Eritril may be available in the countries listed below.
Enalapril maleate (a derivative of Enalapril) is reported as an ingredient of Eritril in the following countries:
International Drug Name Search
RapitilTM Eye Drops
Nedocromil sodium 2.0% w/v.
Presented as a 5 ml sterile, preserved, aqueous solution containing 2% nedocromil sodium in a dropper bottle for administration to the eye.
For the prevention, relief and treatment of allergic conjunctivitis, including seasonal allergic conjunctivitis, allergic conjunctivitis and vernal-kerato conjunctivitis.
Adults (including the elderly) and children aged 6 years and over:
In seasonal allergic conjunctivitis: one drop into each eye twice daily, increasing when necessary to four times daily. In seasonal allergic conjunctivitis therapy should be restricted to 12 weeks.
In vernal kerato-conjunctivitis: one drop into each eye four times daily.
Adults (including the elderly):
In perennial allergic conjunctivitis: one drop into each eye twice daily, increasing when necessary to four times daily.
Rapitil should be used regularly to ensure optimum control of symptoms.
There is only limited clinical trial evidence with Rapitil in children aged below 6 years, therefore use in this age range cannot be recommended.
Contraindicated in patients with known hypersensitivity to any constituent of the formulation.
Patients who use soft contact lenses should be advised not to wear them during the treatment period. In patients who continue to use hard or gas-permeable contact lenses during treatment with the eye drops, the lenses should be taken out of the eye prior to instillation and not inserted again for at least 10 minutes.
None has been reported.
Studies in pregnant and lactating animals have failed to reveal a hazard with nedocromil sodium. However, as with all medications caution should be exercised during pregnancy (especially during the first trimester) and whilst breast feeding.
On the basis of animal studies and its physicochemical properties it is considered that only negligible amounts of nedocromil sodium may pass into human breast milk. There is no information to suggest that the use of nedocromil sodium by nursing mothers has any undesirable effects upon the baby.
No sedative effects have been reported.
Transient stinging and burning may occur after instillation. Other symptoms of local irritation have been reported rarely. Some patients have reported a distinctive taste.
Animal studies have not shown evidence of toxic effects of nedocromil sodium even at high dosage, nor have extended human studies revealed any safety hazard with the drug. Overdosage is unlikely, therefore, to cause problems. However, if suspected, treatment should be supportive and directed to the control of the relevant symptoms.
Pharmacotherapeutic group: Decongestant and other antiallergics
ATC code: S01G X04
Rapitil, the ophthalmic preparation of nedocromil sodium, displays specific anti-allergic and anti-inflammatory properties. Nedocromil sodium has been shown to prevent the release of inflammatory mediators from a range of inflammatory cell types.
Following topical ophthalmic administration, less than 4% of the dose is absorbed following multiple dosing. Absorption occurs primarily through the nasal mucosa as approximately 80% of the ophthalmic dose drains into the nose via the naso-lachrymal duct, although 1-2% of the dose may be absorbed orally.
Nedocromil sodium is reversibly bound to plasma proteins and is not metabolised, but is excreted unchanged in bile and urine. The drug is rapidly cleared from the plasma (plasma clearance 10.2 + 1.3 ml/min/kg - elimination half-life 5.3 + 0.9 min) and accumulation does not occur.
Animal studies have failed to reveal toxic effects with nedocromil sodium even at high doses.
benzalkonium chloride,
sodium chloride,
disodium edetate.
None known.
36 months.
Store below 25°C, away from direct sunlight. Discard any remaining contents four weeks after opening the bottle.
A plastic dropper bottle containing 5ml of sterile, aqueous solution for administration to the eye.
Please refer to enclosed package insert.
Sanofi-aventis
One Onslow Street
Guildford
Surrey
GU1 4YS
UK
PL 04425/0285
26 February 2004
22 July 2010
POM
In the US, Gadodiamide (gadodiamide systemic) is a member of the drug class magnetic resonance imaging contrast media and is used to treat CNS Magnetic Resonance Imaging and Vascular Magnetic Resonance Imaging.
US matches:
Rec.INN
V08CA03
0131410-48-5
C16-H26-Gd-N5-O8
573
Contrast medium, NMR-tomography
[N,N-bis[2-[(Carboxymethyl)[(methylcarbamoyl)methyl]amino]ethyl]glycinato(3-)]gadolinium
International Drug Name Search
Glossary
| BAN | British Approved Name |
| DCF | Dénomination Commune Française |
| IS | Inofficial Synonym |
| OS | Official Synonym |
| PH | Pharmacopoeia Name |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
| USAN | United States Adopted Name |
Rx Only
The active ingredient in Dipentum Capsules (olsalazine sodium) is the sodium salt of a salicylate, disodium 3,3'-azobis (6-hydroxybenzoate) a compound that is effectively bioconverted to 5-aminosalicylic acid (5-ASA), which has anti-inflammatory activity in ulcerative colitis. Its empirical formula is C14H8N2Na2O6 with a molecular weight of 346.21.
The structural formula is:
Olsalazine sodium is a yellow crystalline powder, which melts with decomposition at 240°C. It is the sodium salt of a weak acid, soluble in water and DMSO, and practically insoluble in ethanol, chloroform, and ether. Olsalazine sodium has acceptable stability under acidic or basic conditions.
Dipentum is supplied in hard gelatin capsules for oral administration. The inert ingredient in each 250 mg capsule of olsalazine sodium is magnesium stearate. The capsule shell contains the following inactive ingredients: black iron oxide, caramel, gelatin, and titanium dioxide.
After oral administration, olsalazine has limited systemic bioavailability. Based on oral and intravenous dosing studies, approximately 2.4% of a single 1.0 g oral dose is absorbed. Less than 1% of olsalazine is recovered in the urine. The remaining 98 to 99% of an oral dose will reach the colon, where each molecule is rapidly converted into two molecules of 5-aminosalicylic acid (5-ASA) by colonic bacteria and the low prevailing redox potential found in this environment. The liberated 5-ASA is absorbed slowly resulting in very high local concentrations in the colon.
The conversion of olsalazine to mesalamine (5-ASA) in the colon is similar to that of sulfasalazine, which is converted into sulfapyridine and mesalamine. It is thought that the mesalamine component is therapeutically active in ulcerative colitis (A.K. Azad-Kahn et al, LANCET, 2:892-895, 1977). The usual dose of sulfasalazine for maintenance of remission in patients with ulcerative colitis is 2 grams daily, which would provide approximately 0.8 gram of mesalamine to the colon. More than 0.9 gram of mesalamine would usually be made available in the colon from 1 gram of olsalazine.
The mechanism of action of mesalamine (and sulfasalazine) is unknown, but appears to be topical rather than systemic. Mucosal production of arachidonic acid (AA) metabolites, both through the cyclooxygenase pathways (i.e., prostanoids) and through the lipoxygenase pathways (i.e., leukotrienes [LTs] and hydroxyeicosatetraenoic acids [HETEs]) is increased in patients with chronic inflammatory bowel disease, and it is possible that mesalamine diminishes inflammation by blocking cyclooxygenase and inhibiting prostaglandin (PG) production in the colon.
The pharmacokinetics of olsalazine are similar in both healthy volunteers and in patients with ulcerative colitis. Maximum serum concentrations of olsalazine appear after approximately 1 hour and, even after a 1.0 g single dose, are low (e.g., 1.6 to 6.2 µmol/L). Olsalazine has a very short serum half-life, approximately 0.9 hour. Olsalazine is more than 99% bound to plasma proteins. It does not interfere with protein binding of warfarin. The urinary recovery of olsalazine is below 1%. Total recovery of oral 14C-labeled olsalazine in animals and humans ranges from 90 to 97%. Approximately 0.1% of an oral dose of olsalazine is metabolized in the liver to olsalazine-O-sulfate (olsalazine-S). Olsalazine-S, in contrast to olsalazine has a half-life of 7 days. Olsalazine-S accumulates to steady state within 2 to 3 weeks.
Patients on daily doses of 1.0 g olsalazine for 2 to 4 years show a stable plasma concentration of olsalazine-S (3.3 to 12.4 µmol/L). Olsalazine-S is more than 99% bound to plasma proteins. Its long half-life is mainly due to slow dissociation from the protein binding site. Less than 1% of both olsalazine and olsalazine-S appears undissociated in plasma.
Serum concentrations of 5-ASA are detected after 4 to 8 hours. The peak levels of 5-ASA after an oral dose of 1.0 g olsalazine are low (i.e., 0 to 4.3 µmol/L). Of the total 5-ASA found in the urine, more than 90% is in the form of N-acetyl-5-ASA (Ac-5-ASA). Only small amounts of 5-ASA are detected.
N-acetyl-5-ASA (Ac-5-ASA), the major metabolite of 5-ASA found in plasma and urine, is acetylated (deactivated) in at least two sites, the colonic epithelium and the liver. Ac-5-ASA is found in the serum, with peak values of 1.7 to 8.7 µmol/L after a single 1.0 g dose. Approximately 20% of the total 5-ASA is recovered in the urine, where it is found almost exclusively as Ac-5-ASA. The remaining 5-ASA is partially acetylated and is excreted in the feces. From fecal dialysis, the concentration of 5-ASA in the colon following olsalazine has been calculated to be 18 to 49 mmol/L. No accumulation of 5-ASA or Ac-5-ASA in plasma has been detected. 5-ASA and Ac-5-ASA are 74 and 81%, respectively, bound to plasma proteins.
Preclinical subacute and chronic toxicity studies in rats have shown the kidney to be the major target organ of olsalazine toxicity. At an oral daily dose of 400 mg/kg or higher, olsalazine treatment produced nephritis and tubular necrosis in a 4-week study; interstitial nephritis and tubular calcinosis in a 6-month study, and renal fibrosis, mineralization, and transitional cell hyperplasia in a 1-year study.
Two controlled studies have demonstrated the efficacy of olsalazine as maintenance therapy in patients with ulcerative colitis. In the first, ulcerative colitis patients in remission were randomized to olsalazine 500 mg B.I.D. or placebo, and relapse rates for a six month period of time were compared. For the 52 patients randomized to olsalazine, 12 relapses occurred, while for the 49 placebo patients, 22 relapses occurred. This difference in relapse rates was significant (p<0.02).
In the second study, 164 ulcerative colitis patients in remission were randomized to olsalazine 500 mg B.I.D. or sulfasalazine 1 gram B.I.D., and relapse rates were compared after six months. The relapse rate for olsalazine was 19.5% while that for sulfasalazine was 12.2%, a non-significant difference.
Olsalazine is indicated for the maintenance of remission of ulcerative colitis in patients who are intolerant of sulfasalazine.
Hypersensitivity to olsalazine, other salicylates, or any of the excipients.
Overall, approximately 17% of subjects receiving olsalazine in clinical studies reported diarrhea sometime during therapy. This diarrhea resulted in withdrawal of treatment in 6% of patients. This diarrhea appears to be dose related, although it may be difficult to distinguish from the underlying symptoms of the disease.
Exacerbation of the symptoms of colitis thought to have been caused by mesalamine or sulfasalazine has been noted.
Patients should be instructed to take olsalazine with food. The drug should be taken in evenly divided doses. Patients should be informed that about 17% of subjects receiving olsalazine during clinical studies reported diarrhea sometime during therapy. If diarrhea occurs, patients should contact their physician.
The co-administration of salicylates and low molecular weight heparins or heparinoids may result in an increased risk of bleeding (i.e., hematomas) following neuraxial anesthesia. Salicylates should be discontinued prior to the initiation of a low molecular weight heparin or heparinoid. If this is not possible, it is recommended to monitor patients closely for bleeding.
Increased prothrombin time in patients taking concomitant warfarin has been reported.
The co-administration of olsalazine and 6-mercaptopurine or thioguanine may result in an increased risk of myelosuppression. If co-administered with 6-mercaptopurine, it is recommended to use the lowest possible doses of each drug and to monitor the patient, especially for leukopenia. In case of co-administration with thioguanine, careful monitoring of blood counts is recommended.
It is recommended not to give salicylates for six weeks after the varicella vaccine to avoid a possible increased risk of developing Reye's syndrome.
None known.
In a two year oral rat carcinogenicity study, olsalazine was tested in male and female Wistar rats at daily doses of 200, 400, and 800 mg/kg/day (approximately 10 to 40 times the human maintenance dose, based on a patient weight of 50 kg and a human dose of 1 g). Urinary bladder transitional cell carcinomas were found in three male rats (6%, p=0.022, exact trend test) receiving 40 times the human dose and were not found in untreated male controls. In the same study, urinary bladder transitional cell carcinoma and papilloma occurred in 2 untreated control female rats (2%). No such tumors were found in any of the female rats treated at doses up to 40 times the human dose.
In an eighteen month oral mouse carcinogenicity study, olsalazine was tested in male and female CD-1 mice at daily doses of 500, 1000, and 2000 mg/kg/day (approximately 25 to 100 times the human maintenance dose). Liver hemangiosarcomata were found in two male mice (4%) receiving olsalazine at 100 times the human dose, while no such tumor occurred in the other treated male mice groups or any of the treated female mice. The observed incidence of this tumor is within the 4% incidence in historical controls.
Olsalazine was not mutagenic in in vitro Ames tests, mouse lymphoma cell mutation assays, human lymphocyte chromosomal aberration tests, or the in vivo rat bone marrow cell chromosomal aberration test.
Olsalazine in a dose range of 100 to 400 mg/kg/day (approximately 5 to 20 times the human maintenance dose) did not influence the fertility of male or female rats. The oligospermia and infertility in men associated with sulfasalazine have not been reported with olsalazine.
Olsalazine has been shown to produce fetal developmental toxicity as indicated by reduced fetal weights, retarded ossifications, and immaturity of the fetal visceral organs when given during organogenesis to pregnant rats in doses 5 to 20 times the human dose (100 to 400 mg/kg).
There are no adequate and well-controlled studies in pregnant women. Olsalazine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Small amounts of the active metabolite of olsalazine (5-ASA) may pass into breast milk. Harmful infant effects (diarrhea) have been reported when 5-ASA was used during breastfeeding. Unless the benefit of the treatment outweighs the risks, olsalazine should not be taken by breast-feeding women, or patients should be advised to discontinue breastfeeding if using olsalazine.
Oral administration of olsalazine to lactating rats in doses 5 to 20 times the human dose produced growth retardation in their pups.
Safety and effectiveness in a pediatric population have not been established.
Clinical studies of Dipentum did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, elderly patients should be treated with caution due to the greater frequency of decreased hepatic, renal, or cardiac function, co-existence of other disease, as well as concomitant drug therapy.
Patients with severe allergies or asthma should be monitored for signs of worsening symptoms.
Patients with impaired renal function should be monitored.
Although renal abnormalities were not reported in clinical trials with olsalazine, there have been rare reports from post-marketing experience (see ADVERSE REACTIONS, Postmarketing). Therefore, the possibility of renal tubular damage due to absorbed mesalamine or its n-acetylated metabolite, as noted in the ANIMAL TOXICOLOGY section must be kept in mind, particularly for patients with pre-existing renal disease. In these patients, monitoring with urinalysis, BUN, and creatinine determinations is advised.
Patients with impaired hepatic function should be monitored (see ADVERSE REACTIONS, Postmarketing).
Olsalazine has been evaluated in ulcerative colitis patients in remission, as well as those with acute disease. Both sulfasalazine-tolerant and intolerant patients have been studied in controlled clinical trials. Overall, 10.4% of patients discontinued olsalazine because of an adverse experience compared with 6.7% of placebo patients. The most commonly reported adverse reactions leading to treatment withdrawal were diarrhea or loose stools (olsalazine 5.9%; placebo 4.8%), abdominal pain, and rash or itching (slightly more than 1% of patients receiving olsalazine). Other adverse reactions to olsalazine leading to withdrawal occurred in fewer than 1% of patients (Table 1).
| Olsalazine (N = 441) | Placebo (N = 208) | |
|---|---|---|
| Diarrhea/Loose Stools | 26 (5.9%) | 10 (4.8 %) |
| Nausea | 3 | 2 |
| Abdominal Pain | 5 (1.1%) | 0 |
| Rash/Itching | 5 (1.1%) | 0 |
| Headache | 3 | 0 |
| Heartburn | 2 | 0 |
| Rectal Bleeding | 1 | 0 |
| Insomnia | 1 | 0 |
| Dizziness | 1 | 0 |
| Anorexia | 1 | 0 |
| Light Headedness | 1 | 0 |
| Depression | 1 | 0 |
| Miscellaneous | 4 (0.9%) | 3 (1.4%) |
| Total Number of Patients Withdrawn | 46 (10.4%) | 14 (6.7 %) |
For those controlled studies, the comparative incidences of adverse reactions reported in 1% or more patients treated with olsalazine or placebo are provided in Table 2.
| Adverse Event | Olsalazine (N = 441) % | Placebo (N = 208) % |
|---|---|---|
| Gastrointestinal Disorders | ||
| Diarrhea | 11.1 | 6.7 |
| Abdominal Pain/Cramps | 10.1 | 7.2 |
| Nausea | 5.0 | 3.9 |
| Dyspepsia | 4.0 | 4.3 |
| Bloating | 1.5 | 1.4 |
| Vomiting | 1.0 | - |
| Stomatitis | 1.0 | - |
| Increased Blood in Stool | - | 3.4 |
| Metabolism and Nutrition Disorders | ||
| Anorexia | 1.3 | 1.9 |
| Nervous System Disorders | ||
| Headache | 5.0 | 4.8 |
| Insomnia | - | 2.4 |
| General Disorders and Administration Site Conditions | ||
| Fatigue/Drowsiness/Lethargy | 1.8 | 2.9 |
| Psychiatric Disorders | ||
| Depression | 1.5 | - |
| Ear and Labyrinth Disorders | ||
| Vertigo/Dizziness | 1.0 | - |
| Skin and Subcutaneous Tissue Disorders | ||
| Rash | 2.3 | 1.4 |
| Itching | 1.3 | - |
| Musculoskeletal and Connective Tissue Disorders | ||
| Arthralgia/Joint Pain | 4.0 | 2.9 |
| Infections and Infestations | ||
| Upper Respiratory Infection | 1.5 | - |
Over 2,500 patients have been treated with olsalazine in various controlled and uncontrolled clinical studies. In these as well as in post-marketing experience, olsalazine was administered mainly to patients intolerant to sulfasalazine. There have been rare reports of the following adverse effects in patients receiving olsalazine. These were often difficult to distinguish from possible symptoms of the underlying disease or from the effects of prior and/or concomitant therapy. A causal relationship to the drug has not been demonstrated for some of these reactions.
Blood and Lymphatic System Disorders: Anemia, Eosinophilia, Hemolytic anemia, Interstitial pulmonary disease, Leukopenia, Lymphopenia, Neutropenia, Reticulocytosis, Thrombocytopenia
Cardiac Disorders: Chest pains, Heart block second degree, Myocarditis, Palpitations, Pericarditis, Peripheral edema, Shortness of breath, Tachycardia
A patient who developed thyroid disease 9 days after starting Dipentum was given propranolol and radioactive iodine and subsequently developed shortness of breath and nausea. The patient died 5 days later with signs and symptoms of acute diffuse myocarditis.
Ear and Labyrinth Disorders: Tinnitus
Eye Disorders: Dry eyes, Vision blurred, Watery eyes
Gastrointestinal Disorders: Abdominal pain (upper), Diarrhea with dehydration, Dry mouth, Epigastric discomfort, Flare in symptoms, Flatulence, Increased blood in stool, Pancreatitis, Rectal bleeding, Rectal discomfort
In a double-blind, placebo-controlled study, increased frequency and severity of diarrhea were reported in patients randomized to olsalazine 500 mg B.I.D. with concomitant pelvic radiation.
Rare cases of granulomatous hepatitis and nonspecific, reactive hepatitis have been reported in patients receiving olsalazine. Additionally, a patient developed mild cholestatic hepatitis during treatment with sulfasalazine and experienced the same symptoms two weeks later after the treatment was changed to olsalazine. Withdrawal of olsalazine led to complete recovery in these cases.
General Disorders and Administration Site Conditions: Fever chills, Hot flashes, Irritability, Rigors
Immune System Disorders: Bronchospasm, Erythema nodosum
Laboratory: ALT (SGPT) or AST (SGOT) elevated beyond the normal range.
Musculoskeletal and Connective Tissue Disorders: Muscle cramps
Nervous System Disorders: Insomnia, Paraesthesia, Tremors
Psychiatric Disorders: Mood swings
Renal and Urinary Disorders: Dysuria, Hematuria, Interstitial nephritis, Nephrotic syndrome, Proteinuria, Urinary frequency
Reproductive System and Breast Disorders: Impotence, Menorrhagia
Skin and Subcutaneous Tissue Disorders: Alopecia, Erythema, Photosensitivity reaction
Vascular Disorders: Hypertension, Orthostatic hypotension
The following events have been identified during post-approval use of products that contain (or are metabolized to) mesalamine in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to a combination of seriousness, frequency of reporting, or potential causal connection to mesalamine:
Blood and Lymphatic System Disorders: Aplastic anemia, Pancytopenia
General Disorders and Administration Site Conditions: Pyrexia
Hepatobiliary Disorders: Hepatic enzyme increased, Hepatitis, Increased bilirubin
Reports of hepatotoxicity, including elevated liver function tests (SGOT/AST, SGPT/ALT, GGT, LDH, alkaline phosphatase, bilirubin), jaundice, cholestatic jaundice, cirrhosis, and possible hepatocellular damage including liver necrosis and liver failure. Some of these cases were fatal. One case of Kawasaki-like syndrome, which included hepatic function changes, was also reported.
Musculoskeletal and Connective Tissue Disorders: Myalgia
Respiratory, Thoracic and Mediastinal Disorders: Dyspnoea, Interstitial lung disease
Skin and Subcutaneous Tissue Disorders: Angioneurotic oedema
Nervous System Disorders: Paraesthesia, Peripheral neuropathy
Renal and Urinary Disorders: Interstitial nephritis
None reported.
Drug dependence has not been reported with chronic administration of olsalazine.
No overdosage has been reported in humans. The knowledge of overdosage is limited. Possible overdose symptoms include nausea, vomiting and diarrhea. It is recommended to check hematology, acid-base, electrolyte, liver and kidney status, and to provide supportive treatment. There is no specific antidote to Dipentum.
Maximum single oral doses of 5 g/kg in mice and rats and 2 g/kg in dogs were not lethal. Symptoms of acute toxicity were decreased motor activity and diarrhea in all species tested. In addition, vomiting was reported in dogs.
The usual dosage in adults for maintenance of remission is 1.0 g/day in two divided doses.
Beige colored capsules, containing 250 mg olsalazine sodium imprinted with "Dipentum® 250 mg" on the capsule shell, available as:
Store at 20-25°C (77°F). Excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
Manufactured for:
Alaven Pharmaceutical LLC
Marietta, GA USA
by UCB Manufacturing, Inc.
Rochester, NY 14623 USA
For Medical Inquiries, call 1-888-317-0001
Dipentum is a registered trademark
© 2009, ALAVEN Pharmaceutical LLC, Marietta, GA
All rights reserved. Printed in U.S.A.
Rev. 4E 02/2009
160-0209-01
CIA71870B
CIA60030
NDC 68220-160-10
100 Capsules
Dipentum®
(olsalazine sodium capsules)
250 mg
Rx only
| Dipentum olsalazine sodium capsule, gelatin coated | ||||||||||||||||||||
| ||||||||||||||||||||
| ||||||||||||||||||||
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| NDA | NDA019715 | 07/31/1990 | |
| Labeler - Alaven Pharmaceutical LLC (140210829) |
Relieving congestion and cough and preventing or treating symptoms such as runny nose, sneezing, itching of the nose and throat, and itchy, watery eyes due to colds, flu, or hay fever. It may also be used for other conditions as determined by your doctor.
Diphenhydramine/Hydrocodone/Phenylephrine Syrup is an antihistamine, decongestant, and cough suppressant combination. It works by constricting blood vessels and reducing swelling in the nasal passages, allowing you to breathe more easily. The antihistamine works by blocking the action of histamine, reducing symptoms of an allergic reaction. The cough suppressant works in the brain to decrease the cough reflex to help decrease a dry cough.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Diphenhydramine/Hydrocodone/Phenylephrine Syrup. 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 Diphenhydramine/Hydrocodone/Phenylephrine Syrup. 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 Diphenhydramine/Hydrocodone/Phenylephrine Syrup 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 Diphenhydramine/Hydrocodone/Phenylephrine Syrup 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 Diphenhydramine/Hydrocodone/Phenylephrine Syrup.
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:
Dizziness; drowsiness, excitability; headache; nausea; nervousness or anxiety; trouble sleeping; weakness.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty urinating; fast or irregular heartbeat; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; tremor.
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: Diphenhydramine/Hydrocodone/Phenylephrine 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 blurred vision; confusion; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; unusually fast, slow, or irregular heartbeat; vomiting.
Store Diphenhydramine/Hydrocodone/Phenylephrine Syrup at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Diphenhydramine/Hydrocodone/Phenylephrine Syrup out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Diphenhydramine/Hydrocodone/Phenylephrine Syrup. 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.
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
