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:

Cipla USA Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Lanthanum carbonate chewable tablets are 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

Product summary:

Lanthanum carbonate is supplied as chewable tablets in three dosage strengths for oral administration: 500-mg tablets, 750-mg tablets, and 1000-mg tablets. Each 500-mg chewable tablet is off-white to yellowish white, round flat faced bevel edge debossed “IG” on one side with “476” on the other. 500- mg Patient Pack (2 bottles of 45 tablets, NDC 69097-934-57, per each patient pack) NDC 69097-934-98 Each 750-mg chewable tablet is off-white to yellowish white, round flat faced bevel edge debossed “IG” on one side with “477” on the other. 750-mg Patient Pack (6 bottles of 15 tablets, NDC 69097-935-89, per each patient pack) NDC 69097-935-98 Each 1000-mg chewable tablet is off-white to yellowish white, round flat faced bevel edge debossed “IG” on one side with “478” on the other. 1000-mg Patient Pack (9 bottles of 10 tablets, NDC 69097-936-65, per each patient pack) NDC 69097-936-98 Storage- Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

LANTHANUM CARBONATE- LANTHANUM CARBONATE TABLET, CHEWABLE
Cipla USA Inc.
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MEDICATION GUIDE
LANTHANUM CARBONATE CHEWABLE TABLETS
(LAN-tha-num KAR-bo-nate)
Read this Medication Guide before you start taking lanthanum carbonate
chewable tablets 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 chewable tablets?
Lanthanum carbonate chewable tablets 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 chewable tablets 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 are lanthanum carbonate chewable tablets?
Lanthanum carbonate chewable tablets are 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 chewable tablets?
Do not take lanthanum carbonate chewable tablets if you:
•
have blocked bowels
•
have severe constipation
Lanthanum carbonate chewable tablets have not been studied in children
and adolescents under 18 years
of age.
What should I tell my healthcare provider before taking lanthanum
carbonate chewable tablets?
Lanthanum c

Summary of Product characteristics

LANTHANUM CARBONATE- LANTHANUM CARBONATE TABLET, CHEWABLE
CIPLA USA INC.
----------
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
RECENT MAJOR CHANGES
Warnings and Precautions (5.1) 05/2023
INDICATIONS AND USAGE
Lanthanum carbonate chewable tablets are 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 are 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)
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 SU