■■■■■■■■ analgesic IP 110
■■■■■■■■ analgesic is a pain killer medicine which is a product of US based Amneal pharmaceutical. It is made up of acetaminophen and hydrocodone bitartrate.
Description
Active ingredients of ■■■■■■■■ analgesic Hydrocodone Bitartrate and Acetaminophen is available in tablet form for ■■■■ administration.
It is an opioid analgesic and occurs as fine, white crystals or as a crystalline powder. It is affected by light. Chemical name is 4,5a-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate.
This ■■■■■■■■ analgesic tablet is bitter, white, odorless, crystalline powder, non-■■■■■■, non-salicylate analgesic and antipyretic.
Mechanism of Action
Second ingredient hydrocodone bitartrate is full opioid agonist with relative selectivity for the mu-opioid (μ) receptor, although it can interact with other opioid receptors at higher doses. The main therapeutic action of hydrocodone is analgesia.
This opioid agonists, there is no ceiling effect for analgesia with hydrocodone. It is titrated to provide adequate analgesia and may be limited by adverse reactions, including respiratory and CNS depression.
Mechanism of the analgesic action is unknown. Opioid receptors of CNS for endogenous compounds with opioid-like activity have been identified throughout the brain and spinal cord and are thought to play a role in the analgesic effects of this drug.
Analgesic properties of acetaminophen’s mechanism is not established but is thought to involve central actions.
PRECAUTIONS
There are lots of risks of Driving and Operating Machinery:
Ingredients of ■■■■■■■■ analgesic Hydrocodone Bitartrate and Acetaminophen tablets may impair the mental or physical abilities needed to perform potentially hazardous activities such as driving a car or operating machinery. There is a Warning for patients not to drive or operate dangerous machinery unless they are tolerant to the effects of Hydrocodone Bitartrate and Acetaminophen tablets and know how they will react to the medication.
Information for Patients
Doctors advised the patient to read prescription carefully.
Storage and Disposal:
Risks associated with accidental ingestion, misuse, and abuse, advise patients to store hydrocodone bitartrate and Acetaminophen tablets securely, out of sight and reach of children, and in a place which is not accessible by others, including visitors to the home. Always inform patients that leaving Hydrocodone Bitartrate and Acetaminophen tablets unsecured can pose a deadly risk to others in the home.
Suggest patients and caregivers that when medicines are no longer needed, they should be disposed of promptly. Unwanted, expired, or unused Hydrocodone Bitartrate and Acetaminophen tablets should be disposed of by flushing the unused medication down the toilet if a drug take-back option is not readily available. Drug disposal for a medicines recommended by flushing, as well as additional information on disposal of unused medicines written on prescription.
Drug/Laboratory Test Interactions
Ingredients of ■■■■■■■■ analgesic Acetaminophen may produce false-positive test results for urinary 5-hydroxyindoleacetic acid.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenesis
Medicine use for terms activate the carcinogenic potential of the combination of Hydrocodone Bitartrate and Acetaminophen tablets have not been conducted.
Studies in mice and rats have been completed by the National toxicology program to evaluate the carcinogenic potential of acetaminophen. Years of feeding studies, F344/N rats and B6C3F1 mice were fed a diet containing acetaminophen up to 6,000 ppm. Rats of female gender demonstrated equivocal evidence of carcinogenic activity based on increased incidences of mononuclear cell leukemia at 0.8 times the maximum human daily dose of 4 grams/day, based on a body surface area comparison. While there was no evidence of carcinogenic activity in male rats that received up to 0.7 times or mice at up to 1.2 to 1.4 times, based on a body surface area comparison.
Mutagenesis
Acetaminophen has been reported to be clastogenic when administered at 1,500 mg/kg/day to the rat model (3.6-times, based on a body surface area comparison). While no clastogenicity was noted at a dose of 750 mg/kg/day (1.8-times, based on a body surface area comparison), suggesting a threshold effect.
HOW SUPPLIED
■■■■■■■■ analgesic’s ingredients hydrocodone Bitartrate and Acetaminophen tablets, 10 mg/325 mg, are supplied as white to off-white, scored, oblong biconvex tablets, debossed “IP 110” on obverse and bisected on the reverse. Every tablet contains 10 mg hydrocodone bitartrate, USP and 325 mg acetaminophen, USP.
Available as follows:
Bottles of 100: NDC 53746-110-01
Bottles of 500: NDC 53746-110-05
Bottles of 1000: NDC 53746-110-10
Should be store at 20° to 25°C (68° to 77°F).
Keep in a tight, light-resistant container as defined in the USP with a child-resistant closure.
These ■■■■■■■■ analgesic tablets Hydrocodone Bitartrate and Acetaminophen store securely and dispose of properly.