Naprontag Flex

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Naprontag Flex uses

Naprontag Flex consists of Carisoprodol, Naproxen.

Carisoprodol:


1 INDICATIONS AND USAGE

Naprontag Flex (Carisoprodol) Tablets are indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults.

Naprontag Flex (Carisoprodol) 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 (2) ].

Naprontag Flex (Carisoprodol) Tablets are indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions. (1)

Important Limitations:

  • Should only be used for acute treatment periods up to two or three weeks (1)
  • Not recommended in pediatric patients less than 16 years of age (8.4)

2 DOSAGE AND ADMINISTRATION

The recommended dose of Naprontag Flex (Carisoprodol) is 250 mg to 350 mg three times a day and at bedtime. The recommended maximum duration of Naprontag Flex (Carisoprodol) use is up to two or three weeks.

  • Recommended dose is 250 mg to 350 mg three times a day and at bedtime. (2)

3 DOSAGE FORMS AND STRENGTHS

350 mg Tablets: white, round, unscored tablets debossed "2410 V" on one side and plain on the reverse side.

Tablets: 350 mg (3)

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4 CONTRAINDICATIONS

Naprontag Flex (Carisoprodol) Tablets are contraindicated in patients with a history of acute intermittent porphyria or a hypersensitivity reaction to a carbamate such as meprobamate.

  • Acute intermittent porphyria (4)
  • Hypersensitivity reactions to a carbamate such as meprobamate (4)

5 WARNINGS AND PRECAUTIONS

  • Due to sedative properties, may impair ability to perform hazardous tasks such as driving or operating machinery
  • Additive sedative effects when used with other CNS depressants including alcohol (5.1)
  • Cases of Drug Dependence, Withdrawal, and Abuse (5.2)
  • Seizures (5.3)

5.1 Sedation

Carisoprodol has sedative properties (in the low back pain trials, 13% to 17% of patients who received Naprontag Flex (Carisoprodol) experienced sedation compared to 6% of patients who received placebo) [see ADVERSE REACTIONS (6.1) ] and may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a motor vehicle or operating machinery. There have been post-marketing reports of motor vehicle accidents associated with the use of Naprontag Flex (Carisoprodol).

Since the sedative effects of Naprontag Flex (Carisoprodol) and other CNS depressants (e.g., alcohol, benzodiazepines, opioids, tricyclic antidepressants) may be additive, appropriate caution should be exercised with patients who take more than one of these CNS depressants simultaneously.

5.2 Drug Dependence, Withdrawal, and Abuse

In the postmarketing experience with Naprontag Flex, cases of dependence, withdrawal, and abuse have been reported with prolonged use. Most cases of dependence, withdrawal, and abuse occurred in patients who have had a history of addiction or who used Naprontag Flex (Carisoprodol) in combination with other drugs with abuse potential. However, there have been post-marketing adverse event reports of carisoprodol-associated abuse when used without other drugs with abuse potential. Withdrawal symptoms have been reported following abrupt cessation after prolonged use. To reduce the chance of Naprontag Flex (Carisoprodol) dependence, withdrawal, or abuse, Naprontag Flex (Carisoprodol) should be used with caution in addiction-prone patients and in patients taking other CNS depressants including alcohol, and Naprontag Flex (Carisoprodol) should not be used more than two to three weeks for the relief of acute musculoskeletal discomfort.

Naprontag Flex (Carisoprodol), and one of its metabolites, meprobamate (a controlled substance), may cause dependence [see Clinical Pharmacology (12.3) ].

5.3 Seizures

There have been postmarketing reports of seizures in patients who received Naprontag Flex (Carisoprodol). Most of these cases have occurred in the setting of multiple drug overdoses (including drugs of abuse, illegal drugs, and alcohol) [see Overdosage (10) ].

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6 ADVERSE REACTIONS

Most common adverse reactions are drowsiness, dizziness, and headache (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Qualitest Pharmaceuticals at 1‑800‑444-4011 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1 Clinical Studies Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect rates observed in practice.

The data described below are based on 1387 patients pooled from two double blind, randomized, multicenter, placebo controlled, one-week trials in adult patients with acute, mechanical, lower back pain [see Clinical Studies (14) ]. In these studies, patients were treated with 250 mg of Naprontag Flex (Carisoprodol), 350 mg of Naprontag Flex (Carisoprodol), or placebo three times a day and at bedtime for seven days. The mean age was about 41 years old with 54% females and 46% males and 74% Caucasian, 16% Black, 9% Asian, and 2% other.

There were no deaths and there were no serious adverse reactions in these two trials. In these two studies, 2.7%, 2%, and 5.4% of patients treated with placebo, 250 mg of Naprontag Flex (Carisoprodol), and 350 mg of Naprontag Flex (Carisoprodol), respectively, discontinued due to adverse events; 0.5%, 0.5%, and 1.8% of patients treated with placebo, 250 mg of Naprontag Flex (Carisoprodol), and 350 mg of Naprontag Flex (Carisoprodol), respectively, discontinued due to central nervous system adverse reactions.

Table 1 displays adverse reactions reported with frequencies greater than 2% and more frequently than placebo in patients treated with Naprontag Flex (Carisoprodol) in the two trials described above.

Adverse

Reaction

Placebo

(n=560)

n (%)


Naprontag Flex (Carisoprodol) 250 mg

(n=548)

n (%)

Naprontag Flex (Carisoprodol) 350 mg

(n=279)

n (%)

Drowsiness 31 (6)

73 (13)

47 (17)
Dizziness 11 (2) 43 (8) 19 (7)
Headache 11 (2) 26 (5) 9 (3)

6.2 Postmarketing Experience

The following events have been reported during postapproval use of Naprontag Flex (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 (10) ].

Central Nervous System: Drowsiness, dizziness, vertigo, ataxia, tremor, agitation, irritability, headache, depressive reactions, syncope, insomnia, and seizures [see Overdosage (10) ].

Gastrointestinal: Nausea, vomiting, and epigastric discomfort.

Hematologic: Leukopenia, pancytopenia.

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7 DRUG INTERACTIONS

  • CNS depressants - additive sedative effects (5.1 and 7.1)

7.1 CNS Depressants

The sedative effects of Naprontag Flex (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 Naprontag Flex (Carisoprodol) and meprobamate, a metabolite of Naprontag Flex (Carisoprodol), is not recommended [see Warnings and Precautions (5.1) ].

7.2 CYP2C19 Inhibitors and Inducers

Naprontag Flex (Carisoprodol) is metabolized in the liver by CYP2C19 to form meprobamate [see Clinical Pharmacology (12.3) ]. Co-administration of CYP2C19 inhibitors, such as omeprazole or fluvoxamine, with Naprontag Flex (Carisoprodol) could result in increased exposure of Naprontag Flex (Carisoprodol) and decreased exposure of meprobamate. Co-administration of CYP2C19 inducers, such as rifampin or St. John's Wort, with Naprontag Flex (Carisoprodol) could result in decreased exposure of Naprontag Flex (Carisoprodol) and increased exposure of meprobamate. Low dose aspirin also showed an induction effect on CYP2C19. The full pharmacological impact of these potential alterations of exposures in terms of either efficacy or safety of Naprontag Flex (Carisoprodol) is unknown.

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Pregnancy Category C. There are no data on the use of Naprontag Flex during human pregnancy. Animal studies indicate that Naprontag Flex (Carisoprodol) crosses the placenta and results in adverse effects on fetal growth and postnatal survival. The primary metabolite of Naprontag Flex (Carisoprodol), meprobamate, is an approved anxiolytic. Retrospective, post-marketing studies do not show a consistent association between maternal use of meprobamate and an increased risk for particular congenital malformations.

Teratogenic effects: Animal studies have not adequately evaluated the teratogenic effects of Naprontag Flex (Carisoprodol). There was no increase in the incidence of congenital malformations noted in reproductive studies in rats, rabbits, and mice treated with meprobamate. Retrospective, post-marketing studies of meprobamate during human pregnancy were equivocal for demonstrating an increased risk of congenital malformations following first trimester exposure. Across studies that indicated an increased risk, the types of malformations were inconsistent.

Nonteratogenic effects: In animal studies, Naprontag Flex (Carisoprodol) reduced fetal weights, postnatal weight gain, and postnatal survival at maternal doses equivalent to 1–1.5 times the human dose (based on a body surface area comparison). Rats exposed to meprobamate in-utero showed behavioral alterations that persisted into adulthood. For children exposed to meprobamate in-utero, one study found no adverse effects on mental or motor development or IQ scores. Naprontag Flex (Carisoprodol) should be used during pregnancy only if the potential benefit justifies the risk to the fetus.

8.2 Labor and Delivery

There is no information about the effects of Naprontag Flex (Carisoprodol) on the mother and the fetus during labor and delivery.

8.3 Nursing Mothers

Very limited data in humans show that Naprontag Flex 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 4–6% of the maternal daily dose through 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 were decreased. This information suggests that maternal use of Naprontag Flex (Carisoprodol) may lead to reduced or less effective infant feeding (due to sedation) and/or decreased milk production. Caution should be exercised when Naprontag Flex (Carisoprodol) is administered to a nursing woman.

8.4 Pediatric Use

The efficacy, safety, and pharmacokinetics of Naprontag Flex (Carisoprodol) in pediatric patients less than 16 years of age have not been established.

8.5 Geriatric Use

The efficacy, safety, and pharmacokinetics of Naprontag Flex in patients over 65 years old have not been established.

8.6 Renal Impairment

The safety and pharmacokinetics of Naprontag Flex (Carisoprodol) in patients with renal impairment have not been evaluated. Since Naprontag Flex (Carisoprodol) is excreted by the kidney, caution should be exercised if Naprontag Flex (Carisoprodol) is administered to patients with impaired renal function. Naprontag Flex (Carisoprodol) is dialyzable by hemodialysis and peritoneal dialysis.

8.7 Hepatic Impairment

The safety and pharmacokinetics of Naprontag Flex in patients with hepatic impairment have not been evaluated. Since Naprontag Flex (Carisoprodol) is metabolized in the liver, caution should be exercised if Naprontag Flex (Carisoprodol) is administered to patients with impaired hepatic function.

8.8 Patients with Reduced CYP2C19 Activity

Patients with reduced CYP2C19 activity have higher exposure to Naprontag Flex (Carisoprodol). Therefore, caution should be exercised in administration of Naprontag Flex (Carisoprodol) to these patients [see Clinical Pharmacology (12.3) ].

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9 DRUG ABUSE AND DEPENDENCE

Naprontag Flex (Carisoprodol) is not a controlled substance [see Warnings and Precautions (5.2) ]. Discontinuation of Naprontag Flex (Carisoprodol) in animals or in humans after chronic administration can produce withdrawal signs, and there are published case reports of human Naprontag Flex (Carisoprodol) dependence.

In vitro studies demonstrate that Naprontag Flex (Carisoprodol) elicits barbiturate-like effects. Animal behavioral studies indicate that Naprontag Flex (Carisoprodol) produces rewarding effects. Monkeys self administer Naprontag Flex (Carisoprodol). Drug discrimination studies using rats indicate that Naprontag Flex (Carisoprodol) has positive reinforcing and discriminative effects similar to barbital, meprobamate, and chlordiazepoxide.

10 OVERDOSAGE

Overdosage of Naprontag Flex (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 Naprontag Flex (Carisoprodol) overdosage. Many of the Naprontag Flex (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 Naprontag Flex (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 Naprontag Flex (Carisoprodol) have been reported alone or in combination with CNS depressants.

Treatment of Overdosage: Basic life support measures should be instituted as dictated by the clinical presentation of the Naprontag Flex (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 Naprontag Flex (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. For more information on the management of an overdose of Naprontag Flex (Carisoprodol), contact a Poison Control Center.

11 DESCRIPTION

Naprontag Flex (Carisoprodol) Tablets, USP are available as 350 mg round, white tablets for oral administration. Naprontag Flex (Carisoprodol) is a white, crystalline powder, having a mild, characteristic odor and a bitter taste. It is slightly soluble in water; freely soluble in alcohol, in chloroform, and in acetone; and its solubility is practically independent of pH. Naprontag Flex (Carisoprodol) is present as a racemic mixture. Chemically, Naprontag Flex (Carisoprodol) is N-isopropyl-2-methyl-2-propyl-1,3-propanediol dicarbamate and the molecular formula is C12H24N2O4, with a molecular weight of 260.33. The structural formula is:

Other ingredients in Naprontag Flex (Carisoprodol) Tablets, USP include croscarmellose sodium, hydrogenated vegetable oil, hypromellose, magnesium stearate and microcrystalline cellulose.

This in an image of the structural formula of Naprontag Flex (Carisoprodol).

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

The mechanism of action of Naprontag Flex in relieving discomfort associated with acute painful musculoskeletal conditions has not been clearly identified.

In animal studies, muscle relaxation induced by Naprontag Flex (Carisoprodol) is associated with altered interneuronal activity in the spinal cord and in the descending reticular formation of the brain.

12.2 Pharmacodynamics

Naprontag Flex (Carisoprodol) is a centrally acting skeletal muscle relaxant that does not directly relax skeletal muscles.

A metabolite of Naprontag Flex (Carisoprodol), meprobamate, has anxiolytic and sedative properties. The degree to which these properties of meprobamate contribute to the safety and efficacy of Naprontag Flex (Carisoprodol) is unknown.

12.3 Pharmacokinetics

The pharmacokinetics of Naprontag Flex (Carisoprodol) and its metabolite meprobamate were studied in a crossover study of 24 healthy subjects (12 male and 12 female) who received single doses of 250 mg and 350 mg Naprontag Flex (Carisoprodol). The exposure of Naprontag Flex (Carisoprodol) and meprobamate was dose proportional between the 250 mg and 350 mg doses. The Cmax of meprobamate was 2.5 ± 0.5 μg/mL (mean ± SD) after administration of a single 350 mg dose of Naprontag Flex (Carisoprodol), which is approximately 30% of the Cmax of meprobamate (approximately 8 μg/mL) after administration of a single 400 mg dose of meprobamate.

250 mg

Naprontag Flex (Carisoprodol)

350 mg

Naprontag Flex (Carisoprodol)

Naprontag Flex (Carisoprodol)
Cmax (μg/mL)

1.2 ± 0.5

1.8 ± 1.0
AUCinf (μg*hr/mL)

4.5 ± 3.1

7.0 ± 5.0
Tmax (hr)

1.5 ± 0.8

1.7 ± 0.8
T½ (hr)

1.7 ± 0.5

2.0 ± 0.5
Meprobamate
Cmax (μg/mL)

1.8 ± 0.3

2.5 ± 0.5
AUCinf (μg*hr/mL)

32 ± 6.2

46 ± 9.0
Tmax (hr) 3.6 ± 1.7 4.5 ± 1.9
T½ (hr)

9.7 ± 1.7

9.6 ± 1.5

Absorption: Absolute bioavailability of Naprontag Flex (Carisoprodol) has not been determined. The mean time to peak plasma concentrations (Tmax) of Naprontag Flex (Carisoprodol) was approximately 1.5 to 2 hours. Co-administration of a high-fat meal with Naprontag Flex (Carisoprodol) (350 mg tablet) had no effect on the pharmacokinetics of Naprontag Flex (Carisoprodol). Therefore, Naprontag Flex (Carisoprodol) may be administered with or without food.

Metabolism: The major pathway of Naprontag Flex (Carisoprodol) metabolism is via the liver by cytochrome enzyme CYP2C19 to form meprobamate. This enzyme exhibits genetic polymorphism.

Elimination: Carisoprodol is eliminated by both renal and non-renal routes with a terminal elimination half-life of approximately 2 hours. The half-life of meprobamate is approximately 10 hours.

Gender: Exposure of Naprontag Flex (Carisoprodol) is higher in female than in male subjects (approximately 30–50% on a weight adjusted basis). Overall exposure of meprobamate is comparable between female and male subjects.

Patients with Reduced CYP2C19 Activity: Carisoprodol should be used with caution in patients with reduced CYP2C19 activity. Published studies indicate that patients who are poor CYP2C19 metabolizers have a 4-fold increase in exposure to Naprontag Flex (Carisoprodol), and concomitant 50% reduced exposure to meprobamate compared to normal CYP2C19 metabolizers. The prevalence of poor metabolizers in Caucasians and African Americans is approximately 3–5% and in Asians is approximately 15–20%.

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Long term studies in animals have not been performed to evaluate the carcinogenic potential of Naprontag Flex (Carisoprodol).

Naprontag Flex (Carisoprodol) was not formally evaluated for genotoxicity. In published studies, Naprontag Flex (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. Naprontag Flex (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. Naprontag Flex (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.

Naprontag Flex (Carisoprodol) was not formally evaluated for effects on fertility. Published reproductive studies of Naprontag Flex (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 Naprontag Flex (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.

14 CLINICAL STUDIES

The safety and efficacy of Naprontag Flex (Carisoprodol) for the relief of acute, idiopathic mechanical low back pain was evaluated in two 7-day, double blind, randomized, multicenter, placebo controlled, U.S. trials (Studies 1 and 2). Patients had to be 18 to 65 years old and had to have acute back pain (≤ 3 days of duration) to be included in the trials. Patients with chronic back pain; at increased risk for vertebral fracture (e.g., history of osteoporosis); with a history of spinal pathology (e.g., herniated nucleus pulposis, spondylolisthesis or spinal stenosis); with inflammatory back pain, or with evidence of a neurologic deficit were excluded from participation. Concomitant use of analgesics (e.g., acetaminophen, NSAIDs, tramadol, opioid agonists), other muscle relaxants, botulinum toxin, sedatives (e.g., barbiturates, benzodiazepines, promethazine hydrochloride), and anti-epileptic drugs was prohibited.

In Study 1, patients were randomized to one of three treatment groups (i.e., Naprontag Flex (Carisoprodol) 250 mg, Naprontag Flex (Carisoprodol) 350 mg, or placebo) and in Study 2 patients were randomized to two treatment groups (i.e., Naprontag Flex (Carisoprodol) 250 mg or placebo). In both studies, patients received study medication three times a day and at bedtime for seven days.

The primary endpoints were the relief from starting backache and the global impression of change, as reported by patients, on Study Day 3. Both endpoints were scored on a 5-point rating scale from 0 (worst outcome) to 4 (best outcome) in both studies. The primary statistical comparison was between the Naprontag Flex (Carisoprodol) 250 mg and placebo groups in both studies.

The proportion of patients who used concomitant acetaminophen, NSAIDs, tramadol, opioid agonists, other muscle relaxants, and benzodiazepines was similar in the treatment groups.

The results for the primary efficacy evaluations in the acute, low back pain studies are presented in Table 3.


Number of Patients


n=278

n=269

Relief from Starting Backache, Mean (SE)b


1.1 (0.1)


1.8 (0.1)


2


Difference between Naprontag Flex (Carisoprodol) and Placebo, Mean (SE)b (95% CI)


0.7 (0.5, 0.9)


Global Impression of Change, Mean (SE)b


1.7 (0.1)


2.2 (0.1)

Difference between Naprontag Flex (Carisoprodol) and Placebo, Mean (SE)b (95% CI) 0.5 (0.4, 0.7)
Study Parameter Placebo

Naprontag Flex (Carisoprodol) 250 mg

Naprontag Flex (Carisoprodol)

350 mg

Number of Patients n=269

n=264

n=273
Relief from Starting Backache, Mean (SE)b 1.4 (0.1)

1.8 (0.1)

1.8 (0.1)
1 Difference between Naprontag Flex (Carisoprodol) and Placebo, Mean (SE)b (95% CI)

0.4 (0.2, 0.5)

0.4 (0.2, 0.6)
Global Impression of Change, Mean (SE)b 1.9 (0.1) 2.2 (0.1) 2.2 (0.1)
Difference between Naprontag Flex (Carisoprodol) and Placebo, Mean (SE)b (95% CI)

0.2 (0.1, 0.4)

0.3 (0.1, 0.4)

aThe primary efficacy endpoints (Relief from Starting Backache and Global Impression of Change) were assessed by the patients on Study Day 3. These endpoints were scored on a 5-point rating scale from 0 (worst outcome) to 4 (best outcome).

b Mean is the least squared mean and SE is the standard error of the mean. The ANOVA model was used for the primary statistical comparison between the Naprontag Flex (Carisoprodol) 250 mg and placebo groups.

Patients treated with Naprontag Flex (Carisoprodol) experienced improvement in function as measured by the Roland-Morris Disability Questionnaire (RMDQ) score on Days 3 and 7.

16 HOW SUPPLIED/STORAGE AND HANDLING

350 mg Tablets: white, round, unscored tablets debossed "2410 V" on one side and plain on the reverse side

49999-064-01

Storage:

Store at 20°-25°C (68°-77°F).

17 PATIENT COUNSELING INFORMATION

Patients should be advised to contact their physician if they experience any adverse reactions to Naprontag Flex tablets.

17.1 Sedation

Patients should be advised that Naprontag Flex (Carisoprodol) tablets may cause drowsiness and/or dizziness, and has been associated with motor vehicle accidents. Patients should be advised to avoid taking Naprontag Flex (Carisoprodol) before engaging in potentially hazardous activities such as driving a motor vehicle or operating machinery [see Warnings and Precautions (5.1) ].

17.2 Avoidance of Alcohol and Other CNS Depressants

Patients should be advised to avoid alcoholic beverages while taking Naprontag Flex tablets and to check with their doctor before taking other CNS depressants such as benzodiazepines, opioids, tricyclic antidepressants, sedating antihistamines, or other sedatives [see Warnings and Precautions (5.1) ].

17.3 Naprontag Flex (Carisoprodol) Tablets Should Only Be Used for Short-Term Treatment

Patients should be advised that treatment with Naprontag Flex (Carisoprodol) tablets should be limited to acute use (up to two or three weeks) for the relief of acute, musculoskeletal discomfort. In the post-marketing experience with Naprontag Flex (Carisoprodol) tablets, cases of dependence, withdrawal, and abuse have been reported with prolonged use. If the musculoskeletal symptoms still persist, patients should contact their healthcare provider for further evaluation.

To report SUSPECTED ADVERSE REACTIONS, contact Qualitest Pharmaceuticals at 1-800-444-4011 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Manufactured for:

QUALITEST PHARMACEUTICALS

Huntsville, AL 35811

8181281

Revised: 10/2010

R5

image of label

Naproxen:


Naprontag Flex information

Naprontag Flex (Naproxen) is an anti-inflammatory non-steroidal anti-inflammatory (NSAID) medicine. Naprontag Flex (Naproxen) Actavis's actions help reduce the chemicals found in the patient's organism that are usually responsible for the triggering of inflammation and pain.

Naprontag Flex indications

Naprontag Flex (Naproxen) is a drug normally prescribed in the treatment of pain, stiffness or inflammation that are usually triggered by medical disorders such as Gout, Osteoarthritis, menstruation abdominal cramps, rheumatoid arthritis, ankylosing spondylitis, injury, buritis and tendonitis.

Naprontag Flex (Naproxen) could also be prescribed in the treatment of other medical conditions that have not been mentioned here.

Naprontag Flex warnings

While the patient is following a treatment with Naprontag Flex (Naproxen) Actavis, he or she should avoid consuming big amounts of alcohol. It is recommended that alcohol drinks should be entirely avoided as they increase the danger of stomach bleeding. Therefore, if the patient is consuming more than 3 bottles of different alcoholic beverages he or she might not be allowed to start a treatment with Naprontag Flex (Naproxen) Actavis.

Naprontag Flex (Naproxen) can lead to drowsiness and dizziness. If you are following a treatment with this drug you should be careful while performing actions that require mental and physical alertness. The treatment with Naprontag Flex (Naproxen) should be carefully monitored in the case of patients suffering from any of the next medical disorders:

Allergic reactions to Aspirin (or any other NSAIDs)

Bleeding disorder

Liver problems

High blood pressure

Heart failure

Congestive heart disease

Fluid retention

Ulcer

Kidney disease

Stomach bleeding

If you are suffering from any of these medical disorders you might not be allowed to start a treatment with Naprontag Flex (Naproxen) Actavis.

Naprontag Flex (Naproxen) is a Category B FDA pregnancy drug. Therefore it is not considered to be harmful to an unborn child. However, if you are pregnant, consult with your doctor before starting a treatment with Naprontag Flex (Naproxen) Actavis. Naprontag Flex (Naproxen) (one of Naprontag Flex (Naproxen) Actavis's main ingredients) can pass into breast milk. If you are nursing an infant you should consult with your doctor before starting a treatment with Naprontag Flex (Naproxen) Actavis.

Naprontag Flex intake guidelines

Naprontag Flex (Naproxen) ought to be taken in just like your doctor told you to. Do not disobey the physician's instructions.

You should accompany each dose of the drug with a glass of water (from 6 to 8 ounces of liquid). Do not take Naprontag Flex (Naproxen) on an empty stomach as it can cause stomach upset. Do not stop your treatment with this drug without your doctor's consent even if you do not feel better after a few days of treatment.

Naprontag Flex dosage

Ask your doctor to calculate the dose of Naprontag Flex (Naproxen) that suits you best. The correct dosage varies from one person to another, as it depends on a couple of factors.

Naprontag Flex overdose

Reported Naprontag Flex (Naproxen) overdose symptoms are:

Nausea

Excessive sweating

Vomiting

Tingling sensation in legs and arms

Blurred vision

No or little urine production

Shallow and slow breathing

Stomach pains

Numbness

Ringing in the ears

If you are experiencing any of the symptoms listed here, you are in need of medical attention (inform your doctor immediately).

Naprontag Flex missed dose

Naprontag Flex (Naproxen) can be taken in when you need it or on a regular basis. If you are following a treatment with Naprontag Flex (Naproxen) Actavis, try not to miss any of your doses. If you happen to miss one take it as soon as possible. If it is almost time for another dose, skip the one that you have missed and continue with your regular schedule. You should not take in a double dose of this drug.

Naprontag Flex side effects

Very serious side effects of Naprontag Flex (Naproxen) are bloody vomit or bloody stools.

Other dangerous side effects of Naprontag Flex (Naproxen) are:

Allergic reactions (difficulty while breathing, throat closing, hives, swelling of mouth, lips and tongue).

Tingling

Muscle cramps

Mouth ulcers

Numbness

Fluid retention

Jaundice

Ringing in the ears

Stomach cramps or stomach upsets, indigestion or heartburn

Other side effects of the drug are:

Dizziness

Nausea

Headache

Fatigue

Depression

Dry mouth

Weakness

Irregular menstruation

There are other mild side effects that can also occur if you are taking Naprontag Flex (Naproxen) Actavis. Inform your physician if you feel anything disturbing or unusual.

Naprontag Flex drug reactions

You should inform your doctor if you are following a treatment with any of the drugs listed here:

Aspirin

NSAIDs

Cold and cough medicines

Steroids (like prednisone)

Anti coagulants

Insulin

Lithium

Probenecid

Pepto-Bismol

If you are taking any of these drugs you may not be allowed to start taking Naprontag Flex (Naproxen) Actavis. Ask for your doctor's advice before you start a treatment with this drug.

Naprontag Flex pharmaceutical active ingredients containing related brand and generic drugs:

Active ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


Naprontag Flex available forms, composition, doses:

Form of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.


Naprontag Flex destination | category:

Destination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


Naprontag Flex Anatomical Therapeutic Chemical codes:

A medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


Naprontag Flex pharmaceutical companies:

Pharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


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References

  1. Dailymed."NAPROXEN TABLET [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. Dailymed."CARISOPRODOL TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  3. Dailymed."NAPROXEN: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Naprontag Flex?

Depending on the reaction of the Naprontag Flex after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Naprontag Flex not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Naprontag Flex addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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Review

sdrugs.com conducted a study on Naprontag Flex, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Naprontag Flex consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

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The information was verified by Dr. Rachana Salvi, MD Pharmacology

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