Omeclamox-Pak

Name: Omeclamox-Pak

What should I avoid while taking Omeclamox-Pak (amoxicillin, clarithromycin, and omeprazole)?

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or has blood in it, call your doctor. Do not use any medicine to stop the diarrhea unless your doctor has told you to.

Commonly used brand name(s)

In the U.S.

  • Omeclamox-Pak

Available Dosage Forms:

  • Capsule, Delayed Release
  • Tablet
  • Capsule

If OVERDOSE is suspected

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Adverse Reactions

The following serious adverse reactions are described elsewhere in the labeling:

  • Hypersensitivity [See Contraindications (4.1 )]
  • Myasthenia Gravis [See Warnings and Precautions (5.3 )]
  • Clostridium difficile-associated diarrhea [See Warnings and Precautions (5.4 )]

6.1 Clinical Trials Experience

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

In clinical trials using triple therapy with omeprazole, clarithromycin, and amoxicillin, no adverse reactions unique to triple therapy were observed. Adverse reactions observed were limited to those previously reported with omeprazole, clarithromycin, or amoxicillin alone. The most frequent adverse reactions observed in clinical trials using combination therapy with omeprazole, clarithromycin, and amoxicillin (n = 274) were diarrhea (14%), taste perversion (10%), and headache (7%). None of these occurred at a higher frequency than that reported by patients taking antimicrobial agents alone.

6.2 Adverse Reactions from Labeling for the Individual Components of Omeclamox®-Pak

The safety data below reflect exposure to omeprazole delayed-release capsules and clarithromycin worldwide in clinical trials for various indications using doses and durations of therapy that may differ from how they are used as a component of Omeclamox®-Pak. For complete information on these reactions, see the full prescribing information for omeprazole delayed-release capsules and clarithromycin.

Omeprazole:
The most common adverse reactions reported (i.e., with an incidence rate ≥ 2%) in 3096 patients from omeprazole delayed-release capsules-treated patients enrolled in clinical trials included headache (6.9%), abdominal pain (5.2%), nausea (4.0%), diarrhea (3.7%), vomiting (3.2%), and flatulence (2.7%).

Additional adverse reactions that were reported with an incidence rate ≥ 1% included acid regurgitation (1.9%), upper respiratory infection (1.9%), constipation (1.5%), dizziness (1.5%), rash (1.5%), asthenia (1.3%), back pain (1.1%), and cough (1.1%).
The clinical trial safety profile in patients greater than 65 years of age was similar to that in patients 65 years of age or less.

Clarithromycin:
The most frequently reported events in adults were diarrhea (3%), nausea (3%), abnormal taste (3%), dyspepsia (2%), abdominal pain/discomfort (2%), and headache (2%). Most of these events were described as mild or moderate in severity. Of the reported adverse events, only 1% were described as severe. Fewer than 3% of adult patients without mycobacterial infections discontinued therapy because of drug-related side effects.

Amoxicillin:
[See Adverse Reactions (6.3 )]

6.3 Post-Marketing Experience with the Individual Components of Omeclamox®-Pak

Because these reactions are voluntarily reported from a population of uncertain size, it is not always possible to reliably estimate their actual frequency or establish a causal relationship to drug exposure.

Omeprazole:
Body As a Whole: Hypersensitivity reactions including anaphylaxis, anaphylactic shock, angioedema, bronchospasm, interstitial nephritis, urticaria, (see also Skin below); fever; pain; fatigue; malaise.
Cardiovascular: Chest pain or angina, tachycardia, bradycardia, palpitations, elevated blood pressure, peripheral edema.
Endocrine: Gynecomastia.
Gastrointestinal: Pancreatitis (some fatal), anorexia, irritable colon, fecal discoloration, esophageal candidiasis, mucosal atrophy of the tongue, stomatitis, abdominal swelling, dry mouth. During treatment with omeprazole, gastric fundic gland polyps have been noted rarely. These polyps are benign and appear to be reversible when treatment is discontinued. Gastroduodenal carcinoids have been reported in patients with Zollinger-Ellison syndrome on long-term treatment with omeprazole. This finding is believed to be a manifestation of the underlying condition, which is known to be associated with such tumors.
Hepatic: Liver disease including hepatic failure (some fatal), liver necrosis (some fatal), hepatic encephalopathy hepatocellular disease, cholestatic disease, mixed hepatitis, jaundice, and elevations of liver function tests [ALT, AST, GGT, alkaline phosphatase, and bilirubin].
Metabolic/Nutritional: Hypoglycemia, hyponatremia, weight gain.
Musculoskeletal: Muscle weakness, myalgia, muscle cramps, joint pain, leg pain.
Nervous System/Psychiatric: Psychiatric and sleep disturbances including depression, agitation, aggression, hallucinations, confusion, insomnia, nervousness, apathy, somnolence, anxiety, and dream abnormalities; tremors, paresthesia; vertigo.
Respiratory: Epistaxis, pharyngeal pain.
Skin: Severe generalized skin reactions including toxic epidermal necrolysis (some fatal), Stevens-Johnson syndrome, and erythema multiforme; photosensitivity; urticaria; rash; skin inflammation pruritus; petechiae; purpura; alopecia; dry skin; hyperhidrosis.Special Senses: Tinnitus, taste perversion.
Ocular: Optic atrophy, anterior ischemic optic neuropathy, optic neuritis, dry eye syndrome, ocular irritation, blurred vision, double vision.
Urogenital: Interstitial nephritis, hematuria, proteinuria, elevated serum creatinine, microscopic pyuria, urinary tract infection, glycosuria, urinary frequency, testicular pain.
Hematologic: Agranulocytosis (some fatal), hemolytic anemia, pancytopenia, neutropenia, anemia, thrombocytopenia, leukopenia, leucocytosis.

Clarithromycin:
Hypersensitivity Reactions: Allergic reactions ranging from urticaria and mild skin eruptions to rare cases of anaphylaxis, Stevens-Johnson syndrome, and toxic epidermal necrolysis have occurred.
Gastrointestinal: Glossitis, stomatitis, oral moniliasis, anorexia, vomiting, pancreatitis, tongue discoloration.
Hematologic: Thrombocytopenia, leukopenia, neutropenia.
Other: There have been reports of tooth discoloration in patients treated with clarithromycin. Tooth discoloration is usually reversible with professional dental cleaning.
Nervous System/Psychiatric: There have been isolated reports of hearing loss, which is usually reversible, occurring chiefly in elderly women. Reports of alterations of the sense of smell, usually in conjunction with taste perversion or taste loss have also been reported.
Transient CNS events including anxiety, behavioral changes, confusional states, convulsions, depersonalization, disorientation, hallucinations, insomnia, manic behavior, nightmares, psychosis, tinnitus, tremor, dizziness and vertigo have been reported during postmarketing surveillance. Events usually resolve with discontinuation of the drug.
Hepatic: Hepatic dysfunction, including increased liver enzymes, and hepatocellular and/or cholestatic hepatitis, with or without jaundice, has been infrequently reported with clarithromycin. This hepatic dysfunction may be severe and is usually reversible. In very rare instances, hepatic failure with fatal outcome has been reported and generally has been associated with serious underlying diseases and/or concomitant medications.
Metabolic: There have been rare reports of hypoglycemia, some of which have occurred in patients taking oral hypoglycemic agents or insulin.
Cardiac: As with other macrolides, clarithromycin has been associated with QT prolongation and ventricular arrhythmias, including ventricular tachycardia and torsades de pointes.
Renal: There have been reports of interstitial nephritis coincident with clarithromycin use.

Amoxicillin:
Gastrointestinal: Nausea, vomiting, diarrhea, and hemorrhagic/Clostridium difficile-associated colitis. Onset of Clostridium difficile-associated diarrhea may occur during or after antibiotic treatment [See Warnings and Precautions (5.4)].
Hypersensitivity Reactions: Serum sickness like reactions, erythematous maculopapular rashes, erythema multiforme, Stevens-Johnson syndrome, exfoliative dermatitis, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, hypersensitivity vasculitis and urticaria have been reported. Reactions are more likely to occur in individuals who have previously demonstrated hypersensitivity to penicillins and in those with a history of allergy, asthma, hay fever, or urticaria.
Hepatic: A moderate rise in AST (SGOT) and/or ALT (SGPT) has been noted, but the significance of this finding is unknown. Hepatic dysfunction including cholestatic jaundice, hepatic cholestasis and acute cytolytic hepatitis have been reported.
Renal: Crystalluria has also been reported [See Overdosage (10)].
Hemic and Lymphatic Systems: Anemia, including hemolytic anemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia and agranulocytosis have been reported during therapy with penicillins. These reactions are usually reversible on discontinuation of therapy and are believed to be hypersensitivity phenomena.
Nervous System/Psychiatric: Reversible hyperactivity, agitation, anxiety, insomnia, confusion, behavioral changes, and/or
dizziness have been reported rarely.
Miscellaneous: Tooth discoloration (brown, yellow, or gray staining) has been rarely reported. Most reports occurred in pediatric patients. Discoloration was reduced or eliminated with brushing or dental cleaning in most cases.
Changes in Laboratory Values: Changes in laboratory values with possible clinical significance were as follows: Hepatic – elevated SGPT (ALT) less than 1%, SGOT (AST) less than 1%, GGT less than 1%, alkaline phosphatase less than 1%, LDH less than 1%, total bilirubin less than 1%; Hematologic – decreased WBC less than 1%, elevated prothrombin time 1%; Renal – elevated BUN 4%, elevated serum creatinine less than 1%. GGT, alkaline phosphatase, and prothrombin time data are from adult studies only.

Drug Interactions

Effect of Omeprazole
Omeprazole is a substrate and an inhibitor of CYP2C19 in vivo, a substrate of CYP3A4 in vivo, and an inhibitor of CYP2C19 in vitro. Therefore, omeprazole may affect the metabolism and plasma concentrations of drugs that are metabolized by these CYP enzymes. Although in healthy subjects no interaction with theophylline or propranolol was reported, there have been reports of an interaction with other drugs metabolized via the CYP enzyme system (e.g., cyclosporine, disulfiram, benzodiazepines). Carefully monitor patients taking these drugs to determine if dosage adjustments of these drugs are necessary when taken concomitantly with omeprazole.

Effect of Clarithromycin
Clarithromycin is a substrate and inhibitor of CYP3A enzymes. Coadministration of clarithromycin with drugs metabolized by CYP3A may be associated with elevations in drug concentrations that could increase the therapeutic and adverse effects of the concomitant drug. There have been reports of CYP3A-based interactions of erythromycin and/or clarithromycin with cyclosporine, tacrolimus, alfentanil, rifabutin, methylprednisolone, cilostazol, and bromocriptine. In addition, there have been reports of interactions of erythromycin or clarithromycin with drugs not thought to be metabolized by CYP3A, including: hexobarbital, phenytoin, and valproate.

7.1 Colchicine

Concurrent use of colchicine and Omeclamox®-Pak may increase plasma colchicine concentrations. Colchicine is a substrate for both CYP3A and the efflux transporter, P-glycoprotein (Pgp). The clarithromycin component of Omeclamox®-Pak is known to inhibit CYP3A and Pgp. When clarithromycin and colchicine are administered together, inhibition of Pgp and/or CYP3A by clarithromycin may lead to increased plasma exposure to colchicine. Monitor patients for clinical symptoms of colchicine toxicity [See Warnings and Precautions (5.2 )].

7.2 Ergotamine/Dihydroergotamine

Ergotamine/dihydroergotamine plasma concentrations may increase when administered concomitantly with Omeclamox®-Pak. Post-marketing reports indicate that coadministration of clarithromycin with ergotamine or dihydroergotamine has been associated with acute ergot toxicity characterized by vasospasm and ischemia of the extremities and other tissues including the central nervous system. Concomitant administration of clarithromycin with ergotamine or dihydroergotamine is contraindicated [See Contraindications (4.2 )].

7.3 Pimozide

The coadministration of pimozide and Omeclamox®-Pak may increase the pimozide plasma concentrations due to an interaction with the clarithromycin component of Omeclamox®-Pak . Post-marketing reports indicate that coadministration of clarithromycin with pimozide has been associated with cardiac arrhythmias (QT prolongation, ventricular tachycardia, ventricular fibrillation and torsades de pointes). Two sudden deaths have been reported when clarithromycin was added to ongoing pimozide therapy. Pimozide is metabolized partly by CYP3A4. When clarithromycin and pimozide are administered together, inhibition of CYP3A4 by clarithromycin may lead to increased plasma exposure to pimozide. Omeclamox®-Pak is contraindicated in patients receiving pimozide [See Contraindications (4.2)].

7.4 Antiarrhythmics

 Concurrent use of antiarrhythmic drugs and Omeclamox®-Pak may potentiate the antiarrhythmic effects due to an interaction with the clarithromycin component of Omeclamox®-Pak . There have been post-marketing reports of torsades de pointes occurring with concurrent use of clarithromycin and quinidine or disopyramide. Elevated digoxin serum concentrations in patients receiving clarithromycin and digoxin concomitantly have also been reported in post-marketing surveillance. Some patients have shown clinical signs consistent with digoxin toxicity, including potentially fatal arrhythmias. Monitor electrocardiograms for QTc prolongation during coadministration of Omeclamox®-Pak
with antiarrhythmic drugs. Serum concentrations of antiarrhythmics, including digoxin, should also be monitored.

7.5 Anticoagulants

The simultaneous administration of anticoagulants and Omeclamox®-Pak may alter the anticoagulant effects of warfarin and other oral anticoagulants due to an interaction with the omeprazole and clarithromycin components of Omeclamox®-Pak. Monitor prothrombin time and INR in patients receiving Omeclamox®-Pak and oral anticoagulants simultaneously. There have been reports of increased INR and prothrombin time in patients receiving proton pump inhibitors, including omeprazole, and warfarin concomitantly. Increases in INR and prothrombin time may lead to abnormal bleeding and even death. Spontaneous reports in the post-marketing period suggest that concomitant administration of clarithromycin and oral anticoagulants may potentiate the effects of the oral anticoagulants.

7.6 Antiretroviral Drugs

Concurrent use of antiretroviral agents and Omeclamox®-Pak may alter the antiretroviral effects due to interactions with the omeprazole or clarithromycin components of Omeclamox®-Pak. Omeprazole has been reported to interact with some antiretroviral drugs such as atazanavir, nelfinavir and saquinavir.

Concomitant use of atazanavir or nelfinavir with omeprazole is not recommended unless the benefits of taking atazanavir or nelfinavir with Omeclamox®-Pak outweigh the risks. Coadministration of atazanavir or nelfinavir with proton pump inhibitors is expected to substantially decrease atazanavir or nelfinavir plasma concentrations and thereby reduce the therapeutic effect of either of these drugs [See Clinical Pharmacology (12.3 )].

Coadministration of saquinavir with omeprazole may increase the serum concentrations of saquinavir. Dose reduction of saquinavir should be considered when coadministered with Omeclamox®-Pak [See Clinical Pharmacology (12.3 )].

7.7 Cilostazol

Concomitant administration of Omeclamox®-Pak and cilostazol may increase systemic exposure of cilostazol due to an interaction with the omeprazole component of Omeclamox®-Pak. Therefore, a dose reduction of cilostazol by 50% should be considered when concomitantly administered with Omeclamox®-Pak [ See Clinical Pharmacology (12.3 )].

7.8 Tacrolimus

Concomitant administration of Omeclamox®-Pak and tacrolimus may increase the serum concentrations of tacrolimus due to an interaction with the omeprazole component of Omeclamox®-Pak. Frequent monitoring of whole blood trough concentrations of tacrolimus is recommended when concomitantly administered with Omeclamox®-Pak.

7.9 Theophylline

Omeclamox®-Pak use in patients who are receiving theophylline may be associated with an increase of serum theophylline concentrations due to an interaction with the clarithromycin component of Omeclamox®-Pak. Monitoring of serum theophylline concentrations should be considered for patients receiving high doses of theophylline or with baseline concentrations in the upper therapeutic range [See Clinical Pharmacology (12.3 )].

7.10 Carbamazepine

The simultaneous administration of carbamazepine and Omeclamox®-Pak may alter the effect of carbamazepine due to an interaction with the clarithromycin component of Omeclamox®-Pak. Concomitant administration of single doses of clarithromycin and carbamazepine has been shown to result in increased plasma concentrations of carbamazepine. Blood level monitoring of carbamazepine should be considered when administered concomitantly with Omeclamox®-Pak.

7.11 Sildenafil

The systemic exposure of sildenafil may increase when it is administered concomitantly with Omeclamox®-Pak due to an interaction with the clarithromycin component of Omeclamox®-Pak ; consider a reduction in sildenafil dosage (see sildenafil full prescribing information).

7.12 HMG-CoA Reductase Inhibitors (Statins)

Concurrent use of HMG-CoA reductase inhibitors (statins) and Omeclamox®-Pak may alter the effect of HMG-CoA due to an interaction with the clarithromycin component of Omeclamox®-Pak. As with other macrolides, clarithromycin has been reported to increase concentrations of statins (e.g., lovastatin and simvastatin). Rare reports of rhabdomyolysis have been reported in patients taking these drugs concomitantly.

7.13 Triazolobenziodidiazepines (e.g., triazolam and alprazolam) and related Benzodiazepines (e.g., midazolam)

 The effect of triazolobenziodidiazepines/related benzodiazepines may be altered when administered concomitantly with Omeclamox®-Pak due to an interaction with the clarithromycin component. There have been postmarketing reports of drug interactions and CNS effects (e.g., somnolence and confusion) with the concomitant use of clarithromycin and triazolam.

7.14 Probenecid

Probenecid decreases the renal tubular secretion of amoxicillin. Concurrent use of Omeclamox®-Pak and probenecid may result in increased and prolonged blood concentrations of the amoxicillin component of Omeclamox®-Pak.

7.15 Drugs for which Gastric pH can affect Bioavailability

Due to its effects o n gastric acid secretion, omeprazole can reduce the absorption of drugs where gastric pH is an important determinant of their bioavailability. As with other drugs that decrease the intragastric acidity, the absorption of drugs such as ketoconazole, atazanavir, iron salts, erlotinib, and mycophenolate mofetil can decrease, while the absorption of drugs such as digoxin can increase during treatment with omeprazole.

Concomitant treatment with omeprazole (20 mg daily) and digoxin in healthy subjects increased the bioavailability of digoxin by 10% (30% in two subjects). Coadministration of digoxin with omeprazole is expected to increase the systemic exposure of digoxin. Therefore, patients may need to be monitored when digoxin is taken concomitantly with omeprazole.

Coadministration of omeprazole in healthy subjects and in transplant patients receiving mycophenolate mofetil has been reported to reduce the exposure to mycophenolic acid (MPA), the active moiety, possibly due to a decrease in MPA solubility at an increased gastric pH. The clinical relevance of reduced MPA exposure on organ rejection has not been established in transplant patients receiving proton pump inhibitors (PPIs) and mycophenolate mofetil. Use omeprazole with caution in transplant patients receiving mycophenolate mofetil [See Clinical Pharmacology (12.3 )].

7.16 Drug-Laboratory Test Interactions

High urine concentrations of ampicillin may result in false-positive reactions when testing for the presence of glucose in urine using Clinitest® Benedict’s Solution or Fehling’s Solution. Since this effect may also occur with amoxicillin, it is recommended that glucose tests based on enzymatic glucose oxidase reactions (such as Clinistix®) be used.

Following administration of ampicillin to pregnant women, a transient decrease in plasma concentration of total conjugated estradiol, estriol-glucuronide, conjugated estrone, and estradiol has been noted. This effect may also occur with amoxicillin.

Overdosage

In case of an overdose, patients should contact a physician, poison control center, or emergency room. There is neither a pharmacologic basis nor data suggesting an increased toxicity of the combination compared to individual components.

As with the management of any overdose, the possibility of multiple drug ingestion should be considered. For current information on treatment of any drug overdose, contact your local Poison Control Center at 1-800-222-1222.

Omeprazole:
Reports have been received of overdosage with omeprazole in humans. Doses ranged up to 2400 mg (120 times the usual recommended clinical dose). Manifestations were variable, but included confusion, drowsiness, blurred vision, tachycardia, nausea, vomiting, diaphoresis, flushing, headache, dry mouth, and other adverse reactions similar to those seen in normal clinical experience [See Adverse Reactions (6.3)]. Symptoms were transient, and no serious clinical outcome has been reported when omeprazole was taken alone. No specific antidote for omeprazole overdosage is known. Omeprazole is extensively protein bound and is, therefore, not readily dialyzable. In the event of overdosage, treatment should be symptomatic and supportive.

Single oral doses of omeprazole at 1350, 1339, and 1200 mg/kg were lethal to mice, rats, and dogs, respectively. Animals given these doses showed sedation, ptosis, tremors, convulsions, and decreased activity, body temperature, and respiratory rate and increased depth of respiration.

Clarithromycin:
Overdosage of clarithromycin can cause gastrointestinal symptoms such as abdominal pain, vomiting, nausea, and diarrhea. Adverse reactions accompanying overdosage should be treated by the prompt elimination of unabsorbed drug and supportive measures. As with other macrolides, clarithromycin serum concentrations are not expected to be appreciably affected by hemodialysis or peritoneal dialysis.

Amoxicillin:
In case of overdosage, discontinue medication, treat symptomatically, and institute supportive measures as required. If the overdosage is very recent and there is no contraindication, an attempt at emesis or other means of removal of drug from the stomach may be performed. A prospective study of 51 pediatric patients at a poison-control center suggested that overdosages of less than 250 mg/kg of amoxicillin are not associated with clinical symptoms and do not require gastric emptying.1

Interstitial nephritis resulting in oliguric renal failure has been reported in a small number of patients after overdosage with amoxicillin. Crystalluria, in some cases leading to renal failure, has also been reported after amoxicillin overdosage in adult and pediatric patients. In case of overdosage, adequate intake and diuresis should be maintained to reduce the risk of amoxicillin crystalluria. Renal impairment appears to be reversible with cessation of drug administration. High blood concentrations may occur more readily in patients with impaired renal function because of decreased renal clearance of amoxicillin. Amoxicillin can be removed from circulation by hemodialysis.

Nonclinical Toxicology

13.1 Carcinogenesis and Mutagenesis and Impairment of Fertility

Omeprazole:
In two 24-month carcinogenicity studies in rats, omeprazole at daily doses of 1.7, 3.4, 13.8, 44.0 and 140.8 mg/kg/day (about 0.7 to 57 times a human dose of 20 mg/day, as expressed on a body surface area basis) produced gastric ECL cell carcinoids in a dose-related manner in both males and females; the incidence of this effect was markedly higher in female rats, which had higher blood concentrations of omeprazole. Gastric carcinoids seldom occur in the untreated rat. In addition, ECL cell hyperplasia was present in all treated groups of both sexes. In one of these studies, female rats were treated with 13.8 mg omeprazole/kg/day (about 6 times a human dose of 20 mg/day, based on body surface area) for one year, and then followed for an additional year without the drug. No carcinoids were seen in these rats. An increased incidence of treatment-related ECL cell hyperplasia was observed at the end of one year (94% treated vs. 10% controls). By the second year the difference between treated and control rats was much smaller (46% vs. 26%) but still showed more hyperplasia in the treated group. Gastric adenocarcinoma was seen in one rat (2%). No similar tumor was seen in male or female rats treated for two years.

For this strain of rat no similar tumor has been noted historically, but a finding involving only one tumor is difficult to interpret.
In a 52-week toxicity study in Sprague-Dawley rats, brain astrocytomas were found in a small number of males that received omeprazole at dose levels of 0.4, 2, and 16 mg/kg/day (about 0.2 to 6.5 times the human dose on a body surface area basis). No astrocytomas were observed in female rats in this study or in males or females from a 2-year carcinogenicity study in Sprague- Dawley rats at the high dose of 140.8 mg/kg/day (about 57 times the human dose on a body surface area basis). A 78-week mouse carcinogenicity study of omeprazole did not show increased tumor occurrence, but the study was not conclusive. A 26-week p53 (+/–) transgenic mouse carcinogenicity study was not positive.

Omeprazole was positive for clastogenic effects in an in vitro human lymphocyte chromosomal aberration assay, in one of two in vivo mouse micronucleus tests, and in an in vivo bone marrow cell chromosomal aberration assay. Omeprazole was negative in the in vitro Ames test, an in vitro mouse lymphoma cell forward mutation assay, and an in vivo rat liver DNA damage assay. Omeprazole at oral doses up to 138 mg/kg/day in rats (about 56 times the human dose on a body surface area basis) was found to have no effect on fertility and reproductive performance.

Patient Counseling Information

17.1 Administration

Inform patients that each dose of Omeclamox®-Pak contains four pills : one opaque lavender/grey capsule (omeprazole), one white tablet (clarithromycin) and two opaque, yellow capsules (amoxicillin).

Take each dose of four pills in the morning and four pills in the evening before eating a meal, for 10 days. Capsules and tablets should not be crushed or chewed, and should be swallowed whole [See Dosage and Administration (2)].

17.3 Drug Interactions

 Patients should be advised to report to their doctor the use of any other medications while taking Omeclamox®-Pak [See Drug Interactions (7)].
The simultaneous administration of any of the following drugs with Omeclamox®-Pak may result in clinically significant adverse reactions or even death:

  • Colchicine
  • Ergotamine/dihydroergotamine
  • Pimozide
  • Antiarrhythmic drugs (e.g., quinidine, disopyramide)
  • Digoxin
  • Anticoagulants (e.g., warfarin)
  • Atazanavir
  • Nelfinavir
  • Saquinavir
  • Cilostazol
  • Tacrolimus
  • Theophylline
  • Carbamazepine
  • Sildenafil
  • HMG-CoA reductase inhibitors (also known as statins)
  • Triazolobenziodidiazepines (e.g., triazolam and alprazolam) and related benzodiazepines (e.g., midazolam)
  • Probenecid
  • Drugs for which gastric pH can affect bioavailability

17.4 Clostridium difficile-associated Diarrhea

Advise patients that diarrhea is a common problem caused by omeprazole and antibiotics that usually ends when the drug is discontinued. Sometimes after starting treatment, patients can develop severe diarrhea with watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the drug. If this occurs, patients should contact a physician as soon as possible [See Warnings and Precautions (5.4)].

17.5 Cutaneous or systemic lupus

Advise patients to report any symptoms associated with cutaneous or systemic lupus erythematosus [See Warnings and Precautions (5.7)]

17.6 Antibacterial Resistance

Counsel patients that antibacterial drugs including Omeclamox®-Pak should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Omeclamox®-Pak is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Omeclamox®-Pak or other antibacterial drugs in the future.

Omeclamox®-Pak is distributed by CUMBERLAND PHARMACEUTICALS INC, Nashville, TN 37203.

Omeprazole Delayed-Release Capsules, USP, 20 mg
Manufactured by Dr. Reddy’s Laboratories, Limited, Bachepalli, 502 325, INDIA

Clarithromycin Tablets, USP, 500 mg
Manufactured by Roxane Laboratories, Inc., a division of Boehringer Ingelheim, Columbus, OH 43228, U.S.A.                                                 

Amoxicillin Capsules, USP, 500 mg
Manufactured by Sandoz GmbH, Kundl, AUSTRIA

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For inquires contact Cumberland® Pharmaceuticals 1-877-484-2700

Rev. 10/2016

Principal Display Panel

Omeclamox-Pak 
omeprazole, clarithromycin, amoxicillin kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:66220-422
Packaging
# Item Code Package Description
1 NDC:66220-422-02 10 BLISTER PACK in 1 CARTON
1 1 KIT in 1 BLISTER PACK
2 NDC:66220-422-01 1 KIT in 1 BLISTER PACK
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1
Part 2
Part 3
Part 1 of 3
OMEPRAZOLE 
omeprazole capsule, delayed release
Product Information
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OMEPRAZOLE (OMEPRAZOLE) OMEPRAZOLE 20 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE  
HYPROMELLOSES  
LACTOSE  
MAGNESIUM STEARATE  
MANNITOL  
MEGLUMINE  
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)  
PEG/PPG-30/160 COPOLYMER  
POVIDONE  
ETHYL ACETATE  
D&C RED NO. 28  
FD&C BLUE NO. 1  
FD&C RED NO. 40  
FD&C YELLOW NO. 6  
FERRIC OXIDE YELLOW  
GELATIN  
SILICON DIOXIDE  
SODIUM LAURYL SULFATE  
TITANIUM DIOXIDE  
Product Characteristics
Color GRAY (lavendar and gray) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code R;158;Omeprazol;20;mg
Contains     
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA050824 04/27/2012
Part 2 of 3
CLARITHROMYCIN 
clarithromycin tablet
Product Information
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLARITHROMYCIN (CLARITHROMYCIN) CLARITHROMYCIN 500 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM  
HYPROMELLOSE 2208 (100 MPA.S)  
LACTOSE MONOHYDRATE  
MAGNESIUM STEARATE  
CELLULOSE, MICROCRYSTALLINE  
POLYDEXTROSE  
POLYETHYLENE GLYCOLS  
POVIDONE  
STEARIC ACID  
TALC  
TITANIUM DIOXIDE  
TRIACETIN  
Product Characteristics
Color WHITE Score no score
Shape OVAL (biconvex, beveled edge capsule shaped) Size 19mm
Flavor Imprint Code 54;312
Contains     
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA050824 04/27/2012
Part 3 of 3
AMOXICILLIN 
amoxicillin capsule
Product Information
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMOXICILLIN (AMOXICILLIN ANHYDROUS) AMOXICILLIN ANHYDROUS 500 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE  
SODIUM LAURYL SULFATE  
D&C RED NO. 33  
FD&C BLUE NO. 1  
FD&C RED NO. 40  
FD&C YELLOW NO. 6  
GELATIN  
TITANIUM DIOXIDE  
Product Characteristics
Color ORANGE (peach and orange) Score no score
Shape CAPSULE Size 22mm
Flavor Imprint Code WC;731
Contains     
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA050824 04/27/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA050824 04/27/2012
Labeler - Cumberland Pharmaceuticals Inc. (069532880)
Revised: 10/2016   Cumberland Pharmaceuticals Inc.
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