nonteratogenic Effects – Infants born to mothers dependent on amphetamines have an increased risk of premature delivery and low birth weight. Also, these infants may experience symptoms of withdrawal as demonstrated by dysphoria, including agitation, and significant lassitude.
Nursing Mothers – Amphetamines are excreted in human milk. Mothers taking amphetamines should be advised to refrain from nursing.
Pediatric Use – Long-term effects of amphetamines in pediatric patients have not been well established.
Dextroamphetamine sulfate extended-release capsules are not recommended for use in pediatric patients younger than 6 years of age with Attention Deficit Disorder with Hyperactivity described under INDICATIONS AND USAGE.
Clinical experience suggests that in psychotic children, administration of amphetamines may exacerbate symptoms of behavior disturbance and thought disorder.
Amphetamines have been reported to exacerbate motor and phonic tics and Tourette’s syndrome. Therefore, clinical evaluation for tics and Tourette’s syndrome in children and their families should precede use of stimulant medications.
Data are inadequate to determine whether chronic administration of amphetamines may be associated with growth inhibition; therefore, growth should be monitored during treatment.
Drug treatment is not indicated in all cases of Attention Deficit Disorder with Hyperactivity and should be considered only in light of the complete history and evaluation of the child. The decision to prescribe amphetamines should depend on the physician’s assessment of the chronicity and severity of the child’s symptoms and their appropriateness for his or her age. Prescription should not depend solely on the presence of one or more of the behavioral characteristics.
When these symptoms are associated with acute stress reactions, treatment with amphetamines is usually not indicated.
Cardiovascular – Palpitations, tachycardia, elevation of blood pressure. There have been isolated reports of cardiomyopathy associated with chronic amphetamine use.
Central Nervous System – Psychotic episodes at recommended doses (rare), overstimulation, restlessness, dizziness, insomnia, euphoria, dyskinesia, dysphoria, tremor, headache, exacerbation of motor and phonic tics and Tourette’s syndrome.
Gastrointestinal – Dryness of the mouth, unpleasant taste, diarrhea, constipation, other gastrointestinal disturbances. Anorexia and weight loss may occur as undesirable effects.
Allergic – Urticaria.
Endocrine – Impotence, changes in libido.
Dextroamphetamine sulfate is a Schedule II controlled substance.
Amphetamines have been extensively abused. Tolerance, extreme psychological dependence and severe social disability have occurred. There are reports of patients who have increased the dosage to many times that recommended. Abrupt cessation following prolonged high dosage administration results in extreme fatigue and mental depression; changes are also noted on the sleep EEG.
Manifestations of chronic intoxication with amphetamines include severe dermatoses, marked insomnia, irritability, hyperactivity and personality changes. The most severe manifestation of chronic intoxication is psychosis, often clinically indistinguishable from schizophrenia. This is rare with oral amphetamines.
Individual patient response to amphetamines varies widely. While toxic symptoms occasionally occur as an idiosyncrasy at doses as low as 2 mg, they are rare with doses of less than 15 mg; 30 mg can produce severe reactions, yet doses of 400 to 500 mg are not necessarily fatal.
In rats, the oral LD50 of dextroamphetamine sulfate is 96.8 mg/kg.
Manifestations of acute overdosage with amphetamines include restlessness, tremor, hyperreflexia, rhabdomyolysis, rapid respiration, hyperpyrexia, confusion, assaultiveness, hallucinations, panic states.
Fatigue and depression usually follow the central stimulation.
Cardiovascular effects include arrhythmias, hypertension or hypotension and circulatory collapse. Gastrointestinal symptoms include nausea, vomiting, diarrhea and abdominal cramps. Fatal poisoning is usually preceded by convulsions and coma.
Consult with a Certified Poison Control Center for up-to-date guidance and advice. Management of acute amphetamine intoxication is largely symptomatic and includes gastric lavage, administration of activated charcoal, administration of a cathartic, and sedation. Experience with hemodialysis or peritoneal dialysis is inadequate to permit recommendation in this regard. Acidification of the urine increases amphetamine excretion, but is believed to increase risk of acute renal failure if myoglobinuria is present. If acute, severe hypertension complicates amphetamine overdosage, administration of intravenous phentolamine (Bedford Laboratories) has been suggested. However, a gradual drop in blood pressure will usually result when sufficient sedation has been achieved.
Chlorpromazine antagonizes the central stimulant effects of amphetamines and can be used to treat amphetamine intoxication.
Since much of the dextroamphetamine sulfate extended-release capsule medication is coated for gradual release, therapy directed at reversing the effects of the ingested drug and at supporting the patient should be continued for as long as overdosage symptoms remain. Saline cathartics are useful for hastening the evacuation of pellets that have not already released medication.
Amphetamines should be administered at the lowest effective dosage and dosage should be individually adjusted. Late evening doses should be avoided because of the resulting insomnia.
Narcolepsy – Usual dose is 5 to 60 mg per day in divided doses, depending on the individual patient response.
Narcolepsy seldom occurs in children under 12 years of age; however, when it does, dextroamphetamine sulfate extended-release capsules may be used. The suggested initial dose for patients aged 6 to 12 is 5 mg daily; daily dose may be raised in increments of 5 mg at weekly intervals until an optimal response is obtained. In patients 12 years of age and older, start with 10 mg daily; daily dosage may be raised in increments of 10 mg at weekly intervals until an optimal response is obtained. If bothersome adverse reactions appear (e.g., insomnia or anorexia), dosage should be reduced. Dextroamphetamine sulfate extended-release capsules may be used for once-a-day dosage wherever appropriate.
Attention Deficit Disorder with Hyperactivity – The dextroamphetamine sulfate extended-release capsule formulation is not recommended for pediatric patients younger than 6 years of age.
In pediatric patients 6 years of age and older, start with 5 mg once or twice daily; daily dosage may be raised in increments of 5 mg at weekly intervals until optimal response is obtained. Only in rare cases will it be necessary to exceed a total of 40 mg per day.
Dextroamphetamine sulfate extended-release capsules may be used for once-a-day dosage wherever appropriate.
Where possible, drug administration should be interrupted occasionally to determine if there is a recurrence of behavioral symptoms sufficient to require continued therapy.
Dextroamphetamine Sulfate Extended-Release Capsules – Each capsule, with white opaque cap and white opaque body, contains dextroamphetamine sulfate. The 5 mg capsule is imprinted with an
5 mg Bottles of 100……………….NDC 0406-8960-01
10 mg Bottles of 100……………….NDC 0406-8961-01
15 mg Bottles of 100……………….NDC 0406-8962-01
Store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature].
Dispense in a tight, light-resistant container with a child-resistant closure.
Dextroamphetamine Sulfate Extended-Release Capsules are manufactured by Mallinckrodt Inc., Hobart, NY 13788.
Mallinckrodt Inc.
Hazelwood, MO 63042 USA
Printed in U.S.A.
Rev 01/2011
Mallinckrodt
COVIDIENTM
Dextroamphetamine Sulfate Extended-Release Capsules
CII
Read the Medication Guide that comes with dextroamphetamine sulfate extended-release capsules before you or your child starts 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 doctor about your or your child’s treatment with dextroamphetamine sulfate extended-release capsules.
What is the most important information I should know about Dextroamphetamine Sulfate Extended-Release Capsules?
The following have been reported with use of dextroamphetamine sulfate extended-release capsules and other stimulant medicines.
1. Heart-related problems:
Tell your doctor if you or your child have any heart problems, heart defects, high blood pressure, or a family history of these problems.
Your doctor should check you or your child carefully for heart problems before starting dextroamphetamine sulfate extended-release capsules.
Your doctor should check your or your child’s blood pressure and heart rate regularly during treatment with dextroamphetamine sulfate extended-release capsules.
Call your doctor right away if you or your child has any signs of heart problems such as chest pain, shortness of breath, or fainting while taking dextroamphetamine sulfate extended-release capsules.
2. Mental (Psychiatric) problems:
All Patients
Children and Teenagers
Tell your doctor about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression.
Call your doctor right away if you or your child have any new or worsening mental symptoms or problems while taking dextroamphetamine sulfate extended-release capsules, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious.
What are Dextroamphetamine Sulfate Extended-Release Capsules?
Dextroamphetamine sulfate extended-release capsules are a central nervous system stimulant prescription medicine. It is used for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD).
Dextroamphetamine sulfate extended-release capsules may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD.
Dextroamphetamine sulfate extended-release capsules should be used as a part of a total treatment program for ADHD that may include counseling or other therapies.
Dextroamphetamine sulfate extended-release capsules are also used in the treatment of a sleep disorder called narcolepsy.
Dextroamphetamine sulfate extended-release capsules are a federally controlled substance (CII) because it can be abused or lead to dependence. Keep dextroamphetamine sulfate extended-release capsules in a safe place to prevent misuse and abuse. Selling or giving away dextroamphetamine sulfate extended-release capsules may harm others, and is against the law.
Tell your doctor if you or your child have (or have a family history of) ever abused or been dependent on alcohol, prescription medicines or street drugs.
Who should not take Dextroamphetamine Sulfate Extended-Release Capsules?
Dextroamphetamine sulfate extended-release capsules should not be taken if you or your child:
Dextroamphetamine sulfate extended-release capsules are not recommended for use in children younger than 6 years old.
Dextroamphetamine sulfate extended-release capsules may not be right for you or your child. Before starting dextroamphetamine sulfate extended-release capsules tell your or your child’s doctor about all health conditions (or a family history of) including:
Tell your doctor if you or your child is pregnant, planning to become pregnant, or breastfeeding.
Can Dextroamphetamine Sulfate Extended-Release Capsules be taken with other medicines?
Tell your doctor about all of the medicines that you or your child take including prescription and nonprescription medicines, vitamins, and herbal supplements. Dextroamphetamine sulfate extended-release capsules and some medicines may interact with each other and cause serious side effects. Sometimes the doses of other medicines will need to be adjusted while taking dextroamphetamine sulfate extended-release capsules.
Your doctor will decide whether dextroamphetamine sulfate extended-release capsules can be taken with other medicines.
Especially tell your doctor if you or your child takes:
Know the medicines that you or your child takes. Keep a list of your medicines with you to show your doctor and pharmacist.
Do not start any new medicine while taking dextroamphetamine sulfate extended-release capsules without talking to your doctor first.
How should Dextroamphetamine Sulfate Extended-Release Capsules be taken?
What are possible side effects of Dextroamphetamine Sulfate Extended-Release Capsules?
See “What is the most important information I should know about Dextroamphetamine Sulfate Extended-Release Capsules?” for information on reported heart and mental problems.
Other serious side effects include:
Common side effects include:
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Dextroamphetamine sulfate extended-release capsules may affect your or your child’s ability to drive or do other dangerous activities.
Talk to your doctor if you or your child has side effects that are bothersome or do not go away.
This is not a complete list of possible side effects. Ask your doctor or pharmacist for more information.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store Dextroamphetamine Sulfate Extended-Release Capsules?
General information about Dextroamphetamine Sulfate Extended-Release Capsules
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use dextroamphetamine sulfate extended-release capsules for a condition for which it was not prescribed. Do not give dextroamphetamine sulfate extended-release capsules to other people, even if they have the same condition. It may harm them and it is against the law.
This Medication Guide summarizes the most important information about dextroamphetamine sulfate extended-release capsules. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about dextroamphetamine sulfate extended-release capsules that was written for healthcare professionals, or you can visit www.Mallinckrodt.com or call 1-800-778-7898.
What are the ingredients in Dextroamphetamine Sulfate Extended-Release Capsules?
Active Ingredient: dextroamphetamine sulfate USP
Inactive Ingredients: sugar spheres, titanium dioxide, gelatin, shellac glaze-45%, SD-45 alcohol, iron oxide black, propylene glycol, FD&C Blue #2/Indigo Carmine Lake, FD&C Red #40/Allura Red AC Lake, FD&C Blue #1/Brilliant Blue FCF Lake, D&C Yellow #10 Lake, SD3A alcohol, shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, strong ammonia solution, FD&C Blue #2 Aluminum Lake, D&C Red #7 Calcium Lake, hydroxypropyl methylcellulose/hypromellose, macrogol/polyethylene glycol, purified water, ethylcellulose, ammonium hydroxide 28%, medium chain triglycerides, oleic acid
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Mallinckrodt Inc.
Hazelwood, MO 63042 USA
Rev 01/2011
Mallinckrodt
COVIDIENTM
NDC 0406-8960-01
100 CAPSULES
DEXTROAMPHETAMINE SULFATE
EXTENDED-RELEASE CAPSULES
CII
5 mg
Rx only
Each capsule contains:
Dextroamphetamine Sulfate USP......... 5 mg
PHARMACIST: PLEASE DISPENSE WITH MEDICATION GUIDE PROVIDED WITH PRODUCT
Mallinckrodt
NDC 0406-8961-01
100 CAPSULES
DEXTROAMPHETAMINE SULFATE
EXTENDED-RELEASE CAPSULES
CII
10 mg
Rx only
Each capsule contains:
Dextroamphetamine Sulfate USP......... 10 mg
PHARMACIST: PLEASE DISPENSE WITH MEDICATION GUIDE PROVIDED WITH PRODUCT
Mallinckrodt
NDC 0406-8962-01
100 CAPSULES
DEXTROAMPHETAMINE SULFATE
EXTENDED-RELEASE CAPSULES
CII
15 mg
Rx only
Each capsule contains:
Dextroamphetamine Sulfate USP......... 15 mg
PHARMACIST: PLEASE DISPENSE WITH MEDICATION GUIDE PROVIDED WITH PRODUCT
Mallinckrodt
| DEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE dextroamphetamine sulfate capsule, extended release | ||||||||||||||||||||||||||||||||||||||||||||
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| ANDA | ANDA076353 | 10/07/2011 | |
| DEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE dextroamphetamine sulfate capsule, extended release | |||||||||||||
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Medovascin may be available in the countries listed below.
Lovastatin is reported as an ingredient of Medovascin in the following countries:
International Drug Name Search
Overdose-like side effects (eg, severe drowsiness, coma, confusion, mental changes), uncontrolled muscle movements, stiff or shaky muscles, trouble talking, joint pain, decreased coordination, aggression, dizziness, weakness, high blood pressure, and seizures have occurred in some patients after injection with Olanzapine. In most cases, the reaction occurred within 1 to 3 hours after the injection. You will need to be monitored by a health care professional for at least 3 hours after you receive Olanzapine. However, these symptoms may develop more than 3 hours after you receive a dose of Olanzapine. Tell your doctor right away if you develop any of these symptoms. Discuss any questions or concerns with your doctor.
Olanzapine is an antipsychotic. It may increase the risk of death when used to treat mental problems caused by dementia in elderly patients. Most of the deaths were linked to heart problems or infection. Olanzapine is not approved to treat mental problems caused by dementia.
Treating schizophrenia. It may also be used for other conditions as determined by your doctor.
Olanzapine is an atypical antipsychotic. Exactly how it works is not known. It is thought to affect certain substances in the brain.
Contact your doctor or health care provider right away if any of these apply to you.
Treatments for depression are getting better everyday and there are things you can start doing right away.
Some medical conditions may interact with Olanzapine. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
Some MEDICINES MAY INTERACT with Olanzapine. Tell your health care provider if you are taking any other medicines, especially any of the following:
This may not be a complete list of all interactions that may occur. Ask your health care provider if Olanzapine may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Use Olanzapine as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Olanzapine.
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Back pain; constipation; cough; diarrhea; dizziness; drowsiness; dry mouth; headache; increased appetite; lightheadedness; nausea; pain, redness, or swelling at the injection site; sore throat; stuffy nose; tiredness; vomiting; weight gain.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); abnormal thoughts; chest pain; confusion; decreased urination; disorientation; fainting; fast, slow, or irregular heartbeat; fever, chills, or persistent sore throat; increased saliva production or drooling; increased sweating; memory loss; menstrual changes; muscle pain, weakness, or stiffness; new or worsening mental or mood changes (eg, agitation, depression, hallucinations); one-sided weakness; seizures; severe or prolonged drowsiness, dizziness, or headache; shortness of breath; suicidal thoughts or actions; swelling of the hands, legs, or feet; symptoms of high blood sugar (eg, increased thirst, hunger, or urination; unusual weakness); symptoms of high prolactin levels (eg, enlarged breast size, decreased sexual ability, missed menstrual period, nipple discharge); tremor; trouble concentrating, speaking, or swallowing; trouble sitting still; trouble walking or standing; uncontrolled muscle movements (eg, arm or leg movements, twitching of the face or tongue, jerking or twisting); unusual bruising; vision changes; yellowing of the skin or eyes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
See also: Olanzapine side effects (in more detail)
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include abnormal thinking; aggression; agitation; chest pain; coma; confusion; difficult or slurred speech; fainting; fast or irregular heartbeat; fever; mental or mood changes; seizure; severe drowsiness, dizziness, or weakness; severe or persistent headache; slow or shallow breathing; stiff muscles; sweating; trouble walking; uncontrolled muscle movements.
Olanzapine is usually handled and stored by a health care provider. If you are using Olanzapine at home, store Olanzapine as directed by your pharmacist or health care provider. Keep Olanzapine out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Olanzapine. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
Cystina may be available in the countries listed below.
Cysteine is reported as an ingredient of Cystina in the following countries:
International Drug Name Search
Mycoban may be available in the countries listed below.
Miconazole nitrate (a derivative of Miconazole) is reported as an ingredient of Mycoban in the following countries:
International Drug Name Search
Class: Toxoids
ATC Class: J07AF01
VA Class: IM105
Brands: Decavac
Fixed-combination preparations containing formaldehyde-treated tetanus and diphtheria toxins (toxoids) adsorbed onto aluminum adjuvants.100 113 114 164 The toxoids are used to stimulate active immunity to diphtheria and tetanus.100 113 114 164 Commercially available as diphtheria and tetanus toxoids adsorbed (DT) and tetanus and diphtheria toxoids adsorbed (Td).113 114 164 DT contains a higher dose of diphtheria toxoid than Td.113 114 164 Single-antigen preparation containing tetanus toxoid adsorbed also commercially available.140
DT is used to prevent diphtheria and tetanus in infants and children 6 weeks through 6 years of age.100 114 Td is used to prevent diphtheria and tetanus in adults, adolescents, and children ≥7 years of age.113 164
Diphtheria is caused by toxigenic strains of Corynebacterium diphtheriae or, rarely, toxigenic strains of C. ulcerans.100 101 115 119 132 133 145 161 The overall case-fatality rate for diphtheria is 5–10% with higher death rates (up to 20%) among individuals <5 years of age and >40 years of age.119 162 Diphtheria is uncommon in the US, but toxigenic strains of Corynebacterium continue to circulate in areas of the US where the disease previously was endemic.100 101 119 161 Diphtheria continues to circulate worldwide and is endemic in Albania, Russia, and countries in the former Soviet Union and in many countries in Africa, Latin America, Asia/South Pacific, and the Middle East.100 101 119 Consult the CDC website () should be consulted for information regarding where diphtheria is endemic.115 Before widespread immunization against diphtheria was initiated in the 1940s, there were approximately 100,000–200,000 cases of diphtheria and 13,000–15,000 diphtheria-related deaths each year in the US.119 Most cases of diphtheria occur in individuals who are unvaccinated or incompletely vaccinated against the disease.100 101 119
Tetanus is a potentially fatal disease caused by a neurotoxic exotoxin (tetanospasmin) produced by Clostridium tetani.101 113 114 115 119 C. tetani spores are ubiquitous in the environment worldwide and are found in soil and in animal (e.g., horses, sheep, cattle, dogs, cats, rats, guinea pigs, chickens) and human intestinal tracts.100 101 114 115 119 132 The spores can contaminate open wounds, especially puncture wounds or those with devitalized tissue; anaerobic wound conditions allow the spores to germinate and produce exotoxins that disseminate through the blood and lymphatic system.101 119 132 Neonatal tetanus (tetanus neonatorum) occurs in infants born under nonsterile conditions to women inadequately vaccinated against tetanus; infection usually involves a contaminated umbilical stump and occurs because infant does not have passively-acquired maternal antibodies against tetanus.100 101 113 115 119 132 145 Obstetric tetanus occurs within 6 weeks after delivery or termination of pregnancy because of contaminated wounds or abrasions or unclean deliveries or abortions.145 Generalized tetanus is characterized by rigidity and convulsive muscle spasms that usually involve the jaw (lockjaw) and neck and then become generalized.101 113 115 119 132 Tetanus occurs worldwide, almost exclusively in individuals who are unvaccinated or inadequately vaccinated against the disease.101 115 An average of 31 cases reported each year in the US from 2000 through 2007 (case fatality rate 10%);119 a low of 20 cases reported in 2003.119 Most cases of tetanus in the US occur following acute injuries or wounds (puncture wounds, lacerations, abrasions)119 126 and usually occur in adults 40 years of age or older; however, an increase in the disease has been reported recently in younger adults (e.g., heroin abusers).119 126 Tetanus is not transmitted person-to-person.115 119
USPHS Advisory Committee on Immunization Practices (ACIP), AAP, and American Academy of Family Physicians (AAFP) recommend that all individuals be immunized against diphtheria and tetanus and also immunized against pertussis.100 101 102 132 133 134 135 145 Use of a combination vaccine generally is preferred over separate injections of equivalent component vaccines;102 163 considerations include provider assessment (e.g., number of injections, vaccine availability, likelihood of improved coverage, likelihood of patient return, storage requirements, cost), patient preference, and potential for adverse effects.102 163 Therefore, a fixed-combination preparation containing antigens for all 3 diseases (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed; DTaP) is preferred for primary and booster immunization against these diseases in infants and children 6 weeks through 6 years of age.100 101 102 119 DT should be used for primary or booster immunization against diphtheria and tetanus only when there is a contraindication to the pertussis antigens contained in DTaP.100 101 102 112 113 119
Td usually is the preparation of choice for primary and booster immunization against diphtheria and tetanus in individuals ≥7 years of age.100 101 102 133 134 145 However, to reduce morbidity associated with pertussis in adults, ACIP, AAP, and AAFP recommend that a single dose of a fixed-combination preparation that also contains pertussis antigens (tetanus toxoid and reduced diphtheria toxoid and acellular pertussis vaccine adsorbed; Tdap) be used in place of a required primary or booster dose of Td in all individuals 11–64 years of age, unless the pertussis antigens are contraindicated.102 132 133 134 135 145 Any individual in this age group who previously received a single dose of Tdap should then receive Td for all subsequent primary or booster doses.102 132 133 134 135 145
Combined active immunization with a preparation containing tetanus toxoid adsorbed and passive immunization with tetanus immune globulin (TIG) is used to prevent tetanus in individuals with tetanus-prone wounds who are inadequately vaccinated against tetanus or whose tetanus vaccination status is uncertain.100 101 110 113 132 133 145 164 (See Postexposure Prophylaxis of Tetanus under Uses.)
DT and Td are not indicated for treatment of diphtheria or treatment of tetanus.104 107 114
Because diphtheria and tetanus infections do not necessarily confer immunity, initiate or complete primary immunization against diphtheria and tetanus at the time of recovery from these infections in any previously unvaccinated or incompletely vaccinated individual.100 101 113 119
Travelers who are unvaccinated or incompletely vaccinated against diphtheria and tetanus should receive the remaining recommended doses prior to travel.115
Tetanus, diphtheria, and pertussis occur worldwide; the incidence of pertussis is highest in developing countries and other countries where routine immunization against pertussis is not widely practiced.115
CDC, AAP, and others recommend that travelers be adequately immunized against diphtheria, tetanus, and pertussis before leaving the US.101 108 115
Adults and children 7 years of age or older who are unvaccinated or incompletely vaccinated against diphtheria and tetanus should receive the remaining recommended doses of Td prior to travel.108 115 Those with an uncertain history of vaccination should be considered unvaccinated and should receive the full 3-dose primary immunization series.108 115 133 A routine booster dose of Td should be administered prior to travel if ≥10 years have elapsed since primary immunization or the last booster dose.108 115 A dose of Tdap can be substituted for a booster dose of Td in any adolescent or adult 11–64 years of age who has not previously received a dose of Tdap.108 115 132 133 (See Dosage and Administration.)
Because children 6 weeks through 6 years of age also should be immunized against pertussis, travelers in this age group who are unvaccinated or incompletely vaccinated should receive the remaining required doses of DTaP or, if the pertussis component is contraindicated, the remaining required doses of DT prior to travel.108 115 Previously unimmunized children should receive 3 doses (preferably 4 doses) before travel.108
If necessary to complete the vaccination series before departure, adults, adolescents, and children can receive an accelerated immunization schedule using the age-appropriate minimum intervals between doses.101 108 115 (See Dosage under Dosage and Administration.)
Any individual wounded while traveling who received their most recent dose of a tetanus toxoid-containing preparation >5 years previously may require a dose for postexposure prophylaxis of tetanus, depending on the nature of the wound.115 (See Postexposure Prophylaxis of Tetanus under Uses.)
Postexposure prophylaxis of tetanus in individuals with tetanus-prone wounds who previously received <3 doses of a preparation containing tetanus toxoid adsorbed or whose tetanus vaccination status is unknown or uncertain.100 101 110 113 132 133 145 164
Postexposure prophylaxis of tetanus involves active immunization with a tetanus toxoid-containing preparation with or without passive immunization with a dose of tetanus immune globulin (TIG).100 101 110 113 132 133 145 164
Tetanus-prone wounds include, but are not limited to, wounds contaminated with dirt, feces, soil, or saliva, deep wounds, burns, crush injuries, and wounds containing devitalized or necrotic tissue.100 101 115 119 Tetanus also has been associated with apparently clean, superficial wounds, surgical procedures, insect bites, animal bites, dental infections, chronic sores and infections, and IV drug abuse.115 119
In the event of injury and possible exposure to tetanus, the need for active immunization against tetanus with or without passive immunization with TIG depends on the individual’s vaccination status and the likelihood of contamination with tetanus bacilli (e.g., condition of wound, source of contamination).100 101 132 133 145
Table 1 summarizes ACIP guidelines for active and passive immunization against tetanus in routine wound management.
Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (Tdap). A dose of Tdap is preferred to a dose of Td in adolescents and adults 11 through 64 years of age who have not previously received a dose of Tdap. Use Td in individuals in this age group who previously received a dose of Tdap.
Tetanus and diphtheria toxoids adsorbed for adults use (Td). Td is used in adults, adolescents, and children ≥7 years of age. For children 6 weeks through 6 years of age, DTaP usually is indicated, but DT can be used if pertussis antigens are contraindicated. Monovalent tetanus toxoid adsorbed generally is used only when preparations containing tetanus and diphtheria antigens and preparations containing tetanus, diphtheria, and pertussis antigens are contraindicated or unavailable.
If only 3 doses of tetanus toxoid fluid (no longer commercially available in the US) have been received previously, a fourth dose should be given as a preparation containing tetanus toxoid adsorbed.
Yes, if it has been >10 years since last dose of tetanus toxoid-containing preparation.
Yes, if it has been >5 years since last dose of tetanus toxoid-containing preparation; more frequent booster doses not needed and can accentuate adverse effects.
Adapted from the Recommendations of the Immunization Practices Advisory Committee (ACIP) on prevention of diphtheria, tetanus, and pertussis published in MMWR Recomm Rep. 1991; 40(RR-10):1-28, MMWR Recomm Rep. 2006; 55(RR-3):1-43, and MMWR Recomm Rep. 2006; 55(RR-17):1-37.
Previous Doses of Tetanus Toxoid Adsorbed Received | Clean, Minor Wounds | All Other Wounds | ||
|---|---|---|---|---|
| Tdap or Td | TIG | Tdap or Td | TIG |
Unknown or <3 | Yes | No | Yes | Yes |
≥3 | No | No | No | No |
Any individual whose tetanus vaccination status is unknown or uncertain should be considered to have had no previous doses of tetanus toxoid adsorbed.100 132 133 145
ACIP, AAP, and AAFP recommend that a single dose of Tdap be used in place of a dose of Td for postexposure prophylaxis in individuals 11–64 years of age who have not previously received a dose of Tdap and received their last dose of Td ≥5 years earlier.102 132 133 135 145 Any individual in this age group who previously received a single dose of Tdap should receive Td for postexposure prophylaxis.102 132 133 135 145
Anti-infectives are not indicated for tetanus postexposure prophylaxis since they do not neutralize exotoxin already formed and cannot eradicate C. tetani spores, which may revert to toxin-producing vegetative forms.100 119
Postexposure vaccination in household and other close contacts of an individual with culture-confirmed or suspected diphtheria.100
Regardless of vaccination status, all household and other close contacts of an individual with culture-confirmed or suspected diphtheria should promptly receive anti-infective postexposure prophylaxis (single IM dose of penicillin G benzathine or oral erythromycin given for 7–10 days).100 101 119 161 Take samples for cultures prior to giving the anti-infective and continue to observe individual for 7 days for evidence of disease.100 119 161
In addition, those who previously received <3 doses of a diphtheria toxoid-containing preparation or whose vaccination status is unknown should receive an immediate dose of an age-appropriate preparation containing diphtheria toxoid adsorbed, and the primary vaccination series should be completed.100 101 119 Contacts who previously completed the primary vaccination series should receive a booster dose of an age-appropriate preparation containing diphtheria toxoid adsorbed if it has been ≥5 years since their last booster dose.100 101 119
Diphtheria antitoxin (equine) (available in the US only from the CDC under an investigational new drug [IND] protocol) is no longer routinely recommended for postexposure prophylaxis of diphtheria in contacts,100 101 119 but may be recommended in exceptional circumstances for postexposure prophylaxis in individuals with known or suspected exposure to toxigenic Corynebacterium.143 161 To obtain diphtheria antitoxin (equine), contact the CDC at 404-639-8257 from 8:00 a.m. to 4:30 p.m. EST Monday–Friday or the CDC Director's Emergency Operation Center (DEOC) at 770-488-7100 after hours, on weekends, and holidays.119 143 161
Administer by deep IM injection.113 114 164
Do not administer IV, sub-Q, or intradermally.113 114 164
To ensure a uniform suspension of antigens, shake vial or syringe well prior to administration.113 114 164 After shaking, suspension should be turbid, whitish-gray and free from clumps.113 114 164 Discard if toxoid cannot be resuspended.113 114 164
Do not dilute.113 114 164 Do not mix with any other vaccine or solution.113 114 164
Depending on patient age, administer IM into the midlateral muscles of the thigh or deltoid.112 113 114 164 To ensure delivery into muscle, IM injections should be made at a 90° angle to the skin using a needle length appropriate for the individual's age and body mass, the thickness of adipose tissue and muscle at the injection site, and the injection technique.112
Use the anterolateral thigh for IM injections in infants.112 In young children, use the deltoid muscle if muscle mass is adequate; alternatively, use the anterolateral thigh.112 The deltoid muscle is preferred in adults and adolescents.112
Avoid administering into the gluteal area or areas where there may be a major nerve trunk.113 114 164 Do not use the same muscle site more than once during the course of primary immunization.114
Prior to injection, ensure that needle is not in a blood vessel.114 Although some experts recommend that aspiration (i.e., pulling back on the syringe plunger after needle insertion and before injection) be performed to ensure that a blood vessel has not been entered, ACIP states that this procedure is not required because large blood vessels are not present at recommended IM injection sites.112
Syncope may occur following vaccination (usually in adolescents and young adults).112 Observe vaccinees for approximately 15 minutes after the vaccine dose is administered;112 if syncope occurs, observe patient until symptoms resolve.112
When passive immunization with TIG is indicated in addition to active immunization with a preparation containing tetanus toxoid adsorbed for postexposure prophylaxis of tetanus, DT or Td may be given simultaneously with TIG using different syringes and different injection sites.100 112 132 133 145 164 (See Postexposure Prophylaxis of Tetanus under Uses.)
May be given simultaneously with other age-appropriate vaccines during the same health-care visit (using different syringes and different injection sites).100 101 102 112 (See Interactions.)
When multiple vaccines are administered during a single health-care visit, each vaccine should be given with a different syringe and at different injection sites.112 Separate injection sites by at least 1 inch (if anatomically feasible) to allow appropriate attribution of any local adverse effects that may occur.112 If multiple vaccines must be given into a single limb, the deltoid muscle may be used in older children and adults, but the anterolateral thigh is preferred in infants and younger children.112
DT should only be used in infants and children 6 weeks through 6 years of age.114 Use only when DTaP cannot be used (i.e., when pertussis antigens are contraindicated or cannot be used).100 101 102
Td should only be used in adults, adolescents, and children ≥7 years of age.100 113 164
Medically stable preterm and low birthweight infants should be vaccinated at the usual chronologic age using the usual dosage.100 114 144
The complete vaccination series and recommended booster doses must be administered to ensure optimal protection against diphtheria and tetanus.113 114 Interruptions resulting in intervals between doses longer than recommended do not interfere with the final immunity achieved; there is no need to give additional doses or start the vaccination series over.100 112 114 119
If an accelerated immunization schedule is necessary in infants and children 6 weeks through 6 years of age (e.g., for catch-up immunization, immunization prior to travel), minimum intervals between first, second, and third doses of DT are 4 weeks; minimum intervals between third, fourth, and fifth doses are 6 months.102 108 In adults and children ≥7 years of age, minimum interval between first and second dose of Td is 4 weeks; minimum interval between second and third dose is 6 months.102 108 134
Primary immunization consists of a series of 4 doses with or without a fifth (booster) dose.100 101 102 114 Each dose is 0.5 mL.100 114
ACIP, AAP, and AAFP recommend that the first 3 doses be given 4–8 weeks apart (usually at 2, 4, and 6 months of age) and the fourth dose given approximately 6–12 months after the third dose (usually at 15–18 months of age).100 101 102 Fourth dose may be given as early as 12 months of age, provided at least 6 months have elapsed since the third dose;101 102 this flexibility allows scheduling the fourth dose to coincide with administration of other required vaccines.101
At 4–6 years of age (usually just prior to entry into kindergarten or elementary school), give a fifth (booster) dose to those who completed the primary immunization series before their fourth birthday.100 101 102 114 Fifth dose not necessary if last dose of the primary series was given on or after the fourth birthday.100 101 102 114
If an accelerated schedule is needed (e.g., for travelers), vaccination series may be started as soon as infant is 6 weeks of age; give second and third doses ≥4 weeks after the previous dose.102 Give a fourth and fifth dose ≥6 months after the previous dose; fifth (booster) dose not necessary if child received the fourth dosage at ≥4 years of age.102
Primary immunization consists of a series of 3 doses.102 113 Each dose is 0.5 mL.113 133 164
Give second dose 4–8 weeks after first dose and give third dose 6–12 months after second dose.102 113 133 164
Catch-up vaccination recommended for those who did not receive primary immunization against diphtheria and tetanus with DTaP, DT, or diphtheria and tetanus toxoids and whole-cell pertussis vaccine (DTP; not commercially available in the US).102 135
Primary immunization consists of a series of 3 doses.102 113 133 Each dose is 0.5 mL.113 133 164
Give second dose 4–8 weeks after first dose and give third dose 6–12 months after second dose.102 113 133 164
Adolescents 11–18 years of age who have not previously received a dose of Tdap: Unless the pertussis antigens are contraindicated or should not be used, substitute a single dose of Tdap (0.5 mL) for any 1 of the 3 doses of Td.101 102 133 135 The preferred primary immunization schedule in these individuals is a single dose of Tdap, followed by a dose of Td given at least 4 weeks after the Tdap dose and a second dose of Td given 6–12 months after the first dose of Td.102 133 135
Usual dose is 0.5 mL.100 101 112 113 133 135 164
To maintain adequate immunity against diphtheria and tetanus, ACIP, AAP, AAFP, and others recommend that all individuals who received primary immunization with any preparation containing diphtheria and tetanus toxoids (DT, Td, DTaP, DTP) receive a booster dose of a preparation containing diphtheria and tetanus toxoids at 11–12 years of age, provided at least 5 years have elapsed since the last dose.100 101 102 112 133 135 Alternatively, a booster dose can be given at 14–16 years of age, but administration at 11–12 years of age ensures immunity in this age group and encourages a routine preadolescent preventive care visit that facilitates administration of other vaccines recommended at this age (e.g., MMR, hepatitis B vaccine, HPV vaccine, varicella vaccine, meningococcal vaccine).102 133
Adolescents 11–18 years of age who have not previously received a dose of Tdap: Unless the pertussis component is contraindicated or should not be used, substitute a singledose of Tdap (0.5 mL) instead of Td for the adolescent booster dose given at 11–18 years of age.102 132 135 If Tdap is unavailable or was administered previously, use Td.132
An emergency dose of a preparation containing tetanus toxoid adsorbed may be indicated with or without a dose of TIG.100 101 113 119 133 135 164 (See Postexposure Prophylaxis of Tetanus under Uses.)
Wound care is an essential part of postexposure prophylaxis of tetanus and is necessary regardless of vaccination status.100 101 Clean and debride wounds properly, especially if dirt or necrotic tissue are present; remove all necrotic tissue and foreign material.101
Usual dose is 0.5 mL.100 101 113 164
Individuals who previously received <3 doses of a tetanus-toxoid-containing preparation: Give an emergency booster dose of Td as soon as possible if an injury and possible exposure to tetanus occurs.100 101 113 119
Individuals who previously received ≥3 doses of a tetanus toxoid-containing preparation: Give an emergency booster dose of Td if the injury is a clean, minor wound (not tetanus prone) and >10 years have elapsed since primary immunization against tetanus or the last booster dose of a tetanus toxoid-containing preparation.100 113 119 If injury is extensive (moderately or very tetanus prone), give an emergency booster dose of Td if >5 years have elapsed since primary immunization against tetanus or the last booster dose.100 113 119
Usual dose is 0.5 mL.100 101 113 164
Individuals who previously received <3 doses of a tetanus-toxoid-containing preparation: Give an emergency booster dose of age-appropriate preparation containing tetanus toxoid adsorbed as soon as possible if an injury and possible exposure to tetanus occurs.100 101 113 119 133
Individuals who previously received ≥3 doses of a tetanus toxoid-containing preparation: Give an emergency booster dose of an age-appropriate preparation containing tetanus toxoid adsorbed if the injury is a clean, minor wound (not tetanus prone) and >10 years have elapsed since primary immunization against tetanus or the last booster dose of a tetanus toxoid-containing preparation.100 113 119 133 If injury is extensive (moderately or very tetanus prone), give an emergency booster dose of Td if >5 years have elapsed since primary immunization against tetanus or the last booster dose.100 113 119 133
Adolescents 11–18 years of age who have not previously received a dose of Tdap and received the last dose of a tetanus toxoid-containing preparation ≥5 years earlier: Unless the pertussis component is contraindicated or should not be used, substitute a singledose of Tdap (0.5 mL) instead of Td.133 135 If Tdap is not available or was administered previously, use Td.133 135
Individuals who previously received <3 doses of a diphtheria toxoid-containing preparation or whose vaccination status is unknown: Give an immediate dose of an age-appropriate preparation containing diphtheria toxoid and complete the primary vaccination series.100 101 119
Individuals who previously completed the primary vaccination series but have not received a dose within the last 5 years: Give a booster dose of an age-appropriate preparation containing diphtheria toxoid.100 101 119
Used as an adjunct to anti-infective postexposure prophylaxis.100 101 119 (See Postexposure Prophylaxis of Diphtheria under Uses.)
Primary immunization in previously unvaccinated individuals or those with an uncertain vaccination history consists of a series of 3 doses.100 113 132 134 164 Each dose is 0.5 mL.100 113 132 164
Give second dose 4–8 weeks after first dose and give third dose 6–12 months after second dose.100 113 132 134 164
Adults 19–64 years of age who have not previously received a dose of Tdap: Unless the pertussis component is contraindicated or should not be used, substitute a single dose of Tdap (0.5 mL) instead of any 1 of the 3 doses of Td in the primary series.132 134 Preferably, give a dose of Tdap as the first dose, then give a dose of Td at least 4 weeks after the Tdap dose and at 6–12 months after the first dose of Td.132 If Tdap is not available or was administered previously, use Td.132 134
Usual dose is 0.5 mL.100 132 134 164
After primary immunization, give routine booster dose of Td every 10 years.100 132 134 164 In addition, in the event of an injury and possible exposure to tetanus, an emergency booster dose of Td may be indicated.100 119 132 164 (See Postexposure Prophylaxis of Tetanus under Dosage and Administration.)
Adults 19–64 years of age who have not previously received a dose of Tdap: Unless the pertussis component is contraindicated or should not be used, substitute a single dose of Tdap (0.5 mL) instead of Td.132 134 Thereafter, give routine booster dose of Td every 10 years.132 134
An emergency dose of a preparation containing tetanus toxoid adsorbed may be indicated with or without a dose of TIG.100 101 113 119 132 133 145 164 (See Postexposure Prophylaxis of Tetanus under Uses.)
Wound care is an essential part of postexposure prophylaxis of tetanus.100 101 Wound care is necessary regardless of vaccination status.100 101 Clean and debride wounds properly, especially if dirt or necrotic tissue are present; remove all necrotic tissue and foreign material.101
Usual dose is 0.5 mL.100 113 164
Individuals who previously received <3 doses of a tetanus-toxoid-containing preparation: Give an emergency booster dose of Td (0.5 mL) as soon as possible if an injury and possible exposure to tetanus occurs.100 113 119
Individuals who previously received ≥3 doses of a tetanus toxoid-containing preparation: Give an emergency booster dose of Td if the injury is a clean, minor wound (not tetanus prone) and >10 years have elapsed since primary immunization against tetanus or the last booster dose of a tetanus toxoid-containing preparation.100 113 119 If injury is extensive (moderately or very tetanus prone), give an emergency booster dose of Td if >5 years have elapsed since primary immunization against tetanus or the last booster dose.100 113 119
Adults 19–64 years of age who have not previously received a dose of Tdap: Substitute a single dose of Tdap (0.5 mL) instead a booster dose of Td.132 134
Individuals who previously received <3 doses of a diphtheria toxoid-containing preparation or whose vaccination status is unknown: Give an immediate dose of an age-appropriate preparation containing diphtheria toxoid and complete the primary vaccination series.100 101 119
Individuals who previously completed the primary vaccination series but have not received a dose within the last 5 years: Give a booster dose of an age-appropriate preparation containing diphtheria toxoid.100 101 119
Used as an adjunct to anti-infective postexposure prophylaxis.100 119 (See Postexposure Prophylaxis of Diphtheria under Uses.)
No specific dosage recommendations.
No specific dosage recommendations.
No specific dosage recommendations.
Anaphylaxis or other serious allergic reaction following a dose of any preparation containing diphtheria or tetanus toxoid.113 114 164
