LANTHANUM CARBONATE tablet, chewable

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Lupin Pharmaceuticals, Inc.

INN (International Name):

LANTHANUM CARBONATE - UNII:O7FU5X12W5)

Composition:

LANTHANUM CATION (3+) 500 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Lanthanum carbonate chewable tablet 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 chewable tablets 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 chewable tablet 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 chewable tablets 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 chewable tablets 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 chewable tablets in this population is not recommended. Of the total number of patients in clinical studies of lanthanum carbonate chewable tablets, 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.

Product summary:

Lanthanum carbonate chewable tablets are supplied in three dosage strengths as lanthanum for oral administration: 500 mg tablets, 750 mg tablets, and 1000 mg tablets.   Lanthanum carbonate chewable tablets, 500 mg (as lanthanum) are white to off white round shaped tablets debossed ‘NAT’ on one side and ‘500’ on other side, supplied in patient pack (2 bottles of 45 chewable tablets each NDC 68180-819-52) NDC 68180-819-42. Lanthanum carbonate chewable tablets, 750 mg (as lanthanum) are white to off white round shaped tablets debossed ‘NAT’ on one side and ‘750’ on other side, supplied in patient pack (6 bottles of 15 chewable tablets each NDC 68180-820-53) NDC 68180-820-46. Lanthanum carbonate chewable tablets, 1000 mg (as lanthanum) are white to off white round shaped tablets debossed ‘NAT’ on one side and ‘1000’ on other side, supplied in patient pack (9 bottles of 10 chewable tablets each  NDC 68180-821-10) NDC 68180-821-47. Storage and Handling Store lanthanum carbonate chewable tablets  at 25ºC (77ºF): excursions permitted to 15º to 30˚C (59º to 86ºF). [See USP controlled room temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LANTHANUM CARBONATE - LANTHANUM CARBONATE TABLET, CHEWABLE
LUPIN PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LANTHANUM CARBONATE
CHEWABLE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR LANTHANUM
CARBONATE CHEWABLE TABLETS.
LANTHANUM CARBONATE CHEWABLE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2004
INDICATIONS AND USAGE
Lanthanum carbonate chewable tablet 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
chewable tablets is 1,500 mg in
divided doses. Titrate every 2 to 3 weeks based on serum phosphate
level. (2)
Take lanthanum carbonate chewable tablets with or immediately after
meals. (2)
Lanthanum carbonate chewable tablets: Chew or crush tablet completely
before swallowing. (2)
Consider powder formulation in patients with poor dentition or who
have difficulty chewing tablets (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 chewable tablets have 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 chewable tablets were nausea,
vomiting, and abdominal pain. (6.1)
The following adverse reactions have been identified during
post-approval use of lanthanum carbonate
chewable tablets: consti