Talicia (Page 5 of 9)

8.2 Lactation

Risk Summary

Data from a published clinical lactation study reports that amoxicillin is present in human milk. Published adverse effects with amoxicillin exposure in the breast-fed infant include diarrhea. There are no data on the effects of amoxicillin on milk production. Limited data suggest omeprazole may be present in human milk. There are no clinical data on the effects of omeprazole on the breast-fed infant or on milk production. There are no data on the presence of rifabutin in human milk or the effects of rifabutin on the breast-fed infant or on milk production.

The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for TALICIA and any potential adverse effects on the breast-fed child from TALICIA or from the underlying condition.

8.3 Females and Males of Reproductive Potential

Contraception

Both rifabutin and amoxicillin components of TALICIA interact with hormonal contraceptives resulting in lower levels of these contraceptives. Therefore, female patients taking hormonal contraceptives should use an additional non-hormonal highly effective method of contraception while taking TALICIA [see Drug Interactions (7.1)].

Infertility

Males

Based on findings in rodents, TALICIA may impair fertility in males of reproductive potential [see Nonclinical Toxicology (13.1)].

8.4 Pediatric Use

Safety and effectiveness of TALICIA in pediatric patients below the age of 18 years with H. pylori infection have not been established.

Esomeprazole, an enantiomer of omeprazole, was shown to decrease body weight, body weight gain, femur weight, femur length, and overall growth in juvenile rats at oral doses about 11 to 23 times a daily human dose of 120 mg esomeprazole or omeprazole based on body surface area [see Nonclinical Toxicology (13.2)].

8.5 Geriatric Use

Clinical studies of TALICIA did not include sufficient numbers of subjects aged 65 and older to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger adult patients.

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.

Amoxicillin

An analysis of clinical studies of amoxicillin was conducted to determine whether subjects aged 65 and older respond differently from younger subjects. These analyses 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, it may be useful to monitor renal function in elderly patients taking TALICIA.

Rifabutin

Clinical studies of rifabutin did not include sufficient numbers of subjects aged 65 and older to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

8.6 Renal Impairment

It is recommended to avoid the use of TALICIA in patients with severe renal impairment (GFR < 30 mL/min). Amoxicillin is primarily eliminated by the kidney [see Clinical Pharmacology (12.3)].

8.7 Hepatic Impairment

It is recommended to avoid the use of TALICIA in patients with hepatic impairment. In patients with hepatic impairment (Child-Pugh Class A, B, or C) exposure to omeprazole substantially increased compared to healthy subjects [see Clinical Pharmacology (12.3)].

10 OVERDOSAGE

TALICIA

No information is available on accidental overdosage of TALICIA in humans.

In case of an overdose, patients should contact a physician, poison control center, or emergency room. The available overdosage information for each of the individual components in TALICIA (omeprazole, amoxicillin and rifabutin) are summarized below:

Omeprazole

There have been reports 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.

Amoxicillin

In case of overdosage, discontinue medication, treat symptomatically, and institute supportive measures as required. 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 significant clinical symptoms.

Crystalluria, in some cases leading to renal failure, has also been reported after amoxicillin overdosage. 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.

Rifabutin

No information is available on accidental overdosage of rifabutin in humans.

While there is no experience in the treatment of overdose with rifabutin capsules, clinical experience with rifamycins suggests that gastric lavage to evacuate gastric contents (within a few hours of overdose), followed by instillation of an activated charcoal slurry into the stomach, may help adsorb any remaining drug from the gastrointestinal tract.

Rifabutin is 85% protein bound and distributed extensively into tissues (volume of distribution at steady state: 8 to 9 L/kg). It is not primarily excreted via the urinary route (less than 10% as unchanged drug); therefore, neither hemodialysis nor forced diuresis is expected to enhance the systemic elimination of unchanged rifabutin from the body in a patient with an overdose of rifabutin.

11 DESCRIPTION

TALICIA delayed-release capsules contain omeprazole magnesium, amoxicillin and rifabutin for oral administration. Omeprazole magnesium is included in the delayed-release component of the capsule, and amoxicillin and rifabutin are included in the immediate-release component of the capsule. Each delayed-release capsule contains:

  • omeprazole 10 mg (equivalent to 10.3 mg of omeprazole magnesium)
  • amoxicillin 250 mg (equivalent to 286.9 mg of amoxicillin trihydrate)
  • rifabutin 12.5 mg

Omeprazole magnesium is a proton pump inhibitor. Amoxicillin and rifabutin are antibacterial drugs.

Each TALICIA delayed-release capsule contains the following inactive ingredients: crospovidone, FD&C Red 3, FD&C Yellow 6, gelatin, hydroxypropyl cellulose, hypromellose, magnesium stearate, mannitol-starch, methacrylic acid copolymer, meglumine, pregelatinized starch, silica, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide and triethyl citrate.

Omeprazole Magnesium

Omeprazole magnesium is a white to off-white powder with a melting point with degradation at 200 °C. The salt is slightly soluble (0.25 mg/mL) in water at 25 °C, and it is soluble in methanol. Omeprazole magnesium is 5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridyl) methyl] sulfinyl]benzimidazole, (RS) magnesium salt (2:1). Omeprazole magnesium has a molecular formula of (C17 H19 N3 O3 S)2 Mg, and a molecular weight of 713.12. The structural formula is:

Omeprazole Magnesium Chemical Structure
(click image for full-size original)

Amoxicillin

Amoxicillin is a semisynthetic antibacterial drug, an analog of ampicillin. Chemically it is (2S ,5R ,6R)-6-[(R)-(-)-2- amino-2-(p -hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0] heptane-2-carboxylic acid trihydrate. Amoxicillin has a molecular formula of C16 H19 N3 O5 S•3 H2 O, and a molecular weight of 419.45. The structural formula is:

Amoxicillin Chemical Structure
(click image for full-size original)

Rifabutin

Rifabutin is a red-violet powder soluble in chloroform and methanol, sparingly soluble in ethanol, and very slightly soluble in water (0.19 mg/mL). Its log P value (the base 10 logarithm of the partition coefficient between n-octanol and water) is 3.2 (n-octanol/water).

Rifabutin is (9S,12E,14S,15R,16S,17R,18R,19R,20S,21S,22E,24Z)-6-16,18,20-tetrahydroxy-1′-isobutyl-14-methoxy-7,9,15,17,19,21,25-heptamethylspiro [9,4-(epoxypentadeca[1,11,13]trienimino)-2H-furo[2′,3′:7,8]naphth[1,2-d] imidazole-2,4′-piperidine]-5,10,26-(3H,9H)-trione-16-acetate. Rifabutin has a molecular formula of C46 H62 N4 O11 , and a molecular weight of 847.02. The structural formula is:

Rifabutin Chemical Structure
(click image for full-size original)

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