Penicillamine (Page 5 of 5)

Maintenance Therapy

The maintenance dosage of penicillamine capsules must be individualized, and may require adjustment during the course of treatment. Many patients respond satisfactorily to a dosage within the 500 to 750 mg/day range. Some need less.

Changes in maintenance dosage levels may not be reflected clinically or in the erythrocyte sedimentation rate for 2 to 3 months after each dosage adjustment.

Some patients will subsequently require an increase in the maintenance dosage to achieve maximal disease suppression. In those patients who do respond, but who evidence incomplete suppression of their disease after the first 6 to 9 months of treatment, the daily dosage of penicillamine capsules may be increased by 125 mg or 250 mg/day at 3-month intervals. It is unusual in current practice to employ a dosage in excess of 1 g/day, but up to 1.5 g/day has sometimes been required.

Management of Exacerbations

During the course of treatment some patients may experience an exacerbation of disease activity following an initial good response. These may be self-limited and can subside within 12 weeks. They are usually controlled by the addition of non-steroidal anti-inflammatory drugs, and only if the patient has demonstrated a true “escape” phenomenon (as evidenced by failure of the flare to subside within this time period) should an increase in the maintenance dose ordinarily be considered.

In the rheumatoid patient, migratory polyarthralgia due to penicillamine is extremely difficult to differentiate from an exacerbation of rheumatoid arthritis. Discontinuance or a substantial reduction in dosage of penicillamine capsules for up to several weeks will usually determine which of these processes is responsible for the arthralgia.

Duration of Therapy

The optimum duration of therapy with penicillamine capsules in rheumatoid arthritis has not been determined. If the patient has been in remission for 6 months or more, a gradual, stepwise dosage reduction in decrements of 125 mg or 250 mg/day at approximately 3-month intervals may be attempted.

Concomitant Drug Therapy

Penicillamine Capsules should not be used in patients who are receiving gold therapy, antimalarial or cytotoxic drugs, oxyphenbutazone, or phenylbutazone (see PRECAUTIONS). Other measures, such as salicylates, other non-steroidal anti-inflammatory drugs, or systemic corticosteroids, may be continued when penicillamine is initiated. After improvement commences, analgesic and anti-inflammatory drugs may be slowly discontinued as symptoms permit. Steroid withdrawal must be done gradually, and many months of treatment with penicillamine capsules may be required before steroids can be completely eliminated.

Dosage Frequency

Based on clinical experience, dosages up to 500 mg/day can be given as a single daily dose. Dosages in excess of 500 mg/day should be administered in divided doses.

HOW SUPPLIED

Penicillamine Capsules USP, 250 mg are opaque ivory colored hard gelatin capsules containing white to off white powder and are imprinted with “114” and “NAV” in black ink. They are supplied as follows:

NDC 68475-201-01 in bottles of 100.

Storage

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tightly closed container. Keep container tightly closed.

Manufactured for:

Navinta LLC

1499 lower Ferry Road, Ewing,

NJ 08618

Made in India

Rev. 10/2021

31141021 R0

** For quantitative test for serum ceruloplasmin see: Morell, A.G.; Windsor, J.; Sternlieb, I. ; Scheinberg, I.H.: Measurement of the concentration of ceruloplasmin in serum by determination of its oxidase activity, in “Laboratory Diagnosis of Liver Disease”, F.W. Sunderman; F.W. Sunderman, Jr. (eds.), St. Louis, Warren H. Green, Inc., 1968, pp. 193-195.

*** Scheinberg, I.H.; Sternlieb, I.: N. Engl. J. Med. 293: 1300-1302, Dec. 18, 1975.

† Lotz, M.; Potts, J.T. and Bartter, F.C.: Brit. Med. J. 2: 521, Aug. 28, 1965 (in Medical Memoranda).

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68475-201-01

Rx only

Penicillamine Capsules,

USP

250 mg

100 Capsules

Navinta LLC

fig
(click image for full-size original)
PENICILLAMINE
penicillamine capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68475-201
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PENICILLAMINE (PENICILLAMINE) PENICILLAMINE 250 mg
Inactive Ingredients
Ingredient Name Strength
ALCOHOL
AMMONIA
BUTYL ALCOHOL
D&C YELLOW NO. 10
FERROSOFERRIC OXIDE
GELATIN
ISOPROPYL ALCOHOL
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POTASSIUM HYDROXIDE
PROPYLENE GLYCOL
SHELLAC
TITANIUM DIOXIDE
WATER
Product Characteristics
Color WHITE (ivory) Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code NAV;114
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68475-201-01 100 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA214363 01/01/2022
Labeler — Navinta LLC (130443810)
Registrant — Navinta LLC (130443810)
Establishment
Name Address ID/FEI Operations
Apothecon Pharmaceuticals Pvt Ltd 650468064 MANUFACTURE (68475-201)

Revised: 12/2022 Navinta LLC

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2024. All Rights Reserved.