Omeclamox-Pak

Dosage Forms And Strengths

Omeclamox®-Pak is supplied in a carton containing ten individual daily administration cards. Each card contains:

Two opaque, hard gelatin lavender and grey capsules, with 'R 158' and 'OMEPRAZOLE 20 mg' imprinted on the capsules in black ink, containing off-white to pale-yellow, elliptical spherical pellets.

Two white, biconvex beveled-edge capsule-shaped coated tablets debossed with '54 312' on one side and plain on the other side. Amoxicillin Capsules, USP, 500 mg

Four opaque hard gelatin peach and orange capsules, marked 'WC 731'. Each capsule contains amoxicillin trihydrate, equivalent to 500 mg amoxicillin.

Storage And Handling

Omeclamox®-Pak is supplied in a carton containing ten individual daily administration cards. Each card contains the morning dose and the evening dose of the following three drugs:

Two opaque hard gelatin lavender and grey capsules, with 'R 158' and 'OMEPRAZOLE 20 mg' imprinted on the capsules in black ink, containing off-white to pale-yellow, elliptical spherical pellets.

• Two white, biconvex beveled-edge capsule-shaped coated tablets debossed with '54 312' on one side and plain on the other side.

• Four opaque hard gelatin peach and orange capsules, marked 'WC 731'. Each capsule contains amoxicillin trihydrate equivalent to 500 mg amoxicillin.

NDC 65224-707-11 Carton containing 10 daily administration cards
NDC 65224-707-00 Daily administration card

Store at controlled room temperature between 20°C and 25°C (68°F and 77°F). Protect from light and moisture.

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 Suir Pharma Ireland Ltd., Clonmel, IRELAND. Promoted by: For inquiries contact Cumberland Pharmaceuticals Inc. 1-877-484-2700. Revised: Dec 2014

You should not take this medication if you are allergic to amoxicillin (Amoxil, Augmentin, Moxatag), clarithromycin (Biaxin), omeprazole (Prilosec), or if you have liver disease, or a history of allergic reaction to any antibiotic.

Before you take this medication, tell your doctor if you have kidney disease, myasthenia gravis, or if you are allergic to any drugs.

There are many other drugs that can interact with this medication. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.

While you are taking amoxicillin, clarithromycin, and omeprazole, do not take any of the following medications: ergotamine (Ergomar, Cafergot, Ercaf, Migergot), dihydroergotamine (D.H.E. 45, Migranal Nasal Spray), or pimozide (Orap).

A gout medication called colchicine (Colcrys) can interact with clarithromycin and cause serious or life-threatening medical problems. You should not take colchicine during your treatment with amoxicillin, clarithromycin, and omeprazole, especially if you are an older adult with kidney disease.

Omeclamox®-Pak is a product containing three components: omeprazole, clarithromycin, and amoxicillin. This medicine is used to treat patients with H. pylori infection and duodenal ulcers caused by H. pylori bacteria (germ).

Omeprazole is a proton pump inhibitor (PPI). It works by decreasing the amount of acid produced by the stomach. Clarithromycin and amoxicillin both belong to the class of medicines known as antibiotics. They work by killing bacteria or preventing their growth. However, this medicine will not work for colds, flu, or other virus infections.

This medicine is available only with your doctor's prescription.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of Omeclamox®-Pak in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of Omeclamox®-Pak in the elderly. However, elderly patients are more likely to have kidney problems, which may require caution and an adjustment in the dose for patients receiving this medicine.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Alfuzosin
• Amifampridine
• Amisulpride
• Astemizole
• Bepridil
• Cisapride
• Colchicine
• Conivaptan
• Dihydroergotamine
• Dronedarone
• Eletriptan
• Eliglustat
• Eplerenone
• Ergoloid Mesylates
• Ergonovine
• Ergotamine
• Flibanserin
• Fluconazole
• Isavuconazonium Sulfate
• Ivabradine
• Ketoconazole
• Lomitapide
• Lovastatin
• Lurasidone
• Maraviroc
• Mesoridazine
• Methylergonovine
• Methysergide
• Naloxegol
• Nelfinavir
• Nimodipine
• Pimozide
• Piperaquine
• Posaconazole
• Ranolazine
• Rilpivirine
• Saquinavir
• Silodosin
• Simvastatin
• Sparfloxacin
• Terfenadine
• Thioridazine
• Tolvaptan
• Venetoclax
• Ziprasidone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Ado-Trastuzumab Emtansine
• Afatinib
• Ajmaline
• Alprazolam
• Amiodarone
• Amitriptyline
• Amlodipine
• Amobarbital
• Amprenavir
• Anagrelide
• Apixaban
• Apomorphine
• Aprepitant
• Aprindine
• Aprobarbital
• Aripiprazole
• Aripiprazole Lauroxil
• Arsenic Trioxide
• Artemether
• Asenapine
• Atazanavir
• Atorvastatin
• Avanafil
• Axitinib
• Azithromycin
• Bedaquiline
• Bendamustine
• Betrixaban
• Bosutinib
• Bretylium
• Brexpiprazole
• Brigatinib
• Bromocriptine
• Buserelin
• Butabarbital
• Butalbital
• Cabazitaxel
• Cabozantinib
• Calcifediol
• Carbamazepine
• Cariprazine
• Ceritinib
• Chloroquine
• Chlorpromazine
• Chlortetracycline
• Cholera Vaccine, Live
• Cilostazol
• Ciprofloxacin
• Citalopram
• Clomipramine
• Clonazepam
• Clopidogrel
• Clorazepate
• Clozapine
• Cobicistat
• Cobimetinib
• Conivaptan
• Crizotinib
• Cyclobenzaprine
• Dabigatran Etexilate
• Dabrafenib
• Daclatasvir
• Dasabuvir
• Dasatinib
• Deflazacort
• Degarelix
• Delamanid
• Delavirdine
• Demeclocycline
• Desipramine
• Deslorelin
• Deutetrabenazine
• Dexamethasone
• Digoxin
• Diltiazem
• Disopyramide
• Docetaxel
• Dofetilide
• Dolasetron
• Domperidone
• Donepezil
• Doxepin
• Doxorubicin
• Doxorubicin Hydrochloride Liposome
• Doxycycline
• Droperidol
• Dutasteride
• Ebastine
• Efavirenz
• Enzalutamide
• Eribulin
• Erlotinib
• Erythromycin
• Escitalopram
• Eslicarbazepine Acetate
• Estazolam
• Eszopiclone
• Etravirine
• Everolimus
• Famotidine
• Felbamate
• Felodipine
• Fentanyl
• Fingolimod
• Flecainide
• Fluoxetine
• Fluticasone
• Fosaprepitant
• Foscarnet
• Fosphenytoin
• Galantamine
• Gatifloxacin
• Gefitinib
• Gemifloxacin
• Gonadorelin
• Goserelin
• Granisetron
• Halofantrine
• Haloperidol
• Halothane
• Histrelin
• Hydrocodone
• Hydroquinidine
• Hydroxychloroquine
• Hydroxyzine
• Ibrutinib
• Ibutilide
• Idelalisib
• Ifosfamide
• Iloperidone
• Imipramine
• Indinavir
• Irinotecan
• Irinotecan Liposome
• Isoflurane
• Isradipine
• Itraconazole
• Ivacaftor
• Ixabepilone
• Ketoconazole
• Lapatinib
• Ledipasvir
• Letrozole
• Leuprolide
• Levofloxacin
• Levomilnacipran
• Lopinavir
• Lorcainide
• Losartan
• Lumacaftor
• Lumefantrine
• Lymecycline
• Macitentan
• Manidipine
• Meclocycline
• Mefloquine
• Mephobarbital
• Methacycline
• Methadone
• Methohexital
• Methotrexate
• Metronidazole
• Midazolam
• Midostaurin
• Mifepristone
• Minocycline
• Mizolastine
• Modafinil
• Morphine
• Morphine Sulfate Liposome
• Moxifloxacin
• Mycophenolate Mofetil
• Mycophenolic Acid
• Nafarelin
• Nafcillin
• Nelfinavir
• Netupitant
• Nicardipine
• Nifedipine
• Nilotinib
• Nisoldipine
• Norfloxacin
• Nortriptyline
• Octreotide
• Ofloxacin
• Olanzapine
• Olaparib
• Ombitasvir
• Ondansetron
• Ospemifene
• Oxcarbazepine
• Oxycodone
• Oxytetracycline
• Palbociclib
• Paliperidone
• Panobinostat
• Paritaprevir
• Paroxetine
• Pasireotide
• Pazopanib
• Pentamidine
• Pentobarbital
• Perampanel
• Perphenazine
• Phenobarbital
• Phenytoin
• Pimavanserin
• Pipamperone
• Pirmenol
• Pitolisant
• Pixantrone
• Ponatinib
• Probucol
• Procainamide
• Prochlorperazine
• Promethazine
• Propafenone
• Protriptyline
• Quetiapine
• Quinidine
• Quinine
• Reboxetine
• Regorafenib
• Retapamulin
• Ribociclib
• Rifabutin
• Rifapentine
• Riociguat
• Risperidone
• Ritonavir
• Rivaroxaban
• Roflumilast
• Rolitetracycline
• Romidepsin
• Ruxolitinib
• Salmeterol
• Saquinavir
• Secobarbital
• Sertindole
• Sevoflurane
• Sildenafil
• Simeprevir
• Sirolimus
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Solifenacin
• Sonidegib
• Sorafenib
• Sotalol
• Spiramycin
• St John's Wort
• Sulfamethoxazole
• Sulpiride
• Sunitinib
• Suvorexant
• Tacrolimus
• Tadalafil
• Tamoxifen
• Tamsulosin
• Telaprevir
• Telavancin
• Telithromycin
• Temsirolimus
• Tetrabenazine
• Tetracycline
• Thiopental
• Thiotepa
• Ticagrelor
• Tizanidine
• Tolterodine
• Topotecan
• Toremifene
• Trabectedin
• Tramadol
• Trazodone
• Triazolam
• Trimethoprim
• Trimipramine
• Triptorelin
• Valbenazine
• Vandetanib
• Vardenafil
• Velpatasvir
• Vemurafenib
• Venlafaxine
• Verapamil
• Vilanterol
• Vilazodone
• Vinblastine
• Vincristine
• Vincristine Sulfate Liposome
• Vinflunine
• Vinorelbine
• Vismodegib
• Vorapaxar
• Voriconazole
• Vorinostat
• Warfarin
• Zaleplon
• Zidovudine
• Zileuton
• Zolpidem
• Zuclopenthixol

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acenocoumarol
• Alfentanil
• Armodafinil
• Carbamazepine
• Conjugated Estrogens
• Cyclosporine
• Darunavir
• Delavirdine
• Diazepam
• Digoxin
• Disulfiram
• Esterified Estrogens
• Estradiol
• Estriol
• Estrone
• Estropipate
• Ethinyl Estradiol
• Fluconazole
• Ginkgo Biloba
• Glipizide
• Glyburide
• Hexobarbital
• Indinavir
• Iron
• Khat
• Levothyroxine
• Linezolid
• Methylprednisolone
• Nevirapine
• Pravastatin
• Prednisone
• Probenecid
• Raltegravir
• Repaglinide
• Rifampin
• St John's Wort
• Tipranavir
• Triazolam
• Warfarin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Cranberry

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Diarrhea or
• Kidney disease or
• Liver disease or
• Myasthenia gravis (severe muscle weakness) or
• Systemic lupus erythematosus (SLE)—Use with caution. May make these conditions worse.

• Heart rhythm problems (eg, arrhythmia, QT prolongation, torsades de pointes, ventricular arrhythmia) or
• Mononucleosis—Should not be used in patients with these conditions.

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

Omeclamox®-Pak comes with an individual daily administration card that contains: 2 opaque, lavender and gray capsules of omeprazole, 4 opaque, peach and orange capsules of amoxicillin, and 2 white tablets of clarithromycin.

Swallow the capsules and tablets whole. Do not crush, break, chew, or open any of them. Take each dose on an empty stomach, before the morning and evening meals.

Keep using this medicine for the full treatment time, even if you feel better after the first few doses. Your infection may not clear up if you stop using the medicine too soon.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (kit):
  • For treatment of duodenal ulcers and H. pylori infections:
    • Adults—20 milligrams (mg) or 1 capsule of omeprazole, 1000 mg or 2 capsules of amoxicillin, and 500 mg or 1 tablet of clarithromycin taken as a single dose 2 times per day for 10 days.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

• It is used to treat or prevent GI (gastrointestinal) ulcers caused by infection.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of low magnesium levels like mood changes, muscle pain or weakness, muscle cramps or spasms, seizures, shakiness, not hungry, very bad upset stomach or throwing up, or a heartbeat that does not feel normal.
• Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
• Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
• Signs of a pancreas problem (pancreatitis) like very bad stomach pain, very bad back pain, or very bad upset stomach or throwing up.
• Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• For females, vaginal yeast infection. Report itching or discharge.
• Redness or white patches in mouth or throat.
• A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
• Very bad and sometimes deadly liver problems have happened with Omeclamox-Pak. Call your doctor right away if you have signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Headache.
• Bad taste in your mouth.
• Loose stools (diarrhea).
• Tooth staining.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
• 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.

This information should not be used to decide whether or not to take Omeclamox-Pak or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Omeclamox-Pak. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

8.1 Pregnancy

There are no adequate and well controlled studies of omeprazole, clarithromycin, or amoxicillin (used separately or together) in pregnant women. Clarithromycin demonstrated adverse developmental effects in four animal species at clinically relevant doses. Omeprazole increased embryo-fetal loss in rabbits, but animal studies and multiple human studies do not show an increased risk for major malformations. Omeclamox®-Pak should be used during pregnancy only if the potential benefit justifies the potential risk
to the fetus and there is no appropriate alternative therapy [See Warnings and Precautions (5.1 )].

Omeprazole:
Multiple cohort studies in pregnant women exposed to omeprazole during the first trimester do not show an increased risk of congenital malformations. The majority of experience with omeprazole use during human pregnancy includes first trimester exposure and the duration of use is rarely specified. Three epidemiological studies compared the frequency of congenital malformations among infants born to women who used omeprazole during pregnancy with the frequency of malformations among infants of women exposed to H2-receptor antagonists or controls. One population-based prospective cohort study from the Swedish Medical Birth Registry, reported 955 infants (824 exposed during the first trimester with 39 of these exposed beyond first trimester, and 131 exposed after the first trimester), whose mothers used omeprazole during pregnancy. In utero exposure to omeprazole was not associated with an increased risk of malformations (odds ratio 0.82, 95% CI 0.50-1.34), low birth weight or low Apgar score. While the number of stillbirths and infants born with ventricular septal defects were slightly higher in the omeprazole exposed group, these findings may have been due to chance and do not establish a causal relationship to omeprazole exposure.

A retrospective cohort study reported on 689 pregnant women exposed to either H2-blockers or omeprazole in the first trimester (134 exposed to omeprazole). The overall malformation rate was 4.4% (95% CI 3.6-5.3) and the malformation rate for first trimester exposure to omeprazole was 3.6% (95% CI 1.5-8.1). The relative risk of malformations associated with first trimester exposure to omeprazole compared with non-exposed women was 0.9 (95% CI 0.3-2.2). The study could effectively rule out a relative risk greater than 2.5 for all malformations. Rates of preterm delivery or growth retardation did not differ between the groups.
A controlled prospective observational study followed 113 women exposed to omeprazole during pregnancy (89% first trimester exposures). The reported rates of major congenital malformations was 4% for the omeprazole group, 2% for controls exposed to non teratogens, and 2.8% in disease-paired controls (background incidence of major malformations 1-5%). Rates of spontaneous and elective abortions, preterm deliveries, gestational age at delivery, and mean birth weight did not differ among the groups. The sample size in this study had 80% power to detect a 5-fold increase in the rate of major malformations.

Reproductive and developmental toxicology studies conducted in rats and rabbits during organogenesis at oral omeprazole doses up to 28 times the human dose of 40 mg/day did not show any evidence of fetal structural abnormalities. However, doserelated increases in embryo-lethality, fetal resorptions, and pregnancy loss occurred when pregnant rabbits received omeprazole at doses about 2.8 to 28 times the human dose of 40 mg/day. In a peri- and post-natal development study, when pregnant rats received omeprazole at doses about 2.8 to 28 times the human dose of 40 mg/day, dose-related embryo/fetal toxicity and postnatal developmental toxicity occurred in offspring.

Clarithromycin:
When pregnant monkeys received 70 mg/kg/day oral clarithromycin (approximately equivalent to the maximum recommended human dose (MRHD) on a mg/m2 basis) fetal growth retardation occurred at plasma concentrations that were 2 times the human serum concentrations achieved at the MRHD.

A low incidence of cardiovascular anomalies were observed in fetuses in two rat embryo-fetal studies of clarithromycin administered orally to dams on gestation days 6 to 15 at doses of 150 mg/kg/day, which resulted in plasma concentrations approximately 2 times the human serum concentrations achieved at the MRHD.

Four embryo-fetal studies in mice revealed a variable incidence of cleft palate following oral doses of 500 mg/kg/day and 1000 mg/kg/day (2 and 4 times the MRHD on a mg/m2 basis, respectively) during organogenesis (gestation days 6 to 15). The 1000 mg/kg/day exposure resulted in plasma concentrations 17 times the human serum concentrations achieved at the MRHD.
No teratogenic effects occurred in offspring from two studies in pregnant rabbits that received oral clarithromycin doses up to 125 mg/kg/day (approximately 2 times the maximum recommended human dose on a mg/m2 basis) or intravenous doses of 30 mg/kg/day during the period of major organogenesis.

Amoxicillin:
Reproduction studies have been performed in mice and rats at doses up to 10 times the human dose and revealed no evidence of impaired fertility or harm to the fetus due to amoxicillin.

8.2 Labor and Delivery

Omeprazole:
Several studies have reported no apparent adverse short-term effects on the infant when single dose oral or intravenous omeprazole was administered to over 200 pregnant women as premedication for cesarean section under general anesthesia.

Amoxicillin:
Oral ampicillin-class antibiotics are poorly absorbed during labor. Studies in guinea pigs showed that intravenous administration of ampicillin slightly decreased the uterine tone and frequency of contractions, but moderately increased the height and duration of contractions. However, it is not known whether amoxicillin affects labor or delivery in humans.

8.3 Nursing Mothers

Omeclamox®-Pak contains omeprazole, clarithromycin, and amoxicillin. Information on use of each product during lactation
is provided below.

Omeprazole:
Breast milk concentrations of omeprazole were measured in the breast milk of one woman following oral administration of 20 mg. The peak concentration was 20 mcg/L, less than 7% of the peak maternal serum concentration. Based on this information, the estimated infant daily dose in an exclusively human-milk fed infant is 3 mcg/kg/day. However, due to the potential for tumorigenicity shown for omeprazole in rat carcinogenicity studies, a decision should be made whether to discontinue nursing or express and discard milk during Omeclamox®-Pak treatment.

Clarithromycin:
It is not known whether clarithromycin is excreted in human milk. However, other macrolide antibiotics are excreted in human milk. Clarithromycin is found in animal milk. Caution should be exercised when clarithromycin is administered to a nursing woman.

Amoxicillin:
Penicillins are excreted in human milk. Amoxicillin use by nursing mothers may lead to sensitization of infants. Caution should be exercised when amoxicillin is administered to a nursing woman.

8.4 Pediatric Use

The safety and effectiveness of Omeclamox®-Pak for pediatric patients with H. pylori have not been established.

8.5 Geriatric Use

Omeprazole:
Omeprazole was administered to over 2000 elderly individuals (≥ 65 years of age) in clinical trials in the U.S. and Europe. There were no differences in safety and effectiveness between the elderly and younger subjects. Other reported clinical experience has not identified differences in response between the elderly and younger subjects, but greater sensitivity of some older individuals cannot be ruled out.
Pharmacokinetic studies have shown the elimination rate was somewhat decreased in the elderly and bioavailability was increased. The plasma clearance of omeprazole was 250 mL/min (about half that of young volunteers) and its plasma half-life averaged one hour, about twice that of young healthy volunteers. However, no dosage adjustment is necessary in the elderly [See Clinical Pharmacology (12.3 )].

Clarithromycin:
In a steady-state study in which healthy elderly subjects (age 65 to 81 years old) were given 500 mg every 12 hours, the maximum serum concentrations and area under the curves of clarithromycin and 14-OH clarithromycin were increased compared to those achieved in healthy young adults. These changes in pharmacokinetics parallel known age-related decreases in renal function. In clinical trials, elderly patients did not have an increased incidence of adverse events when compared to younger patients.

Amoxicillin:
An analysis of clinical studies of amoxicillin was conducted to determine whether subjects aged 65 and over respond differently from younger subjects. Of the 1811 subjects treated with amoxicillin, 85% were < 60 years old, 15% were ≥ 61 years old and 7% were ≥ 71 years old. This analysis and other reported clinical experience have not identified differences in responses between the elderly and younger patients, but a greater sensitivity of some older individuals cannot be ruled out.

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection,and it may be useful to monitor renal function.

8.6 Renal Impairment

In the presence of severe renal impairment with or without coexisting hepatic impairment, prolonged dosing intervals for the clarithromycin component may be appropriate.

8.7 Hepatic Impairment

It is recommended to avoid the use of Omeclamox®-Pak in patients with hepatic impairment [See Clinical Pharmacology (12.3 )].

8.8 Asian Patients

It is recommended to avoid the use of Omeclamox®-Pak in Asian patients unless it is deemed that the benefits outweigh the risks [See Clinical Pharmacology (12.3)].