Carisoprodol and Aspirin Tablets, USP for oral use, CIV, Rx only

/Carisoprodol and Aspirin Tablets, USP for oral use, CIV, Rx only
Carisoprodol and Aspirin Tablets, USP for oral use, CIV, Rx only2018-09-06T09:12:40+00:00

Prescription Drug Name:

Carisoprodol and Aspirin Tablets, USP for oral use, CIV, Rx only

ID:

6e7d3064-3529-419b-9ed7-ead7dea87a4d

Code:

34391-3

DESCRIPTION


id: a0fa6156-3b6b-49fd-831d-b7020726899b
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3

Carisoprodol and aspirin tablets, USP is a fixed-dose combination product containing the following two products: • 200 mg of carisoprodol, a centrally-acting muscle relaxant • 325 mg of aspirin, an analgesic with antipyretic and anti-inflammatory properties. It is available as a two-layered, white and lavender, round tablet for oral administration. Carisoprodol: Chemically, carisoprodol is N-isopropyl-2-methyl-2-propyl-1,3-propanediol dicarbamate and its molecular formula is C12H24N2O4, with a molecular weight of 260.33. The structural formula of carisoprodol is: Aspirin:  Chemically,  aspirin  (acetylsalicyclic  acid)  is  2-(acetyloxy)-,  benzoic  acid  and  its molecular  formula is C9H8O4, with a molecular weight of 180.16.   The structural formula of aspirin is: Other ingredients in the carisoprodol and aspirin drug product are croscarmellose sodium, D&C Red#30, FD&C Blue #1, magnesium stearate, microcrystalline cellulose, povidone, starch, and stearic acid.

INDICATIONS AND USAGE


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displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9

Carisoprodol and aspirin tablets are indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. Carisoprodol and aspirin tablets should only be used for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use has not been established and because acute, painful musculoskeletal conditions are generally of short duration (see DOSAGE AND ADMINISTRATION ).

CONTRAINDICATIONS


id: aa2f8b92-41e1-4b59-9f4d-df3e62bd6034
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3

Carisoprodol and aspirin tablets are contraindicated in patients with a history of: a serious GI complication (i.e., bleeding, perforations, obstruction) due to aspirin use
aspirin induced asthma (a symptom complex which occurs in patients who have asthma, rhinosinusitis, and nasal polyps who develop a severe, potentially fatal bronchospasm shortly after taking aspirin or other NSAIDs)
hypersensitivity reaction to a carbamate such as meprobamate
acute intermittent porphyria

WARNINGS


id: a51f3657-7efe-4dac-afe2-5a39d38bdf96
displayName: WARNINGS SECTION
FDA Article Code: 34071-1

Carisoprodol:

ADVERSE REACTIONS


id: a1ee7110-d9a9-478f-82f6-ac6069bfc259
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4

To report SUSPECTED ADVERSE REACTIONS, contact Heritage Pharmaceuticals Inc. at 1-866-901-DRUG (3784) or FDA at 1-800-FDA-1088 or
www.fda.gov/medwatch.
The following adverse reactions which have occurred with the administration of the individual products alone may also occur with the use of carisoprodol and aspirin tablets. The following events have been reported during post-approval individual use of carisoprodol and aspirin. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Carisoprodol: The following events have been reported during post-approval use of carisoprodol. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Cardiovascular: Tachycardia, postural hypotension, and facial flushing (see OVERDOSAGE ). Central Nervous System: Drowsiness, dizziness, vertigo, ataxia, tremor, agitation, irritability, headache, depressive reactions, syncope, insomnia, and seizures (see OVERDOSAGE ). Gastrointestinal: Nausea, vomiting, and epigastric discomfort. Hematologic: Leukopenia, pancytopenia. Aspirin: The most common adverse reactions associated with the use of aspirin have been gastrointestinal, including abdominal pain, anorexia, nausea, vomiting, gastritis, and occult bleeding (see WARNINGS, Serious Gastrointestinal Adverse Reactions and PRECAUTIONS, Gastrointestinal Adverse Reactions ). Other adverse reactions associated with the use of aspirin include elevated liver enzymes, rash, pruritus, purpura, intracranial hemorrhage, interstitial nephritis, acute renal failure, and tinnitus. Tinnitus may be a symptom of high serum salicylate levels (see OVERDOSAGE).

DRUG ABUSE AND DEPENDENCE


id: a2b9b745-6469-4e30-8fc1-07617a077949
displayName: DRUG ABUSE AND DEPENDENCE SECTION
FDA Article Code: 42227-9

Controlled Substance Carisoprodol and aspirin tablets contain carisoprodol, a Schedule IV controlled substance. Carisoprodol has been subject to abuse, misuse, and criminal diversion for nontherapeutic use (see WARNINGS ). Abuse Abuse of carisoprodol poses a risk of overdosage which may lead to death, CNS and respiratory depression, hypotension, seizures and other disorders (see WARNINGS ). Patients at high risk of carisoprodol and aspirin tablets abuse may include those with prolonged use of carisoprodol, with a history of drug abuse, or those who use carisoprodol and aspirin tablets in combination with other abused drugs. Prescription drug abuse is the intentional non-therapeutic use of a drug, even once, for its rewarding psychological or physiological effects. Drug addiction, which develops after repeated drug abuse, is characterized by a strong desire to take a drug despite harmful consequences, difficulty in controlling its use, giving a higher priority to drug use that to obligations, increased tolerance, and sometimes physical withdrawal. Drug abuse and drug addiction are separate and distinct from physical dependence and tolerance (for example, abuse or addiction may not be accompanied by tolerance or physical dependence) (see DEPENDENCE ).

OVERDOSAGE


id: ae201c69-53b0-46eb-9938-46a3aa3d5823
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5

Signs and Symptoms: Any of the following signs and symptoms which have been reported with overdose of the individual products may occur with overdose of carisoprodol and aspirin tablets and may be modified to a varying degree by the effects of the other products present in carisoprodol and aspirin tablets. Carisoprodol: Overdosage of carisoprodol commonly produces CNS depression. Death, coma, respiratory depression, hypotension, seizures, delirium, hallucinations, dystonic reactions, nystagmus, blurred vision, mydriasis, euphoria, muscular incoordination, rigidity, and/or headache have been reported with carisoprodol overdosage. Serotonin syndrome has been reported with carisoprodol intoxication. Many of the carisoprodol overdoses have occurred in the setting of multiple drug overdoses (including drugs of abuse, illegal drugs, and alcohol). The effects of an overdose of carisoprodol and other CNS depressants (e.g., alcohol, benzodiazepines, opioids, tricyclic antidepressants) can be additive even when one of the drugs has been taken in the recommended dosage. Fatal accidental and non-accidental overdoses of carisoprodol have been reported alone or in combination with CNS depressants. Aspirin: Salicylate toxicity may result from an overdose of an acute ingestion or chronic intoxication. Mild to moderate salicylate poisoning is usually associated with plasma salicylic concentrations about 200 µg/mL and is characterized by tinnitus, hearing difficulty, headache, dim vision, dizziness, tachypnea, increased thirst, nausea, vomiting, sweating, and diarrhea. In the early stages of overdose, CNS stimulation and respiratory alkalosis can occur; however, in the later stages CNS depression and metabolic acidosis can occur. Symptoms and signs of severe salicylate poisoning, associated with plasma salicylic concentrations greater than 400 µg/mL, include hyperthermia, dehydration, delirium, GI hemorrhage, pulmonary edema, and CNS depression (e.g., coma). Death is usually due to respiratory failure or cardiovascular collapse. Overdose of aspirin in pediatric patients: Salicylate poisoning should be considered in pediatric patients with symptoms of vomiting, hyperpnea, and hyperthermia. Salicylate poisoning should be considered in infants with metabolic acidosis and all pediatric patients with severe salicylate poisoning. Treatment of Overdosage: Provide symptomatic and supportive treatment, as indicated. For more information on the management of an overdose of carisoprodol and aspirin tablets, USP, contact a Poison Control Center. Carisoprodol: Basic life support measures should be instituted as dictated by the clinical presentation of the carisoprodol overdose. Vomiting should not be induced due to the risk of CNS and respiratory depression and subsequent aspiration. Circulatory support should be administered with volume infusion and vasopressor agents if needed. Seizures should be treated with intravenous benzodiazepines and the reoccurrence of seizures may be treated with phenobarbital.  In cases of severe CNS depression, airway protective reflexes may be compromised and tracheal intubation should be considered for airway protection and respiratory support. For decontamination in cases of severe toxicity, activated charcoal should be considered in a hospital setting in patients with large overdoses who present early and are not demonstrating CNS depression and can protect their airway. Aspirin: Since there are no specific antidotes for salicylate poisoning, the aim of treatment is to enhance elimination of salicylate; reduce further salicylate absorption; correct fluid, electrolyte, or acid/base imbalances; and provide cardio-respiratory support. The acid-base status should be followed closely with serial serum pH determinations (using arterial blood gas). If acidosis is present, intravenous sodium bicarbonate should be given, along with adequate hydration, until salicylate levels decrease to within the therapeutic range. To enhance elimination, forced diuresis and alkalinization of the urine may be beneficial. Gastric emptying and/or lavage are recommended as soon as possible after ingestion, even if the patient has vomited spontaneously. After lavage and/or emesis, administration of activated charcoal is beneficial, if less than 3 hours have passed since ingestion. Charcoal absorption should not be employed prior to emesis and lavage.  In patients with renal insufficiency or in cases of life-threatening aspirin intoxication, hemodialysis or peritoneal dialysis is usually required. Additional treatment of aspirin overdose in pediatric patients: Pediatric patients should be sponged with tepid water. Infusion of glucose may be required to control hypoglycemia. Exchange transfusion may be indicated in infants and young children.

DOSAGE AND ADMINISTRATION


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displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7

The recommended dose of carisoprodol and aspirin tablets is 1 or 2 tablets, four times daily in adults. One carisoprodol and aspirin tablet contains 200 mg of carisoprodol and 325 mg of aspirin. The maximum daily dose (i.e., two tablets taken four times daily) will provide 1600 mg of carisoprodol and 2600 mg of aspirin per day. The recommended maximum duration of carisoprodol and aspirin tablets use is up to two or three weeks.

HOW SUPPLIED


id: ac1014b9-f628-48d1-98f7-3551e9825db8
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Carisoprodol and aspirin tablets are round, convex, two-layered and debossed on the white layer with HP 145 and plain on the light lavender layer. The tablets are available in bottles of 100 (NDC 23155-145-01). Storage: Store at 20°- 25° C (68° to 77° F) [See USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight container. MANUFACTURED FOR:
Heritage Pharmaceuticals Inc.

Eatontown, NJ 07724
1-866-901-DRUG (3784) MF # 0214-05 Issued 10/13

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


id: aff71ad8-f2c4-47d5-afc5-4ccd3e5645db
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

Carisoprodol and Aspirin tablets, USP 200 mg/325 mg , 100 count