Recommended Topic Related To:

Lorcet

"Nov. 1, 2012 -- Two more drugs made by the New England Compounding Center (NECC) are crawling with various kinds of bacteria, FDA tests reveal.

The NECC is the Massachusetts compounding pharmacy whose drugs are the likely source of th"...

Lorcet

Lorcet Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Lorcet is an opioid analgesic indicated for the relief of moderate to severe pain. Nausea, vomiting, constipation, lightheadedness, dizziness, or drowsiness may occur. Serious side effects can include mental/mood changes, severe stomach/abdominal pain, and difficulty urinating. Rare, but serious side effects can include fainting, seizure, slow/shallow breathing, unusual drowsiness/difficulty waking up. There is a risk of addiction to Lorcet.

Dosage of Lorcet should be adjusted according to the severity of the pain and the response of the patient. 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. Many other medications may interact with Lorcet, especially other drugs that cause drowsiness (other narcotics, benzodiazapines, sleep medications, or cold and allergy medications). Tell your doctor all medications you use. Before using Lorcet, women of childbearing age should talk with their doctor(s) about the risks and benefits. Women should tell their doctors if they pregnant or plan to become pregnant. During pregnancy, this medication should be used only when clearly needed. It may slightly increase the risk of birth defects if used during the first two months of pregnancy. The effects of Lorcet while breastfeeding are unknown. Withdrawal symptoms may occur if you suddenly stop using this medication.

Our Lorcet Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Lorcet in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • shallow breathing, slow heartbeat;
  • feeling light-headed, fainting;
  • confusion, fear, unusual thoughts or behavior;
  • seizure (convulsions);
  • problems with urination; or
  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • anxiety, dizziness, drowsiness;
  • mild nausea, vomiting, upset stomach, constipation;
  • headache, mood changes;
  • blurred vision;
  • ringing in your ears; or
  • dry mouth.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Lorcet (Hydrocodone Bitartrate and Acetaminophen Tablet) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Lorcet FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The most frequently reported adverse reactions include lightheadedness, 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

Drowsiness, mental clouding, lethargy, impairment of mental and physical performance, anxiety, fear, dysphoria, psychic dependence, mood changes.

Gastrointestinal System

Prolonged administration of Lorcet® 10/650 may produce constipation.

Genitourinary System

Ureteral spasm, spasm of vesical sphincters and urinary retention have been reported with opiates.

Respiratory Depression

Hydrocodone bitartrate may produce dose-related respiratory depression by acting directly on the brain stem respiratory centers. (see OVERDOSAGE).

Special Senses

Cases of hearing impairment or permanent loss have been reported predominantly in patients with chronic overdose.

Dermatological: Skin rash, pruritus.

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 OVERDOSAGE section.

Drug Abuse And Dependence

Misuse, Abuse, and Diversion of Opioids

Lorcet® 10/650 tablets contain hydrocodone, an opioid agonist, and are a Schedule III controlled substance. Lorcet® 10/650, and other opioids used in analgesia can be abused and are subject to criminal diversion.

Addiction is a primary, chronic, neurobiologic disease, with genetic, psychosocial, and environmental factors influencing its development and manifestations. It is characterized by behaviors that include one or more of the following: impaired control over drug use, compulsive use, continued use despite harm, and craving. Drug addiction is a treatable disease utilizing a multidisciplinary approach, but relapse is common.

“Drug seeking” behavior is very common in addicts and drug abusers. Drug-seeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing or referral, repeated “loss” of prescriptions, tampering with prescriptions and reluctance to provide prior medical records or contact information for other treating physician (s). “Doctor shopping” to obtain additional prescriptions is common among drug abusers and people suffering from untreated addiction.

Abuse and addiction are separate and distinct from physical dependence and tolerance. Physical dependence usually assumes clinically significant dimensions only after several weeks of continued opioid use, although a mild degree of physical dependence may develop after a few days of opioid therapy. Tolerance, in which increasingly large doses are required in order to produce the same degree of analgesia, is manifested initially by a shortened duration of analgesic effect, and subsequently by decreases in the intensity of analgesia. The rate of development of tolerance varies among patients. Physicians should be aware that abuse of opioids can occur in the absence of true addiction and is characterized by misuse for non-medical purposes, often in combination with other psychoactive substances. Lorcet® 10/650, like other opioids, may be diverted for non-medical use. Record-keeping of prescribing information, including quantity, frequency, and renewal requests is strongly advised.

Proper assessment of the patient, proper prescribing practices, periodic reevaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs.

Read the entire FDA prescribing information for Lorcet (Hydrocodone Bitartrate and Acetaminophen Tablet) »

A A A

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 call 1-800-FDA-1088.


Chronic Pain/Back Pain

Find tips and advances in treatment.