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LORTAB
Overview
What is LORTAB?
Hydrocodone bitartrate and acetaminophen is supplied in tablet
form for oral administration.
WARNING: May be habit forming
Hydrocodone bitartrate is an opioid analgesic and antitussive and occurs as
fine, white crystals or as a crystalline powder. It is affected by light. The
chemical name is 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1)
hydrate (2:5). It has the following structural formula:
Acetaminophen, 4’-hydroxyacetanilide, a slightly bitter, white, odorless,
crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic.
It has the following structural formula:
Each LORTAB 7.5/500 tablet contains:
Hydrocodone Bitartrate…………………………………… 7.5 mg
Acetaminophen…………………………………………… 500 mg
In addition, each tablet contains the following inactive ingredients:
colloidal silicon dioxide, croscarmellose sodium, crospovidone, microcrystalline
cellulose, povidone, pregelatinized starch, stearic acid and sugar spheres which
are composed of starch derived from corn, sucrose, FD and C Blue #1 and D and C
Yellow #10. Meets USP dissolution test 1.
What does LORTAB look like?
What are the available doses of LORTAB?
Sorry No records found.
What should I talk to my health care provider before I take LORTAB?
Sorry No records found
How should I use LORTAB?
LORTAB 7.5/500 tablets (hydrocodone bitartrate and acetaminophen
tablets, USP, 7.5 mg/500 mg) are indicated for the relief of moderate to
moderately severe pain.
Dosage should be adjusted according to severity of pain and
response of the patient. However, it should be kept in mind that tolerance to
hydrocodone can develop with continued use and that the incidence of untoward
effects is dose related.
The usual adult dosage is one tablet every four to six hours as needed for
pain. The total daily dosage should not exceed 6 tablets.
What interacts with LORTAB?
Sorry No Records found
What are the warnings of LORTAB?
Sorry No Records found
What are the precautions of LORTAB?
Sorry No Records found
What are the side effects of LORTAB?
Sorry No records found
What should I look out for while using LORTAB?
This product should not be administered to patients who have
previously exhibited hypersensitivity to hydrocodone or acetaminophen.
Patients known to be hypersensitive to other opioids may exhibit cross
sensitivity to hydrocodone.
At high doses or in sensitive patients, hydrocodone may produce
dose-related respiratory depression by acting directly on the brain stem
respiratory center. Hydrocodone also affects the center that controls
respiratory rhythm, and may produce irregular and periodic breathing.
The respiratory depressant effects of narcotics and their
capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in
the presence of head injury, other intracranial lesions or a preexisting
increase in intracranial pressure. Furthermore, narcotics produce adverse
reactions which may obscure the clinical course of patients with head injuries.
The administration of narcotics may obscure the diagnosis or
clinical course of patients with acute abdominal conditions.
LORTAB 7.5/500 tablets contains hydrocodone, an opioid agonist,
and is a Schedule III controlled substance. Opioid agonists have the potential
for being abused and are sought by abusers and people with addiction disorders,
and are subject to diversion.
LORTAB 7.5/500 tablets can be abused in a manner similar to other opioid
agonists, legal or illicit. This should be considered when prescribing or
dispensing LORTAB 7.5/500 tablets in situations where the physician or
pharmacist is concerned about an increased risk of misuse, abuse or diversion
(see
What might happen if I take too much LORTAB?
Following an acute overdosage, toxicity may result from
hydrocodone or acetaminophen.
Hydrocodone:
Acetaminophen:
Early symptoms following a potentially hepatotoxic overdose may include:
nausea, vomiting, diaphoresis and general malaise. Clinical and laboratory
evidence of hepatic toxicity may not be apparent until 48 to 72 hours
post-ingestion.
In adults, hepatic toxicity has rarely been reported with acute overdoses of
less than 10 grams, or fatalities with less than 15 grams.
A single or multiple overdose with hydrocodone and acetaminophen
is a potentially lethal polydrug overdose, and consultation with a regional
poison control center is recommended.
Immediate treatment includes support of cardiorespiratory function and
measures to reduce drug absorption. Vomiting should be induced mechanically, or
with syrup of ipecac, if the patient is alert (adequate pharyngeal and laryngeal
reflexes). Oral activated charcoal (1 g/kg) should follow gastric emptying. The
first dose should be accompanied by an appropriate cathartic. If repeated doses
are used, the cathartic might be included with alternate doses as required.
Hypotension is usually hypovolemic and should respond to fluids. Vasopressors
and other supportive measures should be employed as indicated. A cuffed
endo-tracheal tube should be inserted before gastric lavage of the unconscious
patient and, when necessary, to provide assisted respiration.
Meticulous attention should be given to maintaining adequate pulmonary
ventilation. In severe cases of intoxication, peritoneal dialysis, or preferably
hemodialysis may be considered. If hypoprothrombinemia occurs due to
acetaminophen overdose, vitamin K should be administered intravenously.
Naloxone, a narcotic antagonist, can reverse respiratory depression and coma
associated with opioid overdose. Naloxone hydrochloride 0.4 mg to 2 mg is given
parenterally. Since the duration of action of hydrocodone may exceed that of the
naloxone, the patient should be kept under continuous surveillance and repeated
doses of the antagonist should be administered as needed to maintain adequate
respiration. A narcotic antagonist should not be administered in the absence of
clinically significant respiratory or cardiovascular depression.
If the dose of acetaminophen may have exceeded 140 mg/kg, acetylcysteine
should be administered as early as possible. Serum acetaminophen levels should
be obtained, since levels four or more hours following ingestion help predict
acetaminophen toxicity. Do not await acetaminophen assay results before
initiating treatment. Hepatic enzymes should be obtained initially, and repeated
at 24–hour intervals.
Methemoglobinemia over 30% should be treated with methylene blue by slow
intravenous administration.
The toxic dose for adults for acetaminophen is 10 g.
How should I store and handle LORTAB?
LORTAB 7.5/500 tablets (hydrocodone bitartrate and acetaminophen tablets, USP, 7.5 mg/500 mg) contain hydrocodone bitartrate 7.5 mg and acetaminophen 500 mg. They are supplied as white with green specks, capsule-shaped, bisected tablets, debossed “ucb” on one side and “903” on the other side, in containers of 100 tablets NDC 50474-907-01, and 500 tablets NDC 50474-907-50.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Hydrocodone is a semisynthetic narcotic analgesic and antitussive
with multiple actions qualitatively similar to those of codeine. Most of these
involve the central nervous system and smooth muscle. The precise mechanism of
action of hydrocodone and other opiates is not known, although it is believed to
relate to the existence of opiate receptors in the central nervous system. In
addition to analgesia, narcotics may produce drowsiness, changes in mood and
mental clouding.
The analgesic action of acetaminophen involves peripheral influences, but the
specific mechanism is as yet undetermined. Antipyretic activity is mediated
through hypothalamic heat regulating centers. Acetaminophen inhibits
prostaglandin synthetase. Therapeutic doses of acetaminophen have negligible
effects on the cardiovascular or respiratory systems; however, toxic doses may
cause circulatory failure and rapid, shallow breathing.
Non-Clinical Toxicology
This product should not be administered to patients who have previously exhibited hypersensitivity to hydrocodone or acetaminophen.Patients known to be hypersensitive to other opioids may exhibit cross sensitivity to hydrocodone.
At high doses or in sensitive patients, hydrocodone may produce dose-related respiratory depression by acting directly on the brain stem respiratory center. Hydrocodone also affects the center that controls respiratory rhythm, and may produce irregular and periodic breathing.
The respiratory depressant effects of narcotics and their capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, other intracranial lesions or a preexisting increase in intracranial pressure. Furthermore, narcotics produce adverse reactions which may obscure the clinical course of patients with head injuries.
The administration of narcotics may obscure the diagnosis or clinical course of patients with acute abdominal conditions.
LORTAB 7.5/500 tablets contains hydrocodone, an opioid agonist, and is a Schedule III controlled substance. Opioid agonists have the potential for being abused and are sought by abusers and people with addiction disorders, and are subject to diversion.
LORTAB 7.5/500 tablets can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing LORTAB 7.5/500 tablets in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse or diversion (see
Patients receiving narcotics, antihistamines, antipsychotics, antianxiety agents, or other CNS depressants (including alcohol) concomitantly with hydrocodone bitartrate and acetaminophen tablets may exhibit an additive CNS depression. When combined therapy is contemplated, the dose of one or both agents should be reduced.
The use of MAO inhibitors or tricyclic antidepressants with hydrocodone preparations may increase the effect of either the antidepressant or hydrocodone.
As with any narcotic analgesic agent, LORTAB 7.5/500 tablets should be used with caution in elderly or debilitated patients, and those with severe impairment of hepatic or renal function, hypothyroidism, Addison’s disease, prostatic hypertrophy or urethral stricture. The usual precautions should be observed and the possibility of respiratory depression should be kept in mind.
Hydrocodone suppresses the cough reflex; as with all narcotics, caution should be exercised when LORTAB 7.5/500 tablets are used postoperatively and in patients with pulmonary disease.
The most frequently reported adverse reactions are light-headedness, dizziness, sedation, nausea and vomiting. These effects seem to be more prominent in ambulatory than in non-ambulatory patients, and some of these adverse reactions may be alleviated if the patient lies down.
Other adverse reactions include:
Central Nervous System:
Gastrointestinal System:
Genitourinary System:
Respiratory Depression:
Special Senses:
Dermatological:
The following adverse drug events may be borne in mind as potential effects of acetaminophen: allergic reactions, rash, thrombocytopenia, agranulocytosis.
Potential effects of high dosage are listed in the section.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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