Review N357 One Dide 75 Other Side of White Pill

What is Lortab 7.5 and how is information technology used?

Lortab 7.5 is a prescription medicine used to treat the symptoms of Moderate to Severe Hurting. Lortab seven.5 may be used alone or with other medications.

Lortab 7.5 belongs to a class of drugs called Analgesics, Opioid Combos.

It is not known if Lortab vii.5 is prophylactic and effective in children younger than 2 years of age.

What are the possible side effects of Lortab vii.v?

Lortab 7.five may cause serious side effects including:

• slow animate with long pauses,
• blue colored lips,
• difficult to wake up,
• skin redness,
• rash that spreads and causes blistering and peeling,
• noisy animate,
• sighing,
• shallow breathing,
• lightheadedness,
• nausea,
• upper stomach pain,
• tiredness,
• loss of appetite,
• dark urine,
• clay-colored stools,
• yellowing of the skin or eyes (jaundice),
• vomiting,
• loss of ambition,
• dizziness,
• worsening tiredness,
• weakness,
• agitation,
• hallucinations,
• fever,
• sweating,
• shivering,
• fast heart rate,
• muscle stiffness,
• twitching,
• loss of coordination, and
• diarrhea

Become medical aid right away, if you take any of the symptoms listed above.

The most common side furnishings of Lortab seven.5 include:

• dizziness,
• drowsiness,
• feeling tired,
• nausea,
• vomiting,
• breadbasket pain,
• constipation, and
• headache

Tell the doctor if you have whatever side effect that bothers you or that does non get away.

These are not all the possible side furnishings of Lortab vii.five. For more data, ask your dr. or pharmacist.

Telephone call your doc for medical communication about side effects. Y'all may report side furnishings to FDA at one-800-FDA-1088.

DESCRIPTION

Hydrocodone bitartrate and acetaminophen is supplied in tablet class for oral assistants.

Alert: May be habit forming (encounter PRECAUTIONS, Information for Patients, and DRUG ABUSE AND DEPENDENCE).

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 chemic proper name is four,5α- epoxy-3-methoxy-17-methylmorphinan-vi-one tartrate (1:1) hydrate (2:five). Information technology has the post-obit structural formula:

C₁₈H₂₁NO₃•C₄H₆0_{half dozen} • 2 ½ H₂0               M.Westward. 494.490

Acetaminophen, 4'-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a not-opiate, not-salicylate analgesic and antipyretic. Information technology has the following structural formula:

C_eightH₉NO_two                  One thousand.W. 151.xvi

Each Lortab 7.v (hydrocodone bitartrate and acetaminophen tablets) /500 tablet contains:

Hydrocodone Bitartrate.............................................vii.five mg
Acetaminophen......................................................500 mg

In improver, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone, microcrystalline cellulose, povidone, pregelatinized starch, stearic acid and saccharide spheres which are equanimous of starch derived from corn, sucrose, FD&C Blue #i and D&C Yellow #10. Meets USP dissolution test 1.

INDICATIONS

Lortab vii.5/500 tablets (Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 7.5 mg/500 mg) are indicated for the relief of moderate to moderately severe hurting.

DOSAGE AND Administration

Dosage should be adjusted according to severity of hurting and response of the patient. However, it should be kept in mind that tolerance to hydrocodone tin develop with connected use and that the incidence of untoward effects is dose related.

The usual adult dosage is one tablet every iv to six hours every bit needed for hurting. The full daily dosage should not exceed half-dozen tablets.

HOW SUPPLIED

Lortab ® 7.5/500 tablets (Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 7.five mg/500 mg) contain hydrocodone bitartrate seven.5 mg and acetaminophen 500 mg. They are supplied as white with green specks, capsule-shaped, bisected tablets, debossed "ucb" on i side and "903" on the other side, in containers of 100 tablets NDC 50474-907-01, and 500 tablets NDC 50474-907-l.

STORAGE: Store at 20 to 25°C (68 to 77°F). [see USP Controlled Room Temperature]

Dispense in a tight, low-cal-resistant container with a child-resistant closure.

A Schedule CIII Narcotic

Manufactured for: UCB Pharma, Inc. Smyrna, GA 30080. Manufactured by: Mikart, Inc. Atlanta, GA 30318. Rev. 03/2004. FDA rev date: 8/3/2000

SLIDESHOW

Back Pain: 16 Dorsum Hurting Truths and Myths See Slideshow

Side Effects & Drug Interactions

SIDE EFFECTS

The nearly oft reported adverse reactions are light-headedness, dizziness, sedation, nausea and airsickness. These effects seem to be more prominent in ambulatory than in non-ambulatory patients, and some of these adverse reactions may exist alleviated if the patient lies downwards.

Other adverse reactions include:

Central Nervous Arrangement: Drowsiness, mental clouding, lethargy, impairment of mental and physical performance, feet, fear, dysphoria, psychic dependence, mood changes.

Gastrointestinal System: Prolonged administration of Lortab seven.five (hydrocodone bitartrate and acetaminophen tablets) /500 tablets may produce constipation.

Genitourinary Organization: Ureteral spasm, spasm of vesical sphincters and urinary retentivity have been reported with opiates.

Respiratory Depression: Hydrocodone bitartrate may produce dose-related respiratory depression by interim directly on the brain stalk respiratory centers (run across OVERDOSAGE).

Special Senses: Cases of hearing harm or permanent loss accept been reported predominantly in patients with chronic overdose.

Dermatological: Skin rash, pruritus.

The following adverse drug events may be borne in heed equally potential effects of acetaminophen: allergic reactions, rash, thrombocytopenia, agranulocytosis.

Potential effects of high dosage are listed in the OVERDOSAGE department.

DRUG ABUSE AND DEPENDENCE:

Controlled Substance: Lortab 7.5 (hydrocodone bitartrate and acetaminophen tablets) /500 tablets (Hydrocodone Bitartrate and Acetaminophen Tablets, USP, seven.5 mg/500 mg) are classified as a Schedule III controlled substance.

Abuse and Dependence: Psychic dependence, concrete dependence, and tolerance may develop upon repeated assistants of narcotics; therefore, this product should be prescribed and administered with circumspection. However, psychic dependence is unlikely to develop when hydrocodone bitartrate and acetaminophen tablets are used for a short time for the treatment of pain.

Physical dependence, the condition in which continued assistants of the drug is required to prevent the appearance of a withdrawal syndrome, assumes clinically significant proportions only after several weeks of continued narcotic use, although some mild degree of concrete dependence may develop after a few days of narcotic therapy. Tolerance, in which increasingly large doses are required in order to produce the aforementioned caste of analgesia, is manifested initially by a shortened elapsing of analgesic outcome, and subsequently past decreases in the intensity of analgesia. The rate of development of tolerance varies among patients.

DRUG INTERACTIONS

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 result of either the antidepressant or hydrocodone.

Drug/Laboratory Test Interactions: Acetaminophen may produce simulated-positive test results for urinary v-hydroxyindoleacetic acrid.

WARNINGS

Respiratory Depression: At loftier doses or in sensitive patients, hydrocodone may produce dose-related respiratory depression past interim direct on the brain stalk respiratory eye. Hydrocodone besides affects the center that controls respiratory rhythm, and may produce irregular and periodic breathing.

Caput Injury and Increased Intracranial Force per unit area: The respiratory depressant effects of narcotics and their capacity to drag cerebrospinal fluid pressure may exist markedly exaggerated in the presence of head injury, other intracranial lesions or a preexisting increment in intracranial pressure. Furthermore, narcotics produce adverse reactions which may obscure the clinical class of patients with head injuries.

Astute Abdominal Conditions: The assistants of narcotics may obscure the diagnosis or clinical course of patients with acute intestinal conditions.

PRECAUTIONS

General: Special Take a chance Patients : Equally with whatsoever narcotic analgesic amanuensis, Lortab 7.5 (hydrocodone bitartrate and acetaminophen tablets) /500 tablets should be used with caution in elderly or debilitated patients, and those with severe impairment of hepatic or renal function, hypothyroidism, Addison'south disease, prostatic hypertrophy or urethral stricture. The usual precautions should be observed and the possibility of respiratory depression should be kept in heed.

Cough Reflex : Hydrocodone suppresses the coughing reflex; equally with all narcotics, caution should be exercised when Lortab vii.5 (hydrocodone bitartrate and acetaminophen tablets) /500 tablets are used postoperatively and in patients with pulmonary disease.

Laboratory Tests: In patients with severe hepatic or renal disease, effects of therapy should be monitored with serial liver and/or renal function tests.

Carcinogenesis, Mutagenesis, Damage of Fertility: No adequate studies have been conducted in animals to determine whether hydrocodone or acetaminophen have a potential for carcinogenesis, mutagenesis, or impairment of fertility.

Pregnancy:

Teratogenic Effects: Pregnancy Category C: At that place are no acceptable and well-controlled studies in pregnant women. Lortab 7.v (hydrocodone bitartrate and acetaminophen tablets) /500 tablets should be used during pregnancy only if the potential benefit justifies the potential take chances to the fetus.

Nonteratogenic Effects : Babies born to mothers who accept been taking opioids regularly prior to delivery volition be physically dependent. The withdrawal signs include irritability and excessive crying, tremors, hyperactive reflexes, increased respiratory charge per unit, increased stools, sneezing, yawning, vomiting and fever. The intensity of the syndrome does not always correlate with the duration of maternal opioid apply or dose. There is no consensus on the best method of managing withdrawal.

Labor and Delivery: As with all narcotics, administration of this product to the mother shortly before delivery may result in some caste of respiratory low in the newborn, especially if college doses are used.

Nursing Mothers: Acetaminophen is excreted in chest milk in small amounts, but the significance of its effects on nursing infants is not known. Information technology is not known whether hydrocodone is excreted in man milk. Because many drugs are excreted in human being milk and because of the potential for serious adverse reactions in nursing infants from hydrocodone and acetaminophen, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use: Safety and effectiveness in the pediatric population have not been established.

Geriatric Use: Clinical studies of hydrocodone bitartrate and acetaminophen tablets did not include sufficient numbers of subjects aged 65 and over to decide whether they reply differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose pick for an elderly patient should be cautious, commonly starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant affliction or other drug therapy.

Hydrocodone and the major metabolites of acetaminophen are known to be substantially excreted past the kidney. Thus the run a risk of toxic reactions may be greater in patients with impaired renal office due to the accumulation of the parent compound and/or metabolites in the plasma. Because elderly patients are more likely to take decreased renal role, care should exist taken in dose selection, and it may be useful to monitor renal role.

Hydrocodone may crusade defoliation and over-sedation in the elderly; elderly patients generally should exist started on depression doses of hydrocodone bitartrate and acetaminophen tablets and observed closely.

Overdosage & Contraindications

OVERDOSE

Following an acute overdosage, toxicity may effect from hydrocodone or acetaminophen.

Signs and Symptoms:

Hydrocodone : Serious overdose with hydrocodone is characterized by respiratory depression (a decrease in respiratory rate and/or tidal volume, Cheyne-Stokes respiration, cyanosis) extreme somnolence progressing to shock or blackout, skeletal muscle flaccidity, common cold and damp skin, and sometimes bradycardia and hypotension. In severe overdosage, apnea, circulatory collapse, cardiac arrest and death may occur.

Acetaminophen : In acetaminophen overdosage: dose-dependent, potentially fatal hepatic necrosis is the most serious adverse effect. Renal tubular necrosis, hypoglycemic coma and thrombocytopenia may too occur.

Early on symptoms following a potentially hepatotoxic overdose may include: nausea, vomiting, diaphoresis and general malaise. Clinical and laboratory prove 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.

Treatment: A single or multiple overdose with hydrocodone and acetaminophen is a potentially lethal polydrug overdose, and consultation with a regional poison control eye is recommended.

Immediate treatment includes support of cardiorespiratory role and measures to reduce drug absorption. Vomiting should be induced mechanically, or with syrup of ipecac, if the patient is warning (acceptable pharyngeal and laryngeal reflexes). Oral activated charcoal (one chiliad/kg) should follow gastric elimination. The get-go dose should exist accompanied past an appropriate cathartic. If repeated doses are used, the cathartic might be included with alternate doses as required. Hypotension is usually hypovolemic and should reply to fluids. Vasopressors and other supportive measures should be employed as indicated. A cuffed endo-tracheal tube should exist inserted before gastric lavage of the unconscious patient and, when necessary, to provide assisted respiration.

Meticulous attention should exist given to maintaining adequate pulmonary ventilation. In astringent cases of intoxication, peritoneal dialysis, or preferably hemodialysis may be considered. If hypoprothrombinemia occurs due to acetaminophen overdose, vitamin G should exist administered intravenously.

Naloxone, a narcotic adversary, tin can contrary respiratory depression and blackout associated with opioid overdose. Naloxone hydrochloride 0.4 mg to 2 mg is given parenterally. Since the duration of activeness of hydrocodone may exceed that of the naloxone, the patient should exist kept under continuous surveillance and repeated doses of the adversary should exist administered as needed to maintain acceptable respiration. A narcotic antagonist should not be administered in the absence of clinically meaning respiratory or cardiovascular depression.

If the dose of acetaminophen may have exceeded 140 mg/kg, acetylcysteine should exist administered as early on as possible. Serum acetaminophen levels should be obtained, since levels iv or more hours following ingestion aid predict acetaminophen toxicity. Do non expect acetaminophen analysis results before initiating handling. Hepatic enzymes should exist obtained initially, and repeated at 24-60 minutes intervals.

Methemoglobinemia over 30% should be treated with methylene blue by wearisome intravenous administration.

The toxic dose for adults for acetaminophen is 10 g.

CONTRAINDICATIONS

This production 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.

CLINICAL PHARMACOLOGY

Hydrocodone is a semisynthetic narcotic analgesic and antitussive with multiple actions qualitatively similar to those of codeine. Most of these involve the key nervous system and smooth muscle. The precise mechanism of activeness of hydrocodone and other opiates is non known, although it is believed to chronicle to the beingness of opiate receptors in the central nervous arrangement. 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 equally yet undetermined. Antipyretic activity is mediated through hypothalamic heat regulating centers. Acetaminophen inhibits prostaglandin synthetase. Therapeutic doses of acetaminophen have negligible furnishings on the cardiovascular or respiratory systems; however, toxic doses may cause circulatory failure and rapid, shallow animate.

Pharmacokinetics: The behavior of the individual components is described below.

Hydrocodone: Following a 10 mg oral dose of hydrocodone administered to v adult male person subjects, the mean meridian concentration was 23.6 ± 5.2 ng/mL. Maximum serum levels were achieved at 1.three ± 0.3 hours and the one-half-life was determined to be 3.8 ± 0.iii hours. Hydrocodone exhibits a complex pattern of metabolism including O-demethylation, Northward-demethylation and 6-keto reduction to the corresponding 6-α- and 6-β-hydroxymetabolites.

See OVERDOSAGE for toxicity information.

Acetaminophen: Acetaminophen is rapidly absorbed from the alimentary canal and is distributed throughout nigh torso tissues. The plasma half-life is i.25 to 3 hours, but may be increased by liver impairment and following overdosage. Emptying of acetaminophen is principally by liver metabolism (conjugation) and subsequent renal excretion of metabolites. Approximately 85% of an oral dose appears in the urine within 24 hours of administration, most every bit the glucuronide cohabit, with small-scale amounts of other conjugates and unchanged drug.

Meet OVERDOSAGE for toxicity data.

PATIENT Information

Hydrocodone, similar all narcotics, may impair mental and/or concrete abilities required for the functioning of potentially hazardous tasks such as driving a automobile or operating machinery; patients should be cautioned appropriately.

Alcohol and other CNS depressants may produce an additive CNS depression, when taken with this combination product, and should be avoided.

Hydrocodone may be habit-forming. Patients should take the drug only for equally long every bit it is prescribed, in the amounts prescribed, and no more frequently than prescribed.

From

Written report Problems to the Food and Drug Administration

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or telephone call 1-800-FDA-1088.

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