Prescription Drug Name:

CARISOPRODOL AND ASPIRIN, TABLETS, USP, 200 mg/325 mg

ID:

9d8b08a9-02c8-4b02-9e0e-a24b90d7a7e0

Code:

34391-3

DESCRIPTION


id: 45fcea28-488c-47cc-bc01-be2636035b1a
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3

Carisoprodol and Aspirin tablets, USP are 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, Red and White, round tablet for oral administration. Carisoprodol: Chemically, carisoprodol is N-isopropyl-2-methyl-2-propyl-1,3propanediol dicarbamate and its molecular formula is C12H24N2O4, with a molecular weight of 260.33. The structural formula of carisoprodol is:

INDICATIONS AND USAGE


id: db9b3dfc-08d7-4a00-af13-8c49f6ecde61
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9

Carisoprodol and Aspirin is indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. Carisoprodol and Aspirin 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: a5bcf2a7-7048-4f25-a600-866fa2447d61
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3

Carisoprodol and Aspirin is 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 carbamate such as meprobamate
acute intermittent prophyria

Information for Patients:


id: 7ae61963-3a14-4ed1-9d29-6f6618168a2c
displayName: INFORMATION FOR PATIENTS SECTION
FDA Article Code: 34076-0

Patients should be advised to contact their health care provider if they experience any adverse reactions to Carisoprodol and Aspirin Tablets.

Drug Interactions


id: cae16e0b-8230-40af-b9dc-6bf06f00f11f
displayName: DRUG INTERACTIONS SECTION
FDA Article Code: 34073-7

Carisoprodol: The sedative effect of carisoprodol and other CNS depressants (e.g., alcohol, benzodiazepines, opioids, tricyclic antidepressants) may be additive. Therefore, caution should be exercised with patients who take more than one of these CNS depressants simultaneously. Concomitant use of carisoprodol and meprobamate, a metabolite of carisoprodol, is not recommended (see WARNINGS, Sedation ). Carisoprodol is metabolized in the liver by CYP2C19 to form meprobamate (see CLINICAL PHARMACOLOGY ). Co-administration of CYP2C19 inhibitors, such as omeprazole or fluvoxamine, with carisoprodol could result in increased exposure of carisoprodol and decreased exposure of meprobamate. Co-administration of CYP2C19 inducers, such as rifampin or St. John’s Wort, with carisoprodol could result in decreased exposure of carisoprodol and increased exposure of meprobamate. Low dose aspirin also showed an induction effect of CYP2C19. The full pharmacological impact of these potential alterations of exposures in terms of either efficacy or safety of carisoprodol is unknown. Aspirin: Clinically important interactions may occur when certain drugs or alcohol are administered concomitantly with aspirin. Alcohol: Concomitant use of aspirin with ≥ 3 alcoholic drinks may increase the risk of GI bleeding (see WARNINGS, Serious Gastrointestinal Adverse Reactions ). Anticoagulants: Concomitant use of aspirin and anticoagulants (e.g., heparin, warfarin, clopidogrel) increase the risk of GI bleeding (see WARNINGS, Serious Gastrointestinal Adverse Reactions ). Additionally, aspirin can displace warfarin from protein binding sites, leading to prolongation of the international normalized ratio (INR). Antihypertensives: The concomitant administration of aspirin with angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), beta-blockers, and diuretics may diminish the hypotensive effects of these anti-hypertensive products due to aspirin’s inhibition of renal
prostaglandins, which may lead to decreased renal blood flow and increased sodium and fluid retention. Concomitant use of aspirin and acetazolamide can lead to high serum concentrations of acetazolamide due to competition at the renal tubule for secretion. Corticosteroids: Concomitant administration of aspirin and corticosteroids may decrease salicylate plasma levels. Methotrexate: Aspirin may enhance the toxicity of methotrexate due to displacement of methotrexate from its plasma protein binding sites and/or reduction of the renal clearance of methotrexate. Nonsteroidal anti-inflammatory drugs (NSAIDs): The concurrent use of aspirin with selective and nonselective NSAIDs increases the risk of serious GI adverse reactions (see WARNINGS, Serious Gastrointestinal Adverse Reactions ). Oral Hypoglycemics Agents: Aspirin may increase the serum glucose lowering action of insulin and sulfonylureas leading to hypoglycemia. Products that effect urinary pH: Ammonium chloride and other drugs that acidify the urine can elevate plasma salicylate concentrations. In contrast, antacids, by alkalinizing the urine, may decrease plasma salicylate concentrations. Uricosuric Agents: Salicylates antagonize the uricosuric action of probenecid and sulfinpyrazone.

Carcinogenesis, Mutagenesis, Impairment of Fertility:


id: daf0442c-dd20-4d66-a7b8-deb78da739fb
displayName: CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION
FDA Article Code: 34083-6

No long-term studies of carcinogens have been done with carisoprodol and Aspirin. Carisoprodol: Long term studies in animals have not been performed to evaluate the carcinogenic potential of carisoprodol. Carisoprodol was not formally evaluated for genotoxicity. In published studies, carisoprodol was mutagenic in the in vitro mouse lymphoma cell assay in the absence of metabolizing enzymes, but was not mutagenic in the presence of metabolizing enzymes. Carisoprodol was clastogenic in the in vitro chromosomal aberration assay using Chinese hamster ovary cells with or without the presence of metabolizing enzymes. Other types of genotoxic tests resulted in negative findings. Carisoprodol was not mutagenic in the Ames reverse mutation assay using S. typhimurium strains with or without metabolizing enzymes, and was not clastogenic in an in vivo mouse micronucleus assay of circulating blood cells. Carisoprodol was not formally evaluated for effects on fertility. Published reproductive studies of carisoprodol in mice found no alteration in fertility
although an alteration in reproductive cycles characterized by a greater time spent in estrus was observed at a carisoprodol dose of 1200 mg/kg/ day. In a 13-week toxicology study that did not determine fertility, mouse testes weight and sperm motility were reduced at a dose of 1200 mg/kg/ day. In both studies, the no effect level was 750 mg/kg/day, corresponding to
approximately 2.6 times the human equivalent dosage of 350 mg four times a day, based on a body surface area comparison. The significance of these findings for human fertility is not known. Aspirin: Administration of aspirin for 68 weeks in the feed of rats was not carcinogenic. In the Ames Salmonella assay, aspirin was not mutagenic; however, aspirin did induce chromosome aberrations in cultured human fibroblasts. Aspirin has been shown to inhibit ovulation in rats (see
Pregnancy ).

Pregnancy:


id: a49f120d-b9fb-453c-81b1-eb4616830f5f
displayName: PREGNANCY SECTION
FDA Article Code: 42228-7

Pregnancy Category D. It is not known whether Carisoprodol and Aspirin can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Adequate animal reproduction studies have not been conducted with Carisoprodol and Aspirin. Carisoprodol and Aspirin should be given to a pregnant woman only if clearly needed.

Labor and Delivery


id: fbe64e29-bad2-4269-b367-2d7e0e54999e
displayName: LABOR & DELIVERY SECTION
FDA Article Code: 34079-4

Carisoprodol: There is no information about the effects of carisoprodol on the mother and the fetus during labor and delivery. Aspirin: Ingestion of aspirin within one week of delivery or during labor may prolong delivery or lead to excessive blood loss in the mother, fetus, or neonate. Prolonged labor due to prostaglandin inhibition has been reported with aspirin use.

Nursing Mothers


id: 3ff10fb9-b5b0-461b-b9a7-3a3de8dd5b4a
displayName: NURSING MOTHERS SECTION
FDA Article Code: 34080-2

Carisoprodol: Very limited data in humans show that carisoprodol is present in breast milk and may reach concentrations two to four times the maternal plasma concentrations. In one case report, a breast-fed infant received about 4 to 6% of the maternal daily dose though breast milk and experienced no adverse effects. However, milk production was inadequate and the baby was supplemented with formula. In lactation studies in mice, female pup survival and pup weight at weaning was decreased. This information suggests that maternal use of carisoprodol may lead to reduced or less effective infant feeding (due to sedation) and/or decreased milk production. Caution should be exercised when carisoprodol is administered to a nursing woman. Aspirin: Nursing mothers should avoid the use of aspirin because salicylate is excreted in breast milk which may lead to bleeding in the infant.

Pediatric Use:


id: 3e1d0aeb-3a3b-4cce-98c1-38e936919717
displayName: PEDIATRIC USE SECTION
FDA Article Code: 34081-0

The efficacy, safety, and pharmacokinetics of carisoprodol and Aspirin in pediatric patients less than 16 years of age have not been established.

Geriatric Use:


id: de02b322-233d-4390-a45f-48a37d1c1e9d
displayName: GERIATRIC USE SECTION
FDA Article Code: 34082-8

The efficacy, safety, and pharmacokinetics of Carisoprodol and Aspirin in patients over 65 years of age have not been established.

ADVERSE REACTIONS


id: 895aeef5-a3b5-47b1-a3be-cd5ad9ea132c
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4

To report SUSPECTED ADVERSE REACTIONS, contact Rising Pharmaceuticals at 1-201-961-9000 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 ).

OVERDOSAGE


id: 86b7ada1-b68f-4348-9e49-37f1b42871c4
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 and may be modified to a varying degree by the effects of the other products present in carisoprodol and Aspirin. 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. 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 nonaccidental 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 that 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. Induced emesis is not recommended due to the risk of CNS and respiratory depression, which may increase the risk of aspiration pneumonia. Gastric lavage should be considered soon after ingestion (within one hour). 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. The following types of treatment have been used successfully with an overdose of meprobamate, a metabolite of carisoprodol: activated charcoal (oral or via nasogastric tube), forced diuresis, peritoneal dialysis, and hemodialysis (carisoprodol is also dialyzable). Careful monitoring of urinary output is necessary and overhydration should be avoided. Observe for possible relapse due to incomplete gastric emptying and delayed absorption Aspirin: Since there are no specific antidotes for salicylate poisoning, the aim of the treatment is to enhance elimination
of salicylate; reduce further salicylate absorption; correct fluid, electrolyte, or acid/ibase imbalances; and provide cardio-respiratory support. The acidbase 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


id: 434b8b8e-0787-4799-9e46-7d91739e0abe
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: 3a6191b5-18d0-4c15-9ec1-69335f7dd268
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Carisoprodol and Aspirin Tablets, USP 200mg/325mg are red and white, round unscored convex, two layered tablets debossed on red layer with “CL” over “023” and plain on the white layer. The tablets are available in: Bottles of 100 NDC 64980-175-01.
Bottles of 500 NDC 64980-175-05.

PRINCIPAL DISPLAY PANEL – Principal Display Panel – 100-count Bottle


id: 275a860d-89fa-44ce-b6d8-4a7119f27cb7
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

Rising®        NDC 64980-175-01      CIV Carisoprodol and
Aspirin Tablets, USP 200 mg/325 mg 100 Tablets Rx Only