LANTHANUM CARBONATE tablet, chewable

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

LANTHANUM CARBONATE (UNII: 490D9F069T) (LANTHANUM CATION (3+) - UNII:O7FU5X12W5)

Commercializzato da:

Prasco Laboratories

INN (Nome Internazionale):

LANTHANUM CARBONATE - UNII:O7FU5X12W5)

Composizione:

LANTHANUM CATION (3+) 500 mg

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

LANTHANUM CARBONATE is a phosphate binder indicated to reduce serum phosphate in patients with end-stage renal disease (ESRD). Management of elevated serum phosphorus levels in patients with ESRD usually includes all of the following: reduction in dietary intake of phosphate, removal of phosphate by dialysis, and reduction of intestinal phosphate absorption with phosphate binders. Contraindicated in bowel obstruction, including ileus and fecal impaction. Risk Summary Available data from case reports with use of LANTHANUM CARBONATE in pregnant women are insufficient to identify a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction studies, oral administration of lanthanum carbonate to pregnant rats and rabbits during organogenesis at doses 3 and 2.5 times, respectively, the maximum recommended human dose (MRHD), resulted in no adverse developmental effects. In rabbits, lanthanum carbonate doses 5 times the MRHD was associated with maternal toxicity and resulted in increased post-implantation loss, reduced fetal weights, and delayed fetal ossification (see Data ). Deposition of lanthanum into developing bone, including growth plate, was observed in juvenile animals in long-term animal studies with lanthanum carbonate [see Use in Specific Populations (8.4)] . Use a non-lanthanum containing phosphate binder in a pregnant woman. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defect and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data In pregnant rats, oral administration of lanthanum carbonate at doses as high as 2,000 mg/kg/day during organogenesis resulted in no evidence of harm to the fetus. The MRHD for LANTHANUM CARBONATE is 5,725 mg, representing a dose of 95.4 mg/kg, or 3,530 mg/m2 for a 60-kg patient. The 2,000-mg/kg/day dose in the rat is equivalent to 12,000 mg/m2 , 3 times the MRHD. In pregnant rabbits, oral administration of lanthanum carbonate at 1,500 mg/kg/day (18,000 mg/m2 ; 5 times the daily MRHD) during organogenesis was associated with increased postimplantation loss, reduced fetal weights, and delayed fetal ossification. No effects on the pregnant rabbits or fetuses were observed at 750 mg/kg/day (9,000 mg/m2 ; 2.5 times the MRHD). In a pre- and postnatal development study in the rat, pregnant rats were dosed at up to 2,000 mg/kg/day (12,000 mg/m2 /day; equivalent to 3 times the MRHD) from day 6 of pregnancy through 20 days postpartum (including lactation). At 2,000 mg/kg/day, no maternal toxicity was observed, nor were any changes seen with respect to gestational length or delivery; however, piloerection/pallor, delayed eye opening, decreased body weight, and delayed sexual development were observed in the offspring at 2,000 mg/kg/day. At 200 and 600 mg/kg/day (equivalent to 0.3 and 1 time the MRHD, respectively), slight delays in sexual development (delayed vaginal opening) were observed in the female offspring [see Nonclinical Toxicology (13.2)] . Risk Summary There are no data on the presence of lanthanum carbonate from LANTHANUM CARBONATE in human milk, the effects on the breastfed infant, or the effects on milk production. Deposition of lanthanum into developing bone, including growth plate, was observed in juvenile animals in long-term animal studies with lanthanum carbonate [see Use in Specific Populations (8.4)] . Use a non-lanthanum containing phosphate binder in a lactating woman. The safety and efficacy of LANTHANUM CARBONATE in pediatric patients have not been established. While growth abnormalities were not identified in long-term animal studies, lanthanum was deposited into developing bone, including growth plate. The consequences of such deposition in developing bone in pediatric patients are unknown; therefore, the use of LANTHANUM CARBONATE in this population is not recommended. Of the total number of patients in clinical studies of LANTHANUM CARBONATE, 32% (538) were ≥65 years of age, while 9.3% (159) were ≥75 years of age. No overall differences in safety or effectiveness were observed between patients ≥65 years of age and younger patients.

Dettagli prodotto:

LANTHANUM CARBONATE is supplied as a chewable tablet in three dosage strengths for oral administration: 500-mg tablets, 750-mg tablets, and 1,000-mg tablets. Each chewable tablet is white to off-white round, flat with a beveled edge, and debossed on one side with 'S405' above the dosage strength corresponding to the content of elemental lanthanum. 500-mg Patient Pack (2 bottles of 45 tablets, NDC 66993-422-47, per each patient pack) NDC 66993-422-85. 750-mg Patient Pack (6 bottles of 15 tablets, NDC 66993-423-53, per each patient pack) NDC 66993-423-85. 1,000-mg Patient Pack (9 bottles of 10 tablets, NDC 66993-424-75, per each patient pack) NDC 66993-424-85. Storage and Handling Store LANTHANUM CARBONATE Chewable Tablets at 25°C (77°F): excursions permitted to 15°C to 30°C (59°F to 86°F). [See USP controlled room temperature.]

Stato dell'autorizzazione:

New Drug Application Authorized Generic

Foglio illustrativo

LANTHANUM CARBONATE- LANTHANUM CARBONATE TABLET, CHEWABLE
Prasco Laboratories
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MEDICATION GUIDE
LANTHANUM CARBONATE
(LAN-THA-NUM KAR-BO-NATE)
Read this Medication Guide before you start taking LANTHANUM CARBONATE
and each time you
get a refill. There may be new information. This information does not
take the place of talking to your
healthcare provider about your medical condition or treatment.
What is the most important information I should know about LANTHANUM
CARBONATE?
LANTHANUM CARBONATE may cause a bowel blockage, a hole in the bowel,
or severe constipation,
which can be serious, and sometimes lead to surgery or treatment in a
hospital.
•
You may have a higher risk of bowel blockage, a hole in the bowel, or
severe constipation if you
take LANTHANUM CARBONATE and have:
•
a history of surgery, ulcers or cancer in the stomach or bowel
•
a history of bowel blockage, or problems resulting in a decreased
movement of food
through your stomach and bowel (e.g., feeling full quickly after
eating or constipation)
•
an infection or inflammation of the stomach/bowel (peritonitis)
Do not swallow LANTHANUM CARBONATE Chewable Tablets whole. Chew
tablets completely
before swallowing. If you cannot chew tablets completely, you may
crush the tablets thoroughly before
swallowing or discuss the oral powder formulation with your healthcare
provider.
What is LANTHANUM CARBONATE?
LANTHANUM CARBONATE is a prescription medicine used in people with
end-stage renal disease
(ESRD) to lower the amount of phosphate in the blood.
Who should not take LANTHANUM CARBONATE?
Do not take LANTHANUM CARBONATE if you:
•
have blocked bowels
•
have severe constipation
LANTHANUM CARBONATE has not been studied in children and adolescents
under 18 years of age.
What should I tell my healthcare provider before taking LANTHANUM
CARBONATE?
LANTHANUM CARBONATE may not be right for you. Before starting
LANTHANUM
CARBONATE, tell your healthcare provider if you:
•
have a history of surgery, ulcers or cancer in the stomach or bowel
•

Scheda tecnica

LANTHANUM CARBONATE- LANTHANUM CARBONATE TABLET, CHEWABLE
PRASCO LABORATORIES
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LANTHANUM CARBONATE
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LANTHANUM
CARBONATE.
LANTHANUM CARBONATE CHEWABLE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2004
RECENT MAJOR CHANGES
Warnings and Precautions (5.1)
05/2023
Warnings and Precautions (5.2)
12/2023
INDICATIONS AND USAGE
LANTHANUM CARBONATE is a phosphate binder indicated to reduce serum
phosphate in patients with
end-stage renal disease (ESRD). (1)
DOSAGE AND ADMINISTRATION
The recommended initial total daily dose of LANTHANUM CARBONATE is
1,500 mg in divided doses.
Titrate every 2 to 3 weeks based on serum phosphate level. (2)
Take LANTHANUM CARBONATE with or immediately after meals. (2)
Chew or crush tablet completely before swallowing. (2)
DOSAGE FORMS AND STRENGTHS
LANTHANUM CARBONATE Chewable Tablets: 500 mg, 750 mg, and 1,000 mg.
(3)
CONTRAINDICATIONS
Bowel obstruction, ileus, and fecal impaction. (4)
WARNINGS AND PRECAUTIONS
Serious cases of gastrointestinal obstruction, ileus, subileus,
gastrointestinal perforation, and fecal
impaction. Risks include altered gastrointestinal anatomy,
hypomotility disorders, and concomitant
medications. Advise patients to chew or crush the tablet completely.
(5.1)
LANTHANUM CARBONATE has radio-opaque properties and, therefore, may
give the appearance typical
of an imaging agent during abdominal X-ray procedures. (5.2)
ADVERSE REACTIONS
In controlled trials, the most common adverse reactions that were more
frequent (≥5% difference vs.
placebo) in LANTHANUM CARBONATE were nausea, vomiting, and abdominal
pain. (6.1)
The following adverse reactions have been identified during
post-approval use of LANTHANUM
CARBONATE: constipation, dyspepsia, allergic skin reactions, and tooth
injury while chewing the tablet.
(6.2)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT TAKEDA PHARMACEUTICALS
AT 1-800-828-
2088 OR