Chloortetracycline may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Chlortetracycline hydrochloride (a derivative of Chlortetracycline) is reported as an ingredient of Chloortetracycline in the following countries:
International Drug Name Search
Clop may be available in the countries listed below.
Metoclopramide is reported as an ingredient of Clop in the following countries:
International Drug Name Search
Panleef may be available in the countries listed below.
Tamoxifen citrate (a derivative of Tamoxifen) is reported as an ingredient of Panleef in the following countries:
International Drug Name Search
Amiodarona Larjan may be available in the countries listed below.
Amiodarone hydrochloride (a derivative of Amiodarone) is reported as an ingredient of Amiodarona Larjan in the following countries:
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Miconazolnitraat may be available in the countries listed below.
Miconazole nitrate (a derivative of Miconazole) is reported as an ingredient of Miconazolnitraat in the following countries:
International Drug Name Search
Exil No Worm may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Nitroscanate is reported as an ingredient of Exil No Worm in the following countries:
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Class: Opiate Agonists
VA Class: CN101
CAS Number: 76-42-6
Brands: Combunox, Endocet, Endodan, Endocodone, OxyContin, Oxydose, OxyFast, OxyIR, Percocet, Percodan, Percolone, Roxicet, Roxicodone, Roxiprin, Tylox
Schedule II controlled substance with abuse liability similar to morphine.b
Potential for abuse in a manner similar to other legal or illicit opiates.b Consider abuse potential when prescribing or dispensing oxycodone extended-release tablets (e.g., OxyContin) in situations where the clinician or pharmacist is concerned about increased risk of misuse, abuse, or diversion.b
Oxycodone hydrochloride extended-release tablets (e.g., OxyContin) are a controlled-release oral formulation indicated for the management of moderate to severe pain when a continuous, around-the-clock analgesic is needed for an extended period of time.b
Oxycodone hydrochloride extended-release tablets (e.g., OxyContin) are not intended for use as a prn analgesic.b
Only use the 80-mg formulation in opiate-tolerant patients.b This strength may cause fatal respiratory depression when administered to patients not previously exposed to opiates.b (See Dosage and Administration.)
Oxycodone hydrochloride extended-release tablets are to be swallowed whole and are not to be broken.b
Chewing, crushing, or dissolving the extended-release tablets could result in rapid release and absorption of a potentially fatal dose of oxycodone hydrochloride.b
REMS:
FDA approved a REMS for oxycodone to ensure that the benefits of a drug outweigh the risks. The REMS may apply to one or more preparations of oxycodone and consists of the following: medication guide and elements to assure safe use. See the FDA REMS page () or the ASHP REMS Resource Center ().
Opiate agonist; phenanthrene-derivative.a
Relief of moderate to moderately severe pain.f g h i
Usually, temporary relief of moderate to moderately severe pain such as that associated with acute and some chronic medical disorders including renal or biliary colic, acute trauma, postoperative pain, and cancer.e
Additive analgesic effects with combinations of oxycodone and NSAIAs or acetaminophen because of differing mechanisms of action.c
Consider around-the-clock dosing of analgesics in the initial stages of acute pain to avoid wide swings in pain and sedation often associated with as-needed dosing regimens.e
Extended-release tablets are not intended for use on an as-needed (“prn”) basis, but when a continuous, around-the-clock analgesic is needed for an extended period of time.
For relief of malignant (cancer) pain and chronic nonmalignant pain.e f g h
In the management of chronic pain associated with a terminal illness such as cancer, the principal goal of analgesic therapy is to make the patient relatively pain-free while maintaining as good a quality of life as possible.e
Analgesic therapy must be individualized and titrated according to patient response and tolerance.e f g h i
When opiate therapy is indicated, usually initiate with a mild, oral opiate like oxycodone.e f g h i
Although consideration of the dependence potential of opiate agonists has often limited their effective use by many clinicians in terminally ill patients with severe, chronic pain, such consideration is irrelevant in the context of terminal illness.e
Treatment of continuous or frequently recurring pain is best accomplished by the use of “around-the-clock” dosing regimens designed to prevent pain and minimize fluctuations in serum analgesic concentrations.e f g h
If pain severity increases, switching to more potent analgesics may be necessary; also consider alternative analgesic adjuncts such as tricyclic antidepressants or anticonvulsants (e.g., in the treatment of chronic nonmalignant pain such as neurogenic pain).e f g h
Adjust dosage according to patient tolerance and response; provide supplemental analgesia in the form of conventional preparations or another suitable short-acting analgesic for breakthrough pain or to prevent pain that occurs predictably (e.g., incident pain associated with certain activities).
Only use the 80-mg formulation in opiate-tolerant patients whose opiate requirement is equivalent to a daily oxycodone dosage of 160 mg or more.
Supplemental analgesia may be necessary during therapy with extended-release tablets for breakthrough pain; discontinue any other existing around-the-clock opiate regimens when extended-release oxycodone therapy is initiated.
When therapy with oxycodone extended-release tablets is discontinued, it should be done gradually to avoid precipitation of withdrawal symptoms.
Administer orally.a
Swallow tablets whole; do not divide, crush, or chew. (See Boxed Warning.)
Food does not substantially affect the extent of oral absorption from extended-release tablets.
Suppositories are not commercially available in the US.a
When rectal administration was preferred, conventional oral tablets or solution have been administered rectally†.g
If administered rectally†, insert the dosage form just inside the rectal sphincter for optimal systemic absorption of unmetabolized drug.h g Administration high in the rectal vault can result in rapid first-pass hepatic metabolism, with greatly diminished efficacy.h g
Not usually suitable for long-term administration due to rectal irritation from repeated dosing.g
Although the manufacturer states that extended-release tablets should not be administered rectally, rectal administration of extended-release formulations are used widely for opiate delivery in palliative care.h
Available as oxycodone hydrochloride and oxycodone terephthalate; dosage expressed in terms of the respective salt.b d
Children <50 kg: Usually, initiate with 0.1–0.2 mg/kg every 3–4 hours as needed.f g h i Adjust according to response and tolerance.f g h
Children ≥50 kg: Usually, initiate with 5–10 mg every 3–4 hours as needed.f g h i Adjust according to response and tolerance.f g h
Children 6–12 Years of Age: 0.61 mg of the combined salts every 6 hours.
Children ≥12 Years of Age: 1.22 mg of the combined salts every 6 hours.
Usually, initiate with 5–15 mg every 4–6 hours as needed.a c Adjust according to response and tolerance.c f g h
4.88 mg every 6 hours as the combined salts.a
Nonopiate-containing analgesic fixed combinations: Nonopiate component may limit dosage of opiate component.117 119 120 121 Nonopiate analgesics are available in various fixed ratios with oxycodone and also are available in many other prescription and OTC preparations; ensure that therapy is not duplicated and that nonopiate dosage does not exceed maximum recommended dosages.117 118 119 121
Initially, 10 mg every 12 hours.a Patients previously receiving nonopiate analgesics may continue these drugs as dosage of the extended-release tablets is titrated to provide adequate analgesia.
Calculate the total daily dosage of the conventional preparation and give as extended-release tablets in 2 divided doses at 12-hour intervals.
The equivalent total daily dosage of oxycodone hydrochloride should be calculated based on standard conversion factors suggested by the manufacturer (table below) and administered as extended-release tablets in 2 divided doses at 12-hour intervals. Round down to the nearest whole tablet any calculated doses that do not correspond to an available tablet strength.
Prior Opiate | Factor Oral | Factor Parenteral |
|---|---|---|
Oxycodone | 1 | — |
Codeine | 0.15 | — |
Hydrocodone | 0.9 | — |
Hydromorphone | 4 | 20 |
Levorphanol | 7.5 | 15 |
Meperidine | 0.1 | 0.4 |
Methadone | 1.5 | 3 |
Morphine | 0.5 | 3 |
Table to be used only for conversion to oral oxycodone.b
More conservative conversion for patients receiving high-dose parenteral opiates (e.g., use 0.5 instead of 3 as multiplication factor for high-dose parenteral morphine).b
Patients receiving fentanyl transdermal systems may receive extended-release tablets beginning 18 hours after removal of the transdermal system. Initially, dosage of approximately 10 mg every 12 hours as extended-release tablets can be substituted for each 25-mcg/hour increment in fentanyl transdermal system dosage. Monitor patient closely as clinical experience with this dosage conversion ratio is limited.
When patients are switched from extended-release tablets to a parenteral opiate, conservative dose conversion ratios should be used to avoid toxicity.
Initially, 33–50% of the usual dosage; titrate dosage carefully.
Consider reduction of the initial dosage and adjust according to the clinical situation in impaired renal function (Clcr <60 mL/minute).
Consider dosage reduction.a
Known hypersensitivity to oxycodone or any ingredient in the formulation.c d
Extended-release tablets in significant respiratory depression (in unmonitored settings or the absence of resuscitative equipment), acute or severe bronchial asthma or hypercarbia, or with known or suspected paralytic ileus.b
Possible tolerance, psychologic dependence, and physical dependence following prolonged administration.b c d Use only with careful surveillance in patients with a history of drug or alcohol dependence or abuse.b d
OxyContin has been intentionally abused by crushing extended-release tablets and “snorting” the powder or dissolving the contents in water and injecting the solution IV. The risk of toxicity is increased when used concomitantly with alcohol or other CNS depressants, including other opiates.
Abuse by chewing OxyContin extended-release tablets also reported.
Breaking, chewing, or crushing of extended-release tablets (e.g., OxyContin) results in immediate release of the opiate and the risk of a potentially fatal overdose.
Extended-release tablets (e.g., OxyContin) are subject to diversion and abuse.
Patients should be instructed to keep extended-release tablets (e.g., OxyContin) in a secure place to prevent theft.
Health-care professionals should contact the professional licensing board, or controlled substance authority in their states for information about prevention and detection of abuse or diversion.
Some formulations contain sulfites, which may cause allergic-type reactions (including anaphylaxis and life-threatening or less severe asthmatic episodes) in certain susceptible individuals.a
Potential for increased respiratory depressant effects and elevation of CSF pressure in patients with increased intracranial pressure, head trauma, or other intracranial lesions.b c d
Adverse effects of opiates may obscure the existence, extent, or course of intracranial pathology.b c d
Administration may complicate assessment of patients with acute abdominal conditions.b d
Possible dose-related respiratory depression.b c d
Use with extreme caution in patients with significant chronic obstructive respiratory disease or cor pulmonale, and in patients with substantially decreased respiratory reserve as in patients with hypoxia, hypercapnia, or preexisting respiratory depression.a c b
Possible severe hypotension with extended-release tablets; especially in patients with depleted blood volume or in combination with other hypotensive agents.b (See Drug Interactions.)
Extended-release tablets (e.g., OxyContin) are not indicated for preoperative (preemptive) analgesia, or for the relief of pain in the immediate (initial 12–24 hours) postoperative period in patients not already receiving the drug or in those whose pain is mild or not expected to persist for an extended period of time.
Extended-release tablets (e.g., OxyContin) are indicated for postoperative use only in patients receiving the drug prior to surgery or if the postoperative pain is expected to be moderate to severe and to persist for an extended period of time.
Possible spasm of the sphincter of Oddi; use with caution in patients with biliary tract disease, including acute pancreatitis.b c
May increase serum amylase concentrations.b c
Use with caution in debilitated patients and in those with hypothyroidism, Addison’s disease, and prostatic hypertrophy or urethral stricture.b c d
When used in fixed-combination with other drugs, consider the cautions, precautions, and contraindications applicable to each ingredient.b d
Category Bc j k or C.b d
Most experts state category B, with category D applying if used for prolonged periods or in high doses at term.k
Distributed into milk.c k
Avoid use in nursing women.c If used, observe infant for GI effects, sedation, and changes in feeding patterns.k
Safety and efficacy of the extended-release tablets (e.g., OxyContin) not established in children <18 years of age.b
Safety and efficacy of other preparations not established in children;c d j however, the drug is recommended for use in pediatric patients.a f g h i (See Pediatric Dosage under Dosage and Administration.)
Possibility of reduced clearance in geriatric patients; adjust dosage.b (See Geriatric Patients under Dosage and Administration.)
Decreased clearance.b c Use with caution and consider initial dosage adjustment.b c (See Hepatic Impairment under Dosage and Administration.)
Decreased clearance.b Use with caution and consider initial dosage adjustment.b c (See Hepatic Impairment under Dosage and Administration.)
With conventional preparations: lightheadedness, dizziness, sedation, nausea, vomiting.d With extended-release tablets: constipation, nausea, somnolence, dizziness, vomiting, pruritus, headache, dry mouth, sweating, asthenia.b
Metabolized by CYP2D6.b
Drug | Interaction | Comments |
|---|---|---|
Anticholinergic agents | Possible paralytic ileusd | |
CNS depressants (e.g., opiate agonists, general anesthetics, tranquilizers, phenothiazines, sedatives/hypnotics, alcohol) | Additive CNS effectsb c d | Reduce dosage of one or both agents with conventional preparations;d initiate therapy with oxycodone extended-release tablets using 33–50% the usual dosageb |
Hypotensive agents | Possible additive hypotensive effects with extended-release tabletsb | |
MAO inhibitors | Potentiation of antidepressant effect with other opiatesb e | Use with cautionb |
Skeletal muscle relaxants | Possible enhanced neuromuscular blocking effect resulting in increased respiratory depressionb |
Following oral administration, about 60–87% of an oral dose reaches the systemic circulation.b c g
Relative oral bioavailability of extended-release tablets to conventional oral dosage forms is the same.b
Peak plasma concentrations occur within 1.4–2.6 hours for conventional oral dosage forms.c
Conventional preparations: analgesia within 10–15 minutes; peak at about 1 hour.a g
Extended-release tablets (e.g., OxyContin): analgesia within 1 hour; peak effect also may occur at this time but persists.g
Extended-release tablets (e.g., OxyContin): biphasic absorption; half-lives of 0.6 (initial release) and 6.9 (extended release) hours.a b
Conventional preparations: analgesia effect persists for 3–6 hours.a
Oral solution with a high-fat meal: extent of absorption increases 27%; rate of absorption is not affected.c
Distributed to skeletal muscle, liver, intestinal tract, lungs, spleen, and brain.b
Readily crosses the placenta.e k
Distributes into milk.b c k
About 45%.b c g
Extensively metabolized in the liver to noroxycodone and oxymorphone and their glucuronide conjugates.
Oxymorphone formation mediated by CYP2D6;g approximately 10 times as potent as morphine parenterally and likely contributes to oxycodone’s effects.g
Oxycodone and its metabolites excreted principally in urine.
Conventional preparations: 3.2–5 hours.b g
Extended-release tablets (e.g., OxyContin): apparent half-life 4.5–8 hours.g
Renal impairment: elimination half-life increased by 1 hour compared with normal renal function.g Peak plasma concentrations and AUCs for oxycodone and noroxycodone increased substantially.g
Mild to moderate hepatic impairment: the elimination half-life was increased by 2.3 hours compared with normal hepatic function.g Peak plasma concentrations and AUCs for oxycodone and noroxycodone increased but less substantially than with hepatic impairment.g
Tight, light-resistant containers at 15–30°C.a c d
Tight, light-resistant containers at 25°C (may be exposed to 15–30°C).a d
Principal pharmacologic effects are on CNS and intestines.e
Acts at several sites within the CNS involving several systems of neurotransmitters to produce analgesia; precise mechanism of action not fully elucidated.e
Potential for drug to impair mental alertness or physical coordination; use caution when driving or operating machinery until effects on individual are known.b c d e
Importance of not breaking, crushing, or chewing extended-release tablets (e.g., OxyContin); potentially fatal overdose can occur.b (See Abuse Potential under Cautions.)
Importance of informing clinicians of breakthrough pain or adverse effects.b c
Importance of taking only as prescribed; do not increase dosage or abruptly discontinue without consulting a clinician.b c
Importance of protecting the drug from theft; do not give to anyone other than the individual for whom it was prescribed.b c
Importance of advising patients that the matrix core of Oxycontin extended-release tablet does not completely dissolve and may be passed in the stool.
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs as well as any concomitant illnesses.b c
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.b c
Importance of informing patients of other important precautionary information.b c (See Cautions.)
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Oxycodone preparations are subject to control under the Federal Controlled Substances Act of 1970 as schedule II (C-II) drugs.
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Oral | Capsules | 5 mg* | Oxycodone Hydrochloride Capsules (C-II) | |
OxyIR (C-II) | Purdue Pharma | |||
Solution | 5 mg/5 mL* | Oxycodone Hydrochloride Oral Solution (C-II) | ||
Roxicodone (C-II) | Xanodyne | |||
20 mg/mL* | Oxycodone Hydrochloride Oral Concentrate Solution (C-II) | |||
Oxydose (C-II) | Ethex | |||
OxyFast (C-II) | Purdue Pharma | |||
Roxicodone (C-II) | Xanodyne | |||
Tablets | 5 mg* | Endocodone (C-II; scored) | Endo | |
Oxycodone Hydrochloride Tablets (C-II) | ||||
Percolone (C-II; scored) | Endo | |||
Roxicodone (C-II; scored) | Xanodyne | |||
15 mg | Roxicodone (C-II; scored) | Xanodyne | ||
30 mg | Roxicodone (C-II) | Xanodyne | ||
Tablets, extended-release | 10 mg* | OxyContin (C-II) | Purdue Pharma | |
20 mg* | OxyContin (C-II) | Purdue Pharma | ||
40 mg* | OxyContin (C-II) | Purdue Pharma | ||
80 mg* | OxyContin (C-II) | Purdue Pharma |
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Oral | Capsules | 5 mg Oxycodone Hydrochloride and Acetaminophen 500 mg* | Tylox (C-II) | Ortho-McNeil |
Solution | 5 mg/5 mL Oxycodone Hydrochloride and Acetaminophen 325 mg/5 mL | Roxicet (C-II) | Roxane | |
Tablets | 2.5 mg Oxycodone Hydrochloride and Acetaminophen 325 mg | Percocet (C-II) | Endo | |
5 mg Oxycodone Hydrochloride and Acetaminophen 325 mg* | Endocet (C-II; scored) | Endo | ||
Oxycodone Hydrochloride and Acetaminophen Tablets (C-II) | ||||
Percocet (C-II; scored) | Endo | |||
Roxicet (C-II; scored) | Roxane | |||
5 mg Oxycodone Hydrochloride and Acetaminophen 500 mg | Roxicet Caplets (C-II; scored) | Roxane | ||
7.5 mg Oxycodone Hydrochloride and Acetaminophen 325 mg* | Oxycodone Hydrochloride and Acetaminophen Tablets (C-II) | |||
Percocet (C-II) | Endo | |||
7.5 mg Oxycodone Hydrochloride and Acetaminophen 500 mg* | Endocet (C-II) | Endo | ||
Oxycodone Hydrochloride and Acetaminophen Tablets (C-II) | ||||
Percocet (C-II) | Endo | |||
10 mg Oxycodone Hydrochloride and Acetaminophen 325 mg* | Oxycodone Hydrochloride and Acetaminophen Tablets (C-II) | |||
Percocet (C-II) | Endo | |||
10 mg Oxycodone Hydrochloride and Acetaminophen 650 mg* | Endocet (C-II) | Endo | ||
Oxycodone Hydrochloride and Acetaminophen Tablets (C-II) | ||||
Percocet (C-II) | Endo |
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Oral | Tablets | 4.5 mg Oxycodone Hydrochloride, Oxycodone Terephthalate 0.38 mg, and Aspirin 325 mg* | Endodan (C-II; scored) | Endo |
Oxycodone Hydrochloride and Aspirin Tablets (C-II) | ||||
Percodan (C-II; scored) | Endo | |||
Roxiprin (C-II) | Roxane |
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Oral | Tablets, film-coated | 5 mg with Ibuprofen 400 mg | Combunox (C-II) | Forest |
This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 10/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.
Endocet 10-325MG Tablets (ENDO PHARMACEUTICALS): 20/$34.99 or 30/$52.48
Endocet 10-650MG Tablets (ENDO PHARMACEUTICALS): 20/$35.99 or 30/$48.97
Endocet 5-325MG Tablets (ENDO PHARMACEUTICALS): 30/$17.99 or 90/$53.97
OxyCODONE HCl 10MG Tablets (KVK TECH): 10/$12.99 or 20/$15.99
OxyCODONE HCl 15MG Tablets (ACTAVIS ELIZABETH): 20/$20.78 or 30/$31.16
OxyCODONE HCl 30MG Tablets (ACTAVIS TOTOWA): 20/$27.71 or 30/$41.56
OxyCODONE HCl 5MG Tablets (QUALITEST): 20/$22.76 or 30/$34.14
Oxycodone-Acetaminophen 10-325MG Tablets (MALLINCKRODT PHARM): 20/$40.66 or 30/$60.99
Oxycodone-Acetaminophen 10-650MG Tablets (WATSON LABS): 20/$33.33 or 30/$49.99
Oxycodone-Acetaminophen 5-325MG Tablets (MALLINCKRODT PHARM): 20/$11.99 or 30/$17.99
Oxycodone-Acetaminophen 5-500MG Capsules (MALLINCKRODT PHARM): 20/$15.99 or 30/$23.99
Oxycodone-Acetaminophen 7.5-325MG Tablets (MALLINCKRODT PHARM): 20/$31.99 or 30/$47.99
Oxycodone-Acetaminophen 7.5-500MG Tablets (WATSON LABS): 20/$25.99 or 30/$38.99
Oxycodone-Ibuprofen 5-400MG Tablets (WATSON LABS): 20/$33.33 or 30/$49.99
OxyCONTIN 10MG 12-hr Tablets (PURDUE PHARMA L.P.): 20/$49.99 or 30/$74.99
OxyCONTIN 15MG 12-hr Tablets (PURDUE PHARMA L.P.): 20/$72.99 or 30/$109.49
OxyCONTIN 20MG 12-hr Tablets (PURDUE PHARMA L.P.): 20/$86.99 or 30/$129.96
OxyCONTIN 30MG 12-hr Tablets (PURDUE PHARMA L.P.): 20/$125.99 or 30/$188.96
OxyCONTIN 40MG 12-hr Tablets (PURDUE PHARMA L.P.): 20/$154.99 or 30/$231.97
OxyCONTIN 60MG 12-hr Tablets (PURDUE PHARMA L.P.): 20/$213.99 or 30/$319.96
OxyCONTIN 80MG 12-hr Tablets (PURDUE PHARMA L.P.): 20/$290.99 or 30/$436.49
Percocet 10-325MG Tablets (ENDO PHARMACEUTICALS): 20/$127.99 or 30/$191.99
Percocet 10-650MG Tablets (ENDO PHARMACEUTICALS): 20/$130.99 or 30/$195.97
Percocet 2.5-325MG Tablets (ENDO PHARMACEUTICALS): 30/$90.99 or 60/$180.98
Percocet 5-325MG Tablets (ENDO PHARMACEUTICALS): 20/$94.99 or 30/$141.97
Percocet 7.5-325MG Tablets (ENDO PHARMACEUTICALS): 20/$90.99 or 30/$135.98
Percocet 7.5-500MG Tablets (ENDO PHARMACEUTICALS): 20/$100.99 or 30/$150.98
Percodan 4.5-0.38-325MG Tablets (ENDO PHARMACEUTICALS): 20/$39.59 or 30/$52.77
Roxicet 5-325MG/5ML Solution (ROXANE): 500/$46.19 or 1500/$138.57
Roxicet 5-325MG Tablets (ROXANE): 20/$12.99 or 30/$14.99
Roxicodone 15MG Tablets (XANODYNE PHARMACEUTICALS): 20/$38.37 or 30/$55.86
Roxicodone 30MG Tablets (XANODYNE PHARMACEUTICALS): 20/$73.36 or 30/$97.06
Tylox 5-500MG Capsules (MCNEIL): 20/$49.54 or 30/$74.31
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions October 27, 2011. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
† Use is not currently included in the labeling approved by the US Food and Drug Administration.
117. Jackson KC II, Lipman AG. Nonopioid analgesics. In: Lipman AG, ed. Pain management for primary care clinicians. Bethesda, MD: American Society of Health-System Pharmacists; 2004:43-58.
118. Cranmer KW, Mason M. Special considerations in geriatric pain management. In: Lipman AG, ed. Pain management for primary care clinicians. Bethesda, MD: American Society of Health-System Pharmacists; 2004:219-232.
119. Fakata KL, Miaskowski C, Lipman AG. Chronic malignant pain. In: Lipman AG, ed. Pain management for primary care clinicians. Bethesda, MD: American Society of Health-System Pharmacists; 2004:139-52.
120. McNicol E, Carr DB. Pharmacological treatment of pain. In: McCarberg B, Passik SD, eds. Expert guide to pain management. Philadelphia: American College of Physicians; 2005:145-78.
121. American Pain Society. Principles of analgesic use in the treatment of acute pain and cancer pain. 5th edition. Glenview, IL; 2003:3,9,13,14.
a. AHFS Drug Information 2004. McEvoy GK, ed. Oxycodone. Bethesda, MD: American Society of Health-System Pharmacists; 2004:2056-8.
b. Purdue Pharma L. P. Oxycontin (oxycodone HCL controlled-release) tablets, prescribing information. Stamford, CT; 2003 Jul.
c. Xanodyne Pharmaceuticals Inc. Roxicodone (oxycodone hydrochloride) tablets, prescribing information. 2006 Mar.
d. Endo Pharmaceuticals. Percocet (oxycodone and acetaminophen) tablets prescribing information. Chadds Ford, PA; 2003 Apr.
e. AHFS drug information 2004. McEvoy GK, ed. Opiate agonists general statement. Bethesda, MD: American Society of Hospital Pharmacists; 2004:2030-5.
f. Jacox A, Carr DB, Payne R et al. Management of cancer pain. Clinical practice guideline. Number 9. US Department of Health and Human Services. March 1994. 49-57.
g. Lipman AG. Pain management for primary care physicians. Bethesda, MD: American Society of Health-System Pharmacists; 2004.
h. Principles of Analgesic Use in the Treamtent of Acute Pain and Cancer Pain. 5th ed. American Pain Society.
i. Behrman RE, Kliegman RM, Jenson HB. Nelson textbook of pediatrics, 17th ed.
j. Purdue Pharma. Oxyir (oxycodone hydrochoride) immediate-release capsules prescribing information. Stamford, CT; 2003 Aug.
k. Briggs GG, Freeman RK, Yaffee SJ. Drugs in pregnancy and pactation. 6th ed.
Antivir may be available in the countries listed below.
Aciclovir is reported as an ingredient of Antivir in the following countries:
International Drug Name Search
Karid may be available in the countries listed below.
Clarithromycin is reported as an ingredient of Karid in the following countries:
International Drug Name Search
Generic Name: Demeclocycline Hydrochloride
Class: Tetracyclines
VA Class: AM250
CAS Number: 64-73-3
Antibacterial; tetracycline antibiotic derived from Streptomyces aureofaciens.100
Treatment of respiratory tract infections caused by Mycoplasma pneumoniae.100
Treatment of respiratory tract infections caused by Haemophilus influenzae, Streptococcus pneumoniae, or Klebsiella.100 Should only be used for treatment of infections caused by these bacteria when in vitro susceptibility tests indicate the organism is susceptible.100 a
Treatment of infections caused by Acinetobacter;100 minocycline may be the preferred tetracycline for use as an alternative to imipenem or meropenem.e
Adjunctive treatment of moderate to severe inflammatory acne.100 Not indicated for treatment of noninflammatory acne.a
Treatment of actinomycosis caused by Actinomyces israelii;100 oral tetracyclines used as follow-up after initial parenteral treatment with penicillin G.d
Adjunct to amebicides for treatment of acute intestinal amebiasis.100 Tetracyclines generally not recommended for treatment of amebiasis caused by Entamoeba.d
Alternative to doxycycline for treatment of inhalational anthrax when a parenteral regimen is not available (e.g., when there are supply or logistic problems because large numbers of individuals require treatment in a mass casualty setting).100 A multiple-drug parenteral regimen (ciprofloxacin or doxycycline and 1 or 2 other anti-infectives predicted to be effective) is preferred for treatment of inhalational anthrax that occurs as the result of exposure to anthrax spores in the context of biologic warfare or bioterrorism.f
Treatment of infections caused by Bartonella bacilliformis.100
Treatment of brucellosis;100 tetracyclines considered drugs of choice.d e Used in conjunction with other anti-infectives (e.g., streptomycin or gentamicin and/or rifampin),100 d e especially for severe infections or when there are complications (e.g., endocarditis, meningitis, osteomyelitis).d
Treatment of infections caused by Campylobacter.100 Tetracyclines are alternatives, not drugs of choice.d e
Treatment of chancroid caused by Haemophilus ducreyi.100 Not included in CDC recommendations for treatment of chancroid.101
Treatment of uncomplicated urethral, endocervical, or rectal infections caused by Chlamydia trachomatis.100 Doxycycline is the preferred tetracycline for treatment of these infections, including presumptive treatment of chlamydial infections in patients with gonorrhea.101
Treatment of trachoma and inclusion conjunctivitis caused by C. trachomatis.100 Consider that anti-infectives may not eliminate C. trachomatis in all cases of chronic trachoma.100
Treatment of lymphogranuloma venereum (genital, inguinal, or anorectal infections) caused by C. trachomatis.100 Doxycycline is the preferred tetracycline for these infections.101 d
Treatment of psittacosis (ornithosis) caused by C. psittaci.100 Doxycycline and tetracycline are drugs of choice.a d For initial treatment of severely ill patients, use IV doxycycline.a
Alternative for treatment of infections caused by Clostridium.100 Tetracyclines are alternatives to metronidazole or penicillin G for adjunctive treatment of C. tetani infections.e
Treatment of infections caused by susceptible Escherichia coli, Enterobacter aerogenes, Klebsiella, or Shigella.100 Should only be used for treatment of infections caused by these common gram-negative bacteria when other appropriate anti-infectives are contraindicated or ineffectivea and when in vitro susceptibility tests indicate the organism is susceptible.100 a
Alternative to penicillin G for the treatment of infections caused by Fusobacterium fusiforme (Vincent's infection).100
Alternative for treatment of uncomplicated gonorrhea (including urethritis) caused by susceptible Neisseria gonorrhoeae.100 However, tetracyclines are considered inadequate therapy and are not recommended by CDC for treatment of gonorrhea.101 a
Treatment of granuloma inguinale (donovanosis) caused by Calymmatobacterium granulomatis.100 Doxycycline is the tetracycline recommended as drug of choice by CDC.101
Alternative for treatment of listeriosis caused by Listeria monocytogenes.100 Not usually considered a drug of choice or alternative for these infections.d e
Treatment of nongonococcal urethritis (NGU) caused by Ureaplasma urealyticum, C. trachomatis, or Mycoplasma.100 Doxycycline usually is the tetracycline of choice for NGU.101
Consider that some cases of recurrent urethritis following treatment may be caused by tetracycline-resistant U. urealyticum.101
Treatment of plague caused by Yersinia pestis.100 Regimen of choice is streptomycin or gentamicin (with or without doxycycline).d e
Treatment of relapsing fever caused by Borrelia recurrentis.100 Tetracyclines are drugs of choice.e
Treatment of rickettsial infections including Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by Rickettsiae.100 Tetracyclines are drugs of choice for treatment of most rickettsial infections; doxycycline usually is the preferred tetracycline.a d
Treatment of syndrome of inappropriate antidiuretic hormone secretion† (SIADH).a Only limited value in patients with acute water intoxication caused by excess ADH secretion, but may be effective in inhibiting the action of ADH in patients with chronic form of the disease.a
Also has been used to treat hyponatremia and water retention† in patients with congestive heart failure or cirrhosis, but a high incidence of renal failure has been reported and the drug probably should not be used in these patients.a
Alternative to penicillin G for treatment of primary, secondary, latent, or tertiary syphilis (not neurosyphilis) in nonpregnant adults and adolescents hypersensitive to penicillins.100 Doxycycline and tetracycline are the preferred tetracyclines in patients hypersensitive to penicillins.101 Use tetracyclines only if compliance and follow-up can be ensured since efficacy not well documented.101
Treatment of tularemia caused by Francisella tularensis.100 Tetracyclines considered alternatives to streptomycin (or gentamicin);d e g risk of relapse and primary treatment failure may be higher than with aminoglycosides.g
Treatment of cholera caused by Vibrio cholerae.100 Doxycycline and tetracycline are drugs of choice; used as an adjunct to fluid and electrolyte replacement in moderate to severe disease.d e
Alternative to penicillin G for treatment of yaws caused by Treponema pertenue.100
Administer orally 1 hour before or 2 hours after meals and/or milk.100
Administer with adequate amounts of fluid to reduce the risk of esophageal irritation and ulceration.100
Children >8 years of age: 7–13 mg/kg daily given in 2–4 divided doses.c
150 mg 4 times daily or 300 mg 2 times daily.c
600 mg initially followed by 300 mg every 12 hours for 4 days for a total of 3 g.100
No longer recommended for gonorrhea by CDC or other experts.101
600 mg to 1.2 g daily in 3 or 4 divided doses.b Diuresis usually occurs within 5 days after initiation of therapy and reverses within 2–6 days after drug discontinued.b
Maximum 600 mg daily.c
Adjust dosage by decreasing doses or increasing dosing interval.100
Use with caution.100
Adjust dosage by decreasing doses or increasing dosing interval.100
Use with caution.100
Known hypersensitivity to demeclocycline, other tetracyclines, or any ingredient in the formulation.100
Use during tooth development (e.g., pregnancy, children <8 years of age) may cause permanent yellow-gray to brown discoloration of teeth and enamel hypoplasia100 Effects are most common following long-term use, but may occur following repeated short-term use.100
Tetracyclines form a stable calcium complex in any bone-forming tissue.100 Reversible decrease in fibula growth rate has occurred in prematures receiving tetracycline.100
Use not recommended in children <8 years of age unless other appropriate drugs are ineffective or are contraindicated or unless the benefits in certain indications (e.g., anthrax) outweigh the risks.100 (See Pediatric Use under Cautions.)
Animal studies indicate possible fetal toxicity (e.g., retardation of skeletal development) and embryotoxicity.100 If used during pregnancy or if patient becomes pregnant while receiving demeclocycline, patient should be apprised of the potential hazard to the fetus.100 (See Pregnancy under Cautions.)
Possibility of adverse CNS effects (light-headedness, dizziness, vertigo) that may impair ability to drive vehicles or operate hazardous machinery.100
Benign intracranial hypertension (pseudotumor cerebri) in adults reported with tetracyclines; usually manifested as headache and blurred vision.100 Bulging fontanels reported in infants.100 Effects usually resolve when drug discontinued, but possibility for permanent sequelae exists.100
Tetracyclines have antianabolic effects and may increase BUN.100
In patients with impaired renal function, high serum demeclocycline concentrations may result in azotemia, hyperphosphatemia, and acidosis.100 Excessive drug accumulation and possible liver toxicity may occur if usual dosage is used patients with renal impairment.100 (See Renal Impairment under Dosage and Administration.)
Diabetes insipidus syndrome (polyuria, polydipsia and weakness) reported with long-term demeclocycline therapy.100 Syndrome is nephrogenic, dose-dependent, and reversible when drug discontinued.100
Periodically assess organ system function, including renal, hepatic and hematopoietic, during long-term therapy.100
Photosensitivity, manifested by an exaggerated sunburn reaction, reported with tetracyclines.100
Photosensitivity reactions may develop within a few minutes to several hours after sun exposure and usually persist 1–2 days after discontinuance of the drug.a Most reactions result from accumulation of tetracyclines in skin and are phototoxic in nature; photoallergic reactions may also occur.a
Discontinue drug at first evidence of skin erythema.100
Possible emergence and overgrowth of nonsusceptible bacteria or fungi.100 Discontinue drug and institute appropriate therapy if superinfection occurs.100
Because many strains of Acinetobacter, Bacteroides, Enterobacter, E. coli, Klebsiella, Shigella, S. pyogenes (group A β-hemolytic streptococci), S. pneumoniae, enterococci, and α-hemolytic streptococci are resistant to tetracyclines (including demeclocycline), in vitro susceptibility tests should be performed if the drug is used for treatment of infections caused by these bacteria.100
Incision and drainage or other surgical procedures should be performed in conjunction with demeclocycline therapy when indicated.100
Category D.100 (See Fetal/Neonatal Morbidity under Cautions.)
Distributed into milk;100 discontinue nursing or the drug.100
AAP states maternal use of tetracyclines usually is compatible with breast-feeding since absorption of the drugs by nursing infants is negligible.d
Should not be used in children <8 years of age unless benefits outweigh the risks.100 (See Adverse Dental and Bone Effects under Cautions.)
Use with caution.100 Reduce dosage.100
Use with caution.100 Reduce dosage.100
Because usual dosage of doxycycline can be used in patients with impaired renal function, it may preferred when a tetracycline is indicated in a patient with impaired renal function.b
GI effects (anorexia, nausea, vomiting, diarrhea); maculopapular and erythematous rash; dose-related BUN increase; hypersensitivity reactions.100
Drug | Interaction | Comments |
|---|---|---|
Antacids (aluminum-, calcium-, or magnesium-containing) | Decreased demeclocycline absorption100 | Administer antacids containing aluminum, calcium, or magnesium 1–2 hours before or after demeclocyclinea |
Anticoagulants, oral | Possible increased anticoagulant effect;100 tetracyclines may impair utilization of prothrombin or decrease vitamin K production by intestinal bacteriaa | Monitor PT carefully; adjust anticoagulant dosage as neededa 100 |
Hormonal contraceptives | Possible decreased effectiveness of oral contraceptives100 | Use alternative nonhormonal contraceptivesa |
Iron-containing preparations | Possible decreased absorption of demeclocycline100 | Administer demeclocycline 2 hours before or 3 hours after an oral iron preparationa |
Methoxyflurane | Possible fatal nephrotoxicity100 | Concomitant use not recommendeda |
Penicillins | Possible antagonism100 | Concomitant use not recommendeda |
Approximately 60–80% of a dose absorbed from the GI tract in fasting adults.b Peak serum concentrations attained within 2–4 hours.b c
Food and/or milk decrease GI absorption by ≥50%.b c
Well distributed into body tissues and fluids.c
36–91%.a c
Does not appear to be metabolized.a
Excreted into the GI tract via bile and by nonbiliary routes.a Excreted in urine by glomerular filtration.a c
44% of a 150-mg oral dose excreted in urine and 13–46% excreted in feces as unchanged drug.b c
Adults with normal renal function: 10–17 hours.b c
Patients with severe renal impairment: half-life 42–68 hours.b
20–25°C.100
Usually bacteriostatic,100 a but may be bactericidal in high concentrations or against highly susceptible organisms.a
Inhibits protein synthesis100 in susceptible organisms by reversibly binding to 30S and 50S ribosomal subunits.a
The complete mechanisms by which tetracyclines reduce acne lesions have not been fully elucidated.a The effects appear to result in part from the antibacterial activity of the drugs, but other mechanisms also are involved.a
Spectrum of activity includes many gram-positive and -negative bacteria and various other organisms (e.g., Rickettsia, Chlamydia, Mycoplasma, spirochetes).a c Inactive against fungi and viruses.a
Gram-positive aerobes and anaerobes: active against Actinomyces israelii, Bacillus anthracis, Clostridium, Propionibacterium acnes, and some staphylococci and streptococci.a c Many strains of S. pyogenes and Enterococci are resistant.a
Gram-negative aerobes and anaerobes: active against Bartonella bacilliformis, Brucella, Calymmatobacterium granulomatis, Francisella tularensis, Haemophilus ducreyi, H. influenzae, Neisseria gonorrhoeae, Vibrio cholerae, and Y. pestis.100 Many strains of Acinetobacter, E. aerogenes, E. coli, Klebsiella, and Shigella and nearly all strains of Proteus and Pseudomonas are resistant.a c
Other organisms: active against Rickettsia, Coxiella burnetii, Chlamydia psittaci, C. trachomatis, Mycoplasma hominis, M. pneumoniae, Ureoplasma urealyticum, B. recurrentis, Leptospira, Treponema pallidum, and T. pertenue.a c
Complete cross-resistance usually occurs between demeclocycline and other tetracyclines (doxycycline, minocycline, oxytetracycline, tetracycline).a c
Importance of drinking sufficient quantities of fluids when taking tablets to reduce the risk of esophageal irritation and ulceration.100
Advise patients that absorption of demeclocycline may be reduced when taken with foods, especially those containing calcium, and that tablets should be taken at least 1 hour before or 2 hours after meals and/or milk.100
Advise patients that adverse CNS effects (light-headedness, dizziness, vertigo) may occur and caution should be used when driving vehicles or operating hazardous machinery.100
Advise patients to avoid excessive sunlight or artificial UV light and to discontinue the drug at the first sign of skin erythema;100 consider use of sunscreen or sunblock.a
Advise patients that demeclocycline may decrease effectiveness of oral contraceptives and that alternative nonhormonal contraceptive measures should be used.100
Advise patients that unused supplies of demeclocycline should be discarded by the expiration date.100
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.100 (See Fetal/Neonatal Morbidity under Cautions.)
Importance of informing clinicians of existing or contemplated therapy, including prescription and OTC drugs.100
Importance of informing patients of other important precautionary information. (See Cautions.)
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Bulk | Powder* | |||
Oral | Tablets, film-coated | 150 mg* | Declomycin | Glades |
Demeclocycline Tablets | Barr, Impax | |||
300 mg* | Declomycin | Glades | ||
Demeclocycline Tablets | Barr, Impax |
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions July 2006. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
† Use is not currently included in the labeling approved by the US Food and Drug Administration.
Only references cited for selected revisions after 1984 are available electronically.
100. Lederle Pharmaceuticals. Declomycin (demeclocycline hydrochloride) for oral use prescribing information. Pearl River, NY. 2002 Mar 14.
101. Centers for Disease Control and Prevention. Sexually transmitted diseases treatment guidelines 2002. MMWR Morb Mortal Wkly Rep. 2002; 51(No. RR-6):1-78.
a. AHFS Drug Information 2004. McEvoy GK, ed. Tetracyclines General Statement. American Society of Health-System Pharmacists; 2004:433-49.
b. AHFS Drug Information 2004. McEvoy GK, ed. Demeclocycline hydrochloride. Bethesda, MD: American Society of Health-System Pharmacists; 2004:449.
c. Lederle Pharmaceuticals. Declomycin (demeclocycline hydrochloride) tablets prescribing information. Pearl River, NY. 2003 Jun.
d. Committee on Infectious Diseases, American Academy of Pediatrics. 2000 Red book: report of the Committee on Infectious Diseases. 25th ed. Elk Grove Village, IL: American Academy of Pediatrics: 2000:187-8,192-3,374-9,547-59.
e. Anon. The choice of antibacterial drugs. Med Lett Drugs Ther. 2001; 43:69-78. [PubMed 11518876]
f. Inglesby TV, O’Toole T, Henderson DA et al for the Working Group on Civilian Biodefense. Anthrax as a biological weapon, 2002. Updated recommendations for management. JAMA. 2002; 287:2236-52. [IDIS 480001] [PubMed 11980524]
g. Dennis DT, Inglesby TV, Henderson DA et al for the Working Group on Civilian Biodefense. Tularemia as a biological weapon: medical and public health management. JAMA. 2001; 285:2763-73. [IDIS 465175] [PubMed 11386933]
Rho(D) Immune Globulin (Human)
RhoGAM® Ultra-Filtered PLUS
(300 μg) (1500 IU)
MICRhoGAM® Ultra-Filtered PLUS (50 μg) (250 IU)
Rx Only
For Intramuscular Injection Only
Prefilled syringes, preservative-free (thimerosal free), latex-free delivery system
For administration to Rh-negative women not previously sensitized to the Rho(D) factor, unless the father or baby are conclusively Rh-negative.
For intramuscular use only. Do not inject RhoGAM Ultra-Filtered PLUS (RhoGAM) or MICRhoGAM Ultra-Filtered PLUS (MICRhoGAM) intravenously. In the case of postpartum use, the product is intended for maternal administration. Do not inject the newborn infant. Inject the entire contents of the syringe(s). For single use only. (See WARNINGS AND PRECAUTIONS)
RhoGAM or MICRhoGAM should be administered within 72 hours of delivery or known or suspected exposure to Rh-positive red blood cells. There is little information concerning the effectiveness of Rho(D) Immune Globulin (Human) when given beyond this 72 hour period. In one study, Rho(D) Immune Globulin (Human) provided protection against Rh immunization in about 50% of subjects when given 13 days after exposure to Rh-positive red blood cells.1 Administer every 12 weeks starting from first injection to maintain a level of passively acquired anti-D. If delivery occurs within three weeks after the last antepartum dose, the postpartum dose may be withheld, but a test for fetal-maternal hemorrhage should be performed to determine if exposure to > 15 mL of red blood cells has occurred.2
Parenteral drug products should be inspected visually for particulate matter, discoloration and syringe damage prior to administration. Do not use if particulate matter and / or discoloration are observed. The solution should appear clear or slightly opalescent.
| Indication | Dose | Notes |
|---|---|---|
| Postpartum (if the newborn is Rh-positive) | RhoGAM (300 μg) (1500 IU) | Additional doses of RhoGAM are indicated when the patient has been exposed to > 15 mL of Rh-positive red blood cells. This may be determined by use of qualitative or quantitative tests for fetal-maternal hemorrhage. |
| Administer within 72 hours of delivery. | ||
| Antepartum: | ||
| If antepartum prophylaxis is indicated, it is essential that the mother receive a postpartum dose if the infant is Rh-positive. | |
| If RhoGAM is administered early in pregnancy (before 26 to 28 weeks), there is an obligation to maintain a level of passively acquired anti-D by administration of RhoGAM at 12-week intervals. | ||
| MICRhoGAM (50 μg) (250 IU) | RhoGAM may be administered if MICRhoGAM is not available. |
| Transfusion of Rh-incompatible blood or blood products | Administer within 72 hours of suspected or proven exposure to Rh-positive red blood cells. | |
| MICRhoGAM (50 μg) (250 IU) | RhoGAM may be administered if MICRhoGAM is not available. |
| RhoGAM (300 μg) (1500 IU) | |
| RhoGAM (300 μg) (1500 IU) (multiple syringes) | Additional doses of RhoGAM are indicated when the patient has been exposed to > 15 mL of Rh-positive red blood cells. Administer 20 μg of RhoGAM per mL of Rh-positive red blood cell exposure. Multiple doses may be administered at the same time or at spaced intervals, as long as the total dose is administered within three days of exposure. |
Each single dose prefilled syringe of RhoGAM contains 300 μg (1500 IU) of Rho(D) Immune Globulin (Human). This is the dose for the indications associated with pregnancy at or beyond 13 weeks unless there is clinical or laboratory evidence of a fetal-maternal hemorrhage (FMH) in excess of 15 mL of Rh-positive red blood cells.
Each single dose prefilled syringe of MICRhoGAM contains 50 μg (250 IU) of Rho(D) Immune Globulin (Human). This dose will suppress the immune response to up to 2.5 mL of Rh-positive red blood cells. MICRhoGAM is indicated within 72 hours after termination of pregnancy up to and including 12 weeks gestation. At or beyond 13 weeks gestation, RhoGAM should be administered instead of MICRhoGAM.
Multiple doses of RhoGAM are required if a FMH exceeds 15 mL, an event that is possible but unlikely prior to the third trimester of pregnancy and is most likely at delivery. Patients known or suspected to be at increased risk of FMH should be tested for FMH by qualitative or quantitative methods.3 In efficacy studies, RhoGAM was shown to suppress Rh immunization in all subjects when given at a dose of ≥ 20 μg per mL of Rh-positive red blood cells.4 Thus, a single dose of RhoGAM will suppress the immune response after exposure to≤ 15 mL of Rh-positive red blood cells. However, in clinical practice, laboratory methods used to determine the amount of exposure (volume of transfusion or FMH) to Rh-positive red blood cells are imprecise.5,6 Therefore, administration of more than 20 μg of RhoGAM per mL of Rh-positive red blood cells should be considered whenever a large FMH or red blood cell exposure is suspected or documented.6 Multiple doses may be administered at the same time or at spaced intervals, as long as the total dose is administered within three days of exposure.7
To maintain an adequate level of anti-D, RhoGAM should be administered every 12 weeks. The exact timing for the injection is based on 12 week intervals starting from the administration of the first injection. If delivery of the baby does not occur 12 weeks after the administration of the standard antepartum dose (at 26 to 28 weeks), a second dose is recommended to maximize protection antepartum. If delivery occurs within three weeks after the last antepartum dose, the postpartum dose may be withheld, but a test for FMH should be performed to determine if exposure to > 15 mL of red blood cells has occurred.2
| Administer injection per standard protocol. | |
| Note: When administering an intramuscular injection, place fingers in contact with syringe barrel through windows in shield to prevent possible premature activation of safety guard. |
| Slide safety guard over needle. | |
| After injection, use free hand to slide safety guard over needle. An audible "click" indicates proper activation. Keep hands behind needle at all times. Dispose of the syringe in accordance with local regulations. |
The use of RhoGAM and MICRhoGAM is contraindicated in Rh-positive individuals.
RhoGAM and MICRhoGAM are made from human plasma and may carry a risk of transmitting infectious agents, e.g., viruses, and theoretically the Creutzfeldt-Jakob disease (CJD) agent. The risk that such products will transmit an infectious agent has been reduced by screening plasma donors for prior exposure to certain viruses, by testing plasma for the presence of certain current virus infections and by using pathogen removal and inactivation techniques during the manufacturing process. All of the above steps are designed to increase product safety by reducing the risk of pathogen transmission. Despite these measures, such products can still potentially transmit disease. There is also the possibility that unknown infectious agents may be present in such products. All infections thought by a physician possibly to have been transmitted by these products should be reported by the physician or other healthcare provider in the United States to Ortho-Clinical Diagnostics, Inc. at 1-800-421-3311. Outside the United States, the company distributing these products should be contacted. The physician should discuss the risks and benefits of these products with the patient.
Recovery of anti-D in plasma or serum after injection of RhoGAM or other Rho(D) Immune Globulin (Human) products is highly variable among individuals. Anti-D detection in a patient's plasma is dependent on assay sensitivity and time of sample collection post-injection. Currently there are no requirements or practice standards to test for the presence of anti-D in order to determine adequacy or efficacy of dose following an injection of RhoGAM.
The presence of passively acquired anti-D in the maternal serum may cause a positive antibody screening test. This does not preclude further antepartum or postpartum prophylaxis.
Some babies born to women given Rho(D) Immune Globulin (Human) antepartum have weakly positive direct antiglobulin (Coombs) tests at birth.
Fetal-maternal hemorrhage may cause false blood typing results in the mother. Late in pregnancy or following delivery, there may be sufficient fetal Rh-positive red blood cells in the circulation of the Rh-negative mother to cause a positive antiglobulin test for weak D (Du). In this instance if there is any doubt as to the patient's Rh type, RhoGAM or MICRhoGAM should be administered.9
Adverse events (AE) after administration of RhoGAM and MICRhoGAM are rare.
The most frequently reported AEs are anti-D formation and injection site reactions, such as swelling, induration, redness and mild pain or warmth. Possible systemic reactions are skin rash, body aches or a slight elevation in temperature. Severe systemic allergic reactions are extremely rare. Patients should be observed for at least 20 minutes after administration. There have been no reported fatalities due to anaphylaxis or any other cause related to RhoGAM or MICRhoGAM administration.
As with any Rho(D) Immune Globulin (Human), administration to patients who are Rh-positive or have received Rh-positive red blood cells may result in signs and symptoms of a hemolytic reaction, including fever, back pain, nausea and vomiting, hypo- or hypertension, hemoglobinuria/emia, elevated bilirubin and creatinine and decreased haptoglobin.
RhoGAM and MICRhoGAM contain a small quantity of IgA (less than 15 μg per dose).10 Although high doses of intravenous immune globulin containing IgA at levels of 270-720 μg/mL have been given without incident during treatment of patients with high-titered antibodies to IgA,11 the attending physician must weigh the benefit against the potential risks of hypersensitivity reactions.
Immune globulin preparations including Rho(D) Immune Globulin (Human) may impair the efficacy of live vaccines such as measles, mumps and varicella. Administration of live vaccines should generally be delayed until 12 weeks after the final dose of immune globulin. If an immune globulin is administered within 14 days after administration of a live vaccine, the immune response to the vaccination may be inhibited.12
Because of the importance of rubella immunity among women of childbearing age, the postpartum vaccination of rubella-susceptible women with rubella or MMR vaccine should not be delayed because of the receipt of Rho(D) Immune Globulin (Human) during the last trimester of pregnancy or at delivery. Vaccination should occur immediately after delivery and if possible, testing should be performed after 3 or more months to ensure immunity to rubella and if necessary, to measles.12
Pregnancy Category C
Animal reproduction studies have not been conducted with RhoGAM or MICRhoGAM. The available evidence suggests that Rho(D) Immune Globulin (Human) does not harm the fetus or affect future pregnancies or the reproduction capacity of the maternal recipient.13,14
RhoGAM or MICRhoGAM Rho(D) Immune Globulin (Human) should only be administered to Rh-negative patients exposed or potentially exposed to Rh-positive red blood cells to prevent Rh immunization.
Repeated administration or increased dosage in Rh-negative individuals should not cause more severe or more frequent adverse reactions than the normal dose. Patients who receive RhoGAM or MICRhoGAM for Rh-incompatible transfusion should be monitored by clinical and laboratory means due to the risk of a hemolytic reaction.
RhoGAM and MICRhoGAM Rho(D) Immune Globulin (Human) are sterile solutions containing immunoglobulin G (IgG) anti-D (anti-Rh) for use in preventing Rh immunization. They are manufactured from human plasma containing anti-D. A single dose of RhoGAM contains sufficient anti-D (300 μg or 1500 IU) to suppress the immune response to up to 15 mL of Rh-positive red blood cells.4,15 A single dose of MICRhoGAM contains sufficient anti-D (50 μg or 250 IU) to suppress the immune response to up to 2.5 mL of Rh-positive red blood cells. The anti-D dose is measured by comparison to the RhoGAM in-house reference standard, the potency of which is established relative to the U.S./World Health Organization/European Pharmacopoeia Standard Anti-D Immunoglobulin Rho(D) Immune Globulin (Human) CBER Lot 4: NIBSC Lot 01/572 (285 IU/ampoule).16
Plasma for RhoGAM is typically sourced from a donor center owned and operated by Ortho-Clinical Diagnostics. All donors are carefully screened by history and laboratory testing to reduce the risk of transmitting blood-borne pathogens from infected donors. Each plasma donation is tested and found to be non-reactive for the presence of hepatitis B surface antigen (HBsAg) and antibodies to hepatitis C (HCV) and human immunodeficiency viruses (HIV) 1 and 2. Additionally, plasma is tested by FDA licensed Nucleic Acid Testing (NAT) for HCV and HIV-1 and the results must be negative. Plasma is also tested by investigational NAT for hepatitis B (HBV) and must be non-reactive. However, the significance of a negative result has not been established. Plasma is tested by in-process NAT procedures for hepatitis A virus (HAV) and parvovirus B19 (B19) in a minipool format. Only plasma that has passed virus screening is used for production. The procedure for B19 detects all three genotypes based upon sequence alignment of known virus isolates. The limit of B19 DNA in the manufacturing pool is set not to exceed 104 IU per mL.
Fractionation of the plasma is performed by a modification of the cold alcohol procedure that has been shown to significantly lower viral titers.10 Following plasma fractionation, a viral clearance filtration step and a viral inactivation step are performed. The viral filtration step removes viruses via a size-exclusion mechanism utilizing a patented Viresolve 180 ultrafiltration membrane with defined pore-size distribution of 12-18 nanometers to remove enveloped and non-enveloped viruses. Following viral filtration, quality control tests (CorrTest and diffusion test) are performed on the Viresolve 180 ultrafiltration membrane to insure filter integrity.17 The viral inactivation step utilizes Triton X-100 and tri-n-butyl phosphate (TNBP) to inactivate enveloped viruses such as HCV, HIV and West Nile Virus (WNV)10,18 (Patent Pending).
The donor selection process, the fractionation process, the viral filtration step and the viral inactivation process increase product safety by reducing the risk of transmission of enveloped and non-enveloped viruses. Rho(D) Immune Globulin (Human) intended for intramuscular use and prepared by cold alcohol fractionation has not been shown to transmit hepatitis or other infectious diseases.19 There have been no documented cases of infectious disease transmission by RhoGAM or MICRhoGAM.
Laboratory spiking studies10,20 have shown that the cumulative viral removal and inactivation capability of the RhoGAM / MICRhoGAM manufacturing process is as follows:
| Virus | HIV | BVDV | PRV | PPV | EMC | WNV | HAV |
|---|---|---|---|---|---|---|---|
| Units = log10 reduction HIV Human Immunodeficiency Virus, Model for HIV-1 and 2 and Human T-cell Lymphotropic Virus (HTLV) 1 and 2 BVDV Bovine Viral Diarrhea Virus, Model for Hepatitis C Virus PRV Pseudorabies Virus, Model for Herpes Viruses PPV Porcine Parvovirus, Model for Parvovirus B19 EMC Encephalomyocarditis Virus, Model for Hepatitis A Virus WNV West Nile Virus HAV Hepatitis A Virus ND Not Determined N/A Not Applicable | |||||||
| Lipid Enveloped | Yes | Yes | Yes | No | No | Yes | No |
| Size (nm) | 80-120 | 40-70 | 120-200 | 18-24 | 25-30 | 40-60 | 27-32 |
| Genome | SS-RNA | SS-RNA | DS-DNA | SS-DNA | SS-RNA | SS-RNA | SS-RNA |
| Fractionation | ≥ 7.98 | 7.29 | ≥ 11.74 | 8.30 | ND | ND | ND |
| Viral Filtration | ≥ 5.60 | 5.40 | ≥ 6.20 | 3.30 | 4.16 | ND | ≥ 5.07 |
| Viral Inactivation | ≥ 4.28 | ≥ 4.90 | ≥ 5.58 | N/A | N/A | ≥ 7.05 | N/A |
| Total Viral Reduction | ≥ 17.86 | ≥ 17.59 | ≥ 23.52 | 11.60 | 4.16 | ≥ 7.05 | ≥ 5.07 |
The safety of Rho(D) Immune Globulin (Human) has been further shown in an empirical study of viral marker rates in female blood donors in the United States.21 This study revealed that Rh-negative donors, of whom an estimated 55-60% had received Rho(D) Immune Globulin (Human) for pregnancy-related indications, had prevalence and incidence viral marker rates similar to those of Rh-positive female donors who had not received Rho(D) Immune Globulin (Human).
The final product contains 5 ± 1% IgG, 2.9 mg/mL sodium chloride, 0.01% Polysorbate 80 (non-animal derived) and 15 mg/mL glycine. Small amounts of IgA, typically less than 15 μg per dose, are present.10 The pH range is 6.20 - 6.55 and IgG purity is ≥ 98%. The product contains no added human serum albumin (HSA), no thimerosal or other preservatives and utilizes a latex-free delivery system.
RhoGAM Ultra-Filtered PLUS and MICRhoGAM Ultra-Filtered PLUS are manufactured and distributed by Ortho-Clinical Diagnostics, Inc., Raritan, NJ 08869.
RhoGAM and MICRhoGAM act by suppressing the immune response of Rh-negative individuals to Rh-positive red blood cells. The mechanism of action is unknown. RhoGAM, MICRhoGAM and other Rho(D) Immune Globulin (Human) products are not effective in altering the course or consequences of Rh immunization once it has occurred.
Pharmacokinetic studies after intramuscular injection were performed on sixteen Rh-negative subjects receiving a single dose of (368 μg or 1840 IU) RhoGAM.10 Plasma anti-D levels were monitored for thirteen weeks using a validated Automated Quantitative Hemagglutination method with sensitivity of approximately 1 ng/mL. The following mean pharmacokinetic parameters were obtained from data collected over the first ten weeks of a thirteen-week study:
| Parameter | Mean | SD | Units |
|---|---|---|---|
| Maximum plasma concentration obtained (Cmax) | 54.0 | 13.0 | ng/mL |
| Time to attain Cmax (Tmax) | 4 | days | |
| Elimination half-life (T1/2) | 30.9 | 13.8 | days |
| Volume of distribution (Vd) | 7.3 | 1.5 | liters |
| Clearance (CL) | 150.4 | 53.3 | mL/day |
The Rh-negative obstetrical patient may be exposed to red blood cells from her Rh-positive fetus during the normal course of pregnancy or after obstetrical procedures or abdominal trauma.
An Rh-negative individual transfused with one unit of Rh-positive red blood cells has about an 80% likelihood of producing anti-D.4 However, Rh immunization can occur after exposure to < 1 mL of Rh-positive red blood cells. Protection from Rh immunization is accomplished by administering ≥ 20 μg of RhoGAM or MICRhoGAM per mL of Rh-positive red blood cells within 72 hours of transfusion of incompatible red blood cells.13,22
Rho(D) Immune Globulin (Human) administered at 28 weeks, as well as within 72 hours of delivery, has been shown to reduce the Rh immunization rate to about 0.1-0.2%.23,24 Clinical studies demonstrated that administration of MICRhoGAM within three hours following pregnancy termination was 100% effective in preventing Rh immunization.25
Multiple studies have been performed that prove the safety and efficacy of RhoGAM in both the obstetrical and post transfusion settings.
Freda, Gorman and colleagues26, 27 studied the efficacy of RhoGAM in the postpartum setting in a randomized, controlled study completed in 1967. The control group received no immunoglobulin therapy after delivery, while the test group received 300 μg of RhoGAM intramuscularly within 72 hours of delivery of an Rh-positive infant. Six months after delivery, the incidence of Rh immunization in the control group was 6.4% (32/499) versus 0.13% (1/781) in the RhoGAM group (p < 0.001).
Pollack et al. performed two randomized, placebo-controlled studies in the post transfusion setting that were designed to establish the dose response relationship of RhoGAM. In the first study,15 178 (176 males, 2 females) Rh-negative volunteers received varying volumes of Rh- positive red cells; 92 subjects then received RhoGAM. A single dose of RhoGAM (1.1 mL @ 267 μg/mL) was shown to suppress anti-D formation after injection of up to 15.1 mL of Rh-positive red cells. In a companion study,4 Pollack administered 500 mL of Rh-positive whole blood to 44 Rh-negative male volunteers. Twenty-two (22) subjects received 20 μg RhoGAM per mL of Rh-positive red cells and 22 received no RhoGAM. None of the RhoGAM-treated subjects developed anti-D; 18/22 control arm subjects developed anti-D (p < 0.0001).
Human clinical studies10 were subsequently performed to prove the efficacy of MICRhoGAM and the low protein (5%) formulations. In the MICRhoGAM study, 81 Rh-negative male volunteers received an initial injection of 2.5 mL Rh-positive red cells, followed by a booster injection (0.1 mL) of red cells at 26 weeks; 40 subjects received an injection of MICRhoGAM after the initial red cell injection. None of the subjects who received MICRhoGAM developed anti-D, both before and after the booster red cell injection. A similar study was performed in 1985 using the low protein formulation of RhoGAM. None of the 30 Rh-negative male volunteers who received RhoGAM after injection of 15 mL of Rh-positive red cells developed anti-D.
Store at 2 to 8°C. Do not store frozen. Do not use after the expiration date printed on the syringe.
As with all immune globulin preparations, the physician should discuss the risks and benefits with the patient. The most common adverse reactions are local reactions including swelling, induration, redness and mild pain at the site of injection, and a small number of patients have noted a slight elevation in temperature.
Systemic reactions to RhoGAM or MICRhoGAM are extremely rare, however allergic responses to RhoGAM or MICRhoGAM may occur. Patients should be observed for at least 20 minutes after administration. Patients should be informed of the early signs of hypersensitivity reactions including hives, generalized urticaria, tightness of the chest, wheezing, hypotension and anaphylaxis.
The physician should provide the patient with a completed RhoGAM Patient Identification Card and advise the patient to retain the card and present it to other health care providers when appropriate.
| Section | Revision |
|---|---|
| 10 DESCRIPTION | Modified parvovirus and hepatitis A virus testing. |
U.S. LICENSE 1236
Ortho-Clinical Diagnostics, Inc.
a Johnson&Johnson company
Raritan, New Jersey 08869
© OCD 2007
Printed in U.S.A.
Made by methods of
U.S. Pat. 6,096,872
Patent Pending
Revised February 2008
631203003
PATIENT IDENTIFICATION CARD
Name _____________________________________________________________________________________________________________
Address _____________________________________________________________________________________________________________
I AM Rh NEGATIVE. I have received a protective injection of RhoGAM® or MICRhoGAM® Rho(D) Immune Globulin (Human) Ultra-Filtered PLUS.
IMPORTANT: Anti-Rh antibody (also called anti-D) will be present in my blood for several weeks after the injection, and may be detectable by laboratory testing. The presence of this passive anti-Rh antibody does not disqualify me from receiving additional injections of RhoGAM or MICRhoGAM as indicated and prescribed by my physician.
©Ortho-Clinical Diagnostics, Inc. 2007
Rho(D) Immune Globulin (Human)
RhoGAM® and MICRhoGAM®
Ultra-Filtered PLUS
This 3-part form contains:
U.S. LICENSE 1236
Ortho-Clinical Diagnostics, Inc.
a Johnson&Johnson company
Raritan, New Jersey 08869
631203003
Date of Injection of RhoGAM or MICRhoGAM
Rho(D) Immune Globulin (Human)
RhoGAM®
Ultra-Filtered PLUS – 300 µg Dose (1500 IU*)
Thimerosal-Free
*International Units
Do not store frozen
See Directions for Use
Package Contains:
1 single dose
Active Ingredients
Anti-D Rho Immune Globulin (300 µg), the potency of
which is determined relative to the US/WHO/EP Standard
Anti-D Immunoglobulin Rho(D) Immune Globulin (Human)
CBER Lot 4: NIBSC Lot 01/572 (285 IU/ampoule)
Inactive ingredients
2.9 mg/mL sodium chloride
0.01% polysorbate 80
15 mg/mL glycine
ORTHO
Product Code
780501
Rho(D) Immune Globulin (Human)
MICRhoGAM®
Ultra-Filtered PLUS – 50 µg Dose (250 IU*)
Thimerosal-Free
*International Units
Do not store frozen
See Directions for Use
Package Contains:
1 single dose
Active Ingredients
Anti-D Rho Immune Globulin (50 µg), the potency of
which is determined relative to the US/WHO/EP Standard
Anti-D Immunoglobulin Rho(D) Immune Globulin (Human)
CBER Lot 4: NIBSC Lot 01/572 (285 IU/ampoule)
Inactive ingredients
2.9 mg/mL sodium chloride
0.01% polysorbate 80
15 mg/mL glycine
ORTHO
Product Code
780601
| RhoGAM Ultra-Filtered PLUS human rho(d) immune globulin injection, solution | ||||||||||||||||||||||||||||||||
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| BLA | BLA103777 | 03/09/2007 | |
| MICRhoGAM Ultra-Filtered PLUS human rho(d) immune globulin i |
